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An Investigation of the TReatment of FecAL IncontiNence using the TOPAS Sling System FOR WoMen (TRANSFORM)
Study Timeline: Currently enrolling
The TRANSFORM study is being conducted to determine the effectiveness of an investigational device in reducing episodes of fecal incontinence. This study uses the TOPASTM Sling System which is an investigational device from American Medical Systems (AMS). The TOPASTM Sling System is a small piece of mesh placed behind the anus through small incisions during a minimally invasive surgical procedure.  The mesh creates a sling to give extra support to muscle that has been damaged or weakened
 
 
 
ASD2 (Atrial Spetal Defect) PMS
Study Timeline: Currently Enrolling

The purpose of this study is to gather more information about how effective the Amplatzer Septal Occluder is at closing an atrial septal defect.  Atrial septal defect (ASD) is a congenital (occurring at birth)  heart defect in which the wall that separates the upper heart chambers (atria) does not close completely. The study is also being done to collect information about the safety of the device.  The study is being conducted at up to 30 medical centers across the United States.


 
 
 
ATLAS WORKHORSE: A multi-center, single-arm study of the TAXUS Liberte'-SR stent for the treatment of patients with de novo coronary artery lesions
Study Timeline: Closed to enrollment
This study examines the safety and effectiveness of the TAXUS Liberte'-SR stent in patients with symptomatic heart disease. After determination of eligibility including coronary angiography, all participants will receive the Liberte'-SR drug-eluting stent coated with paclitaxel. Only one heart artery may be treated with the study stent.  Participants will be followed for 5 years.
 
 
 
ATTRACT : Acute Venous Thrombosis: Thrombosis Removal With Adjunctive Catheter-Directed Thrombolysis
Study Timeline: Currently Enrolling

This study is designed to test standard treatment for blood clots with standard treatments and a new treatment. All participants will receive blood-thinning drugs, the standard treatment for blood clots. In addition half of the study participants will be randomly chosen to have their clot dissolved using a clot-busting drug (TPA) that a doctor will inject directly into the clotted vein through a specially designed drug delivery catheter.

Participants are followed for 2 years to assess possible symptoms related to the clot and how well both treatments prevent complications.


 
 
 
AUS - 92
Study Timeline: Currently Enrolling
This study is designed for adults who receive a kidney transplant. It will compare a standard anti-rejection therapy to an experimental anti-rejection therapy. The study will look carefully at how well the experimental anti-rejection therapy works and how it may be potentially less harmful to the transplanted kidney. Participants will be randomly assigned to receive either the standard therapy (CellCept & standard dose tacrolimus) or the experimental therapy combination(Zortress (everolimus) plus lower dose tacrolimus).
 
 
 
BENEFIT
Study Timeline: Closed to enrollment

Belatacept Evaluation of Nephroprotection and Efficacy as First-Line Imunosuppression Trial (BENEFIT)

This study is designed for adults who receive a kidney transplant. It is designed to compare standard anti-rejection medicine to an experimental anti-rejection medicine, Belatacept. It will look carefully at how well the anti-rejection medicine works and if it may be potentially less harmful to the transplanted kidney. Participants will be randomly assigned to receive standard medicine (cyclosporine) or the experimental medicine (Belatacept).


 
 
 
BioSeal-Lung Biopsy Tract Plug Study
Study Timeline: Currently enrolling through Oct 2007
This is a randomized study. Participants will receive either a standard of care lung biopsy procedure or an experimental lung biopsy with the placement of an absorbable plug in the biopsy needle tract.
 
 
 
CLEVER: Claudication: Exercise vs Endoluminal Revascularization
Study Timeline: Currently enrolling
This study is a randomized, multi-center clinical trial designed to determine optimal treatment for individuals with intermittent claudication from peripheral arterial disease (PAD). This study is the only study of its kind to compare medical therapy, supervised exercise training and invasive catheterization/stent revascularization procedures
 
 
 
CLOSURE I :
Study Timeline: Currently open to enrollment

CLOSURE I - Is a Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Starflex Septal Closure System versus Best Medical therapy in Patients with a Stroke and/or Transient Ischemic Attach due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale.

There are two objectives for this study. First, to learn if the study device, when placed in the heart, will safely and effectively prevent a recurrent embolic stroke or TIA (transient ischemic attack) in patients with a patent foramen ovale (PFO). Second, to compare the study device to the best medical therapy. Best medical therapy is the use of aspirin, Coumadin, or a combination of both.

If all eligibility criteria are met, patients are randomized to study device placement or best medical therapy. Clinical follow-up for all patients is at 1, 6, 12 and 24 months post-enrollment.


 
 
 
CORAL : Cardiovascular Outcomes in Renal Atherosclerosis (CORAL)
Study Timeline: Closed to Enrollment
This study is designed for individuals with hypertension and renal stenosis (narrowing of the arteries in the kidney). Participants are assigned to one of two treatment groups. Both groups receive optimal medical therapy for their renal disease, either with or without renal stenting. (Renal stenting is a medical procedure inserting a wire mesh tube into the artery to keep it open.)
 
 
 
COSTAR CObalt chromium STent with Antiproliferative for Restenosis II Trial (The COSTAR II Trial)
Study Timeline: Closed to enrollment

This study examines the safety and effectiveness of two different drug-eluting stents (CoStar(R) and TAXUSTM) in patients with symptomatic heart disease. Participants will have blockage(s) in one, two or three of their heart or coronary arteries as determined by angiography.  They will be randomized to receive either the TAXUS stent (coated with paclitaxel) or the CoStar stent (paclitaxel loaded into reservoirs located within the stent struts). Participants in the trial will be followed for a period of 5 years.


 
 
 
CREST
Study Timeline: Closed to enrollment
This study is designed to compare two treatments for carotid artery stenosis in low-risk patients. Participants are assigned randomly to receive either carotid surgery (standard treatment) or carotid stenting.
 
 
 
Differential Influences of Dietary Amino Acids on Blood Pressure
Study Timeline: In publication

Diets that contain higher levels of plant proteins appear to lower blood pressure (BP), while greater consumption of animal proteins may not. The purpose of this study was to determine if intake of amino acids that vary by food source influence BP in patients at high cardiovascular risk.


 
 
 
ENDEAVOR III: A Randomized Controlled Trial of the Medtronic Endeavor Drug (ABT-578) Eluting Coronary Stent System versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions
Study Timeline: Closed to enrollment
This study examines the safety and effectiveness of two different drug-eluting stents (ENDEAVOR and CYPHER stents) in patients with symptomatic heart disease. Participants will have single, untreated blockage(s) in one of their heart arteries as determined by coronary angiography.  They will be randomized to receive either the ENDEAVOR stent (coated with ABT-578) or the CYPHER stent (coated with sirolimus). Participants will be followed for 5 years.
 
 
 
Gore REVISE (GORE VIABAHN) Endoprosthesis versus Percutaneous Transluminal Angioplasty (PTA) to Revise Arteriovenous Grafts at the Venous Anastomosis in Hemodialysis Patients)
Study Timeline: Currently Enrolling

The Gore REVISE study is a randomized study. It has been designed to establish the effectiveness  and safety of the GORE VIABAHN® Endoprosthesis (stent) with PROPATEN Bioactive Surface in prosthetic hemodialysis grafts. This specialized graft will be used to treat narrowing at the venous end of the graft in order to maintain or re-establish the vascular access for hemodialysis. The goal of the study is to track the natural course of the vascular access as the Subject undergoes regular hemodialysis at their respective dialysis center. Participants will be followed at 1, 3, 6, 12, 18, and 24 - months post-procedure to assess the safety and effectiveness of the treatment.


 
 
 
HeartMate II Left Ventricular Assist Device as Destination Therapy (Permanent Implant)
Study Timeline: Currently enrolling
Patients who are not candidates for heart transplant owing to age or other diseases and have been treated with all medical management available and are still in danger of dying are implanted with this axial flow pump. The patient is randomized to the study device or the only approved device for DT, the HeartMate XVE LVAD. The device is designed to support their heart for years. The patient will be followed for the rest of his life.
 
 
 
IRIS
Study Timeline: Currently open to enrollment
This study is designed to compare the study medication (pioglitazone) vs. a placebo for prevention of stroke and myocardial infarction (heart attack) in individuals who have recently had either an ischemic stroke or a transient ischemic attack.
 
 
 
Medication Intervention in Transitional Care to Optimize Chronic Kidney Disease Outcomes & Costs
Study Timeline: Currently Enrolling

The purpose of the study is to evaluate factors associated with medication discrepancies and adverse events that increase medical liability during transition from hospitals to home.  
Enrolled patients will be individuals with Chronic Kidney Disease (CKD), who were recently in the hospital. Subjects will participate in a focus group to learn more about their recent experiences when discharging from hospital to home. Information will be obtained regarding what health care professionals could do to help them better understand their medicines and how to take them once they return home.  We hope the information gathered will help us find ways to make the hospital discharge process and the first days at home better for patients with CKD.


 
 
 
Oxidative Stress in Chronic Kidney Disease: Diet and Exercise
Study Timeline: Enrolling
This study is designed to test the hypothesis that the healthy lifestyle interventions of increasing aerobic exercise and reducing dietary caloric intake are feasible, safe therapies that can slow the progression of kidney disease. The study will also look at the affects of these interventions on the biomarkers of oxidative stress, inflammation, insulin resistance, and endothelial function in patients with moderate to severe Chronic Kidney Disease (CKD).
This study has what is known as a 2x2 factorial design. Participants can receive one of four combinations of either routine care diet or study diet with calorie restriction combined with either routine activity or an exercise regime.
 
 
 
PIVOTAL: Positive Impact of Endovascular Options for Treating Aneurysms Early
Study Timeline: Closed to enrollment
This study compares Endovascular stent repair versus standard surveillance of patients with small abdominal aortic aneurysms
 
 
 

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