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

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

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

A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations

Date Added
September 25th, 2020
PRO Number
Pro00104024
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with Acute Myelogenous Leukemia (AML). This study will compare standard chemotherapy using daunorubicin, cytarabine and gemtuzumab ozogamicin (GO) to chemotherapy using an experimental drug called CPX-351. CPX-351 is made up of daunorubicin and cytarabine. CPX-351 is made in a way that makes the drugs stay in the bone marrow longer and may be more effective. CPX-351 has been shown to be well-tolerated and effective against leukemia in adults and children. Participants can expect to receive treatment on this study for 6 months and followed for up to 10 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
HCC Clinical Trials Office843-792-9321
hcc-clinical-trials@musc.edu

Effects of a Novel mGluR5 Negative Allosteric Modulator on Alcohol Drinking, Neurochemistry, and Brain Reactivity to Alcohol Cues in Alcohol Use Disorder

Date Added
October 6th, 2020
PRO Number
Pro00102334
Researcher
James Prisciandaro

List of Studies


Keywords
Alcohol, Brain, Drug Studies, Substance Use
Summary

This Phase II clinical research study evaluates both the safety and effectiveness of an FDA-regulated medication presently in the initial stages of development for alcohol use disorder treatment (GET73), and will test whether GET73 alters brain chemicals and function, response to alcohol ingestion, and the desire for alcohol. Participants will be randomly assigned to one of two medication treatment groups (GET73 or placebo). Study medication will be taken for 8 days, with approximately 4 study visits, and a "bar-lab" procedure and 2 MRI brain imaging scans will be completed. Questionnaires and clinical interview measures will be completed at study visits along with consistent assessment of potential side effects from study medication.

Institution
MUSC
Recruitment Contact
Sara Hix
(843) 792-0572
hixs@musc.edu

fRVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial

Date Added
November 16th, 2020
PRO Number
Pro00101067
Researcher
Parneet Grewal

List of Studies

Keywords
Stroke
Summary

An emergency care research study of bleeding in the brain is to be performed in this area.

The Medical University of South Carolina is joining researchers at more than 100 other hospitals across the United States and other countries to conduct a research study of bleeding in the brain called FASTEST. This research study may affect you or someone you know. FASTEST is a research study involving patients who have had bleeding in the brain, also called intracerebral hemorrhage (ICH).

ICH occurs when a weakened blood vessel in the brain breaks and bleeding accumulates in the brain. Most of this bleeding occurs within a few hours of onset of symptoms. The brain injury from ICH is usually very severe, over 40% of people with ICH die within a month, and only 20% can independently care for themselves after 6 months.

There is currently no treatment for ICH that is scientifically proven to improve outcome. The FASTEST research study is being done to determine if recombinant Factor VIIa (rFVIIa), a protein that our body makes to stop bleeding at the site of injury to a blood vessel, can slow bleeding in the brain and improve outcome. rFVIIa is approved for treatment of bleeding in patients who have inherited lack of clotting factors but is not approved for treatment of ICH.

Participants in the FASTEST research study are placed at random, that is by chance, into one of 2 groups. They have an equal chance of getting rFVIIa or placebo (no active ingredient). One group receives rFVIIa intravenously over 2 minutes within two hours of onset of symptoms and the other group receives placebo. We do not know if rFVIIa is better than placebo for patients with bleeding in the brain. The results of the FASTEST research study will help doctors discover if rFVIIa improves outcome in patients with bleeding in the brain. Medical care otherwise will be identical for the two treatment groups, including close management of blood pressure and care within an intensive care unit. Some patients will be enrolled without consent if a family member or representative is not rapidly available.

Before the research study starts, we will consult with the community and need your input as this research may affect you or someone you know, and we need to find out ahead of time what the community thinks about it. Below are links to the the FASTEST site for more information about this research study and how to give your feedback. There are no known risks involved in participating in this survey and your participation is completely voluntary. THANK YOU for your help and time in completing this survey:

Click here for more information or to decline participation in this research study: https://nihstrokenet.org/fastest/home

Click here to access the survey to provide feedback and ask questions:
https://redcap.research.cchmc.org/surveys/?s=YALHC7W838

OR To contact our research study staff at (843-792-3020).
Primary Investigator: Dr. Parneet Grewal
Study Coordinators: Caitlan LeMatty

Institution
MUSC
Recruitment Contact
Caitlan LeMatty
843-792-8606
lemattyc@musc.edu



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