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 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

A PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, TREAT-THROUGH STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION AND MAINTENANCE THERAPY WITH RO7790121 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE

Date Added
July 18th, 2025
PRO Number
Pro00144159
Researcher
Erin Forster

List of Studies


Keywords
Crohn's Disease
Summary

This study will evaluate the efficacy and safety of RO7790121 compared with placebo in patients with moderately to severely active CD. Data on currently available treatments highlights the need for new medications in addressing the high unmet need in CD. The total maximum duration of study participation for an individual is expected to be approximately 70 weeks without OLE participation. With OLE participation, treatment will continue until RO7790121 is commercially available in that region or until the Sponsor decides to terminate the study, whichever is earlier. Approximately 600 patients will be enrolled in the study.

Institution
MUSC
Recruitment Contact
Isabella Brookshire
8437920965
recruitment@musc.edu

Exploring the Interplay of Resiliency and Grit in Athlete Burnout and Injury Rates Among Adolescent Volleyball Players

Date Added
July 18th, 2025
PRO Number
Pro00140770
Researcher
Kelsey Turner

List of Studies

Keywords
Adolescents, Children's Health, Exercise, Pediatrics
Summary

This study aims to look at injury rates experienced during a club travel volleyball season as correlated with self reported scores on the GRIT scale, Brief Resiliency Scale (BRS), and Athlete Burnout Questionnaire (ABQ) in male and female high school age volleyball players. The GRIT asks questions about passion and perseverance to achieve goals.
The BRS asks questions about resiliency after stress.
The ABQ asks questions to understand the determinants and consequences of athlete burnout. Completion of these surveys will take approximately 20 minutes.

Upon receiving and compiling all survey data, appropriate statistical analysis will be performed to assess for trends in the development of injuries and inform best practice on training.

Institution
MUSC
Recruitment Contact
Stephanie McGowan
8437927356
mcgowan@musc.edu

J2T-MC-B002 (ADjoy): A Prospective Observational Cohort Study Evaluating Lebrikizumab Therapy in the Management of Adult and Pediatric Participants 12 Years of Age and Older with Moderate-to-Severe Atopic Dermatitis in North America

Date Added
July 16th, 2025
PRO Number
Pro00142075
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

J2T-MC-B002 (B002) examines the effectiveness of lebrikizumab in treating moderate-to-severe atopic dermatitis (AD). This study involves adult and adolescent patients suffering from eczema, which is characterized by inflammation, redness, and irritation of the skin. Participants will complete symptom assessments during their visits and will schedule appointments within specific timeframes. The study will also observe skin lesions using clinical measures. Participants will remain in the study for up to two years, even if their therapies change, to track disease progression with or without lebrikizumab. This observational study aims to record real-world treatment outcomes for the analysis of lebrikizumab in AD therapy.

Institution
MUSC
Recruitment Contact
Kenreka Yeadon
8438760110
yeadon@musc.edu



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