Examining Return to Substance Use and Preferences for Substance Use Resources Among Postpartum Women

Date Added
January 22nd, 2026
PRO Number
Pro00148416
Researcher
Jordyn Tipsword

List of Studies

Keywords
Women's Health
Summary

This study is for women who have delivered a child in the past 18 months, have experienced one or more traumatic events during their lifetime, and use substances. First, the research involves completing brief screening questions over the phone to determine eligibility for the study. Second, eligible women will be invited to complete a 60- to 90-minute study visit comprised of an online survey and an interview about their opinions on postpartum substance use and potential future resources to help address substance use among postpartum women with trauma histories.

Institution
MUSC
Recruitment Contact
Jordyn Tipsword
8432847995
tipsword@musc.edu

A Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with moderate to severe hidradenitis suppurativa.

Date Added
January 22nd, 2026
PRO Number
Pro00145394
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

M1095-HS-303 is a Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of sonelokimab in participants with moderate to severe HS who were previously enrolled in a parental study.
Rollover to this OLE study will occur at the time of the End-of-Treatment (EOT) visit of the parental study. Upon enrollment into this study, each participant can continue to receive sonelokimab 120 mg every 4 weeks (Q4W) for up to 2 years, with a safety follow-up (SFU). Visit 8 weeks after the last dose of study treatment. Following successful training and supervision, sonelokimab will be self-administered by the participant (or caregiver if required) at home and at the study center.

Institution
MUSC
Recruitment Contact
Kennedy McLeod
843-792-4091
mcleodke@musc.edu

A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescent Congenital Heart Disease: WE BEAT CHD Study

Date Added
January 21st, 2026
PRO Number
Pro00148198
Researcher
Stephanie Gaydos

List of Studies

Keywords
Pediatrics
Summary

The overall goal of this study is to learn how to best support teens with CHD to improve their health and quality of life. Adolescents with moderately and severely complex CHD experience considerable risk of mental health comorbidities. Psychological health is important to cardiovascular health and related outcomes. This study will evaluate the effectiveness of a well-being focused telemedicine intervention in adolescents with CHD. The study is to learn if the WE BEAT program helps teens with CHD improve their ability to cope with stress and anxiety. The study will also create a data bank to study connections between mental health, heart health and biomarkers (hair, saliva, urine, blood samples).

Institution
MUSC
Recruitment Contact
Terry Headley
843-494-3796
headleyt@musc.edu

A Phase 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab versus Placebo, in Combination with Pembrolizumab, Pemetrexed, and Carboplatin, in First-Line Treatment of Participants with Metastatic Non-Squamous Non-Small Cell Lung Cancer (GDFATHER-NSCLC-01)

Date Added
January 21st, 2026
PRO Number
Pro00147574
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies
Summary

This study is testing a new medicine called Visugromab (CTL-002) to see if it helps people with a type of lung cancer called metastatic non-squamous non-small cell lung cancer. Everyone in the study will get standard cancer treatment, but some will also get Visugromab while others get a placebo (a look-alike with no active drug), and who gets what is decided randomly—like flipping a coin. The goal is to find out if Visugromab makes the treatment more effective and safe. The study will last up to two years, with Treatment in cycles lasting 3 weeks, about once a month. Researchers will closely monitor participants to see how well the treatment works and how their bodies respond. Serious risks of treatment may include heart problems, low oxygen levels, infections, organ failure, and inflammation in various parts of the body such as the lungs, liver, intestines, pancreas, and thyroid.

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

Magnetic Cell Selection System for CD34+ Cells From HPC-Apheresis Used in Treatment of Acute Myeloid Leukemia

Date Added
January 20th, 2026
PRO Number
Pro00148616
Researcher
Alexander Coltoff

List of Studies

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

This is a clinical use of an FDA-approved Humanitarian Use Device (HUD) under a Humanitarian Device Exemption (HDE) called Miltenyi Biotec CliniMACS CD34. The intent is to treat patients with Myelodysplastic Syndrome (MDS) in a clinical setting, not to conduct research or gather data on safety or effectiveness. No data will be collected beyond what is required for standard clinical care. Device-related processing will occur at an NMDP Advanced Cell Therapy Lab Solutions facility, and the resulting cell product will be transported to MUSC Hollings Cancer Center for infusion. Eligible patients are in first complete remission and undergoing allogeneic stem cell transplant (SCT) from an HLA-identical matched related donor. Patients will be provided MUSC's standard treatment consent per institutional policies. The HUD will be stored, dispensed, and used at NMDP in accordance with standard operating procedures.

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

A Phase 1a "Window Trial" on Cannabidiol (CBD) for Breast Cancer Primary Tumors

Date Added
January 20th, 2026
PRO Number
Pro00148581
Researcher
Nancy DeMore

List of Studies


Keywords
Cancer/Breast
Summary

This study is for adults with invasive breast cancer who are scheduled to have surgery of the breast. The purpose of the study is to determine whether cannabidiol (CBD) helps to slow the growth or cancer cells and whether or not taking CBD during the waiting period before surgery reduces anxiety. Participation in this study will last approximately 56 days.

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

S2409, PRISM: PRecIsion in SCLC Via a Multicohort Study: Randomized Phase II Studies Evaluating Maintenance Durvalumab with or Without Biomarker-Directed Therapy for Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Date Added
January 16th, 2026
PRO Number
Pro00149185
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung
Summary

This phase II trial tests how well biomarker tests on patients tumor tissue works in selecting personalized treatments for patients with extensive stage small cell lung cancer (ES-SCLC). This study also tests different types of maintenance treatment for ES-SCLC with drugs durvalumab, saruparib, ceralasertib or monalizumab. Maintenance treatment is given after initial treatment and is given to help keep the cancer under control and prevent it from getting worse. Immunotherapy with monoclonal antibodies, such as durvalumab and monalizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Saruparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Ceralasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for tumor cell growth. Giving biomarker selected personalized maintenance treatment with durvalumab, saruparib, ceralasertib or monalizumab may work better in treating patients with ES-SCLC.

Institution
MUSC
Recruitment Contact
Barbara Roe
843-652-1607
broe@tidelandshealth.org

A Randomized Phase II/III Study of Docetaxel and Ramucirumab with or Without Cemiplimab (REGN2810) for Participants Previously Treated with Platinum-based Chemotherapy and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)

Date Added
January 15th, 2026
PRO Number
Pro00149083
Researcher
Christopher Rangel

List of Studies

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

This study is for patients who have non-small cell lung cancer that is stage IV or has returned after remission. The goal is to compare the usual treatment by itself to the usual treatment plus a drug called cemiplimab. "Investigational" means this drug combination has not been approved by the U.S. Food and Drug Administration (FDA). A computer will randomly assign patients to one of two groups. This process is called "randomization." Patients will be placed into a group by chance, like flipping a coin, and will have an equal chance of being in Group 1 or Group 2. The drug is given by infusion. Patients will keep getting treatment until the cancer gets worse. Each treatment cycle lasts 21 days. After the last cycle, patients will be followed for up to 3 years.

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

Evaluation of the Navitor Transcatheter Heart Valve in Low and Intermediate Risk Patients who have Severe, Symptomatic, Aortic Stenosis Requiring Aortic Valve Replacement

Date Added
January 13th, 2026
PRO Number
Pro00148932
Researcher
Daniel Steinberg

List of Studies


Keywords
Heart
Summary

This research study is being done to evaluate a heart valve called the Navitor Transcatheter Aortic Valve, which may help treat people with severe aortic stenosis, a condition where the heart valve becomes too narrow to open properly. You are being asked to participate because your doctor believes you may benefit from a less-invasive valve replacement instead of open-heart surgery. The study will compare the Navitor valve to other FDA-approved transcatheter valves to see how safe and effective it is for people at low or intermediate surgical risk. The Navitor is considered investigational, meaning it is not yet approved in this population, by the Food and Drug Administration (FDA). Participation may last up to 10 years and involve up to 14 visits, some of which may be done remotely. If you join the study, you will have screening tests, the valve procedure, and regular follow-up visits for several years to check your heart health and how well the valve is working. The risks of participating are similar to those of standard transcatheter valve procedures, such as bleeding, stroke, heart rhythm changes, or infection. While you may experience symptom relief and improved heart function, personal benefit is not guaranteed. Your participation may also help improve future treatment options for patients with aortic stenosis.

Institution
MUSC
Recruitment Contact
Shaquanda Goodwine
8438765783
shr37@musc.edu

Clinical Investigation Plan Title: Performance of Liver Stiffness Measurement (LSM) by FibroScan® for the Diagnosis of Elevated Central Venous Pressure (CVP)

Date Added
January 13th, 2026
PRO Number
Pro00148626
Researcher
Michele Esposito

List of Studies

Keywords
Cardiovascular, Heart, Non-interventional
Summary

This study is being done to see how well a device called FibroScan can detect high pressure in the large vein that carries blood to the heart. FibroScan is a quick, painless test that measures how stiff the liver is, and researchers want to know if those measurements can help identify people with elevated central venous pressure. You are being asked to participate because you have been suspected of having, or diagnosed with, heart failure. Everyone in the study will have the same tests, which include a FibroScan exam, heart ultrasound, EKG, blood work, and a right-heart catheterization. The study lasts about one week and includes a screening visit, a baseline visit, and a phone check-in. By taking part, you may help researchers learn whether this noninvasive device can provide useful information about heart function. Participation is completely voluntary, and choosing not to join will not affect your medical care.

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



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