The effect of semaglutide in subjects with non-cirrhotic non-alcoholic steatohepatitis

Date Added
April 13th, 2021
PRO Number
Pro00108809
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

The purpose of this study is to find out about the safety and effectiveness of an investigation drug called Semaglutide for the treatment of NASH. (Non-Alcoholic Steatohepatitis). NASH occurs when the fat buildup in the liver leads to inflammation (hepatitis) and scarring. NASH is associated with increased risk of morbidity (medical problem or complication) and mortality (death). Currently, treatment options are few and insufficient. There is therefore an unmet medical need for effective and safe pharmacological treatment options. The study is designed to last 257 weeks (approximately 4 years and 11 months), with study visits occurring approximately every 4 weeks. Most visits will include blood work and some will include assessments such as body weight and vital signs. Most visits will include reviewing of diary entries during the course of the study. This study also includes weekly injections of semaglutide (or placebo). Semaglutide is a self-administered injection that is given under the skin. Semaglutide has built an extensive amount of data with other trials that have focused on weight management and Type 2 diabetes. Semaglutide is FDA-approved for diabetes treatment, but is investigational for this study. In these previous trials, semaglutide was found to be safe and well-tolerated. This study is randomized, double-blinded, and placebo-controlled. This means that you may receive the study drug or a placebo. Neither the study subject or the study team members will know which each subject will be receiving. Study subjects will be randomized 2:1. This means that subjects will have a greater chance (66%) of receiving the drug versus the placebo.

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
843-876-8439
blanke@musc.edu

Education and Safety for Children with Autism to Prevent Elopement (ESCAPE) Kits Pilot Study

Date Added
April 13th, 2021
PRO Number
Pro00108386
Researcher
Silvia Pereira-Smith

List of Studies


Keywords
Autism
Summary

This study will evaluate elopement prevention kits for children with autism spectrum disorder who exhibit elopement behavior such as dashing or wandering away from safe settings. Caregivers will be asked to rate how useful individual kit items are at reducing elopement, and to provide feedback about how ESCAPE kits affect their stress levels and ability to engage meaningfully in community settings. This study will also investigate how useful kit items are for various age groups in childhood and adolescence. Information will be used to guide development of a larger elopement prevention program.

Institution
MUSC
Recruitment Contact
Jessie Montezuma
843-714-1352
montezum@musc.edu

Internet-delivered Management of Pain Among Cancer Treatment Survivors (IMPACTS)

Date Added
April 12th, 2021
PRO Number
Pro00109105
Researcher
Sarah Marrison

List of Studies


Keywords
Cancer, Pain
Summary

The study is being done to find out if this approach (8 sessions of the Internet-based program with education) is better or worse than the usual approach plus education only for cancer-related pain. The usual approach is defined as care most people get for cancer-related pain.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
(843) 792-9321
hcc-clinical-trials@musc.edu

Weekly Sirolimus Therapy for the Treatment of Venous and Lymphatic Malformations

Date Added
April 6th, 2021
PRO Number
Pro00106369
Researcher
Chelsea Shope

List of Studies

Keywords
Adolescents, Pediatrics, Skin, Vascular
Summary

In current practice, options for venous and lymphatic malformations remain limited. Recently an oral medication, sirolimus, has been found to benefit patients when taken once or twice a day for several months. Unfortunately there are many side effects associated with this medication, some of which can be severe including, neutropenia, oral ulcerations, and lab abnormalities. The purpose of this study is to determine if once weekly dosed sirolimus will be effective for the treatment of venous and lymphatic malformations. Additionally, the study will evaluate patient satisfaction and identify adverse effects. Participants will be on the medication for 6 months with an option to continue after this time period.

Institution
MUSC
Recruitment Contact
Alexandra Richmond
7577776673
ritteral@musc.edu

A PHASE 3, MULTICENTER, OPEN-LABEL EXTENSION STUDY OF ORAL OZANIMOD FOR MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE

Date Added
March 23rd, 2021
PRO Number
Pro00104265
Researcher
Erin Forster

List of Studies


Keywords
Crohn's Disease
Summary

The purpose of this study is to see whether oral Ozanimod is safe and effective for treating Crohn's disease. Adult participants (at least 18 years old) with moderately to severely active Crohn's disease may be eligible.

Only participants who complete the induction and/or maintenance study will be eligible to join this open-label study.

All participants in this study receive active study drug. The dose of study drug you will receive will depend on your prior study. There is no chance of placebo in this study.

This study is designed to last up to 234 weeks (4.5 years). Participants are expected to come to MUSC every 8 or 12 weeks for study visits.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ORAL OZANIMOD AS MAINTENANCE THERAPY FOR MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE

Date Added
March 23rd, 2021
PRO Number
Pro00104264
Researcher
Erin Forster

List of Studies


Keywords
Crohn's Disease
Summary

The purpose of this study is to see whether Ozanimod is safe and effective for treating Crohn's disease. Adult participants (at least 18 years old) with moderately to severely active Crohn's disease may be eligible.

To do this, a comparison will be made between subjects who receive active drug and subjects who receive placebo (a ‘dummy treatment' that looks like the active drug but contains no active ingredient). The chance of being randomized (like drawing names out of a hat) into ozanimod group and receiving ozanimod is 50%. The chance of being randomized into placebo group and receiving placebo is 50%.

If participants' Crohn's disease condition get worse during the study, they will be invited to participate the open-label study, which has no placebo.

This is a one-year study, and participants are expected to come to MUSC every 8 weeks for study visits.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Phase II Trial of the Immune Checkpoint Inhibitor Nivolumab in Patients With Select Rare CNS Cancers

Date Added
March 16th, 2021
PRO Number
Pro00107606
Researcher
Scott Lindhorst

List of Studies


Keywords
Cancer/Brain
Summary

This study is for patients with rare Central Nervous (brain or spine) tumors. The purpose of this study is to determine whether the experimental drug, nivolumab can shrink tumors in patients with rare Central Nervous System (brain or spine) tumors or increase the time it takes for these tumors to grow or spread throughout the body.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

PARALLEL PHASE III RANDOMIZED TRIALS FOR HIGH RISK PROSTATE CANCER EVALUATING DE-INTENSIFICATION FOR LOWER GENOMIC RISK AND INTENSIFICATION OF CONCURRENT THERAPY FOR HIGHER GENOMIC RISK WITH RADIATION (PREDICT-RT*)

Date Added
March 4th, 2021
PRO Number
Pro00108846
Researcher
David Marshall

List of Studies


Keywords
Cancer/Genitourinary, Hormones, Men's Health, Prostate
Summary

This study is for men who have high-risk prostate cancer who plan to be treated with a combination of radiation and hormonal therapy. A tumor genomic analysis (Decipher score) will be used to divide the subjects into two groups. Those with a low genomic risk score will be randomized to either standard treatment with radiation and 24 months of hormonal therapy or to radiation with a shorter, 12 month, course of hormone therapy. Those with a higher genomic risk score or who have lymph node involvement will be randomized to standard treatment with radiation and 24 months of standard hormonal therapy or radiation with 24 months of intensified hormonal therapy.

Institution
MUSC
Recruitment Contact
Amanda Kelley
(864) 725-7125
amanda.kelley@selfregional.org

PARALLEL PHASE III RANDOMIZED TRIALS FOR HIGH RISK PROSTATE CANCER EVALUATING DE-INTENSIFICATION FOR LOWER GENOMIC RISK AND INTENSIFICATION OF CONCURRENT THERAPY FOR HIGHER GENOMIC RISK WITH RADIATION (PREDICT-RT*)

Date Added
March 4th, 2021
PRO Number
Pro00108846
Researcher
David Marshall

List of Studies


Keywords
Cancer/Genitourinary, Hormones, Men's Health, Prostate
Summary

This study is for men who have high-risk prostate cancer who plan to be treated with a combination of radiation and hormonal therapy. A tumor genomic analysis (Decipher score) will be used to divide the subjects into two groups. Those with a low genomic risk score will be randomized to either standard treatment with radiation and 24 months of hormonal therapy or to radiation with a shorter, 12 month, course of hormone therapy. Those with a higher genomic risk score or who have lymph node involvement will be randomized to standard treatment with radiation and 24 months of standard hormonal therapy or radiation with 24 months of intensified hormonal therapy.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Amanda Kelley
(864) 725-7125
amanda.kelley@selfregional.org

Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO

Date Added
March 3rd, 2021
PRO Number
Pro00108563
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients that have been diagnosed with non-small cell lung cancer. The purpose of this study is to compare the usual treatment alone to using pembrolizumab plus the usual treatment. The investigational drug in this study is pembrolizumab. This drug, pembrolizumab is already approved by the FDA for use in patients with more advanced lung cancer. Participants can expect to be on treatment for up to a year. Participants will be followed for up to 10 years after completion of treatment.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu



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