Prophylactic Intra-Operative Ventricular Arrhythmia Ablation in High-Risk LVAD Candidates (PIVATAL)

Date Added
June 12th, 2024
PRO Number
Pro00132289
Researcher
Arman Kilic

List of Studies

Keywords
Cardiovascular
Summary

The study will evaluate the effect of prophylactic intra-operative ventricular tachyarrhythmia ablation (VTA) at the time of left ventricular assist device (LVAD) implantation on post-implant total recurrent VTA events, after accounting for the competing risk of death, from discharge to an average follow-up of 18 months (with a minimum of 9 months) after LVAD implantation.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
(843) 792-8896
overstrm@musc.edu

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

(SUMMIT) A MULTI-PART, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2 CLINICAL STUDY OF THE SAFETY AND EFFICACY OF CGT9486 IN SUBJECTS WITH NONADVANCED SYSTEMIC MASTOCYTOSIS

Date Added
June 21st, 2024
PRO Number
Pro00136659
Researcher
Kelli Williams

List of Studies


Keywords
Blood Disorders, Cancer, Immune System
Summary

The purpose of this study is determine the optimal dose, efficacy and safety of an investigational drug (a new drug not yet approved by the U.S. Food and Drug Administration) in adults with Nonadvanced Systemic Mastocytosis. The investigational drug is known as bezuclastinib and will be taken daily orally. Participation in the study is expected to be approximately 3 years.

Institution
MUSC
Recruitment Contact
Natalie Naylon
8437925824
naylon@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and the Decline in Kidney Function in Participants with Body Mass Index ≥ 27 kg/m2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease

Date Added
June 25th, 2024
PRO Number
Pro00136763
Researcher
Sheldon Litwin

List of Studies


Keywords
Cardiovascular, Kidney, Obesity, Stroke Recovery
Summary

Individuals with obesity and a history of heart or kidney-related disease will be eligible for participation. Study participants will have a 50:50 chance to be randomly assigned to either the treatment (retatrutide) or control (placebo) group. Retatrutide is currently considered an investigational medication as it has not been approved by the FDA for the treatment of obesity or any other medical condition at this time. Study participation will last approximately 5 years and begin with a screening period to ensure correct patient selection. Research clinic visits will occur every 4 weeks initially and then every 12 weeks. Some visits may be completed virtually through telehealth or by phone. Study procedures include but are not limited to: blood draws, questionnaires, self injection of study medication, medical history review, vital signs, and electrocardiogram. The medication will be injected subcutaneously once a week. The medication's purpose is to facilitate weight loss and decrease a subject's risk for heart or kidney related disease progression or events.

Institution
MUSC
Recruitment Contact
Elhaam Borhanian
843-792-5873
borhania@musc.edu

A Comparison of Specific and Shared Effects Associated with Physical Therapy Interventions

Date Added
July 2nd, 2024
PRO Number
Pro00137661
Researcher
Bryan O'Halloran

List of Studies

Keywords
Exercise, Muscle, Pain, Physical Therapy, Rehabilitation Studies
Summary

The purpose of this study is to evaluate how certain procedures work for individuals with chronic neck pain.

Individuals who are 18 years of age or older and have chronic neck pain will participate in this study. The study involves randomly assigning individuals into two treatment groups (i.e. manual therapy and resistance exercise). Both treatments are recommended treatments and are part of clinical practice guidelines and are well supported in the literature.

Participants will be asked to complete a 4-week training program which includes physical examination, education, treatment, and an exercise plan. Participants will also complete a brief set of questionnaires at their baseline visit, 4 weeks, and 6 months after their initial visit

Institution
MUSC
Recruitment Contact
Bryan O'Halloran
8437928224
ohallora@musc.edu

A Phase 2, Open-label, Dose-escalation Study to Evaluate the Safety and Efficacy of RT234 on Exercise Parameters Assessed by Cardiopulmonary Exercise Testing (CPET) in Subjects with Pulmonary Arterial Hypertension (PAH)

Date Added
July 15th, 2024
PRO Number
Pro00136733
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

This is a research study involving an investigational drug called RT234. RT234 is being developed to treat pulmonary arterial hypertension (PAH). Eligible subjects must have a confirmed diagnosis of PAH and be on stable disease-specific PAH background therapy. The purpose of this study is to collect more information about the ability of RT234 to improve exercise capacity and safety of RT234 for the treatment of pulmonary arterial hypertension. The total duration of participation in the study, including screening, will be up to 4 study visits and a follow-up telephone call, over a period of up to 14 weeks. Up to 60 subjects will take part in this study.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

An Open-Label Prospective Multicenter Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in Pulmonary Hypertension – ASCENT Study

Date Added
July 17th, 2024
PRO Number
Pro00136738
Researcher
Rachana Krishna

List of Studies


Keywords
Drug Studies, Interstitial Lung Disease (ILD), Pulmonary Hypertension
Summary

Study LTI-401 is an open-label, multicenter study which will evaluate the safety and tolerability of LIQ861, the study drug, in subjects who have World Health Organization (WHO) Group 1 & 3 Pulmonary Hypertension. The purpose of this research study is to evaluate the long-term safety and tolerability of LIQ861 in patients with WHO Group 3 Pulmonary Hypertension associated with interstitial lung disease (PH-ILD). The investigational form of Treprostinil in this study is called LIQ861, it is delivered to your lungs using a hand-held device called a dry powder inhaler (DPI). Dose levels may be adjusted by the Study Doctor between 26.5 micrograms to 318 micrograms based on your PH-ILD symptoms. The study will include approximately 60 subjects and participation will last 52 weeks.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

SAINT NEUROMODULATION SYSTEM FOR THE TREATMENT OF DEPRESSION IN AN INPATIENT SETTING

Date Added
July 23rd, 2024
PRO Number
Pro00126985
Researcher
Mark George

List of Studies


Keywords
Depression, Mental Health, Suicide
Summary

This is an inpatient clinical trial of a new form of transcranial magnetic stimulation with 10 treatments/day for 5 days, called SAINT. It is jointly funded by the NIH and a TMS company, MAGNUS. It is being done at 5 enrolling sites in the US, with total sampe of 100. Depressed and suicidal inpatients will have an MRI scan, then 5 days of treatment, and then a followup MRI scan. Outcome measures are depression and suicide ratings, as well as MRI changes. It is randomized and double blind, so some patients will not be getting active TMS. Importantly this is an adjunctive treatment study on top of all routine clinical treatments.

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



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