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https://www.readbyqxmd.com/read/28723276/can-an-app-help-identify-psychomotor-function-impairments-during-drinking-occasions-in-the-real-world-a-mixed-method-pilot-study
#1
Brian Suffoletto, Akash Goyal, Juan Carlos Puyana, Tammy Chung
BACKGROUND: Being able to measure the acute effects of alcohol consumption on psychomotor functions in natural settings could be useful in injury prevention interventions. This study examined the feasibility and acceptability of collecting app-based measures of information processing, working memory and gait stability during times of typical alcohol consumption among young adults. METHODS: Ten young adults (aged 21-26) with hazardous drinking completed a baseline assessment and ecological momentary assessments (EMA) on 4 consecutive Fridays and Saturdays, every hour from 8pm to 12am...
July 19, 2017: Substance Abuse
https://www.readbyqxmd.com/read/28722322/advanced-methods-for-dose-and-regimen-finding-during-drug-development-summary-of-the-ema-efpia-workshop-on-dose-finding-london-4-5-december-2014
#2
F T Musuamba, E Manolis, N Holford, Sya Cheung, L E Friberg, K Ogungbenro, M Posch, Jwt Yates, S Berry, N Thomas, S Corriol-Rohou, B Bornkamp, F Bretz, A C Hooker, P H Van der Graaf, J F Standing, J Hay, S Cole, V Gigante, K Karlsson, T Dumortier, N Benda, F Serone, S Das, A Brochot, F Ehmann, R Hemmings, I Skottheim Rusten
Inadequate dose selection for confirmatory trials is currently still one of the most challenging issues in drug development, as illustrated by high rates of late-stage attritions in clinical development and postmarketing commitments required by regulatory institutions. In an effort to shift the current paradigm in dose and regimen selection and highlight the availability and usefulness of well-established and regulatory-acceptable methods, the European Medicines Agency (EMA) in collaboration with the European Federation of Pharmaceutical Industries Association (EFPIA) hosted a multistakeholder workshop on dose finding (London 4-5 December 2014)...
July 19, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28722308/spectroscopic-discrimination-of-diastereomeric-complexes-involving-an-axially-chiral-receptor
#3
Maurizio Speranza, Antonello Filippi, Caterina Fraschetti, Laura Guarcini, Costantino Zazza, Tadashi Ema
The IRMPD spectra of the ESI-formed proton-bound complexes between the axially chiral multifunctional macrocycle MaR and D- and L-phenylalanine (PD and PL) or D- and L-3,4-dihydroxyphenylalanine (DD and DL) have been recorded in the 2800-3700 cm-1 region. While the diastereomeric [MaR*H*PD]+ and [MaR*H*PL]+ complexes did not show any significant spectral differences, the spectrum of [MaR*H*DD]+ clearly diverged from that of its [MaR*H*DL]+ diastereomer. The comparison of the experimental spectra with the B3LYP/6-31G**-calculated harmonic vibrational frequencies of a number of stable structures points to the formation in the ESI source of very similar spectroscopically active structures with the protonated amino acid placed outside the flat cavity of the macrocycle and hydrogen-bonded at its O2 center...
July 19, 2017: Chemphyschem: a European Journal of Chemical Physics and Physical Chemistry
https://www.readbyqxmd.com/read/28721159/pcsk9-inhibitors-from-discovery-of-a-single-mutation-to-a-groundbreaking-therapy-of-lipid-disorders-in-one-decade
#4
Krzysztof Jaworski, Piotr Jankowski, Dariusz A Kosior
Hypercholesterolemia is one of the main risk factors for coronary heart disease and significantly contributes to the high mortality associated with cardiovascular diseases. Statin therapy represents the gold standard in the reduction of low-density lipoprotein cholesterol concentration. Nevertheless, many patients still cannot achieve the recommended target levels, due to either inadequate effectiveness or intolerance of these drugs. Monoclonal antibodies that inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9) have emerged as a promising option in lipid-lowering treatment...
June 2017: Archives of Medical Science: AMS
https://www.readbyqxmd.com/read/28721009/patient-profiles-and-clinical-utility-of-mepolizumab-in-severe-eosinophilic-asthma
#5
REVIEW
Pranabashis Haldar
Mepolizumab (Nucala(®)) is an effective and specific anti-eosinophil molecular therapy that has recently been approved as add-on therapy for the management of severe eosinophilic asthma by the US Food and Drug Administration (FDA), European Medicines Agency (EMA; European Union) and more recently National Institute for Health and Care Excellence (NICE; UK). It is one of several molecular therapies in development for this indication and is illustrative of the strategic trajectory for pharmaceutical drug development taken over the past decade in several disease areas...
2017: Biologics: Targets & Therapy
https://www.readbyqxmd.com/read/28720556/ecological-momentary-assessment-of-physical-activity-validation-study
#6
Gregory Knell, Kelley Pettee Gabriel, Michael S Businelle, Kerem Shuval, David W Wetter, Darla E Kendzor
BACKGROUND: Ecological momentary assessment (EMA) may elicit physical activity (PA) estimates that are less prone to bias than traditional self-report measures while providing context. OBJECTIVES: The objective of this study was to examine the convergent validity of EMA-assessed PA compared with accelerometry. METHODS: The participants self-reported their PA using International Physical Activity Questionnaire (IPAQ) and Behavioral Risk Factor Surveillance System (BRFSS) and wore an accelerometer while completing daily EMAs (delivered through the mobile phone) for 7 days...
July 18, 2017: Journal of Medical Internet Research
https://www.readbyqxmd.com/read/28717844/application-of-the-biopsy-sparing-espghan-guidelines-for-celiac-disease-diagnosis-in-adults-a-real-life-study
#7
Konstantinos Efthymakis, Mariaelena Serio, Angelo Milano, Francesco Laterza, Antonella Bonitatibus, Marta Di Nicola, Matteo Neri
BACKGROUND: Current adult celiac disease diagnosis requires histological confirmation. However, pediatric guidelines have proposed biopsy-sparing algorithms. AIMS: To explore the applicability of the ESPGHAN criteria and assess the accuracy of serology in predicting disease in adults. METHODS: We evaluated 234 consecutive adults showing elevated anti-tTG titers, EMA-positivity, and genetic susceptibility. Patients underwent upper endoscopy with duodenal biopsy...
July 17, 2017: Digestive Diseases and Sciences
https://www.readbyqxmd.com/read/28717397/how-do-we-avoid-disaster-when-exiting-the-european-medicines-agency-making-the-most-of-brexit-in-pharmaceutical-regulation
#8
EDITORIAL
Anthony James Hatswell
As the UK prepares to leave the EU, it must decide what path it is to take with a large number of regulatory and technical agencies who provide collaboration at the European level. In the case of pharmaceuticals, the European Medicines Agency (EMA) provides pan-European licencing for novel pharmaceuticals. Should the UK depart from the EMA system, this article highlights the loss to patients immediately (slower access to novel treatments), and in the long term by having no access to some novel products as companies choose not to launch in the UK...
2017: Ecancermedicalscience
https://www.readbyqxmd.com/read/28716439/renal-cell-carcinoma-unclassified-with-medullary-phenotype-poorly-differentiated-adenocarcinomas-overlapping-with-renal-medullary-carcinoma
#9
Deepika Sirohi, Steven C Smith, Chisato Ohe, Piergiuseppe Colombo, Mukul Divatia, Ema Dragoescu, Priya Rao, Michelle S Hirsch, Ying-Bei Chen, Rohit Mehra, Mahul B Amin
Renal medullary carcinoma (RMC) is a highly aggressive renal cell carcinoma, arising in the collecting system, and requiring careful correlation with status of sickle cell trait. A panel of international experts has recently proposed provisional diagnostic terminology, renal cell carcinoma, unclassified, with medullary phenotype (RCCU-MP), based on encountering an extraordinarily rare tumor with RMC morphology and immunophenotype in an individual proven not to have a hemoglobinopathy. Herein, we extend this observation to a cohort of five such tumors, morphologically similar to RMC, lacking SMARCB1 expression by immunohistochemistry, but each without evidence of a hemoglobinopathy...
July 14, 2017: Human Pathology
https://www.readbyqxmd.com/read/28714407/update-of-standard-practices-for-new-method-validation-in-forensic-toxicology
#10
Sarah M R Wille, Wim Coucke, Thierry De Baere, Frank T Peters
: International agreement concerning validation guidelines is important as reporting reliable analytical data is the backbone of forensic bioanalytical research and applications. Guidelines such as those provided by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the German speaking Gesellschaft für Toxikologie und Forensische Chemie (GTFCH) and the Scientific Working Group of Forensic Toxicology (SWGTOX) provide a standard for fundamental validation parameters such as selectivity, matrix effects, method limits, calibration, accuracy and stability, as well as other parameters such as carryover, dilution integrity and incurred sample reanalysis...
July 14, 2017: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/28713265/a-comparison-of-reimbursement-recommendations-by-european-hta-agencies-is-there-opportunity-for-further-alignment
#11
Nicola Allen, Lawrence Liberti, Stuart R Walker, Sam Salek
Introduction: In Europe and beyond, the rising costs of healthcare and limited healthcare resources have resulted in the implementation of health technology assessment (HTA) to inform health policy and reimbursement decision-making. European legislation has provided a harmonized route for the regulatory process with the European Medicines Agency, but reimbursement decision-making still remains the responsibility of each country. There is a recognized need to move toward a more objective and collaborative reimbursement environment for new medicines in Europe...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28711892/3-d-bioprinting-law-regulation-perspectives
#12
Vitalii Pashkov, Andrii Harkusha
INTRODUCTION: Achieved level of technical progress moves us closer and closer to practical use of 3-d bioprinting technologies in real life. Such perspective raise a wide variety of crucial legal issues from the acceptable model of regulation of the science and its' societal effects to problems of the commercialization of the technology and potential restrictions of its use. Some key points on concept of legal regulation of abovementioned sphere is a base of this study. MATERIAL AND METHODS: Scientific discussion on 3-D bioprinting, European Union`s and US experience in patenting of 3-D bioprinting technologies, European Medicine Agency (EMA) or the US Food and Drug Administration (FDA) regulations, European Medical Technology Industry Association (EUCOMED) Acts...
2017: Wiadomości Lekarskie: Organ Polskiego Towarzystwa Lekarskiego
https://www.readbyqxmd.com/read/28709856/developing-smartphone-apps-for-behavioural-studies-the-alcorisk-app-case-study
#13
Anthony Smith, Kristy de Salas, Ian Lewis, Benjamin Schüz
Advances in mobile technology and significantly increasing utilization of mobile devices such as smartphones and tablets have resulted in a paradigm shift from PC-centric computing to mobile computing. The results of careful analysis conducted of this mobile landscape indicate that there is a growing demand for smart, user-centric, situation-aware mobile software. Invariably, concomitant with this demand is the need for methodologies that can provide support the development of this type of software. In this paper, we propose a semantic framework, called the mobile situation-aware framework, which supports efficient modeling, construction, processing, management, and inference of mobile situation information...
July 11, 2017: Journal of Biomedical Informatics
https://www.readbyqxmd.com/read/28709446/omitting-duodenal-biopsy-in-children-with-suspected-celiac-disease-and-extra-intestinal-symptoms
#14
Mauro Bozzola, Cristina Meazza, Chiara Gertosio, Sara Pagani, Daniela Larizza, Valeria Calcaterra, Ombretta Luinetti, Giovanni Farello, Carmine Tinelli, Lorenzo Iughetti
BACKGROUND: The aim of our study is to evaluate if in children with highly positive serology and HLA-DQ2/DQ8 (triple test, TT) and only extra-intestinal symptoms, it is possible to omit performing an intestinal biopsy for celiac disease (CD) diagnosis, as suggested by the new European Society for Pediatric Gastroenterology, Hepatology and Nutrition ESPGHAN guidelines. METHODS: In this retrospective study a total of 105 patients, suspected of having CD because of extra-intestinal symptoms and showing serum tissue transglutaminase antibody (anti-tTG) and anti-endomysial antibody (EMA) measurements and HLA genotyping, were considered for the final analysis (33 boys and 72 girls; age range 1...
July 15, 2017: Italian Journal of Pediatrics
https://www.readbyqxmd.com/read/28705306/riociguat-for-patients-with-chronic-thromboembolic-pulmonary-hypertension-usefulness-of-transitioning-from-phosphodiesterase-type-5-inhibitor
#15
Keiko Yamamoto, Nobuhiro Tanabe, Rika Suda, Akane Sasaki, Akane Matsumura, Ryogo Ema, Hajime Kasai, Fumiaki Kato, Ayumi Sekine, Rintaro Nishimura, Takayuki Jujo, Toshihiko Sugiura, Ayako Shigeta, Seiichiro Sakao, Koichiro Tatsumi
BACKGROUND: Riociguat, the first approved drug for patients with chronic thromboembolic pulmonary hypertension (CTEPH), is a soluble guanylate cyclase (sGC) Stimulator. It directly stimulates sGC independently of nitric oxide (NO) and increases sGC sensitivity for NO. The safety and efficacy of transitioning from a phosphodiesterase 5 inhibitor (PDE5i) to riociguat is unknown. METHODS AND RESULTS: Twenty-three patients were prospectively enrolled: 8 symptomatic patients with inadequate clinical responses to PDE5i were changed to riociguat (transitioned group); 15 started riociguat anew (new or add-on group)...
July 2017: Respiratory Investigation
https://www.readbyqxmd.com/read/28704672/anthropometric-measures-at-birth-and-early-childhood-are-associated-with-neurodevelopmental-outcomes-among-bangladeshi-children-aged-2-3years
#16
Jane J Lee, Kush Kapur, Ema G Rodrigues, Md Omar Sharif Ibne Hasan, Quazi Quamruzzaman, Robert O Wright, David C Bellinger, David C Christiani, Maitreyi Mazumdar
Among a cohort of children located in rural areas of Bangladesh affected by high levels of exposure to environmental metals, we investigated the associations between anthropometric measures, growth trajectory, and neurodevelopment at age 20-40months. Our study population included mothers and their children who participated in a longitudinal birth cohort study that took in place in the Pabna and Sirajdikhan areas of Bangladesh. Anthropometric measures including weight, length, and head circumference were measured at birth, age 12months, and age 20-40months...
July 10, 2017: Science of the Total Environment
https://www.readbyqxmd.com/read/28703312/violence-exposure-is-associated-with-adolescents-same-and-next-day-mental-health-symptoms
#17
Candice L Odgers, Michael A Russell
BACKGROUND: Young people exposed to violence are at increased risk for mental health and behavioral problems. However, very little is known about the immediate, or same-day, associations between violence exposure and adolescents' mental health symptoms or whether daily symptom or behavioral reactivity marks future problems. METHODS: Young adolescents were assessed three times a day for 30 consecutive days using mobile-phone-based Ecological Momentary Assessment (EMA) (N = 151 adolescents)...
July 13, 2017: Journal of Child Psychology and Psychiatry, and Allied Disciplines
https://www.readbyqxmd.com/read/28702715/-the-eu-portal-implementation-importance-and-features
#18
REVIEW
Harald von Aschen, Hartmut Krafft
The European Medicines Agency (EMA) is developing a web-based EU portal with a database "at Union level as a single entry point for the submission of data and information relating to clinical trials in accordance with" the new EU regulation No. 536/2014. The specifications are mostly published, but some documents are still missing. Because the project is integrated and has dependencies on other projects, this could result in other specification upgrades. The IT solution is under ongoing development until project completion in quarter III of 2019...
July 12, 2017: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
https://www.readbyqxmd.com/read/28698729/neurological-and-vascular-manifestations-of-ethylmalonic-encephalopathy
#19
Ali Reza Tavasoli, Parastoo Rostami, Mahmoud Reza Ashrafi, Parvaneh Karimzadeh
Objective Ethylmalonic encephalopathy (EE) is a severe mitochondrial disease of early infancy clinically characterized by a combination of developmental delay, progressive pyramidal signs, and vascular lesions including petechial purpura, orthostatic acrocyanosis, and chronic hemorrhagic diarrhea. Biochemical hallmarks of the disease are persistently high level of lactate, and C4-C5-acylcarnitines in blood, markedly elevated urinary excretion of methylsuccinic and ethylmalonic (EMA) acids. Here we report two patients with EE as a 16-months-old male infant and a 2-yr-old boy referred to Pediatric Neurology Clinic in Children's Medical Center, Tehran-Iran that in one patient genetic analysis revealed a homozygous mutation of the ETHE1 gene in favor of ethylmalonic acidemia...
2017: Iranian Journal of Child Neurology
https://www.readbyqxmd.com/read/28698083/a-hemorrhagic-clival-chordoma-with-a-long-progression-free-survival-case-report
#20
Marcelo D Vilela, Hugo As Pedrosa, Marco Antonio Dias Filho
BACKGROUND: Chordomas and ecchordosis physaliphora may on rare occasions present with intracranial hemorrhage. Their distinction usually relies on the results of the Ki67 proliferative index, with a result lower than 1% favoring ecchordosis physaliphora. Intracranial hemorrhagic chordomas have been linked to unfavorable prognosis, due to acute neurological deterioration and death, or progression following treatment. To the best of our knowledge, this is the first report of an intracranial hemorrhagic chordoma who had a long progression free survival...
July 8, 2017: World Neurosurgery
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