A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)

Date Added
September 26th, 2019
PRO Number
Pro00092663
Researcher
Theodore Gourdin

List of Studies


Keywords
Cancer/Genitourinary
Summary

This study is for patients with an advanced rare genitourinary cancer. The purpose is to test the good and bad effects of the drugs called cabozantinib, nivolumab and ipilimumab, when given in combination.

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

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

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

A Phase 2b, Multicenter, Randomized, Open-label, Two-Arm Study to Evaluate the Clinical Efficacy and Safety of OHB-607 Compared to Standard Neonatal Care for the Prevention of Bronchopulmonary Dysplasia, the Most Common Cause of Chronic Lung Disease of Prematurity

Date Added
December 10th, 2019
PRO Number
Pro00091762
Researcher
Carol Wagner

List of Studies


Keywords
Children's Health, Infant, Pediatrics
Summary

Babies that are born extremely prematurely are at higher risk of developing chronic (long term) lung disease (CLD) and other complications (problems). The purpose of this study is to test the safety and effectiveness of an investigational drug called mecasermin rinfabate (rhIGF-1/rhIGTBP-3) or OHB-607. The researchers want to find out if OHB-607 can help reduce the risk of chronic lung disease in babies born prematurely and if it can help reduce the risk of other complications.

Institution
MUSC
Recruitment Contact
Della MacNicholas
843-792-8385
macnichd@musc.edu

RECOVER: A PRospective, Multi-cEnter, Randomized Controlled Blinded Trial DemOnstrating the Safety and Effectiveness of VNS Therapy® System as AdjunctivE Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression

Date Added
March 10th, 2020
PRO Number
Pro00095951
Researcher
Mark George

List of Studies


Keywords
Depression, Mental Health, Psychiatry
Summary

Depression is a very common disorder that is most often chronic or recurrent in nature. Many subjects do not respond adequately to an initial antidepressant treatment trial. Subjects who do not respond adequately to multiple therapeutic interventions are considered to have treatment-resistant depression (TRD). Among the treatment options for subjects with TRD is Vagus Nerve Stimulation (VNS) Therapy.This blinded, randomized, multicenter controlled study is intended to collect evidence that VNS Therapy as an adjunctive therapy improves health outcomes for patients with TRD.

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

LUNGMAP: A Master Protocol To Evaluate Biomarker-Driven Therapies And Immunotherapies In Previously-Treated Non-Small Cell Lung Cancer (Lung-Map Screening Study)

Date Added
May 7th, 2020
PRO Number
Pro00099591
Researcher
John Wrangle

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients that have been diagnosed with non-small cell lung cancer. The purpose of this study is to find out if a targeted immunotherapy treatment will have an effect on specific genes and proteins in tumors. This is a screening study in which a tumor sample will be submitted for testing. Based on results, the participant will be assigned to one of the treatment sub-studies.

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

Personalized Lung Cancer Screening (PLuS) Study

Date Added
May 14th, 2020
PRO Number
Pro00098558
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Lung
Summary

This is an observational study that will analyze electronic health records data from real-world populations and settings in order to fully characterize the outcomes of Lung Cancer Screening with Low-Dowse CT scans.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

MPFC Theta Burst Stimulation as a Treatment Tool for Alcohol Use Disorder: Effects on Drinking and Incentive Salience

Date Added
September 1st, 2020
PRO Number
Pro00102709
Researcher
Lisa McTeague

List of Studies


Keywords
Alcohol, Brain, Drug Studies, Psychiatry, Substance Use
Summary

The purpose of this study is to develop transcranial magnetic stimulation (TMS), specifically TMS at a frequency known as theta burst stimulation (TBS), to see how it affects the brain and changes the brain's response to alcohol-related pictures. TMS and TBS are stimulation techniques that use magnetic pulses to temporarily excite specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). TBS, which is a form of TMS, will be applied over the medial prefrontal cortex, (MPFC), which has been shown to be involved with drinking patterns and alcohol consumption. This study will test whether TBS can be used as an alternative tool to reduce the desire to use alcohol and reducing the brain's response to alcohol-related pictures.

Institution
MUSC
Recruitment Contact
Charleston Alcohol Research Center
(843) 792-1222
alcoholstudy@musc.edu

Advanced Cardiac Therapies Improving Outcomes Network to Improve the Health of Pediatric and Congenital Heart Disease Patients with Heart Failure

Date Added
September 21st, 2020
PRO Number
Pro00096494
Researcher
Heather Henderson

List of Studies


Keywords
Cardiovascular, Heart, Pediatrics
Summary

The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) is a distributed network-based learning health system (LHS) of care centers, clinicians, researchers and industry representatives partnering with patients who have heart failure and their caregivers with the ultimate aim of achieving health, longevity and quality of life equivalent to the general population. See https://www.actionlearningnetwork.org for more information. The initial focus will be to apply structured quality improvement methods, advanced information technology systems, and sharing of best practices to track and continuously improve health-related outcomes for children with heart failure requiring advanced therapies. In the future, we plan to collaborate with other established registries and learning network (i.e. UNOS, PHTS and Cardiac Networks United) to create an integrated network that improves care throughout all phases of a patient's illness including chronic heart failure, acute decompensated heart failure, ventricular assist device support and transplant.

Institution
MUSC
Recruitment Contact
Heather Henderson
8437929570
hendhea@musc.edu



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