bluuebunny/crossref_metadata_2025 huggingface dataset:
PENGARUH PROFITABILITAS DAN UKURAN PERUSAHAAN TERHADAP NILAI PERUSAHAAN MANUFAKTUR DENGAN DIVIDEN SEBAGAI MEDIASI
Authors: Dete Yunita , Erawati Teguh
Published: July 2021

ABSTRAKPenelitian ini bertujuan untuk menguji pengaruh profitabilitas dan ukuran perusahaan terhadap nilai perusahaan dengan kebijakan dividen sebagai variabel mediasi pada perusahaan manufaktur yang terdaftar di Bursa Efek Indonesia (BEI). Data yang digunakan dalam penelitian ini adalah data sekunder. Populasi yang digunakan adalah perusahaan manufaktur yang terdaftar di Bursa Efek Indonesia (BEI) periode 2016-2018. Sampel penelitian sebanyak 19 perusahaan manufaktur yang terdaftar di Bursa Efek Indonesia (BEI). Teknik pengumpulan data menggunakan metode purposive sampling. Analisis data menggunakan uji asumsi klasik, analisis regresi linier berganda, analisis jalur. Hasil penelitian menunjukkan bahwa profitabilitas berpengaruh positif signifikan terhadap kebijakan dividen. Ukuran perusahaan berpengaruh positif signifikan terhadap kebijakan dividen. Kebijakan dividen berpengaruh positif signifikan terhadap nilai perusahaan. Profitabilitas berpengaruh positif signifikan terhadap nilai perusahaan. Ukuran perusahaan berpengaruh positif signifikan terhadap nilai perusahaan. Kata kunci: profitabilitas, ukuran perusahaan, kebijakan dividen, nilai perusahaan  ABSTRACTThis study aims to examine the effect of profitability and company size on firm value with dividend policy as a mediating variable in manufacturing companies listed on the Indonesia Stock Exchange (BEI). The data used in this research is secondary data. The population used is manufacturing companies listed on the Indonesia Stock Exchange (IDX) during the period of 2016-2018. The research sample of 19 manufacturing companies listed on the Indonesia Stock Exchange (IDX). Data collection techniques using purposive sampling method. Data analysis using the classical assumption test, multiple linear regression analysis, path analysis. The results showed that profitability had a significant positive effect on dividend policy. The size of the company has a significant positive effect on dividend policy. Dividend policy has a significant positive effect on firm value. Profitability has a significant positive effect on firm value. Company size has a significant positive effect on firm value. Keywords: profitability, company size, dividend policy, company value
PENGARUH KUALITAS PRODUK, PERSEPSI HARGA, DAN KUALITAS LAYANAN TERHADAP KEPUASAN KONSUMEN
Authors: Herdioko Jonathan , W Valentcio Luwiska
Published: July 2021

ABSTRAK Penelitian ini bertujuan untuk mengetahui pengaruh kualitas produk, persepsi harga, dan kualitas pelayanan terhadap kepuasan konsumen pada Toko Tekstil Mac Mohan, Solo. Populasi dalam penelitian ini adalah penduduk Kota Solo. Teknik penyampelan menggunakan non-probability sampling dengan pemilihan 100 responden yang pernah membeli produk di Mac Mohan Solo. Teknik pengumpulan data dilakukan dengan menyebarkan kuesioner yang telah diuji validitas dan reliabilitasnya. Metode analisis regresi linier berganda digunakan dengan uji R2, uji F, dan uji t. Hasil pengujian menghasilkan nilai sig uji F sebesar = 0,00, artinya secara simultan variabel kualitas produk, persepsi harga, dan kualitas pelayanan berpengaruh signifikan terhadap kepuasan konsumen. Hasil uji t menunjukkan bahwa kualitas produk, persepsi harga, dan kualitas layanan secara parsial berpengaruh signifikan terhadap kepuasan pelanggan. Kata Kunci: kualitas produk, persepsi harga, kualitas layanan, kepuasan pelanggan ABSTRACTThis study aims to determine the effect of product quality, price perception, and service quality toward customer satisfaction at Toko Tekstil Mac Mohan, Solo. The population in this study are the residents of Solo. Non-probability sampling method is adopted with a selection of 100 respondents who have bought products at Mac Mohan Solo. Data collection techniques were carried out by distributing questionnaires that had been tested for validity and reliability. The multiple linear regression analysis method is used with R2 test, F test, and t test. The test results produce a sig value of F test of = 0.00, meaning that simultaneously, the variable product quality, price perception, and service quality have a significant effect on customer satisfaction. The t test shows that product quality partially, price perception, and service quality partially have a significant effect on customer satisfaction. Keywords: product quality, price perception, service quality, customer satisfaction
Doorway to Europe: migration and its impact on island tourism
Authors: Agius Karl
Published: July 2021

Lampedusa is today best known in relation to migration. The island has confronted one migration crisis after the other for the past three decades, resulting in extensive media coverage. Whereas Lampedusa, a small island in the central Mediterranean region, has an economy mainly based on tourism, its name remains associated with migration, which is believed to negatively impact the island’s image and the performance of its tourism sector. On the other hand, migration has to some extent, put Lampedusa on the map, helping the island gain popularity. The island’s existing tourism model is based on sun, sand, and sea (3S) and is made attractive by its beaches, one of which has ranked as the best beach in the world, as well as by marketing efforts presenting Lampedusa as 'the Caribbean island of the Mediterranean'. However, migration and 3S are camouflaging other resources that are key to the island’s image. Lampedusa has a terrestrial nature reserve as well as a marine protected area that is home to several charismatic marine species, making it an ideal ecotourism destination. These resources can be used not only to depict a more representative image of the island but also to develop a sustainable tourism model that is suitable to a small island.
Out of character: Reiterating an island’s imaginaries in the face of a changing identity
Authors: Omondiagbe Harriet , Towns David , Wood Jay , Bollard Barbara
Published: July 2021

Island imaginary describes the unspoken or undocumented fabric that weaves together the operations within an island. Yet, these imaginaries are sometimes perceived as intangible and often misunderstood by non-islanders, who attempt to impose contradictory realities on islanders. This study investigates identity through the imaginaries expressed by island residents within the context of a changing identity. Waiheke Island has been experiencing recurrent issues of identity and undergoing transformational developments. We sought to identify components of island identity; factors that undermine island identity; and actions that might contribute to sustaining their identity. We employed a qualitative approach using interviews and thematic analysis. We identified three thematic components of identity, namely place identity, individual identity, and community identity. We determined triggers that could undermine identities such as external infiltration and transportation. Finally, we identified responses that could support residents in affirming or reiterating their identity including island secession, better fund allocation and community efforts. Most respondents value different aspects of their environment for being scenic, safe, special, and shared. Waihekeans prefer to be identified and appreciated for their diverse and unique characteristics, without their identities being undermined. They favour a strategic and controlled form of development, while preserving their uniqueness.
Constructing a criteria-based classification for Small Island Developing States: An Investigation
Authors: MacFeely Steve , Peltola Anu , Barnat Nour , Hoffmeister Onno , Hopp Daniel
Published: July 2021

What makes an island a Small Island Developing State or SIDS? There is no universally agreed definition, so what are the characteristics that single out these islands from the thousands of others? The variety of classifications being used by the United Nations and other International Organisations suggests that the label Small - Island - Developing – States does not adequately describe those characteristics. This article investigates what those characteristics might be and whether a criteria-based classification for Small Island Developing States is feasible.
Social Impact of Industrialization Policies on Fishing Communities in the Outer Islands: Case of Natuna, Indonesia
Authors: Putri Hertria Maharani , Salim Wilmar , Hudalah Delik
Published: July 2021

Natuna Island is one of the outer islands in Indonesia with under-development conditions due to its remote location. The government initiated to build fisheries industrialization and turning them into a growth center. So far, it is considered to only have affected their economic life. In fact, it also impacted the social life of their local community. However, differences in the characteristics of the people on small islands which are different from those on the main islands, may result in the destruction of endogenous social relations of the community by the industrialization process. This paper identifies the impact of exogenous development in the form of fisheries industrialization on the social life of the fisherman using the Social Impact Analysis (SIA) method. Sources of data were obtained from FGD with stakeholders, in-depth and semi-structured interviews, content analysis of related documents, as well as observations. From the study results, it is evident that there have been several negative impacts on fishing community due to fisheries industrialization. This impact results in the loss of social strength in the form of access to marine production bases. Local fishermen are driven out of their own sea areas, in the sense that their fishing grounds are used by other fishermen so that they have to change fishing locations. Second, there is no development of political power in the form of individual access to making decisions, voicing aspirations, and acting as a group because the established institution is only used as a formality to get assistance. Finally, fishermen's self-confidence has decreased because they continue to feel unsupported. The increasing number of new players in the sea area often adds to the fishermen's sense of inferiority. These changes seem to discourage the local community from supporting the implementation of the government development programs.
Prisjećanje na Protagoru
Authors: Bučan Daniel
Published: July 2021

»Πάντων χρημάτων μέτρον ἐστὶν ἄνθρωπος, τῶν μὲν ὄντων ὡς ἔστιν, τῶν δὲ οὐκ ὄντων ὡς οὐκ ἔστιν [Pántôn khrēmátôn métron éstin ánthrôpos, tôn mèn
όntôn hôs éstin, tôn dè ouk όntôn hôs ouk éstin]« – »Čovjek je mjerilo svih stvari, onih koje jesu da jesu, onih koje nisu da nisu«, kaže Protagora. Onaj tko hoće razmotriti Protagorin iskaz (ili raspravljati o
njemu), trebao bi najprije potražiti odgovor ne prethodno pitanje: što je čovjek? Utoliko će se u ovome prilogu našem razgovoru najprije (uz pomoć Aristotela) potražiti neki odgovori na to prethodno pitanje, da bi
se Protagorin iskaz pokušalo razmotriti s vidika tih odgovora te da bi ga se iskušalo u dva različita vida čovjekova života – u vidu što ga Aristotel naziva θεωρετικός βίος (theōretikόs bíos) i u vidu što ga naziva πολιτικός βίος (politikόs bíos). Napokon, ako se prihvati interpretacija Protagorina iskaza kao afirmacija relativističkog načela (kako to u svojoj kritici u Theaitētu drži Platon), pokušat će se mjesto
i smisao relativizma odrediti s obzirom na ta dva vida čovjekova života
te s obzirom na razliku između sofizma i filozofije (sofista i filozofa). Na kraju će biti sugerirano da je Protagorin iskaz moguće i drugačije interpretirati te da svaka od različitih interpretacija može imati valjanu težinu.
Od Hegela prema antičkom žanru gnoma – dijalektika u Sofoklovoj tragediji Kralj Edip
Authors: Rismondo Vladimir
Published: July 2021

Hegelovo viđenje grčke tragedije važna je postaja svakom teorijskom, ali
i praktičnom razmatranju dramskog pisma. Hegel je grčku tragediju promatrao iz perspektive vlastitog dijalektičkog sistema, čime je posredno utjecao i na dramaturšku praksu u 19. i 20. st. Zato se u tekstu razmatra Sofoklovu dramu Kralj Edip, najprije s Hegelovih teorijskih pozicija, a potom i iz praktične dramaturške perspektive po uzoru na vrlo utjecajan priručnik Lajosa Egrija posvećen dramskom pismu.
U radu se, nadalje, istražuje različito poimanje dijalektike u filozofijskom i dramskom dijalogu te se osvrće i na svojevrsnu primijenjenu dijalektičnost u radu grčkih umjetnika 5. st. pr .n. e. Konačno, tekst istražuje ranu grčku literarnu formu gnome te u njoj pokušava pronaći izvore kasnijem grčkom poimanju dijalektike.
Editorial Volumen 13-2
Authors: Reyes Sebastian Camilo , Reyes Guzmán Sebastián Camilo
Published: July 2021

“La violencia no es una entidad ontológica: es unaacusación […] la legitimación de la violencia hace que éstaresulte invisible; por ejemplo, un acto de agresión físicarealizado en defensa propia no es percibido como violento.Cuando la violencia es visible o, más exactamente, cuandoes pronunciable recibe la acusación de ilegitimidad. Ésta esla razón que hace que la violencia constituya un rasgo quecaracteriza al otro; forma parte de la enajenación del otro”.(Renzo Taddei, 2016, p.17)                                                                                                      
La revista Criterios, Cuadernos de Ciencias Jurídicas y Política Internacional, presenta su ejemplar número veintiséis, en el que desarrolla un marco de análisis en relación con dos líneas temáticas de gran envergadura y pertinencia, ambas, estrechamente vinculadas con las dinámicas sociales y las relaciones de poder entre la sociedad civil y la fuerza pública, mediadas a través de un escenario de disputas, desencadenamiento de conflictividades y el uso de la violencia como un mecanismo de pacificación, ese espacio de interlocución y efervescencia, no es otro que la protesta social. En ese sentido, la protesta social en los años recientes para el caso de Colombia se ha configurado como una instancia para tramitar el resquemor, malestar y la disensión por parte de uno o varios sectores de la sociedad ante los direccionamientos políticos y económicos gubernamentales, -como el lugar aciago que ostenta Colombia cuando se examinan los resultados de los últimos años del Indicador de Gini publicado por el Banco Mundial y paralelamente otros estudios sobre inequidad socioeconómica como el Índice de Desarrollo Regional para Latinoamérica, el cual ubica a Colombia como el país más desigual de América Latina en el 2020, -o el caso de la alarmante situación en materia de los Derechos Humanos...(los invitamos a consultar la versión completa en pdf)
Hybrid optimization model for conjunctive use of surface and groundwater resources in water deficit irrigation system
Authors: Sampathkumar Karthikeyan Moothampalayam , Ramasamy Saravanan , Ramasubbu Balamurugan , Karuppanan Saravanan , Lakshminarayanan Balaji
Published: July 2021

The increasing demand for food production with limited available water resources poses a threat to agricultural activities. Conventional optimization algorithms increase the processing stage and perform in the space allocated from user. Therefore, the proposed work was used to design better performance results. The conjunctive allocation of water resources maximizes the net benefit of farmers. In this study, the novel hybrid optimization model developed is the first of its kind and was designed to resolve the sharing of water resource conflict among different reaches based on a genetic algorithm (GA), bacterial foraging optimization (BFO) and ant colony optimization (ACO) to maximize the net benefit of the water deficit in Sathanur reservoir command. The GA-based optimization model considered crop-related physical and economic parameters to derive optimal cropping patterns for three different conjunctive use policies and further allocation of surface and groundwater for different crops are enhanced with the BFO. The allocation of surface and groundwater for the head, middle and tail reaches obtained from the BFO is considered as an input to the ACO as a guiding mechanism to attain an optimal cropping pattern. Comparing the average productivity values, policy 3 (3.665 Rs/m3) has better values relating to policy 1 (3.662 Rs/m3) and policy 2 (3.440 Rs/m3). Thus, the developed novel hybrid optimization model (GA-BFO-ACO) is very promising for enhancing farmer's net income and can be replicated in other irrigated regions to overcome chronic water problems. The productivity value of policy 3 was 6.54% greater than that of policy 2, whereas that of policy 1 was 6.45% greater. Overall, the comparison shows that the better performance analysis of various optimization was done successfully.
O Porto e a sua região, século XI-XVI
Authors: Duarte Luís Miguel , Amaral Luís Carlos
Published: July 2021

This themed dossier that the “História. Revista da Faculdade de Letras” understood to consecrate to a medieval Porto(and its termo) that goes from the sixteenth century to mid / final of the XVI century for a small contribution to shake the almost stagnant watersof the history of the city
As eleições legislativas de 1921 no Alentejo
Authors: Baiôa Manuel
Published: July 2021

This study focuses on the 1922 legislative elections that took place in the six electoral districtsof the Alentejo (Portugal).It addresses topics related to political contextualization, the choice of candidates for deputies, the electoral campaign, clientelism, electoral fraud and agreements.It also presents a review of the electoral results of the Alentejo, moving away from the numbers followed by Portuguese historiography
THE EFFECT OF ARTERIAL HYPERTENSION AND GLUCOSE HOMEOSTASIS VIOLATIONS ON CARDIOMYOPATHY SEVERITY IN PATIENTS WITH ACROMEGALY
Authors: Mykytyuk Myroslava
Published: July 2021

It was study 121 patients with acromegaly (75 women and 46 men) aged 18–75 years old.Changes of glucose homeostasis were presented violations by glucose tolerance (n = 9) and diabetesmellitus (n = 39). Hypertension was found in 74 patients. In patients with acromegaly without arterialhypertension the age, the thickness of the back wall of the left ventricle during diastole, the thicknessof the interventricular septum, the index of left ventricular mass (LVMI) and isovolumetric relaxationtime were significantly lower than in patients with hypertension, the ratio of the maximum velocityof early diastolic filling of the left ventricle and a top speed of left ventricular filling during atrialsystole (E/A) and ejection fraction (EF) were significantly higher. The results of multiple regressionanalysis showed that increased levels of growth hormone in the blood and systolic blood pressureare predictors of increased of LVMI. Elevated levels of diastolic blood pressure and the presence ofviolations of glucose homeostasis are predictors of reduction in ejection fraction (EF). Older patient’sage and increased levels of insulin-like growth factor-1 are predictors of increase in the ratio of E/A. Inpatients with arterial hypertension and normal glucose tolerance rate of left ventricular hypertrophywas significantly higher than in patients with normal glucose tolerance without hypertension, withoutsystolic (SLVD) and diastolic (DLVD) left ventricular dysfunction. In patients with hypertension anddiabetes frequency of the left ventricular hypertrophy, SLVD and DLVD was the highest.
STATUS OF ENDOCRINOLOGICAL SCIENCE AND PROSPECTS FOR ITS DE VELOPMENT IN STATE INSTITUTION «V. DANILE VSK Y INSTITUTE FOR ENDOCRINE PATHOLOGY PROBLEMS OF THE NAMS OF UKRANE» (to the 100th anniversary of its foundation)
Authors: Karachentsev Yuri , Kravchun N. A. , Misiura Katerina
Published: July 2021

The article is devoted to the 100th anniversary of existence of State Institution «V. Danilevsky Institute for Endocrine Pathology Problems of the NAMS of Ukraine». A brief historical background is provided at the beginning of the article. The basic scientific data reflecting the main directions of the Institute’s activity are presented in the article. The results of scientific research over the last 20 years are analyzed in more detail. Achievements in both experimental and clinical endocrinology are highlighted. In many fundamental and clinical aspects of endocrinopathies, in the last 10 years at the Institute 20 monographs and textbooks, 1200 scientific papers in national and foreign publications have been published, over 50 doctoral and PhD theses have been defended. The article ends with perspective directions of the Institute’s scientific activity.
Evaluación genética de ovinos: Catálogo de ejemplares de registro ovino
Authors: Cañas Álvare Jhon Jacobo , Rúa Bustamante Clara Viviana , Ambrosio G. Maximiliano
Published: July 2021

El primer catálogo de reproductores ovinos registrados en la asociación ASOOVINOS- Colombia, resulta de la primera evaluación genética que se realiza con el apoyo del equipo de investigación en pequeños rumiantes del Centro de investigación Motilonia - AGROSAVIA para la asociación a partir de la información recolectada por los técnicos y productores en el Sistema Único de Registro – SUREG durante más de 10 años. Este catálogo se convierte en una herramienta importante para la selección de machos y hembras de diferentes razas ovinas y una caprina como reproductores para uso en los rebaños de ganadería de píe de cría y/o comerciales, o en su defecto para la selección de los hijos de aquellos animales reportados en el catálogo con mayores valores genéticos (Diferencia Esperada de Progenie – DEP) para las características peso al nacimiento y tipo de parto. Para el uso de la información que se presenta en el catálogo es importante la lectura de las definiciones que allí se encuentran para lograr una buena interpretación de los resultados. De acuerdo al ranking de uno a 10, los animales en primer lugar son aquellos que, gracias a la información productiva y genealógica, son “mejoradores” para cada una de las características mencionadas. Se recomienda a ASOOVINOS continuar con la correcta y continua captura de información productiva y genealógica de los animales para registro y la realización anual de una evaluación genética que pueda actualizar el presente catálogo.
COVID-19 Data Utilization in North Carolina: Qualitative Analysis of Stakeholder Experiences
Authors: Patterson Jenny Rees , Shaw Donna , Thomas Sharita R , Hayes Julie A , Daley Christopher R , Knight Stefania , Aikat Jay , Mieczkowska Joanna O , Ahalt Stanley C , Krishnamurthy Ashok K
Published: July 2021

Background

As the world faced the pandemic caused by the novel coronavirus disease 2019 (COVID-19), medical professionals, technologists, community leaders, and policy makers sought to understand how best to leverage data for public health surveillance and community education. With this complex public health problem, North Carolinians relied on data from state, federal, and global health organizations to increase their understanding of the pandemic and guide decision-making.

Objective

We aimed to describe the role that stakeholders involved in COVID-19–related data played in managing the pandemic in North Carolina. The study investigated the processes used by organizations throughout the state in using, collecting, and reporting COVID-19 data.

Methods

We used an exploratory qualitative study design to investigate North Carolina’s COVID-19 data collection efforts. To better understand these processes, key informant interviews were conducted with employees from organizations that collected COVID-19 data across the state. We developed an interview guide, and open-ended semistructured interviews were conducted during the period from June through November 2020. Interviews lasted between 30 and 45 minutes and were conducted by data scientists by videoconference. Data were subsequently analyzed using qualitative data analysis software.

Results

Results indicated that electronic health records were primary sources of COVID-19 data. Often, data were also used to create dashboards to inform the public or other health professionals, to aid in decision-making, or for reporting purposes. Cross-sector collaboration was cited as a major success. Consistency among metrics and data definitions, data collection processes, and contact tracing were cited as challenges.

Conclusions

Findings suggest that, during future outbreaks, organizations across regions could benefit from data centralization and data governance. Data should be publicly accessible and in a user-friendly format. Additionally, established cross-sector collaboration networks are demonstrably beneficial for public health professionals across the state as these established relationships facilitate a rapid response to evolving public health challenges.
Early Experience With Neutralizing Monoclonal Antibody Therapy for COVID-19: Retrospective Cohort Survival Analysis and Descriptive Study
Authors: Jarrett Mark , Licht Warren , Bock Kevin , Brown Zenobia , Hirsch Jamie , Coppa Kevin , Brar Rajdeep , Bello Stephen , Nash Ira
Published: July 2021

Background

Neutralizing monoclonal antibody (MAB) therapies may benefit patients with mild to moderate COVID-19 at high risk for progressing to severe COVID-19 or hospitalization. Studies documenting approaches to deliver MAB infusions and demonstrating their efficacy are lacking.

Objective

We describe our experience and the outcomes of almost 3000 patients who received MAB infusion therapy at Northwell Health, a large integrated health care system in New York.

Methods

This is a descriptive study of adult patients who received MAB therapy between November 20, 2020, to January 31, 2021, and a retrospective cohort survival analysis comparing patients who received MAB therapy prior to admission versus those who did not. A multivariable Cox model with inverse probability weighting according to the propensity score including covariates (sociodemographic, comorbidities, and presenting vital signs) was used. The primary outcome was in-hospital mortality; additional evaluations included emergency department use and hospitalization within 28 days of a positive COVID-19 test for patients who received MAB therapy.

Results

During the study period, 2818 adult patients received MAB infusion. Following therapy and within 28 days of a COVID-19 test, 123 (4.4%) patients presented to the emergency department and were released, and 145 (5.1%) patients were hospitalized. These 145 patients were compared with 200 controls who were eligible for but did not receive MAB therapy and were hospitalized. In the MAB group, 16 (11%) patients met the primary outcome of in-hospital mortality, versus 21 (10.5%) in the control group. In an unadjusted Cox model, the hazard ratio (HR) for time to in-hospital mortality for the MAB group was 1.38 (95% CI 0.696-2.719). Models adjusting for demographics (HR 1.1, 95% CI 0.53-2.23), demographics and Charlson Comorbidity Index (HR 1.22, 95% CI 0.573-2.59), and with inverse probability weighting according to propensity scores (HR 1.19, 95% CI 0.619-2.29) did not demonstrate significance. The hospitalization rate was 4.4% for patients who received MAB therapy within 0 to 4 days, 5% within 5 to 7 days, and 6.1% in ≥8 days of symptom onset (P=.15).

Conclusions

Establishing the capability to provide neutralizing MAB infusion therapy requires substantial planning and coordination. Although this therapy may be an important treatment option for early mild to moderate COVID-19 in patients who are at high risk, further investigations are needed to define the optimal timing of MAB treatment to reduce hospitalization and mortality.
Changes in Anxiety and Stress Among Pregnant Women During the COVID-19 Pandemic: Content Analysis of a Japanese Social Question-and-Answer Website (Preprint)
Authors: Shirabe Ritsuko , Okuhara Tsuyoshi , Yokota Rie , Okada Hiroko , Goto Eiko , Kiuchi Takahiro
Published: July 2021

BACKGROUND

The changing pattern of anxiety and stress experienced by pregnant women during the COVID-19 pandemic is unknown.

OBJECTIVE

We aimed to examine the sources of anxiety and stress in pregnant women in Japan during the COVID-19 pandemic.

METHODS

We performed content analysis of 1000 questions posted on the largest social website in Japan (Yahoo! Chiebukuro) from January 1 to May 25, 2020 (end date of the national state of emergency). The Gwet AC1 coefficient was used to verify interrater reliability.

RESULTS

A total 12 categories were identified. Throughout the study period, anxiety related to going outdoors appeared most frequent, followed by anxiety regarding employment and infection among family and friends. Following the declaration of the state of national emergency at the peak of the infection, infection-related anxiety decreased, whereas anxiety about social support and mood disorders increased. Stress regarding relationships appeared frequent throughout the pandemic.

CONCLUSIONS

The sources of anxiety and stress in pregnant women in Japan changed during the pandemic. Our results suggest the need for rapid communications in the early phase of a pandemic as well as long-term psychosocial support to provide optimal support to pregnant women in Japan. Health care professionals should understand the changing pattern of requirements among pregnant women.
Psychometric Evaluation of a Fear of COVID-19 Scale in China: Cross-sectional Study (Preprint)
Authors: Choi Edmond P H , Duan Wenjie , Fong Daniel Y T , Lok Kris Y W , Ho Mandy , Wong Janet Y H , Lin Chia-Chin
Published: July 2021

BACKGROUND

At the very beginning of the COVID-19 pandemic, information about fear of COVID-19 was very limited in Chinese populations, and there was no standardized and validated scale to measure the fear associated with the pandemic.

OBJECTIVE

This cross-sectional study aimed to adapt and validate a fear scale to determine the levels of fear of COVID-19 among the general population in mainland China and Hong Kong.

METHODS

A web-based questionnaire platform was developed for data collection; the study instruments were an adapted version of the 8-item Breast Cancer Fear Scale (“Fear Scale”) and the 4-item Patient Health Questionnaire. The internal construct validity, convergent validity, known group validity, and reliability of the adapted Fear Scale were assessed, and descriptive statistics were used to summarize the participants’ fear levels.

RESULTS

A total of 2822 study participants aged 18 years or older were included in the analysis. The reliability of the adapted scale was satisfactory, with a Cronbach α coefficient of .93. The item-total correlations corrected for overlap were >0.4, confirming their internal construct validity. Regarding convergent validity, a small-to-moderate correlation between the Fear Scale and the 4-item Patient Health Questionnaire scores was found. Regarding known group validity, we found that the study participants who were recruited from Hong Kong had a higher level of fear than the study participants from mainland China. Older adults had a higher level of fear compared with younger adults. Furthermore, having hypertension, liver disease, heart disease, cancer, anxiety, and insomnia were associated with a higher fear level. The descriptive analysis found that more than 40% of the study participants reported that the thought of COVID-19 scared them. About one-third of the study participants reported that when they thought about COVID-19, they felt nervous, uneasy, and depressed.

CONCLUSIONS

The psychometric properties of the adapted Fear Scale are acceptable to measure the fear of COVID-19 among Chinese people. Our study stresses the need for more psychosocial support and care to help this population cope with their fears during the pandemic.
Circle Microstrip Antenna Simulation for Frequency 3.5 GHz
Authors: Wildan Wildan , Cahyasiwi Dwi Astuti , Alam Syah , Zakariya Mohd Azman , Ramza Harry
Published: July 2021

This research proposed microstrip circular patch antenna simulation at a working frequency 3500 MHz. The antenna has been designed using a Duroid RT5880 substrate with dielectric constant (Îµr) = 2.2, substrate thickness (h) = 1.575 mm, and tangent loss = 0.0009 with microstrip line feeding. The simulation result, return loss value obtained -26.385, VSWR value 1.09, gain value 7.64 dBi, total radiation efficiency value -0.6489 dB, and bandwidth value 72 MHz (3468.8 MHz – 3541.9 MHz).
Deteksi Lokasi Parkir Kendaran Menggunakan ATMega 16 dan Modul GPS
Authors: Tjahjadi Gunawan , Dwi Cahya Nugraha , Yenita Nur Rahma , Alam Syah
Published: July 2021

Penelitian ini mengusulkan sistem deteksi parkir mobil menggunakan ATMega16 dengan modul GPS. Sensor inframerah digunakan  untuk mendeteksi lokasi parkir yang kosong yang selanjutnya diproses oleh ATMega 16 untuk diteruskan ke modul GPS. Modul GPS berfungsi untuk menunjukkan lokasi parkir yang kosong dan ditunjukkan dengan indikator lampu LED. Dari hasil perancangan dan pengujian didapatkan bahwa sitem yang dirancang telah berhasil mendeteksi dan mengarahkan kendaraan menuju ke lokasi parkir yang kosong. Penelitian ini dapat direkomendasikan sebagai sistem parkir otomatis untuk gedung perkantoran.
Alat Ukur Kedalaman Lubang Digital Dengan Memanfaatkan VL6180X
Authors: Gunadi Reza , Rosalina Rosalina , Ramza Harry
Published: July 2021

Di Dunia Industri, Kepresisian dalam pengukuran sangatlah penting, oleh karena itu alat ukur dibuat dengan bentuk digital sehingga memiliki tingkat kepresisian yang tinggi dan mudah dalam penggunaannya. Belum dikembangkannya Alat ukur kedalaman lubang digital membuat beberapa proses di dunia industri menjadi terhambat dan lalai dalam pelaksanaannya. Hal tersebut menyebabkan bahaya kecelakaan terhadap kebocoran lambung kapal melambung tinggi karena belum adanya pengecekan kondisi kapal secara otomatis yang berkala. Selain kecelakaan tersebut, jalanan rusak juga dapat menyebabkan resiko kecelakaan yang tinggi pada pengendara bermotor terutama pada saat kondisi jalan becek. Penelitian ini bertujuan untuk merancang alat yang dapat mengukur kedalaman lubang secara akurat dan mudah dalam pengoperasiannya. Metode yang dipakai dalam perancangan sensor Pendeteksi Kedalaman Lubang ini adalah memanfaatkan sensor VL6180X untuk mendeteksi dan mengukur Kedalaman lubang, microcontroller Atmega 2560 sebagai otak dati pemrosesan data dan LCD karakter 16x2 sebagai output penampil kedalaman lubang. Dari percobaan dan analisis yang dilakukan, dihasilkan bahwa sensor VL6180X efektif dalam mengukur kedalam lubang dan memiliki toleransi sebesar 1cm pada tiap pengukurannya. Maka disimpulkan, sensor VL6180X dapat digunakan sebagai sensor pengukur kedalaman lubang apabila membuat tingkat kerapatan ukurnya 1cm.
Bauhinia variegate (Kanchnara), An ornamental Plant with significant value in Ayurvedic and Folk Medicinal system
Authors: Kumari Isha , Kaurav Hemlata , Choudhary Gitika
Published: July 2021

Medicinal plants are important part of traditional medication system. These plants are also the primary source of modern drugs. One such important medicinal plant is Bauhinia variegate (orchid tree) commonly called as Kanchanara in Hindi and Mountain Ebony in English. It belongs to Caesalpiniaceae family. It is one of the most common tree species found throughout the India. This tree is known for its beautiful scented and aesthetic white pinkish flowers. It is traditionally used in many folk cultures around the country for various kind of disorders. It is commonly used plant species in Indian cuisine. Its flower buds are commonly used as vegetables in many regions of India. It holds a significant place in Ayurveda for its curative and healing properties in many diseases especially cervical lymphadenitis, hemorrhage, rectal prolapse, menorrhagia, leukoderma etc. It is used in many Ayurvedic polyherbal formulations as a main ingredient like Kanchanara Guggulu, Ushirasava, Vidangarishta etc. It has diverse nature of phytochemical constituents present in it which are responsible for extraordinary therapeutic properties like anti-microbial, anti-tumor, anti-diabetic, hepatoprotective, immunomodulatory, haemagglutination, anti-oxidant, antigoitrogenic, nephroprotective. The aim of present review is to provide information related to phytochemistry, traditional uses in Ayurveda and folk medicinal system and therapeutic properties of Bauhinia variegate.
Rubia cordifolia (Manjishtha): A review based upon its Ayurvedic and Medicinal uses
Authors: Kumari Isha , Kaurav Hemlata , Choudhary Gitika
Published: July 2021

Medicinal herbs have a rich history of their utilization for variety of ailments. India is categorized among those countries which have produced vast variety of medicinal plants. India is also called as “Botanical garden of the world”.  Medicinal plants are the source of discovery of new drugs across the world. Most of the drugs available today have some herbal content of plants in them. Rubia Cordifolia (Manjishtha) is a climber herb having small flowers of greenish white colour which are grouped around the purplish fleshy fruits. The roots of Rubia cordifolia imparts red colour from where dye is obtained which is due to the presence of brownish red bark. This plant is mainly cultivated in the hilly areas. Manjishtha has a very significant place in Ayurveda which is one of the most ancient health care systems of the world. Charaka categorized this medicinal herb as varnya (for the enhancement of skin complexion), jvarahara (anti-pyretic), visaghna (a detoxifier) and a rasayana (rejuvenator). While it is categorized as pittasamsamana (one which maintains the pitta dosha of the body i.e. the fire component of the body) by Acharya Sushrut. Manjishtha has potential to pacifiy the pitta dosha. The phytochemical constituents of Rubia Cordifolia (Manjishtha) are associated with wide range of therapeutic properties. In this review, summary of its phytochemistry, its uses in different medicinal systems like Ayurveda and folk system and its scientific therapeutic properties are reported.
Regulatory procedures for emergency approval of medical products by regulatory agencies
Authors: HariCharan G , Ramoju Kishore Kumar , S Suhana , Lindait Yamini
Published: July 2021

Emergency use authorization of medical products by the regulatory agencies is not a usual procedure; it happens to cope with unanticipated health emergencies affecting a large group of population, these can be because of outbreak agents like virus, bacteria, etc., which can cause contagious diseases. Contagious diseases are classified into an outbreak, epidemic and pandemic disease, based on size and intensity of spread of the disease. Epidemic and Pandemic disease conditions such as CoVID-19 will trigger the emergency use authorization of products that help in the control, prevention and/or cure for the disease. EMA and FDA are well known advanced regulatory bodies, with eminent procedures for approval of the medication, harmonization of the standards as per the global regulatory acceptance. However, there are some differences between the two, in case of initiating the procedure, timelines, data required for approval of products under the emergency use. This article focuses on emergency approval of medications, regulations involved in the approval of medications and vaccines by EMA and FDA, some of the important data companies or sponsors need to submit to the regulatory bodies for approval, verification procedure and timelines for evaluation of manufacturer submitted data. Mutual recognition agreement and timeline of Remdesivir for approval by EC and FDA.
FDA's drug regulatory pathways, its development strategies and regulatory considerations
Authors: Dhulia Iva , Patel Himani , Chauhan Narendra , Pardeshi Nidhi
Published: July 2021

People who are interested in drug development may be aware that New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA) are 2 of the FDA's regulatory pathways for how prescription drugs can be approved and ultimately reach the market. In basic terms, NDAs are for new drugs that have not yet been approved and ANDAs are for generic products.

NDA, also called 505 (b)(1), is the format that manufacturers use to bring a formal proposal to the FDA that a new drug should be approved and made available for use by patients in the United States. Under 505(b)(1), all investigations supporting safety and effectiveness, both clinical and nonclinical, are conducted by or on behalf of the sponsor. The other pathway is termed as abbreviated because preclinical and clinical trials are not required. The abbreviated approval pathways are described in section 505(j) and 505(b)(2) of the FD&C Act and known as ANDA and Hybrid applications respectively. Hatch-Waxman amendments in 1984 provided for a suitability petition that allows the application of ANDA for a drug product that differs from the RLD in its dosage form, route of administration, strength, or active ingredient (in a product with more than one active ingredient). The differences allowed for suitability petition and 505(b)(2) application are same but ANDA filed through suitability petition can contain only those differences that do not need clinical evidence for efficacy and safety. This article identifies considerations to help potential applicants determine the appropriate submission pathway, its development strategies to support approval under those pathways.
Regulatory advances and prospects of variation filing for the registered parenteral products in USA and Europe
Authors: Makwana Rajdeep G. , Desai Kuldeep V. , Kikani Vaibhav , Vaja Maulikkumar D.
Published: July 2021

Drug Regulatory Affairs (DRA) is a vital unit in a pharmaceutical company. It is concern about the healthcare product lifecycle, it provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safety and efficacy in pharmaceuticals, veterinary medicines, medical devices, cosmetics and complementary medicines, healthcare products to individuals around the world. Regulatory affairs (RA) professionals are employed in pharmaceutical industry, government, academic research and clinical institutions. As India is growing very rapidly in pharmaceutical sector, there is a need of regulatory affairs professionals to cater the current needs of industries for the global competition. Regulatory affairs professionals are the link between pharmaceutical industries and worldwide regulatory agencies. A regulatory affair is a somewhat new profession which has developed from the desire of governments to defend public health. Substantial documentation and data are required in these types of submissions, resulting in large, complex applications. Today 35 member countries along with 11 candidate countries and 4 international agencies have joined together to create the Pharmaceutical Inspection Cooperation Scheme (PIC/S) to promote a globally accepted GMP. Current constrain of Regulatory Affairs reveals diverse countries need  to follow different regulatory requirements for  marketing authorization  Application (MAA) approval of new drugs. In this present exertion, study expresses the drug approval process and regulatory requirements according to US Food and Drug Administration (UDFDA), European Medical Agency (EMA) and Central Drug Standard Control Organization (CDSCO).
Nitrosamine Impurities: Origin, Control and Regulatory Recommendations
Authors: Dobariya Umesh , Chauhan Narendra , Patel Himani , Pardeshi Nidhi
Published: July 2021

The unexpected finding of presence of nitrosamine impurities, by USFDA and EMA in year 2018, in drugs such as Angiotensin-II Receptor Blockers (ARBs), Ranitidine, Nizatidine and Metformin, has triggered the need for a risk assessment strategy for evaluation and control of these probable human carcinogen - nitrosamine in pharmaceutical product that are at risk. This finding leads to voluntarily recall of products worldwide. The finding of nitrosamines in some types of drug products led FDA and other international regulators to conduct a detailed risk assessment of these impurities in APIs and drug products. Although nitrosamine impurities have been found in only some drug products, regulatory agencies recommended to extend risk analysis in other chemically synthesized APIs and drug products also.
Zonation Drives The Abundance of Understory Exotic Plant Species in Ir. Djuanda Forest Park, West Java
Authors: Cahyanto Tri , Yuni Billy Nabil , Efendi Muhammad
Published: July 2021

Abstract: The understory is an important component in the tropical forests, particularly to contribute to ecosystem services function and playing on succession. However, the study on their existence related to the zonation effect in an ex-situ conservation is still lacking. This study aimed to compare the structure and composition of the understory in the two blocks of Ir. Djuanda Forest Park, Bandung. Data collection was carried out through vegetation analysis using plot methods (sampling plots). A total of 40 sampling plots of 5m x 5m were made in two observation blocks. The Importance Value Index (IVI) for each species was calculated based on their relative density and relative frequency. Seventy-three species of understory from 38 families were found in the observation plots, dominated by Araceae and Moraceae families. The composition of the protected block has higher species richness than the utilization block due to the differences in microclimates conditions. Calliandra calothyrsus, known as an invasive species, has the highest IVI indicating high adaptability to open habitats in the utilization block, while two native species, Plectranthus sp. and Chlorathus elatior, dominate in the protection block. Based on these findings, we showed that forest zonation drives exotic and native species abundance in the ex situ conservation area.Abstrak: Tumbuhan bawah merupakan salah satu komponen penting dalam vegetasi hutan tropis, terutama dalam pelayanan ekosistem dan berperan dalam proses suksesi. Namun, penelitian mengenai keberadaannya dikaitkan dengan pengaruh zonasi di kawasan konservasi secara ex situ masih jarang. Tujuan penelitian ini untuk membandingkan struktur dan komposisi tumbuhan bawah pada dua blok yang berbeda di kawasan Taman Hutan Raya Ir. Djuanda, Bandung. Pengambilan sampel menggunakan analisis vegetasi dengan metode plot (petak contoh). Sebanyak 40 plot kecil berukuran 5mx5m di kedua blok pengamatan. Indeks nilai penting (INP) setiap jenis dihitung berdasarkan kerapatan relatif dan frekuensi relatifnya. Sebanyak 73 jenis dalam 38 suku tumbuhan didata di dalam pengamatan, yang didominasi dari suku Araceae dan Moraceae. Berdasarkan jumlah jenis tumbuhan penyusunnya, blok perlindungan memiliki jenis yang lebih banyak dibandingkan dengan blok pemanfaatan berkaitan dengan berkaitan dengan perbedaan kondisi iklim mikro di kedua blok tersebut. Jenis Calliandra calothyrsus, dikenal sebagai tumbuhan invasif, memiliki nilai INP tertinggi menunjukkan kemampuan adaptasi yang tinggi pada habitat terbuka di blok pemanfaatan, sedangkan tumbuhan asli pegunungan jawa, Plectranthus sp. dan Chloranthus elatior mendominasi pada blok perlindungan. Berdasarkan hasil temuan ini, kita menyarankan bahwa zonasi mempengaruhi kelimpahan tumbuhan eksotik dan asli di kawasan konservasi tumbuhan secara eksitu.