A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis Save

Date Added
May 23rd, 2017
PRO Number
Pro00066711
Researcher
Don Rockey

Silhouette
Keywords
Disease Prevention, Drug Studies, Liver, Stage III, Weight Control
Summary

This is a phase 3, randomized, double-blind, placebo controlled study evaluating the safety and efficacy of an investigational drug called selonsertib in subjects with NASH and bridging (F3) fibrosis.
The primary goal of this study is to evaluate whether selonsertib (SEL) can cause fibrosis reversal and reduce progression to cirrhosis and associated complications in subjects with NASH and bridging (F3) fibrosis. The secondary goal of this study is to assess the safety and tolerability of SEL in subjects with NASH and bridging (F3) fibrosis. Subjects will be treated for 240 weeks, and participation in the study can last up to 260 weeks, which includes an 8-week screening period, a 240-week treatment period, and a 4-week follow-up period and a telephone follow-up at 12 weeks after the Week 240 Visit.

Institution
MUSC
Recruitment Contact
Brittiny Bowers
843-876-2184
wulfb@musc.edu

Adolescents' Weight Management- Is there an app for that? Save

Date Added
March 22nd, 2017
PRO Number
Pro00063390
Researcher
Christine Sangiovanni

Silhouette
Keywords
Adolescents, Nutrition, Obesity, Pediatrics, Weight Control
Summary

Interviews of adolescents 13-17 years old in rural and urban areas of South Carolina will be conducted to identify which weight management apps adolescents think are easy to use, engaging and motivating, and fit their needs for help with managing weight. Features that adolescents prefer will be gathered and health care providers can use this information to recommend immediately available, engaging, and helpful resources for weight management.
Our long-term goal is to optimize the use of mobile apps as beneficial and readily accessible resources to assist primary care providers in the management of overweight/obese adolescents. However, prior to determining if an app is efficacious or even feasible, adolescents' preferences for app features need to be assessed.
The objective of this research is to determine which features of apps adolescents think appeal or detract from the acceptability and usability of weight management apps. Our central hypothesis is that adolescents will prefer to use some apps more than others and this will most likely be due to the preferred specific features available in certain apps, such as goal setting and social connection with friends, peers, or providers.

Institution
MUSC
Recruitment Contact
Christine SanGiovanni
843-876-8671
sangiova@musc.edu

A 5-year Longitudinal Observational Study of the Natural History and Management of Patients with Hepatocellular Carcinoma Save

Date Added
February 28th, 2017
PRO Number
Pro00062918
Researcher
David Koch

Silhouette
Keywords
Cancer, Cancer/Gastrointestinal, Cancer/Other, Digestive System, Genetics, Liver, Obesity, Weight Control
Summary

TARGET-HCC is a 5-year, longitudinal, observational study of the natural history and management of patients with HCC. The study will address important clinical questions that remain unanswered in the management of HCC with a unique research registry of participants with HCC from academic and community real-world practices. TARGET-HCC is disease focused, not drug specific, which allows for continuous acquisition of real-world evidence regarding the natural history, management, and outcomes of treatment with current therapies and new treatments that may be utilized in usual clinical practice.

Institution
MUSC
Recruitment Contact
Francis Beylotte
843-876-4273
beylott@musc.edu

A 5-year Longitudinal Observational Study of Patients with Nonalcoholic Fatty Liver or Nonalcoholic Steatohepatitis Save

Date Added
February 28th, 2017
PRO Number
Pro00062843
Researcher
David Koch

Silhouette
Keywords
Disease Prevention, Genetics, Liver, Obesity, Weight Control
Summary

This is a 5-year, longitudinal, observational study of patients with NAFL or NASH designed to specifically address important clinical questions that remain incompletely answered from registration trials. In addition to the study database, a bio specimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.

Institution
MUSC
Recruitment Contact
Francis Beylotte
843-876-4273
beylott@musc.edu

Internet Assisted Obesity Treatment Enhanced with Financial Incentives Save

Date Added
December 11th, 2015
PRO Number
Pro00050601
Researcher
Delia West
Keywords
Obesity, Weight Control
Summary

This randomized, controlled trial seeks to determine whether incorporating financial incentives increases the amount and duration of weight losses achieved by Internet-delivered behavioral treatment. A total of 416 overweight and obese adults at two study sites (University of Vermont and University of South Carolina will be randomized to: (1) Internet intervention; or 2) Internet intervention plus financial incentives for implementation of key self-management behaviors (daily self-weighing, self-monitoring of dietary intake and achieving step goals) (Internet+Incentives). All participants will receive the same 36-session web-based group weight control program which features synchronous, facilitated chats and online behavioral tools. Assessments will be conducted at 2, 6, 12- and 18 months and will include measures of body weight, treatment engagement (e.g., attendance, self-monitoring, website utilization, motivational factors, weight control behaviors).

Institution
USC
Recruitment Contact
Briana Davis
(803) 576-5807
brianad@mailbox.sc.edu

Weight Loss in Patients with Heart Failure and Preserved Ejection Fraction: A Supervised Diet and Lifestyle Intervention (WTLSSCHF) Save

Date Added
July 21st, 2015
PRO Number
Pro00040117
Researcher
Sheldon Litwin

Silhouette
Keywords
Cardiovascular, Weight Control
Summary

This is a study in which subjects who have heart failure and normal heart pumping function are enrolled in a weight management program. The study will examine the subject's symptoms, exercise capacity and bloodwork to see if there is improvement while on the weight management program and as they transition to a healthly diet and lifestyle.

Institution
MUSC
Recruitment Contact
Lindsey Stewart
(843) 792-1238
stew@musc.edu

Enhancing Quality and Access to Lifestyle Counseling and Health Behavior Change in Racial and Ethnic Minorities- A Practice-Based Research Network Dissemination and Implementation Project Save

Date Added
August 20th, 2014
PRO Number
Pro00033650
Researcher
Chanita Hughes-halbert

Silhouette
Keywords
Obesity, Weight Control
Summary

Racial and ethnic minorities continue to experience significant disparities in quality and access to physician counseling about lifestyle health behavior change. This study focuses on the identification of evidence-based strategies for lifestyle modification and health behavior counseling in primary care. Through this, we will be able to work collaboratively with investigators, health care providers and patients to identify priorities and preferences of healthcare providers and patients to develop practice-based interventions that will effectively address these disparities in primary care settings.

Institution
MUSC
Recruitment Contact
Melanie Jefferson
843-876-2430
sweatma@musc.edu

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