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

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

tDCS Combined with a Brief Cognitive Intervention to Reduce Perioperative Pain and Opioid Requirements in Veterans

Date Added
October 1st, 2019
PRO Number
Pro00091450
Researcher
Jeffrey Borckardt

List of Studies


Keywords
Brain, Joint, Mental Health, Military, Pain, Psychiatry, Surgery
Summary

The purpose of this study is to determine whether a new medical technology can help reduce post-operative total knee or hip pain when combined with a Cognitive-Behavioral intervention (CBI).

This new medical technology, is called transcranial direct current stimulation (tDCS), it uses a very small amount of electricity to temporarily stimulate specific areas of the brain thought to be involved in pain reduction. The electrical current passes through the skin, scalp, hair, and skull and requires no additional medication, sedation, or needles.

This study will investigate the effects of tDCS, the Cognitive-Behavioral (CB) intervention and their combination on pain among veterans following total knee arthroplasty (TKA) or total hip arthroplasty (THA). You may benefit in the form of decreased pain and opioid requirements following your knee or hip replacement surgery. However, benefit is only likely if you are randomized to one of the 3 (out of 4) groups.

This study hopes to determine the effects of these interventions and their combined effect on post-operative pain, opioid use and functioning during the 48-hour post-operative period following a total knee or hip replacement.

Institution
MUSC
Recruitment Contact
Georgia Mappin
(843) 789-7104
georgia.mappin@va.gov

The Randomised Controlled Trial of Frontal and Temporal Electroconvulsive Therapy (ECT) for Severe Depression (The RAFT ECT Study)

Date Added
June 2nd, 2020
PRO Number
Pro00098725
Researcher
Mark George

List of Studies


Keywords
Depression, Mental Health
Summary

This is a research study to find out if a new form of electroconvulsive therapy (ECT) is as effective and safe as a current form. The new form of ECT is called Frontal (Ultrabrief Right Unilateral) ECT. If enrolled in this this study, participants will be randomly assigned (like flipping a coin) to receiving Frontal ECT or the current standard form of ECT called Temporal (Ultrabrief Right Unilateral) ECT.

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

Early measurement of ST2 as a prognostic biomarker for future occurrence of acute GVHD II-IV in a prospective multisite study

Date Added
July 17th, 2020
PRO Number
Pro00100472
Researcher
Sophie Paczesny

List of Studies

Keywords
Cancer
Summary

The purpose of this study is to collect two blood specimens and information about participants who are receiving a standard of care bone marrow or stem cell transplant to use and help better understand graft-versus-host disease (GVHD). One potential new way to help researchers better understand GVHD is through a biomarker (a substance found in your blood/tissue) called ST2. The new information learned from this study could then be used in future research for patients undergoing stem cell transplants. This is a non-interventional study (no drugs involved).

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
843-792-9321

Localizing Epileptic Networks using 3T MRI

Date Added
September 29th, 2020
PRO Number
Pro00102615
Researcher
Alexandra Parashos

List of Studies

Keywords
Epilepsy
Summary

The purpose of this research study is to study the capabilities of new methods for studying the brain using Magnetic Resonance Imaging (MRI). MRI already provides detailed images of brain anatomy, but newer methods including new MRI techniques and magnetic resonance spectroscopy expand this capability. These new MRI methods will not require any invasive procedures. If successful, these new methods will expand the information, which can be obtained from MRI studies of the brain in patients with epilepsy.

Institution
MUSC
Recruitment Contact
Lindsey Weissman
843-792-2330
weissmal@musc.edu

Oxytocin to Enhance Integrated Exposure-Based Treatment of Co-occurring Alcohol Use Disorder and PTSD

Date Added
November 3rd, 2020
PRO Number
Pro00103198
Researcher
Sudie Back

List of Studies


Keywords
Alcohol, Mental Health, Military, Psychiatry, Stress Disorders
Summary

The purpose(s) of the research is to test a new medication in combination with a talk therapy for Veterans experiencing posttraumatic stress disorder (PTSD) and who may have alcohol use disorder (AUD). The study consists of 12 weekly therapy sessions. Once per week before each therapy session, an intranasal dose of investigational medication will be administered. The study also involves 3 and 6-month follow-up appointments and the administration of questionnaires at each visit.

Institution
MUSC
Recruitment Contact
Stacey Sellers
843-792-5807
sellersst@musc.edu

Development and Feasibility Testing of an Integrated PTSD and Adherence Intervention Cognitive Processing Therapy-Lifesteps (CPT-L) to Improve HIV Outcomes

Date Added
February 2nd, 2021
PRO Number
Pro00106801
Researcher
Cristina Lopez

List of Studies


Keywords
Anxiety, Depression, HIV / AIDS
Summary

The purpose of this study is to explore the use of a new treatment program to improve medication adherence for people with HIV and PTSD for patients at local HIV care clinics. Participants will be assigned to one of two groups. Participants in Group A will be asked to attend 12 clinic sessions (twice a week for 6 weeks, 90-minute sessions) via telehealth or in person at a HIV care clinic. Participants in Group B will receive a one session adherence intervention (60 minutes) and get the same standard treatment that someone with a trauma history and co-occurring HIV and PTSD symptoms would receive at a local HIV care clinic. The study is provided at no-cost, and participants may learn useful information and coping skills while being in the study. It is hoped the information that we get from this study will help researchers and clinicians better design treatment programs for people living with HIV and PTSD. Participants will receive study compensation for their time.

Institution
MUSC
Recruitment Contact
Cristina Lopez
843 876-1034
lopezcm@musc.edu

Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF)

Date Added
February 9th, 2021
PRO Number
Pro00104312
Researcher
Daniel Steinberg

List of Studies


Keywords
Heart, Surgery
Summary

This study is being done on patients who have heart failure, a condition where the heart muscle weakens and enlarges and cannot pump blood effectively. The purpose of this study is to assess the safety and effectiveness of a new device called the AccuCinch Ventricular Restoration System and compare it to treatment with standard heart failure medications alone. The AccuCinch Ventricular Restoration System consists of anchors, which attach to your heart muscle, sliders to connect the anchors and a thread like cord that goes through the anchors and is cinched to make your enlarged heart smaller so it can pump more efficiently. The device is implanted in one of the lower pumping chambers of the heart (called left ventricle). The study will have two groups, the treatment group in which participants undergo the device implant in addition to taking heart failure medications and the control group in which participants are treated with heart failure medications alone. Participation will last up to 5 years.

Institution
MUSC
Recruitment Contact
Kavin Panneerselvam
843-792-0464
panneeer@musc.edu

A Phase II Randomized Trial of Adjuvant Therapy With Pembrolizumab After Resection of Recurrent/Second Primary Head and Neck Squamous Cell Carcinoma With High Risk Features

Date Added
May 14th, 2021
PRO Number
Pro00110906
Researcher
Jennifer Harper

List of Studies


Keywords
Cancer, Cancer/Head & Neck
Summary

This study is for patients that have been diagnosed with recurrent or new head and neck squamous cell carcinoma (HNSCC). Patients either have had a recurrence (the tumor has comeback) or a new head and neck cancer in a different area of the head and neck (second primary) which has been removed by surgery. The study drug used is called pembrolizumab. The purpose of this study is to see if adding pembrolizumab to radiation or if using pembrolizumab by itself after surgery compared to the usual approaches with chemotherapy and radiation will increase life expectancy. Participants can expect to be on this study for up to 12 months and then followed for 5 years.

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



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