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Prospective identification of variables as outcomes for treatment (PIVOT): study protocol for a randomised, placebo-controlled trial of hydroxyurea for Ghanaian children and adults with haemoglobin SC disease
BackgroundHaemoglobin SC (HbSC) is a common form of sickle cell disease (SCD), especially among individuals of West African ancestry. Persons with...
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The effect of robot-assisted versus standard training on motor function following subacute rehabilitation after ischemic stroke – protocol for a randomised controlled trial nested in a prospective cohort (RoboRehab)
BackgroundBody weight unloaded treadmill training has shown limited efficacy in further improving functional capacity after subacute rehabilitation...
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A prospective randomised control trial comparing functional with mechanical axis alignment in total knee arthroplasty: study protocol for an investigator initiated trial
BackgroundA drive to improve functional outcomes for patients undergoing total knee arthroplasty (TKA) has led to alternative alignment being used....
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Leg Lymphoedema After Inguinal and Ilio-Inguinal Lymphadenectomy for Melanoma: Results from a Prospective, Randomised Trial
BackgroundThe Evaluation of Groin Lymphadenectomy Extent for Melanoma (EAGLE FM) study sought to address the question of whether to perform inguinal...
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Acute neural effects of the mood stabiliser lamotrigine on emotional processing in healthy volunteers: a randomised control trial
Lamotrigine is an effective mood stabiliser, largely used for the management and prevention of depression in bipolar disorder. The neuropsychological...
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The COMFORT trial: a randomised control trial comparing group-based COMpassion-FOcussed therapy and breathing pattern ReTraining with treatment as usual on the psychological functioning of patients diagnosed with cancer recurrence during COVID
BackgroundA cancer diagnosis is a known precipitant of psychological distress, with fear of recurrence being a well-documented distressing...
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Effect of a self-developed fixation device on preventing endotracheal intubation-related pressure injury: a randomised controlled trial
ObjectiveTo evaluate the effects of our self-developed endotracheal tube fixation device in mechanically ventilated patients.
Methods ...
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The effectiveness and cost-effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) for trauma patients with uncontrolled torso haemorrhage: study protocol for a randomised clinical trial (the UK-REBOA trial)
BackgroundHaemorrhage is the most common cause of preventable death after injury. REBOA is a novel technique whereby a percutaneously inserted...
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Study protocol for a randomised cross-over trial of Neurally adjusted ventilatory Assist for Neonates with Congenital diaphragmatic hernias: the NAN-C study
BackgroundNeurally adjusted ventilatory assist (NAVA) is a mode of mechanical ventilation that delivers oxygen pressures in proportion to electrical...
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A randomised trial of topical polaprezinc to prevent oral mucositis in patients undergoing haematopoietic stem cell transplantation (ToPaZ study)
PurposeOral mucositis (OM) is a common complication in haematopoietic stem cell transplantation (HSCT). Polaprezinc, an anti-ulcer drug, has been...
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Awakening the control of the ankle dorsiflexors in the post-stroke hemiplegic subject to improve walking activity and social participation: the WAKE (Walking Ankle isoKinetic Exercise) randomised, controlled trial
BackgroundStroke is the leading cause of acquired disability in France. While 90% of patients recover the ability to walk, it is often limited with a...
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A trial of intra-pleural bacterial immunotherapy in malignant pleural mesothelioma (TILT) — a randomised feasibility study using the trial within a cohort (TwiC) methodology
BackgroundMalignant pleural mesothelioma (MPM) is an aggressive thoracic malignancy with a poor prognosis. Systemic immunotherapy is an effective...
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The CHARTER-Ireland trial: can nebulised heparin reduce acute lung injury in patients with SARS-CoV-2 requiring advanced respiratory support in Ireland: a study protocol and statistical analysis plan for a randomised control trial
BackgroundCOVID-19 pneumonia is associated with the development of acute respiratory distress syndrome (ARDS) displaying some typical histological...
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Effectiveness of full Pulpotomy compared with Root canal treatment in managing teeth with signs and symptOms indicative of irreversible pulpitis: a protocol for prospectiVE meta-analysis of individual participant data of linked randomised clinical trials (PROVE)
BackgroundFull pulpotomy has been proposed as an alternative to root canal treatment in teeth with signs and symptoms indicative of irreversible...
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The ARIA trial protocol: a randomised controlled trial to assess the clinical, technical, and cost-effectiveness of a cloud-based, ARtificially Intelligent image fusion system in comparison to standard treatment to guide endovascular Aortic aneurysm repair
BackgroundEndovascular repair of aortic aneurysmal disease is established due to perceived advantages in patient survival, reduced postoperative...
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INFERR-Iron infusion in haemodialysis study: INtravenous iron polymaltose for First Nations Australian patients with high FERRitin levels on haemodialysis—a protocol for a prospective open-label blinded endpoint randomised controlled trial
BackgroundThe effectiveness of erythropoiesis-stimulating agents, which are the main stay of managing anaemia of chronic kidney disease (CKD), is...
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The efficacy of intradermal sterile water application in severe renal colic: a randomised clinical trial
It is important to do a fast and effective treatment for patients with renal colic pain in emergency departments for both patients’ comfort and...
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The effectiveness and cost-effectiveness of a group domestic abuse perpetrator programme: protocol for a randomised controlled trial
BackgroundIn contrast to evidence for interventions supporting victim/survivors of domestic violence and abuse (DVA), the effectiveness of...
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Statin and aspirin as adjuvant therapy in hospitalised patients with SARS-CoV-2 infection: a randomised clinical trial (RESIST trial)
BackgroundStatins and aspirin have been proposed for treatment of COVID-19 because of their anti-inflammatory and anti-thrombotic properties. Several...
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Using a BonE BiOPsy (BeBoP) to determine the causative agent in persons with diabetes and foot osteomyelitis: study protocol for a multicentre, randomised controlled trial
BackgroundDiabetic foot osteomyelitis (DFO) poses a major disease burden. It can generally be treated with long-term antibacterial therapy....
