Leicester Clinical Trials Unit

Publications

The publications below are presented in date order with the latest at the top.

Paper: Connectivity-guided intermittent theta burst versus repetitive transcranial magnetic stimulation for treatment-resistant depression: a randomized controlled trial
Journal: Nature Medicine
Year of publication: 2024

Paper: Progressing the understanding of chronic illness and it's treatment: A post-human, ethological understanding of Haemodialysis
Journal: Sage Journal
Year of publication: 2023

Paper: The NightLife study — the clinical and cost-effectiveness of thrice-weekly, extended, in-centre nocturnal haemodialysis versus daytime haemodialysis using a mixed methods approach: study protocol for a randomised controlled trial
Journal: BMC
Year of publication: 2023

Paper: Non-COVID-19 UK clinical trials and the COVID-19 pandemic: impact, challenges and possible solutions
Journal: Trials
Year of publication: 2023

Paper: Reducing the carbon footprint of research: experience from the NightLife Study
Journal: BMJ Open
Year of publication: 2023

Paper: Biographical dialectics: The ongoing and creative problem solving required to negotiate the biographical disruption of chronic illness
Journal: Social Science & Medicine
Year of publication: 2023

Paper: Comparing research recruitment strategies to prospectively identify patients presenting with breathlessness in primary care
Journal: NPJ Primary Care Respiratory Medicine
Year of publication: 2022

Paper: Effectiveness of an intervention for reducing sitting time and improving health in office workers: three arm cluster randomised controlled trial
Journal: BMJ
Year of publication: 2022

Paper: Very early invasive angiography versus standard of care in higher-risk non-ST elevation myocardial infarction: study protocol for the prospective multicentre randomised controlled RAPID N-STEMI trial. 
Journal: BMJ Open
Year of publication: 2022

Paper: Atezolizumab and bevacizumab in patients with relapsed mesothelioma: MIST4—a phase IIa trial with cellular and molecular correlates of efficacy
Journal: ASCO Abstract
Year of publication: 2022

Paper: Connectivity-Guided Theta Burst Transcranial Magnetic Stimulation Versus Repetitive Transcranial Magnetic Stimulation for Treatment-Resistant Moderate to Severe Depression: Magnetic Resonance Imaging Protocol and SARS-CoV-2–Induced Changes for a Randomized Double-blind Controlled Trial.
Journal: Journal of Medical Internet Research
Year of publication: 2022

Paper: Resting-state functional connectivity correlates of anxiety co-morbidity in major depressive disorder.
Journal: Neuroscience and biobehavioural reviews
Year of publication: 2022

Paper: The effectiveness of the Structured Health Intervention For Truckers (SHIFT): A cluster randomised controlled trial (RCT)
Journal: BMC Medicine 
Year of publication: 2022

Paper: Measuring quality of life in trials including patients on hemodialysis: Methodological issues surrounding use of the Kidney Disease Quality of Life Questionnaire. A systematic review.
Journal: Nephrology Dialysis Transplantation (NDT) 
Year of publication: 2022

Paper: The ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation) Randomised Controlled, Feasibility Trial in Older People
Journal: BMJ Open
Year of publication: 2022

Paper: Astegolimab, an anti-ST2, in chronic obstructive pulmonary disease (COPD-ST2OP): a phase 2a, placebo-controlled trial
Journal: The Lancet Respiratory Medicine  
Year of publication: 2022

Paper: Abemaciclib in patients with p16ink4A-deficient mesothelioma (MiST2): a single-arm, open-label, phase 2 trial
Journal: The Lancet Oncology
Year of publication: 2022

Paper: A phase II trial of abemaciclib in patients with p16ink4a negative, relapsed mesothelioma
Journal: ASCO Abstract
Year of publication: 2021

Paper: Breathless and awaiting diagnosis in UK lockdown for COVID-19…We’re stuck
Journal: Primary care respiratory medicine
Year of publication: 2021

Paper: Late Breaking Abstract - Astegolimab, an anti-ST2, in chronic obstructive pulmonary disease - COPD-ST2OP: a phase IIa, placebo-controlled trial
Journal: European Respiratory Journal
Year of publication: 2021

Paper: Feasibility study of a multicentre cluster randomised control trial to investigate the clinical and cost-effectiveness of a structured diagnostic pathway in primary care for chronic breathlessness: protocol paper
Journal: BMJ Open
Year of publication: 2021

Paper: Use of electronic consent and navigating the ethical and governance issues: experience from the NightLife study
Journal: Journal of the American Society of Nephrology 32, 2021: p794
Year of publication: 2021

Paper: Delivering Patient and Public Involvement during the COVID-19 pandemic: experience from the NightLife Study
Journal: Journal of the American Society of Nephrology 32, 2021: p794
Year of publication: 2021

JASN Abstract Supplement PDF.

Paper: Evaluating the clinical experience of a regional in-center nocturnal hemodialysis program: The patient and staff perspective
Journal: Hemodialysis International
Year of publication: 2021

Paper: Rucaparib in patients with BAP1-deficient or BRCA1-deficient mesothelioma (MiST1): an open-label, single-arm, phase 2a clinical trial
Journal: The Lancet
Year of publication: 2021

Paper: MiST1: A phase IIa trial of rucaparib in patients harbouring BAP1/BRCA1 deficient relapsed malignant mesothelioma
Journal: American Society of Clinical Oncology
Year of publication: 2020

Paper: Intravenous sildenafil citrate and post-cardiac surgery acute kidney injury: a double-blind, randomised, placebo-controlled trial
Journal: British Journal of Anaesthesia
Year of publication: 2020

Paper: Connectivity guided theta burst transcranial magnetic stimulation versus repetitive transcranial magnetic stimulation for treatment-resistant moderate to severe depression: study protocol for a randomised double-blind controlled trial (BRIGhTMIND)
Journal: BMJ Open
Year of publication: 2020

Paper: Evaluating and comparing immunostaining and computational methods for spatial profiling of drug response in patient-derived explants
Journal:
Laboratory Investigation
Year of publication:
2020

Paper: It is unprecedented: trial management during the COVID-19 pandemic and beyond
Journal:
Trials
Year of publication:
2020

Paper: Stand Out in Class: restructuring the classroom environment to reduce sitting time – findings from a pilot cluster randomised controlled trial
Journal: International Journal of Behavioral Nutrition and Physical Activity
Year of publication: 2020

Paper: Report of a Delphi exercise to inform the design of a research programme on screening for thoracic aortic disease
Journal: Trials
Year of publication: 2020

Paper: Effects of Low-Energy Diet or Exercise on Cardiovascular Function in Working-Age Adults With Type 2 Diabetes: A Prospective, Randomized, Open-Label, Blinded End Point Trial
Journal: Diabetes Care
Year of publication: 2020

Paper: Rationale and methods for the Exercise for Type 1 Diabetes Education program: a pilot randomized controlled trial of an education program to support adults with type 1 diabetes mellitus (T1DM) to undertake exercise 
Journal: BMJ Open Diabetes Research and Care
Year of publication: 2019

Paper: Molecularly Stratified Umbrella Study, Mesothelioma Stratified Therapy (MiST)
Journal: Trials
Year of publication: 2019

Paper: Are feasibility studies fairly funded? A review of studies conducted in a UKCRC registered Trials Unit
Journal: Trials
Year of publication: 2019

Paper: The benefit of a Lived Experience Advisory Panel (LEAP) in the design and conduct of a clinical trial into depression
Journal: Trials
Year of publication: 2019

Paper: Curcumin Combined with FOLFOX Chemotherapy Is Safe and Tolerable in Patients with Metastatic Colorectal Cancer in a Randomized Phase IIa Trial
Journal: The Journal of Nutrition
Year of publication: 2019

Paper: The Primary-Secondary Care Partnership to Improve Outcomes in Chronic Kidney Disease (PSP-CKD) Study: A Cluster Randomized Trial in Primary Care
Journal: Journal of the American Society of Nephrology
Year of publication: 2019

Paper: ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation) randomised controlled, feasibility in older people trial: a study protocol
Journal: BMJ
Year of publication: 2019

Paper: Development of a group structured education programme to support safe exercise in people with Type 1 diabetes: the EXTOD education programme
Journal: Diabetic Medicine
Year of publication: 2019

Paper: BRIGhTMIND randomised double-blind controlled trial of connectivity guided theta burst transcranial magnetic stimulation versus repetitive transcranial magnetic stimulation for treatment resistant depression: protocol
Journal: Journal of Affective Disorders
Year of publication: 2019

Paper: Radiofrequency ablation compared with argon plasma coagulation after endoscopic resection of high-grade dysplasia or stage T1 adenocarcinoma in Barrett’s esophagus: a randomized pilot study (BRIDE)
Journal: Gastrointestinal Endoscopy
Year of publication: 2019

Paper: Recruitment to and retention of participants to the EXercising for Type 1 Diabetes (EXTOD) Education, pilot randomised controlled trial (RCT) (Poster 208, presented at the Diabetes UK Professional Conference 2019, Liverpool)
Journal: Diabetic Medicine
Year of publication: 2019

Paper: Effect of sildenafil (Revatio) on postcardiac surgery acute kidney injury: a randomised, placebo-controlled clinical trial: the REVAKI-2 trial protocol 
Journal: Openheart
Year of publication: 2018

Paper: Stand Out in Class: restructuring the classroom environment to reduce sedentary behaviour in 9–10-year-olds — study protocol for a pilot cluster randomised controlled trial
Journal: 
Pilot and Feasibility Studies
Year of publication: 2018

Paper: Mental health and well-being in parents of excessively crying infants: Prospective evaluation of a support package
Journal: Child Care Health and Development
Year of publication: 2018

Paper: What are the main inefficiencies in trial conduct: a survey of UKCRC registered clinical trials units in the UK
Journal: Trials
Year of publication: 2018

Paper: Unequal cluster sizes in stepped-wedge cluster randomised trials: a systematic review
Journal: BMJ Open
Year of publication: 2017

Paper: External national validation of the Leicester Self-Assessment score for Type 2 diabetes using data from the English Longitudinal Study of Ageing
Journal: Diabetic Medicine
Year of publication: 2017

Paper: Adjusting trial analyses for continuous stratification variables
Journal: Trials
Year of publication: 2017

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