A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase IIb Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Combination Compared to Zibotentan Monotherapy as well as Zibotentan/Dapagliflozin and Zibotentan Monotherapy Compared to Placebo in Participants with Cirrhosis

Date Added
April 9th, 2024
PRO Number
Pro00134733
Researcher
Don Rockey

List of Studies


Keywords
Body Composition, Digestive System, Drug Studies, Hepatology, Liver
Summary

The purpose of this study is to evaluate the safety of combined zibotentan/dapagliflozin, zibotentan by itself, and a placebo in patients with cirrhosis to evaluated which treats fluid retention the best.

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
8438768439
blanke@musc.edu

A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants with Primary Biliary Cholangitis (PBC)

Date Added
February 26th, 2024
PRO Number
Pro00130418
Researcher
Don Rockey

List of Studies


Keywords
Digestive System, Drug Studies, Hepatology, Liver, Rare Diseases
Summary

The main goal of this study is to evaluate how well taking oral elafibranor 80 mg daily works, compared to a placebo, in reducing or preventing the occurrence of death, liver transplant, worsening of liver disease, and liver disease-related complications in adults with PBC.

Institution
MUSC
Recruitment Contact
Joshua Inman
(843) 876-4303
inmanj@musc.edu

Occult Gastrointestinal Bleeding Caused by Portal Hypertensive Gastropathy in Patients with Cirrhosis

Date Added
May 11th, 2023
PRO Number
Pro00121305
Researcher
Don Rockey

List of Studies


Keywords
Digestive System, Liver, Stomach
Summary

In this study, we will recruit cirrhotic patients who are undergoing endocscopic procedures as part of their standard of care. Their endoscopies will reveal whether they have portal hypertensive gastropathy. After the procedure, we will ask the patients to provide us with a stool sample, which we will assess for occult GI bleeding. For those patients who DO NOT have occult GI bleeding, they will be contacted every 6 months for 2 years to check whether they have developed GI bleeding.

Institution
MUSC
Recruitment Contact
Sara Hatoum
843 792 0650
hatoum@musc.edu

Pediatrics Biorepository for Gastroenterology Clinical Research

Date Added
March 7th, 2023
PRO Number
Pro00126239
Researcher
Benjamin Kuhn

List of Studies

Keywords
Digestive System, Esophagus, Inflammation
Summary

This proposal is to contribute to data registry and sample bank called Pediatrics Biorepository for Gastroenterology Clinical Research. Samples collected in this study may be used for future research which plan to advance the state of science in the hopes to develop novel diagnostic approaches and identify therapeutic targets.

Institution
MUSC
Recruitment Contact
Benjamin Kuhn
(843) 876-0444
kuhnbe@musc.edu

CorEvitas Inflammatory Bowel Disease (IBD) Drug Safety and Effectiveness Registry

Date Added
June 8th, 2022
PRO Number
Pro00120887
Researcher
Erin Forster

List of Studies


Keywords
Crohn's Disease, Digestive System, Non-interventional
Summary

This is a prospective, observational research study for patients with IBD under the care of a gastroenterologist provider. The objective of the Corrona Inflammatory Bowel Diseases (IBD) Registry is to create a national cohort of patients with IBD.The diseases under study include Crohn's Disease (CD), Ulcerative Colitis (UC) and Indeterminate Colitis (IC). Data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of IBD .Approximately 10,000 patients and 150 clinical sites in North America will be recruited to participate with no defined upper limit for either target. The Corrona IBD Registry is a long-term observational study; therefore, the duration of the registry has no pre-determined stop date.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-1221
recruitment@musc.edu

CorEvitas Inflammatory Bowel Disease (IBD) Drug Safety and Effectiveness Registry

Date Added
June 8th, 2022
PRO Number
Pro00120887
Researcher
Erin Forster

List of Studies


Keywords
Crohn's Disease, Digestive System, Non-interventional
Summary

This is a prospective, observational research study for patients with IBD under the care of a gastroenterologist provider. The objective of the Corrona Inflammatory Bowel Diseases (IBD) Registry is to create a national cohort of patients with IBD.The diseases under study include Crohn's Disease (CD), Ulcerative Colitis (UC) and Indeterminate Colitis (IC). Data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of IBD .Approximately 10,000 patients and 150 clinical sites in North America will be recruited to participate with no defined upper limit for either target. The Corrona IBD Registry is a long-term observational study; therefore, the duration of the registry has no pre-determined stop date.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Zerlinna Teague
(843) 792-1221
recruitment@musc.edu

International Intestinal Failure Registry

Date Added
August 4th, 2021
PRO Number
Pro00112520
Researcher
Candi Jump

List of Studies


Keywords
Digestive System, Metabolism, Nutrition, Rare Diseases
Summary

The International Intestinal Failure Registry (IFR) is an initiative of the Intestinal Rehabilitation and Transplant Association (IRTA) and The Transplantation Society (TTS) and will be managed by these organizations. The primary objective of this project is to create a large international database of children with intestinal failure to characterize their management and outcome and guide the development of best practices and evidence-based management.

The primary objective of this project is to create a large international database of children with intestinal failure to characterize their management and outcome and guide the development of best practices and evidence-based management.

Institution
MUSC
Recruitment Contact
Candi Jump
843-792-5021
jump@musc.edu

RETHINK REFLUX Registry Research to further inform thinking about the role of LINX for Ref lux Disease

Date Added
November 17th, 2020
PRO Number
Pro00105721
Researcher
Jeffrey Thomas

List of Studies

Keywords
Digestive System, Esophagus, Stomach
Summary

It is well understood that gastroesophageal reflux disease (GERD) is a serious health condition.1 GERD, which often manifests as heartburn or regurgitation, is a chronic disorder associated with substantial morbidity and has a major adverse impact on patients quality of life.2, 3 Currently, there are limited options for GERD patients seeking a surgical option to treat their disease. One option for anti-reflux surgery is the LINX® Reflux Management System.4 The RETHINK REFLUX Registry (Research to further inform thinking about the role of LINX for Reflux Disease) will monitor long-term outcomes in the areas of safety, effectiveness, health economics and healthcare utilization over 10 years post-LINX surgery.

Institution
Self Regional Healthcare
Recruitment Contact
Heather Rich
864-943-2416
heather.rich@selfregional.org

Protocol for the Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial

Date Added
October 16th, 2019
PRO Number
Pro00093020
Researcher
Thomas Curran

List of Studies


Keywords
Digestive System, Inflammation, Surgery
Summary

The goal of the COSMID (Comparison of Surgery and Medicine on the Impact of Diverticulitis) trial is to determine if elective colectomy is more effective than best medical management for patients with quality of life-limiting diverticular disease. The COSMID trial focuses on both patient-reported outcomes and clinical outcomes that matter to patients. The results are expected to establish an evidence-based approach to the care of millions of patients per year in the United States and help people impacted by this common condition make more informed treatment decisions.

Institution
MUSC
Recruitment Contact
Kandace Taylor
843-792-7082
taylokan@musc.edu

Comparison of 24-hours versus 72-hours of octreotide infusion along with endoscopic therapy in preventing early rebleed from esophageal varices: a multi-center, randomized clinical study

Date Added
July 16th, 2013
PRO Number
Pro00027015
Researcher
Don Rockey

List of Studies


Keywords
Digestive System, Esophagus, Liver, Vascular
Summary

The study will compare two durations of treatment with Octreotide in patients with confirmed esophageal variceal hemorrhage who have undergone successful endoscopy and possible endoscopic therapy for control of bleeding. All procedures including the treatment are the standard of care. Octreotide infusion and endoscopic therapy for esophageal variceal bleeding are not investigational.

Institution
MUSC
Recruitment Contact
Mary Hart
843-876-8439
hartmm@musc.edu



-- OR --