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NCT ID: NCT01873898 Completed - Bleeding Clinical Trials

Clinical Investigation of the Rex Medical -Closerâ„¢ Vascular Closure System -Reduced Time to Ambulation Trial

Start date: June 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of the Rex Medical Closerâ„¢ Vascular Closure System to close the femoral arterial puncture site in subjects who have undergone diagnostic angiography procedures with early ambulation and discharge.

NCT ID: NCT01769001 Completed - Fabry Disease Clinical Trials

An Extension of a Phase 1/2, Open Label, Dose Ranging Study of PRX-102 in Adult Fabry Patients

Start date: March 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Patients will be enrolled into one of three PRX-102 dosing groups (0.2 mg/kg, 1.0 mg/kg, 2.0 mg/kg), to receive the same dose they had received in Phase 1/2 study PB-102-F01, and will continue to receive PRX-102 as an intravenous infusion every 2 weeks for 38 weeks.

NCT ID: NCT01740583 Active, not recruiting - Clinical trials for Mitral Valve Regurgitation

Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation

ALIGN
Start date: November 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to test the safety and device performance of the Mitralign system ("MPAS") to treat functional mitral valve regurgitation.

NCT ID: NCT01678898 Completed - Fabry Disease Clinical Trials

Dose-ranging Study of PRX-102 in Adult Fabry Disease Patients

Start date: October 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This is the first human treatment with PRX-102, an enzyme being developed as a long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (alpha galactosidase deficiency). The safety, tolerability, and exploratory efficacy will be evaluated in this study of increasing doses. Patients will be treated with infusions every two weeks for 12 months.

NCT ID: NCT01411228 Completed - Gaucher Disease Clinical Trials

A Multicenter Extension Study of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease

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

A protocol to extend the assessment of the safety and efficacy of taliglucerase alfa in pediatric subjects (2 to <18 years old) with symptoms and clinical manifestations of Gaucher disease who completed treatment in Protocols PB-06-002 (switchover study from imiglucerase) or PB-06-005 (naïve treatment with taliglucerase alfa).

NCT ID: NCT01321255 Completed - Clinical trials for Myocardial Infarction

Fixed Dose Combination Drug (Polypill)for Secondary Cardiovascular Prevention.

FOCUS
Start date: January 2012
Phase: Phase 3
Study type: Interventional

The aim of the FOCUS project is to test the Fixed Dose Combination concept for cardiovascular prevention in populations of different socio-economic characteristics. At the same time, FOCUS aims to understand the factors determining inappropriate prescribing for secondary cardiovascular prevention and those for poor patients adherence to treatment. This will allow FOCUS to establish recommendations for a better use of medication in patients with ischemic heart disease. In addition, after a successful completion of FOCUS, secondary prevention medication will be available and affordable for a large number of patients in both developed as well as developing countries. There are two Phases in this study: Phase 1: Is a descriptive, non interventional study. Phase 2: Is an interventional, randomized trial with prospective economic evaluation.

NCT ID: NCT01132690 Completed - Gaucher Disease Clinical Trials

A Safety and Efficacy Study of Two Dose Levels of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease

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

This is a multi-center, double-blind trial to assess the safety and efficacy of taliglucerase alfa in untreated subjects (2 to <18 years old) with Gaucher disease randomly assigned to treatment with one of two doses, 30 or 60 units/kg. Subjects will receive an intravenous (IV) infusion of taliglucerase alfa every two weeks. The total duration of treatment will be 12 months. At the end of the 12-month treatment period eligible subjects will be offered enrollment in an open-label extension study if taliglucerase alfa is not commercially available.

NCT ID: NCT01068912 Completed - Influenza Clinical Trials

Dose-Finding Study of Favipiravir in the Treatment of Uncomplicated Influenza

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

This is a Phase 2, randomized, double-blind, placebo-controlled multicenter study evaluating the efficacy and safety of two doses of favipiravir in adult patients with uncomplicated influenza.

NCT ID: NCT00985205 Active, not recruiting - Burns Clinical Trials

The RE-ENERGIZE Study: RandomizEd Trial of ENtERal Glutamine to minimIZE Thermal Injury

RE-ENERGIZE
Start date: December 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to test the following hypotheses: 1. Enteral glutamine administration decreases in-hospital mortality in adult patients with severe thermal burn injuries. 2. Enteral glutamine administration decreases hospital-acquired blood stream infections from Gram negative organisms and length of stay in ICU and hospital for adult patients with severe thermal burn injuries. 3. Enteral glutamine administration will improve the physical function of surviving burn injured patients and reduce their cost of care. The objectives of this trial are to determine the overall treatment effect and safety of glutamine in burn patients. Specifically, the investigators want to assess the following outcomes in a sample of 1200 patients in 80 sites: 1. In patients with severe, life-threatening burn injury, what is the effect of enteral glutamine on time to discharge alive from hospital 2. In patients with severe, life-threatening burn injury, what is the effect of enteral glutamine on 6 month mortality, hospital-acquired blood stream infections from Gram negative organisms, hospital mortality, duration of stay in ICU and hospital, health-related quality of life, and health care resources?

NCT ID: NCT00881777 Terminated - Heart Failure Clinical Trials

Feasibility Study of Radiofrequency Heating of Cardiac Infarction Scar to Treat Heart Failure

RECOVER
Start date: September 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to examine the safety and potential effectiveness of a new surgical procedure for treating heart failure. The experimental treatment is performed during standard coronary artery bypass graft (CABG) surgery, and applies radiofrequency energy to heat a portion of the damaged heart muscle. The tissue heating reduces the enlarged heart of patients suffering from ischemic heart failure, and may result in the heart pumping blood more efficiently, thereby improving the functional status of the patient.