CONQUEST: Platform Clinical Study for Conquering Scleroderma: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2b Platform Clinical Study to Evaluate the Safety and Efficacy of Investigational Products in Participants with Interstitial Lung Disease Secondary to Systemic Sclerosis

Date Added
May 13th, 2025
PRO Number
Pro00135916
Researcher
Faye Hant

List of Studies


Keywords
Autoimmune disease, Drug Studies, Rare Diseases, Scleroderma
Summary

The CONQUEST study is a clinical trial for people with systemic sclerosis associated interstitial lung disease (SSc-ILD). The goal of the research study is to help potentially uncover new SSc-ILD treatment options. The study is sponsored by The Scleroderma Research Foundation and is currently working with 2 pharmaceutical companies to provide the investigational medications (Amlitelimab, a subcutaneous injection/shot and BI 1015550/Nerandomilast, a tablet taken by mouth). Study participation involves a main study which is collecting general information about your scleroderma health and well being and at the same time, a treatment study that is specific to the investigational drug that you are assigned.

An investigational or study drug is not approved by The US Food and Drug Administration. It can only be used in a research study like this one. In this study the ID will be compared with a placebo (dummy drug). The placebo will be a look like the ID but does not have any study drug in it. The comparison with the placebo helps to determine whether the effects seen in your body is because of the ID or not. This is a randomized study, meaning that you will be assigned by chance (like flipping a coin) to receive either the study drug or placebo. The study is double-blinded study, meaning you and your study doctor will not know if you are taking a study drug or placebo but you will know what treatment study you are assigned (Treatment Study A with Amlitelimab or Treatment Study B with BI 1015550/Nerandomilast).

Participation in the overall study will be approximately 60 weeks (4 weeks
Screening, 52 weeks Treatment Period, and 4 weeks Follow-up with visits to the MUSC main campus. Study visits are much like the visits that you have with our Rheumatologist as part of your routine care such as: blood draw, urine collection, physician-led assessments of your disease (for example physical exam and skin thickness testing), tests to assess your pulmonary function and health (Pulmonary Function Test (PFT) and High Resolution Computed Tomography (HRCT)), electrocardiogram, as well as being asked to complete surveys/questionnaires.

Compensation is available with participation.

Institution
MUSC
Recruitment Contact
Miranda Irvin
843-792-8613
sclerodermaresearch@musc.edu

A randomized, controlled trial of varenicline for e-cigarette cessation

Date Added
May 9th, 2025
PRO Number
Pro00142969
Researcher
Benjamin Toll

List of Studies


Keywords
Drug Studies, Substance Use
Summary

This is a smoking cessation study which is examining varenicline for use in reducing or quitting e-cigarettes. Half of the participants will receive a placebo pill and half will receive varenicline. All participants will be asked to complete daily, brief REDCap EMA diaries (to report e-cigarette use, other tobacco use, and record videos of medication taking) and attend research visits every 3 weeks (i.e., weeks 3, 6, 9, 12) to complete additional assessments and receive compensation for doing so.

Institution
MUSC
Recruitment Contact
Rachel Christian
(843)737-1516
chrisrac@musc.edu

A randomized, controlled trial of varenicline for e-cigarette cessation

Date Added
May 9th, 2025
PRO Number
Pro00142969
Researcher
Benjamin Toll

List of Studies


Keywords
Drug Studies, Substance Use
Summary

This is a smoking cessation study which is examining varenicline for use in reducing or quitting e-cigarettes. Half of the participants will receive a placebo pill and half will receive varenicline. All participants will be asked to complete daily, brief REDCap EMA diaries (to report e-cigarette use, other tobacco use, and record videos of medication taking) and attend research visits every 3 weeks (i.e., weeks 3, 6, 9, 12) to complete additional assessments and receive compensation for doing so.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Rachel Christian
(843)737-1516
chrisrac@musc.edu

A randomized, controlled trial of varenicline for e-cigarette cessation

Date Added
May 9th, 2025
PRO Number
Pro00142969
Researcher
Benjamin Toll

List of Studies


Keywords
Drug Studies, Substance Use
Summary

This is a smoking cessation study which is examining varenicline for use in reducing or quitting e-cigarettes. Half of the participants will receive a placebo pill and half will receive varenicline. All participants will be asked to complete daily, brief REDCap EMA diaries (to report e-cigarette use, other tobacco use, and record videos of medication taking) and attend research visits every 3 weeks (i.e., weeks 3, 6, 9, 12) to complete additional assessments and receive compensation for doing so.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Rachel Christian
(843)737-1516
chrisrac@musc.edu

A randomized, controlled trial of varenicline for e-cigarette cessation

Date Added
May 9th, 2025
PRO Number
Pro00142969
Researcher
Benjamin Toll

List of Studies


Keywords
Drug Studies, Substance Use
Summary

This is a smoking cessation study which is examining varenicline for use in reducing or quitting e-cigarettes. Half of the participants will receive a placebo pill and half will receive varenicline. All participants will be asked to complete daily, brief REDCap EMA diaries (to report e-cigarette use, other tobacco use, and record videos of medication taking) and attend research visits every 3 weeks (i.e., weeks 3, 6, 9, 12) to complete additional assessments and receive compensation for doing so.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Rachel Christian
(843)737-1516
chrisrac@musc.edu

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF EFRUXIFERMIN IN SUBJECTS WITH NON-CIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH)/METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS (MASH) AND FIBROSIS

Date Added
May 9th, 2025
PRO Number
Pro00141743
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

Primary objective is to evaluate the effect of EFX compared to placebo on achieving
NASH/MASH resolution AND fibrosis regression at Week 52 (in
Cohort 1 only) and to evaluate the effect of EFX compared to placebo on all-cause
mortality and liver-related clinical outcomes as measured by the
time to first occurrence of any of the predefined, adjudicated events
in subjects with NASH/MASH and fibrosis.

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
843-876-8439
blanke@musc.edu

Circuitry-guided repetitive transcranial magnetic stimulation (rTMS) for tobacco use in Veterans: A comparison of insula-rTMS and prefrontal-rTMS

Date Added
May 6th, 2025
PRO Number
Pro00141919
Researcher
Xingbao Li

List of Studies


Keywords
Brain, Healthy Volunteer Studies, Smoking, Substance Use
Summary

Quitting smoking is hard, and many Veterans struggle even with current treatments. This study is testing a safe, non-invasive brain stimulation called repetitive transcranial magnetic stimulation (rTMS), which is already FDA-approved to help people stop smoking. We're comparing two types—standard and personalized—to see which works better. We aim to find the best option to help Veterans quit for good.

Institution
MUSC
Recruitment Contact
Cyra Valente
843 792-0136
VA email in process (valentec@musc.edu)

The LIGHT-60 Trial - Light Intervention for Geriatric patients Hospitalized for depression Treatment

Date Added
May 6th, 2025
PRO Number
Pro00139703
Researcher
Rindy Fernandes

List of Studies


Keywords
Depression, Geriatrics, Psychiatry, Stress Disorders
Summary

This research study is being conducted to gather information regarding the use of bright light therapy for depression treatment among hospitalized patients 60 years or older. If you choose to participate and meet criteria for inclusion in this study, you will be randomly assigned (like the flip of a coin) to receive either active light therapy or a placebo that is not expected to provide a benefit for your depression. The active treatment has been shown to be effective at reducing the symptoms of depression in other populations, but it has not been rigorously studied in patients 60 years or older who are hospitalized.

Institution
MUSC
Recruitment Contact
Andrew Kern
(843) 852-1374
kerna@musc.edu

LOTAM: A RANDOMIZED, PHASE III CLINICAL TRIAL OF LOW-DOSE TAMOXIFEN FOR SELECTED PATIENTS WITH MOLECULAR LOW-RISK EARLY-STAGE BREAST CANCER

Date Added
May 1st, 2025
PRO Number
Pro00144117
Researcher
Abirami Sivapiragasam

List of Studies

Keywords
Cancer/Breast, Drug Studies, Women's Health
Summary

This study is for subjects that are post-menopausal women that have been diagnosed with early-stage, low molecular risk breast cancer. Subjects are expected to remain in the study for 60months. There will be a total of 25 subjects enrolled locally.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc0clinical-trials@musc.edu

Perioperative Versus Adjuvant Systemic Therapy in Patients with Resectable Non-Small Cell Lung Cancer- Prospect Lung

Date Added
April 30th, 2025
PRO Number
Pro00143693
Researcher
Barry Gibney

List of Studies


Keywords
Cancer, Cancer/Lung, Men's Health, Women's Health
Summary

This is a Phase III study is for patients that have been diagnosed with with early-stage non-small cell lung cancer. The primary purpose of this study is to see if there is a difference in overall survival rate in patients changes based on when they start their drug treatment, either before or after surgical intervention. Participants in this study can expect to be followed for up to 10 years. This study has two groups and a computer will be used to assign study groups. Participants will be randomly assigned to receive either neoadjuvant therapy followed by surgery and adjuvant therapy, or surgery followed by adjuvant therapy. This is called randomization. Patients will have an equal chance of being in either group, similar to flipping a coin.

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



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