Effect and safety of semaglutide 2.4 mg once-weekly as adjunct to intensive behavioural therapy in subjects with overweight or obesity Save

Date Added
June 26th, 2018
PRO Number
Pro00078980
Researcher
Patrick O'neil
Keywords
Drug Studies, Obesity, Weight Control
Summary

The study seeks to determine how well semaglutide, the study medication, works in people suffering from overweight or obesity over a period of 68 weeks along with a 7-week follow-up period. Participants will be randomly assigned to receive semaglutide or an inactive placebo. All participants will receive intensive lifestyle change counseling including a low-calorie diet. Participants will inject themselves once-weekly with study medication. The primary measure of the study will be weight change.

Institution
MUSC
Recruitment Contact
Mary Harley
843-792-5428
harleyma@musc.edu

Effect and safety of semaglutide 2.4 mg once-weekly in subjects with overweight or obesity Save

Date Added
May 22nd, 2018
PRO Number
Pro00077418
Researcher
Patrick O'neil
Keywords
Drug Studies, Obesity, Weight Control
Summary

The study seeks to determine how well semaglutide, the study medication, works in people suffering from overweight or obesity over a period of 68 weeks along with a 7-week follow-up period. Participants will be randomly assigned to receive semaglutide or an inactive placebo. All participants will receive diet and physical activity counseling. Participants will inject themselves once-weekly with study medication. The primary measure of the study will be weight change.

Institution
MUSC
Recruitment Contact
Mary Harley
843-792-5428
harleyma@musc.edu

Improving Healthy Outcomes through Fresh Food Access Save

Date Added
April 18th, 2018
PRO Number
Pro00073034
Researcher
Mark Humphrey
Keywords
Diabetes, Hypertension/ High Blood Pressure, Nutrition, Obesity
Summary

The proposed project recognizes the relationship between food insecurity and social determinants of health. By developing a strong clinic/organization linkage between specific Palmetto Health clinics and FoodShare, we will be able to determine if increasing access to fresh produce through an every other week produce box, participation in cooking classes, and clinician reinforcement improves health outcomes for patients who are identified as food insecure.

Institution
Palmetto
Recruitment Contact
Beverly Wilson
803-665-7800
beverly.wilson@uscmed.sc.edu

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects with Bridging (F3) Fibrosis or Compensated Cirrhosis (F4) due to Nonalcoholic Steatohepatitis (NASH) Save

Date Added
April 10th, 2018
PRO Number
Pro00076641
Researcher
Don Rockey
Keywords
Diabetes, Digestive System, Drug Studies, Exercise, Hypertension/ High Blood Pressure, Liver, Men's Health, Metabolism, Nutrition, Obesity
Summary

This is a Phase 2, randomized, double-blind, placebo-controlled study
evaluating the safety and efficacy of SEL, GS-0976, GS-9674, and
combinations in subjects with bridging fibrosis or compensated
cirrhosis due to NASH.
Subjects meeting the study's entry criteria will be randomly assigned in
a 2:2:1:1:1:1:2 ratio to 1 of 7 treatment groups, with approximately
70 subjects in each combination treatment group and approximately 35
subjects in each single agent or placebo group.

Institution
MUSC
Recruitment Contact
Megan Bickford
843-876-8439
liverstudies@musc.edu

Positive Psychotherapy for Emerging Adult Females with Obesity Save

Date Added
January 2nd, 2018
PRO Number
Pro00072810
Researcher
Lillian Christon arnold
Keywords
Obesity, Women's Health
Summary

Emerging adults with obesity are at risk of developing further health problems as they progress into adulthood. There are limited interventions developed for this population, and no interventions specifically study the role of mood and positive affect on improving motivation for healthy lifestyles. Positive psychological wellbeing is linked to improved cardiometabolic risk and health via improved health behaviors and biological functioning. Given biological and psychological differences between males and females during this transition period, targeted interventions for each gender are needed. In this small pilot study, Quality of Life Therapy (QOLT), an empirically-supported and manual-guided intervention combining CBT and positive psychology techniques, will be adapted for emerging adult females with obesity. For this small pilot, we will use a sample of emerging adult females with obesity (EAO) 18-25 years to refine and test feasibility of QOLT adapted for this specific population (QOLT-EAO), with a focus on developing motivation for healthy lifestyles.

Institution
MUSC
Recruitment Contact
Lillian Christon Arnold
843-792-0686
christon@musc.edu

VAMC Non-Alcoholic Fatty Liver Disease (NAFLD) Research Database Save

Date Added
December 27th, 2017
PRO Number
Pro00056211
Researcher
Wing-kin Syn
Keywords
Diabetes, Digestive System, Liver, Obesity
Summary

Non-Alcoholic fatty liver disease is the most common liver disease, and involves fat deposition in the liver. The fat in the liver can lead to inflammation, scarring, end stage liver disease and potential liver cancer. Some patients with fat in their liver do not see these changes, and our current understanding of why some people are not affected while others see progression of their disease is poor. We are currently in process of initiating studies to learn more about fatty liver disease, and having a database of patients at the VA medical center who are willing to participate in these studies and future studies would help both the patients learn about the new and upcoming therapies, and help the clinical investigators to quickly screen their patients and invite them to participate in their studies.

Institution
MUSC
Recruitment Contact
Akshay Shetty
404-941-6717
shetty@musc.edu

Evaluating race specific AGE accumulation as a behavioral biomarker that can reflect optimal health in prostate cancer survivors Save

Date Added
December 19th, 2017
PRO Number
Pro00071004
Researcher
David Turner
Keywords
Cancer/Other, Exercise, Obesity
Summary

As our bodies use the sugars that we consume for energy they generate waste chemicals known as metabolites. One such group of metabolites is known as advanced glycation end products or AGEs for short. Critically apart from their production as a result of sugar breakdown, AGE levels in the body are also increased by the foods that we eat and when we do not get enough exercise. AGEs may cause many of the side effects experienced by prostate cancer survivors. This study aims to examine the effects of diet change and exercise on AGE levels in prostate cancer survivors.

Institution
MUSC
Recruitment Contact
David Turner
843-876-2309
turnerda@musc.edu

Environmental Influences on Child Health Outcomes (ECHO) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Fetal Growth Study Save

Date Added
October 31st, 2017
PRO Number
Pro00070764
Researcher
John Vena
Keywords
Children's Health, Obesity
Summary

We will recruit mother-child pairs for participation in the study and both the mother and child will be considered study participants. However, in cases where it is not possible to recruit the mother, but the child is available to be in the study we will recruit the child with their parent or legal guardian providing consent for the child's participation in the study

Institution
MUSC
Recruitment Contact
JacKetta Cobbs
843-792-0450
echo-nfgs@musc.edu

Aneurysmal Subarachnoid Hemorrhage Trial RandOmizing Heparin Save

Date Added
September 26th, 2017
PRO Number
Pro00051279
Researcher
Alejandro Spiotta
Keywords
Adolescents, Brain, Drug Studies, Men's Health, Minorities, Obesity, Pain, Stroke, Women's Health
Summary

The purpose of this study is to determine if giving the medicine "heparin" intravenously (through the veins) continuously for up to 14 days to subjects after a brain aneurysm has burst will help improve the chances of subjects having a good recovery after the bleed compared to subjects who get routine brain aneurysm care (standard of care). Patients who get routine care would also get heparin, but they would typically get an overall lower dose and the heparin would be injected under the skin (heparin shot) instead of in the veins.

Institution
MUSC
Recruitment Contact
Amora Mayo-Perez
843-792-1737
mayoaper@musc.edu

Trials and ReseArch NetworkS FOR More South Carolina (TRANSFORM SC) Child Health Recruitment Registry Save

Date Added
June 9th, 2017
PRO Number
Pro00063569
Researcher
Andrew Atz
Keywords
Asthma, Autism, Children's Health, Diabetes, Obesity
Summary

The TRANSFORM network is focused on improving child health outcomes in SC through research on conditions of highest priority for future generations. These include conditions like asthma, autism, diabetes, obesity and early childhood outcomes. To accelerate research study recruitment activities for future projects that TRANSFORM sites may participate in, the TRANSFORM network sites will create a research recruitment registry of families interested in volunteering for research. Participants will enter their own as well as their child(ren)'s information into the electronic registry which can be used to identify people to contact for future studies.

Institution
MUSC
Recruitment Contact
Sarah Newman-Norlund
803-216-3377
Sarah.Newman-Norlund@uscmed.sc.edu

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