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Clinical Studies
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Does Pulmonary Rehabilitation Improve Frailty and Sarcopenia in End Stage Liver Disease?
Rochester, Minn.
The purpose of this study is to assess the impact of exercise on sarcopenia and frailty. The exercise that will be performed in this study will include either pulmonary rehabilitation or a formal home based video strengthening program
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Effects of a Structured, Modified Mediterranean Dietary Intervention After Liver Transplantation (MEDITRAN)
Rochester, Minn.
The purposes of this study are to prospectively evaluate the effects of a structured, modified Mediterranean diet on post-liver transplant weight gain and development of PTMS, to prospectively evaluate the effects of a structured, modified Mediterranean diet on cardiovascular outcomes post-liver transplantation, and to prospectively evaluate the effects of a structured, modified Mediterranean diet on development or recurrence or de novo NAFLD/NASH in liver-transplant patients.
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Mechanisms of Weight Gain at 4 and 12 Months in Patients Post-Liver Transplantation
Rochester, Minn.
The purpose of this study is to understanding the mechanisms of weight gain in patients following liver transplantation, action, and indicate approaches to prevent weight gain.
Closed for Enrollment
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A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects With Nonalcoholic Steatohepatitis (REGENERATE)
Rochester, Minn.
The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.
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A Placebo-Controlled, Multicenter, Double-Blind, Randomized Trial of IDN-6556 in Subjects With Non-Alcoholic Fatty Liver Disease and Raised Transaminases
Rochester, Minn.
The purpose of this study is to determine the safety and efficacy of IDN-6556 compared to placebo in patients with diagnosed fat deposits in their liver (not caused by alcohol) and with abnormal liver tests
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A Registry for Subjects with Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment with a Sofosbuvir-Based Regimen without Interferon for Chronic Hepatitis C Infection
Rochester, Minn.
The purpose of this registry is to enroll patients who have cirrhosis with a sustained viral response after receiving a sofosbuvir-based treatment without interferon, either while participating in a Gilead-sponsored hepatitis C virus study or commercially at selected sites. Once enrolled, the patients will be followed for up to 5 years.
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Does Pulmonary Rehabilitation Improve Frailty and Sarcopenia in End Stage Liver Disease?
Scottsdale/Phoenix, Ariz.
The purpose of this study is to assess the impact of exercise on sarcopenia and frailty. The exercise that will be performed in this study will include either pulmonary rehabilitation or a formal home based video strengthening program
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Efficacy and Safety of Endoscopic Balloon Placement in Cirrhotic Patients Awaiting Liver Transplantation
Rochester, Minn.
The purpose of this study is to determine whether the ORBERA Intragastric Balloon is a safe and effective means for weight loss and improved metabolic disease in patients with cirrhosis requiring liver transplantation.
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Exercise Intervention and Its Impact on Hospitalization - a Mulitcentered Study
Jacksonville, Fla.,
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
Skeletal muscle abnormalities (sarcopenia) and frailty are common complications seen in patients with end-stage liver disease. The presence of these complications portends poor prognosis. The purpose of this study is to assess the impact of a formal home based video strengthening program (REST) on sarcopenia and frailty. We also want to assess the impact of this exercise program on complication rates, hospitalization, on quality of life (QOL) and on survival.
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Microbiome in Liver Transplant Recipients and Associations with Infection and AlloGraft Rejection
Rochester, Minn.
The purpose of this study is to examine the changes in the gut microbiome of patients before and after liver transplantation, including the donor organ microbiome changes to understand how these changes are related to organ rejection, recurrent disease or infection post transplant.
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Post-transplant NASH Protocol to Assess the Development of Metabolic Co-morbidities and Disease Recurrence in Those Transplanted for NASH Cirrhosis
Rochester, Minn.
The purpose of this study is to identify risk factors and potential predictors for NAFLD and NASH recurrence after liver transplantation.
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Prospective, Cross-sectional Study Evaluating the Diagnosis Accuracy of the Controlled Attenuation Parameter(CAP) Measured by FibroScan® (With M and XL Probe) in Patients Referred for Clinically-Indicated Liver Biopsy
Rochester, Minn.
We purpose of this study is to evaluate the diagnosis accuracy of the Controlled Attenuation Parameter (CAP) measured by FibroScan® (both with M and XL probes) in all patients who are undergoing liver biopsy for any liver disease.
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Sarcopenia and Debility Post-Liver Transplant – A Multicentre Study
Rochester, Minn.
Diagnosing sarcopenia using modalities that can be used in routine clinical care is important. Our study will aim to assess the efficacy of the sarcopenia model. If results from this model are highly correlated to the gold standard, CT, then its use will allow for assessment of sarcopenia in routine clinical care.
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