Prospective non-interventional, phase IV, multicenter, study to assess the effectiveness, safety, and tolerability of elafibranor 80mg/day in patients with PBC receiving treatment in real-world settings

Date Added
June 3rd, 2025
PRO Number
Pro00136802
Researcher
Don Rockey

List of Studies


Keywords
Liver, Non-interventional, Rare Diseases
Summary

This is an international, multicenter, study that will not prescribe elafibranor. It is designed primarily to collect data and assess real-world effectiveness of treatment with elafibranor 80mg/day on adult patients with PBC, and to describe the safety of this treatment and its impact on their quality of life, over a period of 24 months.

Institution
MUSC
Recruitment Contact
Joshua Inman
(843) 876-4303
inmanj@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

Biomarkers in Late-Onset Epilepsy of Unknown Etiology

Date Added
June 6th, 2025
PRO Number
Pro00143847
Researcher
Michael Sugarman

List of Studies

Keywords
Aging, Alzheimers, Brain, Central Nervous System, Dementia, Epilepsy, Memory Loss, Non-interventional
Summary

The purpose of this study is to learn more about late-onset epilepsy of unknown etiology (LOEU), which is defined as an onset of seizure activity in late life (age 55 or above) without a clear neurological cause. That is, many older adults will experience seizures due to neurological conditions such as stroke, brain injury, tumor, or infection. However, other individuals will also develop seizures with no identified cause.

Participation entails a single study visit lasting 2-3 hours including a blood draw, completion of standardized cognitive testing, and several questionnaires. The goals of the study include to examine blood markers that can help us to better understand the condition including dementia risk, and how these markers may impact the clinical presentation of the condition. No interventions/treatments are included with this study.

Institution
MUSC
Recruitment Contact
Sarah Helton
843-640-5280
heltons@musc.edu

Piloting a Treatment Decision-Making Algorithm Assessment for Smoking Cessation Medications

Date Added
June 10th, 2025
PRO Number
Pro00140442
Researcher
Rachel Tomko

List of Studies


Keywords
Psychiatry, Smoking
Summary

Eligible participants (ages 18+ whom have daily cigarette use) will attend an in-person assessment (though some aspects of the study, including consent, can be completed remotely). Participants will submit a breath sample for assessment of expired carbon monoxide. Approximately 5-7 days after completion of the in-person assessment, participants will meet with research staff. A medical clinician will meet with the participant to present a smoking cessation treatment recommendation along with resources. Participants will also complete surveys to assess their treatment preferences, motivation, and self-efficacy following receipt of the recommendation.

Institution
MUSC
Recruitment Contact
Kevin Branson
843-792-0493
bransonk@musc.edu

Validation of the Revised Clinician Administered PTSD Scale for DSM-5 (CAPS-5-R)

Date Added
June 16th, 2025
PRO Number
Pro00145011
Researcher
Ronald Acierno

List of Studies

Keywords
Mental Health
Summary

This is a research study to help see if a new interview for posttraumatic stress disorder (PTSD), called the Revised Clinician-Administered PTSD Scale for DSM-5, or the CAPS-5-R for short, is accurate and reliable for veterans. By doing this study, we hope to learn if the CAPS-5-R can be used in VA to diagnose PTSD. Participation will all be done remotely. Joining this study will involve (1) completing some questionnaire measures and (2) completing an interview remotely by videoconference over 2 days at most.

Participants must be Veterans, aged 18 or older in the Ralph H. Johnson VA Health Care System who have experienced trauma or at least one PTSD symptom.

Institution
MUSC
Recruitment Contact
Stephanie Hart
843-789-6519
zeigls@musc.edu

Anthracycline-Free Neoadjuvant Chemoimmunotherapy for Triple Negative Breast Cancer Patients with Cardiomyopathy or at an Elevated Risk of Cardiotoxicity (NeoCARD): A Response Adapted Single-arm Phase 2 Trial

Date Added
June 17th, 2025
PRO Number
Pro00144305
Researcher
Abirami Sivapiragasam

List of Studies

Keywords
Cancer/Breast
Summary

This study is for adult patients with Triple Negative Breast Cancer (TNBC) who are at high risk for cardiotoxicity. The purpose of this study is to evaluate a non-anthracycline-based chemotherapy and immunotherapy regimen to determine if this approach reduces heart-related side effects. Participation will include standard of care visits along with questionnaires and blood draws completed for research purposes. Participation in this study is anticipated to last approximately 6 months with follow up over 2 years.

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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability and Efficacy of Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Patients with Idiopathic Pulmonary Fibrosis

Date Added
June 17th, 2025
PRO Number
Pro00145146
Researcher
Timothy Whelan

List of Studies


Keywords
Interstitial Lung Disease (ILD), Lung, Pulmonary
Summary

This study will compare the safety, tolerability, and efficacy of inhaled study drug LTI-03 to placebo in participants diagnosed with IPF within 5 years of Screening who may be receiving standard of care (SoC) antifibrotic therapy. Taking part in this research is expected to last up to 32 weeks, which includes a 4-week screening period, a 24-week treatment period, and 4-week post-treatment follow-up period. The general procedures include review of eligibility; review of medical and medication history and changes in health; completing questionnaires; undergoing physical exams and having vital signs measured; collecting blood samples; examinations such as ECG, spirometry, HRCT, and DLCO and using an inhaler to take the study drug.

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

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of REGN7544, an Antagonist Monoclonal Antibody to NPR1, in Patients with Sepsis-Induced Hypotension

Date Added
June 19th, 2025
PRO Number
Pro00145352
Researcher
Andrew Goodwin

List of Studies


Keywords
Critical Care
Summary

The study is researching an experimental drug called REGN7544. The study is focused on adult patients (18 to 85 years old) hospitalized due to a serious infection (called "sepsis" in this form) and receiving standard-of-care medications for low blood pressure (called "vasopressors" in this form) due to sepsis. The aim of the study is to see if REGN7544 is safe, tolerable and effective when compared to placebo, by observing the effects on blood pressure and the total amount of vasopressor dose received. The general procedures include collection of information from medical records, some additional testing, such as electrocardiogram, collection of blood, and having blood pressure and heart rate measured .There will also be a screening visit, two telephone visits, and one additional in-person visit. It is expected that taking part in this research will last about 13 weeks (3 months).

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

A Phase 3, Randomized, Double-Blinded, Placebo -Controlled Study ChecKing the Efficacy and Safety of ATAciguat to Slow the Progression of VaLvular DYsfunction in Participants with Moderate Calcific Aortic Valve STenosis (KATALYST-AV)

Date Added
June 24th, 2025
PRO Number
Pro00144738
Researcher
Daniel Steinberg

List of Studies


Keywords
Drug Studies, Heart
Summary

This study is enrolling participants with calcific aortic valve stenosis (CAVS) which is a heart valve disease. Blood pumped out of the heart goes through the aortic valve, and in CAVS, calcium builds up causing the valve to thicken over time so it is not able to open as much or as easily and over time this restricts blood flow. This study involves an investigational medication called ataciguat which is being studied to see how well it can slow the progression of CAVS. Investigational means it has not been approved for commercial use by the Food and Drug Administration (FDA). Ataciguat is taken by mouth daily.

Participation in this study will last about 3 years and include about 14 visits. Study procedures include collection of medical data, physical exams, electrocardiogram (ECG - a recording of your heart's electrical activity), bloodwork, echocardiogram (ultrasound test of the heart), CT scan, questionnaires and home monitoring of your blood pressure and heart rhythm.

Risks related to ataciguat include headache, nausea, abdominal pain, diarrhea and dizziness. Study procedure risks include radiation risks, risks of drawing blood and loss of confidentiality.

Institution
MUSC
Recruitment Contact
Natalie Drain
843-792-5037
drain@musc.edu

A Phase II Study of Ribociclib And Endocrine Treatment of Physician s Choice for Locoregional Recurrent Resected Hormone Receptor Positive HER2 Negative Breast Cancer

Date Added
June 24th, 2025
PRO Number
Pro00144995
Researcher
Abirami Sivapiragasam

List of Studies

Keywords
Cancer, Drug Studies
Summary

The purpose of this study is to find out if adding a drug called ribociclib to the usual hormone therapy drugs can lower the chance of your breast cancer coming back again. This study is for patients with locoregional, recrrent, resected hormonone receptor positive HER2 negative breast cancer. Endocrine therapy has already been approved by the FDA for your type of cancer. Ribociclib has already been approved by the FDA for your type of cancer that has not been removed by surgery or has spread to other parts of the body.

Receiving ribociclib with endocrine therapy is still being studied and to yet approved by the FDA. Ribociclib is taken as a pill and endocrine therapy is taken as an injection. Participants will receive ribociclib with endocrine therapy for up to 3 years and can receive endocrine therapy alone for an additional two years after stopping ribociclib. Participants can remain on the study for up to 5 years.

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



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