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Janus Christian Jakobsen, Christian Gluud, Jørn Wetterslev, Per Winkel
BACKGROUND: Missing data may seriously compromise inferences from randomised clinical trials, especially if missing data are not handled appropriately. The potential bias due to missing data depends on the mechanism causing the data to be missing, and the analytical methods applied to amend the missingness. Therefore, the analysis of trial data with missing values requires careful planning and attention. METHODS: The authors had several meetings and discussions considering optimal ways of handling missing data to minimise the bias potential...
December 6, 2017: BMC Medical Research Methodology
Anders Morten Grejs, Bent Roni Ranghøj Nielsen, Peter Juhl-Olsen, Jakob Gjedsted, Erik Sloth, Johan Heiberg, Christian Alcaraz Frederiksen, Anni Nørgaard Jeppesen, Christophe Henri Valdemar Duez, Per Dreyer Hamre, Eldar Søreide, Hans Kirkegaard
AIM: To evaluate post-cardiac arrest myocardial dysfunction during prolonged targeted temperature management (TTM) compared with standard TTM in comatose out-of-hospital cardiac arrest (OHCA) survivors. METHODS: A randomised, controlled trial comparing myocardial function after TTM at 33 ±1°C for 48h compared with 24h. A total of 105 OHCA patients were computer-randomised to 24h (n=50) or 48h (n=55) of TTM. Transthoracic echocardiography was performed after 24h, 48h and 72h...
June 2017: Resuscitation
Sarah J Arnup, Andrew B Forbes, Brennan C Kahan, Katy E Morgan, Joanne E McKenzie
BACKGROUND: The cluster randomised crossover (CRXO) design is gaining popularity in trial settings where individual randomisation or parallel group cluster randomisation is not feasible or practical. Our aim is to stimulate discussion on the content of a reporting guideline for CRXO trials and to assess the reporting quality of published CRXO trials. METHODS: We undertook a systematic review of CRXO trials. Searches of MEDLINE, EMBASE, and CINAHL Plus as well as citation searches of CRXO methodological articles were conducted to December 2014...
December 6, 2016: Trials
Lena V Nordheim, Malene W Gundersen, Birgitte Espehaug, Øystein Guttersrud, Signe Flottorp
BACKGROUND AND OBJECTIVE: Adolescents are frequent media users who access health claims from various sources. The plethora of conflicting, pseudo-scientific, and often misleading health claims in popular media makes critical appraisal of health claims an essential ability. Schools play an important role in educating youth to critically appraise health claims. The objective of this systematic review was to evaluate the effects of school-based educational interventions for enhancing adolescents' abilities in critically appraising health claims...
2016: PloS One
Maria Drakopoulou, Konstantinos Toutouzas, Konstantinos Stathogiannis, Andreas Synetos, George Trantalis, Dimitrios Tousoulis
Lipid profile management is even more critical in patients treated for secondary prevention, since patients with established coronary heart disease are at higher risk of developing events. Current guidelines encourage lifestyle modification and patient engagement in disease prevention. However, the American College of Cardiology/American Heart Association guidelines seem to differ considerably from their predecessors, having an impact on clinical practice of lipid management. Area covered: This review article discusses and provides a summary of the current recommendations for lipid profile management in patients with coronary heart disease, with a view to present lifestyle modification and novel treatment strategies, and to indicate areas of dispute among recent guidelines...
November 2016: Expert Review of Cardiovascular Therapy
Georgina Charlesworth, Karen Burnell, Nadia Crellin, Zoe Hoare, Juanita Hoe, Martin Knapp, Ian Russell, Jennifer Wenborn, Bob Woods, Martin Orrell
OBJECTIVE: The objective of this study was to evaluate peer support and reminiscence therapy, separately and together, in comparison with usual care for people with dementia and their family carers. DESIGN: Factorial pragmatic randomised trial, analysed by treatment allocated, was used for this study. SETTING: The trial ran in Community settings in England. PARTICIPANTS: People with dementia and their family carers were the participants...
November 2016: Journal of Neurology, Neurosurgery, and Psychiatry
Yanhong Deng, Pan Chi, Ping Lan, Lei Wang, Weiqing Chen, Long Cui, Daoda Chen, Jie Cao, Hongbo Wei, Xiang Peng, Zonghai Huang, Guanfu Cai, Ren Zhao, Zhongcheng Huang, Lin Xu, Hongfeng Zhou, Yisheng Wei, Hao Zhang, Jian Zheng, Yan Huang, Zhiyang Zhou, Yue Cai, Liang Kang, Meijin Huang, Junsheng Peng, Donglin Ren, Jianping Wang
PURPOSE: Total mesorectal excision with fluorouracil-based preoperative chemoradiotherapy and postoperative chemotherapy is a standard treatment of locally advanced rectal cancer. This study investigated the addition of oxaliplatin with and without preoperative radiotherapy. METHODS: In this multicenter, open-label, phase III trial, we randomly assigned (1:1:1) Chinese adults (age 18 to 75 years) with locally advanced stage II/III rectal cancer to three treatments: five 2-week cycles of infusional fluorouracil (leucovorin 400 mg/m(2), fluorouracil 400 mg/m(2), and fluorouracil 2...
September 20, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Smita Awasthi, Reason Wilken, Forum Patel, J Bruce German, David A Mills, Carlito B Lebrilla, Kyoungmi Kim, Samara L Freeman, Jennifer T Smilowitz, April W Armstrong, Emanual Maverakis
BACKGROUND: The development of probiotics as therapies to cure or prevent disease lags far behind that of other investigational medications. Rigorously designed phase I clinical trials are nearly non-existent in the field of probiotic research, which is a contributing factor to this disparity. As a consequence, how to appropriately dose probiotics to study their efficacy is unknown. Herein we propose a novel phase I ascending dose trial of Bifidobacterium longum subsp. infantis (B. infantis) to identify the dose required to produce predominant gut colonisation in healthy breastfed infants at 6 weeks of age...
July 22, 2016: Trials
Blandine Aloy, Imane Tazi, Corinne Isnard Bagnis, Marion Gauthier, Nicolas Janus, Vincent Launay-Vacher, Gilbert Deray, Jérôme Tourret
Tenofovir disoproxil fumarate is currently the cornerstone of HIV treatment. Although it shows an overall good safety profile, numerous cases of nephrotoxicity have been reported. Tenofovir alafenamide is a novel tenofovir prodrug that has been developed to improve renal safety. Pharmacokinetic studies suggest a better renal tolerance of tenofovir alafenamide than tenofovir disoproxil fumarate, probably because tenofovir plasma concentrations are lower after tenofovir alafenamide administration. Consistently in clinical trials, renal tolerance seems to be improved in patients treated with tenofovir alafenamide...
October 2016: AIDS Reviews
Sanna Selinheimo, Aki Vuokko, Markku Sainio, Kirsi Karvala, Hille Suojalehto, Heli Järnefelt, Tiina Paunio
INTRODUCTION: Indoor air-related conditions share similarities with other conditions that are characterised by medically unexplained symptoms (MUS)-a combination of non-specific symptoms that cannot be fully explained by structural bodily pathology. In cases of indoor air-related conditions, these symptoms are not fully explained by either medical conditions or the immunological-toxicological effects of environmental factors. The condition may be disabling, including a non-adaptive health behaviour...
June 6, 2016: BMJ Open
Juergen Drewe, Kathleen A Bucher, Catherine Zahner
The cardinal climacteric symptoms of hot flushes and night sweats affect 24-93% of all women during the physiological transition from reproductive to post-reproductive life. Though efficacious, hormonal therapy and partial oestrogenic compounds are linked to a significant increase in breast cancer. Non-hormonal treatments are thus greatly appreciated. This systematic review of published hormonal and non-hormonal treatments for climacteric, and breast and prostate cancer-associated hot flushes, examines clinical efficacy and therapy-related cancer risk modulation...
2015: SpringerPlus
Ana-Maria Vranceanu, Michiel Hageman, Joost Strooker, Dirk ter Meulen, Mark Vrahas, David Ring
OBJECTIVE: To test the acceptability and feasibility of a mind body skills-based intervention (RRCB) and estimate its preliminary effect in reducing disability and pain intensity as compared to standard care (SC) in patients with acute musculoskeletal trauma. DESIGN: Randomised controlled trial. SETTING: Level I trauma centre. PATIENTS: Adult patients with acute fractures at risk for chronic pain and disability based on scores on two coping with pain measures who presented to an orthopedic trauma center and met inclusion and exclusion criteria...
April 2015: Injury
Caterina Arvia, Valeria Siciliano, Kyriazoula Chatzianagnostou, Gillian Laws, Alfredo Quinones Galvan, Chiara Mammini, Sergio Berti, Sabrina Molinaro, Giorgio Iervasi
AIM: To evaluate the impact on glucose variability (GLUCV) of an nurse-implemented insulin infusion protocol when compared with a conventional insulin treatment during the day-to-day clinical activity. METHODS: We enrolled 44 type 2 diabetic patients (n = 32 males; n = 12 females) with acute coronary syndrome (ACS) and randomy assigned to standard a subcutaneous insulin treatment (n = 23) or a nurse-implemented continuous intravenous insulin infusion protocol (n = 21)...
August 15, 2014: World Journal of Diabetes
Udaya Chand Das, Anita Ross, Geetha Chary
Reconstruction of the annular ligament using vein graft at the stapedotomy site gives a very good gain at low, frequencies as compared to Stapedotomy without a tissue seal It also protects against perilymph leak 1 0 8mm stapedotomy with a 0 4mm piston with 0 2 mm vein graft interposition is a better technique in the surgical treatment of stapes fixation The purpose of the present study is to determine the effectiveness of vein graft in sealing the oval window in small fenestra stapedotomy for stapedial otoselerosis We performed a prospective randomi ed trial in 80 cases of stapedial otoselerosis, 40 with and 40 without having a tissue seal at a tertiary referal center Ihere was a good air bone gap closure in both the groups There was a better gain in the lower frequencies in subjects where the vein graft was used...
April 2004: Indian Journal of Otolaryngology and Head and Neck Surgery
Yan-Rong Liu, Qiang Liu
OBJECTIVE: To assess the efficacy and safety of mouse nerve growth factor (mNGF) in patients with peripheral nerve injury. METHODS: Such electronic database as Cochrane Library (Issue 1, 2011), Medline (1950-2011), Embase (1980-2011), National Knowledge Infrastructure (1979-2011) were searched and meanwhile relevant journals such as Chinese Journal of Orthopaedics, Chinese Journal of Microsurgery, Chinese Journal of Neurosurgery, etc were searched as well to collect all randomized controlled trials and quasi-randomi- zed controlled trials of mNGF on patients with peripheral nerve injury...
2012: Chinese Journal of Traumatology, Zhonghua Chuang Shang za Zhi
Julie A Quinlivan, Shital Julania, Laurence Lam
OBJECTIVE: To estimate whether antenatal dietary interventions restrict maternal weight gain in obese pregnant women without compromising newborn birth weight. DATA SOURCES: PubMed and Cochrane Controlled Trials Register were searched using free-text search terms: pregnancy, obesity, overweight, dietary intervention, lifestyle, and randomis(z)ed controlled trial through March 2011 in a similar search strategy to that used in a previous systematic review. METHODS OF STUDY SELECTION: We included randomized controlled trials in which antenatal dietary intervention was provided to pregnant women who were overweight or obese at booking...
December 2011: Obstetrics and Gynecology
Hao Xu, Da-Zhuo Shi, Bao-Yan Liu
Clinical guideline is of important significance to standardize clinical practice. Clinical guideline of evidence-based medicine puts stress on the classification and evaluation of evidences, especially in randomy controlled trial and gives recommendation based on the different grades and intensities of evidences. Since Chinese medicine has its own theoretical system in diagnosis and treatment, and the integrative Western and Chinese medicine (ICWM) is characterized by complicated intervention, making up a clinical guideline for Chinese medicine or ICWM based on the evidence obtained from modern medical research is apparently not so suitable...
June 2009: Chinese Journal of Integrated Traditional and Western Medicine
Mark Cropley, Alice Theadom, Gabriella Pravettoni, Gemma Webb
The objective of this review was to evaluate the effectiveness of smoking cessation interventions prior to surgery and examine smoking cessation rates at 6 months follow-up. The Cochrane Library Database, PsycINFO, EMBASE, Medline, and Cinahl databases were searched using the terms: smok$, smoking cessation, tobacco, cigar$, preop$, operati$, surg$, randomi*ed control$ trial, intervention, program$, cessation, abstinen$, quit. Further articles were obtained from reference lists. The search was limited to articles on adults, written in English and published up to December 2006...
March 2008: Nicotine & Tobacco Research: Official Journal of the Society for Research on Nicotine and Tobacco
Nicolas Danchin, Michel Cucherat, Christian Thuillez, Eric Durand, Zena Kadri, Philippe G Steg
BACKGROUND: Results of randomized trials of angiotensin-converting enzyme inhibitors in patients with coronary artery disease (CAD) and preserved left ventricular function are conflicting. We undertook this study to determine whether long-term prescription of angiotensin-converting enzyme inhibitors decreases major cardiovascular events and mortality in patients who have CAD and no evidence of left ventricular systolic dysfunction. METHODS: We searched MEDLINE, EMBASE, and IPA databases, the Cochrane Controlled Trials Register (1990-2004), and reports from scientific meetings (2003-2004), and we reviewed secondary sources...
April 10, 2006: Archives of Internal Medicine
Jodie Dodd, Caroline Crowther
AIMS: To compare the benefits and harms of planned elective repeat Caesarean section with induction of labour and to assess different methods of cervical ripening and induction of labour for women with a previous Caesarean birth who require induction of labour in a subsequent pregnancy. METHODS: The Cochrane controlled trials register and MEDLINE (1966-current) were searched using the following terms: vaginal birth after C(a)esare(i)an, trial of labo(u)r, elective C(a)esare(i)an, C(a)esare(i)an repeat, induction of labo(u)r, prostaglandins, prostaglandin E(2), misoprostol, prostaglandin E(1) analogs, mifepristone, oxytocin, Syntocinon, randomis(z)ed controlled trial, randomis(z)ed trial and clinical trial, to identify all published randomised controlled trials with reported data comparing outcomes for women and infants who have a planned elective repeat Caesarean section with induction of labour; and different methods of induction of labour, where a prior birth was by Caesarean section...
October 2004: Australian & New Zealand Journal of Obstetrics & Gynaecology
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