PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE)

Date Added
March 6th, 2023
PRO Number
Pro00125689
Researcher
Leslie Lenert

List of Studies


Keywords
Cholesterol, Dementia, Drug Studies, Geriatrics, Healthy Volunteer Studies, Heart, Memory Loss, Stroke Recovery
Summary

The purpose of this research study is to determine if an already FDA approved drug called atorvastatin can help adults, age 75 or older, live well for longer by preventing dementia, disability, or heart disease. Participants will be assigned by chance to receive either atorvastatin (study drug) or a matching placebo (a tablet that looks like atorvastatin but does not contain any medicine). Study engagement may last up to five years and involves in clinic and/or remote visits, survey questions, potential blood draws, in addition to memory and physical tests. After the first 1-2 visits performed in clinic or remote, the study team will follow-up via phone on a yearly basis to see how participants are doing. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Heart and Vascular Institute
Recruitment Contact
Amy Reynolds
(843) 792-8459
reynoamy@musc.edu

Pediatrics Biorepository for Gastroenterology Clinical Research

Date Added
March 7th, 2023
PRO Number
Pro00126239
Researcher
Benjamin Kuhn

List of Studies

Keywords
Digestive System, Esophagus, Inflammation
Summary

This proposal is to contribute to data registry and sample bank called Pediatrics Biorepository for Gastroenterology Clinical Research. Samples collected in this study may be used for future research which plan to advance the state of science in the hopes to develop novel diagnostic approaches and identify therapeutic targets.

Institution
MUSC
Recruitment Contact
Benjamin Kuhn
(843) 876-0444
kuhnbe@musc.edu

A Randomized Phase II Trial of Consolidation Therapy Following CD19 CAR T-Cell Treatment for Relapsed/Refractory Large B-Cell Lymphoma or Grade IIIB Follicular Lymphoma

Date Added
March 23rd, 2023
PRO Number
Pro00127531
Researcher
Brian Hess

List of Studies


Keywords
Cancer/Lymphoma
Summary

This is a study for patients with relapsed/refractory large B-cell lymphoma or follicular lymphoma. Patients who have either stable disease or a partial response to CD19 CAR T-Cell therapy may be eligible. The purpose of the study is to compare groups of patients who either receive therapy after CAR T-cells and patients that do not receive further therapy after CAR T-cells.

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

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122 in Participants with Parkinson's Disease

Date Added
March 28th, 2023
PRO Number
Pro00123124
Researcher
Christine Cooper

List of Studies


Keywords
Parkinsons
Summary

This study will help determine the safety and effectiveness of BIIB122, compared to placebo (an inactive substance), in people with early-stage Parkinson's disease. The use of BIIB122 in this study is investigational. "Investigational" means that the study drug is currently being tested and is not approved by the U.S. Food and Drug Administration (FDA) or any other health authorities around the world for treating people with PD. The study is expected to last a minimum of 1 year to a maximum of 3 years. You may or may not receive direct medical benefit from participating in this study. Your condition may get better, worse, or stay the same. The information obtained from this study, however, could help other patients with your disease in the future.

Institution
MUSC
Recruitment Contact
Sandra Wilson
8437924616
wilsosan@musc.edu

Pediatrics Biorepository to Support Cardiology Clinical Research

Date Added
April 9th, 2023
PRO Number
Pro00124741
Researcher
Eric Graham

List of Studies


Keywords
Cardiovascular, Heart
Summary

This proposal is to contribute to data registry and sample bank called Pediatrics Biorepository for Cardiology Clinical Research. Samples collected in this study may be used for future research which plan to advance the state of science in the hopes to develop new ways to diagnose and treat children affected with heart conditions.

Institution
MUSC
Recruitment Contact
Eric Graham
843-792-9570
grahamem@musc.edu

BIO-CONDUCT Study BIOTRONIK Conduction System Pacing with the Solia Lead

Date Added
April 11th, 2023
PRO Number
Pro00127714
Researcher
Anne Kroman

List of Studies

Keywords
Cardiovascular, Heart
Summary

This study is enrolling subjects who need a pacemaker implant for a heart rhythm disorder. A pacemaker is a device implanted under the skin in the upper chest, and is designed to send electrical signals to tell the heart to squeeze (contract) through wires called leads. A conventional pacemaker has a lead placed in the right ventricle (lower chamber of the heart) which is referred to as ventricular pacing. This study will investigate conduction system pacing which is pacing from the part of the ventricle that normally carries electricity through the heart. The specific name for this part of the ventricle is the left bundle branch block area. The heart's conduction system initiates impulses that tells the heart muscle to contract in a coordinated fashion. This study will use the Solia S lead, which is considered investigational, meaning it is not yet approved by the Food and Drug Administration (FDA) for conduction system pacing. The Solia S lead is approved for ventricular pacing.

Participation in this study will last about one year and include 4-5 visits, some of which may be done virtually. The study involves collecting data from your pacemaker implant, Solia S placement, completing questionnaires, electrocardiogram, medical history and medications.

Risks include those associated with the pacemaker implant procedure such as potentially longer implant time, a tear in the interventricular septum (the wall separating the lower chambers of the heart) or unsuccessful lead placement. Other study related risks may include the risk of loss of confidentiality, risks of answering a questionnaire or unknown risks. There may be no benefit to you but the information learned may benefit others in the future who need conduction system pacing.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

A Multicenter, Adaptive, Randomized, Controlled Trial Platform To Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections

Date Added
April 12th, 2023
PRO Number
Pro00126098
Researcher
Andrew Goodwin

List of Studies


Keywords
Coronavirus, Critical Care
Summary

The protocol aims to improve standard of care, by ensuring an agile research infrastructure, with an ability to rapidly assess interventions during epidemic transmission of one or more respiratory pathogens adversely affecting public health.

Trials within this protocol can be adaptive, will be randomized, and will have superiority as the primary objective. Comparisons in the trials may be between an unlicensed agent to a blinded placebo plus standard of care (SOC), between an approved off-label agent to a blinded placebo plus SOC, among several active interventions (blinded or non-blinded; i.e., a comparative effectiveness study), or among different treatment strategies.

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

Utility and Histologic Effects of the J-Tip Device in Dermatologic Conditions Requiring Local Anesthesia

Date Added
May 2nd, 2023
PRO Number
Pro00107787
Researcher
Lara Wine Lee

List of Studies


Keywords
Cancer/Skin, Skin
Summary

This project is a pilot study to determine if use of the J-Tip Needle-Free Injection System, used to administer local anesthesia, has any effects on the appearance of skin samples when viewed under a microscope compared with skin samples that have been injected with local anesthesia using a needle. If use of the J-Tip device for local anesthesia delivery is shown not to alter the microscopic appearance of skin, anesthesia for skin biopsies in the future may potentially be performed without a needle, allowing for less fear and pain.

Institution
MUSC
Recruitment Contact
Lara Wine Lee
(843) 792-3021
winelee@musc.edu

A randomized controlled trial of smell training and trigeminal nerve stimulation in the treatment of COVID-related persistent smell loss

Date Added
May 2nd, 2023
PRO Number
Pro00127790
Researcher
Bernadette Cortese

List of Studies


Keywords
Coronavirus, Nervous System, Nose, Psychiatry
Summary

Persistent smell loss that can include diminished or distorted smell function is a common symptom of long COVID syndrome. There are limited treatment options for long COVID-related smell loss. Our study aims to determine the efficacy of two at-home treatments, smell training and non-invasive trigeminal nerve stimulation. This study requires participants to conduct daily at-home treatment sessions, attend three in-person study visits at the MUSC Department of Psychiatry and Behavioral Sciences, and complete electronic questionnaires over the 12-week trial, and again at the six-month timepoint. Participants in this trial may benefit directly with an improvement in sense of smell. However, participation may also help society more generally, as this study will provide new information about long COVID-related smell loss and its treatment.

EEG Substudy:

Long COVID syndrome has been associated with cognitive impairment and may be related to affected emotional regulation. This study will use a electroencephalography (EEG) to examine how the body and brain responses to emotional cues in participants who are currently undergoing treatment for COVID-related smell loss. Participation will aid in the understanding of how emotional processing in long COVID is impacted by treatment for related smell loss.

Blood Analysis Substudy:
Alzheimer's Disease can be precedented by other clinical disorders or neuropsychiatric symptoms. Due to the cognitive deficits that can affect those with Long COVID, this sub study will use a blood sample to investigate if there are blood based biomarkers for Alzheimer's in those who report Long COVID symptoms.

Institution
MUSC
Recruitment Contact
Mary Clare Koebel
843-790-3449
scent-4-longcovid@musc.edu

Impact of stress and craving on return to cannabis use in postpartum women

Date Added
May 2nd, 2023
PRO Number
Pro00128029
Researcher
Constance Guille

List of Studies


Keywords
Drug Studies, Hormones, Non-interventional, Pregnancy, Substance Use, Women's Health
Summary

Cannabis is the most commonly used illicit substance among pregnant and postpartum women, with the postpartum period being a common time for relapse to cannabis. Currently there are no interventions for preventing return to cannabis use during this vulnerable time. The goal of this research is to better understand risk factors such as stress, craving, anxiety, mood, sleep, and hormone levels that may contribute to return to cannabis use during the postpartum period in order to help develop targeted prevention and treatment interventions in the future.

Institution
MUSC
Recruitment Contact
Lisa Nunn
843-792-0476
jenkinli@musc.edu



-- OR --