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
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

Advancing Treatment for Pancreatitis: A Prospective Observational Study of TPIAT (POST) Save

Date Added
August 16th, 2016
PRO Number
Pro00055080
Researcher
Katherine Morgan
Keywords
Diabetes, Digestive System, Insulin, Pancreas, Surgery, Transplant
Summary

The purpose of this research study is to learn more about the outcomes of total pancreatectomy with islet autotransplantation (TPIAT). Total pancreatectomy is the removal of the pancreas and islet autotransplantation is the placement of the insulin producing cells back into you to prevent diabetes. This study is looking to enroll patients who are scheduled to have a TPIAT surgery to treat pancreatitis (inflammation and scarring of the pancreas).

In addition to the routine care for pancreatitis and TPIAT surgery, participation in this study will involve completion of some brief surveys about the subject's health before TPIAT, at 6 months after TPIAT, and each year after the TPIAT surgery for 4 years, as well as a lab test conducted at each of the follow-up visits.

Institution
MUSC
Recruitment Contact
Christine Perez Rosa
843-792-0387
perezaro@musc.edu

A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of Humira® (Adalimumab) in Pediatric Patients with Moderately to Severely Active Crohn's Disease (CD) ? CAPE Save

Date Added
June 16th, 2016
PRO Number
Pro00046546
Researcher
Jose Quiros
Keywords
Bowel, Crohn's Disease, Digestive System, Pediatrics
Summary

A Crohn's Disease Registry for pediatric patients (between the ages of 6 and 17 years) with moderately to severely active Crohn's Disease (CD), who are already taking Humira® (Adalimumab) to treat their condition. Data from the participant's medical record will be collected to study the long-term safety and effectiveness of Humira®. The Registry expects to collect data for 10 years. No study drug will be given.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
843-792-1213
choudhar@musc.edu

A Phase Ib/IIa Randomized, Placebo Controlled Study of the Safety and Efficacy of Once Daily Dosing of STP206 in Premature Very Low Birth Weight and Extremely Low Birth Weight Neonates Save

Date Added
April 26th, 2016
PRO Number
Pro00048200
Researcher
Sarah Taylor
Keywords
Bowel, Digestive System, Disease Prevention, Infant, Nutrition, Pediatrics
Summary

The Sponsor is conducting a clinical study with STP206 for the prevention of Necrotizing Enterocolitis (NEC) in preterm infants weighing less than 4.4 lbs. (2000g). NEC is the most common serious disease of the gut in preterm infants. The purpose of this study is to look at the safety of STP206 in babies born early, and to get early information on whether STP206 may prevent NEC.

STP206 is an investigational product, meaning it is not yet approved by the US Food and Drug Administration for use in the United States. STP206 contains live bacteria and is considered a Live Biotherapeutic. The two types of bacteria are Lactobacillus and Bifidobacteria. These bacteria are used in foods such as cheese, yogurt, sauerkraut, and pickles, and have been consumed safely for years and are commonly contained in probiotic products that are currently sold throughout the world. These bacteria also are normally present in parts of the body such as bowel, mouth, skin, and the vagina. These bacteria generally do not cause disease. There have been studies of probiotic bacteria in premature babies that suggest these types of bacteria are effective in preventing NEC. The purpose of this study is to determine the safety of STP206 and if it is effective in preventing NEC.

Institution
MUSC
Recruitment Contact
Kenreka Yeadon
792-0601
yeadon@musc.edu

Elucidating Mechanisms of Treatment Relapse for Interferon-Free HCV Therapy Save

Date Added
August 18th, 2015
PRO Number
Pro00046669
Researcher
Eric Meissner
Keywords
Digestive System, HIV / AIDS, Immune System, Infectious Diseases, Liver
Summary

Treatment of chronic hepatitis C virus (HCV) infection is now possible with all oral medications. While most patients achieve a sustained virologic response (SVR) after treatment, synonymous with cure, some patients relapse after treatment for reasons that are unclear. The goal of this research is to understand how a person's immune system changes during treatment of HCV infection with all oral therapy, and how these changes might impact the chances of relapse after treatment. To address these questions, blood and clinical information will be collected from study participants over the course of receiving standard of care treatment for HCV infection. This blood and clinical information will be used to conduct laboratory research focused on the immune system.

Institution
MUSC
Recruitment Contact
Stephanie Warth
843-792-5491
warth@musc.edu

Gene Discoveries in Subjects with Crohn?s Disease of African Descent Save

Date Added
September 2nd, 2014
PRO Number
Pro00034427
Researcher
Jose Quiros
Keywords
Bowel, Children's Health, Crohn's Disease, Digestive System, Ethnicity and Disease, Genetics, Minorities, Pediatrics
Summary

A minimum of 1000 AA subjects with IBD will be recruited in the 4 year period; from Emory, Grady and Children?s Healthcare of Atlanta. And a total of 2500 patients form the collaborating institutions.

The primary investigative design will be a paired case-control study. This study will be similar to other IRB approved protocols in which DNA, serum, are collected from children and adults with and without IBD for the purpose of genotype analysis.

Institution
MUSC
Recruitment Contact
Mohammed Al Gadban
843-792-4837
algadban@musc.edu

The Effect of Voluntary Pharyngeal Swallowing Maneuvers on Esophageal Swallowing Physiology in Patients with Dysphagia Save

Date Added
March 4th, 2014
PRO Number
Pro00030431
Researcher
Ashli O'rourke
Keywords
Digestive System, Esophagus
Summary

In this study, patients undergoing a Modified Barium Swallowing Study (MBSS) will also have a high resolution pharyngeal and esophageal manometry catheter in place to measure the pressures generated by the throat (pharynx) and esophagus (food pipe) during swallowing. Certain swallowing behaviors (such as performing an "effortful swallow") will be done to see how these behaviors might affect the swallowing mechanism as a whole.

Institution
MUSC
Recruitment Contact
Ashli O'Rourke
843-876-0112
aorourke@musc.edu

Assessment of Optimal Time to Repeat Endoscopy Following Primary or Secondary Prophylaxis of Esophageal Varices with Band Ligation: A Randomized, Prospective Trial Save

Date Added
July 16th, 2013
PRO Number
Pro00027001
Researcher
Don Rockey
Keywords
Circulation, Digestive System, Esophagus, Liver, Vascular
Summary

This study is to find the best time that a follow up appointment can be scheduled to benefit the patient with liver cirrohis to return after having the bleeding vessels in the esophagus repaired by directing a scope in the esophagus and using bands to stop the bleeding.

Institution
MUSC
Recruitment Contact
Yusuf Shami
843-876-8439
shami@musc.edu

Octreotide Duration Study Save

Date Added
July 16th, 2013
PRO Number
Pro00027015
Researcher
Don Rockey
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 with esophageal banding, hemoclipping, and/or saline and/or ethanolamine injection are not investigational.

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

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