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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/28214596/early-non-response-to-certolizumab-pegol-in-rheumatoid-arthritis-predicts-treatment-failure-at-one-year-data-from-a-randomised-phase-iii-clinical-trial
#5
Francis Berenbaum, Thao Pham, Pascal Claudepierre, Thibault de Chalus, Jean-Michel Joubert, Carine Saadoun, Lionel Riou França, Bruno Fautrel
OBJECTIVES: To compare different early clinical criteria of non-response determined at three months as predictors of clinical failure at one year in patients with rheumatoid arthritis starting therapy with certolizumab pegol. METHODS: Data were derived from a randomised Phase III clinical trial in patients with rheumatoid arthritis who failed to respond to methotrexate monotherapy. Patients included in this post-hoc analysis were treated with certolizumab pegol (400mg qd reduced to 200mg qd after one month) and with methotrexate...
February 15, 2017: Joint, Bone, Spine: Revue du Rhumatisme
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
#6
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/28214140/a-review-of-strategies-for-infarct-size-reduction-during-acute-myocardial-infarction
#7
REVIEW
Yasir Parviz, Sethumadhavan Vijayan, Shahar Lavi
Advances in medical and interventional therapy over the last few decades have revolutionized the treatment of acute myocardial infarction. Despite the ability to restore epicardial coronary artery patency promptly through percutaneous coronary intervention, tissue level damage may continue. The reported 30-day mortality after all acute coronary syndromes is 2 to 3%, and around 5% following myocardial infarction. Post-infarct complications such as heart failure continue to be a major contributor to cardiovascular morbidity and mortality...
February 8, 2017: Cardiovascular Revascularization Medicine: Including Molecular Interventions
https://www.readbyqxmd.com/read/28214093/educating-religious-leaders-to-promote-uptake-of-male-circumcision-in-tanzania-a-cluster-randomised-trial
#8
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
#9
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/28213957/a-bosentan-pharmacokinetic-study-to-investigate-dosing-regimens-in-paediatric-patients-with-pulmonary-arterial-hypertension-future-3
#10
R M F Berger, M Gehin, M Beghetti, D Ivy, A Kusic-Pajic, P Cornelisse, S Grill, D Bonnet
AIM: To investigate whether increasing bosentan dosing frequency from 2 mg/kg twice daily (b.i.d.) to 2 mg/kg three times daily (t.i.d.) in children with pulmonary arterial hypertension (PAH) (from ≥3 months to <12 years of age) would increase exposure. METHODS: An open-label, prospective, randomised, multicentre, multiple-dose, Phase 3 study was conducted. Patients (n = 64) were randomised 1:1 to receive oral doses of bosentan of 2 mg/kg b.i...
February 18, 2017: British Journal of Clinical Pharmacology
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
#11
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/28213775/post-tonsillectomy-pain-after-using-bipolar-diathermy-scissors-or-the-harmonic-scalpel-a-randomised-blinded-study
#12
Linn Arbin, Mats Enlund, Johan Knutsson
OBJECTIVE: To compare the postoperative pain following bipolar diathermy scissors tonsillectomy (higher temperature dissection) with harmonic scalpel tonsillectomy (lower temperature dissection). METHODS: Sixty patients aged 7-40 years planned for tonsillectomy with no other concurrent surgery were randomised to either bipolar diathermy scissors or harmonic scalpel as surgical technique. Blinded to the surgical technique, the patients recorded their pain scores (VAS, 0-10) at awakening and the worst pain level of the day in the postoperative period...
February 17, 2017: European Archives of Oto-rhino-laryngology
https://www.readbyqxmd.com/read/28213743/development-of-cer-001-preclinical-dose-selection-through-to-phase-i-clinical-findings
#13
Constance H Keyserling, Ronald Barbaras, Renee Benghozi, Jean-Louis Dasseux
BACKGROUND: CER-001 comprises recombinant human apolipoprotein A-I complexed with phospholipids that mimics natural, nascent, pre-β high-density lipoprotein (HDL). We present animal model data showing dose-dependent increases in cholesterol efflux with CER-001 and its subsequent elimination by reverse lipid transport, together with inhibition of atherosclerotic plaque progression. We report the first phase I study results with CER-001 in humans, starting at 0.25 mg/kg, which is 1/80th of the safe dose (20 mg/kg) established in 4-week multiple-dose animal studies dosed every second day...
February 17, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28213610/prebiotic-inulin-type-fructans-induce-specific-changes-in-the-human-gut-microbiota
#14
Doris Vandeputte, Gwen Falony, Sara Vieira-Silva, Jun Wang, Manuela Sailer, Stephan Theis, Kristin Verbeke, Jeroen Raes
OBJECTIVE: Contrary to the long-standing prerequisite of inducing selective (ie, bifidogenic) effects, recent findings suggest that prebiotic interventions lead to ecosystem-wide microbiota shifts. Yet, a comprehensive characterisation of this process is still lacking. Here, we apply 16S rDNA microbiota profiling and matching (gas chromatography mass spectrometry) metabolomics to assess the consequences of inulin fermentation both on the composition of the colon bacterial ecosystem and faecal metabolites profiles...
February 17, 2017: Gut
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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