RECOVERS – Realigning Emotion and COgnition Via prEcision Regulation networkS

Date Added
July 5th, 2023
PRO Number
Pro00129566
Researcher
Lisa McTeague

List of Studies


Keywords
Healthy Volunteer Studies
Summary

In this research study, we are examining how brain activity (electrical and blood flow) changes during tests of emotional processing and attention and memory in the magnetic resonance imaging (MRI) scanner. We are also using non-invasive brain stimulation to probe different parts of the brain and measuring brain activity (electrical and blood flow) alongside evidence-based cognitive behavioural therapy. This study includes healthy and clinical participants and researchers hope this will help us develop improved brain-based treatments for emotional difficulties like depression.

Institution
MUSC
Recruitment Contact
Gavin Doyle
8435808136
recovers@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, Rare Diseases
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
Katherine Tucker
843-792-9502
tuckekat@musc.edu

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Date Added
July 5th, 2023
PRO Number
Pro00126590
Researcher
Marc Katz

List of Studies


Keywords
Cardiovascular, Surgery
Summary

This is an Investigational Device Exemption (IDE) clinical research trial (referred to also as a trial or a research trial) sponsored by AtriCure, Inc (the Sponsor) to learn whether the use of the AtriClip® LAA Exclusion System to close off your left atrial appendage (LAA) during your heart surgery will reduce the risk of stroke. The AtriClip has not been well studied or approved by the FDA for stroke prevention; therefore, this procedure is considered investigational.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
8437928896
overstrm@musc.edu

EEG-fNIRS Controlled TMS Real-time Neural Feedback for Anti-Depressive Treatment

Date Added
July 5th, 2023
PRO Number
Pro00124800
Researcher
Mark George

List of Studies


Keywords
Brain, Depression
Summary

Currently rTMS for treating depression is delivered without knowing whether the TMS pulses are synchronized with the patient's brain rhythms. We will study healthy and depressed adults with TMS inside of the MRI scanner or outside of the MRI scanner using optics, and test whether it matters precisely timing the TMS pulses with EEG.

Institution
MUSC
Recruitment Contact
Bridgette Holland
843-638-7517
hollanbr@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

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 Phase 1 Single Dose Escalation Study Evaluating the Safety and Tolerability of VX-522 in Subjects 18 Years of Age and Older With Cystic Fibrosis and a CFTR Genotype Not Responsive to CFTR Modulator Therapy

Date Added
June 27th, 2023
PRO Number
Pro00129073
Researcher
Patrick Flume

List of Studies


Keywords
Cystic Fibrosis
Summary

The purpose of this study is to evaluate the safety and tolerability of single ascending doses (SAD) of VX-52 in patients with Cystic Fibrosis and the CFTR genotype who have not been responsive to CFTR modulator therapy. This is a first in human study.

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

The Janus Rectal Cancer Trial: A Randomized Phase II/III Trial Testing the Efficacy of Triplet versus Doublet Chemotherapy Regarding Clinical Complete Response and Disease-Free Survival in Patients with Locally Advanced Rectal Cancer

Date Added
June 21st, 2023
PRO Number
Pro00129646
Researcher
Toros Dincman

List of Studies

Keywords
Cancer/Gastrointestinal
Summary

This study is for patients with advanced rectal cancer. This study is being done to see if we can increase the clinical complete response rate (tumor disappears by exam, endoscopy, and imaging) by adding a 3rd drug (irinotecan) to the standard regimen of FOLFOX or CAPOX given following long-course chemoradiation.
We are doing this study because we want to find out if this approach is better or worse than the usual approach for your rectal cancer. The usual approach is defined as care most people get for locally advanced rectal cancer.

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

A Phase 2b Randomized, Double-blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn's Disease

Date Added
June 21st, 2023
PRO Number
Pro00128423
Researcher
Erin Forster

List of Studies


Keywords
Ulcerative colitis
Summary

This is a randomized, double-blind, active- and placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of induction and maintenance JNJ-78934804 therapy in participants with moderately to severely active CD who have had an inadequate initial response, loss of response, or intolerance to ≥1 approved ADT (advanced therapy inadequate responder [ADT-IR]). This
dose-ranging study includes participants 18 to 65 years of age (inclusive, at the time of consent) with moderately or severely active CD (defined by a CDAI score ≥220 and ≤450) and either a mean daily abdominal pain (AP) score ≥2 (based on the unweighted CDAI component of AP) or a mean daily stool frequency (SF) count ≥4 (based on the unweighted CDAI component of the number of liquid or very soft stools), of at least 3 months duration, with colitis, ileitis, or ileocolitis previously confirmed in the past by radiology, histology and/or endoscopy. Participants must also have endoscopic evidence of active ileal
and/or colonic CD on the screening video ileocolonoscopy. Overall, the study will evaluate 48 weeks of therapy with JNJ-78934804

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

Feasibility Trial of Preoperative 5-Day Hypofractionated Radiotherapy for Primary Soft Tissue Sarcoma

Date Added
June 20th, 2023
PRO Number
Pro00127066
Researcher
Jennifer Harper

List of Studies


Keywords
Cancer
Summary

This study is for subjects that have been diagnosed with cancer in their arm, leg, or trunk (the part of the body that involves the chest, abdomen, and pelvis). The purpose of this research study is to preserve healthy tissue around the cancer on the arm(s) and/or leg(s) using Hypofractionated Radiotherapy, while treating the cancer and preventing it from spreading to other areas of the body. Participation in the study will take about 15 visits over a period of 15 months.

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



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