A Phase 2, Randomized, Double-blind, Placebo- controlled Study to Evaluate the Efficacy and Safety of Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder

Date Added
July 2nd, 2023
PRO Number
Pro00123547
Researcher
McLeod Gwynette

List of Studies


Keywords
Autism
Summary

Pimavanserin is an antipsychotic may have some beneficial effects on core autism symptoms and co-morbid conditions such as irritability, anxiety, sleep disorders, mood instability due to epilepsy, etc.). These potential benefits stem from pimavanserin's impact on the serotonin system in the body. This study will compare pimavanserin to placebo in the treatment of irritability, core autism symptoms, and co-morbid conditions in children ages 6-17 years old.

Institution
MUSC
Recruitment Contact
McLeod Gwynette
843-792-4113
gwynette@musc.edu

At-Home Transcutaneous Auricular Neuromodulation for Hypermobile Ehlers Danlos Syndrome

Date Added
July 5th, 2023
PRO Number
Pro00128818
Researcher
Bashar Badran

List of Studies


Keywords
Brain
Summary

Hypermobile EDS and hypermobile spectrum disorder (collectively referred to as hEDS) are estimated to affect 1 in 500 individuals worldwide. hEDS patients have limited treatment options for their numerous symptoms that impact the quality of life. This clinical trial tests a new ear stimulation method in hEDS patients to determine if it may improve quality of life.

Institution
MUSC
Recruitment Contact
Dillon Connolly
843-792-9502
connolld@musc.edu

RECOVERS – Realigning Emotion and COgnition Via prEcision Regulation networkS

Date Added
July 5th, 2023
PRO Number
Pro00129566
Researcher
Lisa McTeague

List of Studies


Keywords
Healthy Volunteer Studies
Summary

In this research study, we are using examining how brain activity (electrical and blood flow) changes during tests of emotional processing and attention and memory in the magnetic resonance imaging (MRI) scanner. We are also using non-invasive brain stimulation to probe different parts of the brain and measuring brain activity (electrical and blood flow). This study includes healthy participants and researchers hope this will help us develop improved brain-based treatments for emotional difficulties like depression.

Institution
MUSC
Recruitment Contact
Sarah Huffman
8437925560
huffmans@musc.edu

EEG-fNIRS Controlled TMS Real-time Neural Feedback for Anti-Depressive Treatment

Date Added
July 5th, 2023
PRO Number
Pro00124800
Researcher
Mark George

List of Studies


Keywords
Brain, Depression
Summary

Currently rTMS for treating depression is delivered without knowing whether the TMS pulses are synchronized with the patient's brain rhythms. We will study healthy and depressed adults with TMS inside of the MRI scanner or outside of the MRI scanner using optics, and test whether it matters precisely timing the TMS pulses with EEG.

Institution
MUSC
Recruitment Contact
Bridgette Holland
843-638-7517
hollanbr@musc.edu

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Date Added
July 5th, 2023
PRO Number
Pro00126590
Researcher
Marc Katz

List of Studies


Keywords
Cardiovascular, Surgery
Summary

This is an Investigational Device Exemption (IDE) clinical research trial (referred to also as a trial or a research trial) sponsored by AtriCure, Inc (the Sponsor) to learn whether the use of the AtriClip® LAA Exclusion System to close off your left atrial appendage (LAA) during your heart surgery will reduce the risk of stroke. The AtriClip has not been well studied or approved by the FDA for stroke prevention; therefore, this procedure is considered investigational.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
8437928896
overstrm@musc.edu

A Phase 2a/b, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of OG-6219 in 3 Dose Levels, in Women 18 to 49 Years of Age with Moderate to Severe Endometriosis-related Pain

Date Added
July 5th, 2023
PRO Number
Pro00129682
Researcher
David Soper

List of Studies


Keywords
Obstetrics and Gynecology
Summary

The purpose of this global study is to determine the efficacy, safety, and tolerability of 3 dose levels of OG-6219 (50, 100, and 150 mg twice a day [BID]) in pre-menopausal women between 18 and 49 years of age (inclusive), who have moderate to severe endometriosis-related pain.

Institution
MUSC
Recruitment Contact
Jesslyn Payne
843-792-7525
paynej@musc.edu

A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis (PSC)

Date Added
July 5th, 2023
PRO Number
Pro00127264
Researcher
Don Rockey

List of Studies


Keywords
Drug Studies, Hepatology, Liver, Rare Diseases
Summary

This study will evaluate the effects of elafibranor (the study drug) in participants with Primary Sclerosing Cholangitis (PSC). PSC is a rare disease of the liver that leads to injury and destruction of bile ducts. Damage to bile ducts leads to buildup of bile in the liver, which then causes further damage, and leads to disease progression. This study will compare elafibranor to a placebo, a dummy treatment. The main objective of the trial will be to study the safety and side effects of the study drug. The trial will also study the study drug's effects on blood tests and other tests related to PSC disease activity.

Institution
MUSC
Recruitment Contact
Joshua Inman
843-876-4303
inmanj@musc.edu

Precision rEsearCh pArticipatioN (PECAN) study

Date Added
July 5th, 2023
PRO Number
Pro00126189
Researcher
Paula Ramos

List of Studies


Keywords
Healthy Volunteer Studies, Lupus
Summary

The goal of this study is to understand the knowledge, views and perceptions from diverse communities, primarily from the Lowcountry, about the new field of personalized medicine (or precision health), and what factors might influence participation in precision health research studies. It is hoped that results from this study will help inform future strategies to increase the diversity of participants in precision health research.

Participation involves completion of a one-time survey that takes approximately 20 minutes to complete. Compensation is available.

Institution
MUSC
Recruitment Contact
Paula Ramos
8437927081
thepecanstudy@musc.edu

A randomized, participant- and investigator-blinded, placebo-controlled study to investigate efficacy, safety and tolerability of LTP001 in participants with pulmonary arterial hypertension

Date Added
July 6th, 2023
PRO Number
Pro00128867
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

This study is exploring the safety and efficacy of the study drug LTP001 in subjects with pulmonary arterial hypertension. This is a randomized study and the subjects will be be given the study drug or placebo in a capsule form which they are to take once daily in the morning. Participants will be screened for up to 8 weeks followed by 24 weeks of daily dosing- study visits to the site will occur approximately every 4 weeks. During these study visits there will be study procedures that may include labs for blood and urine, ECGs, vital signs, 6MWD, echocardiogram, or right heart catherization. There is the opportunity for an open-label portion of the study as well.

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

A Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Effect of Resmetirom on Liver-related Outcomes in Patients with Well-compensated (Child-Pugh A) Non-alcoholic Steatohepatitis (NASH) Cirrhosis (MAESTRO-NASH OUTCOMES)

Date Added
July 7th, 2023
PRO Number
Pro00126305
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

To determine the effect of randomized, once daily, oral administration of 80 mg
resmetirom versus matching placebo on patients as measured by time to
experiencing a first adjudicated Composite Clinical Outcome event, defined
as any of the following: all-cause mortality, liver transplant, and significant
hepatic events including hepatic decompensation events (ascites, hepatic
encephalopathy, or gastroesophageal variceal hemorrhage) and confirmed
increase of Model for End-stage Liver Disease (MELD) score from <12 to
≥15

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
18438768439
blanke@musc.edu



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