Protocol for a Research Database for Hematopoietic Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries

Date Added
December 17th, 2002
PRO Number
Pro00136123
Researcher
Michelle Hudspeth

List of Studies


Keywords
Adolescents, Cancer, Transplant
Summary

The Center for International Blood and Marrow Transplant Research (CIBMTR ) keeps a research database. It uses this database to collect and study the medical data for patients that have received Hematopoietic Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries. It also collects and studies data from donors who give bone marrow or peripheral blood stem cells (PBSCs). These therapies are used to treat cancer and other diseases. The purpose of this study is to add more data to the database. Participants will have medical data (data about their disease, transplant or cellular therapy) collected before and after transplant cellular therapy, and once a year afterwards for life.

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

Clinical Database for Rehabilitation Research after Neurological Injury

Date Added
May 7th, 2012
PRO Number
Pro00015991
Researcher
Steven Kautz

List of Studies


Keywords
Healthy Volunteer Studies, Rehabilitation Studies, Spinal Cord, Stroke
Summary

In this study researchers aim to improve the collaborative research efforts of the Center for Rehabilitation Research in Neurological Conditions at the Medical University of South Carolina. The Center is comprised of several laboratories, including: the Communication and Swallowing Laboratory; the Locomotor Energetics and Assessment Laboratory; the Locomotor Rehabilitation Laboratory; the Neuromuscular Assessment Laboratory; and the Upper Extremity Motor Function Laboratory. The PI and investigators will recruit for their current and future studies in the above laboratories from the Clinical Database established here. Studies utilizing the Clinical Database will not include PHI but will only link to the Clinical Database individual patient code. This study is completed by completing a simple screening form with study personnel. Medical care/treatment future participation in studies is not influenced by inclusion in this study. We are also recruiting Healthy Controls for this study.

Institution
MUSC
Recruitment Contact
Aaron Embry
843-792-8198
embry@musc.edu

The Core Center for Clinical Research, Improving Minority Health in Rheumatic Diseases

Date Added
January 15th, 2013
PRO Number
Pro00021985
Researcher
James Oates

List of Studies


Keywords
Autoimmune disease, Environmental Factors, Ethnicity and Disease, Genetics, Healthy Volunteer Studies, Lupus, Minorities, Rare Diseases, Scleroderma
Summary

Systemic lupus erythematosus (lupus; SLE), Systemic Sclerosis (scleroderma; SSc) and Systemic Vasculitis (SV) are relatively rare rheumatic diseases that disproportionately impact the African American community, and particularly African American women. The causes of lupus, scleroderma and vasculitis are unknown, but thought to include both genetic and environmental factors. We are enrolling lupus, scleroderma, and vasculitis patients, and healthy control subjects. This is not a drug study. The purpose of this study is to better understand the factors that predispose people to develop lupus, scleroderma, and vasculitis. Information about medical, social and family history, medications, physical exam findings, and laboratory tests will be collected for analysis. This study will involve approximately 1360 volunteers.

Institution
MUSC
Recruitment Contact
Jonathan Flume
843-792-3926
jof63@musc.edu

An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes

Date Added
February 18th, 2014
PRO Number
Pro00030914
Researcher
Richard Friedman

List of Studies


Keywords
Joint, Pain, Surgery
Summary

The purpose of this study is to collect and evaluate clinical and radiographic outcomes data on patients who have undergone, or will undergo, shoulder replacement surgery. Patients who receive a device from the Equinoxe® Shoulder System, manufactured and distributed by Exactech, Inc as well as patients who receive a device from another shoulder arthroplasty system may be included in this study.

Institution
MUSC
Recruitment Contact
Lisa Mock
843-876-2211
mockl@musc.edu

Collaborative, National Quality and Efficacy Registry for Tracking Disease Progression in Systemic Sclerosis (Scleroderma) Patients

Date Added
November 20th, 2018
PRO Number
Pro00080285
Researcher
Faye Hant

List of Studies


Keywords
Autoimmune disease, Non-interventional, Rare Diseases, Scleroderma, Skin
Summary

The goal of this study is to develop an early systemic sclerosis (SSc) registry in the United States (US). A registry is a group of patients that are observed over time. This is a non-interventional study, meaning that they are no study specific medications to take or procedures to undergo. The specific aims include ongoing assessment of the natural history of early SSc patients by capturing and analyzing clinical data, patient reported outcomes, and laboratory data as seen in the clinic as part of their routine care needs. Additional study visits are not required. This is a multi-center study with sites spread across the U.S. This study is funded by the Scleroderma Research Foundation.

Institution
MUSC
Recruitment Contact
Miranda Irvin
843-792-8613
scleroderma@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

RECOVER: A PRospective, Multi-cEnter, Randomized Controlled Blinded Trial DemOnstrating the Safety and Effectiveness of VNS Therapy® System as AdjunctivE Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression

Date Added
March 10th, 2020
PRO Number
Pro00095951
Researcher
Mark George

List of Studies


Keywords
Depression, Mental Health, Psychiatry
Summary

Depression is a very common disorder that is most often chronic or recurrent in nature. Many subjects do not respond adequately to an initial antidepressant treatment trial. Subjects who do not respond adequately to multiple therapeutic interventions are considered to have treatment-resistant depression (TRD). Among the treatment options for subjects with TRD is Vagus Nerve Stimulation (VNS) Therapy.This blinded, randomized, multicenter controlled study is intended to collect evidence that VNS Therapy as an adjunctive therapy improves health outcomes for patients with TRD.

Institution
MUSC
Recruitment Contact
Morgan Dancy
843-876-5141
maddoxm@musc.edu

A Phase 1/2a, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients With Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

Date Added
August 24th, 2020
PRO Number
Pro00096015
Researcher
John Wrangle

List of Studies


Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with Non-Small Cell Lung Cancer (NSCLC).The investigational drug used in this study is CLN-081.

This study has 3 parts; Phase 1 Dose Escalation, Phase 1 Dose Expansion, and Phase 2a Dose Expansion:
-Phase 1 Dose Escalation: The main aim of this part of the study is to find a maximum tolerated dose for CLN-081. This will be done by slowly increasing the dose given to each participant or to small groups of participants until certain adverse effects are seen. All participants will be closely monitored by the study doctor and team. When the maximum tolerated dose has been found, it will be used in the subsequent parts of the study.
-Phase 1 Dose Expansion: In this part of the study more participants will receive the maximum tolerated dose to confirm the safety of this dose of the study medicine and to explore different dosing schedules, for example, taking the study medicine once a day versus twice a day.
-Phase 2a Dose Expansion: The main aim of this part of the study will be to see how well the study medicine works in reducing tumor size.

Participants can expect to be on this study for about 3 years.

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

MPFC Theta Burst Stimulation as a Treatment Tool for Alcohol Use Disorder: Effects on Drinking and Incentive Salience

Date Added
September 1st, 2020
PRO Number
Pro00102709
Researcher
Lisa McTeague

List of Studies


Keywords
Alcohol, Brain, Drug Studies, Psychiatry, Substance Use
Summary

The purpose of this study is to develop transcranial magnetic stimulation (TMS), specifically TMS at a frequency known as theta burst stimulation (TBS), to see how it affects the brain and changes the brain's response to alcohol-related pictures. TMS and TBS are stimulation techniques that use magnetic pulses to temporarily excite specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). TBS, which is a form of TMS, will be applied over the medial prefrontal cortex, (MPFC), which has been shown to be involved with drinking patterns and alcohol consumption. This study will test whether TBS can be used as an alternative tool to reduce the desire to use alcohol and reducing the brain's response to alcohol-related pictures.

Institution
MUSC
Recruitment Contact
Charleston Alcohol Research Center
(843) 792-1222
alcoholstudy@musc.edu

Alcohol Research Center. Shared clinical assessment core for the Alcohol Research Center clinical projects.

Date Added
October 6th, 2020
PRO Number
Pro00103760
Researcher
Konstantin Voronin

List of Studies


Keywords
Alcohol, Drug Studies
Summary

The purpose of this research study is to determine potential subjects eligibility for participation in the Alcohol Research Center clinical projects based on the results of the screening assessments, which they will complete during this protocol.
Participants will undergo 1-2 days screening procedures. Subjects will be asked to fill out questionnaires, they will be interviewed, will need to provide medical history and have physical exam done and provide a blood sample. Total study consists 1-2 visits which will be completed within approximately one-week period.

Institution
MUSC
Recruitment Contact
Konstantin Voronin
843-792-4887
voronin@musc.edu



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