http://www.clinicaltrials.gov/ct/show/NCT00091689?order=1 3M Pharmaceuticals Study 1501-852A is a Phase 1 Study with the objective of determining safety and the highest tolerated dose of an immune response modifier cream directly applied to advanced, inoperable, melanoma skin lesions. The study will also measure blood levels of the drug and examine the potential anti-tumor activity of the cream. Melanoma Drug:852A Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Study start:September 2004
http://www.clinicaltrials.gov/ct/show/NCT00095160?order=2 3M Pharmaceuticals Study 1493-852A is a phase 1 study with the primary objective of determining safety and the highest tolerated dose of an experimental immune response modifier administered intravenously to patients with solid organ tumors not responsive to currently available treatments. The secondary objective of the study is to monitor the tumor response to this form of treatment. Neoplasms Drug:852A Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Primary Outcomes:Safety and PharmacokineticsSecondary Outcomes:Tumor Response
http://www.clinicaltrials.gov/ct/show/NCT00077779?order=1 Abbott Laboratories The purpose of this study is to test whether Adalimumab (at two different doses) can induce and maintain clinical remission in subjects with active Crohn's disease when compared to placebo (a substance containing no medication) Crohn's Disease Drug:Adalimumab Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control Official Title:A Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Crohns Disease
http://www.clinicaltrials.gov/ct/show/NCT00062699?order=2 Abbott Laboratories To evaluate the survival benefit associated with Zemplar therapy as compared to Calcijex for the treatment of secondary hyperparathyroidism in subjects with Stage V chronic kidney disease on hemodialysis as measured by time to death. End-Stage Kidney Disease Study Type:ObservationalStudy Design:Natural History,Longitudinal,Defined Population,Prospective Study Official Title:A Phase IV, Prospective, Randomized, Active-Controlled, Double-Blind, Double-Dummy, Multi-Center Study to Evaluate the Survival Benefits of Zemplar Relative to Calcijex in Subjects with Stage V Chronic Kidney Disease on Hemodialysis
http://www.clinicaltrials.gov/ct/show/NCT00048425?order=3 Abbott Laboratories The purpose of this study is to evaluate the efficacy of a 24-hour infusion of levosimendan compared with placebo in the treatment of decompensated chronic heart failure. Heart Failure, Congestive Drug:Levosimendan Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00085644?order=4 Abbott Laboratories The objective of this study is to evaluate the safety and efficacy of adalimumab 40mg every other week (eow) compared to placebo in subjects with active ankylosing spondylitis (AS) who have had an inadequate response to or intolerance to one or more non-steroidal anti-inflammatory drugs (NSAID) and who may have additionally failed one or more disease-modifying anti-rheumatic drug (DMARD) therapy. Ankylosing Spondylitis Drug:Adalimumab (D2E7) Phase III Study Type:InterventionalStudy Design:Treatment,Safety/Efficacy Study Official Title:A Phase 3 Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Active Ankylosing Spondylitis
http://www.clinicaltrials.gov/ct/show/NCT00093301?order=5 Wentworth Area Health Services The purpose of the study is to compare the efficacy of levosimendan with that of dobutamine in patients with unstable hemodynamics (shock). Cardiogenic ShockSeptic Shock Drug:LevosimendanDrug:Dobutamine Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Efficacy Study Official Title:Efficacy of Levosimendan in the Critically Ill Patients with Unstable Hemodynamics (the LICI study) - A Double Blind Randomized Pilot Study
http://www.clinicaltrials.gov/ct/show/NCT00048542?order=6 Abbott Laboratories This is a multicenter, Phase III randomized, placebo-controlled study in which polyarticular JRA subjects who are either MTX treated or non-MTX treated will initially receive Adalimumab by subcutaneous injection every other week for a four-month open-label lead-in period. Subjects who respond to the open-label therapy will then be rolled over into the double-blind portion of the study and will be randomized to receive either adalimumab or placebo for an additional 32 weeks or until flare of disease, whichever is earlier. Subjects who experience disease flare during the double-blind portion of the study or subjects who complete 48 weeks of the study will be given the option to receive open-label treatment with adalimumab for an additional 44 weeks. Arthritis, Juvenile Rheumatoid Drug:Adalimumab/anti-TNF alfa Phase III Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00067262?order=7 Abbott Laboratories The purpose of this study is to determine the safety and effectiveness of Depakote ER (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and adolescents ages 10-17 years. Bipolar Disorder Drug:Divalproex Sodium Extended-Release Tablets Phase III Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00061672?order=8 Abbott Laboratories The primary objective of this study is to assess the safety and effectiveness of ABT-510 in subjects with refractory lymphoma. Lymphoma, Non-HodgkinHodgkin's Lymphoma Drug:ABT-510 - Thrombospondin-1 Mimetic Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00086671?order=9 Abbott Laboratories The objective of the trial is to study the safety and effectiveness of ABT-874 administered weekly or every other week in patients with relapsing remitting and secondary progressive multiple sclerosis as compared to placebo. Effectiveness will be measured based on MRI scans done periodically thoughout the study. Multiple SclerosisMultiple Sclerosis, Relapsing RemittingMultiple Sclerosis, Secondary Progressive Drug:ABT-874/Human monoclonal antibody against IL-12 Phase II Study Type:InterventionalStudy Design:Treatment,Safety/Efficacy Study Study start:May 2004
http://www.clinicaltrials.gov/ct/show/NCT00073138?order=10 Abbott Laboratories The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with colorectal cancer. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug. Colorectal Cancer Drug:ABT-751 Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00073151?order=11 Abbott Laboratories The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with non-small cell lung cancer. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug. Non-small cell lung cancer Drug:ABT-751 Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00063102?order=12 Abbott Laboratories The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with breast cancer after having had taxol or taxotere. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug. Breast Cancer Drug:ABT-751 Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00091481?order=13 Abbott Laboratories To show non-inferiority in the incidence rates of elevated calcium-phosphorus product between two treatment groups: 1) a group having an initial dose based on baseline PTH (baseline iPTH/80) and 2) a group having a starting dose based on body weight (0.04 mcg/kg). Kidney Failure, Chronic Drug:Zemplar Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control Official Title:A Randomized, Active-Controlled, Double-Blind Multi-center Study to Compare Initial Dosing Parameters of Zemplar in Stage V Chronic Kidney Disease Subjects on Hemodialysis
http://www.clinicaltrials.gov/ct/show/NCT00073710?order=14 Abbott Laboratories A study to investigate the effects of Zemplar and Calcijex on intestinal calcium absorption in hemodialysis subjects HypoparathyroidismHypercalcemiaChronic Kidney Disease Study Type:ObservationalStudy Design:Natural History Official Title:A Phase IV, Single-Center, Active-Controlled Cross-Over Pilot Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium
http://www.clinicaltrials.gov/ct/show/NCT00053378?order=15 Abbott Laboratories A study to determine the effect of Zemplar on the regulation of serum calcium levels and the need for administration of elemental calcium in hypocalcemic intensive care patients Hypocalcemia Drug:paricalcitol injection (Zemplar)Behavior:Effects on calcium regulationBehavior:Administration of elemental Ca during hypocalcemic ICU pts. Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Factorial Assignment,Safety/Efficacy Study Official Title:A Placebo-Controlled, Double-Blind Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects
http://www.clinicaltrials.gov/ct/show/NCT00091975?order=16 Abbott Laboratories The objective of this study is to determine the safety and efficacy of Zemplar Capsule versus placebo, in decreasing elevated intact parathyroid hormone levels in chronic kidney disease stage 5 subjects with secondary hyperparathyroidism on hemodialysis or peritoneal dialysis, while using the revised dose titration scheme. Kidney Disease Drug:Zemplar Capsule Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control Official Title:A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multi-Center Study to Evaluate the Safety and Efficacy of Zemplar Capsule in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects on Hemodialysis or Peritoneal Dialysis
http://www.clinicaltrials.gov/ct/show/NCT00061867?order=1 Celsion adenocarcinoma of the prostatestage III prostate cancerstage IV prostate cancer Drug:doxorubicin HCl liposomeProcedure:chemotherapyProcedure:hyperthermia Phase I Study Type:InterventionalStudy Design:Treatment Official Title:Phase I Study of Doxorubicin HCl Liposome and Thermal Therapy in Patients With Adenocarcinoma of the Prostate
http://www.clinicaltrials.gov/ct/show/NCT00073372?order=1 Centocor Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled trial to evaluate efficacy and safety of Abciximab in Acute Ischemic Stroke onset within 6 hour time window and subjects who wake from sleep with stroke symptoms, and in whom the planned treatment initiation is within 3 hours of awakening Stroke Drug:Abciximab Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:Abciximab(ReoPro) in Acute Ischemic Stroke: A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial
http://www.clinicaltrials.gov/ct/show/NCT00073437?order=2 Centocor Subjects eligible for this study will have a diagnosis of sarcoidosis for a least one year prior to screening and have evidence of disease on chest X-ray. Sarcoidosis must also have been proven by biopsy. Subjects must be taking a minimum of 10 mg prednisone (or equivalent dose of steroid) per day or one or more immunosuppressants (methotrexate, azathioprine, etc.) for at least the three month period immediately prior to screening. Sarcoidosis Drug:Infliximab Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Safety and Efficacy of Infliximab (Remicade) in Subjects with Chronic Sarcoidosis with Pulmonary Involvement
http://www.clinicaltrials.gov/ct/show/NCT00076726?order=3 Centocor Phase II clinical trial looking for newly diagnosed subjects with giant cell arteritis (GCA) or temporal arteritis. Standard Infliximab care. Subjects may also have polymyalgia rheumatica (PMR). Giant Cell ArteritisGranulomatous Arteritis Drug:biologic therapy Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00046228?order=4 Centocor The purpose of this medical research study is to determine whether the administration of abciximab and reteplase before patients have a coronary intervention, is safe and effective in the treatment of acute myocardial infarction compared to only abciximab given during coronary intervention. Myocardial Infarction Drug:abciximabDrug:reteplase Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Safety/Efficacy Study Official Title:A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Reteplase and Abciximab with Abciximab Alone Administered Early or Just Prior to Primary Percutaneous Coronary Intervention (PCI) for Acute Myocardial Infarction
http://www.clinicaltrials.gov/ct/show/NCT00094458?order=5 Centocor The purpose of this medical research study is to compare the efficacy of infliximab and infliximab plus azathioprine to azathioprine treatment of patients with moderate to severe Crohns Disease. Crohns Disease Drug:InfliximabDrug:Azathioprine Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Safety/Efficacy Study Official Title:Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing Remicade (infliximab) and Remicade plus Azathioprine to Azathioprine in the Treatment of Patients with Crohns Disease Nave to both Immunomodulators and Biologic Therapy
http://www.clinicaltrials.gov/ct/show/NCT00060502?order=6 Centocor Pancreatic NeoplasmsCachexia Drug:Infliximab Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Factorial Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00078312?order=1 Cephalon The primary objective of this study is to evaluate the safety and tolerability of CEP-10953 administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients with excessive sleepiness associated with a current diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS)(regular users of nasal continuous positive airway pressure [nCPAP] therapy), or chronic shift work sleep disorder (SWSD). Safety and tolerability will be evaluated throughout the study through adverse event data, clinical laboratory test evaluations, vital sign measurements, electrocardiography, and physical examination findings. NarcolepsySleep Apnea, ObstructiveSleep Apnea SyndromesShift-Work Sleep Disorder Drug:CEP-10953 Phase III Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Parallel Assignment,Safety/Efficacy Study Official Title:A 12-Month, Open Label, Flexible-Dosage Study of the Safety/Efficacy of CEP 10953 in the Treatment of Excessive Sleepiness Associated With Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
http://www.clinicaltrials.gov/ct/show/NCT00078325?order=2 Cephalon The primary objective of this study is to determine whether treatment with CEP 10953 is more effective than placebo treatment for patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30-minute version) (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI-C) ratings (as related to general condition) at week 12 (or last postbaseline visit). Sleep Apnea, ObstructiveSleep Apnea Syndromes Drug:CEP-10953 Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A 12 Week, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study to Evaluate the Efficacy/Safety of CEP 10953 as Treatment for Adults With Residual Excessive Sleepiness Associated With OSA/H Syndrome
http://www.clinicaltrials.gov/ct/show/NCT00079677?order=3 Cephalon The primary objective of this study is to determine whether treatment with CEP-10953 is more effective than placebo treatment for patients with residual excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30 minute version) (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI C) ratings (as related to general condition) at week 12 (or last postbaseline visit). Obstructive Sleep ApneaSleep Hypopnea Drug:CEP-10953 Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A 12 Week, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study to Evaluate the Efficacy/Safety of CEP 10953 Treatment for Adults With Residual Excessive Sleepiness Associated With OSA/H Syndrome
http://www.clinicaltrials.gov/ct/show/NCT00078377?order=4 Cephalon The primary objective of this study is to determine whether treatment with CEP-10953 is more effective than placebo treatment for patients with excessive sleepiness associated with narcolepsy by measuring mean sleep latency from the Maintenance of Wakefulness (MWT) (20-minute version)(average of 4 naps at 0900, 1100, 1300, and 1500) and by the Clinical Global Impressions of Change (CGI-C) ratings (as related to general condition) at week 12 (or last postbasline visit) Narcolepsy Drug:CEP-10953 Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CEP-10953 (150 and 250 mg/day) as Treatment for Adults with Excessive Daytime Sleepiness Associated with Narcolepsy
http://www.clinicaltrials.gov/ct/show/NCT00080288?order=5 Cephalon The primary objective of this study is to determine whether treatment with CEP 10953 is more effective than placebo treatment for patients with excessive sleepiness associated with chronic shift work sleep disorder (SWSD) by measuring mean sleep latency from the Multiple Sleep Latency Test (MSLT) (20 minutes) and by Clinical Global Impression of Change (CGI C) ratings (for sleepiness during night shifts including the commute to and from work) at week 12 (or last postbaseline visit). Excessive SleepinessShift Work Sleep Disorder Drug:CEP-10953 Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A 12 Week, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CEP 10953 as Treatment for Adults With Excessive Sleepiness Associated With Chronic SWSD
http://www.clinicaltrials.gov/ct/show/NCT00079482?order=6 Cephalon The purpose of the study is to determine whether CEP-701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed acute myeloid leukemia (AML) who achieve a second complete remission (CR). Acute Myeloid Leukemia Drug:lestaurtinib Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Randomized, Open-Label Study of Oral CEP-701 Administered in Sequence With Standard Chemotherapy to Patients With Relapsed Acute Myeloid Leukemia (AML) Expressing FLT-3 Activating Mutations
http://www.clinicaltrials.gov/ct/show/NCT00081601?order=7 Cephalon The purpose of this study is to determine the proportion of patients with a serological prostate specific antigen (PSA) by day 85. Prostate Cancer Drug:CEP-701 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:An Open-Label Phase 2 Study of Oral CEP-701 in Patients With Asymptomatic Hormone-Refractory Cancer With Rising Prostate specific Antigen
http://www.clinicaltrials.gov/ct/show/NCT00087789?order=1 Ceregene This is a Phase I clinical study to assess the safety, tolerability and biologic activity of in vivo AAV-mediated delivery of CERE-110. Six subjects will receive CERE-110 in dose-escalating fashion. All subjects will receive bilateral, stereotactic injections of CERE-110 for a total of four injections to target the basal forebrain region of the brain containing the nucleus basalis of Meynert (NBM). Two doses will be administered to each of three subjects in an open-label manner. A four-week observation period will be implemented after each subject within a cohort is dosed. Three months from the time that the last subject in the first dose cohort has been dosed, escalation to the next dose will proceed if CERE-110 has been shown to be safe. All study participants will be observed for a 24-month period and then followed annually. Alzheimer's Disease Gene Transfer:CERE-110: adeno-associated virus delivery of NGF Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:A Phase I, Dose-Escalating Study to Assess the Safety and Tolerability of CERE-110 [Adeno-Associated Virus (AAV)-Based Vector-Mediated Delivery of Beta-Nerve Growth Factor (NGF)] in Subjects with Mild to Moderate Alzheimer's Disease
http://www.clinicaltrials.gov/ct/show/NCT00030355?order=1 ChemGenex Therapeutics recurrent childhood acute myeloid leukemiarecurrent adult acute myeloid leukemiaadult acute promyelocytic leukemia (M3)childhood acute promyelocytic leukemia (M3)adult acute myeloid leukemia with t(15;17)(q22;q12) Drug:homoharringtonineProcedure:chemotherapy Phase I Study Type:InterventionalStudy Design:Treatment Official Title:Phase I/II Study of Salvage Therapy Comprising Homoharringtonine in Patients With Refractory Acute Promyelocytic Leukemia
http://www.clinicaltrials.gov/ct/show/NCT00006441?order=1 The purpose of this study is to see whether taking interleukin-2 (IL-2) and other anti-HIV drugs affects the course of HIV disease in patients with primary HIV infection (the time period that immediately follows infection with HIV). After primary HIV infection, the actual infection is spread through an increasing amount of HIV virus in the body. Studies have shown that, by taking a combination of anti-HIV drugs, it is possible to reduce the amount of HIV in the body to almost undetectable levels. This study will find out if starting anti-HIV drugs during primary infection will interrupt or reduce the spread of HIV in patients' bodies. HIV Infections Drug:Lamivudine/ZidovudineDrug:Nelfinavir mesylateDrug:Aldesleukin Study Type:InterventionalStudy Design:Treatment,Open Label,Efficacy Study Official Title:A Single Center, Randomized Open Label Study of Initial Interleukin-2 Compared to Delayed Interleukin-2 When Added to Zidovudine, 3TC and Nelfinavir In Order to Modulate Immune Function and to Sustain Suppression of HIV-1 Replication Among Those Persons with Primary or Early HIV Infection
http://www.clinicaltrials.gov/ct/show/NCT00051688?order=2 Chiron Corporation The primary purpose of this study is to determine the best dose of tezacitabine when combined with oxaliplatin in patients with metastatic colorectal cancer. This study will also evaluate tumor response to the combination of anti-cancer drugs. Colorectal Neoplasms Drug:tezacitabineDrug:oxaliplatin Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00054873?order=3 Chiron Corporation The purpose of this study is to evaluate the efficacy and safety of tezacitabine when given alone or in combination with 5-fluorouracil (5-FU) to subjects who have advanced esophageal or gastric adenocarcinoma. Esophageal NeoplasmsStomach NeoplasmsAdenocarcinoma Drug:tezacitabineDrug:5-fluorouracil Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00084071?order=4 Chiron Corporation The purpose of this study is to determine whether tifacogin is effective and safe in the treatment of patients with severe community-acquired pneumonia. Pneumonia Drug:Tifacogin Phase III Study Type:InterventionalStudy Design:Treatment Official Title:Tifacogin (recombinant tissue factor pathway inhibitor) for the Treatment of Patients with Severe Community-Acquired Pneumonia
http://www.clinicaltrials.gov/ct/show/NCT00080470?order=1 Advanced Bionics Urinary Incontinence Device:battery powered bion microstimulator Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Single Blind,Placebo Control,Crossover Assignment,Safety/Efficacy Study Official Title:Battery Powered Bion Clinical Investigation: An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence
http://www.clinicaltrials.gov/ct/show/NCT00043368?order=1 Coley Pharmaceutical Group Neoplasm Metastasis Drug:CpG 7909 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study
http://www.clinicaltrials.gov/ct/show/NCT00070642?order=2 Coley Pharmaceutical Group Melanoma Drug:CPG 7909Drug:DTIC Chemotherapy Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:CPG 7909 Injection with or without Chemotherapy for the Treatment of Stage III b/c or IV Melanoma: A Randomized, Multi-Center, Open Label, Parallel Group, Active-Controlled, Phase II/III Study
http://www.clinicaltrials.gov/ct/show/NCT00043420?order=3 Coley Pharmaceutical Group Lymphoma, T-Cell, Cutaneous Drug:CpG 7909 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Phase I/II Multi-Center, Open Label Study of CpG 7909 in Patients with Cutaneous T-Cell Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00043407?order=4 Coley Pharmaceutical Group Renal Cell CancerPost Nephrectomy Drug:CpG 7909 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Phase I/II Open Label Multi-Center Study of CpG 7909 in Patients with Stage IV Renal Cell Cancer
http://www.clinicaltrials.gov/ct/show/NCT00086177?order=1 Columbia Laboratories This research study is being conducted at over 12 pregnancy research centers in the US. The study will compare an investigational treatment with a placebo (a treatment without medication). Neither the investigators nor the patients in the trial will know which treatment has been assigned. All study medications will be given vaginally once a day. Treatment will begin before pregnancy week 23 and will continue until the end of pregnancy week 36. Pregnancy Drug:8% progesterone vaginal gel Phase IV Study Type:InterventionalStudy Design:Diagnostic,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy, Safety, and Tolerability of 8% Progesterone Vaginal Gel in Preventing Preterm Delivery in Pregnant Women at Increased-Risk for Preterm Delivery
http://www.clinicaltrials.gov/ct/show/NCT00037115?order=1 MidAmerica Neuroscience Institute The participant will receive weekly intramuscular treatment with AVONEX (interferon beta 1-a) and a one-time high dose intravenous methotrexate with Leucovorin rescue, along with the standard solumedrol treatment before beginning AVONEX treatment. Demyelinating DisordersMultiple SclerosisOptic NeuritisMyelitisNeuritis Drug:interferon beta 1aDrug:methotrexateDrug:methylprednisolone Phase IV Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Single Group Assignment,Safety/Efficacy Study Official Title:An Open Label Pilot Study of Induction Therapy with a Single High Dose Bolus of Intravenous Methotrexate with Leucovorin Rescue, Prior to Initiation of AVONEX Treatment, in Patients Presenting with a First Acute Demyelinating Event: Comparison with CHAMPS results.
http://www.clinicaltrials.gov/ct/show/NCT00091741?order=1 Georgetown University The purpose of conducting this already-FDA approved Phase I clinical trial is to evaluate the safety and efficacy of etanercept (Enbrel) on the response rate in HIV-infected subjects who have failed to respond to conventional antiretroviral (HAART) therapy and for whom no alternative therapy exists. The greatest challenge faced by HIV-treating clinicians today is the management of virologic failure and metabolic complications of anti-HIV treatment. Treatment failure can occur because of non-compliance, drug discontinuation, lack of drug potency, inadequate drug plasma concentration or drug resistance. Of these, drug resistance remains the single most important reason for virological failure and rapidly limits treatment options. HIV Infection Drug:Etanercept (Enbrel) Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase I Pilot Study to Evaluate Safety and Efficacy of Etanercept (Enbrel) on the Response Rate of HIV-infected Subjects Who are in Virologic Failure and Who Have Failed to Respond to Standard Antiretroviral Therapy
http://www.clinicaltrials.gov/ct/show/NCT00090714?order=1 Corautus Genetics The purpose of this study is to determine the optimum effective dose of recombinant plasmid DNA [pVGI.1(VEGF2)] gene therapy administered using an experimental cardiac direct injection catheter (Stiletto) system needed to benefit patients with severe Angina Pectoris. Angina Pectoris Gene Transfer:pVGI.1(VEGF2) Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00086164?order=1 Corgentech The purpose of this study is to determine the effect of recipient vein pretreatment of edifoligide (E2F Decoy), compared to placebo, on graft/recipient vein stenosis in polytetrafluoroethylene (PTFE) vascular access grafts placed for hemodialysis at 6 months after enrollment. HyperplasiaChronic Renal Failure Drug:edifoligide (E2F Decoy) Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety Study Official Title:A Phase 1/2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Pilot Trial to Assess the Effect of Treatment of the Recipient Vein of a Polytetrafluoroethylene (PTFE) Vascular Access Graft with Two Concentrations of E2F Decoy as Compared to Placebo on Neointimal Hyperplasia and the Preservation of Graft Function in Patients with Chronic Renal Failure Requiring Hemodialysis
http://www.clinicaltrials.gov/ct/show/NCT00078676?order=1 Corixa Corporation The primary purpose of this trial is to compare safety and efficacy between Bexxar and Zevalin. Follicular LymphomaDiffuse Large Cell Lymphoma Drug:Bexxar - Iodine I 131 Tositumomab Therapeutic RegimenDrug:Zevalin - Ibritumomab Tiuxetan Therapeutic Regimen Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Multi-Center, Randomized, Phase III Study of Iodine I 131 Tositumomab Therapeutic Regimen versus Ibritumomab Tiuxetan Therapeutic Regimen for Patients with Relapsed or Transformed Follicular Non-Hodgkin's Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00062894?order=2 Corixa Corporation The purpose of this study is to assess the blood pharmacokinetics in patients with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's lymphoma who have received a dosimetric dose of fission-derived iodine I 131 tositumomab. Non-Hodgkin's Lymphoma Drug:Iodine I 131 Tositumomab Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Pharmacokinetics Study Official Title:A Multi-Center Study to Examine the Pharmacokinetics, Whole Body and Organ Dosimetry, and Biodistribution of Fission-Derived Iodine I 131 Tositumomab for Patients with Previously Untreated or Relapsed Follicular or Transformed Follicular Non-Hodgkin's Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00022945?order=3 Corixa Corporation The purpose of this study is to test the safety of Iodine-131 Anti-B1 Antibody followed by CHOP and to see what effects it has on patients with previously untreated mantel cell lymphoma. Mantle Cell Lymphoma Drug:Iodine-131 Anti-B1 AntibodyDrug:Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Phase II Study Of Iodine-131 Anti-B1 Antibody Plus CHOP For Patients With Previously Untreated Mantle Cell Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00062907?order=4 Corixa Corporation The purpose of this trial is to examine the safety and immunogenicity of a therapeutic vaccine regimen with recombinant DNA and adenovirus expressing L523S protein in patients with early stage non-small cell lung cancer. The vaccine regimen will consist of two fixed doses of recombinant DNA (pVAX/L523S) followed by two doses of recombinant adenovirus (Ad/L523S). The trial will evaluate the dose escalation of Ad/L523S through three cohorts of patients. Non-small cell lung cancer Vaccine:Recombinant DNA- pVAX/L523SVaccine:Recombinant adenovirus- Ad/L523S Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:Phase I Open-Label Dose Escalation Trial Evaluating The Safety And Immunogenicity Of Sequential Administration Of Recombinant DNA And Adenovirus Expressing L523S Protein In Patients With Early Stage Non-Small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00078598?order=5 Corixa Corporation A total of 506 patients, 253 per arm, will be enrolled at 30 to 40 sites in the United States and Europe. Patients will be randomly assigned to one of two treatment arms. In Arm A, patients will receive 375 mg/m2 of rituximab (US, Canada Rituxan; EU - Mabthera), given as an IV infusion once weekly for 4 weeks. In Arm B, patients will receive Iodine I 131 Tositumomab therapy. For Arm B, patients undergo a two-phase treatment. In the first phase, termed the dosimetric dose, patients will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of Tositumomab (35 mg) that has been labeled with 5 mCi (0.18 GBq) of iodine 131. Whole body gamma camera scans will be obtained three times (Day 0, Day 2, 3, or 4, and Day 6 or 7) following the dosimetric dose. Using the dosimetric data from these three imaging timepoints, the patients weight, and platelet count, a patient-specific administered activity of iodine I 131 Tositumomab (expressed in mCi or GBq) will be calculated to deliver the desired total body dose of radiation (65 or 75 cGy). In the second phase, termed the therapeutic dose, patients in Arm B will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of the patient-specific administered activity of Iodine 131conjugated Tositumomab (35 mg). Patients on study will be followed for response and safety at Week 7, Week 13, and every 3 months for the first and second years, every 6 months for the third year, and then annually for the fourth and fifth years. Patients will be followed for safety only annually for years 6-10. Non-Hodgkin's Lymphoma Drug:Rituximab or Iodine I 131 Tositumomab Therapy Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Multi-Center, Randomized, Phase III Study of Rituximab versus Iodine I 131 Tositumomab Therapy for Patients with Relapsed Follicular Non-Hodgkin's Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00054730?order=1 Cortex Pharmaceuticals Fragile X SyndromeAutism Drug:CX516 (Ampalex) Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:Effects of Ampakine CX516 (Ampalex) on Functioning in Fragile X Syndrome and Autism
http://www.clinicaltrials.gov/ct/show/NCT00061035?order=1 Cosmo Bioscience Dr. Frederick Millard, MD, Associate Clinical Professor at the UCSD Cancer Center, will be conducting a 12-week study in advanced prostate cancer patients. The study will be held at the UCSD Medical Center and will test an experimental investigational gene therapy vaccine designed to make the patient's immune system react against telomerase, an enzyme expressed in prostate cancer cells. Prostatic Neoplasms Vaccine:Transgenic Lymphocyte Immunization Vaccine (TLI) Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Single Group Assignment,Safety Study
http://www.clinicaltrials.gov/ct/show/NCT00086463?order=1 CoTherix The purpose of this study is to determine the safety and efficacy of Iloprost is safe and effective in subjects that have 'Pulmonary Arterial Hypertension' and are concurrently taking bosentan (Tracleer TM). Pulmonary Arterial HypertensionPAHPulmonary Hypertension Drug:Iloprost or placebo Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00098358?order=1 Critical Therapeutics Tissue inflammation is a major component of the acne disease process. Leukotriene B4 (LTB4) is thought to be a major player in the development of tissue inflammation. Synthesis of LTB4 is controlled by the enzyme 5-lipoxygenase. Zileuton blocks the activity of 5-lipoxygenase. This study will test the safety and efficacy of zileuton in the treatment of facial acne. Acne Vulgaris Drug:Zileuton Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Clinical Proof of Concept Study of Zileuton IR in Patients with Moderate to Severe Facial Acne Vulgaris
http://www.clinicaltrials.gov/ct/show/NCT00038766?order=1 Cytokine PharmaSciences The purpose of this study is to determine whether CNI-1493 is safe and effective in the treatment of moderate to severe Crohns Disease. Crohn Disease Drug:CNI-1493 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Efficacy Study Official Title:A Randomized, Double-Blind, Placebo-controlled study of CNI-1493 for Treatment of Moderate to Severe Crohns Disease
http://www.clinicaltrials.gov/ct/show/NCT00017511?order=1 Daiichi Pharmaceuticals Hypopharyngeal CancerLaryngeal Cancerlip and oral cavity cancermetastatic squamous neck cancer with occult primaryNasopharyngeal Canceroral complications of cancer and cancer therapyOropharyngeal Cancerparanasal sinus and nasal cavity cancerradiation toxicitySalivary Gland Cancer Drug:cevimelineProcedure:complications of therapy assessment/managementProcedure:radioprotectionProcedure:supportive care/therapy Phase III Study Type:InterventionalStudy Design:Treatment Official Title:Phase III Randomized Study of Cevimeline in Patients With Xerostomia Secondary to Radiotherapy for Cancer in the Head and Neck Region
http://www.clinicaltrials.gov/ct/show/NCT00077077?order=2 Daiichi Pharmaceuticals unspecified adult solid tumor, protocol specific Drug:DJ-927Drug:capecitabineProcedure:chemotherapy Phase I Study Type:InterventionalStudy Design:Treatment Official Title:Phase I Study of DJ-927 and Capecitabine in Patients With Locally Advanced or Metastatic Solid Tumors
http://www.clinicaltrials.gov/ct/show/NCT00080834?order=3 Daiichi Pharmaceuticals Colon CancerRectal Cancer Drug:DJ-927Procedure:chemotherapy Phase II Study Type:InterventionalStudy Design:Treatment Official Title:Phase II Study of DJ-927 as Second-Line Treatment in Patients With Progressive Locally Advanced or Metastatic Colorectal Adenocarcinoma
http://www.clinicaltrials.gov/ct/show/NCT00072228?order=4 Daiichi Pharmaceuticals unspecified adult solid tumor, protocol specific Drug:gemcitabineDrug:soblidotinProcedure:chemotherapy Phase I Study Type:InterventionalStudy Design:Treatment Official Title:Phase I Study of Soblidotin and Gemcitabine in Patients With Locally Advanced or Metastatic Solid Tumors
http://www.clinicaltrials.gov/ct/show/NCT00064220?order=5 Daiichi Pharmaceuticals adult soft tissue sarcoma Drug:soblidotinProcedure:chemotherapy Phase II Study Type:InterventionalStudy Design:Treatment Official Title:Phase II Study of Soblidotin in Patients With Advanced or Metastatic Soft Tissue Sarcoma Previously Treated With Anthracycline-Based Chemotherapy
http://www.clinicaltrials.gov/ct/show/NCT00060892?order=6 AnGes The primary purpose of this study is to assess the overall safety of different dose regimens of AMG0001 as well as evaluate the improvement of blood perfusion in subjects with critical limb ischemia (CLI). This study will also evaluate the improvement in wound healing without adverse effects on the quality of life, as well as the potential reduction of amputation, mortality and rest pain in the CLI population. Arterial Occlusive DiseasePeripheral Vascular DiseaseIschemia Gene Transfer:HGF transferred via plasmid vector Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of AMG0001 to Improve Perfusion in Critical Leg Ischemia
http://www.clinicaltrials.gov/ct/show/NCT00065442?order=1 Dendreon Prostate Cancer Vaccine:Provenge Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study Official Title:A Randomized, Double Blind, Placebo Controlled Phase 3 Trial of Immunotherapy with PA2024-loaded Autologous APCs (Provenge, APC8015) in Asymptomatic Patients with Gleason Sum less than or equal to 7, Metastatic, AIPC
http://www.clinicaltrials.gov/ct/show/NCT00058981?order=1 DeveloGen Israel, Ltd. Randomized, double-blind, parallel-group study to evaluate DiaPep0277 or placebo at baseline. Study medication will be administered at time 0, 1 and 3 months, and then every 3 months for a total of 8 administrations. The total duration of the trial is 24 months (treatment for 18 months and follow-up for an additional 6 months). Patients will be male or female between the ages of 30 and 55 years, inclusive, within 2 to 60 months of the diagnosis of diabetes mellitus. Subjects must be positive for glutamic acid decarboxylate (GAD) autoantibodies. At the Screen Visit (Visit 2), all subjects will be asked to discontinue their use of all oral antidiabetic medications with the exception of metformin. The subjects will be placed on a stable regimen of insulin and diet (plus metformin if needed). Prior to the Baseline Visit (Visit 3), diabetic control must be achieved by diet and insulin (plus metformin if needed). Diabetes, Autoimmune Drug:DiaPep277 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Safety and Tolerability as Well as the Immunological and Clinical Efficacy of Multiple Subcutaneous Doses of DiaPep277 in LADA Subjects
http://www.clinicaltrials.gov/ct/show/NCT00064649?order=1 The primary objective of this randomized clinical trial is to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride. Benign Prostatic Hyperplasia Device:Transurethral Microwave Thermotherapy (TUMT)Device:Transurethral Needle Ablation (TUNA) TherapyDrug:Finasteride and Alfuzosin Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Safety/Efficacy Study Official Title:Minimally Invasive Surgical Therapy for BPH
http://www.clinicaltrials.gov/ct/show/NCT00095368?order=1 Advancis Pharmaceutical Corporation The purpose of the this study is to evaluate the safety of efficacy of APC-111 775 mg MP tablet once daily dosing for 7 days for treating patients with strep throat. The evaluation will look to confirm if APC-111 eliminates the bacterial infection (Streptococcus pyogenes). PharyngitisTonsillitis Drug:Amoxicillin Pulsatile Release Multiparticulate Tablet (drug) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase III, Randomized, Double-Blind, Double-Dummy Multicenter Study to Evaluate the Efficacy and Safety of 775 mg APC-111 MP Tablet QD for 7 days vs Penicillin VK 250 mg QID for 10 days in Patients with Streptococcus pyogenes
http://www.clinicaltrials.gov/ct/show/NCT00004500?order=1 Meconium Aspiration Drug:Lucinactant Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Active Control,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00007657?order=1 PCI (optimal catheter-based coronary revascularization) + intensive medical therapy is superior to intensive medical therapy alone using the combined endpoint of all-cause mortality or nonfatal MI. Myocardial Ischemia Procedure:Intensive medical therapyProcedure:Percutaneous Coronary Intervention Phase III Study Type:InterventionalStudy Design:Randomized,Open Label,Uncontrolled,Single Group Assignment,Efficacy Study Official Title:Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation
http://www.clinicaltrials.gov/ct/show/NCT00057525?order=1 DynPort Vaccine Company This study will provide preliminary safety and comparative immunogenicity data for the E.coli derived rPA vaccine administered by intramuscular (IM) injection at Day 0 and Month 1.Doses will range from 5 ?g to 100 ?g rPA, and at each dose-level, rPA will either be combined with phosphate-buffered saline (PBS) or adsorbed to Alhydrogel. Anthrax Vaccine:Vaccine Phase I Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety Study Official Title:A Phase 1 Study of Safety and Immunogenicity of E. coli-Derived Recombinant Protective Antigen (rPA), a New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults
http://www.clinicaltrials.gov/ct/show/NCT00097396?order=2 DynPort Vaccine Company The purpose of this study is to evaluate the safety and tolerability of a two-dose schedule of the recombinant plague vaccine rF1V in healthy volunteers when given as an intramuscular (IM) injection at four ascending dose-levels. Pneumonic PlaguePreventive therapy Vaccine:rF1V vaccine Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:A Phase 1, Open-Label, Dose-Escalating Study to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant Plague Vaccine rF1V in Healthy Volunteers
http://www.clinicaltrials.gov/ct/show/NCT00098098?order=3 DynPort Vaccine Company The purpose of this trial is to evaluate the safety and tolerability of a two-dose regimen (Day 0 and Day 28) of recombinant Botulinum Vaccine (rBV) A/B in healthy volunteers when given intramuscularly at three ascending dosage levels by cohort and a two-dose regimen (Day 0 and Day 28) of a formulation containing only antigens at the 40 ug total immunizing protein dosage level. Recombinant Botulinum Vaccine a/B Vaccine:rBV A/B Phase I Study Type:InterventionalStudy Design:Prevention,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:A Phase 1, Open-Label, Dose-Escalating Study to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant Botulinum Vaccine A/B in Healthy Adults
http://www.clinicaltrials.gov/ct/show/NCT00078637?order=1 Eisai Medical Research Inc The purpose of this study is to determine the appropriate dose of E7820 and to evaluate its safety. NeoplasmsLymphoma, Malignant Drug:E7820 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:Phase I and Pharmacokinetic Study of E7820 after Oral Administration to Patients with Malignancy
http://www.clinicaltrials.gov/ct/show/NCT00096473?order=2 Eisai Medical Research Inc Alzheimer's DiseaseDementia Drug:Donepezil hydrochloride Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A 24 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Donepezil Hydrochloride (E2020) in Patients with Severe Alzheimer's Disease Followed by a 12 Week Open-Label Extension Period
http://www.clinicaltrials.gov/ct/show/NCT00060567?order=3 Eisai Medical Research Inc The purpose of this study is to find a safe and effective dose of E7070 when used in combination with irinotecan hydrochloride (CPT-11, Camptosar) in patients with cancer of the GI tract or lungs. Colorectal CancerColorectal CarcinomaColorectal TumorsPulmonary NeoplasmsPulmonary Cancer Drug:E7070Drug:irinotecan hydrochloride Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00046072?order=4 Eisai Medical Research Inc SepsisShock, SepticSepsis SyndromeSepticemiaInfection Drug:lipid A antagonist lyophilized powder Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety/Efficacy Study Official Title:A Double-Blind, Placebo-Controlled Study of E5564, A Lipid A Antagonist, Administered by Twice Daily Infusions in Patients with Severe Sepsis
http://www.clinicaltrials.gov/ct/show/NCT00069277?order=5 Eisai Medical Research Inc To determine the maximum tolerated dose of E7389 when administered on Day 1 of a 21-day cycle to patients with advanced solid tumors that have progressed following standard therapy or for which no standard therapy exists. Advanced Solid Tumors Drug:E7389 BOLD Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:A Phase I Dose-Finding Study of E7389 (Halichondrin B Analog) Administered Once Every Three Weeks In Patients With Advanced Solid Tumors
http://www.clinicaltrials.gov/ct/show/NCT00069264?order=6 Eisai Medical Research Inc To determine the maximum tolerated dose of E7389 in patients with advanced solid tumors that have progressed following standard therapy or for which no standard therapy exists. Advanced Solid Tumors Drug:E7389 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:A Phase I Dose-Finding Study of E7389 (Halichondrin B Analog) in Patients with Advanced Solid Tumors
http://www.clinicaltrials.gov/ct/show/NCT00080197?order=7 Eisai Medical Research Inc The purpose of this study is to determine if E7070 is an efficacious, safe, and tolerable treatment for patients with metastatic breast cancer who have failed, or could not tolerate, prior treatments with an anthracycline, a taxane, and capecitabine. Breast NeoplasmsMetastases Drug:E7070 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:An Open-label Phase II Study of E7070 in Metastatic Breast Cancer Patients Previously Treated with an Anthracycline, a Taxane, and Capecitabine
http://www.clinicaltrials.gov/ct/show/NCT00097721?order=8 Eisai Medical Research Inc The purpose of this study is to determine if E7389 is a safe and effective treatment for advanced/metastatic breast cancer. Breast Neoplasms Drug:E7389 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase II Open Label Study of E7389 (Halichondrin B Analog) in Patients with Advanced/Metastatic Breast Cancer Previously Treated with Chemotherapy Including An Anthracycline and A Taxane
http://www.clinicaltrials.gov/ct/show/NCT00078611?order=1 Elan Pharmaceuticals The purpose of this trial is to evaluate natalizumab in individuals with moderately to severely active Crohns Disease. Crohn's Disease Drug:Antegren(TM) (natalizumab) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Intravenous Antegren(TM) (natalizumab) in Subjects with Moderately to Severely Active Crohns Disease With Elevated C-Reactive Protein
http://www.clinicaltrials.gov/ct/show/NCT00083759?order=2 Elan Pharmaceuticals The purpose of this study is to determine the safety, tolerability and efficacy of natalizumab in subjects diagnosed with moderate to severe rheumatoid arthritis (RA) receiving concomitant treatment with methotrexate (MTX). It is thought that natalizumab may stop the movement of certain white blood cells, known as lymphocytes, into joint tissue. These cells are thought to cause damage in the joints leading to the symptoms of RA. Rheumatoid Arthritis Drug:Natalizumab Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase II, Multicenter, Double-blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Intravenous Antegren (natalizumab 300 mg) in Subjects with Moderate to Severe Rheumatoid Arthritis (RA) Receiving Concomitant Treatment with Methotrexate (MTX)
http://www.clinicaltrials.gov/ct/show/NCT00076544?order=3 Elan Pharmaceuticals The purpose of this open-label study is to give chronic severe pain patients with existing intrathecal pump systems access to ziconotide. Pain Drug:Ziconotide Phase III Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Expanded Access Assignment,Safety Study Official Title:An Open-Label, Long-Term, Multi-Center, Intrathecal Ziconotide (PRIALT) Effectiveness and Safety Trial (ZEST) in Patients with Chronic Severe Pain
http://www.clinicaltrials.gov/ct/show/NCT00074737?order=1 Eleos, Inc. Acute Myelogenous Leukemia Drug:EL625Drug:IdarubicinDrug:Ara-C Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Historical Control,Single Group Assignment,Safety/Efficacy Study Official Title:Open Label, Phase II Dosing Study of Ara-C Chemotherapy in Combination with EL625 and Idarubicin in Refractory and Relapsed Acute Myelogenous Leukemia (AML)
http://www.clinicaltrials.gov/ct/show/NCT00073372?order=1 Centocor Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled trial to evaluate efficacy and safety of Abciximab in Acute Ischemic Stroke onset within 6 hour time window and subjects who wake from sleep with stroke symptoms, and in whom the planned treatment initiation is within 3 hours of awakening Stroke Drug:Abciximab Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:Abciximab(ReoPro) in Acute Ischemic Stroke: A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial
http://www.clinicaltrials.gov/ct/show/NCT00087711?order=2 Eli Lilly and Company This study is a randomized Phase 3 study comparing ALIMTA and cisplatin combination to GEMZAR and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). GEMZAR plus cisplatin is currently the standard of care for NSCLC. It is thought that ALIMTA plus cisplatin may be as effective and may have fewer side effects than the standard of care. Non Small Cell Lung Carcinoma Drug:Alimta and CisplatinDrug:Gemzar and Cisplatin Phase III Study Type:InterventionalStudy Design:Treatment,Randomized Official Title:A Randomized Phase 3 Trial of Alimta (pemetrexed) and Cisplatin versus Gemzar (gemcitabine) and Cisplatin in Patients with Locally Advanced or Metastatic Non Small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00071136?order=3 Eli Lilly and Company Phase 1/2 Dose-Escalating Study of Biweekly ALIMTA and Gemcitabine in Patients with Advanced Cancer. Neoplasms Drug:AlimtaDrug:Gemzar Phase I Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00078260?order=4 Eli Lilly and Company Non-Small-Cell Lung Carcinoma Drug:pemetrexed Phase III Study Type:InterventionalStudy Design:Treatment,Open Label,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00087698?order=5 Eli Lilly and Company This study aims to determine how successful the chemotherapy regimen of Alimta(pemetrexed) plus cisplatin before surgery is at killing all the tumor so that none is left at the time of surgery. Following surgery, all eligible patients will receive radiation to the chest. How patients respond, whether the cancer returns and if so, where, will also be monitored. Pleural Neoplasms Drug:Alimta (pemetrexed) and cisplatin Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00061451?order=6 Eli Lilly and Company The purposes of this study are to determine: 1) The safety of ALIMTA plus Gemcitabine and any side effects that might be associated with the combination of these two drugs. 2) Whether ALIMTA plus Gemcitabine can help patients with non-small cell lung cancer live longer. 3) Whether ALIMTA plus Gemcitabine can make the tumor smaller or disappear, and for how long. 4) To see if patients feel better while taking ALIMTA plus Gemcitabine. Carcinoma, Non-Small-Cell Lung Drug:ALIMTA Plus Gemcitabine Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00061477?order=7 Eli Lilly and Company The purposes of this study are to determine: 1) The safety of ALIMTA plus Gemcitabine and any side effects that might be associated with the combination of these two drugs. 2) Whether ALIMTA plus Gemcitabine can help patients with mesothelioma live longer. 3) Whether ALIMTA plus Gemcitabine can make the tumor smaller or disappear, and for how long. 4) To see if patients feel better while taking ALIMTA plus Gemcitabine. Mesothelioma Drug:ALIMTA Plus Gemcitabine Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00063570?order=8 Eli Lilly and Company The purpose of the study is to determine if the two drugs can help patients feel better while causing the tumor to become smaller or disappear; evaluate the safety of giving both Alimta and Gemzar in patients with advanced breast cancer. Breast Cancer Drug:Pemetrexed (Alimta)-Investigational drugDrug:Gemcitabine (Gemzar) Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00089869?order=9 Eli Lilly and Company Study of a medication for the treatment of Schizophrenia in patients who are already taking Abilify, Risperdol, Seroquel, Zyprexia Schizophrenia Drug:Add on therapy Phase I Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00090012?order=10 Eli Lilly and Company Schizophrenia Drug:OlanzapineDrug:Quetiapine Phase IV Study Type:InterventionalStudy Design:Treatment Official Title:The Comparison of Efficacy and Safety of Continuing Olanzapine to Switching to Quetiapine in Overweight or Obese Patients with Schizophrenia and Schizoaffective Disorder
http://www.clinicaltrials.gov/ct/show/NCT00097591?order=11 Eli Lilly and Company The sponsors of this investigational drug are developing prasugrel as a possible treatment for patients with acute coronary syndrome (heart attack or chest pain) who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a balloon angioplasty). Prasugrel will be compared with clopidogrel to determine which drug is better at reducing deaths, future heart attacks, or stroke. Coronary Arteriosclerosis Drug:Prasugrel Phase III Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00088491?order=12 Eli Lilly and Company Schizophrenic Disorders Drug:Intramuscular Olanzapine Depot Phase III Study Type:InterventionalStudy Design:Treatment Official Title:A Double-Blind, Randomized Study Comparing Instramuscular Olanzapine Depot to Oral Olanzapine and Low-Dose Depot in the Maintenance Therapy of Patients With Schizophrenia
http://www.clinicaltrials.gov/ct/show/NCT00088478?order=13 Eli Lilly and Company Schizophrenia Drug:Intramuscular Olanzapine Depot Phase III Study Type:InterventionalStudy Design:Treatment Official Title:A Double-Blind, Randomized Study Comparing Intramuscular Olanzapine Depot with Placebo in the Treatment of Patients with Schizophrenia
http://www.clinicaltrials.gov/ct/show/NCT00051558?order=14 Eli Lilly and Company Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and there is an increased risk for fractures. Glucocorticoids (a type of cortisone such as prednisone) are prescribed to treat a large number of conditions such as arthritis and asthma. When taken for several months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis called "glucocorticoid-induced osteoporosis." This study will be comparing the effects of the study drug to an available drug called alendronate on glucocorticoid-induced osteoporosis. Osteoporosis Drug:Study drug or Alendronate Sodium Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Study start:November 2002; Expected completion:July 2003
http://www.clinicaltrials.gov/ct/show/NCT00071708?order=15 Eli Lilly and Company The primary objective of this study is to provide duloxetine to investigators for the treatment of patients who have previously participated in neuroscience duloxetine clinical trials and for whom effective alternative therapy is not available. Major Depressive Disorder Drug:Duloxetine Hydrochloride Phase III Study Type:InterventionalStudy Design:Treatment,Open Label Official Title:Open Label Duloxetine Compassionate Use in Patients Who Have Completed a Previous Neuroscience Duloxetine Clinical Trial
http://www.clinicaltrials.gov/ct/show/NCT00088010?order=16 Eli Lilly and Company Osteoporosis, Postmenopausal Drug:Arzoxifene Phase III Study Type:InterventionalStudy Design:Treatment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00085956?order=17 Eli Lilly and Company Postmenopausal Bone Loss Drug:Arzoxifene Phase III Study Type:InterventionalStudy Design:Prevention,Randomized
http://www.clinicaltrials.gov/ct/show/NCT00097500?order=18 Amylin Pharmaceuticals This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus injection) on beta-cell function in subjects with type 2 diabetes mellitus who have not achieved target HbA1c (<=7.0%) using metformin. Subjects will be randomly assigned to add exenatide or insulin glargine to their current antidiabetic treatment regimen for 52 weeks. Type 2 diabetes mellitus Drug:exenatideDrug:Insulin glargine Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase 3, Randomized, Open Label, Comparator Controlled, Parallel Group, Multicenter Study to Compare the Effects of Exenatide and Insulin Glargine on Beta Cell Function and Cardiovascular Risk Markers in Subjects with Type 2 Diabetes Treated with Metformin who have not Achieved Target HbA1c (<=7.0%)
http://www.clinicaltrials.gov/ct/show/NCT00079924?order=19 Eli Lilly and Company The purpose of this study is to compare treatment of postmenopausal women having osteoporosis with teriparatide alone or with teriparatide plus an antiresorptive. Postmenopausal Osteoporosis Drug:teriparatide (FORTEO) Phase IV Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00051909?order=20 Eli Lilly and Company Study of an investigational medication for the treatment of Alzheimer's Disease in patients who are not taking Aricept, Reminyl, Exelon. Alzheimer's Disease Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00088036?order=21 Eli Lilly and Company The purpose of the protocol is to evaluate the efficacy and safety of olanzapine compared with placebo in patients with Borderline Personality Disorder (BPD). Borderline Personality Disorder Drug:Olanzapine and Placebo Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Safety/Efficacy Study Official Title:Efficacy and Safety of Olanzapine in Patients with Borderline Personality Disorder: A Randomized Double-Blind Comparison with Placebo
http://www.clinicaltrials.gov/ct/show/NCT00089817?order=22 Eli Lilly and Company Patients will be randomly assigned to one of two groups. Patients in group one will receive a 1-hour infusion of cisplatin on day 1, dexamethasone by infusion or by mouth on days 1-4, and an infusion of gemcitabine on days 1 and 8. Patients in group two will receive a 24-hour continuous infusion of cisplatin on day 1, dexamethasone as in group one, and a 3-hour infusion of cytarabine twice on day 2. Treatment in both groups may be repeated every 3 weeks for up to three courses. Some patients may then have stem cells collected and will undergo autologous stem cell transplantation. They may then be randomly assigned to one of two groups. Beginning 4 weeks after transplantation, patients in group one will receive an infusion of rituximab every 2 months for up to 1 year. Patients in group two will undergo observation. Quality of life will be assessed periodically. Patients will be evaluated every 1-6 months for approximately 2 years and once a year thereafter. Lymphoma Drug:dexamethasone and cisplatin with gemcitabineDrug:dexamethasone and cisplatin with cytarabine Phase III Study Type:InterventionalStudy Design:Treatment,Randomized Official Title:Phase III Randomized Study of Gemcitabine, Dexamethasone and Cisplatin Versus Dexamethasone, Cytarabine, Cisplatin as salvage chemotherapy before Autologous Stem Cell Transplantation, with or Without Maintenance Rituximab in Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00088465?order=23 Eli Lilly and Company This is a long-term, open-label clinical study designed to enable longer-term treatment of patients completing other clinical studies with intramuscular olanzapine depot. Key objectives of the study are to: Determine how well intramuscular (IM) olanzapine depot works during long-term treatment, Evaluate the safety and tolerability of IM olanzapine depot during long-term treatment, Determine the blood levels of IM olanzapine depot in patients during long-term treatment Schizophrenic Disorders Drug:Intramuscular Olanzapine Depot Phase III Study Type:InterventionalStudy Design:Treatment,Open Label Official Title:An Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder
http://www.clinicaltrials.gov/ct/show/NCT00049764?order=24 Eli Lilly and Company Sepsis Drug:Drotrecogin alfa (activated)(recombinant human Activated Protein C) Phase III Study Type:InterventionalStudy Design:Treatment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00074828?order=25 Eli Lilly and Company LY517717 (a capsule given by mouth) is a blood thinner that may prevent blood clots from forming in the legs and may prevent those blood clots from traveling to the lungs. Leg and lung blood clots occur commonly after patients have surgery to replace a hip or knee joint. These clots often occur while patients are in bed in the hospital after hip or knee joint surgery. The purpose of this study is to test if different dose strengths (amount of drug in the capsules) of LY517717 can prevent blood clots from forming and to determine if LY517717 is safe. This study will compare LY517717 to enoxaparin, another blood thinner. Enoxaparin is one of the standard medications given after hip or knee joint surgery. Total Knee ReplacementTotal Hip Replacement Drug:LY517717 Phase II Study Type:InterventionalStudy Design:Prevention Official Title:Comparison of a New Oral Anticoagulant Therapy to a Marketed Injectable Anticoagulant Therapy for the Prevention of Blood Clots Following Hip or Knee Replacement Surgery
http://www.clinicaltrials.gov/ct/show/NCT00094549?order=26 Eli Lilly and Company The goals of this study are: A. To determine whether olanzapine can help patients with bipolar disorder who currently have mild to moderate mania. B. To assess the safety of olanzapine and any side effects that might be associated with it, as well as the quality of life and functioning of patients treated with olanzapine. C. To assess how olanzapine compares to divalproex. Bipolar Disorder Drug:OlanzapineDrug:Divalproex Phase IV Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00091650?order=27 Eli Lilly and Company The goals of this study are to determine: the safety of olanzapine and any side effects that might be associated with it, how olanzapine compares to placebo, whether olanzapine can help patients with symptoms of Borderline Personality Disorder (BPD), and how much olanzapine should be given to patients. Borderline Personality Disorder Drug:Olanzapine and Placebo Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Safety/Efficacy Study Official Title:Efficacy and Safety of Olanzapine in Patients with Borderline Personality Disorder: A Randomized Flexible Dose Double-Blind Comparison with Placebo
http://www.clinicaltrials.gov/ct/show/NCT00088205?order=28 Eli Lilly and Company The purposes of this study are to determine the safety of oral enzastaurin HCl and any side effects that might be associated with it and whether enzastaurin HCl can help patients with Mantle Cell Lymphoma. Mantle-Cell Lymphoma Drug:Enzastaurin HCl Phase II Study Type:InterventionalStudy Design:Treatment,Safety/Efficacy Study Official Title:A Phase 2 Study of Oral Enzastaurin HCl in Patients with Relapsed Mantle Cell Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00094640?order=29 Eli Lilly and Company The goals of this study are to: Determine the blood levels of intramuscular (IM) olanzapine depot in patients at different points in time after an injection, and compare these levels to the amount of olanzapine in the blood of patients after treated by oral administration with Zyprexa (olanzapine) tablets or by intramuscular administration with Zyprexa IntraMuscular (olanzapine for injection). SchizophreniaSchizoaffective Disorder Drug:Intramuscular Olanzapine Depot Phase I Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00049777?order=30 Eli Lilly and Company The purpose of this study is to evaluate the relative efficacy and safety of prophylactic heparin co-administration during Xigris infusion in the treatment of severe sepsis in the adult. Sepsis Drug:Drotrecogin Alfa (Activated)Drug:Unfractionated heparinDrug:Low molecular weight heparin Phase IV Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00090519?order=31 Eli Lilly and Company The purpose of this study is to determine if ruboxistaurin can help slow the worsening of an eye disease called macular edema in patients with diabetes. Diabetic Retinopathy Drug:Ruboxistaurin Phase III Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00097383?order=32 Eli Lilly and Company This is a non-randomized Phase 2 portion of a study testing ALIMTA and epirubicin in combination for locally advanced or metastatic breast cancer. Epirubicin is a well-established drug for the therapy of breast cancer. Both ALIMTA and epirubicin have been combined with other drugs but they have not yet been combined with each other. It is expected that the patient will benefit from the different mechanisms of action of the two drugs. Breast Cancer Drug:ALIMTA plus Epirubicin Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized Official Title:A Phase 2 Study of Alimta and Epirubicin Administered Every 21 Days in Patients with Locally Advanced or Metastatic Breast Cancer
http://www.clinicaltrials.gov/ct/show/NCT00035321?order=33 Eli Lilly and Company Depressive Disorders Drug:OlanzapineDrug:Fluoxetine Phase III Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00088049?order=34 Eli Lilly and Company The purpose of the protocol is to evaluate the efficacy of olanzapine compared with Aripiprazole in patients with schizophrenia. Schizophrenia Drug:OlanzapineDrug:Aripiprazole Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00042666?order=35 Eli Lilly and Company This study will measure the effectiveness and any side effects of LY317615 in patients with Diffuse large B-cell lymphoma ( a sub-type of Non-Hodgkins Lymphoma). Non-Hodgkin's Lymphoma Drug:LY317615 Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00055250?order=36 Eli Lilly and Company The purpose of this study is to determine the effectiveness and side effects of LY293111 given in combination with gemcitabine (Gemzar) in patients with pancreatic cancer. Pancreatic Cancer Drug:GemzarDrug:LY293111 Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00079872?order=37 Eli Lilly and Company Colorectal Cancer Drug:PemetrexedDrug:IrinotecanDrug:LeucovorinDrug:5-Fluorouracil Phase II Study Type:InterventionalStudy Design:Treatment,Randomized Official Title:A Randomized Phase 2 Trial for First-Line Treatment of Colorectal Cancer
http://www.clinicaltrials.gov/ct/show/NCT00081627?order=1 Adventrx Pharmaceuticals Colon CancerRectal Cancer Drug:CoFactor and 5FU Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Single Group Assignment,Safety/Efficacy Study Official Title:COFU:A Multi-Center Phase II Clinical Trial to Evaluate the Safety and Efficacy of Weekly Treatment with CoFactor and 5-Fluorouracil in Patients with Metastatic Colorectal Carcinoma
http://www.clinicaltrials.gov/ct/show/NCT00093964?order=1 EMD Pharmaceuticals Glioblastoma Multiforme Drug:EMD 121974 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Multicenter, Open-label, Randomized, Uncontrolled, Phase IIa Trial in Subjects with Recurrent Glioblastoma Multiforme to Investigate the Clinical Activity, Safety, and Tolerability of EMD 121974 Administered as a Single Agent in Doses of 500 mg and 2000 mg
http://www.clinicaltrials.gov/ct/show/NCT00073541?order=2 EMD Pharmaceuticals EMD 72000 is an experimental, biological drug. Studies in animals indicate that EMD 72000 blocks a factor found on the surface of many cancer cells. The factor is called epidermal growth factor receptor or EGFR. One type of cancer which frequently contains EGFR is ovarian cancer. This study will test the safety and effects of EMD 72000 in subjects with EGFR-positive recurrent ovarian cancer following standard treatment that has failed. Ovarian Cancer Drug:EMD 72000 Phase II Study Type:InterventionalStudy Design:Treatment,Open Label,Safety/Efficacy Study Official Title:An Open-Label Phase II Study in Subjects with Recurrent EGFR-Positive Ovarian Cancer to Investigate the Safety and Efficacy of EMD 72000 Administered as a Single Agent
http://www.clinicaltrials.gov/ct/show/NCT00039858?order=1 GlaxoSmithKline The purpose of this study is to evaluate the safe and effective dose of Argatroban for prophylaxis and/or treatment of thrombosis in pediatric patients with current or previous diagnosis of heparin-induced thrombocytopenia (HIT) and thrombosis syndrome (HITTS), or who in the opinion of the investigator require alternative anticoagulation due to an underlying condition. ThrombocytopeniaThrombosis Drug:Argatroban Phase IV Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00053716?order=1 Endovasc This is the first clinical research trial in which intravenous Prostaglandin E1 (PGE1 is a vasoactive hormone) will be used as supportive treatment along with the angioplasty procedure to treat or open up a blocked artery within one lower limb or the most affected of two limbs in subjects with Peripheral Arterial Occlusive Disease. Peripheral Vascular Disease Drug:Liprostin [liposomal Prostaglandin E1] Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Expanded Access Assignment,Safety/Efficacy Study Official Title:Phase II, Single Center, Non-Controlled, Open-Label Study of Liposomal Prostaglandin E1 (Liprostin) as Adjunct Therapy with Lower Limb Angioplasty in Patients with Ischemic and Non-Ischemic Peripheral Arterial Occlusive Disease
http://www.clinicaltrials.gov/ct/show/NCT00049790?order=1 EntreMed The purpose of this study is to determine the safety and efficacy of rhAngiostatin protein administered in combination with paclitaxel and carboplatin to patients with non-small-cell lung cancer. Carcinoma, Non-Small-Cell Lung Drug:recombinant human Angiostatin proteinDrug:paclitaxelDrug:carboplatin Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00080002?order=1 Enzon The purpose of this study is to evaluate the safety and efficacy of pegamotecan (PEG-camptothecin) in patients with pathologically-diagnosed locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction who have relapsed or progressed following one prior chemotherapy treatment regimen. Cancer of StomachGastroesophageal Cancer Drug:Pegamotecan Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Effectiveness and Safety Study of Pegamotecan (PEG-Camptothecin) in Patients with Locally Advanced or Metastatic Cancer of the Stomach or Gastroesophageal Junction Who Have Relapsed or Progressed Following a Previous Chemotherapy Treatment
http://www.clinicaltrials.gov/ct/show/NCT00035919?order=1 Gordon, Erlinda, M.D. This is a Phase I safety study of a gene transfer drug for colorectal cancer that has spread to the liver. The main purpose of this study is to determine if it is safe to give this new intervention to persons with cancer, but we will also look for indications that the drug is effective. Although the findings in animals that have cancer are encouraging, this is the first time humans will receive this experimental gene transfer drug. A gene called cyclin G1 has been shown to play a very important part in cancer growth. In animal experiments, a genetically modified virus (or vector)carrying a modified cyclin G1 gene caused the cancerous tumors to grow much slower or even die. In this safety study, the drug will be injected through the liver artery to get it near the cancer that has spread to the liver. The way the gene gets into the cancer cells is by using a targeted vector that concentrates in the area of the cancer to improve the delivery of the killing gene into cancer cells. The vector we are using is a virus that has been changed so that the infectious genes have been removed and instead carries the modified cyclin G1 gene. Colorectal Neoplasms Gene Transfer:Mx-dnG1 Retroviral Vector Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Tumor Site Specific Phase I Evaluation of Safety of Hepatic Arterial Infusion of a Matrix-Targeted Retroviral Vector Bearing a Dominant Negative Cyclin G1 Construct as Intervention for Colorectal Carcinoma Metastatic to Liver
http://www.clinicaltrials.gov/ct/show/NCT00086528?order=1 Exelixis Cancer Drug:XL647 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally to Subjects with Solid Tumors
http://www.clinicaltrials.gov/ct/show/NCT00090025?order=2 Exelixis The main purpose of this study is to determine if XL119 is more effective than the combination of 5-fluorouracil (5FU) and leucovorin (LV) in prolonging the survival of subjects with advanced biliary tumors. Biliary Tract Cancer Drug:XL119Drug:5-Fluorouracil and Leucovorin Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Single Blind,Active Control,Parallel Assignment,Efficacy Study Official Title:A Phase 3 Multicenter, Single-Blind, Randomized Study of XL119 Versus 5-Fluorouracil (5-FU) plus Leucovorin (LV) in Subjects with Advanced Biliary Tumors Not Amenable to Conventional Surgery
http://www.clinicaltrials.gov/ct/show/NCT00085852?order=1 Aeris Therapeutics The purpose of this study is to determine whether the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System is safe in patients with advanced emphysema. Pulmonary Emphysema Procedure:Aeris BLVR TreatmentDrug:Aeris BLVR TreatmentDevice:Aeris BLVR Treatment Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:A Single-center, Non-blinded, Non-randomized, Non-controlled Phase 1 Trial Assessing the Safety of the Aeris Therapeutics Bronchoscopic Lung Volume Reduction (BLVR) System in Patients with Advanced Heterogeneous Emphysema
http://www.clinicaltrials.gov/ct/show/NCT00012324?order=1 Eximias Pharmaceutical localized unresectable adult primary liver canceradvanced adult primary liver cancerrecurrent adult primary liver canceradult primary hepatocellular carcinoma Drug:doxorubicinDrug:nolatrexed dihydrochlorideProcedure:chemotherapy Phase III Study Type:InterventionalStudy Design:Treatment Official Title:Phase III Randomized Study of Nolatrexed Dihydrochloride Versus Doxorubicin in Patients With Unresectable or Recurrent Hepatocellular Carcinoma
http://www.clinicaltrials.gov/ct/show/NCT00088192?order=1 Eyetech Pharmaceuticals To provide Pegaptanib sodium injection to patients with subfoveal choroidal neovascularization (CNV) secondary to AMD, who are unable to participate in any of the Sponsors other clinical studies with this drug for AMD, until such time as the patients lesion is considered to have resolved or stabilized in the opinion of the treating ophthalmologist, or product becomes commercially available. Macular Degeneration Drug:pegaptanib sodium Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:An Open Label, Non-Comparative Protocol for use of Intravitreous Pegaptanib Sodium Injection Every 6 Weeks in Patients with Exudative Age-Related Macular Degeneration (AMD)
http://www.clinicaltrials.gov/ct/show/NCT00088283?order=2 Eyetech Pharmaceuticals Macular Degeneration Drug:pegaptanib sodium Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase II Randomized, Dose-ranging, Double-masked, Multi-center Trial, in Parallel Groups, Determining Safety, Efficacy and PK of Intravitreous Injections of Pegaptanib Sodium Compared to Sham Injection for 30 weeks in Patients with Recent Vision Loss due to Macular Edema Secondary to CRVO
http://www.clinicaltrials.gov/ct/show/NCT00087763?order=3 Eyetech Pharmaceuticals The purpose of this study is to determine if Macugen reduces foveal thickness and improves vision in patients with wet AMD. Macular Degeneration Drug:Macugen (pegaptanib sodium injection) Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Factorial Assignment,Safety/Efficacy Study Official Title:A Phase II Prospective, Randomized, Double-masked, Sham-controlled, Dose-ranging, Multi-center Trial to Assess the Effect of Pegaptanib Sodium on Foveal Thickening in Patients with Exudative Subfoveal Age-related Macular Degeneration (AMD)
http://www.clinicaltrials.gov/ct/show/NCT00053001?order=1 Fallon Clinic de novo myelodysplastic syndromessecondary myelodysplastic syndromespreviously treated myelodysplastic syndromesAnemiaatypical chronic myeloid leukemiamyelodysplastic/myeloproliferative disease, unclassifiable Drug:epoetin alfaDrug:thalidomideProcedure:anti-cytokine therapyProcedure:antiangiogenesis therapyProcedure:biological response modifier therapyProcedure:growth factor antagonist therapyProcedure:hematologic toxicity attenuationProcedure:non-specific immune-modulator therapyProcedure:supportive care/therapy Phase II Study Type:InterventionalStudy Design:Treatment Official Title:Phase II Study of Thalidomide and Epoetin alfa for the Treatment of Anemia in Patients With Low- or Intermediate-Risk Myelodysplastic Syndromes
http://www.clinicaltrials.gov/ct/show/NCT00089115?order=1 Favrille grade 1 follicular lymphomagrade 2 follicular lymphomagrade 3 follicular lymphoma Drug:autologous immunoglobulin idiotype-KLH conjugate vaccineDrug:rituximabDrug:sargramostimProcedure:antibody therapyProcedure:biological response modifier therapyProcedure:colony-stimulating factor therapyProcedure:cytokine therapyProcedure:monoclonal antibody therapyProcedure:tumor cell derivative vaccineProcedure:vaccine therapy Phase III Study Type:InterventionalStudy Design:Treatment Official Title:Phase III Randomized Study of Idiotype-KLH Conjugate Vaccine and Sargramostim (GM-CSF) Versus Placebo and Sargramostim (GM-CSF) Following Treatment with Rituximab in Patients with Grade 1, 2, or 3 Follicular B-Cell Non-Hodgkin's Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00030277?order=1 Focus Surgery stage I prostate cancerstage II prostate cancerrecurrent prostate cancer Procedure:hyperthermiaProcedure:thermal ablation therapy Phase I Study Type:InterventionalStudy Design:Treatment Official Title:Phase I Study of High-Intensity Focused Ultrasound Using the Sonablate System in Patients With Locally Recurrent Prostate Cancer
http://www.clinicaltrials.gov/ct/show/NCT00097942?order=1 Forest Laboratories Standard antipsychotic drug regimens do not fully address the impact of cognitive symptoms associated with schizophrenia. The NMDA receptor has been connected to the pathophysiology of schizophrenia. Memantine is an uncompetitive NMDA receptor antagonist. It is hypothesized that adjunctive therapy with memantine will reduce NMDA receptor hyperactivity, improving signal to noise ratio and thereby improving cognitive symptoms. Schizophrenia Drug:memantine HCl Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine as Adjunctive Treatment to Atypical Antipsychotics in Schizophrenia Patients with Persistent Residual Symptoms
http://www.clinicaltrials.gov/ct/show/NCT00097916?order=2 Forest Laboratories About 65% of patients with severe Alzheimer's Disease (AD) will have symptoms of agitation. There are drawbacks associated with the currently available therapeutic interventions for agitation associated with Alzheimer's Disease. In a recent trial, in the group of patients with moderate to severe AD treated with memantine, there were fewer incidences of agitation. It is hypothesized that memantine will be effective in reducing the symptoms of agitation associated with moderate to severe Alzheimer's Disease. Alzheimer's Disease Drug:memantine HCl Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine in Non-Institutionalized Agitated Patients with Moderate to Severe Alzheimer's Disease
http://www.clinicaltrials.gov/ct/show/NCT00090116?order=3 Forest Laboratories Memory loss and difficulties with thinking associated with Alzheimer's disease may be due to chronic release of a brain chemical called glutamate. Glutamate helps transmit messages between nerve cells through interaction with a certain type of receptor (N-methyl-D-aspartate, NMDA) on the cell. Neramexane is a new drug that blocks the effects of excessive glutamate at the receptor (NMDA receptor antagonist). Alzheimer's Disease Drug:Neramexane Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized, Double-Blind,Placebo-Controlled Evaluation of the Safety and Efficacy of Neramexane Monotherapy in Patients with Moderate to Severe Dementia of the Alzheimer's Type
http://www.clinicaltrials.gov/ct/show/NCT00098124?order=4 Forest Laboratories Antidepressants of all varieties represent a common form of therapy for many chronic states including fibromyalgia. The majority of antidepressants increase the levels of serotonin or norepinephrine in the central nervous system. Milnacipran is a dual norepinephrine and serotonin reuptake inhibitor and may be effective in the treatment of fibromyalgia. Fibromyalgia Drug:milnacipran hydrochloride Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase III Pivotal, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Milnacipran for the Treatment of Fibromyalgia
http://www.clinicaltrials.gov/ct/show/NCT00087724?order=1 Fujisawa Healthcare, Inc. The purpose of this study is to evaluate the safety and efficacy of five fixed dosage levels of FK962 or placebo for 24 weeks in subjects with mild to moderate Alzheimer's disease. Patient visits are every six weeks with limited efficacy measurements at week 6 and 18. Alzheimer's Disease Drug:FK962 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study to Evaluate the Safety and Efficacy of FK962 in Subjects with Mild to Moderate Alzheimer's Disease
http://www.clinicaltrials.gov/ct/show/NCT00087724?order=1 Fujisawa Healthcare, Inc. The purpose of this study is to evaluate the safety and efficacy of five fixed dosage levels of FK962 or placebo for 24 weeks in subjects with mild to moderate Alzheimer's disease. Patient visits are every six weeks with limited efficacy measurements at week 6 and 18. Alzheimer's Disease Drug:FK962 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study to Evaluate the Safety and Efficacy of FK962 in Subjects with Mild to Moderate Alzheimer's Disease
http://www.clinicaltrials.gov/ct/show/NCT00094120?order=1 Genaera Corporation Age-Related Macular Degeneration (AMD) is a degenerative disease of the retina that causes a progressive loss of central vision. AMD is the leading cause of legal blindness among adults age 50 or older in the Western world. AMD presents in two different types - "dry" and the more severe "wet" form. Wet AMD is caused by the growth of abnormal blood vessels in the macula. Squalamine lactate is an investigational drug that may prevent the growth of these abnormal blood vessels. This study will test the safety and efficacy of Squalamine when administered with verteporfin therapy in patients with "wet" AMD. Macular Degeneration Drug:MSI-1256F (Squalamine Lactate) Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:Safety and Efficacy of MSI-1256F (Squalamine Lactate) in Combination with Verteporfin in Patients with "Wet" Age-Related Macular Degeneration (AMD)
http://www.clinicaltrials.gov/ct/show/NCT00089830?order=2 Genaera Corporation Age-Related Macular Degeneration (AMD) is a degenerative eye disease of the retina that causes a progressive loss of central vision. AMD is the leading cause of legal blindness among adults age 50 or older in the Western world. AMD presents in two different types - "dry" and the more severe "wet" form. Wet AMD is caused by the growth of abnormal blood vessels in the macula. Squalamine lactate is an investigational drug that may prevent the growth of these abnormal blood vessels. This study will test the safety and efficacy of Squalamine in the treatment of AMD. Macular Degeneration Drug:MSI-1256F (Squalamine Lactate) Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00082511?order=1 Genelabs Technologies Open label safety and efficacy follow-up. Systemic Lupus Erythematosus Drug:Prasterone (GL701) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Multi-Center, Open-Label Study to Assess the Durability and Safety of the Prevention of Bone Loss by Treatment with GL701 (Prestara) in Women with Systemic Lupus Erythematosus Receiving Treatment with Glucocorticoids
http://www.clinicaltrials.gov/ct/show/NCT00097526?order=1 Genentech This study is a multicenter, open-label, postmarketing surveillance study. The substudy will collect information on BMD in adolescents and young adults with GHD or Turner syndrome who are completing growth hormone (GH) treatment for statural indications. Dwarfism, PituitaryTurner Syndrome Drug:Nutropin [somatropin (rDNA origin) for injection]Drug:Nutropin AQ [somatropin (rDNA origin) injection]Drug:Protropin [somatrem for injection] Phase IV Study Type:ObservationalStudy Design:Natural History,Longitudinal,Defined Population,Prospective Study Official Title:Bone Mineral Density in Adolescent Subjects with Growth Hormone Deficiency Who Are Completing Treatment with Nutropin AQ, Nutropin, or Protropin in the National Cooperative Growth Study (NCGS)
http://www.clinicaltrials.gov/ct/show/NCT00038402?order=2 M.D. Anderson Cancer Center The purpose of this study is to evaluate the addition of Herceptin to standard chemotherapy treatment of patients newly diagnosed with operable breast cancer. Other objectives: 1)to evaluate the potential of this therapy to reduce the size of the tumor and increase the possibility of breast conservative surgery, 2) evaluate the ability of this regimen to prevent recurrence of breast cancer and impact on survival, 3) determine side effect profile with the addition of Herceptin, 4) evaluate significance of HER2 expression by two different methods, and 5) determine correlation of cardiac blood tests with echocardiogram results in the detection of cardiac muscle damage. Breast Cancer Drug:HerceptinDrug:TaxolDrug:FluorouracilDrug:CytoxanDrug:Epirubicin Phase III Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00097578?order=3 Genentech This is an observational study designed to follow patients with metastatic colorectal cancer who are receiving Avastin in combination with first-line chemotherapy regimens and whose cancer has been either previously untreated or treated less than or equal to 3 months prior to enrollment. Colorectal NeoplasmsMetastases Study Type:ObservationalStudy Design:Natural History,Longitudinal,Defined Population,Prospective Study Official Title:An Observational Study of Avastin (Bevacizumab) in Combination with Chemotherapy for First-Line Treatment of Metastatic Colorectal Adenocarcinoma
http://www.clinicaltrials.gov/ct/show/NCT00097240?order=4 Genentech The Raptiva Pregnancy Registry is a prospective observational study established to obtain data on pregnancy outcomes of women who are exposed to Raptiva. PsoriasisPregnancy Study Type:ObservationalStudy Design:Natural History,Prospective Study Official Title:The Raptiva Pregnancy Registry: An Observational Study of the Use and Safety of Raptiva (Efalizumab) during Pregnancy
http://www.clinicaltrials.gov/ct/show/NCT00097565?order=5 Genentech This is a prospective, observational, longitudinal, multicenter study of patients with newly diagnosed follicular Non-Hodgkin's Lymphoma (NHL) designed to delineate differences in clinical outcome by comparing the effectiveness and safety of common treatment regimens. Lymphoma, Non-Hodgkin Drug:Rituxan (rituximab) Phase IV Study Type:ObservationalStudy Design:Natural History,Longitudinal,Defined Population,Prospective Study Official Title:The National Lymphocare Study: An Observational Study of Treatment, Outcomes, and Prognosis in Patients with Follicular Non-Hodgkins Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00097539?order=6 Genentech This study is a multicenter, open label, observational, postmarketing surveillance study of Nutropin AQ, Nutropin, and Protropin in the United States and Canada. This study (and subsequent substudies) were developed to investigate specific aspects of growth hormone (GH) treatment. Growth Disorders Drug:Nutropin [somatropin (rDNA origin) for injection]Drug:Nutropin AQ [somatropin (rDNA origin) injection]Drug:Protropin [somatrem for injection] Phase IV Study Type:ObservationalStudy Design:Natural History,Longitudinal,Defined Population,Prospective Study Official Title:Genentech National Cooperative Growth Study (NCGS) Postmarketing Surveillance Program for Nutropin AQ [Somatropin (rDNA Origin) Injection], Nutropin [Somatropin (rDNA Origin) for Injection], and Protropin [Somatrem for Injection]
http://www.clinicaltrials.gov/ct/show/NCT00069446?order=7 Genentech The purpose of this study is to assess the safety of telbermin applied topically to chronic, diabetic foot ulcers and to explore the possible effectiveness of this treatment to induce healing of diabetic foot ulcers. Diabetic Foot Drug:Vascular endothelial growth factor (VEGF, Telbermin) Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:An Exploratory, Double-blind, Randomized, Placebo-controlled Study Evaluating Topical Recombinant Human Vascular Endothelial Growth Factor (Telbermin) for Induction of Healing of Chronic, Diabetic Foot Ulcers
http://www.clinicaltrials.gov/ct/show/NCT00090051?order=8 Biogen Idec The purpose of this study is to provide treatment for patients who have CLL, and to compare the use of rituximab added to FC with FC alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms. Chronic Lymphocytic Leukemia Drug:Rituxan Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Open-label, multicenter, randomized, comparative, phase III study to evaluate the efficacy and safety of rituximab/fludarabine/cyclophosphamide (FCR) vs. fludarabine/cyclophosphamide (FC) alone in previously treated patients with CD20 positive B-cell CLL
http://www.clinicaltrials.gov/ct/show/NCT00086606?order=9 Genentech Allergy Drug:Xolair (omalizumab) Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment Official Title:A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Oral Food Challenge trial of Xolair (Omalizumab) in Peanut Allergy
http://www.clinicaltrials.gov/ct/show/NCT00077870?order=10 Genentech The purpose of this study is to determine the safe dose of PRO70769 for subjects with moderate to severe rheumatoid arthritis receiving stable doses of concomitant methotrexate. Rheumatoid Arthritis Drug:PRO70769 Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00081614?order=11 Genentech The primary purpose of the study is to assess the potential benefit of combining two targeted therapies (an anti-EGF inhibitor along with an anti-VEGF inhibitor). The goal will be to determine whether the addition of Erlotinib to Avastin will improve the benefit in metastatic renal cell carcinoma (RCC) with regard to time to progression, response rate, duration of response, and survival compared with Avastin alone. Since Avastin has been shown to be active in renal cancer, the goal will be to assess whether this activity can be enhanced with Erlotinib. Renal Cell CarcinomaMetastases Drug:Avastin (bevacizumab)Drug:Tarceva (erlotinib HCl) Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase II, Multicenter, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Tarceva (Erlotinib Hydrochloride) in Combination with Avastin (Bevacizumab) versus Avastin Alone for Treatment of Metastatic Renal Cell Carcinoma
http://www.clinicaltrials.gov/ct/show/NCT00097617?order=12 Genentech This study is a multicenter, open-label, observational, postmarketing surveillance study that will collect information on the use of Genentech growth hormone (GH) preparations to treat children with CRI in the United States. Chronic Renal InsufficiencyEnd-Stage Renal Disease Drug:Nutropin [somatropin (rDNA origin) for injection]Drug:Nutropin AQ [somatropin (rDNA origin) injection]Drug:Protropin [somatrem for injection] Phase IV Study Type:ObservationalStudy Design:Natural History,Longitudinal,Defined Population,Prospective Study Official Title:National Cooperative Growth Study (NCGS) of Nutropin AQ, Nutropin, and Protropin in Children with Growth Failure due to Chronic Renal Insufficiency (CRI) or End Stage Renal Disease (ESRD)
http://www.clinicaltrials.gov/ct/show/NCT00097019?order=13 Genentech This is an open-label, single-arm, two-stage, multicenter Phase II study evaluating the efficacy and safety of bevacizumab in women with platinum resistant, advanced (Stage III or IV) epithelial ovarian cancer (EOC) or primary peritoneal carcinoma (PPC) for whom subsequent Doxil or topotecan therapy also has failed. Ovarian Cancer Drug:Avastin (bevacizumab) Phase II Study Type:InterventionalStudy Design:Treatment,Open Label,Single Group Assignment Official Title:A Multicenter, Single-Arm, Phase II Trial of Bevacizumab in Subjects with Platinum-Resistant Epithelial Carcinoma of the Ovary or Primary Peritoneal Carcinoma for Whom Subsequent Doxil or Topotecan Therapy Has Failed
http://www.clinicaltrials.gov/ct/show/NCT00090623?order=14 Genentech This is a phase III, multicenter, randomized, double masked, sham injection-controlled study of the efficacy and safety of intravitreally administered ranibizumab in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration. Macular Degeneration Drug:rhuFab V2 (ranibizumab) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Safety/Efficacy Study Official Title:A Phase IIIb, Multicenter, Randomized, Double Masked, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab in Subjects with Subfoveal Choroidal Neovascularization (CNV) with or without Classic CNV Secondary to Age Related Macular Degeneration
http://www.clinicaltrials.gov/ct/show/NCT00097201?order=15 Genentech This is a research sample collection substudy of Study U2787g, a phase II, randomized, double-blind, parallel-group, placebo controlled, multicenter study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in adults with Relapsing-Remitting Multiple Sclerosis (RRMS). Multiple Sclerosis Drug:Rituxan (rituximab) Phase II Study Type:InterventionalStudy Design:Treatment Official Title:Research Studies to Characterize the Immunologic and Pharmacodynamic Effects of Rituximab in Patients with Relapsing-Remitting MS (RRMS)
http://www.clinicaltrials.gov/ct/show/NCT00061594?order=16 Genentech This is a phase III, multicenter, randomized, double-masked, active treatment-controlled study of intravitreally administered ranibizumab compared with verteporfin (Visudyne) photodynamic therapy (PDT) in treating subfoveal neovascular mascular degeneration. Macular Degeneration Drug:rhuFab V2 (ranibizumab) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Safety/Efficacy Study Official Title:A Phase III, Multicenter, Randomized, Double Masked, Active Treatment-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) Compared with Verteporfin (Visudyne) Photodynamic Therapy in Subjects with Predominantly Classic Subfoveal Neovascular Age-Related Macular Degeneration
http://www.clinicaltrials.gov/ct/show/NCT00095225?order=17 Genentech This phase II, multicenter, randomized trial is designed to make preliminary evaluations of the efficacy of combining Avastin with docetaxel or Tarceva relative to docetaxel monotherapy in patients with previously treated advanced Non-Small Cell Lung Cancer (NSCLC). Carcinoma, Non-Small-Cell LungLung NeoplasmsAdenocarcinomaCarcinoma, Large Cell Drug:Avastin (bevacizumab)Drug:Tarceva (erlotinib HCl) Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Safety/Efficacy Study Official Title:A Phase II, Multicenter, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Avastin (Bevacizumab) in Combination with Docetaxel or Tarceva (Erlotinib Hydrochloride) Compared with Docetaxel Alone for Treatment of Recurrent or Refractory NonSmall Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00079742?order=18 Genentech The purpose of this study is to evaluate the safety and efficacy of Nutropin AQ in treating growth restriction and increase lean body mass in children with Cystic Fibrosis (CF) and growth restriction. Cystic Fibrosis Drug:Nutropin AQ [somatropin (DNA origin) injection] Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Safety/Efficacy Study Official Title:A Phase II, Multicenter, Randomized, Controlled, Open-label Study of the Safety and Efficacy of Nutropin AQ [somatropin (DNA origin) injection] for the Treatment of Growth Restriction in Children with Cystic Fibrosis
http://www.clinicaltrials.gov/ct/show/NCT00097513?order=19 Genentech This study is a multicenter, open-label, observational, postmarketing surveillance study that will collect information on the use of Genentech growth hormone (GH) preparations to treat GH-deficient subjects with optimal GH dosing during puberty. Dwarfism, Pituitary Drug:Nutropin AQ [somatropin (rDNA origin) injection]Drug:Nutropin [somatropin (rDNA origin) for injection] Phase IV Study Type:ObservationalStudy Design:Natural History,Longitudinal,Defined Population,Prospective Study Official Title:National Cooperative Growth Study (NCGS) of Optimal Nutropin AQ and Nutropin Dosing in Pubertal Growth Hormone-Deficient (GHD) Subjects
http://www.clinicaltrials.gov/ct/show/NCT00096928?order=20 Genentech This study is a multicenter, prospective, 5-year, surveillance study of approximately 5000 Raptiva-treated patients and approximately 2500 comparison patients (not treated with Raptiva) with chronic moderate to severe plaque psoriasis who are candidates for treatment with Raptiva. Psoriasis Drug:Raptiva (efalizumab) Phase IV Study Type:ObservationalStudy Design:Natural History Official Title:Raptiva Epidemiologic Study of Psoriasis Outcomes and Safety Events in Patients with Chronic Moderate to Severe Plaque Psoriasis (Response)
http://www.clinicaltrials.gov/ct/show/NCT00096993?order=21 Genentech This is a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical trial of pertuzumab in combination with gemcitabine relative to placebo in combination with gemcitabine in subjects with advanced ovarian, primary peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy. Ovarian CancerPeritoneal Cancer Drug:rhuMAb 2C4 (pertuzumab) Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control Official Title:A Phase II, Randomized, Placebo Controlled, Double-Blind Study to Evaluate the Efficacy of Pertuzumab (rhuMAb 2C4) in Combination with Gemcitabine and the Effect of Tumor-Based HER2 Activation in Subjects with Platinum-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
http://www.clinicaltrials.gov/ct/show/NCT00097188?order=22 Genentech This is a phase II, randomized, double-blind, parallel group, placebo controlled, multicenter study to evaluate the safety and efficacy of Rituximab in adults with Relapsing-Remitting Multiple Sclerosis (RRMS). Multiple Sclerosis Drug:Rituxan (rituximab) Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase II, Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab (Mabthera/Rituxan) in Adults with Relapsing Remitting Multiple Sclerosis
http://www.clinicaltrials.gov/ct/show/NCT00096941?order=23 Genentech This is a multicenter, open-label extension study. Subjects who have completed 17 cycles (approximately 1 year) of treatment with single-agent pertuzumab in a Genentech-sponsored Phase II cancer study and have shown no signs of unacceptable toxicity are eligible for inclusion in this trial. Cancer Drug:rhuMAb 2C4 (pertuzumab) Phase III Study Type:InterventionalStudy Design:Treatment,Open Label Official Title:An Open-Label, Multicenter Extension Study of Pertuzumab (rhuMAb 2C4) in Subjects Treated with Pertuzumab in a Previous Genentech-Sponsored Phase II Cancer Study
http://www.clinicaltrials.gov/ct/show/NCT00097552?order=24 Genentech This study is a multicenter, open-label, observational, postmarketing surveillance study of Genentech growth hormone (GH) products in the treatment of girls with Turner syndrome in the United States and Canada. Turner Syndrome Drug:Nutropin [somatropin (rDNA origin) for injection]Drug:Nutropin AQ [somatropin (rDNA origin) injection]Drug:Protropin [somatrem for injection] Phase IV Study Type:ObservationalStudy Design:Natural History,Longitudinal,Defined Population,Prospective Study Official Title:Characterization of subjects with Turner Syndrome treated with growth hormone in the national cooperative growth study (NCGS)
http://www.clinicaltrials.gov/ct/show/NCT00096954?order=25 Genentech This is a multicenter, parallel group, double-blind, randomized, placebo controlled study to evaluate the efficacy of Xolair in atopic asthmatics with good lung capacity who remain difficult to treat. Asthma Drug:Xolair (omalizumab) Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study Official Title:A Prospective, Randomized, Double-Blind Study of the Efficacy of Xolair in Atopic Asthmatics with Good Lung Capacity Who Remain Difficult to Treat (Exact)
http://www.clinicaltrials.gov/ct/show/NCT00063154?order=26 Genentech The purpose of this study is to determine if the study drug pertuzumab is effective in treating patients with advanced lung cancer that has recurred following prior chemotherapy. Non-small cell lung cancer Drug:Pertuzumab (rhuMAb 2C4) Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A phase II, open-label, multicenter study to evaluate the effect of tumor-based HER2 activation on the efficacy of rhuMAb 2C4 (pertuzumab) in subjects with recurrent nonsmall cell lung cancer
http://www.clinicaltrials.gov/ct/show/NCT00087529?order=27 Genentech This is a phase II/III, randomized, double-blind, parallel group, placebo controlled, multicenter study to evaluate the safety and efficacy of rituximab in adults with primary progressive multiple sclerosis (PPMS). Primary Progressive Multiple Sclerosis Drug:Rituxan (rituximab) Phase II Study Type:InterventionalStudy Design:Treatment Official Title:A Phase II/III, Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Adults with Primary Progressive Multiple Sclerosis
http://www.clinicaltrials.gov/ct/show/NCT00095706?order=28 Translational Oncology Research International The purpose of this study is to evaluate the safety and effectiveness of combined treatment with trastuzumab (Herceptin) and bevacizumab (anti-VEGF antibody) in patients with HER2-positive metastatic breast cancer. Breast Cancer Drug:Bevacizumab (drug), Herceptin (drug) Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Phase I/II Combined Biological Therapy of Breast Cancer Using Monoclonal Antibodies Directed Against HER2/neu Proto-Oncogene and Vascular Endothelial Growth Factor
http://www.clinicaltrials.gov/ct/show/NCT00097747?order=1 Affymax The purpose of this study is to evaluate the safety, PK, and minimum pharmacologically active dose of Hematide in Healthy Volunteers. Renal Failure, ChronicCancer Drug:Hematide Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety Study Official Title:A Phase 1, Double-blind, Placebo-controlled, Dose Escalation Study of the Safety and Pharmcokinetics of Single Intravenous Doses of Hematide in Healthy Volunteers
http://www.clinicaltrials.gov/ct/show/NCT00071955?order=1 Genitope grade 1 follicular lymphomagrade 2 follicular lymphomagrade 3 follicular lymphoma Drug:autologous immunoglobulin idiotype-KLH conjugate vaccineDrug:sargramostimProcedure:biological response modifier therapyProcedure:colony-stimulating factor therapyProcedure:cytokine therapyProcedure:tumor cell derivative vaccineProcedure:vaccine therapy Phase II Study Type:InterventionalStudy Design:Treatment Official Title:Phase II Study of Immediate or Delayed Autologous Immunoglobulin Idiotype-KLH Conjugate Vaccine and Sargramostim After Rituximab in Patients With Refractory or Progressive Follicular Non-Hodgkin's Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00093314?order=1 Genmab The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Chronic Lymphocytic Leukemia. Chronic Lymphocytic Leukemia Drug:HuMax-CD20 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study Official Title:An Open-labeled, International, Multicenter, Dose Escalating, Phase I/II Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia
http://www.clinicaltrials.gov/ct/show/NCT00093041?order=2 Genmab The purpose of this trial is to determine the safety of HuMax-EGFr as a treatment for head and neck cancer. Head and Neck Neoplasms Drug:HuMax-EGFr Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety Study Official Title:An Open, Single Dose Escalation Study Followed by a Multiple Dose Extension of Anti-EGF Receptor Human Monoclonal Antibody (HuMax-EGFr) in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
http://www.clinicaltrials.gov/ct/show/NCT00092274?order=3 Genmab The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Follicular Lymphoma (FL). Lymphoma, Follicular Drug:HuMax-CD20 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study Official Title:An Open-label, International, Multicenter, Dose Escalating, Phase I/II Study of HuMax-CD20 in Patients with Relapsed or Refractory Follicular Lymphoma Grade I-II
http://www.clinicaltrials.gov/ct/show/NCT00078234?order=1 Genta The treatment combination of Rituxan (rituximab) and fludarabine has previously been reported to produce a high percentage of responses with less toxicity than other combination treatments. However, some leukemia subjects continue to have leukemia despite treatment with these standard anticancer drug therapies, or they may work for only a short period of time. In some subjects, when the leukemia does not respond well to therapy the leukemia cells may be over-producing one or more proteins. One of these proteins is called Bcl-2. Bcl-2 is a protein that appears to protect cancer cells from being killed and thus lengthens the life of the cancer cells. GenasenseTM (oblimersen sodium) is a compound that blocks production of the Bcl-2 protein. By first lowering levels of Bcl-2, it is possible that chemotherapy drugs may work more effectively as a cancer treatment. Genasense may also directly kill CLL cells. This study will test whether treating subjects with Genasense, fludarabine and rituximab is safe and effective. Chronic Lymphocytic Leukemia Drug:Oblimerson sodium, G3139Drug:FludarabineDrug:Rituximab Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Pilot Study of Genasense (Oblimersen Sodium, Bcl-2 Antisense Oligonucleotide), Fludarabine and Rituximab in Previously Treated and Untreated Subjects with Chronic Lymphocytic Leukemia
http://www.clinicaltrials.gov/ct/show/NCT00021749?order=2 Genta This non-randomized study will test the safety and effectiveness of Genasense in patients with CLL. Chronic Lymphocytic LeukemiaCLL Drug:Oblimerson, G3139 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Phase I-II Multicenter Study of Genasense? (Bcl-2 Antisense Oligonucleotide) in Patients with Advanced Chronic Lymphocytic Leukemia
http://www.clinicaltrials.gov/ct/show/NCT00074919?order=1 Genzyme Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The objective of this protocol is to provide enzyme replacement therapy with rhGAA on an expanded access basis, to severely affected patients with infantile-onset Pompe disease for whom there is no alternative treatment and who do not meet the clinical characteristics described in the inclusion criteria for participation in other Genzyme Corporation-sponsored study currently enrolling patients with infantile-onset Pompe disease. Glycogen Storage Disease Type IIGlycogenosis 2 Drug:alglucosidase alfa Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Study start:December 2003
http://www.clinicaltrials.gov/ct/show/NCT00069862?order=2 Genzyme A clinical trial designed to compare the safety and iron excretion properties of desferoxamine (DFO) and GT56-252, an experimental oral iron chelator. beta-Thalassemia Drug:GT56-252Drug:desferoxamine (DFO) Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Crossover Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00081900?order=3 Genzyme Approximately 18-45 patients with Hepatocellular Carcinoma (HCC) will be treated with DENSPM at approximately 5 centers in the United States. First, we will be trying to determine the highest dose that can be given safely and is well tolerated (this is called the maximally tolerated dose, or the MTD, for short). Once that is established, we will enroll additional patients to learn more about potential side effects and to see whether DENSPM can slow the growth of HCC tumors. We also want to learn about the safety of DENSPM. Many medications used to treat cancer cause side effects (discomforts or illness). In this study, we want to understand what side effects occur in patients with HCC who are treated with DENSPM. Carcinoma, Hepatocellular Drug:DENSPM (N1, N11-diethylnorspermine) (drug) Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase 1/2 Study of DENSPM (N1, N11-diethylnorspermine) in Patients with Unresectable Hepatocellular Carcinoma
http://www.clinicaltrials.gov/ct/show/NCT00089947?order=4 Genzyme Renal TransplantationGraft Rejection Drug:Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)] Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Randomized, Prospective, Phase 2 Study Comparing Thymoglobulin in a Rapid Discontinuation of Corticosteroids Protocol with Standard Corticosteroid Therapy in Living Donor Renal Transplantation Using Mycophenolate Mofetil and Tacrolimus Maintenance Therapy
http://www.clinicaltrials.gov/ct/show/NCT00088543?order=5 Genzyme Acute myelogenous leukemia (AML)Acute lymphocytic leukemia (ALL)Graft vs. Host Disease (GvHD) Drug:Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)] Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study Official Title:Pilot Trial of Two Dose Levels of Thymoglobulin as Part of a Myeloablative-Conditioning for a Human Leukocyte Antigen (HLA) Identical Matched Related Donor (MRD) Stem Cell Transplant (SCT) with Cyclosporine (CSa) as Post-transplant Graft vs. Host Disease (GvHD) Prophylaxis
http://www.clinicaltrials.gov/ct/show/NCT00052468?order=1 AGO Ovarian Cancer Study Group stage I ovarian epithelial cancerstage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerFallopian Tube Cancer Drug:carboplatinDrug:gemcitabineDrug:paclitaxelProcedure:adjuvant therapyProcedure:chemotherapyProcedure:conventional surgeryProcedure:surgery Phase III Study Type:InterventionalStudy Design:Treatment Official Title:Phase III Randomized Adjuvant Study of Carboplatin and Paclitaxel With or Without Gemcitabine in Patients With Stage I-IV Ovarian Epithelial or Fallopian Tube Cancer
http://www.clinicaltrials.gov/ct/show/NCT00072553?order=2 GERCOR Stage IV rectal cancerstage IV colon canceradenocarcinoma of the colonadenocarcinoma of the rectumrecurrent rectal cancerrecurrent colon cancer Drug:celecoxibDrug:fluorouracilDrug:leucovorin calciumDrug:oxaliplatinProcedure:adjuvant therapyProcedure:anti-cytokine therapyProcedure:antiangiogenesis therapyProcedure:biological response modifier therapyProcedure:chemotherapyProcedure:conventional surgeryProcedure:enzyme inhibitor therapyProcedure:growth factor antagonist therapyProcedure:neoadjuvant therapyProcedure:surgery Phase II Study Type:InterventionalStudy Design:Treatment Official Title:Phase II Study of Celecoxib, Leucovorin Calcium, Fluorouracil, and Oxaliplatin in Patients With Metastatic Colorectal Cancer
http://www.clinicaltrials.gov/ct/show/NCT00075465?order=3 GERCOR adenocarcinoma of the stomachstage III gastric cancerstage IV gastric cancer Drug:docetaxelDrug:epirubicinProcedure:chemotherapy Phase II Study Type:InterventionalStudy Design:Treatment Official Title:Phase II Study of Docetaxel and Epirubicin as First-Line Therapy in Patients With Locally Advanced or Metastatic Adenocarcinoma of the Stomach
http://www.clinicaltrials.gov/ct/show/NCT00075543?order=4 GERCOR recurrent ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancer Drug:docetaxelDrug:oxaliplatinProcedure:chemotherapy Phase I Study Type:InterventionalStudy Design:Treatment Official Title:Phase I/II Study of Docetaxel and Oxaliplatin in Patients With Stage III or IV Ovarian Epithelial Cancer
http://www.clinicaltrials.gov/ct/show/NCT00075738?order=5 GERCOR stage IV esophageal cancerrecurrent esophageal cancer Drug:cisplatinDrug:fluorouracilDrug:irinotecanDrug:leucovorin calciumProcedure:chemotherapy Phase II Study Type:InterventionalStudy Design:Treatment Official Title:Phase II Study of Fluorouracil, Irinotecan, Leucovorin Calcium, and Cisplatin as First-Line Therapy in Patients With Metastatic Esophageal Cancer
http://www.clinicaltrials.gov/ct/show/NCT00075595?order=6 GERCOR stage IV colon cancerStage IV rectal cancerrecurrent colon cancerrecurrent rectal canceradenocarcinoma of the colonadenocarcinoma of the rectum Drug:fluorouracilDrug:irinotecanDrug:leucovorin calciumProcedure:chemotherapy Phase II Study Type:InterventionalStudy Design:Treatment Official Title:Phase II Study of Fluorouracil, Leucovorin Calcium, and Irinotecan in Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer
http://www.clinicaltrials.gov/ct/show/NCT00075517?order=7 GERCOR stage IIIB non-small cell lung cancerstage IV non-small cell lung cancerAdenocarcinoma of the Lunglarge cell lung cancerSquamous Cell Lung Cancer Drug:docetaxelDrug:gemcitabineProcedure:chemotherapy Phase II Study Type:InterventionalStudy Design:Treatment Official Title:Phase II Study of Gemcitabine and Docetaxel in Patients With Inoperable Stage IIIB or IV Non-Small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00075452?order=8 GERCOR adenocarcinoma of the pancreasstage II pancreatic cancerstage III pancreatic cancerstage IVA pancreatic cancerstage IVB pancreatic cancer Drug:gemcitabineDrug:oxaliplatinProcedure:chemotherapy Phase III Study Type:InterventionalStudy Design:Treatment Official Title:Phase III Randomized Study of Gemcitabine With or Without Oxaliplatin in Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma
http://www.clinicaltrials.gov/ct/show/NCT00075556?order=9 GERCOR stage III colon cancerstage IV colon cancerstage III rectal cancerStage IV rectal canceradenocarcinoma of the rectumadenocarcinoma of the colon Drug:capecitabineProcedure:chemotherapyProcedure:conventional surgeryProcedure:neoadjuvant therapyProcedure:radiation therapyProcedure:surgery Phase II Study Type:InterventionalStudy Design:Treatment Official Title:Phase II Study of Neoadjuvant Radiotherapy and Capecitabine in Patients With Stage III or IV Colorectal Adenocarcinoma
http://www.clinicaltrials.gov/ct/show/NCT00077220?order=10 GERCOR stage II non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancer Drug:carboplatinDrug:paclitaxelProcedure:adjuvant therapyProcedure:chemotherapyProcedure:radiation therapy Phase III Study Type:InterventionalStudy Design:Treatment Official Title:Phase III Randomized Study of Paclitaxel, Carboplatin, and Radiotherapy With or Without Adjuvant Paclitaxel and Carboplatin in Patients With Stage II or III Unresectable Non-Small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00047112?order=11 Federation Francophone de Cancerologie Digestive Adenocarcinoma of the Esophagussquamous cell carcinoma of the esophagusstage I esophageal cancerstage II esophageal cancer Drug:cisplatinDrug:fluorouracilProcedure:chemotherapyProcedure:conventional surgeryProcedure:neoadjuvant therapyProcedure:radiation therapyProcedure:surgery Phase III Study Type:InterventionalStudy Design:Treatment Official Title:Phase III Randomized Study of Neoadjuvant Radio-Chemotherapy and Surgery Versus Surgery Alone in Patients With Resectable Thoracic Esophageal Cancer
http://www.clinicaltrials.gov/ct/show/NCT00071201?order=1 Gilead Sciences This is a multi-center phase 3, open-label, parallel-group study designed to evaluate the efficacy, safety and pharmacokinetics of adefovir dipivoxil liquid suspension in patients with chronic hepatitis B and varying degrees of renal impairment. Chronic Hepatitis B Drug:Adefovir Dipivoxil for oral suspension, 2 mg/mL Phase III Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Parallel Assignment,Safety/Efficacy Study Official Title:A Multi-Center Phase 3, Open-Label, Parallel-Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Adefovir Dipivoxil Liquid Suspension in Patients with Chronic Hepatitis B and Varying Degrees of Renal Impairment
http://www.clinicaltrials.gov/ct/show/NCT00042393?order=2 Gilead Sciences The purpose of this early access protocol is to provide access to adefovir dipivoxil prior to its commercial availability to people with lamivudine-resistant chronic hepatitis B who have limited treatment options. Chronic Hepatitis B Drug:Adefovir Dipivoxil Phase III Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Expanded Access Assignment,Safety Study Official Title:A Phase 3b, Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients with Lamivudine-Resistant Chronic Hepatitis B Who Have Limited Treatment Options
http://www.clinicaltrials.gov/ct/show/NCT00095121?order=3 Gilead Sciences The purpose of this study is to investigate the efficacy and safety of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 to less than 18) compared to placebo following 48 weeks of treatment. Chronic Hepatitis B Drug:Adefovir Dipivoxil, 10 mg tablet or oral suspension, 2 mg/mL Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents (Age 2 to less than 18) with Chronic Hepatitis B
http://www.clinicaltrials.gov/ct/show/NCT00006441?order=1 The purpose of this study is to see whether taking interleukin-2 (IL-2) and other anti-HIV drugs affects the course of HIV disease in patients with primary HIV infection (the time period that immediately follows infection with HIV). After primary HIV infection, the actual infection is spread through an increasing amount of HIV virus in the body. Studies have shown that, by taking a combination of anti-HIV drugs, it is possible to reduce the amount of HIV in the body to almost undetectable levels. This study will find out if starting anti-HIV drugs during primary infection will interrupt or reduce the spread of HIV in patients' bodies. HIV Infections Drug:Lamivudine/ZidovudineDrug:Nelfinavir mesylateDrug:Aldesleukin Study Type:InterventionalStudy Design:Treatment,Open Label,Efficacy Study Official Title:A Single Center, Randomized Open Label Study of Initial Interleukin-2 Compared to Delayed Interleukin-2 When Added to Zidovudine, 3TC and Nelfinavir In Order to Modulate Immune Function and to Sustain Suppression of HIV-1 Replication Among Those Persons with Primary or Early HIV Infection
http://www.clinicaltrials.gov/ct/show/NCT00056407?order=1 GlaxoSmithKline This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment. Prostate Cancer Drug:Oral investigational prostate cancer risk reduction drug Phase III Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00089583?order=2 GlaxoSmithKline This is a 48-week study to collect information on the safety and activity of an investigational medicine in patients, ages 2 to 18 years old, with HIV infection . HIV Infections Drug:Lexiva (GW433908)Drug:Ritonavir Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Parallel Assignment,Safety Study
http://www.clinicaltrials.gov/ct/show/NCT00085813?order=3 GlaxoSmithKline Purpose of study is to determine how effective and safe a new investigational drug is in treating locally advanced or metastatic Non-small Cell Lung cancer in patients who have received a platinum-based chemotherapy and whose disease continues to progress. Treatment involves a 1-hr treatment given intravenously (IV), repeated once every 21 days. A patient may continue treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times over 24 hr period to measure the amount of drug in your body at specific times after the drug is given. Blood samples will also be taken for routine lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment. Non-small cell lung cancer Drug:Investigational Cancer Drug Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00090103?order=4 GlaxoSmithKline This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) are done annually. Benign Prostatic Hyperplasia Drug:AvodartDrug:Tamsulosin Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00056277?order=5 GlaxoSmithKline A Placebo Controlled Study Evaluating Efficacy and Safety of Medication in Patients with Bipolar Disorder Bipolar Disorder Drug:Investigational Bipolar Disorder Drug Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00078572?order=6 GlaxoSmithKline The purpose of this study is to compare the efficacy and safety of an oral dual tyrosine kinase inhibitor in combination with capecitabine versus capecitabine alone in women with locally advanced or metastatic breast cancer that has not responded to previous therapy. Metastatic breast cancer Drug:XelodaDrug:Lapatinib (GW572016) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00082394?order=7 GlaxoSmithKline This clinical research study evaluates the safety and effectiveness of marketed HIV drugs in investigational combinations given to HIV-infected patients who have not received prior therapy. All subjects will be screened and monitored at 12 scheduled clinic visits over a 48-week period and will have a follow up visit or telephone call 4 weeks after the last study visit. Abnormal laboratory values or certain side effects may require additional clinic visits over the course of the study. HIV Infections Drug:Investigational HIV Drugs Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00071747?order=8 GlaxoSmithKline The objective of this study is to evaluate the effectiveness of a marketed drug in the treatment of schizophrenia, as an add-on therapy to antipsychotics over a 12-week period. Subjects with schizophrenia who have been maintained on a stable dose of antipsychotics and who fulfill the screening entrance criteria will have an assessment 1-7 days after the first visit to confirm eligibility. Schizophrenia Drug:Investigational Schizophrenia Drug Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00065182?order=9 GlaxoSmithKline The purpose of this study is to compare the efficacy and safety of a weekly regimen of two FDA approved drugs in combination versus one FDA approved drug in patients with advanced non-small cell lung cancer who have received one previous chemotherapy. Non-small cell lung cancer Drug:Two FDA approved chemotherapy drugs Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00076882?order=10 GlaxoSmithKline This study is an 8-week evaluation of an investigational drug for treating depression in bipolar patients. Depressed patients will be given either an investigational drug or placebo and receive psychiatric assessments of their depression at weekly visits. Study drug and all study-related visits are provided at no cost to the patient. The patient agrees to meet with study research staff for roughly 11 clinic visits. Bipolar Disorder Drug:Investigational Bipolar Disorder Drug Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00085904?order=11 GlaxoSmithKline SB-485232 will be administered as five daily intravenous (IV) infusions repeated every 28 days in adult subjects with advanced solid tumors or lymphomas. Subjects may receive up to 6 cycles of treatment unless progressive disease or unacceptable toxicity is noted. Three dose levels of drug will be investigated. Safety evaluations, including blood sampling for various laboratory tests, will be conducted. Additional blood samples will also be taken to measure the amount of drug in the body at specific times. CancerLymphoma Drug:SB-485232 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Safety Study
http://www.clinicaltrials.gov/ct/show/NCT00085878?order=12 GlaxoSmithKline This is a Phase I, open-label, dose-escalation study of SB-485232. Subjects will receive SB-485232 administered as subcutaneous injections daily for 14 days. Dose escalation (enrollment into the next cohort) cannot occur until all three subjects have completed the previous cohort; 5 doses will be tested. An additional dosing regimen has been added to evaluate higher doses given twice weekly for 7 weeks. Therefore, the full evaluation period for each patient will extend out to approximately eleven weeks after the first day of SB-485232 dosing. Solid Tumors Drug:SB-485232 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Safety Study
http://www.clinicaltrials.gov/ct/show/NCT00058526?order=13 GlaxoSmithKline Breast Cancer Vaccine:Investigational Cancer Vaccine Phase I Study Type:InterventionalStudy Design:Prevention,Non-Randomized,Single Blind,Dose Comparison,Single Group Assignment,Safety Study
http://www.clinicaltrials.gov/ct/show/NCT00062790?order=14 GlaxoSmithKline This study is being done to determine how much certain hormone levels in the prostate decrease when a patient takes dutasteride. Male patients at least 50 years old will take either dutasteride or a placebo (dummy pill) once daily by mouth for 3 months prior to having a surgery to reduce the size of their prostate. During the surgery, very small pieces of the prostate that are removed will be tested to see how much dihydrotestosterone and testosterone (male hormones) are in the tissue. Benign Prostatic Hyperplasia Drug:Dutasteride Phase IV Study Type:InterventionalStudy Design:Diagnostic,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Pharmacokinetics/Dynamics Study
http://www.clinicaltrials.gov/ct/show/NCT00094523?order=15 GlaxoSmithKline HIV Infections Drug:fosamprenavir (Lexiva) Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00039858?order=16 GlaxoSmithKline The purpose of this study is to evaluate the safe and effective dose of Argatroban for prophylaxis and/or treatment of thrombosis in pediatric patients with current or previous diagnosis of heparin-induced thrombocytopenia (HIT) and thrombosis syndrome (HITTS), or who in the opinion of the investigator require alternative anticoagulation due to an underlying condition. ThrombocytopeniaThrombosis Drug:Argatroban Phase IV Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00089986?order=17 GlaxoSmithKline The primary objective of this study is to estimate the size of the GR270773 treatment effect on 28-day all-cause mortality for two doses of GR270773 versus placebo in adult subjects with suspected or confirmed Gram-negative severe sepsis. GR270773 will be administered as a three-day continuous intravenous infusion. SepsisSeptic Shock Drug:Intravenous GR270773- Phospholipid Emulsion Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00044330?order=18 GlaxoSmithKline The purpose of this study is to determine the efficacy of an oral investigational drug for the treatment of metastatic breast cancer tumors that are known to overexpress HER2/neu. Metastatic breast cancer Drug:GW572016 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00085943?order=19 GlaxoSmithKline This randomized, multicenter study will compare the safety and efficacy of Lexiva plus ritonavir versus Kaletra (Lopinavir/ritonavir) over 48 weeks in ART (anti-retroviral therapy)-naive HIV-1 infected subjects while utilizing the Abacavir/lamivudine (ABC/3TC) FDC (fixed-dose combination tablet) as a NRTI (nucleoside reverse transcriptase inhibitor) backbone. This clinical research study evaluates the safety and efficacy (how well it works) of marketed HIV drugs [PI (protease inhibitor) plus NRTIs] given to HIV-infected patients who have not received prior therapy. All subjects will be screened and monitored at 12 scheduled clinic visits over a 48-week period. Abnormal laboratory values or certain side effects may require additional clinic visits over the course of the study. HIV Infections Drug:Lexiva (GW433908)Drug:RitonavirDrug:KaletraDrug:EpivirDrug:Ziagen Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00086658?order=20 GlaxoSmithKline Hypereosinophilic syndrome (HES) is a rare disease with broad clinical signs and symptoms which is diagnosed based on a persistent blood eosinophil count of greater than 1500 cells, various end-organ damages (including skin, heart, lung, nervous system and digestive system etc.), and with exclusion of known secondary causes of hypereosinophilia. HES has a high morbidity/mortality rate. The major treatment of HES has been systemic corticosteroid and other chemotherapeutic drugs (for example, hydroxyurea and interferon) with the intention to lower eosinophil counts and therefore to slow down the progression of disease. Even though corticosteroid and other therapies can effectively reduce eosinophilia in some patients, some may eventually become nonresponsive and intolerable to the amount of side effects of the long-term therapy with these medications. Mepolizumab is a humanized monoclonal antibody that binds specifically to human interleukin 5 (hIL-5) and inhibits its activity. Previous human experience has shown it has been effective in reducing blood eosinophilia in atopic and HES patients and has alleviated some HES clinical signs and symptoms. This study intends to further evaluate the corticosteroid-sparing and clinical benefit of mepolizumab in HES. Hypereosinophilic SyndromeHypereosinophilia Drug:mepolizumab Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00089999?order=21 GlaxoSmithKline This phase II study will evaluate and compare the efficacy and tolerability of two dose schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with advanced or metastatic breast cancer. Breast CancerMetastases Drug:Lapatinib Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Uncontrolled,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00093288?order=22 GlaxoSmithKline Placebo Controlled Study Evaluating the Effectiveness of Medication in Elderly Subjects with Major Depressive Disorder (MDD) Major Depressive Disorder Drug:Investigational Major Depression Disorder drug Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00090077?order=23 GlaxoSmithKline To investigate safety, tolerability and antiviral activity in Non-nucleoside reverse transcriptase inhibitor (NNRTI)-experienced HIV-1 infected patients HIV Infections Drug:Investigational HIV drug Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00041470?order=24 Gralow, Julie, M.D. Breast Cancer Drug:PaclitaxelDrug:VinorelbineDrug:TrastuzumabDrug:Filgrastim Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00097370?order=25 GlaxoSmithKline This is an open label study of mepolizumab 750 mg intravenous in those subjects who participated in study100185 to evaluate the long term safety and efficacy of mepolizumab in subjects with hypereosinophilic syndrome. The study will also evaluate the optimal dosing frequency for clinical use, the effects on corticosteroid reduction, and decrease of signs and symptoms of Hypereosinophilic Syndrome. Hypereosinophilic SyndromeHypereosinophilia Drug:mepolizumab Phase III Study Type:InterventionalStudy Design:Treatment,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00075270?order=26 GlaxoSmithKline The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in first line advanced or metastatic breast cancer. Metastatic breast cancer Drug:PaclitaxelDrug:GW572016 Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00044278?order=27 GlaxoSmithKline This study will evaluate the safety of an investigational medication to treat pediatric patients 1-24 months old with uncontrolled partial seizures. Epilepsy Drug:Investigational Epilepsy Drug Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00065065?order=28 This is a multicenter, randomized, double-blind, placebo-controlled study evaluating rosiglitazone: 4 mg tablets or placebo tablets administered orally twice daily for 12 weeks. The purpose of the study is to evaluate the efficacy and safety of rosiglitazone in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using a standard disease activity index. Calculation of the index requires patients to undergo flexible sigmoidoscopy at the start of the study and at week 12. Ulcerative ColitisInflammatory Bowel Disease Drug:rosiglitazone (Avandia) Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Efficacy Study Official Title:A Randomized, Placebo-controlled Trial of Rosiglitazone for Treatment of Ulcerative Colitis
http://www.clinicaltrials.gov/ct/show/NCT00075049?order=29 Walter Reed Army Institute of Research (WRAIR) This is a double blinded study where 2 test vaccines will be evaluated to see if they protect persons who have never had malaria against malaria infection when bitten by mosquitoes. Malaria Vaccine:RTS,S with AS02A/AS01B adjuvant Phase I Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Active Control,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00097409?order=30 GlaxoSmithKline The purpose of this study is to determine how effective and safe a new investigational drug is in treating persistent or recurrent ovarian cancer in patients who have received a platinum/taxane based chemotherapy and whose disease continues to progress. The treatment involves a 1-hour treatment given intravenously (IV), repeated once every 21 days. A patient may continue to receive the treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times over a 24-hour period to measure the amount of drug in your body at specific times after the drug is given. Blood samples will also be taken for routine lab tests, such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment. Ovarian Cancer Drug:SB-715992 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00094367?order=31 GlaxoSmithKline The purpose of this study is to test the short-term safety of a new once-daily fixed-dose combination tablet containing two drugs for treatment of HIV. HIV Infections Drug:Investigational HIV drug Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety Study
http://www.clinicaltrials.gov/ct/show/NCT00073528?order=32 GlaxoSmithKline This study will compare the efficacy and tolerability of GW572016 administered in combination with letrozole, versus letrozole and placebo, as treatment for hormone receptor-positive advanced or metastatic breast cancer. Breast CancerMetastases Drug:Lapatinib (GW572016)Drug:Letrozole Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00067457?order=33 GlaxoSmithKline The purpose of this study is to compare the safety and effectiveness of as needed versus fixed dosing of an investigational medication for women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy. Irritable Bowel Syndrome Drug:Investigational IBS Drug Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00086593?order=34 GlaxoSmithKline This is a 12-week study for the treatment of chronic persistent symptoms in participants with schizophrenia. Participants on a stable, optimal dose of up to two atypical antipsychotics who fulfill the screening criteria will be randomized to receive either an FDA-approved drug or placebo in addition to the current treatment. Safety will be closely monitored through vital signs, various tests, and blood and urine samples. Schizophrenia Drug:Lamictal Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00071760?order=35 GlaxoSmithKline This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to < 2 years old. HIV Infections Drug:Investigational HIV Drugs Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Parallel Assignment,Safety Study
http://www.clinicaltrials.gov/ct/show/NCT00073008?order=36 GlaxoSmithKline The purpose of this study is to evaluate and compare the efficacy of two dose schedules of an oral investigational drug for the treatment of advanced or metastatic non-small cell lung cancer Non-small cell lung cancer Drug:GW572016 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00089973?order=37 GlaxoSmithKline The purpose of this research study is to find how breast cancer responds to the investigational drug, SB-715992. An investigational drug is a drug that has not been approved by the Food and Drug Administration (FDA) and is available for research use only. In particular, this study will try is to find the answers to the following research questions: 1. Does breast cancer respond to SB-715992? 2. What are the side effects of SB-715992? 3. How much SB-715992 is in the blood at specific times after it is taken? Breast Cancer Drug:SB715992 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Uncontrolled,Single Group Assignment,Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00067561?order=38 GlaxoSmithKline The purpose of this study is to compare the safety and effectiveness of different doses of an investigational medication in women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy. Irritable Bowel Syndrome Drug:Investigational IBS Drug Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00097331?order=39 GlaxoSmithKline The study will evaluate the effectiveness and safety of the investigational drug SB683699 in treating patients with relapsing multiple sclerosis, using data from magnetic resonance imaging (MRI) scans as the main measure. Multiple Sclerosis Drug:SB683699 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00095186?order=1 Agennix The purpose of this study is to determine if orally-administered recombinant human lactoferrin is effective in the treatment of advanced renal cell carcinoma (RCC) in patients who have failed at least one prior systemic therapy for RCC. Carcinoma, Renal Cell Drug:Recombinant Human Lactoferrin Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Multi-Center, Phase 2, Open Label Study of Safety and Efficacy of Oral Recombinant Human Lactoferrin (rhLF) Monotherapy in Patients with Advanced Renal Cell Carcinoma (RCC), Who Have Failed at Least One Regimen of Systemic Therapy for RCC
http://www.clinicaltrials.gov/ct/show/NCT00093132?order=1 GPC Biotech Carcinoma, Non-Small Cell LungLung Cancer Drug:SatraplatinDrug:Docetaxel Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Safety/Efficacy Study Official Title:A Phase 1/2 Study with Satraplatin and Simultaneous Radiation in Locally Advanced Non-Small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00069745?order=2 GPC Biotech Prostate CancerHormone Refractory Prostate CancerOne Prior Cytotoxic Chemotherapy Regimen Drug:SatraplatinDrug:Prednisone Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Multi-National Phase III Study of Satraplatin Plus Prednisone or Placebo Plus Prednisone in Patients with Hormone Refractory Prostate Cancer Previously Treated with One Cytotoxic Chemotherapy Regimen
http://www.clinicaltrials.gov/ct/show/NCT00090376?order=1 Guilford Pharmaceuticals ImpotenceProstate Cancer Drug:GPI 1485 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 3 Arm, 12-Month Study to Evaluate the Effects of GPI 1485 on Erectile Function in Patients Undergoing Bilateral Nerve-Sparing Radical Retropubic Prostatectomy for Prostatic Carcinoma
http://www.clinicaltrials.gov/ct/show/NCT00096408?order=1 Queensland Centre for Gynaecological Cancer The purpose of this study is to determine whether women with Stage I endometrial cancer have the same or better Quality of Life and disease-free survival when treated with Total Laparoscopic Hysterectomy compared to Total Abdominal Hysterectomy. Endometrial Cancer Procedure:Total Laparascopic Hysterectomy Phase III Study Type:InterventionalStudy Design:Educational/Counseling/Training,Randomized,Open Label,Active Control,Parallel Assignment,Efficacy Study Official Title:Total Laparoscopic Hysterectomy for the Treatment of Endometrial Cancer Quality of Life: A Multicentre, Randomised Phase 3 Clinical Trial.
http://www.clinicaltrials.gov/ct/show/NCT00073554?order=1 Nuvelo This trial is for patients with acute occlusion of one of the arteries supplying blood to the leg. The trial is designed to determine the safety and activity of a novel clot dissolving (thrombolytic) drug (alfimeprase). Arterial Occlusive DiseasesPeripheral Vascular DiseasesThrombosis Drug:Alfimeprase Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Historical Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase 2, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Activity of Alfimeprase in Patients with Acute Peripheral Arterial Occlusion
http://www.clinicaltrials.gov/ct/show/NCT00035893?order=1 Hemispherx Biopharma This is an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding Ampligen to a Strategic Therapeutic Intervention (STI) of HAART in patients with plasma HIV RNA < 50 copies/ml (PCR) and CD4 levels > 400. HIV SeropositivityHIV Infection Drug:(Ampligen) polyI-polyC12U Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Parallel Assignment,Safety/Efficacy Study Official Title:The Role of Ampligen in Strategic Therapeutic Intervention (STI) of Highly Active Anti-Retroviral Therapy (HAART): A Multi-Center, Randomized, Controlled Study of Ampligen Potentiation of the HAART-Free Interval.
http://www.clinicaltrials.gov/ct/show/NCT00035581?order=2 Hemispherx Biopharma This is an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding Ampligen to "HAART" in HIV infected patients with CD4 counts >300 and HIV-1 plasma RNA >500 and <30,000 copies/ml (PCR). HIV SeropositivityHIV Infection Drug:(Ampligen) polyI-polyC12U Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00006441?order=1 The purpose of this study is to see whether taking interleukin-2 (IL-2) and other anti-HIV drugs affects the course of HIV disease in patients with primary HIV infection (the time period that immediately follows infection with HIV). After primary HIV infection, the actual infection is spread through an increasing amount of HIV virus in the body. Studies have shown that, by taking a combination of anti-HIV drugs, it is possible to reduce the amount of HIV in the body to almost undetectable levels. This study will find out if starting anti-HIV drugs during primary infection will interrupt or reduce the spread of HIV in patients' bodies. HIV Infections Drug:Lamivudine/ZidovudineDrug:Nelfinavir mesylateDrug:Aldesleukin Study Type:InterventionalStudy Design:Treatment,Open Label,Efficacy Study Official Title:A Single Center, Randomized Open Label Study of Initial Interleukin-2 Compared to Delayed Interleukin-2 When Added to Zidovudine, 3TC and Nelfinavir In Order to Modulate Immune Function and to Sustain Suppression of HIV-1 Replication Among Those Persons with Primary or Early HIV Infection
http://www.clinicaltrials.gov/ct/show/NCT00090636?order=1 Hoffmann-La Roche Myasthenia gravis is a rare, debilitating neurological autoimmune disease. Mycophenolate mofetil (MMF) modulates autoimmune responses through a unique mode of action which may be relevant for autoimmune disease patients. This study will test the safety and efficacy of adjunct MMF to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis. Myasthenia Gravis Drug:mycophenolate mofetil Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Prospective, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, 36-week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Maintain or Improve Symptom Control with Reduced Corticosteroids in Subjects with Myasthenia Gravis
http://www.clinicaltrials.gov/ct/show/NCT00022672?order=2 Hoffmann-La Roche stage IV breast cancerrecurrent breast cancer Drug:anastrozoleDrug:trastuzumabProcedure:antibody therapyProcedure:aromatase inhibitionProcedure:biological response modifier therapyProcedure:endocrine therapyProcedure:hormone therapyProcedure:monoclonal antibody therapy Phase II Study Type:InterventionalStudy Design:Treatment Official Title:Phase II/III Randomized Study of Anastrozole With or Without Trastuzumab (Herceptin) in Postmenopausal Women With Hormone-Receptor Positive HER2-Overexpressing Metastatic Breast Cancer
http://www.clinicaltrials.gov/ct/show/NCT00022698?order=3 Hoffmann-La Roche Colon CancerRectal Cancer Drug:capecitabineDrug:irinotecanProcedure:chemotherapy Phase II Study Type:InterventionalStudy Design:Treatment Official Title:Phase II Study of Capecitabine and Irinotecan in Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal Cancer
http://www.clinicaltrials.gov/ct/show/NCT00069108?order=4 Hoffmann-La Roche The primary purpose of the study is to show that the combination of capecitabine plus oxaliplatin (XELOX) is at least as effective as the combination of fluorouracil/leucovorin (5-FU/LV) plus oxaliplatin (FOLFOX4) in terms of time to tumor progression or death in patients with metastatic colorectal cancer, who have received previous treatment with CPT-11 in combination with fluorouracil/leucovorin as first line therapy. Metastatic Colorectal Cancer Drug:Capecitabine Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label Official Title:Open-label randomized phase 3 study of capecitabine in combo w/ XELOX vs fluorouracil/leucovorin w/ oxaliplatin (FOLFOX4) as treatment for pts w/ metastatic colorectal cancer, who have received prior treatment w/ CPT-11 in combo w/ fluorouracil/leucovorin
http://www.clinicaltrials.gov/ct/show/NCT00081653?order=5 Hoffmann-La Roche The purposes of this study are to study the effect of long-term treatment with monthly oral ibandronate 100 mg and 150 mg, given as a single tablet, on the lumbar spine and hip BMD and bone turnover, and to assess the overall long-term tolerability and safety of the treatment regimens. Osteoporosis Drug:BM 21.0955 Na?H2O Oral (USAN:ibandronate sodium, INN:iband acid) Phase III Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00087568?order=6 Hoffmann-La Roche The objective of this study is to investigate if patients with Chronic Hepatitis C virus who were unable to tolerate or did not respond to 12 weeks of PEG-Intron plus Rebetol/Ribavirin therapy can be safely initiated on Pegasys plus Copegus therapy and tolerate and complete a full course (36 to 60 weeks) of treatment. Hepatitis C Drug:Pegylated Interferon alfa-2a in combination with Ribavirin Phase IV Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00050167?order=7 M.D. Anderson Cancer Center The purpose of this study is to evaluate two taxane regimens (weekly paclitaxel or docetaxel + capecitabine) given in addition to anthracycline based therapy in patients with newly diagnosed breast cancer as adjuvant or neoadjuvant therapy. The objectives of the study are: 1) to evaluate the ability of these two treatments to prevent recurrence and impact survival, 2) to evaluate the ability of the taxane regimens to reduce the tumor size and 3) increase the possibility of breast conservative surgery when given in the neoadjuvant setting. Breast Cancer Drug:PaclitaxelDrug:DocetaxelDrug:CapecitabineDrug:5-fluorouracilDrug:EpirubicinDrug:Cyclophosphamide Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00087646?order=8 Hoffmann-La Roche The objective of this study is to compare the efficacy of the combination of standard dose Pegasys and Copegus given for 72 weeks (including a 12-week high dose induction) versus the standard doses of Pegasys and Copegus given for 48 weeks in patients that did not respond to previous treatment with PEG-Intron in combination with Rebetol/Ribavirin. Hepatitis Drug:Pegylated Interferon alfa-2a in combination with Ribavirin Phase IV Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00087581?order=9 Hoffmann-La Roche renal transplant Drug:mycophenolate mofetil Phase IV Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00077857?order=10 Hoffmann-La Roche The primary purpose of this study is to demonstrate that the combination of capecitabine (950 mg/m2 twice daily d1-14) and docetaxel (75 mg/m2) d1 Q3W is at least equivalent to the combination of capecitabine (1250 mg/m2 twice daily d1-14 ) and docetaxel (75 mg/m2) d1 Q3W in terms of time to disease progression or death due to any cause. Breast (combo) and Colon Cancer (monotherapy) Drug:Capecitabine Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00090753?order=11 Hoffmann-La Roche The purpose of this study is to document that RO0503821 administered for prolonged periods (104 weeks) is efficacious, safe, and well tolerated in patients treated for chronic renal anemia. Renal Anemia Drug:RO0503821 Phase III Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00087620?order=12 Hoffmann-La Roche To evaluate and compare the time to progression of the combination of capecitabine (825 mg/m2 twice daily) and docetaxel (75mg/m2 i.v.) to that of capecitabine (1000 mg/m2 twice daily) until progressive disease followed sequentially by docetaxel (75 mg/m2 i.v. D1 Q3W) Breast Cancer Drug:capecitabine Phase IV Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00077597?order=13 Hoffmann-La Roche The primary purpose of this study is to demonstrate the efficacy of RO0503821 administered intravenously for the treatment of anemia in patients with chronic kidney disease who are on dialysis. The secondary purpose is to assess the safety and tolerability of multiple doses of RO0503821 during the correction and the extension periods in this patient population. Renal Anemia Drug:RO0503821 Phase III Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00077610?order=14 Hoffmann-La Roche The primary purpose of this study is to demonstrate that RO0503821 administered intravenously maintains hemoglobin concentrations in dialysis patients on prior intravenous epoetin maintenance treatment of chronic renal anemia. The secondary purpose is to assess the safety and tolerability of intravenous administration of RO0503821 in this patient patient population. Renal Anemia Drug:RO0503821 Phase III Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00081484?order=15 Hoffmann-La Roche The primary purpose of this study is to demonstrate that RO0503821 administered with pre-filled syringes maintains hemoglobin concentrations in dialysis patients on prior intravenous or subcutaneous epoetin maintenance treatment of chronic renal anemia. Renal Anemia Drug:RO0503821 Phase III Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00090051?order=16 Biogen Idec The purpose of this study is to provide treatment for patients who have CLL, and to compare the use of rituximab added to FC with FC alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms. Chronic Lymphocytic Leukemia Drug:Rituxan Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Open-label, multicenter, randomized, comparative, phase III study to evaluate the efficacy and safety of rituximab/fludarabine/cyclophosphamide (FCR) vs. fludarabine/cyclophosphamide (FC) alone in previously treated patients with CD20 positive B-cell CLL
http://www.clinicaltrials.gov/ct/show/NCT00081471?order=17 Hoffmann-La Roche The primary purpose of this study is to demonstrate the efficacy of RO0503821 treatment administered subcutaneously once every two weeks for correction of anemia in chronic kidney disease patients who are not on dialysis and are not treated with epoetin. Renal Anemia Drug:RO0503821 Phase III Study Type:InterventionalStudy Design:Treatment Official Title:Open-label, randomized, parallel-group, comparative, active-controlled, multi-center study w/ 1 dosing interval during the correction and evaluation periods, and 2 dosing intervals during the extension period
http://www.clinicaltrials.gov/ct/show/NCT00087633?order=18 Hoffmann-La Roche The objective of this study is to study the impact of prophylactic administration of antiviral therapy (Prophylaxis Arm) as compared to initiation of antiviral therapy at the time of clinical recurrence of Hepatitis C infection (Observation Arm). Another primary objective is to compare the efficacy, tolerability and safety of antiviral therapy in posttransplant patients in the two arms. Hepatitis C Drug:Pegylated Interferon alfa-2a in combination with Ribavirin Phase IV Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00087594?order=19 Hoffmann-La Roche The objective of this study is to investigate if patients with Chronic Hepatitis C virus Genotype 1 who are previous intravenous drug users and enrolled in a physician supervised methadone maintenance treatment program can safely tolerate Chronic Hepatitis C treatment consisting of Pegasys plus Copegus. Hepatitis C Drug:Pegylated Interferon alfa-2a in combination with Ribavirin Phase IV Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00089492?order=20 Hoffmann-La Roche The purpose of this study is to evaluate the antiviral activity of Fuzeon (enfuvirtide) 180 mg administered once daily in combination with an Optimized Background (OB) regimen (consisting of 3 to 5 antiretroviral drugs individualized by the physician and the patient based on the patient?s prior treatment history), compared to the currently recommended dosing of Fuzeon 90 mg administered twice daily in combination with an Optimized Background regimen for 48 weeks of treatment. HIV Infections Drug:enfuvirtide Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control Official Title:A Phase II Open-label, Randomized, Active-controlled Study Comparing the Efficacy and Safety of Once Daily Fuzeon (enfuvirtide) Dosing versus the Currently Recommended Twice Daily Dosing in HIV-1 Infected Treatment Experienced Patients
http://www.clinicaltrials.gov/ct/show/NCT00069095?order=21 Hoffmann-La Roche There are two primary purposes of the study. One is to show that the combination of capecitabine plus oxaliplatin (XELOX) with or without bevacizumab is at least as effective as the combination of fluorouracil/leucovorin (5-FU/LV) plus oxaliplatin (FOLFOX-4) with or without bevacizumab in terms of time to tumor progression or death in patients with metastatic colorectal cancer, who have not received previous treatment for metastatic disease. The other is to show that bevacizumab in combination with chemotherapy (XELOX or FOLFOX-4) is better than chemotherapy alone in the same patient population. Metastatic Colorectal Cancer Drug:Capecitabine Phase III Study Type:InterventionalStudy Design:Treatment,Randomized Official Title:A 2x2 (4-way) randomized phase 3 study of capecitabine in combo w/ oxaliplatin (XELOX) w/ or w/out bevacizumab vs. fluorouracil/leucovorin w/ oxaliplatin (FOLFOX-4) w/ or w/out bevacizumab as first-line treatment for pts w/ metastatic colorectal cancer
http://www.clinicaltrials.gov/ct/show/NCT00089479?order=22 Hoffmann-La Roche The purpose of this study is to compare the disease-free survival distributions obtained with 2 different regimens of adjuvant chemotherapy for patients with high-risk breast cancer. Breast Cancer Drug:capecitabine Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label Official Title:A Randomized, Open-Label, Multicenter, Phase III Trial Comparing Regimens of Adriamycin plus Cytoxan Followed by Either Taxotere or Taxotere plus Xeloda as Adjuvant Therapy for Female Patients with High-Risk Breast Cancer
http://www.clinicaltrials.gov/ct/show/NCT00090766?order=23 Hoffmann-La Roche The purposes of this study are to describe the safety and tolerability profile of valganciclovir syrup and tablets in pediatric solid organ transplant recipients, to determine the pharmacokinetics (the body's absorption, distribution, metabolism, and excretion) of ganciclovir following oral administration of valganciclovir syrup and tablets in pediatric solid organ transplant recipients, and to describe the incidence of CMV disease. Cytomegalovirus Infections Drug:valganciclovir hydrochloride Phase II Study Type:InterventionalStudy Design:Treatment Official Title:Safety and Pharmacokinetics of Valganciclovir Syrup Formulation in Pediatric Solid Organ Transplant Recipients
http://www.clinicaltrials.gov/ct/show/NCT00095251?order=1 Vanderbilt University Delirium has recently been shown as a predictor of death, increased cost, and longer length of stay in ventilated patients. Sedative and analgesic medications relieve anxiety and pain, but may contribute to patients transitioning into delirium. It is possible that modifying the paradigm for sedation using novel therapies targeted at different receptors, such as dexmedetomidine targeting alpha2 receptors and sparing the GABA receptors, could provide efficacious sedation yet reduce the development, duration, and severity of acute brain dysfunction (delirium). Delirium Drug:Dexmedetomidine Phase II Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized, Double-blind Trial in Ventilated ICU Patients Comparing Treatment with an Alpha2 Agonist versus a Gamma Aminobutyric Acid (GABA)-Agonist to Determine Delirium Rates, Efficacy of Sedation, Analgesia and Discharge Cognitive Status
http://www.clinicaltrials.gov/ct/show/NCT00088023?order=1 Hudson Health Sciences The purpose of this study is to determine the safety of a short intravenous infusion of PT523 to patients with solid tumors who have failed curative or survival prolonging therapy or for whom no such therapies exist. Neoplasms Drug:PT523 for Injection Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase I Study of PT523 in Patients with Solid Tumors
http://www.clinicaltrials.gov/ct/show/NCT00097435?order=1 Human Genome Sciences This is a Phase 2, multi-center, randomized, open-label study to evaluate the safety, tolerability, and efficacy of Albuferon in subjects with hepatitis C (HEP C) who failed to respond to previous interferon alfa therapy. Hepatitis C Drug:Albuferon plus ribavirin Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study Official Title:A Multi-Center, Randomized, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Albuferon (Recombinant Human Albumin-Interferon Alfa Fusion Protein) in Combination with Ribavirin in Interferon Treatment Experienced Subjects with Chronic Hepatitis C
http://www.clinicaltrials.gov/ct/show/NCT00094848?order=2 Human Genome Sciences The purpose of this study is to evaluate the safety, efficacy and exposure to TRM-1 in subjects with relapsed or refractory Non-Hodgkin's Lymphoma (NHL). Lymphoma, Non-Hodgkin Drug:TRAIL-R1 mAb (TRM-1; HGS-ETR1) Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Multi-Center, Open-Label, Dose-Escalation Study to Evaluate the Safety, Efficacy, and Exposure to TRM-1 (Fully Human Monoclonal Antibody to the TRAIL-R1) in Subjects with Relapsed or Refractory Non-Hodgkins Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00092924?order=3 Human Genome Sciences The purpose of this study is to evaluate the efficacy and safety of TRM-1 in subjects with relapsed or refractory non-small cell lung cancer. Carcinoma, Non-Small-Cell Lung Drug:TRAIL-R1 mAb (TRM-1;HGS-ETR1) Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase 2, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety, and Tolerability of TRM-1 (Fully Human Monoclonal Antibody To TRAIL-R1) in Subjects with Relapsed or Refractory Non-Small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00057265?order=1 Idenix Pharmaceuticals Idenix Pharmaceuticals, Inc is conducting this research study to see if the investigational medication, LdT (Telbivudine), is safe and effective (that is, how well it works by decreasing the level of hepatitis B virus in your blood and improving the condition of your liver) in the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking lamivudine, which is a drug currently approved by the Food and Drug Adminstration (FDA) for the treatment of hepatitis B infection. Chronic Hepatitis B Drug:telbivudine or lamivudine Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00076336?order=2 Idenix Pharmaceuticals Idenix Pharmaceuticals, Inc is conducting this research study to see if the investigational medication, LdT (Telbivudine), is safe and effective (that is, how well it works by decreasing the level of hepatitis B virus in your blood and improving the condition of your liver) in the treatment of decompensated hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking lamivudine, which is a drug currently approved by the Food and Drug Adminstration (FDA) for the treatment of hepatitis B infection. HepatitisHepatitis B, ChronicCirrhosis Drug:Telbivudine (LdT) versus Lamivudine Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Dose Comparison,Parallel Assignment,Safety/Efficacy Study Official Title:Randomized, Double-Blind Trial of Telbivudine versus Lamivudine in Adults with Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
http://www.clinicaltrials.gov/ct/show/NCT00088140?order=1 Idun Pharmaceuticals The purpose of this study is to determine if IDN-6556, when given orally, is safe and effective in patients with chronic hepatitis C virus infection. Hepatitis C, Chronic Drug:IDN-6556 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Dose Response Study of a Caspase Inhibitor in Hepatitis C Patients
http://www.clinicaltrials.gov/ct/show/NCT00080236?order=2 Idun Pharmaceuticals The purpose of the study is to test the safety and effectiveness of IDN-6556 in preventing liver damage that normally occurs when livers are transported before being transplanted and in the immediate post-transplant period. Liver TransplantationHepatitisCholestasisCarcinoma, Hepatocellular Drug:IDN-6556 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:Safety, Tolerability and Efficacy Study of a Caspase Inhibitor, IDN-6556, in Patients Undergoing Orthotopic Liver Transplantation (OLT)
http://www.clinicaltrials.gov/ct/show/NCT00071396?order=1 M.D. Anderson Cancer Center The goal of this clinical research study is to learn if giving CAMPATH-1H with rituximab can shrink or slow the growth of the disease in patients with chronic lymphoid disorders that have either not responded or whose disease has returned after treatment with standard therapies. Chronic Lymphocytic Leukemia Drug:Campath-1HDrug:Rituximab Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Safety/Efficacy Study Official Title:Continuous Infusion Followed by Subcutaneous Injection of Campath-1H Plus Rituximab in the Treatment of CD52- and CD20-Positive Refractory or Relapsed Chronic Lymphoid Disorders
http://www.clinicaltrials.gov/ct/show/NCT00067028?order=2 M.D. Anderson Cancer Center The goal of this clinical research study is to find the best safe dose for 2 different drug combinations. For this purpose, participants will either receive the combination of clofarabine plus idarubicin or clofarabine plus idarubicin and ara-C. Once the best safe dose for these drug combinations are found, the next goal is to compare the drug combinations clofarabine/idarubicin/ara-C, clofarabine/ara-C, and clofarabine/idarubicin in the treatment of patients with acute myeloid leukemia (AML), high-grade myelodysplastic syndrome (MDS), or myeloid blast phase of chronic myeloid leukemia (CML) who have relapsed following their initial therapy. The safety of these treatments will also be studied. Acute Myeloid LeukemiaMyelodysplastic SyndromeChronic Myeloid Leukemia Drug:clofarabineDrug:IdarubicinDrug:Ara-C Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Historical Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Prospective Randomized Phase I/II Study of Clofarabine and Ara-C vs Clofarabine and Idarubicin vs Clofarabine plus Idarubicin and Ara-C in Patients with First Relapse or First Salvage of Primary Refractory acute myeloid leukemia (AML); and High-Grade Myelodysplastic Syndrome (MDS) (>/= 10% Blasts); or with Chronic Myeloid Leukemia (CML) in Myeloid Blasts Phase as Front Line Therapy or in First Salvage Chromosome Positive Chronic Myeloid Leukemia)
http://www.clinicaltrials.gov/ct/show/NCT00081887?order=3 M.D. Anderson Cancer Center The goal of this clinical research study is to find the highest safe dose of clofarabine that can be given on a weekly schedule for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL). The effectiveness of this treatment will also be studied. Chronic Lymphocytic Leukemia Drug:clofarabineDrug:Ara-C Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Safety/Efficacy Study Official Title:Phase I Study of Weekly Clofarabine for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia
http://www.clinicaltrials.gov/ct/show/NCT00088218?order=1 M.D. Anderson Cancer Center Clofarabine is a chemotherapy drug that is designed to interfere with the growth and development of cancer cells. Ara-C is a chemotherapy drug which is approved for the treatment of AML and MDS. Although there is experience with the combination of both drugs, there have not been any phase 1 trials that explored the particular doses and schedule of clofarabine plus ara-C that a patient may receive. Acute Myeloid LeukemiaMyelodysplastic Syndrome Drug:ClofarabineDrug:Ara-C Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Historical Control,Parallel Assignment,Safety/Efficacy Study Official Title:Randomized Phase II Study of Clofarabine alone versus Clofarabine in Combination with Low-Dose Cytarabine (ara-C) in Previously Untreated Patients >= 60 Years with Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
http://www.clinicaltrials.gov/ct/show/NCT00086580?order=2 ILEX Pharmaceuticals This is a Phase III, prospective, multicenter, open-label, randomized, controlled study to evaluate and compare the efficacy and safety of Fludara plus alemtuzumab versus Fludara alone as second-line therapy for patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL). Patients who meet all eligibility criteria and sign the informed consent document may be entered on the study. B-Cell Lymphocytic Leukemia Drug:Alemtuzumab (Campath, MabCampath) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Safety/Efficacy Study Official Title:Phase III Randomized Trial to Evaluate the Efficacy and Safety of Second-Line Therapy with Fludara plus Alemtuzumab (Campath, MabCampath) versus Fludara Alone in Patients with B-Cell Chronic Lymphocytic Leukemia
http://www.clinicaltrials.gov/ct/show/NCT00051701?order=3 ILEX Pharmaceuticals The purpose of this study is to determine the optimal dose of Campath for patients with relapsing or refractory (failed standard therapy) non-Hodgkin's lymphoma. The study will also evaluate the safety of the drug and whether it is effective in treating these patients. Non-Hodgkins Lymphoma Drug:alemtuzumab Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00077961?order=4 ILEX Pharmaceuticals The purpose of this study is to determine the optimal dose of subcutaneous CAMPATH when used in combination with rituximab for patients with relapsing or refractory, low-grade or follicular, CD-20-positive, B-Cell non-Hodgkin's Lymphoma. Safety will be the primary objective of phase I, while the primary objective of phase II will be to determine overall response. Non-Hodgkin's Lymphoma Drug:CAMPATH (alemtuzumab) Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Phase I/II Study of Rituximab plus CAMPATH in Patients with Previously Treated Relapsed or Refractory Low-Grade or Follicular, CD20-positive, B-cell Non-Hodgkin's Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00078026?order=1 ILEX Products Osteoporosis affects millions of postmenopausal women in the USA. The current approved treatments are all drugs that prevent bone loss and possibly result in small gains in bone mass. Another possible treatment consists of drugs that increase bone formation. There are currently two drugs that stimulate bone formation, sodium fluoride and human parathyroid hormone (hPTH). Neither of these two drugs has been approved by the FDA. APOMINE has shown significant bone formation in animal studies. In this study we plan to test whether APOMINE is able to stimulate new bone formation in women with osteoporosis or low bone mass. Osteoporosis Drug:Apomine Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase I/II Randomized Study of the Short-Term Effects of APOMINE vs Placebo in Postmenopausal women with Osteoporosis or Low Bone Mass
http://www.clinicaltrials.gov/ct/show/NCT00081822?order=2 University of Alabama The purpose of this study is to determine the recommended phase II dose of clofarabine when administered in combination with standard dose Ara-C to older (>=60 years of age) patients with newly diagnosed acute myeloid leukemia (AML). Acute Myeloid Leukemia Drug:clofarabineDrug:cytosine arabinoside Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase I/II Study of Clofarabine & Cytosine Arabinoside Therapy for Older Adults with Acute Myeloid Leukemia
http://www.clinicaltrials.gov/ct/show/NCT00082134?order=3 ILEX Products This is a Phase II, non-randomized, open label study of ILX651 in patients with hormone-refractory prostate cancer previously treated with docetaxel. Approximately 40 patients will be enrolled in this study that is expected to last 24 months. All patients will be treated with ILX651 administered IV daily for 5 consecutive days every 21 days. The primary objective of this study is to determine the PSA response rate. The secondary objectives are to determine response of measurable disease, duration of response, time to PSA progression, time to treatment failure, survival, safety and tolerability, and pharmacokinetic profile of ILX651. Hormone-Refractory Prostate Cancer Drug:ILX651 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Every 21 Days in Patients with Hormone-Refractory Prostate Cancer Previously Treated with Docetaxel
http://www.clinicaltrials.gov/ct/show/NCT00068211?order=4 ILEX Products This is a Phase II, non-randomized, open label study of ILX651 in patients with inoperable locally advanced or metastatic melanoma. Approximately 60 patients will be enrolled in this study that is expected to last 18 months. All patients will be treated with ILX651 administered IV daily for 5 consecutive days once every 21 days. The primary objective of this study is to determine the overall response rate for all patients who are treated with ILX651. The secondary objectives are to determine the progression free survival at 18 weeks, duration of response, time to tumor progression, survival, safety/tolerability of ILX651 and to evaluate the pharmacokinetic profile. Melanoma Drug:ILX651 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Once Every 3 Weeks in Patients with Inoperable Locally Advanced or Metastatic Melanoma.
http://www.clinicaltrials.gov/ct/show/NCT00078455?order=5 ILEX Products This is a Phase II, non-randomized, open label study of ILX651 in patients with locally advanced or metastatic non-small cell lung carcinoma (NSCLC). Approximately 60 patients will be enrolled in this study that is expected to last 18 months. All patients will be treated with ILX651 administered intravenously (IV) daily for 5 consecutive days once every 21 days. The primary objective of this study is to determine the overall response rate. The secondary objectives are to determine the progression free survival, duration of response, time to tumor progression, survival, safety/tolerability of ILX651, and to evaluate pharmacokinetic profile. Non-Small-Cell Lung Carcinoma Drug:ILX651 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Once Every 3 Weeks in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma
http://www.clinicaltrials.gov/ct/show/NCT00046696?order=6 ILEX Products A study for patients who have failed standard therapy. If there is no dose limiting toxicities the patients will receive further cycles of therapy if there is no evidence of disease progression. Neoplasms Drug:NM-3 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Safety/Efficacy Study Official Title:A Phase I and Pharmacokinetic Study of NM-3 Administered Orally once or twice Daily on Five Consecutive Days and Repeated Weekly for Six Weeks Every Eight Weeks in Patients with Advanced Solid Tumors.
http://www.clinicaltrials.gov/ct/show/NCT00097214?order=1 ImClone Systems This is a phase II study in previously untreated subjects with histologically or cytologically proven stage IIIB/IV NSCLC designed to determine the efficacy of first line treatment with carboplatin and cetuximab. Non-small cell lung cancer Drug:CetuximabDrug:Carboplatin Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase II Trial of Carboplatin Plus Cetuximab for the Treatment of Stage IIIb/IV Non-Small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00095199?order=2 ImClone Systems This trial is a multicenter, open-label, randomized, phase III study in patients with recurrent or progressive Non-Small Cell Lung Cancer (NSCLC) after failure of an initial platinum-based chemotherapy. Patients will be randomized to one of the following 4 treatment arms: Cetuximab plus Docetaxel, Cetuximab plus Pemetrexed, Docetaxel alone, or Pemetrexed alone. Non-Small-Cell Lung Cancer Drug:DocetaxelDrug:PemetrexedDrug:Cetuximab Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Randomized Phase III Study of Docetaxel or Pemetrexed with or without Cetuximab in Patients with Recurrent or Progressive Non-Small Cell Lung Cancer after Platinum-Based Therapy
http://www.clinicaltrials.gov/ct/show/NCT00063401?order=3 Bristol-Myers Squibb To determine the progression-free survival obtained with cetuximab (C225)/paclitaxel/carboplatin in subjects with newly diagnosed advanced stage ovarian, primary peritoneal, or fallopian tube cancer Ovarian CancerPeritoneal NeoplasmsFallopian Tube Neoplasms Drug:Cetuximab Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase II Study of Cetuximab (C225)/Paclitaxel/Carboplatin for the Initial Treatment of Advanced Stage Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
http://www.clinicaltrials.gov/ct/show/NCT00061815?order=4 ImClone Systems The purpose of this study is to compare overall survival in patients with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with Oxaliplatin, 5-Fluorouracil and Leucovorin (FOLFOX4) and cetuximab with FOLFOX4 alone. Colorectal Cancer Drug:cetuximab Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00063141?order=5 ImClone Systems The purpose of this study is to determine whether overall survival is prolonged in subjects with metastatic, EGFR-positive colorectal cancer treated with cetuximab in combination with irinotecan compared with irinotecan alone as second-line therapy following treatment with a fluoropyrimidine and oxaliplatin based, non-irinotecan-containing regimen. Colorectal Cancer Drug:cetuximab Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00082212?order=6 Bristol-Myers Squibb The purpose of this study is to determine the overall response rate, time to progression, and 1 yr survival with cetuximab in patients with ovarian or primary peritoneal carcinoma. Ovarian Cancer Drug:Cetuximab Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase II Trial of Single-agent Cetuximab Dose Escalated to Rash in Patients with Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
http://www.clinicaltrials.gov/ct/show/NCT00083720?order=7 ImClone Systems Colorectal NeoplasmsMetastasesNeoplasm Drug:Erbitux tm (cetuximab) Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase II Multicenter Study of Erbitux (cetuximab) in Patients with Refractory, EGFR-Negative Metastatic Colorectal Carcinoma
http://www.clinicaltrials.gov/ct/show/NCT00034554?order=8 ImClone Systems Up to 24 patients with stage III or stage IV melanoma will be enrolled. Patients who are currently disease-free but at high risk for relapse are also eligible. Patients will receive vaccinations of gp75 at assigned dose levels. Patients who exhibit serologic and stable/clinical response are eligible to receive booster vaccinations. Patients will be evaluated for safety and efficacy throughout the duration of the study. In this study, the optimal biologically effective dose is defined as the lowest dose of gp75 that results in the production of anti-gp75 antibodies. Malignant Melanoma Vaccine:gp75 DNA vaccine Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Phase I Study of gp75 DNA Vaccine in Patients With AJCC Stage III and IV Melanoma
http://www.clinicaltrials.gov/ct/show/NCT00097227?order=9 ImClone Systems The purpose of the study is to determine if the combination of cetuximab, carboplatin and paclitaxel will shrink a specific type of lung cancer known as non-small cell lung cancer (NSCLC). The safety of this combination will also be evaluated. Non-small cell lung cancer Drug:CetuximabDrug:CarboplatinDrug:Paclitaxel Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized Phase II Trial of Two Dose Schedules of Carboplatin/Paclitaxel/Cetuximab in Stage IIIB/IV Non-small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00051194?order=1 Alcon Research To compare the intraocular pressure(IOP)-lowering efficacy of morning or evening instillations of a combination IOP-lowering therapy in patients with open-angle glaucoma or ocular hypertension. Glaucoma, Open-AngleOcular Hypertension Drug:Combination IOP Lowering Therapy Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A 6-week safety and efficacy study of combination IOP-lowering therapy in patients with open-angle glaucoma or ocular hypertension.
http://www.clinicaltrials.gov/ct/show/NCT00051155?order=2 Alcon Research To compare the safety and IOP-lowering efficacy of TRAVATAN and XALCOM in subjects with open-angle glaucoma or ocular hypertension. Glaucoma, Open-AngleOcular Hypertension Drug:Travoprost (0.004%)Drug:Latanoprost (0.005%)/Timolol (0.5%) Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A 6-week safety and efficacy study of TRAVATAN compared to XALCOM in subjects with open-angle glaucoma or ocular hypertension.
http://www.clinicaltrials.gov/ct/show/NCT00058994?order=3 Alcon Research To demonstrate that anecortave acetate is superior to placebo in maintenance of visual acuity at the 12- and 24-month visits. Macular DegenerationMaculopathy, Age-Related Drug:anecortave acetate Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:An evaluation of safety and efficacy of Anecortave Acetate versus placebo in patients with subfoveal choroidal neovascularization due to exudative age-related macular degeneration.
http://www.clinicaltrials.gov/ct/show/NCT00051129?order=4 Alcon Research To demonstrate that anecortave acetate is superior to placebo in maintenance of visual acuity at the 12- and 24-month visits. Macular DegenerationMaculopathy, Age-RelatedAge-Related MaculopathiesAge-Related MaculopathyMaculopathies, Age-Related Drug:anecortave acetate Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:An evaluation of safety and efficacy of Anecortave Acetate versus placebo in patients with subfoveal choroidal neovascularization due to exudative age-related macular degeneration.
http://www.clinicaltrials.gov/ct/show/NCT00051168?order=5 Alcon Research Long term safety study of TRAVATAN in patients with Open-angle glaucoma or ocular hypertension. Glaucoma, Open-AngleOcular Hypertension Drug:Travoprost (0.004%) Phase IV Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00061503?order=6 Alcon Research The primary objective of this study is to describe the effect of TRAVATAN 0.004% Ophthalmic Solution on aqueous humor dynamics in subjects with a clinical diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT). GlaucomaOcular Hypertension Drug:Travoprost Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Double-Masked, Placebo-Controlled, Paired Comparison Study of the Mechanism of Action of TRAVATAN 0.004% in Subjects with Glaucoma or Ocular Hypertension
http://www.clinicaltrials.gov/ct/show/NCT00065728?order=7 Alcon Research A 24 month study of posterior juxtascleral injections of open label Anecortave Acetate 15mg administered every 6 months. Macular Degeneration Drug:Anecortave Acetate Phase III Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:An Open Label Evaluation of Long Term Efficacy and Safety of Posterior Juxtascleral Injections of Anecortave Acetate 15 mg in Patients with Subfoveal Exudative Age-Related Macular Degeneration (AMD) Who Were Enrolled in Alcon Study C-98-03.
http://www.clinicaltrials.gov/ct/show/NCT00047515?order=8 Alcon Research To compare intraocular pressure lowering effectiveness of a combination drug vs. two individual drugs dosed alone. Open-Angle GlaucomaOcular Hypertension Drug:Alcon Investigational Agent Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Phase III safety and efficacy study to evaluate combination IOP lowering therapy in open angle glaucoma and ocular hypertensive patients C-01-69.
http://www.clinicaltrials.gov/ct/show/NCT00047541?order=9 Alcon Research To compare intraocular pressure lowering effectiveness of a combination drug vs. two individual drugs dosed alone. Open-Angle GlaucomaOcular Hypertension Drug:Alcon Investigational Agent Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Phase III safety and efficacy study to evaluate combination IOP lowering therapy in open angle glaucoma and ocular hypertensive patients C-01-70.
http://www.clinicaltrials.gov/ct/show/NCT00047528?order=10 Alcon Research To compare intraocular pressure lowering effectiveness of a combination drug vs. two individual drugs dosed alone. Open-Angle GlaucomaOcular Hypertension Drug:Alcon Investigational Agent Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Phase III safety and efficacy study to evaluate combination IOP lowering therapy in open angle glaucoma and ocular hypertensive patients (C-02-41).
http://www.clinicaltrials.gov/ct/show/NCT00047606?order=11 Alcon Research The purpose of this study is to evaluate safety and efficacy of two different IOP lowering medications after six weeks of treatment in Caucasian and Japanese subjects. Open-Angle GlaucomaOcular Hypertension Drug:IOP Lowering Medications Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Phase 4 study to compare two different IOP lowering medications for the treatment of Open Angle Glaucoma or Ocular Hypertension in Caucasian and Japanese Subjects C-02-32.
http://www.clinicaltrials.gov/ct/show/NCT00069706?order=12 Alcon Research The purpose of this study is to determine the safety and IOP-lowering ability of a glaucoma therapy in patients with open-angle glaucoma or ocular hypertension. Open-Angle GlaucomaOcular Hypertension Drug:Glaucoma therapy Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00047554?order=13 Alcon Research To monitor iris pigmentation changes over a five year period in subjects with open-angle glaucoma or ocular hypertension who have experienced an iris pigmentation change while dosing with TRAVATAN. Open-Angle GlaucomaOcular Hypertension Drug:TRAVATAN (travoprost ophthalmic solution) 0.004% Phase IV Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:A Phase IV safety study of TRAVATAN 0.004% in subjects with TRAVATAN induced iris pigmentation changes C-01-79.
http://www.clinicaltrials.gov/ct/show/NCT00061516?order=14 Alcon Research To evaluate the safety and efficacy of both BETAXON and AZOPT in pediatric patients. Patients will dose with study drug at 8 am and 8 pm daily for twelve weeks. Patients will have vision tested, slit lamp exam, blood pressure and pulse checks at each visit. Patients will have a dilated fundus exam and corneal measurements taken at first and last visit. GlaucomaOcular Hypertension Drug:BETAXON (levobetaxolol HCl)Drug:AZOPT (brinzolamide) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Study start:January 2003
http://www.clinicaltrials.gov/ct/show/NCT00061542?order=15 Alcon Research To evaluate the safety and efficacy of BETOPTIC S and Timolol Gel-forming solution in pediatric patients. Patients will dose with study drug at 8 am and 8 pm daily for twelve weeks. Patients will have vision tested, slit lamp exam, blood pressure and pulse checks at each visit. Patients will have a dilated fundus exam and corneal measurements taken at first and last visit. GlaucomaOcular Hypertension Drug:BETOPTIC S (betaxolol HCl)Drug:Timolol Gel-forming Solution (timolol maleate) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Study start:January 2003
http://www.clinicaltrials.gov/ct/show/NCT00051181?order=16 Alcon Research To demonstrate that the intraocular pressure(IOP)-lowering efficacy of Travoprost (0.004%) is equal or better than that of Latanoprost 0.005% in patients with chronic angle-closure glaucoma. Glaucoma, Angle-ClosureOcular Hypertension Drug:Travoprost (0.004%)Drug:Latanoprost (0.005%) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A safety and efficacy study of Travoprost 0.004% compared to Latanoprost 0.005% in patients with chronic angle-closure glaucoma.
http://www.clinicaltrials.gov/ct/show/NCT00051142?order=17 Alcon Research To evaluate the safety and IOP-lowering efficacy of Travoprost (0.004%) compared to Latanoprost (0.005%) in patients with chronic open-angle glaucoma or ocular hypertension. Glaucoma, Open-AngleOcular Hypertension Drug:TravoprostDrug:Latanoprost Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A safety and efficacy study of Travoprost 0.004% compared to Latanoprost 0.005% in patients with open-angle glaucoma or ocular hypertension.
http://www.clinicaltrials.gov/ct/show/NCT00083538?order=1 University of Arkansas The purpose of this study is to determine if vaccination with autologous idiotype- or tumor lysate-pulsed dendritic cells induces the generation of anti-idiotypic and anti-tumor immunologic responses. Multiple Myeloma Drug:DexamethasoneDrug:ThalidomideDrug:CisplatinumDrug:AdriamycinDrug:CyclophosphamideDrug:Etoposide Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:UARK 2000-46, A Phase II Study of Tumor Antigen-Pulsed Autologous Dendritic Cell Vaccination Administrated Subcutaneously or Intranodally in Multiple Myeloma Patients
http://www.clinicaltrials.gov/ct/show/NCT00054834?order=1 Immunomedics, Inc. The purpose of this trial is to determine the safety of 90Y-hLL2 at different dose levels in the treatment of Non-Hodgkin's lymphoma. Non-Hodgkins Lymphoma Drug:hLL2 (epratuzumab) Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Single Group Assignment,Safety Study Official Title:A Phase I Clinical Trial of Radiolabeled Immunotherapy with Humanized LL2 in Patients with Refractory or Recurrent Non-Hodgkin's Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00067392?order=1 The purpose of this study is to determine the difference in success when placing implants immediately into an extraction site compared to delaying the implant placement until the extraction site has healed. In addition, the level of bone around the implants will be compared to determine if one method leads to better results over time. Dental Caries Procedure:Dental Implant Phase III Study Type:InterventionalStudy Design:Educational/Counseling/Training,Randomized,Single Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Prospective Evaluation of Immediate Temporized Implants
http://www.clinicaltrials.gov/ct/show/NCT00041574?order=1 INO Therapeutics The purpose of this program is to evaluate the logistic issues and patient requirements for chronic pulsed INOmax delivery in ambulatory, home-care patients. To understand patient needs, patients with a variety of underlying diseases will be included. Safety of chronic therapy will be monitored by serial measurements of methemoglobin, platelet function assay and reported adverse events. Pulmonary HypertensionLung DiseaseSickle Cell DiseaseCardiac transplantLung transplant Drug:INOmax (nitric oxide for inhalation) Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study
http://www.clinicaltrials.gov/ct/show/NCT00041561?order=2 INO Therapeutics The purpose of this study is to determine the effect of nitric oxide for inhalation on the duration of mechanical ventilation in pediatric patients with AHRF. Respiratory InsufficiencyAnoxemia Drug:INOmax (nitric oxide for inhalation) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00060840?order=3 INO Therapeutics Congestive Heart Failure Drug:INOmax (nitric oxide) for inhalation Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00041548?order=4 INO Therapeutics The purpose of this pilot study is to evaluate whether administration of nitric oxide (NO)gas by oxygen hood at 20 ppm significantly increases PaO2, as compared to placebo gas (oxygen), within one hour of initiation and with no significant adverse effects. Lung DiseaseHypoxemiaRespiratory Acidosis Drug:INOmax (nitric oxide for inhalation) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Crossover Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00060450?order=5 INO Therapeutics The purpose of this study is to evaluate the effects of inhaled nitric oxide on both short-term physiology as well as on the development of ischemia-reperfusion lung injury (IRLI) in the immediate post transplant period. The specific hypothesis is that inhaled NO post lung transplantation will improve gas exchange/hemodynamic and thus reduce the development of post transplant IRLI. Ischemia-Reperfusion Injury Drug:INOmax (nitric oxide for inhalation) Phase III Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Crossover Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00008437?order=1 InSightec-TxSonics stage I breast cancerstage II breast cancerstage IIIA breast cancer Procedure:MRI-guided focused ultrasound ablation Phase II Study Type:InterventionalStudy Design:Treatment Official Title:Phase II Pilot Study of MRI-Guided Focused Ultrasound Ablation in Women With Stage I-IIIA Breast Cancer
http://www.clinicaltrials.gov/ct/show/NCT00091637?order=1 Procter & Gamble Pharmaceuticals In the setting of reperfusion therapy in an acute myocardial infarction using primary percutaneous intervention (PCI), the body's own inflammatory system involving the complement cascade may be harmful. This study will test the safety and efficacy of a novel complement inhibitor, pexelizumab to reduce mortality at 90 days. Acute Myocardial Infarction Drug:PexelizumabProcedure:Angioplasty Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:APEX-AMI
http://www.clinicaltrials.gov/ct/show/NCT00088179?order=2 Alexion Pharmaceuticals During a heart bypass procedure, a substance called "complement" is activated by the body. This "complement activation" causes an inflammatory response that can lead to side affects such as chest pain, heart attacks, stroke, heart failure, or death. The purpose of this study is to find out if the study drug (pexelizumab), that blocks "complement activation," can reduce such side effects and be given safely to patients requiring the bypass procedure with the use of the heart-lung machine. Coronary Artery Disease Drug:pexelizumab in conjunction with CABG Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Multicenter, Randomized, Double-Blind, Parallel-group, Placebo-Controlled Study of Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting with Cardiopulmonary Bypass (PRIMO-CABG II)
http://www.clinicaltrials.gov/ct/show/NCT00083967?order=1 Inspire Pharmaceuticals The purpose of this study is to test if denufosol will remove the fluid build-up in the eye so that the retina can be re-attached without invasive surgery. Retinal Detachment Drug:denufosol tetrasodium (INS37217) Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized, Double-Masked, Placebo Controlled, Parallel Group, Multi-Center, Dose-Ranging Study of Denufosol Tetrasodium (INS37217) Intravitreal Injection in Subjects with Rhegmatogenous Retinal Detachment
http://www.clinicaltrials.gov/ct/show/NCT00097344?order=1 Intarcia Therapeutics The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination of an experimental drug, atamestane, plus an FDA-approved drug, toremifene (Fareston), is more effective than another approved drug, letrozole (Femara), in delaying the growth of breast cancer, and whether the side effects of the combined hormonal therapy are different from the side effects of letrozole. Breast NeoplasmsNeoplasms, Hormone-Dependent Drug:AtamestaneDrug:ToremifeneDrug:LetrozoleDrug:Aromatase inhibitionDrug:Estrogen receptor blockerProcedure:Hormone therapyProcedure:Endocrine therapyProcedure:Antiestrogen therapy Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Phase 3 Study of Atamestane Plus Toremifene versus Letrozole in Advanced Breast Cancer
http://www.clinicaltrials.gov/ct/show/NCT00097045?order=2 Intarcia Therapeutics This study is designed to compare the safety, tolerability and antiviral effects of omega interferon administered alone to omega interferon administered with ribavirin in the treatment of subjects with chronic Hepatitis C virus (HCV) infection. Hepatitis C Drug:omega interferonDrug:Ribavirin Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Phase 2 Study of Omega Interferon Alone or in Combination with Ribavirin in Subjects with Hepatitis C
http://www.clinicaltrials.gov/ct/show/NCT00084279?order=1 InterMune To evaluate the safety and tolerability of two different doses of Consensus Interferon-Alpha and Interferon Gamma-1b with or without ribavirin in patients with chronic hepatitis C who are non-responders to PEG-IFN-a 2a or PEG-IFN-a 2b plus ribavirin. Chronic Hepatitis C Drug:Consensus Interferon-Alpha, Interferon Gamma-1b, Ribavirin Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety Study Official Title:Safety and Tolerability of Consensus Interferon-Alpha (CIFN) plus Interferon Gamma-1b (IFN-? 1b) with or without Ribavirin (RBV) in the Treatment of Patients with Chronic Hepatitis C who are Non-responders to PEG-IFN-a (2a or 2b) plus RBV
http://www.clinicaltrials.gov/ct/show/NCT00086541?order=2 InterMune The purpose of this study is to evaluate the safety and efficacy of two different dose levels of Interferon Alfacon-1 with Ribavirin administered daily in Hepatitis C infected patients who are nonresponders to previous pegylated Interferon Alfa plus Ribavirin therapy. Chronic Hepatitis C Drug:Interferon Alfacon-1, Ribavirin Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study Official Title:Phase 3 Safety and Efficacy Study of Two Dose Levels of Interferon Alfacon-1 plus Ribavirin Daily for 48 Weeks vs No-treatment in Hepatitis C Infected Patients (Nonresponders to Previous Pegylated Interferon Alfa plus Ribavirin)
http://www.clinicaltrials.gov/ct/show/NCT00075998?order=3 InterMune Idiopathic Pulmonary FibrosisLung DiseasePulmonary Fibrosis Drug:Interferon gamma-1b ("Actimmune") Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Interferon gamma-1b in Patients with Idiopathic Pulmonary Fibrosis (The INSPIRE Trial)
http://www.clinicaltrials.gov/ct/show/NCT00080223?order=4 InterMune Idiopathic Pulmonary FibrosisPulmonary Fibrosis Drug:Pirfenidone Phase II Study Type:InterventionalStudy Design:Treatment,Open Label,Safety/Efficacy Study Official Title:An Open-Label, Phase 2 Study of the Safety and Efficacy of Oral Pirfenidone in Patients with Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis
http://www.clinicaltrials.gov/ct/show/NCT00063583?order=5 Sharma, Kumar, M.D. The purpose of this study is to determine whether a new investigational drug, pirfenidone, will be an effective therapy for diabetic patients with kidney dysfunction. Our hypothesis is that administration of pirfenidone to type 1 and type 2 diabetic patients with advanced kidney disease will lead to preservation of kidney function. Diabetes MellitusDiabetic Nephropathy Drug:Pirfenidone Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Factorial Assignment,Efficacy Study Official Title:Pirfenidone: A Novel Anti-Scarring Therapy for Diabetic Nephropathy
http://www.clinicaltrials.gov/ct/show/NCT00040716?order=1 Introgen Therapeutics Head and Neck Cancer Drug:Ad5CMV-p53 geneDrug:cisplatinDrug:docetaxelDrug:fluorouracilProcedure:chemotherapyProcedure:gene therapy Phase III Study Type:InterventionalStudy Design:Treatment Official Title:Phase III Randomized Study of Cisplatin and Fluorouracil With Versus Without Ad5CMV-p53 Gene Therapy (INGN 201) in Patients With Unresectable Recurrent Squamous Cell Carcinoma of the Head and Neck (T302)
http://www.clinicaltrials.gov/ct/show/NCT00040703?order=2 Introgen Therapeutics Head and Neck Cancer Drug:Ad5CMV-p53 geneDrug:methotrexateProcedure:chemotherapyProcedure:gene therapy Phase III Study Type:InterventionalStudy Design:Treatment Official Title:Phase III Randomized Study of Ad5CMV-p53 Gene Therapy (INGN 201) Versus Methotrexate in Patients With Refractory Squamous Cell Carcinoma of the Head and Neck (T301)
http://www.clinicaltrials.gov/ct/show/NCT00041626?order=3 Introgen Therapeutics There is a need for more treatment options for patients with recurrent squamous cell cancer of the head and neck (SCCHN). These tumors usually have a variety of genetic defects that include disruption of the p53 pathway, a pathway that would ordinarily work to prevent the development of tumors. In this study the transfer of the p53 gene to tumor cells using a modified adenovirus (INGN 201) in combination with chemotherapy (cisplatin and fluorouracil) will be compared to chemotherapy with cisplatin and fluorouracil in patients who have failed surgery and radiotherapy. Carcinoma, Squamous Cell Gene Transfer:INGN 201 Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00041613?order=4 Introgen Therapeutics There is a need for more treatment options for patients with recurrent squamous cell cancer of the head and neck (SCCHN). These tumors usually have a variety of genetic defects that include disruption of the p53 pathway, a pathway that would ordinarily work to prevent the development of tumors. In this study the transfer of the p53 gene to tumor cells using a modified adenovirus (INGN 201) will be compared to methotrexate in patients who have failed surgery, radiotherapy and chemotherapy with platinum or taxanes. Carcinoma, Squamous Cell Gene Transfer:INGN 201 Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00071552?order=1 IVAX Research The primary objective of this study is to evaluate the effect of Beclomethasone dipropionate HFA on small airways compared to Fluticasone propionate powder for inhalation administered twice daily to poorly controlled asthmatics. Asthma Drug:Beclomethasone dipropionate HFA Phase IV Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00094016?order=2 IVAX Research The primary objective of this study is to compare the QVAR-Easi-Breathe 100 mcg/day and QVAR-Easi-Breathe 200 mcg/day with placebo relative to changes in forced expiratory volume in 1 second (FEV1) results following 12 weeks of treatment. Secondary objectives such as daily asthma symptoms scores (per week), morning peak expiratory flow (PEF) values, nocturnal awakening and utilization of rescue medication per day also will be evaluated. In addition, an exploratory evaluation will assess the comparability of the two devices (i.e., QVAR-Easi-Breathe versus QVAR-MDI) at the same dose levels. Asthma Drug:beclomethasone dipropionate Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Parallel Assignment,Safety/Efficacy Study Official Title:Safety and Efficacy Evaluation of Two Doses of HFA-Propelled Beclomethasone Dipropionate (QVAR) versus Placebo by Breath Operated and Metered Dose Inhalers in Mild to Moderate Asthmatic Children
http://www.clinicaltrials.gov/ct/show/NCT00034814?order=3 IVAX Research This study is to see if talampanel helps and is safe to use on adults with partial seizures. Epilepsy Drug:Talampanel Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00062504?order=4 IVAX Research Approximately 91 patients with high grade gliomas will be evaluated. The primary objective is to determine if Talampanel can significant delay progression in patient by measuring the number of patient who are progression free at 6 months after dosing. Glioblastoma MultiformeAnaplastic AstrocytomaAnaplastic OligodendrogliomaAnaplastic Mixed Oligoastrocytoma Drug:Talampanel Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00071539?order=5 IVAX Research Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be effective in treating malignant glioma. Recurrent Glioblastoma Multiforme Drug:TP-38 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00003034?order=1 Alfacell localized malignant mesotheliomaadvanced malignant mesotheliomarecurrent malignant mesothelioma Drug:doxorubicinDrug:ranpirnaseProcedure:chemotherapy Phase III Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00006195?order=1 The overall purpose of this research is to look at how two of the most commonly prescribed newer antipsychotic medications, risperidone and olanzapine, affect substances in the body such as glucose and insulin. Undesirable changes in blood sugar control, or glucose regulation, and type 2 diabetes can occur more commonly in individuals with schizophrenia compared to healthy subjects and subjects with other psychiatric conditions. While abnormalities in glucose regulation were first reported in schizophrenia before the introduction of antipsychotic medications, antipsychotic treatment may contribute significantly to abnormalities in glucose regulation. Attention to the way that antipsychotic medications may affect glucose regulation has increased as doctors have become more concerned in general about disease- and drug-related medical complications, including weight gain during antipsychotic treatment. Schizophrenia Drug:risperidoneDrug:olanzapine Study Type:InterventionalStudy Design:Treatment,Open Label
http://www.clinicaltrials.gov/ct/show/NCT00082602?order=2 Janssen Pharmaceutica The purpose of this study is to evaluate the safety and tolerability of an extended release formulation of the drug galantamine using a rapid dose escalation regimen. Alzheimer's Disease Drug:galantamine ER Phase III Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Safety Study Official Title:Galantamine ER Open Label Rapid Dose Escalation Trial in Alzheimers Disease
http://www.clinicaltrials.gov/ct/show/NCT00086112?order=3 Janssen Pharmaceutica This is a medical research study using a drug called Risperdal (risperidone) in subjects with Generalized Anxiety Disorder. Anxiety Disorders Drug:Risperidone Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind Official Title:A Double-Blind Study Comparing Adjunctive Risperidone versus Placebo in Generalized Anxiety Disorder that Is Not Responding to Standard Therapy
http://www.clinicaltrials.gov/ct/show/NCT00095134?order=4 Janssen Pharmaceutica The purpose of this trial is to evaluate the efficacy and safety of risperidone versus placebo in subjects with Major Depressive Disorder with sub-optimal response to antidepressant therapy. Major Depressive Disorder Drug:risperidone Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Double-Blind Study Comparing Adjunctive Risperidone versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy
http://www.clinicaltrials.gov/ct/show/NCT00097032?order=5 Janssen Pharmaceutica The purpose of this study is to determine whether the sedating (causing sleepiness) effects of risperidone or quetiapine alter cognitive (person's ability to think, perceive, recognize, remember, judge, and reason) functioning in subjects with stable Bipolar I Disorder. Bipolar Disorder Drug:risperidoneDrug:quetiapine Phase IV Study Type:InterventionalStudy Design:Educational/Counseling/Training,Randomized,Double-Blind,Active Control,Crossover Assignment,Safety Study Official Title:Differences in Cognitive Function Due to Acute Sedative Effects of Risperidone and Quetiapine in Stable Bipolar I Outpatients
http://www.clinicaltrials.gov/ct/show/NCT00097708?order=1 Jazz Pharmaceuticals The purpose of this study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder. Anxiety Disorder Drug:experimental anti-anxiety drug Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Double-Blind, Placebo Controlled Trial of an Experimental Medication For the Treatment of Generalized Anxiety Disorder
http://www.clinicaltrials.gov/ct/show/NCT00097695?order=1 Jerini AG The purpose of this study is to assess the efficacy and safety of Icatibant, a bradykinin antagonist in the treatment of acute cutaneous and/or abdominal attacks in patients with hereditary angioedema (HAE). Angioedema Drug:Icatibant Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:Randomized, Double Blind, Placebo-Controlled, Multicenter Study of a Subcutaneous Formulation of Icatibant for the Treatment of Hereditary Angioedema
http://www.clinicaltrials.gov/ct/show/NCT00078039?order=1 Johnson & Johnson Pharmaceutical Research and Development, L.L.C. The primary objective of the double blind phase of this study is to evaluate the efficacy and safety of 3 fixed dosages of extended release (ER) OROS paliperidone (6, 9, and 12 mg/day) compared with placebo in subjects with schizophrenia. The efficacy response will be measured by the change in the Positive and Negative Syndrome Scale (PANSS) total score from start of treatment to the end of double blind phase. Schizophrenia Drug:Paliperidone Phase III Study Type:InterventionalStudy Design:Educational/Counseling/Training,Randomized,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized, Double-blind, Placebo- and Active-controlled Parallel Group Study to Evaluate the Efficacy and Safety of 3 Fixed Dosages of Extended Release OROS Paliperidone (6, 9, and 12mg/day) and Olanzapine (10mg/day) with Open-label Extension in the Treatment of Subjects with Schizophrenia
http://www.clinicaltrials.gov/ct/show/NCT00094926?order=2 Johnson & Johnson Pharmaceutical Research and Development, L.L.C. This is a prospective double-blind, multi-center trial designed to evaluate the efficacy of Risperdal CONSTA as augmentation therapy of treatment-as-usual in adult subjects with frequently relapsing bipolar disorder. Bipolar Disorder Drug:Addition of Risperidal CONSTA to treatment-as-usual Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Prospective, Randomized, Double-blind, Placebo-controlled Study of the Effectiveness and Safety of Risperidal CONSTA Augmentation in Adult Patients with Frequently-relapsing Bipolar Disorder
http://www.clinicaltrials.gov/ct/show/NCT00034749?order=3 Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Schizophrenia Drug:Risperidone Phase III Study Type:InterventionalStudy Design:Treatment Study start:April 2001
http://www.clinicaltrials.gov/ct/show/NCT00086684?order=4 ALZA The purpose of this research study is to test two doses of a drug called ELMIRON (pentosan polysulfate sodium). ELMIRON has been approved by the U.S. FDA for the relief of bladder pain or discomfort associated with interstitial cystitis (IC). You may not be on other medications that could affect your IC symptoms such as antihistamines, antidepressants, anticholingergics, or antispasmodics. Interstitial Cystitis Drug:ELMIRONDrug:Placebo Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study Official Title:Multi-center, Randomized, Double-blind, PBO-controlled Parallel Evaluation of the Efficacy and Tolerability of ELMIRON
http://www.clinicaltrials.gov/ct/show/NCT00072670?order=5 Johnson & Johnson Pharmaceutical Research and Development, L.L.C. This is a study to test the safety and effectiveness of an investigational chemotherapy agent in men with advanced prostate cancer. After a subject meets all entry criteria and signs informed consent he will be enrolled in the study. Participants will be required to attend regular clinic visits to receive study medication and have their status monitored. They will also be required to have PSA levels measured multiple times throughout the study. A detailed explanation can be provided by the investigator conducting this study. Prostate Cancer Drug:ET-743 (YONDELIS) Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00083668?order=6 Johnson & Johnson Pharmaceutical Research and Development, L.L.C. The primary objective of the double-blind phase of this study is to evaluate the efficacy and safety of 3 fixed dosages of ER OROS paliperidone(3, 9, and 15mg/day) compared with placebo in subjects with schizophrenia. The efficacy response will be measured by the change in the Positive and Negative Syndrome Scale (PANSS) total score from start of treatment to the end of the double-blind phase. Schizophrenia Drug:Paliperidone Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized, Double-Blind, Placebo-and Active-Controlled, Parallel-Group, Dose-Response Study to Evaluate the Efficacy and Safety of 3 Fixed Dosages of Extended Release OROS Paliperidone (3, 9 and 15 mg/day) and Olanzapine (10mg/day), with Open-Label Extension, in the Treatment of Subjects with Schizophrenia
http://www.clinicaltrials.gov/ct/show/NCT00088075?order=7 Johnson & Johnson Pharmaceutical Research and Development, L.L.C. This clinical study is to evaluate the efficacy, safety and tolerability of 2 doses range of Risperidone (1-3 mg/day, and 4-6 mg/day) versus placebo (an inactive substance like a sugar pill) in adolescents (age 13-17) with Schizophrenia (i.e. abnormal behavior and thoughts). The trial is about 6-7 weeks. Schizophrenia Drug:Risperidone Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized, Double-blind, Placebo-Controlled Clinical Study of the Efficacy and Safety of Risperidone for the Treatment of Schizophrenia in Adolescents
http://www.clinicaltrials.gov/ct/show/NCT00051753?order=8 Johnson & Johnson Pharmaceutical Research and Development, L.L.C. The purpose of this study is to demonstrate non-inferiority of levofloxacin compared with amoxicillin/clavulanate on the clinical response at the end of therapy in infants and children who have recurrent and/or persistent acute otitis media. Otitis Media Drug:LevofloxacinDrug:Augmentin ES-600 Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Single Group Assignment,Safety/Efficacy Study Official Title:A Multicenter, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Levofloxacin in the Treatment of Children Who Have Recurrent and/or Persistent Acute Otitis Media
http://www.clinicaltrials.gov/ct/show/NCT00091910?order=9 Johnson & Johnson Pharmaceutical Research and Development, L.L.C. A randomized trial to determine whether giving epoetin alfa to treat anemia in critically ill patients admitted to ICUs, results in fewer blood transfusions given. A subject's participation in the study will last about 5 months. Subjects will receive up to 3 weekly doses of epoetin alfa or placebo while they are in the hospital. Once discharged from the hospital, subjects will be seen periodically for blood tests and a physical exam. Anemia Drug:epoetin alfa Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00085748?order=10 Johnson & Johnson Pharmaceutical Research and Development, L.L.C. This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study. The study consists of a screening phase, a double-blind treatment phase, and an optional open-label treatment phase. For administrative purposes, the screening and the double-blind treatment phases together are named R076477-SCH-302 and the open-label treatment phase is named R076477-SCH-702. The primary objective of the study is to evaluate the safety and tolerability of flexible dosages of Extended Release (ER) OROS paliperidone as compared with placebo in subjects with schizophrenia who are 65 years of age or older. The primary objective of the open-label extension is the long-term assessment of safety and tolerability of ER OROS paliperidone in subjects diagnosed with schizophrenia. Schizophrenia Drug:paliperidone Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety Study
http://www.clinicaltrials.gov/ct/show/NCT00091442?order=11 Johnson & Johnson Pharmaceutical Research and Development, L.L.C. This study will evaluate the safety and effectiveness of a combination of doxorubicin HCl liposome injection (DOXIL/CAELYX) and docetaxel in women with recurrent advanced breast cancer who received anthracycline in the adjuvant or neoadjuvant setting. The safety and effectiveness of the combination will be compared to treatment with docetaxel alone (monotherapy). The purpose of this research study is to determine if overall survival for the docetaxel and DOXIL/CAELYX treated group is longer than that for the group treated with docetaxel alone. Additional comparisons between the two treatment groups include: response rate (how much your tumor shrinks in response to the drug), time to progression, safety, and quality of life. Cancer of Breast Drug:DOXIL/CAELYXDrug:Docetaxel Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Parallel Assignment Official Title:A Randomized Controlled Study of Docetaxel Monotherapy or DOXIL/CAELYX and Docetaxel for the Treatment of Advanced Breast Cancer
http://www.clinicaltrials.gov/ct/show/NCT00060944?order=12 Johnson & Johnson Pharmaceutical Research and Development, L.L.C. This is a study to test the safety and effectiveness of an investigational chemotherapy agent in subjects with advanced liposarcoma or leiomyosarcoma. Subjects who meet all entry criteria and have signed the informed consent will be enrolled in the study. Participants will be required to attend regular clinic visits to receive study medication and have their status monitored. They will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation can be provided by the investigator conducting the study LiposarcomaLeiomyosarcoma Drug:ET743 I.V. administration Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized, Multicenter,Open-label Study of YONDELIS, ET-743 (ecteinascidin) Administered by Two Different Schedules (Weekly for 3 of 4 Weeks vs. q3 Weeks) in Subjects With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma Following Treatment with an Anthracycline and Ifosfamide
http://www.clinicaltrials.gov/ct/show/NCT00086320?order=13 Johnson & Johnson Pharmaceutical Research and Development, L.L.C. The purpose of this study is to determine the efficacy and safety of OROS paliperidone compared with placebo in the prevention of recurrence of symptoms of schizophrenia. Schizophrenia Drug:ER OROS Paliperidone Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety/Efficacy Study Official Title:A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study With An Open-Label Extension Evaluating Extended Release OROS Paliperidone in the Prevention of Recurrence in Subjects With Schizophrenia
http://www.clinicaltrials.gov/ct/show/NCT00077727?order=14 Johnson & Johnson Pharmaceutical Research and Development, L.L.C. This is an exploratory study which will evaluate Galantamine in cognitive deficits (learning) in patients with schizophrenia. The trial will last for 8 weeks. Efficacy and safety will be studied. The patients must be on a stable dose of an antipsychotic and smoke cigarettes. Schizophrenia Drug:Galantamine ER Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Primary Outcomes:Computerized Cognitve test battery
http://www.clinicaltrials.gov/ct/show/NCT00076115?order=15 Johnson & Johnson Pharmaceutical Research and Development, L.L.C. The purpose of this study is to determine the safety and effectiveness of Risperidone compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and adolescents ages 10-17 years. Bipolar Disorder Drug:Risperidone Phase III Study Type:InterventionalStudy Design:Treatment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00093990?order=16 Johnson & Johnson Pharmaceutical Research and Development, L.L.C. This study tests the effectiveness of tipifarnib in older patients with acute myeloid leukemia. In this study, half the patients will receive tipifarnib and the other half of the patients will receive the standard treatment of the hospital. Myeloid LeukemiaAcute Disease Procedure:Bone marrow aspirateDrug:Tipifarnib Phase III Study Type:InterventionalStudy Design:Treatment Official Title:A Randomized Study of Tipifarnib Versus Best Supportive Care (Including Hydroxyurea) in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) in Subjects 70 Years or Older (Farnesyl transferase Inhibition Global Human Trials AML 301 [F.I.G.H.T. AML 301])
http://www.clinicaltrials.gov/ct/show/NCT00074997?order=17 Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Phase II trial to determine safety and efficacy of an anti-HIV-1 gene transfer product. HIV Infections Gene Transfer:OZ1 (anti-HIV-1 gene) Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized Phase II, Double-blind, Controlled Trial to Evaluate the Safety and Efficacy of Autologous CD34+ Hematopoietic Progenitor Cells Transduced with Placebo or an Anti-HIV-1 Ribozyme (OZ1) in Patients with HIV-1 Infection
http://www.clinicaltrials.gov/ct/show/NCT00093197?order=1 KAI Pharmaceuticals Restoring blood flow to coronary arteries as quickly as possible is the best way to reduce the damage to the muscle that occurs with a heart attack. However, up to 25-50% of patients who have angioplasty may have ongoing damage to the heart muscle when the blockage is opened and blood flow is restored. Complications which may result from this ongoing damage include a larger area of damaged muscle in the heart, enlargement of the heart, an increased risk of death, and an increased risk of heart failure. Some of the ongoing damage may involve increased levels of the protein kinase C (PKC) enzyme. KAI-9803 is a selective inhibitor of delta PKC. In this study, delta PKC is used with angioplasty and other standard procedures to restore blood flow after a heart attack. This study is designed to evaluate safety of different amounts of KAI-9803 when used in treating heart attack patients undergoing angioplasty. We will also try to evaluate whether KAI-9803 can reduce the amount of heart muscle damage and the complications that may occur in these patients. Myocardial Infarction Drug:KAI-9803 for Injection Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety Study Official Title:Intracoronary KAI-9803 for Injection as an Adjunct to Primary Percutaneous Coronary Intervention for Acute ST-Elevation Myocardial Infarction
http://www.clinicaltrials.gov/ct/show/NCT00079638?order=1 Kos Pharmaceuticals The purpose of this study is to evaluate the effectiveness of first-line treatment using Niaspan (an extended release version of niacin) and statins versus other drugs that lower lipid levels, in subjects with elevated fat levels in their blood (dyslipidemia). Statins are a class of medication that is often prescribed to patients who need to lower their cholesterol levels. DyslipidemiaCoronary Heart DiseaseAtherosclerosisStrokeDiabetes Drug:NiacinDrug:AtorvastatinDrug:SimvastatinDrug:EzetimibeDrug:Rosuvastatin Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study Official Title:Comparative Efficacy Evaluation of Lipid Levels when Treated with Niaspan and Statin or Other Lipid-Modifying Therapies
http://www.clinicaltrials.gov/ct/show/NCT00071266?order=2 Kos Pharmaceuticals Intermittent ClaudicationPeripheral Vascular Disease Drug:Niacin Extended Release and Lovastatin Tablets Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients with Intermittent Claudication a Matrix Design
http://www.clinicaltrials.gov/ct/show/NCT00062556?order=3 Kos Pharmaceuticals Intermittent ClaudicationPeripheral Vascular Disease Drug:Niacin Extended Release and Lovastatin Tablets Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Dose Comparison,Parallel Assignment,Safety/Efficacy Study Official Title:Effect of Niacin ER/Lovastatin on Peak Walking Time in Patients with Intermittent Claudication
http://www.clinicaltrials.gov/ct/show/NCT00080275?order=4 Kos Pharmaceuticals Coronary Heart DiseaseDyslipidemiaAtherosclerosisHypercholesterolemiaStroke Drug:Niacin Extended-Release and simvastatinDrug:Zocor (simvastatin) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:An Open-Label Evaluation of the Safety and Efficacy of a Combination of Niacin ER and Simvastatin in Patients with Dyslipidemia (OCEANS)
http://www.clinicaltrials.gov/ct/show/NCT00082251?order=5 Kos Pharmaceuticals Dyslipidemia Drug:Niacin extended release and simvastatin Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:The Safety and Efficacy of a Combination of Niacin ER and Simvastatin in Patients with Dyslipidemia: A Dose-Ranging Study
http://www.clinicaltrials.gov/ct/show/NCT00089804?order=1 La Jolla Pharmaceutical Company The primary purpose of this study is to determine whether LJP 394 is more effective than placebo in delaying time to renal flare in SLE patients with a history of renal disease. Lupus Erythematosus, SystemicLupus Nephritis Drug:abetimus sodium (LJP 394) Phase IV Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 100 mg and 300 mg of LJP 394 in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal Disease
http://www.clinicaltrials.gov/ct/show/NCT00070421?order=1 Leap of Faith Technologies childhood Hodgkin's lymphomachildhood non-Hodgkin's lymphomachildhood solid tumorLeukemiapsychosocial effects and treatment Procedure:cancer prevention interventionProcedure:complementary and alternative therapyProcedure:complications of therapy assessment/managementProcedure:psychosocial assessment/careProcedure:supportive care/therapy Phase I Study Type:InterventionalStudy Design:Treatment Official Title:Phase I/II Study of @neWorld: A Virtual Community for Pediatric Patients With Cancer
http://www.clinicaltrials.gov/ct/show/NCT00051532?order=1 LEO Pharma The purpose of the study is to determine whether Seocalcitol is effective in the treatment of advanced primary liver cancer (hepatocellular carcinoma). Liver Neoplasms Drug:Seocalcitol Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Expanded Access Assignment,Efficacy Study Official Title:Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma. Efficacy of Seocalcitol (EB 1089) Enteric-Coated Capsules (5ug) or Placebo in the Treatment of Patients with Hepatocellular Carcinoma not Amenable to Curative Treatment.
http://www.clinicaltrials.gov/ct/show/NCT00051545?order=2 LEO Pharma To evaluate the efficacy of Seocalcitol in prolonging time to relapse following intended curative resection or percutaneous ablative treatment, i.e. percutaneous ethanol injection(s), percutaneous acetic acid injection(s), percutaneous microwave coagulation therapy, or percutaneous radiofrequency ablation for hepatocellular carcinoma. Liver Neoplasms Drug:Seocalcitol Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Expanded Access Assignment,Efficacy Study Official Title:Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma. Efficacy of Seocalcitol (EB 1089) Enteric-Coated Capsules (5 ug) or Placebo in Prolonging Time to Relapse Following Intended Curative Resection or Percutaneous Ablative Treatment for Hepatocellular Carcinoma.
http://www.clinicaltrials.gov/ct/show/NCT00063076?order=1 M.D. Anderson Cancer Center The rationale for the use of bexarotene in alopecia areata comes from the drugs' immunomodulatory effects. It has been shown to be effective in inflammatory dermatoses, many of which are known to have T-cell mediated mechanisms. Alopecia areata is an organ-specific autoimmune reaction mediated by perifollicular T lymphocytes that clear upon resolution of disease. Therefore, since bexarotene is able to reduce or clear T-cell from the skin in CTCL lesions, we hypothesize that it may be effective in alopecia areata in eliminating the T-cells around the hair follicles. Alopecia Areata Drug:Targretin Gel 1% Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00051025?order=2 Ligand Pharmaceuticals The purpose of this study is to look at the safety and effectiveness of ONTAK in previously treated patients with NHL. Non-Hodgkin's LymphomaLymphoma, B-CellLymphoma, Low-Grade Drug:ONTAK Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized, Multicenter, Phase II Evaluation of ONTAK (Denileukin Diftitox) in Patients with Previously Treated, Indolent, B-Cell, Non-Hodgkin's Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00050999?order=3 Ligand Pharmaceuticals The purpose of this study is to compare the effectiveness of two dose levels of ONTAK (denileukin diftitox) in treating patients who have recurrent or persistent cutaneous T-cell lymphoma. Lymphoma, T-Cell, CutaneousMycosis FungoidesSezary Syndrome Drug:ONTAK Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Multicenter Phase III Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy of Two Dose Levels of DAB389IL-2 (9 and 18 mcg/kg/day) in Cutaneous T-Cell Lymphoma (CTCL) Patients with Stage Ia-III Disease who, following less than or equal to 3 Previous Therapies, have Recurrent or Persistent Disease that has been Biopsy-documented to Express CD25
http://www.clinicaltrials.gov/ct/show/NCT00051012?order=4 Ligand Pharmaceuticals The purpose of this study is to provide an opportunity for patients who exhibit progressive disease while receiving placebo on the companion 93-04-11 study to receive ONTAK. It is also designed to determine the effectiveness of ONTAK in Cutaneous T-cell Lymphoma (CTCL) patients whose tumors do not express CD25. Lymphoma, T-Cell, CutaneousMycosis FungoidesSezary Syndrome Drug:ONTAK Phase IV Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Multicenter Open-label Study to Evaluate the Safety and Efficacy of DAB389IL-2 in Cutaneous T-cell Lymphoma (CTCL) Patients following Protocol 93-04-10, Protocol 93-04-11, or Protocol 92-04-01 or who meet the Requirements for Protocol 93-04-11 except have Biopsy-documented CTCL that does not Express CD25
http://www.clinicaltrials.gov/ct/show/NCT00055146?order=5 Ligand Pharmaceuticals The purpose of this study is to evaluate the safety and effectiveness of ONTAK in previously treated patients with chronic lymphocytic leukemia (CLL) Leukemia, Lymphocytic, Chronic Drug:ONTAK Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Multicenter, Phase II Study of ONTAK (Denileukin Diftitox) in Patients with Previously-Treated Chronic Lymphocytic Leukemia
http://www.clinicaltrials.gov/ct/show/NCT00076687?order=1 Allergan Stroke Drug:BOTOX (Botulinum Toxin Type A) Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety Study Official Title:A Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Safety Study of Pulmonary Function in Patients with Reduced Lung Function Treated with BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex for Focal Upper Limb Poststroke Spasticity
http://www.clinicaltrials.gov/ct/show/NCT00025818?order=2 Allergan A six-month clinical research trial to evaluate the effectiveness of an investigational medication for the treatment of dry eye syndrome in patients that have been diagnosed with moderate to severe dry eye syndrome, an autoimmune disorder AND/OR females 65 years of age or older. Keratoconjunctivitis SiccaSjogren's SyndromeLupus Erythematosus, SystemicArthritis, RheumatoidScleroderma, Systemic Drug:Ophthalmic Emulsion Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00068068?order=1 Light Sciences Corporation The purpose of this study is to determine whether the Litx platform is safe and effective in the treatment of liver metastasis arising from colorectal cancer. Litx is a next-generation photodynamic therapy platform in which the drug, talaporfin sodium (LS11), is activated by light from the light-emitting diode (LED)-based light infusion device, inserted directly into the tumor through the skin prior to treatment. Liver MetastasisColorectal NeoplasmsLiver NeoplasmsNeoplasm Metastasis Drug:Talaporfin sodium (LS11)Device:LED-based light infusion deviceDevice:Light emitting diodes (LED)Procedure:Photodynamic therapyProcedure:PhototherapyProcedure:Chemotherapy Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Safety and efficacy of treating refractory cancers with the Litx system: Phase II safety and efficacy study in patients with liver metastases from colorectal cancer that have failed chemotherapy
http://www.clinicaltrials.gov/ct/show/NCT00083785?order=2 Light Sciences Corporation The purpose of this study is to determine whether the Litx system is safe and effective in combination with chemotherapy in the treatment of liver metastasis arising from colorectal cancer. Litx is a next-generation photodynamic therapy platform in which the drug, talaporfin sodium (LS11), is activated by light from the light-emitting diode (LED)-based light infusion device, inserted directly into the tumor through the skin prior to treatment. Liver MetastasisColorectal NeoplasmsLiver NeoplasmsNeoplasm Metastasis Drug:Talaporfin sodium (LS11)Device:LED-based light infusion deviceDevice:Light emitting diodes (LED)Procedure:Photodynamic therapyProcedure:PhototherapyProcedure:Chemotherapy Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Safety and effectiveness of treating cancers with the Litx system and chemotherapy. Section A: phase II safety and effectiveness study in patients with liver metastases from colorectal cancer
http://www.clinicaltrials.gov/ct/show/NCT00084331?order=1 Lorus Therapeutics Stage IV Renal Cell Cancerrecurrent renal cell cancer Drug:GTI-2040Drug:capecitabineProcedure:antisense therapyProcedure:chemotherapy Phase I Study Type:InterventionalStudy Design:Treatment Official Title:Phase I/II Study of GTI-2040 and Capecitabine in Patients With Advanced or Metastatic Renal Cell Cancer
http://www.clinicaltrials.gov/ct/show/NCT00056173?order=2 Lorus Therapeutics This phase II, 43 patient trial, will evaluate the efficacy of GTI-2040, an antisense oligonucleotide complementary to the R2 component of ribonucleotide reductase (RNR) mRNA, in combination with capecitabine, in the setting of advanced/metastatic renal cell carcinoma. Preclinical studies have shown synergy between GTI-2040 and capecitabine against renal cell carcinoma. Carcinoma, Renal CellMetastases, Neoplasm Drug:GTI-2040 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase I/II Study of GTI-2040 and Capecitabine Combination Therapy in Patients With Advanced or Metastatic Renal Cell Carcinoma (mRCC)
http://www.clinicaltrials.gov/ct/show/NCT00087776?order=1 Luitpold Pharmaceuticals The primary objective of this trial is to compare the survival of patients with metastatic malignant melanoma treated with Taxoprexin Injection to those treated with Dacarbazine. In addition, the response rate to each drug, response duration, time to progression and time to treament failure will be measured. Toxicity will be evaluated and compared between the two groups. Malignant Melanoma Drug:Chemotherapy Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00091377?order=1 Marshall Edwards, Inc recurrent ovarian epithelial cancerFallopian Tube Cancerperitoneal cavity cancer Drug:cisplatinDrug:paclitaxelDrug:phenoxodiolProcedure:chemosensitization/potentiationProcedure:chemotherapyProcedure:enzyme inhibitor therapyProcedure:protein tyrosine kinase inhibitor therapy Phase I Study Type:InterventionalStudy Design:Treatment Official Title:Phase I/II Randomized Study of Phenoxodiol Chemosensitization With Cisplatin or Paclitaxel in Patients With Recurrent Late-Stage Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer That is Refractory or Resistant to Platinum and/or Taxane Drugs
http://www.clinicaltrials.gov/ct/show/NCT00080769?order=1 McNeil Consumer & Specialty Pharmaceuticals lip and oral cavity cancerNasopharyngeal Canceroral complications of chemotherapy and head and neck radiationOropharyngeal Cancer Drug:benzydamine hydrochlorideProcedure:complications of therapy assessment/managementProcedure:radioprotectionProcedure:supportive care/therapy Phase III Study Type:InterventionalStudy Design:Treatment Official Title:Phase III Randomized Study of Benzydamine Hydrochloride for the Treatment of Radiation-Induced Oral Mucositis in Patients With Cancer of the Oral Cavity, Oropharynx, and/or Nasopharynx Undergoing Radiotherapy
http://www.clinicaltrials.gov/ct/show/NCT00051441?order=2 McNeil Consumer & Specialty Pharmaceuticals Mouth Neoplasms Drug:Benzydamine Hydrochloride Oral Rinse Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Double-Blind, Randomized, Vehicle-Controlled Study Comparing the Safety and Efficacy of Benzydamine HCl 0.15% Oral Rinse Including a Separate Open-Label Standard of Care Arm in Subjects with Radiation-Induced Mucositis.
http://www.clinicaltrials.gov/ct/show/NCT00083304?order=1 Allos Therapeutics Breast CancerMetastases Procedure:Whole brain radiation therapy with supplemental oxygenDrug:RSR13 Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Single Group Assignment,Safety/Efficacy Study Official Title:Phase 3, Randomized, Open-label, Comparative Study of Standard Whole Brain Radiation Therapy with Supplemental Oxygen, with or without Concurrent RSR13 (efaproxiral), in Women with Brain Metastases from Breast Cancer
http://www.clinicaltrials.gov/ct/show/NCT00094653?order=1 Medarex The purpose of this study is to determine the safety and efficacy of MDX-010 (anti-CTLA4) in combination with MDX-1379 in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing IL-2, dacarbazine, and/or temozolamide, have 1) relapsed following an objective response (PR/CR); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379. MelanomaMetastases Drug:MDX-010 (anti-CTLA4) monoclonal antibodyVaccine:MDX-1379 Melanoma Peptide Vaccine Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Safety/Efficacy Study Official Title:A Randomized, Double-Blind, Multicenter Study Comparing MDX-010 Monotherapy, MDX-010 in Combination with a Melanoma Peptide Vaccine, and Melanoma Vaccine Monotherapy in HLA-A2*0201-Positive Patients with Previously Treated Unresectable Stage III or IV Melanoma
http://www.clinicaltrials.gov/ct/show/NCT00079859?order=1 Medical Research Laboratories International The purpose of this study is to determine if implitapide, used in conjunction with other lipid-lowering therapies, is safe and effective when compared to placebo in lowering low-density lipoprotein cholesterol (LDL-C) in patients with heterozygous familial hypercholesterolemia (HeFH). Familial Hypercholesterolemia Drug:Implitapide Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety/Efficacy Study Official Title:Safety and Efficacy Study of Implitapide Compared with Placebo in Patients with Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy
http://www.clinicaltrials.gov/ct/show/NCT00079846?order=2 Medical Research Laboratories International The purpose of this study is to determine if implitapide, used in conjunction with other lipid-lowering therapies, is safe and effective when compared to placebo in lowering low-density lipoprotein cholesterol (LDL-C) in patients with homozygous familial hypercholesterolemia (HoFH). Familial Hypercholesterolemia Drug:Implitapide Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety/Efficacy Study Official Title:Safety and Efficacy Study of Implitapide Compared with Placebo in Patients with Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy
http://www.clinicaltrials.gov/ct/show/NCT00080132?order=3 Medical Research Laboratories International The purpose of this study is to determine if implitapide is effective in lowering triglyceride (TG) levels in patients with Fredrickson Type I or V hypertriglyceridemia where the maximum tolerable medication and diet were not sufficient. Hypertriglyceridemia Drug:implitapide Phase II Study Type:InterventionalStudy Design:Treatment,Open Label,Safety/Efficacy Study Official Title:An Open-label, Dose-escalating Efficacy and Safety Study of Implitapide in Patients with Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-lowering Therapy
http://www.clinicaltrials.gov/ct/show/NCT00079508?order=1 The Medicines Company The purpose of this study is to demonstrate that in patients with heparin-induced thrombocytopenia (HIT)/heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) Type II undergoing cardiac surgery on cardiopulmonary bypass (CPB), Angiomax is a safe and effective anticoagulant. Cardiovascular DiseaseCoronary Artery Bypass Surgery Drug:Angiomax (bivalirudin) Phase III Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase III Study of Angiomax (bivalirudin) in Patients with HIT/HITTS Type II Undergoing Cardiac Surgery on Cardiopulmonary Bypass (CPB)
http://www.clinicaltrials.gov/ct/show/NCT00073580?order=2 The Medicines Company The purpose of this study is to examine the safety and efficacy of Angiomax as an anticoagulation in patients with heparin-induced thrombocytopenia (HIT)/heparin-induced thrombocytopenia with thrombosis syndrome (HITTS) undergoing off-pump coronary artery bypass (OPCAB) surgery. ThrombocytopeniaThrombosisCardiac DiseaseCoronary Artery Bypass Surgery Drug:Angiomax (bivalirudin) anticoagulant Phase III Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Safety/Efficacy Study Official Title:Angiomax in Patients with HIT/HITTS Type II Undergoing Off-PUMP CABG
http://www.clinicaltrials.gov/ct/show/NCT00093184?order=3 The Medicines Company The purpose of this study is to demonstrate the benefit of bivalirudin in combination with clopidogrel with provisional GPIIb/IIIa inhibitor use, in reducing the bleeding complications associated with early invasive management of patients presenting with an ST Elevation Myocardial Infarction (STEMI) and undergoing primary PCI, while providing similar rates of ischemic events when compared to published results of relevant trials. Myocardial Infarction Drug:Angiomax (bivalirudin) anticoagulant Phase III Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Study Evaluating the Safety and Efficacy of Bivalirudin in the Management of Patients with ST-Segment Elevation Acute Myocardial Infarction Undergoing Primary PCI (BIAMI)
http://www.clinicaltrials.gov/ct/show/NCT00093912?order=4 The Medicines Company The purpose of this study is to establish the safety of clevidipine in the treatment of perioperative hypertension. Hypertension Drug:Clevelox (clevidipine) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety Study Official Title:Evaluation of Clevelox in the Perioperative Treatment of Hypertension Assessing Safety Events (with Sodium Nitroprusside as Active Comparator) (ECLISPE-SNP)
http://www.clinicaltrials.gov/ct/show/NCT00093925?order=5 The Medicines Company The purpose of this study is to establish the safety of clevidipine in the treatment of postoperative hypertension. Hypertension Drug:Clevelox (clevidipine) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety Study Official Title:Evaluation of Clevelox in the Postoperative Treatment of Hypertension Assessing Safety Events (with nicardipine as Active comparator) (ECLIPSE-NIC)
http://www.clinicaltrials.gov/ct/show/NCT00093886?order=6 The Medicines Company The purpose of this study is to establish the safety of clevidipine in the treatment of preoperative hypertension. Hypertension Drug:Clevelox (clevidipine) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety Study Official Title:Evaluation of Clevelox in the Preoperative Treatment of Hypertension Assessing Safety Events (with Nitroglycerin as Active Comparator) (ECLIPSE-NTG)
http://www.clinicaltrials.gov/ct/show/NCT00079586?order=7 The Medicines Company The purpose of this study is to demonstrate that in patients undergoing coronary artery bypass grafting (CABG) or CABG-Valve, or Isolated Cardiac Valve surgery on CPB (cardiac surgery), Angiomax is a safe and effective alternative anticoagulant to heparin with protamine reversal. Cardiovascular DiseaseCoronary Artery Bypass Surgery Drug:Angiomax (bivalirudin) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Study Comparing Angiomax (bivalirudin) to Heparin with Protamine Reversal in Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass (CPB)
http://www.clinicaltrials.gov/ct/show/NCT00093158?order=8 The Medicines Company Unstable AnginaMyocardial InfarctionAcute Disease Drug:Angiomax (bivalirudin) anticoagulant Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:The ACUITY Trial: A Randomized Comparison of Angiomax (bivalirudin) versus Heparin (unfractionated heparin or enoxaparin) in Patients Undergoing Early Invasive Management for Acute Coronary Syndromes without ST-Segment Elevation
http://www.clinicaltrials.gov/ct/show/NCT00043277?order=9 The Medicines Company Thrombosis Drug:Angiomax (bivalirudin) Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Safety/Efficacy Study Official Title:Pilot Dose Finding And Efficacy Study Of Angiomax (bivalirudin) As Primary Anticoagulation In Infants Under Six Months With Thrombosis
http://www.clinicaltrials.gov/ct/show/NCT00093262?order=10 The Medicines Company The purpose of this study is to determine the efficacy of clevidipine injection versus placebo in treating postoperative hypertension. Hypertension Drug:Clevelox (clevidipine) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study Official Title:Efficacy Study of Clevidipine (Clevelox) Assessing its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2)
http://www.clinicaltrials.gov/ct/show/NCT00093249?order=11 The Medicines Company The purpose of this study is to determine the efficacy of clevidipine injection versus placebo in treating preoperative hypertension. Hypertension Drug:Clevelox (clevidipine) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study Official Title:Efficacy Study of Clevidipine (Clevelox) Assessing its Preoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-1)
http://www.clinicaltrials.gov/ct/show/NCT00072930?order=1 MedImmune, Inc. Prostate Cancer Drug:MEDI-522Drug:DocetaxelDrug:PrednisoneDrug:Zoledronic acid Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label Official Title:Phase II, Randomized, Open-Label, Two-Arm, Multicenter Study of MEDI-522, a HuMA Directed Against the Human Alpha V Beta 3 Integrin, in Combination with Docetaxel, Prednisone, and Zoledronic Acid in the Treatment of Patients with Metastatic Androgen-Independent Prostate Cancer
http://www.clinicaltrials.gov/ct/show/NCT00086099?order=2 MedImmune, Inc. LeukemiaAcute Myeloid Leukemia Drug:Ethyol Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label Official Title:A Phase IB/II, Randomized, Open-Label, Multicenter Study Evaluating Whether the Addition of Amifostine (Ethyol) will Enable the Safe Increase in Dose Intensity of Idarubicin in Combination with Cytosine Arabinoside in Older Patients with Newly Diagnosed, Previously Untreated Acute Myeloid Leukemia
http://www.clinicaltrials.gov/ct/show/NCT00081315?order=3 MedImmune, Inc. The primary objective of this study is to assess the activity of subcutaneous (SC) amifostine on the incidence and severity of acute radiochemotherapy-induced esophagitis in patients with unresectable Stage IIIA or IIIB non-small cell lung cancer (NSCLC) receiving combined modality therapy. EsophagitisPneumonitisNon-small cell lung cancer Drug:Amifostine Phase II Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind Official Title:Phase II, Randomized, Double-Blind, Multicenter Trial of Subcutaneous Amifostine (Ethyol) versus Placebo in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients with Unresectable Non-Small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00064649?order=1 The primary objective of this randomized clinical trial is to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride. Benign Prostatic Hyperplasia Device:Transurethral Microwave Thermotherapy (TUMT)Device:Transurethral Needle Ablation (TUNA) TherapyDrug:Finasteride and Alfuzosin Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Safety/Efficacy Study Official Title:Minimally Invasive Surgical Therapy for BPH
http://www.clinicaltrials.gov/ct/show/NCT00095095?order=1 Medtronic Bakken Research Center Lumbar spinal fusion is commonly performed as a last resort in patients with chronic low back pain caused by degenerative changes and instability of the spine. The aim of this study is to compare two fusion devices, which are used in spinal surgery in order to promote the fusion of two lumbar vertebrae. Low Back PainSpondylolisthesisSpinal StenosisIntervertebral Disc Displacement Device:Posterior Lumber Interbody Fusion Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Single Blind,Uncontrolled,Parallel Assignment,Safety/Efficacy Study Official Title:Lumbar Interbody Fusion Using The Telamon Peek Versus The Telamon Hydrosorb Fusion Device - A Prospective, Randomized Controlled Trial To Assess Surgical And Clinical Outcomes
http://www.clinicaltrials.gov/ct/show/NCT00090246?order=1 Merck The purpose of this study is to assess the safety and efficacy of 2 doses of an approved drug for a new indication in the prevention of postoperative nausea and vomiting in patients receiving general anesthesia for open abdominal surgery requiring overnight hospital stay. Postoperative Nausea and Vomiting Phase II Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study, to Examine the Safety, Tolerability, and Efficacy of 2 doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting
http://www.clinicaltrials.gov/ct/show/NCT00094627?order=2 Merck The purpose of the study is to test the safety and effectiveness of the Investigational Drug on insomnia. Primary Insomnia Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment
http://www.clinicaltrials.gov/ct/show/NCT00083343?order=3 Merck Candida is the most common fungal pathogen identified in hospitalized patients. This study will seek to enroll adult patients (18 years of age or older) with invasive Candida infections (involving deep tissues and organs). The study will not enroll patients whose only site of Candida infection was the bloodstream. Patients that fulfill all study entry criteria will receive a single daily dose of caspofungin. Caspofungin, an intravenous echinocandin antifungal agent, is already approved for the treatment of invasive candidiasis. The dosage strength and duration of caspofungin will be individualized for each patient based on disease, severity of disease and extent of infection. Candidiasis Drug:Caspofungin Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00090168?order=4 Merck A 6-week treatment study to compare the reduction in cholesterol of two investigational drugs for high cholesterol, in patients with hypercholesterolemia and atherosclerotic or coronary vascular disease. HypercholesterolemiaAtherosclerotic DiseaseCoronary Disease Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Multicenter Study to Assess the Cholesterol Lowering Level of Switching to an Investigational Drug Compared to Doubling the Dose of an Investigational Drug in Patients with Hypercholesterolemia and Atherosclerotic or Coronary Vascular Disease
http://www.clinicaltrials.gov/ct/show/NCT00082524?order=5 Merck This study is an open label, noncomparative study using an investigational agent for the treatment of documented Candida or Aspergillus infections in pediatric patients (ages 2-17 years). AspergillosisCandidiasis Phase II Study Type:InterventionalStudy Design:Treatment,Open Label,Uncontrolled,Single Group Assignment,Safety Study
http://www.clinicaltrials.gov/ct/show/NCT00095069?order=6 Merck The purpose of this trial is to study the safety and effectiveness of an investigational medication for adults with insomnia. Insomnia Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Research Study to Evaluate the Efficacy and Safety of an Investigational Drug for Insomnia in Adults
http://www.clinicaltrials.gov/ct/show/NCT00094666?order=7 Merck The purpose of the study is to test the safety and effectiveness of an Investigational Drug on insomnia in the elderly. Primary Insomnia Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment
http://www.clinicaltrials.gov/ct/show/NCT00080444?order=8 Merck The purpose of this study is to demonstrate that this investigational drug prevents nausea and vomiting caused by cisplatin cancer chemotherapy in adolescent patients. Vomiting Phase IV Study Type:InterventionalStudy Design:Prevention,Randomized,Safety Study
http://www.clinicaltrials.gov/ct/show/NCT00095056?order=9 Merck The purpose of this study is to determine the safety and tolerability of an investigational drug in patients with Type 2 Diabetes Mellitus (a specific type of diabetes) and Chronic Renal Insufficiency (inadequate kidney function). Diabetes Mellitus, Type 2Chronic Renal Insufficiency Phase II Study Type:InterventionalStudy Design:Treatment,Randomized Official Title:A Study with an Investigational Drug in Patients with Type 2 Diabetes Mellitus and Chronic Renal Insufficiency
http://www.clinicaltrials.gov/ct/show/NCT00093106?order=10 Merck The purpose of this study is to evaluate the cholesterol lowering efficacy of an investigational drug in patients with Type II diabetes (high blood sugar). HypercholesterolemiaDiabetes Mellitus, Type II Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00094757?order=11 Merck The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus (a specific type of diabetes). Diabetes Mellitus, Type 2 Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00094770?order=12 Merck The purpose of this investigational study is to determine the safety and effectiveness of an investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes). Diabetes Mellitus, Type 2 Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00092898?order=13 Merck This is a 6-month study with patients who have the rare disease, sitosterolemia which may result in heart-related diseases. These patients have unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study investigates whether absorption of these non-cholesterols can be reduced in these patients. Lipid Metabolism, Inborn ErrorsHeart Disease Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment
http://www.clinicaltrials.gov/ct/show/NCT00076973?order=14 Merck The purpose of this study is to look at whether an investigational drug can treat the breathing symptoms of RSV bronchiolitis in children 3 to 24 months of age. Bronchiolitis Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00097929?order=15 Merck A study to determine the safety, tolerability, and anti-tumor effectiveness of an oral investigational drug in the treatment of relapsed diffuse large B-cell lymphoma. B-Cell Lymphoma Drug:Suberoylanilide Hydroxamic Acid (SAHA) Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00082537?order=16 Merck This study is a double-blind, randomized study of the investigational agent versus liposomal amphotericin B in the empirical treatment of pediatric patients (ages 2 through 17 years) who have an absolute neutrophil count (ANC) below 500/microliter and who have fever despite broad antibiotic coverage. Such patients would be candidates for empirical therapy with an intravenous anti-fungal agent. NeutropeniaFever Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Single Group Assignment,Safety Study
http://www.clinicaltrials.gov/ct/show/NCT00095576?order=17 Merck This study will test the safety and efficacy of an investigational HIV vaccine. Efficacy will be measured by either prevention of HIV infection or control of HIV viral load in subjects who become HIV infected. AIDSHIV Infections Vaccine:Investigational vaccine Phase II Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00092989?order=18 Merck The purpose of this study is to evaluate improved results of treatment for patients entering an emergency department with asthma attacks when given an investigational IV administration of an approved drug in addition to approved standard treatment. Asthma Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00090285?order=19 Merck Condylomata Acuminata Vaccine:investigational vaccine Phase II Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study Official Title:A Study to Evaluate the Efficacy of an Investigational Vaccine in Reducing the Incidence of Anogenital Warts in Young Men
http://www.clinicaltrials.gov/ct/show/NCT00064649?order=20 The primary objective of this randomized clinical trial is to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride. Benign Prostatic Hyperplasia Device:Transurethral Microwave Thermotherapy (TUMT)Device:Transurethral Needle Ablation (TUNA) TherapyDrug:Finasteride and Alfuzosin Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Safety/Efficacy Study Official Title:Minimally Invasive Surgical Therapy for BPH
http://www.clinicaltrials.gov/ct/show/NCT00087516?order=21 Merck The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus. Diabetes Mellitus, Type 2 Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00090259?order=22 Merck A multicenter study to evaluate potential decrease in hospitalization events and time between events and increasing longevity in patients with symptomatic congestive heart failure and intolerant of first-line medication for heart failure. This study will evaluate if higher doses of the investigational drug given daily will be superior to the lower dose of the same investigational drug given daily. Heart Failure Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00091559?order=23 Merck A study for patients diagnosed with advanced cutaneous T-cell lymphoma (stage 1B or higher) who have progressive, persistent, or recurrent disease on or following 2 other therapies, one of which must have contained Targretin (bexarotene)or for patients who are not candidates or could not tolerate Targretin therapy. Cutaneous T-Cell LymphomaSezary SyndromeMycosis Fungoides Drug:Suberoylanilide Hydroxamic Acid (SAHA) Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00080171?order=24 Knee osteoarthritis (OA) is the most common cause of disability in adults. The "Osteoarthritis Initiative (OAI): A Knee Health Study" is a nationwide research study that will help researchers gather more information about the physical changes that occur prior to the onset of arthritis symptoms or before OA gets worse. The purpose of this study is to examine people who have knee OA or are at high risk for knee OA; information will be used to better understand how to prevent and treat knee OA. OsteoarthritisKnee Osteoarthritis Study Type:ObservationalStudy Design:Natural History,Longitudinal,Defined Population,Prospective Study
http://www.clinicaltrials.gov/ct/show/NCT00007657?order=25 PCI (optimal catheter-based coronary revascularization) + intensive medical therapy is superior to intensive medical therapy alone using the combined endpoint of all-cause mortality or nonfatal MI. Myocardial Ischemia Procedure:Intensive medical therapyProcedure:Percutaneous Coronary Intervention Phase III Study Type:InterventionalStudy Design:Randomized,Open Label,Uncontrolled,Single Group Assignment,Efficacy Study Official Title:Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation
http://www.clinicaltrials.gov/ct/show/NCT00086502?order=26 Merck The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus. Diabetes Mellitus, Type 2 Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00095017?order=27 Merck The purpose of this study is to compare the effectiveness of an investigational drug versus placebo in the treatment of metastatic bone cancer pain in patients diagnosed with breast or prostate cancer and a bone neoplasm. Patients in the study will be taking opioids to treat moderate to severe pain for their bone metastases and will remain on their opioids during the entire course of the study. Bone Neoplasms Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:Study to Assess the Safety and Efficacy of an Investigational Drug versus Placebo in the Treatment of Cancer Pain
http://www.clinicaltrials.gov/ct/show/NCT00095043?order=28 Merck The purpose of this trial is to study the safety of an investigational drug on insomnia in the elderly. Insomnia Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Research Study to Evaluate the Safety of an Investigational Study Drug for Insomnia in the Elderly
http://www.clinicaltrials.gov/ct/show/NCT00090272?order=29 Merck The objective of this study is to evaluate the safety and efficacy of a one time dose of an intravenous marketed drug being evaluated for a new indication as compared to a marketed drug already approved for the prevention of surgical site infection following colorectal surgery. Colorectal Surgery Phase II Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of a Single Dose of a Marketed Drug Being Studied for a New Indication to Treat Surgical Site Infection following Colorectal Surgery as Compared to a Marketed Drug Approved for this Indication
http://www.clinicaltrials.gov/ct/show/NCT00092053?order=30 Merck The purpose of this study is to evaluate the efficacy and safety of an investigational drug in postmenopausal women with osteoporosis. Postmenopausal Osteoporosis Phase II Study Type:InterventionalStudy Design:Randomized,Double-Blind,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00093899?order=31 Merck The purpose of this study is to assess the cholesterol lowering effects of an investigational drug in patients with mixed hyperlipidemia (high cholesterol and high triglycerides). HyperlipidemiaHypercholesterolemiaHypertriglyceridemia Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00090220?order=32 Merck This study is to assess the tolerability and efficacy of a vaccine being evaluated to reduce the incidence of human papillomavirus infection and disease (external genital warts and vulvar, vaginal, and cervical cancer) in women. Healthy Vaccine:Investigational Vaccine Phase II Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00095004?order=33 Merck The purpose of this study is to test the effectiveness of an approved drug in the early treatment of migraine. Migraine Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00097838?order=1 Alphavax The purpose of this study is to evaluate the safety of and immune response to an alphavirus replicon, HIV-1 subtype C gag vaccine, AVX101, in HIV uninfected adults in the United States, South Africa, and Botswana. HIV Infections Vaccine:AVX101 Phase I Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety Study Official Title:A Phase I, Dose Escalation, Safety, and Immunogenicity Trial of an Alphavirus Replicon HIV-1 Subtype C gag Vaccine (AVX101) in Healthy HIV-1 Uninfected Adult Participants
http://www.clinicaltrials.gov/ct/show/NCT00093964?order=1 EMD Pharmaceuticals Glioblastoma Multiforme Drug:EMD 121974 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Multicenter, Open-label, Randomized, Uncontrolled, Phase IIa Trial in Subjects with Recurrent Glioblastoma Multiforme to Investigate the Clinical Activity, Safety, and Tolerability of EMD 121974 Administered as a Single Agent in Doses of 500 mg and 2000 mg
http://www.clinicaltrials.gov/ct/show/NCT00073541?order=2 EMD Pharmaceuticals EMD 72000 is an experimental, biological drug. Studies in animals indicate that EMD 72000 blocks a factor found on the surface of many cancer cells. The factor is called epidermal growth factor receptor or EGFR. One type of cancer which frequently contains EGFR is ovarian cancer. This study will test the safety and effects of EMD 72000 in subjects with EGFR-positive recurrent ovarian cancer following standard treatment that has failed. Ovarian Cancer Drug:EMD 72000 Phase II Study Type:InterventionalStudy Design:Treatment,Open Label,Safety/Efficacy Study Official Title:An Open-Label Phase II Study in Subjects with Recurrent EGFR-Positive Ovarian Cancer to Investigate the Safety and Efficacy of EMD 72000 Administered as a Single Agent
http://www.clinicaltrials.gov/ct/show/NCT00073736?order=1 Metabasis Therapeutics Hepatocellular carcinoma (HCC) is the most common primary cancer of the liver. MB07133 is being developed for the treatment of inoperable HCC, using a platform technology known as HepDirectTM, which enables drugs to be targeted specifically to the liver. The objective for this study is to determine the safety and tolerability of MB07133. Hepatocellular Carcinoma Drug:MB07133 Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:A Phase 1/2 Open-Label Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenous Infusion of MB07133 in Subjects with Unresectable Hepatocellular Carcinoma and Child-Pugh Class A Liver Function
http://www.clinicaltrials.gov/ct/show/NCT00073177?order=1 Pfizer This study is to evaluate the efficacy and safety of an oral investigational drug in patients with stable asthma. Patient will be withdrawn from their current controller medication and enter a run-in phase. Throughout the study patients will have supplies of rescue medication (inhaled albuterol/salbutamol). After completion of the run-in phase, patients will be re-evaluated and those who meet all entry criteria will be randomized at a 1:1:1 ratio to receive either, the investigational drug at 250 mcg, 500 mcg or placebo daily. During the 24-week double-blind treatment period patients will be evaluated in the morning at the investigators clinic at weeks 2, 4, 8, 12, 18, and 24. At each clinic visit, patients will complete relevant questionnaires, undergo spirometry, review of electronic diaries, and complete laboratory procedures. Asthma Drug:Investigational New Drug Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00076076?order=2 ALTANA Pharma The purpose of this study is to determine whether roflumilast is effective in the treatment of asthma. Asthma Drug:Roflumilast Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:FLASH Study: A 24 week randomized, controlled study of roflumilast versus placebo in patients with asthma
http://www.clinicaltrials.gov/ct/show/NCT00076089?order=3 ALTANA Pharma The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD). Chronic Obstructive Pulmonary Disease Drug:Roflumilast Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00074906?order=4 ALTANA Pharma Study to demonstrate that administration of Venticute increases survival of patients with pneumonia or aspiration of gastric contents leading to intubation, mechanical ventilation, and severe oxygenation impairment Pneumonia Drug:lusupultide Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study Official Title:Venticute in Patients with Pneumonia or Aspiration of Gastric Contents Leading to Intubation, Ventilation, and Severe Oxygenation Impairment: A randomized, multinational, multicenter, parallel group, double blind, control group study
http://www.clinicaltrials.gov/ct/show/NCT00044226?order=1 Milkhaus Laboratory Patients who are currently symptomatic and have been diagnosed with BPH by a physician may qualify for this 20-week study. Patients must not be diabetic, must not have prostate cancer and must not have had any surgery to repair your prostate or treat your BPH. Patients will first undergo a phone screening to confirm their eligibility and interest and to rule out any exclusionary history or medications. Eligible patients will be scheduled to come in to the clinic to sign an Informed Consent Form. Patients will then undergo blood and urine tests, a complete physical examination and history and answer several questionnaires to determine their eligibility. Patients will have a total of at least 7-8 visits over 20 weeks to the clinic during this study.Qualified patients receive free study medication, free medical care (physical examinations, EKG, laboratory tests) for the duration of the study. Prostatic Hyperplasia Drug:ML-04A Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety/Efficacy Study Official Title:A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Clinical trial to Evaluate the Efficacy and Safety of Two Dosing Regimens of ML-04A in Subjects with Symptomatic Benign Prostatic Hyperplasia
http://www.clinicaltrials.gov/ct/show/NCT00084851?order=1 Millennium Pharmaceuticals recurrent mantle cell lymphoma Drug:bortezomibProcedure:enzyme inhibitor therapy Phase II Study Type:InterventionalStudy Design:Treatment Official Title:Phase II Study of Bortezomib in Patients With Relapsed or Refractory Mantle Cell Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00089895?order=2 Millennium Pharmaceuticals The purpose of this study is to see if early INTEGRILIN (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention compared to placebo. Myocardial Ischemia Drug:eptifibatide Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:Early Glycoprotein IIb/IIIa Inhibition : A Randomized, Placebo-Controlled Trial Evaluating the Clinical Benefits of Early Front-loaded Eptifibatide in the Treatment of Patients with Non-ST-segment Elevation Acute Coronary Syndrome
http://www.clinicaltrials.gov/ct/show/NCT00070837?order=3 Millennium Pharmaceuticals The purpose of the study is to determine the highest dose of MLN2704 that can be given multiple times safely to patients with prostate cancer, and to identify any side effects associated with taking the drug. This study will also evaluate how MLN2704 is taken up, broken down and eliminated by the body. Prostatic Neoplasms Drug:MLN2704 (DM1 conjugated monoclonal antibody MLN591) Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 (DM1 conjugated monoclonal antibody MLN591) in Subjects with Metastatic Androgen-Independent Prostate Cancer
http://www.clinicaltrials.gov/ct/show/NCT00052000?order=4 Millennium Pharmaceuticals This is the first study of MLN2704 administered to humans. The purpose of the study is to determine the highest dose of MLN2704 that can be given safely to patients with prostate cancer, and to identify any side effects associated with taking the drug. This study will also evaluate how MLN2704 is taken up (absorbed), broken down (metabolized) and eliminated (excreted) by the body. This process is called pharmacokinetic analysis. Prostate Cancer Drug:MLN2704 (DM1 conjugated monoclonal antibody MLN591) Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase 1 Single Ascending Dose Trial of MLN2704 (DM1 conjugated monoclonal antibody MLN591) in Subjects with Metastatic Androgen Independent Prostate Cancer
http://www.clinicaltrials.gov/ct/show/NCT00059618?order=5 M.D. Anderson Cancer Center The goal of this clinical research study is to find the highest safe dose of PS-341 that can be given with carboplatin chemotherapy as a treatment for patients with ovarian, abdominal, or fallopian tube cancer. Researchers also hope to find out if giving these drugs together will help shrink or slow the growth of tumors in patients who are considered resistant to platinum drugs. The safety of these drugs will also be studied. Ovarian CancerPrimary Peritoneal CancerFallopian Tube Cancer Drug:PS-341 and Carboplatin Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Expanded Access Assignment,Safety/Efficacy Study Official Title:A Phase I Study Evaluating the Safety and Tolerability of PS-341 and Carboplatin in Patients with Platinum- and Taxane-Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer
http://www.clinicaltrials.gov/ct/show/NCT00080405?order=6 Millennium Pharmaceuticals The purpose of this study is to characterize the clinical pharmacokinetic and pharmacodynamic profiles of the 2 doses of VELCADE (bortezomib) for Injection. Patients who volunteer to participate in the pharmacogenetic portion of the study, an additional blood sample will be collected before the Cycle 1 Day 1 dose of bortezomib to assess the genotype of drug metabolizing enzymes. Multiple Myeloma Drug:Bortezomib Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Single Group Assignment,Pharmacokinetics/Dynamics Study
http://www.clinicaltrials.gov/ct/show/NCT00064584?order=7 Millennium Pharmaceuticals This is the first study of the drug CT53518 when given to humans. The purpose of this study is to determine the highest dose of CT53518 that can safely be given to patients with Acute Myelogenous Leukemia (AML) and to identify the side effects associated with taking the drug. The study will evaluate how CT53518 is absorbed, broken down, and eliminated by the body. Additionally, the study will evaluate the effects of the drug on a specific type of cell in bone marrow and blood, known as a blast. Acute Myelogenous LeukemiaMyelodysplastic Syndrome Drug:CT53518 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety Study Official Title:Tolerability and PK/PD of Multiple Oral Doses of CT53518 in Patients with Acute Myelogenous Leukemia
http://www.clinicaltrials.gov/ct/show/NCT00083460?order=8 University of Arkansas The purpose of this study is to assess the toxicity of PS-341 combined with one of four doses of thalidomide in patients with refractory multiple myeloma, and to find the most appropriate doses of PS-341 and thalidomide in the combination. Multiple Myeloma Drug:PS-341Drug:ThalidomideDrug:Dexamethasone Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:UARK 2001-37, A Phase I Exploratory Study of Combination PS-341 and Thalidomide in Refractory Multiple Myeloma
http://www.clinicaltrials.gov/ct/show/NCT00063726?order=9 Millennium Pharmaceuticals The purpose of this study is to allow patients to receive VELCADE (bortezomib) for Injection who experienced progressive disease(PD) while receiving high-dose dexamethasone from the M34101-039 study. Multiple Myeloma Drug:bortezomib Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Single Group Assignment,Safety/Efficacy Study Official Title:An International, Non-Comparative, Open-Label Study of PS-341 Administered to Patients With Multiple Myeloma who Experienced Relapsed or Progressive Disease After Receiving at Least Four Previous Treatment Regimens or Experienced Progressive Disease After Receiving Dexamethasone in Millennium Protocol M34101-039
http://www.clinicaltrials.gov/ct/show/NCT00081939?order=10 University of Arkansas Multiple Myeloma Drug:VelcadeDrug:Thalidomide Phase III Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Efficacy Study Official Title:A Phase 2 Study Incorporating Bone Marrow Microenvironment (ME) Co-Targeting Bortezomib into Tandem Melphalan-Based Autotransplants with DT PACE for Induction/Consolidation and Thalidomide + Dexamethasone for Maintenance
http://www.clinicaltrials.gov/ct/show/NCT00063713?order=11 Millennium Pharmaceuticals The purpose of this study is to find out whether treatment with VELCADE will increase the time it takes for lymphoma to get worse. Mantle Cell Lymphoma Drug:VELCADE TM (bortezomib) for Injection Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase 2 Study of VELCADE in Subjects with Relapsed or Refractory Mantle Cell Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00085696?order=12 Millennium Pharmaceuticals The purpose of this study is to evaluate the safety and effectiveness of VELCADE when given in combination with rituximab in patients with Relapsed or Refractory Indolent B-Cell Lymphoma. This study will investigate if treatment with VELCADE and rituximab increases the time it takes your lymphoma to get worse. B-Cell LymphomaFollicular LymphomaMarginal Lymphoma Drug:VELCADE and rituximab Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase 2 Study of VELCADE (bortezomib) with Rituximab in Subjects with Relapsed or Refractory Indolent B-Cell Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00059657?order=1 Mitsubishi Pharma Corporation Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia (CLI), which is the most severe form of peripheral arterial disease(PAD);This trial is designed to assess the efficacy and safety of the drug in the treatment of CLI. Critical Limb Ischemia due to peripheral arterial disease Drug:Ecraprost in lipid emulsion Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A double-blind, randomized, placebo-controlled study to assess the efficacy and safety of CirculaseTM in conjunction with peripheral revascularization for the treatment of critical leg ischemia
http://www.clinicaltrials.gov/ct/show/NCT00078013?order=2 Mitsubishi Pharma Corporation This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The primary objectives of this study are to examine the safety, tolerability, and efficacy of intravenous MCC-135 in limiting final infarct size, as measured by single photon emission computed tomography (SPECT), in patients who require percutaneous coronary intervention (PCI) for a first-documented ST-segment elevation acute myocardial infarction (AMI). Myocardial Infarction Drug:MCC-135 Phase II Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Examine the Safety and Efficacy of Intravenous MCC-135 as an Adjunct to Standard Therapy with Primary PCI in Patients Diagnosed as Having an ST Elevation Acute Myocardial Infarction
http://www.clinicaltrials.gov/ct/show/NCT00091598?order=1 Myogen The primary objective is to determine the effect of ambrisentan on exercise capacity in subjects with PAH. Pulmonary Hypertension Drug:Ambrisentan Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Dose Comparison,Parallel Assignment,Safety/Efficacy Study Official Title:ARIES 1 and ARIES 2: Ambrisentan in PAH - A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension
http://www.clinicaltrials.gov/ct/show/NCT00077948?order=2 Myogen Beta-blocker medications have been shown to improve heart function and prolong the lives of patients with chronic heart failure (CHF). Some people with advanced CHF have difficulty taking beta-blocker medications due to troublesome side effects, such as low blood pressure and/or low heart rate, severe tiredness, dizziness, or shortness of breath. In other words, they have difficulty tolerating beta-blocker medications. The purpose of this study is to determine if enoximone can improve a patient's ability to tolerate a beta-blocker medication. Heart Failure, Congestive Drug:enoximone plus metoprolol succinateDrug:metoprolol succinate alone Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase III, Randomized, Double-Blind, Double Placebo-Controlled, Multicenter, Three Parallel Group Study of Enoximone Plus Extended-Release Metoprolol Succinate in Advanced CHF Subjects Previously Intolerant to Beta-Blocker Treatment
http://www.clinicaltrials.gov/ct/show/NCT00063089?order=1 Nabi Biopharmaceuticals Altastaph has been developed to help the removal of S. aureus from the bloodstream. The main objective of this study will be to test the safety and behavior of Altastaph in patients with S.aureus bacteremia and continuing fever Staphylococcal Infections Drug:S. aureus Immune Globulin Intravenous (Human) 5% Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety Study Official Title:Initial Safety and Pharmacokinetics trial of Immune Globulin to Staphylococcus aureus Capsule Polysaccharide (Altastaph) in subjects with S. aureus Bacteremia and Persistent Fever
http://www.clinicaltrials.gov/ct/show/NCT00066989?order=2 Nabi Biopharmaceuticals The main objective will be to test the safety of two intravenous infusions of Altastaph, a human immunoglobulin product. The study will also test the ability of Altastaph to protect against S. aureus infection. Staphylococcal Infections Drug:Staphylococcus aureus Immune Globulin (Human) 5% Phase II Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety Study Official Title:A Double Blind, Randomized, Multicenter Stratified Study to Assess the Safety of an Intravenous Staphylococcus aureus Immune Globulin (Human) [Altastaph] in Low-Birth-Weight-Neonates
http://www.clinicaltrials.gov/ct/show/NCT00071214?order=3 Nabi Biopharmaceuticals Two part study testing the effectiveness and safety of StaphVAX vaccine in chronic hemodialysis patients against infection by Staphylococcus aureus Staphylococcal InfectionsKidney Failure, Chronic Vaccine:S. aureus Type 5 and 8 Capsular Polysaccharide Conjugate Vaccine Phase III Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study Official Title:A phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Efficacy of StaphVAX, a Bivalent Staphylococcus aureus Glycoconjugate Vaccine in Adults on Hemodialysis
http://www.clinicaltrials.gov/ct/show/NCT00089427?order=1 Neopharm This Phase 1 study in patients with newly diagnosed malignant glioma is designed to determine the highest dose of IL13-PE38QQR that can be safely administered by Convection Enhanced Delivery (CED) to the area around the tumor site after the tumor is surgically removed (resection). In addition, the patient will receive radiation therapy and may or may not be treated with oral temozolomide. Glioblastoma MultiformeAnaplastic AstrocytomaOligoastrocytoma Drug:IL13-PE38QQRProcedure:Surgery for placementProcedure:Radiation therapyDrug:Temozolomide with radiation therapy Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Single Group Assignment,Safety Study Official Title:Phase I Study of Convection Enhanced Delivery (CED) of IL13-PE38QQR Infusion After Resection Followed by Radiation Therapy With or Without Temozolomide in Patients With Newly Diagnosed Supratentorial Malignant Glioma
http://www.clinicaltrials.gov/ct/show/NCT00046540?order=2 Neopharm Neoplasms Drug:Liposome-encapsulated SN38 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study
http://www.clinicaltrials.gov/ct/show/NCT00080418?order=3 Neopharm The purpose of this study is to determine the highest dose of Liposome Entrapped Paclitaxel Easy to Use formulation (LEP-ETU) that can be safely administered by an intravenous infusion to patients with advanced cancer. Neoplasm Drug:Liposome Entrapped Paclitaxel Easy to Use Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Single Group Assignment,Safety Study Official Title:Phase I Study of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) Formulation in Patients with Advanced Cancer
http://www.clinicaltrials.gov/ct/show/NCT00076986?order=4 Neopharm The purpose of the PRECISE trial is to determine whether overall survival duration, safety, and quality of life are improved for patients treated with IL13-PE38QQR compared to patients treated with GLIADEL Wafer following surgical tumor removal in the treatment of first recurrence of glioblastoma multiforme. Glioblastoma Multiforme Drug:IL13-PE38QQRProcedure:surgery and catheter placement (2 procedures)Drug:prolifespan 20 with carmustine implant (GLIADEL Wafer)Procedure:surgery and wafer placement (1 procedure) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Efficacy Study Official Title:PRECISE - Phase III Randomized Evaluation of Convection Enhanced Delivery of IL13-PE38QQR Compared to GLIADEL Wafer with Survival Endpoint in Glioblastoma Multiforme Patients at First Recurrence
http://www.clinicaltrials.gov/ct/show/NCT00087542?order=1 ACADIA Pharmaceuticals Inc. The primary objective is to demonstrate that the investigational new drug, ACP-103, is well tolerated by, and will not worsen parkinsonism in, patients with Parkinson's disease and psychosis. The secondary objectives are to determine whether ACP-103 will ameliorate psychosis in patients with Parkinson's disease and whether ACP-103 is safe in Parkinson's disease patients taking multiple anti-parkinsonian medications. HallucinationsPsychosesParkinson's Disease Drug:ACP-103 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00083564?order=1 NeoRx Corporation The phase III study of STR (Skeletal Targeted Radiotherapy) is a multi-center, randomized, controlled study, designed to evaluate the safety and efficacy of STR in patients with primary refractory multiple myeloma. These are patients who have failed to achieve at least a partial response to conventional therapy and have been undergoing treatment for less than 18 months. The trial is expected to enroll approximately 240 evaluable patients, half on the experimental arm and half on the control arm. Patients on the experimental arm will receive STR at a dose of 750 mCi/m2 plus the chemotherapy drug melphalan at 200 mg/m2, followed by autologous (self-donor) stem cell transplantation. Patients on the control arm will receive melphalan only, followed by transplantation. Patients on both study arms will be evaluated for response to treatment six months after transplantation, using an immunofixation assay to detect myeloma protein in patient samples. Analysis of patient samples will be conducted at a central laboratory, and blinded results will be reviewed by an independent panel of experts. The studys primary endpoint is complete response, as determined by the complete disappearance of myeloma protein at six months post-transplant. Multiple Myeloma Drug:STR(TM) (Skeletal Targeted Radiotherapy, Holmium-166-DOTMP) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized Multicenter Study to Compare the Safety and Efficacy of 166Ho-DOTMP plus Melphalan to Melphalan Alone as Conditioning for Autologous Peripheral Blood Stem Cell Transplant in Subjects with Primary Refractory Multiple Myeloma
http://www.clinicaltrials.gov/ct/show/NCT00041795?order=1 NeoTherapeutics This study will assess the safety and efficacy of Neotrofin in treating the peripheral neuropathy that results from chemotherapy for cancer. Peripheral Nervous System DiseasesChemotherapy-Induced Peripheral Neuropathy Drug:leteprinim potassium (Neotrofin) Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of Neotrofin to Treat Patients with Sensory or Motor Neuropathy Caused by Chemotherapy for Cancer
http://www.clinicaltrials.gov/ct/show/NCT00088166?order=1 Neurobiological Technologies Brain EdemaBrain Tumor Drug:XERECEPT (corticorelin acetate) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Safety/Efficacy Study Official Title:A Phase III Randomized, Double-Blind, Dexamethasone-Sparing Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Placebo for Control of Symptoms Associated with Peritumoral Brain Edema in Patients with Malignant Brain Tumor who Require Chronic Administration of High-Dose Dexamethasone
http://www.clinicaltrials.gov/ct/show/NCT00091013?order=2 Neurobiological Technologies adult brain tumorbrain metastasesCerebral Edema Drug:dexamethasoneDrug:human corticotropin-releasing factorProcedure:cerebral edema managementProcedure:endocrine therapyProcedure:hormone therapyProcedure:steroid therapyProcedure:supportive care/therapy Phase III Study Type:InterventionalStudy Design:Treatment Official Title:Phase III Randomized Study of Human Corticotropin-Releasing Factor to Control Symptoms Associated With Peritumoral Edema in Patients With Malignant Brain Tumors Requiring Chronic Administration of High-Dose Dexamethasone
http://www.clinicaltrials.gov/ct/show/NCT00088673?order=1 Neurochem Inc. The purpose of this Phase III study is to evaluate the efficacy and safety of Alzhemed compared to placebo (inactive substance pill) in patients with mild to moderate Alzheimers disease. Alzheimer Disease Drug:Alzhemed Phase III Study Type:InterventionalStudy Design:Educational/Counseling/Training,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase III Study of the Efficacy and Safety of Alzhemed in Patients with Mild to Moderate Alzheimers Disease
http://www.clinicaltrials.gov/ct/show/NCT00079495?order=1 Neurocrine Biosciences Multiple Sclerosis Drug:NBI-5788 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of NBI-5788 in Patients with Relapsing Multiple Sclerosis
http://www.clinicaltrials.gov/ct/show/NCT00085761?order=1 NeurogesX The purpose of the study is to determine if an investigational drug, NGX-4010 (high-concentration capsaicin patch), is safe, tolerable and effective in treating painful HIV-associated neuropathy. HIV InfectionsPeripheral Nervous System DiseasesPain Drug:Capsaicin Dermal Patch Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Safety/Efficacy Study Official Title:An International, Multicenter, Randomized, Double-blind, 12-Week Controlled Study of NGX-4010 for Treatment of Painful HIV-Associated Neuropathy
http://www.clinicaltrials.gov/ct/show/NCT00079781?order=1 NeuroPace The purpose of the Responsive Neurostimulator (RNS) system feasibility clinical investigation is to demonstrate safety, and to provide evidence of efficacy of the NeuroPace RNS system in reducing the number of seizures in patients having medically refractory epilepsy. Epilepsy Device:Responsive Neurostimulator Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Responsive Neurostimulator (RNS) System Feasibility Clinical Investigation
http://www.clinicaltrials.gov/ct/show/NCT00090480?order=1 NewLink Genetics Corporation Breast Cancer Vaccine:HyperAcute - Breast cancer vaccine Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase I/II Study of an Antitumor Vaccination Using alpha(1,3)Galactosyltransferase Expressing Allogeneic Tumor Cells in Patients with Relapsed or Refractory Breast Cancer
http://www.clinicaltrials.gov/ct/show/NCT00089713?order=1 Alteon Inc. This study comprises a 3- to 6-week hydrochlorothiazide run in phase, followed by a 12 week double-blind treatment phase, followed by a 2 week single-blind follow-up hydrochlorothiazide treatment phase. The combined total duration of patient participation is approximately 17-20 weeks. Four double-blind treatment groups approximately equal in size (98) will comprise the study population: placebo or various alagebrium dose groups (10, 50, or 150 mg/day). Hypertension Drug:alagebrium chloride (ALT-711) Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:Effect of ALT-711 in Combination With Fixed-Dose Hydrochlorothiazide Therapy on Systolic Blood Pressure in Hypertensive Patients
http://www.clinicaltrials.gov/ct/show/NCT00076648?order=1 Northfield Laboratories This study is designed to assess the survival benefit of administering PolyHeme to severely injured trauma patients in hemorrhagic shock beginning in the prehospital setting, where blood is not available, and continuing throughout a 12-hour postinjury hospital setting. Hemorrhagic Shock Drug:Poly SFH-P Injection Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase III, Randomized, Controlled, Open-Label, Multicenter, Parallel Group Study Using Provisions for Exception from Informed Consent Requirements Designed to Evaluate the Safety and Efficacy of Poly SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme(R)] When Used to Treat Patients in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Prehospital Setting
http://www.clinicaltrials.gov/ct/show/NCT00090727?order=1 Novacea Solid MalignanciesNon-Hodgkin's Lymphoma Drug:AQ4N Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Parallel Assignment,Safety Study Official Title:A Phase 1, Open-Label, Dose-Escalation Study of AQ4N Administered Intravenously in Patients with Advanced Malignancies
http://www.clinicaltrials.gov/ct/show/NCT00066885?order=2 Novacea This Phase 1/2 clinical trial is a multi-center, open-label study with two main objectives. The first is to determine the maximum-tolerated dose of DN-101 when administered in combination with Taxotere (docetaxel) every three weeks. The second is to evaluate the safety and objective tumor response rate of the combination in NSCLC. DN-101 doses will be escalated at three dosing levels. Patients will receive oral DN-101 on day one, followed by intravenous docetaxel on day two of a 21-day cycle. Treatment cycles will be repeated at the same dose level each 21 days until disease progression or unacceptable toxicity. Carcinoma, Non-Small-Cell Lung Drug:calcitriol + docetaxel Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase 1/2 Multicenter, Open Label, Dose Ranging Study of DN-101 and Taxotere in Patients with Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) who Have Failed Previous Therapy with Platinum-Based Chemotherapy
http://www.clinicaltrials.gov/ct/show/NCT00097864?order=1 Novartis Pharmaceuticals A study of two drugs, Lotrel (amlodipine/benazepril) and benazepril/HCTZ, for effectiveness in reducing heart disease and deaths from heart attacks. Heart Disease Drug:Lotrel (benazepril/amlodipine)Drug:benazepril plus hydrochlorothiazide Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Comparison of the Safety and Effectiveness of Lotrel and Benazapril+HCTZ in Reducing Heart Disease and Heart Attacks
http://www.clinicaltrials.gov/ct/show/NCT00063479?order=2 Novartis Pharmaceuticals The primary purpose of this trial is to evaluate whether the investigational medication is safe, effective and has the ability to increase spine bone density in osteogenesis imperfecta (OI) patients. Osteogenesis Imperfecta Drug:Zoledronic Acid Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00098735?order=3 Novartis Pharmaceuticals In patients who receive an organ transplant, their body considers this organ as foreign and attempts to destroy it. This is called rejection. All patients who receive an organ transplant, will take a combination of anti-rejection medications. These medications prevent the new organ from being rejected from the body. FTY720 is a new compound that helps prevent organ rejection. Kidney Transplantation Drug:FTY720 Phase III Study Type:InterventionalStudy Design:Diagnostic,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Primary Outcomes:To compare efficacy of FTY720 in combination with two other drugs vs. a marketed drug to prevent rejection.
http://www.clinicaltrials.gov/ct/show/NCT00079937?order=4 Novartis Pharmaceuticals This study will look at data collected over 1 year to determine the effectiveness of omalizumab (Xolair) in controlling moderate-to-severe allergic asthma in children 6 to 12 years of age whose asthma is persistent and not well controlled. This study will also evaluate the safety of this treatment in terms of side effects and other clinical and laboratory measures. Asthma Drug:Omalizumab Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00097825?order=5 Novartis Pharmaceuticals The goal of this study is to determine the effectiveness and safety of an annual intravenous treatment of zoledronic acid for the treatment of osteoporosis in men. All patients will receive calcium and vitamin D supplements. Osteoporosis Drug:Zoledronic Acid Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Primary Outcomes:Change in Bone Mineral Density
http://www.clinicaltrials.gov/ct/show/NCT00088127?order=6 Novartis Pharmaceuticals This study will investigate the effect of EPO906 given once every 3 weeks to patients with advanced non-small cell lung cancer. Non-small cell lung cancerNSCLC Drug:CEPO906A Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Safety/Efficacy Study Official Title:An Open Label, Phase I/II Dose Escalating Study Evaluating the Safety and Efficacy of EPO906 q3w in Patients with Non-Small-Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00098046?order=7 Novartis Pharmaceuticals Varicella zoster virus causes chickenpox in children and shingles in adults. Chickenpox is usually a self-limiting illness characterized by fever and a rash. Serious complications can include secondary bacterial infections, pneumonia, and encephalitis. Anti-viral treatment is not a standard of care in immunocompetent children, but is recommended whenever a risk of complication exists. This study will evaluate the safety and blood levels of a new formulation of Famvir in children 1-12 years of age. ChickenpoxHerpes Zoster Drug:famciclovir (Famvir) Phase III Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:Pharmacokinetics and Safety of Famciclovir (Famvir) Oral Pediatric Formulation in Children 1-12 Years of Age with Varicella Zoster Infection
http://www.clinicaltrials.gov/ct/show/NCT00098059?order=8 Novartis Pharmaceuticals Herpes simplex virus causes cold sores (fever blisters) and can lead to painful lesions in the mouth in healthy children. Children with impaired immune systems might develop severe complications. Famvir (famciclovir) is a drug approved to treat herpes simplex and varicella zoster infection in adults. This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age. Herpes Simplex Drug:Famvir (famciclovir) Phase III Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:Pharmacokinetics and Safety of Famvir (famciclovir) Pediatric Formulation in Children 1-12 Years of Age with Herpes Simplex Infection
http://www.clinicaltrials.gov/ct/show/NCT00081926?order=9 Novartis Pharmaceuticals This study will evaluate the molecular response to high dose Gleevec in newly diagnosed patients with Chronic myelogenous Leukemia (CML) in Chronic Phase. This study will evaluate the ability of Gleevec to reduce the amount of abnormal protein that occurs in patients with CML. Patients who are eligible to participate will be treated for 18 months. This trial will include male or female patients 18 years or older who are newly diagnosed (within 6 months) with CML. Chronic Myelogenous Leukemia Drug:Gleevec Phase IV Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00051636?order=10 Novartis Pharmaceuticals HORIZON TOP will study the effect of zoledronic acid given once as an iv infusion compared to 60 days of oral risedronate in patients with Pagets disease of bone. The effect will be demonstrated in the reduction of serum alkaline phosphatase (SAP). Paget's Disease of Bone Drug:Zoledronic Acid Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00051649?order=11 Novartis Pharmaceuticals HORIZON TOP will study the effect of zoledronic acid given once as an iv infusion compared to 60 days of oral risedronate in patients with Pagets disease of bone. The effect will be demonstrated in the reduction of serum alkaline phosphatase (SAP). Paget's Disease of Bone Drug:Zoledronic Acid Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00086268?order=12 Novartis Pharmaceuticals This study will evaluate the effects of an investigational drug in combination with chemotherapy in patients with stage IIIB/IV non-small cell lung cancer. This study will measure the effects of this combination on progression of lung cancer, cancer response to treatments, and development of cancer-related bone lesions. Non Small Cell Lung Carcinoma Drug:zoledronic acidDrug:TaxotereDrug:Carboplatin Phase II Study Type:InterventionalStudy Design:Prevention,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Primary Outcomes:Proportion of patients without disease progressionSecondary Outcomes:Time to disease progression; Response rate; Time to progression in bone; Overall survival; Safety
http://www.clinicaltrials.gov/ct/show/NCT00080171?order=13 Knee osteoarthritis (OA) is the most common cause of disability in adults. The "Osteoarthritis Initiative (OAI): A Knee Health Study" is a nationwide research study that will help researchers gather more information about the physical changes that occur prior to the onset of arthritis symptoms or before OA gets worse. The purpose of this study is to examine people who have knee OA or are at high risk for knee OA; information will be used to better understand how to prevent and treat knee OA. OsteoarthritisKnee Osteoarthritis Study Type:ObservationalStudy Design:Natural History,Longitudinal,Defined Population,Prospective Study
http://www.clinicaltrials.gov/ct/show/NCT00076362?order=14 Novartis Pharmaceuticals Obesity Drug:Sandostatin LAR Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00087659?order=15 Novartis Pharmaceuticals This study is being conducted to compare the effect of an investigational drug versus placebo on bone loss in men with prostate cancer who are receiving Androgen Deprivation Therapy (ADT). The study drug or placebo will be administered every three months of four treatments in one year. In order to participate, male patients 18 years and older must be consecutive veterans from participating Veterans Administration Medical Centers. Prostate Cancer Drug:Zometa Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Placebo Control,Single Group Assignment,Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00088231?order=16 M.D. Anderson Cancer Center The goal of this clinical research study is to find the highest safe doses of PTK 787 (vatalanib) and Gleevec (imatinib mesylate) that can be given to treat Chronic Myelogenous Leukemia-Blastic Phase (CML-BP), Refractory Acute Myelogenous Leukemia (AML), or Agnogenic Myeloid Metaplasia (AMM). Another goal is to see how effective this combination treatment is. Acute Myelogenous LeukemiaAgnogenic Myeloid MetaplasiaChronic Myelogenous Leukemia Drug:imatinib mesylate (Gleevec)Drug:PTK 787 (vatalanib) Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Ph I/II Study of PTK 787 (vatalanib) and Gleevec (imatinib) in Patients with Refractory Acute Myelogenous Leukemia (AML), Agnogenic Myeloid Metaplasia (AMM), and Chronic Myelogenous Leukemia- blastic phase (CML-BP)
http://www.clinicaltrials.gov/ct/show/NCT00087685?order=17 M.D. Anderson Cancer Center Endometrial Cancer Drug:RAD001 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Efficacy Study Official Title:A Phase II Study of RAD001 in Patients with Recurrent Endometrial Cancer
http://www.clinicaltrials.gov/ct/show/NCT00081874?order=18 M.D. Anderson Cancer Center The goal of this clinical research study is to find the highest safe dose of RAD001 that can be given as a treatment for leukemia, mantle cell lymphoma, or myelofibrosis. Another goal is to learn how effective the dose that is found is as a treatment. RAD001 is a new drug that was designed to block proteins that are important in the development and growth of cancer. LeukemiaMantle Cell LymphomaMyelofibrosis Drug:RAD001 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Phase I/II Study of RAD001 in Patients with Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Chronic Myeloid Leukemia in Blastic-Phase, Agnogenic Myeloid Metaplasia, Chronic Lymphocytic Leukemia, T-Cell Leukemia, or Mantle Cell Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00098241?order=19 Novartis Pharmaceuticals The purpose of this study is to evaluate the safety and tolerability of RAD001 (Certican) administered to pediatric renal transplant recipients, and to provide additional safety data. Kidney Transplantation Drug:Certican Phase III Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Multicenter Trial of the Safety & Efficacy of Certican in Pediatric de novo Renal Transplant Patients
http://www.clinicaltrials.gov/ct/show/NCT00097955?order=20 Novartis Pharmaceuticals Study of the efficacy and safety of aliskiren when used for patients with hypertension, type 2 diabetes, and kidney disorders to monitor improvement in any of these conditions. Diabetic Nephropathy Drug:aliskiren Phase II Study Type:InterventionalStudy Design:Educational/Counseling/Training,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:Safety and Efficacy of the Antihypertensive Drug Aliskiren in Patients with Hypertension, Type 2 Diabetes and Proteinuria
http://www.clinicaltrials.gov/ct/show/NCT00097968?order=21 Novartis Pharmaceuticals Everolimus is an immunosuppressive drug that is being studied for preventing acute rejection that can happen after heart transplantation. It is usually used in combination with other immunosuppressive drugs such as cyclosporine. The purpose of this study is to evaluate the change in kidney function after beginning everolimus, while determining the most effective Neoral (cyclosporine) dose to take with everolimus, in adult cardiac transplant patients who have had their transplanted heart for at least 1 year and who have cardiac allograft vasculopathy. Graft Rejection Drug:everolimus Phase III Study Type:InterventionalStudy Design:Prevention,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:An Open-Label, Single Arm, Pilot Study of the Renal Safety of Everolimus in Addition to Neoral in Cardiac Transplant Recipients with Established Allograft Vasculopathy
http://www.clinicaltrials.gov/ct/show/NCT00088582?order=22 Novartis Pharmaceuticals 5 month study comparing SOM230 s.c. and Sandostatin s.c. in acromegalic patients. Acromegaly Drug:SOM230 s.c.Drug:Sandostatin s.c. Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Crossover Assignment,Safety/Efficacy Study Official Title:A Multicenter, Randomized, Crossover, Open Label Dose Finding Study to Compare the Safety, Efficacy and PK/PD Relationship of Multiple Doses of SOM230 and Sandostatin in Acromegalic Patients
http://www.clinicaltrials.gov/ct/show/NCT00088595?order=23 Novartis Pharmaceuticals Study evaluating SOM230 in patients with metastatic carcinoid tumors Carcinoid Tumors Drug:Sandostatin LARDrug:SOM230 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:An Open-label, Multicenter, Phase II Study Evaluating the Safety and Efficacy of Twice Daily Dosing of SOM230 in Patients with Metastatic Carcinoid Tumors
http://www.clinicaltrials.gov/ct/show/NCT00098007?order=24 Novartis Pharmaceuticals The study is designed to evaluate whether Neoral dose optimization together with a therapeutic drug monitoring of Certican will prevent renal dysfunction as observed in the pivotal cardiac trial while maintaining the efficacy. This objective will be assessed by comparing renal function post-transplant between 2 groups of patients. Heart transplantation Drug:Everolimus (Certican) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study Primary Outcomes:To determine whether Neoral dose optimization can improve renal function in de novo heart recipients receiving Neoral in addition to Everolimus; This will be assessed by comparing renal function post-transplant between 2 groups of patients.
http://www.clinicaltrials.gov/ct/show/NCT00088608?order=25 Novartis Pharmaceuticals The study treatment period is 15 days in length and includes patients with pituitary Cushings disease who are candidates for surgical intervention as well as and patients who have recurrent Cushings post operatively. Cushing's Syndrome Drug:SOM230 s.c. Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Single Group Assignment,Safety/Efficacy Study Official Title:A Multicenter, Open Label Study to Assess the Safety and Efficacy of 600 g SOM230, Administered Subcutaneously, b.i.d. in patients with Cushings disease
http://www.clinicaltrials.gov/ct/show/NCT00046254?order=26 Novartis Pharmaceuticals To evaluate that an investigational drug given once yearly for two years to men and women after surgical repair of a recent hip fracture will significantly reduce the rate of all re-occurring (new) skeletal fractures. All patients will receive vitamin D and calcium. OsteoporosisHip Fracture Drug:Zoledronic Acid Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00050258?order=27 Novartis Pharmaceuticals This HORIZON TOP trial will study the effect of zoledronic acid given once as an IV infusion compared to 60 days of oral risedronate in patients with Paget's disease of bone. The effect will be demonsrated in the reduction of serum alkaline phosphatase (SAP). Paget's Disease of Bone Drug:zoledronic acid Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00052013?order=28 Novartis Pharmaceuticals The purpose of this study is to determine whether PTK787/ZK 222584 is effective in treating hemangioblastoma of the brain and/or retina in patients with von Hippel-Lindau disease. The study will also assess safety and tolerability of PTK787/ZK 222584, and changes in markers of angiogenesis (new blood vessel growth). von Hippel-Lindau DiseaseCNS hemangioblastomaRetinal Hemangioblastoma Drug:PTK787/ZK 222584 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase II Open-Label Study of Oral, Continuous, Once Daily PTK787/ZK 222584 in Patients with von Hippel-Lindau Disease (VHL) and Hemangioblastoma (HB)
http://www.clinicaltrials.gov/ct/show/NCT00072904?order=1 To recruit 150 adult patients with cystic fibrosis related diabetes (CFRD) without fasting hyperglycemia for a multi-center, twelve month, placebo-controlled intervention trial testing the ability of insulin or repaglinide to improve body mass index (BMI) and stabilize pulmonary function in cystic fibrosis (CF). Cystic FibrosisDiabetes Mellitus Drug:Insulin AspartDrug:Rapaglinide Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00097084?order=2 Novo Nordisk The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type II diabetes. Diabetes Mellitus, Type II Drug:insulin detemirDrug:Lantus (insulin glargine)Drug:Novolog (insulin aspart) Phase III Study Type:InterventionalStudy Design:Treatment,Safety/Efficacy Study Official Title:Safety and Efficacy of Insulin Detemir plus Insulin Aspart vs. Insulin Glargine plus Insulin Aspart as Mealtime Insulin in Type II Diabetes
http://www.clinicaltrials.gov/ct/show/NCT00097877?order=3 Novo Nordisk The purpose of this study is to test whether NovoLog Mix twice a day with Metformin improves glycemic control vs. once daily Lantus with Metformin in patients with Type 2 Diabetes who are inadequately controlled on basal insulin plus oral antidiabetic therapy. Type 2 diabetes mellitus Drug:NovoLog Mix 70/30Drug:Lantus Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:NovoLog Mix 70/30 (biphasic insulin aspart 70/30) bid vs. Once Daily Lantus (insulin glargine) in Subjects with Type 2 Diabetes and Inadequate Glycemic Control on Basal Insulin Plus Oral Antidiabetic Therapy: A Multicenter, Randomized, Open-Label, Parallel Group Study
http://www.clinicaltrials.gov/ct/show/NCT00097279?order=4 Novo Nordisk The purpose of this study is to test whether NovoLog Mix 70/30 is a safe and at least as effective alternative in combination with two oral anti-diabetics compared to the two oral anti-diabetics alone for the control of blood glucose. Diabetes Mellitus, Type II Drug:NovoLog Mix 70/30 (biphasic insulin aspart 70/30)Drug:Glucophage (metformin)Drug:Actos (pioglitazone) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Safety/Efficacy Study Official Title:A Multicenter, Open-Label, Randomized Trial to Compare the Efficacy and Safety of NovoLog Mix 70/30 taken BID in Combination with Metformin and Pioglitazone to Metformin and Pioglitazone Alone in Insulin Naive Subjects with Type 2 Diabetes
http://www.clinicaltrials.gov/ct/show/NCT00095082?order=5 Novo Nordisk The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type I diabetes. Diabetes Mellitus, Type I Drug:insulin detemirDrug:Lantus (insulin glargine)Drug:Novolog (insulin aspart) Phase III Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00097071?order=6 Novo Nordisk The purpose of this study is to test whether insulin aspart (NovoLog) is a safe and at least as effective alternative to insulin lispro (Humalog) for the control of blood glucose in children and adolescents using Continuous External Infusion (CSII) (Insulin Pumps). Diabetes Mellitus, Type I Drug:insulin aspartDrug:insulin lispro Phase III Study Type:InterventionalStudy Design:Treatment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00095732?order=1 Altus Pharmaceuticals The purpose of this study is to determine the most effective dose of a new enzyme therapy on oral nutrient absorption in cystic fibrosis (CF) subjects with exocrine pancreatic insufficiency. Cystic FibrosisPancreatic Insufficiency Drug:TheraCLEC Total Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Dose Comparison,Parallel Assignment,Efficacy Study Official Title:A Phase 2, Randomized, Double Blind, Parallel Dose Ranging Study of Oral TheraCLEC - Total in Cystic Fibrosis Subjects with Exocrine Pancreatic Insufficiency
http://www.clinicaltrials.gov/ct/show/NCT00022295?order=1 Novogen unspecified adult solid tumor, protocol specific Drug:phenoxodiolProcedure:enzyme inhibitor therapyProcedure:protein tyrosine kinase inhibitor therapy Phase I Study Type:InterventionalStudy Design:Treatment Official Title:Phase IB Study of Phenoxodiol in Patients With Refractory Solid Tumors
http://www.clinicaltrials.gov/ct/show/NCT00060671?order=1 Novuspharma The purpose of this study is to determine whether combining pixantrone (BBR 2778, INN name pending) with the monoclonal antibody rituximab, leads to an increase in the period of patients remission, compared to rituximab alone. Lymphoma, FollicularLymphoma, Mixed-Cell, FollicularLymphoma, Small Cleaved-Cell, FollicularLymphoma, Low-Grade Drug:rituximabDrug:Pixantrone (BBR 2778) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Efficacy Study Official Title:An Open-Label, Randomized, Phase III Comparative Trial of BBR 2778 + Rituximab Versus Rituximab in the Treatment of Patients with Relapsed or Refractory Indolent Non-Hodgkins Lymphoma (NHL)
http://www.clinicaltrials.gov/ct/show/NCT00060684?order=2 Novuspharma The aim of this trial is to determine the appropriate dose of pixantrone to be used in this combination and obtain data on the combinations safety and activity profile. Lymphoma, Low-GradeLymphoma, Small LymphocyticLymphoma, Mixed-Cell, FollicularLymphoma, Small Cleaved-Cell, Follicular Drug:Pixantrone (BBR 2778)Drug:fludarabineDrug:dexamethasoneDrug:rituximab Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase I Trial of BBR 2778 in Combination with Fludarabine, Dexamethasone and Rituximab in the Treatment of Patients with Relapsed or Refractory Indolent Non-Hodgkins Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00072839?order=1 NPS Allelix Corp. The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease. Crohn's Disease Drug:ALX-0600 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Pilot Study of the Safety and Efficacy of ALX-0600 in Subjects with Moderately Active Crohn's Disease
http://www.clinicaltrials.gov/ct/show/NCT00081458?order=2 NPS Allelix Corp. The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS). Short Bowel SyndromeParenteral Nutrition Drug:Teduglutide Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Study of the Efficacy and Safety of Teduglutide in Subjects with Parenteral Nutrition-Dependent Short Bowel Syndrome
http://www.clinicaltrials.gov/ct/show/NCT00094003?order=1 NS Pharma, Inc. This study is to investigate the safety of NS-9 and to see how well it is tolerated in patients with cancer that has metastasized (spread) to the liver from another primary tumor. NS-9 is a drug developed to go to the liver to cause cell death specifically in tumor cells. This study is also set up to determine the best dose to use. Liver NeoplasmsNeoplasm MetastasisLocal Neoplasm Recurrences Drug:NS-9 [Poly I: Poly C] Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:A Phase I, Open-Label, Dose Escalation Study of Intravenously Administered NS-9 in Subjects with Liver Metastases from Various Primary Cancers
http://www.clinicaltrials.gov/ct/show/NCT00073554?order=1 Nuvelo This trial is for patients with acute occlusion of one of the arteries supplying blood to the leg. The trial is designed to determine the safety and activity of a novel clot dissolving (thrombolytic) drug (alfimeprase). Arterial Occlusive DiseasesPeripheral Vascular DiseasesThrombosis Drug:Alfimeprase Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Historical Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase 2, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Activity of Alfimeprase in Patients with Acute Peripheral Arterial Occlusion
http://www.clinicaltrials.gov/ct/show/NCT00073515?order=2 Nuvelo This trial is for patients with a central venous catheter (a vascular access device) that is not functioning properly (unable to withdraw blood). The trial compares a new blood clot dissolving agent (alfimeprase) against the currently used treatment. Catheters, Indwelling Drug:Alfimeprase Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase 2, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Alfimeprase for Restoring Function in Occluded Central Venous Catheters
http://www.clinicaltrials.gov/ct/show/NCT00086684?order=1 ALZA The purpose of this research study is to test two doses of a drug called ELMIRON (pentosan polysulfate sodium). ELMIRON has been approved by the U.S. FDA for the relief of bladder pain or discomfort associated with interstitial cystitis (IC). You may not be on other medications that could affect your IC symptoms such as antihistamines, antidepressants, anticholingergics, or antispasmodics. Interstitial Cystitis Drug:ELMIRONDrug:Placebo Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study Official Title:Multi-center, Randomized, Double-blind, PBO-controlled Parallel Evaluation of the Efficacy and Tolerability of ELMIRON
http://www.clinicaltrials.gov/ct/show/NCT00085345?order=1 Oncotherapeutics stage II multiple myelomastage III multiple myelomarefractory plasma cell neoplasm Drug:arsenic trioxideDrug:ascorbic acidDrug:melphalanProcedure:chemosensitization/potentiationProcedure:chemotherapy Phase IV Study Type:InterventionalStudy Design:Treatment Official Title:Phase IV Study of Melphalan, Arsenic Trioxide, and Ascorbic Acid in Patients With Relapsed or Refractory Multiple Myeloma
http://www.clinicaltrials.gov/ct/show/NCT00083421?order=1 Ono Pharma The purpose of this study is to establish the presence of an effect of treatment with ONO-2506PO in patients with Alzheimer's Disease, based upon cognitive and global scales. Alzheimer's Disease Drug:ONO-2506PO Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Study start:May 2004
http://www.clinicaltrials.gov/ct/show/NCT00046761?order=2 Ono Pharma The primary objective of this study is to compare the efficacy of ONO-2506 versus placebo in neurological stroke outcome in patients with acute ischemic stroke. Cerebrovascular Accident Drug:ONO-2506 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00007826?order=1 Onyvax Colon CancerRectal Cancer Drug:BCGDrug:alum adjuvantDrug:monoclonal antibody 105AD7 anti-idiotype vaccineProcedure:antibody therapyProcedure:biological response modifier therapyProcedure:monoclonal antibody therapyProcedure:non-specific immune-modulator therapyProcedure:non-tumor cell derivative vaccineProcedure:vaccine therapy Phase I Study Type:InterventionalStudy Design:Treatment Official Title:Phase I/II Study of Monoclonal Antibody 105AD7 Anti-Idiotype Vaccine and ONYCR1, ONYCR2, and ONYCR3 Allogeneic Adenocarcinoma Cell-Based Vaccines in Patients With Locally Advanced or Metastatic Adenocarcinoma of the Colon or Rectum
http://www.clinicaltrials.gov/ct/show/NCT00073307?order=1 Bayer Corporation The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY 43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease. Carcinoma, Renal Cell Drug:BAY 43-9006, A Raf Kinase and VEGFR Inhibitor Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase III Randomized Study of BAY 43-9006 in Patients with Unresectable and/or Metastatic Renal Cell Cancer
http://www.clinicaltrials.gov/ct/show/NCT00097422?order=1 Optimer Pharmaceuticals The purpose of this study is to investigate the safety and perform preliminary clinical evaluation in patients with mild to moderate CDAD. Diarrhea Drug:OPT-80 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study Official Title:An Open-Label, Dose Ranging, Randomized Clinical Evaluation of OPT-80 in Patients with Clostridium difficile-Associated Diarrhea (CDAD)
http://www.clinicaltrials.gov/ct/show/NCT00064428?order=1 Organon The purpose of this research study is to determine the efficacy and safety of fondaparinux (Arixtra) in preventing death and repeat heart attacks and their complications. Myocardial Infarction Drug:fondaparinux sodiumDrug:heparinDrug:Glucose-insulin-potassium (GIK) Phase III Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Safety and efficacy trial evaluating fondaparinux use in a broad range of patients with ST segment elevation acute MI
http://www.clinicaltrials.gov/ct/show/NCT00083941?order=1 Oxford BioMedica Stage IV Renal Cell Cancer Drug:TroVax in combination with IL-2 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Safety/Efficacy Study Official Title:Clinical Trial Phase II (Single Centre Study) : A Preliminary Study of the Safety, Immunogenicity, and Clinical Efficacy of TroVax Given in Conjunction with Interleukin 2 (IL-2) in the Treatment of Stage IV Renal Cell Cancer
http://www.clinicaltrials.gov/ct/show/NCT00058955?order=1 Orphan Medical The purpose of this study is to learn more about the effects of gamma-hydroxybutyric acid (GHB) by comparing its physiological, behavioral and subjective effects with those of several other drugs. Sedative abuse Drug:sodium oxybate, triazolam and pentobarbital Phase I Study Type:InterventionalStudy Design:Prevention,Non-Randomized,Double-Blind,Placebo Control,Crossover Assignment,Pharmacodynamics Study
http://www.clinicaltrials.gov/ct/show/NCT00087555?order=2 Orphan Medical The purpose of this study is to determine whether Xyrem (sodium oxybate) is effective when used alone to treat the pain and sleep disturbances of fibromyalgia. Fibromyalgia Drug:Xyrem (sodium oxybate) oral solution Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem(R) (sodium oxybate) with Placebo for the Treatment of Fibromyalgia
http://www.clinicaltrials.gov/ct/show/NCT00086281?order=3 Orphan Medical To study the effect of Xyrem (9 g), Xyrem (9 g) plus modafinil 200 mg administered the morning prior to Xyrem, positive control (zolpidem 10 mg), and placebo on the frequency and outcome of events of sleep-disordered breathing in patients with obstructive sleep apnea syndrome (OSAS). Obstructive Sleep Apnea Syndrome Drug:Xyrem (sodium oxybate) oral solutionDrug:ModafinilDrug:Zolpidem Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Crossover Assignment,Safety/Efficacy Study Official Title:Randomized, Placebo-Controlled Multicenter Trial of the Effects of Orally Administered Xyrem (sodium oxybate) and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients
http://www.clinicaltrials.gov/ct/show/NCT00089570?order=1 Orphan Therapeutics The purpose of this study is to determine whether terlipressin is safe and effective in the treatment of patients with hepatorenal syndrome type 1 when compared to placebo. Hepatorenal Syndrome Drug:terlipressin Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase III Study of Intravenous Terlipressin in Patients with Hepatorenal Syndrome Type 1
http://www.clinicaltrials.gov/ct/show/NCT00093223?order=1 American Bioscience This trial will treat patients with a new chemotherapeutic medicine who have undergone a successful and uncomplicated de novo stent placement in up to two native coronary arteries. The purpose of the trial is to determine the appropriate dose of the new medicine for future trials and to evaluate the incidence of treatment-emergent adverse events and serious adverse events. Angina PectorisCoronary Artery Disease Drug:ABI-007 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Uncontrolled,Parallel Assignment,Safety Study Primary Outcomes:Safety and tolerability for ABI-007; Incidence of treatment-emergent adverse events and serious adverse events.; Major Adverse Cardiac Events at 2 months following the stent procedure.Secondary Outcomes:Major Adverse Cardiac Events at 6 months.; Evaluation of restenosis at 6 months.
http://www.clinicaltrials.gov/ct/show/NCT00093145?order=2 American Bioscience This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Carboplatin and Herceptin. Patients will be given the combination therapy on a weekly basis and may continue on therapy as long as their condition improves and drug toxicity is tolerated. Breast Cancer Drug:ABI-007 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Parallel Assignment,Safety/Efficacy Study Primary Outcomes:Percentage of patients who achieve an objective confirmed complete or partial target lesion response based on the RECIST response criteria.Secondary Outcomes:Percentage of patients with stable disease for 16 weeks; time to disease progression; duration of response; patient survival
http://www.clinicaltrials.gov/ct/show/NCT00073723?order=3 American Bioscience The anticancer agent paclitaxel (Taxol for Injection Concentrate, Bristol-Meyers Squibb) has a broad spectrum of activity against several human cancers including carcinomas of ovary, breast, lung, esophagus and head and neck cancer. Taxol has shown remarkable activity against metastatic breast cancer, yielding response rates in the range of 40% to 60% in chemotherapy-naive patients and 25%-30% in patients refractory to anthracycline-containing regimens (Taxol package insert). The major limitation of Taxol is its poor water soluability requiring Cremophor (containing castor oil and ethanol) as a solvent. Taxol in this vehicle must be administered over 3-24 hours, and hypersensitivity reactions to Cremophor require a premedication routine of a corticosteroid, an antihistamine, and an H2 antagonist. Non-small cell lung cancer Drug:ABI-007 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:An open-label, Phase I/II Trial of ABI-007 (A Cremophor EL-Free, Protein Stabilized, Nanoparticle, Paclitaxel) Administered Weekly in Chemotherapy Naive Patients with Advanced Non-Small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00093119?order=4 American Bioscience This trial will treat patients previously treated for advanced (metastatic) melanoma (skin cancer) with a new chemotherapeutic medicine. The new chemotherapy will be administered weekly in cycles of three weekly doses followed by one week rest. A minimum of three cycles of therapy will be given to determine the anti-tumor response of the new chemotherapy. Patients may continue to stay on therapy a maximum of 9-12 cycles if treatment shows continuing benefit. MelanomaMetastases Drug:ABI-007 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase II Trial of ABI-007 in Previously Treated Patients with Metastatic Melanoma
http://www.clinicaltrials.gov/ct/show/NCT00072631?order=1 OSI Pharmaceuticals The purpose of this study is to determine if erlotinib will improve disease at doses that produce its characteristic rash in patients with advanced Non-Small Cell Lung Cancer. Carcinoma, Non-Small-Cell Lung Drug:Tarceva (Trademark) (erlotinib HCl, OSI-774) Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase II, Open-label, Intra-patient Dose-escalation Study of Erlotinib in Patients with Advanced Non-small Cell Lung Cancer who have Failed Prior Chemotherapy
http://www.clinicaltrials.gov/ct/show/NCT00085839?order=2 OSI Pharmaceuticals The purpose of this study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated Non-Small Cell Lung Cancer (NSCLC) and an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 2. The study will also evaluate the safety of single-agent erlotinib in this patient population. Non-Small Cell Lung Carcinoma Drug:Tarceva (Trademark) (erlotinib HCl, OSI-774)Drug:Combination carboplatin and paclitaxel Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized Phase II Study of Single Agent Erlotinib [Tarceva (TM), OSI-774] versus Standard Chemotherapy (Paclitaxel and Carboplatin) in Patients with Previously Untreated Advanced NSCLC and a Poor Performance Status
http://www.clinicaltrials.gov/ct/show/NCT00088270?order=3 OSI Pharmaceuticals Multi-center, randomized Phase II study to evaluate the efficacy and safety of OSI-7904L versus 5 FU/LV in biliary tract cancer. Bilary Tract Cancer Drug:OSI-7904LDrug:5-Fluorouracil/Leucovorin Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized, Open Label, Phase II Study of OSI-7904L versus 5-FU/LV as First-Line Treatment in Patients with Unresectable, Locally Advanced or Metastatic Adenocarcinoma of the Biliary Tract
http://www.clinicaltrials.gov/ct/show/NCT00048776?order=1 Otsuka America Pharmaceutical Juvenile secondary Raynauds (ray-knows) Phenomenon is a disorder of the blood vessels in the fingers and sometimes can affect the toes, nose, or ears. Children with secondary Raynauds Phenomenon have an underlying condition such as systemic lupus, scleroderma, or mixed connective tissue disease. When children with secondary Raynauds are exposed to chilly or cold conditions from weather, cold temperatures, or even holding cold items from the refrigerator, their fingers may become cold, numb, hurt, and/or turn purple or white. The investigational drug, Pletal(cilostazol), which has been approved for other conditions, inhibits the ability of one type of blood cell, platelets, to form blood clots, and also widens narrowed blood vessels. It has been used in a variety of other conditions in which blood flow is decreased. This study will test the safety and effectiveness Pletal(cilostazol) to lessen the severity of the symptoms and decrease the number of secondary Raynauds episodes in juvenile patients. Raynaud's Disease Drug:Pletal Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00048763?order=2 Otsuka America Pharmaceutical Juvenile primary Raynauds (ray-knows) Phenomenon is a disorder of the blood vessels in the fingers and sometimes can affect the toes, nose, or ears. When children with primary Raynauds Phenomenon are exposed to chilly or cold conditions from weather, cold temperatures, or even holding cold items from the refrigerator, their fingers may become cold, numb, hurt, and/or turn purple or white. Children with primary Raynauds Phenomenon have no underlying systemic disease. The cause for their symptoms is unknown. The investigational drug, Pletal(cilostazol), which has been approved for other conditions, inhibits the ability of one type of blood cell, platelets, to form blood clots, and also widens narrowed blood vessels. It has been used in a variety of other conditions in which blood flow is decreased. This study will test the safety and effectiveness Pletal(cilostazol) to lessen the severity of the symptoms and decrease the number of primary Raynauds episodes in juvenile patients. Raynaud's Disease Drug:Pletal Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00092508?order=1 Otsuka Maryland Research Institute This dose comparison study, taking place at over 200 sites worldwide, will compare the dosing, safety and efficacy of an investigational medicine OPC-6535 to the dosing, safety and efficacy of Asacol in the maintenance of remission in subjects with ulcerative colitis. Ulcerative Colitis Drug:OPC-6535Drug:Asacol Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Dose Comparison,Parallel Assignment,Safety/Efficacy Study Official Title:Phase 3, Multi-Center, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25 mg QD and 50 mg QD of OPC-6335 Oral Tablets and 800 mg BID of Asacol in the Maintenance of Ulcerative Colitis Remission
http://www.clinicaltrials.gov/ct/show/NCT00071331?order=2 Otsuka Maryland Research Institute The purpose of this study is to compare the effectiveness of tolvaptan or placebo in adults with worsening congestive heart failure (CHF). Congestive Heart Failure Drug:Tolvaptan Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:Protocol 156-03-236: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long Term Efficacy and Safety of Oral Tolvaptan Tablets in Subjects Hospitalized with Worsening Congestive Heart Failure
http://www.clinicaltrials.gov/ct/show/NCT00064441?order=3 Otsuka Maryland Research Institute Ulcerative Colitis Drug:OPC-6535 Tablets (drug) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:FACTS I: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis
http://www.clinicaltrials.gov/ct/show/NCT00064454?order=4 Otsuka Maryland Research Institute Ulcerative Colitis Drug:OPC-6535 Tablets (drug) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:FACTS II: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis
http://www.clinicaltrials.gov/ct/show/NCT00043758?order=5 Otsuka Maryland Research Institute The purpose of this study is to study the effects of tolvaptan on the size and function of the left heart chamber (ventricle) in patients with congestive heart failure (CHF) Congestive Heart Failure Drug:Tolvaptan Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00072683?order=6 Otsuka Maryland Research Institute The purpose of this study is to determine whether tolvaptan is effective in treating patients with hyponatremia Hyponatremia Drug:tolvaptan Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Safety/Efficacy Study Official Title:Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of the Effects of Oral Tolvaptan in Patients with Hyponatremia
http://www.clinicaltrials.gov/ct/show/NCT00083941?order=1 Oxford BioMedica Stage IV Renal Cell Cancer Drug:TroVax in combination with IL-2 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Safety/Efficacy Study Official Title:Clinical Trial Phase II (Single Centre Study) : A Preliminary Study of the Safety, Immunogenicity, and Clinical Efficacy of TroVax Given in Conjunction with Interleukin 2 (IL-2) in the Treatment of Stage IV Renal Cell Cancer
http://www.clinicaltrials.gov/ct/show/NCT00094536?order=1 American Medical Systems Menorrhagia Procedure:HerOption Endometrial Cryoablation Therapy Phase IV Study Type:InterventionalStudy Design:Educational/Counseling/Training,Non-Randomized,Open Label,Historical Control,Parallel Assignment,Efficacy Study Official Title:A Study to Evaluate the Effectiveness of Extended Treatment Regimens with the Her Option Cryoablation Therapy System for Treatment of Menorrhagia
http://www.clinicaltrials.gov/ct/show/NCT00073177?order=1 Pfizer This study is to evaluate the efficacy and safety of an oral investigational drug in patients with stable asthma. Patient will be withdrawn from their current controller medication and enter a run-in phase. Throughout the study patients will have supplies of rescue medication (inhaled albuterol/salbutamol). After completion of the run-in phase, patients will be re-evaluated and those who meet all entry criteria will be randomized at a 1:1:1 ratio to receive either, the investigational drug at 250 mcg, 500 mcg or placebo daily. During the 24-week double-blind treatment period patients will be evaluated in the morning at the investigators clinic at weeks 2, 4, 8, 12, 18, and 24. At each clinic visit, patients will complete relevant questionnaires, undergo spirometry, review of electronic diaries, and complete laboratory procedures. Asthma Drug:Investigational New Drug Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00094094?order=2 Pfizer This is a Phase 2 study being conducted at multiple centers in the United States. Patients having non-small cell lung cancer that has spread to other parts of the body (i.e., metastatic) or is locally advanced (i.e., Stage IIIB with malignant pleural effusion) are eligible to participate. Patients must have disease that has been treated with no more than 1 prior treatment for metastatic disease (prior adjuvant treatment for localized disease does not count as prior treatment for metastatic disease). The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective treatment for advanced non-small cell lung cancer as shown by the number of patients in the study who experience significant and durable tumor shrinkage. Non-Small-Cell Lung CarcinomaMetastases Drug:AG-013736 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Phase 2 Study of the Anti-angiogenesis Agent AG-013736 in Patients with Advanced Non-Small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00094107?order=3 Pfizer This is a Phase 2 study being conducted at multiple centers in the United States. Patients having melanoma that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have disease that has been treated with no more than 1 prior treatment for metastatic disease (prior adjuvant treatment for localized disease does not count as prior treatment for metastatic disease). The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective treatment for metastatic melanoma as shown by the number of patients in the study who experience significant and durable tumor shrinkage. MelanomaMetastases Drug:AG-013736 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Phase 2 Study of the Anti-angiogenesis Agent AG-013736 in Patients with Metastatic Melanoma
http://www.clinicaltrials.gov/ct/show/NCT00037050?order=4 Pfizer This study will treat patients who have a short term central catheter that is thought to be infected with a specific bacteria (gram positive bacteria) Bacterial InfectionsGram-Positive Bacterial InfectionsBacteremia Drug:AntibioticDrug:VancomycinDrug:OxacillinDrug:Dicloxacillin Phase III Study Type:InterventionalStudy Design:Treatment Study start:April 2002
http://www.clinicaltrials.gov/ct/show/NCT00082563?order=5 Pfizer The purpose of this study is to determine if Azithromycin in combination with chloroquine is superior to chloroquine alone in eradicating P. falciparum asexual parasitemia in asymptomatic, semi-immune adults in Western Kenya. Plasmodium falciparum Malaria Drug:Azithromycin/ChloroquineDrug:Chloroquine Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase II, Double Blind, Randomized, Comparative Trial of Azithromycin in Combination with Chloroquine Versus Chloroquine in the Eradication of Asymptomatic Plasmodium Falciparum Infection in Semi-Immune Adults
http://www.clinicaltrials.gov/ct/show/NCT00084227?order=6 Pfizer The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is non-inferior to atovaquone-proguanil for the treatment of symptomatic, uncomplicated malaria due to P. falciparum. Plasmodium falciparum Malaria Drug:Azithromycin/ChloroquineDrug:Atovaquone/Proguanil Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind Official Title:A Phase II/III, Randomized, Double Blind, Comparative Trial Of Azithromycin Plus Chloroquine Versus Atovaquone-Proguanil For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In South America
http://www.clinicaltrials.gov/ct/show/NCT00082576?order=7 Pfizer The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is non-inferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum. Plasmodium falciparum Malaria Drug:Azithromycin/ChloroquineDrug:Mefloquine Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase II/III, Randomized, Double-Blind, Comparative Trial of Azithromycin Plus Chloroquine Versus Mefloquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in Uganda
http://www.clinicaltrials.gov/ct/show/NCT00084240?order=8 Pfizer The primary objective is to confirm the hypothesis that azithromycin (optimal dose once daily for three days) plus chloroquine is non-inferior to sulfadoxine-pyrimethamine plus chloroquine for the treatment of uncomplicated, symptomatic malaria due to P. falciparum. Plasmodium falciparum Malaria Drug:Azithromycin/ChloroquineDrug:Sulfadoxine-Pyrimethamine/Chloroquine Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind Official Title:A Phase II/III, Randomized, Comparative, Double Blind Trial Of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine For The Treatment Of Uncomplicated, Symptomatic Falciparum Malaria In Jakarta, Indonesia
http://www.clinicaltrials.gov/ct/show/NCT00086489?order=9 Pfizer The purpose of this study is to assess the efficacy, safety, and tolerability of monoclonal antibody therapy using 2 regimens for the treatment of advanced melanoma Melanoma Drug:CP-675,206 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study Official Title:Phase 2, Open-label, Randomized Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of 2 Regimens of CP-675,206 in Patients with Advanced Melanoma
http://www.clinicaltrials.gov/ct/show/NCT00096473?order=10 Eisai Medical Research Inc Alzheimer's DiseaseDementia Drug:Donepezil hydrochloride Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A 24 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Donepezil Hydrochloride (E2020) in Patients with Severe Alzheimer's Disease Followed by a 12 Week Open-Label Extension Period
http://www.clinicaltrials.gov/ct/show/NCT00078000?order=11 Pfizer The purpose of this study is to test whether SU011248 has activity and is safe in patients with Metastatic Breast Cancer (MBC). Breast CancerNeoplasm Metastasis Drug:SU011248 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase II Study of the Efficacy and Safety of SU011248 in Patients with Anthracycline- and Taxane-Refractory Metastatic Breast Cancer
http://www.clinicaltrials.gov/ct/show/NCT00082589?order=12 Pfizer The purpose of this study is to determine whether eplerenone slows or prevents further enlargement of the heart. It will also evaluate whether eplerenone improves or stabilizes the heart's pumping ability. Congestive Heart Failure Drug:Eplerenone Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study Official Title:Study to Evaluate the Effects of Eplerenone versus Placebo on Cardiac Remodeling in Patients with Left Ventricular Systolic Dysfunction and Mild to Moderate Heart Failure
http://www.clinicaltrials.gov/ct/show/NCT00076076?order=13 ALTANA Pharma The purpose of this study is to determine whether roflumilast is effective in the treatment of asthma. Asthma Drug:Roflumilast Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:FLASH Study: A 24 week randomized, controlled study of roflumilast versus placebo in patients with asthma
http://www.clinicaltrials.gov/ct/show/NCT00087503?order=14 Pfizer Gastric Cancer Drug:Edotecarin Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase II Efficacy and Safety Study of Intravenous Edotecarin in Patients with Advanced Gastric Cancer that has Progressed or Recurred After Prior Fluoropyrimidine-based Chemotherapy
http://www.clinicaltrials.gov/ct/show/NCT00088192?order=15 Eyetech Pharmaceuticals To provide Pegaptanib sodium injection to patients with subfoveal choroidal neovascularization (CNV) secondary to AMD, who are unable to participate in any of the Sponsors other clinical studies with this drug for AMD, until such time as the patients lesion is considered to have resolved or stabilized in the opinion of the treating ophthalmologist, or product becomes commercially available. Macular Degeneration Drug:pegaptanib sodium Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:An Open Label, Non-Comparative Protocol for use of Intravitreous Pegaptanib Sodium Injection Every 6 Weeks in Patients with Exudative Age-Related Macular Degeneration (AMD)
http://www.clinicaltrials.gov/ct/show/NCT00067314?order=16 Pfizer This international study will study how metastatic breast cancer responds to the investigational drug treatment, what are the side effects of the investigational drug when given to women with metastatic breast cancer and how often do these side effects occur. The study will also analyze how fast investigational drug and its breakdown products are cleared from the blood in these patients. Breast NeoplasmsNeoplasm Metastasis Drug:Edotecarin Phase II Study Type:InterventionalStudy Design:Treatment Official Title:A Phase II Study of Intravenous Edotecarin (PHA 782615) in Patients with Anthracycline and Taxane Refractory or Chemo-resistant Metastatic Breast Cancer (Please Note: The anthracycline/taxane refractory cohort is no longer enrolling, the trial is now only enrolling for the chemotherapy resistant cohort)
http://www.clinicaltrials.gov/ct/show/NCT00075192?order=17 Pfizer This is a multi-center, open label, randomized study. Patients will be randomized to one of the following arms with an allocation ratio of 3:1, respectively: Arm A: Investigational Drug + neoadjuvant hormone therapy (NHT) OR Arm B: neoadjuvant hormone therapy. After randomization, patients will receive study treatment for three cycles (one cycle is defined as 28 days). After completion of three cycles, patients will undergo a prostatectomy and pathology assessments will be completed at a central laboratory, the Armed Forces Institute of Pathology (AFIP) in Washington, DC. Up to 52 response evaluable patients are expected to be enrolled in this study. Prostate Cancer Drug:Investigational New Drug Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Efficacy Study Official Title:Investigational Drug with Neoadjuvant Hormone Therapy or Hormone Therapy Alone in Patients with High Risk Prostate Cancer
http://www.clinicaltrials.gov/ct/show/NCT00087490?order=18 Pfizer This is a Phase IV randomized, multi-center, open label trial to compare the clinical safety and efficacy of linezolid to vancomycin in the treatment of complicated skin and soft tissue infections due to methicillin-resistant staphylococcus aureus in adult subjects hospitalized for at least one day. Staphylococcal Skin InfectionsSoft Tissue Infections Drug:LinezolidDrug:Vancomycin Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Single Group Assignment Official Title:Linezolid in the Treatment of Subjects with Complicated Skin and Soft Tissue Proven to be due to Methicillin-Resistant Staphylococcus Aureus
http://www.clinicaltrials.gov/ct/show/NCT00084266?order=19 Pfizer Linezolid is the first of a new class of antibiotics with a unique mechanism of action against Methicillin-Resistant Staphylococcus Aureus (MRSA). This is a Phase IV, double-blinded, randomized study for patients with hospital acquired pneumonia proven to be caused by MRSA. Patients will be treated with linezolid or vancomycin for a minimum of 7 days and up to a maximum of 14 days. The primary objective of this study is to compare the clinical efficacy of linezolid to vancomycin in treatment of pneumonia due to MRSA. Pneumonia Drug:LinezolidDrug:Vancomycin Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00035854?order=20 Pfizer This study will treat pediatric patients who have infections that are due to a specific bacteria (Vancomycin-Resistant Enterococcus) Bacterial Infections Drug:Antibiotic Phase III Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00076089?order=21 ALTANA Pharma The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD). Chronic Obstructive Pulmonary Disease Drug:Roflumilast Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00074867?order=22 Pfizer The purpose of this study is to determine whether the investigational drug, an oral VEGFR-2 tyrosine kinase inhibitor is effective in the treatment of epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancer for patients who have failed first line platinum-based therapy and have a persistent rising CA-125. Ovarian Cancer Drug:Investigational New Drug Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Efficacy Study Official Title:A Clinical Efficacy Study of an Oral Tyrosine Kinase Inhibitor of VEGFR-2 to Treat Recurrent or Persistent Small-volume Epithelial Ovarian Cancer, Primary Peritoneal Serous Cancer, or Fallopian Tube Cancer
http://www.clinicaltrials.gov/ct/show/NCT00080171?order=23 Knee osteoarthritis (OA) is the most common cause of disability in adults. The "Osteoarthritis Initiative (OAI): A Knee Health Study" is a nationwide research study that will help researchers gather more information about the physical changes that occur prior to the onset of arthritis symptoms or before OA gets worse. The purpose of this study is to examine people who have knee OA or are at high risk for knee OA; information will be used to better understand how to prevent and treat knee OA. OsteoarthritisKnee Osteoarthritis Study Type:ObservationalStudy Design:Natural History,Longitudinal,Defined Population,Prospective Study
http://www.clinicaltrials.gov/ct/show/NCT00007657?order=24 PCI (optimal catheter-based coronary revascularization) + intensive medical therapy is superior to intensive medical therapy alone using the combined endpoint of all-cause mortality or nonfatal MI. Myocardial Ischemia Procedure:Intensive medical therapyProcedure:Percutaneous Coronary Intervention Phase III Study Type:InterventionalStudy Design:Randomized,Open Label,Uncontrolled,Single Group Assignment,Efficacy Study Official Title:Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation
http://www.clinicaltrials.gov/ct/show/NCT00088283?order=25 Eyetech Pharmaceuticals Macular Degeneration Drug:pegaptanib sodium Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase II Randomized, Dose-ranging, Double-masked, Multi-center Trial, in Parallel Groups, Determining Safety, Efficacy and PK of Intravitreous Injections of Pegaptanib Sodium Compared to Sham Injection for 30 weeks in Patients with Recent Vision Loss due to Macular Edema Secondary to CRVO
http://www.clinicaltrials.gov/ct/show/NCT00087763?order=26 Eyetech Pharmaceuticals The purpose of this study is to determine if Macugen reduces foveal thickness and improves vision in patients with wet AMD. Macular Degeneration Drug:Macugen (pegaptanib sodium injection) Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Factorial Assignment,Safety/Efficacy Study Official Title:A Phase II Prospective, Randomized, Double-masked, Sham-controlled, Dose-ranging, Multi-center Trial to Assess the Effect of Pegaptanib Sodium on Foveal Thickening in Patients with Exudative Subfoveal Age-related Macular Degeneration (AMD)
http://www.clinicaltrials.gov/ct/show/NCT00068029?order=27 Pfizer The purpose of this study is to compare the safety and tolerability of combination therapy with Sandostatin LAR plus Pegvisomant to that of Sandostatin LAR alone or Pegvisomant alone. Acromegaly Drug:Pegvisomant/ Sandostatin LARDrug:Sandostatin LAR Phase IV Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00031018?order=28 In this phase I-II parallel design, randomized, double-blind clinical trial we will determine if 3,000 or 30,000 units ingested hrIFN-a prevents deterioration of cognitive functioning in patients with dementia of Alzheimer's type (AD) and whether ingested hrIFN-a treatment decreases acute phase reactants and pro-inflammatory cytokine IL-6 in mild to moderate AD. We predict that the novel anti-inflammatory agent ingested human recombinant interferon alpha (hrIFN-a) will modulate inflammation and inhibit the natural history of AD progression. If you are eligible, you will receive Aricept for 5 weeks (donezepil) and thereafter in addition to Aricept either placebo (inactive substance) or interferon alpha at 3,000 or 30,000 units every day for 12 months. Memory DisordersAlzheimer's Disease Drug:AriceptDrug:IFN-alpha2A Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00076024?order=29 Pfizer The primary purpose of the study is to determine the time to progression of the combination of study drug and docetaxel versus docetaxel alone in patients who have not received prior chemotherapy for metastatic breast cancer. The secondary purpose of the study is to determine the dose of study drug that can be given with docetaxel administered on an every 3 week schedule. Breast Cancer Drug:Investigational New Drug/DocetaxelDrug:Docetaxel Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Safety/Efficacy Study Official Title:Phase 2 Randomized, Placebo-controlled, Double Blind Study of Study Drug in Combination with Docetaxel versus Docetaxel Alone for Patients with Metastatic Breast Cancer
http://www.clinicaltrials.gov/ct/show/NCT00074854?order=30 Pfizer The purpose of this study is to determine whether the investigational drug, an oral VEGFR-2 tyrosine kinase inhibitor when given in combination with chemotherapy (carboplatin and paclitaxel) is effective in the treatment of advanced stage non-small cell lung cancer Lung CancerCarcinoma, Non-Small-Cell Lung Drug:Investigational New DrugDrug:CarboplatinDrug:CimetidineDrug:DexamethasoneDrug:DiphenhydramineDrug:Paclitaxel Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Uncontrolled,Parallel Assignment,Efficacy Study Official Title:A Clinical Efficacy Study of an Oral Tyrosine Kinase Inhibitor of VEGFR-2 given in Combination with Chemotherapy (Paclitaxel and Carboplatin) vs. Chemotherapy Alone for the Treatment of Advanced Stage Non-small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00092001?order=31 Pfizer The purpose of this study is to test whether SU011248 has activity and is safe in patients with metastatic non-small cell lung cancer (NSCLC) who have failed a platinum-containing regimen and docetaxel. Non-Small-Cell Lung Carcinoma Drug:SU011248 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase 2 Efficacy and Safety Study of SU011248 in Patients with Metastatic Non-Small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00056693?order=32 Pfizer The primary objective of the study is to determine the efficacy and safety of SU011248 as a treatment for patients with advanced unresectable neuroendocrine tumor; however, CURRENTLY ONLY RECRUITING FOR PATIENTS SPECIFICALLY WITH PANCREATIC ISLET CELL TUMORS. Neuroendocrine TumorCarcinoid Tumor Drug:SU011248 Phase II Study Type:InterventionalStudy Design:Treatment,Safety/Efficacy Study Official Title:Phase II Study of SU011248 in Patients with Neuroendocrine Tumors; however, CURRENTLY ONLY RECRUITING FOR PATIENTS SPECIFICALLY WITH PANCREATIC ISLET CELL TUMORS
http://www.clinicaltrials.gov/ct/show/NCT00094055?order=33 Pfizer This is a Phase 2 study being conducted at multiple centers in the United States. Patients having thyroid cancer that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have disease that was not controlled by previous treatment with radioactive iodine (131I) or not be good candidates for such treatment. The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective treatment for metastatic thyroid cancer as shown by the number of patients in the study who experience significant and durable tumor shrinkage. Thyroid CancerMetastases Drug:AG-013736 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Phase 2 Study of the Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer
http://www.clinicaltrials.gov/ct/show/NCT00090532?order=34 Pfizer Investigational Drug being studied to treat patients with Age-Related Macular Degeneration. A total of 144 subjects may be enrolled in the trial. Subjects will be male or female at least 55 years of age with "wet" age-related macualr degeneration. age-related macular degeneration Drug:Investigational New Drug Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00068042?order=35 Pfizer The purpose of the study is to determine if Pegvisomant is more efficacious than Sandostatin LAR Depot in normalizing IGF-I levels in treatment naive patients with acromegaly. Acromegaly Drug:PegvisomantDrug:Sandostatin LAR Phase IV Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00073476?order=36 Pfizer The purpose of this study is to determine whether a new research medication is effective and safe for the treatment of acute stroke when given within 6 hours of the onset of stroke. Acute Stroke Drug:Investigational New Drug Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Study start:November 2003
http://www.clinicaltrials.gov/ct/show/NCT00075218?order=37 Pfizer The study is for patients with malignant gastrointestinal stromal tumor who have received treatment with imatinib mesylate and either experienced progression of disease or intolerance. Patients will be randomly assigned to receive either SU011248 or placebo. Patients randomized to receive placebo will be offered crossover to receive SU011248 at the time their disease progresses on study. Gastrointestinal Neoplasms Drug:SU011248 Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of SU011248 in Patients with Malignant GIST that Have Progressed During or Not Tolerated Treatment with Imatinib Mesylate (GLEEVEC)
http://www.clinicaltrials.gov/ct/show/NCT00077987?order=38 Pfizer The purpose of this study is to test whether SU011248 is active and safe in patients with metastatic colorectal cancer who have received and failed several specific standard therapies. Colorectal CancerNeoplasm Metastasis Drug:SU011248 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase II Study of the Efficacy and Safety of SU011248 in Patients with Metastatic Colorectal Cancer who Previously Failed Treatment with Irinotecan-, Oxaliplatin-, and Fluoropyrimidine, with and without Bevacizumab
http://www.clinicaltrials.gov/ct/show/NCT00089648?order=39 Pfizer The purpose of this study is to test whether SU011248 has activity and is safe in patients with Renal Cell Carcinoma (RCC) and who have failed prior therapy with bevacizumab (Avastin). Renal Cell Carcinoma Drug:SU011248 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase 2 Study of SU011248 in the Treatment of Patients with Bevacizumab (Avastin)-Refractory Metastatic Renal Cell Carcinoma
http://www.clinicaltrials.gov/ct/show/NCT00083889?order=40 Pfizer The purpose of this study is to test whether SU011248 has activity and is safe compared to Interferon-alfa in patients with metastatic Renal Cell Carcinoma (RCC). Renal Cell Carcinoma Drug:SU011248Drug:Interferon-alfa Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase 3, Randomized Study of SU011248 versus Interferon-alfa as First-Line Systemic Therapy for Patients with Metastatic Renal Cell Carcinoma
http://www.clinicaltrials.gov/ct/show/NCT00094029?order=41 Pfizer The purpose of this study is to permit access to SU011248 for treatment use by patients with GIST given the following conditions: a) patients undergo screening, but are not eligible for participation in ongoing clinical studies such as A6181004; AND b) patients have GIST which standard treatments have not been able to control with acceptable toxicity AND c) patients have the potential to derive clinical benefit from treatment with SU011248. Gastrointestinal Neoplasm Drug:SU011248 Phase III Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Treatment Protocol for Patients with Gastrointestinal Stromal Tumor (GIST) who are ineligible for Participation in Other SU011248 Protocols, are Refractory to Standard Therapy and May Derive Benefit from Treatment with SU011248
http://www.clinicaltrials.gov/ct/show/NCT00074841?order=42 Pfizer This primary objective of this study is to assess whether the combination of Azithromycin with chloroquine is non-inferior to the combination of sulfadoxine-pyrimethamine plus chloroquine, when used to treat uncomplicated cases of malaria due to Plasmodium falciparum in adults in India. Plasmodium falciparum Malaria Drug:Azithromycin/ChloroquineDrug:Sulfadoxine-Pyrimethamine/Chloroquine Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Active Control,Efficacy Study Official Title:A Phase II/III, Randomized, Comparative Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in India
http://www.clinicaltrials.gov/ct/show/NCT00098306?order=43 Pfizer HIV Infection Drug:UK-427,857 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of a Novel CCR5 Antagonist, UK-427,857, in Combination with Optimized Background Therapy versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-experienced HIV-1 Infected Subjects
http://www.clinicaltrials.gov/ct/show/NCT00098722?order=44 Pfizer HIV Infection Drug:UK-427,857 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of a Novel CCR5 Antagonist, UK-427,857, in Combination with Optimized Background Therapy versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced HIV-1 Infected Subjects
http://www.clinicaltrials.gov/ct/show/NCT00098748?order=45 Pfizer HIV Infection Drug:UK-427,857 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Multicenter, Randomized, Double-blind, Placebo Controlled Trial of a Novel CCR5 Antagonist, UK-427,857, in Combination with Optimized Background Therapy versus Optimized Background Therapy Alone for the Treatment of Antiretroviral Experienced, non CCR5-tropic HIV-1 Infected Subjects
http://www.clinicaltrials.gov/ct/show/NCT00098293?order=46 Pfizer HIV Infection Drug:UK-427,857 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Multicenter, Randomized, Double-blind, Comparative Trial of a Novel CCR5 Antagonist, UK-427,857, in Combination with Zidovudine/Lamivudine versus Efavirenz in Combination with Zidovudine/Lamivudine for the Treatment of Antiretroviral-nave HIV-1 Infected Subjects
http://www.clinicaltrials.gov/ct/show/NCT00050167?order=1 M.D. Anderson Cancer Center The purpose of this study is to evaluate two taxane regimens (weekly paclitaxel or docetaxel + capecitabine) given in addition to anthracycline based therapy in patients with newly diagnosed breast cancer as adjuvant or neoadjuvant therapy. The objectives of the study are: 1) to evaluate the ability of these two treatments to prevent recurrence and impact survival, 2) to evaluate the ability of the taxane regimens to reduce the tumor size and 3) increase the possibility of breast conservative surgery when given in the neoadjuvant setting. Breast Cancer Drug:PaclitaxelDrug:DocetaxelDrug:CapecitabineDrug:5-fluorouracilDrug:EpirubicinDrug:Cyclophosphamide Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00038402?order=1 M.D. Anderson Cancer Center The purpose of this study is to evaluate the addition of Herceptin to standard chemotherapy treatment of patients newly diagnosed with operable breast cancer. Other objectives: 1)to evaluate the potential of this therapy to reduce the size of the tumor and increase the possibility of breast conservative surgery, 2) evaluate the ability of this regimen to prevent recurrence of breast cancer and impact on survival, 3) determine side effect profile with the addition of Herceptin, 4) evaluate significance of HER2 expression by two different methods, and 5) determine correlation of cardiac blood tests with echocardiogram results in the detection of cardiac muscle damage. Breast Cancer Drug:HerceptinDrug:TaxolDrug:FluorouracilDrug:CytoxanDrug:Epirubicin Phase III Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00080028?order=1 Pharmacyclics The purpose of this study is to evaluate the safety of adding the investigational drug Motexafin Gadolinium to the standard treatment of radiation therapy and chemotherapy with drugs called 5-FU and cisplatin in patients with advanced head and neck cancer. Head and Neck CancerOropharynx CancerLarynx CancerHypopharynx Cancer Drug:Motexafin Gadolinium Injection Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:Phase I Trial of Motexafin Gadolinium and Chemoradiation in Locally Advanced, Squamous Cell Carcinoma of the Head and Neck
http://www.clinicaltrials.gov/ct/show/NCT00080041?order=2 Pharmacyclics The primary purpose of this study is to evaluate the safety, toxicities, and dosage for investigational drug Motexafin Gadolinium administered with docetaxel to patients with advanced solid tumors. Secondly, tumor response to the combined treatment will be evaluated. Breast NeoplasmsOvarian NeoplasmsProstatic NeoplasmsLung Neoplasms Drug:Motexafin Gadolinium Injection Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:Phase I Trial of Motexafin Gadolinium (MGd) and Docetaxel Administered at 3-Week Intervals for Advanced Solid Tumors
http://www.clinicaltrials.gov/ct/show/NCT00080054?order=3 Pharmacyclics The purpose of this study is to find out about the safety of adding the investigational drug motexafin gadolinium to a standard course of chemotherapy with temozolomide for patients with malignant glioma. Secondly, the study will determine how many patients will respond to this treatment. GliomaGlioblastomaAstrocytomaOligodendrogliomaBrain Neoplasm Drug:Motexafin Gadolinium Injection Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Phase I Trial of Motexafin Gadolinium (MGd) in Combination with Temozolomide for Treatment of Malignant Gliomas
http://www.clinicaltrials.gov/ct/show/NCT00086034?order=4 Pharmacyclics The primary purpose of this study is to find out if motexafin gadolinium may be an effective treatment for patients with non-Hodgkin's lymphoma (NHL). Secondly, the safety and side effects of motexafin gadolinium will be evaluated. LymphomaNon-Hodgkin's Lymphoma Drug:Motexafin gadolinium Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Phase II Trial of Motexafin Gadolinium (MGd) in Patients with Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00096837?order=5 Pharmacyclics The purpose of the study is to determine if the drug motexafin gadolinium will be an effective treatment for patients who have relapsed or refractory multiple myeloma. Multiple Myeloma Drug:Motexafin Gadolinium Injection Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:An Open-Label Phase II Trial of Motexafin Gadolinium (MGd) in Patients with Relapsed or Refractory Multiple Myeloma
http://www.clinicaltrials.gov/ct/show/NCT00054795?order=6 Pharmacyclics The primary purpose of the study is to determine if patients with brain metastases from non-small cell lung cancer treated with Motexafin Gadolinium and whole brain radiation therapy retain their neurologic function and ability to think for a longer time compared to patients treated with whole brain radiation therapy alone. Brain NeoplasmsCarcinoma, Non-Small-Cell LungMetastases, Neoplasm Drug:Motexafin Gadolinium Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Randomized Phase III Trial of Xcytrin (Motexafin Gadolinium) Injection for the Treatment of Brain Metastases in Patients with Non-Small Cell Lung Cancer Undergoing Whole Brain Radiation Therapy
http://www.clinicaltrials.gov/ct/show/NCT00089635?order=1 Amgen The purpose of this study is to determine if ABX-EGF will have clinically meaningful anti-tumor activity in patients with metastatic colorectal cancer who have developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy. Colorectal CancerMetastases Drug:ABX-EGF Phase II Study Type:InterventionalStudy Design:Treatment,Efficacy Study Official Title:A Phase 2 Multicenter Single Arm Clinical Trial of ABX-EGF Monotherapy in Subjects with Metastatic Colorectal Cancer Whose Tumors Express Low or Negative EGFr Levels of Immunohistochemistry Following Treatment with Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy
http://www.clinicaltrials.gov/ct/show/NCT00091832?order=2 Amgen This study is to evaluate various doses and schedules for AMG 162 administration and characterize the safety profile in this indication. Breast CancerMetastases Drug:AMG 162 Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00089674?order=3 Amgen This study will evaluate AMG 162 in the treatment of bone loss in subjects undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer. Prostate Cancer Drug:AMG 162 Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control Official Title:A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer
http://www.clinicaltrials.gov/ct/show/NCT00089661?order=4 Amgen The purpose of this trial is to evaluate AMG 162 in the treatment of bone loss in subjects undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer. Breast Cancer Drug:AMG 162 Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control Official Title:A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer
http://www.clinicaltrials.gov/ct/show/NCT00094809?order=5 Amgen The purpose of this research study is to evaluate the safety and effectiveness of Neulasta in reducing infection when given after one of three chemotherapy regimens (FOIL, FOLFOX or FOLFIRI) in patients with locally advanced or metastatic colorectal cancer. This study is considered to be "investigational" because the time between receiving Neulasta and the next cycle of chemotherapy is only 11 days. Colon CancerColorectal CancerRectal Cancer Drug:Neulasta Phase II Study Type:ObservationalStudy Design:Natural History Official Title:Chemotherapy Administered Every 2 weeks With or Without a Single Injection of Pegfilgrastim as First or Second-Line Treatment in Subjects with Locally Advanced or Metastatic Colon Cancer
http://www.clinicaltrials.gov/ct/show/NCT00094484?order=6 Amgen The purpose of this study is to evaluate the efficacy and safety of cinacalcet compared with placebo in patients with stage 3 and 4 Chronic Kidney Disease (CKD). Kidney DiseasesChronic Disease Drug:Cinacalcet HCl Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Safety/Efficacy Study Official Title:A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Chronic Kidney Disease Subjects with Secondary Hyperparathyroidism Not Receiving Dialysis
http://www.clinicaltrials.gov/ct/show/NCT00095277?order=7 Amgen The purpose of this trial is to demonstrate benefit with respect to hematopoietic response in subjects with anemia of cancer randomized to Darbepoetin Alfa once every 4 weeks. Anemia Drug:Darbepoetin Alfa Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control Official Title:A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Darbepoetin Alfa Administered Once Every 4 Weeks in the Treatment of Subjects with Anemia of Cancer
http://www.clinicaltrials.gov/ct/show/NCT00095498?order=8 Amgen This study will determine the efficacy, safety, and tolerability of AMG 162 in the treatment of Rheumatoid Arthritis (RA). Rheumatoid Arthritis Drug:AMG 162 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Safety/Efficacy Study Official Title:A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 162 in the Treatment of Rheumatoid Arthritis
http://www.clinicaltrials.gov/ct/show/NCT00078819?order=9 Amgen This study will evaluate the safety and efficacy of etanercept (Enbrel) in children with Psoriasis. This is a Phase 3 blinded, placebo-controlled study. Psoriasis Drug:Enbrel Phase III Study Type:InterventionalStudy Design:Treatment,Placebo Control,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00041470?order=10 Gralow, Julie, M.D. Breast Cancer Drug:PaclitaxelDrug:VinorelbineDrug:TrastuzumabDrug:Filgrastim Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00035620?order=11 Amgen Physicians are conducting a clinical trial for patients with sarcoma. Sarcoma is a type of bone cancer that can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced. Neutrophils are a type of white blood cells that fight infection and are produced in the bone marrow. If the neutrophil count becomes too low due to chemotherapy, a potentially serious condition called neutropenia occurs. Neutropenia is serious because it can affect the body's ability to protect against many types of infections. Pegfilgrastim is an investigational drug being evaluated for its potential ability to increase the number of neutrophils. The purpose of this study is to determine the safety and effectiveness of pegfilgrastim in preventing neutropenia following chemotherapy in patients up through the age of 11 with sarcoma. SarcomaNeutropenia Drug:pegfilgrastim Phase II Study Type:InterventionalStudy Design:Prevention,Randomized,Open Label,Active Control,Safety/Efficacy Study Official Title:A Study of Single Dose Per Cycle Filgrastim-SD/01 as an Adjunct to VAdriaC/IE Chemotherapy in Pediatric Sarcoma Patients
http://www.clinicaltrials.gov/ct/show/NCT00094822?order=12 Amgen The purpose of this research study is to evaluate the safety and effectiveness of Neulasta (pegfilgrastim) in reducing infection when given on the same day versus one day after the completion of chemotherapy (docetaxel and carboplatin) in patients with advanced or metastatic non-small cell lung cancer (NSCLC). This study is considered to be "investigational" because previous studies with Neulasta used next day dosing and not same day dosing. Lung CancerCarcinoma, Non-Small-Cell Lung Drug:pegfilgrastim Phase II Study Type:ObservationalStudy Design:Natural History
http://www.clinicaltrials.gov/ct/show/NCT00070616?order=13 Amgen Open label palifermin will be administered to subjects who are at a risk of developing mucositis after radiotherapy and chemotherapy followed by blood stem cell support. The amount of palifermin in the blood following administration will be evaluated. The safety of palifermin administration and its effect on reducing mucositis will also be evaluated. LeukemiaLymphomaMyeloma Drug:Palifermin Phase I Study Type:InterventionalStudy Design:Treatment,Open Label Study start:December 2001
http://www.clinicaltrials.gov/ct/show/NCT00078793?order=14 Amgen This study will evaluate long-term safety of etanercept in children with Polyarticular course or systemic juvenile rheumatoid arthritis (JRA). Arthritis, Juvenile Rheumatoid Drug:Enbrel Phase IV Study Type:InterventionalStudy Design:Treatment,Safety Study Official Title:Phase IV Registry of Etanercept (Enbrel) In Children with Juvenile Rheumatoid Arthritis
http://www.clinicaltrials.gov/ct/show/NCT00078806?order=15 Amgen This study will determine the efficacy of etanercept in children with systemically active systemic onset juvenile rheumatoid arthritis (SOJRA). Arthritis, Juvenile Rheumatoid Drug:Enbrel Phase III Study Type:InterventionalStudy Design:Treatment,Placebo Control,Safety/Efficacy Study Official Title:Phase 3 Safety and Efficacy Study of Etanercept (Enbrel) In Children with Systemic Onset Juvenile Rheumatoid Arthritis
http://www.clinicaltrials.gov/ct/show/NCT00040651?order=16 Scleroderma, or systemic sclerosis, is a diffuse connective tissue disease characterized by changes in the skin, blood vessels, skeletal muscles, and internal organs. The purpose of this study is to determine the safety and value of self bone marrow transplants after chemotherapy in patients with severe scleroderma. SclerodermaSystemic Sclerosis Drug:FludarabineDrug:CyclophosphamideDrug:ThymoglobulinProcedure:LeukapheresisProcedure:Self bone marrow transplant Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study Official Title:Transplantation with T-Cell Depleted Autologous Peripheral Stem Cells for Severe Systemic Sclerosis: A Phase I Dose Escalation Study
http://www.clinicaltrials.gov/ct/show/NCT00093873?order=17 Amgen This study will determine the safety and pharmacokinetics of AMG 706 in subjects with advanced solid tumors. Tumors Drug:AMG 706 Phase I Study Type:InterventionalStudy Design:Treatment,Open Label,Dose Comparison,Pharmacokinetics Study Official Title:A Phase 1, First in Human, Open-Label, Dose Finding Study Evaluating the Safety and Pharmacokinetics of AMG 706 in Subjects with Advanced Solid Tumors
http://www.clinicaltrials.gov/ct/show/NCT00096915?order=18 Amgen The purpose of this study is to evaluate the efficacy of Darbepoetin Alfa given once monthly to treat anemia in dialysis patients who were previously treated with Darbepoetin Alfa every other week. Kidney DiseasesChronic Disease Drug:Darbepoetin Alfa Phase III Study Type:InterventionalStudy Design:Treatment,Single Group Assignment Official Title:A Multicenter, Single-arm Study Evaluating Once Monthly Darbepoetin Alfa Dosing in Subjects with Chronic Kidney Disease (CKD) Receiving Dialysis
http://www.clinicaltrials.gov/ct/show/NCT00089960?order=19 Amgen This study will determine the safety and effectiveness of AMG 706 in patients with advanced GIST. Gastrointestinal Cancer Drug:AMG 706 Phase II Study Type:InterventionalStudy Design:Treatment,Open Label Official Title:An Open Label Study of AMG 706 in Subjects with Advanced Gastrointestinal Stromal Tumors (GISTs) who developed Progressive Disease or Relapsed While on Imatinib Mesylate
http://www.clinicaltrials.gov/ct/show/NCT00037518?order=20 Amgen This study will assess an investigational medication for patients with severe primary hyperparathyroidism or parathyroid cancer. HyperparathyroidismParathyroid Neoplasms Drug:AMG 073 Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00091858?order=21 Amgen The purpose of this study is to evaluate the efficacy of darbepoetin alfa versus placebo in reducing the occurrences of red blood cell transfusions in subjects with anemia of cancer who are not receiving chemotherapy. AnemiaCancer Drug:Darbepoetin Alfa Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Efficacy Study Official Title:A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer
http://www.clinicaltrials.gov/ct/show/NCT00095264?order=22 Amgen The purpose of this study is to assess the effect of 13 weeks of darbepoetin alfa treatment on erythroid response in anemic subjects with low risk Myelodysplastic Syndrome (MDS). Myelodysplastic Syndromes Drug:Darbepoetin Alfa Phase II Study Type:InterventionalStudy Design:Treatment Study start:October 2004
http://www.clinicaltrials.gov/ct/show/NCT00093977?order=23 Amgen The purpose of this study is to determine whether darbepoetin alfa manufactured by the current "roller bottle" technology and darbepoetin alfa manufactured by a serum free process have a comparable safety profile. Kidney DiseaseChronic Disease Drug:darbepoetin alfa Phase III Study Type:ObservationalStudy Design:Defined Population,Prospective Study Official Title:An Open-label, Single-Arm Study to Assess the Safety of Darbepoetin Alfa Manufactured by a Serum Free Bioreactor Technology in Subjects with Chronic Kidney Disease
http://www.clinicaltrials.gov/ct/show/NCT00091793?order=24 Amgen This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia, and to further test the safety and tolerability of AMG 162 in this population. Postmenopausal Osteoporosis Drug:AMG 162 Phase III Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind Official Title:A Randomized, Double-Blind Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
http://www.clinicaltrials.gov/ct/show/NCT00089791?order=25 Amgen This study will evaluate the effectiveness and safety of AMG 162 in treating women with Postmenopausal Osteoporosis. Osteoporosis Drug:AMG 162 Phase III Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00094835?order=26 Amgen Lung CancerCarcinoma, Non-Small-Cell Lung Drug:AMG 706 Phase I Study Type:InterventionalStudy Design:Treatment,Open Label,Pharmacokinetics Study Official Title:An Open-label, Dose-finding Study to Evaluate the Safety and Pharmacokinetics (PK) of AMG 706 with Carboplatin/Paclitaxel, AMG 706 with Panitumumab and AMG 706 with Panitumumab and Carboplatin/Paclitaxel in the Treatment of Subjects with Advanced Non-Small Cell Lung Cancer (NSCLC)
http://www.clinicaltrials.gov/ct/show/NCT00094861?order=27 Amgen The purpose of this study is to determine if palifermin will reduce the incidence of dysphagia in patients receiving concurrent chemoradiotherapy for treatment of Non-Small Cell Lung Cancer (NSCLC). Carcinoma, Non-Small-Cell LungLung Cancer Drug:palifermin Phase II Study Type:InterventionalStudy Design:Treatment,Safety/Efficacy Study Official Title:A Phase 2 Study to Evaluate the Efficacy and Safety of Palifermin (Recombinant Human Keratinocyte Growth Factor) in the Reduction of Dysphagia in Patients Receiving Concurrent Chemoradiotherapy followed by Consolidation Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
http://www.clinicaltrials.gov/ct/show/NCT00086086?order=28 Amgen The purpose of this study is to see if darbepoetin alfa can correct anemia, and have an effect on exercise ability (6-minute walk) and heart failure symptoms. Heart Failure, CongestiveAnemia Drug:Darbepoetin Alfa Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control Official Title:A Double-blind, Randomized, Placebo-controlled, Multi-Center Study to Evaluate the Effects of Treatment With 2-Regimens of Subcutaneous (SC) Darbepoetin Alfa (Weight-based Dosing & Fixed Dosing) on Hemoglobin Concentration Response in Subjects with Symptomatic Congestive Heart Failure (CHF) & Anemia
http://www.clinicaltrials.gov/ct/show/NCT00083616?order=29 Amgen The purpose of this study is to determine that ABX-EGF will have clinically meaningful anti-tumor activity in patients with metastatic colorectal cancer who have developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy. Colorectal CancerMetastases Drug:ABX-EGF Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00093015?order=30 Amgen This study will assess the effect of anemia therapy with darbepoetin alfa on the composite event comprising all-cause mortality and cardiovascular (CV) events in subjects with both chronic kidney disease (CKD) and type 2 diabetes mellitus (DM). Kidney DiseasesNephritisDiabetes Mellitus Drug:darbepoetin alfa Phase III Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00091806?order=31 Amgen The purpose of this study is to evaluate the safety and pharmacokinetics of two dose schedules of panitumumab in subjects with advanced solid tumors. Tumor Drug:panitumumab (ABX-EGF) Phase I Study Type:InterventionalStudy Design:Treatment,Open Label,Pharmacokinetics Study Official Title:An Open-Label, Clinical Trial Evaluating the Safety and Pharmacokinetics of Two Dose Schedules of Panitumumab in Subjects with Advanced Solid Tumors
http://www.clinicaltrials.gov/ct/show/NCT00039884?order=32 Amgen This is a clinical trial (a type of research study) designed to describe the efficacy (effectiveness) and toxicity (safety) of a new medical treatment, NESP (Novel Erythropoiesis Stimulating Protein). This study will be offered to patients with cervical cancer undergoing a combination of chemotherapy and radiation. This treatment may lower your red blood cells. The use of NESP may stimulate the body to produce more red blood cells. Our hypothesis is that higher red blood cells will be beneficial to the patient during treatment for cervical cancer. AnemiaCervix Neoplasms Drug:NESP - Novel Erythropoiesis Stimulating Protein Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Single Blind,Placebo Control,Single Group Assignment,Safety/Efficacy Study Official Title:Phase II Study of NESP (Novel Erythropoiesis Stimulating Protein) During Concurrent Chemo-Radiation for the Treatment of Cervical Carcinoma.
http://www.clinicaltrials.gov/ct/show/NCT00072670?order=1 Johnson & Johnson Pharmaceutical Research and Development, L.L.C. This is a study to test the safety and effectiveness of an investigational chemotherapy agent in men with advanced prostate cancer. After a subject meets all entry criteria and signs informed consent he will be enrolled in the study. Participants will be required to attend regular clinic visits to receive study medication and have their status monitored. They will also be required to have PSA levels measured multiple times throughout the study. A detailed explanation can be provided by the investigator conducting this study. Prostate Cancer Drug:ET-743 (YONDELIS) Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00060944?order=2 Johnson & Johnson Pharmaceutical Research and Development, L.L.C. This is a study to test the safety and effectiveness of an investigational chemotherapy agent in subjects with advanced liposarcoma or leiomyosarcoma. Subjects who meet all entry criteria and have signed the informed consent will be enrolled in the study. Participants will be required to attend regular clinic visits to receive study medication and have their status monitored. They will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation can be provided by the investigator conducting the study LiposarcomaLeiomyosarcoma Drug:ET743 I.V. administration Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized, Multicenter,Open-label Study of YONDELIS, ET-743 (ecteinascidin) Administered by Two Different Schedules (Weekly for 3 of 4 Weeks vs. q3 Weeks) in Subjects With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma Following Treatment with an Anthracycline and Ifosfamide
http://www.clinicaltrials.gov/ct/show/NCT00083200?order=1 PharmaNet recurrent breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancer Drug:capecitabineDrug:docetaxelProcedure:chemotherapy Phase II Study Type:InterventionalStudy Design:Treatment Official Title:Phase II Randomized Study of Two Dose Levels of Capecitabine With Docetaxel in Women With Locally Advanced or Metastatic Breast Cancer Who Have Failed Prior Anthracycline-Based Chemotherapy
http://www.clinicaltrials.gov/ct/show/NCT00040300?order=1 Pharmasset The purpose of this study is to evaluate Racivir. The safety, most effective dosage, and how the body reacts to Racivir will be studied. HIV Infections Drug:Racivir Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Parallel Assignment,Pharmacokinetics Study
http://www.clinicaltrials.gov/ct/show/NCT00040274?order=2 Pharmasset The purpose of this study is to evaluate DPC 817. The safety, dosages, and how the body responds to the drug will be studied. HIV Infections Drug:DPC 817 Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Crossover Assignment,Pharmacokinetics Study Official Title:A Placebo-Controlled, Dose-Escalation Study in HIV-1 Infected Subjects to Characterize the Safety, Tolerability, and Pharmacokinetics of Single Oral Doses of DPC 817
http://www.clinicaltrials.gov/ct/show/NCT00071799?order=1 Pharmion The purpose of this study is to determine whether patients with high-risk myelodysplastic syndromes (MDS) treated with azacitidine have improved survival compared to conventional care treatments. The study will also assess the effect of treatments on response, duration of response, and transformation to acute myeloid leukemia (AML). Myelodysplastic Syndromes Drug:Azacitidine Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Primary Outcomes:Survival
http://www.clinicaltrials.gov/ct/show/NCT00076609?order=1 PhytoCeutica Capecitabine is a chemotherapeutic that has been approved for use in breast and colorectal cancers. The advantages of capecitabine are that (1) it is an oral drug; and (2) it is less toxic than many other chemotherapeutics. In an off-label hepatocellular carcinoma (HCC) clinical study, the response rate with capecitabine was 13%. The botanical drug PHY906--currently manufactured pursuant to GMP standards and regulations--has been used in China for over 1800 years to treat gastrointestinal-related ailments. Recently, preclinical studies demonstrated that PHY906 potentiates the anti-tumor effect of capecitabine. This trial will evaluate the safety and efficacy of PHY906 in enhancing the anti-tumor effects of capecitabine. Hepatocellular CarcinomaLiver Cancer Drug:PHY906Drug:capecitabine Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase I/II Study of Botanical PHY906 Plus Capecitabine for Advanced Unresectable Hepatocellular Carcinoma
http://www.clinicaltrials.gov/ct/show/NCT00083252?order=1 Point Therapeutics The purpose of this study is to assess the antitumor activity and safety of the combination of talabostat and cisplatin in patients with metastatic melanoma. MelanomaSkin Cancer Drug:talabostat (PT-100) tabletsDrug:cisplatin Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00080080?order=2 Point Therapeutics The purpose of this study is to determine the antitumor activity (response rate, time to tumor progression, survival) and safety of docetaxel in combination with talabostat in patients with advanced non-small cell lung cancer (NSCLC) who have failed a prior platinum-containing regimen. Lung Cancer Drug:talabostat (PT-100) tabletsDrug:Docetaxel Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Phase 2 Study of Talabostat and Docetaxel in Advanced Non-Small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00086203?order=3 Point Therapeutics The objective of this study is to assess the efficacy and safety of talabostat and rituximab in patients with advanced CLL who failed to respond, or have progressed following a prior response, to a fludarabine/rituximab (FR)-containing regimen. Chronic Lymphocytic Leukemia Drug:Talabostat (PT-100) tabletsDrug:Rituximab Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00083239?order=4 Point Therapeutics The purpose of this study is to assess the antitumor activity and safety of talabostat in patients with metastatic melanoma. MelanomaSkin Cancer Drug:talabostat (PT-100) tablets Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00013143?order=1 Adverse drug reaction reporting systems Behavior:Assessment of ADE profiling of patient's added to provider information prior to treatment Study Type:InterventionalStudy Design:Educational/Counseling/Training,Randomized,Single Blind,Active Control,Single Group Assignment
http://www.clinicaltrials.gov/ct/show/NCT00097500?order=1 Amylin Pharmaceuticals This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus injection) on beta-cell function in subjects with type 2 diabetes mellitus who have not achieved target HbA1c (<=7.0%) using metformin. Subjects will be randomly assigned to add exenatide or insulin glargine to their current antidiabetic treatment regimen for 52 weeks. Type 2 diabetes mellitus Drug:exenatideDrug:Insulin glargine Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase 3, Randomized, Open Label, Comparator Controlled, Parallel Group, Multicenter Study to Compare the Effects of Exenatide and Insulin Glargine on Beta Cell Function and Cardiovascular Risk Markers in Subjects with Type 2 Diabetes Treated with Metformin who have not Achieved Target HbA1c (<=7.0%)
http://www.clinicaltrials.gov/ct/show/NCT00054977?order=1 Pro-Pharmaceuticals This is a Phase I, multi-center study of a carbohydrate (DAVANAT) which has been shown to increase the anti-tumor activity of 5-fluorouracil in mice. 5-Fluorouracil is a chemotherapy drug commonly used in cancer patients. Patients with different type of solid tumors who have failed standard, approved treatments can be enrolled in the study. Different doses of DAVANAT will be given alone in Cycle 1, and in combination with 5-fluorouracil in cycle 2. Patients will be on study for approximately 90 days. The main reason for doing the study is to determine the safety of the drug given alone and in combination. In patients who have cancer that can be measured by CT scan, it will be determined whether the tumors change in size (get bigger, smaller or stay the same)after Cycle 2. Colorectal CancerLung CancerBreast CancerHead and Neck CancerProstate Cancer Drug:DAVANATDrug:5-fluorouracil Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase I Open-Label Study To Evaluate The Safety and Tolerability Of Escalating Doses Of DAVANAT (A Galactomannan Derivative) In the Presence and Absence Of 5-Fluorouracil (5-FU) In Subjects with Advanced Solid Tumors
http://www.clinicaltrials.gov/ct/show/NCT00006432?order=1 There is some consensus that high fat diets can contribute to the development of obesity and type 2 diabetes in humans and animals. An increase in dietary fat has been shown to produce obesity and diabetes in mice; such diet-induced diabetes can be reversed by reducing the fat in the diet. In humans, there is some evidence that low-fat diets can produce acute improvements in blood sugar control in type 2 diabetes-even in the absence of weight loss. In most human studies, however, dietary fat reduction has been accompanied by a reduction in total calorie intake. It is thus not possible to separate the effects of these 2 metabolic changes. The purpose of this study is to gather preliminary information on the effect of a very-low-fat diet on blood metabolism in persons with type 2 diabetes. The design incorporates controlled feeding procedures, and 30 men and women with type 2 diabetes will be given all foods for 4 weeks--a 2-week diet standardization period (diet composition: 35% fat, 15% protein, 50% carbohydrate), followed by a 2-week experimental diet period. The experimental diet conditions are A) continuation of the moderately-high-fat standardization diet, or B) a very-low-fat diet composed of 10% fat, 15% protein, 75% carbohydrate. Outcomes will be measured after the standardization and the experimental periods. The primary outcome variable is fasting plasma glucose; secondary outcomes are fasting insulin, carbohydrate (meal) tolerance, insulin secretion and blood lipids. In addition, we will gather descriptive data on the potential acceptability and utility of a very-low-fat diet constructed using the fat substitute, olestra (sucrose polyester). There are no results yet. Diabetes Mellitus, Non-Insulin-Dependent Procedure:very low fat diet Study Type:InterventionalStudy Design:Treatment,Randomized,Single Blind Study start:January 2000
http://www.clinicaltrials.gov/ct/show/NCT00091637?order=2 Procter & Gamble Pharmaceuticals In the setting of reperfusion therapy in an acute myocardial infarction using primary percutaneous intervention (PCI), the body's own inflammatory system involving the complement cascade may be harmful. This study will test the safety and efficacy of a novel complement inhibitor, pexelizumab to reduce mortality at 90 days. Acute Myocardial Infarction Drug:PexelizumabProcedure:Angioplasty Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:APEX-AMI
http://www.clinicaltrials.gov/ct/show/NCT00088179?order=3 Alexion Pharmaceuticals During a heart bypass procedure, a substance called "complement" is activated by the body. This "complement activation" causes an inflammatory response that can lead to side affects such as chest pain, heart attacks, stroke, heart failure, or death. The purpose of this study is to find out if the study drug (pexelizumab), that blocks "complement activation," can reduce such side effects and be given safely to patients requiring the bypass procedure with the use of the heart-lung machine. Coronary Artery Disease Drug:pexelizumab in conjunction with CABG Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Multicenter, Randomized, Double-Blind, Parallel-group, Placebo-Controlled Study of Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting with Cardiopulmonary Bypass (PRIMO-CABG II)
http://www.clinicaltrials.gov/ct/show/NCT00097851?order=1 Progen Industries Limited PI-88 is a new experimental drug that inhibits tumour growth by reducing the formation of new blood vessels into tumours. Docetaxel is a standard second-line treatment offered to patients with non-small-cell lung cancer who havent responded to first-line therapies (platinum-based drugs or radiotherapy). Of this group of patients, only 20% remain progression-free 6 months after starting docetaxel treatment. The PR88202 study has been designed to compare two different cancer treatments (docetaxel only, and docetaxel plus PI-88) and to work out which is more effective against the cancer. It is hoped that the combination of PI-88 with docetaxel will allow patients to extend the time it takes for their disease to progress, and also to improve their quality of life. Carcinoma, Non-Small-Cell Lung Drug:docetaxelDrug:PI-88 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Historical Control,Parallel Assignment,Safety/Efficacy Study Official Title:Phase II Trial of Docetaxel with PI-88 in Patients with Advanced Non-Small-Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00055185?order=1 Progenics Pharmaceuticals The purpose of this study is to determine any adverse effects of PRO 542 after administration and to determine the anti-HIV effects of PRO 542 in the patient. HIV InfectionsAcquired Immune Deficiency Syndrome Drug:CD4-IgG2 (PRO 542) Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00073853?order=1 Proneuron Biotechnologies Spinal Cord Injury Procedure:Autologous Incubated Macrophages (cell therapy) Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase II Multicenter, Randomized-Controlled Study to Evaluate the Safety and Efficacy of Autologous Incubated Macrophages for the Treatment of Patients with Complete Spinal Cord Injuries
http://www.clinicaltrials.gov/ct/show/NCT00032305?order=1 Protein Design Labs The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat severe ulcerative colitis refractory to steroid therapy. The research is being conducted at up to 8 clinical research sites in the US and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work. Ulcerative Colitis Drug:Visilizumab Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Single Group Assignment,Safety Study Official Title:A Phase I, Dose-Escalation, Pilot Study of Visilizumab in Patients With Severe Ulcerative Colitis That is Refractory to Corticosteroids
http://www.clinicaltrials.gov/ct/show/NCT00050648?order=2 Protein Design Labs This study compares the efficacy and analyzes the cellular effects of anti-TAC (Daclizumab) and Cyclosporine in the treatment of psoriasis vulgaris. This is a three-armed study-Daclizumab alone, Cyclosporine alone, and the combination of both Daclizumab and Cyclosporine. Psoriasis Drug:DaclizamubDrug:Cyclosporine Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Use of humanized CD25 (anti-TAC) monoclonal antibody and cyclosporine for the treatment of active Psoriasis.
http://www.clinicaltrials.gov/ct/show/NCT00050661?order=3 Protein Design Labs This study is designed to study disease relapse after NBUVB and how the administration of Daclizumab/placebo alters disease relapse. Psoriasis Drug:Daclizumab Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:Use of Humanized CD25 (anti-TAC) Monoclonal Antibody/ Placebo to Prevent Relapse of Psoriasis Vulgaris following NBUVB Therapy
http://www.clinicaltrials.gov/ct/show/NCT00077012?order=1 QLT Inc Benign Prostatic Hyperplasia Drug:QLT0074Drug:Photodynamic therapy Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase I/II Dose Escalation Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Transurethral Photodynamic Therapy with QLT0074 for Benign Prostatic Hyperplasia
http://www.clinicaltrials.gov/ct/show/NCT00074620?order=1 Speedel Bio The study will look at the safety profile (unwanted effects) of the long-lasting anticoagulant PEG-hirudin (SPP200) and compare these unwanted effects to those of unfractionated heparin, commonly used in haemodialysis to avoid clotting of the graft and of the haemodialysis machine. Chronic Kidney FailureVascular Graft Occlusion Drug:PEG-hirudin Phase II Study Type:InterventionalStudy Design:Prevention,Randomized,Open Label,Active Control,Parallel Assignment,Safety Study Official Title:A Randomised, Multicenter, Open-label, Parallel group Study to Assess the Safety of PEG-hirudin (SPP200) Compared to Unfractionated Heparin as Anticoagulant Treatment in Patients Undergoing Haemodialysis via an Arteriovenous Graft
http://www.clinicaltrials.gov/ct/show/NCT00016692?order=2 Quintiles The purpose of the study is to see if Z-100 (an investigational drug) treatment is safe in HIV patients who have never received treatment for their HIV, who have not been taking highly active antiretroviral therapy (HAART) for at least 8 weeks, or who have been stable on their current first or second HAART regimen for at least 12 weeks. HIV Infections Drug:Z-100 Phase I Study Type:InterventionalStudy Design:Treatment,Double-Blind,Safety/Efficacy Study Official Title:A Phase 1b Multicenter Double-Blind, Placebo-Controlled, Randomized Study on the Safety and Tolerability of Z-100 in Early HIV-1 Infected Patients
http://www.clinicaltrials.gov/ct/show/NCT00060515?order=1 Repligen Corporation The objective of the study is to determine the safety and tolerability of RG2133 in patients with Mitochondrial Disease. Mitochondrial Diseases Drug:RG2133 (2',3',5'-tri-O-acetyluridine) Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized Official Title:An Open-Label Dose-Escalation Phase I Study to Asses the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RG2133 (2',3',5'-tri-O-acetyluridine) in the Treatment of Inherited Mitochondrial Diseases
http://www.clinicaltrials.gov/ct/show/NCT00036244?order=2 Repligen Corporation The purpose of the study is to determine whether multiple doses of secretin are safe and effective in the treatment of children with autism. Autism Drug:RG1068 (Synthetic Human Secretin) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Efficacy Study Official Title:A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Efficacy, Safety and Tolerability of RG1068 (Synthetic Human Secretin) in Children with Autism
http://www.clinicaltrials.gov/ct/show/NCT00036231?order=3 Repligen Corporation The purpose of the study is to determine the effect of multiple doses of secretin on autism. Autism Drug:RG1068 (Synthetic Human Secretin) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Efficacy Study Official Title:A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Efficacy, Safety and Tolerability of RG1068 (Synthetic Human Secretin) in Children with Autism and Gastrointestinal Dysfunction
http://www.clinicaltrials.gov/ct/show/NCT00093093?order=1 Ribapharm The purpose of this study is to determine the safety and effectiveness of viramidine to ribavirin in chronic hepatitis C patients who have never before received treatment. Chronic Hepatitis C Drug:ViramidineDrug:RibavirinDrug:pegylated interferon alfa-2a Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of Viramidine to Ribavirin in Treatment-Naive Patients With Chronic Hepatitic C
http://www.clinicaltrials.gov/ct/show/NCT00002158?order=1 Romark Laboratories L.C. The purpose of this study is to see if nitazoxanide (NTZ) can be used to treat AIDS patients suffering from cryptosporidiosis (diarrhea caused by the parasite Cryptosporidium). CryptosporidiosisHIV Infections Drug:Nitazoxanide Study Type:InterventionalStudy Design:Treatment Official Title:Open-Label Compassionate Use of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients
http://www.clinicaltrials.gov/ct/show/NCT00093951?order=1 Saegis Pharmaceuticals The purpose of this trial is to determine the effect of a new drug, SGS742, on memory and cognition in patients with mild to moderate Alzheimer's disease. Alzheimer's Disease Drug:SGS742 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Safety/Efficacy Study Official Title:A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Study of the Efficacy and Safety of SGS742 in Subjects with Mild to Moderate Alzheimer's Disease
http://www.clinicaltrials.gov/ct/show/NCT00069758?order=1 Salmedix Non-Hodgkin's Lymphoma Drug:SDX-105 Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Multi-Center Phase II Study to Investigate the Safety and Activity of SDX-105 (Bendamustine) in Patients with Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab
http://www.clinicaltrials.gov/ct/show/NCT00076349?order=2 Salmedix Non-Hodgkin's Lymphoma Drug:RituximabDrug:SDX-105 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Multi-Center Phase II Study to Investigate the Safety and Activity of SDX-105 (Bendamustine) in Combination with Rituximab in Patients with Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)
http://www.clinicaltrials.gov/ct/show/NCT00040651?order=1 Scleroderma, or systemic sclerosis, is a diffuse connective tissue disease characterized by changes in the skin, blood vessels, skeletal muscles, and internal organs. The purpose of this study is to determine the safety and value of self bone marrow transplants after chemotherapy in patients with severe scleroderma. SclerodermaSystemic Sclerosis Drug:FludarabineDrug:CyclophosphamideDrug:ThymoglobulinProcedure:LeukapheresisProcedure:Self bone marrow transplant Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study Official Title:Transplantation with T-Cell Depleted Autologous Peripheral Stem Cells for Severe Systemic Sclerosis: A Phase I Dose Escalation Study
http://www.clinicaltrials.gov/ct/show/NCT00094081?order=1 Sanofi-Synthelabo The trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin and radiation versus cisplatin and radiation. Head and Neck Neoplasms Drug:Cisplatin, TirapazamineProcedure:Radiation Therapy Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Phase III Randomized Trial of Concomitant Radiation, Cisplatin, and Tirapazamine versus Concomitant Radiation and Cisplatin in Patients with Advanced Head and Neck Cancer
http://www.clinicaltrials.gov/ct/show/NCT00070655?order=2 Sanofi-Synthelabo Atrial Fibrillation Drug:SR34006 (idraparinux sodium) InjectionDrug:vitamin K antagonist (warfarin or acenocoumarol) tablets Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Safety/Efficacy Study Official Title:The AMADEUS trial, A Multicenter, Randomized, Open-label, Assessor Blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous Idraparinux (SR34006) with Adjusted-dose Oral Vitamin-K Antagonists in the Prevention of Thromboembolic Events in Patients with Atrial Fibrillation
http://www.clinicaltrials.gov/ct/show/NCT00094965?order=3 Sanofi-Synthelabo Gastrointestinal Cancer Drug:FOLFOX4 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Parallel Assignment Official Title:Phase II Trial of Oxaliplatin in Combination with Bolus/Infusional 5FU/LV (FOLFOX4) in Patients with Advanced Gastrointestinal (GI) Cancers with Varying Degrees of Renal Impairment
http://www.clinicaltrials.gov/ct/show/NCT00087802?order=4 Sanofi-Synthelabo The purpose of this study is to compare combination treatment of gemcitabine + oxaliplatin (GEMOX) with carboplatin + paclitaxel (CP) to determine if there is a difference in response and safety between the two drug combinations for the treatment of advanced non-small cell lung cancer (NSCLC). Carcinoma, Non-Small-Cell Lung Drug:Gemcitabine/Oxaliplatin (GEMOX)Drug:Carboplatin/Paclitaxel (CP) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase III Randomized Trial of Gemcitabine/Oxaliplatin (GEMOX) versus Carboplatin/Paclitaxel (CP) as First-line Therapy in Patients with Advanced Non-small Cell Lung Cancer (NSCLC)
http://www.clinicaltrials.gov/ct/show/NCT00064649?order=5 The primary objective of this randomized clinical trial is to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride. Benign Prostatic Hyperplasia Device:Transurethral Microwave Thermotherapy (TUMT)Device:Transurethral Needle Ablation (TUNA) TherapyDrug:Finasteride and Alfuzosin Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Safety/Efficacy Study Official Title:Minimally Invasive Surgical Therapy for BPH
http://www.clinicaltrials.gov/ct/show/NCT00067093?order=6 Sanofi-Synthelabo Patients who have deep vein thrombosis (blood clot in the leg) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (blood thinning) drug administered once each week, SanOrg34006, with the standard way of treating deep vein thrombosis. The standard treatment includes injections or infusions of an anticoagulant drug (Unfractionated Heparin or low molecular weight heparin) for about a week, followed by vitamin K antagonist (VKA) anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth. Eligible patients will be assigned to treatment with either SanOrg34006 or the combination of Unfractionated Heparin or low molecular weight heparin plus a VKA (warfarin or acenocoumarol) by random chance. Treatment will be known to both patients and their doctors. Deep Vein Thrombosis Drug:SanOrg34006Drug:LMW heparinDrug:Unfractionated heparinDrug:Vitamin K antagonist (VKA) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Study start:July 2003
http://www.clinicaltrials.gov/ct/show/NCT00071279?order=7 Sanofi-Synthelabo Pulmonary EmbolismDeep Vein Thrombosis Drug:SR34006 (idraparinux sodium) Injection Phase III Study Type:InterventionalStudy Design:Randomized,Double-Blind,Safety/Efficacy Study Official Title:The Van Gogh-extension trial, a Multicenter, International, Randomized, Double-blind, Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous SR34006 with Placebo in the Long-term Prevention of Symptomatic Venous Thromboembolism in Patients with Symptomatic Pulmonary Embolism or Deep-vein Thrombosis who Completed 6 Months of Treatment with Vitamin K Antagonist or SR34006
http://www.clinicaltrials.gov/ct/show/NCT00062803?order=8 Sanofi-Synthelabo Pulmonary Embolism Drug:SR34006Drug:(LMW)heparinDrug:Warfarin VKADrug:Acenocoumarol VKA Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Safety/Efficacy Study Official Title:The Van Gogh-PE trial, a Multicenter, International, Randomized, Open-label, Assessor-blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous SR34006 with the Combination of (LMW)Heparin and Vitamin K Antagonist (VKA) in the Treatment of Acute Symptomatic Pulmonary Embolism
http://www.clinicaltrials.gov/ct/show/NCT00080210?order=1 Savient Pharmaceuticals This is a randomized, open-label, multicenter, parallel-groups study of multiple intravenous doses of Puricase, administered intravenously, in 40 patients with symptomatic gout. Subjects must wash out of any uric acid-lowering agents for one week before being dosed, and must refrain from using such agents throughout the study. Gout Drug:Puricase Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase II Study of Multiple Doses of Intravenous Puricase in Subjects with Hyperuricemia and Refractory Gout
http://www.clinicaltrials.gov/ct/show/NCT00079820?order=1 Acambis The purpose of this study is to gather information on the safety and the effectiveness of an investigational vaccine for the prevention of smallpox disease. Smallpox was one of the major causes of death and sickness through the first half of the 20th century, but a global program of smallpox eradication resulted in the elimination of the natural disease. The last cases of smallpox in the United States occurred in 1949 in Texas. Today, only laboratory workers who work with smallpox-related viruses, military personnel, and health care workers are vaccinated. Historically, individuals in the US were vaccinated with a product such as Dryvax, which contains the virus vaccinia in the same family as smallpox. This virus could promote immunity to smallpox, but not produce the disease itself. Although effective, these vaccines are not safe to use in people with atopic dermatitis (eczema, allergic immune response to allergens), children less than 1 year of age, and people with a compromised immune system, occurring in certain diseases (HIV positive individuals and AIDS), and following treatment with certain types of drugs. It is important to find a safe vaccine that can be used to protect people who cannot receive routine vaccinia-based smallpox vaccine. The vaccine in this study is known as Modified Vaccinia Ankara or MVA vaccine. It is the objective of this study to find out if MVA vaccine is safe and effective in providing immunity to smallpox. The effectiveness of this vaccine will be measured in two ways. The first way is to find out if there are specific antibodies in your blood following MVA vaccination. Antibodies are chemicals your body produces to fight smallpox virus. The second way is to see whether or not there is a typical skin reaction following vaccination with a traditional smallpox vaccine, given about three months after vaccination with the MVA vaccine. The typical reaction in an unvaccinated person to smallpox vaccine is formation of a blister or pox which occurs at the site of vaccination. In a person with immunity to smallpox the skin reaction is much less, and typically consists of a little swelling at the site of vaccination. Smallpox Vaccine:ACAM3000 MVA VaccineVaccine:Dryvax Smallpox Vaccine Phase I Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety Study
http://www.clinicaltrials.gov/ct/show/NCT00060892?order=1 AnGes The primary purpose of this study is to assess the overall safety of different dose regimens of AMG0001 as well as evaluate the improvement of blood perfusion in subjects with critical limb ischemia (CLI). This study will also evaluate the improvement in wound healing without adverse effects on the quality of life, as well as the potential reduction of amputation, mortality and rest pain in the CLI population. Arterial Occlusive DiseasePeripheral Vascular DiseaseIschemia Gene Transfer:HGF transferred via plasmid vector Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of AMG0001 to Improve Perfusion in Critical Leg Ischemia
http://www.clinicaltrials.gov/ct/show/NCT00081510?order=1 Schering-Plough Breast Cancer Drug:farnesyl Protein Transferase Inhibitor - Lonafarnib Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized, Double-Blind, Phase 2 Study of Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer
http://www.clinicaltrials.gov/ct/show/NCT00089895?order=2 Millennium Pharmaceuticals The purpose of this study is to see if early INTEGRILIN (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention compared to placebo. Myocardial Ischemia Drug:eptifibatide Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:Early Glycoprotein IIb/IIIa Inhibition : A Randomized, Placebo-Controlled Trial Evaluating the Clinical Benefits of Early Front-loaded Eptifibatide in the Treatment of Patients with Non-ST-segment Elevation Acute Coronary Syndrome
http://www.clinicaltrials.gov/ct/show/NCT00034632?order=3 Schering-Plough This study is designed to evaluate the safety, tolerance and efficacy of Posaconazole (SCH 56592) under an open label, treatment protocol for subjects with invasive fungal infections: A. which are refractory or resistant to standard antifungal therapies; B. for which there are currently no effective therapies; C. with a prior history of serious, severe or life-threatening toxicities while receiving antifungal therapy; D. with pre-existing organ dysfunction which precludes the administration of standard antifungal therapies. Mycoses Drug:Posaconazole oral suspension Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:Open Label, treatment protocol for the Safety and Efficacy of Posaconazole (SCH 56592) in the Treatment of Invasive Fungal Infections
http://www.clinicaltrials.gov/ct/show/NCT00081770?order=4 Schering-Plough The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1) PEG-Intron 1.5 g/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2) PEG-Intron 1g/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3) PEGASYS 180 g/wk plus COPEGUS 1000-1200 mg/day. Chronic Hepatitis C Drug:PEG-Intron Plus REBETOLDrug:PEGASYS Plus COPEGUS Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study Official Title:Comparison of PEG-Intron 1.5g/kg/wk Plus REBETOL vs PEG-Intron 1g/kg/wk Plus REBETOL vs PEGASYS 180g/wk Plus COPEGUS in Previously Untreated Adult Subjects With Chronic Hepatitis C Infected with Genotype 1
http://www.clinicaltrials.gov/ct/show/NCT00048724?order=5 Schering-Plough The objective of the study is to evaluate the safety and efficacy of PEG-Intron vs. no treatment for the prevention of disease progression in adult subjects with compensated cirrhosis secondary to chronic hepatitis C, who failed to respond to therapy with an a interferon plus ribavirin. Chronic Hepatitis CCirrhosis Drug:Peginterferon alfa 2-b Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Uncontrolled,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00039871?order=6 Schering-Plough The objective of this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus REBETOL 800-1400 mg/day in adults with chronic hepatitis C with moderate to severe liver fibrosis or cirrhosis who failed to respond to previous treatment with an a interferon in combination with ribavirin. Patients who do not respond to PEG-Intron plus Rebetol will be enrolled in a long-term maintenance study to evaluate the effectiveness of PEG-intron therapy monotherapy versus no treatment for the prevention of disease progression (Protocols P02569 and P02570). Chronic Hepatitis CLiver FibrosisCirrhosis Drug:Peginterferon alfa-2BDrug:Ribavirin Phase III Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:PEG-Intron Plus REBETOL for the Treatment of Subjects with Chronic Hepatitis C who Failed to Respond to Previous Combination Therapy (Any alpha Interferon Treatment in Combination with Ribavirin)
http://www.clinicaltrials.gov/ct/show/NCT00049842?order=7 Schering-Plough The objective of the study is to evaluate the safety and efficacy of PEG-Intron vs. no treatment for the prevention of fibrosis progression in adult subjects with moderate to severe liver fibrosis secondary to chronic hepatitis, who failed PEG-Intron plus Rebetol treatment in protocol P02370. Chronic Hepatitis CLiver Fibrosis Drug:Peginterferon alfa-2b Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Uncontrolled,Parallel Assignment,Safety/Efficacy Study Official Title:Prevention of Disease Progress in Chronic Hepatitis C Patients with Significant Liver Fibrosis who failed PEG-Intron + Rebetol in P02370
http://www.clinicaltrials.gov/ct/show/NCT00044486?order=8 Schering-Plough This trial is in high risk patients to determine the safety and efficacy of posaconazole vs. fluconazole in the prophylaxis against development of invasive fungal infections. Profound, prolonged neutropenia (Absolute neutrophil count<500 cells/cubic mm for at least 7 days) due to induction chemotherapy for acute myelogenous leukemia, or myelodysplastic syndrome. Treatment Duration: maximum of 12 weeks Follow-Up 2 months. Endpoints: incidence of proven or probable IFI according to EORTC/MSG criteria within the neutropenic episode and within 100 days of randomization as determined by external expert review. Leukemia, Myelocytic, AcuteMyelodysplastic SyndromesNeutropenia Drug:Posaconazole oral suspension Phase III Study Type:InterventionalStudy Design:Prevention,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized Controlled Trial of Posaconazole (SCH 56592) vs. Standard Azole Therapy for the Prevention of Invasive Fungal Infections Among High-Risk Neutropenic Patients
http://www.clinicaltrials.gov/ct/show/NCT00076856?order=9 Schering-Plough The purpose of this study is to demonstrate improvement in overall survival for the combination of whole brain radiation therapy (WBRT) plus temozolomide (TMZ) vs WBRT plus placebo. Secondary objective is to demonstrate an improvement in the time to radiological CNS progression with the addition of TMZ to WBRT. Carcinoma, Non-Small-Cell LungNeoplasm MetastasisBrain Neoplasms Drug:Temozolomide Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:Randomized Double-Blind Placebo-Controlled Ph 3 Std of Temozolomide or Placebo added to whole Brain Radiation Therapy for the Treatment of Brain Metastases from Non-Small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00091572?order=10 Schering-Plough The purpose of this study is to ascertain if the extended schedule of Temozolomide, which allows increased doses and potential depletion of the enzyme underlaying resistance, is a more effective treatment of metastatic melanoma than single agent dacarbazine. Melanoma Drug:TemozolomideDrug:Dacarbazine Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Extended Schedule, Escalated Dose Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group
http://www.clinicaltrials.gov/ct/show/NCT00082082?order=1 SciClone Pharmaceuticals The objective of this Phase II trial is to compare the efficacy and safety of 6 months of treatment with thymalfasin plus trans arterial chemoembolization (TACE) with TACE alone in adult patients with non-surgical hepatocellular carcinoma (HCC). Carcinoma, Hepatocellular Drug:Thymalfasin (thymosin alpha-1)Procedure:Trans arterial chemoembolization (TACE) Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Parallel Assignment,Safety/Efficacy Study Official Title:A Trial of Thymalfasin with Trans Arterial Chemo-Embolization (TACE) in the Treatment of Adult Patients with Unresectable Hepatocellular Carcinoma: A Phase II Trial
http://www.clinicaltrials.gov/ct/show/NCT00095680?order=1 Scios Scio-469 belongs to a new class of treatment that inhibits p38 MAP kinase. p38 MAPK activation controls the production of a number of factors that play a pathogenic role in the development of multiple myeloma (MM), most prominently IL-6, as well as IL-1, TNF, PGE2, IL-11, VEGF, macrophage inflammatory protein-1 (MIP-1), and RANKL. These factors are produced by MM cells and bone marrow stromal cells (BMSCs) when stimulated by secreted factors or by adherence of MM cells to BMSCs. A cytokine network, in which these factors induce each other in feed forward loops, sets up a perpetuating activated state that supports MM cell growth, survival, resistance to cytotoxic chemotherapy, and the development of osteolytic lesions. Disrupting this network at multiple points through the inhibition of p38 MAPK is thus expected to reduce MM growth and survival, increase sensitivity to cytotoxic agents, and reduce pain and fractures from osteolytic lesions. The main objective of this study is to assess the long-term efficacy of SCIO-469 as monotherapy, or in combination with Bortezomib in relapsed, refractory patients with multiple myeloma (MM) who have previously demonstrated clinical benefit in the Scios B003 study. Multiple Myeloma Drug:SCIO-469 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Safety/Efficacy Study Official Title:A 24-Week, Open-Label Extension Study of the Efficacy, Safety, and Tolerability of Oral SCIO-469 in Treatment of Relapsed, Refractory Patients with Mutliple Myeloma
http://www.clinicaltrials.gov/ct/show/NCT00091520?order=2 Scios The purpose of this study is to evaluate the efficacy and safety of Natrecor(R) administered as serial infusions to heart failure (HF) patients in the outpatient setting. Heart Failure, Congestive Drug:Natrecor(R) (nesiritide) Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00090792?order=3 Scios Drug:SCIO-A014 Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety/Efficacy Study Official Title:A Pilot, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate Nesiritide Infusion, Initiated Post-Induction of Anesthesia, in the Management of Coronary Artery Bypass Graft (CABG) Patients Requiring Cardiopulmonary Bypass (CPB)
http://www.clinicaltrials.gov/ct/show/NCT00089921?order=4 Scios Rheumatoid Arthritis Drug:SCIO-469 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase II, 24-week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy of Oral SCIO-469 in Subjects with Active Rheumatoid Arthritis Who are Not Receiving DMARDs Other than Hydroxychloroquine
http://www.clinicaltrials.gov/ct/show/NCT00087867?order=5 Scios Scio-469 belongs to a new class of treatment that inhibits p38 MAP kinase. p38 MAPK activation controls the production of a number of factors that play a pathogenic role in the development of multiple myeloma (MM), most prominently IL-6, as well as IL-1, TNF, PGE2, IL-11, VEGF, macrophage inflammatory protein-1 ?(MIP-1), and RANKL. These factors are produced by MM cells and BMSCs when stimulated by secreted factors or by adherence of MM cells to BMSCs. A cytokine network, in which these factors induce each other in feed forward loops, sets up a perpetuating activated state that supports MM cell growth, survival, resistance to cytotoxic chemotherapy, and the development of osteolytic lesions. Disrupting this network at multiple points through the inhibition of p38?MAPK is thus expected to reduce MM growth and survival, increase sensitivity to cytotoxic agents, and reduce pain and fractures from osteolytic lesions. The main objective of this study is to assess the efficacy of SCIO-469 as monotherapy in relapsed, refractory patients with multiple myeloma (MM), based on response rates. Multiple Myeloma Drug:SCIO-469 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Safety/Efficacy Study Official Title:An Open-label Study of the Efficacy, Safety, and Tolerability of Oral SCIO-469 in Treatment of Relapsed, Refractory Patients with Multiple Myeloma
http://www.clinicaltrials.gov/ct/show/NCT00086333?order=1 Seattle Genetics This is an open-label, randomized phase II trial of a monoclonal antibody (mAb) drug immunoconjugate, SGN-15, administered weekly in combination with weekly docetaxel. The primary objective of the study is to determine the optimal interval between SGN-15 and docetaxel using FDG-PET imaging as a surrogate marker of response. In addition, clinical response rate, duration of response, and survival data will be collected. Non-Small Cell Lung Carcinoma Drug:SGN-15, Docetaxel Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Parallel Assignment Official Title:A Phase II Study Using FDG-PET to Investigate the Dosing Schedule and Response of Combination SGN-15 (cBR96-Doxorubicin Immunoconjugate) and Docetaxel in Patients with Stage IV or Stage IIIB Non-Small Cell Lung Carcinoma Ineligible for Combined Modality Treatment with Curative Intent
http://www.clinicaltrials.gov/ct/show/NCT00079755?order=2 Seattle Genetics To investigate safety and antitumor activity of SGN-30 in patients with Hodgkin's disease (HD) and anaplastic large cell lymphoma (ALCL). Hodgkin's DiseaseAnaplastic Large-Cell Lymphoma Drug:SGN-30 (anti-CD30 mAb) Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase II Multi-Dose Study of SGN-30 (anti-CD30 mAb) in Patients with Refractory or Recurrent Hodgkin's Disease or Anaplastic Large Cell Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00079716?order=3 Seattle Genetics The purpose of this study is to determine the safety and activity of SGN-40 in a weekly dosage schedule as a single agent. Multiple Myeloma Drug:SGN-40 (anti-huCD40 mAb) Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:A Phase I, Multi-Dose Study of SGN-40 (anti-huCD40 mAb) in Patients with Refractory or Recurrent Multiple Myeloma
http://www.clinicaltrials.gov/ct/show/NCT00065663?order=1 Selective Genetics Patients with diabetes may develop chronic wounds that respond poorly to treatment. Gene therapy with the platelet-derived growth factor-B gene has been shown to help with the healing of chronic wounds. This study will evaluate a new way to deliver the gene to the wound tissue. Wounds and InjuriesDiabetesDiabetic Foot UlcersFoot wounds Gene Transfer:GAM501 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Factorial Assignment,Safety Study Official Title:Growth Factor Gene Therapy for Wound Healing
http://www.clinicaltrials.gov/ct/show/NCT00090129?order=1 Serono The primary objective is to assess the safety and efficacy of an initial 12-week treatment course with onercept 150mg three times a week (TIW) for the induction of remission in subjects with moderate to severe plaque psoriasis, compared to matching placebo. Psoriatic Arthritis Drug:Onercept (r-hTBP-1) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Multicenter, Randomized, Double-blind, Placebo controlled Phase III Study of Subcutaneously Administered Onercept in the Treatment and Re-treatment of Subjects with Moderate to Severe Plaque Psoriasis
http://www.clinicaltrials.gov/ct/show/NCT00046163?order=1 Shire Pharmaceutical Development Hypotension, Orthostatic Drug:midodrine hydrochloride (ProAmatine) Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase IV, Multi-Center, Double-Blind, Parallel Group, Randomized, Placebo-Controlled Study to Assess the Clinical Benefit of Three Doses of Midodrine Hydrochloride (ProAmatine) in Subjects with Neurogenic Orthostatic Hypotension
http://www.clinicaltrials.gov/ct/show/NCT00046475?order=2 Shire Pharmaceutical Development Hypotension, Orthostatic Drug:Midodrine Hydrochloride Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Crossover Assignment,Safety/Efficacy Study Official Title:A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Crossover Study to Assess the Clinical Benefit of Midodrine Hydrochloride in Patients with Neurogenic Orthostatic Hypotension
http://www.clinicaltrials.gov/ct/show/NCT00032903?order=1 Sigma-Tau Research, Inc. Gimatecan is Sigma-Tau Research's new, potent, oral Topoisomerase I inhibitor. Drugs in this class play a crucial role in destroying DNA replication in tumors. We are conducting this study to determine the Maximum Tolerated Dose of our compound. In addition, we plan to assess the drug's ability to affect the evolution of malignant gliomas, when given as a capsule, rather than by intravenous injection. Malignant Glioma Drug:Gimatecan (ST 1481) Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:Oral ST1481 in adults with Malignant Glioma: a Phase I-II Clinical Trial
http://www.clinicaltrials.gov/ct/show/NCT00033202?order=2 Sigma-Tau Research, Inc. Gimatecan is sigma-tau Researchs new, potent, oral Topoisomerase I inhibitor. Drugs in this class play a crucial role in destroying DNA replication in tumors. We are conducting this study to determine the Maximum Tolerated Dose of our compound, when given as a capsule, rather than by intravenous injection. Solid Malignancies Drug:Gimatecan (ST-1481) Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:Phase I study of Oral ST1481 Administered Once Weekly Every 3 out 4 Weeks in Patients with Advanced Solid Malignancies.
http://www.clinicaltrials.gov/ct/show/NCT00091052?order=1 Sirius Medicine unspecified adult solid tumor, protocol specific Drug:sargramostimProcedure:biological response modifier therapyProcedure:colony-stimulating factor therapyProcedure:cytokine therapyProcedure:non-specific immune-modulator therapyProcedure:radiation therapy Phase I Study Type:InterventionalStudy Design:Treatment Official Title:Phase I/II Study of Contrast-Enhanced High-Dose Radiotherapy and Sargramostim (GM-CSF) in Patients With Advanced Solid Malignancies
http://www.clinicaltrials.gov/ct/show/NCT00029523?order=1 SkyePharma The purpose of this study is to find out how well an experimental drug called DepoCyt works for neoplastic meningitis (cancer that has spread to the tissues around the brain and spinal cord). DepoCyt is a new slow-release form of the cancer drug called ara-C (cytarabine). Cytarabine has been used for many years to treat cancer. Meningeal Neoplasms Drug:Intrathecal (injected into the spinal fluid) DepoCytDrug:Intrathecal methotrexateDrug:Intrathecal cytarabine (also known as ara-C) Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized Clinical Study to Determine the Patient Benefit and Safety of Depocyt (Cytarabine Liposome Injection) for the Treatment of Neoplastic Meningitis
http://www.clinicaltrials.gov/ct/show/NCT00034320?order=1 Columbia Presbyterian Medical Center The patient will receive paclitaxel and carboplatin in high dose before one stem cell infusion. When the patient has recovered sufficiently from this first cycle they will be given high dose topotecan and etopophos in combination and then given a second stem cell infusion. When the patient has recovered sufficiently from this second cycle, they will be given high dose thiotepa and then given a third stem cell infusion. Following these procedures, the doctor will assess several forms of data which are routinely analyzed after high dose chemotherapy, including recovery of marrow function, side effects of the treatment, possible relapse of the cancer, and survival. Ovarian Neoplasms Drug:induction chemo and G-CSFDevice:central venous catheterProcedure:stem cell harvestDrug:Paclitaxel/CarboplatinProcedure:stem cell infusionDrug:Topotecan/EtopophosDrug:Thiotepa therapy Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Single Group Assignment,Safety/Efficacy Study Official Title:Phase 1-2 study of tandem cycles of high dose chemotherapy followed by autologous hematopoietic stem cell support in women with persistent or recurrent advanced (Stage III or IV) epithelial ovarian cancer.
http://www.clinicaltrials.gov/ct/show/NCT00018759?order=2 This study aims to determine if treatment with an SSRI antidepressant medication, paroxetine, is associated with cellular calcium response to serotonin, platelet serotonin receptors, and improvement in mood in depressed patients with or without hypertension. It is hypothesized that platelets of hypertensive patients with depressive symptomatology with be hyper-responsive to serotonin. Additionally, treatment with an SSRI antidepressant is expected to produce a down-regulation of the serotonin receptor with an associated reduction in platelet cytosolic calcium response as well as improved mood. DepressionHypertension Drug:paroxetineBehavior:ongoing psychological screening Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Parallel Assignment,Pharmacodynamics Study Study start:March 2001; Expected completion:October 2003
http://www.clinicaltrials.gov/ct/show/NCT00096668?order=1 Sonus Pharmaceuticals This is an open label study where each patient will receive TOCOSOL(R) Paclitaxel 120mg/m2 every week for first line treatment of metastatic breast cancer. Patients will be followed to determine the efficacy of treatment (as measured by objective response rate), and the safety associated with weekly administration of TOCOSOL Paclitaxel. Breast Cancer Drug:TOCOSOL(R) Paclitaxel Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase 2 Multicenter Evaluation of the Safety and Efficacy of TOCOSOL(R) Paclitaxel (S-8184 Paclitaxel Injectable Emulsion) as Initial Treatment of Patients with Metastatic Breast Cancer
http://www.clinicaltrials.gov/ct/show/NCT00034177?order=2 Sonus Pharmaceuticals Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly S-8184 paclitaxel injectable emulsion in second line treatment of patients locally advanced, metastatic, or recurrent transitional cell carcinoma of the urothelium. Urologic Neoplasms Drug:S-8184 Paclitaxel Injectable Emulsion Phase II Study Type:InterventionalStudy Design:Treatment Official Title:A PHASE IIA MULTICENTER EVALUATION OF THE SAFETY AND EFFICACY OF WEEKLY ADMINISTRATION OF S-8184 PACLITAXEL INJECTABLE EMULSION IN SECOND LINE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED, METASTATIC, OR RECURRENT TRANSITIONAL CELL CARCINOMA OF THE UROTHELIUM
http://www.clinicaltrials.gov/ct/show/NCT00077688?order=3 Sonus Pharmaceuticals Phase 2B, multicenter study evaluating the safety and efficacy of weekly TOCOSOL Paclitaxel in taxane-naive patients receiving second line chemotherapy for metastatic or locally advanced, unresectable transitional cell carcinoma of the urothelium Bladder NeoplasmsUreteral NeoplasmsUrethral NeoplasmsCarcinoma, Transitional Cell Drug:TOCOSOL Paclitaxel Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase 2 Multicenter Evaluation of the Safety and Efficacy of TOCOSOL(TM) Paclitaxel (S-8184 Paclitaxel Injectable Emulsion) in Patients with Metastatic or Locally Advanced, Unresectable Transitional Cell Carcinoma of the Urothelium
http://www.clinicaltrials.gov/ct/show/NCT00090090?order=1 Spectrum Pharmaceuticals, Inc To determine the safety and efficacy of elsamitrucin in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL). To determine if elsamitrucin is efficacious in a particular pathologic NHL subtype(s). B-Cell LymphomaT-Cell Lymphoma Drug:Elsamitrucin Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Multi-Center, Open-label, Non-Randomized Phase II Study of Elsamitrucin (SPI 28090) In Patients with relapsed or refractory non-Hodgkin's Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00074620?order=1 Speedel Bio The study will look at the safety profile (unwanted effects) of the long-lasting anticoagulant PEG-hirudin (SPP200) and compare these unwanted effects to those of unfractionated heparin, commonly used in haemodialysis to avoid clotting of the graft and of the haemodialysis machine. Chronic Kidney FailureVascular Graft Occlusion Drug:PEG-hirudin Phase II Study Type:InterventionalStudy Design:Prevention,Randomized,Open Label,Active Control,Parallel Assignment,Safety Study Official Title:A Randomised, Multicenter, Open-label, Parallel group Study to Assess the Safety of PEG-hirudin (SPP200) Compared to Unfractionated Heparin as Anticoagulant Treatment in Patients Undergoing Haemodialysis via an Arteriovenous Graft
http://www.clinicaltrials.gov/ct/show/NCT00038714?order=1 Stressgen Biotechnologies Recurrent Respiratory Papillomatosis (RRP) causes wart-like lesions along the throat area and can obstruct the airway or become malignant. The cause has been related to specific types of Human Papillomavirus (HPV). The purpose of the study is to assess the clinical effectiveness of a trial drug, SGN-00101, in children with RRP and also assess its safety. PapillomaRecurrent Respiratory Papillomatosis Drug:SGN-00101 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase II Trial of SGN-00101 In The Treatment of Pediatric Recurrent Respiratory Papillomatosis
http://www.clinicaltrials.gov/ct/show/NCT00088634?order=1 Sumitomo Pharmaceuticals America A 6-week in-patient and out-patient study to test the effectiveness and safety of a new medication in the treatment of schizophrenia Schizophrenia Drug:SM-13496 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Double-blind Fixed-dose Study Antipsychotic and Placebo in the Treatment of Schizophrenia
http://www.clinicaltrials.gov/ct/show/NCT00088621?order=2 Sumitomo Pharmaceuticals America A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia Schizophrenia Drug:SM-13496 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:An Open-Label, Multicenter, Twelve-Month Study of Safety and Tolerability in the Treatment of Schizophrenia
http://www.clinicaltrials.gov/ct/show/NCT00091585?order=1 Sunesis Pharmaceuticals The purpose of this study is to determine whether SNS-595 given intravenously once every 3 weeks is safe. Neoplasms Drug:SNS-595 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:Phase I Open-label, Multicenter, Dose-escalation Clinical Study of the Initial Safety and Pharmacokinetic Profiles of Intravenous Administration of SNS-595 in Patients with Advanced Malignancies
http://www.clinicaltrials.gov/ct/show/NCT00094159?order=2 Sunesis Pharmaceuticals The purpose of this study is to determine whether SNS-595 given intravenously weekly for 3 weeks is safe. Neoplasms Drug:SNS-595 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:Phase I Open-label, Multicenter, Dose-escalation Clinical Study of the Safety and Pharmacokinetic Profiles of Weekly Intravenous Administrations of SNS-595 in Patients with Advanced Malignancies
http://www.clinicaltrials.gov/ct/show/NCT00043381?order=1 SuperGen To compare the safety and efficacy profiles of decitabine to those of supportive care in adults with advanced-stage myelodysplastic syndrome (MDS) Myelodysplastic Syndrome Drug:decitabine (5-aza-2'deoxycytidine) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized, Open-label, Phase III Trial of Decitabine (5-aza-2deoxycytidine) versus Supportive Care in Adults with Advanced-stage Myelodysplastic Syndrome
http://www.clinicaltrials.gov/ct/show/NCT00032773?order=2 SuperGen To determine a safe and effective dose of pentostatin in steroid-refractory aGvHD and to identify the minimal effective dose of pentostatin defined as the lowest dose that produces a response in 20% or more of patients while producing treatment failure (defines as death, grade 3/4 toxicity, or progressive disease) in 40% or less of patients. Acute Graft Versus Host Disease Drug:pentostatin for injection Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Single Group Assignment,Safety/Efficacy Study Official Title:A sequentially adaptive, open label, dose-finding, Phase I/II trial of pentostatin in the treatment of steroid-refractory acute graft versus host disease (aGvHD)
http://www.clinicaltrials.gov/ct/show/NCT00075010?order=3 M.D. Anderson Cancer Center Valproic acid is a medication that is currently used in the prevention of seizures, bipolar disorder, and migraine headaches. Researchers hope that it may improve the effects of decitabine. Decitabine is a chemotherapy drug with known activity in leukemia and myelodysplastic syndromes. LeukemiaMyelodysplastic Syndromes Drug:5-aza-2'-deoxycytidine (decitabine) (DAC)Drug:Valproic Acid Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Single Group Assignment,Safety/Efficacy Study Official Title:Phase I/II Study of 5-aza-2'-Deoxycytidine and Valproic Acid in Patients with Relapsed/Refractory Leukemia or Myelodysplastic Syndromes
http://www.clinicaltrials.gov/ct/show/NCT00067808?order=4 M.D. Anderson Cancer Center Methylation is a change that occurs to DNA that has an effect on gene usage in human cells. Abnormal methylation is very common in leukemias. Decitabine is a new drug that blocks DNA methylation. The goal of this clinical research study is learn if decitabine (given at 3 different doses) can help to control MDS. The safety of these 3 treatments will also be studied. Myelodysplastic SyndromeChronic Myelomonocytic Leukemia Drug:Decitabine Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Single Group Assignment,Safety/Efficacy Study Official Title:Phase II Randomized Study of three Different Schedules of Low-Dose Decitabine (5-AZA-2'-Deoxycytidine) in Myelodysplastic Syndrome (MDS)
http://www.clinicaltrials.gov/ct/show/NCT00041990?order=5 SuperGen To determine the safety and efficacy of decitabine in patients with Philadelphia chromosome-positive chronic myelogenous leukemia accelerated phase that were previously treated with imatinib mesylate (STI 571) and became resistant/refractory or were found to be intolerant to the drug. Chronic Myelogenous Leukemia Drug:decitabine (5-aza-2'deoxycytidine) Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A phase II, multicenter study of decitabine (5-aza-2deoxycytidine) in chronic myelogenous leukemia accelerated phase refractory to imatinib mesylate (STI 571)
http://www.clinicaltrials.gov/ct/show/NCT00042003?order=6 SuperGen To determine the safety and efficacy of decitabine in patients with Philadelphia chromosome-positive chronic myelogenous leukemia blastic phase that were previously treated with imatinib mesylate (STI 571) and became resistant/refractory or were found to be intolerant to the drug. Chronic Myelogenous Leukemia Drug:decitabine (5-aza-2'deoxycytidine) Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A phase II, multicenter study of decitabine (5-aza-2deoxycytidine) in chronic myelogenous leukemia blast phase refractory to imatinib mesylate (STI 571)
http://www.clinicaltrials.gov/ct/show/NCT00042016?order=7 SuperGen To determine the safety and efficacy of decitabine in patients with Philadelphia chromosome-positive chronic myelogenous leukemia chronic phase that were previously treated with imatinib mesylate (STI 571) and became resistant/refractory or were found to be intolerant to the drug. Chronic Myelogenous Leukemia Drug:decitabine (5-aza-2'deoxycytidine) Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A phase II, multicenter study of decitabine (5-aza-2deoxycytidine) in chronic myelogenous leukemia chronic phase refractory to imatinib mesylate (STI 571)
http://www.clinicaltrials.gov/ct/show/NCT00090376?order=1 Guilford Pharmaceuticals ImpotenceProstate Cancer Drug:GPI 1485 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 3 Arm, 12-Month Study to Evaluate the Effects of GPI 1485 on Erectile Function in Patients Undergoing Bilateral Nerve-Sparing Radical Retropubic Prostatectomy for Prostatic Carcinoma
http://www.clinicaltrials.gov/ct/show/NCT00088114?order=1 Synta Pharmaceuticals, Corp. Neoplasms Drug:STA-4783/paclitaxel Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Single Group Assignment,Safety Study Official Title:A Phase I Trial of STA-4783 in Patients Receiving Paclitaxel for Treatment of Solid Tumors
http://www.clinicaltrials.gov/ct/show/NCT00088088?order=2 Synta Pharmaceuticals, Corp. This study is for patients who have Stage IIIb or Stage IV NSCLC and have never had chemotherapy before for their disease. The first phase of the study recently completed and for the second phase of the study patients are randomly assigned to receive either paclitaxel and carboplatin or paclitaxel and carboplatin and study drug (STA 4783). Treatment will be every 3 weeks for 6 cycles. stage IIIB non-small cell lung cancerstage IV non-small cell lung cancer Drug:PaclitaxelDrug:CarboplatinDrug:STA 4783 Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Efficacy Study Official Title:A Phase I/II Trial of STA-4783 in Combination with Paclitaxel and Carboplatin for the Treatment of Chemotherapy Naive Patients with Stage IIIB or Stage IV Non-Small Cell Lung Cancer (NSCLC)
http://www.clinicaltrials.gov/ct/show/NCT00084214?order=3 Synta Pharmaceuticals, Corp. This study is designed to assess the efficacy of a weekly treatment regimen of STA-4783 and paclitaxel in comparison to paclitaxel alone on tumor response in metastatic melanoma patients. Melanoma Drug:STA-4783Drug:Paclitaxel Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Uncontrolled,Parallel Assignment,Safety/Efficacy Study Official Title:A Two-Stage Trial of STA-4783 in Combination with Weekly Paclitaxel for Treatment of Patients with Metastatic Melanoma
http://www.clinicaltrials.gov/ct/show/NCT00088101?order=4 Synta Pharmaceuticals, Corp. The purpose of this study is to determine the safety, toxicity and patient tolerance of STA-5312 administered intravenously to patients with relapsed or refractory hematological malignancies. Hematological MalignanciesLeukemiaLymphoma Drug:STA-5312 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase I Trial of STA-5312 Administered on Alternate Weekdays Every Two Weeks to Patients with Hematologic Malignancies
http://www.clinicaltrials.gov/ct/show/NCT00088062?order=5 Synta Pharmaceuticals, Corp. The purpose of this study is to determine the safety and tolerability of STA-5326 given once daily or twice daily to Crohn's Disease patients with moderate disease. Crohn's Disease Drug:STA-5326 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase I/IIa Trial of STA-5326 in Crohn's Disease Patients with CDAI Scores of 220-450
http://www.clinicaltrials.gov/ct/show/NCT00087997?order=6 Synta Pharmaceuticals, Corp. The purpose of this study is to evaluate the safety and effectiveness of an experimental study drug (STA-4783) combined with an approved cancer medicine, paclitaxel, in the treatment of soft tissue sarcomas. Paclitaxel (Taxol) has been approved and used in the United States since 1992. Soft Tissue Sarcoma Drug:STA-4783 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00072787?order=1 Taiho Pharma USA, Inc. Gastric Cancer Drug:S-1Drug:cisplatin Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase I/II, Open-Label, Nonrandomized, Dose-Finding Safety, Tolerance, Pharmacokinetic, and Efficacy Study of Orally Administered S-1 in Combination With Cisplatin in Patients With Advanced Gastric Cancer
http://www.clinicaltrials.gov/ct/show/NCT00089700?order=1 Tanox This is a 48-week study to compare TNX-355 plus OBT to placebo plus OBT in HIV subjects. You must have a stable viral load of at least 10,000 copies/ml, been treated with highly active antiretroviral therapy (HAART) for at least 6 months, be triple class experienced, and presently failing or have failed a HAART regimen. Subjects will receive infusions every week for 8 weeks, then every two weeks. HIV Infections Drug:TNX-355 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Three-Arm Study of the Anti-CD4 Monoclonal Antibody TNX-355 with Optimized Background Therapy in Treatment-Experienced Subjects Infected with HIV-1
http://www.clinicaltrials.gov/ct/show/NCT00073463?order=1 Targeted Genetics Coporation The purpose of this study is to confirm the improvement in pulmonary function and cytokine levels observed in the recently completed multidose aerosol study for the treatment of Cystic Fibrosis (CF). Cystic Fibrosis Gene Transfer:tgAAVCF Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Multicenter, Double-Blind, Placebo Controlled, Phase II Study of Aerosolized tgAAVCF for the Treatment of Cystic Fibrosis
http://www.clinicaltrials.gov/ct/show/NCT00088556?order=1 Telik The purpose of this trial is to study the efficacy and safety of the triplet combination of TLK286, carboplatin and paclitaxel as first-line therapy for patients with advanced non-small cell lung cancer. Carcinoma, Non-Small-Cell Lung Drug:TLK286Drug:carboplatinDrug:paclitaxel Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Safety/Efficacy Study Official Title:Phase 1-2a Dose-Ranging Study of the Triplet Combination of Carboplatin, Paclitaxel and TLK286 as First-Line Therapy in Advanced Non-Small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00035867?order=2 Telik The purpose of this study is to determine the safety and efficacy of TLK199 in patients with myelodysplastic syndrome (MDS). Myelodysplastic Syndromes Drug:TLK199 HCl Liposomes for Injection Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Phase 1-2a Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
http://www.clinicaltrials.gov/ct/show/NCT00080340?order=3 Telik The purpose of this study is to determine if TLK286(Telcyta) is more effective than gefitinib (Iressa) in the treatment of non-small cell lung cancer. Non Small Cell Lung Carcinoma Drug:TLK286 (Telcyta) HCl for InjectionDrug:gefitinib (Iressa) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Phase 3 Randomized Study of TLK286 (Telcyta) versus Gefitinib (Iressa) as Third-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00077883?order=4 Telik The purpose of this trial is to study the efficacy and safety of the combination of TLK286 with cisplatin as first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer. Non-small cell lung cancer Drug:TLK286, cisplatin Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label Official Title:Phase 1-2a Dose-Ranging Study of TLK286 in Combination with Cisplatin as First-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00057720?order=5 Telik The purpose of this study is to demonstrate superiority in survival in favor of TLK286 as compared to active control therapy with Doxil/Caelyx or Hycamtin in the intent-to-treat (ITT) populations. Ovarian Neoplasms Drug:TLK286 HCl for injectionDrug:topotecan hydrochloride for injectionDrug:doxorubicin HCl liposome injection Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Safety/Efficacy Study Official Title:Phase 3 Randomized Study of TLK286 (Telcyta) versus Doxil/Caelyx or Hycamtin as Third-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-1 (Assessment of Survival In Solid Tumors-1)]
http://www.clinicaltrials.gov/ct/show/NCT00057772?order=1 Theradex grade 1 follicular lymphomagrade 2 follicular lymphomaindolent, adult non-Hodgkin's lymphomamarginal zone lymphomaSmall Lymphocytic Lymphoma Drug:dexamethasoneDrug:fludarabineDrug:pixantroneDrug:rituximabProcedure:antibody therapyProcedure:biological response modifier therapyProcedure:chemotherapyProcedure:monoclonal antibody therapy Phase I Study Type:InterventionalStudy Design:Treatment Official Title:Phase I Study of Pixantrone, Fludarabine, Dexamethasone, and Rituximab in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00069966?order=2 Theradex recurrent adult diffuse large cell lymphomaanaplastic large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent grade 3 follicular lymphomarecurrent adult Burkitt's lymphoma Drug:cisplatinDrug:cytarabineDrug:filgrastimDrug:methylprednisoloneDrug:pixantroneDrug:rituximabProcedure:antibody therapyProcedure:autologous bone marrow transplantationProcedure:biological response modifier therapyProcedure:bone marrow ablation with stem cell supportProcedure:bone marrow transplantationProcedure:chemotherapyProcedure:colony-stimulating factor therapyProcedure:cytokine therapyProcedure:monoclonal antibody therapyProcedure:peripheral blood stem cell transplantation Phase II Study Type:InterventionalStudy Design:Treatment Official Title:Phase II Study of Pixantrone, Cytarabine, Methylprednisolone, and Cisplatin in Patients With Aggressive Non-Hodgkin's Lymphoma in First Relapse
http://www.clinicaltrials.gov/ct/show/NCT00054613?order=1 Therakos The purpose of this study is to determine whether extracorporeal photoimmune therapy with UVADEX (ECP) added to standard therapy is effective in the treatment of chronic graft-versus-host disease (GvHD). Graft-Versus-Host Disease Drug:MethoxsalenProcedure:Extracorporeal Photopheresis Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Single Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized Single-Blind Study of Extracorporeal Photoimmune Therapy with UVADEX in Conjunction with Standard Therapy Alone for the Treatment of Patients with Corticosteroid-Refractory, Corticosteroid-Dependent, or Corticosteroid-Intolerant Chronic Graft-versus-Host Disease
http://www.clinicaltrials.gov/ct/show/NCT00091819?order=1 Theravance Study 0017 compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections. Staphylococcal Skin Infection Drug:Telavancin Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase 3, Randomized, Double Blind, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Complicated Gram positive Skin and Skin Structure Infections with a Focus on Patients with Infections Due to Methicillin-resistant Staphylococcus aureus
http://www.clinicaltrials.gov/ct/show/NCT00062647?order=2 Theravance The purpose of this study is to determine whether telavancin (TD-6424, ARBELIC) can be safety administered to patients with bloodstream infections and whether telavancin is effective in treating these infections. Gram-Positive Bacterial Infections Drug:Telavancin (TD-6424, Arbelic) Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase 2, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous ARBELIC (TD 6424) for Treatment of Uncomplicated Staphylococcus aureus Bacteremia
http://www.clinicaltrials.gov/ct/show/NCT00058747?order=1 Antigenics Leukemia, Myeloid, Chronic Drug:Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec. Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Phase II Exploratory Study Of AG-858 Plus Gleevec In Patients With Chronic Myelogenous Leukemia (CML) In Chronic Phase Who Are Cytogenetically Positive After Treatment With Gleevec
http://www.clinicaltrials.gov/ct/show/NCT00098085?order=2 Antigenics Antigenics is enrolling patients in a Phase II study testing the feasibility to derive an autologous investigational vaccine (HSPPC-96) from the tumor tissue of patients with resectable non-small cell lung cancer. Vaccine production will be attempted on all patients who undergo surgery and meet all inclusion/exclusion criteria. Non-Small-Cell Lung CarcinomaLung CancerPulmonary Cancer Vaccine:HSPPC-96 Phase II Study Type:InterventionalStudy Design:Educational/Counseling/Training,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase II Study of the Feasibility to Derive Autologous Vaccine (HSPPC-96) from Tumor Tissue for Clinical Administration in Patients with Resectable Non-Small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00082459?order=3 Antigenics The goal of this trial is to determine the safety of HSPPC-96 and which route of administration achieves a better response with the vaccine. HSPPC-96 is an immunotherapeutic agent made from an individual patients tumor. Renal Cell Carcinoma Vaccine:autologous human tumor-derived HSPPC-96 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Randomized Phase II Study Investigating the Route of Administration of Oncophage (HSPPC-96) in Patients with Metastatic Renal Cell Carcinoma
http://www.clinicaltrials.gov/ct/show/NCT00096707?order=1 Threshold Pharmaceuticals The objectives of this study are to evaluate the safety, tolerability, pharmacokinetics, and biologic effect (FDG PET, preliminary efficacy) of daily oral doses of 2DG with and without weekly docetaxel in subjects with advanced solid tumors. Lung CancerBreast CancerPancreatic CancerHead and Neck CancerGastric Cancer Drug:2-deoxy-D-glucose (2DG) Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Single Group Assignment,Safety Study Official Title:Phase I Dose Escalation Trial of 2-deoxy-D-glucose (2DG) Alone and in Combination with Docetaxel in Subjects with Advanced Solid Malignancies
http://www.clinicaltrials.gov/ct/show/NCT00071097?order=1 Tibotec Pharmaceutical The purpose of this study is to determine the effectiveness, safety, and tolerability (how well the body stands the drug) of an investigational protease inhibitor (PI) called TMC114 given with low dose ritonavir. Subjects who have previously received all three licensed classes of HIV antiviral drugs (known as nucleoside reverse transcriptase inhibitors (NRTI), nonnucleoside reverse transcriptase inhibitors (NNRTI) and protease inhibitors (PI)), and who are on a stable PI-containing regimen not including an NNRTI may be eligible to participate. Four doses of TMC-114/ritonavir will be studied. 300 patients in the United States and Puerto Rico will participate. The duration of the study is 48 weeks. HIV Infections Drug:TMC114Drug:ritonavir Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Safety/Efficacy Study Official Title:A Phase II randomized, controlled, partially blinded, 48-week trial to investigate dose response of TMC114/RTV in 3 class-experienced, multi PI-experienced HIV-1 infected subjects
http://www.clinicaltrials.gov/ct/show/NCT00081588?order=2 Tibotec Pharmaceutical HIV Infections Drug:TMC114Drug:ritonavir Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:An open label of TMC114/RTV in HIV-1 infected subjects who failed trial treatments in sponsor selected trials with TMC114
http://www.clinicaltrials.gov/ct/show/NCT00082095?order=1 Tibotec Therapeutics The purpose of this study is to compare the anti-cancer effects and the side effects of two chemotherapy medications, pegylated liposomal doxorubicin and capecitabine, in the treatment of metastatic breast cancer. Quality of life while taking chemotherapy will also be monitored to better understand how women 60 years of age and older feel day-to-day while taking either pegylated liposomal doxorubicin or capecitabine. Breast Cancer Drug:Doxorubicin HCl liposome injectionDrug:Capecitabine Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label Official Title:A Randomized, Open-Label Trial Comparing Treatment with Either Pegylated Liposomal Doxorubicin or Capecitabine as First Line Chemotherapy for Metastatic Breast Cancer in Women 60 Years and Older
http://www.clinicaltrials.gov/ct/show/NCT00097981?order=2 Tibotec Therapeutics The primary purposes for this study is to compare the complete response (CR) rate in subjects with newly diagnosed Multiple Myeloma treated with thalidomide plus dexamethasone (Thal/Dex) versus DOXIL plus Dexamethasone and Thalidomide (Dd-T). Multiple Myeloma Drug:Doxorubicin HCl liposome injectionDrug:DexamethasoneDrug:Thalidomide Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label Official Title:A Randomized, Open-Label, Multi-Center Trial Comparing Thalidomide plus Dexamethasone (Thal/Dex) versus DOXIL plus Dexamethasone and Thalidomide (Dd-T) in Subjects with Newly Diagnosed Multiple Myeloma
http://www.clinicaltrials.gov/ct/show/NCT00074542?order=1 Tillotts Pharma AG Crohn's Disease Drug:Epanova (Omega-3 Free Fatty Acids) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase III Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Multi-Centre Study to Assess the Efficacy and Safety of Omega-3 Free Fatty Acids (Epanova) for the Maintenance of Symptomatic Remission in Subjects with Crohn's Disease
http://www.clinicaltrials.gov/ct/show/NCT00083473?order=1 Titan Pharmaceuticals This pilot study will assess the safety and efficacy of Pivanex alone in patients with chronic lymphocytic leukemia (CLL) who have relapsed or refractory disease after previous chemotherapy treatment. Pivanex is an investigational agent. Leukemia, Lymphocytic, ChronicLymphoma, Small Lymphocytic Drug:Pivanex Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Pilot Study of Pivanex, a Histone Deacetylase Inhibitor, in Patients with Chronic Lymphocytic Leukemia
http://www.clinicaltrials.gov/ct/show/NCT00050687?order=2 Titan Pharmaceuticals This study will test the safety, tolerance, and efficacy of different doses of oral gallium maltolate. Patients will receive oral gallium maltolate twice daily for 28-consecutive days followed by 14 days off treatment. This dosing cycle will be repeated. Adverse effects will be assessed and the levels of gallium in serum will be measured. Any effect of the drug on the cancer and any improvement in cancer-related symptoms will also be measured. Prostatic NeoplasmsMultiple MyelomaBladder NeoplasmsLymphoma Drug:Gallium maltolate Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:A randomized, serum level-targeted study investigating the safety and pharmacokinetics of orally administered gallium maltolate in patients with various refractory malignancies.
http://www.clinicaltrials.gov/ct/show/NCT00059007?order=3 Berlex Laboratories The purpose of the STEPS clinical research study is to evaluate the effect and safety of Spheramine implantation in patients with Parkinsons disease. Spheramine is a cell therapy that consists of human retinal pigment epithelial (RPE) cells attached to microscopic gelatin beads (microcarriers). The RPE cells produce L-DOPA and are believed to directly enhance brain levels of dopamine. This clinical study will enroll 68 participants with advanced Parkinsons disease. Half of the participants will be randomly (by chance) assigned to receive Spheramine, and half will receive placebo (sham or mock surgical treatment). If Spheramine is proven to be both beneficial and safe in this study, those participants who had the placebo treatment will be offered Spheramine at the end of the trial. Parkinson Disease Procedure:Spheramine Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:Study of the safety, tolerability and efficacy of Spheramine implanted bilaterally into the postcommissural putamen of patients with advanced Parkinsons disease
http://www.clinicaltrials.gov/ct/show/NCT00040170?order=1 Transgene This study involves the use of an experimental product, TG4010. The purpose of the study is to determine if TG4010 can stimulate the body's immune system to help it fight the cancer. Prostatic Neoplasms Vaccine:MVA-MUC1-IL2 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Uncontrolled,Parallel Assignment,Safety/Efficacy Study Official Title:Randomized Multicenter Phase II Study Evaluating Two dosing Schedules of TG4010(MVA-MUC1-IL2) in Patients with Adenocarcinoma of the Prostate
http://www.clinicaltrials.gov/ct/show/NCT00017992;jsessionid=E6FBFD5EA62EEB2F43DD64441AEBE0F4?order=1 Triangle Pharmaceuticals The purpose of this study is to see if emtricitabine is safe in children infected with HIV and to determine the best dose. HIV Infections Drug:Lopinavir/RitonavirDrug:EmtricitabineDrug:Stavudine Phase II Study Type:InterventionalStudy Design:Treatment,Pharmacodynamics Study Official Title:An Open-Label Study of a Once Daily Dose of Emtricitabine in Combination with Other Antiretroviral Agents in HIV-Infected Pediatric Patients
http://www.clinicaltrials.gov/ct/show/NCT00021502?order=1 Apex Bioscience To determine the safety and effectiveness of pyridoxylated hemoglobin polyoxyethylene conjugate (PHP) administered by continuous intravenous (IV) infusion in systemic inflammatory response syndrome (SIRS) patients with shock. PHP is a human-derived chemically modified hemoglobin preparation. PHP selectively scavenges excess nitric oxide (NO) and does so in a catalytic, concentration-dependent reaction that results in the formation of the non-toxic NO metabolite, nitrate. PHP is postulated to reduce excess, toxic levels of NO while allowing critical beneficial levels of the molecule to persist. ShockSystemic Inflammatory Response Syndrome Drug:pyridoxalated hemoglobin polyoxyethylene conjugate (PHP) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Placebo Control,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase 3, Multi-Center, Randomized, Placebo Controlled Study of PHP when Administered by Continuous Infusion in Patients with Shock Associated with Systemic Inflammatory Response Syndrome (SIRS)
http://www.clinicaltrials.gov/ct/show/NCT00004497?order=1 OBJECTIVES: I. Determine the safety and efficacy of UT-15 in patients with severe symptomatic primary pulmonary hypertension. Pulmonary Hypertension Drug:UT-15 Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control Study start:October 1998
http://www.clinicaltrials.gov/ct/show/NCT00058929?order=2 United Therapeutics Pulmonary Arterial HypertensionPulmonary Hypertension Drug:treprostinil sodium Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Multicenter, Randomized, Parallel Placebo-Controlled Study of the Safety and Efficacy of Subcutaneous Remodulin Therapy After Transition From Flolan in Patients with Pulmonary Arterial Hypertension
http://www.clinicaltrials.gov/ct/show/NCT00050375?order=1 Unither Pharmaceuticals This study will compare the time to disease relapse between OvaRex MAb-B43.13-treated patients and placebo-treated patients. This study will also compare assessments of survival, quality of life, immune response and safety between active and placebo groups. Ovarian Cancer Drug:oregovomab Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Double-Blind, Placebo-Controlled, Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post Chemotherapy Consolidation for Epithelial Carcinoma of Ovarian, Tubal or Peritoneal Origin
http://www.clinicaltrials.gov/ct/show/NCT00086632?order=2 Unither Pharmaceuticals An experimental treatment with OvaRex MAb-B43.13 (oregovomab), called immunotherapy is being tested in ovarian cancer patients. Immunotherapy causes the bodys defenses to react against cancer cells. The purpose of this research study is to determine if immunotherapy with oregovomab can create an immune response and enable the body to fight the disease and help ovarian cancer patients live longer. Patients with a possible diagnosis of ovarian cancer will be screened for study participation pre-surgery and, if eligible, will receive oregovomab during front-line chemotherapy treatment for ovarian cancer and quarterly for about a year following chemotherapy. Patients who experience disease progression will be discontinued from oregovomab therapy. Patients will also have urine, blood and tissue samples collected to assess the immune response to oregovomab. Ovarian Cancer Drug:oregovomab Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Historical Control,Parallel Assignment Official Title:An Open-Label, Phase II Study of Ovarex MAb-B43.13 as an Adjuvant Treatment to Platinum-based Front-line Chemotherapy of Advanced Epithelial Carcinoma of Ovarian, Tubal, or Peritoneal Origin
http://www.clinicaltrials.gov/ct/show/NCT00064649?order=1 The primary objective of this randomized clinical trial is to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride. Benign Prostatic Hyperplasia Device:Transurethral Microwave Thermotherapy (TUMT)Device:Transurethral Needle Ablation (TUNA) TherapyDrug:Finasteride and Alfuzosin Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Safety/Efficacy Study Official Title:Minimally Invasive Surgical Therapy for BPH
http://www.clinicaltrials.gov/ct/show/NCT00078221?order=1 Vascular Sciences Corporation AMD is a progressive disease of the retina which is nourished by a network of tiny blood vessels. There is evidence to suggest that the flow of nutrients to the retina is impaired in patients with AMD. Rheopheresis blood filtration uses blood filters that deplete excesses of large proteins, fats and other substances from the blood, improving blood flow to the macula, potentially improving vision. Macular Degeneration Device:Rheopheresis blood filtration Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00088504?order=1 Vertex Pharmaceuticals Hepatitis CHepatitis Drug:MerimepodibDrug:PEG-Interferon-alpha 2a (Pegasys)Drug:Ribavirin (Copegus) Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase 2b Study of Merimepodib in Combination with Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin in Subjects with Chronic Hepatitis C Non-Responsive to Prior Therapy with Pegylated Interferon Alfa and Ribavirin
http://www.clinicaltrials.gov/ct/show/NCT00089596?order=1 ViaCell This study hopes to show that specially treated umbilical cord cells, called stem cells, can be safely given to a person after they receive chemoradiation therapy or chemotherapy for their illness. During chemoradiation therapy or chemotherapy, a person loses all of the cells that are needed to make the different types of cells in their blood, including their immune system cells. These cells must be replaced in order for the blood and immune systems to work properly. Some people receive bone marrow transplants or other types of stem cell transplants to get the cells they need. CB001 is being developed as an option for people who need bone marrow transplants or other types of transplants to replace those cells. It is also being developed for people who do not have the option of other types of transplants. Acute Lymphocytic LeukemiaAcute Myeloid LeukemiaMyelodysplastic Syndrome Procedure:Expansion of umbilical cord stem cells Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:A Safety Study of Infusion of Ex Vivo Selectively Amplified Unrelated Cord Blood Stem Cells in Subjects with Hematological malignancies Receiving Unrelated Cord Blood Transplantation
http://www.clinicaltrials.gov/ct/show/NCT00044356?order=1 Vical The purpose of this clinical trial is to determine if Allovectin-7, an experimental gene-based immunotherapy, can shrink melanoma tumors. The trial will also examine if this treatment can improve the time to disease progression. MelanomaMetastatic MelanomaMalignant MelanomaSkin Cancer Gene Transfer:Allovectin-7 Phase II Study Type:InterventionalStudy Design:Treatment,Open Label,Historical Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase II Study of High-Dose Allovectin-7 in Patients with Advanced Metastatic Melanoma
http://www.clinicaltrials.gov/ct/show/NCT00064064?order=1 Vion Pharmaceuticals recurrent non-small cell lung cancerstage IV non-small cell lung cancer Drug:3-APDrug:gemcitabineProcedure:chemosensitization/potentiationProcedure:chemotherapyProcedure:enzyme inhibitor therapy Phase II Study Type:InterventionalStudy Design:Treatment Official Title:Phase II Study of 3-AP (Triapine) and Gemcitabine in Patients With Metastatic Non-Small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00064051?order=2 Vion Pharmaceuticals stage II pancreatic cancerstage III pancreatic cancerstage IVA pancreatic cancerstage IVB pancreatic cancerrecurrent pancreatic cancer Drug:3-APDrug:gemcitabineProcedure:chemosensitization/potentiationProcedure:chemotherapyProcedure:enzyme inhibitor therapy Phase II Study Type:InterventionalStudy Design:Treatment Official Title:Phase II Study of 3-AP (Triapine) and Gemcitabine in Patients With Unresectable or Metastatic Pancreatic Cancer
http://www.clinicaltrials.gov/ct/show/NCT00098436?order=3 Vion Pharmaceuticals adult acute lymphoblastic leukemiaadult acute myeloid leukemiachildhood acute lymphoblastic leukemiachildhood acute myeloid leukemia and other myeloid malignanciesChronic Myelogenous Leukemiasecondary acute myeloid leukemia Drug:VNP40101MDrug:temozolomideProcedure:chemosensitization/potentiationProcedure:chemotherapy Phase I Study Type:InterventionalStudy Design:Treatment Official Title:Phase I Study of Temozolomide and VNP40101M in Patients With Relapsed or Refractory Leukemias
http://www.clinicaltrials.gov/ct/show/NCT00070538?order=4 Vion Pharmaceuticals adult acute lymphoblastic leukemiaadult acute myeloid leukemiachildhood acute myeloid leukemia and other myeloid malignanciesChronic Myelogenous LeukemiaChronic Myelomonocytic Leukemia Drug:VNP40101MDrug:cytarabineProcedure:chemotherapy Phase I Study Type:InterventionalStudy Design:Treatment Official Title:Phase I Study of VNP40101M and Cytarabine in Patients With Hematologic Malignancies
http://www.clinicaltrials.gov/ct/show/NCT00083187?order=5 Vion Pharmaceuticals adult acute myeloid leukemiaatypical chronic myeloid leukemiaChronic Myelomonocytic Leukemiamyelodysplastic and myeloproliferative diseaseMyelodysplastic Syndromes Drug:VNP40101MDrug:hydroxyureaProcedure:chemosensitization/potentiationProcedure:chemotherapy Phase II Study Type:InterventionalStudy Design:Treatment Official Title:Phase II Study of VNP40101M in Patients With Acute Myelogenous Leukemia or High-Risk Myelodysplasia
http://www.clinicaltrials.gov/ct/show/NCT00030225?order=1 VitaGen The purpose of this study is to determine if treatment with the ELAD Bioartificial Liver Assist Device is beneficial to patients in Acute Liver Failure either as a bridge to liver transplant or bridge to native liver recovery. Fulminant Hepatic Failure Device:Extracorporeal Liver Assist Device Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00076440?order=1 Voyager Pharmaceutical Corporation ALADDIN is a research study to investigate the safety and effectiveness of leuprolide (a hormone drug) to improve the cognitive function and slow the progression of Alzheimer's disease (AD) in men 65 years and older with mild to moderate Alzheimer's disease who reside in the community. Alzheimer Disease Drug:Leuprolide acetate Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00076960?order=1 WellSpring Pharmaceutical Corporation The purpose of this protocol is to make Stanate (TM) (Stannsoporfin, tin-mesoporphyrin) available to infants who meet the following criteria: 1) the infant has a very high level of bilirubin without and adequate clinical response to phototherapy 2)requires exchange transfusion and 3) the family refuses to allow the administration of blood products, particularly on religious grounds, such as the Jehovah's Witness Community. Neonatal JaundiceJaundiceHyperbilirubinemia Drug:Stanate (TM), stannsoporfin, tin-mesoporphyrin Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Compassionate Use of Stannsoporfin as an Adjuvant to Phototherapy to Reduce the Need for Exchange Transfusions
http://www.clinicaltrials.gov/ct/show/NCT00044785?order=1 Wellstat Therapeutics CPT-11 and 5Fluorouracil (5FU) combined with leucovorin has become the standard of care for colorectal cancer. PN401 permits treatment with higher than normal doses of 5FU, which could increase its therapeutic potential. It is hypothesized that adding PN401 to the CPT-11, 5FU, leucovorin regimen will reduce toxicity and will allow higher doses of 5FU to be well tolerated and therefore potentially increase effectiveness. Solid Tumors Drug:triacetyluridineDrug:fluorouracilDrug:leucovorinDrug:camptosar Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A phase I study of escalating doses of CPT-11 and 5fluorouracil (5FU) plus PN401 with a fixed dose of leucovorin in patients with solid tumor malignancies.
http://www.clinicaltrials.gov/ct/show/NCT00024427?order=2 Wellstat Therapeutics adenocarcinoma of the pancreasDrug ToxicityPancreatic Cancer Drug:fluorouracilDrug:gemcitabineDrug:triacetyluridineProcedure:chemoprotectionProcedure:chemotherapyProcedure:drug modulationProcedure:high-dose chemotherapyProcedure:supportive care/therapy Phase III Study Type:InterventionalStudy Design:Treatment Official Title:Phase III Randomized Study of Triacetyluridine and High-Dose Fluorouracil Versus Gemcitabine in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
http://www.clinicaltrials.gov/ct/show/NCT00087022?order=1 Wilex renal clear cell carcinomastage I renal cell cancerstage II renal cell cancerstage III renal cell cancerStage IV Renal Cell Cancer Drug:monoclonal antibody G250Procedure:adjuvant therapyProcedure:antibody therapyProcedure:biological response modifier therapyProcedure:monoclonal antibody therapy Phase III Study Type:InterventionalStudy Design:Treatment Official Title:Phase III Randomized Study of Adjuvant Chimeric Monoclonal Antibody cG250 (WX-G250; Rencarex) Versus Placebo in Patients With Primary Non-metastatic Clear Cell Renal Cell Carcinoma at High Risk for Recurrence After Nephrectomy (ARISER: Adjuvant Rencarex Immunotherapy trial to Study Efficacy in non-metastatic Renal cell carcinoma)
http://www.clinicaltrials.gov/ct/show/NCT00083525?order=2 Wilex The purpose of this study is to determine the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics, and pharmacodynamics of the combination of WX-UK1 and capecitabine in patients with advanced malignancies. Advanced malignancies Drug:WX-UK1 in combination with Capecitabine Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study
http://www.clinicaltrials.gov/ct/show/NCT00077935?order=1 Winston Laboratories The purpose of this study is to evaluate the safety of Civamide Cream 0.075% as a Treatment in Subjects with Osteoarthritis (OA) of the Knee(s). Osteoarthritis, Knee Drug:Civamide Phase III Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Single Group Assignment,Safety Study Official Title:An Open-Label Multicenter Study Evaluating the Safety of Civamide Cream 0.075% as a Treatment in Subjects with Osteoarthritis of the Knee(s)
http://www.clinicaltrials.gov/ct/show/NCT00040521?order=1 Wyeth-Ayerst Research To assess the activity of multiple doses of oral rhIL-11 in patients with active Crohns disease (Crohns Disease Activity Index [CDAI] score from 220-400). Crohn Disease Drug:Recombinant Human Interleukin-11 (rhIL-11) Phase II Study Type:InterventionalStudy Design:Treatment Official Title:A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of Orally Administered Recombinant Human Interleukin-11 (rhIL-11) for the Treatment of Patients With Active Crohns Disease
http://www.clinicaltrials.gov/ct/show/NCT00037583?order=2 Wyeth-Ayerst Research The primary objectives are a) to establish the maximum tolerated dose (MTD) of gemtuzumab ozogamicin in combination with cytarabine and daunorubicin, and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine and daunorubicin. Acute Myeloid Leukemia Drug:Gemtuzumab Ozogamicin Phase II Study Type:InterventionalStudy Design:Treatment Official Title:A Dose-Ranging Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (go) Given in Combination with Cytarabine and Daunorubicin in Relapsed or Refractory Patients and in Younger de novo Patients with Acute Myeloid Leukemia (AML)
http://www.clinicaltrials.gov/ct/show/NCT00065468?order=3 Wyeth-Ayerst Research Carcinoma, Renal CellKidney Neoplasms Drug:Interferon AlfaDrug:CCI-779Drug:Interferon Alfa and CCI-779 Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Safety/Efficacy Study Official Title:A Phase 3, Three-Arm, Randomized, Open-Label Study of Interferon Alfa Alone, CCI-779 Alone, and the Combination of Interferon Alfa and CCI-779 in First-Line Poor-Prognosis Subjects With Advanced Renal Cell Carcinoma.
http://www.clinicaltrials.gov/ct/show/NCT00081744?order=4 Wyeth-Ayerst Research Surgical Wound InfectionAbdominal Abscess Drug:TigecyclineDrug:Imipenem/Cilastatin Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Safety/Efficacy Study Official Title:A Multicenter, Double-Blind, Randomized Comparison Study Of the Efficacy and Safety of Tigecycline to Imipenem/ Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Subjects
http://www.clinicaltrials.gov/ct/show/NCT00044733?order=5 Wyeth-Ayerst Research The primary objective of this study is to evaluate the safety of gemtuzumab ozogamicin in relapsed CD33-positive AML patients who received HSCT. If the MTD dose is not reached, 9 mg/m2 will be the maximum tested dose. A secondary objective is to assess efficacy in terms of the number of patients attaining a complete (CR) or morphological (CRp) remission. Acute Myelogenous Leukemia Drug:Mylotarg (gemtuzumab ozogamicin) Injection Phase II Study Type:InterventionalStudy Design:Open Label Official Title:A Dose-Finding study of the safety of Gemtuzumab Zogamicin as single agent treatment of patients with relapsed Acute Myelogenous Leukemia after autologous or allogenic Hematopoietic Stem Cell Transplant (HSCT)
http://www.clinicaltrials.gov/ct/show/NCT00075257?order=6 Wyeth-Ayerst Research Major Depressive Disorder Drug:DVS-233 SR Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of DVS-233 SR For Prevention Of Depressive Relapse In Adult Outpatients With Major Depressive Disorder
http://www.clinicaltrials.gov/ct/show/NCT00095342?order=7 Wyeth-Ayerst Research The primary objective of this clinical research study is to compare the efficacy and the safety of 3 dose levels of oral TMI-005 in comparison with placebo in subjects with active Rheumatoid Arthritis (RA) who have been receiving stable doses of Methotrexate (MTX). Rheumatoid Arthritis Drug:TMI-005 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Double-Blind, Placebo-Controlled, Parallel, Randomized Study to Evaluate the Efficacy and Safety of 3 Oral Dose Levels of TMI-005 in Subjects with Active Rheumatoid Arthritis on a Background of Methotrexate
http://www.clinicaltrials.gov/ct/show/NCT00044759?order=8 Wyeth-Ayerst Research To compare the safety and efficacy of piperacillin/tazobactam (4 g/500 mg) administered intravenously every 6 hours to cefepime (2 g) administered intravenously every 8 hours for the empiric treatment of neutropenic fever in patients with a hematologic malignancy or lymphoma. Hematologic Neoplasms Drug:Piperacillin/Tazobactam (Tazocin) Phase III Study Type:InterventionalStudy Design:Treatment Official Title:A randomized, open-label, multi-center, comparative study of the efficacy and safety of piperacillin/tazobactam to cefepime for the empiric treatment of neutropenic fever in patients with a hematologic malignancy or lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00044928?order=9 Wyeth-Ayerst Research A Phase IV, multicenter study of hospitalized patients with complicated intra-abdominal infection. Abscess, Intra-AbdominalPeritonitis Drug:Piperacillin/Tazobactam Phase IV Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00081575?order=10 Wyeth-Ayerst Research This is a phase 3, multicenter, randomized, double-blind (third party unblinded) comparison of the efficacy and safety of IV tigecycline with those of IV levofloxacin in subjects hospitalized with CAP. Subjects who have clinical signs and symptoms of CAP and who are hospitalized as a result will be considered for enrollment. Subjects will be randomly assigned (in a 1:1 ratio) to receive either tigecycline or levofloxacin via IV administration. Subjects will be hospitalized and will receive IV test article for a minimum of 7 days (14 doses) and a maximum of 14 days (28 doses). Pneumonia Drug:TigecyclineDrug:Levofloxacin Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Safety/Efficacy Study Official Title:A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study Of The Efficacy And Safety Of Intravenous Tigecycline Vs Intravenous Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia
http://www.clinicaltrials.gov/ct/show/NCT00038922?order=11 Wyeth-Ayerst Research Ulcerative Colitis Drug:rhIL-11 Phase I Study Type:InterventionalStudy Design:Treatment Official Title:A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Safety and Exploratory Pharmacogenomic Study of Orally Administered Recombinant Human Interleukin Eleven (rhIL-11) in Patients With Mild to Moderate Left-Sided Ulcerative Colitis
http://www.clinicaltrials.gov/ct/show/NCT00088647?order=12 Wyeth-Ayerst Research The primary objective of this clinical research study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD) of intravenous (IV) MST-997 formulated in Intralipid 20% administered on a weekly schedule to subjects with advanced malignant solid tumors. Breast CancerNeoplasms, BreastNon-Small-Cell Lung Carcinoma Drug:MST-997 Phase I Study Type:InterventionalStudy Design:Treatment,Open Label,Safety Study Official Title:A Phase 1 Dose-Escalation Study of Intravenous MST-997 Formulated in Intralipid 20% Administered Weekly in Subjects with Advanced Malignant Solid Tumors
http://www.clinicaltrials.gov/ct/show/NCT00063219?order=13 Wyeth-Ayerst Research Carcinoma, Non-Small-Cell Lung Drug:MAC-321 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label Official Title:A Phase 2, open-label study of MAC-321 administered intravenously as a single agent for the treatment of non-small cell lung cancer refractory to platinum-based therapy
http://www.clinicaltrials.gov/ct/show/NCT00083993?order=14 Wyeth-Ayerst Research Breast CancerMetastases Drug:Temsirolimus (CCI-779)Drug:Letrozole Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control Official Title:A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study of Oral CCI-779 Administered in Combination with Letrozole vs. Letrozole Alone as First Line Hormonal Therapy in Postmenopausal Women with Locally Advanced or Metastatic Breast Cancer
http://www.clinicaltrials.gov/ct/show/NCT00037570?order=15 Wyeth-Ayerst Research This study will evaluate the effect of two regimens of intravenous pantoprazole versus intravenous ranitidine on intragastric pH after endoscopic hemostatic therapy in patients with bleeding peptic ulcer. Peptic Ulcer Hemorrhage Drug:Pantoprazole Phase II Study Type:InterventionalStudy Design:Prevention,Randomized Official Title:A Randomized Study of the Effect of Intravenous Pantoprazole on Gastric pH After Successful Hemostasis in Patients with Bleeding Peptic Ulcer
http://www.clinicaltrials.gov/ct/show/NCT00040495?order=16 Wyeth-Ayerst Research The purpose of this study is to evaluate the efficacy and safety of intravenous pantoprazole in the prevention of rebleeding in patients with bleeding peptic ulcer disease after successful endoscopic hemostatic therapy. Peptic Ulcer Hemorrhage Drug:Pantoprazole Phase III Study Type:InterventionalStudy Design:Prevention,Safety/Efficacy Study Official Title:An Efficacy and Safety Study of Intravenous Pantoprazole in the Prevention of Recurrent Peptic Ulcer Bleeding After Successful Hemostasis
http://www.clinicaltrials.gov/ct/show/NCT00073749?order=17 Wyeth-Ayerst Research This is an open-label, phase 1 study of the safety, tolerability, and pharmacokinetics (PK) of CMC-544 administered intravenously as a single agent to subjects with B-cell Non-Hodgkin's Lymphoma (NHL). CMC-544 will be given intravenously (IV) approximately once every 21 days (plus or minus 2 days) for at least 4 doses unless there is evidence of progressive disease (PD). Dose escalation decisions will be based on toxicity assessed in the first 21 days after the first dose. Subjects may receive additional doses of CMC-544, beyond the first 4 doses, if eligible. Lymphoma, Non-Hodgkin'sB-Cell Lymphoma Drug:CMC-544 Phase I Study Type:InterventionalStudy Design:Treatment,Open Label,Safety Study
http://www.clinicaltrials.gov/ct/show/NCT00086346?order=18 Wyeth-Ayerst Research To determine the effect of conversion from calcineurin inhibitor to sirolimus (Rapamune) treatment on kidney function. This study will also evaluate the safety and efficacy of the conversion of therapies. Liver TransplantationHepatic Transplantation Drug:Sirolimus Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00093171?order=19 Wyeth-Ayerst Research The primary objective of this clinical research study is to assess the safety and efficacy of rFIX for a minimum of 6 months in previously treated patients (PTPs) with hemophilia B (FIX:C ?2%) during standard-of-care treatment (on-demand, prophylaxis, and through major and minor surgical procedures). Hemophilia B Drug:rFIX Phase III Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Safety/Efficacy Study Official Title:An Open-label Safety and Efficacy Study of Recombinant Human Factor IX (rFIX; BeneFIX) in Previously Treated Patients (PTPs) with Hemophilia B (FIX:C ?2%)
http://www.clinicaltrials.gov/ct/show/NCT00092976?order=20 Wyeth-Ayerst Research The primary objective of this clinical research study is to evaluate the safety and efficacy of ReFacto in subjects with hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local laboratory. Hemophilia A Drug:ReFacto Phase IV Study Type:InterventionalStudy Design:Treatment,Open Label,Safety/Efficacy Study Official Title:A Phase IV Study of the Safety and Efficacy of ReFacto (moroctocog alfa, B-domain deleted recombinant Factor VIII) in Subjects with Hemophilia A Undergoing Major Surgery Monitored Using the Chromogenic Substrate Assay at the Local Laboratory
http://www.clinicaltrials.gov/ct/show/NCT00037557?order=21 Wyeth-Ayerst Research To characterize the safety and efficacy of rFIX in children less than 6 years of age with severe hemophilia B in the setting of acute bleeding episodes, prophylaxis, and/or surgery. Hemophilia B Drug:BeneFIX Phase III Study Type:InterventionalStudy Design:Treatment Official Title:An Open-Label, Single-Arm, Safety and Efficacy Study of Recombinant Human Factor IX (rFIX; BeneFIX) in Children Less Than 6 Years of Age With Severe Hemophilia B
http://www.clinicaltrials.gov/ct/show/NCT00092911?order=22 Wyeth-Ayerst Research The main objective of this study is to compare the antidepressant efficacy and safety of DVS-233 SR versus placebo in adult outpatients with Major Depressive Disorder. DepressionDepressive DisorderMajor Depressive Disorder Drug:DVS-233 SR Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy And Safety Study of a Flexible Dose of DVS-233 SR in Adult Outpatients with Major Depressive Disorder
http://www.clinicaltrials.gov/ct/show/NCT00087737?order=23 Wyeth-Ayerst Research The main objective of this study is to compare the antidepressant efficacy and safety of DVS-233 SR versus placebo in adult outpatients with major depressive disorder (MDD). After a screening period of 10 + or - 4 days, eligible subjects will be treated for 8 weeks. An additional 2 weeks will be allowed for tapering test article. Subjects will return for a follow-up visit 7 days after discontinuing test article. Major Depressive Disorder Drug:DVS-233 SRDrug:Venlafaxine ER Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Flexible-Dose Study of DVS-233 SR and Venlafaxine ER in Adult Outpatients With Major Depressive Disorder
http://www.clinicaltrials.gov/ct/show/NCT00090649?order=24 Wyeth-Ayerst Research The primary objective of this study is to compare the antidepressant efficacy and safety of DVS-233 SR with those of placebo in adult outpatients with major depressive disorder (MDD). Major Depressive Disorder Drug:DVS-233 SRDrug:Venlafaxine ER Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Flexible-Dose Study Of DVS-233 SR And Venlafaxine ER In Adult Outpatients With Major Depressive Disorder
http://www.clinicaltrials.gov/ct/show/NCT00079989?order=25 Wyeth-Ayerst Research The primary objective of this study is to evaluate the safety and efficacy of tigecycline in the treatment of subjects with selected serious infections caused by resistant gram-negative bacteria, e.g., Acinetobacter baumannii, Enterobacter species, Klebsiella pneumoniae or other resistant gram-negative pathogens, for whom antibiotics have failed or who cannot tolerate other appropriate antimicrobial therapies. Gram-Negative Bacterial InfectionsPneumoniaBacteremia Drug:tigecycline Phase III Study Type:InterventionalStudy Design:Treatment,Open Label,Safety/Efficacy Study Official Title:A phase 3, open-label, noncomparative study of tigecycline for the treatment of subjects with selected serious infections due to resistant Gram-negative organisms such as Enterobacter Species, Acinetobacter baumannii, and Klebsiella pneumoniae
http://www.clinicaltrials.gov/ct/show/NCT00079976?order=26 Wyeth-Ayerst Research BacteremiaPneumonia, BacterialSkin Diseases, Bacterial Drug:TigecyclineDrug:LinezolidDrug:Vancomycin Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Safety/Efficacy Study Official Title:A clinical research study to evaluate the safety and efficacy of tigecycline in the treatment of selected serious infections caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)
http://www.clinicaltrials.gov/ct/show/NCT00080496?order=27 Wyeth-Ayerst Research Pneumonia Drug:TigecyclineDrug:ImipenemDrug:Cilastatin Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Safety/Efficacy Study Official Title:A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study Of The Efficacy And Safety Of Tigecycline Vs Imipenem/Cilastatin For The Treatment Of Subjects With Nosocomial Pneumonia
http://www.clinicaltrials.gov/ct/show/NCT00079885?order=28 Wyeth-Ayerst Research This is a phase 3, multicenter, randomized, double-blind (third party unblinded) comparison of the efficacy and safety of tigecycline with those of levofloxacin in subjects initially hospitalized with community-acquired pneumonia (CAP). Subjects who have clinical signs and symptoms of CAP and who are hospitalized as a result will be considered for enrollment. Subjects will be randomly assigned (in a 1:1 ratio) to receive either tigecycline or levofloxacin via intravenous (IV) administration. Initially, subjects will be hospitalized and will receive IV test article for a minimum of 3 days (6 doses) and a maximum of 14 days (28 doses). Pneumonia Drug:tigecyclineDrug:levofloxacin Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Safety/Efficacy Study Official Title:A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study Of The Efficacy And Safety Of Tigecycline Vs Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia
http://www.clinicaltrials.gov/ct/show/NCT00087854?order=1 Xanthus Life Sciences The purpose of this study is to assess the safety and efficacy of Amonafide in men with androgen-independent prostate cancer, assigned to individualized doses of Amonafide based on acetylator phenotype information (doses adjusted on individual metabolism). Prostate Cancer Drug:Amonafide L-malate (drug) Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Pharmacokinetics Study Official Title:Dose-defining Study of a NAT2 Phenotype-based Dosing Regimen of Intravenous Amonafide L-malate Administered Weekly in Men with Androgen-independent Prostate Cancer (AIPC)
http://www.clinicaltrials.gov/ct/show/NCT00058656?order=1 Xcyte Therapies Patients will have immune cells collected and then expanded outside of the body. Patients will receive an infusion of a large number of expanded immune cells. There will be three dose levels studied. The goal of the study will be to determine the safety as well as potential efficacy of this treatment. Chronic Lymphocytic Leukemia Procedure:Infusion of Activated & Expanded Autologous T Cells Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase I/II Study of Xcellerated T Cells(tm) in Patients with Chronic Lymphocytic Leukemia (CLL)
http://www.clinicaltrials.gov/ct/show/NCT00081783?order=2 Xcyte Therapies This is a Phase II single arm study of a novel T cell immunotherapy in patients with indolent non-Hodgkins lymphoma (NHL). Eligible patients will have relapsed or refractory disease after receiving at least one and no more than four prior regimens. Patients will receive Xcellerated T CellsTM, an ex vivo activated and expanded autologous T cell product, in an attempt to enhance immune responses with anti-tumor activity. The primary endpoint of the study is to evaluate the efficacy of Xcellerated T Cells in patients with indolent NHL. Secondary endpoints are to evaluate the safety of the therapy in this patient population, and to evaluate changes in the number and phenotype of T- and B-lymphocytes, as well as changes in the T cell receptor repertoire, hemoglobin levels, platelet counts and quantitative immunoglobulin levels. In a subset of patients, fine-needle aspirates of malignant lymph nodes will be performed to assess changes in the lymphocyte composition and phenotype. Bone marrow aspirates will be similarly evaluated. Finally, anti-tumor immune responses will be evaluated in patients amenable to biopsy of enlarged lymph nodes. Non-Hodgkin's Lymphoma Drug:Xcellerated T Cells Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase II Study of Xcellerated T CellsTM in Patients with Relapsed or Refractory Indolent Non-Hodgkins Lymphoma (NHL)
http://www.clinicaltrials.gov/ct/show/NCT00078065?order=3 Xcyte Therapies Multiple Myeloma Drug:Xcellerated T Cells Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Randomized Phase II Study of Xcellerated T CellsTM with or without Prior Fludarabine Therapy in Patients with Multiple Myeloma
http://www.clinicaltrials.gov/ct/show/NCT00087230?order=1 Xenova Biomedix adult glioblastomarecurrent adult brain tumoradult giant cell glioblastomaadult gliosarcoma Drug:carboplatinDrug:carmustineDrug:cisplatinDrug:lomustineDrug:nimustineDrug:procarbazineDrug:temozolomideDrug:transferrin-CRM107Drug:vincristineProcedure:antibody therapyProcedure:biological response modifier therapyProcedure:chemotherapyProcedure:immunotoxin therapy Phase III Study Type:InterventionalStudy Design:Treatment Official Title:Phase III Randomized Study of Intratumoral Transferrin-CRM107 Versus Best Standard Chemotherapy in Patients With Progressive and/or Recurrent Unresectable Glioblastoma Multiforme
http://www.clinicaltrials.gov/ct/show/NCT00083447?order=2 Xenova Biomedix Glioblastoma Multiforme Drug:TransMID Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase III Multicenter Study of Intratumoral/Interstitial Therapy with TransMID Compared to Best Standard of Care in Patients with Progressive and/or Recurrent, Non-Resectable Glioblastoma Multiforme
http://www.clinicaltrials.gov/ct/show/NCT00082472?order=1 Zivena This study is intended to show whether inhaled chemotherapy can be added to a standard IV chemotherapy regime, to investigate the additional toxicities and to show initial evidence of efficacy of the combination. NSCLC Drug:Doxorubicin HCl Inhalation SolutionDrug:DocetaxelDrug:Cisplatin Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Phase I/II Study of Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients with Locally Advanced or Metastatic Unresectable Non Small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00095108?order=1 ZymoGenetics This study is being done to see if an experimental drug called recombinant interleukin-21 (rIL-21) when given to patients with stage 4 malignant melanoma or stage 4 kidney cancer is safe and has any effect on these types of cancers. MelanomaKidney NeoplasmsMetastases Drug:Recombinant Human Interleukin-21 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Recombinant Human Interleukin-21 (rIL-21) in Subjects with Metastatic Melanoma or Metastatic Renal Cell Carcinoma
http://www.clinicaltrials.gov/ct/show/NCT00083928?order=1 ngstrom Pharmaceuticals The purpose of this study is to determine whether injections of 6 are effective in treating ovarian cancer patients who have completed first-line therapy and currently have no detectable cancer but have experienced a doubling of CA 125 levels. Ovarian CancerPrimary Peritoneal Carcinoma Drug:6 subcutaneous injection Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase 2 Randomized, Double-Blind Trial of the Clinical Activity and Safety of 6 in Patients with Asymptomatic CA125 Progression of Epithelial Ovarian Cancer after First-Line Chemotherapy
http://www.clinicaltrials.gov/ct/show/NCT00087984?order=1 Argos Therapeutics The purpose of this trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of administering a dendritic cell vaccine to patients with metastatic renal cell carcinoma. Renal Cell Carcinoma Vaccine:Dendritic cell vaccine Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00060632?order=1 Ariad Pharmaceuticals Phase 1 trial to determine the safety, tolerability and maximum tolerated dose (MTD) of AP23573 in patients with refractory or recurrent malignancies, including myeloma and lymphoma. TumorsLymphomaMultiple Myeloma Drug:AP23573 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:A Phase I, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of Weekly Administration of AP23573, an mTOR Inhibitor, in Patients with Refractory or Advanced Malignancies
http://www.clinicaltrials.gov/ct/show/NCT00087451?order=2 Ariad Pharmaceuticals A Phase I, open-label, non-randomized, sequential dose escalation cohort trial of the safety, tolerability, and maximum tolerated dose (MTD) of AP23573 when administered intravenously as a 30-minute infusion, once daily for five days, repeated every two weeks, to patients with progressive or recurrent malignant glioma. Malignant GliomaGlioblastomaGliosarcoma Drug:AP23573 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:A Phase I Sequential Ascending Dose Trial of AP23573 in Patients with Progressive or Recurrent Malignant Glioma
http://www.clinicaltrials.gov/ct/show/NCT00086125?order=3 Ariad Pharmaceuticals The purpose of this phase II study is to assess the efficacy of AP23573 in patients with specified relapsed or refractory hematological malignancies. Hematologic MalignanciesLeukemiaMyelodysplastic SyndromesMyeloid MetaplasiaLymphoma Drug:AP23573 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Parallel Assignment,Efficacy Study Official Title:A Phase II Study of AP23573, an mTOR Inhibitor, in Patients with Relapsed or Refractory Hematologic Malignancies
http://www.clinicaltrials.gov/ct/show/NCT00093080?order=4 Ariad Pharmaceuticals The purpose of this study is to assess the efficacy of AP23573 in patients with advanced sarcoma when administered once daily for 5 consecutive days (QDx5) every two weeks. LeiomyosarcomaLiposarcomaOsteosarcomaSarcoma, Soft TissueMetastases Drug:AP23573 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase II Study of AP23573, an mTOR Inhibitor, in Patients with Advanced Sarcoma
http://www.clinicaltrials.gov/ct/show/NCT00075933?order=1 ArQule Cancer Drug:ARQ 501 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:A Phase I Clinical, Pharmacokinetic Study of ARQ 501 in Subjects with Advanced Solid Tumors
http://www.clinicaltrials.gov/ct/show/NCT00085787?order=1 Array BioPharma The purpose of this study is to assess the tolerability of ARRY-142886 in patients with advanced solid malignancies that have failed standard therapy or for whom no standard therapy exists and determine the maximum tolerated dose as defined by significant dose limiting toxicity. Cancer Drug:ARRY-142886 Phase I Study Type:InterventionalStudy Design:Treatment,Open Label,Pharmacokinetics/Dynamics Study Official Title:A Phase I, Open-label, Multiple Dose Study to Assess the Tolerability, Pharmacokinetics and Pharmacodynamics of ARRY-142886 Given on a Daily Oral Regime in Subjects with Advanced Solid Malignancies
http://www.clinicaltrials.gov/ct/show/NCT00055302?order=1 AstraZeneca The primary objective of this study is to evaluate the safety and efficacy of anastrozole 1 mg given once daily in subjects with McCune-Albright Syndrome. McCune-Albright Syndrome Drug:Arimidex 1 mg Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:An Open-label Study Evaluating the Safety and Efficacy of Anastrozole (ARIMIDEX) in the Treatment of Precocious Puberty in girls with McCune-Albright Syndrome
http://www.clinicaltrials.gov/ct/show/NCT00088790?order=2 AstraZeneca Purpose of this study is to assess the safety and tolerability of AZD5438 given orally to patients with advanced solid malignancies advanced, solid, malignancies Drug:AZD5438 Phase I Study Type:InterventionalStudy Design:Treatment Official Title:Phase I Study to Assess the Safety and Tolerability of AZD5438 in Patients with Advanced Solid Malignancies
http://www.clinicaltrials.gov/ct/show/NCT00069290?order=3 AstraZeneca This study is being carried out to see if ZD1839 is effective in treating metastatic breast cancer in combination with Nolvadex, and if so, how it compares with Nolvadex alone. Breast Neoplasms Drug:Gefitinib (ZD1839)Drug:Nolvadex Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind Official Title:A Phase II randomised, double-blind, stratified, multi-centre trial comparing the Nolvadex 20 mg and placebo combination to the Nolvadex 20 mg and ZD1839 (IRESSA) 250 mg combination in patients with metastatic breast cancer and estrogen receptor (ER) and/or progesterone (PR) positive tumours
http://www.clinicaltrials.gov/ct/show/NCT00083954?order=4 AstraZeneca The purpose of this study is to determine whether treatment with Seroquel for two months is effective in treating a depressive episode in patients diagnosed with bipolar depression. Bipolar Disorder Drug:Quetiapine Fumarate Phase III Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00098345?order=5 AstraZeneca The purpose of this open label, two stage, phase II study is to evaluate the efficacy and tolerability of ZD6474 in patients with locally advanced or metastatic hereditary medullary thyroid carcinoma. Thyroid Cancer Drug:ZD6474 Phase II Study Type:InterventionalStudy Design:Treatment,Open Label,Efficacy Study Official Title:Open Label, Phase II Thyroid Cancer
http://www.clinicaltrials.gov/ct/show/NCT00077948?order=6 Myogen Beta-blocker medications have been shown to improve heart function and prolong the lives of patients with chronic heart failure (CHF). Some people with advanced CHF have difficulty taking beta-blocker medications due to troublesome side effects, such as low blood pressure and/or low heart rate, severe tiredness, dizziness, or shortness of breath. In other words, they have difficulty tolerating beta-blocker medications. The purpose of this study is to determine if enoximone can improve a patient's ability to tolerate a beta-blocker medication. Heart Failure, Congestive Drug:enoximone plus metoprolol succinateDrug:metoprolol succinate alone Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase III, Randomized, Double-Blind, Double Placebo-Controlled, Multicenter, Three Parallel Group Study of Enoximone Plus Extended-Release Metoprolol Succinate in Advanced CHF Subjects Previously Intolerant to Beta-Blocker Treatment
http://www.clinicaltrials.gov/ct/show/NCT00079833?order=7 AstraZeneca This research study will determine if esomeprazole, when administered twice daily at 40, 80, or 120 mg doses, can control excessive stomach acid secretion. Zollinger-Ellison Syndrome Drug:Esomeprazole magnesium Phase III Study Type:InterventionalStudy Design:Treatment,Open Label Official Title:A Phase III, Multicenter, Open-Label Study To Evaluate the Control of Gastric Acid Secretion with Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome For 12 Months
http://www.clinicaltrials.gov/ct/show/NCT00065325?order=8 AstraZeneca The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Aromasin (exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first. Breast NeoplasmsMetastases, Neoplasm Drug:FULVESTRANT Phase III Study Type:InterventionalStudy Design:Treatment Official Title:The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women with Advanced Breast Cancer
http://www.clinicaltrials.gov/ct/show/NCT00093002?order=9 AstraZeneca The purpose of this study is to evaluate fulvestrant in the preliminary stage of breast cancer treatment and assess the relationship between dose, exposure, degree of reduction in tumor markers, and efficacy in postmenopausal women with estrogen receptor positive disease. Breast Cancer Drug:Fulvestrant (FASLODEX) Phase II Study Type:InterventionalStudy Design:Treatment,Efficacy Study Official Title:A Study to Compare the Effects on Proliferation and the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg with Fulvestrant (FASLODEX) 250 mg when given as a Neoadjuvant Treatment in Postmenopausal Women with Estrogen Receptor Positive Breast Cancer
http://www.clinicaltrials.gov/ct/show/NCT00090675?order=10 AstraZeneca In this Phase IIIb, randomized, double-blind, maintenance study, 300 subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) (Stage IIIB {T4-pleural effusion} and IV) who have SD or objective tumor response immediately following the completion of 4-6 cycles of front line, platinum-based, doublet chemotherapy will be randomized in a double-blind manner to receive either ZD1839 or placebo. Non-Small-Cell Lung Carcinoma Drug:ZD1839 Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control Official Title:A Phase IIIb Randomized, Double-Blind Study Comparing Maintenance ZD1839 (IRESSA) or Placebo Following Completion of Front Line, Platinum-Based, Double Chemotherapy in Subjects with Advanced or Metastatic Non-Small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00076388?order=11 AstraZeneca The purpose of this study is to compare the overall survival between ZD1839 (Iressa) and docetaxel. Patients must be 18 years or over with locally advanced or metastatic recurrent non-small cell lung cancer that have previously received platinum-based chemotherapy. Platinum-based chemotherapy regimens will most commonly consist of either cisplatin or carboplatin in combination with one of the following chemotherapeutic agents: paclitaxel, gemcitabine, vinorelbine, or docetaxel. Patients will either be given ZD1839 250mg/day orally or docetaxel 75 mg intravenously over 1 hour every 3 weeks. Non-Small-Cell Lung Carcinoma Drug:IressaDrug:Docetaxel Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Parallel Assignment Official Title:A Randomized, Open-Label, Parallel Group, International, Multicenter, Phase III Study of Oral ZD1839 (IRESSA) Versus Intravenous Docetaxel (TAXOTERE) in Patients With Locally Advanced or Metastatic Recurrent Non-Small Cell Lung Cancer who have Previously Received Platinum-Based Chemotherapy
http://www.clinicaltrials.gov/ct/show/NCT00094328?order=12 AstraZeneca The primary objective of this study is to investigate whether bicalutamide given in combination with anastrozole once daily for 12 months is effective in treating testotoxicosis in boys. Testotoxicosis is a condition that causes early puberty in boys including growth in height, and development of muscles and sexual organs. Puberty, Precocious Drug:BicalutamideDrug:Anastrozole Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:An Open-label, Non-comparative, Multi-centre Study to Assess the Efficacy and Safety of Bicalutamide When Used in Combination with Anastrozole for the Treatment of Gonadotropin-independent Precocious Puberty in Boys with Testotoxicosis
http://www.clinicaltrials.gov/ct/show/NCT00085891?order=13 AstraZeneca The purpose of this study is to demonstrate superior efficacy of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of patients with schizophrenia. Schizophrenia Drug:quetiapine fumarate tablets Phase III Study Type:InterventionalStudy Design:Treatment,Safety/Efficacy Study Official Title:Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) and Placebo in the Treatment of Acutely Ill Patients with Schizophrenia
http://www.clinicaltrials.gov/ct/show/NCT00090324?order=14 AstraZeneca The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of adolescent patients with schizophrenia. Schizophrenia Drug:Quetiapine fumarate Phase III Study Type:InterventionalStudy Design:Treatment,Placebo Control,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00090311?order=15 AstraZeneca The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of children and adolescent patients with Bipolar I mania. Bipolar Disorder Drug:Quetiapine fumarate Phase III Study Type:InterventionalStudy Design:Treatment,Placebo Control,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00082277?order=16 AstraZeneca The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer and who are high or moderate risk of fragility fracture. It is also conducted to determine the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at low risk of fragility fracture. Breast Cancer Drug:risedronate sodium (ACTONEL TM) 35 mg per week, oral Phase III Study Type:InterventionalStudy Design:Treatment Official Title:A Multicenter Phase III/IV Study of the Effects of Risedronate Sodium on Bone in Postmenopausal Women with Hormone-Receptor-Positive Early Breast Cancer, Treated with Anastrozole and Stratified by Fragility Risk
http://www.clinicaltrials.gov/ct/show/NCT00061022?order=17 AstraZeneca This study will determine if NXY-059 will improve recovery from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strengthen and coordination. Cerebral StrokeStroke, AcuteCerebrovascular StrokeIschemic Attack, Transient Drug:NXY-059 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Factorial Assignment,Safety/Efficacy Study Official Title:SAINT (Stroke - Acute Ischemic - NXY Treatment) A Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter, Phase IIb/III Study to Assess the Efficacy and Safety of Intravenous NXY-059 in Acute Ischemic Stroke
http://www.clinicaltrials.gov/ct/show/NCT00075959?order=18 AstraZeneca This study will determine if NXY-059 is safe in patients with an acute stroke caused by bleeding in the central nervous system. Intracerebral Hemorrhage Drug:NXY-059 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Factorial Assignment,Safety Study Official Title:CHANT (Cerebral Hemorrhage And NXY Treatment) A Double-Blind, Randomized, Placebo-Controlled, Parallel group, Multicenter, Phase IIb Study to Assess the Safety and Tolerability of Intravenous Infusion of NXY-059 in Adult Patients with Acute Intracerebral Hemorrhage (ICH)
http://www.clinicaltrials.gov/ct/show/NCT00081380?order=19 AstraZeneca The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase. Bipolar Disorder Drug:Seroquel, quetiapine fumarate (atypical antipsychotic)Drug:lithium (mood stabilizer)Drug:divalproex (mood stabilizer) Phase III Study Type:InterventionalStudy Design:Prevention Official Title:and Safety of Seroquel plus mood stabilizer compared to placebo plus mood stabilizer in the maintenance of Bipolar I disorder
http://www.clinicaltrials.gov/ct/show/NCT00072878?order=20 AstraZeneca This study is being carried out to determine if ZD1839 (gefitinib) improves the quality of life for patients with squamous cell carcinoma of the head and neck, and if so, how it compares with the standard therapy given to patients with these cancers (a drug called Methotrexate). Carcinoma, Squamous CellNeoplasms, Squamous CellHead and Neck Neoplasms Drug:Gefitinib Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Parallel Assignment Official Title:A Phase III Randomised, Stratified, Parallel Group, Multi-Centre, Comparative Study Of Zd1839 (Iressa) 250 Mg And 500 Mg Versus Methotrexate For Previously Treated Patients With Squamous Cellcarcinoma Of The Head And Neck
http://www.clinicaltrials.gov/ct/show/NCT00052169?order=21 National Surgical Adjuvant Breast and Bowel Project (NSABP) The purpose of this study is to learn how breast cancer tumors respond to treatment combining the drugs docetaxel and ZD1839. Breast Neoplasms Drug:ZD1839 in combination with docetaxel Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase 2, multi-center trial of ZD1839 (IRESSA) in combination with docetaxel as first-line treatment in patients with advanced breast cancer
http://www.clinicaltrials.gov/ct/show/NCT00077025?order=22 AstraZeneca This study is being carried out to see if treatment with ZD1839 (Gefitinib) combined with Arimidex (Anastrozole) has improved efficacy over Arimidex alone in preventing progression of metastatic breast cancer. Breast Cancer Drug:GefitinibDrug:Anastrozole Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Efficacy Study Official Title:Phase II Multicenter, Double-Blind, Randomized Trial Comparing Anastrozole (ZD1033, ArimidexTM)-Placebo to the Combination Anastrozole-ZD1839 (gefitinib, IRESSATM) in Postmenopausal Patients with Estrogen Receptor (ER) and/or Progesterone Receptor (PgR) Metastatic Breast Cancer
http://www.clinicaltrials.gov/ct/show/NCT00090363?order=23 AstraZeneca Randomized, double-blind, parallel-group, placebo-controlled, multi-centre study to assess ZD4054 in pain-free or mildly symptomatic patient with prostate cancer and bone metastases who have rising serum prostate specific antigen (PSA) Prostate Cancer Drug:ZD4054 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment Official Title:Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-centre Study to Assess ZD4054 in Pain-free or Mildly symptomatic Patients with Prostate Cancer and Bone Metastases who have Rising Serum Prostate Specific Antigen (PSA)
http://www.clinicaltrials.gov/ct/show/NCT00071188?order=24 AstraZeneca The purpose of the run-in phase of this study is to determine the appropriate and tolerable dose of ZD6474 (200mg or 300mg) to be administered in combination with paclitaxel and carboplatin in subjects with previously untreated locally advanced or metastatic NSCLC. The purpose of the randomization phase of this study is to determine the efficacy of ZD6474 alone versus that of ZD6474 in combination with paclitaxel and carboplatin versus that of paclitaxel and carboplatin alone in subjects with previously untreated locally advanced or metastatic NSCLC. Carcinoma, Non-Small-Cell Lung Drug:ZD6474Drug:PaclitaxelDrug:Carboplatin Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Safety/Efficacy Study Official Title:A Randomized, Partially Blinded, Phase II Study to Assess the Safety, Tolerability and Efficacy of ZD6474 Alone or in Combination with Paclitaxel and Carboplatin in Subjects with Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
http://www.clinicaltrials.gov/ct/show/NCT00066898?order=1 AtheroGenics To assess the safety and efficacy of AGI-1067, as compared to placebo, in the treatment of vascular inflammation and atherosclerosis by assessing the reduction in cardiovascular events. AtherosclerosisCoronary Artery DiseaseMyocardial InfarctionUnstable Angina Drug:AGI-1067 Phase III Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:Reduction of Vascular Inflammation and Coronary Atherosclerosis with AGI-1067, a V-Protectant, Reduces Cardiovascular Events in Patients With Coronary Artery Disease
http://www.clinicaltrials.gov/ct/show/NCT00056524?order=1 Avanir Pharmaceuticals The purpose of this study is to evaluate the safety of AVP-923 for the treatment of emotional lability. Amyotrophic Lateral SclerosisMultiple SclerosisAlzheimer's DiseaseStrokeTraumatic Brain Injury Drug:AVP-923 Phase III Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study Official Title:An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients with Pseudobulbar Affect.
http://www.clinicaltrials.gov/ct/show/NCT00082121?order=1 Avant Immunotherapeutics During cardiac surgery, a substance called complement is released by the body. This complement causes inflammation, which can lead to side effects such as chest pain, heart attacks, or heart failure. The purpose of this study is to determine if the study drug (TP10), which blocks complement release, can reduce such side events and be taken safely in women. Myocardial IschemiaCoronary ArteriosclerosisAortic Valve InsufficiencyMitral Valve Insufficiency Drug:TP10 Phase II Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00081796?order=1 Aventis Pharmaceuticals The purpose of this clinical trial is to determine if the investigational drug is a better treatment than capecitabine (Xeloda) for advanced breast cancer in patients that no longer benefit from docetaxel and/or paclitaxel. Breast CancerMetastases Drug:RPR109881 IV Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized, Open-label, Phase III Study of an Investigational Drug IV Every 3 Weeks versus Capecitabine (Xeloda) Tablets Twice Daily for 2 Weeks in 3-Week Cycles in Patients with Metastatic Breast Cancer Progressing after Taxanes and Anthracycline
http://www.clinicaltrials.gov/ct/show/NCT00046501?order=2 Aventis Pharmaceuticals The purpose of the study is to compare the effect in blood sugar control between Lantus and twice daily intermediate acting insulins (NPH or Lente) when used as the basal insulin in a multiple daily injection setting with fast acting insulin (Lispro) Diabetes Mellitus Drug:Lantus (insulin glargine [rDNA origin] injection)Drug:Humulin NDrug:Humulin LDrug:Lispro Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Morning LANTUS v. intermediate-acting insulin 2x/day as basal insulin in a multiple daily inj. w/ Humalog in adolescents w/ Type 1 diabetes mellitus: an active-controlled, open, randomized, gender-stratified, two-arm, parallel-group study
http://www.clinicaltrials.gov/ct/show/NCT00046462?order=3 Aventis Pharmaceuticals The purposes of the study is to determine whether blood sugar control is different between Lantus and a third oral anti-diabetic agent when added to patients who fail a thiazolidinedione and sulfonylurea or metformin combination. Diabetes Mellitus Drug:Lantus (insulin glargine [rDNA origin] injection)Drug:MetforminDrug:GlyburideDrug:Thiazolidinedione Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Substituting Lantus(insulin glargine[rDNAorigin]inj) for a thiazolidinedione vs. a 3rd oral agent as add-on therapy in patients failing a thiazolidinedione & sulfonylurea or Metformin Combination
http://www.clinicaltrials.gov/ct/show/NCT00077792?order=4 Aventis Pharmaceuticals The primary objective of the study is to determine whether enoxaparin compared to unfractionated heparin will reduce the composite endpoint of all-cause mortality and non-fatal myocardial re-infarction within 30 days after randomization in patients with acute ST-segment elevation myocardial infarction who are eligible to receive fibrinolytic therapy Myocardial InfarctionAcute ST-segment elevation Drug:Enoxaparin sodium Phase III Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A randomized, double-blind, double-dummy , parallel group, multinational, clinical study to evaluate the efficacy and safety of enoxaparin versus unfractionated heparin in patients with acute ST-segment elevation myocardial infarction receiving fibrinolytic therapy
http://www.clinicaltrials.gov/ct/show/NCT00077818?order=5 Aventis Pharmaceuticals The purpose of this study is to determine the efficacy and safety of enoxaparin compared to unfractionated heparin (UFH) for patients diagnosed with Acute Coronary Syndrome (ACS) in the emergency department (ED). Efficacy is assessed by using a composite score consisting of 30-day all-cause mortality, non-fatal myocardial infarction (MI) and recurrent angina requiring revascularization. Acute coronary syndrome Drug:Enoxaparin sodium Phase IV Study Type:InterventionalStudy Design:Prevention,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A prospective, open-label, randomized, parallel-group investigation to evaluate the efficacy and safety of enoxaparin versus unfractionated heparin in subjects who present to the emergency department with acute coronary syndrome
http://www.clinicaltrials.gov/ct/show/NCT00077805?order=6 Aventis Pharmaceuticals The purpose of this study is to evaluate the efficacy and safety of enoxaparin versus unfractionated heparin (UFH) in the prevention of venous thromboembolism (VTE) in patients following acute ischemic stroke. Acute ischemic stroke Drug:Enoxaparin sodium Phase IV Study Type:InterventionalStudy Design:Prevention,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:An Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Efficacy and Safety of Enoxaparin Versus Unfractionated Heparin in the Prevention of Venous Thromboembolism in Patients Following Acute Ischemic Stroke
http://www.clinicaltrials.gov/ct/show/NCT00077753?order=7 Aventis Pharmaceuticals To demonstrate the efficacy and safety of enoxaparin in the extended venous thromboembolism (VTE) prophylaxis for 28 +/- 4 days, compared to placebo, both following 10 +/- 4 days of initial treatment with enoxaparin, in acutely ill medical patients with prolonged immobilization Venous Thromboembolism Drug:enoxaparin sodium Phase IV Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Double-Blind, Placebo-Controlled, Parallel, Multicenter Study on Extended VTE Prophylaxis in Acutely Ill Medical Patients with Prolonged Immobilization
http://www.clinicaltrials.gov/ct/show/NCT00093275?order=8 Aventis Pharmaceuticals The purpose of this study is to determine whether HP184 is effective in the treatment of chronic spinal cord injury (CSCI). Spinal Cord Injury Drug:HP184 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Efficacy and Safety of HP184 in Chronic Spinal Cord Injury Subjects
http://www.clinicaltrials.gov/ct/show/NCT00087958?order=9 Aventis Pharmaceuticals The purpose of this clinical trial is to determine if the investigational drug is able to reduce/shrink advanced breast cancer tumors in patients who no longer benefit from anthracyclines, taxanes and capecitabine. Breast Cancer Drug:XRP9881 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Phase II Multi-center, Open-label, Non-randomized Study of an Intravenous Investigational Drug Given Every 3 Weeks to Patients with Metastatic Breast Cancer Progressing after Therapy with Anthracyclines, Taxanes and Capecitabine
http://www.clinicaltrials.gov/ct/show/NCT00043784?order=10 Aventis Pharmaceuticals Patients experiencing a mild heart attack will receive one of two medications which thin the blood to discern which is superior. Unstable AnginaMyocardial InfarctionMyocardial Ischemia Drug:enoxaparin Phase IV Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Prospective, Randomized, Open-label, Multicenter Study in Patients Presenting with Acute Coronary Syndromes (ACS)
http://www.clinicaltrials.gov/ct/show/NCT00069784?order=11 Aventis Pharmaceuticals Diabetes Mellitus, Non-Insulin-Dependent Drug:Lantus injectionDrug:Omacor (ethyl esters of omega-3 polyunsaturated fatty acids) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Factorial Assignment,Efficacy Study Official Title:A Multicenter, International Randomized, 2x2 Factorial Design Study to Evaluate the Effects of Lantus (Insulin Glargine) versus Standard Care, and of Omega-3 Fatty Acids versus Placebo, in reducing Cardiovascular Morbidity and Mortality in High Risk People with Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Early Type 2 Diabetes Mellitus: The ORIGIN Trial (Outcome Reduction with Initial Glargine Intervention)
http://www.clinicaltrials.gov/ct/show/NCT00077844?order=12 Aventis Pharmaceuticals The purpose of this study is to evaluate the efficacy and safety of intravenous enoxaparin versus intravenous unfractionated heparin (UFH) in patients undergoing non-emergent PCI, as assessed by measuring the incidence of non-coronary artery bypass graft (CABG) major and minor bleeding. Percutaneous Coronary Intervention Drug:Enoxaparin sodium Phase II Study Type:InterventionalStudy Design:Prevention,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:An international phase 2-3, stratified, randomized, open-label, parallel-group clinical trial to evaluate the safety and efficacy of a single intravenous bolus of enoxaparin versus intravenous unfractionated heparin in patients undergoing non-emergent Percutaneous Coronary Intervention
http://www.clinicaltrials.gov/ct/show/NCT00066885?order=13 Novacea This Phase 1/2 clinical trial is a multi-center, open-label study with two main objectives. The first is to determine the maximum-tolerated dose of DN-101 when administered in combination with Taxotere (docetaxel) every three weeks. The second is to evaluate the safety and objective tumor response rate of the combination in NSCLC. DN-101 doses will be escalated at three dosing levels. Patients will receive oral DN-101 on day one, followed by intravenous docetaxel on day two of a 21-day cycle. Treatment cycles will be repeated at the same dose level each 21 days until disease progression or unacceptable toxicity. Carcinoma, Non-Small-Cell Lung Drug:calcitriol + docetaxel Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase 1/2 Multicenter, Open Label, Dose Ranging Study of DN-101 and Taxotere in Patients with Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) who Have Failed Previous Therapy with Platinum-Based Chemotherapy
http://www.clinicaltrials.gov/ct/show/NCT00091845?order=1 AVI BioPharma West Nile Fever Drug:AVI-4020 Injection Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety/Efficacy Study Official Title:An Exploratory Study of the Safety, Tolerability, Pharmacokinetics and Potential Effectiveness of AVI-4020 Injection in Patients Presenting with Presumptive Acute Neuroinvasive West Nile Virus (WNV) Disease
http://www.clinicaltrials.gov/ct/show/NCT00069186?order=1 The Avicena Group The purpose of this study is to determine whether nine months of administation of creatine monohydrate results in an increase in muscle strength in patients with amyotrophic lateral sclerosis (ALS). Amyotrophic Lateral Sclerosis (ALS) Drug:Creatine Monohydrate Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Expanded Access Assignment,Safety/Efficacy Study Official Title:A Phase III, Multi-Center, Double-Blind, Placebo Controlled, Randomized Study of Creatine Monohydrate in Patients with Amyotrophic Lateral Sclerosis
http://www.clinicaltrials.gov/ct/show/NCT00076557?order=1 Avigen In this study a modified virus called adeno-associated virus (AAV) will be used to transfer a normal gene for human clotting factor IX into patients with severe hemophilia B (AAV human Factor IX vector). Gene therapy is a very new medical technique being used in a number of clinical studies for diseases such as cancer and cystic fibrosis. At this time, the U.S. Food and Drug Administration has approved no gene transfer products for commercial use. To date, 8 subjects have received AAV vector in the muscle for a hemophilia B trial by intramuscular injection, and, to date, 6 subjects have been treated with AAV vector in the current hemophilia B liver trial. Eleven cystic fibrosis subjects have received AAV vector into their nasal sinuses or lungs to date. In this study, AAV human Factor IX vector will be injected into the liver using a catheter inserted into a large blood vessel (called the proper hepatic artery or the right hepatic artery). Hemophilia B Gene Transfer:Adeno-Associated Viral with Human Factor IX Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase I Safety Study in Subjects with Severe Hemophilia B (Factor IX Deficiency) Using Adeno-Associated Viral Vector to Deliver the Gene for Human Factor IX into the Liver
http://www.clinicaltrials.gov/ct/show/NCT00082186?order=1 Actelion The objective of the study is to evaluate the effects of chronic TRACLEER treatment on testicular function via semen analysis in male patients with primary pulmonary arterial hypertension (PPH). Hypertension, Pulmonary Drug:Tracleer (bosentan) Phase IV Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Factorial Assignment,Safety Study Official Title:TRACLEER (bosentan) Pulmonary Arterial Hypertension A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER treatment on testicular function in male patients with pulmonary arterial hypertension
http://www.clinicaltrials.gov/ct/show/NCT00091715?order=2 Actelion The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) Class III and IV, to patients suffering from PAH Class II. Pulmonary Hypertension Drug:bosentan Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients with Mildly Symptomatic Pulmonary Arterial Hypertension (PAH)
http://www.clinicaltrials.gov/ct/show/NCT00044915?order=1 Bayer Corporation The purpose of this trial is to evaluate Repinotan HCl in patients with acute ischemic stroke. At study entry patients will be randomized to Repinotan HCl or placebo in a 1:1 ratio. The total treatment period wil be 72 hours. Acute ischemic stroke Drug:Repinotan HCl Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment Official Title:A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Effects of a Targeted Exposure of Intravenous Repinotan in Patients with Acute Ischemic Stroke
http://www.clinicaltrials.gov/ct/show/NCT00059462?order=2 Bayer Corporation The purpose of this study is to evaluate the safety of the experimental drug Bay 50-4798 in HIV positive patients receiving HAART and to test the drugs effect on the CD4+ T-cell count. HIV Infections Drug:Interleukin-2 SA Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control
http://www.clinicaltrials.gov/ct/show/NCT00073307?order=3 Bayer Corporation The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY 43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease. Carcinoma, Renal Cell Drug:BAY 43-9006, A Raf Kinase and VEGFR Inhibitor Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase III Randomized Study of BAY 43-9006 in Patients with Unresectable and/or Metastatic Renal Cell Cancer
http://www.clinicaltrials.gov/ct/show/NCT00071396?order=1 M.D. Anderson Cancer Center The goal of this clinical research study is to learn if giving CAMPATH-1H with rituximab can shrink or slow the growth of the disease in patients with chronic lymphoid disorders that have either not responded or whose disease has returned after treatment with standard therapies. Chronic Lymphocytic Leukemia Drug:Campath-1HDrug:Rituximab Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Safety/Efficacy Study Official Title:Continuous Infusion Followed by Subcutaneous Injection of Campath-1H Plus Rituximab in the Treatment of CD52- and CD20-Positive Refractory or Relapsed Chronic Lymphoid Disorders
http://www.clinicaltrials.gov/ct/show/NCT00086775?order=2 Berlex Laboratories refractory chronic lymphocytic leukemiaB-cell Chronic Lymphocytic Leukemia Drug:alemtuzumabDrug:fludarabineDrug:rituximabProcedure:antibody therapyProcedure:biological response modifier therapyProcedure:chemosensitization/potentiationProcedure:chemotherapyProcedure:monoclonal antibody therapy Phase II Study Type:InterventionalStudy Design:Treatment Official Title:Phase II Randomized Study of Fludarabine and Alemtuzumab Versus Fludarabine and Rituximab in Patients With Refractory or Relapsed B-Cell Chronic Lymphocytic Leukemia
http://www.clinicaltrials.gov/ct/show/NCT00059007?order=3 Berlex Laboratories The purpose of the STEPS clinical research study is to evaluate the effect and safety of Spheramine implantation in patients with Parkinsons disease. Spheramine is a cell therapy that consists of human retinal pigment epithelial (RPE) cells attached to microscopic gelatin beads (microcarriers). The RPE cells produce L-DOPA and are believed to directly enhance brain levels of dopamine. This clinical study will enroll 68 participants with advanced Parkinsons disease. Half of the participants will be randomly (by chance) assigned to receive Spheramine, and half will receive placebo (sham or mock surgical treatment). If Spheramine is proven to be both beneficial and safe in this study, those participants who had the placebo treatment will be offered Spheramine at the end of the trial. Parkinson Disease Procedure:Spheramine Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:Study of the safety, tolerability and efficacy of Spheramine implanted bilaterally into the postcommissural putamen of patients with advanced Parkinsons disease
http://www.clinicaltrials.gov/ct/show/NCT00098332?order=1 BioCryst Pharmaceuticals Cutaneous T-Cell Lymphomamycosis fungoides and Sezary syndrome Drug:forodesineProcedure:enzyme inhibitor therapy Phase I Study Type:InterventionalStudy Design:Treatment Official Title:Phase I Study of Forodesine (BCX-1777) in Patients With Refractory Stage IIA-IVB Cutaneous T-Cell Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00095381?order=2 BioCryst Pharmaceuticals Leukemia, T-Cell Drug:forodesine hydrochloride (BCX-1777) Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Efficacy Study Official Title:A Phase II, Multi-Center Open-Label, Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients with Advanced T-Cell Leukemia with an Option of Long-Term Forodesine Hydrochloride (BCX-1777) Use
http://www.clinicaltrials.gov/ct/show/NCT00035022?order=3 BioCryst Pharmaceuticals The purpose of this study is to determine if intravenous BCX-1777 can be given safely to improve relapsed or refractory aggressive T-cell leukemias and lymphomas. Leukemia, LymphocyticLymphoma Drug:BCX-1777 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Phase I-II Study of Intravenous BCX-1777 in Relapsed or Refractory Aggressive (High Grade) T-Cell Malignancies
http://www.clinicaltrials.gov/ct/show/NCT00057512?order=1 BioCure Medical The purpose of this study will be to determine the safety and tolerability of intratumoral M4N. Patients suffering from cancer of the head and neck that is recurrent after primary treatment with surgery, radiation therapy, and/or chemotherapy may be eligible. The design is a Phase 1 dose escalation study of M4N administered intratumorally once weekly, initially for three weeks. Dose will be escalated on the starting schedule to a target of 20 mg/cm3 tumor volume and then, new patient cohorts will have their schedule extended to weekly M4N for 4 weeks. Dose escalation will continue, assuming tolerability, so that cohorts will be treated for 6 weeks, and finally, 8 weeks. Head and Neck Neoplasms Drug:Tetra-O-Methyl Nordihydroguaiaretic Acid (M4N) Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00078611?order=1 Elan Pharmaceuticals The purpose of this trial is to evaluate natalizumab in individuals with moderately to severely active Crohns Disease. Crohn's Disease Drug:Antegren(TM) (natalizumab) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Intravenous Antegren(TM) (natalizumab) in Subjects with Moderately to Severely Active Crohns Disease With Elevated C-Reactive Protein
http://www.clinicaltrials.gov/ct/show/NCT00090038?order=2 Biogen Idec The purpose of this study is to provide treatment for patients who have relapsed Non-Hodgkin's lymphoma (NHL) or refractory NHL, and to test the immunity of study subjects after receiving four treatments with rituximab. Non-Hodgkin's Lymphoma Drug:Rituxan Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Bio-equivalence Study Official Title:A Multicenter Study to Evaluate the Effect of Rituximab (IDEC-102) on Primary Humoral Response, Recall Response, and Maintenance of Acquired Immunity to Specific Antigens
http://www.clinicaltrials.gov/ct/show/NCT00083759?order=3 Elan Pharmaceuticals The purpose of this study is to determine the safety, tolerability and efficacy of natalizumab in subjects diagnosed with moderate to severe rheumatoid arthritis (RA) receiving concomitant treatment with methotrexate (MTX). It is thought that natalizumab may stop the movement of certain white blood cells, known as lymphocytes, into joint tissue. These cells are thought to cause damage in the joints leading to the symptoms of RA. Rheumatoid Arthritis Drug:Natalizumab Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase II, Multicenter, Double-blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Intravenous Antegren (natalizumab 300 mg) in Subjects with Moderate to Severe Rheumatoid Arthritis (RA) Receiving Concomitant Treatment with Methotrexate (MTX)
http://www.clinicaltrials.gov/ct/show/NCT00090051?order=4 Biogen Idec The purpose of this study is to provide treatment for patients who have CLL, and to compare the use of rituximab added to FC with FC alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms. Chronic Lymphocytic Leukemia Drug:Rituxan Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Open-label, multicenter, randomized, comparative, phase III study to evaluate the efficacy and safety of rituximab/fludarabine/cyclophosphamide (FCR) vs. fludarabine/cyclophosphamide (FC) alone in previously treated patients with CD20 positive B-cell CLL
http://www.clinicaltrials.gov/ct/show/NCT00046488?order=5 Biogen Idec To determine what side effects and what clinical effects if any the administration of this investigational product, IDEC-152 (an antibody against CD23 which is an important protein on leukemia cells and certain cells in the body's immune system), has on the CLL patient population. Leukemia, Lymphocytic, Chronic Drug:IDEC-152 Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase I Multicenter, Dose-Escalation Study of IDEC-152 (Anti-CD23 Monoclonal Antibody) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
http://www.clinicaltrials.gov/ct/show/NCT00057343?order=6 Biogen Idec The purpose of this study is to provide treatment for patients who have relapsed NHL or refractory NHL, and to determine the effectiveness and safety of the Zevalin and Rituxan regimens or Rituxan therapy alone on your disease. Non-Hodgkin's Lymphoma Drug:Zevalin (ibritumomab tiuxetan)Drug:Rituxan (rituximab) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Prospectively Randomized, Phase III, Multicenter, Controlled Trial to Evaluate the Safety and Efficacy of the Zevalin Therapeutic Regimen Plus Rituxan Compared With Rituxan Alone in Patients With Relapsed or Refractory Follicular Non-Hodgkins Lymphoma
http://www.clinicaltrials.gov/ct/show/NCT00050765?order=1 Bioheart, Inc. MyoCell implantation by epicardial injection during CABG surgery has the potential to add a new dimension to the management of post-infarct deterioration of cardiac function. Based on existing non-clinical studies and clinical reports, implantation of autologous skeletal myoblasts appears to lead to the replacement of non-functioning myocardial scar with functioning muscle and appears to improve myocardial performance relative to case without myoblast implantation. In a few investigational patients, myoblast implantation can be, and has been, done in conjunction with CABG and appears to have the potential to provide for additive treatment during surgery. The present study is being conducted to evaluate more fully the safety of MyoCell implantation via epicardial injection during CABG surgery and its effect on regional myocardial function. Congestive Heart FailureCoronary Artery DiseaseMyocardial Infarction Drug:MyoCell Autologous Myoblasts Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Factorial Assignment,Safety Study Official Title:A Phase I Multi-Center Study to Assess the Safety and Cardiovascular Effects of MyoCell Implantation in Patients with a Previous MI and Placement of an ICD Requiring De Novo Coronary Artery Bypass Graft Therapy
http://www.clinicaltrials.gov/ct/show/NCT00054678?order=2 Bioheart, Inc. The MyoCell implantation using the MyoCath delivery catheter system may have the potential to add a new dimension to the management of post-infarct deterioration of cardiac function in subjects with congestive heart failure. Based on pre-clinical studies, implantation of autologous skeletal myoblasts may lead to replacement of non-functioning myocardial scar with functioning muscle and improvement in myocardial performance. Preliminary data in human subjects suggest skeletal myoblast implantation at the time of CABG may lead to the same effects. In principal, myoblast implantation by catheter delivery may offer the same therapeutic benefit. The present clinical study is to be conducted primarily to evaluate the safety of MyoCell implantation using the MyoCath delivery system and secondarily to evaluate the effect on regional myocardial function post treatment. Congestive Heart FailureCoronary Artery DiseaseMyocardial Infarction Drug:MyoCellDevice:MyoCath Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Factorial Assignment,Safety Study Official Title:A Phase I, Open-Label, Non-Randomized, Dose Escalation, Multi Center Study to Assess the Safety and Cardiovascular Effects of Autologous Skeletal Myoblast (MyoCell) Implantation by a Transendocardial Catheter Delivery System (MyoCath) in Congestive Heart Failure Patients Post Myocardial Infarction(s) With Previous Placement of an Implantable Cardioverter Defibrillator (ICD)
http://www.clinicaltrials.gov/ct/show/NCT00067470?order=1 BioMarin Pharmaceutical The purpose of the study is to evaluate the ability of rhASB versus placebo to enhance endurance in patients with Mucopolysaccharidosis VI (MPS VI), as evidenced by an increase in the number of meters walked in the 12 minute walk test at Week 24 compared with baseline. Mucopolysaccharidosis VI Drug:N-acetylgalactosamine 4-sulfatase Phase III Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00080015?order=1 Biomeasure Inc, Ipsen Group This is a Phase II, open-label, multicenter, single-arm, exploratory proof of concept study. Diflomotecan (7 mg fixed dose) will be administered as a 20-minute IV infusion once every 3 weeks in patients with sensitive small cell lung cancer (SCLC) with progressive disease after first-line treatment with a platinum-based regimen. Small Cell Lung Cancer Drug:Diflomotecan (BN80915) Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00056537?order=1 Active Biotech Research The drug ABR-217620 is a combination of two proteins, one that recognizes tumor cells and one that triggers an attack on the tumor cells by activating some white blood cells belonging to the body's normal immune system. In animals, this results in an accumulation of white blood cells in the cancer that can fight the cancer. This study will test how much of the drug can be given to patients with non-small cell lung cancer without causing unacceptable side effects. Carcinoma, Non-Small-Cell Lung Drug:ABR-217620 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study Official Title:An open-label, phase I, repeat dose-escalation study of ABR-217620 in patients with advanced non-small cell lung cancer.
http://www.clinicaltrials.gov/ct/show/NCT00044291?order=1 BioMedicines The purpose of this study is to determine whether the first line combination hormonal therapy of an experimental drug, atamestane, plus an FDA-approved drug, toremifene (Fareston), is more effective than another approved drug, letrozole (Femara), in delaying the growth of breast cancer in postmenopausal patients with locally advanced or metastatic breast cancer, and whether the side effects of the combination are different from the side effects of letrozole. Breast NeoplasmsNeoplasms, Hormone-Dependent Drug:atamestaneDrug:toremifeneDrug:letrozoleDrug:aromatase inhibitionProcedure:hormone therapyProcedure:endocrine therapyProcedure:antiestrogen therapy Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00039780?order=1 BioNumerik Pharmaceuticals, Inc. The purpose of this study is to determine whether BNP7787 is effective in preventing or reducing neurotoxicity (nerve damage) caused by paclitaxel (Taxol). Breast NeoplasmsBreast DiseasesMetastases, Neoplasm Drug:BNP7787Drug:weekly paclitaxel Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:BNP7787 vs. Placebo for Prevention of Paclitaxel Neurotoxicity: A Double-Blind Multicenter Randomized Phase 3 Trial in Patients with Metastatic Breast Cancer
http://www.clinicaltrials.gov/ct/show/NCT00062478?order=2 BioNumerik Pharmaceuticals, Inc. The purpose of this study is to determine if Karenitecin (BNP1350) is effective in the treatment of Brain Tumors Brain NeoplasmsMalignant Neoplasms, BrainBrain Tumors Drug:Karenitecin (BNP1350) Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:PHASE 2 TREATMENT OF ADULTS WITH PRIMARY MALIGNANT GLIOMA WITH KARENITECIN
http://www.clinicaltrials.gov/ct/show/NCT00097903?order=3 BioNumerik Pharmaceuticals, Inc. The purpose of this study is to determine the maximum safe dose of orally administered Karenitecin (BNP1350). A second purpose is to determine the effectiveness of using this dose in patients with lung cancer. CarcinomaCarcinoma, Non-Small-Cell Lung Drug:Karenitecin (BNP1350) Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Phase 1/2 Trial of Oral Karenitecin in Patients with Solid Tumors and Patients with Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)
http://www.clinicaltrials.gov/ct/show/NCT00091676?order=1 Biovest International The primary objective of this Phase 3 study is to definitively confirm the safety and efficacy of BiovaxId, an autologous tumor derived immunoglobulin idiotype vaccine, as measured by a significant prolongation of the period of disease free survival when administered to patients with indolent follicular Non-Hodgkin's Lymphoma (NHL) during their first complete remission. Non-Hodgkins Lymphoma Vaccine:tumor specific immune response Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:Randomized Trial of Patient Specific Vaccination in First Complete Remission with Conjugated Follicular Lymphoma-Derived Idiotype with Local GM-CSF
http://www.clinicaltrials.gov/ct/show/NCT00096616?order=1 Boehringer Ingelheim Pharmaceuticals The purpose of this study is to demonstrate the superior bronchodilator efficacy of inhaled Combivent CFC MDI vs. Albuterol HFA MDI in moderate to severe asthma patients. Asthma Drug:Combivent CFC MDIDrug:Albuterol HFA MDI Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Crossover Assignment,Efficacy Study Official Title:A Single Dose, Randomized, Double-blind, Crossover Comparison of Combivent MDI and Albuterol HFA MDI in Patients with Moderate to Severe Persistent Asthma and Persistent Symptoms Despite Treatment with Inhaled Corticosteroids
http://www.clinicaltrials.gov/ct/show/NCT00055406?order=2 Boehringer Ingelheim Pharmaceuticals The purpose of this study is to determine the efficacy and appropriate dose of NS 2330 to treat Dementia of the Alzheimer's Type (DAT) and improve cognition. Alzheimer Disease Drug:NS 2330 Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Efficacy Study Official Title:Phase II Double Blind, Random, Dose-Ranging, Placebo Controlled, Multicenter, Evaluation Of Three Doses of NS 2330 in Patients with Mild to Moderate Dementia of the Alzheimers Type
http://www.clinicaltrials.gov/ct/show/NCT00097799?order=3 Boehringer Ingelheim Pharmaceuticals This open label and non-randomized treatment protocol will provide access to the investigational drug tipranavir for HIV-infected adult patients with no other treatment options who require tipranavir to construct a viable antiretroviral (ARV) regimen for therapy. Participation is open to all U.S. physicians who care for HIV-infected patients. All patients will provide written consent prior to participation. Eligible patients will receive 500 mg tipranavir co-administered with 200 mg ritonavir, twice daily (b.i.d.), orally, beginning on Day 0. Tipranavir, provided by the Sponsor, will be dispensed at Day 0, Month 1, 2, and 3 and every 3 months thereafter. Ritonavir is not provided and must be prescribed by the treating physician. Safety evaluations will be performed at Months 1, 2, and 3 and every 3 months thereafter. Data collection includes demographics, concomitant ARV medication, non-serious adverse events (AEs) leading to discontinuation from study, all serious adverse events (SAEs), and select laboratory parameters. Severity of AEs will be graded using the 1992 version of the Division of AIDS (DAIDS) grading scale. Viral load and CD4+ cell count values, measured at intervals required by current standard of care, will be collected to monitor the therapeutic effect of the TPV/r-containing ARV regimen. Enrollment of new patients will close once marketing approval is received. Study participation for all enrolled patients will end once tipranavir becomes commercially available and the patients may be transferred to marketed drug without interruption in TPV/r administration. HIV Infection Drug:Tipranavir co-administered with low dose ritonavir Phase III Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label Official Title:An Open-label, Non-randomized Treatment Protocol of TPV/r in PI-experienced Patients with HIV-1 Infection (the tipranavir Expanded Access Program)
http://www.clinicaltrials.gov/ct/show/NCT00062660?order=4 Boehringer Ingelheim Pharmaceuticals The purpose of this study is to provide early access to tipranavir and evaluate the safety/tolerability of tipranavir in patients with progressive, systemic HIV-1 disease who have failed or are intolerant to currently approved HIV treatments and are ineligible or unable to participate in other tipranavir trials. HIV Infections Drug:Tipranavir/Ritonavir Phase III Study Type:InterventionalStudy Design:Treatment,Open Label,Safety Study Study start:May 2003
http://www.clinicaltrials.gov/ct/show/NCT00095147?order=1 Bristol-Myers Squibb The purpose of this clinical research study is to learn if Abatacept in combination with Methotrexate and Infliximab demonstrate a greater reduction in disease activity over placebo. Rheumatoid Arthritis Drug:Abatacept Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control Official Title:A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Comparative Study of Abatacept or Infliximab in Combination with Methotrexate in Controlling Disease Activity in Subjects with Rheumatoid Arthritis Having Inadequate Clinical Response to Methotrexate
http://www.clinicaltrials.gov/ct/show/NCT00095511?order=2 Bristol-Myers Squibb The purpose of this trial is to test the safety & efficacy of aripiprazole in patients with Bipolar Mania for a period of at least 12 weeks. Bipolar Disorder Drug:aripiprazole Phase III Study Type:InterventionalStudy Design:Treatment,Safety/Efficacy Study Official Title:A Phase III Study of Aripiprazole in Patients with Acute Mania
http://www.clinicaltrials.gov/ct/show/NCT00095810?order=3 Bristol-Myers Squibb The purpose of this clinical research study is to assess the safety and tolerability of aripiprazole in patients with psychosis associated with Parkinson's disease. Parkinson's DiseasePsychoses Drug:aripiprazole Phase II Study Type:InterventionalStudy Design:Treatment Official Title:An Open-Label Study of Aripiprazole to Evaluate the Safety and Tolerability in Patients with Psychosis Associated with Parkinson's Disease
http://www.clinicaltrials.gov/ct/show/NCT00095173?order=4 Bristol-Myers Squibb The primary purpose of the clinical research study is to assess the safety of treating children and juvenile subjects with BMS-188667 (Abatacept). In addition, the study will assess the effectiveness of BMS-188667 in reducing disease activity of Juvenile Rheumatoid Arthritis (JRA) or Juvenile Idiopathic Arthritis (JIA) as measured by the time to occurrence of disease flare. Juvenile Rheumatoid Arthritis Drug:Abatacept Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Safety/Efficacy Study Official Title:A Phase III, Multi-Center, Multi-National, Randomized, Withdrawal Study to Evaluate the Safety and Efficacy of BMS-188667 in Children and Adolescents with Active Polyarticular Juvenile Rheumatoid Arthritis (JRA)
http://www.clinicaltrials.gov/ct/show/NCT00097357?order=5 Bristol-Myers Squibb The purpose of this study is to learn if BMS-562247 can prevent blood clots in the legs and lungs in men and women following unilateral total knee replacement surgery. The safety of this treatment will also be studied. Venous ThrombosisPulmonary EmbolismPreventive therapy Drug:BMS-562247 Phase II Study Type:InterventionalStudy Design:Prevention Official Title:A Phase 2 Study of BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery
http://www.clinicaltrials.gov/ct/show/NCT00095537?order=6 Bristol-Myers Squibb The purpose of this trial is to identify the highest oral dose of BMS-599626, a drug that is directed against EGFR and HER2 proteins, that can be given safely on a daily schedule of 21 days with a 7 day rest period in patients with cancer who no longer benefit from other commonly used treatments. The study will also test for other proteins that may be affected by BMS-599626; and the level of study drug in the blood will be studied. CancerMetastases Drug:BMS-599626 Phase I Study Type:InterventionalStudy Design:Treatment Official Title:Phase I Study of BMS-599626 in Patients with Advanced Solid Malignancies
http://www.clinicaltrials.gov/ct/show/NCT00097214?order=7 ImClone Systems This is a phase II study in previously untreated subjects with histologically or cytologically proven stage IIIB/IV NSCLC designed to determine the efficacy of first line treatment with carboplatin and cetuximab. Non-small cell lung cancer Drug:CetuximabDrug:Carboplatin Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase II Trial of Carboplatin Plus Cetuximab for the Treatment of Stage IIIb/IV Non-Small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00096785?order=8 Bristol-Myers Squibb The purpose of this study is to evaluate antiviral activity and efficacy of entecavir compared to adefovir (a drug recently approved for the treatment of chronic Hepatitis b virus) in adults with chronic hepatitis B who have not been treated yet with an antiviral medicine. Hepatitis BChronic Disease Drug:entecavirDrug:adefovir Phase III Study Type:InterventionalStudy Design:Treatment Official Title:A Phase IIIb Comparative Trial of Entecavir versus Adefovir in the Treatment of Chronic Hepatitis B Infection
http://www.clinicaltrials.gov/ct/show/NCT00065507?order=9 Bristol-Myers Squibb This is a phase IIIb comparative study of entecavir 1.0 mg QD vs adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation. The patients are treated for up to 96 weeks. Hepatitis B Drug:Entecavir Phase III Study Type:InterventionalStudy Design:Treatment Study start:July 2003
http://www.clinicaltrials.gov/ct/show/NCT00096746?order=10 Bristol-Myers Squibb This study will compare the response of subjects who failed a first-line ATV-containing regimen and who have the 150L-containing virus to subsequent protease inhibitor (PI)-containing therapy with that of a cohort who has failed a first-line reverse transcriptase inhibitor (NNRTI), and is subsequently receiving PI-containing therapy. HIV Infection Drug:Protease inhibitor, NRTI, NtRTi Phase IV Study Type:ObservationalStudy Design:Natural History,Longitudinal,Defined Population,Prospective Study Official Title:A Phase IV Study of the Effect of the Atazanavir (ATV) 150L Mutation on Subsequent Treatment Response
http://www.clinicaltrials.gov/ct/show/NCT00095524?order=11 Bristol-Myers Squibb The primary purpose of this study is to compare the affects of aripiprazole and olanzapine on weight change. Body Weight ChangeSchizophreniaPsychotic Disorder Drug:Aripiprazole Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind Official Title:A Multicenter, Randomized, Double-Blind Study on the Effects of Aripiprazole in Overweight Patients Treated with Olanzapine for Schizophrenia or Schizoaffective Disorder
http://www.clinicaltrials.gov/ct/show/NCT00096811?order=12 Bristol-Myers Squibb The purpose of this clinical research study is to provide entecavir to subjects with chronic Hepatitis B infection who have failed or who have demonstrated intolerance of marketed therapies or for those in whom use of these agents is contraindicted and that have no other available treatment options. Hepatitis BChronic Disease Drug:Entecavir Phase III Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00082433?order=13 Bristol-Myers Squibb The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine alone in women with metastatic breast cancer. Patients should have previously received an anthracycline and a taxane. The safety of this treatment will also be studied. CancerBreast Cancer Drug:ixabepilone Phase III Study Type:InterventionalStudy Design:Treatment Official Title:A Phase III Study of novel epothilone (ixabepilone) plus capecitabine versus capecitabine alone in patients with advanced breast cancer previously treated with an anthracycline and a taxane
http://www.clinicaltrials.gov/ct/show/NCT00038402?order=14 M.D. Anderson Cancer Center The purpose of this study is to evaluate the addition of Herceptin to standard chemotherapy treatment of patients newly diagnosed with operable breast cancer. Other objectives: 1)to evaluate the potential of this therapy to reduce the size of the tumor and increase the possibility of breast conservative surgery, 2) evaluate the ability of this regimen to prevent recurrence of breast cancer and impact on survival, 3) determine side effect profile with the addition of Herceptin, 4) evaluate significance of HER2 expression by two different methods, and 5) determine correlation of cardiac blood tests with echocardiogram results in the detection of cardiac muscle damage. Breast Cancer Drug:HerceptinDrug:TaxolDrug:FluorouracilDrug:CytoxanDrug:Epirubicin Phase III Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00095719?order=15 Bristol-Myers Squibb The purpose of this trial is to test the safety & tolerability of intramuscular aripiprazole in acutely agitated patients diagnosed with Dementia. DementiaAlzheimer's Disease Drug:Aripiprazole Phase III Study Type:InterventionalStudy Design:Treatment Official Title:A Safety & Tolerability Study of Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed with Dementia
http://www.clinicaltrials.gov/ct/show/NCT00095238?order=16 Bristol-Myers Squibb The purpose of this clinical research study is to learn if Irbesartan is superior to placebo in reducing mortality and cardiovascular morbidity in subjects with heart failure with preserved systolic function. The safety of this treatment will also be studied. Congestive Heart Failure Drug:Irbesartan Phase III Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00095290?order=17 Bristol-Myers Squibb Albumin in the urine is usually a signal that you might be at risk of cardiovascular complications. The purpose of this study is to determine if the albumin in your urine can be decreased by the treatment regimen that consists of irbesartan taken at the same time with ramipril. Albuminuria Drug:IrbesartanDrug:ramipril Phase IV Study Type:InterventionalStudy Design:Prevention Official Title:Irbesartan vs. Placebo in Combination with Ramipril for Treatment of Albuminuria in Subjects at Elevated CV Risk
http://www.clinicaltrials.gov/ct/show/NCT00095394?order=18 Bristol-Myers Squibb The purpose of this clinical research is to learn if severe hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs. Hypertension Drug:Irbesartan/HCTZ Phase III Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00095550?order=19 Bristol-Myers Squibb The purpose of this clinical research is to learn if moderate hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs. Hypertension Drug:Irbesartan/HCTZ Phase III Study Type:InterventionalStudy Design:Treatment,Safety/Efficacy Study Official Title:The Efficacy and Safety of Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Patients with Moderate Hypertension
http://www.clinicaltrials.gov/ct/show/NCT00095745?order=20 Bristol-Myers Squibb This trial is a 52-week safety study to evaluate the safety of adjunctive aripiprazole in outpatients with major depressive disorder who have experienced an incomplete response to an ongoing antidepressant trial. Major Depressive Disorder Drug:aripiprazoleDrug:marketed antidepressant medication Phase III Study Type:InterventionalStudy Design:Treatment,Safety Study
http://www.clinicaltrials.gov/ct/show/NCT00094991?order=21 Bristol-Myers Squibb The purpose of this study is to learn more about how muraglitazar lowers blood sugar in people with type 2 diabetes. The safety of this treatment will also be studied. Diabetes Mellitus, Type 2 Drug:Muraglitazar Phase III Study Type:InterventionalStudy Design:Treatment Official Title:Mechanism of Action and Efficacy
http://www.clinicaltrials.gov/ct/show/NCT00041470?order=22 Gralow, Julie, M.D. Breast Cancer Drug:PaclitaxelDrug:VinorelbineDrug:TrastuzumabDrug:Filgrastim Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00080262?order=23 Bristol-Myers Squibb The purpose of this research study is to assess the response rate of the investigational drug BMS-247550 (Ixabepilone) in women with metastatic breast cancer who are refractory to an anthracycline, a taxane, and capecitabine. Breast CancerMetastases Drug:Ixabepilone (BMS-247550) Phase II Study Type:InterventionalStudy Design:Treatment Official Title:Phase II Study of Novel Epothilone (BMS-247550) in Patients with MBC who are Refractory to an Anthracycline, a Taxane, and Capecitabine
http://www.clinicaltrials.gov/ct/show/NCT00080301?order=24 Bristol-Myers Squibb The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine is better than capecitabine alone in shrinking or slowing the growth of the cancer in women with metastatic breast cancer who are resistant to taxane and received anthracycline chemotherapy. The safety of this treatment will also be studied. Breast CancerMetastases Drug:BMS-247550 Phase III Study Type:InterventionalStudy Design:Treatment Official Title:A Phase III Study of Novel Epothilone plus Capecitabine versus Capecitabine Alone in Patients with Advanced Breast Cancer Previously Treated with Anthracycline and who are Taxane Resistant
http://www.clinicaltrials.gov/ct/show/NCT00063401?order=25 Bristol-Myers Squibb To determine the progression-free survival obtained with cetuximab (C225)/paclitaxel/carboplatin in subjects with newly diagnosed advanced stage ovarian, primary peritoneal, or fallopian tube cancer Ovarian CancerPeritoneal NeoplasmsFallopian Tube Neoplasms Drug:Cetuximab Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase II Study of Cetuximab (C225)/Paclitaxel/Carboplatin for the Initial Treatment of Advanced Stage Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
http://www.clinicaltrials.gov/ct/show/NCT00037089?order=26 Edelman, Martin, M.D. This study is for patients with esophageal cancer that has spread to other areas. The purpose of this study is to: 1. Determine how well a combination of taxol, UFT, and leucovorin work in these patients, 2. Determine the survival of patients with metastatic esophageal carcinoma treated with this combination of drugs. 3. Identify the side effects of this drug combination. Esophageal Neoplasm Drug:UFT (Tegafur/Uracil) Phase II Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00061815?order=27 ImClone Systems The purpose of this study is to compare overall survival in patients with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with Oxaliplatin, 5-Fluorouracil and Leucovorin (FOLFOX4) and cetuximab with FOLFOX4 alone. Colorectal Cancer Drug:cetuximab Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00063141?order=28 ImClone Systems The purpose of this study is to determine whether overall survival is prolonged in subjects with metastatic, EGFR-positive colorectal cancer treated with cetuximab in combination with irinotecan compared with irinotecan alone as second-line therapy following treatment with a fluoropyrimidine and oxaliplatin based, non-irinotecan-containing regimen. Colorectal Cancer Drug:cetuximab Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00007202?order=29 The purpose of this study is to determine the safety and effectiveness of stavudine (d4T), didanosine (ddI), and BMS-232632 when given early in the course of HIV infection. Acute HIV infection may develop in patients that are exposed to the HIV virus. Following infection, the viral load (level of HIV in the blood) rises rapidly over the next few days to weeks. It is not known which is the best treatment in patients with very early HIV infection. Researchers believe these patients may respond well to strong early treatment. A combination consisting of enteric-coated didanosine (ddI-EC), stavudine (d4T), and the HIV-1 protease inhibitor, BMS-232632, will be tested. HIV Infections Drug:AtazanavirDrug:StavudineDrug:Didanosine Phase II Study Type:InterventionalStudy Design:Treatment,Safety Study Official Title:A Pilot Open-Label Phase II Clinical Trial to Evaluate the Safety and Efficacy of a Compact Three Drug Antiretroviral Treatment Regimen for Subjects with Acute HIV-1 Infection or Recent HIV-1 Seroconversion
http://www.clinicaltrials.gov/ct/show/NCT00095030?order=30 Bristol-Myers Squibb The purpose of this clinical research study is to learn whether a muraglitazar-metformin combination is at least as effective as a glimepiride-metformin combination to treat type 2 diabetics who are not sufficiently controlled with metformin alone. The safety of this treatment will also be studied. Diabetes Mellitus, Type 2 Drug:muraglitazar Phase III Study Type:InterventionalStudy Design:Treatment Official Title:A Phase III Study Comparing Maraglitazar with Glimepride in Type 2 Diabetics who are not Controlled with Metformin Alone
http://www.clinicaltrials.gov/ct/show/NCT00082212?order=31 Bristol-Myers Squibb The purpose of this study is to determine the overall response rate, time to progression, and 1 yr survival with cetuximab in patients with ovarian or primary peritoneal carcinoma. Ovarian Cancer Drug:Cetuximab Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase II Trial of Single-agent Cetuximab Dose Escalated to Rash in Patients with Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
http://www.clinicaltrials.gov/ct/show/NCT00095758?order=32 Bristol-Myers Squibb This trial is a 14 week, randomized, double-blind, placebo controlled study, to assess the safety and efficacy of aripiprazole as adjunctive treatment to an ongoing antidepressant treatment in patients with Major Depressive Disorder. Major Depressive Disorder Drug:aripiprazoleDrug:marketed antidepressant Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00095823?order=33 Bristol-Myers Squibb This trial is a 14 week, randomized, double-blind, placebo controlled study, to assess the safety and efficacy of aripiprazole as adjunctive treatment to an ongoing antidepressant treatment in patients with Major Depressive Disorder. Major Depressive Disorder Drug:aripiprazoleDrug:marketed antidepressant Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00097266?order=34 Bristol-Myers Squibb The purpose of this research study is to confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania. Bipolar Disorder Drug:aripiprazole Phase III Study Type:InterventionalStudy Design:Treatment,Safety/Efficacy Study Official Title:A Phase III Study of Aripiprazole in Patients with Acute Bipolar Mania
http://www.clinicaltrials.gov/ct/show/NCT00080314?order=35 Bristol-Myers Squibb The purpose of this study is to evaluate flexible doses (5-30mg) of aripiprazole versus placebo in patients with bipolar depression. Bipolar Disorder Drug:Aripiprazole Phase III Study Type:InterventionalStudy Design:Treatment,Placebo Control Official Title:A Placebo-Controlled Study of Aripiprazole in Patients with Bipolar I Disorder with a Major Depression Episode
http://www.clinicaltrials.gov/ct/show/NCT00094432?order=36 Bristol-Myers Squibb The purpose of this study is to evaluate several doses of aripiprazole in patients with bipolar depression. Bipolar I Disorder Drug:aripiprazole Phase III Study Type:InterventionalStudy Design:Treatment
http://www.clinicaltrials.gov/ct/show/NCT00082199?order=37 Bristol-Myers Squibb The purpose of this clinical research study is to learn whether subjects treated with aripiprazole are able to abstain from alcohol use for a greater number of days than subjects treated with placebo. The safety of using aripiprazole will also be studied. Alcoholism Drug:Aripiprazole Phase IV Study Type:InterventionalStudy Design:Treatment Official Title:A Phase 4 Study of Aripiprazole in Subjects with Alcoholism
http://www.clinicaltrials.gov/ct/show/NCT00083720?order=38 ImClone Systems Colorectal NeoplasmsMetastasesNeoplasm Drug:Erbitux tm (cetuximab) Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase II Multicenter Study of Erbitux (cetuximab) in Patients with Refractory, EGFR-Negative Metastatic Colorectal Carcinoma
http://www.clinicaltrials.gov/ct/show/NCT00034320?order=39 Columbia Presbyterian Medical Center The patient will receive paclitaxel and carboplatin in high dose before one stem cell infusion. When the patient has recovered sufficiently from this first cycle they will be given high dose topotecan and etopophos in combination and then given a second stem cell infusion. When the patient has recovered sufficiently from this second cycle, they will be given high dose thiotepa and then given a third stem cell infusion. Following these procedures, the doctor will assess several forms of data which are routinely analyzed after high dose chemotherapy, including recovery of marrow function, side effects of the treatment, possible relapse of the cancer, and survival. Ovarian Neoplasms Drug:induction chemo and G-CSFDevice:central venous catheterProcedure:stem cell harvestDrug:Paclitaxel/CarboplatinProcedure:stem cell infusionDrug:Topotecan/EtopophosDrug:Thiotepa therapy Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Single Group Assignment,Safety/Efficacy Study Official Title:Phase 1-2 study of tandem cycles of high dose chemotherapy followed by autologous hematopoietic stem cell support in women with persistent or recurrent advanced (Stage III or IV) epithelial ovarian cancer.
http://www.clinicaltrials.gov/ct/show/NCT00097227?order=40 ImClone Systems The purpose of the study is to determine if the combination of cetuximab, carboplatin and paclitaxel will shrink a specific type of lung cancer known as non-small cell lung cancer (NSCLC). The safety of this combination will also be evaluated. Non-small cell lung cancer Drug:CetuximabDrug:CarboplatinDrug:Paclitaxel Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study Official Title:A Randomized Phase II Trial of Two Dose Schedules of Carboplatin/Paclitaxel/Cetuximab in Stage IIIB/IV Non-small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00074256?order=1 British Biotech Pharmaceuticals adult solid tumorgastrointestinal carcinoid tumorNeuroendocrine CarcinomaNon-small cell lung cancerpulmonary carcinoid tumorSmall Cell Lung Cancer Drug:BB-10901Procedure:antibody conjugate therapyProcedure:antibody therapyProcedure:biological response modifier therapy Phase I Study Type:InterventionalStudy Design:Treatment Official Title:Phase I/II Study of BB-10901 in Patients With Recurrent or Refractory Small Cell Lung Cancer, Other Pulmonary Tumors of Neuroendocrine Origin, Non-Pulmonary Small Cell Carcinoma, Metastatic Carcinoid Tumor, or Other CD56+ Solid Tumors
http://www.clinicaltrials.gov/ct/show/NCT00065429?order=2 British Biotech Pharmaceuticals This is a phase I, open-label, dose escalation study to assess the safety, tolerability, PK and efficacy of BB-10901, administered weekly for 4 weeks. Once the MTD has been defined, a phase II efficacy expansion will follow. Based on the predicted PK of BB-10901, this weekly dosing schedule is expected to provide intermittent rather than continuous plasma exposure of the drug conjugate. Small Cell Lung Cancer Drug:BB-10901 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Factorial Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00040586?order=1 BZL Biologics The monoclonal antibody J591 is being investigated as therapy for patients with prostate cancer, in combination with recombinant interleukin-2 (Proleukin, Aldesleukin). The study is an open-label, non-randomized phase II study for patients with documented hormone refractory prostate cancer. Prostatic Neoplasms Drug:Monoclonal Antibody J591 and Recombinant Interleukin-2 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Phase II Trial of Monoclonal Antibody J591 in Combination with Low-Dose Interleukin-2 in Patients with Recurrent Prostate Cancer
http://www.clinicaltrials.gov/ct/show/NCT00086216?order=1 Callisto Pharmaceuticals This is a phase I/IIa clinical trial to find the maximum tolerated dose of atiprimod and to determine the efficacy of the drug in relapsed multiple myeloma patients. The trial is ongoing at the Dana Farber Cancer Institute in Boston and the MD Anderson Cancer Center in Houston Texas. Patients who have failed two prior treatments are eligible for entry in the trial. Multiple Myeloma Drug:Atiprimod Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:An Open-label Study of the Safety and Efficacy of Atiprimod Treatment for Patients with Refractory or Relapsed Multiple Myeloma
http://www.clinicaltrials.gov/ct/show/NCT00052156?order=1 CancerVax Corporation This is a Phase III study in patients with melanoma that has spread to the lymph nodes and/or a distant organ, and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax vaccine to prevent or slow the recurrence of melanoma. Malignant Melanoma Vaccine:CancerVax vaccine (CANVAXIN) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase III Randomized Double-Blind Pivotal Trial of Immunotherapy with a Polyvalent Melanoma Vaccine, CancerVax vaccine plus BCG versus Placebo plus BCG as a Post-surgical Treatment for Stage IV Melanoma
http://www.clinicaltrials.gov/ct/show/NCT00032318?order=1 Cardio Vascular Genetic Engineering Treatment for no-options heart patients with coronary artery disease. Procedure involves the injection into the heart of a protein growth factor that stimulates the growth of new blood vessels around blocked coronary arteries. Coronary DiseaseCoronary Heart DiseaseMyocardial IschemiaCoronary Arteriosclerosis Drug:Human Fibroblast Growth Factor 1 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00063687?order=1 Cardiome Pharma The OPT-CHF (OxyPurinol Therapy for CHF) study is designed to demonstrate the efficacy and safety of oral oxypurinol vs. placebo in a randomized, double-blind, twenty-four week trial in 400 patients in up to 50 centers. Measures of clinical efficacy (NYHA class and Patient Global Assessment) as well as clinical outcomes (e.g., death, worsening heart failure, and hospitalization) will be assessed as a composite endpoint in this trial. Congestive Heart Failure Drug:Oxypurinol Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase II-III Prospective, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oxypurinol Added to Standard Therapy in Patients with NYHA Class III-IV Congestive Heart Failure
http://www.clinicaltrials.gov/ct/show/NCT00032318?order=1 Cardio Vascular Genetic Engineering Treatment for no-options heart patients with coronary artery disease. Procedure involves the injection into the heart of a protein growth factor that stimulates the growth of new blood vessels around blocked coronary arteries. Coronary DiseaseCoronary Heart DiseaseMyocardial IschemiaCoronary Arteriosclerosis Drug:Human Fibroblast Growth Factor 1 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00087672?order=1 M.D. Anderson Cancer Center The goal of this clinical research study is to learn if CC-5013, a derivative of thalidomide, can improve myelofibrosis. The safety of CC-5013 in myelofibrosis will also be studied. Myelofibrosis Drug:CC-5013 Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study Official Title:Phase II Study of CC-5013 in Myelofibrosis
http://www.clinicaltrials.gov/ct/show/NCT00083382?order=2 University of Arkansas The purpose of this research is to study how helpful the combination of thalidomide and Pamidronate or thalidomide and Zometa is in controlling the myeloma disease and to study any side effects. Multiple Myeloma Drug:PamidronateDrug:ThalidomideDrug:Zometa Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:UARK 98-036, A Phase II Trial of Combination Bisphosphonate and Anti-Angiogenesis Therapy with Pamidronate and Thalidomide in Patients with Smoldering/Indolent Myeloma
http://www.clinicaltrials.gov/ct/show/NCT00083408?order=3 University of Arkansas The purpose of this research is to study how helpful the combination of thalidomide and Pamidronate is in controlling multiple myeloma and to study any side effects that may be experienced. Multiple Myeloma Drug:PamidronateDrug:Thalidomide Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:UARK 99-016, A Phase II Trial of Combination Bisphosphonate and Anti-Angiogenesis Therapy with Pamidronate and Thalidomide in Patients with Multiple Myeloma and Poor Hematopoietic Stem Cell Reserve
http://www.clinicaltrials.gov/ct/show/NCT00091624?order=4 Celgene Corporation A Phase I Study of CC-5013 in combination with Doxil, Vincristine and Decadron (DVd) in Subjects with Relapsed or Refractory Multiple Myeloma Multiple Myeloma Drug:CC-5013 Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Single Group Assignment,Safety Study
http://www.clinicaltrials.gov/ct/show/NCT00074646?order=5 Celgene Corporation Phase I trial of CC-8490 for the treatment of subjects with recurrent/refractory high-grade gliomas GlioblastomaMalignant Gliomas Drug:CC-8490 Phase I Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Uncontrolled,Safety/Efficacy Study
http://www.clinicaltrials.gov/ct/show/NCT00083460?order=6 University of Arkansas The purpose of this study is to assess the toxicity of PS-341 combined with one of four doses of thalidomide in patients with refractory multiple myeloma, and to find the most appropriate doses of PS-341 and thalidomide in the combination. Multiple Myeloma Drug:PS-341Drug:ThalidomideDrug:Dexamethasone Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:UARK 2001-37, A Phase I Exploratory Study of Combination PS-341 and Thalidomide in Refractory Multiple Myeloma
http://www.clinicaltrials.gov/ct/show/NCT00057564?order=7 Celgene Corporation Randomized subjects will receive study drug, either thalidomide plus high-dose dexamethasone or placebo identical in appearance to thalidomide plus high-dose dexamethasone, in 4-week cycles. Subjects will remain on study drug until they experience disease progression or until the subject discontinues for any other reason. Subjects will have visits every cycle and all subjects will be followed for survival even after discontinuation from study drug. Multiple Myeloma Drug:ThalidomideDrug:Dexamethasone Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Multicenter Parallel-Group, Placebo Controlled, Randomized, Double-Blind Study of Combination Thalidomide Plus Glucocorticoid Therapy Versus Glucocorticoid Therapy Alone as Induction Therapy for Previously Untreated Subjects with Multiple Myeloma
http://www.clinicaltrials.gov/ct/show/NCT00090493?order=8 University of Arkansas The hope is that the peptide vaccines will stimulate the immune system to attack and kill the myeloma cells. The purpose is to generate anti-myeloma T-cells which will kill myeloma cells and nothing else. Multiple Myeloma Vaccine:MAGE-A3 Phase I Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:UARK 2003-26, A Pilot Study of MAGE-A3 and NY-ESO-1 Immunotherapy in Combination with DTPACE Chemotherapy and Autologous Transplantation in Multiple Myeloma
http://www.clinicaltrials.gov/ct/show/NCT00083538?order=9 University of Arkansas The purpose of this study is to determine if vaccination with autologous idiotype- or tumor lysate-pulsed dendritic cells induces the generation of anti-idiotypic and anti-tumor immunologic responses. Multiple Myeloma Drug:DexamethasoneDrug:ThalidomideDrug:CisplatinumDrug:AdriamycinDrug:CyclophosphamideDrug:Etoposide Phase II Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:UARK 2000-46, A Phase II Study of Tumor Antigen-Pulsed Autologous Dendritic Cell Vaccination Administrated Subcutaneously or Intranodally in Multiple Myeloma Patients
http://www.clinicaltrials.gov/ct/show/NCT00081939?order=10 University of Arkansas Multiple Myeloma Drug:VelcadeDrug:Thalidomide Phase III Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Efficacy Study Official Title:A Phase 2 Study Incorporating Bone Marrow Microenvironment (ME) Co-Targeting Bortezomib into Tandem Melphalan-Based Autotransplants with DT PACE for Induction/Consolidation and Thalidomide + Dexamethasone for Maintenance
http://www.clinicaltrials.gov/ct/show/NCT00089726?order=1 Cell Genesys Lung CancerCarcinoma, Non-Small-Cell Lung Vaccine:CG8123Drug:Cyclophosphamide Phase II Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Single Group Assignment,Safety/Efficacy Study Official Title:A Phase II Randomized Study of GM-CSF Gene-Modified Autologous Tumor Vaccine (CG8123) with and without Low-Dose Cyclophosphamide in Advanced Stage Non-Small Cell Lung Cancer
http://www.clinicaltrials.gov/ct/show/NCT00089856?order=2 Cell Genesys The purpose of this study is to compare the duration of survival between GVAX prostate cancer vaccine and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past. Prostate Cancer Vaccine:Immunotherapy with allogeneic prostate vaccineDrug:Chemotherapy (Taxotere and prednisone) Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study Official Title:A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients with Metastatic Hormone-Refractory Prostate Cancer who are Chemotherapy-Nave
http://www.clinicaltrials.gov/ct/show/NCT00088530?order=1 Cell Therapeutics Lymphoma, Non-Hodgkin Drug:BBR2778 Phase III Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Single Group Assignment,Safety/Efficacy Study Official Title:Pixantrone (BBR 2778) versus Other Chemotherapeutic Agents for Third-line Single Agent Treatment of Patients with Relapsed Aggressive Non-Hodgkins Lymphoma: A Randomized, Controlled, Phase III Comparative Trial