212 research outputs found

    АНАЛІЗ ВІДМІННОСТЕЙ РЕГІОНАЛЬНОГО РОЗВИТКУ В УМОВАХ СОЦІАЛЬНОЇ КРИЗИ В УКРАЇНІ

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    The article proposes an approach to assessing the level of the social crisis in Ukraine, based on the use of expert assessment, factor analysis and cluster analysis. The authors identify the factors that most influence the crisis processes in Ukrainian society, namely: living standards, unemployment, the ecological situation in Ukraine, political instability, corrupt authorities, social security and economic situation. For the analysis of the social crisis in the regions expert data and statistical data were used which allowed to identify a more adequate and realistic state of affairs. On the basis of the factors that form the social crisis in the regions, the classification of regions of Ukraine of the group with high, medium and low level of social crisis has been carried out. This analysis will allow to affect the state of development of social processes in the regions with the implementation of programs of socio–economic development.В статье предложен подход к оценке уровня социального кризиса в Украине, основанный на использовании методов экспертной оценки, факторного и кластерного анализа. Авторами выявлены факторы, наиболее влияющие на кризисные процессы в украинском обществе, а именно: уровень жизни, уровень безработицы, экологическая ситуация в Украине, политическая нестабильность, коррумпированность власти, социальная безопасность и материальное положение. Для анализа социального кризиса в регионах были использованы данные, полученные экспертным путем, и статистические данные, что позволило определить более адекватную и реальную оценку состояния вещей. На основе факторов, формирующих социальный кризис в регионах, осуществлена классификация регионов Украины на группы с высоким, средним и низким уровнем социального кризиса. Проведенный анализ позволит учитывать состояние развития социальных процессов в регионах при внедрении программ социально–экономического развития.У статті запропоновано підхід до оцінки рівня соціальної кризи в Україні, що базується на використанні методів експертного оцінювання, факторного та кластерного аналізу. Авторами виявлено фактори, що найбільше впливають на кризові процеси в українському суспільстві, а саме: рівень життя, рівень безробіття, екологічна ситуація в Україні, політична нестабільність, корумпованість влади, соціальна безпека та матеріальне становище. Для аналізу соціальної кризи в регіонах було використано дані, отримані експертним шляхом, та статистичні дані, що дозволило визначити більш адекватну і реальну оцінку стану речей. На основі факторів, які формують соціальну кризу в регіонах, здійснено класифікацію регіонів України на групи з високим, середнім та низьким рівнем соціальної кризи. Здійснений аналіз дозволить враховувати стан розвитку соціальних процесів у регіонах при впровадженні програм соціально–економічного розвитку

    Geometric estimation of volcanic eruption column height from GOES-R near-limb imagery-Part 2: Case studies

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    In a companion paper (Horváth et al., 2021), we introduced a new technique to estimate volcanic eruption column height from extremely oblique near-limb geostationary views. The current paper demonstrates and validates the technique in a number of recent eruptions, ranging from ones with weak columnar plumes to subplinian events with massive umbrella clouds and overshooting tops that penetrate the stratosphere. Due to its purely geometric nature, the new method is shown to be unaffected by the limitations of the traditional brightness temperature method, such as height underestimation in subpixel and semitransparent plumes, ambiguous solutions near the tropopause temperature inversion, or the lack of solutions in undercooled plumes. The side view height estimates were in good agreement with plume heights derived from ground-based video and satellite stereo observations, suggesting they can be a useful complement to established techniques

    Efficacy and safety of rozanolixizumab in moderate to severe generalized myasthenia gravis : a phase 2 randomized control trial

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    OBJECTIVE: To explore the clinical efficacy and safety of subcutaneous (SC) rozanolixizumab, an anti-neonatal Fc receptor humanized monoclonal antibody, in patients with generalized myasthenia gravis (gMG). METHODS: In this phase 2a, randomized, double-blind, placebo-controlled, 2-period, multicenter trial (NCT03052751), patients were randomized (1:1) in period 1 (days 1-29) to 3 once-weekly (Q1W) SC infusions of rozanolixizumab 7 mg/kg or placebo. In period 2 (days 29-43), patients were re-randomized to either rozanolixizumab 7 mg/kg or 4 mg/kg (3 Q1W SC infusions), followed by an observation period (days 44-99). Primary endpoint was change from baseline to day 29 in Quantitative Myasthenia Gravis (QMG) score. Secondary endpoints were change from baseline to day 29 in MG-Activities of Daily Living (MG-ADL) and MG-Composite (MGC) scores and safety. RESULTS: Forty-three patients were randomized (rozanolixizumab 21, placebo 22 [period 1]). Least squares (LS) mean change from baseline to day 29 for rozanolixizumab vs placebo was as follows: QMG (LS mean -1.8 vs -1.2, difference -0.7, 95% upper confidence limit [UCL] 0.8; p = 0.221; not statistically significant), MG-ADL (LS mean -1.8 vs -0.4, difference -1.4, 95% UCL -0.4), and MGC (LS mean -3.1 vs -1.2, difference -1.8, 95% UCL 0.4) scores. Efficacy measures continued to improve with rozanolixizumab 7 mg/kg in period 2. The most common adverse event in period 1 was headache (rozanolixizumab 57%, placebo 14%). CONCLUSION: Whereas change from baseline in QMG was not statistically significant, the data overall suggest rozanolixizumab may provide clinical benefit in patients with gMG and was generally well tolerated. Phase 3 evaluation is ongoing (NCT03971422). CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with gMG, rozanolixizumab is well-tolerated, but did not significantly improve QMG score

    Epistemic policy networks in the European Union’s CBRN risk mitigation policy

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    This paper offers insights into an innovative and currently flagship approach of the European Union (EU) to the mitigation of chemical, biological, radiological, and nuclear (CBRN) risks. Building on its long-time experience in the CBRN field, the EU has incorporated methods familiar to the students of international security governance: it is establishing regional networks of experts and expertise. CBRN Centers of Excellence, as they are officially called, aim to contribute to the security and safety culture in different parts of Africa, the Middle East, South East Asia, and South East Europe, in the broadly construed CBRN area. These regional networks represent a modern form of security cooperation, which can be conceptualized as an epistemic policy networks approach. It offers flexibility to the participating states, which have different incentives to get involved. At the same, however, the paper identifies potential limitations and challenges of epistemic policy networks in this form

    Toward a Regulatory Pathway for the Use of in Silico Trials in The Ce Marking of Medical Devices

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    In Silico Trials methodologies will play a growing and fundamental role in the development and de-risking of new medical devices in the future. While the regulatory pathway for Digital Patient and Personal Health Forecasting solutions is clear, it is more complex for In Silico Trials solutions, and therefore deserves a deeper analysis. In this position paper, we investigate the current state of the art towards the regulatory system for in silico trials applied to medical devices while exploring the European regulatory system toward this topic. We suggest that the European regulatory system should start a process of innovation: in principle to limit distorted quality by different internal processes within notified bodies, hence avoiding that the more innovative and competitive companies focus their attention on the needs of other large markets, like the USA, where the use of such radical innovations is already rapidly developing

    A 4 year follow-up study of cognitive functioning in patients with type 2 diabetes mellitus

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    Contains fulltext : 90777.pdf (publisher's version ) (Open Access)AIMS/HYPOTHESIS: Type 2 diabetes mellitus is associated with moderate decrements in cognitive functioning, mainly in verbal memory, information-processing speed and executive functions. How this cognitive profile evolves over time is uncertain. The present study aims to provide detailed information on the evolution of cognitive decrements in type 2 diabetes over time. METHODS: Sixty-eight patients with type 2 diabetes and 38 controls matched for age, sex and estimated IQ performed an elaborate neuropsychological examination in 2002-2004 and again in 2006-2008, including 11 tasks covering five cognitive domains. Vascular and metabolic determinants were recorded. Data were analysed with repeated measures analysis of variance, including main effects for group, time and the group x time interaction. RESULTS: Patients with type 2 diabetes showed moderate decrements in information-processing speed (mean difference in z scores [95% CI] -0.37 [-0.69, -0.05]) and attention and executive functions (-0.25 [-0.49, -0.01]) compared with controls at both the baseline and the 4 year follow-up examination. After 4 years both groups showed a decline in abstract reasoning (-0.16 [-0.30, -0.02]) and attention and executive functioning (-0.29 [-0.40, -0.17]), but there was no evidence for accelerated cognitive decline in the patients with type 2 diabetes as compared with controls (all p > 0.05). CONCLUSIONS/INTERPRETATION: In non-demented patients with type 2 diabetes, cognitive decrements are moderate in size and cognitive decline over 4 years is largely within the range of what can be viewed in normal ageing. Apparently, diabetes-related cognitive changes develop slowly over a prolonged period of time.8 p

    The Pixel Luminosity Telescope: a detector for luminosity measurement at CMS using silicon pixel sensors

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    The Pixel Luminosity Telescope is a silicon pixel detector dedicated to luminosity measurement at the CMS experiment at the LHC. It is located approximately 1.75 m from the interaction point and arranged into 16 “telescopes”, with eight telescopes installed around the beam pipe at either end of the detector and each telescope composed of three individual silicon sensor planes. The per-bunch instantaneous luminosity is measured by counting events where all three planes in the telescope register a hit, using a special readout at the full LHC bunch-crossing rate of 40 MHz. The full pixel information is read out at a lower rate and can be used to determine calibrations, corrections, and systematic uncertainties for the online and offline measurements. This paper details the commissioning, operational history, and performance of the detector during Run 2 (2015–18) of the LHC, as well as preparations for Run 3, which will begin in 2022

    Multicentre, double-blind, crossover trial to identify the Optimal Pathway for TreatIng neurOpathic paiN in Diabetes Mellitus (OPTION-DM): study protocol for a randomised controlled trial

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    BACKGROUND: The number of people with diabetes is growing rapidly. Diabetes can cause nerve damage leading to severe pain in the feet, legs and hands, which is known as diabetic peripheral neuropathic pain (DPNP). In the UK, the National Institute for Health and Care Excellence (NICE) recommends amitriptyline, duloxetine, pregabalin or gabapentin as initial treatment for DPNP. If this is not effective, adding one of the other drugs in combination with the first is recommended. NICE points out that these recommendations are not based on robust evidence. The OPTION-DM randomised controlled trial has been designed to address this evidence deficit, with the aims of determining the most clinically beneficial, cost-effective and tolerated treatment pathway for patients with DPNP. METHODS/DESIGN: A multicentre, double-blind, centre-stratified, multi-period crossover study with equal allocation to sequences (1:1:1:1:1:1) of treatment pathways. Three hundred and ninety-two participants will be recruited from secondary care DPNP centres in the UK. There are three treatment pathways: amitriptyline supplemented with pregabalin, pregabalin supplemented with amitriptyline and duloxetine supplemented with pregabalin. All participants will receive all three pathways and randomisation will determine the order in which they are received. The primary outcome is the difference between 7-day average 24-h pain scores on an 11-point NRS scale measured during the final follow-up week of the treatment pathway. Secondary outcomes for efficacy, cost-effectiveness, safety, patient-perceived tolerability and subgroup analysis will be measured at week 6 and week 16 of each pathway. DISCUSSION: The study includes direct comparisons of the mainstay treatment for DPNP. This novel study is designed to examine treatment pathways and capture clinically relevant outcomes which will make the results generalisable to current clinical practice. The study will also provide information on health economic outcomes and will include a subgroup study to provide information on whether patient phenotypes predict response to treatment. TRIAL REGISTRATION: ISRCTN17545443 . Registered on 12 September 2016
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