A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects with Metastatic Castration-Resistant Prostate Cancer

Date Added
April 2nd, 2025
PRO Number
Pro00142948
Researcher
Theodore Gourdin

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health
Summary

This study is for patients that have been diagnosed with metastatic castration-resistant prostate cancer. The study is testing an investigational drug called JANX007. Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of the study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of JANX007 when administered as a single agent. The drug is given to participants by IV infusion. Participants in this study can expect to be in this study until disease progression or unacceptable toxicity.

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

A Qualitative Investigation of Patient, Family, and Provider Treatment Preferences in PTSD and Alcohol Use Disorder

Date Added
April 1st, 2025
PRO Number
Pro00142158
Researcher
Sarah Giff

List of Studies

Keywords
Alcohol, Anxiety, Military, Psychiatry, Stress Disorders, Substance Use
Summary

Co-occurring post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) disproportionately affects Veterans and has significant negative impacts on the safety, wellbeing, and quality of life of Veterans, their romantic partners, and their families. However, treatments that address co-occurring PTSD-AUD and restore Veterans' psychosocial functioning are lacking. This project is designed to learn more to facilitate improving treatment approaches aimed at reducing symptoms of co-occurring PTSD-AUD and improving functioning among Veterans and their partners. The goal of this project is to learn from Veterans, family members, and treatment providers in order to inform an adaptation of a brief dyadic AUD intervention to be delivered alongside integrated PTSD-AUD treatment for Veteran couples.

Institution
MUSC
Recruitment Contact
Sarah Giff
(843) 792-5569
giff@Musc.edu

3D CTA Fusion for Prostate Artery Embolization: A Randomized Controlled Trial

Date Added
April 1st, 2025
PRO Number
Pro00140426
Researcher
Stephen Stringfellow

List of Studies

Keywords
Men's Health
Summary

This research study is focused on evaluating the effectiveness of a new imaging technique for a procedure called Prostate Artery Embolization (PAE), which is used to treat an enlarged prostate. The study compares two groups of patients: one group receives PAE with advanced imaging called 3D CTA fusion, and the other group receives PAE using the standard imaging method. The goal is to determine if using 3D CTA fusion can make the procedure faster, reduce the amount of radiation exposure, and decrease the need for contrast dye during the procedure. By studying these two groups, researchers hope to identify ways to make PAE safer and more efficient​

Institution
MUSC
Recruitment Contact
Derek Groskreutz
8432437260
groskreu@musc.edu

Operant conditioning of the wrist extensor motor evoked potential to target corticospinal plasticity and upper limb motor recovery after cervical spinal cord injury

Date Added
April 1st, 2025
PRO Number
Pro00138869
Researcher
Allison Lewis

List of Studies

Keywords
Central Nervous System, Nervous System, Rehabilitation Studies, Spinal Cord
Summary

Individuals with chronic cervical spinal cord injury will complete a 10-week training protocol where they receive non-invasive brain stimulation and feedback on the size of the corresponding muscle response (wrist extensor). We will assess the impact of the brain stimulation training on 1) the brain-to-spinal cord-to-muscle connection and 2) motor functions of the arm and hand. Also, brain and spine magnetic resonance imaging will be collected before and after the training. The imaging measurements will tell us about how spinal damage, brain function, and brain structure relate to motor presentation and the response to the training.

Institution
MUSC
Recruitment Contact
Blair Dellenbach
843-792-6313
stecb@musc.edu

Randomized Controlled Trial of MAGIcTouch - Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease

Date Added
April 1st, 2025
PRO Number
Pro00137869
Researcher
Adam Tanious

List of Studies

Keywords
Vascular
Summary

The purpose of this research is to evaluate the efficacy of a new investigational Sirolimus coated balloon device in the treatment of insufficient blood flow of legs (peripheral arterial disease, PAD).

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

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects with Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy

Date Added
March 28th, 2025
PRO Number
Pro00141998
Researcher
Kimberly Hashemi

List of Studies

Keywords
Skin
Summary

This Phase 3, randomized, placebo-controlled, double-blind study evaluates the efficacy and safety of Upadacitinib in adults and adolescents with moderate to severe hidradenitis suppurativa who have failed anti-TNF therapy. The study includes a 35-day screening period, a 16-week placebo-controlled, double-blind treatment period (Period 1), a 20-week re-randomized extension treatment period (Period 2), a 68-week long-term extension treatment period (Period 3), and a 30-day follow-up period.

Institution
MUSC
Recruitment Contact
Neharika Talasila
843-792-6882
talasila@musc.edu

A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING EFFICACY AND SAFETY OF GIREDESTRANT COMPARED WITH FULVESTRANT, BOTH COMBINED WITH A CDK4/6 INHIBITOR, IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WITH RESISTANCE TO PRIOR ADJUVANT ENDOCRINE THERAPY

Date Added
March 28th, 2025
PRO Number
Pro00141609
Researcher
Abirami Sivapiragasam

List of Studies

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

The study is designed for patients with Estrogen Receptor (ER) positive, HER2-negative advanced breast cancer resistance to prior adjuvant endocrine treatment. The purpose of the study is to determine the effectiveness of Giredestrant compared with Fulvestrant in combinationof CDK4/6i (Palbociclib, Ribociclib and Abemaciclib). The study drug being utilized is giredestrant. The FDA approved drugs will also be utilized: Zoladex and Lupron (LHRH - Luteinizing hormone-releasing hormone agonists) drugs; as well as, Palbociclib, Ribociclib , Fulvestrant, and Abemaciclib.

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

Vitaccess Real MG Registry

Date Added
March 28th, 2025
PRO Number
Pro00137745
Researcher
Katherine Ruzhansky

List of Studies


Keywords
Autoimmune disease
Summary

The aim of the registry is to collect data about the day-to-day impact of MG that is not routinely collected when you visit the clinic for check-ups. We will use the data in a number of registry-based studies that will allow for better information and treatments to be provided to MG patients in the future.

.You can take part in the registry if you:
• have been diagnosed with MG
• are 18 years or older
• live in the US, UK (England or Scotland only), Germany, France, or Italy, and
• have access to a smartphone/computer/laptop

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

Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence—A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)

Date Added
March 27th, 2025
PRO Number
Pro00142210
Researcher
Abirami Sivapiragasam

List of Studies

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

The study is for patient that have been diagnosed with ER positive HER2 negative early breast cancer. The main purpose is to determine the efficacy and safety of Elacestrant relative to the standard Endocrine therapy. Subject are expected to be enrolled into the study for 36 months.

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

A Phase 3. Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Date Added
March 27th, 2025
PRO Number
Pro00138507
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with NASH/MASH cirrhosis and fibrosis stage 4.

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



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