Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having Heart Failure with Preserved Ejection Fraction: Randomized Controlled Feasibility Trial- The REBALANCE-HF Study

Date Added
February 9th, 2021
PRO Number
Pro00107509
Researcher
Sheldon Litwin

List of Studies


Keywords
Cardiovascular
Summary

This study will include volunteers diagnosed with a form of heart failure that is characterized by a weakened heart muscle that appears to be pumping in a normal manner. This condition is called "heart failure with preserved ejection fraction" or HFpEF. For these individuals, it has been determined that the health problems and symptoms experienced may be due to a significant increase in the pressure of one of the chambers of the heart. This pressure build-up causes a variety of symptoms, including tiredness, difficulty breathing, and reduced ability to exercise/walk.

This study is to help evaluate a new device (the "Satera Ablation System") designed to reduce the build-up of pressure described above. The Satera Ablation system is a catheter used to ablate or destroy the splanchnic nerve on one side of the body. The Sponsor believes by destroying this nerve there may be some reduction in the symptoms caused by HFpEF. The procedure using the Satera Ablation System will be performed in the catheterization lab and does not involve surgery. Participants will stay overnight in the hospital following the procedure for observation.

The length of subject participation in the study will be approximately 24 months and includes 5 office visits, 1 phone call and 2 procedures. Participants in this research study will be randomized to either the treatment group or the control group and have a 2:1 chance of receiving the research treatment with the Satera Ablation System at the time of randomization.

This study will help us learn more about how safe and effective the Satera Ablation System is in treating the symptoms of patients with HFpEF.

Institution
MUSC
Recruitment Contact
Renee Baxley
843-792-1105
baxleyr@musc.edu

Pilot Trial of Belimumab in Early Lupus

Date Added
February 9th, 2021
PRO Number
Pro00104939
Researcher
Melissa Cunningham

List of Studies


Keywords
Drug Studies, Lupus
Summary

This is a study looking at the effects of Belimumab, a medication approved by the FDA to treat lupus, in people who have been recently diagnosed with lupus. It proposes that the early use of Belimumab may prevent long-term tissue damage from the disease. The study will last 2 years with clinic visits every 4 weeks.

Institution
MUSC
Recruitment Contact
Emma Hatch
843-792-4296
hatchem@musc.edu

Modeling and Modulating Mechanisms of Escape, Avoidance, and Approach in the Anxiety Disorder Spectrum

Date Added
February 2nd, 2021
PRO Number
Pro00106843
Researcher
Christopher Sege

List of Studies


Keywords
Anxiety, Brain
Summary

This is a study to find out if a device that temporarily alters brain activity (repetitive transcranial magnetic stimulation, rTMS) might be used to change how people with anxiety or related concerns cope with emotional situations. The study is recruiting people who recently started treatment for anxiety or a related concern. The study involves 3 visits to MUSC. At the first visit, participants do interviews and surveys asking about anxiety and related concerns, and they also do tasks where they see and react to emotional pictures while their brain activation is measured. At the next two visits, participants receive rTMS that uses a magnet placed on top of the head to alter brain activity temporarily (for about an hour). After rTMS, participants do two tasks where they see and react to emotional situations while wearing sensors on their hand, arms, face, and head.

Each visit in this study is expected to last between 2 – 3 hours. This study is not a treatment study, but it could help improve treatment in the future. Participants in this study are paid for their time.

Institution
MUSC
Recruitment Contact
Christopher Sege
8437928465
sege@musc.edu

Priming the rehabilitation engine: aerobic exercise as the fuel to spark behavioral improvements in stroke

Date Added
February 2nd, 2021
PRO Number
Pro00105988
Researcher
Ryan Ross

List of Studies

Keywords
Exercise, Rehabilitation Studies, Stroke, Stroke Recovery
Summary

Stroke is a leading cause of disability in the U.S. and many Veteran stroke survivors live with severe disability. Despite recent advances in rehabilitation treatments many stroke survivors have persistent physical and mental difficulties such as reduced arm and leg function, difficulty thinking, and depression.
Developing treatments that address these problems is necessary to improve long-term recovery for stroke survivors. Aerobic exercise (AEx) can improve physical and mental function, and reduce depression. Additionally, AEx may enhance physical rehabilitation by making the brain more receptive to, and consequently improving the response to a rehabilitation treatment. Therefore, combining AEx with physical rehabilitation has the potential to improve multiple parts of stroke recovery. This study will examine the effect of combining AEx with physical rehabilitation on physical and mental function in stroke survivors. By gaining a better understanding of the effects of this combined intervention we aim to advance the rehabilitative care of Veteran stroke survivors.

Institution
MUSC
Recruitment Contact
Ryan Ross
843-792-3477
rossre@musc.edu

Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer

Date Added
January 19th, 2021
PRO Number
Pro00106552
Researcher
Jennifer Harper

List of Studies


Keywords
Cancer/Breast
Summary

This study is for patients who have low risk breast cancer as indicated by their Oncotype DX Recurrence Score. The purpose of this study is to compare any good and bad effects of not giving regional radiotherapy to using regional radiotherapy.

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

A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Date Added
December 22nd, 2020
PRO Number
Pro00106138
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Leukemia, Pediatrics
Summary

This study is for patients that have newly diagnosed High-Risk B-ALL, Risk-Adapted Post-Induction therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy. The treatment involves medicine called chemotherapy, which fights cancer. Some patients may also need radiation therapy depending on whether the cancer has spread to the brain and spinal fluid, or the testes for males. The investigational drug on this study is inotuzumab ozogamicin. Participants can expect to be on this study for a little over 2 years and followed for up to 10 years.

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

An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors

Date Added
November 24th, 2020
PRO Number
Pro00105157
Researcher
John Kaczmar

List of Studies


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

This study is for patients that have been diagnosed with advanced or resistant skin cancer (melanoma), non-melanoma skin cancer (NMSC), non-small cell lung cancer (NSCLC), certain types of solid tumors, or bladder cancer (UBC). The investigational drug in this study is RP1. RP1 is a herpes simplex virus (a microscopic life form commonly known as the "cold sore virus") that has been genetically changed to grow in and destroy cancer cells. This treatment will be injected directly into tumors. The purpose of this study is to test the safety and how well RP1 works when it is injected into certain types of solid tumors in combination with another cancer drug, called nivolumab. Participants can expect to be in this study for about 2 to 3 years.

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

Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

Date Added
November 19th, 2020
PRO Number
Pro00105634
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT). The treatment involves cancer fighting medicine called chemotherapy plus radiation therapy and/or surgery. Participants can expect to be on this study for up to 10 months and be followed by the treatment team for up to 5 years.

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

A PHASE III TRIAL OF PERIOPERATIVE VERSUS ADJUVANT CHEMOTHERAPY FOR RESECTABLE PANCREATIC CANCER

Date Added
November 6th, 2020
PRO Number
Pro00104900
Researcher
William Hawkins

List of Studies

Keywords
Cancer/Gastrointestinal, Pancreas
Summary

This study is for patients with pancreatic cancer. The purpose is to see if researchers can increase the chance of pancreatic cancer staying away by giving them chemotherapy before and after surger

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



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