Neo-TILs: A Phase II Study of Biomarker-Guided De-escalation Using Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Triple Negative Breast Cancer (TNBC) Patients with Elevated Tumor-Infiltrating Lymphocytes (TILs)

Date Added
June 16th, 2026
PRO Number
Pro00150734
Researcher
Abirami Sivapiragasam

List of Studies

Keywords
Cancer/Breast
Summary

This study is for adult patients with Triple Negative Breast Cancer (TNBC) who have high levels of tumor infiltrating lymphocytes (TIL), a specific type of white blood cell. The purpose of this study is to evaluate a non-anthracycline-based treatment regimen to determine if this approach is effective in patients with high TIL levels. 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 5 years.

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

OVAFIT-TIL: A Phase Ib Study of Autologous, Metabolically Optimized, CD137⁺ Tumor-Infiltrating Lymphocytes Followed by Consolidative Oral Cyclophosphamide, Bevacizumab, and Pembrolizumab in Recurrent Ovarian Cancer

Date Added
June 16th, 2026
PRO Number
Pro00150423
Researcher
Brian Orr

List of Studies

Keywords
Cancer/Gynecological
Summary

This study is for adult female patients that have been diagnosed with recurrent ovarian cancer. The purpose of this study is to evaluate whether therapy with tumor-infiltrating lymphocytes (TILs) enhances the immune response against cancer cells. Participants will undergo standard procedures such as blood collection for laboratory testing, physical exams, and imaging. In addition to standard of care treatment, TILs will be collected from the tumor, grown in a lab, and infused back into the body. Participants will also take three drugs (oral cyclophosphamide, bevacizumab, and pembrolizumab) following the TIL infusion. Participation in this study is expected to last approximately one year.

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

Customized Repair for Extensive Aortic pathology using Thoracoabdominal Endografts (CREATE)

Date Added
June 16th, 2026
PRO Number
Pro00149865
Researcher
Ryan King

List of Studies

Keywords
Surgery, Vascular
Summary

The purpose of this research study is to evaluate the safety and effectiveness of a
physician-modified endograft (tubular medical device used to reinforce weakened or damaged blood vessels) for repairing serious diseases of the aorta (largest artery in the human body, responsible for blood from the heart to the rest of the body). This device is considered investigational, and this research study received an Investigational Device Exemption (IDE) from the FDA.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu

Progesterone Supplementation for the Prevention of Preeclampsia: A Randomized Controlled Trial

Date Added
June 16th, 2026
PRO Number
Pro00145923
Researcher
Brittany Austin

List of Studies

Keywords
Obstetrics and Gynecology
Summary

Preeclampsia is a pregnancy complication characterized by high blood pressure and signs of organ dysfunction, usually occurring after 20 weeks of pregnancy. It can lead to serious health problems for both the pregnant person and the baby. Although some risk factors for preeclampsia are known, effective strategies to prevent the condition remain limited.

The purpose of this research study is to determine whether vaginal progesterone can help prevent preeclampsia in pregnant individuals. Progesterone is a hormone that is naturally produced during pregnancy and is already used for certain pregnancy-related conditions.

Participants who choose to join the study will be randomly assigned (by chance, like flipping a coin) to receive either vaginal progesterone or no medication. Participants will use the study medication as directed during pregnancy and will continue to receive their routine prenatal care.

Researchers will collect information from prenatal visits, medical records, and delivery outcomes to determine whether progesterone reduces the risk of developing preeclampsia and improves pregnancy outcomes. The information gained from this study may help identify a safe and effective way to prevent preeclampsia and improve the health of pregnant individuals and their babies in future pregnancies.

Institution
MUSC
Recruitment Contact
Jesslyn Payne
843-792-7525
paynej@musc.edu

Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients with Chronic Heart Failure

Date Added
June 9th, 2026
PRO Number
Pro00150995
Researcher
Sheldon Litwin

List of Studies


Keywords
Heart
Summary

This study is enrolling subjects with heart failure and a preserved fraction meaning the heart is too stiff to fill properly to meet the body's needs. This study is researching an investigational device (study device) called the Alleviant ALV1 System. Investigational means it has not been approved for commercial use by the Food and Drug Administration. (FDA) This study will test the safety and effectiveness of the Alleviant ALV1 System. The Alleviant ALV1 System is intended to create a shunt (an opening) in the heart to allow for proper blood flow through the heart which may improve your symptoms. No device is left in your heart it is just used to create the shunt. This is a randomized study which means subjects are assigned by chance to either have the study device create this shunt or not have the study device create the shunt. Randomization is 50/50 meaning there is a 50% chance to have the study device create a shunt and a 50% chance the study device will not be used. Using the study device to create the shunt is performed during a right heart catheterization (RHC) so all subjects will undergo the RHC but only 50% will have the shunt. Neither the subjects nor the study doctor will know which group subjects are randomized to but other study staff will know in the event this information is needed. All subjects will stay overnight in the hospital after the procedure. Other study related procedures include echocardiograms - ultrasound test of the heart, electrocardiograms (ECG) - a tracing of the heart's electrical activity, blood work, questionnaires, 6 minute hall walk test, and assessments of heart failure status. Risks include risks related to the study device including blood vessel damage from placing the device in the vein to get to the heart, risks from the right heart catheterization such as bleeding or bruising, abnormal heart beats, and risks related to study related procedures. There may be risks that are not known at this time. Participation in this study is expected to last about 60 months and include approximately 15 in person visits and 3 telephone calls.

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

Efficacy and safety of NNC0487-0111 compared to placebo on morbidity and mortality in people with heart failure with preserved or mildly reduced ejection fraction and obesity (HF-POLARIS).

Date Added
June 9th, 2026
PRO Number
Pro00150347
Researcher
Daniel Silverman

List of Studies

Keywords
Diabetes, Drug Studies, Heart, Kidney, Obesity
Summary

Individuals with obesity and a history of heart failure (condition where heart does not effectively pump) with a preserved or mildly reduced ejection fraction (measure of the heart's pumping ability) will be eligible for participation. Study participants will have a 50:50 chance to be randomly assigned to either the treatment (NNC0487-0111) or control (placebo) group. NNC0487-011 and placebo will be delivered in an injectable pen device for a subcutaneous, once weekly injection. Placebo means there is no active study treatment) Study participation will last approximately three years and begin with a screening period to ensure correct patient selection. After the screening period, research clinic visits will occur every 4 weeks initially and then every 12 weeks. Some visits may be completed virtually through telehealth or by phone. Study procedures include but are not limited to: blood draws, questionnaires, self injection of study medication, medical history review, vital signs, and electrocardiogram (test that records the heart's electrical activity) The study's primary objective is to demonstrate that study drug vs. once weekly placebo, with standard of care, reduces the risk of a composite heart failure outcome consisting of cardiovascular death, heart failure hospitalization, or urgent heart failure visit in patients with heart failure with a preserved or mildly reduced ejection fraction and obesity.

Institution
MUSC
Recruitment Contact
Elhaam Borhanian
843-792-5873
borhania@musc.edu

A Phase IIb Randomized, Double-blind, Placebo-controlled, Parallel, Multidose Study to Evaluate the Efficacy, Safety, and PK of AZD0292 in Participants 12 years of age and older with Bronchiectasis and Chronic Pseudomonas aeruginosa Colonization

Date Added
June 2nd, 2026
PRO Number
Pro00151105
Researcher
Patrick Flume

List of Studies


Keywords
Bronchiectasis, Lung, Pulmonary
Summary

This study is being conducted to evaluate the drug AZD0292, including how safe it is, how long it stays in the blood, and if it may help in reducing the number of exacerbations in people with Pseudomonas aeruginosa in their lungs. These patients have more frequent lung exacerbations and reduced quality of life. Pseudomonas aeruginosa is a bacteria that can make the symptoms of bronchiectasis worse. The study drug (AZD0292) works by attaching to Pseudomonas aeruginosa, thereby reducing its effects on the lungs and improving symptoms.
This study aims not only to test AZD0292 but is also being done to better understand bronchiectasis disease and its associated health problems.
Study drug (AZD0292) or placebo, will be given to participants as an intravenous (IV) infusion. The study is double-blinded.
About 435 participants with bronchiectasis 12 years of age and older, weighing at least 35kg will take part in this study. This study will be conducted globally in approximately 25 countries.

Institution
MUSC
Recruitment Contact
Rohini Rao
8437926109
recruitment@musc.edu

Varenicline as a Treatment for Cannabis Use Disorder

Date Added
June 2nd, 2026
PRO Number
Pro00150924
Researcher
Aimee McRae-Clark

List of Studies


Keywords
Drug Studies, Substance Use
Summary

Marijuana is the most commonly used illicit drug. There is high demand for effective interventions for cannabis use disorder, yet few specific treatments for have been developed. This study will evaluate the efficacy of varenicline for reducing marijuana use in people who use marijuana frequently.

Institution
MUSC
Recruitment Contact
Amanda Wagner
843-792-0484
wagne@musc.edu

Stress-reduction intervention for dementia caregivers: The UNDERSTAND Program

Date Added
June 2nd, 2026
PRO Number
Pro00150764
Researcher
Diana Layne

List of Studies


Keywords
Alzheimers, Dementia, Stress Disorders
Summary

This study is for family members and informal caregivers who support an adult with mild cognitive impairment or early Alzheimer's disease. Researchers are testing a 10‑week, online program designed to help caregivers feel supported and better manage caregiving‑related stress. The program includes education about dementia and future planning, brief relaxation exercises, and opportunities to connect with other caregivers by sharing experiences in a supportive setting. Participants will be randomly assigned to receive one or more parts of the program, which helps researchers understand which types of support are most helpful. All study activities can be completed from home. Findings from this study will be used to improve and expand support programs for families impacted by dementia.

Institution
MUSC
Recruitment Contact
Mohan Madisetti
(843) 792-2059
madisett@musc.edu

Targeting Incentive Salience and Cognitive Flexibility Circuitry: Evaluating the Effects of Accelerated rTMS in Alcohol Use Disorder

Date Added
June 2nd, 2026
PRO Number
Pro00150512
Researcher
Lisa McTeague

List of Studies


Keywords
Alcohol, Brain, Drug Studies, Psychiatry, Substance Use
Summary

This study systematically evaluates the efficacy of a highly promising neuromodulation strategy - continuous theta burst (cTBS) transcranial magnetic stimulation - as a tool to change alcohol use behavior (Aim 1) and neurobehavioral concomitants of that behavior (Aim 2) in non-treatment seeking individuals with alcohol use disorder (AUD). In addition, we can begin to test prediction of individual treatment response based on an electrocortical signature of sign tracking (exploratory aim). This study is a double-blind, active sham-controlled study in community dwelling, non-treatment seeking individuals who meet DSM 5 criteria for AUD. Participants will be randomized to one of three groups: cTBS to ventromedial prefrontal cortex, cTBS to pre-supplementary motor area, or sham stimulation (10 sessions in one day). Participants will undergo comprehensive outcomes assessment, with measures including pre- and immediately post-cTBS clinical assessments (e.g., interview, Timeline Follow-back), alcohol craving tests, structural and fMRI, MRS, and EEG/ERP during salience- and cognitive flexibility-related tasks. To test alcohol craving and also use in alcohol-available settings, participants will complete a bar-lab session post-cTBS only (to avoid potential habituation to alcohol cues within the laboratory setting). Finally at 1-week post-treatment participants will complete craving and Timeline Follow-back measures remotely via REDCap.

Institution
MUSC
Recruitment Contact
Charleston Alcohol Research Center
(843) 792-1222
alcoholstudy@musc.edu



-- OR --