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https://www.readbyqxmd.com/read/27906598/managing-high-altitude-pulmonary-edema-with-oxygen-alone-results-of-a-randomized-controlled-trial
#1
Uday Yanamandra, Velu Nair, Surinderpal Singh, Amul Gupta, Deepak Mulajkar, Sushma Yanamandra, Konchok Norgais, Ruchira Mukherjee, Vikrant Singh, Srinivasa A Bhattachar, Sagarika Patyal, Rajan Grewal, Bhushan Chopra
Yanamandra, Uday, Velu Nair, Surinderpal Singh, Amul Gupta, Deepak Mulajkar, Sushma Yanamandra, Konchok Norgais, Ruchira Mukherjee, Vikrant Singh, Srinivasa A. Bhattachar, Sagarika Patyal, and Rajan Grewal. High-altitude pulmonary edema management: Is anything other than oxygen required? Results of a randomized controlled trial. High Alt Med Biol. 00:000-000, 2016.-Treatment strategies for management of high-altitude pulmonary edema (HAPE) are mainly based on the observational studies with only two randomized controlled trials, thus the practice is very heterogeneous and individualized as per the choice of treating physician...
December 1, 2016: High Altitude Medicine & Biology
https://www.readbyqxmd.com/read/27906080/tonic-and-burst-spinal-cord-stimulation-waveforms-for-the-treatment-of-chronic-intractable-pain-study-protocol-for-a-randomized-controlled-trial
#2
Konstantin V Slavin, Richard B North, Timothy R Deer, Peter Staats, Kristina Davis, Roni Diaz
BACKGROUND: Burst stimulation is a novel form of neurostimulation for the treatment of chronic pain which has demonstrated promise in small uncontrolled studies, but has not yet gained approval for use in the U.S. We report the study methods for an ongoing multicenter, randomized, controlled, cross-over study designed to gain United States Food and Drug Administration (FDA) approval for burst stimulation. METHODS: Participants who are candidates for a currently approved neurostimulation device were enrolled and screened...
December 1, 2016: Trials
https://www.readbyqxmd.com/read/27902612/intubation-without-use-of-stylet-for-mcgrath-videolaryngoscopy-in-patients-with-expected-normal-airway-a-randomized-noninferiority-trial
#3
Hyun Jeong Kwak, Sook Young Lee, Su Youn Lee, Yong Beom Kim, Jong Yeop Kim
BACKGROUND: During McGrath videolaryngoscope (VL) intubation, a styletted endotracheal tube maintaining an upward distal tip angle is recommended by some manufacturers. However, a styletted endotracheal tube can elicit rare but potentially serious complications. The purpose of this study was to demonstrate that a nonstyletted tube with exaggerated curvature would be noninferior to a styletted tube for orotracheal intubation using McGrath VL in patients with expected normal airway, by comparing the time to intubation and ease of intubation...
November 2016: Medicine (Baltimore)
https://www.readbyqxmd.com/read/27893326/randomized-prospective-biomarker-trial-of-ercc1-for-comparing-platinum-and-nonplatinum-therapy-in-advanced-non-small-cell-lung-cancer-ercc1-trial-et
#4
Siow Ming Lee, Mary Falzon, Fiona Blackhall, James Spicer, Marianne Nicolson, Abhro Chaudhuri, Gary Middleton, Samreen Ahmed, Jonathan Hicks, Barbara Crosse, Mark Napier, Julian M Singer, David Ferry, Conrad Lewanski, Martin Forster, Sally-Ann Rolls, Arrigo Capitanio, Robin Rudd, Natasha Iles, Yenting Ngai, Michael Gandy, Rachel Lillywhite, Allan Hackshaw
Purpose Retrospective studies indicate that expression of excision repair cross complementing group 1 (ERCC1) protein is associated with platinum resistance and survival in non-small-cell lung cancer (NSCLC). We conducted the first randomized trial, to our knowledge, to evaluate ERCC1 prospectively and to assess the superiority of nonplatinum therapy over platinum doublet therapy for ERCC1-positive NSCLC as well as noninferiority for ERCC1-negative NSCLC. Patients and Methods This trial had a marker-by-treatment interaction phase III design, with ERCC1 (8F1 antibody) status as a randomization stratification factor...
November 28, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/27893068/immunogenicity-of-the-9-valent-hpv-vaccine-using-2-dose-regimens-in-girls-and-boys-vs-a-3-dose-regimen-in-women
#5
Ole-Erik Iversen, Maria Jose Miranda, Angels Ulied, Terje Soerdal, Erica Lazarus, Kulkanya Chokephaibulkit, Stan L Block, Ales Skrivanek, Abdul Ghani Nur Azurah, Siew Moy Fong, Vladimir Dvorak, Kyung-Hyo Kim, Ramon M Cestero, Matitiahu Berkovitch, Mehmet Ceyhan, Misoo C Ellison, Michael A Ritter, Shuai S Yuan, Mark J DiNubile, Alfred J Saah, Alain Luxembourg
Importance: Human papillomavirus (HPV) infections cause anogenital cancers and warts. The 9-valent HPV vaccine provides protection against 7 high-risk types of HPV responsible for 90% of cervical cancers and 2 other HPV types accounting for 90% of genital warts. Objective: To determine whether HPV type-specific antibody responses would be noninferior among girls and boys aged 9 to 14 years after receiving 2 doses of the 9-valent HPV vaccine compared with adolescent girls and young women aged 16 to 26 years receiving 3 doses...
November 21, 2016: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/27891757/a-randomized-double-blind-phase-iii-study-to-evaluate-efficacy-and-safety-of-once-daily-treatment-of-alogliptin-and-metformin-hydrochloride-in-japanese-patients-with-type-2-diabetes
#6
Kohei Kaku, Shuuji Sumino, Masafumi Katou, Yuya Nishiyama, Yoshinobu Kinugawa
This randomized, double-blind, phase III study evaluated the efficacy and safety of once-daily (q.d.) treatment of alogliptin (25 mg q.d.) alone or with metformin hydrochloride (500 mg q.d. or 250 mg twice daily [b.i.d.]) in Japanese patients with type 2 diabetes. The primary endpoint was change in haemoglobin A1c (HbA1c) from baseline to the end of treatment (week 24). The least-squares mean (LSM) change in HbA1c from baseline (standard error) to the end of treatment (week 24) was 0.16% (0.072) in alogliptin alone, -0...
November 28, 2016: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/27887662/the-effects-of-water-lubrication-of-tracheal-tubes-on-post-intubation-airway-complications-study-protocol-for-a-randomized-controlled-trial
#7
Eugene Kim, Seong Mi Yang, So Jeong Yoon, Jae-Hyon Bahk, Jeong-Hwa Seo
BACKGROUND: Water is known to have lubricating properties, thus it is used for lubrication of tracheal tubes to reduce airway injuries caused by intubation. However, there is no definite evidence to substantiate the beneficial effects of lubricating tracheal tubes using water for attenuating airway injuries. Moreover, the lubrication pretreatment may cause contamination of the tube, leading to respiratory infections. Therefore, this trial aims to assess whether no pretreatment of tracheal tubes does not increase post-intubation airway complications as compared with water lubrication of tubes...
November 25, 2016: Trials
https://www.readbyqxmd.com/read/27883997/cbt4bn-a-randomized-controlled-trial-of-online-chat-and-face-to-face-group-therapy-for-bulimia-nervosa
#8
Stephanie C Zerwas, Hunna J Watson, Sara M Hofmeier, Michele D Levine, Robert M Hamer, Ross D Crosby, Cristin D Runfola, Christine M Peat, Jennifer R Shapiro, Benjamin Zimmer, Markus Moessner, Hans Kordy, Marsha D Marcus, Cynthia M Bulik
OBJECTIVE: Although cognitive-behavioral therapy (CBT) represents the first-line evidence-based psychotherapy for bulimia nervosa (BN), most individuals seeking treatment do not have access to this specialized intervention. We compared an Internet-based manualized version of CBT group therapy for BN conducted via a therapeutic chat group (CBT4BN) to the same treatment conducted via a traditional face-to-face group therapy (CBTF2F). METHOD: In a two-site, randomized, controlled noninferiority trial, we tested the hypothesis that CBT4BN would not be inferior to CBTF2F...
November 25, 2016: Psychotherapy and Psychosomatics
https://www.readbyqxmd.com/read/27883116/zabofloxacin-for-chronic-bronchitis
#9
B Kocsis, D Szabo
Treatment of lower respiratory tract infection poses as an ongoing challenge among respiratory tract diseases. Bacterial infections are causes of acute exacerbations in chronic bronchitis and indications for antibacterial therapy. Several antibiotics were applied to treat bacterial infections in chronic bronchitis, among them fluoroquinolones are considered potent, broad-spectrum agents with excellent tissue penetration. This monograph focuses on zabofloxacin, a novel fluoroquinolone agent recently approved and launched in South Korea, and summarizes the drug's antibacterial efficacy, pharmacokinetic properties and toxicity...
September 2016: Drugs of Today
https://www.readbyqxmd.com/read/27881925/efficacy-and-tolerability-balance-of-oxycodone-naloxone-and-tapentadol-in-chronic-low-back-pain-with-a-neuropathic-component-a-blinded-end-point-analysis-of-randomly-selected-routine-data-from-12-week-prospective-open-label-observations
#10
Michael A Ueberall, Gerhard H H Mueller-Schwefe
OBJECTIVE: To evaluate the benefit-risk profile (BRP) of oxycodone/naloxone (OXN) and tapentadol (TAP) in patients with chronic low back pain (cLBP) with a neuropathic component (NC) in routine clinical practice. METHODS: This was a blinded end point analysis of randomly selected 12-week routine/open-label data of the German Pain Registry on adult patients with cLBP-NC who initiated an index treatment in compliance with the current German prescribing information between 1st January and 31st October 2015 (OXN/TAP, n=128/133)...
2016: Journal of Pain Research
https://www.readbyqxmd.com/read/27881559/safety-and-tolerability-of-csl112-a-reconstituted-infusible-plasma-derived-apolipoprotein-a-i-after-acute-myocardial-infarction-the-aegis-i-trial-apoa-i-event-reducing-in-ischemic-syndromes-i
#11
C Michael Gibson, Serge Korjian, Pierluigi Tricoci, Yazan Daaboul, Megan Yee, Purva Jain, John H Alexander, P Gabriel Steg, A Michael Lincoff, John J P Kastelein, Roxana Mehran, Denise M D'Andrea, Lawrence I Deckelbaum, Bela Merkely, Maciej Zarebinski, Ton Oude Ophuis, Robert A Harrington
BACKGROUND: -Human or recombinant apolipoprotein A-I (apoA-I) has been shown to increase high-density lipoprotein-mediated cholesterol efflux capacity and to regress atherosclerotic disease in animal and clinical studies. CSL112 is an infusible, plasma-derived apoA-I that has been studied in normal subjects or those with stable coronary artery disease. This study aimed to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of CSL112 in patients with a recent acute myocardial infarction...
November 15, 2016: Circulation
https://www.readbyqxmd.com/read/27881151/gentamicin-versus-ceftriaxone-for-the-treatment-of-gonorrhoea-g-tog-trial-study-protocol-for-a-randomised-trial
#12
Clare Brittain, Margaret Childs, Lelia Duley, Jan Harding, Trish Hepburn, Garry Meakin, Alan A Montgomery, Wei Tan, Jonathan D C Ross
BACKGROUND: Gonorrhoea is a common sexually transmitted infection which causes genital pain and discomfort; in women it can also lead to pelvic inflammatory disease and infertility, and in men to epididymo-orchitis. Current treatment is with ceftriaxone, but there is increasing evidence of antimicrobial resistance which is reducing its effectiveness against gonorrhoea. A small, but increasing, number of patients have already been found to have highly resistant strains of gonorrhoea which has been associated with clinical failure...
November 24, 2016: Trials
https://www.readbyqxmd.com/read/27878839/a-u-statistics-based-approach-to-sample-size-planning-of-two-arm-trials-with-discrete-outcome-criterion-aiming-to-establish-either-superiority-or-noninferiority
#13
Stefan Wellek
In current practice, the most frequently applied approach to the handling of ties in the Mann-Whitney-Wilcoxon (MWW) test is based on the conditional distribution of the sum of mid-ranks, given the observed pattern of ties. Starting from this conditional version of the testing procedure, a sample size formula was derived and investigated by Zhao et al. (Stat Med 2008). In contrast, the approach we pursue here is a nonconditional one exploiting explicit representations for the variances of and the covariance between the two U-statistics estimators involved in the Mann-Whitney form of the test statistic...
November 22, 2016: Statistics in Medicine
https://www.readbyqxmd.com/read/27870737/the-influence-of-body-mass-index-on-sensorimotor-block-and-vasopressor-requirement-during-spinal-anesthesia-for-elective-cesarean-delivery
#14
T C Ngaka, J F Coetzee, R A Dyer
BACKGROUND: It has been suggested that the dose requirement for spinal anesthesia (SA) is lower in obese patients for cesarean delivery (CD). In this prospective, observational, noninferiority study, we tested the hypothesis that obesity would not have a clinically important effect on vasopressor requirements or block height. METHODS: Two groups of 25 parturients, group O (body mass index [BMI] >40 kg/m) and group N (BMI <32 kg/m) requiring elective CD were recruited...
December 2016: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/27870603/indirect-comparison-of-novel-oral-anticoagulants-in-women-with-nonvalvular-atrial-fibrillation
#15
Alex Moseley, Rami Doukky, Kim Allan Williams, Amir K Jaffer, Annabelle Santos Volgman
BACKGROUND: For nonvalvular atrial fibrillation (NVAF), novel oral anticoagulants (NOACs) have been found noninferior to warfarin for stroke/systemic embolization prevention, and major bleeding events. Recent meta-analysis of NOACs versus warfarin in atrial fibrillation (AF) showed that women on warfarin have greater risk of stroke/embolism than men, and when both are treated with NOACs, differences disappear. METHODS: NOACs differ in pharmacologic properties, thus they may differ from one another in their effects on women with AF...
November 21, 2016: Journal of Women's Health
https://www.readbyqxmd.com/read/27866717/adrenocortical-carcinoma-with-inferior-vena-cava-tumor-thrombus
#16
Danuel V Laan, Cornelius A Thiels, Amy Glasgow, Kevin B Wise, Geoffrey B Thompson, Melanie L Richards, David R Farley, Mark J Truty, Travis J McKenzie
BACKGROUND: The safety, efficacy, and prognostic implications of resection of adrenocortical carcinoma with inferior vena cava tumor thrombus are poorly described. METHODS: A retrospective review was performed during a 30-year period on patients who underwent resection of locally advanced, nonmetastatic adrenocortical carcinoma. We compared patients with and without inferior vena cava tumor thrombus, examining perioperative characteristics, completeness of resection, mortality, and survival...
November 17, 2016: Surgery
https://www.readbyqxmd.com/read/27864713/a-prospective-randomized-study-for-efficacy-of-an-uncovered-double-bare-metal-stent-compared-to-a-single-bare-metal-stent-in-malignant-biliary-obstruction
#17
Hyun Jik Lee, Moon Jae Chung, Jeong Yup Park, Seung Woo Park, Chung Mo Nam, Si Young Song, Seungmin Bang
BACKGROUND AND AIMS: A biliary self-expandable metal stent (SEMS) is commonly used to relieve malignant biliary obstruction. The aim of this study was to compare the efficacy of a conventional uncovered SEMS with that of a newly developed uncovered double bare metal stent in reducing the risk of stent occlusion caused by tumor ingrowth. PATIENTS AND METHODS: We performed a prospective, open-labeled, randomized trial in 71 patients at Severance Hospital, Yonsei University College of Medicine from June 2013 to June 2014...
November 18, 2016: Surgical Endoscopy
https://www.readbyqxmd.com/read/27863843/score2-report-2-study-design-and-baseline-characteristics
#18
Ingrid U Scott, Paul C VanVeldhuisen, Michael S Ip, Barbara A Blodi, Neal L Oden, Maria Figueroa, Pravin U Dugel
PURPOSE: To describe the design and baseline characteristics of participants in the Study of COmparative Treatments for REtinal Vein Occlusion 2 (SCORE2) and to compare with cohorts from other retinal vein occlusion trials. DESIGN: Phase III prospective, multicenter, randomized clinical trial designed to assess whether intravitreal bevacizumab is noninferior to intravitreal aflibercept for treatment of decreased vision attributable to macular edema associated with central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO)...
November 15, 2016: Ophthalmology
https://www.readbyqxmd.com/read/27861924/intratympanic-dexamethasone-in-sudden-sensorineural-hearing-loss-a-systematic-review-and-meta-analysis
#19
REVIEW
Nagi G El Sabbagh, Maida J Sewitch, Aren Bezdjian, Sam J Daniel
OBJECTIVE: Systemic dexamethasone has demonstrated conclusive benefits in reversing sudden sensorineural hearing loss (SSNHL) despite considerable number of potential side effects. In contrast, the intratympanic route of steroid administration averts several possible complications. This study aims to examine the literature to delineate the efficacy and side effect of intratympanic dexamethasone (ITD) injection for the treatment of SSNHL. DATA SOURCE: Cochrane, Embase, and MEDLINE electronic databases from January 1950 to August 2014, with an update performed on November 10, 2014...
November 15, 2016: Laryngoscope
https://www.readbyqxmd.com/read/27851857/assessing-the-efficacy-and-safety-of-eravacycline-vs-ertapenem-in-complicated-intra-abdominal-infections-in-the-investigating-gram-negative-infections-treated-with-eravacycline-ignite-1-trial-a-randomized-clinical-trial
#20
Joseph Solomkin, David Evans, Algirdas Slepavicius, Patrick Lee, Andrew Marsh, Larry Tsai, Joyce A Sutcliffe, Patrick Horn
Importance: Eravacycline is a novel, fully synthetic fluorocycline antibiotic of the tetracycline class with in vitro activity against clinically important gram-negative, gram-positive aerobic, and facultative bacteria including most of those resistant to cephalosporins, fluoroquinolones, β-lactam/β-lactamase inhibitors, multidrug resistant strains and carbapenem-resistant Enterobacteriaceae, and most anaerobic pathogens. Objective: To evaluate the efficacy and safety of eravacycline compared with ertapenem in adult hospitalized patients with complicated intra-abdominal infections (cIAIs)...
November 16, 2016: JAMA Surgery
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