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The challenge of establishing treatment efficacy for cutaneous vascular manifestations of systemic sclerosis
John D Pauling
Jan 01, 0001
INTRODUCTION: The cutaneous vascular manifestations of systemic sclerosis (SSc) comprise Raynaud's phenomenon, cutaneous ulceration, telangiectasia formation and critical digital ischaemia; each of which are associated with...
Study protocol for a randomised, controlled platform trial estimating the effect of autobiographical Memory Flexibility training (MemFlex) on relapse of recurrent major depressive disorder.
Improving phase II oncology trials using best observed RECIST response as an endpoint by modelling continuous tumour measurements.
In many phase II trials in solid tumours, patients are assessed using endpoints based on the Response Evaluation Criteria in Solid Tumours (RECIST) scale. Often, analyses are based on the response rate. This is the proportion of...
continuous tumour shrinkage endpoints longitudinal model phase II cancer trial Clinical Trials Phase II as Topic Colonic Neoplasms Computer Simulation Disease Progression Endpoint Determination Humans Logistic Models Medical Oncology Neoplasms Randomized Controlled Trials as Topic Research Design Treatment Outcome
The SOFA score-development, utility and challenges of accurate assessment in clinical trials.
The Sequential Organ Failure Assessment or SOFA score was developed to assess the acute morbidity of critical illness at a population level and has been widely validated as a tool for this purpose across a range of healthcare...
Re-formulating Gehan's design as a flexible two-stage single-arm trial.
BACKGROUND: Gehan's two-stage design was historically the design of choice for phase II oncology trials. One of the reasons it is less frequently used today is that it does not allow for a formal test of treatment efficacy, and...
Oral famotidine versus placebo in non-hospitalised patients with COVID-19
Christina M Brennan, Sandeep Nadella, Xiang Zhao, Richard J Dima, Nicole Jordan-Martin, Breanna R Demestichas, Sam O Kleeman, Miriam Ferrer, Eva Carlotta von Gablenz, Nicholas Mourikis, Michael E Rubin, Harsha Adnani, Hassal Lee, Taehoon Ha, Soma Prum, Cheryl B Schleicher, Sharon S Fox, Michael G Ryan, Christina Pili, Gary Goldberg, James M Crawford, Sara Goodwin, Xiaoyue Zhang, Jonathan B Preall, Ana SH Costa, Joseph Conigliaro, Joseph R Masci, Jie Yang, David A Tuveson, Kevin J Tracey, Tobias Janowitz
Mar 14, 2022
OBJECTIVE: We assessed whether famotidine improved inflammation and symptomatic recovery in outpatients with mild to moderate COVID-19. DESIGN: Randomised, double-blind, placebo-controlled, fully remote, phase 2 clinical trial...
Spotlight on landmark oncology trials
The era of precision oncology is marked with prominent successes in the therapy of advanced soft tissue sarcomas, breast cancer, ovarian cancer and haematological neoplasms, among others. Moreover, recent trials of immune...
Complement inhibition in ANCA vasculitis.
David Jayne
Feb 21, 2020
A role for the alternative complement pathway has emerged in the understanding of ANCA vasculitis pathogenesis. Current therapies of ANCA vasculitis are limited by partial efficacy and toxicity and many patients pursue a...
ANCA C5a clinical trial complement Therapy Vasculitis Aniline Compounds Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Antibodies Monoclonal Clinical Trials Phase II as Topic Complement C5a Complement Inactivating Agents Complement Pathway Alternative Humans Neutrophil Activation Nipecotic Acids
Costs and staffing resource requirements for adaptive clinical trials
Nina Wilson, Katie Biggs, Sarah Bowden, Julia Brown, Munyaradzi Dimairo, Laura Flight, Jamie Hall, Anna Hockaday, Thomas Jaki, Rachel Lowe, Caroline Murphy, Philip Pallmann, Mark A. Pilling, Claire Snowdon, Matthew R. Sydes, Sofía S. Villar, Christopher J. Weir, Jessica Welburn, Christina Yap, Rebecca Maier, Helen Hancock, James M. S. Wason
Oct 28, 2021
Abstract: Background: Adaptive designs offer great promise in improving the efficiency and patient-benefit of clinical trials. An important barrier to further increased use is a lack of understanding about which additional...
Bayesian adaptive clinical trial designs for respiratory medicine.
The use of Bayesian adaptive designs for clinical trials has increased in recent years, particularly during the COVID-19 pandemic. Bayesian adaptive designs offer a flexible and efficient framework for conducting clinical trials...
MesoTRAP
Claire Matthews, Carol Freeman, Linda D Sharples, Julia Fox-Rushby, Angela Tod, Nicholas A Maskell, John G Edwards, Aman S Coonar, Pasupathy Sivasothy, Victoria Hughes, Najib M Rahman, David A Waller, Robert Campbell Rintoul
Apr 05, 2019
INTRODUCTION: One of the most debilitating symptoms of malignant pleural mesothelioma (MPM) is dyspnoea caused by pleural effusion. MPM can be complicated by the presence of tumour on the visceral pleura preventing the lung from...
Asbestos Induced Lung Disease Mesothelioma Pleural Disease Thoracic Surgery Adult Catheters Indwelling Clinical Trials Phase III as Topic England Feasibility Studies Female Humans Lung Neoplasms Male Mesothelioma Mesothelioma Malignant Multicenter Studies as Topic Observational Studies as Topic Pilot Projects Pleural Effusion Malignant Pleural Neoplasms Pleurodesis Randomized Controlled Trials as Topic Sample Size Survival Analysis Thoracic Surgery Video-Assisted Treatment Outcome
Ischemia-reperfusion injury in renal transplantation
Renal ischemia-reperfusion injury (IRI) is a significant clinical challenge faced by clinicians perioperatively in kidney transplantation. Recent work has demonstrated the key importance of transmembrane receptors in the injured...
ischemia-reperfusion injury tubular epithelial cells Allografts Basic Helix-Loop-Helix Transcription Factors Clinical Trials Phase II as Topic Epithelial Cells Humans Hypoxia-Inducible Factor 1 Kidney Failure Chronic Kidney Transplantation Kidney Tubules Receptors Lysosphingolipid Reperfusion Injury Signal Transduction Toll-Like Receptors
The use of a risk assessment and decision support tool (CRISP) compared with usual care in general practice to increase risk-stratified colorectal cancer screening
Jennifer G Walker, Finlay Macrae, Ingrid Winship, Jasmeen Oberoi, Sibel Saya, Shakira Milton, Adrian Bickerstaffe, James G Dowty, Richard De Abreu Lourenço, Malcolm Clark, Louise Galloway, George Fishman, Fiona M Walter, Louisa Flander, Patty Chondros, Driss Ait Ouakrim, Marie Pirotta, Lyndal Trevena, Mark A Jenkins, Jon D Emery
Sep 05, 2018
BACKGROUND: Australia and New Zealand have the highest incidence rates of colorectal cancer worldwide. In Australia there is significant unwarranted variation in colorectal cancer screening due to low uptake of the...
colorectal cancer screening Decision support Faecal occult blood test General Practice Precision Medicine Precision screening PRIMARY CARE Risk assessment tool risk-stratified screening Aged Clinical Trials Phase II as Topic Colorectal Neoplasms Decision Support Techniques Early Detection of Cancer Female General Practice Humans Male Middle Aged Multicenter Studies as Topic Predictive Value of Tests Primary Health Care Prognosis Randomized Controlled Trials as Topic Risk Assessment Risk Factors Time Factors Victoria
Comparison of the Journey II bicruciate stabilised (JII-BCS) and GENESIS II total knee arthroplasty for functional ability and motor impairment
Iain McNamara, Valerie Pomeroy, Allan B Clark, Graham Creelman, Celia Whitehouse, J Wells, B Harry, Toby O Smith, Juliet High, Ann Marie Swart, Celia Clarke
Feb 09, 2023
OBJECTIVES: To determine if a newer design of total knee replacement (TKR) (Journey II BCS) produces superior patient-reported outcomes scores and biomechanical outcomes than the older, more established design (Genesis II)....
A Systematic Review And Meta-Analysis of Clinical Trials of Mesenchymal Stem Cell Therapy for Cartilage Repair.
BACKGROUND: Osteoarthritis (OA) is a major global burden creating significant morbidity worldwide. Current curative therapies are expensive, challenging to access and have significant risks, making them infeasible and difficult...
The Edinburgh Consensus
Craig W Ritchie, Tom C Russ, Sube Banerjee, Bob Barber, Andrew Boaden, Nick C Fox, Clive Holmes, Jeremy D Isaacs, Ira Leroi, Simon Lovestone, Matt Norton, John O'Brien, Jim Pearson, Richard Perry, James Pickett, Adam D Waldman, Wai Lup Wong, Martin N Rossor, Alistair Burns
Oct 30, 2017
CONTEXT: This commentary discusses the implications of disease-modifying treatments for Alzheimer's disease which seem likely to appear in the next few years and results from a meeting of British experts in neurodegenerative...
A Bayesian adaptive design for biomarker trials with linked treatments.
James MS Wason, Jean E Abraham, Richard D Baird, Ioannis Gournaris, Anne-Laure Vallier, James D Brenton, Helena M Earl, Adrian P Mander
Oct 15, 2015
Tackling gaps in developing life-changing treatments for dementia.
Rui Mauricio, Caroline Benn, John Davis, Gerry Dawson, Lee A Dawson, Alison Evans, Nick Fox, John Gallacher, Mike Hutton, John Isaac, Declan NC Jones, Lesley Jones, Giovanna Lalli, Vincenzo Libri, Simon Lovestone, Catherine Moody, Wendy Noble, Hugh Perry, James Pickett, David Reynolds, Craig Ritchie, Jonathan D Rohrer, Carol Routledge, James Rowe, Heather Snyder, Tara Spires-Jones, Jina Swartz, Luc Truyen, Paul Whiting, Therapeutics for Dementia Consortium
Jul 12, 2019
Since the G8 dementia summit in 2013, a number of initiatives have been established with the aim of facilitating the discovery of a disease-modifying treatment for dementia by 2025. This report is a summary of the findings 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
GDNF and Parkinson's Disease
Roger A Barker, Anders Björklund, Don M Gash, Alan Whone, Amber Van Laar, Jeffrey H Kordower, Krystof Bankiewicz, Karl Kieburtz, Mart Saarma, Sigrid Booms, Henri J Huttunen, Adrian P Kells, Massimo S Fiandaca, A Jon Stoessl, David Eidelberg, Howard Federoff, Merja H Voutilainen, David T Dexter, Jamie Eberling, Patrik Brundin, Lyndsey Isaacs, Leah Mursaleen, Eros Bresolin, Camille Carroll, Alasdair Coles, Brian Fiske, Helen Matthews, Codrin Lungu, Richard K Wyse, Simon Stott, Anthony E Lang
Jul 17, 2020
The concept of repairing the brain with growth factors has been pursued for many years in a variety of neurodegenerative diseases including primarily Parkinson's disease (PD) using glial cell line-derived neurotrophic factor...
Assessing the impact of COVID-19 on liver cancer management (CERO-19).
Sergio Muñoz-Martínez, Victor Sapena, Alejandro Forner, Jean-Charles Nault, Gonzalo Sapisochin, Lorenza Rimassa, Bruno Sangro, Jordi Bruix, Marco Sanduzzi-Zamparelli, Wacław Hołówko, Mohamed El Kassas, Tudor Mocan, Mohamed Bouattour, Philippe Merle, Frederik JH Hoogwater, Saleh A Alqahtani, Helen L Reeves, David J Pinato, Emmanouil Giorgakis, Tim Meyer, Gerda Elisabeth Villadsen, Henning Wege, Massimiliano Salati, Beatriz Mínguez, Giovan Giuseppe Di Costanzo, Christoph Roderburg, Frank Tacke, María Varela, Peter R Galle, Mario Reis Alvares-da-Silva, Jörg Trojan, John Bridgewater, Giuseppe Cabibbo, Christian Toso, Anja Lachenmayer, Andrea Casadei-Gardini, Hidenori Toyoda, Tom Lüdde, Rosanna Villani, Ana María Matilla Peña, Cassia Regina Guedes Leal, Monica Ronzoni, Manuel Delgado, Christie Perelló, Sonia Pascual, José Luis Lledó, Josepmaria Argemi, Bristi Basu, Leonardo da Fonseca, Juan Acevedo, Alexander R Siebenhüner, Chiara Braconi, Brandon M Meyers, Alessandro Granito, Margarita Sala, Carlos Rodríguez-Lope, Lorraine Blaise, Manuel Romero-Gómez, Federico Piñero, Dhanny Gomez, Vivianne Mello, Rogerio Camargo Pinheiro Alves, Alex França, Fernanda Branco, Giovanni Brandi, Gustavo Pereira, Susanna Coll, Maria Guarino, Carlos Benítez, Maria Margarita Anders, Juan C Bandi, Mercedes Vergara, Mariona Calvo, Markus Peck-Radosavljevic, Ignacio García-Juárez, Vincenzo Cardinale, Mar Lozano, Martina Gambato, Stefano Okolicsanyi, Dalia Morales-Arraez, Alessandra Elvevi, Alberto E Muñoz, Alberto Lué, Massimo Iavarone, Maria Reig
Sep 02, 2021
BACKGROUND & AIMS: The coronavirus disease 2019 (COVID-19) pandemic has posed unprecedented challenges to healthcare systems and it may have heavily impacted patients with liver cancer (LC). Herein, we evaluated whether the...
BCLC Barcelona Clinic Liver Cancer CERO-19 Liver Cancer Outcome in the COVID-19-pandemic Project covid-19 covid-19 Coronavirus disease 2019 Cholangiocarcinoma Clinical Trials ENS-CCA European Network for the Study of Cholangiocarcinoma HCC hepatocellular carcinoma hepatocellular carcinoma LC liver cancer LT liver transplantation Liver Cancer Management Nurses SARS-CoV-2 severe acute respiratory syndrome coronavirus-2 iCCA intrahepatic cholangiocarcinoma
Protocol for a randomised controlled trial investigating an intervention to boost decentering in response to distressing mental experiences during adolescence
Marc P Bennett, Rachel Clare Knight, Darren Dunning, Alan Archer-Boyd, Sarah-Jayne Blakemore, Edwin Dalmaijer, Tamsin Ford, J Mark G Williams, Hannah Clegg, Willem Kuyken, Tierney So, Gemma Wright, Bert Lenaert, Maris Vainre, Peter Watson, MYRIAD team, Tim Dalgleish
May 01, 2022
INTRODUCTION: Decentering describes the ability to voluntarily adopt an objective self-perspective from which to notice internal, typically distressing, stressors (eg, difficult thoughts, memories and feelings). The...
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