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Efficacy and Mechanism Evaluation
ISSN 2050-4373 · NIHR Journals Library · 45 artikel di indeks
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Artikel Jurnal
MOTILITY: Small bowel motility quantified by cine MRI as a predictor of longer term response in patients with Crohn’s disease commencing biological therapy
Background Small bowel Crohn’s disease is increasingly treated with biological therapies. Although many patients do not achieve response or remission, this is unpredictable. Motility magnetic resonance imaging reliably measures Crohn’s disease inflammation, but its predictive ability for…
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A psychological talking therapy for suicidality in people experiencing non-affective psychosis: Mechanism and efficacy outcomes of the CARMS (Cognitive AppRoaches to coMbatting Suicidality) randomised controlled trial
Background Suicide is a leading cause of death worldwide, particularly in people with severe mental health problems, including schizophrenia. The development, and testing, of suicide-focused psychological interventions which can combat suicidal experiences is an unrealised necessity. However, it is…
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The effect of appendectomy on the clinical course of ulcerative colitis: a synopsis of the ACCURE randomised controlled trial
Background Chronic relapsing diseases, such as ulcerative colitis, incur considerable long-term health burden to the patient and the state. Early interventions that reduce the rate of relapse could provide considerable benefits to patients and the health service. Research has shown that the…
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Lessons learned from a UK platform trial during the COVID-19 pandemic and beyond: The BEAT-Severe Asthma Trial
Background It is estimated that around 5% of people with asthma have severe asthma. Severe asthma typically presents with poor symptom control, impaired lung function and asthma exacerbations, despite regular inhaled steroids and additional controller medications. In the BEyond Allergic Th2-Severe…
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Desensitisation to cow’s milk, following partially or extensively hydrolysed formulae feeding regimens, in infants with allergy to cow’s milk: the DREAM RCT Synopsis (The DREAM study)
Background Immunoglobulin E-mediated (immediate) cow’s milk allergy is one of the most frequent food allergies in infants, with a significant adverse impact on quality of life. There is no satisfactory treatment for cow’s milk allergy, and guidelines recommend milk avoidance, feeding with…
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Study into the Reversal of Septic Shock with Beta Blockade (Landiolol): the STRESS-L randomised trial
Background Autonomic dysfunction and tachycardia are associated with poor outcomes in septic shock. Noradrenaline is recommended to maintain blood pressure but has been associated with harm. Beta-blockade has been associated with improved survival. We hypothesised that beta1 receptor antagonism…
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Intraoperative Fluorescence Angiography to Prevent Anastomotic Leak in Rectal Cancer Surgery: a synopsis of the IntAct trial
Background Anastomotic leak is the most feared complication of rectal cancer surgery, being reported in 10–15% of patients. Indocyanine green near-infrared angiography has been introduced to evaluate anastomotic blood supply and reduce anastomotic leak, with promising results. Objective and main…
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MR-Pro-adrenomedullin (MR-proADM) and Host Immune Response Biomarkers Evaluation of procalcitonin-guided antibiotic duration in Children with Infection for Stratification of Effectiveness: the PRECISE Study
Background The host-response to bacterial infection is highly heterogeneous; there is therefore a need for stratified treatment strategies instead of the traditional ‘one-size-fits-all’ approach. A precision medicine approach can improve patient outcomes by identifying endotypes in whom an…
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Effectiveness, safety and cost-effectiveness of methotrexate versus ciclosporin for severe childhood atopic dermatitis: a synopsis of the TREAT RCT
Parts of this abstract have been reproduced from Flohr C, Rosala-Hallas A, Jones AP, Beattie P, Baron S, Browne F, et al.; TREAT Trial Investigators. Efficacy and safety of ciclosporin versus methotrexate in the treatment of severe atopic dermatitis in children and young people (TREAT): a…
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Addition of a dendritic cell vaccine to conditioning cyclophosphamide and chemoembolisation to prolong progression-free survival in patients with hepatocellular carcinoma: the ImmunoTACE RCT
Background A previous study by our group using dendritic cells pulsed ex vivo with the lysate of the HepG2 cell line showed clinical benefit with evidence of antigen-specific T-cell responses in some patients with advanced hepatocellular carcinoma. This trial set out to investigate the activity of…
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Understanding mechanisms of colorectal cancer chemoprevention using seAFOod polyp prevention trial outcomes and its Biobank: STOP-ADENOMA synopsis
Background The 2 × 2 factorial seAFOod trial demonstrated that aspirin and omega-3 polyunsaturated fatty acid eicosapentaenoic acid reduce colorectal polyp number (a biomarker of colorectal cancer risk) during colonoscopy surveillance in the Bowel Cancer Screening Programme. The lack of a risk…
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Rheumatoid Arthritis Prevention: catalysing PlatfORm Trial delivery (RAPPORT)
Background Rheumatoid arthritis is a chronic disease of immune dysregulation affecting 1% of United Kingdom adults at an estimated cost to the taxpayer exceeding £5B per annum. Recently, enhanced pathophysiological understanding and a growing array of rational therapeutic candidates have converged…
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Cannabidiol as a treatment for patients who are clinically at high risk of developing psychosis: learnings from the CANTOP-RCT
Background There are no licensed pharmacological treatments for people who are at clinical high risk of developing psychosis. Although psychological interventions are well tolerated, they do not appear to reduce the risk of later transition to psychosis. Clinically high-risk people commonly…
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60-month follow-up of Long Limb vs. Standard Limb Roux-en-Y gastric bypass for type 2 diabetes and obesity: the LONG LIMB RCT
Background Roux-en-Y gastric bypass is an established treatment option for type 2 diabetes and obesity. However, the optimal lengths for the small intestinal limbs remain controversial with variation in practice. A longer biliopancreatic limb length of 150 cm (‘Long Limb’) was hypothesised to…
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Building an international precision medicine platform trial for the acute respiratory distress syndrome (ARDS): an expert consensus project report
Background Almost all large-scale trials of disease-modifying therapeutic agents in critical care have failed to show benefit for patients, which may be explained in part by the clinical and biological heterogeneity inherent in virtually all critical illness syndromes. Enrichment strategies have…
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Designing a precision-medicine platform trial to improve the nutritional care and intestinal health of very preterm babies: the COLLABORATE study
Background Nutrition is essential for preterm brain development. Optimal nutrition is dependent upon gastrointestinal health. Primary objective To form a multiprofessional collaboration to design the world’s first neonatal precision-medicine platform trial to test new and existing nutritional…
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Developing a Randomised Efficacy PREcision medicine Platform trial design for Cavernomas: the CARE PREP study
Background Symptomatic cerebral cavernous malformations are a rare sporadic or familial disease, which may cause haemorrhagic strokes or epileptic seizures. In 2015, a James Lind Alliance Priority Setting Partnership ranked targeted drug therapies as fourth of the top 10 research priorities for…
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Antimicrobial-impregnated urinary catheters against urinary tract infection for long-term indwelling urinary catheter users: lessons from the CAUTI RCT
Background Indwelling urinary catheters are drainage devices inserted into the bladder and are held in place by an inflatable balloon. The use of urinary catheters, while essential to bladder management, places the user at risk of catheter-associated urinary tract infections. Prevention of such…
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Multimodal versus non-contrast computed tomography for assessment of acute ischaemic stroke: the PRACTISE RCT
Background Non-contrast computed tomography has low sensitivity to brain ischaemia. Higher sensitivity of computed tomography perfusion and computed tomography angiography may identify more thrombolysis-eligible patients, but the role of these imaging modalities in thrombolysis treatment decisions…
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Understanding mechanisms of thrombosis and thrombocytopenia with adenoviral SARS-CoV-2 vaccines: a comprehensive synopsis
Background Thrombosis with thrombocytopenia syndrome is a rare condition known to occur spontaneously or after heparin use. With the advent of COVID-19 vaccines during the pandemic, thrombosis with thrombocytopenia syndrome cases emerged post administration of adenoviral vaccines, termed…