The Rhythm Evaluation for Anticoagulation with Continuous Monitoring of Atrial Fibrillation

Date Added
May 23rd, 2023
PRO Number
Pro00128438
Researcher
Rachel Kaplan

List of Studies

Keywords
Cardiovascular
Summary

This research is being done to assess whether it is safe and effective to stop oral anticoagulation medications (a blood-thinning medication) during prolonged periods of normal heart rhythm in participants with infrequent episodes of atrial fibrillation (AF).

You may qualify for this study if you have a history of atrial fibrillation (AF) and are currently taking an oral anticoagulant (a blood-thinning medication). You will be randomized to one of two groups: Control Group or Study Intervention Group.

If you are randomized to the Control group, you will be asked to stay on your previously prescribed oral anticoagulant. If you are randomized to the Study Intervention group, you will be asked to take the oral anticoagulant for 30 days only if a prolonged episode of AF is detected on an AF-sensing Apple smartwatch you will be provided.

Institution
MUSC
Recruitment Contact
Kavin Panneerselvam
843-792-0464
panneeer@musc.edu

A randomized, double-blind, double-dummy, parallel group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib

Date Added
June 13th, 2023
PRO Number
Pro00128476
Researcher
Andrew Keegan

List of Studies

Keywords
Multiple Sclerosis
Summary

The main purpose of the study is to find out if patients treated with remibrutinib may experience fewer Multiple Sclerosis relapses (also called clinical attacks, exacerbations or flare ups) than patients treated with teriflunomide (also known as Aubagio). Teriflunomide is an approved medication for the treatment of relapsing MS. This clinical study will have two parts. The first part is the masked part in which neither you nor your doctor know if you receive remibrutinib or teriflunomide and will last up for a maximum of up to 30 months (~2.5 years). This is followed by an Extension Part which will have treatment and safety follow up periods; during the treatment period remibrutinib treatment is provided to all participants who had completed core part of study for a maximum of up to 5 years.

Institution
MUSC
Recruitment Contact
Alison Line
Alison Line
line@musc.edu

A Phase 1 Study of the SHP2 Inhibitor BBP-398 (formerly known as IACS-15509) in Combination with the Programmed Death Receptor-1 Blocking Antibody Nivolumab in Patients with Advanced Non-Small Cell Lung Cancer with a KRAS Mutation

Date Added
June 27th, 2023
PRO Number
Pro00127111
Researcher
Mariam Alexander

List of Studies

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

This study is recruiting patients who have advanced non-small cell lung cancer (NSCLC) with a KRAS mutation whose cancer has not responded to standard of care treatment. (All human cells have a gene called KRAS. If cells have a KRAS mutation, the cells may multiply out of control which can cause cancer.) This study has two parts. The first part of the study is being done to find the safety, tolerability and safe dose of a study drug called BBP-398 when it is used in combination with another drug that has already been approved for use by the Food and Drug Administration, called Nivolumab. The second part of the study is being done to further understand the how tumors are affected by the study drug, BBP-398, and Nivolumab. About 26 patients in the United States will participate in this study. You may be eligible if you have NSCLC with a KRAS mutation that has not responded to standard treatment. Patients who enroll in this study will be required to come to MUSC for study treatments and follow-up visits. The participation in the study can last up to 2 years with a follow up period of 3 years.

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

Impact of capturing ictal events with ultra-long-term ambulatory EEG monitoring with REMI.

Date Added
June 27th, 2023
PRO Number
Pro00129426
Researcher
Jonathan Halford

List of Studies


Keywords
Epilepsy
Summary

This study is being done to understand whether a different type of electroencephalography (EEG) monitoring that permits longer monitoring is able to capture more seizures than regular EEG monitoring, and whether this new type of monitoring will improve clinical care. This type of EEG monitoring (REMI) is currently cleared by the United States Government Food and Drug Administration (or FDA) for use in hospitals but not yet cleared to be used at home.
Eligible subjects who have EEG monitoring scheduled with either a 3-day EEG monitoring performed at home or with a 3-day EEG monitoring schedule at the Medical University of South Carolina (MUSC). Subjects are in the study for approximately 4 weeks and will need to come to the study center for one or two visits. They will be asked to wear 4 of Epitel's REMI Sensors on their head, in addition to the regular EEG electrodes, for two 2-week REMI EEG monitoring periods. A 2nd visit (clinic visit) at MUSC may be needed if the recording is at MUSC, in order to start the second REMI EEG monitoring session.
At the end of the study, three independent epileptologists will review the REMI EEG recordings and compile a report of any findings. They will then provide this report to the subject's neurologist who will assess the value of the additional EEG information, and save the report within the MUSC medical record.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
18437921115
bulgarino@musc.edu

A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular lesions located in the infrapoplitEal Arteries beLow the knee (DEEPER REVEAL)

Date Added
June 27th, 2023
PRO Number
Pro00128401
Researcher
Antwana Wright

List of Studies

Keywords
Circulation, Surgery, Vascular
Summary

This study is for patients that have Critical Limb Ischemia (CLI), a form of Peripheral Arterial Disease (PAD) in which an artery (blood vessel) in their lower leg (calf) may have become blocked. This study involves the use of an investigational devices called a stent (a small mesh tube typically used to hold open blood vessels). The study device (stent) that will be used in this study is called the Bare Temporary Spur Stent System. It is intended to be used for treatment of Critical Limb Ischemia (CLI). The stent portion is made of nitinol, a metal commonly used in stents. It is unique from other similar approved devices, such as balloons and stents, because it consists of a delivery system that can deliver and re-capture the Bare Temporary Spur Stent and balloon, so that no metal is left behind in the body. The Bare Temporary Spur Stent has small spurs (spikes) on the outer surface of the stent, which pierce the inner lining of the artery. Together, the spurs and the stent may help to support the artery as it rebounds after the balloon inflation. The purpose of this is to help the artery stay open so that there is a channel for blood flow to the foot.

Institution
MUSC
Recruitment Contact
Kaylie Lively
843-792-1851
lively@musc.edu

Confidence Optimization through Resources for Education, Engagement, and Empowerment (CORE) Study

Date Added
June 29th, 2023
PRO Number
Pro00128946
Researcher
Erin Forster

List of Studies


Keywords
Inflammatory Bowel Disease
Summary

This research study is being conducted to gather information about patients with inflammatory bowel disease (IBD) to better understand their knowledge and preferences about self-help resources and learn how to help patients better manage their disease. Participation in this study will involve signing a research consent form, completing questionnaires, and the opportunity to participate in self-help resources. Some participants may be offered the opportunity to participate in a virtual focus group, as well. Participation in the study will last approximately 3 months.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
843-792-0965
recruitment@musc.edu

A Phase 2, Randomized, Double-blind, Placebo- controlled Study to Evaluate the Efficacy and Safety of Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder

Date Added
July 2nd, 2023
PRO Number
Pro00123547
Researcher
McLeod Gwynette

List of Studies


Keywords
Autism
Summary

Pimavanserin is an antipsychotic may have some beneficial effects on core autism symptoms and co-morbid conditions such as irritability, anxiety, sleep disorders, mood instability due to epilepsy, etc.). These potential benefits stem from pimavanserin's impact on the serotonin system in the body. This study will compare pimavanserin to placebo in the treatment of irritability, core autism symptoms, and co-morbid conditions in children ages 6-17 years old.

Institution
MUSC
Recruitment Contact
McLeod Gwynette
843-792-4113
gwynette@musc.edu

At-Home Transcutaneous Auricular Neuromodulation for Hypermobile Ehlers Danlos Syndrome

Date Added
July 5th, 2023
PRO Number
Pro00128818
Researcher
Bashar Badran

List of Studies


Keywords
Brain
Summary

Hypermobile EDS and hypermobile spectrum disorder (collectively referred to as hEDS) are estimated to affect 1 in 500 individuals worldwide. hEDS patients have limited treatment options for their numerous symptoms that impact the quality of life. This clinical trial tests a new ear stimulation method in hEDS patients to determine if it may improve quality of life.

Institution
MUSC
Recruitment Contact
Dillon Connolly
843-792-9502
connolld@musc.edu

A randomized, participant- and investigator-blinded, placebo-controlled study to investigate efficacy, safety and tolerability of LTP001 in participants with pulmonary arterial hypertension

Date Added
July 6th, 2023
PRO Number
Pro00128867
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

This study is exploring the safety and efficacy of the study drug LTP001 in subjects with pulmonary arterial hypertension. This is a randomized study and the subjects will be be given the study drug or placebo in a capsule form which they are to take once daily in the morning. Participants will be screened for up to 8 weeks followed by 24 weeks of daily dosing- study visits to the site will occur approximately every 4 weeks. During these study visits there will be study procedures that may include labs for blood and urine, ECGs, vital signs, 6MWD, echocardiogram, or right heart catherization. There is the opportunity for an open-label portion of the study as well.

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

A Non-Interventional Study Evaluating the Impact of TRIKAFTA® Initiation on Children and Caregivers of Children With Cystic Fibrosis Aged 2-5 Years in a Real-World Setting

Date Added
July 17th, 2023
PRO Number
Pro00128569
Researcher
Sylvia Szentpetery

List of Studies


Keywords
Cystic Fibrosis
Summary

This is a intervention longitudinal study for children with CF and caregivers. Children aged 2-5 who are diagnosed with CF and are eligible for TRIKAFTA will be invited to participate in this study. The treating physicians will manage children with CF in accordance to their medical judgement and data will be collected throughout the study. Children with CF and caregivers may be enrolled up to 3 months before their child initiates TRIKAFTA and site personnel will record date for the study in that time (such as pulmonary exacerbations, medical history, and medication history.) Caregivers will also report PROS (patient reported outcomes) and CGRO (caregiver-reported outcomes).

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



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