A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome + save

Date Added
September 25th, 2012
PRO Number
Pro00016924
Researcher
Todd Dantzler
Keywords
Bowel, Colonoscopy, Digestive System
Summary

This study will test the effectiveness and safety of JNJ-27018966. The drug is an oral tablet being tested to see if it may be useful in treating patients with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d). Participants will either receive the real drug or placebo.

Institution
MUSC
Recruitment Contact
Stephanie Warth
843-876-7233
warth@musc.edu

Respiratory Phase Training Effects on Swallow Impairment in Head and Neck Cancer + save

Date Added
October 5th, 2009
IRB Number
19238
Researcher
Bonnie Harris
Keywords
Breathing, Cancer/Head & Neck, Digestive System
Summary

This study is investigating a new behavioral swallowing therapy for patients treated for cancers of the head and neck who have received maximum benefit from traditional behavioral swallowing therapy.

You will need to participate in a series of screening tests in order to proceed to the experimental swallowing therapy portion of the study including a chest exam, a cognitive screening, and an x-ray swallow study.

The swallowing studies will take approximately 30 minutes. If you qualify for the treatment portion of the study, there will be two sessions a week for 4 weeks for a total of 8 sessions. Each swallow therapy session will last approximately one hour. Your total study duration will be 12 weeks including the follow-up swallowing study.

The experimental portion of this study includes a new method of training your breathing and swallowing pattern. The goal of the therapy is to improve your swallowing, but this method has not been tested in any known studies. You will undergo 8 weeks of training and attend two one-hour sessions each week.

Institution
MUSC
Recruitment Contact
Anita Cheslek or Julie Blair
843-792-7162
blairju@musc.edu

CCK-Dysregulation: Mechanisms of Abnormal Food Regulation and Obesity + save

Date Added
October 5th, 2009
IRB Number
19449
Researcher
Kelly Holes Lewis
Keywords
Anxiety, Body Composition, Brain, Depression, Digestive System, Disease Prevention, Healthy Volunteer Studies, Hormones, Men's Health, Mental Health, Metabolism, Nutrition, Obesity, Psychiatry, Stress Disorders, Weight Control, Women's Health
Summary

Volunteers are needed for a study designed to help understand why people overeat and become overweight. If you are normal weight or obese and are currently not dieting and haven't been recently, please give us a call. This is a one-day study and compensation is available. As part of this study, you will also be given a complete body composition analysis along with a full detailed report regarding the results of the analysis.

Institution
MUSC
Recruitment Contact
Kelly Holes-Lewis, MD
843-792-0194
holeslew@musc.edu

Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction (EPISOD) + save

Date Added
October 5th, 2009
IRB Number
17712
Researcher
Joseph Romagnuolo
Keywords
Digestive System
Summary

Primary Study Objective: To ascertain whether subjects with SOD III respond to sphincterotomy

Secondary Study Objectives:
To evaluate:
-the association between the results of Sphincter of Oddi Manometry (SOM) (abnormal/normal) and the primary outcome (success/failure)
-the success rate (as defined in the primary) of subjects who receive biliary sphincterotomy alone versus subjects who receive both biliary and pancreatic sphincterotomy in the subgroup of patients with manometrically proven hypertension of the pancreatic sphincter
-the effects of pre-specified prognostic factors on the primary outcome
-anxiety and depression scores over time and their relation to study outcomes
-the economic impact of SOD III, and of endoscopic sphincterotomy in patients with SOD III
-conduct conduct a careful follow-up study (EPISOD2) of standard of care treatment (separate protocol).

Institution
MUSC
Recruitment Contact
Rebekah Whichard, CCRC
(843) 876-7233
richreb@musc.edu

Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction: EPISOD2 - A Naturalistic Follow Up Study + save

Date Added
October 5th, 2009
IRB Number
17713
Researcher
Joseph Romagnuolo
Keywords
Digestive System
Summary

The main purpose of the EPISOD2 research study is to follow patients with suspected Sphincter of Oddi Dysfunction who have had ERCP, Sphincter of Oddi Manometry and possibly a sphincterotomy to see whether these procedures are effective.

Institution
MUSC
Recruitment Contact
Rebekah Whichard, CCRC
(843) 876-7233
richreb@musc.edu