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https://www.readbyqxmd.com/read/28648803/sorafenib-in-combination-with-transarterial-chemoembolisation-in-patients-with-unresectable-hepatocellular-carcinoma-tace-2-a-randomised-placebo-controlled-double-blind-phase-3-trial
#1
Tim Meyer, Richard Fox, Yuk Ting Ma, Paul J Ross, Martin W James, Richard Sturgess, Clive Stubbs, Deborah D Stocken, Lucy Wall, Anthony Watkinson, Nigel Hacking, T R Jeffry Evans, Peter Collins, Richard A Hubner, David Cunningham, John Neil Primrose, Philip J Johnson, Daniel H Palmer
BACKGROUND: Transarterial chemoembolisation (TACE) is the standard of care for patients with intermediate stage hepatocellular carcinoma, while the multikinase inhibitor sorafenib improves survival in patients with advanced disease. We aimed to determine whether TACE with sorafenib improves progression-free survival versus TACE with placebo. METHODS: We did a multicentre, randomised, placebo-controlled, phase 3 trial (TACE 2) in 20 hospitals in the UK for patients with unresectable, liver-confined hepatocellular carcinoma...
June 22, 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28647736/no-severe-hypercalcemia-with-daily-vitamin-d3-supplementation-of-up-to-30-%C3%A2%C2%B5g-during-the-first-year-of-life
#2
Saara Valkama, Elisa Holmlund-Suila, Maria Enlund-Cerullo, Jenni Rosendahl, Helena Hauta-Alus, Otto Helve, Timo Hytinantti, Heli Viljakainen, Sture Andersson, Outi Mäkitie
BACKGROUND: Vitamin D supplementation is widely recommended for infants, but the optimal dose remains unclear. High intake may result in hypercalcemia. METHODS: We evaluated the incidence of hypercalcemia during the first year of life in a cohort of 987 healthy children who received 10 or 30 μg of vitamin D3 supplementation daily. Ionized calcium (Ca-ion) was analyzed at 6 and 12 months, and serum 25-hydroxyvitamin D (25-OHD) and parathyroid hormone (PTH) concentration at 12 months...
June 23, 2017: Hormone Research in Pædiatrics
https://www.readbyqxmd.com/read/28647651/concomitant-vasopressin-and-hydrocortisone-therapy-on-short-term-hemodynamic-effects-and-vasopressor-requirements-in-refractory-septic-shock
#3
Mitchell S Buckley, Robert MacLaren
PURPOSE: The objective of this study was to evaluate the short-term hemodynamic effects as well as vasopressor requirements with concomitant vasopressin (AVP) and hydrocortisone (HCT) compared to either agent alone in refractory septic shock. MATERIALS AND METHODS: This was a retrospective, cohort study conducted in adult septic shock patients. Patients received continuous infusion AVP at 0.04units/min and/or HCT 200-300mg intravenous daily in divided doses for refractory septic shock...
June 17, 2017: Journal of Critical Care
https://www.readbyqxmd.com/read/28647106/-outpatient-consumption-of-antibiotics-with-a-bacterial-resistance-risk-in-2014-in-france
#4
Marie-Céline Casaurancq, Emilie Patras de Campaigno, Manuela Rueter, Bérangère Baricault, Robert Bourrel, Maryse Lapeyre-Mestre, Agnès Sommet
AIM: This article proposes a description of French regional consumption of antibiotics with a bacterial resistance risk (amoxicillin+clavulanic acid, third-generation cephalosporins [C3G] and fluoroquinolones). METHODS: Antibiotics reimbursements data were obtained by Open Medic website. The antibiotic consumption profile has been established using some indicators of the European Surveillance of Antimicrobial Consumption (ESAC) in daily-defined dose per 1000 inhabitants per day (DID) or in percentage...
May 26, 2017: Thérapie
https://www.readbyqxmd.com/read/28645941/a-first-time-in-human-study-of-gsk2636771-a-phosphoinositide-3-kinase-beta-selective-inhibitor-in-patients-with-advanced-solid-tumors
#5
Joaquin Mateo, Gopinath Ganji, Charlotte Lemech, Howard A Burris, Sae-Won Han, Karen E Swales, Shaun Decordova, Maurice P DeYoung, Deborah A Smith, Shanker Kalyana-Sundaram, Jiuhua Wu, Monica Motwani, Rakesh Kumar, Jerry M Tolson, Sun Young Rha, Hyun Cheol Chung, Joseph Paul Eder, Sunil Sharma, Yung-Jue Bang, Jeffrey R Infante, Li Yan, Johann S de Bono, Hendrik-Tobias Arkenau
The phosphoinositide 3 kinase (PI3K)/protein kinase B (AKT) pathway is commonly activated in several tumor types. Selective targeting of p110β could result in successful pathway inhibition while avoiding the on and off target effects of pan-PI3K inhibitors. GSK2636771 is a potent, orally bioavailable, adenosine triphosphate-competitive, selective inhibitor of PI3Kβ.<br /><br />Experimental Design: <p>We evaluated the safety, pharmacokinetics, pharmacodynamics and antitumor activity of GSK2636771 to define the recommended Phase II dose (RP2D)...
June 23, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28642008/concurrent-once-daily-versus-twice-daily-chemoradiotherapy-in-patients-with-limited-stage-small-cell-lung-cancer-convert-an-open-label-phase-3-randomised-superiority-trial
#6
Corinne Faivre-Finn, Michael Snee, Linda Ashcroft, Wiebke Appel, Fabrice Barlesi, Adityanarayan Bhatnagar, Andrea Bezjak, Felipe Cardenal, Pierre Fournel, Susan Harden, Cecile Le Pechoux, Rhona McMenemin, Nazia Mohammed, Mary O'Brien, Jason Pantarotto, Veerle Surmont, Jan P Van Meerbeeck, Penella J Woll, Paul Lorigan, Fiona Blackhall
BACKGROUND: Concurrent chemoradiotherapy is the standard of care in limited-stage small-cell lung cancer, but the optimal radiotherapy schedule and dose remains controversial. The aim of this study was to establish a standard chemoradiotherapy treatment regimen in limited-stage small-cell lung cancer. METHODS: The CONVERT trial was an open-label, phase 3, randomised superiority trial. We enrolled adult patients (aged ≥18 years) who had cytologically or histologically confirmed limited-stage small-cell lung cancer, Eastern Cooperative Oncology Group performance status of 0-2, and adequate pulmonary function...
June 19, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28639555/ginkgo-biloba-and-lycopene-are-effective-on-cisplatin-induced-ototoxicity
#7
Erkan Esen, Fatih Özdoğan, Seren Gülşen Gürgen, Halil Erdem Özel, Serdar Başer, Selahattin Genç, Adin Selçuk
OBJECTIVE: The purpose of this study was to examine the anti-ototoxic impact of Ginkgo biloba extract and lycopene on the model of cisplatin-induced ototoxicity in rats. MATERIALS AND METHODS: Thirty-two Wistar albino rats were examined with the distortion product otoacoustic emission (DPOAE) test (MADSEN Capella2 ; GN Otometrics, ICS Medical, Chicago USA), and they were randomly divided into four groups. Group 1 (n=8) was defined as the healthy control group. Cisplatin was given intraperitoneally as single dose of 12 mg/kg to group 2 (n=8), group 3 (n=8), and group 4 (n=8)...
June 21, 2017: Journal of International Advanced Otology
https://www.readbyqxmd.com/read/28638826/anxiolytics-sedatives-and-hypnotics-prescribed-by-dentists-in-brazil-in-2010
#8
Patrícia Azevedo Lino, Maria Auxiliadora Parreiras Martins, Maria Elisa de Souza E Silva, Mauro Henrique Nogueira Guimarães de Abreu
OBJECTIVE: To describe dental prescriptions for anxiolytics, sedatives, and hypnotics for Brazilian outpatients in 2010. METHODS: A cross-sectional study was conducted using data on the use of anxiolytics, sedatives, and hypnotics from the Brazilian Health Surveillance Agency, Brazil, 2010. For each prescription, prescribed drugs and the prescribed amount were identified. Prescribed medications were classified according to Anatomical Therapeutic Chemical code. We calculated the number of Defined Daily Doses (DDD) for anxiolytics, sedatives, and hypnotics by code, their mean DDD, and DDD per inhabitant per year...
2017: BioMed Research International
https://www.readbyqxmd.com/read/28633804/protective-effect-of-n-acetylcysteine-on-progression-to-end-stage-renal-disease-necessity-for-prospective-clinical-trial
#9
Chen-Yi Liao, Chi-Hsiang Chung, Chai-Chao Wu, Fu-Huang Lin, Chang-Huei Tsao, Chih-Chiang Wang, Wu-Chien Chien
BACKGROUND: We aimed to evaluate the potential benefits of N-acetylcysteine (NAC) on the risk of chronic kidney disease (CKD) progression to dialysis-requiring end-stage renal disease (ESRDd). METHODS: In a population-based cohort study of 145,062 individuals, 123,608 CKD patients who were followed up for 10years were included, and CKD patients treated with NAC (ICD-9-CM) were compared with those who were not treated. Using propensity score matching, we analyzed the predictors of CKD progression to ESRDd by Cox proportional hazards regression with adjustments for sex, age, and comorbidities, and evaluated the effect of NAC using cumulative defined daily dose (cDDD)...
June 17, 2017: European Journal of Internal Medicine
https://www.readbyqxmd.com/read/28624695/first-in-human-phase-i-study-of-oral-s49076-a-unique-met-axl-fgfr-inhibitor-in-advanced-solid-tumours
#10
Jordi Rodon, Sophie Postel-Vinay, Antoine Hollebecque, Paolo Nuciforo, Analia Azaro, Valérie Cattan, Lucie Marfai, Isabelle Sudey, Karl Brendel, Audrey Delmas, Stéphanie Malasse, Jean-Charles Soria
BACKGROUND AND OBJECTIVES: S49076 is a novel ATP-competitive tyrosine kinase inhibitor of MET, AXL and FGFR with a unique selectivity profile. A phase I open-label study was undertaken to establish the tolerability profile and determine the recommended dose (RD) and administration schedule. MATERIALS AND METHODS: Patients with advanced solid tumours received S49076 orally once-daily (qd) or twice-daily (bid) in continuous 21-day cycles at escalating doses guided by a 3 + 3 design and followed by an expansion phase at the RD...
June 15, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28624279/the-use-of-national-level-data-to-describe-trends-in-intramammary-antimicrobial-usage-on-irish-dairy-farms-from-2003-to-2015
#11
Simon J More, Tracy A Clegg, Finola McCoy
In this study, we used national-level data to describe trends in on-farm intramammary antimicrobial usage in Ireland from 2003 to 2015. We calculated actual sales of intramammary tubes and the quantity of active substance sold, by year, product type [lactation or dry cow therapy (DCT)], antimicrobial group, World Health Organization antimicrobial classification, and from 2009 to 2015, prescribing route. We also estimated on-farm usage of lactation and dry cow intramammary antimicrobials using defined daily dose (DDDvet) and defined course dose (DCDvet) calculations, and dry cow coverage...
June 14, 2017: Journal of Dairy Science
https://www.readbyqxmd.com/read/28623386/the-antipsychotic-agent-quetiapine-is-increasingly-not-used-as-such-dispensed-prescriptions-in-norway-2004-2015
#12
Pål Gjerden, Jørgen G Bramness, Ingunn Fride Tvete, Lars Slørdal
PURPOSE: The antipsychotic agent quetiapine was introduced in Norway in 2003. We have assessed changes in dispensed prescriptions, including dosing, of quetiapine in Norway from 2004 to 2015. METHODS: Data on the sales of antipsychotics and antidepressants were drawn from the Norwegian Prescription Database. A total of 47,474 outpatients filled 195,622 prescriptions of quetiapine. Reimbursement codes, use of antipsychotics or antidepressants 12 months prior to the first prescription of quetiapine and estimated mean volume used measured as defined daily doses (DDDs) per day were used as proxies for diagnoses...
June 16, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28620303/effect-of-genetic-variability-in-the-cyp4f2-cyp4f11-and-cyp4f12-genes-on-liver-mrna-levels-and-warfarin-response
#13
J E Zhang, Kathrin Klein, Andrea L Jorgensen, Ben Francis, Ana Alfirevic, Stephane Bourgeois, Panagiotis Deloukas, Ulrich M Zanger, Munir Pirmohamed
Genetic polymorphisms in the gene encoding cytochrome P450 (CYP) 4F2, a vitamin K oxidase, affect stable warfarin dose requirements and time to therapeutic INR. CYP4F2 is part of the CYP4F gene cluster, which is highly polymorphic and exhibits a high degree of linkage disequilibrium, making it difficult to define causal variants. Our objective was to examine the effect of genetic variability in the CYP4F gene cluster on expression of the individual CYP4F genes and warfarin response. mRNA levels of the CYP4F gene cluster were quantified in human liver samples (n = 149) obtained from a well-characterized liver bank and fine mapping of the CYP4F gene cluster encompassing CYP4F2, CYP4F11, and CYP4F12 was performed...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28617681/psychotropic-drugs-prescription-in-undocumented-migrants-and-indigent-natives-in-italy
#14
Cesare Cerri, Gianfrancesco Fiorini, Silvia Bini, Antonello E Rigamonti, Nicoletta Marazzi, Alessandro Sartorio, Silvano G Cella
To evaluate psychotropic drug use in undocumented migrants and natives in the same conditions of poverty. We studied drug dispensation by a nongovernmental organization during the year 2014. Drugs were identified according to the Anatomical Chemical Therapeutic classification and their quantity was measured in defined daily doses (DDD). We determined the percentage of patients taking at least one medicine with psychotropic activity in relation to the total number of patients receiving medicines of any class...
June 14, 2017: International Clinical Psychopharmacology
https://www.readbyqxmd.com/read/28609534/effect-of-low-dose-ferrous-sulfate-vs-iron-polysaccharide-complex-on-hemoglobin-concentration-in-young-children-with-nutritional-iron-deficiency-anemia-a-randomized-clinical-trial
#15
Jacquelyn M Powers, George R Buchanan, Leah Adix, Song Zhang, Ang Gao, Timothy L McCavit
Importance: Iron-deficiency anemia (IDA) affects millions of persons worldwide, and is associated with impaired neurodevelopment in infants and children. Ferrous sulfate is the most commonly prescribed oral iron despite iron polysaccharide complex possibly being better tolerated. Objective: To compare the effect of ferrous sulfate with iron polysaccharide complex on hemoglobin concentration in infants and children with nutritional IDA. Design, Setting, and Participants: Double-blind, superiority randomized clinical trial of infants and children aged 9 to 48 months with nutritional IDA (assessed by history and laboratory criteria) that was conducted in an outpatient hematology clinic at a US tertiary care hospital from September 2013 through November 2015; 12-week follow-up ended in January 2016...
June 13, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28608330/opioid-analgesic-use-in-australia-and-the-netherlands-a-cross-country-comparison
#16
Francisca N Wagemaakers, Samantha A Hollingworth, Sanne Kreijkamp-Kaspers, Ernest H L Tee, Anne J Leendertse, Mieke L van Driel
Background Increasing use of opioid analgesics (OA) has been reported worldwide. Objective To compare the use of OA in two countries in order to better understand these trends. Setting Outpatient settings in Australia and The Netherlands. Method We analysed publicly available government data on outpatient OA dispensing over 15 years (2000-2014). We compared dispensing trends for specific OA and explored medical (national clinical guidelines), contextual and policy-related factors to explain differences in use between the two countries...
June 12, 2017: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/28600210/accelerated-versus-standard-epirubicin-followed-by-cyclophosphamide-methotrexate-and-fluorouracil-or-capecitabine-as-adjuvant-therapy-for-breast-cancer-in-the-randomised-uk-tact2-trial-cruk-05-19-a-multicentre-phase-3-open-label-randomised-controlled-trial
#17
David Cameron, James P Morden, Peter Canney, Galina Velikova, Robert Coleman, John Bartlett, Rajiv Agrawal, Jane Banerji, Gianfilippo Bertelli, David Bloomfield, A Murray Brunt, Helena Earl, Paul Ellis, Claire Gaunt, Alexa Gillman, Nicholas Hearfield, Robert Laing, Nicholas Murray, Niki Couper, Robert C Stein, Mark Verrill, Andrew Wardley, Peter Barrett-Lee, Judith M Bliss
BACKGROUND: Adjuvant chemotherapy for early breast cancer has improved outcomes but causes toxicity. The UK TACT2 trial used a 2×2 factorial design to test two hypotheses: whether use of accelerated epirubicin would improve time to tumour recurrence (TTR); and whether use of oral capecitabine instead of cyclophosphamide would be non-inferior in terms of patients' outcomes and would improve toxicity, quality of life, or both. METHODS: In this multicentre, phase 3, randomised, controlled trial, we enrolled patients aged 18 years or older from 129 UK centres who had histologically confirmed node-positive or high-risk node-negative operable breast cancer, had undergone complete excision, and were due to receive adjuvant chemotherapy...
June 6, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28599987/characterizing-the-time-course-of-antihypertensive-activity-and-optimal-dose-range-of-fimasartan-via-mechanism-based-population-modeling
#18
Jürgen B Bulitta, Soo Heui Paik, Yong Ha Chi, Tae Hwan Kim, Soyoung Shin, Cornelia B Landersdorfer, Yuanyuan Jiao, Rajbharan Yadav, Beom Soo Shin
Fimasartan is a novel angiotensin II receptor blocker. Our aims were to characterize the time-course of the antihypertensive activity of fimasartan via a new population pharmacokinetic/pharmacodynamic model and to define its optimal dose range. We simultaneously modelled all fimasartan plasma concentrations and 24-h ambulatory blood pressure monitoring (ABPM) data from 39 patients with essential hypertension and 56 healthy volunteers. Patients received placebo, 20, 60, or 180mg fimasartan every 24h for 28days and healthy volunteers received placebo or 20 to 480mg as a single oral dose or as seven doses every 24h...
June 6, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28599067/external-adjustment-of-unmeasured-confounders-in-a-case-control-study-of-benzodiazepine-use-and-cancer-risk
#19
L C Thygesen, A Pottegård, A K Ersbøll, S Friis, T Stürmer, J Hallas
INTRODUCTION: Previous studies have reported diverging results on the association between benzodiazepine use and cancer risk. METHODS: We investigated this association in a matched case-control study including incident cancer cases during 2002-2009 in the Danish Cancer Registry (n=94,923) and age and sex-matched (1:8) population controls (n=759,334). Long-term benzodiazepine use was defined as ≥500 defined daily doses 1-5 years prior to the index date. We implemented propensity score (PS) calibration using external information on confounders available from a survey of the Danish population...
June 9, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28598975/vitamin-d-deficiency-and-clinical-correlations-in-systemic-sclerosis-patients-a-retrospective-analysis-for-possible-future-developments
#20
Amelia Chiara Trombetta, Vanessa Smith, Emanuele Gotelli, Massimo Ghio, Sabrina Paolino, Carmen Pizzorni, Amber Vanhaecke, Barbara Ruaro, Alberto Sulli, Maurizio Cutolo
OBJECTIVE: Assessment of serum 25-hydroxyvitamin D (25(OH)D) correlations with clinical parameters and evaluation of the efficacy of standard oral supplementation in systemic sclerosis (SSc) patients. METHODS: 154 SSc patients were recruited, in all seasons. Serum 25(OH)D concentrations were evaluated using LIAISON 25-OH (Diasorin, Italy). Medsger disease severity scale (DSS), nailfold videocapillaroscopy (NVC) and all instrumental exam contemplated by international guidelines were performed...
2017: PloS One
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