National Health Service (NHS) Clinical Trials This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of oesophageal varices: study protocol for a randomised controlled trial
DiscussionThe BOPPP trial aims to investigate the clinical and cost-effectiveness of carvedilol in patients with cirrhosis and small oesophageal varices to determine whether this non-selective beta-blocker can prevent or reduce hepatic decompensation. There is clinical equipoise on whether intervening in cirrhosis, at an earlier stage of portal hypertension, with NSBB therapy is beneficial. Should the trial yield a positive result, we anticipate that the administration and use of carvedilol will become widespread with pathways developed to standardise the administration of the medication in primary care.Ethics and dissemin...
Source: Trials - April 16, 2024 Category: Research Source Type: clinical trials

Navigating uncharted territory with a borrowed map: lessons from setting up the BATH-OUT-2 randomised controlled trial in adult social care and housing services in English local authorities
AbstractPopulations around the world are rapidly ageing and more people are living with multiple long-term conditions. There is an urgent need for evidence about high quality, cost-effective, and integrated systems of health and social care. Health research funders are now also prioritising research in adult social care and wider local authority settings, e.g. housing services.Developing the evidence base for adult social care should include implementing randomised controlled trials, where appropriate. Within the UK, the clinical trial is the established road map for evaluating interventions in the National Health Service ...
Source: Trials - March 25, 2024 Category: Research Source Type: clinical trials

A cluster-randomized study to evaluate the effectiveness and cost-effectiveness of the Assessment of Burden of Chronic Conditions (ABCC) tool in South Tyrolean primary care for patients with COPD, asthma, type 2 diabetes, and heart failure: the ABCC South Tyrol study
This study aims to validate the German and Italian versions of the ABCC tool and evaluate its effectiveness and cost-effectiveness in the South Tyrolean Primary Care setting.MethodsThis is a cluster-randomized study involving approximately 400 patients with COPD, asthma, type 2 diabetes, and heart failure who received care from the South Tyrolean General Practices. Initially, the ABCC tool will be translated into German and Italian and validated. Subsequently, half of the participants will use the validated ABCC tool for patient-reported outcome measurement assessments, while the other half will receive usual care. The pri...
Source: Trials - March 20, 2024 Category: Research Source Type: clinical trials

The IMPROVE trial: study protocol for a pragmatic cluster randomised controlled trial to assess the effectiveness of using lay health workers to improve uptake and completion of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease
DiscussionImproving outcomes for chronic obstructive pulmonary disease and access to PR are priorities for the UK National Health Service (NHS) in its long-term plan. The trial hypothesis is that volunteer PR buddies, who are recruited and trained by local PR teams, are an effective and cost-effective way to improve the uptake and completion rates of PR. The trial is pragmatic, since it will test whether the intervention can be incorporated into NHS PR services. Information obtained in this trial may be used to influence policy on the use of PR buddies in PR and other similar services in the NHS.Trial registrationISRCTN126...
Source: Trials - March 19, 2024 Category: Research Source Type: clinical trials

A Retrospective Chart Review to Investigate Clinical Remission in Patients With Severe Asthma Treated With Biologics in the United Kingdom National Health Service
Conditions: Asthma Interventions: Drug: Biologic treatment Sponsors: AstraZeneca Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 15, 2024 Category: Research Source Type: clinical trials

Increasing access to CBT for psychosis patients: study protocol for a randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by assistant psychologists (GiVE3)
This study will investigate the clinical and cost-effectiveness of the GiVE intervention when delivered by assistant psychologists following a brief training.MethodsThis study is a pragmatic, two-arm, parallel group, superiority RCT comparing the GiVE intervention (delivered by assistant psychologists) and treatment as usual to treatment as usual alone, recruiting across three sites, using 1:1 allocation and blind post-treatment and follow-up assessments. A nested qualitative study will develop a model for implementation.DiscussionIf the GiVE intervention is found to be effective when delivered by assistant psychologists, ...
Source: Trials - September 15, 2023 Category: Research Source Type: clinical trials

Evaluation of interventions to prevent vasovagal reactions among whole blood donors: rationale and design of a large cluster randomised trial
DiscussionThe STRIDES trial should yield novel information about interventions, singly and in combination, for the prevention of VVRs, with the aim of generating policy-shaping evidence to help inform blood services to improve donor health, donor experience, and service efficiency.Trial registrationISRCTN: 10412338. Registration date: October 24, 2019. (Source: Trials)
Source: Trials - August 10, 2023 Category: Research Source Type: clinical trials

Effectiveness of laparoscopic removal of isolated superficial peritoneal endometriosis for the management of chronic pelvic pain in women (ESPriT2): protocol for a multi-centre randomised controlled trial
DiscussionThis trial aims to provide high quality evidence of the clinical and cost-effectiveness of surgical removal of isolated SPE.Trial registrationISRCTN registry ISRCTN27244948. Registered 6 April 2021. (Source: Trials)
Source: Trials - June 22, 2023 Category: Research Source Type: clinical trials

Reverse shoulder arthroplasty versus hemiarthroplasty versus non-surgical treatment for older adults with acute 3- or 4-part fractures of the proximal humerus: study protocol for a randomised controlled trial (PROFHER-2: PROximal Fracture of Humerus Evaluation by Randomisation – Trial Number 2)
DiscussionThe PROFHER-2 trial is designed to provide a robust answer to guide the treatment of patients aged 65 years or over who sustain 3- and 4-part proximal humeral fractures. The pragmatic design and recruitment from around 40 UK NHS hospitals will ensure immediate applicability and generalisability of the trial findings. The full trial results will be made available in a relevant open-access peer-revi ewed journal.Trial registrationISRCTN76296703. Prospectively registered on 5th April 2018 (Source: Trials)
Source: Trials - April 13, 2023 Category: Research Source Type: clinical trials

Extended-release pharmacotherapy for opioid use disorder (EXPO): protocol for an open-label randomised controlled trial of the effectiveness and cost-effectiveness of injectable buprenorphine versus sublingual tablet buprenorphine and oral liquid methadone
This study will determine (A) the effectiveness and cost-effectiveness — monthly injectable, extended-release (BUP-XR) in a head-to-head comparison with BUP-SL and MET, and (B) the effectiveness of BUP-XR with adjunctive PSI versus BUP-SL and MET with PSI. Safety, retention, craving, substance use, quality-adjusted life years, social functioning, and subjective recov ery from OUD will be also evaluated.MethodsThis is a pragmatic, multi-centre, open-label, parallel-group, superiority RCT, with a qualitative (mixed-methods) evaluation. The study population is adults. The setting is five National Health Service community tr...
Source: Trials - August 19, 2022 Category: Research Source Type: clinical trials

Prevention and early treatment of the long-term physical effects of COVID-19 in adults: design of a randomised controlled trial of resistance exercise —CISCO-21
DiscussionEthical approval has been granted by the National Health Service (NHS) West of Scotland Research Ethics Committee (REC) (reference: GN20CA537) and recruitment is ongoing. Trial findings will be disseminated through patient and public forums, scientific conferences and journals.Trial registrationClinicialTrials.govNCT04900961. Prospectively registered on 25 May 2021 (Source: Trials)
Source: Trials - August 15, 2022 Category: Research Source Type: clinical trials

Proper understanding of recurrent stress urinary incontinence treatment in women (PURSUIT): a randomised controlled trial of endoscopic and surgical treatment
DiscussionThere is a lack of high-quality, randomised, scientific evidence for which treatment is best for women presenting with recurrent SUI. The PURSUIT study will benefit healthcare professionals and patients and provide robust evidence to guide further treatment and improve symptoms and quality of life for women with this condition.Trial registrationInternational Standard Randomised Controlled Trials Number (ISRCTN) registry ISRCTN12201059. Registered on 09 January 2020 (Source: Trials)
Source: Trials - August 3, 2022 Category: Research Source Type: clinical trials

The ALLEGRO trial: a placebo controlled randomised trial of intravenous lidocaine in accelerating gastrointestinal recovery after colorectal surgery
DiscussionA 6 –12-h perioperative intravenous infusion of 2% lidocaine is a cheap addition to usual anaesthetic/analgesic practice in elective colorectal surgery with a low incidence of adverse side-effects. If successful in achieving quicker return of gut function for more patients, it would reduce the rate of postoperative ileus and reduce the duration of inpatient recovery, resulting in reduced pain and discomfort with faster recovery and discharge from hospital. Since colorectal surgery is a common procedure undertaken in every acute hospital in the UK, a reduced length of stay and reduced rate of pos toperative ileu...
Source: Trials - January 28, 2022 Category: Research Source Type: clinical trials

Evaluating Diuretics in Normal Care (EVIDENCE): protocol of a cluster randomised controlled equivalence trial of prescribing policy to compare the effectiveness of thiazide-type diuretics in hypertension
We describe an approach to rapidly generate externally valid evidence of comparative safety and effectiveness using the example of two widely used diuretics for the management of hypertension.Methods and analysisThe EVIDENCE (Evaluating Diuretics in Normal Care) study has a prospective, cluster-randomised, open-label, blinded end-point design. By randomising prescribing policy in primary care practices, the study compares the safety and effectiveness of commonly used diuretics in treating hypertension. Participating practices are randomised 1:1 to a policy of prescribing either indapamide or bendroflumethiazide when clinic...
Source: Trials - November 17, 2021 Category: Research Source Type: clinical trials

An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial
This article describes the protocol for a multi-centre RCT evaluating the clinical- and cost-effectiveness of an early vocational rehabilitation intervention aimed at supporting adults to return to work following a stroke. Evidence favouring the ESSVR intervention would support its roll-out in NHS settings.Trial registrationISRCTN,ISRCTN12464275. Registered on 26 February 2018. (Source: Trials)
Source: Trials - December 9, 2020 Category: Research Source Type: clinical trials