Research Evaluating Vagal Excitation and Anatomical Links

Date Added
June 13th, 2024
PRO Number
Pro00136451
Researcher
Mark George

List of Studies


Keywords
Depression, Epilepsy, Mental Health
Summary

This is an NIH sponsored trial across the US where patients who have been or will be implanted with cervical vagus nerve stimulation (VNS) are then tested in a variety of ways to determine the activity of the VNS on different organs in their body. This will involve implantation for those who qualify, and then two trips to the University of Minnesota for more extensive testing. The device, implantation and travel are all at no cost.

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

Treatment In Thoracic Aortic Aneurysm: Surgery versus. Surveillance (TITAN:SvS)

Date Added
June 18th, 2024
PRO Number
Pro00129203
Researcher
Sanford Zeigler

List of Studies


Keywords
Cardiovascular
Summary

To undertake the first prospective randomized controlled trial that compares early aortic surgery to aneurysm surveillance.

The purpose of the study is to compare different treatment plans for patients with abnormal aortas. Patients who have an abnormal aorta measuring at least 5.5cm will have surgery to replace the aorta. We do not know, however, whether patients with abnormal aortas that are not quite 5.5cm should have surgery or should be monitored to see if their aorta continues to grow. Therefore, through this registry and interventional study, the hope is to collect more data on which treatment is better for the patient. The interventional group will undergo surgery to repair their abnormal aorta, and the surveillance group will be closely monitored and medically managed per standard of care. Both groups will have data collected from their care and at the end of the study this data will be analyzed. The goal of this study is to determine if performing surgery earlier helps to prevent abnormal aortas below 5.5cm from tearing or bursting.

Institution
MUSC
Recruitment Contact
Hannah Culpepper
8437927244
culpepph@musc.edu

A Phase II Study of Fingolimod in Patients with Non-Small Cell and Small Cell Lung Cancer

Date Added
June 18th, 2024
PRO Number
Pro00137404
Researcher
Mariam Alexander

List of Studies

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

This study is for subjects that have been diagnosed with lung cancer and the disease has progressed on prior therapy. The purpose of the study is to determine the safety and efficacy of Fingolimod and whether it can aid in treatment against lung cancer tumors. Fingolimod is not FDA approved and is considered an investigational drug. Subjects can expect to be in this study for about 8 months, with routine visits occurring at MUSC.

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

RELIANCE: A phase 1, randomized, double-blinded, placebo-controlled, trial evaluating the long-term safety and tolerability of Imatinib for the treatment of Lymphangioleiomyomatosis (LAMP-2 Trial)

Date Added
July 30th, 2024
PRO Number
Pro00136539
Researcher
Charlie Strange

List of Studies


Keywords
Kidney, Lung, Pulmonary, Rare Diseases, Women's Health
Summary

The purpose of this medical research study is to evaluate the safety and effectiveness of a new medication called imatinib mesylate in the treatment of Lymphangioleiomyomatosis (LAM). LAM is a rare disease in which abnormal cells (called LAM cells) grow out of control. Over time, LAM cells destroy healthy lung tissue and cause respiratory disease or failure.

Many patients with LAM are currently treated with a medication called sirolimus (rapamycin). Sirolimus slows the growth of LAM cells.

Imatinib mesylate (hereafter called imatinib) is approved by the Food and Drug Administration (FDA) for the treatment of some cancers that share common pathways with LAM cells. Laboratory studies suggest that imatinib could completely block the growth of LAM cells through initiation of targeted cell death.

An important purpose of this research is to determine the safety of imatinib in people with LAM. This study will also evaluate the short-term effectiveness of imatinib. Participants will be randomized to receiving imatinib (study medication) or placebo (no treatment) for the 180 day duration of participation. The study is being conducted at the Medical University of South Carolina and at Columbia University in New York (CUMC). Each site will enroll 10 participants.

Institution
MUSC
Recruitment Contact
Mary Hayden
(843) 792-8438
blantonm@musc.edu

Aging Neural Systems and Communication Difficulties

Date Added
August 2nd, 2024
PRO Number
Pro00135808
Researcher
Kenneth Vaden

List of Studies


Keywords
Aging, Brain, Healthy Volunteer Studies, Hearing
Summary

As people get older, understanding speech in a noisy environment can become more difficult. The MUSC Hearing Research Program is seeking healthy adults between 25 and 89 years of age to participate in a research study to investigate the connection between listening difficulties and the brain. Payment is provided for participation and scheduling is flexible. The study involves two visits. Participants must be able to complete an MRI. Please contact us if you would like to participate in this research or learn more about our study.

Institution
MUSC
Recruitment Contact
Kenneth Vaden
8437925916
scanlab@musc.edu

Tracking Brain Imaging Changes in Depression over Clinical Accelerated TMS Therapy at the Individual Level

Date Added
August 6th, 2024
PRO Number
Pro00138260
Researcher
Xiaolong Peng

List of Studies


Keywords
Brain, Depression
Summary

The aim of this study is to use magnetic resonance imaging (MRI) to capture images of participants' brains and apply an image processing method called INSCAPE to assess brain states. This study will recruit participants who are scheduled to receive accelerated Transcranial Magnetic Stimulation (TMS) therapy for Major Depressive Disorder (MDD). Participation in this study involves two visits, each including a 30-minute MRI scan. The interval between each visit is about one week. Depressed participants will also complete mood assessments at various intervals while they are receiving accelerated TMS for depression.

Institution
MUSC
Recruitment Contact
Katherine Tucker
843-792-9502
tuckekat@musc.edu

A Phase II Study of Naxitamab Added to Induction Therapy for Subjects With Newly Diagnosed High-Risk Neuroblastoma

Date Added
August 8th, 2024
PRO Number
Pro00134887
Researcher
Jacqueline Kraveka

List of Studies


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

This study is for patient that have been diagnosed with High Risk Neuroblastoma. The investigational drug in this study is naxitamab. The purpose of this study is to test the safety of adding an Anti-GD2 Immunotherapy agent (naxitamab) to your standard therapy during the induction phase of care. Read the sections on risks and benefits carefully and be sure you understand them. This study will also look at the effectiveness of this treatment.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinicaltrials@musc.edu

A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)

Date Added
August 9th, 2024
PRO Number
Pro00133370
Researcher
Brian Hess

List of Studies


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

This study is for subjects that have been diagnosed with Follicular Lymphoma.
This study is testing an investigational drug(s) called Epcoritamab that is not approved by the FDA (Food and Drug Administration). The purpose of this study is to see if the combination of the study drug epcoritamab with rituximab and lenalidomide has a better response rate than standard of care chemoimmunotherapy in the treatment of follicular lymphoma. The total study treatment duration is up to 2.5 years. You may stop the study treatment early if you do not respond after 6 months, your disease worsens, you no longer tolerate the study drug(s), or you withdraw from the study.

Once you finish the study treatment or discontinued study treatment early, you will continue to the Post-Study Treatment Follow Up Period, you will come back to the study clinic every 6 months for the first 3 years and then yearly to have imaging scans and blood work to check if your disease is in remission or worsen.

If your disease worsens or if you start a new FL treatment, you will enter the Long-term Follow Up Period, you will be called by telephone or your health record will be reviewed to check on your well-being and to see what your next treatment plan will be. This follow-up may last up to 15 years.

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

A Phase 3, Multicenter, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging of Men with Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy with Pelvic Lymph Node Dissection (Pathfinder)

Date Added
August 16th, 2024
PRO Number
Pro00135932
Researcher
Robert Grubb

List of Studies


Keywords
Bladder, Cancer, Cancer/Genitourinary
Summary

The purpose of this research study is to see how effective the use of copper Cu 64 PSMA I&T Injection is in imaging prostate cancer tumors for staging of men with newly diagnosed intermediate or high risk prostate cancer who are planned to have radical prostatectomy with pelvic lymph node dissection. Three hundred twenty-three (323) patients are planned for enrollment in this Phase 3 study, at approximately 60 sites in the U.S. and Europe. Copper Cu 64 PSMA I&T Injection is an investigational imaging agent, given to you via IV injection, that may make tumors from prostate cancer show up better during a nuclear medicine imaging scan. The imaging scan is a type of nuclear medicine imaging test, which means it uses a radioactive drug and a special camera to create pictures of your tumor(s). Copper Cu 64 PSMA I&T Injection is investigational in the United States which means that the U.S. Food and Drug Administration (FDA) has not yet approved it.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

TRiCares Topaz Transfemoral TRICUspid Heart Valve REplacement System Early Feasibility Study (TRICURE EFS)

Date Added
August 27th, 2024
PRO Number
Pro00138879
Researcher
Nicholas Amoroso

List of Studies


Keywords
Cardiovascular, Heart
Summary

You are invited to volunteer in this clinical research study because you have been diagnosed with tricuspid valve regurgitation.

The type of research study you are being asked to join is called an Early Feasibility Study. This means the device and procedure you are receiving (the treatment) have not been previously studied in humans, and that you will be among the first patients in the world to undergo this treatment. The Device you are receiving is not approved by the United States Food and Drug Administration and its safety and effectiveness are unknown.

Participants will undergo right heart catheterizations, computed tomography (CT) scans without iodinated contrast, multiple ultrasounds of the heart, labs, and other assessments. The length of subject participation in the study is 5 years and includes 11 research visits. You will have a screening right heart catheterization (RHC) to check the pressures and function of your heart. The research procedure and placement of the TRIcares Topaz Transfemoral Tricuspid heart Valve (Topaz Tricuspid Valve) will be placed in a hybrid operating room. This procedure is done by entering a vein in your groin known as the femoral vein. The purpose of this device is to eliminate the regurgitation or leaking in the tricuspid valve of the heart to help reduce the symptoms caused by this leaky valve.

The most common risks associated with the research procedure are those related to the right heart catheterization (RHC) and Topaz Tricuspid valve procedure. Major risks include bleeding and damage to the heart or surrounding blood vessels. There are no known benefits of the research device. There may be possible benefits from the research procedure including improvement in quality of life or a decrease in the symptoms caused by tricuspid regurgitation. The information that we obtain from your participation in this study will help us learn more about how safe and effective this approach is in treating the symptoms of individuals similar to yourself.

Institution
MUSC
Recruitment Contact
Shaquanda Goodwine
843-876-5783
shr37@musc.edu



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