Sleep and Activity Habits of Inpatients with Chest Tubes: A Pilot Observational Trial

Date Added
April 9th, 2025
PRO Number
Pro00140546
Researcher
Christopher Gilbert

List of Studies

Keywords
Lung, Pulmonary
Summary

This is a non-invasive, observational study aiming to collect data on the impact chest tubes have on inpatients during their hospitalizations. Sleep and activity patterns, as well as select vital signs will be tracked using an MUSC-owned Apple Watch, which subjects will wear, and an MUSC-owned iPhone, for up to seven days during admission to the hospital. Each day, a study coordinator will visit subjects to collect a brief sleep survey. Participation may last up to 7 days while subjects are admitted and have a chest tube in place. Upon completion of the study, a study coordinator will collect the Apple Watch and iPhone for data analysis.

This pilot data will provide initial information on the feasibility of collecting and performing a larger study on the inpatient mobility, activity, and sleep.

Institution
MUSC
Recruitment Contact
Randal Neff
8437924557
Neffr@musc.edu

A prospective, multicenter clinical trial of the TricValve® Transcatheter Bicaval Valve System in subjects with severe tricuspid regurgitation.

Date Added
April 22nd, 2025
PRO Number
Pro00143868
Researcher
Nicholas Amoroso

List of Studies


Keywords
Cardiovascular, Heart, Surgery
Summary

This study is enrolling subjects with tricuspid regurgitation, which is what occurs when the tricuspid heart valve on the right side of the heart does not close properly and blood leaks backwards. Over time this can lead to symptoms like shortness of breath and fluid build up in the legs, abdomen, and lungs. This study involves a new investigational device called the TricValve® Transcatheter Bicaval Valve system to treat the leaky valve. Investigational means it is not approved for commercial use by the Food and Drug Administration. (FDA) This study will last about 5 years and include about 11 visits. Study related procedures include physical exams, right heart catheterization (an invasive procedure to check pressures inside the heart), echocardiograms (ultrasound test of the heart), CT scan, blood work, questionnaires, hall walk test and procedure to place the device. Risks include those related to the device and procedure such as infection, failure of the device, worsening of your symptoms or other cardiac complications. There are also risks associated with study testing such as radiation risks, blood draw risks, loss of confidentiality and unknown risks. There is potential benefit to you and to others in the future from what is learned from this study.

Institution
MUSC
Recruitment Contact
Natalie Drain
843-876-5037
drain@musc.edu

A Phase 2, Double-Blind, Proof of Concept Study to Evaluate Mazdutide Compared with Placebo in Participants with Alcohol Use Disorder

Date Added
April 23rd, 2025
PRO Number
Pro00142519
Researcher
Sarah Book

List of Studies


Keywords
Substance Use
Summary

This is a 28-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, Mazdutide, affects craving for alcohol and/or alcohol drinking while taking the study drug. Participants will be randomly assigned to Mazdutide or a matched placebo

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

An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH)

Date Added
April 24th, 2025
PRO Number
Pro00137101
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

This is a multicenter, open-label extension (OLE) study to see how safe and effective an inhaled medication called seralutinib is for people with Pulmonary Arterial Hypertension (PAH). The primary objective of this study was to assess improvement in cardiopulmonary hemodynamics as measured by change in pulmonary vascular resistance (PVR) from baseline to Week 24. The secondary objective of this study was to assess improvement in exercise capacity as measured by change in six-minute walk distance (6MWD) from baseline to Week 24.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@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

A Phase 3 Randomized Study Comparing Talquetamab in Combination with Pomalidomide (Tal-P), Talquetamab in Combination with Teclistamab (Tal-Tec), and Investigator's Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants with Relapsed or Refractory Myeloma who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide

Date Added
April 30th, 2025
PRO Number
Pro00141089
Researcher
Kimberly Green

List of Studies

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

This is a randomized, Phase 3, active-controlled, parallel, multicenter, interventional, open-label study in participants with relapsed or refractory multiple myeloma who have received 1 to 4 prior lines of therapyincluding an anti-CD38 mAb and lenalidomide.An IRC will be commissioned to adjudicate participants' response to treatment and disease progression.An IDMC will be commissioned to review safety periodically and efficacy at prespecified interim analysis
timepoints.The study will include a Screening Phase, a Treatment Phase, and a Follow-up Phase. The Screening Phase will be up to 28 days before randomization. The Treatment Phase will extend from C1D1 until confirmed disease progression, death, intolerable toxicity, withdrawal of consent, or discontinuation of all study treatment (whichever occurs first). Participants can continue therapy with talquetamab/teclistamab (as appropriate) for up to 26cycles if they have no sign of PD or toxicity. Following the Treatment Phase, participants will continue in the Follow-up Phase until death, withdrawal of consent, loss to
follow-up, orend of the study, whichever occurs first. The EOS is considered as completion of the final OS analysis, which will occur after approximately 311 death events for each comparison.

Institution
MUSC
Recruitment Contact
Shanta Salzer
(843)792-9300
salzers@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 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

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



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