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https://www.readbyqxmd.com/read/29137830/efficacy-and-safety-of-tamsulosin-in-medical-expulsive-therapy-for-distal-ureteral-stones-with-renal-colic-a-multicenter-randomized-double-blind-placebo-controlled-trial
#1
Zhangqun Ye, Guohua Zeng, Huan Yang, Kun Tang, Xiaochun Zhang, Hong Li, Weibing Li, Zhong Wu, Lingwu Chen, Xingfa Chen, Xiankui Liu, Yaoliang Deng, Tiejun Pan, Jinchun Xing, Shusheng Wang, Yue Cheng, Xiaojian Gu, Wenxi Gao, Jianggen Yang, Yonghai Zhang, Qiwu Mi, Lin Qi, Jiongming Li, Weilie Hu, Peiyu Liang, Zhaolin Sun, Changbao Xu, Yongfu Long, Yongbin Liao, Siping Liu, Guoqing Liu, Xun Xu, Wei He, Zhiqiang Chen, Hua Xu
BACKGROUND: Recent large high-quality trials have questioned the clinical effectiveness of medical expulsive therapy using tamsulosin for ureteral stones. OBJECTIVE: To evaluate the efficacy and safety of tamsulosin for distal ureteral stones compared with placebo. DESIGN, SETTING, AND PARTICIPANTS: We conducted a double-blind, placebo-controlled study of 3296 patients with distal ureteral stones, across 30 centers, to evaluate the efficacy and safety of tamsulosin...
November 11, 2017: European Urology
https://www.readbyqxmd.com/read/29136445/effect-of-varying-doses-of-epicutaneous-immunotherapy-vs-placebo-on-reaction-to-peanut-protein-exposure-among-patients-with-peanut-sensitivity-a-randomized-clinical-trial
#2
Hugh A Sampson, Wayne G Shreffler, William H Yang, Gordon L Sussman, Terri F Brown-Whitehorn, Kari C Nadeau, Amarjit S Cheema, Stephanie A Leonard, Jacqueline A Pongracic, Christine Sauvage-Delebarre, Amal H Assa'ad, Frederic de Blay, J Andrew Bird, Stephen A Tilles, Franck Boralevi, Thierry Bourrier, Jacques Hébert, Todd D Green, Roy Gerth van Wijk, André C Knulst, Gisèle Kanny, Lynda C Schneider, Marek L Kowalski, Christophe Dupont
Importance: Epicutaneous immunotherapy may have potential for treating peanut allergy but has been assessed only in preclinical and early human trials. Objective: To determine the optimal dose, adverse events (AEs), and efficacy of a peanut patch for peanut allergy treatment. Design, Setting, and Participants: Phase 2b double-blind, placebo-controlled, dose-ranging trial of a peanut patch in peanut-allergic patients (6-55 years) from 22 centers, with a 2-year, open-label extension (July 31, 2012-July 31, 2014; extension completed September 29, 2016)...
November 14, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/29136387/randomized-multicenter-placebo-controlled-clinical-trial-of-duloxetine-versus-placebo-for-aromatase-inhibitor-associated-arthralgias-in-early-stage-breast-cancer-swog-s1202
#3
N Lynn Henry, Joseph M Unger, Anne F Schott, Louis Fehrenbacher, Patrick J Flynn, Debra M Prow, Carl W Sharer, Gary V Burton, Charles S Kuzma, Anna Moseley, Danika L Lew, Michael J Fisch, Carol M Moinpour, Dawn L Hershman, James L Wade
Purpose Adherence to aromatase inhibitor (AI) therapy for early-stage breast cancer is limited by AI-associated musculoskeletal symptoms (AIMSS). Duloxetine is US Food and Drug Administration approved for treatment of multiple chronic pain disorders. We hypothesized that treatment of AIMSS with duloxetine would improve average joint pain compared with placebo. Methods This randomized, double-blind, phase III trial included AI-treated postmenopausal women with early-stage breast cancer and who had average joint pain score of ≥ 4 out of 10 that developed or worsened since AI therapy initiation...
November 14, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29132440/influence-of-successful-periodontal-intervention-in-renal-disease-inspired-study-protocol-for-a-randomised-controlled-pilot-clinical-trial
#4
Praveen Sharma, Paul Cockwell, Thomas Dietrich, Charles Ferro, Natalie Ives, Iain L C Chapple
BACKGROUND: Patients with chronic kidney disease (CKD) exhibit increased morbidity and mortality which is associated with an increased systemic inflammatory burden. Identifying and managing comorbid diseases that contribute to this load may inform novel care pathways that could have a beneficial impact on the morbidity/mortality associated with CKD. Periodontitis, a highly prevalent, chronic inflammatory disease affecting the supporting structures of teeth, is associated with an increased systemic inflammatory and oxidative stress burden and the successful treatment of periodontitis has been shown to reduce both...
November 13, 2017: Trials
https://www.readbyqxmd.com/read/29128692/coast-cisplatin-ototoxicity-attenuated-by-aspirin-trial-a-phase-ii-double-blind-randomised-controlled-trial-to-establish-if-aspirin-reduces-cisplatin-induced-hearing-loss
#5
Simon J Crabb, Karen Martin, Julia Abab, Ian Ratcliffe, Roger Thornton, Ben Lineton, Mary Ellis, Ronald Moody, Louise Stanton, Angeliki Galanopoulou, Tom Maishman, Thomas Geldart, Mike Bayne, Joe Davies, Carolynn Lamb, Sanjay Popat, Johnathan K Joffe, Chris Nutting, John Chester, Andrew Hartley, Gareth Thomas, Christian Ottensmeier, Robert Huddart, Emma King
BACKGROUND: Cisplatin is one of the most ototoxic chemotherapy drugs, resulting in a permanent and irreversible hearing loss in up to 50% of patients. Cisplatin and gentamicin are thought to damage hearing through a common mechanism, involving reactive oxygen species in the inner ear. Aspirin has been shown to minimise gentamicin-induced ototoxicity. We, therefore, tested the hypothesis that aspirin could also reduce ototoxicity from cisplatin-based chemotherapy. METHODS: A total of 94 patients receiving cisplatin-based chemotherapy for multiple cancer types were recruited into a phase II, double-blind, placebo-controlled trial and randomised in a ratio of 1:1 to receive aspirin 975 mg tid and omeprazole 20 mg od, or matched placebos from the day before, to 2 days after, their cisplatin dose(s), for each treatment cycle...
November 9, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/29126030/evaluating-the-effect-of-adding-fish-oil-to-fingolimod-on-tnf-%C3%AE-il1%C3%AE-il6-and-ifn-%C3%AE-in-patients-with-relapsing-remitting-multiple-sclerosis-a-double-blind-randomized-placebo-controlled-trial
#6
Sasan Zandi-Esfahan, Mehdi Fazeli, Vahid Shaygannejad, Javad Hasheminia, Shervin Badihian, Maryam Aghayerashti, Helia Maghzi
OBJECTIVES: Fish oil is claimed to improve outcome in multiple sclerosis (MS) through anti-inflammatory and antioxidant effects by reducing cytokines including TNF-α, IFN-γ, IL6, and IL-1β. We aimed to evaluate the efficacy of adding fish oil to Fingolimod on these serum cytokines. PATIENTS AND METHODS: This double-blind randomized trial was conducted during April 2015 to September 2016 in Isfahan, Iran. Patients with diagnosis of relapsing remitting MS, aged 18-45years old and expanded disability status scale (EDSS) ≤5 were enrolled in the study...
October 3, 2017: Clinical Neurology and Neurosurgery
https://www.readbyqxmd.com/read/29124412/evaluation-of-a-short-formation-on-the-performance-of-point-of-care-renal-ultrasound-performed-by-physicians-without-previous-ultrasound-skills-prospective-observational-study
#7
François Javaudin, François Mounier, Philippe Pes, Idriss Arnaudet, Frédéric Vignaud, Eric Frampas, Philippe Le Conte
BACKGROUND: Point-of-Care Ultrasound (PoCUS) is recommended by emergency medicine societies for the detection of hydronephrosis. Training of certified Emergency Physicians (EP) without prior ultrasound experience remains debated. We investigate performance of a brief training session for the detection of hydronephrosis with PoCUS performed by EP without previous ultrasound experience. PATIENTS AND METHODS: This was a prospective observational study of a convenience sample of patients older than 18 years with presumed renal colic, acute pyelonephritis or documented acute renal failure...
November 9, 2017: Critical Ultrasound Journal
https://www.readbyqxmd.com/read/29122370/effectiveness-of-the-graded-motor-imagery-to-improve-hand-function-in-patients-with-distal-radius-fracture-a-randomized-controlled-trial
#8
Burcu Dilek, Cigdem Ayhan, Gozde Yagci, Yavuz Yakut
STUDY DESIGN: Single-blinded randomized controlled trial. INTRODUCTION: Pain management is essential in the early stages of the rehabilitation of distal radius fractures (DRFx). Pain intensity at the acute stage is considered important for determining the individual recovery process, given that higher pain intensity and persistent pain duration negatively affect the function and cortical activity of pain response. Graded motor imagery (GMI) and its components are recent pain management strategies, established on a neuroscience basis...
November 6, 2017: Journal of Hand Therapy: Official Journal of the American Society of Hand Therapists
https://www.readbyqxmd.com/read/29110679/high-throughput-gadobutrol-enhanced-cmr-a-time-and-dose-optimization-study
#9
Tommaso D'Angelo, Chrysanthos Grigoratos, Silvio Mazziotti, Konstantinos Bratis, Faraz Pathan, Alfredo Blandino, Elen Elen, Valentina O Puntmann, Eike Nagel
BACKGROUND: Reducing time and contrast agent doses are important goals to provide cost-efficient cardiovascular magnetic resonance (CMR) imaging. Limited information is available regarding the feasibility of evaluating left ventricular (LV) function after gadobutrol injection as well as defining the lowest dose for high quality scar imaging. We sought to evaluate both aspects separately and systematically to provide an optimized protocol for contrast-enhanced CMR (CE-CMR) using gadobutrol...
November 6, 2017: Journal of Cardiovascular Magnetic Resonance
https://www.readbyqxmd.com/read/29108817/chronic-oral-methylene-blue-treatment-in-a-rat-model-of-focal-cerebral-ischemia-reperfusion
#10
Lei Huang, Jianfei Lu, Bianca Cerqueira, Yichu Liu, Zhao Jiang, Timothy Q Duong
A single acute low-dose methylene blue (MB), an FDA-grandfathered drug, has been shown to ameliorate behavioral deficits and reduces MRI-defined infarct volume in experimental ischemic stroke when administered intravenously or intraperitoneally. The efficacy of chronic MB treatment in ischemic stroke remains unknown. In a randomized, double-blinded and vehicle-controlled design, we investigated the efficacy of chronic oral MB administration in ischemic stroke longitudinally up to 60 days post injury using MRI and behavioral tests, with end-point histology...
November 3, 2017: Brain Research
https://www.readbyqxmd.com/read/29108526/stabilising-sleep-for-patients-admitted-at-acute-crisis-to-a-psychiatric-hospital-owls-an-assessor-blind-pilot-randomised-controlled-trial
#11
Bryony Sheaves, Daniel Freeman, Louise Isham, Josephine McInerney, Alecia Nickless, Ly-Mee Yu, Stephanie Rek, Jonathan Bradley, Sarah Reeve, Caroline Attard, Colin A Espie, Russell Foster, Anna Wirz-Justice, Eleanor Chadwick, Alvaro Barrera
BACKGROUND: When patients are admitted onto psychiatric wards, sleep problems are highly prevalent. We carried out the first trial testing a psychological sleep treatment at acute admission (Oxford Ward sLeep Solution, OWLS). METHODS: This assessor-blind parallel-group pilot trial randomised patients to receive sleep treatment at acute crisis [STAC, plus standard care (SC)], or SC alone (1 : 1). STAC included cognitive-behavioural therapy (CBT) for insomnia, sleep monitoring and light/dark exposure for circadian entrainment, delivered over 2 weeks...
November 7, 2017: Psychological Medicine
https://www.readbyqxmd.com/read/29105594/tolvaptan-in-later-stage-autosomal-dominant-polycystic-kidney-disease
#12
Vicente E Torres, Arlene B Chapman, Olivier Devuyst, Ron T Gansevoort, Ronald D Perrone, Gary Koch, John Ouyang, Robert D McQuade, Jaime D Blais, Frank S Czerwiec, Olga Sergeyeva
BACKGROUND: In a previous trial involving patients with early autosomal dominant polycystic kidney disease (ADPKD; estimated creatinine clearance, ≥60 ml per minute), the vasopressin V2-receptor antagonist tolvaptan slowed the growth in total kidney volume and the decline in the estimated glomerular filtration rate (GFR) but also caused more elevations in aminotransferase and bilirubin levels. The efficacy and safety of tolvaptan in patients with later-stage ADPKD are unknown. METHODS: We conducted a phase 3, randomized withdrawal, multicenter, placebo-controlled, double-blind trial...
November 16, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29102979/effect-of-febuxostat-on-ambulatory-blood-pressure-in-subjects-with%C3%A2-hyperuricemia-and-hypertension-a-phase-2-randomized-placebo-controlled-study
#13
Lhanoo Gunawardhana, Lachy McLean, Henry A Punzi, Barbara Hunt, Robert N Palmer, Andrew Whelton, Daniel I Feig
BACKGROUND: Hyperuricemia is associated with hypertension, with elevated serum uric acid levels postulated to have a causal role in the development of hypertension. Consequently, serum uric acid reduction may help lower blood pressure (BP). A Phase 2, double-blind, placebo-controlled trial was conducted to assess the potential BP-lowering effects of the xanthine oxidase inhibitor febuxostat in subjects with hypertension and hyperuricemia (serum uric acid ≥0.42 mmol/L [≥7.0 mg/dL])...
November 4, 2017: Journal of the American Heart Association
https://www.readbyqxmd.com/read/29099344/tezacaftor-ivacaftor-in-patients-with-cystic-fibrosis-homozygous-for-phe508del
#14
Jennifer L Taylor-Cousar, Anne Munck, Edward F McKone, Cornelis K van der Ent, Alexander Moeller, Christopher Simard, Linda T Wang, Edward P Ingenito, Charlotte McKee, Yimeng Lu, Julie Lekstrom-Himes, J Stuart Elborn
Background Combination treatment with the cystic fibrosis transmembrane conductance regulator (CFTR) modulators tezacaftor (VX-661) and ivacaftor (VX-770) was designed to target the underlying cause of disease in patients with cystic fibrosis. Methods In this phase 3, randomized, double-blind, multicenter, placebo-controlled, parallel-group trial, we evaluated combination therapy with tezacaftor and ivacaftor in patients 12 years of age or older who had cystic fibrosis and were homozygous for the CFTR Phe508del mutation...
November 3, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29099333/tezacaftor-ivacaftor-in-residual-function-heterozygotes-with-cystic-fibrosis
#15
Steven M Rowe, Cori Daines, Felix C Ringshausen, Eitan Kerem, John Wilson, Elizabeth Tullis, Nitin Nair, Christopher Simard, Linda Han, Edward P Ingenito, Charlotte McKee, Julie Lekstrom-Himes, Jane C Davies
Background Cystic fibrosis is an autosomal recessive disease caused by mutations in the CFTR gene that lead to progressive respiratory decline. Some mutant CFTR proteins show residual function and respond to the CFTR potentiator ivacaftor in vitro, whereas ivacaftor alone does not restore activity to Phe508del mutant CFTR. Methods We conducted a randomized, double-blind, placebo-controlled, phase 3, crossover trial to evaluate the efficacy and safety of ivacaftor alone or in combination with tezacaftor, a CFTR corrector, in 248 patients 12 years of age or older who had cystic fibrosis and were heterozygous for the Phe508del mutation and a CFTR mutation associated with residual CFTR function...
November 3, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29096835/rationale-and-design-of-multiselect-a-european-multicenter-study-on-the-effect-of-lipoprotein-a-elimination-by-lipoprotein-apheresis-on-cardiovascular-outcomes
#16
Bernd Hohenstein, Ulrich Julius, Peter Lansberg, Beate Jaeger, Klaus-Peter Mellwig, Norbert Weiss, Xina Graehlert, Ingo Roeder, Wolfgang Ramlow
BACKGROUND: Dyslipidemia is a well-known risk factor for atherosclerosis and subsequent cardiovascular disease (CVD). While low density lipoprotein cholesterol (LDL-C) is well-established and taken into consideration for risk management and therapy, lipoprotein(a) is another established CVD risk factor frequently not undergoing screening due to a lack of medical treatment options. For patients suffering from CVD due to massive elevation of Lp(a) in presence of normal LDL-C levels, lipoprotein apheresis is the only available treatment option...
November 2017: Atherosclerosis. Supplements
https://www.readbyqxmd.com/read/29091570/nusinersen-versus-sham-control-in-infantile-onset-spinal-muscular-atrophy
#17
RANDOMIZED CONTROLLED TRIAL
Richard S Finkel, Eugenio Mercuri, Basil T Darras, Anne M Connolly, Nancy L Kuntz, Janbernd Kirschner, Claudia A Chiriboga, Kayoko Saito, Laurent Servais, Eduardo Tizzano, Haluk Topaloglu, Már Tulinius, Jacqueline Montes, Allan M Glanzman, Kathie Bishop, Z John Zhong, Sarah Gheuens, C Frank Bennett, Eugene Schneider, Wildon Farwell, Darryl C De Vivo
BACKGROUND: Spinal muscular atrophy is an autosomal recessive neuromuscular disorder that is caused by an insufficient level of survival motor neuron (SMN) protein. Nusinersen is an antisense oligonucleotide drug that modifies pre-messenger RNA splicing of the SMN2 gene and thus promotes increased production of full-length SMN protein. METHODS: We conducted a randomized, double-blind, sham-controlled, phase 3 efficacy and safety trial of nusinersen in infants with spinal muscular atrophy...
November 2, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29083986/effect-of-general-anesthesia-versus-conscious-sedation-for-stroke-thrombectomy-on-angiographic-workflow-in-a-randomized-trial-a-post-hoc-analysis-of-the-siesta-trial
#18
Johannes A R Pfaff, Silvia Schönenberger, Simon Nagel, Peter A Ringleb, Werner Hacke, Martin Bendszus, Julian Bösel, Markus Alfred Möhlenbruch
Purpose To investigate whether the sedation mode (ie, conscious sedation [CS] vs general anesthesia [GA]) affects the angiographic workflow applied for treatment of endovascular stroke in a post hoc analysis of a recent randomized controlled trial, Sedation versus Intubation for Endovascular Stroke Treatment (SIESTA). Materials and Methods SIESTA was an institutional review board-approved, single-center, prospective, randomized, parallel-group, open-label treatment trial with a blinded end-point evaluation to compare GA with CS for treatment of endovascular stroke in 73 and 77 patients, respectively...
October 30, 2017: Radiology
https://www.readbyqxmd.com/read/29074312/understanding-the-patient-experience-with-carcinoid-syndrome-exit-interviews-from-a-randomized-placebo-controlled-study-of-telotristat-ethyl
#19
Lowell Anthony, Claire Ervin, Pablo Lapuerta, Matthew H Kulke, Pamela Kunz, Emily Bergsland, Dieter Hörsch, David C Metz, Janice Pasieka, Nick Pavlakis, Marianne Pavel, Martyn Caplin, Kjell Öberg, John Ramage, Emily Evans, Qi Melissa Yang, Shanna Jackson, Karie Arnold, Linda Law, Dana B DiBenedetti
PURPOSE: Telotristat ethyl, an oral tryptophan hydroxylase inhibitor, is intended to treat carcinoid syndrome by reducing serotonin production. Telotristat ethyl was evaluated in TELESTAR, a Phase III study for patients who had carcinoid syndrome with at least 4 bowel movements (BMs) per day and who were receiving somatostatin analogue therapy. This interview substudy was conducted to provide insight into the patient experience in TELESTAR and to help understand whether reductions in BM frequency (the primary end point) and other symptoms were clinically meaningful...
October 23, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/29073240/the-course-of-the-radial-nerve-in-the-distal-humerus-a-novel-anatomy-based-radiographic-assessment
#20
H P Theeuwes, B van der Ende, J W Potters, A J Kerver, J H J M Bessems, G-J Kleinrensink
METHODS AND FINDINGS: Measurements were done on both arms of ten specially embalmed specimens. Arms were dissected and radiopaque wires attached to the radial nerve in the distal part of the upper arm. Digital radiographs were obtained to determine the course of the radial nerve in the distal 20 cm of the humerus in relation to bony landmarks; medial epicondyle and capitellum-trochlea projection (CCT). Analysis was done with ImageJ and Microsoft Excel software. We also compared humeral nail specifications from different companies with the course of the radial nerve to predict possible radial nerve damage...
2017: PloS One
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