A PHASE 3 RANDOMIZED, DOUBLE-BLIND, 52-WEEK PLACEBOCONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NON SEGMENTAL VITILIGO

Date Added
March 2nd, 2023
PRO Number
Pro00126424
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

Ritlecitinib (PF 06651600) is an investigational drug (referred to as "study drug" from here on) and is being developed as possible study treatment for participants with non segmental vitiligo (both active and stable vitiligo). The study drug will be compared with a placebo to find out if the study drug is better than the placebo for the study treatment of vitiligo. The duration of this study is a maximum of 60 weeks. There will be an initial screening period of 30 days where the study doctor will determine eligibility. If eligible, participants will be randomly assigned to receive the study drug or a placebo during a 52 week study treatment period. At the end of the treatment period, participants will enter a 4 week Follow Up Period.

Institution
MUSC
Recruitment Contact
Tiffany Vereen
843-792-6882
vereent@musc.edu

Pilot Study to Evaluate Circulating Tumor DNA in Classical Hodgkin Lymphoma and Primary Mediastinal Large B-cell Lymphoma

Date Added
February 28th, 2023
PRO Number
Pro00121859
Researcher
Brian Hess

List of Studies


Keywords
Cancer, Cancer/Lymphoma
Summary

The purpose of this research study is to find new ways of detecting and treating Hodgkin lymphoma and primary mediastinal B-cell lymphoma (a cancer of mature B-lymphocytes). It is a form of non-Hodgkin lymphoma, a type of cancer that originates in cells of the immune system, called lymphocytes. The information we learn by doing this research study may help study doctors identify new ways of treating your type of lymphoma. Participants in this study will provide archival (stored) tissue and blood samples. Participation is expected to last about 8 months. The risks and discomforts of this study are minimal. All blood specimens requested for this study will be collected at the time of routine procedures.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-7792-9321
hcc-clinicaltrials@musc.edu

Brensocatib in Patients with Non-Cystic Fibrosis Bronchiectasis

Date Added
February 23rd, 2023
PRO Number
Pro00126306
Researcher
Patrick Flume

List of Studies


Keywords
Interstitial Lung Disease (ILD)
Summary

The Program will allow access to brensocatib for patients who have completed the INS1007-301 ASPEN Clinical Trial. Patients will receive brensocatib 10 mg orally once daily. Eligible, compliant patients may receive brensocatib in this program until the drug is commercially available or until Insmed terminates the program.

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

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

Examining Provider and Caregiver Perceptions of an Automated Clinical Support Tool to identify Child Risk in Primary Care

Date Added
February 12th, 2023
PRO Number
Pro00125560
Researcher
Hannah Espeleta

List of Studies

Keywords
Children's Health, Pediatrics
Summary

This study wants to understand how we can better identify children who have experienced or are at risk to experience child maltreatment. We will be interviewing caregivers of children and primary care providers (nurses, pediatricians, social workers) to understand their perspectives on screening for child safety risks in primary care settings. Interviews with providers will also focus on their feedback on a new tool to designed to detect child safety risks within health care settings. Findings will help inform best practice in integrated health care settings.

Institution
MUSC
Recruitment Contact
Hannah Espeleta
843-792-6098
espeleta@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

Baroreflex Activation Therapy in left Ventricular Assist Device patients study

Date Added
January 31st, 2023
PRO Number
Pro00115552
Researcher
Brian Houston

List of Studies


Keywords
Cardiovascular, Heart
Summary

This study will examine whether a baroreflex activation therapy device (a small pacemakers that are helpful in heart failure) is beneficial for left ventricular assist device (LVAD) patients. For patients who have a baroreflex activation therapy device and LVAD, we assess whether baroreflex activation therapy helps them feel better and have fewer symptoms. We will also look at whether it helps with recovery of their weak heart. Participation in this study will last 6 months and require 3 clinic visits. At each visit, a participant's symptoms will be assessed, they will have pictures of their heart taken to determine function, and bloodwork will be drawn.

Institution
MUSC
Recruitment Contact
Renee Baxley
843-792-1105
baxleyr@musc.edu

A RANDOMIZED PHASE III TRIAL OF PRE-OPERATIVE COMPARED TO POST-OPERATIVE STEREOTACTIC RADIOSURGERY IN PATIENTS WITH RESECTABLE BRAIN METASTASES

Date Added
January 25th, 2023
PRO Number
Pro00126162
Researcher
Charlotte Rivers

List of Studies


Keywords
Cancer/Brain
Summary

This study is for patients with brain cancer. The study is being done to see if giving radiation before surgery will improve the length of time without the cancer returning, worsening or causing scarring in the brain.

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



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