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 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

Outcomes for violently injured patients after injury and the role of Hospital Violence Intervention Programs (HVIPs) in post injury recovery and safety

Date Added
May 13th, 2025
PRO Number
Pro00142353
Researcher
Ashley Hink

List of Studies

Keywords
Critical Care
Summary

The purpose of the study is to assess services, experiences, needs and outcomes for patients that experience violent injuries in the year after injury, and to assess differences among those that are served by the Turning the Tide Violence Intervention Program (TTVIP) compared to those who are not. This will be done through a series of four 25-35 minute surveys that will be administered over the course of a year. Participants will be asked questions about their physical and mental health, violence exposures and risk, healthcare experience, ongoing needs, services provided by the TTVIP and overall recovery. This information will be used to better understand the experiences of patients that experience a violent injury, how HVIPs impact their outcomes, and how healthcare teams and hospital violence intervention programs (HVIPs) can be improved within trauma centers.

Institution
MUSC
Recruitment Contact
Claire Jacoby
8437691689
Jacobyc@musc.edu

Neuron23, Inc. / "A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NEU-411 in Companion Diagnostic-Positive Participants with Early Parkinson's Disease (NEULARK)"

Date Added
May 13th, 2025
PRO Number
Pro00142584
Researcher
Christine Cooper

List of Studies


Keywords
Parkinsons
Summary

The goal of the research study is to see if NEU-411 (1) will help prevent or slow the worsening of LRRK2 driven Parkinson's Disease (PD) and, (2) is safe. This study will also determine how your body processes NEU 411 and what NEU-411 does to your body. The study doctor will discuss with you whether you are eligible to be part of this study. As part of this study, you will receive either NEU-411 or placebo (inactive substance). The study drug is in tablet form and is taken by mouth. The study will last about 67 weeks. You will come in for 19 visits. In addition to in-person visits with the study team, you will be required to complete daily tests using a smartphone and occasionally be asked to wear a smartwatch continuously for 1-week periods. These technologies will be provided to you for use during the duration of the study and you will be trained on how to perform these activities. The NEU-411 is investigational and has not been approved by the US Food and Drug Administration as well as the investigational Companion Diagnostic (CDx).

Institution
MUSC
Recruitment Contact
Robin Bulgarino
8437921115
bulgarino@musc.edu

Optimizing Pain Treatment In Children On Mechanical Ventilation

Date Added
May 13th, 2025
PRO Number
Pro00144293
Researcher
Austin Biggs

List of Studies

Keywords
Critical Care, Pediatrics
Summary

This is a double blind randomized controlled trial designed to test the effects of intravenous acetaminophen (IV-A) and/or intravenous ketorolac (IV-K) at reducing pain in children with acute respiratory failure (ARF) on invasive mechanical ventilation (MV). Consented participants will be randomized in equal proportions to receive IV-A, IV-K, both, or neither.

Institution
MUSC
Recruitment Contact
Layla Al Sarraf
843-876-5203
alsarral@musc.edu

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

ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression ADVENT LTO Study

Date Added
May 14th, 2025
PRO Number
Pro00140422
Researcher
Jeffrey Winterfield

List of Studies


Keywords
Heart
Summary

This study is enrolling participants who completed the FARAPULSE ADVENT study and are now nearing the 3 year post atrial fibrillation ablation timepoint. Atrial fibrillation is an irregular heart rhythm caused by electrical signals misfiring. An ablation is a procedure in which those signals are targeted and destroyed to stop the atrial fibrillation. This study will consist of reviewing and collecting medical records since the ablation procedure as well as optional questionnaires and wearing a heart monitor for 7 days to capture the heart's electrical activity. There are no study related follow up visits. Study related risks include loss of confidentiality and possible skin reaction to the electrodes (sticky patches placed on the chest to detect the heart's electrical activity). Individual benefit is not expected but the information learned may contribute to knowledge in this field.

Institution
MUSC
Recruitment Contact
Chandler Schwede
843-792-5998
schwede@musc.edu

Investigation of a Novel, magNetically levitated VAD for the treatment of refractOry left Ventricular heArT failurE (INNOVATE Trial)

Date Added
May 15th, 2025
PRO Number
Pro00143150
Researcher
Arman Kilic

List of Studies

Keywords
Cardiovascular, Heart, Surgery
Summary

The objective of the study is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3™ (HM3) LVAS (Abbott) when used for the treatment of advanced, refractory, left ventricular heart failure.

Institution
MUSC
Recruitment Contact
Deanna DeHoff
(843) 792-8522
dehoff@musc.edu

A PROSPECTIVE, MULTICOUNTRY STUDY TO ESTIMATE THE INCIDENCE OF AND PROVIDE A BEST PRACTICE MODEL FOR MONITORING THE DEVELOPMENT OF POST-STROKE SPASTICITY

Date Added
May 15th, 2025
PRO Number
Pro00142456
Researcher
Parneet Grewal

List of Studies

Keywords
Stroke, Stroke Recovery
Summary

This study is looking for participants who have had a stroke for the first time and have also had weakness (known as "paresis") in their arms or legs. People who have weakness in their arms or legs after their stroke are at risk of developing spasticity. Spasticity is a condition where muscles stiffen or tighten involuntarily, preventing normal movement, and sometimes causing discomfort or pain.

This study is looking at the proportion of first-ever stroke participants with paresis who develop spasticity up to 12 months after their stroke. We would like to do this by contacting you regularly to see whether you have developed spasticity. The study period for each individual participant will vary depending on whether and when spasticity or problematic spasticity develops.

Institution
MUSC
Recruitment Contact
Caitlan LeMatty
843-792-8606
lemattyc@musc.edu

Randomized Phase II/III Trial of 2nd Line Nivolumab + Paclitaxel + Ramucirumab versus Paclitaxel + Ramucirumab in Patients with PD-L1 CPS 1 Advanced Gastric and Esophageal Adenocarcinoma (PARAMUNE)

Date Added
May 15th, 2025
PRO Number
Pro00144480
Researcher
Toros Dincman

List of Studies

Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

The purpose of this study is to compare the usual treatment alone to the usual treatment plus nivolumab. This study seeks to find if this approach is better or worse than standard of care for colon cancer. Treatment and follow up for this study may be up to 3 years. The procedures include CT or MRI scans and chemotherapy. Risks include diarrhea, nausea, vomiting, hair loss, anemia, sores in mouth, and muscle weakness. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.

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



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