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 + save

Date Added
June 18th, 2013
PRO Number
Pro00011805
Researcher
Robert Stuart
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
Jessica Simons
843-792-2708
simonsjl@musc.edu

A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients + save

Date Added
May 29th, 2013
PRO Number
Pro00017387
Researcher
Jennifer Jaroscak
Keywords
Cancer, Children's Health, Men's Health, Minorities, Pediatrics, Transplant, Women's Health
Summary

This study if for patients that have a blood disease and it's been determined that the best option for treating that blood disease is a cord blood transplant. Cord blood (CB) is blood that is taken from the umbilical cord and placenta of healthy newborn babies after childbirth. The cord blood collected from a newborn baby is called a cord blood unit. The United States Food and Drug Administration (FDA) considers cord blood to be a biological drug. These are considered “investigational” products. This study will evaluate the safety of administration of the investigational cord blood units by carefully documenting all infusion-related problems.

Institution
MUSC
Recruitment Contact
Jessica Simons
843-792-2708
simonsjl@musc.edu

Telemedicine in the Evaluation of Alzheimer’s Disease in a Rural, African American Population + save

Date Added
May 21st, 2013
PRO Number
Pro00008892
Researcher
Jacobo Mintzer
Keywords
Aging, Alzheimers, Dementia, Ethnicity and Disease, Memory Loss, Minorities
Summary

The goal of this project is to address the issue of reduced access to healthcare among elderly, African American populations in rural communities. Specifically the goal is to improve access to Alzheimer ’s disease diagnosis within elderly, African American populations living in rural areas. The Medical University of South Carolina research team will partner with a rural South Carolina clinical practice where elderly, African American patients receive all other aspects of their care. Through the use of telemedicine it is our intent to develop a new methodology for diagnosing Alzheimer ’s disease in rural African American populations.

Institution
MUSC
Recruitment Contact
Courtney O'Neill
843-740-1592
oneillc@musc.edu

A PHASE II, OPEN-LABEL, RANDOMIZED STUDY OF MEHD7945A VERSUS CETUXIMAB IN PATIENTS WITH RECURRENT/METASTATIC SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK WHO HAVE PROGRESSED DURING OR FOLLOWING PLATINUM-BASED CHEMOTHERAPY + save

Date Added
April 22nd, 2013
PRO Number
Pro00016993
Researcher
Paul O'brien
Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Minorities, Women's Health
Summary

The main purpose of this study is to find out what effects, good and/or bad, MEHD7945A has on you and your cancer. In this study there will be two treatment arms. You will be treated with either MEHD7945A or cetuximab, a drug that is commonly used for your type of cancer. You will not be treated with both drugs at the same time.

Institution
MUSC
Recruitment Contact
Adam Fiebelkorn
843-792-6349
fiebelko@musc.edu

Characterization of Peripheral Blood Monocytosis and Reactive Lymphocytosis in Patients with Mast Cell Activation Syndrome (MCAS) + save

Date Added
February 15th, 2013
PRO Number
Pro00015857
Researcher
Lawrence Afrin
Keywords
Blood Disorders, Men's Health, Minorities, Women's Health
Summary

This study is for patients suspected of having Mast Cell Activation Syndrome (MCAS). MCAS is a state in which some portion of the body’s mast cells – which ordinarily produce many different signals influencing other cells to alter their behavior so as to maintain a state of health – produce signals which are abnormal in their intensity, duration, and/or location in the body, potentially causing a wide variety of acute and chronic symptoms and complications.
This research study seeks to understand how many mast cells are circulating in the blood of MCAS patients and whether there are increased blood levels in MCAS patients of certain signals which cause increases in certain types of white blood cells which commonly are seen in excess in MCAS patients.

Institution
MUSC
Recruitment Contact
Rachel Whirley
843-792-9579
whirley@musc.edu

Improving Informed Decision Making for Prostate Cancer Screening + save

Date Added
January 18th, 2013
PRO Number
Pro00015140
Researcher
Marvella Ford
Keywords
Cancer, Minorities, Prostate
Summary

African American (AA) men have the highest rate of prostate cancer death in the U.S. The proposed study will test whether giving AA men information that is tailored to their prostate cancer risk factors helps them to make informed decisions about receiving prostate cancer screening. If it is effective, the intervention could be widely used in clinical settings.

Institution
MUSC
Recruitment Contact
Melanie Jefferson
843-876-2452
sweatma@musc.edu

The Multidisciplinary Clinical Research Center for Rheumatic Diseases in African Americans + save

Date Added
January 15th, 2013
PRO Number
Pro00021985
Researcher
Gary Gilkeson
Keywords
Autoimmune disease, Environmental Factors, Ethnicity and Disease, Genetics, Healthy Volunteer Studies, Lupus, Minorities, Rare Diseases, Scleroderma
Summary

Systemic lupus erythematosus (lupus; SLE) and Systemic Sclerosis (scleroderma; SSc) are relatively rare rheumatic diseases that disproportionately impact the African American community, and particularly African American women. The causes of lupus and scleroderma are unknown, but thought to include both genetic and environmental factors. We are enrolling lupus and scleroderma 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 and scleroderma. Information about medical, social and family history, medications, physical exam findings, and laboratory tests will be collected for analysis. This study will involve approximately 910 volunteers.

Institution
MUSC
Recruitment Contact
Carol Lambourne
843-792-1192
lambourc@musc.edu

Roles of intratumor macrophages and the master chaperone for Toll-like receptors in colon cancer + save

Date Added
October 30th, 2012
PRO Number
Pro00010913
Researcher
Zihai Li
Keywords
Cancer, Cancer/Other, Men's Health, Minorities, Non-interventional, Surgery, Women's Health
Summary

This study will help to understand the roles of the immune system in controlling colon cancer. It may advance science, leading to future development of an effective treatment of colon cancer.

Institution
MUSC
Recruitment Contact
Zihai Li
843-792-1034
zihai@musc.edu

Quantifying Normal Swallow Physiology across the Adult Lifespan + save

Date Added
October 2nd, 2012
PRO Number
Pro00011566
Researcher
Kendrea Focht
Keywords
Aging, Healthy Volunteer Studies, Minorities
Summary

This novel prospective study will involve 120 adult participants (20 years and older) with no previous or current complaint/diagnosis of swallowing problems (dysphagia), as well as no history of any neurologic, otolaryngologic, or gastroenterologic diagnoses potentially causing dysphagia. Each participant will undergo a Modified Barium Swallow Study (MBSS) using the standardized MBSImP™© protocol, which will be digitally recorded for later scoring using the MBSImP™© scoring form and penetration-aspiration scale (PAS). Measurements include 17 physiologic components of swallowing performance, PAS, kinematic (relative distance), termporal (timing) measures of structural movements across 12 swallows of standardized viscosities, and respiratory-swallow coordination patterns during MBSS. Appropriate statistical analyses will be performed and reported.

Institution
MUSC
Recruitment Contact
Kendrea Focht
843-792-6953
focht@musc.edu

Expanded Access Program of Ponatinib (AP24534) for Patients with Refractory Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia + save

Date Added
September 11th, 2012
PRO Number
Pro00019630
Researcher
Luciano Costa
Keywords
Cancer, Cancer/Lymphoma, Drug Studies, Men's Health, Minorities, Women's Health
Summary

The purpose of the research study is for patients who have Chronic Myeloid Leukemia (CML) or Philadelphia Positive Acute Lymphoblastic Leukemia (Ph+ ALL) to receive an experimental treatment and other standard treatments haven’t worked or are no longer working for your Leukemia. The purpose of the expanded access program is to provide patients the opportunity to receive the experimental drug ponatinib (also known as AP24534) for treatment of this condition. Ponatinib is being studied as a possible cancer treatment for CML and Ph+ ALL. Experimental means that ponatinib has not yet been approved by any governmental health authority including the US Food and Drug Administration (FDA).

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzersl@musc.edu