IBD Qorus: Improving the Quality of Care for Adults with Inflammatory Bowel Disease

Date Added
February 22nd, 2023
PRO Number
Pro00125585
Researcher
Erin Forster

List of Studies


Keywords
Inflammatory Bowel Disease
Summary

The goal of this study is to collect health information from adults with IBD to better understand the disease and ultimately improve care for participants and other adults living with IBD. Participation in this study is voluntary. If a subject agrees to be in this study, we will collect information electronically (through a web-based platform called IBD Qorus) from the subject and the subject's IBD health care provider about their IBD health information.

Approximately 50 sites across the U.S. are currently participated in this study. The study is sponsored by the non-profit Crohn's and Colitis Foundation.

With the collected medical data, the study will focus on the strategy of identifying goals (or targets) of IBD care, developing a strategy to reach these goals, and then continuously evaluating progress of achieving these targets and modifying the treatment plan.

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

Investigating the effect of the oral microbiome on cognition in HIV-infected chronic cannabis users

Date Added
February 9th, 2023
PRO Number
Pro00117243
Researcher
Wei Jiang

List of Studies


Keywords
Brain, Dental, HIV / AIDS, Memory Loss, Mental Health, Nervous System, Psychiatry, Substance Use
Summary

This study will examine how marijuana use can affect oral bacteria and brain health in people with HIV and without HIV. Early studies show that marijuana users have more oral bacteria than non-marijuana users. The increase in bacteria is believed to affect brain health. Participation in the study will be one visit. The visit will take approximately 120 minutes.

Institution
MUSC
Recruitment Contact
Wei Jiang
843-876-2457
jianw@musc.edu

Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and Co-Occurring PTSD: A Randomized Clinical Trial

Date Added
February 8th, 2023
PRO Number
Pro00126431
Researcher
Sudie Back

List of Studies


Keywords
Alcohol, Mental Health
Summary

A large proportion of individuals with alcohol use disorder (AUD) also meet criteria
for posttraumatic stress disorder (PTSD). Trauma-focused, cognitive-behavioral therapy delivered alongside interventions for substance use disorders are most effective. Cognitive Processing Therapy (CPT) for PTSD and Relapse Prevention (RP) for AUD are two of the most widely used and effective treatments for these
conditions. The purpose of this study is to examine the CPT-RP, as compared to RP alone, in reducing (1) alcohol use frequency and quantity and (2) PTSD symptom severity among individuals with current AUD/PTSD.

Institution
MUSC
Recruitment Contact
Stacey Sellers
843-792-5807
sellersst@musc.edu

A PHASE 3, OPEN-LABEL, RANDOMIZED, STANDARD OF CARECONTROLLED, PARALLEL ARM STUDY TO DEMONSTRATE EFFICACY AND SAFETY OF ARINA-1 IN THE PREVENTION OF BRONCHIOLITIS OBLITERANS SYNDROME PROGRESSION IN PARTICIPANTS WITH BILATERAL LUNG TRANSPLANT

Date Added
February 8th, 2023
PRO Number
Pro00126240
Researcher
Timothy Whelan

List of Studies


Keywords
Interstitial Lung Disease (ILD)
Summary

The study will be an open-label, randomized, parallel arm study that will include a
treatment arm and control arm. Participants will have clinic visits at screening, randomization (day 1) and weeks 4, 12, 18, and 24. After week 24, participants will have clinic visits at weeks 32, 40, and 48. Participants will also have a telehealth visit on day 2 and phone calls to assess adverse events (AEs), serious adverse events (SAEs), and review patient education will occur during weeks 5, 8, 36, and 44. The phone calls may be converted to telehealth visits or clinic visits and / or followed by clinic visits, if the study team deems it necessary. Pulmonary function testing, quality of life survey (St. George's Respiratory Questionnaire (SGRQ)), and blood draw will occur at each clinic visit.

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

A Neural Basis for Cognitive Decline Following Deep Brain Stimulation

Date Added
January 25th, 2023
PRO Number
Pro00125181
Researcher
Daniel Lench

List of Studies

Keywords
Brain, Parkinsons
Summary

The objective of this research study is to identify brain biomarkers using MRI scans that can predict an individual's response to Deep Brain Stimulation (DBS). A total of 55 participants with Parkinson's Disease planning to undergo DBS will be recruited from MUSC's Clinical DBS Program. Participants will undergo two visits which include a 2.5-hour pre-DBS questionnaire and MRI scanning visit, and a 3.5-hour post-DBS cognitive assessment visit. In addition control participants without Parkinson's Disease will be recruited to undergo MRI scanning and cognitive assessments.

Institution
MUSC
Recruitment Contact
Daniel Lench
843-792-9115
lenchd@musc.edu

BLINDED REFERENCE SET FOR MULTICANCER EARLY DETECTION BLOOD TESTS

Date Added
January 24th, 2023
PRO Number
Pro00125723
Researcher
Brian Hess

List of Studies


Keywords
Cancer
Summary

This study is for patients with cancer and is being done to see if blood samples from patients with and without certain types of cancer help researchers develop a future blood test for use in detecting cancer early.

Institution
MUSC
Recruitment Contact
Barbara Roe
843-652-1607
broe@tidelandshealth.org

The efficacy of the Smart Pass filter to Reduce the Risk for inappropriate subcutaneous implantable cardioverter-defibrillator shocks from myopotential interference

Date Added
January 23rd, 2023
PRO Number
Pro00117025
Researcher
Michael Gold

List of Studies


Keywords
Heart
Summary

This study is enrolling participants who are already implanted with a S-ICD device (Subcutaneous Implantable Cardioverter Defibrillator, which is a device designed to monitor heart rhythms and deliver a shock to the heart to stop life threatening heart rhythms), and are undergoing a routine outpatient clinic follow up appointment to have their S-ICD checked. The aim of the study is to see if a feature in the device can recognize muscle movement and differentiate movement from irregular heart signals. The study involves doing some simple arm exercises while collecting device data, both with this feature turn on and then with it turned off. Participants will be randomized to either have the feature turned on or off initially then it will be programmed the alternative way and the same exercise testing will be repeated. The study will involve just one visit.

Institution
MUSC
Recruitment Contact
Olivia Washington
843-792-5863
washoliv@musc.edu

A Phase 2 Open-Label, Multicenter Clinical Study of the Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients With Advanced Systemic Mastocytosis

Date Added
January 11th, 2023
PRO Number
Pro00123694
Researcher
Kelli Williams

List of Studies


Keywords
Blood Disorders, Cancer/Other, 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 Advanced Systemic Mastocytosis. The investigational drug is known as CGT9486 and will be taken daily orally. Participation in the study is expected to be approximately 6 years.

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

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency–Associated Liver Disease With METAVIR Stage F2 to F4 Fibrosis

Date Added
January 10th, 2023
PRO Number
Pro00125124
Researcher
Charlie Strange

List of Studies


Keywords
Pulmonary
Summary

This study will evaluate the safety and effectiveness of fazirsiran (investigational drug) compared with placebo (an inactive substance) in patients with alpha-1 antitrypsin deficiency associated liver disease (AATD-LD). If eligible, subjects will be randomized (assigned to a group by chance) to receive either fazirsiran or placebo to be administered subcutaneously (an injection under the skin). Subjects will be treated on Day 1, at Week 4, and then every 12 weeks for 196 weeks. Subjects will be followed for 6 months after their last dose of study drug or placebo for a total study duration of approximately 230 weeks (including 10 weeks of the screening period which is the time needed to assess if a subject is eligible for the study).

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

Non-cigarette tobacco products as harm reduction tools in smokers who failed to quit with traditional methods

Date Added
January 3rd, 2023
PRO Number
Pro00125514
Researcher
Tracy Smith

List of Studies


Keywords
Smoking
Summary

This study evaluates whether non-cigarette tobacco products (e-cigarettes) can help smokers quit smoking as compared to traditional quit methods (nicotine replacement therapy or varenicline/Chantix). Participants in this study will be randomly assigned to one of two groups, then will have a choice between the offered products of that group. Participants in the e-cigarette group will have a choice of e-cigarette brand and flavor. Participants in the medication group will have choice between nicotine replacement therapy (patches and lozenges) or varenicline, also known as Chantix. Participation will last 6 months and will include weekly phone calls for the initial 7-weeks plus a 11-week phone call and a 6-month follow-up visit. Participants will also complete electronic daily diaries during the first 7-weeks.

Institution
MUSC
Recruitment Contact
J'Neice Hunter
843-876-2291
paynejne@musc.edu



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