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

AWARE-IBD  

Working with patients to redesign hospital services for people with gut conditions like Crohn's Disease and Ulcerative Colitis (together known as Inflammatory Bowel Disease or IBD). 

  • Chief investigator: Prof Alan Lobo, Sheffield Teaching Hospitals NHS Foundation Trust
  • Funding body: The Health Foundation

AWARE-IBD Website


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

DAFNEplus

Developing and trialling the DAFNEplus (Dose for Adjustment for Normal Eating) intervention. A lifelong approach to promote effective self-management in adults with type 1 diabetes

  • Chief investigator: Prof Simon Heller, Sheffield Teaching Hospitals NHS Foundation Trust / University of Sheffield
  • Funding body: NIHR Programme Grants for Applied Research (PGfAR)

DAFNEplus Website

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


F

FIRST

Flexor Injury Rehabilitation Splint Trial

A pragmatic multi-centre randomised control trial (RCT) comparing splints following repair of finger flexor tendons.

  • Chief investigator: Emma Bamford, Hand Therapist, Extended Scope Practitioner, Pulvertaft Hand Centre, Derby
  • Funding body: NIHR Health Technology Assessment (HTA)

FIRST Website


H

HELP Fertility?

What is the clinical and cost-effectiveness of hysteroscopic removal of submucosal fibroids and polyps in women presenting with infertility and recurrent miscarriage?

  • Chief investigator: Mostafa Metwally, Sheffield Teaching Hospitals NHS Foundation Trust
  • Funding body: NIHR Health Technology Assessment (HTA)

HELP Fertility? Website

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

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

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

MIND

MedIcal studeNt mental health stuDy

  • Chief investigator: Elena Sheldon, University of Sheffield
  • Funding body: British Medical Association

MIND Website

MissionEB

Double-blinded placebo control study of Mesenchymal Intravenous Stromal cell Infusions in children with recessive dystrophic Epidermolysis Bullosa (EB).

  • Chief investigator: Dr Anna Martinez, Great Ormond Street Hospital for Children NHS Foundation Trust
  • Funding body: NIHR Efficacy and Mechanism Evaluation (EME) Programme, NHS England and Cure EB

MissionEB Website

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

ORION

RadiO fRequency ablatION for haemorrhoids

  • Chief investigator: Prof Steven Brown, Sheffield Teaching Hospitals NHS Foundation Trust
  • Funding body: NIHR Health Technology Assessment (HTA)

ORION Website


P

PANDA (Methods project)

A Practical Adaptive and Novel Designs Toolkit (PANDA)

  • Chief investigator: Dr Munya Dimairo, University of Sheffield
  • Funding body: NIHR Clinical Trials Unit (CTU) Support Funding

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

PRAISE

Pain Relief After Instrumented Spinal surgEry trial

The PRAISE trial aims to find out if a) standard pain relief,  i.e., morphine through a drip and other painkillers such as paracetamol during surgery, b) injection of opioids into spinal fluid during surgery, or c) ultrasound-guided pain ‘block’ of numbing at the end of surgery is best for pain relief and helping patients to recover after lumbar spine surgery, and whether any of them is better value for money. 

  • Chief investigator: Prof Matthew Wilson, University of Sheffield
  • Funding body: NIHR Health Technology Assessment (HTA)

PRAISE Website

PRAMS

Perinatal Redesign for Accessing Mental Health Services

  • Chief investigator: Dr Kelly Mackenzie, University of Sheffield
  • Funding body: NIHR Three Schools Mental Health Programme

PRAMS Website

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

STOP-OHSS

Shaping and Trialling Outpatient Protocols for Ovarian HyperStimulation Syndrome

  • Chief investigator: Mostafa Metwally, Sheffield Teaching Hospitals NHS Foundation Trust
  • Funding body: NIHR Health Technology Assessment (HTA)

STOP-OHSS Website


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

Centres of excellence

The University's cross-faculty research centres harness our interdisciplinary expertise to solve the world's most pressing challenges.