№ lp_1_2_40940
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This document provides guidelines for the completion and submission of safety reports for SUSARs, SSIs, and summary reporting in the context of multi-centre applications at Bellberry approved sites.
Note: Year
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The STOP-ACEi Trial: A multi-centre Randomised Controlled Trial of Angiotensin Converting Enzyme inhibitor (ACEi) / Angiotensin Receptor Blocker (ARB) withdrawal in advanced renal disease.
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
Mental Health Intervention for Children with Epilepsy (MICE): A randomised controlled, multi-centre clinical trial evaluating the clinical effectiveness of psychological therapy in addition to usual care compared to assessment-enhanced usual care alone
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.
Topics: SUSARs SSIs Multi-centre