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Clinical statistical analysis plan for the ACCURE trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicentre trial
BackgroundThe primary treatment of ulcerative colitis (UC) is medical therapy using a standard step-up approach. An appendectomy might modulate the...
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Alternative consent methods used in the multinational, pragmatic, randomised clinical trial SafeBoosC-III
BackgroundThe process of obtaining prior informed consent for experimental treatment does not fit well into the clinical reality of acute and...
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Biomarker Driven Antifungal Stewardship (BioDriveAFS) in acute leukaemia—a multi-centre randomised controlled trial to assess clinical and cost effectiveness: a study protocol for a randomised controlled trial
BackgroundAcute leukaemias (AL) are life-threatening blood cancers that can be potentially cured with treatment involving myelosuppressive,...
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The effects of cerebral oximetry in mechanically ventilated newborns: a protocol for the SafeBoosC-IIIv randomised clinical trial
BackgroundThe SafeBoosC project aims to test the clinical value of non-invasive cerebral oximetry by near-infrared spectroscopy in newborn infants....
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Clinical antiviral efficacy of favipiravir in early COVID-19 (PLATCOV): an open-label, randomised, controlled, adaptive platform trial
Brief summaryIn early symptomatic COVID-19 treatment, high dose oral favipiravir did not accelerate viral clearance.
BackgroundFavipiravir, an...
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Sodium-hyaluronate mouthwash on radiotherapy-induced xerostomia: a randomised clinical trial
IntroductionRadiotherapy-induced xerostomia (RIX) is one of the most common adverse effects of radiotherapy (RT) in head and neck cancer patients...
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Robotic-assisted total knee arthroplasty in clinical practice: protocol for a randomised controlled trial
Between 2 and 20% of patients who undergo total knee arthroplasty (TKA) report restricted motion and anterior knee pain. Non-optimal alignment of the...
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NON-pharmacological Approach Less Invasive Surfactant Administration (NONA-LISA) trial: protocol for a randomised controlled trial
IntroductionUsing pre-procedure analgesia with the risk of apnoea may complicate the Less Invasive Surfactant Administration (LISA) procedure or...
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Personalising genetic counselling (POETIC) trial: Protocol for a hybrid type II effectiveness-implementation randomised clinical trial of a patient screening tool to improve patient empowerment after cancer genetic counselling
BackgroundGenetic counselling aims to identify, and address, patient needs while facilitating informed decision-making about genetic testing and...
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Video clips for patient comprehension of atrial fibrillation and deep vein thrombosis in emergency care. A randomised clinical trial
Integrating video clips in the discharge process may enhance patients’ understanding and awareness of their condition. To determine the effect of...
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Detailed statistical analysis plan for a secondary Bayesian analysis of the SafeBoosC-III trial: a multinational, randomised clinical trial assessing treatment guided by cerebral oximetry monitoring versus usual care in extremely preterm infants
BackgroundExtremely preterm infants have a high mortality and morbidity. Here, we present a statistical analysis plan for secondary Bayesian analyses...
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Clinical sonochemotherapy of inoperable pancreatic cancer using diagnostic ultrasound and microbubbles: a multicentre, open-label, randomised, controlled trial
ObjectivesSonochemotherapy, which uses microbubble (MB)-assisted ultrasound (US) to deliver chemotherapeutic agents, has the potential to enhance...
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Influence of gastric residual assessment in preterm neonates on time to achieve enteral feeding (the GRASS trial)—Multi-centre, assessor-blinded randomised clinical trial
PurposeGastric residual measurement is routinely performed in premature infants prior to feeding despite a lack of evidence of benefit. We aimed to...
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Conditional versus non-conditional incentives to maximise return of participant completed questionnaires in clinical trials: a cluster randomised study within a trial
BackgroundHigh participant retention enhances the validity of clinical trials. A monetary incentive can increase retention, but it is not known if...
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A randomised clinical trial study assessing the efficacy of 5% losartan potassium loaded in ethosomal gel to treat human keloids: a trial protocol
BackgroundKeloid is a skin disorder that results from excessive fibrous tissue growth in the area of the initial trauma. Treating keloids can be...
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Clinical insight among persons with schizophrenia spectrum disorders treated with amisulpride, aripiprazole or olanzapine: a semi-randomised trial
BackgroundAntipsychotic treatment may improve clinical insight. However, previous studies have reported inconclusive findings on whether...
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Study protocol for the management of impacted maxillary central incisors: a multicentre randomised clinical trial: the iMAC Trial
BackgroundFailure of eruption of the maxillary permanent incisor teeth usually presents in the mixed dentition between the ages of 7 and 9 years....
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Community-based management of a five-arm randomised clinical trial in COVID-19 outpatients in South Africa: challenges and opportunities
BackgroundRepeated COVID-19 waves and corresponding mitigation measures have impacted health systems globally with exceptional challenges. In...
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Trial Forge Guidance 4: a guideline for reporting the results of randomised Studies Within A Trial (SWATs)
BackgroundEvidence to support decisions on trial processes is minimal. One way to generate this evidence is to use a Study Within A Trial (SWAT) to...
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Low tidal volume ventilation for patients undergoing laparoscopic surgery: a secondary analysis of a randomised clinical trial
BackgroundWe recently reported the results for a large randomized controlled trial of low tidal volume ventilation (LTVV) versus conventional tidal...