Advanced Wireless Augmented Reality-Enhanced Exposure Therapy for Posttraumatic Stress Disorder

Date Added
June 4th, 2024
PRO Number
Pro00135785
Researcher
Ronald Acierno

List of Studies

Keywords
Anxiety, Mental Health, Military, Stress Disorders
Summary

The purpose of this study is to get feedback on an existing augmented reality (AR) software developed by researchers at Wayne State University (phase I) and then use the refined software, along with Prolonged Exposure (PE) therapy to treat Veterans and military personnel with posttraumatic stress disorder (PTSD).

AR involves wearing goggles through which you can see the real world, however virtual objects can be added to the environment (for example, like in the popular phone game Pokemon Go).

The technology was originally designed to help first responders, specifically police and firefighters, to overcome their avoidance of normal life situations caused by their trauma experience and PTSD. This includes a crowded party, a grocery store, a police roll call room and a fire station. This technology is now being expanded to include other common scenarios that military personnel and Veterans with PTSD may avoid.

This study will occur in 2 phases. Phase 1 will focus on getting feedback on the AR program from people who have completed PE therapy before to refine the technology. In phase 2, 40 Veterans and military personnel will be randomly selected to receive PTSD therapy + the refined AR technology or PE therapy alone.

This study is open to Veterans and active duty military personnel. All study activities will take place at the Ralph H. Johnson VA Health Care System and surrounding community-based outpatient clinics. This study is not open to civilians/non military personnel at this time.

Institution
MUSC
Recruitment Contact
Stephanie Hart
843-789-6519
zeigls@musc.edu

A prospective trial of varenicline and incentives for e-cigarette cessation in adults who co-use cannabis

Date Added
June 4th, 2024
PRO Number
Pro00136601
Researcher
Erin McClure

List of Studies


Keywords
Smoking, Substance Use
Summary

The purpose of this study is to better understand tobacco outcomes using a commonly prescribed stop smoking medication (varenicline) and financial incentives for adults who also use cannabis. Varenicline is not FDA approved for e-cigarette cessation, but is FDA approved for cigarette cessation. We are also interested in how cannabis/marijuana and tobacco interact during a tobacco quit attempt. All participants will receive e-cigarette cessation treatment for 12 weeks. To qualify, participants must be between the ages of 18-40 and use both tobacco and cannabis. Participants do not need to be interested in quitting cannabis to qualify. This study is being conducted at three sites: the Medical University of South Carolina in Charleston, SC, Behavioral Health Services in Pickens, SC, and MUSC Lancaster

Institution
MUSC
Recruitment Contact
Emma Mandel
843-792-4097 or 843-830-0165
smokingstudy@musc.edu

A prospective trial of varenicline and incentives for e-cigarette cessation in adults who co-use cannabis

Date Added
June 4th, 2024
PRO Number
Pro00136601
Researcher
Erin McClure

List of Studies


Keywords
Smoking, Substance Use
Summary

The purpose of this study is to better understand tobacco outcomes using a commonly prescribed stop smoking medication (varenicline) and financial incentives for adults who also use cannabis. Varenicline is not FDA approved for e-cigarette cessation, but is FDA approved for cigarette cessation. We are also interested in how cannabis/marijuana and tobacco interact during a tobacco quit attempt. All participants will receive e-cigarette cessation treatment for 12 weeks. To qualify, participants must be between the ages of 18-40 and use both tobacco and cannabis. Participants do not need to be interested in quitting cannabis to qualify. This study is being conducted at three sites: the Medical University of South Carolina in Charleston, SC, Behavioral Health Services in Pickens, SC, and MUSC Lancaster

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Emma Mandel
843-792-4097 or 843-830-0165
smokingstudy@musc.edu

Human/Machine Interface: What the HeartMate 3 ® Device Tells Us About the Future

Date Added
June 5th, 2024
PRO Number
Pro00125199
Researcher
Brian Houston

List of Studies


Keywords
Cardiovascular, Heart
Summary

This is a multi-center study that we have been invited to join that will evaluate the LVAD pump function in relation to adverse events. We are the 8th largest implanting center for LVADs in the United States and feel it is important to be a part of this.

Institution
MUSC
Recruitment Contact
Elizabeth Hambright
781-603-5611
hambrige@musc.edu

A Phase 1b/2a Study To Evaluate The Safety Of CMTX-101 In Combination With Inhaled Tobramycin In People With Cystic Fibrosis Chronically Infected With Pseudomonas aeruginosa

Date Added
June 10th, 2024
PRO Number
Pro00137048
Researcher
Patrick Flume

List of Studies


Keywords
Cystic Fibrosis
Summary

This is a double-blind, randomized, placebo-controlled study of CMTX-101 in pwCF who are 18 years of age or older and chronically infected with P. aeruginosa. This study will evaluate the safety and tolerability, PK, immunogenicity, reduction of pulmonary P. aeruginosa burden, and exploratory endpoints of CMTX-101 in up to 41 participants. This study has 2 parts.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Follow-Up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten (CK-3773274) in Hypertrophic Cardiomyopathy (HCM)

Date Added
June 11th, 2024
PRO Number
Pro00137149
Researcher
Jessica Atkins

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart, Men's Health, Women's Health
Summary

This study is for patients with hypertrophic cardiomyopathy (HCM). HCM is a condition where the heart muscle becomes abnormally thickened, which can sometimes block the blood flow out of the heart and results in the heart muscle working harder to pump blood to the body. Participants who have completed participation in a previous HCM study investigating the study drug, called aficamten (CK-3773274), will be eligible to participate in this study.

The study is done to collect long-term safety and tolerability data, including assessments of cardiac structure and function during chronic dosing with aficamten. Aficamten is a tablet taken by mouth. This is an open label study (the participants and study team will know the dose of aficamten taken at any given time). If your screening results show you are eligible to continue in the study, you will visit the research site for the "first dosing day" (Day 1), followed by visits at Weeks 2, 4, 6, 12, then every 12 weeks thereafter. Study related procedures include blood work, echocardiograms (ultrasound test of the heart), electrocardiogram (recording of heart's electrical activity), physical exams, and questionnaires. Risks associated with this study include shortness of breath, nausea, diarrhea, headaches and dizziness.

Institution
MUSC
Recruitment Contact
Cara Breunig
843-792-7519
breunig@musc.edu

A Phase 3b/4 Randomized, Open-label, Efficacy Assessor-Blinded Study, to Evaluate the Efficacy and Safety of Upadacitinib for the Treatment of Adult Subjects with Moderate to Severe Atopic Dermatitis and Inadequate Response to Dupilumab (SWITCH-UP)

Date Added
June 12th, 2024
PRO Number
Pro00137232
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a global, Phase 3b/4, randomized, open-label, efficacy assessor-blinded, multi-center study that will evaluate upadacitinib compared to dupilumab in adult subjects with moderate to severe AD and inadequate response to dupilumab after at least 6 months of current use. The study consists of a 35-day Screening Period; an 8-week randomized, open-label, efficacy assessor blinded treatment period for all participants (Period 1); a 24-week open-label, efficacy assessor-blinded extension period for all participants who finish Period 1 (Period 2) (total duration of Period 1 and Period 2 is 32 weeks); and a 30-day Follow-up visit.

Institution
MUSC
Recruitment Contact
Alyson Winter
843-876-3209
wintera@musc.edu

Prophylactic Intra-Operative Ventricular Arrhythmia Ablation in High-Risk LVAD Candidates (PIVATAL)

Date Added
June 12th, 2024
PRO Number
Pro00132289
Researcher
Arman Kilic

List of Studies

Keywords
Cardiovascular
Summary

The study will evaluate the effect of prophylactic intra-operative ventricular tachyarrhythmia ablation (VTA) at the time of left ventricular assist device (LVAD) implantation on post-implant total recurrent VTA events, after accounting for the competing risk of death, from discharge to an average follow-up of 18 months (with a minimum of 9 months) after LVAD implantation.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
(843) 792-8896
overstrm@musc.edu

Research Evaluating Vagal Excitation and Anatomical Links

Date Added
June 13th, 2024
PRO Number
Pro00136451
Researcher
Mark George

List of Studies


Keywords
Depression, Epilepsy, Mental Health
Summary

This is an NIH sponsored trial across the US where patients who have been or will be implanted with cervical vagus nerve stimulation (VNS) are then tested in a variety of ways to determine the activity of the VNS on different organs in their body. This will involve implantation for those who qualify, and then two trips to the University of Minnesota for more extensive testing. The device, implantation and travel are all at no cost.

Institution
MUSC
Recruitment Contact
Morgan Dancy
843-876-5141
maddoxm@musc.edu

Treatment In Thoracic Aortic Aneurysm: Surgery versus. Surveillance (TITAN:SvS)

Date Added
June 18th, 2024
PRO Number
Pro00129203
Researcher
Sanford Zeigler

List of Studies


Keywords
Cardiovascular
Summary

To undertake the first prospective randomized controlled trial that compares early aortic surgery to aneurysm surveillance.

The purpose of the study is to compare different treatment plans for patients with abnormal aortas. Patients who have an abnormal aorta measuring at least 5.5cm will have surgery to replace the aorta. We do not know, however, whether patients with abnormal aortas that are not quite 5.5cm should have surgery or should be monitored to see if their aorta continues to grow. Therefore, through this registry and interventional study, the hope is to collect more data on which treatment is better for the patient. The interventional group will undergo surgery to repair their abnormal aorta, and the surveillance group will be closely monitored and medically managed per standard of care. Both groups will have data collected from their care and at the end of the study this data will be analyzed. The goal of this study is to determine if performing surgery earlier helps to prevent abnormal aortas below 5.5cm from tearing or bursting.

Institution
MUSC
Recruitment Contact
Hannah Culpepper
8437927244
culpepph@musc.edu



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