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NCT ID: NCT01240915 Completed - Colitis, Ulcerative Clinical Trials

A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis

Start date: February 2011
Phase: Phase 2
Study type: Interventional

MultiStem(r) is a new biological product, manufactured from human stem cells obtained from adult bone marrow or other nonembryonic tissue sources. Factors expressed by MultiStem cells are believed to reduce inflammation and regulate immune system function, protect damaged or injured cells and tissue, promote formation of new blood vessels, and augment tissue repair and healing. MultiStem cell treatment resulted in significant efficacy in a mouse model of Graft versus Host Disease with almost complete reversal of gastrointestinal pathology (similar to pathology that would be expected in Ulcerative Colitis). These data, together with safety data generated in 2 other clinical trials, suggest that MultiStem has the potential to be a new treatment option for patients with ulcerative colitis. This is the first study of MultiStem in this patient population and will cautiously explore the safety/toleration and potential benefit of this new treatment in patients with moderate to severe disease.

NCT ID: NCT01239732 Completed - Ovarian Cancer Clinical Trials

A Study of the Addition of Avastin (Bevacizumab) to Carboplatin and Paclitaxel Therapy in Patients With Ovarian Cancer

Start date: December 2010
Phase: Phase 3
Study type: Interventional

This open-label, non-comparative, multi-center study will assess the safety profile and efficacy of Avastin (bevacizumab) when added to carboplatin and paclitaxel therapy in patients with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma. Patients will receive 15 mg/kg Avastin intravenously on Day 1 of every cycle for up to 36 cycles of 3 weeks each, carboplatin (AUC 5-6 mg/ml/min) on Day 1 every 3 weeks for a maximum of 8 cycles and paclitaxel 175 mg/m2 on Day 1 every 3 weeks or 80 mg/m2 every week for a maximum of 8 cycles. The anticipated time on study drug will be 108 weeks or until disease progression or unacceptable toxicity.

NCT ID: NCT01235962 Completed - Cancer Clinical Trials

A Study to Evaluate Pazopanib as an Adjuvant Treatment for Localized Renal Cell Carcinoma (RCC)

PROTECT
Start date: November 30, 2010
Phase: Phase 3
Study type: Interventional

This randomized Phase III study is to evaluate whether pazopanib compared with placebo can prevent or delay recurrence of kidney cancer in patients with moderately high or high risk of developing recurrence after undergoing kidney cancer surgery.

NCT ID: NCT01235585 Completed - Schizophrenia Clinical Trials

A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25306)

Start date: December 2010
Phase: Phase 3
Study type: Interventional

This randomized, multi-center, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with sub-optimally controlled symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.

NCT ID: NCT01234779 Completed - Schizophrenia Clinical Trials

A Study of RO4917838 (Bitopertin) in Patients With Acute Exacerbation of Schizophrenia

Start date: February 2011
Phase: Phase 2
Study type: Interventional

This randomized, double-blind, placebo- and active-controlled, parallel group study will evaluate the safety and efficacy of RO4917838 (bitopertin) in patients with acute exacerbation of schizophrenia. Patients will be randomized to receive either RO4917838 10 mg or RO4917838 30 mg or olanzapine 15 mg or placebo orally daily for 4 weeks as inpatients, with a 4-week follow-up period.

NCT ID: NCT01234350 Completed - Prostate Cancer Clinical Trials

A Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON

Start date: January 2011
Phase:
Study type: Observational

This study is a large observational study, set-up to observe how long-term treatment with FIRMAGON (hormone regulator) compare to other treatments in regards to cardiovascular events, changes in bone density, changes in blood sugar levels or liver enzyme levels in subjects with prostate cancer. Subjects will be treated according to their routine clinical care and not dictated by the study. As the study is observational in nature, the study will collect data relating to the events specified above. Subjects that agree to this study will be followed-up for 5 years. Subject data will be collected every 3 months for the first 2 years and every 6 months for the last 3 years.

NCT ID: NCT01234311 Completed - Prostate Cancer Clinical Trials

A Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer

Start date: March 2011
Phase: Phase 3
Study type: Interventional

This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of tasquinimod on delaying disease progression compared with placebo. Approximately 1200 eligible patients with metastatic CRPC will be randomly assigned in a 2:1 ratio to 1 of 2 treatment groups: Treatment Group A (tasquinimod 0.25, 0.5, or 1 mg/day; n=800) or Treatment Group B (placebo; n=400).

NCT ID: NCT01233869 Completed - Clinical trials for Polycystic Kidney, Autosomal Dominant

Bosutinib For Autosomal Dominant Polycystic Kidney Disease

Start date: December 2010
Phase: Phase 2
Study type: Interventional

This purpose of this study is to determine if bosutinib reduces the rate of kidney enlargement in subjects with autosomal dominant polycystic kidney disease (ADPKD) entering the study with a total kidney volume greater than or equal to 750 cc and eGFR greater than or equal to 60 mL/min/1.73m2.

NCT ID: NCT01233258 Completed - Hemophilia A Clinical Trials

A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A

Leopold II
Start date: January 2011
Phase: Phase 3
Study type: Interventional

The objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy with BAY81-8973 is superior to on-demand therapy with BAY81-8973 in patients with severe Hemophilia A. The hypothesis is that prophylaxis will result in fewer bleeds than on-demand treatment.

NCT ID: NCT01232491 Completed - Clinical trials for Diabetes Mellitus, Type 2

Impact of Dietary Intervention on Weight Change in Subjects With Type 2 Diabetes

DIETâ„¢
Start date: October 2010
Phase: Phase 4
Study type: Interventional

This trial is conducted in Europe, and North and South America. The aim of this trial is to investigate if a dietary intervention has an effect on weight when initiating insulin treatment in subjects with type 2 diabetes currently treated with oral antidiabetic drugs (OADs).