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Displaying 1 - 21 of 21

The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves). (MITRAL-II)

Condition: Valve Disease / Mitral Valve Disease
Investigator: Isaac George, MD
Status: Currently Recruiting
This is a prospective multicenter study whose purpose is to establish the safety and effectiveness of the Edwards SAPIEN 3 and SAPIEN 3 Ultra valves with Commander delivery system in patients with severe symptomatic calcific mitral valve disease with severe mitral annular calcification (which is a progressive loss of function of the mitral valve due to…
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Effect of lowering insulin levels on blood sugar

Condition: Endocrine & Metabolic Disease
Investigator: Joshua Cook, MD, PhD
Status: Currently Recruiting
We are conducting a research study on how insulin controls blood sugar in both healthy people and those at risk of type 2 diabetes. We are seeking adult volunteers, aged 18-65, who have body mass indices either in the lean range (18-25 kg/m2) or in the obesity range (30-45 kg/m2) but who do not have prediabetes or diabetes. Participants will undergo a…
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Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial in Patients with Mitral Regurgitation

Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Currently Recruiting
The study is designed to compare the safety and effectiveness of the PASCAL System to the MitraClip System for reduction of degenerative mitral regurgitation.
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MitraClip REPAIR MR Study in Patients with Primary Mitral Regurgitation

Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Currently Recruiting
This is a randomized controlled trial (RCT) that will compare the clinical outcome of MitraClip device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team. In this trial,…
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Lowering Insulin Levels in Fatty Liver Disease

Condition: Endocrine & Metabolic Disease
Investigator: Joshua Cook, MD, PhD
Status: Currently Recruiting
We are conducting a research study on the effect of high insulin levels on the buildup of excessive liver fat ("fatty liver disease") in people at risk for type 2 diabetes. We are seeking adult volunteers, aged 18-70, who are overweight or obese with a body mass index of 27-50, and have been diagnosed with, or are at risk for, prediabetes.…
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Body composition and metabolic manifestations of PCOS

Condition: Endocrine & Metabolic Disease
Investigator: Aviva Sopher, MD, MS
Status: Closed
Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women ofreproductive age, affecting about 7% of this population when using the strictest diagnostic criteria and frequently presents in adolescence and young adulthood. Diagnostic features of PCOS includehyperandrogenism and ovulatory dysfunction. Additionally, both obese and…
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A study for patients with Cushing's disease using study drug osilodrostat

Condition: Endocrine & Metabolic Disease / Cushing's Disease
Investigator: Pamela Freda, MD
Status: Closed
This study is for individuals who have Cushings disease and want to join voluntarily in this study to find out if a study drug called osilodrostat (LCI699) is safe and has beneficial effects in people who have Cushings disease. Cushings disease is a rare but debilitating disease. Cushings disease is caused by a benign tumor of the pituitary gland. The tumor…
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Using New Tumor Markers in Blood (POMC, ACTH, and AgRP) to Diagnose and Track Cushing's Syndrome and Other Neuroendocrine Tumors

Condition: Endocrine & Metabolic Disease / Cushing's Disease
Investigator: Amanda Tsang
Status: Closed
The purpose of this study is to determine if measuring blood levels of proteins called POMC, AgRP, and chromogrannin A (CGA) can be used to diagnose and track tumor growth and recurrence in patients that have ACTH-dependent Cushing's syndrome, non-secreting pituitary tumors, and other neuroendocrine tumors. We invite you to participate if you have: a…
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Metabolism Study

Condition: Endocrine & Metabolic Disease
Investigator: Judith Korner, MD
Status: Closed
The purpose of these studies is to gain an understanding of the mechanisms that promote weight loss and improved glucose control. The ultimate goal is to identify therapeutic pathways for obesity and diabetes as a way to optimize surgical procedures and discover novel non-surgical targets for safe and effective drug therapy. Participants with obesity will…
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Temporary Insulin Resistance

Condition: Endocrine & Metabolic Disease
Investigator: Joshua Cook, MD, PhD
Status: Closed
We are recruiting healthy volunteers, aged 18-65, for a research study on the buildup of excessive liver fat ("fatty liver disease") in people with or at risk for type 2 diabetes because their bodies are resistant to the actions of the blood sugar-lowering hormone, insulin. To do this, we seek to induce temporary insulin resistance in 10-12…
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Effect of Lowering Insulin Levels on Blood Sugar

Condition: Endocrine & Metabolic Disease
Investigator: Joshua Cook, MD, PhD
Status: Closed
We are conducting a research study on how much insulin is needed to control blood sugar in people at risk for type 2 diabetes. We are seeking adult volunteers, aged 18-65, who are overweight or obese with a body mass index of 25-45 and have been diagnosed with or are at risk for prediabetes. Participants will undergo two pancreatic clamp procedures…
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Study of The Medtronic Intrepid Transcatheter Mitral Valve Replacement System in Patients with Severe, Symptomatic Mitral Regurgitation

Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
This study is designed to look at the safety and performance of The Intrepid TMVR System using transfemoral transseptal access (TF). TF is a procedure that requires access to the femoral vein by an incision in the lower limb between the knee and the hip. The study population is for patients with severe, symptomatic mitral regurgitation (MR), a condition…
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PARTNER 3 Trial: Mitral Valve in Valve

Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
The study is assessing the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.
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Millipede Transcatheter Annuloplasty Ring System in Patients with Functional Mitral Regurgitation

Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
The Millipede Feasibility Study is a prospective, open-label, single-arm study to assess the safety and feasibility of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation. The Millipede Annuloplasty Ring System is a novel transcatheter, fully adjustable, complete annuloplasty repair device for the treatment…
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Edwards Cardioband System & medical therapy versus medical therapy alone in patients with functional mitral regurgitation and heart failure

Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
The purpose of this study is to evaluate a new device to treat patients who may benefit from the repair of their mitral heart valve due to mitral regurgitation. The device is called the Edwards Cardioband System (Edwards Cardioband System or the device). The device is investigational in the United States but has been approved in Europe. This clinical study…
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A study for patients with Cushing's disease using study drug LCI699

Condition: Endocrine & Metabolic Disease / Cushing's Disease
Investigator: Pamela Freda, MD
Status: Closed
The purpose of this study is to confirm the effectiveness and safety of LCI699 in treating patients with Cushing's disease. Patients will be treated with the invesitigational drug LCI699 at doses up to 60 mg a day, and possibly for a short period of time with placebo. A placebo is a dummy drug ("pill") with no active medicine inside.
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A study for patients with acromegaly using study drug Octreotide

Condition: Endocrine & Metabolic Disease
Investigator: Pamela Freda, MD
Status: Closed
This study is for patients who have been diagnosed with acromegaly and have been treated with the injectable medications ocreotide or lanreotide for at least 6 months. You should have had the same dose for at least 4 months, and be adequately controlled. The purpose of this study is to compare the safety and effectiveness of an investigational new drug…
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Study for individuals who have had gastric bypass surgery at least one year prior and have type 2 diabetes.

Condition: Endocrine & Metabolic Disease
Investigator: Blandine Laferrere, MD, PhD
Status: Closed
This is a research study for subjects who have had gastric bypass surgery at least one year ago, and currently have type 2 diabetes. This study is looking at the treatment of diabetes after gastric bypass surgery. About 40% of patients do not experience diabetes remission after gastric bypass surgery. Of the patients who initially go into remission, about…
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The CorCinch-HFrEF Study in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF)

Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
This trial is a non-randomized, prospective, multi-center early feasibility study to evaluate the safety and performance of the AccuCinch system in patients with Heart Failure and Reduced Ejection Fraction HFrEF
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A study for adults with growth hormone deficiency using study drug NNC0195-0092

Condition: Endocrine & Metabolic Disease / Growth Hormone Deficiency
Investigator: Pamela Freda, MD
Status: Closed
The purpose of this study is to investigate how well weekly injections of the growth hormone drug NNC0195-0092 works in adults with growth hormone deficiency. Growth hormone deficiency is a disorder that involves the pituitary gland (a small gland located at the base of the brain). The gland produces growth hormone and other hormones (chemical messengers of…
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Ectopic fat in PCOS

Condition: Endocrine & Metabolic Disease
Investigator: Aviva Sopher, MD, MS
Status: Closed
Polycystic ovary syndrome (PCOS) is a common disorder. Young women with PCOS have irregular or absence of menstruation and excessive acne and or hair on their bodies. They may have multiple cysts on their ovaries. Adolescents and women affected with PCOS are at risk of developing abnormalities in their blood including high fat, low HDL cholesterol (good…
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