Recruiting

Greenlight Plus Study: A Randomized Study of Approaches to Early Childhood Obesity Prevention

Posted on by Jodi Snare

Study Updated 03/05/2024

Study Website: https://www.greenlight-program.org/
ClinicalTrials.gov#: NCT04042467
Study Design: Interventional
PCORnet Infrastructure: Collaboration, CDM (+ supplemental data), Engagement, Single IRB
Principal Investigator: William Heerman
Site Name: Vanderbilt University Medical Center (VUMC)
PCORnet® Network Partner: STAR
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2018
Study Duration: 2019 – 2024
Participating Clinical Research Networks: INSIGHT, STAR
Therapeutic Area: Mental and Behavioral Health
Condition: Behavior, Health; Child Obesity
Population: up to 21 Days (Child)
Status: Recruiting

Research Question(s):
Does a text-messaging intervention improve healthy weight trajectories among children ages 0-2 compared to a health communication intervention delivered in pediatric primary care clinics?

PANDA – MSD: Predictive Analytics via Networked Distributed Algorithms for Multi – System Diseases

Posted on by Jodi Snare

Study Updated 03/28/2024

Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement
Principal Investigator: Jiang Bian
Site Name: University of Florida and University of Florida Health
PCORnet® Network Partner: OneFlorida+
Funder: NIH
Funding Date: 2022
Study Duration: 2022 – 2026
Participating Clinical Research Networks: OneFlorida+, STAR
Therapeutic Area: Rare Disease
Condition: Granulomatosis with Polyangiitis (GPA); Psoriatic Arthritis (PsA)
Population: 18 Years and older (Adult, Older Adult )
Status: Recruiting

Research Question(s):
Can the use of EHR data develop predictive tools to assist healthcare providers in reaching earlier diagnoses and interventions, and improve the diagnostic journey and clinical outcomes of patients with rare diseases?

Comparative Effectiveness of Palliative Surgery vs Additional Anti-Seizure Medications for Lennox-Gastaut Syndrome

Posted on by Jodi Snare

Study Updated 03/05/2024

ClinicalTrials.gov#: NCT05374824
Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement
Principal Investigator: Sandi Lam
Site Name: Lurie Children’s Hospital
PCORnet® Network Partner: PEDSnet
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Funding Date: 2021
Study Duration: 2022 – 2025
Participating Clinical Research Networks: GPC, OneFlorida+, PaTH, PEDSnet, STAR
Therapeutic Area: Neurosciences
Condition: Lennox Gastaut Syndrome
Population: up to 25 Years (Child,  Adult)
Status: Recruiting

Research Question(s):

  1. Which treatment options are most likely to improve important clinical outcomes in my child (or patient) with LGS?
  2. My child has hundreds of seizures a week, and multiple different drugs have failed to get her seizures under control. What is the best possible next step?

PRECIDENTD – PREvention of CardIovascular and DiabEtic kidNey disease in Type 2 Diabetes

Posted on by Jodi Snare

Study Updated 03/05/2024

Study Website: PRECIDENTD
ClinicalTrials.gov#: NCT05390892
Study Design: Interventional
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: Brendan Everett
Site Name: Brigham and Women’s Hospital
PCORnet® Network Partner: External
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Funding Date: 2021
Study Duration: 2022 – 2028
Participating Clinical Research Networks: GPC, INSIGHT, PaTH, STAR
Therapeutic Area: Cardiovascular
Condition: Type2Diabetes; Atherosclerotic Cardiovascular Disease (ASCVD)
Population: 40 Years to 80 Years (Adult, Older Adult)
Status: Recruiting

Research Question(s):

  1. In patients with type 2 diabetes, are SGLT2 inhibitors or GLP-1 recent agonists better for preventing heart attack, stroke, blood vessel disease, heart failure, kidney disease, and death?
  2. Is combination therapy with both medication classes better than one therapy alone?

Outcomes Database to Prospectively Assess Changing Therapy Landscape in Renal Cell Carcinoma (ODYSSEY RCC)

Posted on by Jodi Snare

Study Updated 03/28/2024

ClinicalTrials.gov#: NCT04919122
Study Design: Prospective Observational
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement
Principal Investigator: Dan George
Site Name: Duke Clinical Research Institute
PCORnet® Network Partner: Coordinating Center
Funder: Exelixis, Bristol Myers Squibb, Merck, Pfizer
Funding Date: 2020
Study Duration: 2022 – 2026
Participating Clinical Research Networks: GPC, PaTH, REACHnet, STAR
Therapeutic Area: Oncology
Condition: Metastatic Renal Cell Carcinoma
Population: 19 Years and older (Adult, Older Adult)
Status: Recruiting

Research Question(s):

Can a research registry of patients with metastatic renal cell carcinoma (mRCC) patients help us better understand cancer management and health-related quality of life while receiving mRCC specific treatment? In combination with patient and physician surveys, PCORnet will be used to help us answer these questions.

ACTIV-6: COVID-19 Study of Repurposed Medications

Posted on by Jodi Snare

Study Updated 03/28/2024

Study Website: The Activ-6 Study
ClinicalTrials.gov#: NCT04885530
Study Design: Interventional
PCORnet Infrastructure: Collaboration, Engagement, Single IRB
Principal Investigator: Adrian Hernandez
Site Name: Duke Clinical Research Institute
PCORnet® Network Partner: Coordinating Center
Funder: NIH
Funding Date: 2021
Study Duration: 2021 – 2024
Participating Clinical Research Networks: GPC, INSIGHT, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Infectious Disease
Condition: COVID-19
Population: 30 Years and older (Adult, Older Adult)
Status: Recruiting

Research Question(s):
Can repurposed medications reduce symptoms of non-hospitalized participants with mild to moderate COVID-19?

Primary Publication(s):
Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19
Naggie S, Boulware DR, Lindsell CJ, et al. Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2022;328(16):1595–1603. doi:10.1001/jama.2022.18590

Effect of Fluvoxamine vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19
McCarthy MW, Naggie S, Boulware DR, et al. Effect of Fluvoxamine vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2023;329(4):296–305. doi:10.1001/jama.2022.24100

Biologic Abatement and Capturing Kids’ Outcomes and Flare Frequency in Juvenile Spondyloarthriti s (BACK-OFF JSpA)

Posted on by Jodi Snare

Study Updated 03/05/2024

Study Website: The BACK-OFF JSpA Study
ClinicalTrials.gov#: NCT04891640
Study Design: Interventional
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: Pamela Weiss
Site Name: The Children’s Hospital of Philadelphia
PCORnet® Network Partner: PEDSnet
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2020
Study Duration: 2021 – 2025
Participating Clinical Research Networks: GPC, PaTH, PEDSnet, STAR
Therapeutic Area: Auto Immune
Condition: Juvenile Spondyloarthritis
Population: 8 Years to 21 Years (Child,  Adult)
Status: Recruiting

Research Question(s):

This trial will compare how patients with inactive spondyloarthritis on tumor necrosis factor inhibitor (TNFi) treatment respond to three treatment options that doctors currently use:

  • Continue standard TNFi medication,
  • Space out the time between usual TNFi medication doses, or
  • Stop the TNFi medication. If we can safely prolong the time between doses or completely take away TNFi therapy in this population, we may remove unnecessary medication exposure, improve patient quality of life, and lower medication costs.

Pragmatic Evaluation of Events and Benefits of Lipid-lowering in Older Adults (PREVENTABLE)

Posted on by Jodi Snare

Study Updated 03/28/2024

Study Website: PREVENTABLE
ClinicalTrials.gov#: NCT04262206
Study Design: Interventional
PCORnet Infrastructure: Collaboration, CDM (+ supplemental data), Engagement, Single IRB
Principal Investigator: Karen Alexander
Site Name: Duke Clinical Research Institute
PCORnet® Network Partner: Coordinating Center
Funder: NIH; (Project webpage)
Funding Date: 2019
Study Duration: 2020 – 2026
Participating Clinical Research Networks: GPC, INSIGHT, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Cardiovascular
Condition: Cognitive Impairment, Mild; Dementia; Cardiovascular Diseases
Population: 75 Years and older (Older Adult)
Status: Recruiting

Research Question(s):
Can a statin help prevent dementia and disability in adults aged 75 or older, as well as heart attacks and other cardiovascular-related deaths, while not increasing risks of adverse health outcomes?

Primary Publication(s):
The PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE) trial: Study design and procedures for cognitive assessment and adjudication
Sachs BC, Rapp SR, Kistler CE, et al. The pragmatic evaluation of events and benefits of lipid-lowering in older adults (PREVENTABLE) trial: study design and procedures for cognitive assessment and adjudication. Alzherimers. Dement., 2021; 17(Supp.9).