Repository of Phase Signals for Pulmonary Hypertension Algorithm Development

Date Added
September 10th, 2019
PRO Number
Pro00089125
Researcher
Thomas Todoran

List of Studies


Keywords
Cardiovascular
Summary

The purpose of this study is to build a repository (collection) of heart signals from eligible subjects. The experimental part of this study is the collection of 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 and paired with the subject's heart catheterization results for future use in research and development activities sponsored by Analytics 4 Life. The study will include up to 1500 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

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

Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of TU-100 as an Adjunct to an Enhanced Recovery after Surgery (ERAS) Protocol in Subjects Undergoing Bowel Resection

Date Added
May 4th, 2021
PRO Number
Pro00105858
Researcher
Thomas Curran

List of Studies


Keywords
Digestive System, Surgery
Summary

This study is testing a traditional Japanese medicine called Daikenchuto (TU-100) for restoring gastrointestinal function after bowel resection surgery. Subjects will be randomized to either TU-100 or placebo for up to 10 days after surgery and will be followed for 30 days after surgery.

Institution
MUSC
Recruitment Contact
Caitlin Schaffner
843-792-7558
schaffne@musc.edu

A Study to Assess the Long-term Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects with Narcolepsy

Date Added
February 14th, 2022
PRO Number
Pro00116774
Researcher
Thomas Uhde

List of Studies


Keywords
Sleep Disorders
Summary

The study is designed to look at the usefulness and safety of AXS-12 or placebo for the treatment of Narcolepsy. The open-label treatment period is 24 weeks, which will be followed by a double-blind treatment period of 4 weeks, for a total of up to 28 weeks with 13 visits. Narcolepsy is a chronic sleep disorder characterized by overwhelming daytime drowsiness and sudden attacks of sleep. Study staff nor the participants will know if they are receiving a study drug or placebo. Participants will be male or female subjects 15-75 years old with a diagnosis of narcolepsy. Study drug will be administered as a pill.

Institution
MUSC
Recruitment Contact
Richard Simmons
8437927439
simmr@musc.edu

PEERLESS Study

Date Added
September 13th, 2022
PRO Number
Pro00121998
Researcher
Thomas Todoran

List of Studies


Keywords
Blood Disorders, Lung
Summary

This study is for participants who have been diagnosed with a pulmonary embolism or PE. A PE is a blood clot in the lung. This study is comparing the FlowTriever Retrieval/Aspiration System to any commercially available Catheter Directed Thrombolysis system in participants who have a PE and undergo a procedure to remove the clot. Participants will be randomized which means they will be randomly assigned like the flip of a coin to have the procedure done wit the the FlowTriever system or a CDT system. All of the devices being used in this study are FDA approved for this indication. This study involves collecting data from the time of diagnosis through 30 days post procedure. Study participation will last about 30 days.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843.792.2944
adamsde@musc.edu

A Phase 2, Placebo-Controlled, Double-Blind, Randomized Withdrawal Study to Determine the Safety and Efficacy of Oral SDX in Patients with Idiopathic Hypersomnia (IH)

Date Added
April 5th, 2023
PRO Number
Pro00127155
Researcher
Thomas Uhde

List of Studies


Keywords
Sleep Disorders
Summary

The current study will investigate the safety, efficacy and pharmacokinetics of serdexmethylphenidate (SDX) compared to placebo in subjects with Idiopathic Hypersomnia (IH). The study may inform about the best dosing regimen, optimal dose range, duration of treatment, and secondary endpoints for a future Phase 3 study.

Institution
MUSC
Recruitment Contact
Richard Simmons
843-792-7439
simmr@MUSC.edu

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



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