PubMed Journals Articles About "Human Medicines European Public Assessment Report EPAR Firdapse" - Page: 20 RSS

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Showing "Human medicines European public assessment report EPAR Firdapse" PubMed Articles 476–500 of 44,000+

Validity of hepatitis B and hepatitis C case definitions.

Globally, an estimated 257 million people are living with chronic hepatitis B (HBV) infection and an estimated 71 million people with the chronic hepatitis C virus (HCV). The true public health dimensions and impact of hepatitis epidemics are poorly understood. Case definitions are fundamental parts of disease surveillance, representing sets of standardised criteria used to assess whether or not a person has a certain disease. The study evaluated the sensitivity and specificity of hepatitis B and hepatitis ...

An Academic-Practice Partnership at the University of Washington School of Public Health: The Student Epidemic Action Leaders (SEAL) Team.

In 2015, the University of Washington School of Public Health, Department of Epidemiology established the Student Epidemic Action Leaders (SEAL) team to provide public health students with experience in field epidemiology in state and local public health communicable disease divisions. The University of Washington Department of Epidemiology developed the SEAL team in collaboration with the Washington State Department of Health to offer public health graduate students opportunities to contribute to the real-...

The Fourth Hurdle.

The fourth hurdle in drug development and patient access to new therapeutics is reimbursement. The evidentiary requirements that are sufficient to regulators may not be sufficient to allow health technology assessment (HTA) bodies to make informed cost-effectiveness and formulary decisions. The accompanying paper by Vreman et al confirms that facilitated regulatory pathways may result in regulatory approvals but may not result in patient access to new and important medicines. This article is protected by c...

Gender-related issues in the pharmacology of new anti-obesity drugs.

Four new medicines-liraglutide, lorcaserin, bupropion/naltrexone, and phentermine/topiramate-have been recently added to the pharmacological arsenal for obesity treatment and could represent important tools to manage this epidemic disease. To achieve satisfactory anti-obesity goals, the use of these new medicines should be optimized and tailored to specific patient subpopulations also by applying dose adjustments if needed. In the present review, we posit that gender could be among the factors influencing t...

Challenges in outlier surgeon assessment in the era of public reporting.

To assess the effect of various evaluation and reporting strategies in determining outlier surgeons, defined by having worse-than-expected mortality after cardiac surgery.

Performance of simplified tables for high blood pressure screening in a European pediatric population.

We assessed the performance of the simplified American Academy Pediatrics (AAP) 2017 guideline table and a simplified table based on the Fourth Report blood pressure (BP) reference tables for high BP screening compared with the European Society Hypertension 2016 guideline diagnostic thresholds.

Integrated analysis of in vitro data and the adverse outcome pathway framework for prioritization and regulatory applications: An exploratory case study using publicly available data on piperonyl butoxide and liver models.

The integration of existing knowledge to support the risk assessment of chemicals is an ongoing challenge for scientists, risk assessors and risk managers. In addition, European Union regulations limiting the use of new animal testing in cosmetics makes already existing information even more valuable. Applying a previous SEURAT-1 program framework to derive predictions of in vivo toxicity responses for a compound, we selected piperonyl butoxide (PBO) as a case study for identification of knowledge and metho...

How to improve clinical practice on forced medication in psychiatric practice: Suggestions from the EUNOMIA European multicentre study.

The decision to adopt forced medication in psychiatric care is particularly relevant from a clinical and ethical viewpoint. The European Commission has funded the EUNOMIA study in order to develop European recommendations for good clinical practice on coercive measures, including forced medication.

Human gait symmetry assessment using a depth camera and mirrors.

It is proposed in this paper a reliable approach for human gait symmetry assessment using a Time-of-Flight (ToF) depth camera and two mirrors. The setup formed from these devices provides a sequence of 3D point clouds that is the input of our system. A cylindrical histogram is estimated for describing the posture in each point cloud. The sequence of such histograms is then separated into two sequences of sub-histograms representing two half-bodies. A cross-correlation technique is finally applied to provide...

Human Papillomavirus Infection and Transmission Among Couples Through Heterosexual Activity (HITCH) Cohort Study: Protocol Describing Design, Methods, and Research Goals.

Human papillomavirus (HPV) epidemiological research has generally been individual based, typically focusing on women, with couple-based research mostly consisting of cross-sectional assessment of prevalent HPV infection in both partners.

Bioequivalence of topical generic products. Part 1: Where are we now?

Regulatory accepted methods for bioequivalence assessment of topical generic products generally involve long and expensive clinical endpoint studies. The only alternative relies on pharmacodynamic trials, solely applicable to corticosteroids. Considerable efforts have been channelled towards the development and validation of other analytical surrogates. The majority of these alternative methods rely on in vitro methodologies that allow a more sensitive and reproducible bioequivalence assessment, avoiding at...

Prenatal Echocardiographic Assessment of Right Aortic Arch.

To report our experience with fetal diagnosis of right aortic arch (RAA) variants based on the ductus arteriosus (DA) anatomy and brachiocephalic vessel branching pattern (BVBP) respectively to the trachea and to establish whether the echocardiographic "V-shaped" or "U-shaped" appearances of the fetal upper mediastinum were sufficiently accurate for fetal aortic arch (AA) assessment.

The reliability of methods to estimate the number and size of human motor units and their use with large limb muscles: common mistake.

Lead-based paint remains a major public health concern: A critical review of global production, trade, use, exposure, health risk, and implications.

Human exposure to lead (Pb) is a growing global public health concern. Elevated blood lead is thought to cause the mental retardation of >0.6 million children globally each year, and has recently been attributed to ~18% of all-cause mortality in the US. Due to the severe health risk, the international community, led by the United Nations Environment Programme (UNEP) and the World Health Organization (WHO), is actively supporting the global phase-out of lead-based paint by 2020. However, there are many signi...

The "Risser+" grade: a new grading system to classify skeletal maturity in idiopathic scoliosis.

This study aims to propose and validate a new unified "Risser+" grade that combines the North American (NA) and European (EU) variants of the classic Risser score. The "Risser+ " grade can effectively combine the North American and European Risser Classifications for skeletal maturity with adequate intra-rater/inter-rater reliability and agreement.

Examination of future colleagues: We need an assessment culture.

How do we know that the newly graduated student have the competencies required to work as a doctor? Assessments are an integral part of a medical program and are also required to be specified in the syllabi. High-quality assessments are in line with both learning outcomes and content of the courses. Complex learning outcomes require different assessment methods, multiple examiners, and psychometric analysis of the results. Further, the assessment criteria have to be known in advance, and feedback to student...

Toxicity Assessment of Six Titanium Dioxide Nanoparticles in Human Epidermal Keratinocytes.

The aim of this study was to evaluate and compare the toxicity of six different types of titanium dioxide (TiO) nanoparticles (NP) on human epidermal keratinocytes (HEK).

Effectiveness of a learning support program for respiratory physical assessment: A quasi-experimental study.

Although the need for physical assessment in home nursing care has been shown, little research has examined the development of visiting nurses' physical assessment capabilities.

Culture results from wound biopsy versus wound swab: does it matter for the assessment of wound infection?

The aim of this study was to determine whether assessment of wound infection differs when culture results from wound biopsy versus wound swab are available in clinical practice.

Public health services: reading their available reports.

The objective of this study is to analyze the performance of regional public health services in Spain using the information accessible in their annual reports. A search of these was conducted, and 9 were obtained from the 17 Autonomous Communities. Their analysis shows some variation in the structure of the organizations providing public health services, as well as in the published contents and in the indicators used for management. The service portfolio, annual objectives and resources allocated are not al...

Impact of Human Activities on Fasciolosis Transmission.

Fasciolosis is a worldwide disease caused by the liver fluke Fasciola spp. This food- and water-borne disease is a major public health and veterinary issue. It is currently (re)emerging in several regions mainly due to the rapid evolution of human activities. This article reviews the current knowledge of the impact of irrigation-system management, livestock management, and human diet and hygiene habits on the emergence of fasciolosis. We also identify the gaps in this knowledge and the possible solutions fo...

Transmissibility of emerging viral zoonoses.

Effective public health research and preparedness requires an accurate understanding of which virus species possess or are at risk of developing human transmissibility. Unfortunately, our ability to identify these viruses is limited by gaps in disease surveillance and an incomplete understanding of the process of viral adaptation. By fitting boosted regression trees to data on 224 human viruses and their associated traits, we developed a model that predicts the human transmission ability of zoonotic viruses...

Stronger responders-uptake and decline of HPV-vaccination in Denmark.

The purpose of this study was to identify the stronger responders behind the fluctuating coverage with the HPV-vaccine in Denmark in order to facilitate information campaigns targeted at specific subgroups.

Exploring the impact of Brexit.

Sam Foster, Chief Nurse, Oxford University Hospitals, presents a risk assessment of the potential effects of leaving the European Union on nursing and the NHS more widely.

Monkeypox - Enhancing Public Health Preparedness for an Emerging Lethal Human Zoonotic Epidemic Threat in the Wake of the Smallpox Post-Eradication Era.

The identification of monkeypox in 3 separate patients in the United Kingdom in September raised media and political attention on an emerging public health threat. Nigeria, whose last confirmed case of monkeypox was in 1978, is currently experiencing an unusually large and outbreak of human monkeypox cases, a 'One Human-Environmental-Animal Health' approach is being effectively used to define and tackle the outbreak. As of 13th October 2018, there have been one hundred and sixteen confirmed cases the majori...

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