PCORI 1: Improving Maternal Mental Health & Substance Use Disorder Screening and Treatment

Date Added
November 1st, 2022
PRO Number
Pro00123833
Researcher
Constance Guille

List of Studies


Keywords
Depression, Mental Health, Obstetrics and Gynecology, Post Partum Depression, Pregnancy, Psychiatry, Substance Use, Women's Health
Summary

The purpose of the study is to compare a text message based mental health and substance use screening and referral to treatment program, called Listening to Women and Pregnant and Postpartum People (LTWP), to standard of care in-person mental health and substance use screening to look at rates of treatment attendance and retention in treatment. Participation would involve completing online surveys. You may be eligible to participate if you are age 18-45 years, are pregnant and entering prenatal care in one of MUSC's OB clinics, and attended a prenatal appointment at an MUSC clinic.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Edie Douglas
843-792-5958
douglaed@musc.edu

PCORI 1: Improving Maternal Mental Health & Substance Use Disorder Screening and Treatment

Date Added
November 1st, 2022
PRO Number
Pro00123833
Researcher
Constance Guille

List of Studies


Keywords
Depression, Mental Health, Obstetrics and Gynecology, Post Partum Depression, Pregnancy, Psychiatry, Substance Use, Women's Health
Summary

The purpose of the study is to compare a text message based mental health and substance use screening and referral to treatment program, called Listening to Women and Pregnant and Postpartum People (LTWP), to standard of care in-person mental health and substance use screening to look at rates of treatment attendance and retention in treatment. Participation would involve completing online surveys. You may be eligible to participate if you are age 18-45 years, are pregnant and entering prenatal care in one of MUSC's OB clinics, and attended a prenatal appointment at an MUSC clinic.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Edie Douglas
843-792-5958
douglaed@musc.edu

Standardizing Treatments for Pulmonary Exacerbations: A platform for evaluating treatment decisions to improve outcomes (STOP360)

Date Added
November 22nd, 2022
PRO Number
Pro00124625
Researcher
Christina Mingora

List of Studies

Keywords
Cystic Fibrosis
Summary

The primary objective of this platform trial is to evaluate the efficacy and safety of differing treatments in CF pulmonary exacerbations during a planned 14 day course of IV antimicrobials. Primary efficacy will be evaluated as the difference in mean ppFEV1 (pulmonary function testing) changes from Visit 1 to Visit 2 (Day 28 ± 2 days) between intervention arms. The study will compare treatment of an intravenous aminoglycoside and β-lactams (AG) versus intravenous β-lactams only (non-AG) in people with CF diagnosed with a pulmonary exacerbation who will be treated for Pa.

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

Impact of Disparities in Food Security on Glycemic Control and Health Care Utilization Among Youth and Young Adults with Diabetes 2

Date Added
November 30th, 2022
PRO Number
Pro00124480
Researcher
Angela Liese

List of Studies

Keywords
Diabetes
Summary

This study includes a longitudinal mixed methods study of 360 YYA with diabetes in SC, CO, and WA conducted with SFS 1 participants. SFS 2 will have two parts: (1) an intense, longitudinal study consisting of two 14-day assessment periods spaced 9 months apart which will include CGM, EMA, accelerometry, and surveys in all participants (the EMA study); and (2) a concurrent events qualitative study with a subset of participants (30 T1D, 15 T2D) who will complete 13 one-on-one, semi-structured interviews throughout the 9-month assessment period (the qualitative study).

Institution
USC
Recruitment Contact
Krystal Cooper
803-777-4485
hugheskp@mailbox.sc.edu

ProspEctive, Single ARm, Multi-center Clinical InveStigation to EValuatE the Safety and Effectiveness of AMDS in the TREatment of Acute DeBakey Type I Dissection: PERSEVERE

Date Added
December 8th, 2022
PRO Number
Pro00121704
Researcher
Sanford Zeigler

List of Studies


Keywords
Surgery, Vascular
Summary

The purpose of this research study is to find out if AMDS is safe and effective in the treatment of acute dissection (sudden tear). For patients whose aortic anatomy is suitable for treatment with AMDS, the use of this device may promote healing of the aortic walls and possibly reduce the need for additional aortic surgeries. If conventional surgery, in combination with AMDS, is effective, it is believed that this could lead to improved aortic healing; an improvement in healing could reduce the risk of hospitalization and reoperation in the chest compared to conventional surgery alone.

Institution
MUSC
Recruitment Contact
ShaVon Capers
843-792-7244
caperssh@musc.edu

Measurement-Based Stroke Tele- Occupational Therapy to Improve Community and Home Activity Performance

Date Added
December 15th, 2022
PRO Number
Pro00125524
Researcher
Michelle Woodbury

List of Studies


Keywords
Rehabilitation Studies, Stroke, Stroke Recovery
Summary

This small stroke rehabilitation study will test the feasibility of a new method to personalize a home exercise program for arm/hand recovery. The research study will last ~8 weeks. Participants will be included if they are adults who have experienced a stroke that has caused one arm/hand to become weak, are able to come to the MUSC main campus 3 times for ~2hr arm movement evaluations, and are willing and able to engage in 60 minute telerehabilitation video visits with an occupational therapist 1-2 times per week for 6 weeks. We anticipate that the results of this study will enable occupational therapists and stroke survivors to, together, design home exercise programs that are meaningful, motivating and effective.

Institution
MUSC
Recruitment Contact
Julianne Laura
843-985-1773
roseju@musc.edu

Physical Rehabilitation for Older Patients with Acute Heart Failure with Preserved Ejection Fraction (REHAB-HFpEF)

Date Added
December 29th, 2022
PRO Number
Pro00124781
Researcher
Sheldon Litwin

List of Studies


Keywords
Heart, Rehabilitation Studies
Summary

REHAB-HFpEF is a multicenter, randomized, attention-controlled, single-blind trial to examine the hypothesis that, a novel, tailored, progressive, multi-domain physical rehabilitation intervention administered to older patients with acute decompensated heart failure (ADHF) with preserved ejection fraction (HFpEF) beginning early during hospitalization and continuing for 12 weeks in a structured outpatient setting, and continuing as a maintenance program will reduce the rate of combined all-cause rehospitalization and death at 6 months (the primary outcome), and reduce major mobility disability (MMD) prevalence at 6 months (the secondary outcome). This trial, REHAB-HFpEF, builds upon preliminary studies, including the phase 2 REHAB-HF trial, which suggests this intervention may yield significant benefits for this population which are largely older, frail, and with few evidence-based treatment options.

The study will recruit a total of 880 consenting patients >=60 years old hospitalized with ADHF with HFpEF. Following informed consent and baseline testing, the participants will be randomized in a 1:1 fashion to receive a novel, progressive, multi-domain rehabilitation and exercise training intervention or attention control. The intervention will include strength, balance, endurance, and mobility training and the specific training exercises will be tailored based on participant performance in each of these domains. The intervention will begin as soon as possible after randomization during the hospitalization and will continue 3 times per week in an outpatient setting for 12 weeks. Those randomized to the attention control will be contacted bi-weekly by study staff to maintain contact, collect information regarding health status, clinical events, and physical activity/exercise, and ensure retention; they do not receive any specific exercise recommendations. Both arms will receive all services ordered by their primary physician (usual care) and undergo measures of physical function, cognitive function, and quality of life (QOL).

Institution
MUSC
Recruitment Contact
Renee Baxley
843-792-1105
baxleyr@musc.edu

An Open-label Extension Study of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis

Date Added
January 5th, 2023
PRO Number
Pro00125928
Researcher
Rachana Krishna

List of Studies


Keywords
Interstitial Lung Disease (ILD)
Summary

Following the study Entry Visit, subjects will return at Week 4,
Week 12, and every 12 weeks thereafter. Study visits will continue
for up to 6 years or until the subject prematurely discontinues study
treatment due to an adverse event or other reason, inhaled treprostinil
becomes commercially available for IPF in the region in which the
study is conducted, or the study is discontinued by the Sponsor
(whichever is sooner). Subjects will also be contacted by telephone or
email at least weekly until Week 12 and monthly thereafter in
between study visits to discuss study drug titration, assess study drug
tolerability, monitor adverse event, document changes to concomitant
medications, and remind subjects to bring in all study drug and a
device to their next clinic visit.

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

A Feasibility Study of Peripheral Nerve Stimulation Therapy for Atrial Fibrillation.

Date Added
January 10th, 2023
PRO Number
Pro00125256
Researcher
Rachel Kaplan

List of Studies

Keywords
Heart, Nerve
Summary

This study's objective is to determine if electrical stimulation can safely reduced atrial fibrillation, which is an abnormal heart rhythm that begins in the top chambers of the heart. Electrical stimulation will be delivered to the wrists or in the ear. Participation will last about 6 weeks and require 3 clinic visits. Participants will be asked to wear a heart monitor and patch to monitor the heart rate and rhythm, keep a diary to collect information on atrial fibrillation, undergo randomization (being randomly assigned, like drawing straws) and use the study device per randomization assignment. Participants are randomized in a 1:1:1 fashion to a wrist worn study device, an ear piece study device or a sham wrist worn study device. A sham device looks like the real wrist worn device but does not deliver any electrical stimulation.

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

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency–Associated Liver Disease With METAVIR Stage F2 to F4 Fibrosis

Date Added
January 10th, 2023
PRO Number
Pro00125124
Researcher
Charlie Strange

List of Studies


Keywords
Pulmonary
Summary

This study will evaluate the safety and effectiveness of fazirsiran (investigational drug) compared with placebo (an inactive substance) in patients with alpha-1 antitrypsin deficiency associated liver disease (AATD-LD). If eligible, subjects will be randomized (assigned to a group by chance) to receive either fazirsiran or placebo to be administered subcutaneously (an injection under the skin). Subjects will be treated on Day 1, at Week 4, and then every 12 weeks for 196 weeks. Subjects will be followed for 6 months after their last dose of study drug or placebo for a total study duration of approximately 230 weeks (including 10 weeks of the screening period which is the time needed to assess if a subject is eligible for the study).

Institution
MUSC
Recruitment Contact
Mary Hayden
843-792-8438
blantonm@musc.edu



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