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https://www.readbyqxmd.com/read/29779247/randomised-controlled-trials-define-shape-of-dose-response-for-pollinex-quattro-birch-allergoid-immunotherapy
#1
Margitta Worm, Tim Higenbottam, Oliver Pfaar, Ralph Mösges, Werner Aberer, Kulasiri Gunawardena, Dorothea Wessiepe, Denise Lee, Matthias F Kramer, Murray Skinner, Bev Lees, Stefan Zielen
BACKGROUND: The Birch Allergoid, Tyrosine Adsorbate, Monophosphoryl Lipid A (POLLINEX® Quattro Plus 1.0 ml Birch 100%) is an effective, well-tolerated short course subcutaneous immunotherapy. We performed two phase II studies to determine its optimal cumulative dose. METHODS: The studies were conducted in Germany, Austria and Poland (EudraCT numbers: 2012-004336-28 PQBirch203 and 2015-000984-15 PQBirch204) using a wide range of cumulative doses. In both studies, subjects were administered 6 therapy injections weekly outside the pollen season...
May 19, 2018: Allergy
https://www.readbyqxmd.com/read/29778737/cancer-immunotherapy-efficacy-and-patients-sex-a-systematic-review-and-meta-analysis
#2
Fabio Conforti, Laura Pala, Vincenzo Bagnardi, Tommaso De Pas, Marco Martinetti, Giuseppe Viale, Richard D Gelber, Aron Goldhirsch
BACKGROUND: Despite the acknowledged sex-related dimorphism in immune system response, little is known about the effect of patients' sex on the efficacy of immune checkpoint inhibitors as cancer treatments. We did a systematic review and meta-analysis to assess the heterogeneity of immune checkpoint inhibitor efficacy between men and women. METHODS: We systematically searched PubMed, MEDLINE, Embase, and Scopus, from database inception to Nov 30, 2017, for randomised controlled trials of immune checkpoint inhibitors (inhibitors of PD-1, CTLA-4, or both) that had available hazard ratios (HRs) for death according to patients' sex...
May 16, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29778403/the-cf-sputum-induction-trial-cf-spit-to-assess-lower-airway-bacterial-sampling-in-young-children-with-cystic-fibrosis-a-prospective-internally-controlled-interventional-trial
#3
Katherine Ronchetti, Jo-Dee Tame, Christopher Paisey, Lena P Thia, Iolo Doull, Robin Howe, Eshwar Mahenthiralingam, Julian T Forton
BACKGROUND: Pathogen surveillance is challenging but crucial in children with cystic fibrosis-who are often non-productive of sputum even if actively coughing-because infection and lung disease begin early in life. The role of sputum induction as a diagnostic tool for infection has not previously been systematically addressed in young children with cystic fibrosis. We aimed to assess the pathogen yield from sputum induction compared with that from cough swab and single-lobe, two-lobe, and six-lobe bronchoalveolar lavage...
May 16, 2018: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/29778364/prevention-of-cardiovascular-events-in-asian-patients-with-ischaemic-stroke-at-high-risk-of-cerebral-haemorrhage-picasso-a-multicentre-randomised-controlled-trial
#4
Bum Joon Kim, Eun-Jae Lee, Sun U Kwon, Jong-Ho Park, Yong-Jae Kim, Keun-Sik Hong, Lawrence K S Wong, Sungwook Yu, Yang-Ha Hwang, Ji Sung Lee, Juneyoung Lee, Joung-Ho Rha, Sung Hyuk Heo, Sung Hwan Ahn, Woo-Keun Seo, Jong-Moo Park, Ju-Hun Lee, Jee-Hyun Kwon, Sung-Il Sohn, Jin-Man Jung, Jose C Navarro, Dong-Wha Kang
BACKGROUND: The optimal treatment for patients with ischaemic stroke with a high risk of cerebral haemorrhage is unclear. We assessed the efficacy and safety of cilostazol versus aspirin, with and without probucol, in these patients. METHODS: In this randomised, controlled, 2 × 2 factorial trial, we enrolled patients with ischaemic stroke with a history of or imaging findings of intracerebral haemorrhage or two or more microbleeds from 67 centres in three Asian countries...
June 2018: Lancet Neurology
https://www.readbyqxmd.com/read/29778344/impact-of-clinical-pharmacist-engagement-in-ward-teams-on-the-number-of-drug-related-readmissions-among-swedish-older-patients-with-dementia-or-cognitive-impairment-an-economic-evaluation
#5
Maria Sjölander, Lars Lindholm, Bettina Pfister, Jeanette Jonsson, Jörn Schneede, Hugo Lövheim, Maria Gustafsson
BACKGROUND: Clinical pharmacists play an increasing role in the pharmacological treatment of hospital-admitted older patients with dementia or cognitive impairment. In an earlier randomised controlled trial, clinical pharmacist involvement in the ward team could significantly reduce drug-related readmissions in patient subgroups. However, the economic impact of the intervention has not been addressed so far. OBJECTIVES: To evaluate the economic impact of clinical pharmacist engagement in hospital ward teams for medication therapy management in older patients with dementia or cognitive impairments...
May 16, 2018: Research in Social & Administrative Pharmacy: RSAP
https://www.readbyqxmd.com/read/29778325/tranexamic-acid-for-hyperacute-primary-intracerebral-haemorrhage-tich-2-an-international-randomised-placebo-controlled-phase-3-superiority-trial
#6
Nikola Sprigg, Katie Flaherty, Jason P Appleton, Rustam Al-Shahi Salman, Daniel Bereczki, Maia Beridze, Hanne Christensen, Alfonso Ciccone, Ronan Collins, Anna Czlonkowska, Robert A Dineen, Lelia Duley, Juan Jose Egea-Guerrero, Timothy J England, Kailash Krishnan, Ann Charlotte Laska, Zhe Kang Law, Serefnur Ozturk, Stuart J Pocock, Ian Roberts, Thompson G Robinson, Christine Roffe, David Seiffge, Polly Scutt, Jegan Thanabalan, David Werring, David Whynes, Philip M Bath
BACKGROUND: Tranexamic acid can prevent death due to bleeding after trauma and post-partum haemorrhage. We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in adults with stroke due to intracerebral haemorrhage. METHODS: We did an international, randomised placebo-controlled trial in adults with intracerebral haemorrhage from acute stroke units at 124 hospital sites in 12 countries. Participants were randomly assigned (1:1) to receive 1 g intravenous tranexamic acid bolus followed by an 8 h infusion of 1 g tranexamic acid or a matching placebo, within 8 h of symptom onset...
May 15, 2018: Lancet
https://www.readbyqxmd.com/read/29777632/predictor-factors-for-long-term-outcomes-stability-of-coronally-advanced-flap-with-or-without-connective-tissue-graft-in-the-treatment-of-single-maxillary-gingival-recessions-9-years-results-of-a-randomised-controlled-clinical-trial
#7
Giulio Rasperini, Raffaele Acunzo, Gaia Pellegrini, Giorgio Pagni, Maurizio Tonetti, Giovan Paolo Pini Prato, Pierpaolo Cortellini
AIM: To assess the clinical outcomes 9 years after the surgical treatment of single maxillary gingival recessions and identify predictors for long-term gingival margin stability. MATERIALS AND METHODS: Twenty-five gingival recession (Miller Class I and II) were randomly treated with CAF plus CTG or CAF alone. Outcomes included Complete Root Coverage (CRC), Recession Reduction (REC), Keratinized Tissue (KT) gain and dentin hypersensitivity, and were evaluated at 6-month, 1-year and 9-year...
May 19, 2018: Journal of Clinical Periodontology
https://www.readbyqxmd.com/read/29777625/is-methotrexate-an-effective-and-safe-treatment-for-maintaining-hair-regrowth-in-people-with-alopecia-totalis-a-critically-appraised-topic
#8
R Browne, L Stewart, H C Williams
AIM: To assess the effects of methotrexate for maintaining hair regrowth in alopecia totalis. METHODS: We critically appraised the literature identified from searching PubMed, Ovid MEDLINE, Ovid Embase and Cochrane Central (October 2017), using the search terms ("alopecia areata" OR "alopecia totalis" OR "alopecia universalis") AND (methotrexate). RESULTS: Two prospective studies and 11 retrospective case series were included comprising 226 patients with alopecia varying from 30% hair loss to alopecia universalis at baseline...
May 19, 2018: British Journal of Dermatology
https://www.readbyqxmd.com/read/29777534/is-it-necessary-to-have-a-dentist-within-an-intensive-care-unit-team-report-of-a-randomised-clinical-trial
#9
Wanessa Teixeira Bellissimo-Rodrigues, Mayra Gonçalves Menegueti, Gilberto Gambero Gaspar, Hayala Cristina Cavenague de Souza, Maria Auxiliadora-Martins, Anibal Basile-Filho, Roberto Martinez, Fernando Bellissimo-Rodrigues
OBJECTIVE: To evaluate the effectiveness of dental treatment in improving oral health in critical patients. METHODS: This randomised clinical trial was conducted in a general intensive care unit (ICU) at a tertiary care public facility from 1 January 2011 to 8 August 2013. Data from 254 adult patients staying in the ICU for 48 hours or more were analysed. The experimental group (n = 127) had access to dental treatment provided by a dentist four to five times a week, in addition to routine oral hygiene, whereas the control group (n = 127) had access only to routine oral hygiene, including topical application of chlorhexidine, provided by the ICU nursing staff...
May 18, 2018: International Dental Journal
https://www.readbyqxmd.com/read/29777264/empagliflozin-reduces-cardiovascular-events-mortality-and-renal-events-in-participants-with-type-2-diabetes-after-coronary-artery-bypass-graft-surgery-subanalysis-of-the-empa-reg-outcome%C3%A2-randomised-trial
#10
Subodh Verma, C David Mazer, David Fitchett, Silvio E Inzucchi, Egon Pfarr, Jyothis T George, Bernard Zinman
AIMS/HYPOTHESIS: After coronary artery bypass graft (CABG) surgery in individuals with type 2 diabetes, there remains a considerable residual cardiovascular risk. In the EMPA-REG OUTCOME® trial in participants with type 2 diabetes and established cardiovascular disease, empagliflozin reduced the risk of cardiovascular death by 38%, all-cause mortality by 32%, hospitalisation for heart failure by 35% and incident or worsening nephropathy by 39% vs placebo when given in addition to standard of care...
May 19, 2018: Diabetologia
https://www.readbyqxmd.com/read/29776950/clinical-effects-and-safety-of-electroacupuncture-for-the-treatment-of-post-stroke-depression-a-systematic-review-and-meta-analysis-of-randomised-controlled-trials
#11
Xue-Bin Li, Jie Wang, An-Ding Xu, Jian-Min Huang, Lan-Qing Meng, Rui-Ya Huang, Jing Xu
OBJECTIVE: The aim of this systematic review was to assess the efficacy/effectiveness and safety of electroacupuncture (EA) in the treatment of post-stroke depression (PSD). METHODS: A comprehensive literature search in the Pubmed, Embase, CENTRAL, ISI Web of Science, CNKI and Wanfang databases was conducted, and all relevant randomised controlled trials (RCTs) were screened for eligibility by two independent reviewers. The Cochrane Collaboration's tool and Jadad score were used to assess the risk of bias of included studies, and only RCTs scoring ≥3 were included in a meta-analysis...
May 18, 2018: Acupuncture in Medicine: Journal of the British Medical Acupuncture Society
https://www.readbyqxmd.com/read/29776919/behaviour-modification-interventions-to-optimise-red-blood-cell-transfusion-practices-a-systematic-review-and-meta-analysis
#12
Lesley J J Soril, Thomas W Noseworthy, Laura E Dowsett, Katherine Memedovich, Hannah M Holitzki, Diane L Lorenzetti, Henry Thomas Stelfox, David A Zygun, Fiona M Clement
OBJECTIVE: To assess the impact of behaviour modification interventions to promote restrictive red blood cell (RBC) transfusion practices. DESIGN: Systematic review and meta-analysis. SETTING, PARTICIPANTS, INTERVENTIONS: Seven electronic databases were searched to January 2018. Published randomised controlled trials (RCTs) or non-randomised studies examining an intervention to modify healthcare providers' RBC transfusion practice in any healthcare setting were included...
May 18, 2018: BMJ Open
https://www.readbyqxmd.com/read/29776895/islet-transplantation-versus-insulin-therapy-in-patients-with-type-1-diabetes-with-severe-hypoglycaemia-or-poorly-controlled-glycaemia-after-kidney-transplantation-trimeco-a-multicentre-randomised-controlled-trial
#13
Sandrine Lablanche, Marie-Christine Vantyghem, Laurence Kessler, Anne Wojtusciszyn, Sophie Borot, Charles Thivolet, Sophie Girerd, Domenico Bosco, Jean-Luc Bosson, Cyrille Colin, Rachel Tetaz, Sophie Logerot, Julie Kerr-Conte, Eric Renard, Alfred Penfornis, Emmanuel Morelon, Fanny Buron, Kristina Skaare, Gwen Grguric, Coralie Camillo-Brault, Harald Egelhofer, Kanza Benomar, Lionel Badet, Thierry Berney, François Pattou, Pierre-Yves Benhamou
BACKGROUND: Islet transplantation is indicated for patients with type 1 diabetes with severe hypoglycaemia or after kidney transplantation. We did a randomised trial to assess the efficacy and safety of islet transplantation compared with insulin therapy in these patients. METHODS: In this multicentre, open-label, randomised controlled trial, we randomly assigned (1:1) patients with type 1 diabetes at 15 university hospitals to receive immediate islet transplantation or intensive insulin therapy (followed by delayed islet transplantation)...
May 15, 2018: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/29776475/a-systematic-review-of-the-psychometric-properties-of-the-modified-behavioral-pain-scale-mbps
#14
REVIEW
Dianne J Crellin, Franz E Babl, Nick Santamaria, Denise Harrison
PROBLEM: Clinicians and researchers require a valid way to assess procedural pain experienced by infants and children. The Modified Behavioral Pain Scale (MBPS) has been used to assess immunisation pain. However, it is unknown whether it is valid for this purpose and whether use can be extended to other procedures. The aim of this study was to rigorously assess evidence addressing the psychometric properties of this scale and to provide recommendations for its use. ELIGIBILITY CRITERIA: Psychometric evaluation studies reporting feasibility, reliability, validity, or utility data for the MBPS applied to children (birth to 18years) and randomised controlled trials (RCT) using the MBPS were included...
May 2018: Journal of Pediatric Nursing
https://www.readbyqxmd.com/read/29776444/mediastinal-staging-of-non-small-cell-lung-cancer-by-endobronchial-and-endoscopic-ultrasonography-with-or-without-additional-surgical-mediastinoscopy-mediastrial-study-protocol-of-a-multicenter-randomised-controlled-trial
#15
Jelle E Bousema, Marcel G W Dijkgraaf, Nicole E Papen-Botterhuis, Hermien W Schreurs, Jos G Maessen, Erik H van der Heijden, Willem H Steup, Jerry Braun, Valentin J J M Noyez, Fieke Hoeijmakers, Naomi Beck, Martijn van Dorp, Niels J M Claessens, Birgitta I Hiddinga, Johannes M A Daniels, David J Heineman, Harmen R Zandbergen, Ad F T M Verhagen, Paul E van Schil, Jouke T Annema, Frank J C van den Broek
BACKGROUND: In case of suspicious lymph nodes on computed tomography (CT) or fluorodeoxyglucose positron emission tomography (FDG-PET), advanced tumour size or central tumour location in patients with suspected non-small cell lung cancer (NSCLC), Dutch and European guidelines recommend mediastinal staging by endosonography (endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS)) with sampling of mediastinal lymph nodes. If biopsy results from endosonography turn out negative, additional surgical staging of the mediastinum by mediastinoscopy is advised to prevent unnecessary lung resection due to false negative endosonography findings...
May 18, 2018: BMC Surgery
https://www.readbyqxmd.com/read/29776434/choice-of-outcomes-and-measurement-instruments-in-randomised-trials-on-elearning-in-medical-education-a-systematic-mapping-review-protocol
#16
Gloria C Law, Christian Apfelbacher, Pawel P Posadzki, Sandra Kemp, Lorainne Tudor Car
BACKGROUND: There will be a lack of 18 million healthcare workers by 2030. Multiplying the number of well-trained healthcare workers through innovative ways such as eLearning is highly recommended in solving this shortage. However, high heterogeneity of learning outcomes in eLearning systematic reviews reveals a lack of consistency and agreement on core learning outcomes in eLearning for medical education. In addition, there seems to be a lack of validity evidence for measurement instruments used in these trials...
May 17, 2018: Systematic Reviews
https://www.readbyqxmd.com/read/29776399/simulation-based-power-calculations-for-planning-a-two-stage-individual-participant-data-meta-analysis
#17
Joie Ensor, Danielle L Burke, Kym I E Snell, Karla Hemming, Richard D Riley
BACKGROUND: Researchers and funders should consider the statistical power of planned Individual Participant Data (IPD) meta-analysis projects, as they are often time-consuming and costly. We propose simulation-based power calculations utilising a two-stage framework, and illustrate the approach for a planned IPD meta-analysis of randomised trials with continuous outcomes where the aim is to identify treatment-covariate interactions. METHODS: The simulation approach has four steps: (i) specify an underlying (data generating) statistical model for trials in the IPD meta-analysis; (ii) use readily available information (e...
May 18, 2018: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/29776349/randomised-controlled-trial-rct-of-cannabinoid-replacement-therapy-nabiximols-for-the-management-of-treatment-resistant-cannabis-dependent-patients-a-study-protocol
#18
Anjali K Bhardwaj, David J Allsop, Jan Copeland, Iain S McGregor, Adrian Dunlop, Marian Shanahan, Raimondo Bruno, Nghi Phung, Mark Montebello, Craig Sadler, Jessica Gugusheff, Melissa Jackson, Jennifer Luksza, Nicholas Lintzeris
BACKGROUND: The cannabis extract nabiximols (Sativex®) effectively supresses withdrawal symptoms and cravings in treatment resistant cannabis dependent individuals, who have high relapse rates following conventional withdrawal treatments. This study examines the efficacy, safety and cost-effectiveness of longer-term nabiximols treatment for outpatient cannabis dependent patients who have not responded to previous conventional treatment approaches. METHODS/DESIGN: A phase III multi-site outpatient, randomised, double-blinded, placebo controlled parallel design, comparing a 12-week course of nabiximols to placebo, with follow up at 24 weeks after enrolment...
May 18, 2018: BMC Psychiatry
https://www.readbyqxmd.com/read/29775878/repositioning-of-diabetes-treatments-for-depressive-symptoms-a-systematic-review-and-meta-analysis-of-clinical-trials
#19
REVIEW
Calum D Moulton, Christopher W P Hopkins, Khalida Ismail, Daniel Stahl
Depression is a common comorbidity in diabetes but conventional antidepressant treatments do not consistently improve outcomes. We tested whether established diabetes treatments can also improve depressive symptoms and examined biological correlates of response. We performed a multi-database systematic search of all clinical trials, which measured the effect of licensed diabetes treatments on depressive symptoms using a validated questionnaire. Results of randomised controlled trials (RCT's) were pooled for meta-analysis...
May 7, 2018: Psychoneuroendocrinology
https://www.readbyqxmd.com/read/29775501/educational-interventions-for-improving-primary-caregiver-complementary-feeding-practices-for-children-aged-24-months-and-under
#20
REVIEW
Dachi Arikpo, Ededet Sewanu Edet, Moriam T Chibuzor, Friday Odey, Deborah M Caldwell
BACKGROUND: Although complementary feeding is a universal practice, the methods and manner in which it is practiced vary between cultures, individuals and socioeconomic classes. The period of complementary feeding is a critical time of transition in the life of an infant, and inappropriate complementary feeding practices, with their associated adverse health consequences, remain a significant global public health problem. Educational interventions are widely acknowledged as effective in promoting public health strategy, and those aimed at improving complementary feeding practices provide information about proper complementary feeding practices to caregivers of infants/children...
May 18, 2018: Cochrane Database of Systematic Reviews
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