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External data required timely response by the Trial Steering-Data Monitoring Committee for the NALoxone InVEstigation (N-ALIVE) pilot trial
The prison-based N-ALIVE pilot trial had undertaken to notify the Research Ethics Committee and participants if we had reason to believe that the N-ALIVE pilot trial would not proceed to the main trial. In this paper, we...
6 versus 12 months of adjuvant trastuzumab for HER2-positive early breast cancer (PERSEPHONE)
Helena M Earl, Louise Hiller, Anne-Laure Vallier, Shrushma Loi, Karen McAdam, Luke Hughes-Davies, Adrian N Harnett, Mei-Lin Ah-See, Richard Simcock, Daniel Rea, Sanjay Raj, Pamela Woodings, Mark Harries, Donna Howe, Kerry Raynes, Helen B Higgins, Maggie Wilcox, Chris Plummer, Janine Mansi, Ioannis Gounaris, Betania Mahler-Araujo, Elena Provenzano, Anita Chhabra, Jean E Abraham, Carlos Caldas, Peter S Hall, Christopher McCabe, Claire Hulme, David Miles, Andrew M Wardley, David A Cameron, Janet A Dunn, PERSEPHONE Steering Committee and Trial Investigators
Mar 08, 2019
Adult Aged Aged 80 and over Antineoplastic Agents Immunological Breast Neoplasms Chemotherapy Adjuvant Disease-Free Survival Drug Administration Schedule Female Humans Infusions Intravenous Injections Subcutaneous Middle Aged Prospective Studies Receptor ErbB-2 Trastuzumab Treatment Outcome United Kingdom Young Adult
Factorial Structure and Validity of Depression (PHQ-9) and Anxiety (GAD-7) Scales after Traumatic Brain Injury
Ali Teymoori, Anastasia Gorbunova, Fardzadeh E. Haghish, Ruben Real, Marina Zeldovich, Yi-Jhen Wu, Suzanne Polinder, Thomas Asendorf, David Menon, CENTER-TBI Investigators and Participants CENTER-TBI Investigators and Participants, Nicole v. Steinbüchel
Mar 25, 2020
Background: The dimensionality of depression and anxiety instruments have recently been a source of controversy. Objectives and Design: In a European-wide sample of patients after Traumatic Brain Injury (TBI), we aim to examine...
Value of risk scores in the decision to palliate patients with ruptured abdominal aortic aneurysm.
MJ Sweeting, P Ulug, J Roy, R Hultgren, R Indrakusuma, R Balm, MM Thompson, RJ Hinchliffe, SG Thompson, JT Powell, Ruptured Aneurysm Collaborators: AJAX Trial investigators, ECAR Trial investigators, IMPROVE Trial investigators: management committee, STAR Cohort investigators
Mar 12, 2018
Endovascular versus open repair of abdominal aortic aneurysm in 15-years' follow-up of the UK endovascular aneurysm repair trial 1 (EVAR trial 1)
Relationship between islet autoantibody status and the clinical characteristics of children and adults with incident type 1 diabetes in a UK cohort.
Vassiliki Bravis, Akaal Kaur, Helen C Walkey, Ian F Godsland, Shivani Misra, Polly J Bingley, Alistair JK Williams, David B Dunger, Colin M Dayan, Mark Peakman, Nick S Oliver, Desmond G Johnston, Patient Advocate Group and Investigators ADDRESS-2 Management Committee
Jul 30, 2018
OBJECTIVES: To describe the characteristics of children and adults with incident type 1 diabetes in contemporary, multiethnic UK, focusing on differences between the islet autoantibody negative and positive. DESIGN...
Supervising projects you don’t (fully) understand
Strategically important projects involve high stakes, uncertainty, and stakeholder complexity, with contingencies and risks typically surfacing repeatedly as the project evolves. This is challenging not only for the project...
The Positive Choices trial
Ruth Ponsford, Rebecca Meiksin, Elizabeth Allen, GJ Melendez-Torres, Stephen Morris, Catherine Mercer, Rona Campbell, Honor Young, Maria Lohan, Karin Coyle, Chris Bonell
Nov 22, 2021
BACKGROUND: Positive Choices is a whole-school social marketing intervention to promote sexual health among secondary school students. Intervention comprises school health promotion council involving staff and students...
Endovascular Repair of Abdominal Aortic Aneurysm in Patients Physically Ineligible for Open Repair
Michael J Sweeting, Rajesh Patel, Janet T Powell, Roger M Greenhalgh, EVAR Trial Investigators
Dec 06, 2017
OBJECTIVE: The aim of the study was to compare long-term total and aneurysm-related mortality in physically frail patients with abdominal aortic aneurysm (AAA) randomized to either early endovascular aneurysm repair (EVAR) or...
The Positive Choices trial
Ruth Ponsford, Rebecca Meiksin, Elizabeth Allen, GJ Melendez-Torres, Steve Morris, Catherine Mercer, Rona Campbell, Honor Young, Maria Lohan, Karin Coyle, Chris Bonell
Apr 11, 2022
BACKGROUND: Positive Choices is a whole-school social marketing intervention to promote sexual health among secondary school students. Intervention comprises school health promotion council involving staff and students...
ADOLESCENTS Cluster trials Pregnancy Public Health Schools Sexual competence Sexual health Sexually Transmitted Infections Whole-school Adolescent Child Female Health Status Disparities Humans Male Pregnancy Randomized Controlled Trials as Topic School Health Services Schools Sexual health Social Marketing
The Positive Choices trial
Ruth Ponsford, Rebecca Meiksin, Elizabeth Allen, GJ Melendez-Torres, Stephen Morris, Catherine Mercer, Rona Campbell, Honor Young, Maria Lohan, Karin Coyle, Chris Bonell
Jan 07, 2022
BACKGROUND: Positive Choices is a whole-school social marketing intervention to promote sexual health among secondary school students. Intervention comprises school health promotion council involving staff and students...
Editor's Choice - Re-interventions After Repair of Ruptured Abdominal Aortic Aneurysm
Janet T Powell, Michael J Sweeting, Pinar Ulug, Matthew M Thompson, Robert J Hinchliffe, IMPROVE Trial Investigators
May 25, 2018
OBJECTIVE/BACKGROUND: The aim was to describe the re-interventions after endovascular and open repair of rupture, and investigate whether these were associated with aortic morphology. METHODS: In total, 502 patients from the...
Protocol of a randomised controlled trial of real-time continuous glucose monitoring in neonatal intensive care 'REACT'.
Kathryn Beardsall, Lynn Thomson, Catherine Guy, Mirjam M van Weissenbruch, Isabel Iglesias, Priya Muthukumar, Sateesh Kumar Somisetty, Simon Bond, Stavros Petrou, David Dunger, REACT Investigators
Nov 19, 2018
INTRODUCTION: Hyperglycaemia is common in the very preterm infant and has been associated with adverse outcomes. Preventing hyperglycaemia without increasing the risk of hypoglycaemia has proved challenging. The development of...
Rectal cancer management during the COVID-19 pandemic (ReCaP)
RE Clifford, D Harji, L Poynter, R Jackson, R Adams, NS Fearnhead, D Vimalachandran, ReCaP Steering Committee and Collaborators
Jun 07, 2021
Concerns over unacceptable high mortality in patients with rectal cancer undergoing surgery or systemic therapy who contract COVID-19 have led to widespread adoption of alternative treatment strategies.The ReCaP study aimed to...
Combined steering and direct tilt control for the enhancement of narrow tilting vehicle stability
Narrow tilting vehicles offer an opportunity to reduce both traffic congestion and carbon emissions by having a small road footprint, a low weight and a small frontal area. Their narrow track requires that they tilt into corners...
Surveillance arterioveNous fistulAs using ultRasound (SONAR) trial in haemodialysis patients
James Richards, Mohammed Hossain, Dominic Summers, Matthew Slater, Matthew Bartlett, Vasilis Kosmoliaptsis, Edward Cf Wilson, Regin Lagaac, Anna Sidders, Claire Foley, Emma Laing, Valerie Hopkins, Chloe Fitzpatrick-Creamer, Cara Hudson, Helen Thomas, Sam Turner, Andrew Tambyraja, Subash Somalanka, James Hunter, Sam Dutta, Sarah Lawman, Tracey Salter, Mohammed Aslam, Atul Bagul, Rajesh Sivaprakasam, George Smith, Zia Moinuddin, Simon Knight, Paul Gibbs, Reza Motallebzadeh, Nicholas Barnett, Gavin Pettigrew, SONAR trial group
Oct 21, 2019
INTRODUCTION: Arteriovenous fistulas (AVFs) are considered the best and safest modality for providing haemodialysis in patients with end-stage renal disease. Only 20% of UK centres achieve the recommended 80% target for...
Thromboembolic complications in 3,544 patients undergoing radical prostatectomy with or without lymph node dissection.
Stavros I Tyritzis, Anna Wallerstedt, Gunnar Steineck, Tommy Nyberg, Jonas Hugosson, Anders Bjartell, Ulrica Wilderäng, Thordis Thorsteinsdottir, Stefan Carlsson, Johan Stranne, Eva Haglind, Nils Peter Wiklund, LAPPRO Steering Committee
Jun 15, 2018
PURPOSE: Lymph node dissection in patients with prostate cancer may increase complications. An association of lymph node dissection with thromboembolic events was suggested. We compared the incidence and investigated predictors...
Phonotactic steering and representation of directional information in the ascending auditory pathway of a cricket.
Directional hearing is crucial for animals depending on acoustic signals to locate a mate. We focused on crickets to explore the reliability of directional information forwarded to the brain by the ascending auditory interneuron...
Graduated compression stockings as adjuvant to pharmaco-thromboprophylaxis in elective surgical patients (GAPS study)
Joseph Shalhoub, Rebecca Lawton, Jemma Hudson, Christopher Baker, Andrew Bradbury, Karen Dhillon, Tamara Everington, Manjit S Gohel, Zaed Hamady, Beverley J Hunt, Gerrard Stansby, David Warwick, John Norrie, Alun H Davies, GAPS trial investigators
May 15, 2020
OBJECTIVES: To investigate whether the use of graduated compression stockings (GCS) offers any adjuvant benefit when pharmaco-thromboprophylaxis is used for venous thromboembolism prophylaxis in patients undergoing elective...
Dexamethasone for adult patients with a symptomatic chronic subdural haematoma (Dex-CSDH) trial
Angelos G Kolias, Ellie Edlmann, Eric P Thelin, Diederik Bulters, Patrick Holton, Nigel Suttner, Kevin Owusu-Agyemang, Yahia Z Al-Tamimi, Daniel Gatt, Simon Thomson, Ian A Anderson, Oliver Richards, Peter Whitfield, Monica Gherle, Karen Caldwell, Carol Davis-Wilkie, Silvia Tarantino, Garry Barton, Hani J Marcus, Aswin Chari, Paul Brennan, Antonio Belli, Simon Bond, Carole Turner, Lynne Whitehead, Ian Wilkinson, Peter J Hutchinson, British Neurosurgical Trainee Research Collaborative (BNTRC) and Dex-CSDH Trial Collaborators
Feb 07, 2019
BACKGROUND: Chronic subdural haematoma (CSDH) is a common neurosurgical condition, typically treated with surgical drainage of the haematoma. However, surgery is associated with mortality and morbidity, including up to 20%...
chronic subdural haematoma Dexamethasone Neurology Neurosurgery Randomised control trial Cost-Benefit Analysis Dexamethasone Double-Blind Method Drug Administration Schedule Drug Costs Glucocorticoids Hematoma Subdural Chronic Humans Multicenter Studies as Topic Randomized Controlled Trials as Topic Time Factors Treatment Outcome United Kingdom
Combined steering and direct tilt control for the enhancement of narrow tilting vehicle stability
Narrow tilting vehicles offer an opportunity to reduce both traffic congestion and carbon emissions by having a small road footprint, a low weight and a small frontal area. Their narrow track requires that they tilt into corners...
Diffuse Intracranial Injury Patterns Are Associated with Impaired Cerebrovascular Reactivity in Adult Traumatic Brain Injury
Frederick A Zeiler, François Mathieu, Miguel Monteiro, Ben Glocker, Ari Ercole, Erta Beqiri, Manuel Cabeleira, Nino Stocchetti, Peter Smielewski, Marek Czosnyka, Virginia Newcombe, David K Menon, the CENTER-TBI High-Resolution ICU (HR ICU) Sub-Study Participants and Investigators CENTER-TBI High-Resolution ICU (HR ICU) Sub-Study Participants and Investigators
Feb 28, 2020
Recent single-center retrospective analysis displayed the association between admission computed tomography (CT) markers of diffuse intracranial injury and worse cerebrovascular reactivity. The goal of this study was to further...
Multiple Interventions for Diabetic Foot Ulcer Treatment Trial (MIDFUT)
Sarah Brown, Jane Nixon, Myka Ransom, Rachael Gilberts, Nikki Dewhirst, Elizabeth McGinnis, Roberta Longo, Frances Game, Chris Bojke, Paul Chadwick, Akila Chandrasekar, Ian Chetter, Howard Collier, Catherine Fernandez, Shervanthi Homer-Vanniasinkam, Edward Jude, Richard Leigh, Richard Lomas, Peter Vowden, James Wason, Linda Sharples, David Russell
Apr 30, 2020
Introduction: Diabetes affects more than 425 million people worldwide with a lifetime risk of diabetic foot ulcer (DFU) of up to 25%. Management includes wound debridement, wound dressings, offloading, treatment of infection and...
Multiple Interventions for Diabetic Foot Ulcer Treatment Trial (MIDFUT)
Sarah Brown, Jane Nixon, Myka Ransom, Rachael Gilberts, Nikki Dewhirst, Elizabeth McGinnis, Roberta Longo, Frances Game, Chris Bojke, Paul Chadwick, Akila Chandrasekar, Ian Chetter, Howard Collier, Catherine Fernandez, Shervanthi Homer-Vanniasinkam, Edward Jude, Richard Leigh, Richard Lomas, Peter Vowden, James Wason, Linda Sharples, David Russell
May 11, 2020
INTRODUCTION: Diabetes affects more than 425 million people worldwide with a lifetime risk of diabetic foot ulcer (DFU) of up to 25%. Management includes wound debridement, wound dressings, offloading, treatment of infection and...
Clinical Trials DIABETES & ENDOCRINOLOGY Diabetic Foot statistics & research methods wound management Acellular Dermis Adult Clinical Trials Phase II as Topic Clinical Trials Phase III as Topic Cost-Benefit Analysis Debridement Diabetes mellitus Diabetic Foot Humans Multicenter Studies as Topic Negative-Pressure Wound Therapy Quality of life Quality-Adjusted Life Years Randomized Controlled Trials as Topic Skin Transplantation Wound Healing
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