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https://www.readbyqxmd.com/read/28077531/sodium-bicarbonate-does-not-prevent-postoperative-acute-kidney-injury-after-off-pump-coronary-revascularization-a-double-blinded-randomized-controlled-trial
#1
S Soh, J W Song, J K Shim, J H Kim, Y L Kwak
BACKGROUND: Acute kidney injury (AKI) is a common morbidity after off-pump coronary revascularization. We investigated whether perioperative administration of sodium bicarbonate, which might reduce renal injury by alleviating oxidative stress in renal tubules, prevents postoperative AKI in off-pump coronary revascularization patients having renal risk factors. METHODS: Patients (n=162) having at least one of the following AKI risk factors were enrolled: (i) age >70 yr; (ii) diabetes mellitus; (iii) chronic renal disease; (iv) congestive heart failure or left ventricular ejection fraction <35%; and (v) reoperation or emergency...
October 2016: British Journal of Anaesthesia
https://www.readbyqxmd.com/read/28070957/controlled-trial-of-hartmann-s-solution-versus-0-9-saline-for-diabetic-ketoacidosis
#2
Michael Yung, Georgia Letton, Steve Keeley
AIM: We aimed to determine whether using a balanced salt solution, Hartmann's solution (HS), in diabetic ketoacidosis (DKA) shortens the time to normalise acid-base status through the avoidance of hyperchloremic metabolic acidosis compared with 0.9% normal saline (NS). METHODS: We conducted a double-blind, randomised controlled trial comparing HS to NS as the initial intravenous fluid in children with DKA. Patients were stratified by severity (pH < 7.1) and known or new diabetes...
January 2017: Journal of Paediatrics and Child Health
https://www.readbyqxmd.com/read/28068987/effects-of-acetyl-dl-leucine-on-cerebellar-ataxia-alcat-trial-study-protocol-for-a-multicenter-multinational-randomized-double-blind-placebo-controlled-crossover-phase-iii-trial
#3
Katharina Feil, Christine Adrion, Julian Teufel, Sylvia Bösch, Jens Claassen, Ilaria Giordano, Holger Hengel, Heike Jacobi, Thomas Klockgether, Thomas Klopstock, Wolfgang Nachbauer, Ludger Schöls, Claudia Stendel, Ellen Uslar, Bart van de Warrenburg, Ingrid Berger, Ivonne Naumann, Otmar Bayer, Hans-Helge Müller, Ulrich Mansmann, Michael Strupp
BACKGROUND: Cerebellar ataxia (CA) is a frequent and often disabling condition that impairs motor functioning and impacts on quality of life (QoL). No medication has yet been proven effective for the symptomatic or even causative treatment of hereditary or non-hereditary, non-acquired CA. So far, the only treatment recommendation is physiotherapy. Therefore, new therapeutic options are needed. Based on three observational studies, the primary objective of the acetyl-DL-leucine on ataxia (ALCAT) trial is to examine the efficacy and tolerability of a symptomatic therapy with acetyl-DL-leucine compared to placebo on motor function measured by the Scale for the Assessment and Rating of Ataxia (SARA) in patients with CA...
January 10, 2017: BMC Neurology
https://www.readbyqxmd.com/read/28068788/a-double-blind-randomized-placebo-controlled-trial-of-lactobacillus-helveticus-and-bifidobacterium-longum-for-the-symptoms-of-depression
#4
Amy R Romijn, Julia J Rucklidge, Roeline G Kuijer, Chris Frampton
OBJECTIVES: This trial investigated whether probiotics improved mood, stress and anxiety in a sample selected for low mood. We also tested whether the presence or severity of irritable bowel syndrome symptoms, and levels of proinflammatory cytokines, brain-derived neurotrophic factor and other blood markers, would predict or impact treatment response. METHOD: Seventy-nine participants (10 dropouts) not currently taking psychotropic medications with at least moderate scores on self-report mood measures were randomly allocated to receive either a probiotic preparation (containing Lactobacillus helveticus and Bifidobacterium longum) or a matched placebo, in a double-blind trial for 8 weeks...
January 1, 2017: Australian and New Zealand Journal of Psychiatry
https://www.readbyqxmd.com/read/28066111/clinical-effectiveness-and-safety-of-low-cost-versus-innovator-brand-amlodipine-in-hypertension-a-single-blinded-randomized-crossover-noninferiority-trial
#5
Alak Kumar Das, Suparna Chatterjee, Jyotirmoy Pal
OBJECTIVES: A single-blinded, randomized, crossover, noninferiority trial was conducted to evaluate clinical effectiveness and safety of low-cost brand (LCB) versus innovator brand (IB) amlodipine in essential hypertension. MATERIALS AND METHODS: The primary end-point was change of systolic blood pressure (BP) from baseline to study end. Adult patients with Stage 1 hypertension or isolated systolic hypertension were randomized to receive 5 mg amlodipine LCB or IB once daily for 6 weeks in each period in a 2 × 2 crossover manner with three follow-up visits in each sequence...
November 2016: Indian Journal of Pharmacology
https://www.readbyqxmd.com/read/28059912/phenol-injection-versus-excision-with-open-healing-in-pilonidal-disease-a-prospective-randomized-trial
#6
Ismail Calikoglu, Kamil Gulpinar, Derya Oztuna, Atilla Halil Elhan, Osman Dogru, Cihangir Akyol, Bulent Erkek, Mehmet Ayhan Kuzu
BACKGROUND: Minimally invasive procedures may be an alternative to surgical excisions for pilonidal disease. OBJECTIVE: The aim of the study was to compare phenol injection versus excision with open healing technique. DESIGN: This is a prospective randomized study (ACTRN12612000868886). SETTINGS: This study was conducted at the Ankara University and Ufuk University Departments of Surgery. PATIENTS: One hundred forty patients were randomly assigned to phenol injection (n = 70) or excision with open healing (n = 70)...
February 2017: Diseases of the Colon and Rectum
https://www.readbyqxmd.com/read/28059869/a-longitudinal-supra-inguinal-fascia-iliaca-compartment-block-reduces-morphine-consumption-after-total-hip-arthroplasty
#7
Matthias Desmet, Kris Vermeylen, Imré Van Herreweghe, Laurence Carlier, Filiep Soetens, Stijn Lambrecht, Kathleen Croes, Hans Pottel, Marc Van de Velde
BACKGROUND AND OBJECTIVES: The role of a fascia iliaca compartment block (FICB) for postoperative analgesia after total hip arthroplasty (THA) remains questionable. High-dose local anesthetics and a proximal injection site may be essential for successful analgesia. High-dose local anesthetics may pose a risk for local anesthetic systemic toxicity. We hypothesized that a high-dose longitudinal supra-inguinal FICB is safe and decreases postoperative morphine consumption after anterior approach THA...
January 3, 2017: Regional Anesthesia and Pain Medicine
https://www.readbyqxmd.com/read/28057361/efficacy-and-safety-of-guselkumab-an-anti-interleukin-23-monoclonal-antibody-compared-with-adalimumab-for-the-treatment-of-patients-with-moderate-to-severe-psoriasis-with-randomized-withdrawal-and-retreatment-results-from-the-phase-iii-double-blind-placebo
#8
Kristian Reich, April W Armstrong, Peter Foley, Michael Song, Yasmine Wasfi, Bruce Randazzo, Shu Li, Y-K Shen, Kenneth B Gordon
BACKGROUND: Phase II data suggested that guselkumab, an anti-interleukin-23 monoclonal antibody, was efficacious in psoriasis. OBJECTIVE: We sought to assess efficacy and safety of guselkumab in moderate to severe psoriasis versus placebo and adalimumab, including interrupted treatment and switching adalimumab nonresponders to guselkumab. METHODS: Patients were randomized to guselkumab 100 mg (weeks 0 and 4, then every 8 weeks; n = 496); placebo→guselkumab (weeks 0, 4, and 12 then guselkumab at weeks 16 and 20; n = 248); or adalimumab (80 mg week 0, then 40 mg week 1, and every 2 weeks through week 23; n = 248)...
December 29, 2016: Journal of the American Academy of Dermatology
https://www.readbyqxmd.com/read/28045953/double-blind-controlled-randomized-trial-of-cyclophosphamide-versus-methylprednisolone-in-secondary-progressive-multiple-sclerosis
#9
Bruno Brochet, Mathilde S A Deloire, Paul Perez, Timothé Loock, Louise Baschet, Marc Debouverie, Sophie Pittion, Jean-Christophe Ouallet, Pierre Clavelou, Jérôme de Sèze, Nicolas Collongues, Patrick Vermersch, Hélène Zéphir, Giovanni Castelnovo, Pierre Labauge, Christine Lebrun, Mikael Cohen, Aurélie Ruet
BACKGROUND: Therapeutic options are limited in secondary progressive multiple sclerosis (SPMS). Open-label studies suggested efficacy of monthly IV cyclophosphamide (CPM) without induction for delaying progression but no randomized trial was conducted so far. OBJECTIVE: To compare CPM to methylprednisolone (MP) in SPMS. METHODS: Randomized, double-blind clinical trial on two parallel groups. Patient with SPMS, with a documented worsening of the Expanded Disability Status Scale (EDSS) score during the last year and an EDSS score between 4·0 and 6·5 were recruited and received one intravenous infusion of treatment (CPM: 750 mg /m2 body surface area-MP: 1g) every four weeks for one year, and every eight weeks for the second year...
2017: PloS One
https://www.readbyqxmd.com/read/28039321/impact-of-cerebrovascular-events-older-than-one-year-on-ischemic-and-bleeding-outcomes-with-cangrelor-in-percutaneous-coronary-intervention
#10
Neal N Sawlani, Robert A Harrington, Gregg W Stone, Ph Gabriel Steg, C Michael Gibson, Christian W Hamm, Matthew J Price, Jayne Prats, Efthymios N Deliargyris, Kenneth W Mahaffey, Harvey D White, Deepak L Bhatt
BACKGROUND: Cangrelor is a potent intravenous adenosine diphosphate-receptor antagonist that in the CHAMPION trials reduced the 48-hour and 30-day rates of ischemic events during percutaneous coronary intervention without an increase in severe bleeding. METHODS AND RESULTS: CHAMPION PCI (A Clinical Trial to Demonstrate the Efficacy of Cangrelor), CHAMPION PLATFORM (Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition), and CHAMPION PHOENIX (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention) were 3 randomized, double-blind, double-dummy trials in which cangrelor was compared with clopidogrel during percutaneous coronary intervention...
January 2017: Circulation. Cardiovascular Interventions
https://www.readbyqxmd.com/read/28034081/randomized-double-blind-phase-iii-trial-of-ipilimumab-versus-placebo-in-asymptomatic-or-minimally-symptomatic-patients-with-metastatic-chemotherapy-naive-castration-resistant-prostate-cancer
#11
Tomasz M Beer, Eugene D Kwon, Charles G Drake, Karim Fizazi, Christopher Logothetis, Gwenaelle Gravis, Vinod Ganju, Jonathan Polikoff, Fred Saad, Piotr Humanski, Josep M Piulats, Pablo Gonzalez Mella, Siobhan S Ng, Dirk Jaeger, Francis X Parnis, Fabio A Franke, Javier Puente, Roman Carvajal, Lisa Sengeløv, M Brent McHenry, Arvind Varma, Alfonsus J van den Eertwegh, Winald Gerritsen
Purpose Ipilimumab increases antitumor T-cell responses by binding to cytotoxic T-lymphocyte antigen 4. We evaluated treatment with ipilimumab in asymptomatic or minimally symptomatic patients with chemotherapy-naive metastatic castration-resistant prostate cancer without visceral metastases. Patients and Methods In this multicenter, double-blind, phase III trial, patients were randomly assigned (2:1) to ipilimumab 10 mg/kg or placebo every 3 weeks for up to four doses. Ipilimumab 10 mg/kg or placebo maintenance therapy was administered to nonprogressing patients every 3 months...
January 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28034079/phase-iii-double-blind-randomized-trial-that-compared-maintenance-lapatinib-versus-placebo-after-first-line-chemotherapy-in-patients-with-human-epidermal-growth-factor-receptor-1-2-positive-metastatic-bladder-cancer
#12
Thomas Powles, Robert A Huddart, Tony Elliott, Shah-Jalal Sarker, Charlotte Ackerman, Robert Jones, Syed Hussain, Simon Crabb, Satinder Jagdev, John Chester, Serena Hilman, Mark Beresford, Graham Macdonald, Sundar Santhanam, John A Frew, Andrew Stockdale, Simon Hughes, Daniel Berney, Simon Chowdhury
Purpose To establish whether maintenance lapatinib after first-line chemotherapy is beneficial in human epidermal growth factor receptor (HER) 1/HER2-positive metastatic urothelial bladder cancer (UBC). Methods Patients with metastatic UBC were screened centrally for HER1/HER2 overexpression. Patients who screened positive for HER1/2 and who did not have progressive disease during chemotherapy (four to eight cycles) were randomly assigned one to one to lapatinib or placebo after completion of first-line/initial chemotherapy for metastatic disease...
January 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28029926/fish-oil-derived-fatty-acids-in-pregnancy-and-wheeze-and-asthma-in-offspring
#13
RANDOMIZED CONTROLLED TRIAL
Hans Bisgaard, Jakob Stokholm, Bo L Chawes, Nadja H Vissing, Elin Bjarnadóttir, Ann-Marie M Schoos, Helene M Wolsk, Tine M Pedersen, Rebecca K Vinding, Sunna Thorsteinsdóttir, Nilofar V Følsgaard, Nadia R Fink, Jonathan Thorsen, Anders G Pedersen, Johannes Waage, Morten A Rasmussen, Ken D Stark, Sjurdur F Olsen, Klaus Bønnelykke
Background Reduced intake of n-3 long-chain polyunsaturated fatty acids (LCPUFAs) may be a contributing factor to the increasing prevalence of wheezing disorders. We assessed the effect of supplementation with n-3 LCPUFAs in pregnant women on the risk of persistent wheeze and asthma in their offspring. Methods We randomly assigned 736 pregnant women at 24 weeks of gestation to receive 2.4 g of n-3 LCPUFA (fish oil) or placebo (olive oil) per day. Their children formed the Copenhagen Prospective Studies on Asthma in Childhood2010 (COPSAC2010) cohort and were followed prospectively with extensive clinical phenotyping...
29, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/28029173/a-randomized-trial-evaluating-whether-topiramate-aids-smoking-cessation-and-prevents-alcohol-relapse-in-recovering-alcohol-dependent-men
#14
Robert M Anthenelli, Jaimee L Heffner, Esther Wong, Jessie Tibbs, Katie Russell, Melodie Isgro, Elizabeth Dinh, Chris Wehrle, Matthew J Worley, Neal Doran
BACKGROUND: Alcohol and nicotine dependence frequently co-occur, and quitting smoking might enhance long-term alcohol abstinence. Topiramate appears to help non-alcohol-dependent individuals quit smoking, and our pilot work suggested efficacy only in men. It also prevents relapse to alcohol in recently detoxified alcoholics. We evaluated topiramate in abstinent alcohol-dependent men to assess whether this medication (i) promotes smoking cessation and (ii) prevents alcohol and other drug relapse in the context of smoking cessation treatment...
December 28, 2016: Alcoholism, Clinical and Experimental Research
https://www.readbyqxmd.com/read/28027518/impact-of-industry-collaboration-on-randomised-controlled-trials-in-oncology
#15
Anne Linker, Annie Yang, Nitin Roper, Evans Whitaker, Deborah Korenstein
BACKGROUND: Industry funders can simply provide money or collaborate in trial design, analysis or reporting of clinical trials. Our aim was to assess the impact of industry collaboration on trial methodology and results of randomised controlled trials (RCT). METHODS: We searched PubMed for oncology RCTs published May 2013 to December 2015 in peer-reviewed journals with impact factor > 5 requiring reporting of funder role. Two authors extracted methodologic (primary end-point; blinding of the patient, clinician and outcomes assessor; and analysis) and outcome data...
December 24, 2016: European Journal of Cancer
https://www.readbyqxmd.com/read/28027332/opicapone-as-adjunct-to-levodopa-therapy-in-patients-with-parkinson-disease-and-motor-fluctuations-a-randomized-clinical-trial
#16
Andrew J Lees, Joaquim Ferreira, Olivier Rascol, Werner Poewe, José-Francisco Rocha, Michelle McCrory, Patricio Soares-da-Silva
Importance: Catechol O-methyltransferase (COMT) inhibitors are an established treatment for end-of-dose motor fluctuations associated with levodopa therapy in patients with Parkinson disease (PD). Current COMT inhibitors carry a high risk for toxic effects to hepatic cells or show moderate improvement. Opicapone was designed to be effective without the adverse effects. Objective: To evaluate the efficacy and safety of 25- and 50-mg/d dosages of opicapone compared with placebo as adjunct to levodopa therapy in patients with PD experiencing end-of-dose motor fluctuations...
December 27, 2016: JAMA Neurology
https://www.readbyqxmd.com/read/28011247/health-status-of-patients-with-moderate-to-severe-copd-after-treatment-with-nebulized-arformoterol-tartrate-or-placebo-for-1-year
#17
James F Donohue, Vaidyanathan Ganapathy, Vamsi Bollu, Michael D Stensland, Lauren M Nelson
PURPOSE: Chronic obstructive pulmonary disease (COPD) is a progressive disease that impairs both objectively measured lung function and patient-reported health status. In a randomized clinical trial of patients with moderate to severe COPD, we compared changes in health status after adding arformoterol tartrate or placebo to patients' treatment regimens. METHODS: In this multicenter, double-blind trial, patients were randomized to receive nebulized arformoterol 15 µg BID (n = 420) or matched placebo (n = 421)...
December 20, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/28010953/the-japan-statin-treatment-against-recurrent-stroke-j-stars-echo-study-rationale-and-trial-protocol
#18
Kazunori Toyoda, Kazuo Minematsu, Masahiro Yasaka, Yoji Nagai, Naohisa Hosomi, Hideki Origasa, Kazuo Kitagawa, Shinichiro Uchiyama, Masatoshi Koga, Masayasu Matsumoto
OBJECTIVE: The preventive effect of 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statins) on progression of carotid intima-media complex thickness (IMT) has been shown exclusively in nonstroke Western patients. The Japan Statin Treatment Against Recurrent Stroke (J-STARS) Echo Study aims to determine the effect of pravastatin on carotid IMT in Japanese patients with hyperlipidemia who developed noncardioembolic ischemic stroke. DESIGN: This is a substudy of the J-STARS, a multicenter, randomized, open-label, blinded-end point, parallel-group trial to examine whether pravastatin reduces stroke recurrence in patients with noncardioembolic stroke...
December 20, 2016: Journal of Stroke and Cerebrovascular Diseases: the Official Journal of National Stroke Association
https://www.readbyqxmd.com/read/28008281/nicoboxil-nonivamide-cream-effectively-and-safely-reduces-acute-nonspecific-low-back-pain-a-randomized-placebo-controlled-trial
#19
Zuzana Blahova, Janina Claudia Holm, Thomas Weiser, Erika Richter, Matthias Trampisch, Elena Akarachkova
BACKGROUND/OBJECTIVE: Low back pain affects many patients and has a high socioeconomic impact. Topical capsaicinoids have been used for decades to treat musculoskeletal pain. This study investigated the effects of the fixed dose combination (FDC) of nonivamide (a capsaicinoid) and nicoboxil (a nicotinic acid ester) cream in the treatment of acute nonspecific low back pain. MATERIALS AND METHODS: This phase III randomized, double-blind, placebo-controlled, multinational, multi-center trial investigated efficacy, safety, and tolerability of topical nicoboxil 1...
2016: Journal of Pain Research
https://www.readbyqxmd.com/read/28006041/efficacy-and-safety-of-ciprofloxacin-plus-fluocinolone-in-otitis-media-with-tympanostomy-tubes-in-pediatric-patients-a-randomized-clinical-trial
#20
Zorik Spektor, Felix Pumarola, Khaleed Ismail, Brent Lanier, Iftikhar Hussain, John Ansley, Henry F Butehorn, Kenneth Esterhuizen, John Byers, Franklin Douglis, Bryan Lansford, F Javier Hernández
Importance: Acute otitis media with tympanostomy tubes (AOMT) in children commonly presents with otorrhea and negatively affects their daily activities. Objective: To evaluate the efficacy and safety of topical ciprofloxacin, 0.3%, plus fluocinolone acetonide, 0.025%, otic solution relative to ciprofloxacin, 0.3%, otic solution alone and fluocinolone acetonide, 0.025%, otic solution alone in the treatment of AOMT in children. Design, Setting, and Participants: Two twin multicenter, randomized, double-blind clinical trials with identical designs were conducted from June 24, 2011, through June 23, 2014, at ear, nose, and throat pediatric practices, general practices, hospitals, and clinical research centers...
December 22, 2016: JAMA Otolaryngology—Head & Neck Surgery
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