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NCT ID: NCT01050751 Completed - Healthy Volunteers Clinical Trials

Bioavailability Of Lersivirine Single 750 Mg Tablet Versus 3 X 250 Mg Tablets

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

This is a randomized study to assess whether the pharmacokinetics of a new single 750 mg tablet is similar to 3 x 250 mg tablets (750 mg total).

NCT ID: NCT01050582 Completed - Schizophrenia Clinical Trials

A Study to Evaluate the Safety and the Effects of Risperidone Compared With Other Atypical Antipsychotic Drugs on the Growth and Sexual Maturation in Children

Start date: October 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effects of risperidone compared with other atypical antipsychotic drugs on the physical maturity, growth and development of children, and the risk of prolactin-related adverse events (side effects) associated to these drugs.

NCT ID: NCT01050478 Completed - Acute Disease Clinical Trials

IMPACT: A Study to Explore the Efficacy and Safety of Paliperidone ER in Patients With Acute Agitation

Start date: March 2010
Phase: Phase 4
Study type: Interventional

This study will investigate the effect of paliperidone ER (in combination with or without benzodiazepines) in patients presenting with symptoms of agitation and/or aggression in the context of psychosis, and will generate data regarding both efficacy and safety in the acute setting.

NCT ID: NCT01045304 Completed - Clinical trials for Breast Cancer, Metastatic

Study of SAR240550 (BSI-201) in Combination With Gemcitabine/Carboplatin, in Patients With Metastatic Triple Negative Breast Cancer

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

Primary Objective: - To assess the objective response rate (ORR) of iniparib (SAR240550) administered as a 60min intravenous (IV) infusion twice weekly or weekly, in combination with gemcitabine/carboplatin chemotherapy regimen in patients with metastatic Triple Negative Breast Cancer (mTNBC). Secondary Objectives: - To assess the clinical benefit rate (CBR) defined as the rate of complete response (CR), partial response (PR) and stable disease (SD) lasting at least 24 weeks; - To assess Progression-free survival (PFS) and the overall survival (OS); - To assess the safety profile of each schedule of iniparib; - To assess the biological activity in tumor tissue (substudy); - To evaluate the pharmacokinetic (PK) profile of iniparib (substudy); - To characterize molecular and biological profile of tumors (substudy); - To assess the effect of iniparib on poly(ADP)-ribose (PAR) level in peripheral blood mononuclear cells (PBMC) (substudy).

NCT ID: NCT01045291 Completed - Heart Failure Clinical Trials

Pacing for Heart Failure With Preserved Ejection Fraction

HFpEF
Start date: June 2010
Phase: N/A
Study type: Interventional

The purpose of this research study is to evaluate the safety of a new pacing method (Fusion Pacing) for heart failure patients with an ejection fraction (EF) greater than 50% over a period of 4 months, and determine the effects on different measures of heart failure. This new pacing method may allow the heart to pump more efficiently. Participation in this study will last approximately 8 months.

NCT ID: NCT01045057 Completed - Larynx Cancer Clinical Trials

Clinical Feasibility of New Tracheoesophageal Puncture Set

Start date: December 2009
Phase: N/A
Study type: Interventional

During a total laryngectomy a puncture is created in the tracheoesophageal wall and a voice prosthesis is inserted. With this voice prosthesis the patient learns to speak again. During this study a new surgical tool will be investigated that creates the puncture and places the voice prosthesis.

NCT ID: NCT01044732 Completed - Clinical trials for Colorectal Neoplasms

Third Eye Retroscope Randomized Clinical Evaluation

TERRACE
Start date: March 2009
Phase: N/A
Study type: Interventional

The Third Eye® Retroscope® is a device that can be inserted through the instrument channel of a standard colonoscope to provide an additional, retrograde (or backward) view that reveals areas behind folds and flexures in the colon, and might detect additional polyps that cannot be seen with the colonoscope alone. Patients who participate as subjects in the study will undergo two complete colonoscopy procedures, a standard colonoscopy and a colonoscopy in which a Third Eye Retroscope is used along with the same colonoscope. Half of the patients will have the standard colonoscopy first followed by the Third Eye colonoscopy, and the other half will have the Third Eye procedure first. Results from the two groups will be analyzed and compared to determine the effectiveness of the Third Eye Retroscope for detecting additional adenomas and other polyps compared with the standard colonoscope alone.

NCT ID: NCT01043120 Completed - Clinical trials for In Vitro Fertilisation (IVF) Treatment

Effect of Oxytocin Antagonist on Reduction of Uterine Contractions

EFFORT
Start date: February 2010
Phase: Phase 2
Study type: Interventional

The main purpose of this clinical research trial was to evaluate the effects of barusiban compared to placebo on uterine contractions on luteal phase uterine contractions in oocyte donors supplemented with progesterone.

NCT ID: NCT01041885 Completed - Clinical trials for Articular Cartilage Lesion of the Knee

INSTRUCT for Repair of Knee Cartilage Defects

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

The purpose of this study is to investigate whether the INSTRUCT therapy is safe and effective in the treatment of cartilage defects of the knee.

NCT ID: NCT01041404 Completed - Gastric Cancer Clinical Trials

ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer

Start date: September 2005
Phase: Phase 3
Study type: Interventional

This parallel, randomized, open-label, multi-centre study will evaluate the effect on overall survival of trastuzumab (Herceptin) in combination with a chemotherapy compared to the chemotherapy alone in patients with HER2-positive advanced gastric cancer. Trastuzumab (Herceptin) will be administered as intravenous infusion of 6 mg/kg (loading dose 8 mg/kg) every 3 weeks. The chemotherapy consists of a combination of 6 cycles of fluorouracil (800 mg/m2/day intravenous infusion every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks), or capecitabine (Xeloda, 1000 mg/m2 po twice daily for 14 days every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks). Treatment with trastuzumab (Herceptin) will continue until disease progression. The target sample size is 300-600 patients.