HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation With Randomization to Either Single Cycle or to Three Tandem Cycles of Marrow-Ablative Chemotherapy With Autologous Hematopoietic Progenitor Cell Rescue

Date Added
June 12th, 2019
PRO Number
Pro00089045
Researcher
Sandeepkumar Kuril

List of Studies


Keywords
Cancer, Pediatrics
Summary

This study is for participants who have been diagnosed with a brain tumor called either a medulloblastoma or Central Nervous System embryonal tumors of the brain or spinal cord. The investigational drugs used in this study are thiotepa, etoposide and carboplatin. The purpose of this study is to test tumor for biologic markers that will help us know how to best treat each subject on this treatment study. Participants can expect to be on this study for up to 5 years and followed until end of study or disease progression.

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

hAAT-engineered Mesenchymal Stem Cells for the Treatment of Chronic Pain

Date Added
June 10th, 2019
PRO Number
Pro00088074
Researcher
Hongjun Wang

List of Studies


Keywords
Pain
Summary

Under this study, we would like to collect specimens from CP patients who will undergo pancreatic resection at the VA Hospital for in vitro experiments. In these experiments, we will determine whether immune cells from CP patients are different from cells from healthy donors purchased from ATCC or other commercial sources. We will then assess whether pre-culture of immune cells from CP patients with MSCs can shift them to less pro-inflammatory phenotypes that won't induce inflammation in neuronal cells. All studies will be done in vitro in the cell culture system. Exploring mechanisms that contribute to chronic pain is vital for veterans' health and VA healthcare.

Institution
MUSC
Recruitment Contact
Wenyu Gou
843-792-6396
gou@musc.edu

Neuroimaging to Examine Behavior

Date Added
May 21st, 2019
PRO Number
Pro00087701
Researcher
Amber Jarnecke

List of Studies


Keywords
Alcohol, Anxiety, Brain, Healthy Volunteer Studies, Mental Health, Non-interventional, Stress Disorders, Substance Use
Summary

This study will examine the neural circuitry associated with craving, behavioral disinhibition, and threat-reactivity. The study will involve 2 visits. During the first visit, participants will complete questionnaires and interviews in a private room and do some tests to measure alcohol use. During the second visit, participants will complete a neuroimaging scan of their brain.

Institution
MUSC
Recruitment Contact
Amber Jarnecke
843-779-2159
jarnecka@musc.edu

Cellular Therapy for Type 1 Diabetes using Mesenchymal Stem Cells

Date Added
May 21st, 2019
PRO Number
Pro00085542
Researcher
Hongjun Wang

List of Studies


Keywords
Diabetes
Summary

The goal of this study is to determine the safety and efficacy of fresh metabolically active allogeneic umbilical cord-derived mesenchymal stromal cells (UC-MSCs) for the treatment of new-onset type 1 diabetes (T1D) and to understand the mechanisms of protection. If proven effective, such a strategy can be used as a therapeutic option for T1D patients and potentially other autoimmune disorders.

Institution
MUSC
Recruitment Contact
Leah Benn
843-792-2813
bennle@musc.edu

Pulmonary Hemodynamics during Exercise - Research Network

Date Added
May 16th, 2019
PRO Number
Pro00087395
Researcher
Ryan Tedford

List of Studies


Keywords
Cardiovascular, Heart
Summary

Elevated pressures in the heart can represent a severe medical condition known as pulmonary hypertension. This can result in chronic right heart failure. An abnormal increase in this pressure during exercise may be represent an early stage of vascular lung disease. This study will investigate the prognostic implications of the measured pressures obtained during exercise while undergoing a right heart catheterization procedure based on a large scale multi-center approach by using retrospective and prospective analysis of hemodynamic data.

Institution
MUSC
Recruitment Contact
Brandon Sykes
843-876-5873
sykesb@musc.edu

Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and Chemotherapy (ALLELE Study)

Date Added
May 15th, 2019
PRO Number
Pro00081406
Researcher
Michelle Hudspeth

List of Studies


Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with Epstein-Barr Virus associated Post-Transplant Lymphoproliferative Disorder (EBV-PTLD). The investigational drug in this study is tabelecleucel. Tabelecleucel is a product containing special immune allogeneic cells, called EBV-Cytotoxic T Lymphocytes (EBV-CTLs), that are made in the laboratory starting with cells from a healthy person who is immune to EBV. The purpose of this study is to test how well tabelecleucel works to treat EBV-PTLD following SOT in patients who have not responded to rituximab or rituximab plus chemotherapy treatment and to see what side effects happen. Your participation will help us to understand more about tabelecleucel. In the first 12-month period, participants will be asked to come to the clinic for an estimated 11 to 19 study visits and a minimum of 2 scans, depending on the number of cycles of treatment they are given. After treatment is done, participants will enter into the follow-up phase, and will continue to come into the clinic for scheduled check-ups for up to 24 months after the first dose of tabelecleucel was given. Participant information on the status of their disease and any new treatment will be collected for up to an additional 3 years. Participants can expect to be in this study for up to five years total.

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

Neuromodulation of Cognitive Control Neurocircuits for Stroke Rehabilitation

Date Added
May 7th, 2019
PRO Number
Pro00086015
Researcher
Lisa McTeague

List of Studies


Keywords
Memory Loss, Stroke, Stroke Recovery
Summary

The goal of this study is to determine the pattern of cognitive impairment in chronic stroke, both in terms of performance during cognitive testing as well as brain neurocircuit activation.

Institution
MUSC
Recruitment Contact
Lisa McTeague
843-792-8274
mcteague@musc.edu

eACT (epilepsy: Adherence in children and technology)

Date Added
May 4th, 2019
PRO Number
Pro00087259
Researcher
Janelle Wagner

List of Studies


Keywords
Children's Health, Epilepsy, Pediatrics
Summary

The aim of this multi-site study is to evaluate the effectiveness of mHealth intervention strategies for improving anti-epileptic drug adherence in caregivers of young children with epilepsy. A 2-month baseline period will be followed by two stages. In Stage 1 (3-months), caregivers will received either 1) a mHealth education module and automated digital reminders or 2) the mHealth education module, automated digital reminders, and individualized adherence feedback based. In Stage 2 (2-months), caregivers will either receive 1) continued individualized adherence feedback or 2) individualized adherence feedback and a mHealth problem-solving module. The primary outcome is electronically-monitored adherence. Secondary outcomes include seizure severity/frequency, quality of life and healthcare utilization.

Institution
MUSC
Recruitment Contact
Shannon Williams
843-792-2201
wilshann@musc.edu

A prospective trial of varenicline and incentives for tobacco cessation in adults

Date Added
April 6th, 2019
PRO Number
Pro00086954
Researcher
Erin McClure

List of Studies


Keywords
Smoking, Substance Use
Summary

The purpose of this study is to better understand tobacco outcomes using a well-known stop smoking medication called varenicline, counseling and financial incentives among those who use tobacco and cannabis/marijuana. All participants will receive tobacco cessation treatment for 12 weeks. To qualify, participants must be between the ages of 18-40 and use both tobacco and cannabis/marijuana. You do not need to be interested in quitting cannabis/marijuana to qualify. This study is being conducted at three sites: the Medical University of South Carolina in Charleston, SC, Behavioral Health Services in Pickens, SC, and the Medical University of South Carolina in Florence, SC.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Kemi Chukwuka
843-792-4097 or 843-830-0165
smokingstudy@musc.edu

A prospective trial of varenicline and incentives for tobacco cessation in adults

Date Added
April 6th, 2019
PRO Number
Pro00086954
Researcher
Erin McClure

List of Studies


Keywords
Smoking, Substance Use
Summary

The purpose of this study is to better understand tobacco outcomes using a well-known stop smoking medication called varenicline, counseling and financial incentives among those who use tobacco and cannabis/marijuana. All participants will receive tobacco cessation treatment for 12 weeks. To qualify, participants must be between the ages of 18-40 and use both tobacco and cannabis/marijuana. You do not need to be interested in quitting cannabis/marijuana to qualify. This study is being conducted at three sites: the Medical University of South Carolina in Charleston, SC, Behavioral Health Services in Pickens, SC, and the Medical University of South Carolina in Florence, SC.

Institution
MUSC
Recruitment Contact
Kemi Chukwuka
843-792-4097 or 843-830-0165
smokingstudy@musc.edu



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