bluuebunny/crossref_metadata_2025_split huggingface dataset:
A Post Hoc Analysis of Statin Use in Tolvaptan Autosomal Dominant Polycystic Kidney Disease Pivotal Trials
Authors: Shoaf Susan E. , Ouyang John , Sergeyeva Olga , Estilo Alvin , Li Hui , Leung Deborah 
Published: April 2020

Background and objectives
Tolvaptan is approved to slow kidney function decline in adults with autosomal dominant polycystic kidney disease (ADPKD) at risk of rapid progression. Because in vitro studies indicated that the tolvaptan oxobutyric acid metabolite inhibits organic anion–transporting polypeptide (OATP)1B1 and OATP1B3, United States prescribing information advises avoiding concurrent use with OATP1B1/1B3 substrates, including hepatic hydroxymethyl glutaryl–CoA reductase inhibitors (statins). This post hoc analysis of the pivotal phase 3 tolvaptan trials (Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes [TEMPO] 3:4 trial [NCT00428948] and Replicating Evidence of Preserved Renal Function: an Investigation of Tolvaptan Safety and Efficacy in ADPKD [REPRISE] trial [NCT02160145]) examined the safety of concurrent tolvaptan/statin use.

Design, setting, participants, & measurements
The trials randomized a combined total of 2815 subjects with early- to late-stage ADPKD to tolvaptan (n=1644) or placebo (n=1171) for 3 years (TEMPO 3:4) and 1 year (REPRISE). Statin use was unrestricted, and 597 subjects (21.2% overall; 332 [20.2%] tolvaptan, 265 [22.6%] placebo) received statins. Statin use (duration, dose change, statin change, permanent discontinuation), incidences of statin-related adverse events, and hepatic transaminase elevations were determined for subjects who received tolvaptan+statin, placebo+statin, tolvaptan alone, and placebo alone.

Results
No differences in statin use parameters between tolvaptan- and placebo-treated subjects were observed. No statistically significant increases in commonly reported statin-related adverse events (e.g., musculoskeletal disorders, gastrointestinal symptoms) were seen between subjects receiving tolvaptan+statin and placebo+statin. For example, in TEMPO 3:4, frequencies were 5.4% and 7.8%, respectively, for myalgia (difference −2.4%; 95% confidence interval, −11.2% to 6.4%) and 9.3% and 7.8%, respectively, for abdominal pain (difference 1.5%; −7.9% to 10.9%). In an analysis that excluded participants concurrently using allopurinol, the frequency of alanine transaminase or aspartate transaminase >3× upper limit of normal in the pooled study populations was 3.6% for the tolvaptan+statin group and 2.3% for the placebo+statin group (difference 1.4%; −2.0% to 4.7%).

Conclusions
Tolvaptan has been used safely in combination with statins in clinical trials.

Podcast
This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2020_04_06_CJN.08170719.mp3
Darbepoetin Alfa in Patients with Advanced CKD without Diabetes: Randomized, Controlled Trial
Authors: Hayashi Terumasa , Maruyama Shoichi , Nangaku Masaomi , Narita Ichiei , Hirakata Hideki , Tanabe Kenichiro , Morita Satoshi , Tsubakihara Yoshiharu , Imai Enyu , Akizawa Tadao ,   for the PREDICT Investigators
Published: April 2020

Background and objectives
Large, randomized, controlled trials targeting higher hemoglobin level with erythropoiesis-stimulating agents for Western patients with CKD showed harm. However, the effect of anemia correction using erythropoiesis-stimulating agents may differ between CKD subpopulations. The Prevention of ESKD by Darbepoetin Alfa in CKD Patients with Non-diabetic Kidney Disease study, a multicenter, randomized, open-label, parallel-group study, aimed to examine the effect of targeting hemoglobin levels of 11–13 g/dl using darbepoetin alfa with reference to a low-hemoglobin target of 9–11 g/dl on kidney outcome in patients with advanced CKD without diabetes in Japan.

Design, setting, participants, & measurements
We enrolled 491 patients with CKD without diabetes, and an eGFR of 8–20 ml/min per 1.73 m2. Of these 491 patients, 239 and 240 were ultimately assigned to the high- and low-hemoglobin groups, respectively (12 patients were excluded). The primary outcome was a kidney composite end point (starting maintenance dialysis, kidney transplantation, eGFR≤6 ml/min per 1.73 m2, and 50% reduction in eGFR).

Results
Mean hemoglobin levels were 11.2±1.1 and 10.0±0.9 g/dl in the high- and low-hemoglobin groups, respectively, during the mean study period of 73.5±29.7 weeks. The kidney composite end point occurred in 105 (44%) and 116 (48%) patients in the high- and low-hemoglobin groups, respectively (log-rank test; P=0.32). The adjusted Cox proportional hazards model showed that the hazard ratio for the high- versus low-hemoglobin group was 0.78 (95% confidence interval, 0.60 to 1.03; P=0.08). Cardiovascular events occurred in 19 (8%) and 16 (7%) patients in each group, respectively, with no significant between-group difference (log-rank test; P=0.66).

Conclusions
Targeting a higher hemoglobin level (11–13 g/dl) with darbepoetin alfa did not improve kidney outcome compared with targeting a lower hemoglobin level (9–11 g/dl) in patients with advanced CKD without diabetes.

Clinical Trial registry name and registration number
Prevention of ESKD by Darbepoetin Alfa in CKD Patients with Non-diabetic Kidney Disease (PREDICT), NCT01581073.
Visiones del neoclásico en la Arquitectura
Authors: Pérez Ramos Yúmari 
Published: April 2020

En la historia, el Neoclasicismo fue un parteaguas en las formas de vida de la humanidad, pero principalmente fue un movimiento estético que influyó de gran manera en el arte, la arquitectura y el urbanismo. Visiones del neoclásico en la Arquitectura ofrece una revisión desde esta disciplina en el continente americano, en particular, en dos países vecinos: México y Guatemala.
El libro es coordinado por Diana Ramiro Esteban y Luis Arnal Simón, ambos doctores en Arquitectura e investigadores del Centro de Investigaciones en Arquitectura, Urbanismo y Paisaje, de la Facultad de Arquitectura, de la Universidad Nacional Autónoma de México. Entre los coautores se incluyen eméritos, académicos, investigadores y estudiantes que conjugan sus conocimientos para recoger distintas interpretaciones y puntos de vista del neoclásico; ellos son Karim Chew, Xavier Cortés Rocha, Mario Ceballos, Verónica Carrera, Mario Ramírez de León, Martha Fernández, Isabel Cervantes, Ana López e Isis Isidoro y, junto con los coordinadores, son los ejecutores de esta obra.
QUANDO É CENOGRAFIA?
Authors: Machado João Carlos 
Published: April 2020

A partir de questões levantadas nas recentes edições das Quadrienais de Praga e das experiências artísticas e de pesquisa do autor, o texto trata de algumas possíveis definições dos conceitos de cenografia, performance, performatividade e teatralidade, buscando estabelecer distinções e aproximações entre as artes cênicas e as artes visuais, principalmente no campo da escultura. Para tanto são analisadas questões levantadas por autores como Rosalind Krauss e Josette Féral, entre outros, pertinentes às concepções culturalmente construídas destes campos e conceitos, bem como aos modos de pensar o fazer e os processos criativos destas áreas. Palavras-chave Cenografia. Teatralidade. Performance. Escultura.
Nurse-Performed Ultrasound-Guided Technique for Difficult Peripheral Intravenous Access in Critically Ill Patients: A Randomized Controlled Trial
Authors: Nishizawa Takuya , Matsumoto Takashi , Todaka Takafumi , Sasano Mikio , Kitagawa Hironobu , Shimabuku Ayano 
Published: April 2020

Highlights

Abstract
Purpose: The aim of this study was to compare nurse-performed ultrasound (US)-guided technique with standard of care (SOC) technique for difficult peripheral intravenous (PIV) access among patients admitted to the intensive care unit (ICU).
Materials and Methods: This was a randomized, prospective, open-label single-site study. ICU nurses completed a standardized training program for US-guided PIV access placement before patient enrollment. ICU patients with difficult PIV access were randomized to either nurse-performed US-guided technique or SOC technique. Primary outcome was success rate on the first attempt. Secondary outcomes were success rate after 2 attempts and frequency of complications after successful placement.
Results: A total of 60 patients were enrolled; 30 were randomized to receive US-guided technique, and 30 to SOC technique. Success rate on the first attempt was significantly higher with US-guided technique compared with SOC technique (70% vs 40%; P &lt; 0.05). Success rates after 2 attempts were 73.3% for US-guided technique and 46.6% for SOC technique (P = 0.065). Extravasation after successful placement occurred in 13.6% of patients with US-guided technique, and 28.6% of patients with SOC technique (P = 0.394).
Conclusions: Among ICU patients with difficult PIV access, US-guided PIV access placement by nurses who underwent standardized training was more successful than placement with SOC technique.
Effect of Deep Margin Elevation on CAD/CAM-Fabricated Ceramic Inlays
Authors: Vertolli TJ , Martinsen BD , Hanson CM , Howard RS , Kooistra S , Ye L 
Published: April 2020

Clinical Relevance
Using the deep margin elevation technique in preparations extending beyond the cemento-enamel junction appears to be beneficial in maintaining structural integrity of CAD/CAM-fabricated feldspathic ceramic inlays.

SUMMARY
Objective: To evaluate the effect of deep margin elevation on structural and marginal integrity of ceramic inlays.
Methods and Materials: Forty extracted human third molars were collected and randomly separated into four groups (n=10/group). In group 1 (enamel margin group), the gingival margin was placed 1 mm supragingival to the cemento-enamel junction (CEJ). In group 2 (cementum margin group), the gingival margin was placed 2 mm below the CEJ. In group 3 (glass ionomer [GI] margin group), the gingival margin was placed 2 mm below the CEJ, and then the margin elevated with GI to the CEJ. In group 4 (resin-modified glass ionomer [RMGI] margin group), the gingival margin was placed 2 mm below the CEJ, and then the margin elevated with RMGI to the CEJ. Standardized ceramic class II inlays were fabricated with computer-aided design/computer-aided manufacturing and bonded to all teeth, and ceramic proximal box heights were measured. All teeth were subjected to 10,000 cycles of thermocycling (5°C/55°C) and then underwent 1,200,000 cycles of vertical chewing simulation at 50 N of force. Ceramic restorations and marginal integrity were assessed with a Hirox digital microscope. The Fisher exact test (two-tailed) with adjusted p-values (α=0.05) and logistic regression were used for statistical analysis.
Results: The cementum margin group had a significantly higher ceramic fracture rate (90%) compared to other groups (10% in enamel margin and GI margin groups, p=0.007; 0% in RMGI group, p&lt;0.001). Logistic regression showed that with increased ceramic proximal box heights, the probability of ceramic fracture increased dramatically.
Conclusion: Deep marginal elevation resulted in decreased ceramic fracture when preparation margins were located below the CEJ. There was no difference found between margin elevation with GI or RMGI. Increased heights of ceramic proximal box may lead to an increased probability of ceramic fracture.
EDITORIAL DA REVISTA E-CURRICULUM: A PESQUISA CIENTÍFICA EM TEMPOS ADVERSOS
Authors: Chizzotti Antonio , Almeida Maria Elizabeth Bianconcini de 
Published: April 2020

A educação passou por grandes crises ao longo dos anos. Nesse ano, porém, de modo singular, a crise assumiu proporções inéditas provocada pelos confrontos políticos internacionais e nacionais e pela guerra fiscal entre as potências econômicas. Essa situação, agravada pela pandemia do novo Coronavírus, alcunhada COVID-19, trouxe problemas inesperados, com alto grau de incidência na vida particular e na vida social, e com consequências inéditas na educação e no currículo.A insegurança social com o governo do país e o acirramento das tensões políticas geraram um clima de exasperação da retórica partidária, que adentrou a vida acadêmica, contaminou o discurso científico e comprometeu tanto o apoio quanto o financiamento da pesquisa brasileira. A sobreposição de uma pandemia de dimensões globais, trazida pelo Coronavírus, adensou o clima de acirramento social e trouxe um agravamento das disputas partidárias com sérias consequências para a vida econômica e social. No campo da gestão da educação, as providências erráticas do Ministério da Educação agravaram, ainda mais, o campo da pesquisa e da educação nacional, com consequências profundas nas atividades cientificas dos educadores e da pesquisa acadêmica. O que torna o momento atual, particularmente, preocupante é que o espaço para o debate sobre os rumos da educação nacional tem sido, progressivamente, diminuído e substituído por uma retórica tribal de opiniões exasperadas, que acirra os ânimos, obscurece os esforços dos pesquisadores e ameaça comprometer a produção científica no Brasil.Nesse contexto singular da vida nacional e da produção e da difusão científicas, a Revista e-Curriculum, fiel ao seu compromisso de contribuir com o incremento da produção e difusão dos esforços científicos dos pesquisadores, tratou, de modo especial, nesse número, de ampliar as possibilidades de oportunizar a publicação de autores nacionais que, afrontando as adversidades do momento histórico do país, mantiveram seus esforços de investigação e de produção científica, a fim de lograr a construção de um contexto dialógico e colaborativo com o objetivo de superar as hostilidades interpessoais, as diatribes políticas e contribuir com os esforços coletivos na superação de uma crise, ainda em curso, e de consequências prospectivas muito graves.
Arctic entrepreneurship development factors
Authors: Pilyasov Alexander N. 
Published: April 2020

When studying Arctic entrepreneurship, the researcher encounters many paradoxes. Against the background of a powerfully developed topic of entrepreneurship and entrepreneurship in regional science, the layer of work on the entrepreneur in the Arctic is extremely thin. What is even worse – well-known mainstream theories turns out to be unsuitable for the study of Arctic entrepreneurship.Under these conditions, the only way out for a researcher is to attach to a zonal paradigm and recognize the Arctic as an anti-mainland, and Arctic entrepreneur as the full antipode of a continental fellow. The adherence to the zonal paradigm removes contradictions and equips the researcher with a comparative method to elaborate all facets of the Arctic exceptionalism in the figure of the entrepreneur. The entrepreneur here is understood as a close «relative» to the indigenous peoples and the entire Arctic economy, the Arctic environment, and their specific behavioral traits and adaptation strategies to natural and economic extremes.The most important factors in the development of entrepreneurship in the Arctic, which create a mosaic picture of situations in the Arctic territories, are: the geographical location – an island or quasi-mainland position; the presence of large resource corporations and a specific stage of their exploitation of the resource field; the institutional structure of the local economy in terms of the degree of nationalization. The cumulative impact of these factors creates a multi-faceted picture, when the Murmansk oblast is at one pole of the extreme favorable conditions for business, and the Chukotka autonomous okrug is at the other extreme hardness.However, the favorable factors themselves do not guarantee the active development of entrepreneurship. The example of the Murmansk oblast demonstrates the opposite: the conditions for entrepreneurs here are so comfortable that they prefer to slip to the south, where there is no need to bear the burden of northern guarantees and compensations for the employee, and from there to conduct their business activities.
A serviço da Medicina: origem da disciplina de Química no Compêndio Histórico da Universidade de Coimbra (1771)
Authors: Santos Ademir , Custódio Renato 
Published: April 2020

O estudo objetiva contribuir para a discussão sobre a origem da disciplina de Química e a sua institucionalização no campo educacional. A metodologia está embasada em pesquisa documental. O procedimento analítico foi realizado por meio de análise de conteúdo do Compêndio Histórico da Universidade de Coimbra e parametrizado por referencial que trata da história das disciplinas escolares. As análises produziram as categorias finais ensino da Química e conteúdos da Química, compostas por termos que, tanto em sua definição como pelos conteúdos de ensino que foram gerados ao longo da história, expressam características que vinculam a utilização da Química aos estudos da Medicina. Os resultados mostram que os conteúdos referentes à Química identificados no Compêndio apresentam um caráter seminal, manifestando aspectos da gênese e da implementação da Química como disciplina escolar. Concluímos que na origem da disciplina se encontra sua importância para os estudos superiores de Medicina, o que revela uma das finalidades que presidiram sua institucionalização no campo educacional.
Madness is the emergency exit
Authors: Silva Filho Gedion Caldas da , Xavier Bruno Gadelha 
Published: April 2020

A expansão do controle jurisdicional do Estado, bem como o frequente uso dos plenos poderes, denota uma clara cerceação de direitos e garantias fundamentais que, em seu próprio âmbito, resulta na eterna anomia entre norma e direito. O estado de necessidade, do qual se baseia a exceção, como pode-se constatar ao longo da história em muitos Estados contemporâneos, é utilizado como solo fértil para cessação desenfreada de direitos e garantias que, em regra, não podem ser suspensos no plano de direito. Para a percepção desse fenômeno, além de ferramenta essencial para o estudo, as mídias literárias proporcionam uma fonte inesgotável de analogias com o instituto do estado de exceção. Isto posto, analisar-se-á a conexão dos personagens Batman e Coringa em The Killing Joke, de modo que, nesse sentido, sua relação configura a própria exceção em si.
Palavras-Chave: Direito. Estado de Exceção. Literatura. The Killing Joke.
Identity-based Earning Discrimination among Chinese People
Authors: Siddique Abu Bakkar 
Published: April 2020

Abstract

Hukou registration is an instrument to control nonplanned population and capital movements, which the Chinese Communist Party has been exploiting extensively since the 1950s. It requires that each Chinese citizen be classified as either an agricultural or nonagricultural hukou inheritor and be distinguished by their location with respect to an administrative unit. Hukou distribution used to be entirely determined by birth, but nowadays, Chinese citizens can self-select their hukou status based on their ability that causes selection bias in conventional wage decomposition by hukou types. To avoid this bias, I estimated hukou-based earning discrimination by matching Chinese individuals based on a rich set of individual-, family-, and society-level characteristics. By deploying a recent nationally representative dataset, this paper finds that significant earning discriminations exist against agricultural hukou people. I further investigated the impact of hukou adoption within work ownership, work and employer types, and labor contract conditions. I argue that earning difference by hukou is not due to rural–urban segregations; rather, it is systematic and institutionally enforced. This is because, contrary to self-employment and no labor contract conditions, discrimination exists only when others employ them and where a labor contract condition is enforced. Moreover, they face discrimination only when they work for the Chinese government, not when they work for private firms, and they face higher discrimination in nonagriculture-related professions compared to agriculture-related professions.
BIMBINGAN KELOMPOK DENGAN TEKNIK ROLE PLAYING UNTUK MENGEMBANGKAN REGULASI EMOSI
Authors: Firdaus Lathifa Amalia 
Published: April 2020

Regulasi emosi adalah cara individu mengolah emosi yang individu miliki, kapan individu merasakannya dan bagaimana individu mengalami atau mengekspresikan emosi tersebut. Tujuan penelitian ini untuk mengetahui pengaruh layanan bimbingan kelompok dengan teknik role playing terhadap regulasi emosi siswa. Jenis penelitian ini adalah kuantitatif desain true eksperimen. Populasi penelitian siswa kelas X AKL SMK N 2 Semarang. Sampling yang digunakan dalam penelitian ini simple random sampling. Analisis hasil perhitungan Uji t signifikansi (sig) <0.05. Nilai Sig. (2-tailed) sebesar 0.002<0.05. Nilai ttabel=2.110. Uji-t dengan SPSS 16.0 for windows, diketahui thitung=3.597. thitung>ttabel maka Ho ditolak dan Ha diterima, sehingga hipotesisnya (Ha) berbunyi “ada pengaruh layanan bimbingan kelompok dengan teknik role playing terhadap regulasi emosi siswa kelas X SMK N 2 Semarang” diterima.
Organizational Well-Being at Government Corporation
Authors: Rinanda Syahida Tiara , Ardiwinata Maya Rosmayati , Nugraha Yus 
Published: April 2020

Every company needs a good synergy between the organization and employees so that the company can progress and develop. It is important to build an organizational environment that promotes well-being of its members in the organization, by creating an effective, reflective and affective environment so that employees can work efficiently organized and responsible for achieving organizational goals.This study will describe organizational well-being that owned by one of the government-owned companies that produce vaccines, refer to how the company provides an effective, reflective, and affective environment (Prilleltensky & Prilleltensky, 2006), with a total of 550 permanent employees from all directorates in the company.The results of this study describe organizational well-being in the company shows that employees have a fairly positive perspective in looking at effective environment conditions to support organizational goals, reflective to be able to improving themselves through evaluation, and affective in mutual support and warm conditions.
Keywords: Organizational Well-Being, Effective Environment, Reflective Environment, Affective Environment