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https://www.readbyqxmd.com/read/28918534/do-surgical-helmet-systems-affect-intraoperative-wound-contamination-a-randomised-controlled-trial
#1
Otis C Shirley, Ali Bayan, Mark Zhu, James P Dalton, Siouxsie Wiles, Simon W Young
BACKGROUND: Deep infection following arthroplasty remains a devastating complication. Some registry data suggests that modern positive-pressure surgical helmet systems (SHS) are associated with a paradoxical increase in infection rates, and as such their role in arthroplasty remains unclear. The aim of this study was to investigate whether SHS increase wound contamination in total knee arthroplasty (TKA) and if this contamination can be reduced by placing tape around the gown/glove interface...
September 16, 2017: Archives of Orthopaedic and Trauma Surgery
https://www.readbyqxmd.com/read/28918414/a-protocol-of-a-cross-sectional-study-evaluating-an-online-tool-for-early-career-peer-reviewers-assessing-reports-of-randomised-controlled-trials
#2
Anthony Chauvin, David Moher, Doug Altman, David L Schriger, Sabina Alam, Sally Hopewell, Daniel R Shanahan, Alessandro Recchioni, Philippe Ravaud, Isabelle Boutron
INTRODUCTION: Systematic reviews evaluating the impact of interventions to improve the quality of peer review for biomedical publications highlighted that interventions were limited and have little impact. This study aims to compare the accuracy of early career peer reviewers who use an innovative online tool to the usual peer reviewer process in evaluating the completeness of reporting and switched primary outcomes in completed reports. METHODS AND ANALYSIS: This is a cross-sectional study of individual two-arm parallel-group randomised controlled trials (RCTs) published in the BioMed Central series medical journals, BMJ, BMJ Open and Annals of Emergency Medicine and indexed with the publication type 'Randomised Controlled Trial'...
September 15, 2017: BMJ Open
https://www.readbyqxmd.com/read/28918408/effectiveness-cost-utility-and-implementation-of-a-decision-aid-for-patients-with-localised-prostate-cancer-and-their-partners-study-protocol-of-a-stepped-wedge-cluster-randomised-controlled-trial
#3
Hoda H M Al-Itejawi, Cornelia F van Uden-Kraan, Peter M van de Ven, Veerle M H Coupé, André N Vis, Jakko A Nieuwenhuijzen, Jeroen A van Moorselaar, Irma M Verdonck-de Leeuw
INTRODUCTION: Patient decision aids (PDAs) have been developed to help patients make an informed choice for a treatment option. Despite proven benefits, structural implementation falls short of expectations. The present study aims to assess the effectiveness and cost-utility of the PDA among newly diagnosed patients with localised prostate cancer and their partners, alongside implementation of the PDA in routine care. METHODS/ANALYSIS: A stepped-wedge cluster randomised trial will be conducted...
September 15, 2017: BMJ Open
https://www.readbyqxmd.com/read/28918395/non-invasive-high-frequency-oscillatory-ventilation-in-preterm-infants-a-randomised-controlled-cross-over-trial
#4
Daniel Klotz, Hendryk Schneider, Stefan Schumann, Benjamin Mayer, Hans Fuchs
OBJECTIVE: Non-invasive high-frequency oscillatory ventilation (nHFOV) has recently been described as a novel mode of respiratory support for premature infants. This study was designed to determine whether nHFOV decreases CO2 partial pressure (pCO2) in premature infants more effectively than non-invasive continuous positive airway pressure (nCPAP). DESIGN: Non-blinded prospective randomised controlled cross-over study. SETTING: University Medical Center tertiary neonatal intensive care unit...
September 16, 2017: Archives of Disease in Childhood. Fetal and Neonatal Edition
https://www.readbyqxmd.com/read/28918381/assessing-decisional-capacity-for-research-participation-in-psychiatric-patients-and-their-relatives
#5
Donae Elizabeth George, Saumil Dholakia, Prathap Tharyan
A cross-sectional study among adult inpatients with non-organic psychiatric disorders, and among their key relatives, assessed their comprehension and recall of key information in consent forms. It also assessed their capacity to consent to participate in two hypothetical randomised controlled trials (RCTs) with different potential risks and burdens, using structured questionnaires and recorded interviews. Of the 24 participants (12 patient-key relative dyads), seven patients (58%) and three key relatives (25%) were clinically judged to lack the capacity to consent...
August 8, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28918315/does-cognitive-behavioural-therapy-for-insomnia-improve-cognitive-performance-a-systematic-review-and-narrative-synthesis
#6
REVIEW
Vanessa Herbert, Simon D Kyle, Daniel Pratt
Individuals with insomnia report difficulties pertaining to their cognitive functioning. Cognitive behavioural therapy for insomnia (CBT-I) is associated with robust, long-term improvements in sleep parameters, however less is known about the impact of CBT-I on the daytime correlates of the disorder. A systematic review and narrative synthesis was conducted in order to summarise and evaluate the evidence regarding the impact of CBT-I on cognitive functioning. Reference databases were searched and studies were included if they assessed cognitive performance as an outcome of CBT-I, using either self-report questionnaires or cognitive tests...
July 12, 2017: Sleep Medicine Reviews
https://www.readbyqxmd.com/read/28917657/oral-all-trans-retinoic-acid-plus-danazol-versus-danazol-as-second-line-treatment-in-adults-with-primary-immune-thrombocytopenia-a-multicentre-randomised-open-label-phase-2-trial
#7
Fei-Er Feng, Ru Feng, Min Wang, Jia-Min Zhang, Hao Jiang, Qian Jiang, Jin Lu, Hui Liu, Jun Peng, Ming Hou, Jian-Liang Shen, Jing-Wen Wang, Lan-Ping Xu, Kai-Yan Liu, Xiao-Jun Huang, Xiao-Hui Zhang
BACKGROUND: Primary immune thrombocytopenia is a severe bleeding disorder. About 50-85% of patients achieve initial remission from first-line therapies, but optimal second-line treatment remains a challenge. All-trans retinoic acid (ATRA) has an immunomodulatory effect on haemopoiesis, making it a possible treatment option. We aimed to evaluate the efficacy and safety of ATRA plus danazol versus danazol in non-splenectomised patients with corticosteroid-resistant or relapsed primary immune thrombocytopenia...
September 13, 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28917594/key-steps-in-conducting-systematic-reviews-for-underpinning-clinical-practice-guidelines-methodology-of-the-european-association-of-urology
#8
Thomas Knoll, Muhammad Imran Omar, Steven Maclennan, Virginia Hernández, Steven Canfield, Yuhong Yuan, Max Bruins, Lorenzo Marconi, Hein Van Poppel, James N'Dow, Richard Sylvester
CONTEXT: The findings of systematic reviews (SRs) and meta-analyses (MAs) are used for clinical decision making. The European Association of Urology has committed increasing resources into the development of high quality clinical guidelines based on such SRs and MAs. OBJECTIVE: In this paper, we have summarised the process of conducting SRs for underpinning clinical practice guidelines under the auspices of the European Association of Urology Guidelines Office. EVIDENCE ACQUISITION: The process involves explicit methods and the findings should be reproducible...
September 13, 2017: European Urology
https://www.readbyqxmd.com/read/28917545/effects-of-acarbose-on-cardiovascular-and-diabetes-outcomes-in-patients-with-coronary-heart-disease-and-impaired-glucose-tolerance-ace-a-randomised-double-blind-placebo-controlled-trial
#9
Rury R Holman, Ruth L Coleman, Juliana C N Chan, Jean-Louis Chiasson, Huimei Feng, Junbo Ge, Hertzel C Gerstein, Richard Gray, Yong Huo, Zhihui Lang, John J McMurray, Lars Rydén, Stefan Schröder, Yihong Sun, Michael J Theodorakis, Michal Tendera, Lynne Tucker, Jaakko Tuomilehto, Yidong Wei, Wenying Yang, Duolao Wang, Dayi Hu, Changyu Pan
BACKGROUND: The effect of the α-glucosidase inhibitor acarbose on cardiovascular outcomes in patients with coronary heart disease and impaired glucose tolerance is unknown. We aimed to assess whether acarbose could reduce the frequency of cardiovascular events in Chinese patients with established coronary heart disease and impaired glucose tolerance, and whether the incidence of type 2 diabetes could be reduced. METHODS: The Acarbose Cardiovascular Evaluation (ACE) trial was a randomised, double-blind, placebo-controlled, phase 4 trial, with patients recruited from 176 hospital outpatient clinics in China...
September 12, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28917544/effects-on-the-incidence-of-cardiovascular-events-of-the-addition-of-pioglitazone-versus-sulfonylureas-in-patients-with-type-2-diabetes-inadequately-controlled-with-metformin-tosca-it-a-randomised-multicentre-trial
#10
Olga Vaccaro, Maria Masulli, Antonio Nicolucci, Enzo Bonora, Stefano Del Prato, Aldo P Maggioni, Angela A Rivellese, Sebastiano Squatrito, Carlo B Giorda, Giorgio Sesti, Paolo Mocarelli, Giuseppe Lucisano, Michele Sacco, Stefano Signorini, Fabrizio Cappellini, Gabriele Perriello, Anna Carla Babini, Annunziata Lapolla, Giovanna Gregori, Carla Giordano, Laura Corsi, Raffaella Buzzetti, Gennaro Clemente, Graziano Di Cianni, Rossella Iannarelli, Renzo Cordera, Olga La Macchia, Chiara Zamboni, Cristiana Scaranna, Massimo Boemi, Ciro Iovine, Davide Lauro, Sergio Leotta, Elisabetta Dall'Aglio, Emanuela Cannarsa, Laura Tonutti, Giuseppe Pugliese, Antonio C Bossi, Roberto Anichini, Francesco Dotta, Antonino Di Benedetto, Giuseppe Citro, Daniela Antenucci, Lucia Ricci, Francesco Giorgino, Costanza Santini, Agostino Gnasso, Salvatore De Cosmo, Donatella Zavaroni, Monica Vedovato, Agostino Consoli, Maria Calabrese, Paolo di Bartolo, Paolo Fornengo, Gabriele Riccardi
BACKGROUND: The best treatment option for patients with type 2 diabetes in whom treatment with metformin alone fails to achieve adequate glycaemic control is debated. We aimed to compare the long-term effects of pioglitazone versus sulfonylureas, given in addition to metformin, on cardiovascular events in patients with type 2 diabetes. METHODS: TOSCA.IT was a multicentre, randomised, pragmatic clinical trial, in which patients aged 50-75 years with type 2 diabetes inadequately controlled with metformin monotherapy (2-3 g per day) were recruited from 57 diabetes clinics in Italy...
September 12, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28917378/chinese-herbal-medicine-dengzhan-xixin-injection-for-acute-ischemic-stroke-a-systematic-review-and-meta-analysis-of-randomised-controlled-trials
#11
REVIEW
Jin-Gen Li, Li-Qiong Wang, Xiao-Ying Yang, Zhuo Chen, Lily Y W Lai, Hao Xu, Jian-Ping Liu
OBJECTIVE: To evaluate the effectiveness and safety of Chinese herbal medicine Dengzhan Xixin (Erigeron breviscapus) injection for acute ischemic stroke. DESIGN: Systematic review and meta-analysis (CRD42016038413, http://www.crd.york.ac.uk/PROSPERO). METHODS: Six electronic databases were searched from inception to March 2016 for randomised controlled trials (RCTs) of Dengzhan Xixin (DZXX) injection for acute ischemic stroke. The methodological quality of RCTs was assessed by the Cochrane risk of bias tool...
October 2017: Complementary Therapies in Medicine
https://www.readbyqxmd.com/read/28917231/portion-controlled-ready-to-eat-meal-replacement-is-associated-with-short-term-weight-loss-a-randomised-controlled-trial
#12
Rebecca Kuriyan, Deepa P Lokesh, Ninoshka D'Souza, Divya J Priscilla, Chandni Halcyon Peris, Sumithra Selvam, Anura V Kurpad
BACKGROUND AND OBJECTIVES: Strategies to prevent and treat overweight/obesity are urgently needed. This study assessed the effect of a short-term intake of ready-to-eat cereal on body weight and waist circumference of overweight/obese individuals in comparison to a control group. METHODS AND STUDY DESIGN: A randomized, controlled 2-arm trial was carried out on 101 overweight/obese (Body Mass Index - 29.2±2.4 kg/m2) females aged 18 to 44 years, at St. John's Medical College Hospital...
2017: Asia Pacific Journal of Clinical Nutrition
https://www.readbyqxmd.com/read/28917230/energy-restriction-combined-with-green-coffee-bean-extract-affects-serum-adipocytokines-and-the-body-composition-in-obese-women
#13
Fatemeh Haidari, Mehnoosh Samadi, Majid Mohammadshahi, Mohammad Taha Jalali, Kambiz Ahmadi Engali
BACKGROUND AND OBJECTIVES: Obesity has become a public health problem and is a cause of some preventable illnesses. Among several methods for treating obesity, the use of food supplements is highly common. A commonly used food supplement is green coffee bean extract. The objective of this study was to evaluate the efficacy of green coffee bean extract combined with an energy-restricted diet on the body composition and serum adipocytokines in obese women. METHODS AND STUDY DESIGN: In this randomised clinical trial, 64 obese women aged 20-45 years were selected and divided into two groups: an intervention group (receiving 400 mg green coffee bean extract for 8 weeks) and control group (receiving placebo)...
2017: Asia Pacific Journal of Clinical Nutrition
https://www.readbyqxmd.com/read/28916992/longevity-of-daily-oral-vitamin-d3-supplementation-differences-in-25ohd-and-24-25-oh-2d-observed-2%C3%A2-years-after-cessation-of-a-1-year-randomised-controlled-trial-victory-recall
#14
H M Macdonald, A Gryka, J C Y Tang, L S Aucott, W D Fraser, A D Wood
To determine how long vitamin D lasts after supplementation ceases, the marker of status was measured 2 and 3 years after a 1-year trial. Compared to placebo, the proportion of vitamin D-deficient women was still lower, if they had taken daily vitamin D3, after 2 years, indicating its longevity. INTRODUCTION: The purpose of this study was to determine longevity of vitamin D status following cessation of vitamin D3 supplementation, 2 and 3 years after a 1-year randomised, double-blind placebo controlled trial and to investigate possible predictive factors...
September 15, 2017: Osteoporosis International
https://www.readbyqxmd.com/read/28916443/aq-13-an-investigational-antimalarial-versus-artemether-plus-lumefantrine-for-the-treatment-of-uncomplicated-plasmodium-falciparum-malaria-a-randomised-phase-2-non-inferiority-clinical-trial
#15
Ousmane A Koita, Lansana Sangaré, Haiyan D Miller, Aliou Sissako, Moctar Coulibaly, Trevor A Thompson, Saharé Fongoro, Youssouf Diarra, Mamadou Ba, Ababacar Maiga, Boubakar Diallo, David M Mushatt, Frances J Mather, Jeffrey G Shaffer, Asif H Anwar, Donald J Krogstad
BACKGROUND: Chloroquine was used for malaria treatment until resistant Plasmodium falciparum was identified. Because 4-aminoquinolines with modified side chains, such as AQ-13, are active against resistant parasites, we compared AQ-13 against artemether plus lumefantrine for treatment of uncomplicated P falciparum malaria. METHODS: We did a randomised, non-inferiority trial. We screened men (≥18 years) with uncomplicated malaria in Missira (northeast Mali) and Bamako (capital of Mali) for eligibility (≥2000 asexual P falciparum parasites per μL of blood)...
September 12, 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28916371/ramucirumab-plus-docetaxel-versus-placebo-plus-docetaxel-in-patients-with-locally-advanced-or-metastatic-urothelial-carcinoma-after-platinum-based-therapy-range-a-randomised-double-blind-phase-3-trial
#16
Daniel P Petrylak, Ronald de Wit, Kim N Chi, Alexandra Drakaki, Cora N Sternberg, Hiroyuki Nishiyama, Daniel Castellano, Syed Hussain, Aude Fléchon, Aristotelis Bamias, Evan Y Yu, Michiel S van der Heijden, Nobuaki Matsubara, Boris Alekseev, Andrea Necchi, Lajos Géczi, Yen-Chuan Ou, Hasan Senol Coskun, Wen-Pin Su, Miriam Hegemann, Ivor J Percent, Jae-Lyun Lee, Marcello Tucci, Andrey Semenov, Fredrik Laestadius, Avivit Peer, Giampaolo Tortora, Sufia Safina, Xavier Garcia Del Muro, Alejo Rodriguez-Vida, Irfan Cicin, Hakan Harputluoglu, Ryan C Widau, Astra M Liepa, Richard A Walgren, Oday Hamid, Annamaria H Zimmermann, Katherine M Bell-McGuinn, Thomas Powles
BACKGROUND: Few treatments with a distinct mechanism of action are available for patients with platinum-refractory advanced or metastatic urothelial carcinoma. We assessed the efficacy and safety of treatment with docetaxel plus either ramucirumab-a human IgG1 VEGFR-2 antagonist-or placebo in this patient population. METHODS: We did a randomised, double-blind, phase 3 trial in patients with advanced or metastatic urothelial carcinoma who progressed during or after platinum-based chemotherapy...
September 12, 2017: Lancet
https://www.readbyqxmd.com/read/28916367/rucaparib-maintenance-treatment-for-recurrent-ovarian-carcinoma-after-response-to-platinum-therapy-ariel3-a-randomised-double-blind-placebo-controlled-phase-3-trial
#17
Robert L Coleman, Amit M Oza, Domenica Lorusso, Carol Aghajanian, Ana Oaknin, Andrew Dean, Nicoletta Colombo, Johanne I Weberpals, Andrew Clamp, Giovanni Scambia, Alexandra Leary, Robert W Holloway, Margarita Amenedo Gancedo, Peter C Fong, Jeffrey C Goh, David M O'Malley, Deborah K Armstrong, Jesus Garcia-Donas, Elizabeth M Swisher, Anne Floquet, Gottfried E Konecny, Iain A McNeish, Clare L Scott, Terri Cameron, Lara Maloney, Jeff Isaacson, Sandra Goble, Caroline Grace, Thomas C Harding, Mitch Raponi, James Sun, Kevin K Lin, Heidi Giordano, Jonathan A Ledermann
BACKGROUND: Rucaparib, a poly(ADP-ribose) polymerase inhibitor, has anticancer activity in recurrent ovarian carcinoma harbouring a BRCA mutation or high percentage of genome-wide loss of heterozygosity. In this trial we assessed rucaparib versus placebo after response to second-line or later platinum-based chemotherapy in patients with high-grade, recurrent, platinum-sensitive ovarian carcinoma. METHODS: In this randomised, double-blind, placebo-controlled, phase 3 trial, we recruited patients from 87 hospitals and cancer centres across 11 countries...
September 12, 2017: Lancet
https://www.readbyqxmd.com/read/28916311/lenalidomide-maintenance-after-first-line-therapy-for-high-risk-chronic-lymphocytic-leukaemia-cllm1-final-results-from-a-randomised-double-blind-phase-3-study
#18
Anna Maria Fink, Jasmin Bahlo, Sandra Robrecht, Othman Al-Sawaf, Ali Aldaoud, Holger Hebart, Kathleen Jentsch-Ullrich, Steffen Dörfel, Kirsten Fischer, Clemens-Martin Wendtner, Thomas Nösslinger, Paolo Ghia, Francesc Bosch, Arnon P Kater, Hartmut Döhner, Michael Kneba, Karl-Anton Kreuzer, Eugen Tausch, Stephan Stilgenbauer, Matthias Ritgen, Sebastian Böttcher, Barbara Eichhorst, Michael Hallek
BACKGROUND: The combined use of genetic markers and detectable minimal residual disease identifies patients with chronic lymphocytic leukaemia with poor outcome after first-line chemoimmunotherapy. We aimed to assess lenalidomide maintenance therapy in these high-risk patients. METHODS: In this randomised, double-blind, phase 3 study (CLLM1; CLL Maintenance 1 of the German CLL Study Group), patients older than 18 years and diagnosed with immunophenotypically confirmed chronic lymphocytic leukaemia with active disease, who responded to chemoimmunotherapy 2-5 months after completion of first-line therapy and who were assessed as having a high risk for an early progression with at least a partial response after four or more cycles of first-line chemoimmunotherapy, were eligible if they had high minimal residual disease levels or intermediate levels combined with an unmutated IGHV gene status or TP53 alterations...
September 12, 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28916306/end-to-side-versus-side-to-side-anastomosis-in-upper-limb-arteriovenous-fistula-for-dialysis-access-a-systematic-review-and-a-meta-analysis
#19
Khalid Bashar, Mekki Medani, Hiba Bashar, Khalid Ahmed, Thomas Aherne, Tony Moloney, Stewart R Walsh
OBJECTIVES: To systematically assess the difference between both procedures in terms of access maturation, patency and postoperative complications. BACKGROUND: An arteriovenous fistula (AVF) is the best modality for haemodialysis (HD) access. The end-to-side (ETS) technique has been suggested in the literature to produce superior results to the side-to-side approach; however, in the absence of a systematic review, this practice remains debatable. METHODS: Online search for randomised controlled trials (RCTs) and observational studies that compared the end-to-side versus the side-to-side anastomosis techniques in creating an upper limb AVF...
September 12, 2017: Annals of Vascular Surgery
https://www.readbyqxmd.com/read/28916164/-analysis-of-clinical-relevance-applied-to-3methods-of-reducing-weight-in-overweight-or-obesity-followed-up-for-one-year
#20
M L Tárraga Marcos, J M Panisello Royo, J A Carbayo Herencia, N Rosich Domenech, J Alins Presas, E Castell Panisello, P J Tárraga López
OBJECTIVE: To analyse the effect of the use/implementation of 3methods to reduce weight in overweight or obese patients during one year of follow up. MATERIAL AND METHODS: The design corresponds to a double-blind, randomised, controlled clinical trial with 3arms, and 12 months of follow-up. Patients were randomised into 3intervention groups: obesity motivational intervention, with a nurse previously trained in motivational intervention by expert psychologists (G1; n=60); lower intensity consultation, non-motivational group, with digital platform support (G2; N=61), and a third group that received recommendations for weight loss and follow-up in Primary Care Clinic (G3; n=59)...
September 12, 2017: Hipertensión y Riesgo Vascular
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