A Randomized Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-Risk Germ Cell Tumors

Date Added
July 3rd, 2019
PRO Number
Pro00089975
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed metastatic germ cell tumors. This study will compare the standard chemotherapy regimen with an accelerated chemotherapy regimen using the same drugs to see if the accelerated chemotherapy regimen is beneficial but not more toxic than the standard chemotherapy regimen. The accelerated chemotherapy is experimental. Participants can expect to be on study for about 3 months and continue to be followed for up to 5 years.

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

A Randomized Controlled Trial Comparing Monitored Anesthesia Care versus General Anesthesia with Transesophageal Echocardiography for Transcatheter Aortic Valve Replacement

Date Added
June 18th, 2019
PRO Number
Pro00088473
Researcher
George Whitener

List of Studies


Keywords
Cardiovascular, Heart, Surgery
Summary

This study is being done to evaluate the impact that monitored anesthetic care (MAC) versus general endotracheal anesthesia (GETA) has on hospital length of stay, rate of ICU admission, or procedural mortality. Also, we hope to determine if the use of Transesophageal Echocardiography (TEE) during GETA impacts device success and durability. Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis may be eligible candidates for this study.

Institution
MUSC
Recruitment Contact
Wanda Jones
8437921869
joneswr@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

Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or large b-cell lymphoma patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release

Date Added
May 28th, 2019
PRO Number
Pro00088512
Researcher
Brian Hess

List of Studies


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

This study is for patients who have been diagnosed with B-cell acute lymphoblastic leukemia (ALL) or large B-cell lymphomas. The investigational drug in this study is CTL019 (Tisagenlecleucel). The purpose of this study is to provide the investigational drug as a possible cancer treatment that would otherwise be unavailable. Patients can expect to be in this study for up to 3 months and in follow up for 15 years.

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

PHASE III RANDOMIZED TRIAL OF STANDARD SYSTEMIC THERAPY (SST) VERSUS STANDARD SYSTEMIC THERAPY PLUS DEFINITIVE TREATMENT (SURGERY OR RADIATION) OF THE PRIMARY TUMOR IN METASTATIC PROSTATE CANCER

Date Added
March 19th, 2019
PRO Number
Pro00086529
Researcher
David Marshall

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Prostate
Summary

This study is for men who have prostate cancer. The purpose of this study is to compare the effects, good and/or bad, of adding either prostate removal surgery or radiation therapy of the prostate to standard systemic therapy (SST), which is used to treat prostate cancer.

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

The Impact of a Gravity versus Vacuum Based Indwelling Tunneled Pleural Drainage System on Pain: A Multicenter, Randomized Trial

Date Added
March 7th, 2019
PRO Number
Pro00084785
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer
Summary

The purpose of this study is to compare the effects (good and bad) of the different types of drainage in people receiving indwelling tunneled pleural catheters and the effect this has on pain during the drainage period.

Institution
MUSC
Recruitment Contact
Katherine Wallace
843-792-4557
wallacka@musc.edu

Integrated Analysis of Toric Intra-Ocular Lens Rotation with Ray-Tracing Aberrometry

Date Added
March 4th, 2019
PRO Number
Pro00081873
Researcher
Karolinne Rocha

List of Studies


Keywords
Vision/ Eye
Summary

The purpose of this project is to identify the postoperative alignment of toric intraocular lenses (IOLs) in patients who have undergone cataract surgery.

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
longmart@musc.edu



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