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https://www.readbyqxmd.com/read/28645983/the-effect-of-magnesium-supplementation-on-vascular-calcification-in-chronic-kidney-disease-a-randomised-clinical-trial-magical-ckd-essential-study-design-and-rationale
#1
Iain Bressendorff, Ditte Hansen, Morten Schou, Charlotte Kragelund, Lisbet Brandi
INTRODUCTION: Chronic kidney disease (CKD) is associated with an increased risk of cardiovascular disease and mortality, which is thought to be caused by increased propensity towards vascular calcification (VC). Magnesium (Mg) inhibits phosphate-induced VC in vitro and in animal models and serum Mg is inversely associated with cardiovascular mortality in predialysis CKD and in end-stage renal disease. This paper will describe the design and rationale of a randomised double-blinded placebo-controlled multicentre clinical trial, which will investigate whether oral Mg supplementation can prevent the progression of coronary artery calcification (CAC) in subjects with predialysis CKD...
June 23, 2017: BMJ Open
https://www.readbyqxmd.com/read/28639937/a-multicentre-randomised-controlled-trial-of-intravenous-immunoglobulin-compared-with-standard-therapy-for-the-treatment-of-transverse-myelitis-in-adults-and-children-strive
#2
Michael Absoud, Peter Brex, Olga Ciccarelli, Onyinye Diribe, Gavin Giovannoni, Jennifer Hellier, Rosemary Howe, Rachel Holland, Joanna Kelly, Paul McCrone, Caroline Murphy, Jackie Palace, Andrew Pickles, Michael Pike, Neil Robertson, Anu Jacob, Ming Lim
BACKGROUND: Transverse myelitis (TM) is an immune-mediated disorder of the spinal cord that affects adults and children and that causes motor, sensory and autonomic dysfunction. There is a prolonged recovery phase, which may continue for many years. Neuromyelitis optica (NMO) is an uncommon relapsing inflammatory central nervous system condition in which TM can be the first presenting symptom. As TM and NMO affect many patients in the prime of their working life, the disorder can impose a significant demand on health resources...
May 2017: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/28639542/fluticasone-propionate-and-fluticasone-propionate-salmeterol-multidose-dry-powder-inhalers-compared-with-placebo-for-persistent-asthma
#3
L D Sher, G Yiu, A Sakov, S Liu, C F Caracta
BACKGROUND: A novel, inhalation-driven, multidose dry powder inhaler (MDPI) has been developed, which allows for lowerdoses of fluticasone propionate (Fp) and Fp/salmeterol (FS) for the treatment of patients with asthma. OBJECTIVE: This phase III, multicenter, double-blind, parallel-group study (NCT02141854) evaluated the efficacy and safetyof Fp MDPI and FS MDPI versus placebo MDPI. METHODS: Patients aged greater than or equal to 12 years with persistent asthma who previously took an inhaled corticosteroid with or without a long-acting beta-agonist entered a 14- to 21-day run-in period, during which they received single-blind, low-dose Fp MDPI 50 microgram (1 inhalation twice daily [b...
June 21, 2017: Allergy and Asthma Proceedings:
https://www.readbyqxmd.com/read/28638546/comparing-the-effect-of-diode-laser-against-acyclovir-cream-for-the-treatment-of-herpes-labialis
#4
Marieh Honarmand, Leila Farhadmollashahi, Ehsan Vosoughirahbar
BACKGROUND: Recently alternative therapies such as the use of diode laser therapy have been introduced for recurrent herpes labial infection. The aim of this study was to evaluate the effectiveness of diode laser for treatment of recurrent herpes labialis. MATERIAL AND METHODS: This was single-blind randomized clinical trial to evaluate the efficacy of diode laser for the treatment of recurrent herpes labial. In total, 60 patients whit recurrent herpes simplex labialis were selected and randomly divided in to three groups...
June 2017: Journal of Clinical and Experimental Dentistry
https://www.readbyqxmd.com/read/28637741/the-closed-trial-clonidine-compared-with-midazolam-for-sedation-of-paediatric-patients-in-the-intensive-care-unit-study-protocol-for-a-multicentre-randomised-controlled-trial
#5
Antje Neubert, Manuel Alberto Baarslag, Monique van Dijk, Joost van Rosmalen, Joseph F Standing, Yucheng Sheng, Wolfgang Rascher, Deborah Roberts, Jackie Winslade, Louise Rawcliffe, Sara M Hanning, Tuuli Metsvaht, Viviana Giannuzzi, Peter Larsson, Pavla Pokorná, Alessandra Simonetti, Dick Tibboel
INTRODUCTION: Sedation is an essential part of paediatric critical care. Midazolam, often in combination with opioids, is the current gold standard drug. However, as it is a far-from-ideal agent, clonidine is increasingly being used in children. This drug is prescribed off-label for this indication, as many drugs in paediatrics are. Therefore, the CLOSED trial aims to provide data on the pharmacokinetics, safety and efficacy of clonidine for the sedation of mechanically ventilated patients in order to obtain a paediatric-use marketing authorisation...
June 21, 2017: BMJ Open
https://www.readbyqxmd.com/read/28637193/effect-of-intensive-personalized-5as-5rs-intervention-on-smoking-cessation-in-hospitalized-acute-coronary-syndrome-patients-not-ready-to-quit-immediately-a-randomized-controlled-trial
#6
Jing-Guang Luo, Ling Han, Li-Wei Chen, Yun Gao, Xiao-Jun Ding, Ying Li, Ye Ja, Ming Yang, Chang-Sheng Ma
Introduction: The acute coronary syndrome (ACS) patients who are not ready to quit smoking immediately have an extremely low rate of cessation. This study aims to investigate the efficacy of intensive personalized '5As+5Rs'intervention (IPANR intervention) on smoking cessation in this population. Methods: A parallel-group randomized controlled trial was carried out, which compared IPANR intervention with routine 5Rs (control) at Fu Xing Hospital, Capital Medical University, Bei Jing, China...
June 20, 2017: Nicotine & Tobacco Research: Official Journal of the Society for Research on Nicotine and Tobacco
https://www.readbyqxmd.com/read/28636855/efficacy-of-recombinant-influenza-vaccine-in-adults-50-years-of-age-or-older
#7
Lisa M Dunkle, Ruvim Izikson, Peter Patriarca, Karen L Goldenthal, Derek Muse, Janice Callahan, Manon M J Cox
BACKGROUND: Improved influenza vaccines are needed to control seasonal epidemics. This trial compared the protective efficacy in older adults of a quadrivalent, recombinant influenza vaccine (RIV4) with a standard-dose, egg-grown, quadrivalent, inactivated influenza vaccine (IIV4) during the A/H3N2-predominant 2014-2015 influenza season, when antigenic mismatch between circulating and vaccine influenza strains resulted in the reduced effectiveness of many licensed vaccines. METHODS: We conducted a randomized, double-blind, multicenter trial of RIV4 (45 μg of recombinant hemagglutinin [HA] per strain, 180 μg of protein per dose) versus standard-dose IIV4 (15 μg of HA per strain, 60 μg of protein per dose) to compare the relative vaccine efficacy against reverse-transcriptase polymerase-chain-reaction (RT-PCR)-confirmed, protocol-defined, influenza-like illness caused by any influenza strain starting 14 days or more after vaccination in adults who were 50 years of age or older...
June 22, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28636851/first-line-nivolumab-in-stage-iv-or-recurrent-non-small-cell-lung-cancer
#8
COMMENT
David P Carbone, Martin Reck, Luis Paz-Ares, Benjamin Creelan, Leora Horn, Martin Steins, Enriqueta Felip, Michel M van den Heuvel, Tudor-Eliade Ciuleanu, Firas Badin, Neal Ready, T Jeroen N Hiltermann, Suresh Nair, Rosalyn Juergens, Solange Peters, Elisa Minenza, John M Wrangle, Delvys Rodriguez-Abreu, Hossein Borghaei, George R Blumenschein, Liza C Villaruz, Libor Havel, Jana Krejci, Jesus Corral Jaime, Han Chang, William J Geese, Prabhu Bhagavatheeswaran, Allen C Chen, Mark A Socinski
BACKGROUND: Nivolumab has been associated with longer overall survival than docetaxel among patients with previously treated non-small-cell lung cancer (NSCLC). In an open-label phase 3 trial, we compared first-line nivolumab with chemotherapy in patients with programmed death ligand 1 (PD-L1)-positive NSCLC. METHODS: We randomly assigned, in a 1:1 ratio, patients with untreated stage IV or recurrent NSCLC and a PD-L1 tumor-expression level of 1% or more to receive nivolumab (administered intravenously at a dose of 3 mg per kilogram of body weight once every 2 weeks) or platinum-based chemotherapy (administered once every 3 weeks for up to six cycles)...
June 22, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28632587/the-clinical-outcome-of-computer-navigated-compared-with-conventional-knee-arthroplasty-in-the-same-patients-a-prospective-randomized-double-blind-long-term-study
#9
Young-Hoo Kim, Jang-Won Park, Jun-Shik Kim
BACKGROUND: The available comparative studies of computer navigation-assisted and conventional knee arthroplasties have short-term follow-up periods. Therefore, the clinical benefits after long-term follow-up are not clear. The purposes of the current long-term study were to compare clinical outcomes, alignment of the knee components, prevalence of aseptic loosening of the components, implant survival, and complications of total knee arthroplasties performed with and without computer navigation...
June 21, 2017: Journal of Bone and Joint Surgery. American Volume
https://www.readbyqxmd.com/read/28625387/design-and-rationale-for-the-influenza-vaccination-after-myocardial-infarction-iami-trial-a-registry-based-randomized-clinical-trial
#10
Ole Fröbert, Matthias Götberg, Oskar Angerås, Lena Jonasson, David Erlinge, Thomas Engstrøm, Jonas Persson, Svend E Jensen, Elmir Omerovic, Stefan K James, Bo Lagerqvist, Johan Nilsson, Amra Kåregren, Rasmus Moer, Cao Yang, David B Agus, Andrejs Erglis, Lisette O Jensen, Lars Jakobsen, Evald H Christiansen, John Pernow
BACKGROUND: Registry studies and case-control studies have demonstrated that the risk of acute myocardial infarction (AMI) is increased following influenza infection. Small randomized trials, underpowered for clinical end points, indicate that future cardiovascular events can be reduced following influenza vaccination in patients with established cardiovascular disease. Influenza vaccination is recommended by international guidelines for patients with cardiovascular disease, but uptake is varying and vaccination is rarely prioritized during hospitalization for AMI...
July 2017: American Heart Journal
https://www.readbyqxmd.com/read/28625368/effect-of-aspirin-on-renal-disease-progression-in-patients-with-type-2-diabetes-a-multicenter-double-blind-placebo-controlled-randomized-trial-the-renal-disease-progression-by-aspirin-in-diabetic-patients-leda-trial-rationale-and-study-design
#11
Francesco Violi, Giovanni Targher, Annarita Vestri, Roberto Carnevale, Maurizio Averna, Alessio Farcomeni, Andrea Lenzi, Francesco Angelico, Francesco Cipollone, Daniele Pastori
Type 2 diabetes mellitus (T2DM) is one of the most common causes of chronic kidney disease and kidney failure. It has been estimated that the annual decline of estimated glomerular filtration rate (eGFR) among patients with T2DM is approximately 2.0-2.5mL min(-1) y(-1). Cyclooxygenase-dependent eicosanoids, such as 11-dehydro-thromboxane (Tx)B2, are increased in T2DM patients and are potentially involved in the regulation of renal blood flow. Animal models showed that cyclooxygenase inhibitors, such as aspirin, are associated with improvements in renal plasma flow and eGFR values...
July 2017: American Heart Journal
https://www.readbyqxmd.com/read/28625255/-effect-of-vitamin-d3-on-the-severity-and-prognosis-of-patients-with-sepsis-a-prospective-randomized-double-blind-placebo-study
#12
Fulai Ding, Bin Zang, Jiahong Fu, Kaiqiang Ji
OBJECTIVE: To observe the relationship between vitamin D3 and the severity as well as prognosis in patients with sepsis, and to explore whether exogenous vitamin D3 can improve the prognosis in patients with sepsis. METHODS: A prospective randomized double-blind placebo study was conducted. Fifty-seven patients with sepsis admitted to intensive care unit (ICU) of Shengjing Hospital Affiliated to China Medical University from March to November in 2015 were enrolled...
February 2017: Zhonghua Wei Zhong Bing Ji Jiu Yi Xue
https://www.readbyqxmd.com/read/28624096/a-multiregional-randomized-evaluation-of-the-lipid-modifying-efficacy-and-tolerability-of-anacetrapib-added-to-ongoing-statin-therapy-in-patients-with-hypercholesterolemia-or-low-high-density-lipoprotein-cholesterol
#13
Christie M Ballantyne, Sukrut Shah, Aditi Sapre, Tanya B Ashraf, Sandra C Tobias, Tayfun Sahin, Ping Ye, Yugang Dong, Wayne Huey-Heng Sheu, Duk-Hyun Kang, Paulo Roberto Ferreira Rossi, Yulia Moiseeva, Ignacio Rodriguez Briones, Amy O Johnson-Levonas, Yale B Mitchel
This phase 3, multiregional, randomized, double-blind, placebo-controlled study assessed the efficacy/safety profile of anacetrapib added to ongoing therapy with statin ± other lipid-modifying therapies in patients with hypercholesterolemia who were not at their low-density lipoprotein (LDL-C) goal (as per the National Cholesterol Education Program Adult Treatment Panel III guidelines) and in those with low high-density lipoprotein cholesterol (HDL-C). Patients on a stable dose of statin ± other lipid-modifying therapies and with LDL-C ≥70 to <115, ≥100 to <145, ≥130, or ≥160 mg/dl for very high, high, moderate, or low CHD risk or at LDL-C goal (per CHD risk category) with HDL-C ≤40 mg/dl were randomized in a ratio of 1:1 to anacetrapib 100 mg (n = 290) or placebo (n = 293) for 24 weeks, followed by a 12-week off-drug phase...
April 12, 2017: American Journal of Cardiology
https://www.readbyqxmd.com/read/28613956/effect-of-age-on-the-efficacy-and-safety-of-lenvatinib-in-radioiodine-refractory-differentiated-thyroid-cancer-in-the-phase-iii-select-trial
#14
Marcia S Brose, Francis P Worden, Kate L Newbold, Matthew Guo, Arti Hurria
Purpose In the Study of (E7080) Lenvatinib in Differentiated Cancer of the Thyroid (SELECT), lenvatinib significantly prolonged progression-free survival (PFS) versus placebo in patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC). This prespecified subanalysis investigated the effect of age on the efficacy and safety of lenvatinib. Patients and Methods This randomized, double-blind, phase III study enrolled patients with histologically confirmed RR-DTC stratified by age (≤ 65 or > 65 years)...
June 14, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28611125/design-and-rationale-of-the-phase-3-attr-act-clinical-trial-tafamidis-in-transthyretin-cardiomyopathy-clinical-trial
#15
Mathew S Maurer, Perry Elliott, Giampaolo Merlini, Sanjiv J Shah, Márcia Waddington Cruz, Alison Flynn, Balarama Gundapaneni, Carolyn Hahn, Steven Riley, Jeffrey Schwartz, Marla B Sultan, Claudio Rapezzi
Transthyretin amyloidosis is a rare, life-threatening disease resulting from aggregation and deposition of transthyretin amyloid fibrils in various tissues. There are 2 predominate phenotypic presentations of the disease: transthyretin familial amyloid polyneuropathy, which primarily affects the peripheral nerves, and transthyretin cardiomyopathy (TTR-CM), which primarily affects the heart. However, there is a wide overlap with symptoms at presentation and disease course being highly variable and influenced by the underlying transthyretin mutation, age of the affected individual, sex, and geographic location...
June 2017: Circulation. Heart Failure
https://www.readbyqxmd.com/read/28609567/safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-the-novel-crth2-antagonist-bi-1021958-at-single-oral-doses-in-healthy-men-and-multiple-oral-doses-in-men-and-women-with-well-controlled-asthma
#16
Andy Fowler, Rüdiger Koenen, James Hilbert, Jon Blatchford, Dominik Kappeler, Ewald Benediktus, Chester Wood, Abhya Gupta
BI 1021958, a novel antagonist of the chemoattractant-receptor-homologous molecule (CRTH2), targets airway inflammation in asthma by inhibiting prostaglandin binding to CRTH2 receptors. Two phase 1 studies assessed BI 1021958 safety/tolerability and pharmacokinetics (PK)/pharmacodynamics (PD) following single doses in healthy men and multiple doses in men/women with well-controlled asthma. Studies 1 had 2 parts: a placebo-controlled, fixed-sequence, single-blind, single-rising-dose part (n = 56) and a randomized, 2-way crossover, open-label, repeated-dose part studying the food effect on PK/PD (n = 12)...
June 13, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28608739/safety-of-repeated-dose-intratympanic-injections-with-am-101-in-acute-inner-ear-tinnitus
#17
Hinrich Staecker, Michael Morelock, Timothy Kramer, Pavel Chrbolka, Joong Ho Ahn, Thomas Meyer
Objective To evaluate the safety and tolerability of repeated intratympanic administration of the gel-formulated NMDA receptor antagonist AM-101 in acute patients with inner ear tinnitus. Study Design Prospective, double-blind, randomized, placebo-controlled study. Setting Sixty-nine secondary and tertiary sites in North America, Europe, and Asia. Subjects and Methods In total, 343 subjects with persistent acute tinnitus after traumatic cochlear injury or otitis media were randomized to receive 3 intratympanic doses of either AM-101 0...
June 1, 2017: Otolaryngology—Head and Neck Surgery
https://www.readbyqxmd.com/read/28604926/ads-5102-amantadine-extended-release-capsules-for-levodopa-induced-dyskinesia-in-parkinson-disease-ease-lid-study-a-randomized-clinical-trial
#18
Rajesh Pahwa, Caroline M Tanner, Robert A Hauser, Stuart H Isaacson, Paul A Nausieda, Daniel D Truong, Pinky Agarwal, Keith L Hull, Kelly E Lyons, Reed Johnson, Mary Jean Stempien
Importance: Medical treatment of levodopa-induced dyskinesia (LID) in Parkinson disease (PD) is an unmet need. Objective: To evaluate the efficacy and safety of ADS-5102 (amantadine) extended-release 274-mg capsules for treatment of LID in patients with PD. Design, Setting, and Participants: A randomized, double-blind, placebo-controlled clinical trial was conducted between May 7, 2014, and July 22, 2015, at 44 North American sites among patients with PD treated with levodopa who experienced at least 1 hour of troublesome dyskinesia per day with at least mild functional impact...
June 12, 2017: JAMA Neurology
https://www.readbyqxmd.com/read/28601891/effect-of-liraglutide-treatment-on-prediabetes-and-overweight-or-obesity-in-clozapine-or-olanzapine-treated-patients-with-schizophrenia-spectrum-disorder-a-randomized-clinical-trial
#19
Julie R Larsen, Louise Vedtofte, Mathilde S L Jakobsen, Hans R Jespersen, Michelle I Jakobsen, Camilla K Svensson, Kamuran Koyuncu, Ole Schjerning, Peter S Oturai, Andreas Kjaer, Jimmi Nielsen, Jens J Holst, Claus T Ekstrøm, Christoph U Correll, Tina Vilsbøll, Anders Fink-Jensen
Importance: Compared with the general population, patients with schizophrenia have a 2- to 3-fold higher mortality rate primarily caused by cardiovascular disease. Previous interventions designed to counteract antipsychotic-induced weight gain and cardiometabolic disturbances reported limited effects. Objectives: To determine the effects of the glucagon-like peptide-1 receptor agonist liraglutide added to clozapine or olanzapine treatment of schizophrenia spectrum disorders...
June 10, 2017: JAMA Psychiatry
https://www.readbyqxmd.com/read/28601388/a-randomized-placebo-controlled-phase-1b-2-study-of-rilotumumab-or-ganitumab-in-combination-with-platinum-based-chemotherapy-as-first-line-treatment-for-extensive-stage-small-cell-lung-cancer
#20
Bonnie Glisson, Benjamin Besse, Manuel Cobo Dols, Sarita Dubey, Marco Schupp, Rajul Jain, Yizhou Jiang, Hari Menon, Kristiaan Nackaerts, Sergey Orlov, Luis Paz-Ares, Rodryg Ramlau, Rui Tang, Yilong Zhang, Min Zhu
INTRODUCTION/BACKGROUND: In this randomized, double-blind, placebo-controlled phase 1b/2 study we assessed the efficacy/safety of rilotumumab or ganitumab combined with etoposide and carboplatin or cisplatin as first-line treatment in patients with extensive stage small-cell lung cancer (ES-SCLC). PATIENTS AND METHODS: In the phase 1b study, patients received rilotumumab 15 mg/kg or ganitumab 18 mg/kg with etoposide and carboplatin or cisplatin. In the phase 2 study, patients were randomly assigned 1:1:1 to receive placebo, rilotumumab, or ganitumab with etoposide and carboplatin or cisplatin...
May 10, 2017: Clinical Lung Cancer
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