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NCT ID: NCT01865084 Terminated - Clinical trials for Muscular Dystrophy, Duchenne

A Study of Tadalafil for Duchenne Muscular Dystrophy

Start date: September 2013
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to determine if tadalafil can slow the decline in walking ability of boys who have Duchenne muscular dystrophy (DMD). The study will also assess the safety of tadalafil and any side effects that might be associated with it in boys who have DMD. Participants will receive study treatment (tadalafil or placebo) for the first 48 weeks of the study, and can then continue into an open label extension (OLE) that consists of two periods during which all participants will receive tadalafil. In OLE period 1, all participants will receive tadalafil for 48 weeks. Participants completing OLE period 1 will continue into OLE period 2 and will receive tadalafil for at least another 48 weeks.

NCT ID: NCT01849965 Terminated - Clinical trials for Diabetic Foot Ulcers

Phase 3 Study Evaluating Efficacy and Safety of DSC127 Compared With Vehicle and With Standard-of-care in Diabetic Foot Ulcers

STRIDE 2
Start date: April 2013
Phase: Phase 3
Study type: Interventional

To determine if aclerastide (DSC127) is effective in increasing incidence of complete wound closure up to 10 weeks confirmed 2 weeks later, compared with vehicle (gel without active ingredient) and compared with a standard-of-care gel, in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 diabetic foot ulcers, 0.75 - 6cm2 in size.

NCT ID: NCT01812174 Terminated - Heart Valve Disease Clinical Trials

On-X Heart Valve - 17mm Aortic and 23mm Mitral

Start date: November 18, 2011
Phase: N/A
Study type: Interventional

This study examines the hemodynamic and hemolytic properties of two additional smaller size valves to the On-X line of valves already approved by FDA.

NCT ID: NCT01771133 Terminated - Obesity Clinical Trials

Pregnancy and EARly Lifestyle Improvement Study

PEARLS
Start date: January 2013
Phase: N/A
Study type: Interventional

The investigators propose to conduct a randomized controlled trial in 200 overweight/obese pregnant women and their offspring. The prenatal intervention will emphasize improving diet and physical activity. The lifestyle intervention will be delivered within an empowerment theoretical framework through a combination of group sessions, individual counseling, and by monitoring compliance to diet and physical activity to further tailor the intervention. The post-partum intervention sessions will include mothers and their offspring and will focus on breastfeeding, improving physical activity and quality of the diet and feeding practices through the first post-partum year. As part of routine prenatal care, participants in both the control and intervention arms will be given health-related advice. Since the majority of participants are expected to be eligible for the Women, Infants and Children (WIC) program, both groups will also receive assistance through WIC as per their routine policies. Our primary outcome is Gestational Weight Gain (GWG). The major secondary outcome of interest is infant BMI z-score at 12 months of age, and the investigators will also be evaluating several metabolic outcomes in mothers and infants.

NCT ID: NCT01729286 Terminated - Clinical trials for Foot Ulcer, Diabetic

Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix

HEALED
Start date: September 2012
Phase: N/A
Study type: Interventional

The objective of this study is to compare the effectiveness of PriMatrix Moist Wound Therapy (MWT) with Standard of Care MWT for the treatment of chronic diabetic foot ulcers in subjects with diabetes mellitus and without significantly compromised arterial circulation.

NCT ID: NCT01714817 Terminated - Lupus Nephritis Clinical Trials

Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

Start date: January 22, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate (Abatacept) for treatment of lupus nephritis when used on a background of Cellcept (mycophenolate) and prednisone (corticosteroids)

NCT ID: NCT01687998 Terminated - Clinical trials for Cardiovascular Diseases

A Study of Evacetrapib in High-Risk Vascular Disease

ACCELERATE
Start date: October 2012
Phase: Phase 3
Study type: Interventional

The purpose of the ACCELERATE study is to evaluate the efficacy and safety of evacetrapib in participants with high-risk vascular disease (HRVD).

NCT ID: NCT01676701 Terminated - Clinical trials for Rheumatoid Arthritis

Evaluation of Tabalumab Using Auto-Injector or Prefilled Syringe in Participants With Rheumatoid Arthritis (RA)

Start date: September 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the serum concentration of tabalumab after the administration using either prefilled syringe or auto-injector after the initial loading dose and after 12 weeks of treatment. Treatment period is followed by 40 weeks optional safety extension.

NCT ID: NCT01672879 Terminated - Clinical trials for Liver Fibrosis Due to NASH

Simtuzumab (SIM, GS-6624) in the Treatment of Cirrhosis Due to NASH

NASH
Start date: October 29, 2012
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the safety and efficacy of SIM (formerly referred to as GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic Steatohepatitis (NASH). It will consist of 2 phases: - Randomized Double-Blind Phase - Open-Label Phase (optional)

NCT ID: NCT01672866 Terminated - Clinical trials for Liver Fibrosis Due to NASH

Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

Start date: December 5, 2012
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate whether SIM (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants with NASH. It will consist of 2 phases: - Randomized Double-Blind Phase - Open-Label Phase (optional)