bluuebunny/crossref_metadata_2025_split huggingface dataset:
FDA-Catalyst—Using FDA’s Sentinel Initiative for large-scale pragmatic randomized trials: Approach and lessons learned during the planning phase of the first trial
Authors: Cocoros Noelle M , Pokorney Sean D , Haynes Kevin , Garcia Crystal , Al-Khalidi Hussein R , Al-Khatib Sana M , Archdeacon Patrick , Goldsack Jennifer C , Harkins Thomas , Lin Nancy D , Martin David , McCall Debbe , Nair Vinit , Parlett Lauren , Temple Robert , McMahill-Walraven Cheryl , Granger Christopher B , Platt Richard 
Published: November 2018

Background: The US Food and Drug Administration’s Sentinel Initiative is well positioned to support pragmatic clinical trials. FDA-Catalyst combines direct contact with health plan members and/or providers with data in the Sentinel infrastructure. Here, we describe the rationale, feasibility analyses, and lessons learned from the planning phase of the first large pragmatic trial conducted using the Sentinel Initiative’s delivery system capabilities—IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (the IMPACT-AFib trial). Methods: During the planning phase, we convened representatives from five commercial health plans, FDA, study coordinating centers, and a patient representative for protocol development, institutional review board preparation, and other activities. Administrative claims data from the plans were included in a retrospective cohort analysis to assess sample size for the trial. Members ≥30 years old with ≥365 days of medical/pharmacy coverage, ≥2 diagnosis codes for atrial fibrillation, a guideline-based indication for oral anticoagulant use for stroke prevention, and no evidence of oral anticoagulant use in the 365 days prior to the index atrial fibrillation diagnosis in 2013 were included. Exclusions for the analysis included other conditions requiring anticoagulation, history of intracranial hemorrhage, and gastrointestinal bleed. We calculated rates of oral anticoagulant use, transient ischemic attack or stroke, and bleeding in the 365 days following the index atrial fibrillation diagnosis. Results: A total of 44,786 members with atrial fibrillation with no evidence of recent oral anticoagulant use were identified. In total, 87% (n = 38,759) were classified as having a guideline-based indication for oral anticoagulants. Of those, 33% (n = 12,867) had a new oral anticoagulant dispensed during the following year, 15% (n = 5917) were hospitalized for stroke or transient ischemic attack, and 9% (n = 3469) for bleeding events. This information was used to develop the trial protocol including sample size, power calculations, and level of randomization. Conclusion: Sentinel infrastructure generated preliminary data that supported planning and implementation of a large pragmatic trial embedded in health plans. This planning identified unanticipated challenges that must be addressed in similar trials.
Glycocalyx Degradation Is Independent of Vascular Barrier Permeability Increase in Nontraumatic Hemorrhagic Shock in Rats
Authors: Guerci Philippe , Ergin Bulent , Uz Zuhre , Ince Yasin , Westphal Martin , Heger Michal , Ince Can 
Published: November 2018

BACKGROUND:
Glycocalyx shedding after traumatic hemorrhagic or septic shock, as well as different resuscitation fluids, has been causally linked to increased vascular barrier permeability (VBP) resulting in tissue edema. In nontraumatic hemorrhagic shock (NTHS), it remains questionable whether glycocalyx degradation in itself results in an alteration of VBP. The composition of fluids can also have a modulatory effect on glycocalyx shedding and VBP. We hypothesized that the shedding of the glycocalyx during NTHS has little effect on VBP and that the composition of fluids can modulate these effects.

METHODS:
Fully instrumented Wistar-albino rats were subjected to a pressure-controlled NTHS (mean arterial pressure of 30 mm Hg) for 60 minutes. Animals were fluid resuscitated with Ringer’s acetate, balanced hydroxyethyl starch (HES) solution, or 0.9% normal saline to a mean arterial pressure of 80 mm Hg and compared with shams or nonresuscitated NTHS. Glycocalyx shed products were determined at baseline and 60 minutes after fluid resuscitation. Skeletal muscle microcirculation was visualized using handheld vital microscopy. VBP changes were assessed using plasma decay of 3 fluorescent dyes (40- and 500-kDa dextran and 70-kDa albumin), Evans blue dye exclusion, intravital fluorescence microscopy, and determination of tissue edema (wet/dry weight ratio).

RESULTS:
All glycocalyx shedding products were upgraded as a result of NTHS. Syndecan-1 significantly increased in NTHS (mean difference, −1668; 95% confidence interval [CI], −2336 to −1001; P < .0001), balanced crystalloid (mean difference, −964.2; 95% CI, −1492 to −436.4; P = .0001), and HES (mean difference, −1030; 95% CI, −1594 to −465.8; P = .0001) groups at the end of the experiment compared to baseline. Hyaluronan levels were higher at the end of the experiment in nonresuscitated NTHS (−923.1; 95% CI, −1216 to −630; P = .0001) and balanced crystalloid (−1039; 95% CI, −1332 to −745.5; P = .0001) or HES (−394.2; 95% CI, −670.1 to −118.3; P = .0027) groups compared to controls. Glycocalyx shedding resulted in microcirculation alterations as observed by handheld video microscopy. Total vessel density was altered in the normal saline (mean difference, 4.092; 95% CI, 0.6195–7.564; P = .016) and hemorrhagic shock (mean difference, 5.022; 95% CI, 1.55–8.495; P = .0024) groups compared to the control group, as well as the perfused vessel density and mean flow index. Despite degradation of endothelial glycocalyx, VBP as determined by 4 independent assays remained intact and continued to be so following fluid resuscitation.

CONCLUSIONS:
NTHS induced glycocalyx shedding and microcirculation alterations, without altering VBP. Fluid resuscitation partially restored the microcirculation without altering VBP. These results challenge the concept that the glycocalyx barrier is a significant contributor to VBP.
Gait Mechanics and T1ρ MRI of Tibiofemoral Cartilage 6 Months after ACL Reconstruction
Authors: PFEIFFER STEVEN J. , SPANG JEFFREY , NISSMAN DANIEL , LALUSH DAVID , WALLACE KYLE , HARKEY MATTHEW S. , PIETROSIMONE LAURA S. , SCHMITZ RANDY , SCHWARTZ TODD , BLACKBURN TROY , PIETROSIMONE BRIAN 
Published: November 2018

ABSTRACT

Purpose
Aberrant walking biomechanics after anterior cruciate ligament reconstruction (ACLR) are hypothesized to be associated with deleterious changes in knee cartilage. T1ρ magnetic resonance imaging (MRI) is sensitive to decreased proteoglycan density of cartilage. Our purpose was to determine associations between T1ρ MRI interlimb ratios (ILR) and walking biomechanics 6 months after ACLR.

Methods
Walking biomechanics (peak vertical ground reaction force (vGRF), vGRF loading rate, knee extension moment, knee abduction moment) were extracted from the first 50% of stance phase in 29 individuals with unilateral ACLR. T1ρ MRI ILR (ACLR limb/uninjured limb) was calculated for regions of interest in both medial and lateral femoral (LFC) and medial and lateral tibial condyles. Separate, stepwise linear regressions were used to determine associations between biomechanical outcomes and T1ρ MRI ILR after accounting for walking speed and meniscal/chondral injury (P ≤ 0.05).

Results
Lesser peak vGRF in the ACLR limb was associated with greater T1ρ MRI ILR for the LFC (posterior ΔR
2 = 0.14, P = 0.05; central ΔR
2 = 0.15, P = 0.05) and medial femoral condyle (central ΔR
2 = 0.24, P = 0.01). Lesser peak vGRF loading rate in the ACLR limb (ΔR
2 = 0.21, P = 0.02) and the uninjured limb (ΔR
2 = 0.27, P = 0.01) was associated with greater T1ρ MRI ILR for the anterior LFC. Lesser knee abduction moment for the injured limb was associated with greater T1ρ MRI ILR for the anterior LFC (ΔR
2 = 0.16, P = 0.04) as well as the posterior medial tibial condyle (ΔR
2 = 0.13, P = 0.04).

Conclusion
Associations between outcomes related to lesser mechanical loading during walking and greater T1ρ MRI ILR were found 6 months after ACLR. Although preliminary, our results suggest that underloading of the ACLR limb at 6 months after ACLR may be associated with lesser proteoglycan density in the ACLR limb compared with the uninjured limb.
Establishing an international laboratory network for neglected tropical diseases: Understanding existing capacity in five WHO regions
Authors: Dean Laura , Njelesani Janet , Mulamba Charles , Dacombe Russell , Mbabazi Pamela S. , Bates Imelda 
Published: November 2018

Background. Limited laboratory capacity is a significant bottleneck in meeting global targets for the control and elimination of neglected tropical diseases (NTD). Laboratories are essential for providing clinical data and monitoring data about the status and changes in NTD prevalence, and for detecting early drug resistance. Currently NTD laboratory networks are informal and specialist laboratory expertise is not well publicised, making it difficult to share global expertise and provide training, supervision, and quality assurance for NTD diagnosis and research. This study aimed to identify laboratories within five World Health Organisation regions (South-East Asia, Eastern Mediterranean, Americas, Western Pacific and Europe) that provide NTD services and could be regarded as national or regional reference laboratories, and to conduct a survey to document their networks and capacity to support NTD programmes. Methods. Potential NTD reference laboratories were identified through systematic searches, snowball sampling and key informants. Results. Thirty-two laboratories responded to the survey. The laboratories covered 20 different NTDs and their main regional and national roles were to provide technical support and training, research, test validation and standard setting. Two thirds of the laboratories were based in academic institutions and almost half had less than 11 staff. Although greater than 90 per cent of the laboratories had adequate technical skills to function as an NTD reference laboratory, almost all laboratories lacked systems for external verification that their results met international standards. Conclusions. This study highlights that although many laboratories believed they could act as a reference laboratory, only a few had all the characteristics required to fulfil this role as they fell short in the standard and quality assurance of laboratory processes. Networks of high quality laboratories are essential for the control and elimination of disease and this study presents a critical first step in the development of such networks for NTDs.
СВЯЗЬ ПЕРФЕКЦИОНИЗМА И ПРОКРАСТИНАЦИИ У СТУДЕНТОВ РАЗЛИЧНЫХ НАПРАВЛЕНИЙ ПОДГОТОВКИ
Authors: Romanova Marina Vladimirovna 
Published: November 2018

Цель. Статья посвящена актуальной теме в рамках современной педагогической психологии. Целью работы является изучение связи прокрастинации и перфекционизма у студентов различных направлений подготовки.Методология и методы работы. В качестве методологической основы исследования выступают работы отечественных и зарубежных исследователей, в которых раскрываются понятия «прокрастинация» и «перфекционизм». Основным методом исследования является тестирование.Результаты. Статья включает в себя теоретический анализ изучаемых феноменов. Представлены результаты исследования выраженности прокрастинации и перфекционизма у студентов вуза. Описана связь между изучаемыми явлениями у учащихся различных направлений подготовки. В исследовании приняло участие 73 студента.Область применения результатов. Результаты исследования могут быть применены в учебно-воспитательном процессе вуза, а также в рамках профилактических и психокоррекционных работ со студентами различных направлений подготовки.
Características do Pino de Fibra de Vidro e aplicações Clínicas: Uma Revisão da Literatura
Authors: Leal Gláucia Sampaio , Souza Luciana Thaís Rangel , Dias Yonara Viana , Lessa Anne Maria Guimarães 
Published: November 2018

Dentes tratados endodonticamente que possuem grande perda de estrutura coronária necessitam de ancoragem intrarradicular para que posteriormente seja restabelecida forma e função. Dentre os retentores intrarradiculares, o pino de fibra de vidro tem se destacado por ser um material biocompatível que apresenta módulo de elasticidade semelhante a dentina e constitui um material estético que exige menor tempo clínico e de fácil aplicação. Os pinos de fibra de vidro apresentam uma alternativa clínica aos núcleos metálicos fundidos por representarem uma opção de pinos intrarradiculares com características mecânicas ideais ao remanescente dentário, além de permitir estética superior. Sendo assim, este trabalho propõe uma revisão de literatura sobre as características inerentes a este tipo de pino e sua aplicabilidade clínica.
Marketing Digital como Estratégia Competitiva dentro das Organizações: Um Estudo de Caso em uma Rede Empresarial na Região do Cariri - CE
Authors: Silva Francisco Wagner Alves da , Lima Pedro Ferreira de , Lima Márcia Maria Leite 
Published: November 2018

A comunicação via mídias e redes sociais digitais é uma atividade estratégica de suporte para alavancar as vendas de produtos e serviços de empresas. O objetivo geral deste estudo é avaliar a influência do marketing digital sob o volume de vendas em um grupo empresarial da Região do Cariri – CE. Para o alcance dos resultados foi realizado um estudo bibliográfico, analise documental, com métodos estatísticos inferencial, descritiva, de cunho quantitativa, através de teste de normalidade. Os resultados deste estudo evidenciam que é fundamental o gerenciamento das mídias digitais dentro de uma organização. Foi observado que a implantação das mídias digitais dentro do grupo empresarial de um modo geral não afetou de forma positiva as vendas.
Percepção da População do Centro da Cidade de Juazeiro do Norte sobre a Expansão dos Empreendimentos de Origem Asiática
Authors: Melo Maria Luana de , Alencar Tharsis De Sá Barreto Diaz Cidália 
Published: November 2018

Evidencia-se ao longo dos relatos históricos a forte imigração asiática para o Brasil ao longo dos anos, motivados pela oportunidade de trabalho, desenvolvendo principalmente atividades voltadas para agricultura em lavouras de café, como também pela motivação de iniciar uma nova vida. Atualmente ainda é notório o fluxo de imigração, principalmente chinesa, para o nosso país, distribuídos por várias regiões do país. Dado o exposto a pesquisa tem como objetivo compreender como a população do centro da cidade enxerga à expansão de empresas de origem asiática na cidade de Juazeiro do Norte. Identificando o que tem ocasionado tal expansão dessas empresas de acordo com a percepção dos mesmos. A pesquisa em questão é de natureza básica, de abordagem quantitativa e trata-se de uma pesquisa de opinião desenvolvida com a população do centro da cidade de Juazeiro do Norte. De acordo com a percepção dos entrevistados esses empreendimentos de origem asiática estão avançando e crescendo cada vez mais na economia da cidade e isto pode estar diretamente ligado a forma de atuação dessas empresas, ofertando produtos similares aos originais a preços baixos, mas mantendo a qualidade. E tal crescimento pode afetar os empreendimentos locais, que irão sofrer com a forte concorrência desses empreendimentos.
Qualidade de Vida no Trabalho dos Analistas de Crédito Bancário em Vitória da Conquista/BA
Authors: Santos Catilira Goncalves , Sampaio Leonardo Costa 
Published: November 2018

A categoria bancária tem sido alvo das mudanças decorrentes da reestruturação dos processos de trabalho e das mudanças nos modelos de gestão que foram aplicadas de forma mais abrangente. Desta forma, o ambiente de trabalho frequentemente apresenta situações geradoras de estresse, em que o indivíduo avalia as exigências do ambiente como uma sobrecarga e podendo afetar o seu bem-estar psicológico e físico. O objetivo geral do estudo é avaliar a qualidade de vida no trabalho dos analistas de crédito bancário e os objetivos específicos são: Traçar o perfil socioeconômico e sociodemográfico da população estudada; Identificar os principais sintomas referentes ao estresse no ambiente de trabalho; avaliar a qualidade de vida dos analistas de crédito; verificar quais atividades os participantes da pesquisa realizam fora do trabalho. A metodologia caracteriza - se como descritiva e exploratória. Essa pesquisa foi realizada com analistas de crédito bancário da cidade de Vitória da Conquista, Bahia. Utilizou-se o questionário validado Medical Outcomes Study 36 – Item Short – Form Health Survey para testar a qualidade de vida, além de uma ficha de perfil do participante e uma entrevista relacionada à sua rotina fora do ambiente de trabalho. Os resultados deste trabalho contribuem de forma positiva e construtiva para o tema da qualidade de vida, pois quantifica as suspeitas e cria perfis no que diz respeito ao estresse e a sua relação com a rotina de trabalho. Conclui-se que a limitação por aspectos físicos e a dor são os elementos que mais agravam a qualidade de vida no trabalho da amostra, o que aponta para a necessidade de propor estratégias de enfrentamento e a melhora no ambiente de trabalho como a diminuição dos fatores estressores.
Considerações Epistemológicas sobre Dislexia: Uma Abordagem das Consequências para a Aprendizagem
Authors: Sá Maria Aldenora Alves de , Menezes Aurelania Maria De Carvalho , Sobral Maria do Socorro Cecílio 
Published: November 2018

Este artigo científico teve por objetivo abordar a partir de uma discussão teórica sobre a questão da dislexia suas consequências dentro do processo de ensino e aprendizagem. A justificativa consistiu em oportunizar o conhecimento de caminhos pedagógicos para vencer tais obstáculos na escola, explicitando de forma primeira o conceito de dislexia, suas possíveis causas, criando um aprofundamento discursivo do tema sobre as consequências que ele cria no campo da formação intelectual do aluno, tudo isso condensado a partir de produções científicas de autores que debruçaram-se sobre o tema, em artigos científicos, uma vez que a proposta metodológica deste artigo baseia-se em uma escavação teórica do assunto, possibilitando a criação de uma discussão maior, tendo por fim, a produção de um novo ponto discursivo no ambiente acadêmico e científico acerca deste amplo e tão abrangente tema que se configura nesse entrelaçamento da questão da dislexia e educação.
From the Editor
Authors: Goss David A. 
Published: November 2018

Historical narratives reflect the biases of their creators. In order to promote his own interests, sporting goods magnate A.G. Spalding created a "creation myth" that baseball was a uniquely American sport which evolved from the English game "rounders." While historians later debunked this assertion and established an earlier and more complicated origin story for baseball, Spalding's historical narrative persists in popular culture. Optometry has a similar "creation myth" which holds that the profession began at the turn-of-the 20th century in the United States with the founding members of the American Optometric Association (AOA) and the move to make optometry a legislated profession. However, optometry's origins are much older, beginning in the late 13th century and, therefore, can be divided into periods. The period beginning in 1890 and which saw the founding of the AOA should be viewed as the beginning of "modern optometry." Optometry historians should recognize the importance of all periods of optometry history.
Pseudo-differential operators on homogeneous spaces of compact and Hausdorff groups
Authors: Kumar Vishvesh 
Published: November 2018

Abstract
Let G be a compact Hausdorff group and let H be a closed subgroup of G. We introduce pseudo-differential operators with symbols on the homogeneous space

G
/
H

{G/H}

. We present a necessary and sufficient condition on symbols for which these operators are in the class of Hilbert–Schmidt operators. We also give a characterization of and a trace formula for the trace class pseudo-differential operators on the homogeneous space

G
/
H

{G/H}

.
Impact of progestogens on hemostasis
Authors: Skouby Sven O. , Sidelmann Johannes J. 
Published: November 2018

Abstract
Combined hormonal contraception containing estrogen and progestogen and postmenopausal hormone therapy with estrogen ± progestogen are reported risk factors for venous thrombosis. The thrombotic risk varies by estrogen dose and type of progestogen. Estrogen combined with “newer generation” progestogens in combined oral contraceptives may have higher thrombotic risk than estrogen combined with older generation progestogens. Among postmenopausal women thrombotic risk also varies by type of hormone and mode of delivery. Although the risk of thrombosis with the different hormonal compounds is uncertain, it has definitely been attributed to the pharmacological effect of the hormones on hemostasis. Animal and cell culture studies have demonstrated the pharmacodynamics of progestogens with respect to hemostasis. Extrapolation from these studies to clinical conditions and further to clinical end points such as cardiovascular disease is, however, controversial. Few clinical studies have focused on the effect of progestogen only therapy on the hemostatic system in vivo. Most of the current knowledge regarding the in vivo effect of progestogens on hemostasis is obtained from studies with combined contraceptives. These results obviously reflect the combined influence of both estrogen and progestogen on hemostasis, and extrapolation to progestogen-only conditions is challenging. This paper discusses the pharmacodynamics of progestogens in relation to the hemostatic system, addressing results obtained in animal and cell culture studies and in clinical studies employing progestogen-only and combined oral contraceptives. The compiled results suggest that the major effect of progestogens on hemostasis is related to alterations in platelet function and the tissue factor pathway of coagulation. More studies focusing on these topics are warranted.
Effect of MgO/Al2O3Ratio on Viscosity of Blast Furnace Primary Slag
Authors: Jiao Kexin , Zhang Jianliang , Liu Zhengjian , Chen Chunlin 
Published: November 2018

AbstractThe effects of MgO, Al2O3, C/S (CaO/SiO2) and FeO on the viscosity and the liquidus temperature (TLQ) of blast furnace (BF) primary slag were analyzed by using multiphase equilibrium. The results show that theTLQof primary slag exhibits a minimum value at 12 wt% Al2O3and 14 wt% Al2O3when MgO contents are 8 wt% and 10 wt%, respectively. It can be suggested that the content of MgO in primary slag is prone to be retained at different value when Al2O3is different for smooth operation. The suitable value of MgO/Al2O3ratio increases with the increase of Al2O3content from 10 wt% to 18 wt% in the primary slag and the proper MgO/Al2O3ratio is 0.4–0.55. TheTLQof the slag increases with the increase of C/S when Al2O3content is lower than 14 wt%, while it decreases with the increase of the C/S when Al2O3is higher than 14 wt%. The slag viscosity decreases with the increase of FeO content. The isoviscosity curves become closer and closer when FeO is in a low level. In the condition of the high Al2O3content, improving the reduction degree of iron ore in the upper area of the BF can achieve a lowerTLQand have a smooth operation.