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

The use of healthcare systems data for RCTs
ConclusionsHSD is being used in around two thirds of the studies but cannot yet be used to support PRO data collection within the cohort we examined. Comparison with an earlier cohort demonstrates an increase in the number of RCTs planning to use HSD. (Source: Trials)
Source: Trials - January 29, 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

RObotic-Assisted Rehabilitation for balance and gait in Stroke patients (ROAR-S): study protocol for a preliminary randomized controlled trial
ConclusionsThe study aims to evaluate the improvement in balance, fatigue, quality of life, and motor and cognitive performance after combined conventional and robotic balance treatment with Hunova ® (Movendo Technology srl, Genoa, IT) compared with conventional therapy alone. Robotic assessment to identify the most appropriate and individualized rehabilitation treatment may allow reducing disability and improving quality of life in the frail population. This would reduce direct and indirect social costs of care and treatment for the National Health Service and caregivers.Trial registrationClinicalTrials.gov NCT05280587. ...
Source: Trials - October 12, 2022 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

Use of routinely collected health data in randomised clinical trials: comparison of trial-specific death data in the BOSS trial with NHS Digital data
ConclusionNHS Digital death data is useful for calculating overall survival where trial-specific follow-up is only every 2 years from randomisation and the follow-up requires patient response. The cancer data was not a large enough sample to assess usability. We suggest that this assessment of registry data is done for more phase III RCTs and for more registry data to get a more complete picture of when RCHD would be useful in phase III RCT.Trial registrationISRCTN54190466 (BOSS) 1 Oct 2009. (Source: Trials)
Source: Trials - September 26, 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

Optimisation of the ActWELL lifestyle intervention programme for women attending routine NHS breast screening clinics
ConclusionsThe optimisation process has facilitated the development and evaluation of a programme that enables the delivery of a promising intervention to achieve weight management in post-menopausal women.Trial registrationISRCTN:ISRCTN11057518. Registered on 21 July 2017. Retrospectively registered. (Source: Trials)
Source: Trials - June 4, 2020 Category: Research Source Type: clinical trials