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A digital intervention to reduce home-office workers’ sedentary behaviour: protocol for the evaluation of the Click2Move programme, a cluster randomised controlled trial
Published 2025-01-01“…Methods A two-arm cluster randomised controlled trial will be undertaken among hybrid office employees. …”
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Comparative analysis of LMA Blockbuster® clinical performance: Blind versus Miller laryngoscope-guided insertion in paediatric general anaesthesia – A double-blinded, randomised controlled trial
Published 2024-10-01“…Methods: This randomised controlled trial study enroled 100 patients aged 1–4 years undergoing elective surgery. …”
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243
PROcalcitonin and NEWS2 evaluation for Timely identification of sepsis and Optimal use of antibiotics in the emergency department (PRONTO): protocol for a multicentre, open-label, randomised controlled trial
Published 2022-06-01“…The PROcalcitonin and NEWS2 evaluation for Timely identification of sepsis and Optimal (PRONTO) study is a randomised controlled trial (RCT) in adults with suspected sepsis presenting to the ED to compare standard clinical management based on NEWS2 scoring plus PCT-guided risk assessment with standard clinical management based on NEWS2 scoring alone and compare if this approach reduces prescriptions of antibiotics without increasing mortality.Methods and analysis PRONTO is a parallel two-arm open-label individually RCT set in up to 20 NHS EDs in the UK with a target sample size of 7676 participants. …”
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Clinical benefits of modifying the evening light environment in an acute psychiatric unit: A single-centre, two-arm, parallel-group, pragmatic effectiveness randomised controlled trial.
Published 2024-12-01“…Modifying inpatient evening light exposure may be a low-intensity intervention for mental disorders, but few randomised controlled trials (RCTs) exist. We report a large-scale pragmatic effectiveness RCT exploring whether individuals with acute psychiatric illnesses experience additional benefits from admission to an inpatient ward where changes in the evening light exposure are integrated into the therapeutic environment.…”
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Protocol for the impact of machine learning-based clinician decision support algorithims in perioperative care (IMAGINATIVE) in Singapore general hospital : a large prospective randomised controlled trial
Published 2024-12-01“…The IMAGINATIVE Trial aims to evaluate the efficacy of such systems in a large academic medical centre.Methods and analysis This study adopts type 1 effectiveness-implementation study design within a randomised controlled trial framework. Patients will be randomly assigned in a 1:1 ratio to either the CARES-guided group (unblinded to risk level) or the unguided group (blinded to the risk level). …”
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Parenting with nutrition education and unconditional cash reduce maternal depressive symptoms and improve quality of life: findings from a cluster randomised controlled trial in urban Bangladesh
Published 2024-12-01“…Methods The study was a cluster randomised controlled trial with two arms: i) intervention: parenting with nutrition education and unconditional cash and ii) comparison: unconditional cash in an urban setting in Bangladesh. …”
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Study protocol of a randomised controlled trial on SISU, a software agent providing a brief self-help intervention for adults with low psychological well-being
Published 2021-02-01“…The aim of this trial is to evaluate the clinical effectiveness and acceptance of the brief software agent-based IMI SISU in comparison with a waitlist control group.Methods and analysis Within a two-group randomised controlled trial, a total of 120 adult participants living with low well-being (Well-being Scale/WHO-5) will be recruited in Germany, Austria and Switzerland. …”
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Home high-flow therapy during recovery from severe chronic obstructive pulmonary disease (COPD) exacerbation: a mixed-methods feasibility randomised control trial
Published 2025-01-01“…This study evaluated the feasibility of conducting a randomised controlled trial to evaluate clinical, patient-reported and physiological effects of home high-flow therapy (HFT) in addition to usual medical therapy, in eucapnic patients recovering from AECOPD to support the design of a phase 3 trial.Methods A mixed-methods feasibility randomised controlled trial (quantitative primacy, concurrently embedded qualitative evaluation) (ISRCTN15949009) recruiting consecutive non-obese patients hospitalised with AECOPD not requiring acute non-invasive ventilation. …”
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Vaginal progesterone as luteal phase support in natural cycle frozen-thawed embryo transfer (ProFET): protocol for a multicentre, open-label, randomised controlled trial
Published 2022-07-01“…To date, only a few studies have investigated if progesterone supplementation is beneficial in these cycles and the level of evidence for progesterone supplementation is very low.Methods and analysis The ProFET trial is a multicentre, open-label, randomised controlled trial powered for this investigation, including 1800 women with regular menstrual cycles (24–35 days), aged 18–43 years planned for natural cycle-FET receiving a single blastocyst for transfer. …”
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Effectiveness of using implementation frameworks to facilitate the implementation of a stroke management guideline in the traditional Chinese medicine hospitals in China: protocol for a factorial randomised controlled trial
Published 2025-01-01“…This study aims to evaluate the effectiveness of three popular frameworks—Consolidated Framework for Implementation Research (CFIR), Theoretical Domains Framework (TDF) and Normalization Process Theory (NPT)—in improving implementation outcomes for the integrated TCM and Western medicine clinical practice guideline for stroke management.Methods and analysis This study employs a hybrid type III design with a factorial randomised controlled trial, where 45 TCM hospitals will be randomly assigned to one of eight experimental conditions based on the use or non-use of each framework (CFIR, TDF, NPT). …”
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Exercise medicine as adjunct therapy during RADIation for CAncer of the prostaTE to improve treatment efficacy – protocol for the ERADICATE study: a phase II randomised controlled trial
Published 2025-01-01“…Methods The ERADICATE study is a two-arm, parallel group, phase II randomised controlled trial. Fifty patients diagnosed with prostate cancer will be randomised (1:1) to either an exercise intervention group (EBRT + exercise) or a usual care control group (EBRT only) for the duration of treatment (i.e., 2 to 8 weeks of EBRT). …”
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Oral health improvement for nursing home residents through delegated remotivation and reinstruction (MundZaRR Study): study protocol of a cluster-randomised controlled trial
Published 2020-09-01“…A two-arm clustered, randomised controlled trial (ratio of 1:1 via block randomisation) will be performed in LRC in Rhineland-Palatinate, Germany. …”
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Comparative Evaluation of Functional Outcomes in High Condylar Fractures Treated with Closed Methods with and without Temporomandibular Joint Arthrocentesis: A Research Protocol for a Randomised Controlled Trial
Published 2025-02-01“…Materials and Methods: A randomised controlled trial will be conducted at Siddharth Gupta Memorial Cancer Hospital, Sawangi, Wardha, Maharashtra, India, from September 2024 to May 2026, involving 10 patients. …”
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Effectiveness of ‘Tackle Your Tics’, a brief, intensive group-based exposure therapy programme for children with tic disorders: study protocol of a randomised controlled trial
Published 2022-06-01“…To study the effectiveness of Tackle Your Tics and identify predictors/moderators at baseline, a single-blinded randomised controlled trial (n=104) is conducted, comparing Tackle Your Tics (n=52) with a waiting list condition lasting 3 months (n=52). …”
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Supplemental oxygen strategies in infants with bronchopulmonary dysplasia after the neonatal intensive care unit period: study protocol for a randomised controlled trial (SOS BPD study)
Published 2022-07-01“…The aim of this study is to compare the use of a higher oxygen saturation limit (≥95%) to a lower oxygen saturation limit (≥90%) after 36 weeks PMA in infants diagnosed with moderate or severe BPD.Methods and analysis This non-blinded, multicentre, randomised controlled trial will recruit 198 preterm born infants with moderate or severe BPD between 36 and 38 weeks PMA. …”
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