GBM AGILE Trial

Date Added
January 21st, 2020
PRO Number
Pro00089802
Researcher
Scott Lindhorst

List of Studies


Keywords
Brain Tumor, Glioblastoma
Summary

Glioblastoma adaptive, global, innovative learning environment or GBM AGILE trial is to identify effective therapies and improve survival for a type of brian cancer called glioblastoma (GBM) and to match effective therapies with adult patients with newly diagnosed or recurring glioblastoma. Eligible participants will have a 50/50 chance of taking either standard therapy medications or a medication not yet approved by the FDA called regorafenib during their standard of care treatment for GBM.

Institution
MUSC
Recruitment Contact
John Keller
843-792-2209
Kellej@musc.edu

Neurophysiological characterization of dry needling in people with spasticity due to stroke

Date Added
March 3rd, 2020
PRO Number
Pro00095077
Researcher
Aiko Thompson

List of Studies


Keywords
Central Nervous System, Physical Therapy, Rehabilitation Studies, Stroke, Stroke Recovery
Summary

The study team is recruiting 20 adults with spasticity due to chronic stroke and 20 adults with no neurological injuries for a 4 day study over 1 week. In people with chronic stroke, one of the most common and disabling problems is spasticity (increased muscle tone or muscle stiffness). The purpose of this research study is to examine effects of dry needling on the nervous system (pathways between the muscle, spinal cord, and brain) in people with spasticity due to chronic stroke. Dry needling is a procedure in which a thin, stainless steel needle is inserted into your skin to produce a muscle twitch response. It is intended to release a knot in your muscle and relieve pain.

The total study duration is 4 visits over one week. The first visit will take about 1.5 hours, during which the study team will determine the best electrode placement and create a removeable cast of your arm or leg to aid in placing electrodes in the next visits. The second visit will take about 3 hours, during which dry needling will take place, and the fourth and fifth visits will take about 1.5 hour. During all visits you will be asked to participate in examinations of reflexes (muscle responses to non-invasive nerve stimulation) and arm/leg function.

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

Single Institution Registry of Prostatic Artery Embolization for Lower Urinary Tract Symptoms due to Benign Prostatic Obstruction

Date Added
March 13th, 2020
PRO Number
Pro00097914
Researcher
Stephen Stringfellow

List of Studies

Keywords
Aging, Bladder
Summary

This study will collect prospective data on clinical indications, outcomes, and adverse events related to Prostatic Artery Embolization (PAE) at the Medical University of South Carolina. Patients undergoing surgical treatment for benign prostatic obstruction causing LUTS will also be allowed to enroll in this registry for the purposes of comparison. Patients will be followed at 1, 3, and 12 months post-procedure, for a period of up to 5 years. Patients will remain enrolled in the registry for a period of 5 years.

Institution
MUSC
Recruitment Contact
Andre Uflacker
8438765556
uflackera@musc.edu

Pulmonary Hypertension Association Registry (PHAR)

Date Added
March 18th, 2020
PRO Number
Pro00097483
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

The PHAR is a multicenter, prospective registry of newly evaluated patients at PHCCs in the United States who have either PAH or CTEPH. Baseline information will be collected at the time of initial evaluation at the PHCC (within six months of the initial outpatient PHCC visit) with follow-up data collected at approximately 6-month intervals. This study will determine how patients with PH are evaluated, tested, and treated, and will observe how well patients do. The goal of the project is to see if patients with PH are treated according to recommended guidelines and to see if there are certain factors which lead to better or worse outcomes in patients with PH. There is no intervention or study medication used and there is no limitation to how a patient is treated in this study.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Randomized Placebo-controlled Trial of Zoledronic Acid for Prevention of Fractures in Patients with Parkinson's Disease

Date Added
March 31st, 2020
PRO Number
Pro00095121
Researcher
Vanessa Hinson

List of Studies


Keywords
Parkinsons
Summary

This randomized clinical trial is designed to test the efficacy of ZA-5 mg in PD patients. This trial will also address barriers to treatment of patients with PD by providing rigorous evidence about whether ZA reduces fracture risk in patients with PD, simplifying treatment by giving ZA at home without extra medical visits and BMD testing, and overcoming poor persistence with oral therapies because one infusion may prevent bone loss for at least 2 years. The outcome of this trial will demonstrate how a home-based fracture prevention can reach older PD patients who would not otherwise receive treatment to reduce their high risk of fractures.

Institution
MUSC
Recruitment Contact
Timothy Sheehan
843-792-0372
sheehant@musc.edu

Operant Conditioning of Spinal Reflexes to Enhance Motor Function Recovery after Spinal Cord injury

Date Added
April 7th, 2020
PRO Number
Pro00095583
Researcher
Aiko Thompson

List of Studies


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

The purpose of the first portion of this study is to gather feedback from clinicians on the usability of the current system and procedure, so the researchers can make reflex training more useful and usable for improving recovery after spinal cord injury or other nervous system injuries and diseases. The researchers are recruiting 20 therapists who have been actively practicing physical medicine and 30 adults with no known neurological conditions to test system usability and the reflex operant conditioning protocol. For this portion of the study, there are 5 visits. We will also recruit 15 adults with no neurological injuries, 15 adults with neuropathic pain, and 15 adults with non-neuropathic pain to participate in one visit to provide feedback on sensation caused by stimulating electrodes.

The purpose of the second part of the study is to validate the capacity of the system to change the size of the targeted reflex. For this the researchers are recruiting 25 individuals with chronic incomplete SCI who have spasticity in the leg to participate in the reflex training procedure. The study involves approximately 45 visits with a total study duration of about 6 months.

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

Integrated Early Intervention for Alcohol Use Disorder and Posttraumatic Stress Disorder Following Sexual Assault

Date Added
May 5th, 2020
PRO Number
Pro00099114
Researcher
Christine Hahn

List of Studies


Keywords
Women's Health
Summary

This study is for women who have experienced a sexual assault in the past one year and use alcohol. The research involves completing a five to seven week behavioral treatment for stress and alcohol use. Participants will complete surveys during visits. Participants may also be asked to complete brief daily assessments on their smart phones.

Institution
MUSC
Recruitment Contact
Christine Hahn
8437923386
hahnc@musc.edu

LUNGMAP: A Master Protocol To Evaluate Biomarker-Driven Therapies And Immunotherapies In Previously-Treated Non-Small Cell Lung Cancer (Lung-Map Screening Study)

Date Added
May 7th, 2020
PRO Number
Pro00099591
Researcher
John Wrangle

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients that have been diagnosed with non-small cell lung cancer. The purpose of this study is to find out if a targeted immunotherapy treatment will have an effect on specific genes and proteins in tumors. This is a screening study in which a tumor sample will be submitted for testing. Based on results, the participant will be assigned to one of the treatment sub-studies.

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

Personalized Lung Cancer Screening (PLuS) Study

Date Added
May 14th, 2020
PRO Number
Pro00098558
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Lung
Summary

This is an observational study that will analyze electronic health records data from real-world populations and settings in order to fully characterize the outcomes of Lung Cancer Screening with Low-Dowse CT scans.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

Influenza and Other Emerging Respiratory Pathogens Surveillance Registry

Date Added
May 21st, 2020
PRO Number
Pro00099865
Researcher
Austin Biggs

List of Studies

Keywords
Children's Health, Coronavirus
Summary

The largest published COVID-19 pediatric series to date included only 13 patients considered to be critically ill and only described the Chinese outbreak. There are essentially no data outside of this and nothing to begin to understand the prevalence of severe/critical pediatric COVID-19, the risk factors associated with this illness, outcomes from COVID-19, and factors (patient or treatment) that may be associated with an improved or worsened outcome. This study will identify all children admitted to an inpatient unit with a diagnosis of COVID-19. Clinical data will be collected through medical record review to describe in detail the demographics and clinical characteristics, including clinical course and treatment, of infected children who require hospitalization.

Institution
MUSC
Recruitment Contact
Andrew Atz
843-876-1698
atzam@musc.edu



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