A Qualitative Investigation of Patient, Family, and Provider Treatment Preferences in PTSD and Alcohol Use Disorder

Date Added
April 1st, 2025
PRO Number
Pro00142158
Researcher
Sarah Giff

List of Studies

Keywords
Alcohol, Anxiety, Military, Psychiatry, Stress Disorders, Substance Use
Summary

Co-occurring post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) disproportionately affects Veterans and has significant negative impacts on the safety, wellbeing, and quality of life of Veterans, their romantic partners, and their families. However, treatments that address co-occurring PTSD-AUD and restore Veterans' psychosocial functioning are lacking. This project is designed to learn more to facilitate improving treatment approaches aimed at reducing symptoms of co-occurring PTSD-AUD and improving functioning among Veterans and their partners. The goal of this project is to learn from Veterans, family members, and treatment providers in order to inform an adaptation of a brief dyadic AUD intervention to be delivered alongside integrated PTSD-AUD treatment for Veteran couples.

Institution
MUSC
Recruitment Contact
Sarah Giff
(843) 792-5569
giff@Musc.edu

A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects with Metastatic Castration-Resistant Prostate Cancer

Date Added
April 2nd, 2025
PRO Number
Pro00142948
Researcher
Theodore Gourdin

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health
Summary

This study is for patients that have been diagnosed with metastatic castration-resistant prostate cancer. The study is testing an investigational drug called JANX007. Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of the study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of JANX007 when administered as a single agent. The drug is given to participants by IV infusion. Participants in this study can expect to be in this study until disease progression or unacceptable toxicity.

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

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 Forrester
843-876-5037
drain@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

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

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

Ablation-index Guided Scar-Mediated Ventricular Tachycardia Ablation in Patients with Ischemic Cardiomyopathy (AIM-VT) - A Prospective Single-Blinded, Multicenter Randomized Controlled Trial

Date Added
May 27th, 2025
PRO Number
Pro00143262
Researcher
Chau Vo

List of Studies

Keywords
Heart
Summary

This study is enrolling subjects who are undergoing a planned radiofrequency catheter ablation (RFCA) to treat ventricular tachycardia (VT). VT is a type of irregular heart rhythm originating from the lower chambers of the heart and is commonly treated with RFCA. During a catheter ablation procedure, flexible tubes are guided through blood vessels in your heart where the location of the source of your abnormal arrhythmia is identified. One of the flexible catheters, called an ablation catheter, is then used to deliver energy from its tip to burn the areas of abnormal tissue within the scar which may be causing the ventricular tachycardias. The ablation procedure utilized in this study will be guided by an Ablation Index; a formula developed to assist physicians performing ablation procedures to guide the duration of applications of radiofrequency energy delivery. Participants will be randomized into the control group, where the study doctor will utilize traditional, non-AI guided ablation, or the intervention group, where the study doctor will utilize AI-guided ablation.

This study will last up to 1 year post-ablation procedure for participants and will include up to 4 visits (ablation procedure and 3 follow-up standard of care follow-up visits). Study procedures include the initial, planned ablation procedure, and collection of medical history and images.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@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



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