CorEvitas International Adolescent Atopic Dermatitis (AD) Drug Safety and Effectiveness Registry

Date Added
May 21st, 2025
PRO Number
Pro00140864
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

An international research registry called the CorEvitas International Adolescent Atopic Dermatitis (AD) Registry (the "CorEvitas Registry"). This observational registry studies adolescent patients with AA between 12-17 years of age under the care of a dermatology provider diagnosed with moderate to severe atopic dermatitis.

Institution
MUSC
Recruitment Contact
Mary Tyler Lillich
843-876-9302
lillich@musc.edu

A Phase 2, Multicenter, Double-blind, Extension Study to Evaluate the Effects of Sotatercept for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved Ejection Fraction (HFpEF)

Date Added
May 27th, 2025
PRO Number
Pro00143751
Researcher
Daniel Silverman

List of Studies

Keywords
Cardiovascular, Pulmonary Hypertension
Summary

The purpose of the study is to evaluate the safety and how well the medication sotatercept works versus placebo in treating Heart Failure with a Preserved Ejection Fraction. The study will also look at information obtained from the tests performed as part of the study to see if subjects have improvement in symptoms of heart failure. Participation in this study will last approximately 26 months. During the study period subjects will be asked to attend regular study visits with the research coordinator. These visits will include such activities as blood tests, questionnaires, physical evaluation by a study doctor, a right heart catheterization with exercise, echocardiogram, and 6 minute hall walks. There will be 35 visits as part of participation in this clinical trial.

Participants will be randomized to either the treatment group (and receive the medication) or the control group (and not receive the medication). Subjects will have a 2:1 chance of receiving the study medication during their participation in the trial. The treatment assignment is determined by randomization, where a computer selects at random which treatment group you will be in (like drawing straws). Neither the subject, nor the blinded personnel will know which group subjects are in. Neither the subject nor the study doctor will decide what group subjects are assigned. Participants from the placebo group in CADENCE who enter HARMONIZE at Visit 9a will be randomized 1:1 to one of the active treatment groups. Participants from an active treatment group in CADENCE entering HARMONIZE after Visit 9a will be allocated to continue in the same treatment group (ie, sotatercept dose level) as in CADENCE.

Institution
MUSC
Recruitment Contact
Madison Johnson
843-792-4615
johme@musc.edu

Sex differences in the genetics of cannabinoid metabolism

Date Added
May 29th, 2025
PRO Number
Pro00144812
Researcher
Erin Martin

List of Studies

Keywords
Substance Use
Summary

This study will examine genetic factors that contribute to the different ways people feel after consuming cannabis. People that use cannabis at least 4 days per week will participate in a study involving 1 in-person visit followed by a 5-day remote assessment period. The in-person visit will determine if an individual is eligible for study participation and their blood will be drawn to assess genetics. During the remote assessment period, participants will complete multiple short surveys per day describing their feelings and their recent cannabis use.

Institution
MUSC
Recruitment Contact
Erin Martin
843-876-3528
marterin@musc.edu

CorEvitas International Adolescent Alopecia Areata (AA) Drug Safety and Effectiveness Registry

Date Added
May 29th, 2025
PRO Number
Pro00139971
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

An international research registry called the CorEvitas International Adolescent Alopecia Areata (AA) Registry (the "CorEvitas Registry"). This observational registry studies adolescent patients with AA between 12-17 years of age under the care of a dermatology provider diagnosed with moderate to severe alopecia areata.

Institution
MUSC
Recruitment Contact
Mary Tyler Lillich
843-876-9302
lillich@musc.edu

A phase 2, randomized, investigator and participant blinded, placebo-controlled, parallel-group study to investigate the safety, tolerability, and preliminary efficacy of TMP-301 treatment in adult patients with alcohol use disorder (AUD).

Date Added
May 30th, 2025
PRO Number
Pro00143607
Researcher
Sarah Book

List of Studies


Keywords
Alcohol, Substance Use
Summary

This is a 16-week-long treatment study for people with Alcohol Use Disorder who want to stop or cut down their drinking. The purpose of this study is to determine whether an investigational medication, TMP-301, affects craving for alcohol and/or alcohol drinking while taking the study drug. Participants will be randomly assigned to TMP-301or a matched placebo

Institution
MUSC
Recruitment Contact
Konstantin Voronin
843-792-4887
voronin@musc.edu

TEAM-HF: Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients with Advancing Heart Failure

Date Added
May 30th, 2025
PRO Number
Pro00143811
Researcher
Arman Kilic

List of Studies

Keywords
Heart
Summary

The TEAM-HF trial aims to find out whether measuring pressure in the heart and lungs using an implantable device called a CardioMEMS can help identify heart failure patients who are getting worse and may benefit from earlier treatment with a heart pump called an LVAD. It also seeks to determine if patients with advanced heart failure, who are not on IV medications for their heart failure but still have high pressures in their heart and lungs can improve with LVAD therapy.

Institution
MUSC
Recruitment Contact
Melissa Lamicq
843-792-1851
lamicq@musc.edu

Prospective non-interventional, phase IV, multicenter, study to assess the effectiveness, safety, and tolerability of elafibranor 80mg/day in patients with PBC receiving treatment in real-world settings

Date Added
June 3rd, 2025
PRO Number
Pro00136802
Researcher
Don Rockey

List of Studies


Keywords
Liver, Non-interventional, Rare Diseases
Summary

This is an international, multicenter, study that will not prescribe elafibranor. It is designed primarily to collect data and assess real-world effectiveness of treatment with elafibranor 80mg/day on adult patients with PBC, and to describe the safety of this treatment and its impact on their quality of life, over a period of 24 months.

Institution
MUSC
Recruitment Contact
Joshua Inman
(843) 876-4303
inmanj@musc.edu

Pilot Evaluation of a 2D Embodied Conversational Agent to Support Speech Engagement in Parkinson's Disease

Date Added
June 4th, 2025
PRO Number
Pro00145307
Researcher
Kelly Richardson

List of Studies

Keywords
Parkinsons
Summary

We are testing a 2D system designed to help people with Parkinson's disease practice their speech. In this study, participants will speak with a virtual character, called an embodied conversational agent, using a laptop. Our goal is to see if this technology is helpful and easy to use for people with Parkinson's disease to use. This research will help us learn whether using virtual characters at home could support long-term speech improvements.

Institution
MUSC
Recruitment Contact
Kelly Richardson
8437929468
richkell@musc.edu

Biomarkers in Late-Onset Epilepsy of Unknown Etiology

Date Added
June 6th, 2025
PRO Number
Pro00143847
Researcher
Michael Sugarman

List of Studies

Keywords
Aging, Alzheimers, Brain, Central Nervous System, Dementia, Epilepsy, Memory Loss, Non-interventional
Summary

The purpose of this study is to learn more about late-onset epilepsy of unknown etiology (LOEU), which is defined as an onset of seizure activity in late life (age 60 or above) without a clear neurological cause. That is, many older adults will experience seizures due to neurological conditions such as stroke, brain injury, tumor, or infection. However, other individuals will also develop seizures with no identified cause.

Participation entails a single study visit lasting 2-3 hours including a fasting blood draw, completion of standardized cognitive testing, and several questionnaires. The goals of the study include to examine blood markers that can help us to better understand the condition including dementia risk, and how these markers may impact the clinical presentation of the condition. No interventions/treatments are included with this study.

Institution
MUSC
Recruitment Contact
Sarah Helton
843-640-5280
heltons@musc.edu

A Phase 2, Open-Label, 4-Week Safety Study of Roflumilast Cream 0.05% Administered Once Daily in Infants Aged 3 Months to Less Than 2 Years with Atopic Dermatitis

Date Added
June 6th, 2025
PRO Number
Pro00144456
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This study aims to evaluate the safety and tolerability of ARQ-151 cream 0.05% in infants with mild to moderate eczema after daily application for four weeks. ARQ-151 contains the active ingredient roflumilast, which reduces the activity of the enzyme PDE-4 involved in inflammation. Since eczema is an inflammatory skin disease, ARQ-151 could potentially help treat this condition.

Institution
MUSC
Recruitment Contact
Madeline Richmond
843-792-1436
richmoma@musc.edu



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