The Effects of Concussion, Ankle Sprain, and Cognitive Load on Postural Stability

Date Added
July 14th, 2025
PRO Number
Pro00143180
Researcher
Eugene Hong

List of Studies


Keywords
Brain, Exercise
Summary

The purpose of this study is to compare balance control during a single leg squat with and without a cognitive task between individuals with a history of concussion and individuals with a history of concussion and ankle sprain. Adults with a history of concussion, history of ankle sprain, history of both, or no history of ankle sprain or concussion will be enrolled. Participants will perform twelve trials of a single leg squat, half of which include listening to and recalling a series of words. This study will allow for possible avenues of improved evaluation and rehabilitation of individuals with a history of concussion and/or ankle sprain for healthcare professionals.

Institution
MUSC
Recruitment Contact
Vanessa Gruskiewicz
9094653702
ramireva@musc.edu

Randomized Phase II study of the Addition of Targeted Therapeutic Agents to Tafasitamab-based Therapy in Non-Transplant-Eligible Patients With Relapsed/Refractory Large B-cell Lymphoma

Date Added
July 10th, 2025
PRO Number
Pro00146204
Researcher
Brian Hess

List of Studies


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

This is a randomized, phase II study for patients with Relapsed/Refractory Large B-Cell Lymphoma. The purpose of this study is to determine how long people with Large B-Cell Lymphoma can live without their disease getting worse when treated with two different combinations of cancer drugs. One group will get tafasitamab + lenalidomide + tazemetostat, and the other group will get tafasitamab + lenalidomide + zanubrutinib. The researchers want to see which combination works better. They also want to figure out the best and safest dose of each drug combination to use in future studies. Tafasitamab is a lab-made antibody that helps the immune system find and attack cancer cells. Lenalidomide is a drug that boosts the immune system and helps fight cancer. Tazemetostat is a drug that blocks a protein (EZH2) that helps cancer cells grow. Zanubrutinib is a drug that blocks another protein (BTK) involved in cancer cell survival. The treatment period may last approximately 1 year and the follow up period may last up to 3 years.

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

Randomized Phase II Trial of Anti-LAG-3 and Anti-PD-1 Blockade vs. SOC in Patients With Recurrent Glioblastoma

Date Added
July 10th, 2025
PRO Number
Pro00143650
Researcher
Scott Lindhorst

List of Studies


Keywords
Cancer, Cancer/Brain, Men's Health, Women's Health
Summary

This is a phase 2 study for patients that have been diagnosed with recurrent glioblastoma, a type of brain cancer. This study is testing an investigational combination of two drugs, reltalimab and nivolumab."Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The main purpose of this study is to see if there is a difference in overall survival rate in patients who receive a combination of retatlimab and nivolumab versus those who receive the standard of care treatment, lomustine, in patients with recurrent brain cancer. Participants in this study can expect to be in this study for up to five years from the day study participation starts. Subjects with investigational project being given on day 1 of each cycle, a cycle being 28 days. Cycles will continue until disease gets worse or study doctor decides it is in the subject's best interest to stop. Study will be divided into group 1 and 2. Group 1 will receive investigational drugs and group 2 will receive the standard of care. A computer will be used to assign groups in a process called randomization. Much like a toss of a coin, subjects will have equal opportunity to randomized to either group 1 or 2.

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

A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Date Added
July 9th, 2025
PRO Number
Pro00144899
Researcher
Denise Gabrielle Sese

List of Studies

Keywords
Interstitial Lung Disease (ILD), Pulmonary Hypertension
Summary

The purpose of this study is to observe and capture demographic characteristics,
treatment patterns, and clinical outcomes of interest for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) to further clinical understanding of the epidemiological landscape and outcomes of the disease and treatment. This study will follow patients for up to 5 years after enrollment.

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

Randomized Phase 2 Trial of Sacituzumab Govitecan With or Without Pembrolizumab in First-line Metastatic PD-L1-negative TNBC

Date Added
July 8th, 2025
PRO Number
Pro00145388
Researcher
Abirami Sivapiragasam

List of Studies

Keywords
Cancer, Drug Studies
Summary

The purpose of this study is to compare the progression-free survival (PFS) of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone in patients with PD-L1-negative metastatic TNBC, who have not received prior therapy for metastatic breast cancer and who have not received a prior PD-1/L1 inhibitor.

Subjects can remain on study for as long as they are benefitting from treatment - there are no set number of visits required to participate in this study. Sacituzumab govitecan and pembrolizumab are taken via intravenous (IV) infusion. Risks include decrease in white blood cell count, anemia, nausea, joint pain, and headache.

The U.S. Food and Drug Administration (FDA) has approved Sacituzumab govitecan for metastatic triple-negative breast cancer, however, it is considered experimental in this study because it is currently only approved for patients who have had more treatment than patients eligible to participate in this study. The FDA has approved Pembrolizumab for metastatic triple-negative breast cancer, but it is also considered experimental in this study because it is not currently approved for patients with PD-L1 negative cancer.

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

A randomized controlled study of the Prevail Drug-Coated Balloon in subjects with in-stent restenosis and a single arm prospectively enrolled study of the Prevail Drug-Coated Balloon for de novo lesions in small vessel disease (Prevail Global)

Date Added
July 8th, 2025
PRO Number
Pro00144658
Researcher
Anbukarasi Maran

List of Studies


Keywords
Heart
Summary

This study is evaluating the clinical safety and efficacy of Prevail Drug-Coated Balloon (DCB) in the treatment of in-stent restenosis (ISR) which is the narrowing of heart arteries (blood vessels) previously treated with stents (mesh like medical device that helps keep arteries open) and in new narrowing of arteries in small vessels. The DCB is a small balloon that has medication on it. The medication is designed to reduce the re-occurrence of narrowing in blood vessels. All participants who have a previous stent will be chosen at random to be treated with either the Prevail DCB or the Agent DCB. You will have a 50:50 chance of being assigned to either DCB. The Prevail DCB is considered investigational meaning it has not yet been approved by the Food and Drug Administration (FDA). The Agent DCB is FDA approved. If you are being treated due to a new lesion in a small blood vessel, you will be treated with the Prevail DCB. Study related procedures include the following: electrocardiograph (known as an ECG, which is a test that shows your heart's electrical activity), blood draws, physical examinations, a review of chest pain, and medication history. Participation in this study will take about 5 years and include about 9 visits. Risks include risks related to the DCBs including allergic reaction, GI symptoms or changes to blood counts.

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

LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Protocol for Patients Living with Metastatic Lung Cancer

Date Added
July 8th, 2025
PRO Number
Pro00144605
Researcher
Kelly Hyland

List of Studies

Keywords
Cancer/Lung
Summary

LiveWell is a telehealth-delivered coping skills training program for people living with advanced lung cancer. LiveWell teaches skills from dialectical behavioral therapy, a type of evidence-based psychotherapy, that have been specifically adapted for people living with advanced lung cancer. The skills (e.g., mindfulness, distress tolerance, emotion regulation, interpersonal effectiveness) are designed to help you live as well as possible, with cancer. We are interested in seeing whether the program can help you to balance your emotions and better manage distress (e.g., anxiety, sadness) and symptoms (e.g., fatigue, breathlessness, pain) that can be common when living with lung cancer.
 
If you participate in this study, you will be randomly assigned to one of two groups: the LiveWell group, or usual care. LiveWell involves meeting with a skills trainer once per week for eight weeks via telemedicine, in addition to receiving your usual cancer care. Meetings last 45-60 minutes and are scheduled at a time that works best for you. You will not know whether you will be in the LiveWell group or the usual care group before enrolling in the study, but you will know which group you are in after enrolling. Participants in both groups will complete questionnaires three times: at baseline, 8 weeks later, and 3 months after that. For most people, your participation will last approximately 5 months.  You will be compensated for completing study questionnaires.
 

Institution
MUSC
Recruitment Contact
Kelly Hyland
843-876-8861
hylandk@musc.edu

A U.S. REGISTRY OF EOSINOPHILIC ESOPHAGITIS PATIENTS TREATED WITH DUPIXENT® AS STANDARD OF CARE

Date Added
July 8th, 2025
PRO Number
Pro00134489
Researcher
Kelli Williams

List of Studies


Keywords
Adolescents, Allergy, Esophagus, Pediatrics, Rare Diseases
Summary

This observational research study is to better understand patients with eosinophilic esophagitis (EoE) who have recently been prescribed DUPIXENT® (dupilumab). The purpose of this research study is to look at how DUPIXENT is used in normal care of patients with EoE.

Possible benefits to others include a better understanding of EoE and helping to inform research and clinical trial design leading to treatment decisions in this patient population going forward.

Institution
MUSC
Recruitment Contact
Linda Wozniak
843-876-8651
wozniakl@musc.edu

Advanced Fibrosis Detection and a Predictive Diagnostic Model for Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Primary Care

Date Added
July 3rd, 2025
PRO Number
Pro00145783
Researcher
Andrew Schreiner

List of Studies


Keywords
Diabetes, Liver, Obesity
Summary

This proposal evaluates the implementation of a novel, non-interruptive, electronic health record alert for metabolic dysfunction-associated steatotic liver disease (MASLD) fibrosis risk assessment in primary care patients with MASLD using a stepped wedge, cluster randomized design. We will evaluate the clinical outcome of advanced liver fibrosis detection and the implementation outcomes of adoption, penetration, fidelity, and sustainability. This work will generate generalizable data to dramatically enhance MASLD management in primary care.

Institution
MUSC
Recruitment Contact
Chloe Cooper
843-876-0448
coopechl@musc.edu

A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors

Date Added
July 3rd, 2025
PRO Number
Pro00145386
Researcher
Theodore Gourdin

List of Studies


Keywords
Cancer, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Lung, Drug Studies, Liver, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with recurrent, progressive as well as advanced, metastatic hepatocellular carcinoma (HCC), cervical cancer (CC), melanoma, head and neck squamous cell carcinoma (HNSCC) or non-small cell lung cancer (NSCLC). The study is testing an investigational drug called DB-1311. Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of the study is to determine the recommended phase II dose of DB-1311 in combination with BNT327 or DB-1311 in combination with DB-1305 by assessing the safety and tolerability. The drug is given to participants by IV infusion. Participants in this study can expect to be in this study for 72 months.

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



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