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Randomised controlled trials

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https://www.readbyqxmd.com/read/28214913/assessment-of-efficacy-and-safety-of-the-herbal-medicinal-product-bno-1016-in-chronic-rhinosinusitis
#1
J Palm, I Steiner, D Abramov-Sommariva, A Ammendola, S Mitzenheim, H Steindl, M Wonnemann, C Bachert
BACKGROUND: The objective of this clinical trial (CRS-02) was to assess the efficacy, safety and tolerability of two dosages of the herbal medicinal product BNO 1016 (Sinupret extract) in patients with chronic rhinosinusitis (CRS). METHODOLOGY: 929 patients suffering from CRS were enrolled in this randomised placebo-controlled trial with a treatment period of 12 weeks. The primary endpoint was the mean Major Symptom Score (MSS) in week 8 and week 12 compared to placebo...
February 19, 2017: Rhinology
https://www.readbyqxmd.com/read/28214798/intensive-blood-pressure-lowering-in-patients-with-acute-intracerebral-haemorrhage-clinical-outcomes-and-haemorrhage-expansion-systematic-review-and-meta-analysis-of-randomised-trials
#2
Gregoire Boulouis, Andrea Morotti, Joshua N Goldstein, Andreas Charidimou
INTRODUCTION: It is unclear whether intensive lowering of blood pressure (BP) at the acute phase of intracerebral haemorrhage (ICH) is beneficial. We performed a meta-analysis of randomised controlled trials (RCTs) to assess whether intensive BP lowering in patients with acute ICH is safe and effective in improving clinical outcomes. METHODS: We searched PubMed, EMBASE and the Cochrane databases for relevant RCTs and calculated pooled OR for 3-month mortality (safety outcome) and 3-month death or dependency (modified Rankin Scale (mRs) ≥3;efficacy outcome), in patients with acute ICH randomised to either intensive BP-lowering or standard BP-lowering treatment protocols...
February 18, 2017: Journal of Neurology, Neurosurgery, and Psychiatry
https://www.readbyqxmd.com/read/28214791/a-need-to-stand-united-reply-to-the-wame-secretary
#3
John H Noble
I believe Dr Winker and I agree more than differ about the need for authors of medical journal reports of randomised controlled trial (RCT) findings to acknowledge when they make post hoc adjustments to the original content that they submit to obtain FDA marketing approval for a new drug or medical device.
February 13, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28214653/neoadjuvant-chemotherapy-followed-by-concurrent-chemoradiotherapy-versus-concurrent-chemoradiotherapy-alone-in-locoregionally-advanced-nasopharyngeal-carcinoma-a-phase-iii-multicentre-randomised-controlled-trial
#4
Su-Mei Cao, Qi Yang, Ling Guo, Hai-Qiang Mai, Hao-Yuan Mo, Ka-Jia Cao, Chao-Nan Qian, Chong Zhao, Yan-Qun Xiang, Xiu-Ping Zhang, Zhi-Xiong Lin, Wei-Xiong Li, Qing Liu, Fang Qiu, Rui Sun, Qiu-Yan Chen, Pei-Yu Huang, Dong-Hua Luo, Yi-Jun Hua, Yi-Shan Wu, Xing Lv, Lin Wang, Wei-Xiong Xia, Lin-Quan Tang, Yan-Fang Ye, Ming-Yuan Chen, Xiang Guo, Ming-Huang Hong
BACKGROUND: The role of neoadjuvant chemotherapy (NACT) for locoregionally advanced nasopharyngeal carcinoma (NPC) is unclear. We aimed to evaluate the feasibility and efficacy of NACT followed by concurrent chemoradiotherapy (CCRT) versus CCRT alone in locoregionally advanced NPC. METHODS: Patients with stage III-IVB (excluding T3N0-1) NPC were randomly assigned to receive NACT followed by CCRT (investigational arm) or CCRT alone (control arm). Both arms were treated with 80 mg/m(2) cisplatin every 3 weeks concurrently with radiotherapy...
February 16, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28214374/a-systematic-review-of-known-interventions-for-the-treatment-of-chronic-non-hypovolaemic-hypotonic-hyponatraemia-and-a-meta-analysis-of-the-vaptans
#5
REVIEW
Sunil Bhandari, Alessandro Peri, Iain Cranston, Rachael McCool, Alison Shaw, Julie Glanville, Larisa Petrakova, Karl O'Reilly
International and national guidelines on the treatment of chronic non-hypovolaemic hypotonic hyponatraemia differ; therefore we have undertaken this systematic review and meta-analysis to investigate the efficacy and safety of interventions for the treatment of chronic non-hypovolaemic hypotonic hyponatraemia. Following registration of the review protocol with PROSPERO, systematic literature searches were conducted to identify randomised and quasi-randomised controlled trials assessing any degree of fluid restriction or any drug treatment with the aim of increasing serum sodium concentration in patients with chronic non-hypovolaemic hypotonic hyponatraemia...
February 18, 2017: Clinical Endocrinology
https://www.readbyqxmd.com/read/28214093/educating-religious-leaders-to-promote-uptake-of-male-circumcision-in-tanzania-a-cluster-randomised-trial
#6
Jennifer A Downs, Agrey H Mwakisole, Alphonce B Chandika, Shibide Lugoba, Rehema Kassim, Evarist Laizer, Kinanga A Magambo, Myung Hee Lee, Samuel E Kalluvya, David J Downs, Daniel W Fitzgerald
BACKGROUND: Male circumcision is being widely deployed as an HIV prevention strategy in countries with high HIV incidence, but its uptake in sub-Saharan Africa has been below targets. We did a study to establish whether educating religious leaders about male circumcision would increase uptake in their village. METHODS: In this cluster randomised trial in northwest Tanzania, eligible villages were paired by proximity (<60 km) and the time that a free male circumcision outreach campaign from the Tanzanian Ministry of Health became available in their village...
February 14, 2017: Lancet
https://www.readbyqxmd.com/read/28214091/multidonor-intensive-faecal-microbiota-transplantation-for-active-ulcerative-colitis-a-randomised-placebo-controlled-trial
#7
Sudarshan Paramsothy, Michael A Kamm, Nadeem O Kaakoush, Alissa J Walsh, Johan van den Bogaerde, Douglas Samuel, Rupert W L Leong, Susan Connor, Watson Ng, Ramesh Paramsothy, Wei Xuan, Enmoore Lin, Hazel M Mitchell, Thomas J Borody
BACKGROUND: The intestinal microbiota is implicated in the pathogenesis of ulcerative colitis. Faecal microbiota transplantation is a novel form of therapeutic microbial manipulation, but its efficacy in ulcerative colitis is uncertain. We aimed to establish the efficacy of intensive-dosing, multidonor, faecal microbiota transplantation in active ulcerative colitis. METHODS: We conducted a multicentre, double-blind, randomised, placebo-controlled trial at three hospitals in Australia...
February 14, 2017: Lancet
https://www.readbyqxmd.com/read/28213797/long-term-outcomes-of-tot-and-tvt-procedures-for-the-treatment-of-female-stress-urinary-incontinence-a-systematic-review-and-meta-analysis
#8
REVIEW
Umberto Leone Roberti Maggiore, Enrico Finazzi Agrò, Marco Soligo, Vincenzo Li Marzi, Alex Digesu, Maurizio Serati
INTRODUCTION AND HYPOTHESES: One of the most relevant topics in the field of pelvic floor dysfunction treatment is the long-term efficacy of surgical procedures, in particular, the use of prosthesis. Hence, a systematic review and meta-analysis was conducted to evaluate the long-term effectiveness and safety of midurethral sling (MUS) procedures for stress urinary incontinence (SUI), as reported in randomised controlled trials (RCTs) and non-randomised studies. METHODS: This systematic review is based on material searched and obtained via PubMed/Medline, Scopus, and the Cochrane Library between January 2000 and October 2016...
February 17, 2017: International Urogynecology Journal
https://www.readbyqxmd.com/read/28213601/protocol-for-a-scoping-review-of-post-trial-extensions-of-randomised-controlled-trials-using-individually-linked-administrative-and-registry-data
#9
Tiffany Fitzpatrick, Laure Perrier, Andrea C Tricco, Sharon E Straus, Peter Jüni, Merrick Zwarenstein, Lisa M Lix, Mark Smith, Laura C Rosella, David A Henry
INTRODUCTION: Well-conducted randomised controlled trials (RCTs) provide the least biased estimates of intervention effects. However, RCTs are costly and time-consuming to perform and long-term follow-up of participants may be hampered by lost contacts and financial constraints. Advances in computing and population-based registries have created new possibilities for increasing the value of RCTs by post-trial extension using linkage to routinely collected administrative/registry data in order to determine long-term interventional effects...
February 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28213598/informing-efficient-randomised-controlled-trials-exploration-of-challenges-in-developing-progression-criteria-for-internal-pilot-studies
#10
Kerry N L Avery, Paula R Williamson, Carrol Gamble, Elaine O'Connell Francischetto, Chris Metcalfe, Peter Davidson, Hywel Williams, Jane M Blazeby
OBJECTIVES: Designing studies with an internal pilot phase may optimise the use of pilot work to inform more efficient randomised controlled trials (RCTs). Careful selection of preagreed decision or 'progression' criteria at the juncture between the internal pilot and main trial phases provides a valuable opportunity to evaluate the likely success of the main trial and optimise its design or, if necessary, to make the decision not to proceed with the main trial. Guidance on the appropriate selection and application of progression criteria is, however, lacking...
February 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28213595/qualitative-study-of-the-breather-trial-short-cycle-antiretroviral-therapy-is-it-acceptable-to-young-people-living-with-hiv
#11
Sarah Bernays, Sara Paparini, Janet Seeley, Stella Namukwaya Kihika, Diana Gibb, Tim Rhodes
OBJECTIVES: A qualitative study of the BREATHER (PENTA 16) randomised clinical trial, which compared virological control of Short Cycle Therapy (SCT) (5 days on: 2 days off) with continuous efavirenz (EFV)-based antiretroviral therapy (CT) in children and young people (aged 8-24) living with HIV with viral load <50 c/mL to examine adaptation, acceptability and experience of SCT to inform intervention development. SETTING: Paediatric HIV clinics in the UK (2), Ireland (1), the USA (1) and Uganda (1)...
February 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28213593/randomised-double-blind-parallel-group-placebo-controlled-study-to-evaluate-the-analgesic-efficacy-and-safety-of-vvz-149-injections-for-postoperative-pain-following-laparoscopic-colorectal-surgery
#12
Srdjan S Nedeljkovic, Darin J Correll, Xiaodong Bao, Natacha Zamor, Jose L Zeballos, Yi Zhang, Mark J Young, Johanna Ledley, Jessica Sorace, Kristen Eng, Carlyle P Hamsher, Rajivan Maniam, Jonathan W Chin, Becky Tsui, Sunyoung Cho, Doo H Lee
INTRODUCTION: In spite of advances in understanding and technology, postoperative pain remains poorly treated for a significant number of patients. In colorectal surgery, the need for developing novel analgesics is especially important. Patients after bowel surgery are assessed for rapid return of bowel function and opioids worsen ileus, nausea and constipation. We describe a prospective, double-blind, parallel group, placebo-controlled randomised controlled trial testing the hypothesis that a novel analgesic drug, VVZ -149, is safe and effective in improving pain compared with providing opioid analgesia alone among adults undergoing laparoscopic colorectal surgery...
February 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28213592/the-evidence-of-benefits-of-exercise-training-in-interstitial-lung-disease-a-randomised-controlled-trial
#13
Leona M Dowman, Christine F McDonald, Catherine J Hill, Annemarie L Lee, Kathryn Barker, Claire Boote, Ian Glaspole, Nicole S L Goh, Anne M Southcott, Angela T Burge, Rebecca Gillies, Alicia Martin, Anne E Holland
BACKGROUND: Uncertainty exists regarding the clinical relevance of exercise training across the range of interstitial lung diseases (ILDs). OBJECTIVE: To establish the impact of exercise training in patients with ILDs of differing aetiology and severity. METHODS: 142 participants with ILD (61 idiopathic pulmonary fibrosis (IPF), 22 asbestosis, 23 connective tissue disease-related ILD (CTD-ILD) and 36 with other aetiologies) were randomised to either 8 weeks of supervised exercise training or usual care...
February 17, 2017: Thorax
https://www.readbyqxmd.com/read/28213587/emergency-extracorporeal-life-support-and-ongoing-resuscitation-a-retrospective-comparison-for-refractory-out-of-hospital-cardiac-arrest
#14
A Schober, F Sterz, H Herkner, C Wallmueller, C Weiser, P Hubner, C Testori
BACKGROUND: In refractory cardiac arrest, with cardiopulmonary resuscitation (CPR) for more than 30 min, chances of survival are small. Extracorporeal cardiopulmonary resuscitation (ECPR) is an option for certain patients with cardiac arrest. The aim of this study was to evaluate characteristics of patients selected for ECPR. METHODS: Anonymised data of adult patients suffering refractory cardiac arrest, transported with ongoing CPR to an ED of a tertiary care centre between 2002 and 2012 were analysed...
February 17, 2017: Emergency Medicine Journal: EMJ
https://www.readbyqxmd.com/read/28213479/impact-of-searching-clinical-trial-registries-in-systematic-reviews-of-pharmaceutical-treatments-methodological-systematic-review-and-reanalysis-of-meta-analyses
#15
Marie Baudard, Amélie Yavchitz, Philippe Ravaud, Elodie Perrodeau, Isabelle Boutron
Objective To evaluate the impact of searching clinical trial registries in systematic reviews.Design Methodological systematic review and reanalyses of meta-analyses.Data sources Medline was searched to identify systematic reviews of randomised controlled trials (RCTs) assessing pharmaceutical treatments published between June 2014 and January 2015. For all systematic reviews that did not report a trial registry search but reported the information to perform it, the World Health Organization International Trials Registry Platform (WHO ICTRP search portal) was searched for completed or terminated RCTs not originally included in the systematic review...
February 17, 2017: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/28213367/antibiotic-prophylaxis-for-infective-endocarditis-a-systematic-review-and-meta-analysis
#16
Thomas J Cahill, James L Harrison, Paul Jewell, Igho Onakpoya, John B Chambers, Mark Dayer, Peter Lockhart, Nia Roberts, David Shanson, Martin Thornhill, Carl J Heneghan, Bernard D Prendergast
OBJECTIVE: The use of antibiotic prophylaxis (AP) for prevention of infective endocarditis (IE) is controversial. In recent years, guidelines to cardiologists and dentists have advised restriction of AP to high-risk groups (in Europe and the USA) or against its use at all (in the UK). The objective of this systematic review was to appraise the evidence for use of AP for prevention of bacteraemia or IE in patients undergoing dental procedures. METHODS: We conducted electronic searches in Medline, Embase, Cochrane Library and ISI Web of Science...
February 17, 2017: Heart: Official Journal of the British Cardiac Society
https://www.readbyqxmd.com/read/28213300/experiences-of-stigma-and-discrimination-faced-by-family-caregivers-of-people-with-schizophrenia-in-india
#17
Mirja Koschorke, R Padmavati, Shuba Kumar, Alex Cohen, Helen A Weiss, Sudipto Chatterjee, Jesina Pereira, Smita Naik, Sujit John, Hamid Dabholkar, Madhumitha Balaji, Animish Chavan, Mathew Varghese, R Thara, Vikram Patel, Graham Thornicroft
Stigma associated with schizophrenia significantly affects family caregivers, yet few studies have examined the nature and determinants of family stigma and its relationship to their knowledge about the condition. This paper describes the experiences and determinants of stigma reported by the primary caregivers of people living with schizophrenia (PLS) in India. The study used mixed methods and was nested in a randomised controlled trial of community care for people with schizophrenia. Between November 2009 and October 2010, data on caregiver stigma and functional outcomes were collected from a sample of 282 PLS-caregiver dyads...
February 1, 2017: Social Science & Medicine
https://www.readbyqxmd.com/read/28212466/withdrawn-propranolol-for-migraine-prophylaxis
#18
REVIEW
Klaus Linde, Karin Rossnagel
BACKGROUND: Propranolol is one of the most commonly prescribed drugs for migraine prophylaxis. OBJECTIVES: We aimed to determine whether there is evidence that propranolol is more effective than placebo and as effective as other drugs for the interval (prophylactic) treatment of patients with migraine. SEARCH METHODS: Potentially eligible studies were identified by searching MEDLINE/PubMed (1966 to May 2003) and the Cochrane Central Register of Controlled Trials (Issue 2, 2003), and by screening bibliographies of reviews and identified articles...
February 17, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28212463/efficacy-and-tolerability-of-an-inhaled-selective-glucocorticoid-receptor-modulator-azd5423-in-copd-patients-phase-ii-study-results
#19
Piotr Kuna, Magnus Aurivillius, Carin Jorup, Susanne Prothon, Ziad Taib, Staffan Edsbäcker
AZD5423 is a novel, inhaled, selective glucocorticoid receptor modulator (SGRM), which in an allergen challenge model in asthmatics improved lung function and airway hyper-reactivity. In the current trial, AZD5423 was for the first time tested in patients with chronic obstructive pulmonary disease (COPD). In this double-blind, randomised and parallel group study, we examined airway and systemic effects of two doses of AZD5423, inhaled via Turbuhaler for 12 weeks, in 353 symptomatic COPD patients (average pre-bronchodilator forced expiratory volume in one second (FEV1) at screening was 50-52% of predicted normal)...
February 17, 2017: Basic & Clinical Pharmacology & Toxicology
https://www.readbyqxmd.com/read/28212353/effect%C3%A2-of%C3%A2-fibre%C3%A2-supplementation%C3%A2-on%C3%A2-body%C3%A2-weight%C3%A2-and%C3%A2-composition-%C3%A2-frequency%C3%A2-of%C3%A2-eating%C3%A2-and%C3%A2-dietary%C3%A2-choice%C3%A2-in%C3%A2-overweight%C3%A2-individuals
#20
Vicky A Solah, Deborah A Kerr Wendy J Hunt, Stuart K Johnson, Carol J Boushey, Edward J Delp, Xingqiong Meng, Roland J Gahler, Anthony P James, Aqif S Mukhtar, Haelee K Fenton, Simon Wood
Fibre supplementation can potentially reduce energy intake and contribute to weight loss. The mechanism may be reduced frequency of eating, resulting in reduced food consumption. The objective of this research was to determine the effectiveness of fibre supplementation with PolyGlycopleX® (PGX®), on body weight and composition, frequency of eating and dietary intake in 118 overweight adults. In a three-arm, parallel, blind, randomised controlled trial participants were randomised to one of three groups; 4...
February 16, 2017: Nutrients
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