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

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

Digital Wellness Nurse – FIT Families: Virtual Family Intervention for Adolescent Obesity

Date Added
June 13th, 2025
PRO Number
Pro00144641
Researcher
Phillippe Cunningham

List of Studies


Keywords
Adolescents, Exercise, Minorities, Nutrition, Weight Control
Summary

The purpose of this study is to test whether a mobile app, the Digital Wellness Nurse (DWN), can help African American families with weight problems lead healthier lifestyles. Participants in this study will receive education and tips on physical activity and healthy eating through weekly videos and online meetings with a community health worker (CHW) via the DWN app. The meetings with the CHW will take place once a week for 12 weeks. During these meetings, adolescents and their caregiver will set weekly goals and have the chance to earn incentives for meeting them. While in the study, participants will be asked to wear a Fitbit to track physical activity and to complete a monthly survey about eating and physical activity habits. At the end of the study, participants will be asked to participate in a focus group and talk about their experiences with the app and the study. Participation in this study may improve physical well-being, but that cannot be guaranteed.

Institution
MUSC
Recruitment Contact
Jennifer Powell
843-876-0926
smithjl@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

A Phase II Double-Blinded, Placebo-Controlled Trial of Prostate Oligometastatic Radiotherapy With Or Without Androgen Deprivation Therapy In Oligometastatic Prostate Cancer (NRG PROMETHEAN)

Date Added
June 6th, 2025
PRO Number
Pro00144873
Researcher
Brian Lally

List of Studies

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

The purpose of this study is to determine if we lower the chance of your prostate cancer growing or spreading by adding the drug relugolix to the usual radiation therapy? This study seeks to find if this approach is better or worse than standard of care for prostate cancer.

Treatment and follow up for this study may be up to 5 years. The procedures include blood samples, PET scans, hormone therapy and radiation therapy. Risks include diarrhea, back pain, weight gain, and headache. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.

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

A Phase 2, Open-Label, 4-Week Safety Study of Roflumilast Cream 0.05% Administered Once Daily in Infants Aged 3 Months to Less Than 2 Years with Atopic Dermatitis

Date Added
June 6th, 2025
PRO Number
Pro00144456
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This study aims to evaluate the safety and tolerability of ARQ-151 cream 0.05% in infants with mild to moderate eczema after daily application for four weeks. ARQ-151 contains the active ingredient roflumilast, which reduces the activity of the enzyme PDE-4 involved in inflammation. Since eczema is an inflammatory skin disease, ARQ-151 could potentially help treat this condition.

Institution
MUSC
Recruitment Contact
Madeline Richmond
843-792-1436
richmoma@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 60 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 fasting 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



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