An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Persons with REM Sleep Behavior Disorder (RBD)

Date Added
September 3rd, 2026
PRO Number
Pro00151041
Researcher
Christine Cooper

List of Studies

Keywords
Parkinsons, Sleep Disorders
Summary

The purpose of this study is to determine if a drug called adalimumab can reduce or prevent emergence or progression of synuclein-related neurodegeneration, or nerve cell death, in people diagnosed with REM Sleep Behavior Disorder (RBD.) About 108 individuals, aged 50-80, will be enrolled in this study, half of whom will receive the active study drug and half of whom will receive placebo. Participants would receive 40 mg adalimumab, administered subcutaneously every 2 weeks or matching placebo for up to 2 years (96 weeks).

Institution
MUSC
Recruitment Contact
Sandra Wilson
8437924616
movementresearch@musc.edu

LiveWell mBC: Pilot Test of an Adapted Dialectical Behavioral Therapy Skills Training Program in Groups of Women Living With Metastatic Breast Cancer

Date Added
May 8th, 2026
PRO Number
Pro00149650
Researcher
Kelly Hyland

List of Studies

Keywords
Cancer/Breast, Mental Health, Stage IV
Summary

LiveWell mBC is a group-based skills training program for women with metastatic breast cancer (mBC). The program teaches skills from dialectical behavioral therapy, an evidence-based psychotherapy, that have been adapted specifically to help women live as well as possible, with metastatic breast cancer. LiveWell mBC involves meeting with a small group of women with mBC plus two skills trainers 9 times total via telemedicine. Meetings include orientation plus 8 sessions learning and practicing skills including mindfulness, emotion regulation, distress tolerance and interpersonal effectiveness and they last 90 minutes each. We are interested in seeing whether the program can help women to balance their emotions and better manage distress (e.g., anxiety, sadness) and symptoms (e.g., fatigue, breathlessness, pain) that can be common when living with mBC.

Participants will be randomly assigned to one of two groups. They will have a 2 in 3 chance of being assigned to LiveWell mBC (experimental group) and a 1 in 3 chance of being assigned to Usual Care (control group). Women in the usual care group will continue to receive their standard oncology care. Participants in both groups will complete questionnaires four times total. Participants may be invited to participate in an exit interview about their experience. Participants will be compensated for completing questionnaires and the interview. For most people, participation will last approximately 4 months.

Institution
MUSC
Recruitment Contact
Kathryn Moody
843-792-9698
moodykat@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

Characterizing the immune profile in osteogenesis imperfecta patients.

Date Added
September 11th, 2026
PRO Number
Pro00147003
Researcher
Meenal Mehrotra

List of Studies

Keywords
Bone, Genetics, Immune System, Inflammation, Rare Diseases
Summary

In our preclinical mouse studies we have identified immune dysfunction in mouse models of osteogenesis imperfecta, also known as brittle bone disease. We then successfully restored bone strength in these mice with our patented adoptive cell therapy treatment.

In this study we will collect small volume blood samples from patients with osteogenesis imperfecta. We will then analyze these blood samples through a variety of methods to determine if osteogenesis imperfecta patients have the same immune dysfunction as we have seen in our mice studies.

Institution
MUSC
Recruitment Contact
Meenal Mehrotra
860-593-9842
mehrotra@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 approximately 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 Health Florence Medical Center
Recruitment Contact
Sarah Helton
843-640-5280
heltons@musc.edu

Triptorelin and Protection of Ovarian Reserve in Adolescents and Young Adults with Cancer

Date Added
July 23rd, 2026
PRO Number
Pro00151284
Researcher
Anca Dumitriu

List of Studies

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

This study is recruiting patients receiving cancer treatment that includes a type of drug called an "alkylating agent", which may cause side effects such as damage to the ovaries (female reproductive organs). The goal of the study is to determine the feasibility of conducting a cross network, multi-site, randomized clinical trial of triptorelin among newly diagnosed adolescent and young adult (AYA) female cancer patients age <40 years (exclusive of breast cancer). The triptorelin used in this study may affect how different parts of your body work such as your liver, kidneys, heart, and blood. Participants will receive the medications through an intramuscular (IM) injection in their arm. Study participation is expected to last up to three years.

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

20190341: A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non–Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)

Date Added
July 8th, 2026
PRO Number
Pro00150758
Researcher
Wael Ghalayini

List of Studies

Keywords
Cancer/Lung
Summary

This study is being conducted to determine how well participants with stage IV or advanced stage IIIB/C nonsquamous non-small cell lung cancer (NSCLC), that has certain biomarkers (negative for PD-L1, and positive for KRAS p.G12C) respond to treatment with chemotherapy (carboplatin and pemetrexed) combined with either sotorasib or pembrolizumab. The study will determine whether sotorasib and chemotherapy reduces the risk of your cancer getting worse and improves your survival (i.e. increases the chance of you living longer) compared to the current standard treatment with pembrolizumab and chemotherapy. In this study, participants will be screened and if they meet criteria will be enrolled into the main study and assigned, by chance, into one of 2 groups. You will have an equal chance of taking sotorasib platinum doublet combination chemotherapy or pembrolizumab platinum doublet combination chemotherapy. It is hoped that the information gained from the study will help refine future chemotherapy programs.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Freida Davidson
843-674-5172
cormackf@musc.edu

ColoSeal™ ICD System Anastomotic Protection Pivotal Study

Date Added
July 31st, 2026
PRO Number
Pro00150028
Researcher
Maggie Westfal

List of Studies

Keywords
Surgery
Summary

Adult subjects with rectal cancer undergoing sphincter sparing resection and colonic anastomosis. Post-operative follow-up will occur at 7-10 days, 30 days, 90 days, 180 days, and 270 days.

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

Healthcare experience and needs among loved ones of violently injured patients

Date Added
September 9th, 2026
PRO Number
Pro00149490
Researcher
Ashley Hink

List of Studies

Keywords
Critical Care
Summary

The purpose of the study is to better understand the experience of loved ones whose family members were treated for violence injuries at MUSC, and what services could potentially be improved. This study will involve administering surveys to loved ones of patients who are treated for injuries due to intentional violence at MUSC. They will be recruited via flyers and information sheets. Survey questions will address perceptions of their loved ones healthcare experience, interactions with staff members, impact of the Turning the Tide Violence Intervention Program (TTVIP), what perceived needs they have, and what services have been provided. Responses of those that have loved ones who enrolled in TTVIP compared to those who did not will be compared to assess for differences.

Institution
MUSC
Recruitment Contact
Claire Jacoby
8437691689
jacobyc@musc.edu

An Open-Label, Phase 2 Study Evaluating the Safety of Inhaled Mosliciguat with Inhaled Treprostinil in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease

Date Added
March 31st, 2026
PRO Number
Pro00150037
Researcher
Rahul Argula

List of Studies

Keywords
Lung, Pulmonary
Summary

The purpose of the study is to find out if mosliciguat, the investigational drug that is being studied, with treprostinil, is safe and effective in treating adults who live with PH-ILD. Approximately 20 participants diagnosed with PH-ILD who are currently on a stable dose of inhaled treprostinil who meet all inclusion and no exclusion criteria will be enrolled. Part 1 of the study will take about 5 ½ months. Part 2 of the study is optional if you choose to participate in the extension period. Part 2 does not have a set end date and your participation in Part 2 will end if you or your study doctor decide to stop your participation or the Sponsor ends the study.

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



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