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Displaying 1 - 22 of 22

Ultra-Processed Food Effect on Weight Change

Condition: Obesity
Investigator: Kathryn Whyte, PhD, RDN
Status: Currently Recruiting
The purpose of this study is to assess energy balance during two different diet periods.
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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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Weight Loss Study: Genetic Variations and Response to Naltrexone/Bupropion

Condition: Obesity
Investigator: Judith Korner, MD
Status: Currently Recruiting
The purpose of this study is to evaluate if genetic variations are associated with the amount of weight loss with diet and while taking an FDA-approved medication for weight loss. The participation lasts ten months and includes six in-person visits at CUIMC with blood sampling and questionnaires, virtual nutritional counseling, and taking an oral weight…
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POWERS - Understanding Body Changes After Weight Loss

Condition: Obesity
Investigator: Rudolph Leibel, MD
Status: Currently Recruiting
The Physiology of the Weight Reduced State (POWERS) is a national research study designed to discover and learn what happens to the human body after weight loss and to learn why some people regain their lost weight. Understanding why this happens could help health professionals improve strategies for successful weight loss maintenance after weight loss.…
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Effect of lowering insulin levels on blood sugar

Condition: Obesity
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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Early Age-Related Hearing Loss Investigation (EARHLI)

Condition: Ear, Nose and Throat / Hearing Loss
Investigator: Justin Golub, MD, MS
Status: Currently Recruiting
Early Age-Related Hearing Loss Investigation (EARHLI) is a study to obtain information on how a hearing aid-based intervention can prevent cognitive decline in those at risk for Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD). Age-related hearing loss (ARHL) is the third most common chronic condition in older adults. The…
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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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Temporary Insulin Resistance

Condition: Obesity
Investigator: Joshua Cook, MD, PhD
Status: Currently Recruiting
We are recruiting volunteers, aged 18-70, 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 temporarily induce or accentuate insulin resistance in 14…
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Biobank of Blood Samples from Overweight or Obese Patients

Condition: Obesity
Investigator: Joshua Cook, MD, PhD
Status: Currently Recruiting
We are seeking adult volunteers with body mass index in the obesity range (30-45 kg/m2) to come in for a single study visit where they answer some health questions and have a small volume of blood drawn (25 cc/1.7 tbsp). We will measure levels of the blood sugar-lowering hormone insulin as well as glucose (sugar), certain fats, and other molecules related…
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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: Obesity
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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Speech Perception in Hearing Impaired Listeners

Condition: Ear, Nose and Throat / Hearing Loss
Investigator: Nima Mesgarani, PhD
Status: Currently Recruiting
The purpose of this study is to learn more about the mechanisms of hearing loss, specifically to learn how abnormalities in the brain may produce certain experiences that are common in patients with hearing loss. Individuals with hearing loss will be compared to individuals with normal hearing.
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Pancreatic Clamp Study: Lowering Insulin Levels During Temporary Insulin Resistance

Condition: Obesity
Investigator: Joshua Cook, MD, PhD
Status: Closed
We're conducting a research study on how much insulin is needed to control blood sugar in people who are made temporarily resistant to insulin's effects. Insulin is the main hormone (chemical signal) that the body uses to lower the levels of sugar in the blood. We are interested in looking at insulin levels because we think that lowering insulin…
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Effect of Lowering Insulin Levels on Blood Sugar

Condition: Obesity
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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A Study of the Gene Therapy CGF166 in Patients with Severe-to-Profound Hearing Loss

Condition: Ear, Nose and Throat / Hearing Loss
Investigator: Lawrence Lustig, MD
Status: Closed
The purpose of this research is to find out whether it is safe to use a virus to deliver a new gene to the inner ear of people with hearing loss. This is a kind of gene therapy which involves gene transfer. Once the genetic material and vector are surgically administered to you, it is not possible to remove these agents. The study is designed to evaluate…
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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 to Assess Safety and Effectiveness of Study Drug OTO-104 in Patients at Risk of Hearing Loss From Cisplatin Chemotherapy

Condition: Ear, Nose and Throat / Hearing Loss
Investigator: Alice Lee, MD
Status: Closed
Cisplatin is a chemotherapy medicine that is used to treat a variety of cancers. At high total (cumulative) doses it can be associated with progressive and irreversible hearing loss. The purpose of this study is see if injections of OTO-104 can protect against hearing loss associated with cisplatin therapy in the treatment of cancer. OTO-104 contains an…
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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 Adults with Sudden Sensorineural Hearing Loss Using the drug Am-111 to Evaluate its Effectiveness in Restoring Hearing Loss

Condition: Ear, Nose and Throat / Hearing Loss
Investigator: Anil Lalwani, MD
Status: Closed
Acute inner ear hearing loss is the sudden onset of hearing loss, usually in one ear, without any known cause. Acute hearing loss can permanently destroy some of the hair cells (that govern the sense of hearing) and / or hearing nerve in the inner ear.The drug AM-111 has been developed to protect the hearing cells and nerve following sudden inner ear…
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