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

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

NRG-GU013: THE PHASE III ‘HIGH FIVE TRIAL' FIVE FRACTION RADIATION FOR HIGH-RISK PROSTATE CANCER

Date Added
June 20th, 2025
PRO Number
Pro00145135
Researcher
David Marshall

List of Studies


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

This study is for patients that have been diagnosed with prostate cancer. This study will compare metastasis-free survival, determined using conventional imaging, between men with high-risk prostate cancer randomized to ultrahypofractionation (stereotactic body radiation therapy [SBRT]) to those randomized to moderate hypofractionation and conventional fractionation. Participants can expect to remain in the study for 11 years and 10 months.

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

A RANDOMIZED PHASE III CLINICAL TRIAL FOR THE ADDITION OF DOCETAXEL TO ANDROGEN RECEPTOR PATHWAY INHIBITORS IN PATIENTS WITH METASTATIC CASTRATION SENSITIVE PROSTATE CANCER AND SUBOPTIMAL PSA RESPONSE (TRIPLE-SWITCH)

Date Added
June 20th, 2025
PRO Number
Pro00144119
Researcher
Kevin Becker

List of Studies

Keywords
Cancer/Genitourinary, Drug Studies, Prostate
Summary

This study is for subjects that have been diagnosed with prostate cancer. Subjects can expect to remain in the study for up to 39 months or longer. There will be a total of 16 enrolled locally. The study is set to enroll subjects for 39 months.

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

Pivotal Method-Comparison Study for the Cardiac Performance System (CPS) to Measure Hemodynamic Parameters

Date Added
June 19th, 2025
PRO Number
Pro00145464
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

Patients suspected of having compromised heart function often require invasive right heart catheterization for diagnosis and management. This study is testing the Cardiac Performance System (CPS), a non-invasive device that uses sensors and electrocardiogram (ECG) electrodes to measure heart function. The purpose of this study is to determine if the CPS provides pulmonary pressure assessment similar to that obtained through right heart catherization.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-0965
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

OPtimal Adult Heart Transplant Immunosuppression with MicroRNA Levels

Date Added
June 17th, 2025
PRO Number
Pro00145519
Researcher
Ryan Tedford

List of Studies


Keywords
Heart, Transplant
Summary

This study is looking at people who have recently had a heart transplant to see if a simple blood test can help doctors better understand how the immune system is doing. By checking tiny molecules called microRNAs in the blood, researchers hope to find a way to tell if a patient might have problems like infection or rejection of their new heart. The goal is to help adjust medications so patients stay healthier after their transplant. The study involves taking blood samples during regular doctor visits over three years, but it doesn't change any of the usual care the patients would already get.

Institution
MUSC
Recruitment Contact
Shaquanda Goodwine
843-876-5783
shr37@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

Prospective Randomized Pilot Trial of Formoterol in Patients with Diabetic Kidney Disease

Date Added
June 17th, 2025
PRO Number
Pro00144030
Researcher
Joshua Lipschutz

List of Studies


Keywords
Diabetes
Summary

The purpose of the study is to evaluate if formoterol fumarate is effective in treating patients with diabetic kidney disease. Study participants will be randomly assigned to either receive formoterol fumarate (in addition to their current standard of care treatment) or standard of care treatment only. Study participants will have a 50% chance of receiving formoterol fumarate and a 50% chance of not receiving formoterol fumarate. Both groups will continue their standard of care treatment during the study.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-0965
recruitment@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



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