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Displaying 1 - 18 of 18

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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Osteoarthritis of the Knee (STAR OA) Stud

Condition: Bone & Muscle
Investigator: Xiang-Dong Edward Guo, PhD
Status: Currently Recruiting
The Bone Bioengineering Laboratory and Division of Rheumatology at CUIMC are doing a study to learn more about the progression of knee osteoarthritis (OA). We are recruiting patients 55-75 years old who may or may not have OA of the knee(s). This study involves a screening and enrollment visit with annual visits for 3 years. Study activities include a hip…
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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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Study of Women After Menopause who are Taking Medication and/or Receiving Counseling/Therapy for Depression

Condition: Bone & Muscle
Investigator: Marcella Walker, MD
Status: Currently Recruiting
Depression and some antidepressants may be associated with an increased risk of breaking a bone. It is not clear why this could be the case. It is possible that depression and/or certain medications used for the treatment of depression cause bone loss, increase the risk of falls, are associated with lower physical activity, or effects on muscle function.…
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Personalized Approaches to Kidney Bone Core

Condition: Bone & Muscle
Investigator: Mishaela Rubin, MD
Status: Closed
Precision Medicine Approaches to Renal Osteodystrophy is a study designed to discover new markers of how the kidney affects your bone health. This study will evaluate how your bone is reacting to your kidney problem both before and after you start your bone treatment for hyperparathyroidism or osteoporosis. We are looking for people who are interested in…
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Pregnancy and Lactation Associated Osteoporosis Study

Condition: Bone & Muscle
Investigator: Adi Cohen, MD
Status: Closed
We are studying the causes of and potential treatments for pregnancy & lactation-associated osteoporosis (PLO). We know little about the clinical features, causes, and prognosis of PLO. Our goal is to define the clinical characteristics of PLO and better understand similarities/differences among the women. We are looking for women with fractures during/…
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Exploratory Evaluation of 11C-NOP46 (Chronic Pain Patients)

Condition: Bone & Muscle
Investigator: Akiva Mintz, MD, PhD
Status: Closed
Pain is a natural response to injury to let us know there may be damage to our bodies. Pain is the way our body tells us that we must take care of ourselves. Chronic pain is different and lasts for a long time. In some cases, chronic pain remains without any sign of body damage. Today, there is no way for a doctor to measure someone's chronic pain or…
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Study of ATENOLOL to Prevent Bone Loss in Postmenopausal Women

Condition: Bone & Muscle
Investigator: Elizabeth Shane, MD
Status: Closed
The goal of this study is to learn whether treatment with a safe, commonly used drug called ATENOLOL prevents bone loss in women after menopause. Who Qualifies? Healthy post-menopausal women who are between the ages of 50 and 75. You may not be eligible if you have certain medical conditions. What's Involved? If you are eligible, you will be assigned…
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Inflammation in Rotator Cuff Injury and Repair

Condition: Bone & Muscle
Investigator: William Levine, MD
Status: Closed
The shoulder joint is the most mobile joint in the human body, steered by a group of muscles and their respective tendons, together called the rotator cuff. A consequence of this mobility is a vulnerability to degradation, or wear and tear, of tendons and inflammation in the surrounding area. Our study aims to create biological samples and data bank to get…
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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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Bone health in children who are short

Condition: Bone & Muscle
Investigator: Patricia Vuguin, MD
Status: Closed
The purpose of this study is to learn more about the bones in children who are short. This study will help to see if the bones of short children who have low levels of growth hormone or children who are short but have normal levels of growth hormone are any different from children of average height. Bones have spongy inner parts and harder outer parts and…
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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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Small Fiber Neuropathy in Juvenile Fibromyalgia

Condition: Bone & Muscle
Investigator: Alexis Boneparth, MD
Status: Closed
Juvenile fibromyalgia (JFM) is a cause of chronic, whole-body pain. The cause of JFM is unknown. One of the possible causes of JFM is a problem with nerves called "small fiber neuropathy." This is a problem where small nerve fibers in the skin are not working properly and patients can have pain as a result. Recent studies have found evidence of…
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Difficult to walk, climb stairs or get up from a chair? 65 years or older? You may be eligible for a muscle function study (SARA-INT)!

Condition: Bone & Muscle
Investigator: Moise Desvarieux, MD, PhD
Status: Closed
We are looking for people ages 65 and older to help us evaluate if an investigational drug improves muscle function, which can reduce risk of falls and fractures. To be considered for the study, you: 1. Must complete a pre-screening phone interview to assess your eligibility 2. If you are eligible, you will be invited to attend an in-person appointment at…
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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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