Comparison of Length of Stay for Infants with GBS Unknown Mothers with Adequate vs Inadequate Treatment Save

Date Added
April 6th, 2018
PRO Number
Pro00077255
Researcher
Rachel Sigrest
Keywords
Children's Health, Disease Prevention, Infant, Non-interventional, Obstetrics and Gynecology, Pediatrics, Pregnancy, Women's Health
Summary

The primary investigators/residents have noted during clinical rotations that a significant number of GBS unknown mothers at SRHS are being treated with intrapartum antibiotics even without the presence of risk factors, presumably to decrease postpartum/neonatal length of stay.
Our study, a retrospective chart review, will determine whether or not length of stay is affected by treating GBS unknown mothers with intrapartum antibiotics in the absence of the aforementioned risk factors.
Potential benefits include the cost-effectiveness of decreased length of stay for these patients as well as decreased exposure to nosocomial infections for neonates. However, antibiotic stewardship and patient safety are also considerations. Another potential option for these patients is rapid GBS testing with PCR which can provide results in 1-2 hours compared with 24-48 hours for the standard culture. PCR is not currently available at SMC.

Institution
Spartanburg
Recruitment Contact
Rachel Sigrest
8643800885
racheljames1985@gmail.com

A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease Save

Date Added
October 24th, 2017
PRO Number
Pro00070046
Researcher
Nilesh Lodhia

Silhouette
Keywords
Crohn's Disease, Disease Prevention
Summary

This is a 5 year observational study of patients with Inflammatory Bowel Disease (IBD), which includes Crohn's disease, Ulcerative colitis and Indeterminate colitis, to learn more about people who have IBD and the medications that they take. The study includes an optional biospecimen repository to investigate viral resistance, genomics, and biomarkers, and that retrospective data on these IBD patients will be reserved.

Institution
MUSC
Recruitment Contact
Jamila Keith
843-876-7233
keithja@musc.edu

Empowering Rural Teens through Photovoice to Influence the Health of their Community Save

Date Added
July 28th, 2017
PRO Number
Pro00067937
Researcher
Michelle Nichols

Silhouette
Keywords
Adolescents, Disease Prevention, Environmental Factors, Ethnicity and Disease, Exercise, Minorities, Non-interventional, Nutrition, Obesity
Summary

This study will recruit adolescents who are enrolled in a Teen Health Careers Program to participate in a community-engaged study. This study will seek to understand the barriers and facilitators to physical activity and nutritious foods throughout their daily lives. Adolescents will use take digital images to capture aspects of their daily lives using photography.

Institution
MUSC
Recruitment Contact
Michelle Nichols
(843) 792-1802
nicholmg@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis Save

Date Added
May 23rd, 2017
PRO Number
Pro00066711
Researcher
Don Rockey

Silhouette
Keywords
Disease Prevention, Drug Studies, Liver, Stage III, Weight Control
Summary

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.

Institution
MUSC
Recruitment Contact
Brittiny Bowers
843-876-2184
wulfb@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH) Save

Date Added
May 23rd, 2017
PRO Number
Pro00066720
Researcher
Don Rockey

Silhouette
Keywords
Disease Prevention, Drug Studies, Liver, Stage III
Summary

This is a Phase 3, randomized, double-blind, placebo-controlled study
evaluating the safety and efficacy of a drug called selonsertib in subjects with compensated cirrhosis due to non-alcoholic steatohepatitis (NASH). The primary goal of this study is to evaluate whether selonsertib (SEL) can reverse the liver fibrosis seen in patients with NASH cirrhosis and reduce the potential complications associated with cirrhosis. A secondary goal of this study is to assess the safety and tolerability of the drug, selonsertib, in subjects with NASH cirrhosis. Participation in this 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 visit 12 weeks after the week 240 visit.

Institution
MUSC
Recruitment Contact
Brittiny Bowers
843-876-2184
wulfb@musc.edu

INtervention Study In overweiGHT patients with COPD (INSIGHT COPD) Save

Date Added
March 21st, 2017
PRO Number
Pro00062895
Researcher
Tatsiana Beiko

Silhouette
Keywords
Disease Prevention, Exercise, Lung, Nutrition, Obesity, Pulmonary
Summary

We are conducting the INSIGHT COPD study because symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap. There are many medications for patients with COPD, but there is little mention of weight loss as a possible treatment in current research. We are trying to find out if a lifestyle program that promotes modest weight loss and increased physical activity will improve COPD symptoms and lead to better exercise tolerance for those with a high BMI. We are also looking at the effects on shortness of breath, quality-of-life, and cardiovascular disease risk factors. The INSIGHT COPD trial is taking place at many sites across the United States including MUSC, and is planning to enroll approximately 1000 people.

Institution
MUSC
Recruitment Contact
Danielle Woodford
(843) 792-6280
woodfordd@musc.edu

A 5-year Longitudinal Observational Study of Patients with Nonalcoholic Fatty Liver or Nonalcoholic Steatohepatitis Save

Date Added
February 28th, 2017
PRO Number
Pro00062843
Researcher
David Koch

Silhouette
Keywords
Disease Prevention, Genetics, Liver, Obesity, Weight Control
Summary

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.

Institution
MUSC
Recruitment Contact
Francis Beylotte
843-876-4273
beylott@musc.edu

The Influence of Colorectal Cancer Risk Factors within Normal Colonic Mucosa and Colon Polyps: A Feasibility Study Save

Date Added
January 17th, 2017
PRO Number
Pro00060146
Researcher
Kristin Wallace

Silhouette
Keywords
Cancer, Cancer/Gastrointestinal, Colonoscopy, Disease Prevention, Immune System, Inflammation, Minorities
Summary

The purpose of the study is to determine the feasibility of enrolling patients, obtaining colorectal cancer risk factor data via an in-person questionnaire, and procuring three types of biologic samples (normal mucosa biopsies, a salvia sample, and polyp tissue (if applicable)).

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
8438762445
blanke@musc.edu

Randomized Trial to Prevent Vascular Events in HIV ? REPRIEVE (A5332) Save

Date Added
June 16th, 2015
PRO Number
Pro00042920
Researcher
Allison Eckard

Silhouette
Keywords
Cardiovascular, Cholesterol, Disease Prevention, Drug Studies, Heart, HIV / AIDS, Infectious Diseases
Summary

Pitavastatin lowers high cholesterol and triglyceride levels in the blood. The primary purpose of this study is to determine the effects of pitavastatin on lowering the traditional risk factors for cardiological events in patients who have HIV.

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

CureGN: Cure Glomerulonephropathy Network Save

Date Added
December 2nd, 2014
PRO Number
Pro00038759
Researcher
Katherine Twombley

Silhouette
Keywords
Adolescents, Children's Health, Disease Prevention, Kidney, Minorities, Pediatrics
Summary

Adult and Pediatric patients with glomerular disease:
Patients of all ages are needed to participate in a research study to investigate glomerular disease and create a worldwide database to help in the research and future treatment of this disease. To join this study, you must have a type of glomerular disease, have had a first kidney biopsy within the last 5 years, not be on dialysis, or not have had a kidney transplant.

The study is projected to last 4 years, and all study procedures will be done at regular clinic visits (between 1 and 3 yearly). Study procedures include filling out questionnaires and a blood draw at each visit.

Compensation is available for study participation.

Institution
MUSC
Recruitment Contact
Lauren Card
843-792-5935
cardl@musc.edu

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