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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: NCT01234337 Completed - Breast Cancer Clinical Trials

Phase III Trial Comparing Capecitabine in Combination With Sorafenib or Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer

Start date: February 21, 2011
Phase: Phase 3
Study type: Interventional

The objective of this phase-III trial is to compare the efficacy and safety of sorafenib in combination with capecitabine versus capecitabine in combination with placebo in the treatment of subjects with locally advanced or metastatic HER2-negative breast cancer who are resistant to or have failed prior taxane and an anthracycline or for whom further anthracycline therapy is not indicated. After signing consent there can be up to 28 days before starting the treatment during which time a number of tests will be carried out which will include tumor evaluations and medical history. The following tests and evaluations will have to be done within 7 days of the start of treatment,on Day 1 of every cycle and at the end of study: Electrocardiogram, blood tests, patient quality of life questionnaires and a complete physical exam and vital signs. Treatment will be given in 21 day cycles with sorafenib/placebo to be taken every day for 21 days and capecitabine to be taken for the first 14 days. Patients will come in weekly for the first 6 weeks and then on Day1 for every cycle after the first 2 cycles. During the weekly visits the subjects will be check for any side effects and blood draws will happen for the study on Day 1 of each cycle. Subjects will be followed for overall survival.

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: NCT01234168 Completed - Clinical trials for Neuroendocrine Tumors

A Study to Assess Neuroendocrine Tumour (NET) Patients Currently Treated by Somatuline Autogel for History of Carcinoid Syndrome Associated With Episodes of Diarrhea

SYMNET
Start date: October 2010
Phase:
Study type: Observational

The purpose of the protocol is to to assess subject's overall satisfaction regarding control of diarrhea. The study aims to supplement results obtained through clinical trials with data obtained from a population of patients receiving treatment with Somatuline Autogel in routine practice.

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: NCT01233726 Completed - Critical Illness Clinical Trials

Effects of a Complete Diet in Critically Ill Patients With Stress Hyperglycemia

Start date: April 2010
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the beneficial effects of the administration of a complete diet rich in monounsaturated fatty acids and slow absorption carbohydrate in patients with stress hyperglycemia(T-Diet Plus Diabet IR). The main objective of this project is to evaluate blood glucose metabolic control, insulin requirements, insulin action resistance, lipid profile and to reduce infectious complications on mechanical ventilation ICU patients after the administration of a complete diet enriched in MUFA and slow absorption carbohydrates, without fructose.

NCT ID: NCT01233440 Completed - Hemophilia B Clinical Trials

Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein in Subjects With Hemophilia B

Start date: October 2010
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to assess the safety of IV administration of rIX-FP. Safety will be evaluated by adverse events and laboratory changes over time. The secondary objective of the study is to evaluate the pharmacokinetics parameters, following a single intravenous dose of rIX-FP.

NCT ID: NCT01233245 Completed - Clinical trials for Secondary Progressive MS (SPMS)

BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus Program

Start date: April 2004
Phase: N/A
Study type: Observational

This is an observational survey to assess the factors that influence adherence to Betaferon therapy in multiple sclerosis patients using elements of the BetaPlus support program, including the nurse support and auto-injectors. The patients were evaluated under normal clinical practice and were asked to fill out the quality of life FAMS questionnaire, Coping processes (WCQ - Ways of Coping Questionnaire) and depression questionnaire CES-D.

NCT ID: NCT01232569 Completed - Clinical trials for Rheumatoid Arthritis

A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

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

This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients with active, moderate to severe rheumatoid arthritis. In the double-blind part of the study, patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study, patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from Week 24 to Week 96 using a pre-filled syringe or an auto-injector.