Completed trials and studies

An alphabetical list of all completed trials and studies undertaken by the Clinical Trials Research Unit.

Off

A

ACCESS (Methods project)

A collaborative study between CTUs and other researchers to identify the activities needed to improve representation of under-served groups in trials and understand their implementation.

  • Chief investigator: Katie Biggs, University of Sheffield
  • Funding body: NIHR

ACCESS summary

ACE (Methods project)

Adaptive designs CONSORT Extension

  • Chief investigator: Dr. Munya Dimairo, University of Sheffield
  • Funding body: National Institute for Health Research CTU Funding

ACE summary

ACUTE 

 (Use, Treatment Effect and Economics) feasibility study: A pilot randomised controlled trial of prehospital CPAP for acute respiratory failure.

  • Chief investigator: Gordon Fuller, University of Sheffield
  • Funding body: Health Technology Assessment

ACUTE summary

ASPECT

Alleviating Specific Phobias Experienced by Children Trial

  • Chief investigator: Professor Barry Wright, Leeds and York Partnership NHS Foundation Trust
  • Funding body: Health Technology Assessment

ASPECT summary

ASTIClite

Autologous Stem Cell Transplantation In refractory Crohn’s Disease – Low-Intensity Therapy Evaluation

  • Chief investigator: Professor James Lindsay, Bart's Health NHS Trust
  • Funding body: Efficacy and Mechanism Evaluation (EME) Programme

ASTIClite summary


B

BEADS

BEhavioural Activation therapy for Depression after Stroke

  • Chief investigator: Shirley Thomas, Division of Rehabilitation & Ageing, University of Nottingham
  • Funding body: Health Technology Assessment

BEADS summary

Big CACTUS

A study to assess the clinical and cost-effectiveness of aphasia computer treatment versus usual stimulation or attention control long-term post-stroke (CACTUS)

  • Chief investigator: Dr Rebecca Palmer, Rehabilitation and Assistive Technology (RAT) group, ScHARR
  • Funding body: Health Technology Assessment

Big CACTUS summary

Booster Trial

A randomised controlled trial and cost-effectiveness evaluation of 'booster' interventions to sustain increases in physical activity in middle-aged adults in deprived urban neighbourhoods

  • Chief investigator: Professor Liddy Goyder, Public Health, ScHARR
  • Funding body: Health Technology Assessment

Booster Trial summary

BRAINS (Methods project)

Benefit-risk is a methodology used to simultaneously evaluate multiple aspects of a treatment, ie the effectiveness on the primary health outcome, safety and cost.

  • Chief investigator: Professor Steven Julious, University of Sheffield    
  • Funding body: Medical Research Council

BRAINS summary


C

CACTUS 

Computerised assisted language therapy pilot study

  • Chief investigator: Dr Rebecca Palmer, Sheffield Teaching Hospitals
  • Funding body: Research for Patient Benefit

CACTUS summary

CFHealthHub Data Observatory

  • Chief investigator: Dr Martin Wildman, Sheffield Teaching Hospitals
  • Funding body: NIHR Programme Grant for Applied Research

CFHealthHub Data Observatory summary

CFHealthHub RCT

Development and evaluation of an intervention to support adherence to treatment in adults with Cystic Fibrosis

  • Chief investigator: Dr Martin Wildman, Sheffield Teaching Hospitals
  • Funding body: NIHR Programme Grant for Applied Research

CFHealthHub RCT summary

COMMEND

A feasibility study and randomised controlled trial of acceptance and COMmitment therapy for people with Motor nEuroN Disease

  • Chief investigator: Dr Rebecca Gould, University College London
  • Funding body: Health Technology Assessment

View project summary

CoSMoS

CBT Software for the treatment of depression in people with MS

  • Chief investigator: Dr Cindy Cooper, CTRU
  • Funding body: MS Society Symptom Relief Research Initiative

CoSMoS summary


D

DAVROS

Development and validation of risk-adjusted outcomes for systems of emergency medical care

  • Chief investigator: Prof Steve Goodacre, MCRU Emergency & Immediate Care, ScHARR
  • Funding body: Medical Research Council

DIAMOND (Methods project)

Development of generalisable methodology for n-of-1 trials delivery for very low volume treatments.

  • Chief investigator: Liv Hawksworth, Research Assistant, Sheffield Clinical Trials Research Unit)     
  • Funding body: NIHR CTU Support Funding

DIAMOND summary

DiPALS 

A Randomised Controlled Trial Evaluating NeuRx/4 Diaphragm Pacing in Patients with Respiratory Muscle Weakness Due to Motor Neurone Disease

  • Chief investigator: Dr Chris McDermott, Sheffield Institute of Translational Neuroscience
  • Funding body: NIHR Health Technology Assessment

DiPALS summary 

DiPEP

Diagnosis of Pulmonary Embolism in Pregnancy

  • Chief investigator: Prof Steve Goodacre, University of Sheffield
  • Funding body: Health Technology Assessment

DiPEP summary


E

ENACT (Methods project)

EcoNomics of Adaptive Clinical Trials

  • Chief investigator: Laura Flight, University of Sheffield    
  • Funding body: NIHR CTU Support Funding (2019 call)

ENACT summary

The Endometrial Scratch Trial

The Endometrial Scratch Trial

  • Chief investigator: Mostafa Metwally, Sheffield Teaching Hospital
  • Funding body: Health Technology Assessment

Endometrial Scratch summary

Equality, Diversity and Inclusion (EDI) in early phase trials (Methods project)

  • Chief investigator: Mostafa Metwally, Sheffield Teaching Hospital
  • Funding body: Health Technology Assessment

Project summary

E-SEE

Enhancing Social-Emotional Health and Wellbeing in the Early Years: A Community-based Randomised Controlled Trial (and Economic) Evaluation of the Incredible Years Infant and Toddler (0-2) Parenting Programmes

  • Chief investigator: Dr Tracey Bywater, Institute for Effective Education, University of York
  • Funding body: National Institute for Health Research

E-SEE summary


H

HubBLe

Haemorrhoidal Artery Ligation (HAL) versus Rubber Band Ligation (RBL) for haemorrhoids

  • Chief investigator: Steven Brown, Sheffield Teaching Hospitals NHS Foundation Trust
  • Funding body: Health Technology Assessment

HubBLe summary

Hydro-DMD

Hydrotherapy for Duchenne Muscular Dystrophy (DMD): a pilot and feasibility randomised controlled trial in children

  • Chief investigator: Dr Peter Baxter, Sheffield Children's NHS Foundation Trust
  • Funding body: Health Technology Assessment

HydroDMD summary


I

I-Socialise

Investigating SOcial Competence and Isolation in children with Autism taking part in LEGO-based therapy clubs In School Environments

  • Chief investigator: Prof Barry Wright, University of York
  • Funding body: NIHR Public Health Research Programme

I-Socialise summary


J

JtD: Journeying Through Dementia

  • Chief investigator: Professor Gail Mountain, University of Bradford
  • Funding body: Health Technology Assessment

JtD summary


L

Learning from COVID-19 Efficient Trial Adaptations (Methods project)

  • Chief investigator: Robin Chatters, University of Sheffield    
  • Funding body: NIHR CTU Support Funding

Trial summary

Lifestyle Matters

  • Chief investigator: Professor Gail Mountain, ScHARR, The University of Sheffield
  • Funding body: Medical Research Council

Lifestyle Matters summary


M

MAGIC

Melatonin for Anxiety prior to General anaesthesia In Children

  • Chief investigator: Professor Chris Deery, School of Clinical Dentistry
  • Funding body: Health Technology Assessment

MAGIC summary

MATTS

Major Trauma Triage Tool Study

  • Chief investigator: Gordon Fuller, University of Sheffield
  • Funding body: Health Technology Assessment

View project summary

MERIDIAN

Magnetic Resonance Imaging to Enhance the Diagnosis of Fetal Development Brain Abnormalities In Utero

  • Chief investigator: Professor Paul Griffiths, Academic Unit of Radiology, The University of Sheffield
  • Funding body: NIHR Health Technology Assessment

MERIDIAN summary

MG 

(3MG - Magnesium sulphate for treatment of severe acute asthma).

  • Chief investigator: Professor Steve Goodacre, MCRU Emergency & Immediate Care
  • Funding body: Health Technology Assessment

3MG summary

MSS3

Multiple Symptoms Study 3: Pragmatic trial of a community-based clinic for patients with persistent (medically unexplained) physical symptoms

  • Chief investigator: Professor Chris Burton, Academic Unit of Primary Medical Care, University of Sheffield
  • Funding body: NIHR Health Services and Delivery Research (NIHR HS&DR) Programme

View project summary


O

OPTION-DM

Optimal Pathway for TreatIng neurOpathic paiN in Diabetes Mellitus trial

  • Chief investigator: Professor Solomon Tesfaye, Sheffield Teaching Hospitals
  • Funding body: NIHR Health Technology Assessment

OPTION-DM summary


P

PANDA (Methods project)

A Practical Adaptive and Novel Designs Toolkit (PANDA)

  • Chief investigator: Prof Steve Goodacre, University of Sheffield
  • Funding body: NIHR Health Technology Assessment

PANDA summary

PHEWS

(Pre-Hospital Early Warning scores for Sepsis) Accuracy, impact and cost-effectiveness of pre-hospital clinical early warning scores for adults with suspected sepsis

  • Chief investigator: Prof Steve Goodacre, University of Sheffield
  • Funding body: NIHR Health Technology Assessment

PHEWS summary

PITSTOP

PIlonidal sinus Treatment: STudying the OPtions

  • Chief investigator: Professor Steven Brown, Sheffield Teaching Hospitals
  • Funding body: NIHR Health Technology Assessment

PITSTOP summary

PLEASANT 

Preventing and Lessening Exacerbations of Asthma in School-age children Associated with a New Term

  • Chief investigator: Prof Steven Julious, ScHARR, The University of Sheffield
  • Funding body: NIHR Health Technology Assessment

PLEASANT summary 

PLINY 

(Putting Life in Years): Evaluation of the Comparative Effectiveness and Cost Effectiveness of an Intervention to Promote Mental Wellbeing in Community Living Older People

  • Chief investigator: Prof Gail Mountain, Health Services Research, ScHARR
  • Funding body: NIHR Public Health Research Programme

PLINY summary

PoPSTER

Patient preferences and current Practice for adults with STERoid-resistant ulcerative colitis

  • Chief investigator: Professor Alan Lobo, Sheffield Teaching Hospitals NHS Foundation Trust
  • Funding body: NIHR Health Technology Assessment

PoPSTER summary

PRACTICE

Pulmonary Rehabilitation and ACTIvity after COPD Exacerbations

  • Chief investigator: Dr Rodney Hughes, Sheffield Teaching Hospitals NHS Foundation Trust
  • Funding body: Health Technology Assessment

PRACTICE summary

PRIEST

Pandemic Respiratory Infection Emergency System Triage

  • Chief investigator: Professor Steve Goodacre, University of Sheffield
  • Funding body: NIHR Health Technology Assessment

PRIEST summary


R

REEACT

The randomised evaluation of the effectiveness and acceptability of computerised therapy.

  • Chief investigator: Dr Simon Gilbody, University of York
  • Funding body: Health Technology Assessment

REPOSE

The Relative Effectiveness of Pumps over MDI and Structured Education for Type-1 Diabetes

  • Chief investigator: Professor Simon Heller, School of Medicine, The University of Sheffield
  • Funding body: Health Technology Assessment

REPOSE summary

RHABIT

Recording HArms in Behavioural Change Intervention Trials

  • Chief investigator: Professor Steven Brown, Sheffield Teaching Hospitals
  • Funding body: NIHR Health Technology Assessment (HTA)

View project summary


S

SABRE

Hypertonic Saline in Acute Bronchiolitis: A Randomised Controlled Trial and Economic Evaluation

  • Chief investigator: Kelechi Ugonna, Sheffield Children's Hospital 
  • Funding body: Health Technology Assessment

SABRE summary

STEPWISE

STructured Education for People WIth SchizophrEnia

  • Chief investigator: Professor Richard Holt, University of Southampton
  • Funding body: Health Technology Assessment

STEPWISE summary


T

TABUL

(The role of ultrasound compared to biopsy of temporal arteries in the diagnosis and treatment of giant cell arteritis)

  • Chief investigator: Dr Raashid Luqmani, University of Oxford
  • Funding body: Health Technology Assessment

TABUL summary

TUDCA

Testing the safety and effect of tauroursodeoxycholic acid on disease progression

  • Chief investigator: Professor Chris McDermott, University of Sheffield
  • Funding body: Horizon 2020 Research and Innovation Programme

View project summary


V

VTEAM

Venous Thromboembolism Assessment Model Study: The cost-effectiveness of venous thromboembolism risk assessment tools for hospital inpatients

  • Chief investigator: Prof Steve Goodacre, University of Sheffield
  • Funding body: NIHR Health Technology Assessment

VTEAM summary

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