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https://www.readbyqxmd.com/read/28926353/randomized-double-blind-placebo-and-active-comparator-controlled-crossover-study-evaluating-the-abuse-potential-of-the-antiepileptic-drug-lacosamide-in-healthy-recreational-drug-users
#1
Kerri A Schoedel, Jens-Otto Andreas, Pamela Doty, Klaus Eckhardt, Edward M Sellers
PURPOSE: This phase 1, randomized, double-blind, placebo- and active comparator-controlled crossover study assessed the abuse potential of the antiepileptic drug, lacosamide. METHODS: After a qualification phase, 38 healthy, recreational central nervous system-depressant users were randomized to treatment sequences comprising single oral therapeutic (200 mg) and supratherapeutic (800 mg) doses of lacosamide, alprazolam (1.5 and 3 mg), and placebo. Subjective effects were assessed for 24 hours following each dose using a range of scales, with a 5- to 9-day washout between treatments...
September 18, 2017: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/28926170/efficacy-and-safety-of-saxagliptin-in-combination-with-metformin-as-initial-therapy-in-chinese-patients-with-type-2-diabetes-results-from-the-start-study-a-multicenter-randomized-double-blind-active-controlled-phase-3-trial
#2
Jingtao Dou, Jianhua Ma, Jun Liu, Changjiang Wang, Eva Johnsson, Hui Yao, June Zhao, Changyu Pan
OBJECTIVE: To assess the efficacy and safety of saxagliptin plus metformin over 24 weeks in pharmacotherapy-naïve Chinese patients with type 2 diabetes mellitus and inadequate glycemic control (HbA1c 8.0-12.0%). RESEARCH DESIGN AND METHODS: In this multicenter, double-blind, active-controlled study (The START study: NCT02273050), patients were randomized (1:1:1) to saxagliptin 5 mg plus metformin, saxagliptin 5 mg plus placebo, or metformin plus placebo. Saxagliptin was taken once daily; metformin was taken once/twice daily and was titrated from 500 mg to a maximum of 2000 mg/day over 8 weeks...
September 19, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28923573/neoadjuvant-buparlisib-plus-trastuzumab-and-paclitaxel-for-women-with-her2-primary-breast-cancer-a-randomised-double-blind-placebo-controlled-phase-ii-trial-neophoebe
#3
Sibylle Loibl, Lorena de la Pena, Valentina Nekljudova, Dimitrios Zardavas, Stefan Michiels, Carsten Denkert, Mahdi Rezai, Begoña Bermejo, Michael Untch, Soo Chin Lee, Sabine Turri, Patrick Urban, Sherko Kümmel, Guenther Steger, Andrea Gombos, Michael Lux, Martine J Piccart, Gunter Von Minckwitz, José Baselga, Sherene Loi
AIM: The Neoadjuvant PI3K inhibition in HER2 OverExpressing Breast cancEr (NeoPHOEBE) trial evaluated the efficacy and safety of buparlisib, a pan-phosphatidylinositol 3-kinase (PI3K) inhibitor, plus trastuzumab and paclitaxel as neoadjuvant treatment for human epidermal growth factor receptor-2 positive (HER2+) breast cancer. METHODS: NeoPHOEBE was a neoadjuvant, phase II, randomised, double-blind study. Women with HER2+ breast cancer were randomised within two independent cohorts by PIK3CA mutation status and, in each cohort stratified by oestrogen receptor (ER) status to receive buparlisib or placebo plus trastuzumab (first 6 weeks) followed by buparlisib or placebo with trastuzumab and paclitaxel...
September 15, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28922786/relapse-free-survival-as-a-surrogate-for-overall-survival-in-the-evaluation-of-stage-ii-iii-melanoma-adjuvant-therapy
#4
Stefan Suciu, Alexander M M Eggermont, Paul Lorigan, John M Kirkwood, Svetomir N Markovic, Claus Garbe, David Cameron, Srividya Kotapati, Tai-Tsang Chen, Keith Wheatley, Natalie Ives, Gaetan de Schaetzen, Achmad Efendi, Marc Buyse
Background: We assessed whether relapse-free survival (RFS; time until recurrence/death) is a valid surrogate for overall survival (OS) among resected stage II-III melanoma patients through a meta-analysis of randomized controlled trials. Methods: Individual patient data (IPD) on RFS and OS were collected from 5826 patients enrolled in 11 randomized adjuvant trials comparing interferon (IFN) to observation. In addition, IPD from two studies comparing IFN and vaccination in 989 patients were included...
January 1, 2018: Journal of the National Cancer Institute
https://www.readbyqxmd.com/read/28920049/effect-of-selenium-on-stress-response-in-coronary-artery-bypass-graft-surgery-a-clinical-trial
#5
Ali Mirmansouri, Vali Imantalab, Ali Mohammadzadeh Jouryabi, Gholamreza Kanani, Bahram Naderi Nabi, Farnoush Farzi, Gelareh Biazar, Samaneh Ghazanfar Tehran, Masoud Tarbiat
BACKGROUND: In spite of significant improvements in surgical and anesthetic techniques, acute stress response to surgery remains a main cause of mortality and morbidity in coronary artery bypass graft (CABG) surgery patients. Therefore, doing research to find safe and effective modalities with more cardio protective properties seems necessary. OBJECTIVES: In this study, we sought to determine whether intravenous injection of 600 μg Selenium (Se) prior to surgery would limit stress response measured by blood sugar...
February 2017: Anesthesiology and Pain Medicine
https://www.readbyqxmd.com/read/28913896/a-novel-non-azole-topical-treatment-reduces-malassezia-numbers-and-associated-dermatitis-a-short-term-prospective-randomized-blinded-and-placebocontrolled-trial-in-naturally-infected-dogs
#6
Ylva Sjöström, Paul Mellor, Kerstin Bergvall
BACKGROUND: Malassezia yeast overgrowth on the skin is a common and often recurrent cause of dermatitis in dogs; it can be an exacerbating factor of atopic dermatitis. Anti-fungal drugs have been a standard treatment, but there is some concern that resistance may be evolving in a spectrum of Malassezia species. Safe, efficient and easy-to-use alternatives are needed. OBJECTIVES: To assess if a commercially available topical non-azole solution applied to paws affected by Malassezia-associated dermatitis (MAD), could ameliorate Malassezia numbers and associated signs over a short term (14 day) trial...
September 14, 2017: Veterinary Dermatology
https://www.readbyqxmd.com/read/28911934/evaluation-of-the-efficacy-and-safety-of-dienogest-in-the-treatment-of-painful-symptoms-in-patients-with-adenomyosis-a-randomized-double-blind-multicenter-placebo-controlled-study
#7
Yutaka Osuga, Haruka Fujimoto-Okabe, Atsushi Hagino
OBJECTIVE: To evaluate the efficacy and safety of dienogest (DNG), a progestational 19-norsteroid, in patients with symptomatic adenomyosis. DESIGN: Phase III, randomized, double-blind, multicenter, placebo-controlled study. SETTING: Clinical study sites in Japan. PATIENT(S): Sixty-seven patients with adenomyosis. INTERVENTION(S): Patients were randomly assigned to receive DNG (2 mg/d, orally) or placebo for 16 weeks...
September 11, 2017: Fertility and Sterility
https://www.readbyqxmd.com/read/28906040/a-blinded-randomized-clinical-trial-evaluating-the-efficacy-and-safety-of-lokivetmab-compared-to-ciclosporin-in-client-owned-dogs-with-atopic-dermatitis
#8
Hilde Moyaert, Leen Van Brussel, Stasia Borowski, Monica Escalada, Sean P Mahabir, Rodney R Walters, Michael R Stegemann
BACKGROUND: Lokivetmab is an injectable anti-canine-IL-31 monoclonal antibody to treat clinical manifestations of atopic dermatitis (AD) in dogs. HYPOTHESIS/OBJECTIVES: To characterize the efficacy and safety of lokivetmab, and to demonstrate its noninferiority to ciclosporin under field conditions. ANIMALS: Dogs with chronic AD (n = 274) were enrolled from 40 practices in Belgium, The Netherlands, France and Germany. METHODS: Animals were randomized (1:1) to oral ciclosporin (5 mg/kg/once daily) or monthly injectable lokivetmab (1-3...
September 14, 2017: Veterinary Dermatology
https://www.readbyqxmd.com/read/28902590/long-term-outcomes-of-patent-foramen-ovale-closure-or-medical-therapy-after-stroke
#9
Jeffrey L Saver, John D Carroll, David E Thaler, Richard W Smalling, Lee A MacDonald, David S Marks, David L Tirschwell
Background Whether closure of a patent foramen ovale reduces the risk of recurrence of ischemic stroke in patients who have had a cryptogenic ischemic stroke is unknown. Methods In a multicenter, randomized, open-label trial, with blinded adjudication of end-point events, we randomly assigned patients 18 to 60 years of age who had a patent foramen ovale (PFO) and had had a cryptogenic ischemic stroke to undergo closure of the PFO (PFO closure group) or to receive medical therapy alone (aspirin, warfarin, clopidogrel, or aspirin combined with extended-release dipyridamole; medical-therapy group)...
September 14, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28902534/phase-iii-randomized-placebo-controlled-double-blind-trial-of-motesanib-amg-706-in-combination-with-paclitaxel-and-carboplatin-in-east-asian-patients-with-advanced-nonsquamous-non-small-cell-lung-cancer
#10
Kaoru Kubota, Hiroshige Yoshioka, Fumihiro Oshita, Toyoaki Hida, Kiyotaka Yoh, Hidetoshi Hayashi, Terufumi Kato, Hiroyasu Kaneda, Kazuhiko Yamada, Hiroshi Tanaka, Yukito Ichinose, Keunchil Park, Eun Kyung Cho, Kyung-Hee Lee, Chih-Bin Lin, James Chih-Hsin Yang, Kaori Hara, Takayuki Asato, Kazuhiko Nakagawa
Purpose This phase III, randomized, placebo-controlled, double-blind study determined whether motesanib improved progression-free survival (PFS) compared with placebo in combination with paclitaxel and carboplatin (P/C) in East Asian patients with stage IV/recurrent nonsquamous non-small-cell lung cancer. Patients and Methods Patients were randomly assigned (1:1) to receive oral motesanib 125 mg or placebo once daily plus paclitaxel 200 mg/m(2) IV and carboplatin area under the concentration-time curve 6 mg/mL ⋅ min IV for up to six 3-week cycles...
September 13, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28902028/a-101-a-proprietary-topical-formulation-of-high-concentration-hydrogen-peroxide-solution-a-randomized-double-blind-vehicle-controlled-parallel-group-study-of-the-dose-response-profile-in-subjects-with-seborrheic-keratosis-of-the-face
#11
Janet C DuBois, Michael Jarratt, Brian B Beger, Mark Bradshaw, Christopher V Powala, Stuart D Shanler
BACKGROUND: Seborrheic keratosis (SK) is a common benign skin tumor, yet no topical treatments are approved in the United States. OBJECTIVE: To evaluate the proprietary, stabilized, high-concentration hydrogen peroxide-based topical solution A-101 (32.5% and 40% concentrations) for treatment of facial SK lesions. MATERIALS AND METHODS: In this multicenter, double-blind, vehicle-controlled study, eligible subjects were randomly assigned to receive up to 2 treatments of A-101 40%, A-101 32...
September 4, 2017: Dermatologic Surgery: Official Publication for American Society for Dermatologic Surgery [et Al.]
https://www.readbyqxmd.com/read/28901219/primary-prevention-of-stroke-and-cardiovascular-disease-in-the-community-prevents-methodology-of-a-health-wellness-coaching-intervention-to-reduce-stroke-and-cardiovascular-disease-risk-a-randomized-clinical-trial
#12
Susan Mahon, Rita Krishnamurthi, Alain Vandal, Emma Witt, Suzanne Barker-Collo, Priya Parmar, Alice Theadom, Alan Barber, Bruce Arroll, Elaine Rush, Hinemoa Elder, Jesse Dyer, Valery Feigin
Rationale Stroke is a major cause of death and disability worldwide, yet 80% of strokes can be prevented through modifications of risk factors and lifestyle and by medication. While management strategies for primary stroke prevention in high cardiovascular disease risk individuals are well established, they are underutilized and existing practice of primary stroke prevention are inadequate. Behavioral interventions are emerging as highly promising strategies to improve cardiovascular disease risk factor management...
January 1, 2017: International Journal of Stroke: Official Journal of the International Stroke Society
https://www.readbyqxmd.com/read/28899222/effects-of-sotagliflozin-added-to-insulin-in-patients-with-type-1-diabetes
#13
Satish K Garg, Robert R Henry, Phillip Banks, John B Buse, Melanie J Davies, Gregory R Fulcher, Paolo Pozzilli, Diane Gesty-Palmer, Pablo Lapuerta, Rafael Simó, Thomas Danne, Darren K McGuire, Jake A Kushner, Anne Peters, Paul Strumph
Background In most patients with type 1 diabetes, adequate glycemic control is not achieved with insulin therapy alone. We evaluated the safety and efficacy of sotagliflozin, an oral inhibitor of sodium-glucose cotransporters 1 and 2, in combination with insulin treatment in patients with type 1 diabetes. Methods In this phase 3, double-blind trial, which was conducted at 133 centers worldwide, we randomly assigned 1402 patients with type 1 diabetes who were receiving treatment with any insulin therapy (pump or injections) to receive sotagliflozin (400 mg per day) or placebo for 24 weeks...
September 13, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28893186/determining-the-optimal-number-of-independent-components-for-reproducible-transcriptomic-data-analysis
#14
Ulykbek Kairov, Laura Cantini, Alessandro Greco, Askhat Molkenov, Urszula Czerwinska, Emmanuel Barillot, Andrei Zinovyev
BACKGROUND: Independent Component Analysis (ICA) is a method that models gene expression data as an action of a set of statistically independent hidden factors. The output of ICA depends on a fundamental parameter: the number of components (factors) to compute. The optimal choice of this parameter, related to determining the effective data dimension, remains an open question in the application of blind source separation techniques to transcriptomic data. RESULTS: Here we address the question of optimizing the number of statistically independent components in the analysis of transcriptomic data for reproducibility of the components in multiple runs of ICA (within the same or within varying effective dimensions) and in multiple independent datasets...
September 11, 2017: BMC Genomics
https://www.readbyqxmd.com/read/28893134/mepolizumab-for-eosinophilic-chronic-obstructive-pulmonary-disease
#15
Ian D Pavord, Pascal Chanez, Gerard J Criner, Huib A M Kerstjens, Stephanie Korn, Njira Lugogo, Jean-Benoit Martinot, Hironori Sagara, Frank C Albers, Eric S Bradford, Stephanie S Harris, Bhabita Mayer, David B Rubin, Steven W Yancey, Frank C Sciurba
Background Patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype may benefit from treatment with mepolizumab, a monoclonal antibody directed against interleukin-5. Methods We performed two phase 3, randomized, placebo-controlled, double-blind, parallel-group trials comparing mepolizumab (100 mg in METREX, 100 or 300 mg in METREO) with placebo, given as a subcutaneous injection every 4 weeks for 52 weeks in patients with COPD who had a history of moderate or severe exacerbations while taking inhaled glucocorticoid-based triple maintenance therapy...
September 11, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28892526/rivaroxaban-vs-warfarin-sodium-in-the-ultra-early-period-after-atrial-fibrillation-related-mild-ischemic-stroke-a-randomized-clinical-trial
#16
Keun-Sik Hong, Sun U Kwon, Sang Hun Lee, Ji Sung Lee, Yong-Jae Kim, Tae-Jin Song, Young Dae Kim, Man-Seok Park, Eung-Gyu Kim, Jae-Kwan Cha, Sang Min Sung, Byung-Woo Yoon, Oh Young Bang, Woo-Keun Seo, Yang-Ha Hwang, Seong Hwan Ahn, Dong-Wha Kang, Hyun Goo Kang, Kyung-Ho Yu
Importance: In atrial fibrillation (AF)-related acute ischemic stroke, the optimal oral anticoagulation strategy remains unclear. Objective: To test whether rivaroxaban or warfarin sodium is safer and more effective for preventing early recurrent stroke in patients with AF-related acute ischemic stroke. Design, Setting, and Participants: A randomized, multicenter, open-label, blinded end point evaluation, comparative phase 2 trial was conducted from April 28, 2014, to December 7, 2015, at 14 academic medical centers in South Korea among patients with mild AF-related stroke within the previous 5 days who were deemed suitable for early anticoagulation...
September 11, 2017: JAMA Neurology
https://www.readbyqxmd.com/read/28892457/romosozumab-or-alendronate-for-fracture-prevention-in-women-with-osteoporosis
#17
Kenneth G Saag, Jeffrey Petersen, Maria Luisa Brandi, Andrew C Karaplis, Mattias Lorentzon, Thierry Thomas, Judy Maddox, Michelle Fan, Paul D Meisner, Andreas Grauer
Background Romosozumab is a monoclonal antibody that binds to and inhibits sclerostin, increases bone formation, and decreases bone resorption. Methods We enrolled 4093 postmenopausal women with osteoporosis and a fragility fracture and randomly assigned them in a 1:1 ratio to receive monthly subcutaneous romosozumab (210 mg) or weekly oral alendronate (70 mg) in a blinded fashion for 12 months, followed by open-label alendronate in both groups. The primary end points were the cumulative incidence of new vertebral fracture at 24 months and the cumulative incidence of clinical fracture (nonvertebral and symptomatic vertebral fracture) at the time of the primary analysis (after clinical fractures had been confirmed in ≥330 patients)...
September 11, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28892431/nintedanib-plus-pemetrexed-cisplatin-in-patients-with-malignant-pleural-mesothelioma-phase-ii-results-from-the-randomized-placebo-controlled-lume-meso-trial
#18
Federica Grosso, Nicola Steele, Silvia Novello, Anna K Nowak, Sanjay Popat, Laurent Greillier, Thomas John, Natasha B Leighl, Martin Reck, Paul Taylor, David Planchard, Jens Benn Sørensen, Mark A Socinski, Ute von Wangenheim, Arsène Bienvenu Loembé, José Barrueco, Nassim Morsli, Giorgio Scagliotti
Purpose LUME-Meso is a phase II/III randomized, double-blind trial designed to assess efficacy and safety of nintedanib plus chemotherapy as first-line treatment of malignant pleural mesothelioma (MPM). Phase II results are reported here. Patients and Methods Chemotherapy-naïve patients with unresectable, nonsarcomatoid MPM (Eastern Cooperative Oncology Group performance status 0 to 1), stratified by histology (epithelioid or biphasic), were randomly assigned in a 1:1 ratio to up to six cycles of pemetrexed and cisplatin plus nintedanib (200 mg twice daily) or placebo followed by nintedanib plus placebo monotherapy until progression...
September 11, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28891855/patient-satisfaction-with-propofol-for-outpatient-colonoscopy-a-prospective-randomized-double-blind-study
#19
Anantha Padmanabhan, Christoforos Frangopoulos, Lynn E T Shaffer
BACKGROUND: Previous literature has shown that propofol has ideal anesthetic properties for patients undergoing colonoscopy, a common procedure at outpatient surgery centers. However, there is a paucity of information regarding patient satisfaction with propofol. OBJECTIVE: The aim of this study was to evaluate patient satisfaction with propofol compared with nonpropofol (fentanyl/midazolam) anesthesia for outpatient colonoscopies. Safety and complications were secondary end points...
October 2017: Diseases of the Colon and Rectum
https://www.readbyqxmd.com/read/28891423/adjuvant-nivolumab-versus-ipilimumab-in-resected-stage-iii-or-iv-melanoma
#20
Jeffrey Weber, Mario Mandala, Michele Del Vecchio, Helen J Gogas, Ana M Arance, C Lance Cowey, Stéphane Dalle, Michael Schenker, Vanna Chiarion-Sileni, Ivan Marquez-Rodas, Jean-Jacques Grob, Marcus O Butler, Mark R Middleton, Michele Maio, Victoria Atkinson, Paola Queirolo, Rene Gonzalez, Ragini R Kudchadkar, Michael Smylie, Nicolas Meyer, Laurent Mortier, Michael B Atkins, Georgina V Long, Shailender Bhatia, Celeste Lebbé, Piotr Rutkowski, Kenji Yokota, Naoya Yamazaki, Tae M Kim, Veerle de Pril, Javier Sabater, Anila Qureshi, James Larkin, Paolo A Ascierto
Background Nivolumab and ipilimumab are immune checkpoint inhibitors that have been approved for the treatment of advanced melanoma. In the United States, ipilimumab has also been approved as adjuvant therapy for melanoma on the basis of recurrence-free and overall survival rates that were higher than those with placebo in a phase 3 trial. We wanted to determine the efficacy of nivolumab versus ipilimumab for adjuvant therapy in patients with resected advanced melanoma. Methods In this randomized, double-blind, phase 3 trial, we randomly assigned 906 patients (≥15 years of age) who were undergoing complete resection of stage IIIB, IIIC, or IV melanoma to receive an intravenous infusion of either nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks (453 patients) or ipilimumab at a dose of 10 mg per kilogram every 3 weeks for four doses and then every 12 weeks (453 patients)...
September 10, 2017: New England Journal of Medicine
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