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Randomised controlled trials

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https://www.readbyqxmd.com/read/28351116/management-of-people-with-early-or-very-early-stage-hepatocellular-carcinoma-an-attempted-network-meta-analysis
#1
REVIEW
Avik Majumdar, Davide Roccarina, Douglas Thorburn, Brian R Davidson, Emmanuel Tsochatzis, Kurinchi Selvan Gurusamy
BACKGROUND: Hepatocellular carcinoma (primary liver cancer) is classified in many ways. The Barcelona Clinic Liver Cancer (BCLC) group staging classifies the cancer based on patient's life expectancy. People with very early- or early-stage hepatocellular carcinoma have single tumour or three tumours of maximum diameter of 3 cm or less, Child-Pugh status A to B, and performance status 0 (fully functional). Management of hepatocellular carcinoma is uncertain. OBJECTIVES: To assess the comparative benefits and harms of different interventions used in the treatment of early or very early hepatocellular carcinoma through a network meta-analysis and to generate rankings of the available interventions according to their safety and efficacy...
March 28, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28351060/blood-pressure-variability-in-obstructive-sleep-apnoea-data-from-4-randomised-controlled-cpap-withdrawal-trials
#2
Franziska Lettau, Esther I Schwarz, John R Stradling, Malcolm Kohler
BACKGROUND: Increased daytime blood pressure variability (BPV) is associated with cardiovascular risk. Preliminary data suggest that obstructive sleep apnoea (OSA) might contribute to increased daytime BPV. OBJECTIVE: The aim of this study was to evaluate the effect of continuous positive airway pressure (CPAP) therapy withdrawal on daytime BPV. METHODS: A total of 183 patients previously diagnosed with OSA and treated with CPAP were randomised to either continue or withdraw from CPAP within 4 trials...
March 29, 2017: Respiration; International Review of Thoracic Diseases
https://www.readbyqxmd.com/read/28350796/the-impact-of-individual-cognitive-stimulation-therapy-icst-on-cognition-quality-of-life-caregiver-health-and-family-relationships-in-dementia-a-randomised-controlled-trial
#3
Martin Orrell, Lauren Yates, Phuong Leung, Sujin Kang, Zoe Hoare, Chris Whitaker, Alistair Burns, Martin Knapp, Iracema Leroi, Esme Moniz-Cook, Stephen Pearson, Stephen Simpson, Aimee Spector, Steven Roberts, Ian Russell, Hugo de Waal, Robert T Woods, Vasiliki Orgeta
BACKGROUND: Cognitive stimulation therapy (CST) is a well-established group psychosocial intervention for people with dementia. There is evidence that home-based programmes of cognitive stimulation delivered by family caregivers may benefit both the person and the caregiver. However, no previous studies have evaluated caregiver-delivered CST. This study aimed to evaluate the effectiveness of a home-based, caregiver-led individual cognitive stimulation therapy (iCST) program in (i) improving cognition and quality of life (QoL) for the person with dementia and (ii) mental and physical health (well-being) for the caregiver...
March 2017: PLoS Medicine
https://www.readbyqxmd.com/read/28346536/water-sanitation-and-hygiene-wash-and-environmental-risk-factors-for-soil-transmitted-helminth-intensity-of-infection-in-timor-leste-using-real-time-pcr
#4
Suzy J Campbell, Susana V Nery, Rebecca Wardell, Catherine A D'Este, Darren J Gray, James S McCarthy, Rebecca J Traub, Ross M Andrews, Stacey Llewellyn, Andrew J Vallely, Gail M Williams, Archie C A Clements
BACKGROUND: No investigations have been undertaken of risk factors for intensity of soil-transmitted helminth (STH) infection in Timor-Leste. This study provides the first analysis of risk factors for intensity of STH infection, as determined by quantitative PCR (qPCR), examining a broad range of water, sanitation and hygiene (WASH) and environmental factors, among communities in Manufahi District, Timor-Leste. METHODS: A baseline cross-sectional survey of 18 communities was undertaken as part of a cluster randomised controlled trial, with additional identically-collected data from six other communities...
March 27, 2017: PLoS Neglected Tropical Diseases
https://www.readbyqxmd.com/read/28345792/adding-fast-acting-insulin-aspart-to-basal-insulin-significantly-improved-glycaemic-control-in-patients-with-type-2-diabetes-a-randomised-18-week-open-label-phase-3-trial-onset-3
#5
Helena W Rodbard, Devjit Tripathy, Maricela Vidrio Velázquez, Marek Demissie, Søren Can Tamer, Milivoj Piletič
AIM: To confirm glycaemic control superiority of mealtime fast-acting insulin aspart (faster aspart) in a basal-bolus (BB) regimen versus basal-only insulin. MATERIALS AND METHODS: In this open-label, randomised, 18-week trial (51 sites; 6 countries) adults (n = 236) with inadequately controlled type 2 diabetes (T2D; mean glycosylated haemoglobin [HbA1c ] ±SD: 7.9 ± 0.7% [63.1 ± 7.5 mmol/mol) receiving basal insulin and oral antidiabetic drugs underwent 8-week optimisation of prior once-daily basal insulins followed by randomisation 1:1 to a BB regimen with faster aspart (n = 116) or continuation of once-daily basal insulin (n = 120), both with metformin...
March 27, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28345503/physical-fitness-and-shapes-of-subcortical-brain-structures-in-children
#6
Francisco B Ortega, Daniel Campos, Cristina Cadenas-Sanchez, Signe Altmäe, Cristina Martínez-Zaldívar, Miguel Martín-Matillas, Andrés Catena, Cristina Campoy
A few studies have recently reported that higher cardiorespiratory fitness is associated with higher volumes of subcortical brain structures in children. It is, however, unknown how different fitness measures relate to shapes of subcortical brain nuclei. We aimed to examine the association of the main health-related physical fitness components with shapes of subcortical brain structures in a sample of forty-four Spanish children aged 9·7 (sd 0·2) years from the NUtraceuticals for a HEALthier life project...
March 27, 2017: British Journal of Nutrition
https://www.readbyqxmd.com/read/28345499/synbiotic-supplementation-in-lean-patients-with-non-alcoholic-fatty-liver-disease-a-pilot-randomised-double-blind-placebo-controlled-clinical-trial
#7
Fatemeh Mofidi, Hossein Poustchi, Zahra Yari, Babak Nourinayyer, Shahin Merat, Maryam Sharafkhah, Reza Malekzadeh, Azita Hekmatdoost
Although non-alcoholic fatty liver disease (NAFLD) is the leading aetiology of liver disorders in the world, there is no proven treatment for NAFLD patients with normal or low BMI. The aim of this study was to evaluate the efficacy of synbiotics supplementation in NAFLD patients with normal or low BMI. In this randomised, double-blind, placebo-controlled, clinical trial, fifty patients with NAFLD were assigned to take either a synbiotic supplement or a placebo capsule for 28 weeks. Both groups were advised to follow a healthy lifestyle...
March 27, 2017: British Journal of Nutrition
https://www.readbyqxmd.com/read/28345122/effect-of-laser-on-pain-relief-and-wound-healing-of-recurrent-aphthous-stomatitis-a-systematic-review
#8
REVIEW
Valerie G A Suter, Sophia Sjölund, Michael M Bornstein
The aim of this systematic review was to assess a potential benefit of laser use in the treatment of recurrent aphthous stomatitis (RAS). The primary outcome variables were pain relief, duration of wound healing and reduction in episode frequency. A PICO approach was used as a search strategy in Medline, Embase and Cochrane databases. After scanning and excluding titles, abstracts and full texts, 11 studies (ten RCTs and one non-randomised controlled trial) were included. Study selection and data extraction was done by two observers...
March 27, 2017: Lasers in Medical Science
https://www.readbyqxmd.com/read/28344517/economic-evaluation-of-participatory-learning-and-action-with-women-s-groups-facilitated-by-accredited-social-health-activists-to-improve-birth-outcomes-in-rural-eastern-india
#9
Rajesh Kumar Sinha, Hassan Haghparast-Bidgoli, Prasanta Kishore Tripathy, Nirmala Nair, Rajkumar Gope, Shibanand Rath, Audrey Prost
BACKGROUND: Neonatal mortality remains unacceptably high in many low and middle-income countries, including India. A community mobilisation intervention using participatory learning and action with women's groups facilitated by Accredited Social Health Activists (ASHAs) was conducted to improve maternal and newborn health. The intervention was evaluated through a cluster-randomised controlled trial conducted in Jharkhand and Odisha, eastern India. This aims to assess the cost-effectiveness this intervention...
2017: Cost Effectiveness and Resource Allocation: C/E
https://www.readbyqxmd.com/read/28344112/efficacy-and-safety-of-once-weekly-semaglutide-versus-once-daily-insulin-glargine-as-add-on-to-metformin-with-or-without-sulfonylureas-in-insulin-naive-patients-with-type-2-diabetes-sustain-4-a-randomised-open-label-parallel-group-multicentre-multinational
#10
Vanita R Aroda, Stephen C Bain, Bertrand Cariou, Milivoj Piletič, Ludger Rose, Mads Axelsen, Everton Rowe, J Hans DeVries
BACKGROUND: Several pharmacological treatment options are available for type 2 diabetes; however, many patients do not achieve optimum glycaemic control and therefore new therapies are necessary. We assessed the efficacy and safety of semaglutide, a glucagon-like peptide-1 (GLP-1) analogue in clinical development, compared with insulin glargine in patients with type 2 diabetes who were inadequately controlled with metformin (with or without sulfonylureas). METHODS: We did a randomised, open-label, non-inferiority, parallel-group, multicentre, multinational, phase 3a trial (SUSTAIN 4) at 196 sites in 14 countries...
March 23, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28343401/effect-of-probiotic-on-innate-inflammatory-response-and-viral-shedding-in-experimental-rhinovirus-infection-a-randomised-controlled-trial
#11
R B Turner, J A Woodfolk, L Borish, J W Steinke, J T Patrie, L M Muehling, S Lahtinen, M J Lehtinen
Ingestion of probiotics appears to have modest effects on the incidence of viral respiratory infection. The mechanism of these effects is not clear; however, there is evidence from animal models that the probiotic may have an effect on innate immune responses to pathogens. The purpose of this randomised, placebo-controlled study was to determine the effect of administration of Bifidobacterium animalis subspecies lactis Bl-04 on innate and adaptive host responses to experimental rhinovirus challenge. The effect on the response of chemokine (C-X-C motif) ligand 8 (CXCL8) to rhinovirus infection was defined as the primary endpoint for the study...
March 27, 2017: Beneficial Microbes
https://www.readbyqxmd.com/read/28342907/active-placebo-control-groups-of-pharmacological-interventions-were-rarely-used-but-merited-serious-consideration-a-methodological-overview
#12
Jakob Solgaard Jensen, Andreas Ørsted Bielefeldt, Asbjørn Hróbjartsson
OBJECTIVES: Active placebos are control interventions that mimic the side-effects of the experimental interventions in randomised trials and are sometimes used to reduce the risk of unblinding. We wanted to assess how often randomised clinical drug trials implement active placebo control groups; to provide a catalogue, and a characterisation, of such trials; and to analyse methodological arguments for and against use of active placebo. STUDY DESIGN: An overview consisting of three thematically linked sub-studies...
March 22, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28342891/cost-utility-of-group-acceptance-and-commitment-therapy-for-fibromyalgia-versus-recommended-drugs-an-economic-analysis-alongside-a-6-month-randomised-controlled-trial-conducted-in-spain-effigact-study
#13
Juan V Luciano, Francesco D'Amico, Albert Feliu-Soler, Lance M McCracken, Jaume Aguado, María T Peñarrubia-María, Martin Knapp, Antoni Serrano-Blanco, Javier García-Campayo
The aim of this study was to analyse the cost-utility of a group-based form of Acceptance and Commitment Therapy (GACT) in patients with fibromyalgia (FM) compared to patients receiving recommended pharmacological treatment (RPT) or on a waiting list (WL). The data were derived from a previously published study, an RCT that focused on clinical outcomes. Health economic outcomes included health-related quality of life and healthcare use at baseline and at 6-month follow-up using the EuroQol (EQ-5D-3L) and the Client Service Receipt Inventory (CSRI), respectively...
March 22, 2017: Journal of Pain: Official Journal of the American Pain Society
https://www.readbyqxmd.com/read/28342731/preferred-management-of-primary-deep-arm-vein-thrombosis
#14
REVIEW
F J Vazquez, P Paulin, D Poodts, E Gándara
OBJECTIVE: Given its rarity, the management of primary upper extremity deep vein thrombosis is controversial. Although anticoagulation alone is commonly advocated for its treatment, it is unclear if this will reduce the risk of developing post-thrombotic syndrome (PTS). The aim of this "Evidence Driven" Clinical Scenario is to evaluate whether more aggressive treatments (including catheter directed thrombolysis or surgery) might help reduce the risk of PTS or recurrent venous thromboembolism in patients with primary upper extremity deep vein thrombosis (DVT)...
March 22, 2017: European Journal of Vascular and Endovascular Surgery
https://www.readbyqxmd.com/read/28342682/a-home-program-of-strength-training-movement-strategy-training-and-education-did-not-prevent-falls-in-people-with-parkinson-s-disease-a-randomised-trial
#15
Meg E Morris, Nicholas F Taylor, Jennifer Watts, Andrew Evans, Malcolm Horne, Peter Kempster, Mary Danoudis, Jennifer J McGinley, Clarissa Martin, Hylton B Menz
QUESTIONS: For people with idiopathic Parkinson's disease, does a 6-week, comprehensive, home exercise program reduce falls and disability and improve health-related quality of life? Is the program cost-effective? DESIGN: Randomised, controlled trial with concealed allocation and assessor blinding. PARTICIPANTS: One hundred and thirty-three community-dwelling adults with Parkinson's disease. INTERVENTION: The experimental group completed a 6-week home program comprising progressive resistance strength training, movement strategy training and falls education...
March 14, 2017: Journal of Physiotherapy
https://www.readbyqxmd.com/read/28342389/pilot-randomised-controlled-trial-comparing-the-risk-of-neonatal-respiratory-distress-in-elective-caesarean-section-at-38-weeks-gestation-following-a-course-of-corticosteroids-versus-caesarean-at-39-weeks
#16
Nicolas Sananès, Antoine Koch, Benoît Escande, Germain Aissi, Gabrielle Fritz, Emmanuel Roth, Michèle Weil, Ahmad Bakri, Chantal Bolender, Nicolas Meyer, Christophe Vayssiere, Adrien Gaudineau, Israël Nisand, Romain Favre, Pierre Kuhn, Bruno Langer
INTRODUCTION: The objective of this study was to compare neonatal respiratory morbidity and rate of emergency caesarean section between elective caesarean sections at 38 gestational weeks following a course of corticosteroids and planned caesarean sections at 39 gestational weeks. MATERIAL AND METHODS: This was a multicentre randomised controlled trial. The study was conducted between 2007 and 2013 in level 2 and 3 maternity units in France. A total of 208 women with an indication for elective caesarean section were enrolled and 200 analysed in per-protocol analysis...
March 10, 2017: European Journal of Obstetrics, Gynecology, and Reproductive Biology
https://www.readbyqxmd.com/read/28342113/crizotinib-for-untreated-anaplastic-lymphoma-kinase-positive-non-small-cell-lung-cancer-an-evidence-review-group-perspective-of-a-nice-single-technology-appraisal
#17
REVIEW
Philip Morgan, Nerys Woolacott, Mousumi Biswas, Teumzghi Mebrahtu, Melissa Harden, Robert Hodgson
As part of the National Institute for Health and Care Excellence (NICE) single technology appraisal process, the manufacturer of crizotinib submitted evidence on the clinical and cost effectiveness of crizotinib in untreated anaplastic lymphoma kinase-positive (ALK-positive) non-small-cell lung cancer (NSCLC). Crizotinib has previously been assessed by NICE for patients with previously treated ALK-positive NSCLC (TA 296). It was not approved in this previous appraisal, but had been made available through the cancer drugs fund...
March 24, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/28341726/rest-and-treatment-rehabilitation-following-sport-related-concussion-a-systematic-review
#18
REVIEW
Kathryn J Schneider, John J Leddy, Kevin M Guskiewicz, Tad Seifert, Michael McCrea, Noah D Silverberg, Nina Feddermann-Demont, Grant L Iverson, Alix Hayden, Michael Makdissi
AIM OR OBJECTIVE: The objective of this systematic review was to evaluate the evidence regarding rest and active treatment/rehabilitation following sport-related concussion (SRC). DESIGN: Systematic review. DATA SOURCES: MEDLINE (OVID), CINAHL (EbscoHost), PsycInfo (OVID), Cochrane Central Register of Controlled Trials (OVID), SPORTDiscus (EbscoHost), EMBASE (OVID) and Proquest DissertationsandTheses Global (Proquest) were searched systematically...
March 24, 2017: British Journal of Sports Medicine
https://www.readbyqxmd.com/read/28341688/global-cardiovascular-risk-assessment-in-the-primary-prevention-of-cardiovascular-disease-in-adults-systematic-review-of-systematic-reviews
#19
Dylan R J Collins, Alice C Tompson, Igho J Onakpoya, Nia Roberts, Alison M Ward, Carl J Heneghan
OBJECTIVE: To identify, critically appraise and summarise existing systematic reviews on the impact of global cardiovascular risk assessment in the primary prevention of cardiovascular disease (CVD) in adults. DESIGN: Systematic review of systematic reviews published between January 2005 and October 2016 in The Cochrane Library, EMBASE, MEDLINE or CINAHL databases, and post hoc analysis of primary trials. PARTICIPANTS, INTERVENTIONS, OUTCOMES: Systematic reviews of interventions involving global cardiovascular risk assessment relative to no formal risk assessment in adults with no history of CVD...
March 24, 2017: BMJ Open
https://www.readbyqxmd.com/read/28341515/computerised-interpretation-of-fetal-heart-rate-during-labour-infant-a-randomised-controlled-trial
#20
(no author information available yet)
BACKGROUND: Continuous electronic fetal heart-rate monitoring is widely used during labour, and computerised interpretation could increase its usefulness. We aimed to establish whether the addition of decision-support software to assist in the interpretation of cardiotocographs affected the number of poor neonatal outcomes. METHODS: In this unmasked randomised controlled trial, we recruited women in labour aged 16 years or older having continuous electronic fetal monitoring, with a singleton or twin pregnancy, and at 35 weeks' gestation or more at 24 maternity units in the UK and Ireland...
March 21, 2017: Lancet
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