ACCORD: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalised Patients: A structured summary of a study protocol for a randomised controlled trial
AbstractObjectivesStage 1: To evaluate the safety and efficacy of candidate agents as add-on therapies to standard of care (SoC) in patients hospitalised with COVID-19 in a screening stage.Stage 2: To confirm the efficacy of candidate agents selected on the basis of evidence from Stage 1 in patients hospitalised with COVID-19 in an expansion stage.Trial designACCORD is a seamless, Phase 2, adaptive, randomised controlled platform study, designed to rapidly test candidate agents in the treatment of COVID-19. Designed as a master protocol with each candidate agent being included via its own sub-protocol, initially randomisin...
Source: Trials - July 31, 2020 Category: Research Source Type: clinical trials
RECOVERY- Respiratory Support: Respiratory Strategies for patients with suspected or proven COVID-19 respiratory failure; Continuous Positive Airway Pressure, High-flow Nasal Oxygen, and standard care: A structured summary of a study protocol for a randomised controlled trial
AbstractObjectiveThe trial objective is to determine if Continuous Positive Airway Pressure (CPAP) or High-Flow Nasal Oxygen (HFNO) is clinically effective compared to standard oxygen therapy in patients with confirmed or suspected COVID-19.Trial designAdaptive (group-sequential), parallel group, pragmatic, superiority randomised controlled, open-label, multi-centre, effectiveness trial.ParticipantsThe trial is being conducted across approximately 60 hospitals across England, Wales, Scotland, and Northern Ireland. Inpatients at participating hospitals are eligible to participate if they have respiratory failure with suspec...
Source: Trials - July 29, 2020 Category: Research Source Type: clinical trials
AGILE-ACCORD: A Randomized, Multicentre, Seamless, Adaptive Phase I/II Platform Study to Determine the Optimal Dose, Safety and Efficacy of Multiple Candidate Agents for the Treatment of COVID-19: A structured summary of a study protocol for a randomised platform trial
AbstractObjectivesPhase I - To determine the optimal dose of each candidate (or combination of candidates) entered into the platform.Phase II - To determine the efficacy and safety of each candidate entered into the platform, compared to the current Standard of Care (SoC), and recommend whether it should be evaluated further in a later phase II& III platforms.Trial designAGILE-ACCORD is a Bayesian multicentre, multi-arm, multi-dose, multi-stage open-label, adaptive, seamless phase I/II randomised platform trial to determine the optimal dose, activity and safety of multiple candidate agents for the treatment of COVID-19...
Source: Trials - June 19, 2020 Category: Research Source Type: clinical trials
The smoking cessation in pregnancy incentives trial (CPIT): study protocol for a phase III randomised controlled trial
AbstractBackgroundEighty per cent of UK women have at least one baby, making pregnancy an opportunity to help women stop smoking before their health is irreparably compromised. Smoking cessation during pregnancy helps protect infants from miscarriage, still birth, low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. UK national guidelines highlight lack of evidence for effectiveness of financial incentives to help pregnant smokers quit. This includes a research recommendation: within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smo...
Source: Trials - February 14, 2020 Category: Research Source Type: clinical trials
Nasal Airway Obstruction Study (NAIROS): a phase III, open-label, mixed-methods, multicentre randomised controlled trial of septoplasty versus medical management of a septal deviation with nasal obstruction
DiscussionThe NAIROS trial will evaluate the clinical effectiveness and cost-effectiveness of septoplasty versus medical management for adults with a deviated septum and symptoms of nasal blockage. Identifying those individuals most likely to benefit from surgery should enable more efficient and effective clinical decision-making, and avoid unnecessary operations where there is low likelihood of patient benefit.Trial registrationEudraCT: 2017 –000893-12, ISRCTN:16168569. Registered on 24 March 2017. (Source: Trials)
Source: Trials - February 13, 2020 Category: Research Source Type: clinical trials
Rugby Fans in Training New Zealand (RUFIT-NZ): protocol for a randomized controlled trial to assess the effectiveness and cost-effectiveness of a healthy lifestyle program for overweight men delivered through professional rugby clubs in New Zealand
The objective of this trial is to determine the effectiveness and cost-effectiveness of the Rugby Fans in Training New Zealand (RUFIT-NZ) pro gram.MethodsA pragmatic, two-arm, multi-center, randomized controlled trial involving 308 overweight and obese men aged 30 –65 years, randomized to either an intervention group (n = 154) or a wait-list control group (n = 154). The intervention-group participated in the 12-week RUFIT-NZ program, a gender-sensitized, healthy lifestyle intervention adapted to the environment and cultural diversity of NZ and delivered through professional rugby clubs....
Source: Trials - February 4, 2020 Category: Research Source Type: clinical trials
Clinician –researchers and custodians of scarce resources: a qualitative study of health professionals’ views on barriers to the involvement of teenagers and young adults in cancer trials
ConclusionsNeither lack of individual equipoise nor experiences of traditional forms of role conflict accounted for the low levels of involvement of TYA with cancer in clinical trials. However, prominent tensions around the management of scarce resources provided an alternative explanation for TYA ’s limited access to cancer trials. The prevailing approach to decision-making about whether and which trials to support was recognised as contributing to inequalities in access and care. Professionals’ choices, however, were made in the context of scarcity, and structured by incentives and sanc tions understood by th...
Source: Trials - January 10, 2020 Category: Research Source Type: clinical trials
A systematic review identifying common data items in neonatal trials and assessing their completeness in routinely recorded United Kingdom national neonatal data
ConclusionHigh-impact neonatal clinical trials share common data items. In the United Kingdom, these items can be obtained at a high level of completeness from routinely recorded data held in the NNRD. The feasibility and efficiency using routinely recorded EPR data, such as that held in the NNRD, for clinical trials, rather than collecting these items anew, should be examined.Trial registrationPROSPERO registration numberCRD42016046138. Registered prospectively on 17 August 2016. (Source: Trials)
Source: Trials - December 16, 2019 Category: Research Source Type: clinical trials
A multicentre parallel-group randomised trial assessing multiparametric MRI characterisation and image-guided biopsy of prostate in men suspected of having prostate cancer: MULTIPROS study protocol
DiscussionThe primary objective is to determine whether mpMRI can improve PCa detection and characterisation. The key secondary objective is to determine whether MRI/US fusion-guided biopsy can reduce the number of false-negative biopsies. Ethical approval was obtained from the East of Scotland Research Ethics Committee 1 (14/ES/1070) on 20 November 2014. The results of this study will be used for publication and presentation in national and international journals and at scientific conferences.Trial registrationClinicalTrials.gov,NCT02745496. Retrospectively registered on 20 April 2016. (Source: Trials)
Source: Trials - November 21, 2019 Category: Research Source Type: clinical trials
Effect of the SCOT-HEART 2 Trial on Lifestyle.
Conditions: Coronary Artery Disease; Primary Prevention Intervention: Other: Delivery of CT scan results Sponsors: University of Edinburgh; British Heart Foundation; NHS Lothian Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - November 7, 2019 Category: Research Source Type: clinical trials
Labelled Carbon Sucrose Breath Test (13C-SBT) as a Marker of Environmental Enteropathy
Conditions: Glucose-Galactose Malabsorption; Enteropathy; Malnutrition, Child; Intestinal Permeability; Linear Growth Failure Intervention: Sponsors: University of Virginia; International Atomic Energy Agency; Flinders University; International Centre for Diarrhoeal Disease Research, Bangladesh; St. John's Research Institute; The University of The West Indies; Mmust Masinde Muliro University of Science and Tech nology; Asociaci&oacut...
Source: ClinicalTrials.gov - September 30, 2019 Category: Research Source Type: clinical trials
Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: study protocol for a randomised controlled trial
DiscussionThe population we aim to recruit are traditionally referred to as “hard to reach”, therefore we will monitor referrals received from maternity and social care pathways and will be open to innovation to boost referral rates. We will set geographically acceptable group locations for participants, to limit challenges we foresee for group participation and retenti on. We anticipate the results of the trial will help inform policy and practice in supporting women with additional health and social care needs during antenatal and early postnatal periods. This is currently a high priority for the Scottish and...
Source: Trials - August 14, 2019 Category: Research Source Type: clinical trials
Brushing RemInder 4 Good oral HealTh (BRIGHT) trial: does an SMS behaviour change programme with a classroom-based session improve the oral health of young people living in deprived areas? A study protocol of a randomised controlled trial
DiscussionThe findings of the trial have implications for embedding oral health interventions into school curricula guidance produced by national bodies, including departments for education and dental public health and guideline-development organisations.Trial registrationISRCTN registry,ISRCTN12139369. Registered on 10 May 2017. (Source: Trials)
Source: Trials - July 23, 2019 Category: Research Source Type: clinical trials
Antibiotic Review Kit for Hospitals (ARK-Hospital): study protocol for a stepped-wedge cluster-randomised controlled trial
AbstractBackgroundTo ensure patients continue to get early access to antibiotics at admission, while also safely reducing antibiotic use in hospitals, one needs to target the continued need for antibiotics as more diagnostic information becomes available. UK Department of Health guidance promotes an initiative called ‘Start Smart then Focus’: early effective antibiotics followed by active ‘review and revision’ 24–72 h later. However in 2017,
Source: Trials - July 11, 2019 Category: Research Source Type: clinical trials
Achieving Self-Directed Integrated Cancer Aftercare (ASICA) in melanoma: protocol for a randomised patient-focused pilot trial of delivering the ASICA intervention as a means to earlier detection of recurrent and second primary melanoma
This study will determine if a full-scale randomised controlled trial can be undertaken in the UK NHS to provide the high-quality evidence needed to determine the effectiveness of the intervention. ASICA is a pilot study evaluating the effectiveness of the practice of digitally supported TSSE in those affected by melanoma.Trial registrationClinical Trials.gov,NCT03328247. Registered on 1 November 2017. (Source: Trials)
Source: Trials - June 3, 2019 Category: Research Source Type: clinical trials
Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (The SCOT-HEART 2 Trial)
Condition: Cardiovascular Diseases Interventions: Diagnostic Test: Computed tomography coronary angiography; Other: ASSIGN Score Sponsors: University of Edinburgh; British Heart Foundation; NHS Lothian Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - April 18, 2019 Category: Research Source Type: clinical trials
Dietary Nitrate Intake in Vegetarians Compared and Omnivores
Condition: Blood Pressure Interventions: Other: Placebo mouthwash; Other: Chlorhexidine mouthwash Sponsors: University of Plymouth; University of the West of Scotland Completed (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - March 12, 2019 Category: Research Source Type: clinical trials