Trials Journal

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Overview

publication venue for

• PReventing Injury in Skilled nursing facilities through optimizing Medications (PRISM), a protocol for a cluster randomized trial to reduce injurious falls in post-acute care..  26:-. 2025
• Engaging English- and Spanish-speaking older adults with and without possible cognitive impairment in advance care planning group visits: protocol for the ENgaging in Advance Care Planning Talks (ENACT) randomized controlled trial..  26:-. 2025
• Sensor-controlled digital game for Native American adults in the Lumbee Tribe with hypertension self-management: study protocol for a randomized controlled trial..  26:-. 2025
• A community health worker-delivered intervention (STEPS) to support chronic pain self-management among older adults in an underserved urban community: protocol for a randomized trial..  26:-. 2025
• Cognitive Level Enhancement through Vision Exams and Refraction (CLEVER): study protocol for a randomised controlled trial..  26:-. 2025
• Agile monitoring dashboard for clinical research studies..  25:-. 2024
• Estimates of intra-cluster correlation coefficients from 2018 USA Medicare data to inform the design of cluster randomized trials in Alzheimer's and related dementias..  25:-. 2024
• Integrating the Memory Support Intervention into the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C): can improving memory for treatment in midlife and older adults improve patient outcomes? Study protocol for a randomized controlled trial..  25:-. 2024
• Hypotension prediction index guided goal-directed therapy to reduce postoperative acute kidney injury during major abdominal surgery: study protocol for a multicenter randomized controlled clinical trial..  25:-. 2024
• Experience with a hybrid recruitment approach of patient-facing web portal screening and subsequent phone and medical record review for a neurosurgical intervention trial for chronic ischemic stroke disability (PISCES III)..  25:-. 2024
• Partnering with social service staff to implement pragmatic clinical trials: an interim analysis of implementation strategies..  24:-. 2023
• Delirium and neuropsychological recovery among emergency general surgery survivors (DANE): study protocol for a randomized controlled trial and collaborative care intervention..  24:-. 2023
• Clinical reasoning in pragmatic trial randomization: a qualitative interview study..  24:-. 2023
• A health-system-embedded deprescribing intervention targeting patients and providers to prevent falls in older adults (STOP-FALLS trial): study protocol for a pragmatic cluster-randomized controlled trial..  24:-. 2023
• TReating Incontinence for Underlying Mental and Physical Health (TRIUMPH): a study protocol for a multicenter, double-blinded, randomized, 3-arm trial to evaluate the multisystem effects of pharmacologic treatment strategies for urgency-predominant urinary incontinence in ambulatory older women..  24:-. 2023
• Effectiveness and cost-effectiveness of a personalised self-management intervention for living with long COVID: protocol for the LISTEN randomised controlled trial..  24:-. 2023
• Emergency department-based, nurse-initiated, serious illness conversation intervention for older adults: a protocol for a randomized controlled trial..  23:-. 2022
• Study in Parkinson's disease of exercise phase 3 (SPARX3): study protocol for a randomized controlled trial..  23:-. 2022
• AZTEC-azithromycin therapy for prevention of chronic lung disease of prematurity: a statistical analysis plan for clinical outcomes..  23:-. 2022
• Protocol for a multi-center randomized controlled trial to evaluate the benefits of exercise incentives and corticosteroid injections in osteoarthritis of the knee (MOVE-OK)..  23:-. 2022
• Favipiravir and/or nitazoxanide: a randomized, double-blind, 2×2 design, placebo-controlled trial of early therapy in COVID-19 in health workers, their household members, and patients treated at IMSS (FANTAZE)..  23:-. 2022
• Decreasing delirium through music listening (DDM) in critically ill, mechanically ventilated older adults in the intensive care unit: a two-arm, parallel-group, randomized clinical trial..  23:-. 2022
• Communication Bridge™-2 (CB2): an NIH Stage 2 randomized control trial of a speech-language intervention for communication impairments in individuals with mild to moderate primary progressive aphasia..  23:-. 2022
• The Project ENABLE Cornerstone randomized controlled trial: study protocol for a lay navigator-led, early palliative care coaching intervention for African American and rural-dwelling advanced cancer family caregivers..  23:-. 2022
• Study protocol for comparing Screening, Brief Intervention, and Referral to Treatment (SBIRT) to referral as usual for depression in African American churches..  23:-. 2022
• Sharing research results with Latina breast cancer survivors who participated in a community-engaged behavioral RCT study: a descriptive cross-sectional survey study..  23:-. 2022
• Update to the study protocol for an implementation-effectiveness trial comparing two education strategies for improving the uptake of noninvasive ventilation in patients with severe COPD exacerbation..  22:-. 2021
• Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA..  22:-. 2021
• Minimally invasive versus open distal pancreatectomy for pancreatic ductal adenocarcinoma (DIPLOMA): study protocol for a randomized controlled trial..  22:-. 2021
• Lifestyle, Exercise and Activity Package for People living with Progressive Multiple Sclerosis (LEAP-MS): adaptions during the COVID-19 pandemic and remote delivery for improved efficiency..  22:-. 2021
• Virtualized clinical studies to assess the natural history and impact of gut microbiome modulation in non-hospitalized patients with mild to moderate COVID-19 a randomized, open-label, prospective study with a parallel group study evaluating the physiologic effects of KB109 on gut microbiota structure and function: a structured summary of a study protocol for a randomized controlled study..  22:-. 2021
• Early antiviral treatment in outpatients with COVID-19 (FLARE): a structured summary of a study protocol for a randomised controlled trial..  22:-. 2021
• Transitional care from skilled nursing facilities to home: study protocol for a stepped wedge cluster randomized trial..  22:-. 2021
• Strategy for addressing research-site overlap in pragmatic clinical trials: lessons learned from the NIH-DOD-VA Pain Management Collaboratory (PMC)..  21:-. 2020
• A technology-enhanced model of care for transitional palliative care versus attention control for adult family caregivers in rural or medically underserved areas: study protocol for a randomized controlled trial..  21:-. 2020
• A tai chi/qigong intervention for older adults living with HIV: a study protocol of an exploratory clinical trial..  21:-. 2020
• Resident-to-resident elder mistreatment (R-REM) intervention for direct care staff in assisted living residences: study protocol for a cluster randomized controlled trial..  21:-. 2020
• Community Tele-pal: A community-developed, culturally based palliative care tele-consult randomized controlled trial for African American and White Rural southern elders with a life-limiting illness..  21:-. 2020
• Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA..  21:-. 2020
• Correction to: Evaluating the effects of the novel GLP-1 analogue liraglutide in Alzheimer's disease: study protocol for a randomised controlled trial (ELAD study)..  21:-. 2020
• A trauma medical home, evaluating collaborative care for the older injured patient: study protocol for a randomized controlled trial..  21:-. 2020
• LIVE@Home.Path-innovating the clinical pathway for home-dwelling people with dementia and their caregivers: study protocol for a mixed-method, stepped-wedge, randomized controlled trial..  21:-. 2020
• Supporting caregivers of veterans with Alzheimer's disease and traumatic brain injury: study protocol for a randomized controlled trial..  21:-. 2020
• Examining the benefits and harms of Alzheimer's disease screening for family members of older adults: study protocol for a randomized controlled trial..  21:-. 2020
• Vitamin D supplementation compared to placebo in people with First Episode psychosis - Neuroprotection Design (DFEND): a protocol for a randomised, double-blind, placebo-controlled, parallel-group trial..  21:-. 2020
• Can selenium deficiency in Malawi be alleviated through consumption of agro-biofortified maize flour? Study protocol for a randomised, double-blind, controlled trial..  20:-. 2019
• A randomized trial of a specialist palliative care intervention for patients undergoing surgery for cancer: rationale and design of the Surgery for Cancer with Option of Palliative Care Expert (SCOPE) Trial..  20:-. 2019
• Overcoming challenges to data quality in the ASPREE clinical trial..  20:-. 2019
• Oleogel-S10 Phase 3 study "EASE" for epidermolysis bullosa: study design and rationale..  20:-. 2019
• Evaluating the effects of the novel GLP-1 analogue liraglutide in Alzheimer's disease: study protocol for a randomised controlled trial (ELAD study)..  20:-. 2019
• Preventing falls among older fallers: study protocol for a two-phase pilot study of the multicomponent LIVE LiFE program..  20:-. 2019
• Supporting breast cancer screening decisions for caregivers of older women with dementia: study protocol for a randomized controlled trial..  19:-. 2018
• Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study..  19:-. 2018
• Adherence to the International Committee of Medical Journal Editors' (ICMJE) prospective registration policy and implications for outcome integrity: a cross-sectional analysis of trials published in high-impact specialty society journals..  19:-. 2018
• Improving Recovery and Outcomes Every Day after the ICU (IMPROVE): study protocol for a randomized controlled trial..  19:-. 2018
• Mobile critical care recovery program (m-CCRP) for acute respiratory failure survivors: study protocol for a randomized controlled trial..  19:-. 2018
• Combined Cognitive-Behavioural and Physiotherapeutic Therapy for Patients with Chronic Pelvic Pain Syndrome (COMBI-CPPS): study protocol for a controlled feasibility trial..  19:-. 2018
• Decreasing Delirium through Music (DDM) in critically ill, mechanically ventilated patients in the intensive care unit: study protocol for a pilot randomized controlled trial..  18:-. 2017
• Development of an infant feeding core outcome set for childhood obesity interventions: study protocol..  18:-. 2017
• Perceived barriers and facilitators to Risk Based Monitoring in academic-led clinical trials: a mixed methods study..  18:-. 2017
• Association of the FDA Amendment Act with trial registration, publication, and outcome reporting..  18:-. 2017
• HELP! Problems in executing a pragmatic, randomized, stepped wedge trial on the Hospital Elder Life Program to prevent delirium in older patients..  18:-. 2017
• A randomised controlled trial of calcium channel blockade (CCB) with Amlodipine For the treatment oF subcortical ischaEmic vasCular demenTia (AFFECT): study protocol..  17:-. 2016
• Participation of the elderly, women, and minorities in pivotal trials supporting 2011-2013 U.S. Food and Drug Administration approvals..  -. 2016
• Characterisation of trials where marketing purposes have been influential in study design: a descriptive study..  -. 2016
• Use of PRECIS ratings in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory..  -. 2016
• Prevention of delirium (POD) for older people in hospital: study protocol for a randomised controlled feasibility trial..  -. 2015
• Online parent-targeted cognitive-behavioural therapy intervention to improve quality of life in families of young cancer survivors: study protocol for a randomised controlled trial..  -. 2015
• Predictors of clinical trial data sharing: exploratory analysis of a cross-sectional survey..  -. 2014
• The Indiana University Cognitive Health Outcomes Investigation of the Comparative Effectiveness of dementia screening (CHOICE) study: study protocol for a randomized controlled trial..  -. 2014
• Medication adherence and tolerability of Alzheimer's disease medications: study protocol for a randomized controlled trial..  -. 2013
• Effectiveness and neural mechanisms associated with tDCS delivered to premotor cortex in stroke rehabilitation: study protocol for a randomized controlled trial..  -. 2013
• Improving delirium care in the intensive care unit: the design of a pragmatic study..  -. 2011
• Study protocol for the recreational stimulation for elders as a vehicle to resolve delirium superimposed on dementia (Reserve For DSD) trial..  -. 2011
• Development of an infant feeding core outcome set for childhood obesity interventions: Study protocol 2017
• Development of an infant feeding core outcome set for childhood obesity interventions: study protocol 2017
• Perceived barriers and facilitators to Risk Based Monitoring in academic-led clinical trials: A mixed methods study 2017
• Perceived barriers and facilitators to Risk Based Monitoring in academic-led clinical trials: a mixed methods study 2017

Identity

International Standard Serial Number (ISSN)

• 1745-6215