A non-interventional, post-authorisation safety study of patients treated with efgartigimod alfa

Date Added
August 7th, 2025
PRO Number
Pro00145070
Researcher
Katherine Ruzhansky

List of Studies


Keywords
Non-interventional
Summary

This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment will be eligible to enroll into the non-efgartigimod cohort.
Enrolment of patients will be over at least a 5-year period. The follow up of patients will continue for 5 years from the time the last patient has been enrolled. Patients will be followed up regardless of whether they continue or discontinue efgartigimod.

Institution
MUSC
Recruitment Contact
Alison Line
8437922845
line@musc.edu

Sharing Our Stories: The Realities of Living with Ehlers Danlos Syndromes

Date Added
August 7th, 2025
PRO Number
Pro00144466
Researcher
Michelle Nichols

List of Studies


Keywords
Autoimmune disease, Chronic Fatigue, Genetics, Joint, Non-interventional, Pain, Rheumatoid
Summary

Sharing Our Stories: The Realities of Living with Ehlers Danlos Syndromes (EDS) is a research study to help better understand what it is like to live with EDS. Adults with EDS will complete a one-time video interview with a member of the research team. We hope to better understand the challenges adults with EDS face and learn from them things that make it more difficult and easier to receive care, what their needs are and recommendations for improving an earlier diagnosis, care, and treatment.

Institution
MUSC
Recruitment Contact
Michelle Nichols
843-876-6463
nicholmg@musc.edu

A Phase I, First-in-human, Open-label, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BNT317 in Patients With Advanced Solid Tumors

Date Added
August 7th, 2025
PRO Number
Pro00143120
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Drug Studies
Summary

This study is for patients that have been diagnosed with advanced solid tumors. This study is testing an investigational drug called BNT317. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to evaluate the safety, tolerability, absorption of BNT317. BNT317 is administered via intravenous (IV) infusion. Participants can continue to receive this study drug until it no longer gives them benefit. Researchers will continue to follow-up with patients long-term.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

Genetic Registry for Upper Tract Urothelial Carcinoma

Date Added
August 6th, 2025
PRO Number
Pro00146501
Researcher
Matvey Tsivian

List of Studies

Keywords
Cancer/Genitourinary
Summary

This research study is for adult patients diagnosed with Upper Tract Urothelial Carcinoma (UTUC). The purpose of this study is to determine how often genetic variants are found in patients with UTUC. As part of this research study, the research team will collect health information about you from your medical record and blood, saliva, and tissue samples will be collected for genetic testing.

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

Investigating the Feasibility, Efficacy, and Renormalization of Pain-Regulation Brain Circuits Underlying At-Home Transcutaneous Auricular Neuromodulation (tAN) for Managing Chronic Post-Stroke Pain

Date Added
August 5th, 2025
PRO Number
Pro00145968
Researcher
Xiaolong Peng

List of Studies


Keywords
Pain, Stroke
Summary

The purpose of this study is to explore whether 4 weeks of at-home transcutaneous auricular neurostimulation (tAN) can reduce chronic pain after a stroke. We will recruit up to 24 participants with chronic post-stroke upper extremity pain. The goal is to determine if there is a pain reduction after ear stimulation.

Institution
MUSC
Recruitment Contact
Falon Sutton
843-792-9502
suttonf@musc.edu

Phase 3, Randomized, Controlled, Open-label Study to Compare the Efficacy and Safety of Bemnifosbuvir-Ruzasvir Fixed-dose Combination (BEM/RZR FDC) Versus Sofosbuvir-Velpatasvir Fixed-dose Combination (SOF/VEL FDC) in Subjects with Chronic Hepatitis C Virus (HCV) Infection

Date Added
August 1st, 2025
PRO Number
Pro00143821
Researcher
Eric Meissner

List of Studies


Keywords
Infectious Diseases
Summary

The purpose of this clinical research study is to evaluate the safety and effectiveness of the investigational drug called bemnifosbuvir-ruzasvir (BEM/RZR) in comparison to the FDA approved comparator drug in treating chronic Hepatitis C Virus (HCV) infection.

Institution
MUSC
Recruitment Contact
Jamila Williams
(843) 792-1088
keithja@musc.edu

The Effectiveness of screening women with lower genital tract neoplasia or cancers for anal cancer precursors.

Date Added
August 1st, 2025
PRO Number
Pro00131770
Researcher
Ashish Deshmukh

List of Studies

Keywords
Cancer, Cancer/Gynecological
Summary

The goal of this study is to utilize prospectively collected information from a multisite single-arm trial of 300 HIV uninfected people assigned female gender at birth with lower genital tract neoplasia ("WLGTN") to conduct a unique multidisciplinary study that will clarify issues surrounding anal cancer screening tests in this population as well as help to comprehend the natural history of anal dysplasia among WLGTN. This single arm clinical trial will evaluate screening (diagnostic) tests for anal cancer screening in a population that is not currently routinely screened, determine the prevalence and incidence of aHSIL and
collect data regarding the acceptability of different anal cancer screening approaches. The initial screening interventions will include the collection of (1) anal cytology, obtained by clinician using a water moistened cytobrush; (2) self-collected HPV testing specimens (by subjects, using a Dacron swab); (3) a clinician collected HPV specimen. Anal specimens will be collected by insertion of the cytobrush or moistened Dacron swab into the anal canal until resistance is not met; approximately 5 cm. These tests are followed by a brief standardized exam to determine any external anogenital lesions or pathology, performed by the investigator conducting anoscopy. A digital rectal exam will also be done on all patients. Results of these tests will be confirmed in all patients using high resolution anoscopy (HRA) with biopsy of suspicious lesions. Following standard practices, subjects are treated with 3% acetic acid and Lugol's iodine.

Institution
MUSC
Recruitment Contact
Alexis Nuzzo
123-456-7890
nuzzo@musc.edu

The APPROVE Trial: A randomized controlled trial evaluating the efficacy and safety of a prescription digital therapeutic for treatment of overactive bladder in women

Date Added
July 25th, 2025
PRO Number
Pro00144788
Researcher
Amy Askew

List of Studies

Keywords
Obstetrics and Gynecology
Summary

This trial will be a randomized controlled trial designed to determine if women with overactive bladder (OAB), treated with the prescription digital therapeutic (PDTx) demonstrate greater improvement in OAB-related health as compared to standard behavioral education with informational handouts.

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

A Phase 2, Randomized, Controlled, Open-Label, Adaptive Dose Design, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Two Different Dwell Times of VS-01 on Top of Standard of Care versus Standard of Care Alone in Patients with Overt Hepatic Encephalopathy

Date Added
July 22nd, 2025
PRO Number
Pro00144936
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

To evaluate the efficacy of two different dwell times (3 hours and 4 hours) of i.p. VS-01, administered once daily for up to 4 days on top of SOC compared to SOC alone in treating OHE in patients with AD of liver
cirrhosis or ACLF grade 1 measured by time to improvement of OHE.

Institution
MUSC
Recruitment Contact
Joshua Inman
843-876-8439
inmanj@musc.edu

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Suvorexant for the Treatment of Insomnia in Participants with Opioid Use Disorder (MK-4305-098)

Date Added
July 18th, 2025
PRO Number
Pro00146129
Researcher
Allison Wilkerson

List of Studies


Keywords
Drug Studies, Sleep Disorders
Summary

This research is being done to see if the drug suvorexant is effective as treatment for insomnia in people who have opioid use disorder and who are utilizing stable medications for opioid use disorder (MOUD). It is a 13-week study, and the study drug will be compared to a placebo.

Institution
MUSC
Recruitment Contact
Kyle Williams
843-876-6399
kyw210@musc.edu



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