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

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

A pragmatic remote approach to improve transitions of care and retention in opioid use disorder treatment: Qualitative Interviews

Date Added
May 20th, 2025
PRO Number
Pro00141967
Researcher
Allison Smith

List of Studies


Keywords
Psychiatry, Substance Use
Summary

The primary objective of this proposal is to conduct surveys and qualitative interviews to get feedback from (1) stakeholders and (2) people with lived experience of opioid use and a related medical hospitalization, on the barriers and facilitators of new potential strategy of treatment. The potential proposed intervention we will ask questions about is the direct mailing medications for opioid use disorder (OUD) in an attempt to overcome many of the barriers that interfere with treatment retention (i.e. transportation). Qualitative interviews will be used to get feedback on the feasibility, appropriateness, and acceptability of mailing maintenance medications for OUD after a hospital discharge. In a future study, this feedback will be used to develop a protocol to test this method.

Institution
MUSC
Recruitment Contact
Allison Smith
843-792-0686
smithall@musc.edu

Autophagy Maintenance (AUTOMAIN) Therapy in High-Grade Serous Ovarian Cancer: A Phase II Trial

Date Added
May 20th, 2025
PRO Number
Pro00143653
Researcher
Brian Orr

List of Studies

Keywords
Cancer, Cancer/Genitourinary, Cancer/Other, Drug Studies, Women's Health
Summary

This study is for patients that have been diagnosed with ovarian cancer who are taking bevacizumab. This study is testing two investigational drugs called nelfinavir and hydroxychloroquine. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA) for the treatment of cancer. The primary purpose of this study is to see if these two medications in combination with bevacizumab are safe and effective in ovarian cancer. These drugs will be given by mouth. Participants in this study can expect to be in this study for 6 months for data collection, but may continue on the study medications longer if seeing benefit.

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

Adolescent Perspectives on Adapting Written Exposure Therapy for Adolescents with PTSD

Date Added
May 21st, 2025
PRO Number
Pro00144898
Researcher
Emily Tilstra-Ferrell

List of Studies

Keywords
Adolescents
Summary

The proposed research will qualitatively examine adolescent perspectives on adapting Written Exposure Therapy (WET), an evidence-based treatment for posttraumatic stress disorder (PTSD) among adults, for use with adolescents. The present study will take the first step in adapting WET for adolescents by conducting interviews with adolescents with PTSD. Interview questions will focus on identifying perceptions of WET and recommendations for adapting WET for the needs of adolescents. A brief survey will also be conducted. Participation in the interview and survey will involve a one-time study visit that lasts up to 60 minutes and can be conducted in person or virtually. Adolescent participants need be accompanied by a caregiver either in person or virtually.

Institution
MUSC
Recruitment Contact
Emily Tilstra-Ferrell
843-471-0302
ferrelle@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



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