Building a Repository of Cardiac Phase Signals for Algorithm Development Recruiting Mostly Female Subjects

Date Added
September 10th, 2019
PRO Number
Pro00088809
Researcher
Thomas Todoran

List of Studies


Keywords
Cardiovascular
Summary

The purpose of this study is to build a repository of heart signals from eligible subjects. The experimental part of this study is the collection of the participant's heart signals using a device similar to a heart monitor called the Phase Signal Acquisition System. The signals will be electronically sent to a storage center, then compared to the results of the participant's heart catheterization and saved for future research and development activities sponsored by Analytics 4 Life. The study will include up to 2500 participants at up to 20 research sites in the United States and will require approximately one hour of the subject's time. There are no follow-up visits.

Institution
MUSC
Recruitment Contact
Anthony Awkar
7928526
awkar@musc.edu

Protocol for the Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial

Date Added
October 16th, 2019
PRO Number
Pro00093020
Researcher
Thomas Curran

List of Studies


Keywords
Digestive System, Inflammation, Surgery
Summary

The goal of the COSMID (Comparison of Surgery and Medicine on the Impact of Diverticulitis) trial is to determine if elective colectomy is more effective than best medical management for patients with quality of life-limiting diverticular disease. The COSMID trial focuses on both patient-reported outcomes and clinical outcomes that matter to patients. The results are expected to establish an evidence-based approach to the care of millions of patients per year in the United States and help people impacted by this common condition make more informed treatment decisions.

Institution
MUSC
Recruitment Contact
Kandace Taylor
843-792-7082
taylokan@musc.edu

RETHINK REFLUX Registry Research to further inform thinking about the role of LINX for Ref lux Disease

Date Added
November 17th, 2020
PRO Number
Pro00105721
Researcher
Jeffrey Thomas

List of Studies

Keywords
Digestive System, Esophagus, Stomach
Summary

It is well understood that gastroesophageal reflux disease (GERD) is a serious health condition.1 GERD, which often manifests as heartburn or regurgitation, is a chronic disorder associated with substantial morbidity and has a major adverse impact on patients quality of life.2, 3 Currently, there are limited options for GERD patients seeking a surgical option to treat their disease. One option for anti-reflux surgery is the LINX® Reflux Management System.4 The RETHINK REFLUX Registry (Research to further inform thinking about the role of LINX for Reflux Disease) will monitor long-term outcomes in the areas of safety, effectiveness, health economics and healthcare utilization over 10 years post-LINX surgery.

Institution
Self Regional Healthcare
Recruitment Contact
Heather Rich
864-943-2416
heather.rich@selfregional.org

A Prospective, Single-arm, Multi-center, Open-label Trial Evaluating the Continuous Application of Prevena™ Therapy for up to 14 days

Date Added
April 20th, 2023
PRO Number
Pro00124286
Researcher
Thomas Curran

List of Studies


Keywords
Surgery
Summary

The purpose of this study is to demonstrate that the continuous use of negative pressure dressings for up to 14 days has similar benefits and risks to the continuous use for up to 7 days. The 3M study product being used in this study includes the PREVENA Plus Incision Management System with PREVENA Dressings (Peel & Place, Customizable and ARTHRO●FORM). The study product is considered investigational because it has not been approved by the FDA for continuous use for up to 14 days. It is currently approved for use for up to 7 days.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
(843) 792-8896
(843) 792-8896

Characterization of barriers and facilitators of guideline concordant extended venous thromboembolism prophylaxis after major cancer surgery

Date Added
July 26th, 2023
PRO Number
Pro00127734
Researcher
Thomas Curran

List of Studies


Keywords
Bowel, Cancer/Gastrointestinal, Surgery
Summary

While blood clots after major cancer surgery are common and harmful to patients, the medications available to decrease blood clot risk are seldom used despite the recommendation of multiple professional medical societies. The reasons why these medications are seldom prescribed is not well understood. We aim to characterize barriers and facilitators to extended blood clot prophylaxis guideline adherence as perceived by stakeholders via interviews with a diverse group of patients and surgeons at hospitals within the MUSC Health system that routinely perform cancer surgery. These findings will inform educational interventions to improve the use of guideline concordant care and mitigate observed disparities in cancer care.

Institution
MUSC
Recruitment Contact
Natalie Koren
843-792-0109
korenn@musc.edu

Characterization of barriers and facilitators of guideline concordant extended venous thromboembolism prophylaxis after major cancer surgery

Date Added
July 26th, 2023
PRO Number
Pro00127734
Researcher
Thomas Curran

List of Studies


Keywords
Bowel, Cancer/Gastrointestinal, Surgery
Summary

While blood clots after major cancer surgery are common and harmful to patients, the medications available to decrease blood clot risk are seldom used despite the recommendation of multiple professional medical societies. The reasons why these medications are seldom prescribed is not well understood. We aim to characterize barriers and facilitators to extended blood clot prophylaxis guideline adherence as perceived by stakeholders via interviews with a diverse group of patients and surgeons at hospitals within the MUSC Health system that routinely perform cancer surgery. These findings will inform educational interventions to improve the use of guideline concordant care and mitigate observed disparities in cancer care.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Natalie Koren
843-792-0109
korenn@musc.edu

Characterization of barriers and facilitators of guideline concordant extended venous thromboembolism prophylaxis after major cancer surgery

Date Added
July 26th, 2023
PRO Number
Pro00127734
Researcher
Thomas Curran

List of Studies


Keywords
Bowel, Cancer/Gastrointestinal, Surgery
Summary

While blood clots after major cancer surgery are common and harmful to patients, the medications available to decrease blood clot risk are seldom used despite the recommendation of multiple professional medical societies. The reasons why these medications are seldom prescribed is not well understood. We aim to characterize barriers and facilitators to extended blood clot prophylaxis guideline adherence as perceived by stakeholders via interviews with a diverse group of patients and surgeons at hospitals within the MUSC Health system that routinely perform cancer surgery. These findings will inform educational interventions to improve the use of guideline concordant care and mitigate observed disparities in cancer care.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Natalie Koren
843-792-0109
korenn@musc.edu

Pulmonary Artery Denervation Clinical Study using the Gradient Denervation System in Heart Failure Patients with Pulmonary Hypertension Group 2

Date Added
March 26th, 2024
PRO Number
Pro00135798
Researcher
Thomas Todoran

List of Studies


Keywords
Cardiovascular, Heart, Pulmonary Hypertension
Summary

This study is for patients who have heart failure with pulmonary hypertension. Heart failure means that the heart cannot pump blood as well as normal. Pulmonary hypertension happens when the pressure in the blood vessels leading from the heart to the lungs is too high, blood flowing through the lungs is limited, and the pressure in the lungs increases when you are physically active, causing symptoms of shortness of breath and tiredness.

The study uses the Gradient device to see if can help treat heart failure with pulmonary hypertension. This device and therapy is still investigational, which means it is currently not approved by a regulatory agency (such as U.S Food and Drug Administration) for regular hospital use and it includes only individuals who choose to take part. Risks in this study include those for standard cardiac catheterization techniques and the administration of anesthesia including allergic reactions, low blood pressure, skin rash, or difficulty breathing; however, all of the risks may not be known. The study will last approximately 3 years and includes the following visits: Baseline/Screening, Procedure, Discharge, 1 month, 6 months and visits annually for 3 years. Study related procedures include a physical exam, blood testing, 6 minute walk test, echocardiogram, CT scan and a Right heart catheterization.

Institution
MUSC
Recruitment Contact
Anthony Awkar
843 876-5009
awkar@musc.edu

A Two-Part Multicenter, Double-Blind, Randomized Placebo-Controlled Study to Evaluate Efficacy and Safety and the Maintenance of Effect of 20-mg Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients with Major Depressive Disorder with Insomnia Symptoms

Date Added
August 9th, 2024
PRO Number
Pro00138340
Researcher
Thomas Uhde

List of Studies


Keywords
Depression, Sleep Disorders
Summary

This Study will assess whether 20 mg of seltorexant compared with placebo as adjunctive therapy to an SSRI/SNRI antidepressant improves depressive symptoms in participants with MDD and insomnia who have had an inadequate response to current SSRI/SNRI antidepressant therapy.

Institution
MUSC
Recruitment Contact
Matthew Woodson
8437925428
woodsonm@musc.edu

A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjunctive Aticaprant Plus an Antidepressant for Relapse Prevention in Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia

Date Added
September 18th, 2024
PRO Number
Pro00138636
Researcher
Thomas Uhde

List of Studies


Keywords
Depression, Mental Health
Summary

This study will assess an adjunctive treatment for major depressive disorder (MDD) called Aticaprant. Adults with MDD that are currently on an antidepressant but continue to experience prominent anhedonia may qualify.

Institution
MUSC
Recruitment Contact
Matthew Woodson
8437925428
woodsonm@musc.edu



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