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Efficacy and Mechanism Evaluation
ISSN 2050-4365 · NIHR Journals Library · 97 artikel di indeks
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Artikel Jurnal
Rituximab compared to intravenous cyclophosphamide in adults with connective tissue disease-associated interstitial lung disease: the RECITAL RCT
Background Interstitial lung disease frequently complicates systemic autoimmune disorders including scleroderma, idiopathic inflammatory myositis and mixed connective tissue disease, resulting in considerable morbidity and mortality. Based on the results of trials undertaken in scleroderma…
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Artikel Jurnal
Resuscitation with pre-hospital blood products in adults with trauma-related haemorrhagic shock: the RePHILL RCT
Background The treatment of traumatic haemorrhagic shock has been transformed through better haemorrhage control, use of tranexamic acid and use of blood products. The improved survival seen from these strategies has stimulated an interest in pre-hospital transfusion. Objectives To determine if the…
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Evaluation of efficacy, outcomes and safety of infant haemodialysis and ultrafiltration in clinical use: I-KID a stepped wedge cluster RCT
Abstract Background Critically unwell babies in intensive care units may develop acute renal failure. Options for renal replacement therapy are limited by their small size and available technology. Objectives To determine the clinical efficacy, outcomes and safety profile of the NIDUS® (a novel…
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Artikel Jurnal
Autologous stem cell transplantation with low-dose cyclophosphamide to improve mucosal healing in adults with refractory Crohn’s disease: the ASTIClite RCT
Some text in this abstract has been reproduced from Lindsay J, Din S, Hawkey C, Hind D, Irving P, Lobo A, et al. OFR-9 An RCT of autologous stem-cell transplantation in treatment refractory Crohn’s disease (low-intensity therapy evaluation): ASTIClite. Gut 2021;70(Suppl. 4):A4. Background…
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Artikel Jurnal
The impact of the Speech Systems Approach on intelligibility for children with cerebral palsy: a secondary analysis
Background The motor speech disorder, dysarthria, is common in cerebral palsy. The Speech Systems Approach therapy programme, which focuses on controlling breath supply and speech rate, has increased children’s intelligibility. Objective To ascertain if increased intelligibility is due to better…
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Artikel Jurnal
Preventing kidney transplant failure by screening for antibodies against human leucocyte antigens followed by optimised immunosuppression: OuTSMART RCT
Design Investigator-led, prospective, open-labelled marker-based strategy (hybrid) randomised trial. Background Allografts in 3% of kidney transplant patients fail annually. Development of antibodies against human leucocyte antigens is a validated predictive biomarker of allograft failure. Under…
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Ondansetron for irritable bowel syndrome with diarrhoea: randomised controlled trial
Background Irritable bowel syndrome with diarrhoea is characterised by frequent, loose or watery stools with associated urgency, resulting in marked reduction of quality of life. Ondansetron, a 5-hydroxytryptamine-3 receptor antagonist, has been shown to benefit patients with irritable bowel…
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Artikel Jurnal
Virtual reality supported therapy for the negative symptoms of schizophrenia: the V-NeST feasibility RCT
Background Negative symptoms are typically observed in people with schizophrenia and indicate a loss or reduction of a normal function (e.g. reduced motivation and affect display). Despite obstructing people’s recovery, intervention development receives limited attention. Objectives This study…
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Subacromial spacers for adults with symptomatic, irreparable rotator cuff tears: the START:REACTS novel group sequential adaptive RCT
Background A balloon spacer is a relatively simple addition to an arthroscopic debridement procedure for irreparable rotator cuff tears. Objective To evaluate the clinical and cost-effectiveness of a subacromial balloon spacer for individuals undergoing arthroscopic debridement for irreparable…
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Artikel Jurnal
Neuromuscular electrical stimulation as an adjunct to standard care in improving walking distances in intermittent claudication patients: the NESIC RCT
Background Peripheral arterial disease is common and associated with increased cardiovascular morbidity and mortality. While patients with peripheral arterial disease are known to benefit from supervised exercise therapy, it is not always available. Neuromuscular electrical stimulation devices may…
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Artikel Jurnal
Gefitinib and methotrexate to resolve tubal ectopic pregnancy: the GEM3 RCT
Background Tubal ectopic pregnancies can cause significant morbidity or even death. Current treatment is with methotrexate or surgery. However, methotrexate treatment can fail in approximately 30% of women. Gefitinib, an epidermal growth factor receptor inhibitor, may improve the effects of…
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Artikel Jurnal
Bilateral versus single internal thoracic coronary artery bypass grafting: the ART RCT
Background There is debate whether the use of more arterial grafts during coronary artery bypass graft surgery provides advantages to the standard operation using the left internal thoracic artery plus vein grafts. We review data from the Arterial Revascularisation Trial to determine whether there…
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Ulipristal acetate versus levonorgestrel-releasing intrauterine system for heavy menstrual bleeding: the UCON randomised controlled trial and mechanism of action study
Background Heavy menstrual bleeding affects one in four women and negatively impacts quality of life. The levonorgestrel-releasing intrauterine system is an effective long-term treatment but is discontinued by many due to unpredictable bleeding, or adverse effects. The selective progesterone…
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Monoclonal antibody BTT1023 targeting vascular adhesion protein 1 for treating primary sclerosing cholangitis: BUTEO single-arm Phase II trial
Background: Primary sclerosing cholangitis is a progressive and fibrotic liver disease. Treatments remain inadequate, and patients with persistent elevations in activity of alkaline phosphatase are at greatest risk of disease progression. Studies in patient cohorts have implicated the serum amine…
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The interleukin 1 receptor antagonist anakinra to reduce disease severity of palmoplantar pustulosis in adults: APRICOT RCT and PLUM mechanistic study
Background: Palmoplantar pustulosis is a rare, debilitating, chronic skin disease involving the hands and feet, and there are limited treatment options. Mechanistic findings suggest that interleukin 1 may be a pathogenic driver. Objective: To determine whether or not anakinra [Sobi (Swedish Orphan…
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Artikel Jurnal
Treatment guided by fractional exhaled nitric oxide in addition to standard care in 6- to 15-year-olds with asthma: the RAACENO RCT
Background: The role of fractional exhaled nitric oxide in guiding asthma treatment in children is uncertain. Objective: To compare treatment guided by both fractional exhaled nitric oxide and symptoms (intervention) with treatment guided by symptoms alone (standard care) in children with asthma…
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Molecular selection of therapy in metastatic colorectal cancer: the FOCUS4 molecularly stratified RCT
Background: Complex trials with innovative designs are becoming increasingly common and offer the potential to improve patient outcomes in a shorter time frame. There is evidence that patients with colorectal cancer fall into different subgroups with varying responsiveness to therapy, and that this…
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An adapted social communication intervention at home and education to promote social communication change in children with severe autism: the PACT-G RCT
Background: Prior evidence suggests that behaviours closely related to the intervention delivered for autism are amenable to change, but it becomes more difficult when generalising treatment effects beyond that immediate context. Objectives: The objectives were (1) to test an early autism social…
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Leucine and perindopril to improve physical performance in people over 70 years with sarcopenia: the LACE factorial RCT
Background: Angiotensin-converting enzyme inhibitors and leucine are promising potential treatments for sarcopenia. Neither has yet been tested in adequately powered randomised trials in patients with sarcopenia. Objectives: To determine the efficacy of leucine and perindopril in improving physical…
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Artikel Jurnal
Rituximab versus tocilizumab and B-cell status in TNF-alpha inadequate-responder rheumatoid arthritis patients: the R4-RA RCT
Background: Although biological therapies have transformed the outlook for those with rheumatoid arthritis, there is a lack of any meaningful response in approximately 40% of patients. The role of B cells in rheumatoid arthritis pathogenesis is well recognised and is supported by the clinical…