№ files_lp_4_process_3_128069
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This document is a checklist for reporting a randomised clinical trial, including details on trial design, participants, interventions, statistical methods, and outcomes.
Year:
2018
Region / city:
Dawro zone, southwest Ethiopia
Topic:
Clinical trial reporting
Document type:
Checklist
Organization:
Jimma University, Wolkite University, Dawro Zone Administration
Author:
Unknown
Target audience:
Researchers, trial organizers
Trial period:
January to June 2017
Date of approval:
2018
Date of amendments:
None
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Year:
2023
Region / city:
Melbourne, Australia; Ottawa, Canada; Birmingham, UK; Tours, France; Aurora, Colorado, USA
Theme:
Reporting guidelines, Randomized controlled trials, Medical research
Document type:
Report
Organization:
Monash University, Ottawa Hospital Research Institute, University of Birmingham, University of Tours, Queen Mary University of London, University of Colorado Anschutz Medical Campus, Duke University, University of Ottawa
Author:
Joanne E McKenzie, Monica Taljaard, Karla Hemming, Sarah J Arnup, Bruno Giraudeau, Sandra Eldridge, Richard Hooper, Brennan C Kahan, Tianjing Li, David Moher, Elizabeth L Turner, Jeremy M Grimshaw, Andrew B Forbes
Target audience:
Researchers, Academics, Medical professionals
Period of validity:
Not specified
Approval date:
Not specified
Date of revisions:
Not specified
Year:
2001
Region / city:
International
Topic:
Clinical Trials, CONSORT Statement
Document type:
Guidelines
Organization / institution:
CONSORT Group
Author:
Moher D, Schulz KF, Altman DG, et al
Target audience:
Researchers, Clinical trial professionals, Medical statisticians
Validity period:
N/A
Approval date:
2001
Date of changes:
N/A
Year:
2025
Region / City:
Global
Topic:
Randomised Trial Reporting
Document Type:
Guideline
Organization / Institution:
CONSORT
Author:
Hopewell S, Chan AW, Collins GS, Hróbjartsson A, Moher D, Schulz KF, et al.
Target Audience:
Researchers, Health professionals, Trial Coordinators
Effective Date:
2025
Date of Approval:
2025
Date of Changes:
N/A
Title:
Supplemental Material: CONSORT Flow Diagrams and Online Self-Regulation Training “Take Control” for Study 1 (Germany) and Study 2 (Ireland)
Language:
English
Type of document:
Supplemental material
Related studies:
Study 1 (Germany); Study 2 (Ireland)
Content components:
CONSORT flow diagrams; storyboard of online training; confirmatory factor analyses; manipulation checks
Training title:
Online Self-Regulation Training: Take Control
Modules:
Module 1 – Working Effectively and Contentedly; Module 2 – Staying Focused – Working Concentrated; Module 3 – Booster Session
Country of Study 1:
Germany
Country of Study 2:
Ireland
Institution mentioned:
Federal Institute for Occupational Safety and Health Germany
Duration of training:
Two weeks
Target group:
Employees engaged in location- and time-flexible work
Format:
Online training program with weekly modules and daily exercises
Year:
1608–1611
Region:
Scotland, England, Denmark
Subject:
Royal wardrobe inventory, court dress, material culture
Document type:
Historical article
Institution:
Cambridge University Library (original inventory)
Author:
Not specified
Intended audience:
Scholars of early modern history and fashion
Key figures:
Anna of Denmark, James VI and I, Frederik II, Sofie of Mecklenburg-Güstrow, Christian IV
Content focus:
Detailed description of royal garments, gift exchange practices, visual diplomacy
Period covered:
Late 16th to early 17th century
Related events:
Marriage of Anna of Denmark to James VI of Scotland (1589), accession to English crown (1603)
Keywords:
wardrobe, inventory, embroidery, lace, portraiture, masque, gift exchange, Jacobean fashion
Year:
2024
Region / City:
N/A
Topic:
Critical Appraisal
Document Type:
Checklist
Organization / Institution:
Critical Appraisal Skills Programme (CASP)
Author:
Critical Appraisal Skills Programme (CASP)
Target Audience:
Healthcare professionals, researchers
Date of Approval:
N/A
Date of Modification:
N/A
Protocol version:
6.0
Date:
18 September 2020
Study name:
rEECur
Study design:
International randomised controlled trial
Medical condition:
Recurrent and primary refractory Ewing sarcoma
Intervention:
Chemotherapy
Sponsor:
University of Birmingham
Sponsor protocol number:
RG_13-277
CRCTU number:
SA2015
EudraCT number:
2014-000259-99
ISRCTN reference number:
ISRCTN36453794
Chief Investigator:
Dr Martin McCabe
Coordinating institution:
Cancer Research UK Clinical Trials Unit, University of Birmingham
Geographic scope:
International
Participating regions:
United Kingdom, Germany, Italy, France, Spain, Scandinavia, Australia, New Zealand, Switzerland
Target population:
Patients with recurrent or primary refractory Ewing sarcoma
Regulatory status:
Ethics and regulatory approval required per participating country
Amendment history:
Substantial amendments between 2014 and 2016
Document type:
Clinical trial protocol
Randomisation method:
Centralised online randomisation
Trial phase:
Phase II (Germany-specific limitation noted)
Year:
2021
Region / city:
Not specified
Topic:
Randomised controlled trials, research appraisal
Document type:
Checklist
Organization / institution:
Critical Appraisal Skills Programme (CASP)
Author:
Not specified
Target audience:
Healthcare professionals, researchers, educators
Period of validity:
Not specified
Approval date:
Not specified
Date of revisions:
16 September 2020
Year:
2023
Region / City:
Not specified
Topic:
Postpartum hypertension, clinical trials, remote monitoring
Document Type:
Research Article
Organization / Institution:
Not specified
Authors:
Adi Hirshberg, Katheryne Downes, Sindhu Srinivas
Target Audience:
Researchers, healthcare professionals
Period of validity:
Not specified
Approval Date:
Not specified
Date of changes:
Not specified
Note:
Year
Year:
2021
Note:
Region / City
Topic:
Randomised Controlled Trial, Health Care
Document Type:
Checklist
Organization / Institution:
Critical Appraisal Skills Programme (CASP)
Author:
CASP
Target Audience:
Healthcare practitioners, researchers, educators
Year:
2021
Region / City:
N/A
Subject:
Critical Appraisal, Randomized Controlled Trial
Document Type:
Checklist
Organization / Institution:
Critical Appraisal Skills Programme (CASP)
Author:
Critical Appraisal Skills Programme
Target Audience:
Healthcare practitioners, researchers
Period of Validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Year:
2021
Region / city:
Global
Topic:
Health research methodology
Document type:
Checklist
Author:
Critical Appraisal Skills Programme (CASP)
Intended audience:
Healthcare practitioners, researchers
Period of validity:
N/A
Approval date:
N/A
Date of updates:
16 September 2020
Year:
2019
Region / City:
Vienna, Europe
Theme:
Colorectal surgery, patient safety, surgical quality improvement
Document type:
Study protocol
Organization / Institution:
European Society of Coloproctology (ESCP)
Authors:
Mary L Venn, James Glasbey, Dmitri Nepogodiev, Elizabeth Li, Ana Minaya-Bravo, Ionut Negoi, Matteo Frasson, Richard Hooper, Charles Knowles, Dion Morton
Target audience:
Surgeons, anaesthetists, operating room staff
Study period:
Multi-phase, ongoing
Ethics approval:
Health Research Authority (HRA), REC reference 19/HRA/5656
Clinical trial registration:
NIHR CRN IRAS ID 272250, ClinicalTrials.gov NCT04270721
Funding:
ESCP and Ethicon (educational grant)
Conflict of interest:
MF consults for Johnson & Johnson Medical N.V.; other authors declare no conflicts
Type of intervention:
Hospital-level education-based quality improvement programme
Primary outcome:
30-day anastomotic leak rate
Year:
2025
Region / City:
UK
Subject:
Constipation, Functional Disorders
Document Type:
Research Study
Organization / Institution:
Not specified
Author:
Wilkinson-Smith V, Scott M, Menys A, et al.
Target Audience:
Healthcare professionals, Researchers
Period of Validity:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2023
Region / city:
Melbourne, Australia; Ottawa, Canada; Birmingham, UK; Tours, France; Aurora, Colorado, USA
Theme:
Reporting guidelines, Randomized controlled trials, Medical research
Document type:
Report
Organization:
Monash University, Ottawa Hospital Research Institute, University of Birmingham, University of Tours, Queen Mary University of London, University of Colorado Anschutz Medical Campus, Duke University, University of Ottawa
Author:
Joanne E McKenzie, Monica Taljaard, Karla Hemming, Sarah J Arnup, Bruno Giraudeau, Sandra Eldridge, Richard Hooper, Brennan C Kahan, Tianjing Li, David Moher, Elizabeth L Turner, Jeremy M Grimshaw, Andrew B Forbes
Target audience:
Researchers, Academics, Medical professionals
Period of validity:
Not specified
Approval date:
Not specified
Date of revisions:
Not specified
Year:
2013
Region / City:
Leeds, Yorkshire and The Humber
Theme:
Clinical trials, Chronic Kidney Disease
Document type:
Research study protocol
Organization:
University of Birmingham Clinical Trials Unit, Hull and East Yorkshire Hospitals NHS Trust
Author:
Prof Sunil Bhandari
Target audience:
Healthcare professionals, nephrologists, researchers
Period of validity:
3 years
Approval date:
2013
Change date:
N/A
Study reference number:
11/30/07
Ethics committee reference:
13/YH/0394
EudraCT number:
2013-003798-82
Sponsor:
Hull and East Yorkshire Hospitals NHS Trust
Funding source:
Efficacy and Mechanism Evaluation (EME) programme, National Institute for Health Research (NIHR), Medical Research Council (MRC)
Note:
Contextual description
Title of research:
Automating patient inhaler technique when using pressurised Metered Dose Inhalers: testing the functionality and impact of the aflo™ digital respiratory management platform in a randomised controlled trial in a primary care setting
Type of document:
Participant information sheet
Study design:
Randomised controlled trial
Setting:
Primary care
Target population:
Children aged 5 years or over with a diagnosis of asthma
Inclusion criteria:
Diagnosis of asthma; confirmed suitable by GP; access to smartphone and WIFI/4G; currently prescribed a spacer; adherence or symptom control issues
Intervention:
aflo™ digital respiratory management platform and inhaler device
Control:
Standard care
Study duration:
24 weeks
Appointments:
Three visits (baseline, 12 weeks, 24 weeks)
Procedures:
Questionnaires; inhaler technique demonstration; blood pressure measurement; lung function test; spirometry data access; blood sample collection
Sample collection:
Up to 8 ml blood at first appointment
Funding body:
Respiratory Analytics Ltd
Ethics approval:
West Midlands - Edgbaston Research Ethics Committee; MHRA
Compensation:
Travel reimbursement and £20 voucher
Data handling:
Anonymised data analysis; GP access to results
Year:
2023
Region / City:
United Kingdom
Topic:
Clinical Trials, Neonatology, Supplementation
Document Type:
Research Protocol
Institution:
University of Oxford
Author:
Julie-Clare Becher, David Quine, Magda Rudnicka, Colette Jacobs, Hilary Cruickshank, Fiona McKeown, Anne Marshall, Alison Wood
Target Audience:
Healthcare professionals, Researchers
Period of Validity:
From study start to 12 months post EDD
Approval Date:
Not specified
Date of Changes:
Not specified
Context:
A research protocol for a clinical trial studying the impact of long-term feed supplementation on developmental outcomes of neonates with hypoxic-ischemic encephalopathy.
Year:
2023
Region / City:
England, Northern Ireland
Topic:
Mental Health, Epilepsy, Psychological Therapy
Document Type:
Clinical Trial Report
Organization:
UCL Great Ormond Street Institute of Child Health
Author:
Sophie D. Bennett, J. Helen Cross, Kashfia Chowdhury, Tamsin Ford, Isobel Heyman, Anna E. Coughtrey, Emma Dalrymple, Sarah Byford, Bruce Chorpita, Peter Fonagy, Rona Moss-Morris, Colin Reilly, Jonathan A. Smith, Terence Stephenson, Sophia Varadkar, James Blackstone, Harriet Quartly, Tyler Hughes, Amy Lewins, Elana Moore, Fahreen Walji, Alice Welch, Emily Whelan, Alice Zacharia, Anais D’Oelsnitz, Mariam Shah, Laila Xu, Aikaterini Vezyroglou, Kirsten Mitchell, Isabella E. Nizza, Poushali Ganguli, Roz Shafran
Target Audience:
Researchers, Clinicians, Policy Makers, Families
Period of Action:
August 2019 – February 2022
Approval Date:
Not specified
Date of Changes:
Not specified
Summary:
Randomised controlled trial assessing the effectiveness of the Mental Health Intervention for Children with Epilepsy (MICE) in treating mental health difficulties in children and young people with epilepsy, alongside usual care.