Investigating the association of the oral microbiome and Alzheimer's disease and other neurologic disorders

Date Added
January 30th, 2026
PRO Number
Pro00148657
Researcher
Andrew Keegan

List of Studies

Keywords
Alzheimers, Multiple Sclerosis
Summary

The purpose of this study is to better understand how the oral microbiome (bacteria in the mouth) may be associated with different neurologic conditions like Alzheimer's disease and Multiple Sclerosis. This will require one visit, typically less than an hour. We will collect some information about the subject's past medical history including dental history as well as collect saliva and perform a nasal swab. This will also include a measure of genetics. There will be an optional blood collection. Samples will also be stored for future research.

Institution
MUSC
Recruitment Contact
Alison Line
843-792-2845
line@musc.edu

CAR: Complex Aneurysm Registry - Real-World Evidence Data Collection for Intracranial Aneurysm Treatment Devices

Date Added
January 30th, 2026
PRO Number
Pro00141690
Researcher
Alejandro Spiotta

List of Studies


Keywords
Surgery
Summary

The Car study is being done to collect real-world evidence of how commercially available MicroVention intracranial aneurysm treatment devices function and look at safety outcomes over a year when used per standard of care. The treating physician will use the device they think is most appropriate for each patient. The study will also be used to develop a full database in an effort to inform future studies and further the understanding of the safety and performance of these devices across a wide range of patient populations and disease characteristics.

Institution
MUSC
Recruitment Contact
Emily Infinger
843-792-6210
infingem@musc.edu

Phase 2 Study of the Efficacy and Safety of ORC-13661 for the Prevention of Drug-Induced Hearing Loss in Patients Receiving Intravenous Amikacin Therapy for Pulmonary Non-Tuberculous Mycobacterium Disease

Date Added
January 27th, 2026
PRO Number
Pro00147995
Researcher
Patrick Flume

List of Studies


Keywords
Lung, Nontuberculous mycobacteria (NTM), Pulmonary
Summary

The purpose of the study is to learn more about an experimental drug called ORC-13661 that may be helpful in treating hearing loss due to antibiotic use. The study is researching whether the drug is safe and tolerable, and trying to find out whether the drug may be able to mitigate or prevent hearing loss in patients being treated with intravenous (IV) amikacin. Participation in the study will consist of up to 10 visits over up to 129 days. The Day 1 visit (following the screening visit) will last up to 8 hours, while other visits will last up to 5 hours Participants will be randomly assigned to receive either ORC-13661at a higher dose or a lower dose or a placebo (a pill that looks the same as the study drug but has no real medicine in it), for up to 90 days to be taken along with IV amikacin. Participants will be asked to have a number of tests and procedures, which include questionnaires about family, medical, and hearing history, physical and hearing examination, and assessments of hearing.

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

exPDite-2: A Phase 3 Study to Assess the Efficacy and Safety of Midbrain Dopaminergic Neuronal Cell Therapy (Bemdaneprocel) for Participants With Parkinsons Disease

Date Added
January 27th, 2026
PRO Number
Pro00147082
Researcher
Andrew Ameri

List of Studies

Keywords
Movement Disorders, Parkinsons
Summary

This study will test if bemdaneprocel (the "study drug") is safe and effective in improving symptoms in participants with Parkinson's Disease. The symptoms of PD are due to a loss of cells that make a specific chemical in your brain called dopamine. The study drug is a cell therapy that contains live brain cells that produce dopamine. This study will last 5 to 8 years, and depending on randomization group between 23-32 study visits.

Institution
MUSC
Recruitment Contact
Sandra Wilson
843-792-4616
wilsosan@musc.edu

An Open-label, Phase 1/2 Trial of Gene Therapy 4D-710 in Adults with Cystic Fibrosis

Date Added
January 27th, 2026
PRO Number
Pro00146219
Researcher
Patrick Flume

List of Studies


Keywords
Cystic Fibrosis
Summary

The study will test an investigational drug known as 4D-710. An "investigational drug" is one that has not yet been approved for use by a Health Authority such as the United States Food and Drug Administration (FDA). 4D-710 is being studied as a potential treatment for cystic fibrosis lung disease. This is the first study to test 4D-710 in humans. The purpose of this study is to see if 4D-710 is safe for use in adults with cystic fibrosis and to see if 4D-710 can help lung function.

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

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer

Date Added
January 27th, 2026
PRO Number
Pro00146193
Researcher
Abirami Sivapiragasam

List of Studies

Keywords
Cancer/Breast, Drug Studies, Women's Health
Summary

This study is for patients that have been diagnosed with breast cancer. The purpose of this research is to assess the safety and efficacy of sacituzumab tirumotecan (sac-TMT) in people with certain types of breast cancer who will have surgery to remove their breast cancer. This trial will compare two treatment plans that patients will receive before their surgery. One of these treatment plans will involve patients receiving Sac-TMT and pembrolizumab (pembro), followed by chemotherapy and pembro. Patients enrolled in the other treatment plan will receive chemotherapy and pembro. Patients will be given the drug intravenously (a needle in a vein). Patients may experience a decrease in white blood cells, platelets, and red blood cells (anemia). Patients are expected to remain in the study for a minimum of 30 months or longer. There will be a total of 12 patients locally enrolled.

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

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



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