Mobile Health Reaction Time and Behavior Study

Date Added
September 3rd, 2024
PRO Number
Pro00138757
Researcher
Austin Hahn

List of Studies

Keywords
Alcohol
Summary

This study tests a mobile app that aims to reduce alcohol use and risky sexual behavior.

Interested individuals will complete an online screener to see if they are eligible. Eligible participants will complete six mobile sessions over the course of about 45 days.

The first and the last session will be completed via video conference with a member of the research staff. The second through fifth sessions are completed independently on the mobile app. Sessions involve survey questionnaires, clinical interviews, and computerized tasks. Participants will be compensated for completed study sessions.

Institution
MUSC
Recruitment Contact
Amy Boatright
843-779-2552
boatrigh@musc.edu

Group Parenting Program for Managing Disruptive Behavior in Young Children

Date Added
September 8th, 2024
PRO Number
Pro00138994
Researcher
Rosmary Ros-Demarize

List of Studies


Keywords
ADD/ADHD, Autism, Pediatrics
Summary

The purpose of this research is to assess a group-based telehealth parenting program for child ages 2-6 years old with a neurodevelopmental diagnosis and behavior problems. Families will complete an online intake assessment, 6 group-based telehealth PCIT sessions, and an online post intervention assessment. Families will be compensated for their time.

Institution
MUSC
Recruitment Contact
Alexandra Marsden
843-714-1352
autismresearch@musc.edu

Product Surveillance Registry

Date Added
September 9th, 2024
PRO Number
Pro00119849
Researcher
Venkateshwar Gottipaty

List of Studies

Keywords
Cardiovascular, Coronary Artery Disease, Heart
Summary

There may be at least 15,000 people who are part of this registry at any one time. The device has already been cleared or approved by the U.S. Food and Drug Administration ("FDA"). The registry is not an experimental clinical study.

Institution
MUSC Heart and Vascular Institute
Recruitment Contact
Jacqueline Sheriod-Scott
8032552927
sheriods@musc.edu

A Phase 3, Multicenter, Randomized, Double-blind, Single-dose Study to Evaluate the Efficacy and Safety of ZILRETTA in Participants with Glenohumeral Osteoarthritis.

Date Added
September 10th, 2024
PRO Number
Pro00134950
Researcher
Josef Eichinger

List of Studies


Keywords
Arthritis, Bone, Drug Studies, Pain
Summary

The purpose of this study is to evaluate the safety and efficacy of the study drug ZILRETTA (Triamcinolone Acetonide, extended release) compared to a placebo (saline solution). The study drug is administered through an ultrasound-guided injection to the affected shoulder. 66.6 percent of participants will receive Zilretta and 33 percent will receive placebo.
The study Drug ZILRETTA, is currently FDA-approved for knee osteoarthritis and is being investigated in this study for treatment of shoulder osteoarthritis. The study population consists of adults 50-80 years of age who have been diagnosed with Osteoarthritis of the shoulder by x-ray. The study has 9 study visits over 24-week's and will include, but is not limited to a questionnaire, medical examination, shoulder x-ray and blood draws. Each visit should last less than 1 hour, depending on the procedures performed. The most common side effects of the study drug are joint pain, headaches, upper respiratory infections, back pain, joint swelling, and cold symptoms.

Institution
MUSC
Recruitment Contact
Robert Reis
8437925025
reisb@musc.edu

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study of Acoramidis for Transthyretin Amyloidosis Prevention in the Young (ACT-EARLY Trial)

Date Added
September 10th, 2024
PRO Number
Pro00138908
Researcher
Jan Griffin

List of Studies

Keywords
Heart
Summary

The purpose of this study is to evaluate the safety and effectiveness of acoramidis (AG-10) and determine if it can help people with the genetic TTR variant that can cause ATTR-CM. The sponsor (Eidos) is conducting a research study to see if the study medicine will help in slowing the development and/or progression of a rare disease called Symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-CM). AG-10 is an investigational drug. "Investigational" means that AG-10 is not yet approved for use in any settings outside of clinical research studies like this one and is considered experimental. Cardiomyopathy is a disease of the heart muscle that makes it harder for the heart to pump blood to the rest of the body. AG-10 has been shown to reduce the level of TTR in the blood of animals and healthy volunteers tested to date. Reducing the amount of TTR in your blood may reduce the amount of amyloid deposits in your body and may keep your cardiomyopathy from getting worse over time.

If you meet the requirements and agree to participate in this study, you will go through a 2 part screening period and if approved you will begin treatment. You will be randomized, like flipping a coin, to drug or placebo and take two pills once every day for 60 months.
Your participation in this study will last up to 60 month and will consist of clinic visits and follow up visits at home via the telephone. Some tests requires of you will include an echo, ECG, cardioradionuclide scans (scans that use radioactive agents to look at images of the heart like a PET scan), MRIs, blood tests, nerve conduction test, urine samples, and skin biopsies.

Institution
MUSC
Recruitment Contact
Elhaam Borhanian
8437925873
borhania@musc.edu

A Phase 1/2, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of SNDX-5613 in Combination with Intensive Chemotherapy in Participants with Newly Diagnosed Acute Myeloid Leukemias Harboring Alterations in Lysine-specific Methyltransferase 2A (KMT2A/MLL), Nucleophosmin 1 (NPM1), and Nucleoporin 98 (NUP98) Genes

Date Added
September 12th, 2024
PRO Number
Pro00136971
Researcher
Praneeth Baratam

List of Studies

Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This is a is a Phase 1, open-label, dose-escalation, and dose-expansion multicenter study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and clinical activity of SNDX-5613 in combination with intensive chemotherapy in participants with newly diagnosed Acute Myeloid Leukemias harboring alterations in KMT2A, NPM1, or NUP98 genes. The primary purpose of this study is to identify the maximum tolerated dose of SNDX-5613 (Revumenib) to be used in both a combination with intensive chemotherapy and alone. SNDX-5613 (Revumenib) is an "investigational" (not yet FDA approved) treatment. The study will enroll approximately 76 patients in 3 phases with each receiving cycles of chemotherapy followed by SNDX-5613 in the Induction and Consolidation phases followed by SNDX-5613 alone in the Maintenance Monotherapy phase if eligible. The study includes screening, treatment, safety follow-up, and survival follow-up periods over the course of 18 months. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit in participating in this study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

A Research Study to Advance the CF Therapeutics Pipeline for People without Modulators

Date Added
September 18th, 2024
PRO Number
Pro00139279
Researcher
Patrick Flume

List of Studies


Keywords
Cystic Fibrosis
Summary

This is a prospective, longitudinal, multicenter, nonrandomized observational study to obtain research quality data across key outcome measures in people with Cystic Fibrosis who are ineligible and/or not taking a approved CFTR modulator and who are not receiving an investigational therapy.

Participants will be seen at study sites for research visits to include spirometry, patient reported outcomes (PROs), and blood collections on Day 0, Day 90 (3 months), Day 180 (6 months), and Day 360 (12 months). Participants will complete home spirometry as well during this period.

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

Adapting and Piloting the Managing Emotions to Reduce Alcohol-Facilitated Aggression (MERA-A) Intervention among Veterans

Date Added
October 1st, 2024
PRO Number
Pro00139264
Researcher
Julianne Flanagan

List of Studies


Keywords
Alcohol
Summary

Rates of heavy episodic drinking (HED) among military veterans are almost double that of the general population. Veterans also experience more serious negative health consequences of HED, including high-risk behaviors such as aggression. Research shows there is a link between HED and aggression. However, no programs exist to reduce alcohol-related aggression among veterans. The purpose of this study is to examine the feasibility and acceptability of adapting a current therapy - Managing Emotions to Reduce Aggression (MERA) - to include alcohol-focused Motivational Interviewing plus Feedback (MIF). We will use a brief, four session protocol that includes an hour of talk therapy, plus completion of surveys at each of the four sessions.

Institution
MUSC
Recruitment Contact
Stacey Sellers
843-792-5807
sellersst@musc.edu

A Phase III, Randomized, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared with Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients with Heart Failure and Impaired Kidney Function

Date Added
October 8th, 2024
PRO Number
Pro00138745
Researcher
Vishal Rao

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart, Kidney
Summary

We are doing this study to learn more about how effective, safe and tolerable an experimental drug called balcinrenone is when used in combination with dapagliflozin for treating patients with heart failure and impaired kidney function and also to better understand the studied disease and associated health problems. Dapagliflozin is an approved drug to treat patients with heart failure, chronic kidney disease and type 2 diabetes mellitus.

Institution
MUSC
Recruitment Contact
Lauren Wakefield
843-876-5049
wakefila@musc.edu

A Phase 3, Open-label, Efficacy-Assessor-Blinded Study, Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Children from 2 to Less than 12 Years of Age with Moderate to Severe Atopic Dermatitis (START UP)

Date Added
October 9th, 2024
PRO Number
Pro00138750
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This study is being conducted at approximately 150 research centers worldwide and is expected to enroll approximately 675 pediatric subjects in total with moderately to severely AD. This study will have 2 cohorts, a Randomized Cohort, and a Dupilumab-Inadequate Responder / Dupilumab Medically Inadvisable Cohort. The study comprises a 35-day Screening Period; a 16-week, open-label, efficacy assessor blinded study treatment period for the subjects in the randomized cohort; an open-label period up to Week 160 for subjects in the upadacitinib study treatment arms across both cohorts (Randomized Cohort and Dupi-IR/Dupilumab Medically Inadvisable Cohort); an open label period up to Week 52 for subjects in the dupilumab arm; and a 30-day Follow up Visit/call after the last dose is administered for upadacitinib or dupilumab.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-9784
rowle@musc.edu



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