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https://www.readbyqxmd.com/read/28433560/glycaemic-control-and-hypoglycaemia-with-insulin-glargine-300-u-ml-compared-with-glargine-100-u-ml-in-japanese-adults-with-type-2-diabetes-using-basal-insulin-plus-oral-anti-hyperglycaemic-drugs-edition-jp-2-randomised-12-month-trial-including-6-month-extension
#1
Y Terauchi, M Koyama, X Cheng, M Sumi, M C Riddle, G B Bolli, T Hirose
AIMS: To compare insulin glargine 300 U/mL (Gla-300) with glargine 100 U/mL (Gla-100) in Japanese adults with uncontrolled type 2 diabetes on basal insulin and oral anti-hyperglycaemic drugs over 12 months. METHODS: EDITION JP 2 was a randomised, open-label, phase 3 study. Following a 6-month treatment period, participants continued receiving previously assigned once daily Gla-300 or Gla-100, plus oral anti-hyperglycaemic drugs, in a 6-month extension period. Glycaemic control, hypoglycaemia and adverse events were assessed...
April 19, 2017: Diabetes & Metabolism
https://www.readbyqxmd.com/read/28432861/spirometry-and-volumetric-capnography-in-lung-function-assessment-of-obese-and-normal-weight-individuals-without-asthma
#2
Mariana S Ferreira, Roberto T Mendes, Fernando A L Marson, Mariana P Zambon, Maria A R G M Antonio, Ilma A Paschoal, Adyléia A D C Toro, Silvana D Severino, Maria A G O Ribeiro, José D Ribeiro
OBJECTIVE: To analyze and compare lung function of obese and healthy, normal-weight children and adolescents, without asthma, through spirometry and volumetric capnography. METHODS: Cross-sectional study including 77 subjects (38 obese) aged 5-17 years. All subjects underwent spirometry and volumetric capnography. The evaluations were repeated in obese subjects after the use of a bronchodilator. RESULTS: At the spirometry assessment, obese individuals, when compared with the control group, showed lower values of forced expiratory volume in the first second by forced vital capacity (FEV1/FVC) and expiratory flows at 75% and between 25 and 75% of the FVC (p<0...
April 19, 2017: Jornal de Pediatria
https://www.readbyqxmd.com/read/28431485/efficacy-of-golimumab-in-belgian-patients-with-active-rheumatoid-arthritis-despite-treatment-with-non-biologic-disease-modifying-anti-rheumatic-drugs-sub-analysis-of-the-go-more-study
#3
Patrick Durez, Marie Vanthuyne, Muhammad S Soyfoo, Ilse Hoffman, Michel Malaise, Piet Geusens
OBJECTIVES: The GO-MORE trial (NCT00975130) was a phase 3 study in 40 countries evaluating the efficacy and safety of golimumab as add-on therapy in biologic-naïve adults with active rheumatoid arthritis despite stable treatment with disease-modifying anti-rheumatic drugs. To inform local practice in Belgium and examine the role of baseline disease activity in treatment response, we compared the efficacy of golimumab in the Belgian subpopulation and the rest of the world. METHODS: Baseline disease activity and six-month efficacy rates in the GO-MORE trial were compared for the Belgian subpopulation and the rest of the world by t-tests and chi-squared tests...
April 21, 2017: Acta Clinica Belgica
https://www.readbyqxmd.com/read/28430838/elevated-pulse-pressure-levels-are-associated-with-increased-in-hospital-mortality-in-acute-spontaneous-intracerebral-hemorrhage
#4
Jason J Chang, Yasser Khorchid, Kira Dillard, Ali Kerro, Lucia Goodwin Burgess, Georgy Cherkassky, Nitin Goyal, Kristina Chapple, Anne W Alexandrov, David Buechner, Andrei V Alexandrov, Georgios Tsivgoulis
OBJECTIVES: Clinical outcome after intracerebral hemorrhage (ICH) remains poor. Definitive phase-3 trials in ICH have failed to demonstrate improved outcomes with intensive systolic blood pressure (SBP) lowering. We sought to determine whether other BP parameters-diastolic BP (DBP), pulse pressure (PP), and mean arterial pressure (MAP)-showed an association with clinical outcome in ICH. METHODS: We retrospectively analyzed a prospective cohort of 672 patients with spontaneous ICH and documented demographic characteristics, stroke severity, and neuroimaging parameters...
April 19, 2017: American Journal of Hypertension
https://www.readbyqxmd.com/read/28430515/scattering-theory-on-surface-majorana-fermions-by-an-impurity-in-3-he-b
#5
Yasumasa Tsutsumi
We have formulated the scattering theory on Majorana fermions emerging in the surface bound state of the superfluid ^{3}He B phase (^{3}He-B) by an impurity. By applying the theory to the electron bubble, which is regarded as the impurity, trapped below a free surface of ^{3}He-B, the observed mobility of the electron bubble [J. Phys. Soc. Jpn. 82, 124607 (2013)JUPSAU0031-901510.7566/JPSJ.82.124607] is quantitatively reproduced. The mobility is suppressed in low temperatures from the expected value in the bulk ^{3}He-B by the contribution from the surface Majorana fermions...
April 7, 2017: Physical Review Letters
https://www.readbyqxmd.com/read/28430175/carfilzomib-lenalidomide-dexamethasone-vs-lenalidomide-dexamethasone-in-relapsed-multiple-myeloma-by-previous-treatment
#6
M A Dimopoulos, A K Stewart, T Masszi, I Špička, A Oriol, R Hájek, L Rosiñol, D Siegel, G G Mihaylov, V Goranova-Marinova, P Rajnics, A Suvorov, R Niesvizky, A Jakubowiak, J San-Miguel, H Ludwig, S Ro, S Aggarwal, P Moreau, A Palumbo
Carfilzomib, a proteasome inhibitor, is approved as monotherapy and in combination with dexamethasone or lenalidomide-dexamethasone (Rd) for relapsed or refractory multiple myeloma. The approval of carfilzomib-lenalidomide-dexamethasone (KRd) was based on results from the randomized, phase 3 study ASPIRE (NCT01080391), which showed KRd significantly improved progression-free survival (PFS) vs Rd (median 26.3 vs 17.6 months; hazard ratio (HR)=0.690; P=0.0001). This subgroup analysis of ASPIRE evaluated KRd vs Rd by number of previous lines of therapy and previous exposure to bortezomib, thalidomide or lenalidomide...
April 21, 2017: Blood Cancer Journal
https://www.readbyqxmd.com/read/28429976/reimbursement-changes-and-drug-switching-are-severe-patients-more-affected
#7
Shou-Hsia Cheng, Chi-Chen Chen, Hung-Chih Kuo, Chi-Chuan Wang
Objectives To examine the long-term effects of drug reimbursement adjustments on drug-switching decisions and to investigate whether patients with complicated or severe conditions are more affected. Methods A population-based, longitudinal study with a before-and-after design. Analysis of 141,703 patients with type 2 diabetes covered by the universal health insurance program in Taiwan. Observation of five 6-month phases before and after a drug reimbursement adjustment implemented in October 2009. Drug switching was defined as a brand change within the same anatomical therapeutic chemical group between two consecutive physician visits...
April 2017: Journal of Health Services Research & Policy
https://www.readbyqxmd.com/read/28429860/safety-tolerability-and-efficacy-of-lixisenatide-in-combination-with-oral-antidiabetic-treatment-in-japanese-patients-with-type-2-diabetes-an-open-label-multicenter-study
#8
Yutaka Seino, Aleksandra Stjepanovic, Akane Takami, Hiroki Takagi
AIM/INTRODUCTION: To assess overall safety and efficacy of lixisenatide in combination with background oral antidiabetic drug treatment in Japanese patients with type 2 diabetes, as required by Japanese guidelines. MATERIALS AND METHODS: A Phase 3, multicenter, uncontrolled, open-label, four-arm, parallel-group study in Japanese outpatients with type 2 diabetes; patients received once-daily lixisenatide in combination with biguanide, thiazolidinedione, alpha-glucosidase inhibitors, or glinide (NCT01940965)...
April 21, 2017: Journal of Diabetes Investigation
https://www.readbyqxmd.com/read/28427800/the-effect-of-optune%C3%A2-tumor-treating-fields-transducer-arrays-on-skin-radiation-dose-during-radiotherapy
#9
Edward Bender, Kevin Kozak, Steven Howard, Lori Hayes, John Bayouth, H Ian Robins
A Phase 3 clinical study demonstrated that the addition of 200kHz Tumor Treating Fields (TTF) to temozolomide in the post-radiation (RT) phase of therapy in newly diagnosed glioblastoma increases progression free and overall survival (resulting in FDA and European Union approval). Preclinical studies have demonstrated the ability of TTF to act as a radiosensitizer, suggesting concurrent TTF and RT may have clinical utility. The removal and replacement of TTF transducer arrays from the scalps of patients on a daily basis, i...
April 17, 2017: Journal of Clinical Neuroscience: Official Journal of the Neurosurgical Society of Australasia
https://www.readbyqxmd.com/read/28427160/biomarker-analysis-of-the-phase-3-torch-trial-for-first-line-erlotinib-versus-chemotherapy-in-advanced-non-small-cell-lung-cancer-patients
#10
Lucia Kim, Mauro Saieg, Massimo Di Maio, Ciro Gallo, Charles Butts, Fortunato Ciardiello, Ronald Feld, Dengxiao Cheng, Vittorio Gebbia, Marco Angelo Burgio, Yasmin Alam, Simona Signoriello, Antonio Rossi, Natasha Leighl, Paolo Maione, Alessandro Morabito, Geoffrey Liu, Ming-Sound Tsao, Francesco Perrone, Cesare Gridelli
BACKGROUND: The TORCH phase III trial compared the efficacy of first-line erlotinib followed by chemotherapy at progression (experimental arm) with the reverse sequence (standard arm) in unselected advanced non-small cell lung cancer (NSCLC) patients. Here we report biomarker analyses. METHODS: EGFR and KRAS mutation, expression of EGFR family members and of cMET and PTEN and EGFR and ABCG2 germline polymorphisms were tested on tumor tissue or blood samples to either confirm previously proposed predictive role or describe it in an explorative setting...
February 25, 2017: Oncotarget
https://www.readbyqxmd.com/read/28426550/neuropathic-pain-after-chronic-nerve-constriction-may-not-correlate-with-chloride-dysregulation-in-mouse-trigeminal-nucleus-caudalis-neurons
#11
Alberto Castro, Ying Li, Charles Raver, Ramesh Chandra, Radi Masri, Mary Kay Lobo, Asaf Keller
Changes in chloride reversal potential in rat spinal cord neurons have previously been associated with persistent pain in nerve injury and inflammation models. These changes correlate with a decrease in the expression of the potassium% chloride transporter, KCC2, and with increases in neuronal excitability. Here, we test the hypothesis that similar changes occur in mice with neuropathic pain induced by chronic constriction injury of the trigeminal infraorbital nerve (CCI¬-ION). This model allows us to distinguish an acute pain phase (3-¬5 days after injury) from a persistent pain phase (12¬-14 days after CCI-¬ION)...
April 18, 2017: Pain
https://www.readbyqxmd.com/read/28425345/surrogate-marker-analysis-in-cancer-clinical-trials-through-time-to-event-mediation-techniques
#12
Sjouke Vandenberghe, Luc Duchateau, Leen Slaets, Jan Bogaerts, Stijn Vansteelandt
The meta-analytic approach is the gold standard for validation of surrogate markers, but has the drawback of requiring data from several trials. We refine modern mediation analysis techniques for time-to-event endpoints and apply them to investigate whether pathological complete response can be used as a surrogate marker for disease-free survival in the EORTC 10994/BIG 1-00 randomised phase 3 trial in which locally advanced breast cancer patients were randomised to either taxane or anthracycline based neoadjuvant chemotherapy...
January 1, 2017: Statistical Methods in Medical Research
https://www.readbyqxmd.com/read/28425024/lesinurad-a-review-in-hyperuricaemia-of-gout
#13
Emma D Deeks
Lesinurad (Zurampic(®)) is an oral selective inhibitor of the URAT1 and OAT4 uric acid (UA) transporters of the kidney, via which it inhibits UA reabsorption and thus increases renal UA excretion and lowers serum UA (sUA) levels. Lesinurad 200 mg once daily is indicated for use in combination with a xanthine oxidase inhibitor (XOI) to treat hyperuricaemia in adults with gout who have not achieved target sUA levels with an XOI alone. Approval was based on three 12-month phase 3 trials that evaluated lesinurad in combination with allopurinol in adults with gout inadequately responsive to allopurinol (CLEAR 1 and 2) and in combination with febuxostat in adults with tophaceous gout (CRYSTAL)...
April 19, 2017: Drugs & Aging
https://www.readbyqxmd.com/read/28424260/upregulation-of-zinc-absorption-matches-increases-in-physiologic-requirements-for-zinc-in-women-consuming-high-or-moderate-phytate-diets-during-late-pregnancy-and-early-lactation
#14
K Michael Hambidge, Leland V Miller, Manolo Mazariegos, Jamie Westcott, Noel W Solomons, Victor Raboy, Jennifer F Kemp, Abhik Das, Norman Goco, Ty Hartwell, Linda Wright, Nancy F Krebs
Background: Estimated physiologic requirements (PRs) for zinc increase in late pregnancy and early lactation, but the effect on dietary zinc requirements is uncertain.Objective: The aim of this study was to determine changes in daily fractional absorbed zinc and total absorbed zinc (TAZ) from ad libitum diets of differing phytate contents in relation to physiologic zinc requirements during pregnancy and lactation.Methods: This was a prospective observational study of zinc absorption at 8 (phase 1) and 34 (phase 2) wk of gestation and 2 (phase 3) and 6 (phase 4) mo of lactation...
April 19, 2017: Journal of Nutrition
https://www.readbyqxmd.com/read/28419747/a-randomized-placebo-and-positive-controlled-single-dose-crossover-thorough-qt-qtc-study-assessing-the-effect-of-daprodustat-on-cardiac-repolarization-in-healthy-subjects
#15
Stephen Caltabiano, Jon Collins, Gul Serbest, Lisa Morgan, Deborah A Smith, Ramiya Ravindranath, Alexander R Cobitz
Daprodustat (GSK1278863) is a prolyl hydroxylase inhibitor in phase 3 clinical studies for the treatment of anemia associated with chronic kidney disease. This study was conducted to evaluate the effect of daprodustat on cardiac repolarization and enrolled 55 healthy adult male (29) and female (26) subjects who received single-dose 75 and 500 mg daprodustat, 400 mg moxifloxacin, and placebo. Mean placebo-corrected change from baseline QT interval for daprodustat showed no statistically significant increase...
April 17, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28419732/a-phase-1-randomized-placebo-controlled-study-assessing-the-pharmacokinetics-safety-and-tolerability-of-retosiban-in-healthy-nonpregnant-japanese-subjects
#16
Stephen Caltabiano, Mindy He Magee, Feng Liu, Kathleen J Beach
This study characterized the pharmacokinetics, safety, and tolerability of retosiban in healthy, nonpregnant Japanese women prior to the enrollment of Japanese women in preterm labor in phase 3 trials. This study had 2 cohorts. Cohort 1 was a double-blind, sponsor-open, randomized study in Japanese women. Cohort 2 was an open-label study in white women to compare the pharmacokinetics with those of Japanese women. Retosiban was administered as a 6 mg/h infusion for 24 hours, followed by a 12 mg/h infusion over the next 24 hours; each infusion was preceded by a 6 mg loading dose administered over 5 minutes...
April 17, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28419486/population-pharmacokinetic-analysis-of-bortezomib-in-pediatric-leukemia-patients-model-based-support-for-body-surface-area-based-dosing-over-the-2-to-16-year-age-range
#17
Michael J Hanley, Diane R Mould, Timothy J Taylor, Neeraj Gupta, Kaveri Suryanarayan, Rachel Neuwirth, Dixie-Lee Esseltine, Terzah M Horton, Richard Aplenc, Todd A Alonzo, Xiaomin Lu, Ashley Milton, Karthik Venkatakrishnan
This population analysis described the pharmacokinetics of bortezomib after twice-weekly, repeat-dose, intravenous administration in pediatric patients participating in 2 clinical trials: the phase 2 AALL07P1 (NCT00873093) trial in relapsed acute lymphoblastic leukemia and the phase 3 AAML1031 (NCT01371981) trial in de novo acute myelogenous leukemia. The sources of variability in the pharmacokinetic parameters were characterized and quantified to support dosing recommendations. Patients received intravenous bortezomib 1...
April 18, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28419462/modeling-and-simulation-of-pivotal-clinical-trials-using-linked-models-for-multiple-endpoints-in-chronic-obstructive-pulmonary-disease-with-roflumilast
#18
Axel Facius, Andreas Krause, Laurent Claret, Rene Bruno, Gezim Lahu
Roflumilast is a selective phosphodiesterase 4 inhibitor (PDE4i) for the treatment of severe chronic obstructive pulmonary disease (COPD). In 2 large phase 3 trials in a broader population of COPD patients (BY217/M2-111, ClinicalTrials.gov: NCT00076089 and BY217/M2-112, ClinicalTrials.gov: NCT00430729), treatment with roflumilast reduced the rate of exacerbations; however, the reduction did not reach statistical significance. Two linked dose-response models for the primary (annualized COPD exacerbation counts) and secondary (change from baseline in forced expiratory volume in 1 second [FEV1 ]) end points were therefore developed to characterize and quantify effect sizes and the patient characteristics influencing them...
April 17, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28419068/visual-improvements-in-vaginal-mucosa-correlate-with-symptoms-of-vva-data-from-a-double-blind-placebo-controlled-trial
#19
James A Simon, David F Archer, Risa Kagan, Brian Bernick, Shelli Graham, Ginger D Constantine, Sebastian Mirkin
OBJECTIVE: To evaluate the response of the vaginal mucosa with TX-004HR and its correlation with vulvar and vaginal atrophy (VVA) symptoms, and whether visual examination is a useful measure for assessing VVA. METHODS: REJOICE was a 12-week, phase 3, multicenter, randomized, double-blind, placebo-controlled study of a vaginal, muco-adhesive, 17β-estradiol softgel capsule (TX-004HR 4, 10, and 25 μg) in postmenopausal women with VVA and moderate-to-severe dyspareunia...
April 17, 2017: Menopause: the Journal of the North American Menopause Society
https://www.readbyqxmd.com/read/28418716/development-and-initial-validation-of-the-five-factor-model-adolescent-personality-questionnaire-ffm-apq
#20
Mary E Rogers, A Ian Glendon
This research reports on the 4-phase development of the 25-item Five-Factor Model Adolescent Personality Questionnaire (FFM-APQ). The purpose was to develop and determine initial evidence for validity of a brief adolescent personality inventory using a vocabulary that could be understood by adolescents up to 18 years old. Phase 1 (N = 48) consisted of item generation and expert (N = 5) review of items; Phase 2 (N = 179) involved item analyses; in Phase 3 (N = 496) exploratory factor analysis assessed the underlying structure; in Phase 4 (N = 405) confirmatory factor analyses resulted in a 25-item inventory with 5 subscales...
April 18, 2017: Journal of Personality Assessment
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