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

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

Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of TU-100 as an Adjunct to an Enhanced Recovery after Surgery (ERAS) Protocol in Subjects Undergoing Bowel Resection

Date Added
May 4th, 2021
PRO Number
Pro00105858
Researcher
Thomas Curran

List of Studies


Keywords
Digestive System, Surgery
Summary

This study is testing a traditional Japanese medicine called Daikenchuto (TU-100) for restoring gastrointestinal function after bowel resection surgery. Subjects will be randomized to either TU-100 or placebo for up to 10 days after surgery and will be followed for 30 days after surgery.

Institution
MUSC
Recruitment Contact
Caitlin Schaffner
843-792-7558
schaffne@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
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

A Phase 3 Open-Label Clinical Study to Evaluate the Safety and Tolerability of Rebiotix RBX2660 (microbiota suspension) in Subjects with Recurrent Clostridium difficile Infection

Date Added
September 10th, 2019
PRO Number
Pro00089814
Researcher
Scott Curry

List of Studies


Keywords
Digestive System, Infectious Diseases
Summary

An open-label clinical study in which all subjects will receive the same investigational drug, for people with recurrent Clostridium difficile infection (CDI), which is an infection in the intestines. This infection causes severe diarrhea. Recurrent Clostridium difficile (C. diff) infection is being studied as part of a medical research study for an investigational new drug called RBX2660, an enema made of a solution of stool (poop or feces).

Institution
MUSC
Recruitment Contact
Scott Curry
843-876-8646
currysr@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 --