An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH)

Date Added
April 24th, 2025
PRO Number
Pro00137101
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

This is a multicenter, open-label extension (OLE) study to see how safe and effective an inhaled medication called seralutinib is for people with Pulmonary Arterial Hypertension (PAH). The primary objective of this study was to assess improvement in cardiopulmonary hemodynamics as measured by change in pulmonary vascular resistance (PVR) from baseline to Week 24. The secondary objective of this study was to assess improvement in exercise capacity as measured by change in six-minute walk distance (6MWD) from baseline to Week 24.

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

ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression ADVENT LTO Study

Date Added
May 14th, 2025
PRO Number
Pro00140422
Researcher
Jeffrey Winterfield

List of Studies


Keywords
Heart
Summary

This study is enrolling participants who completed the FARAPULSE ADVENT study and are now nearing the 3 year post atrial fibrillation ablation timepoint. Atrial fibrillation is an irregular heart rhythm caused by electrical signals misfiring. An ablation is a procedure in which those signals are targeted and destroyed to stop the atrial fibrillation. This study will consist of reviewing and collecting medical records since the ablation procedure as well as optional questionnaires and wearing a heart monitor for 7 days to capture the heart's electrical activity. There are no study related follow up visits. Study related risks include loss of confidentiality and possible skin reaction to the electrodes (sticky patches placed on the chest to detect the heart's electrical activity). Individual benefit is not expected but the information learned may contribute to knowledge in this field.

Institution
MUSC
Recruitment Contact
Chandler Schwede
843-792-5998
schwede@musc.edu

Center for Circadian Rhythms and Alcohol-Induced Tissue Damage: Biorepository

Date Added
May 29th, 2025
PRO Number
Pro00144279
Researcher
Garth Swanson

List of Studies

Keywords
Alcohol
Summary

The long-term objective of this proposed R24 program is to enhance our understanding of how circadian rhythm disruption contributes to vulnerability to alcohol-induced organ damage, and to explore the underlying mechanisms (e.g. microbiota) that could lead to the identification of novel therapeutic targets. This knowledge aims to inform the development of innovative strategies to prevent and to treat alcohol-related pathologies.

Institution
MUSC
Recruitment Contact
Keaveny (Katy) Donovan
8437927974
donova@musc.edu

OASIS Project 1: Development of a text message-based approach to depression screening for cancer survivors

Date Added
May 30th, 2025
PRO Number
Pro00143112
Researcher
Evan Graboyes

List of Studies


Keywords
Cancer
Summary

Depression is common among cancer survivors, but current ways to address this area of care are lacking. In this project, we will work with cancer survivors and oncology providers to build a text-message based approach to screen cancer survivors for depression. Long term, we hope this research can be used to improve screening for depression for cancer survivors

Institution
MUSC
Recruitment Contact
Nivetha Baskar
843-792-0719
baskar@musc.edu

A phase 2, randomized, investigator and participant blinded, placebo-controlled, parallel-group study to investigate the safety, tolerability, and preliminary efficacy of TMP-301 treatment in adult patients with alcohol use disorder (AUD).

Date Added
May 30th, 2025
PRO Number
Pro00143607
Researcher
Sarah Book

List of Studies


Keywords
Alcohol, Substance Use
Summary

This is a 16-week-long treatment study for people with Alcohol Use Disorder who want to stop or cut down their drinking. The purpose of this study is to determine whether an investigational medication, TMP-301, affects craving for alcohol and/or alcohol drinking while taking the study drug. Participants will be randomly assigned to TMP-301or a matched placebo

Institution
MUSC
Recruitment Contact
Konstantin Voronin
843-792-4887
voronin@musc.edu

Pilot Evaluation of a 2D Embodied Conversational Agent to Support Speech Engagement in Parkinson's Disease

Date Added
June 4th, 2025
PRO Number
Pro00145307
Researcher
Kelly Richardson

List of Studies

Keywords
Parkinsons
Summary

We are testing a 2D system designed to help people with Parkinson's disease practice their speech. In this study, participants will speak with a virtual character, called an embodied conversational agent, using a laptop. Our goal is to see if this technology is helpful and easy to use for people with Parkinson's disease to use. This research will help us learn whether using virtual characters at home could support long-term speech improvements.

Institution
MUSC
Recruitment Contact
Kelly Richardson
8437929468
richkell@musc.edu

Randomized Phase 2 Trial of Sacituzumab Govitecan With or Without Pembrolizumab in First-line Metastatic PD-L1-negative TNBC

Date Added
July 8th, 2025
PRO Number
Pro00145388
Researcher
Abirami Sivapiragasam

List of Studies

Keywords
Cancer, Drug Studies
Summary

The purpose of this study is to compare the progression-free survival (PFS) of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone in patients with PD-L1-negative metastatic TNBC, who have not received prior therapy for metastatic breast cancer and who have not received a prior PD-1/L1 inhibitor.

Subjects can remain on study for as long as they are benefitting from treatment - there are no set number of visits required to participate in this study. Sacituzumab govitecan and pembrolizumab are taken via intravenous (IV) infusion. Risks include decrease in white blood cell count, anemia, nausea, joint pain, and headache.

The U.S. Food and Drug Administration (FDA) has approved Sacituzumab govitecan for metastatic triple-negative breast cancer, however, it is considered experimental in this study because it is currently only approved for patients who have had more treatment than patients eligible to participate in this study. The FDA has approved Pembrolizumab for metastatic triple-negative breast cancer, but it is also considered experimental in this study because it is not currently approved for patients with PD-L1 negative cancer.

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

Randomized Phase II study of the Addition of Targeted Therapeutic Agents to Tafasitamab-based Therapy in Non-Transplant-Eligible Patients With Relapsed/Refractory Large B-cell Lymphoma

Date Added
July 10th, 2025
PRO Number
Pro00146204
Researcher
Brian Hess

List of Studies


Keywords
Cancer, Cancer/Lymphoma, Drug Studies, Men's Health, Women's Health
Summary

This is a randomized, phase II study for patients with Relapsed/Refractory Large B-Cell Lymphoma. The purpose of this study is to determine how long people with Large B-Cell Lymphoma can live without their disease getting worse when treated with two different combinations of cancer drugs. One group will get tafasitamab + lenalidomide + tazemetostat, and the other group will get tafasitamab + lenalidomide + zanubrutinib. The researchers want to see which combination works better. They also want to figure out the best and safest dose of each drug combination to use in future studies. Tafasitamab is a lab-made antibody that helps the immune system find and attack cancer cells. Lenalidomide is a drug that boosts the immune system and helps fight cancer. Tazemetostat is a drug that blocks a protein (EZH2) that helps cancer cells grow. Zanubrutinib is a drug that blocks another protein (BTK) involved in cancer cell survival. The treatment period may last approximately 1 year and the follow up period may last up to 3 years.

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



-- OR --