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Landscape of clinical trial activity focusing on Indigenous health in Australia: an overview using clinical trial registry data from 2008-2018
BackgroundAboriginal and Torres Strait Islander peoples (hereafter respectfully referred to as Indigenous Australians) represent about 3% of the...
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The Symptom Monitoring with Feedback Trial (SWIFT): protocol for a registry-based cluster randomised controlled trial in haemodialysis
BackgroundKidney failure prevalence is increasing worldwide. Haemodialysis, peritoneal dialysis or kidney transplantation are undertaken to extend...
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Feasibility of Symptom monitoring WIth Feedback Trial (SWIFT) for adults on hemodialysis: a registry-based cluster randomized pilot trial
BackgroundPatients with kidney failure on hemodialysis (HD) experience considerable symptom burden and poor health-related quality of life (HRQoL)....
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Improving outcomes for patients with lymphoma: design and development of the Australian and New Zealand Lymphoma and Related Diseases Registry
BackgroundLymphoma is a malignancy of lymphocytes and lymphoid tissues comprising a heterogeneous group of diseases, with up to 80 entities now...
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The establishment of a multiple myeloma clinical registry in the Asia–Pacific region: The Asia–Pacific Myeloma and Related Diseases Registry (APAC MRDR)
BackgroundMultiple myeloma (MM) is the second most common haematological cancer worldwide. Along with related diseases including monoclonal...
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Multi-center, pragmatic, cluster-randomized, controlled trial of standardized peritoneal dialysis (PD) training versus usual care on PD-related infections (the TEACH-PD trial): trial protocol
BackgroundPeritoneal dialysis (PD)-related infections, such as peritonitis, exit site, and tunnel infections, substantially impair the sustainability...
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Mānuka oil based ECMT-154 versus vehicle control for the topical treatment of eczema: study protocol for a randomised controlled trial in community pharmacies in Aotearoa New Zealand
BackgroundEczema is a chronic, relapsing skin condition commonly managed by emollients and topical corticosteroids. Prevalence of use and demand for...
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Prospective benchmarking of an observational analysis in the SWEDEHEART registry against the REDUCE-AMI randomized trial
Prospective benchmarking of an observational analysis against a randomized trial increases confidence in the benchmarking process as it relies...
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SCANPatient: study protocol for a multi-centre, batched, stepped wedge, comparative effectiveness, randomised clinical trial of synoptic reporting of computerised tomography (CT) scans assessing cancers of the pancreas
BackgroundComplete surgical removal of pancreatic ductal adenocarcinoma (PDAC) is central to all curative treatment approaches for this aggressive...
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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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Registry-based randomised controlled trials: conduct, advantages and challenges—a systematic review
BackgroundRegistry-based randomised controlled trials (rRCTs) have been described as pragmatic studies utilising patient data embedded in large-scale...
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Probiotic supplementation and risk of necrotizing enterocolitis and mortality among extremely preterm infants—the Probiotics in Extreme Prematurity in Scandinavia (PEPS) trial: study protocol for a multicenter, double-blinded, placebo-controlled, and registry-based randomized controlled trial
BackgroundExtremely preterm infants, defined as those born before 28 weeks’ gestational age, are a very vulnerable patient group at high risk for...
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Evaluating an emotion coaching programme for parents of young adolescents attending Child Adolescent Mental Health Services (CAMHS) in New Zealand: protocol for a multi-site feasibility trial including co-design with service users
BackgroundEarly adolescence is a time of increased vulnerability for the development of common mental health conditions such as anxiety and...
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Flexible bronchoscopy insufflated and high-flow nasal oxygen pilot trial (BUFFALO protocol pilot trial)
BackgroundHypoxaemia occurs in approximately 30% of children during anaesthesia for flexible bronchoscopy. High-flow nasal oxygen (HFNO) can prolong...
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A phase 3 randomised double-blind placebo-controlled trial of mirtazapine as a pharmacotherapy for methamphetamine use disorder: a study protocol for the Tina Trial
BackgroundThere are no approved pharmacotherapies for methamphetamine use disorder. Two preliminary phase 2 randomised controlled trials have found...
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Treatment of Impetigo with Antiseptics—Replacing Antibiotics (TIARA) trial: a single blind randomised controlled trial in school health clinics within socioeconomically disadvantaged communities in New Zealand
BackgroundImpetigo is a common and contagious bacterial skin infection, affecting children worldwide, but it is particularly prevalent in...
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Optimising diagnosis and management of kidney disease: an implementation trial of a clinical decision support system future health today
BackgroundChronic kidney disease affects more than 10% of the world’s population and is a non-communicable disease of global concern and priority....
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Which strategies support the effective use of clinical practice guidelines and clinical quality registry data to inform health service delivery? A systematic review
BackgroundEmpirical evidence suggests data and insights from the clinical practice guidelines and clinical quality registries are not being fully...
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The effect of smartphone-based monitoring and treatment including clinical feedback versus smartphone-based monitoring without clinical feedback in bipolar disorder: the SmartBipolar trial—a study protocol for a randomized controlled parallel-group trial
IntroductionA substantial proportion of patients with bipolar disorder experience daily subsyndromal mood swings, and the term “mood instability”...
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Rugby Fans in Training New Zealand (RUFIT NZ): a randomized controlled trial to assess the effectiveness of a healthy lifestyle program for overweight men delivered through professional rugby clubs
BackgroundA healthy lifestyle program that appeals to, and supports, overweight and obese New Zealand (NZ) European, Māori (indigenous) and Pasifika...