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

Identification and characterization of "permeability factor" in blood and body fluids of patients with proteinuric kidney diseases

Date Added
January 2nd, 2013
PRO Number
Pro00018380
Researcher
Milos Budisavljevic

List of Studies


Keywords
Kidney
Summary

Overwhelming evidence exists that some types of proteinuric kidney diseases are caused by the factor(s) present in patients' blood and body fluids. Identification and characterization of such factor(s) would greatly help in better and noninvasive diagnosis of such conditions, development of better therapeutic options, and potentially revealing underlying pathogenic mechanisms.
Owing to the tremendous capabilities of the proteomics facility within the Division of Nephrology we developed experiments that we think will result in significant improvement in our knowledge of major kidney diseases.

Institution
MUSC
Recruitment Contact
Linda Walker
(843) 792-6109
walkerlp@musc.edu

Phase III Trial of Dose Escalated Radiation Therapy and Standard Androgen Deprivation Therapy (ADT) with a GnRH Agonist vs. Dose Escalated Radiation Therapy and Enhanced ADT with a GnRH Agonist and TAK-700 for Men with High Risk Prostate Cancer

Date Added
October 2nd, 2012
PRO Number
Pro00018969
Researcher
David Marshall

List of Studies


Keywords
Cancer, Prostate
Summary

The purpose of this study is to compare the effects of hormone therapy (androgen deprivation) and TAK-700 plus radiation therapy with hormone therapy (androgen deprivation) and radiation therapy on patients with prostate cancer.
There are 2 treatment groups in this study. Group 1will receive hormone therapy plus radiation therapy only and Group 2 will receive hormone therapy and TAK-700 plus radiation therapy.
Subjects will receive hormone therapy for 24 months. Radiation will be given in 44 treatments over approximately 2 months. If the subject is in Group 2 they will take TAK-700 for 24 months. After the subject is finished receiving therapy, the study doctor will ask the subject to visit the office for follow-up exams every 6 months for 3 years and then once a year.

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-9007
brisend@musc.edu

The POSEIDON Kidney Disease Registry and Biobank

Date Added
September 18th, 2012
PRO Number
Pro00019764
Researcher
Joshua Lipschutz

List of Studies


Keywords
Kidney, Rare Diseases, Transplant, Urinary
Summary

Currently, kidney disease affects up to 20% of the US population and is a strong contributor to morbidity and mortality in these patients. Specific therapies and diagnostic tools for kidney disease have been very slow to develop because of the absence of high quality samples and data that can be used for research studies. The purpose of this study is to develop a registry and sample bank called Poseidon (Prevention, Optimizing Safety, Early Intervention and DetectiOn in Nephrology) biobank that can be used for future research. In this study, patients can consent to donating their residual kidney tissue if they undergo a kidney biopsy and blood or urine during routine clinical care procedures. We will also collect blood and urine outside of clinical care.This study will allow biomedical research the ability to obtain specimens from patients with relevant diseases and appropriate clinical data. This study will collect patient demographic, clinical and historical data for a registry and patient samples will be deposited in the Poseidon biobank. Patients do not have to be diagnosed with Kidney Disease to be included in this study.

Institution
MUSC
Recruitment Contact
Linda Walker
8437926109
walkerlp@musc.edu

OUTCOMES OF PATIENTS WITH AUTOLOGUS MID-URETHRAL SLING AFTER FAILURE OF MID-URETHRAL MESH SLING

Date Added
June 29th, 2012
PRO Number
Pro00012059
Researcher
Eric Rovner

List of Studies


Keywords
Urinary
Summary

Mid-urethral slings have been widely accepted as a treatment of choice for patients with stress urinary incontinence (SUI). Mid-Urethral sling surgery has been associated with good success rate and minimal morbidity.Minor complications are associated with these surgeries including bladder perforation, urethral injury or post operative complication such as de novo urgency and urge urinary incontinence, urinary retention or incomplete bladder emptying. Treatment approaches for complications included sling excision and urethral/bladder/ vaginal defect repair after sling intrusion or extrusion into these organs. Treatments for postoperative voiding dysfunction include clean intermittent catheterization, mid-urethral sling lysis, sling incision and formal urethrolysis. With urethrolysis, obstruction has been reported to be relieved in 65% to 93 with preservation of continence in 80% to 100% while the rate of SUI postoperative is 0 % to 19%.autologus fascial sling for relieve of obstruction with 54% of patients had no recurrence of their SUI [25]. On the other hand, there have been no published data on the use of autologus fascia lata pubovaginal sling to treat patient with recurrent SUI after incision of the mid-urethral mish slings. Urethral injection of bulking agent have been reported with 34% cure [26] and re-do mid urethral sling was reported to have only 53% success over 17 months of follow-up [9].
Our aim is to evaluate the subjective and objective outcomes of salvage treatment of failed mid-urethral mesh sling with sling incision, urethrolysis, autologus facial pubovaginal sling or other forms of diversion if needed. We also will evaluate if this procedure will help to improve in the quality of life of these patients.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
843-876-0630
ude.csum@njiknej

AALL1131: A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (IND#73789, NSC#732517) in Patients with Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations

Date Added
June 22nd, 2012
PRO Number
Pro00016822
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Leukemia, Pediatrics
Summary

To collect information about the patient's leukemia and to seek the optimal treatment for children with ALL based on the individual level of risk of the cancer coming back after treatment. The risk groups are defined as a result of recent research conducted by the Children's Oncology Group (COG). We would like to learn if the use of an experimental intrathecal therapy (ITT), which has been given to many people with ALL and has been well tolerated, would be better at preventing relapse in the central nervous system and improve disease outcomes in children with High Risk ALL.

Institution
MUSC
Recruitment Contact
Jacqueline Kraveka
843-792-2957
kravekjm@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

Language Development in Teens and Young Adults with Fragile X Syndrome or Autism

Date Added
January 25th, 2012
PRO Number
Pro00014212
Researcher
Jessica Klusek

List of Studies

Keywords
Adolescents, Autism, Healthy Volunteer Studies, Language
Summary

We are recruiting mothers of children with typical development, autism, or fragile X syndrome.

This study focuses on parental experiences and normal individual differences that may influence child language development. The broader goal of the study is to understand which family experiences support language development in children who have neurodevelopmental disabilities, such as autism. We are recruiting families who have children who are typically developing, have autism, or have fragile X syndrome.

Institution
USC
Recruitment Contact
Jessica Klusek
803 777 5676
klusek@mailbox.sc.edu

A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer

Date Added
January 10th, 2012
PRO Number
Pro00015069
Researcher
Megan Ruppel

List of Studies

Keywords
Cancer, Cancer/Breast
Summary

The purpose of this study is to compare the good and bad effects of a new approach that includes surgery plus radiation for the tumor in your breast to the standard approach of continued treatment with the medication which is working to control your tumor.

Institution
MUSC
Recruitment Contact
Katherine Halloran
843-792-7035
halloran@musc.edu

A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications

Date Added
August 16th, 2011
PRO Number
Pro00011805
Researcher
Michelle Hudspeth

List of Studies


Keywords
Cancer, Children's Health, Men's Health, Minorities, Pediatrics, Transplant, Women's Health
Summary

The primary purposes of this study are to:
•Provide access to cord blood units for recipients whose best choice for a cord blood unit(s) do not meet all FDA standards, but do meet standards set by the NMDP on this study.
•Assess how well and how quickly blood counts return to normal after transplant in recipients on this study.

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



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