A randomized trial of low versus moderate exposure busulfan for infants with severe combined immunodeficiency (SCID) receiving TCRαβ+/CD19+ depleted transplantation: A Phase II study by the Primary Immune Deficiency Treatment Consortium (PIDTC) and Pediatric Transplantation & Cellular Therapy Consortium (PTCTC) PIDTC "CSIDE" Protocol (Conditioning SCID Infants Diagnosed Early) PTCTC NMD 1801

Date Added
November 5th, 2019
PRO Number
Pro00091878
Researcher
Michelle Hudspeth

List of Studies


Keywords
Cancer, Infant, Pediatrics
Summary

This study is for children age 0-2 who have been diagnosed with severe combined immunodeficiency (SCID). In this study, participants will be randomized (select by chance) into groups that will decide the dose of chemotherapy they will receive, receive chemotherapy prior to a blood stem cell transplant, and have blood drawn for research tests. The purpose of this research study is to find out if lower doses of a chemotherapy drug called busulfan before stem cell transplant can help patients with SCID, and to see if the device the CliniMACS® is effective in preparing donor stem cells before the transplant. Participants can expect to be in this study for up to 3 years.

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

Randomized Controlled Trial of Olanzapine for the Control of Chemotherapy-induced Vomiting in Children Receiving Highly Emetogenic Chemotherapy

Date Added
November 5th, 2019
PRO Number
Pro00091874
Researcher
Michelle Hudspeth

List of Studies


Keywords
Cancer, Transplant
Summary

This study is for subjects that are about to receive high dose cyclophosphamide before a blood or bone marrow transplant (BMT). The investigational drug in this study is Olanzapine.This research is being done to find out whether adding olanzapine to standard antiemetics will be helpful in controlling CINV in children receiving chemotherapy a blood or bone marrow transplant. To find this out, some of the participants in this study will get olanzapine and others will receive a placebo (a substance that looks like olanzapine but does not have any active or medicinal ingredients). This will allow us to compare treatment of CINV with and without olanzapine.

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

Development of an Olfactory Screening Instrument

Date Added
October 19th, 2019
PRO Number
Pro00093106
Researcher
Zachary Soler

List of Studies


Keywords
Non-interventional, Nose
Summary

The main objective of this project is to develop a quick and efficient screening instrument to accurately identify individuals with olfactory dysfunction (from all causes of olfactory dysfunction). We hope to systematically develop an olfaction screening instrument that is highly correlated to objective olfaction, as currently, this does not exist. Our overall hypothesis is that we can reliably predict an abnormal objective olfaction score using the screening instrument we develop.

Institution
MUSC
Recruitment Contact
Preeti Kohli
516-713-9934
kohlip@musc.edu

Protocol for the Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial

Date Added
October 16th, 2019
PRO Number
Pro00093020
Researcher
Thomas Curran

List of Studies


Keywords
Digestive System, Inflammation, Surgery
Summary

The goal of the COSMID (Comparison of Surgery and Medicine on the Impact of Diverticulitis) trial is to determine if elective colectomy is more effective than best medical management for patients with quality of life-limiting diverticular disease. The COSMID trial focuses on both patient-reported outcomes and clinical outcomes that matter to patients. The results are expected to establish an evidence-based approach to the care of millions of patients per year in the United States and help people impacted by this common condition make more informed treatment decisions.

Institution
MUSC
Recruitment Contact
Kandace Taylor
843-792-7082
taylokan@musc.edu

Right Ventricular Reserve Measures with Cardiac MRI

Date Added
October 16th, 2019
PRO Number
Pro00085562
Researcher
Ryan Tedford

List of Studies


Keywords
Cardiovascular, Heart, Sarcoidosis, Scleroderma, Shortness of Breath
Summary

This research study aims to determine a less invasive way to assess heart function by taking measurements of the heart while subjects are performing an exercise cardiac MRI. Subjects will undergo two exercise phases and MRI measurements will be taken after each exercise phase. These measurements will be compared to available clinical data (including demographic, hemodynamic, radiologic, and functional) and future outcome data.

Institution
MUSC
Recruitment Contact
Melissa Lamicq
843-876-5783
lamicq@musc.edu

Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery (ASPIRE)

Date Added
October 7th, 2019
PRO Number
Pro00092649
Researcher
Christine Holmstedt

List of Studies


Keywords
Stroke
Summary

The purpose of the study is to compare the effects of apixaban (also known as Eliquis®) with aspirin in patients with atrial fibrillation and a recent brain hemorrhage to see which is better in preventing strokes and death.

Subjects will be in the research study for up to 3 years (minimum of 1 year). About 700 people will take part in this study at approximately 125 sites throughout the United States.

Institution
MUSC
Recruitment Contact
Vicki Streets
843-792-8606
streetsv@musc.edu

Enhancing Prolonged Exposure Therapy for PTSD with Oxytocin

Date Added
October 1st, 2019
PRO Number
Pro00091548
Researcher
Julianne Flanagan

List of Studies


Keywords
Military
Summary

Posttraumatic stress disorder (PTSD) is a chronic, debilitating condition that affects our nation's Veterans at staggering rates. The purpose of this study is to examine the ability of a medication (oxytocin) to enhance Prolonged Exposure (PE) therapy for Veterans with Posttraumatic Stress Disorder (PTSD). PE is a widely used cognitive behavioral intervention (talk therapy) for Posttraumatic Stress Disorder (PTSD). In order to accomplish this goal, we are recruiting participants for a clinical trial. Participants enrolled in this trial will complete 10 weeks of a treatment phase, that includes weekly doses of either the investigational study medication or an inactive placebo. In addition, all participants will receive 10 weekly sessions of PE talk therapy. Once per week before each therapy session, participants will take a dose of medication intranasally. This study has the potential to improve patient care practices, advance the science in this area, and decrease public health costs.

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

A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients with Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)

Date Added
September 12th, 2019
PRO Number
Pro00090077
Researcher
John Wrangle

List of Studies


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

This study is for patients that have been diagnosed with Resectable Stages II and III Non-small Cell Lung Cancer (NSCLC). The investigational drug in this study is durvalumab. The purpose of this study is to see if durvalumab will work and be safe for the treatment of resectable NSCLC. Participants can expect to be on this study for about 5 years.

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

Building a Repository of Cardiac Phase Signals for Algorithm Development Recruiting Mostly Female Subjects

Date Added
September 10th, 2019
PRO Number
Pro00088809
Researcher
Thomas Todoran

List of Studies


Keywords
Cardiovascular
Summary

The purpose of this study is to build a repository of heart signals from eligible subjects. The experimental part of this study is the collection of the participant's heart signals using a device similar to a heart monitor called the Phase Signal Acquisition System. The signals will be electronically sent to a storage center, then compared to the results of the participant's heart catheterization and saved for future research and development activities sponsored by Analytics 4 Life. The study will include up to 2500 participants at up to 20 research sites in the United States and will require approximately one hour of the subject's time. There are no follow-up visits.

Institution
MUSC
Recruitment Contact
Anthony Awkar
7928526
awkar@musc.edu



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