Human Samples Biorepository

Date Added
August 21st, 2018
PRO Number
Pro00072807
Researcher
Federica del Monte

List of Studies


Keywords
Aging, Cardiovascular, Coronary Artery Disease, Genetics, Heart, Military, Sarcoidosis, Scleroderma, Transplant, Vascular
Summary

The purpose of the study is to generate a bio bank of specimens for research. We will tissue that would otherwise be discarded from clinical or surgical procedure and information from medical records. We will also collect discarded blood, urines and sputum. Collecting samples will help to better understanding the mechanisms of cardiovascular diseases, identify biomarkers for early diagnosis and to predict safety and efficacy of new therapies.

Institution
MUSC
Recruitment Contact
Federica del Monte
843-792-8397
delmonte@musc.edu

Evaluation of a Web-Based Tool for Alcohol Use Following Interpersonal Violence

Date Added
September 23rd, 2018
PRO Number
Pro00080368
Researcher
Christine Hahn

List of Studies


Keywords
Alcohol, Substance Use, Women's Health
Summary

The purpose of this study is to gather feedback to inform the development of a web-based tool that provides screening and education about alcohol use following interpersonal violence. People who have experienced sexual assault or domestic violence in the last year and drink alcohol, or are currently in treatment for alcohol use, will be asked to provide feedback about a web-based tool for alcohol use. 60-minute interviews will be conducted and will involve viewing the content of the web-based tool and providing feedback. Additionally, feedback given during interviews will be analyzed and then individuals who have used the web-based tool will complete a survey following the tool use if they report using substances. The tool will be tested for use with English and Spanish speakers.

Additionally, the web-based tool will be adapted for use among SMW and TGD survivors of sexual assault. Two areas of the original tool will be adapted: 1) psychoeducation and normative feedback will be made specific to SMW and TGD people's experiences, and 2) sexual and gender minority stress content will be added (i.e., information about sexual and gender-identity related stressors and their association with distress and alcohol use). We will gather feedback via qualitative interviews from 30 SMW and TGD survivors of sexual assault who report alcohol misuse or heavy drinking in the past month.

Institution
MUSC
Recruitment Contact
Christine Hahn
843-792-0259
hahnc@musc.edu

A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors

Date Added
October 8th, 2018
PRO Number
Pro00082427
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with Germ Cell Tumors. The purpose of this study is to evaluate whether a strategy of complete surgical resection followed by surveillance can maintain an overall survival rate of at least 95.7% at two years for pediatric, adolescent and adult patients (ages 0- 50 years) with Stage I (low risk) malignant germ cell tumors, and at least 98% for patients with ovarian pure immature teratoma. The drugs used in this study are carboplatin and cisplatin. Participants will be followed for up to 10 years.

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

Measurement of gait mechanics and movement in the lower extremity amputee

Date Added
October 30th, 2018
PRO Number
Pro00082064
Researcher
Aaron Embry

List of Studies

Keywords
Exercise, Movement Disorders, Physical Therapy, Rehabilitation Studies
Summary

Walking after a lower extremity amputation is often difficult. It is important that researchers and clinicians understand the mechanisms that inhibit normal walking function. In this study, we are recruiting individuals with lower extremity limb loss for a walking and balance investigation. We will also be studying matched healthy controls to do similar study procedures. All study procedures will occur on the campus of MUSC by a licensed Physical Therapist and experienced researcher. Any questions should be directed to the coordinator listed.

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

Prospective, observational, longitudinal study in pediatric patients with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not medically advisable

Date Added
December 20th, 2018
PRO Number
Pro00084090
Researcher
Lara Wine Lee

List of Studies


Keywords
Pediatrics, Skin
Summary

This study will assess the features of children, younger than 12 years old, with moderate to severe eczema, also known as atopic dermatitis, when their condition is not adequately controlled with topical therapies (creams or lotions) or when those therapies are not medically advisable.

This is not a treatment study. You and your child will complete questionnaires describing how their condition effects them. Information related to your child's illness will be collected by reviewing their medical chart and by assessments performed by the study team. Participation in this study will involve at least 12 visits that will take place over a period of 10 years.

The information collected in this study may lead to an improved understanding of your child's illness and may provide healthcare providers with important information for treating atopic dermatitis in the future.

Institution
MUSC
Recruitment Contact
Susannah Wakefield
843-792-5935
dermresearch@musc.edu

Health Effects After Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-Related Cardiomyopathy

Date Added
January 9th, 2019
PRO Number
Pro00084750
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Cancer/Leukemia, Cancer/Lymphoma, Pediatrics
Summary

This study is for patients that have been diagnosed with Leukemia or Lymphoma. and have been treated on one of the following studies: Pediatric Oncology Group (POG) 9404, 9425, 9426, or Dana Farber Cancer Institute (DFCI) ALL Consortium 95-01. The purpose of this study is to look at the heart function of patients selected by change to get DRZ compared to the heart function of patients selected by chance not to get DRZ. In this study, they will also look at gender, age at cancer diagnosis, current age, dose of chemotherapy, and if chest radiation influences the risk of early heard damage. Participants in this clinical trial are expected to come to one clinic visit.

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

International Collaborative Treatment Protocol for Children and Adolescents with Langerhans Cell Histiocytosis

Date Added
February 5th, 2019
PRO Number
Pro00084129
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Pediatrics, Transplant
Summary

This study is for patients that have been diagnosed with multisystem Langerhans cell histiocytosis (LCH). The purpose of this study is to find out if prolonging the treatment and adding a drug called 6-mercaptopurine will be beneficial. Other goals include fining out if these changes will result in fewer patients having relapse of their LCH, and fewer patients having long term disease related problems. Participants can expect to be in this study for up to 24 months and will be followed on this study fir at least 5 years.

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

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

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



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