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.
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.
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.
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).
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.
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.