bluuebunny/crossref_metadata_2025_split huggingface dataset:
Analysis of Noncompliances with Legislative Requirements in Pharmacovigilance Materials of Registration Dossiers
Authors: Zhuravleva E. O. , Velts N. Yu. , Kutekhova G. V. 
Published: December 2021

Since 1 January 2021 the authorisation of medicines in the Russian Federation has to be performed according to the Eurasian Economic Union (EAEU) procedure. The Pharmacovigilance System Master File (PSMF) is the main document describing the pharmacovigilance system of the marketing authorisation holder (MAH) or its authorised representative. The aim of the study was to analyse noncompliances with the EAEU requirements, which were revealed during PSMF assessment.Materials and methods: the authors analysed 687 pharmacovigilance documents included in registration dossiers that were submitted for assessment from 1 January to 30 June, 2021. Results: the authors identified and systematised the main noncompliances with the EAEU requirements in terms of presentation, content, completeness of each PSMF section. They analysed the frequency of noncompliances in PSMFs and identified the most frequent flaws of MAHs’ pharmacovigilance systems.Conclusions: the authors give recommendations for elimination of significant noncompliances identified during PSMF assessment, which may include: timely updating, maintenance, and revision of the documents in accordance with changes in legislation and any other significant changes, regular training of pharmacovigilance staff, etc. The results of this review will be useful for MAHs as the main participants of the marketing authorisation process who are directly involved in the pharmacovigilance system management at the pre- and post-authorisation stages, and will help them prevent potential mistakes when drawing up pharmacovigilance system documents.
Integration of Negativity, Powerlessness and the Role of the Mediopassive: Resilience Factors and Mechanisms in the Perspective of Religion and Spirituality
Authors: Richter Cornelia 
Published: December 2021

Abstract
Defining psychological resilience while taking into account all of its different facets has proven to be a difficult task, requiring an interdisciplinary and transdisciplinary approach. This article will present some of the theologically relevant current findings of the new research group on “Resilience in Religion and Spirituality” (DFG-FOR 2686) working in cooperation between theology, philosophy, psychosomatic medicine, palliative care, and spiritual care (chapter 1). Even though our project builds on factors and mechanisms of resilience already intensively discussed (chapter 2), we will add some further aspects on resilience as a multidimensional and dynamic process of adaption (chapter 3) and on the integration of negative experiences, of endurance, of the formation of powerlessness and of the mediopassive (chapter 4). This will allow for some prospective considerations on understanding challenges and problems of the current SARS-CoV-2 pandemic (chapter 5).
Introduction
Authors: Lohlker Rüdiger 
Published: December 2021

Abstract
The contributions of this issue show an understanding of disease(s) and religion in a multifaceted way. Covering traditions of Christianity, Islam, Taoism, indigenous Indonesian people, fundamentalism, and secularism discourses allow for an approach to liminal situations related to diseases and healing and resilience towards the challenges these situations mean. Philosophical reflections, empirical research, theological discussions, studying ideas on sciences, and theoretical reflections on practical dimensions of resilience contribute to a stimulating mosaic of ideas.
Wordsworth’s Lucy poems as the Reflections of the French Revolution: A New Historicist Study
Authors: Atta Salman Mohammed 
Published: December 2021

Abstract
The current study takes a New Historic outlook toward William Wordsworth’s the “Lucy Poems” and believes that by a minute scrutiny of these poems we can expose the power structure and the dominant discourses that according to New Historicism have shaped the poet’s character, society and world. Accordingly, the paper suggests that the poet through symbolic and non-symbolic ways has embedded historical and political facts in these poems. To do so, the research will reveal some controversial correspondences among these poems, William Wordsworth’s life and historical facts of the French Revolution. To support this idea, the study will bring quotations not only from modern conspicuous literary critics but also from the poets and Romantic contemporaries to show how the historical and political discourses of the period have greatly influenced both William Wordsworth and even the literature of the whole era, i.e., Romanticism. As a matter of fact, this research intends to connect the “Lucy Poems” to the contemporary historical context and the poet’s ideals of the Revolution in France. The findings, however, reveal that William Wordsworth has been submissive to the historical events of his time.
كازاخستان: الاصلاحات السياسية والاقتصادية تجربة رائدة في بناء الاقتصاد الوطني وتحقيق الاستقرار السياسي
Authors: شدهان الزهيري ستار 
Published: December 2021

شهدت كازاخستان انعكاسات سياسية واقتصادية بعد الاستقلال في عام 1991، وساهمت هذه الإصلاحات في بناء دولة مؤسسية ، وترسيخ النظام الديمقراطي واقتصاد السوق الحر ، حيث تمكنت الدولة من تحقيق الاستقرار السياسي وصياغة سياسات اقتصادية إصلاحية أثرت على جذب الاستثمار الأجنبي والتوسع. وأثر النشاط الاقتصادي الوطني ومن ثم تحقيق نموه الاقتصادي على واقع المواطن الاقتصادي والدولي
ألفاظ السماءفي شعر يحيى السماوي ديوان (قليلك.. لا كثيرهن، أطفئيني بنارك، نهر بثلاث ضفاف) أنموذجا
Authors: خضير عباس فراس , معروف يحيى , اميري جهانكير , عز الدين الخطيب علي 
Published: December 2021

إن الخوض في أية دراسة نقدية لشعر شاعر ما، تتطلب عددا من المفاتيح التي يجب أن يمتلكها الناقد كي يقوم بفتح أبواب مغارات تلك القصائد، نعم، فهي أشبه بمغارات علي بابا، التي لاتفتح إلا بوجود كلمة السر، وكلمة السر هذه لا يملكها إلا الناقد الجامع لشروط النقد. وهي كثيرة، كالموهبة والثقافة العالية وسعة الاطلاع على المنجز الشعري، إلى غير ذلك من العوامل التي تقوم بإنجاح عملية القراءة النقدية.
كما أن دراسة أي منجز شعري لأي شاعر من الشعراء، تحتاج إلى معرفة واطلاع واسعَيْن على نتاجه الأدبي الذي سيشكل بلا شك نقطة الانطلاق الأولى للخوض في مغامرة النقد.
في هذا الموقع من الدراسة سنقوم بدراسة ألفاظ السماء التي تعد من مظاهر الطبيعة في نصوص الشاعر العراقي يحيى السماوي، الذي تشكلت شخصيته الشعرية من خلال مزيج سحري جمع عذوبة الريف ونقائه، وجمال المدينة وطقوسها المتعددة، فهو شاعر ينتمي إلی الجنوب العراقي، وللجنوب ميزة خاصة لا يعرفها إلا الذين ذاقوا طعم البرحي واستنشقوا عبير الأهوار .
بين أيدينا ثلاثة دواوين ستكون هي المادة الشعرية المدروسة في هذا المقال, وهي (قليلك.. لا كثيرهن، أطفئيني بنارك، نهر بثلاث ضفاف)، والتي سترافقنا على مدار الدراسة، وقد جاء اختيارها من بين عدد كبير من دواوينه، وفقا لميزات أبرزها، أنها متنوعة التجارب، فهي متعددة لم تقف على تجربة واحدة، وهذا سيمنحنا فرصة كبيرة للكشف عن التنوع فيها.
كما أنها تمثلت مراحل تطور لغة النص الشعري لديه، فهي دواوين توزعت على أبرز المراحل الشعرية في مسيرته الأدبية، لذا فإننا من خلالها نستطيع إعطاء مؤشرات حول تطور لغته وأدائها الشعري.
إن البحث يسعى للإجابة عن عدد من الأسئلة المهمة:

هل منحت ألفاظ السماء أبعادا جديدة لثقافة الشاعر؟ بحيث يمكن أن نقول عنها فعلا، إنها استطاعت أن تؤثر في ثقافته، نضجا، وعمقا، ووسعت من دائرة خياله الشعري؟
هل استعمل الشاعر ألفاظ السماء بصورتها المرجعية المعجمية أم أنه استطاع أن يتخذ منها قناعاً يخفى خلفه دلالاته ومقصدياته؟
هل استطاع السماوي أن يميز نفسه من الشعراء الآخرين أثناء توظيفه لألفاظ السماء، أم أنه سار على وفق التصورات التي قدمها سابقيه أو من الجيل نفسه ولم يأت بجديد؟

هذه حزمة من الأسئلة التي فيما يبدو أن علينا أن نجيب عنها وأن نتابعها أثناء التحليل، وهي من صميم عملنا النقدي.
WORKSHOP AUTOCAD 2D DI SMK NEGERI 1 SUAK TAPEH KABUPATEN BANYUASIN
Authors: Purwanto Herri , Adiguna Adiguna , Amiwarti Amiwarti , Setiobudi Agus , Alzahri Syahril , Firdaus Muhammad 
Published: December 2021

Kegiatan Pengabdian pada Masyarakat (PPM) yang dilakukan oleh dosen Prodi Teknik Sipil Universitas PGRI Palembang di SMK Negeri 1 Suak Tapeh Kabupaten Banyuasin ini bertujuan agar siswa dan guru dapat mengenal dan menambah pengetahuan tentang dasar-dasar dalam menggambar suatu desain konstruksi dengan menggunakan aplikasi autoCAD 2D dasar dengan menggambar bangun sederhana seperti trapesium, lingkaran dan rumah sederhana, serta dapat mengoperasikan dan mengaplikasikan aplikasi program AutoCAD 2D dalam kegiatan proses belajar mengajar di sekolah. Cara atau metode yang diterapkan adalah dengan memberikan penjelasan teori secara lisan dan mempraktekkan langsung di laboratorium komputer sekolah. Jumlah peserta yang hadir ada sebanyak 30 siswa yang sebagian besar belum mengenal autoCAD. Setelah mengikuti dan praktek langsung, dari 30 siswa yang mengikuti workshop ini berdasarkan hasil pantauan di layar komputer siswa terlihat hampir 90 % siswa dapat mengikuti dengan baik dan dapat menggambar sesuai yang diarahkan instruktur. Terdapat 7 % siswa yang belum bisa mengikuti secara optimal dengan kondisi gambar yang dibuat belum sesuai ketentuan dan ada 3 % siswa yang tidak bisa mengikuti disebabkan masalah di komputer yang digunakan
PENINGKATAN KINERJA GURU DALAM PENGEMBANGAN EVALUASI PEMBELAJARAN MELALUI SUPERVISI AKADEMIS KEPALA SEKOLAH DI SMP NEGERI 4 LUBUKLINGGAU
Authors: Erlinda Erlinda 
Published: December 2021

Penelitian ini bertujuan untuk mendapatkan informasi dan membahas tentang peningkatan kinerja guru dalam pengembangan evaluasi pembelajaran melalui supervisi akademis kepala sekolah di SMP Negeri 4 Lubuklinggau. Penelitian ini merupakan penelitian tindakan sekolah yang terdiri dar dua siklus dimana masing-masing siklus terdiri dari empat tahapan yaitu perencanaan, pelaksanaan observasi dan refleksi. Penelitian ini dilaksanakan di SMP Negeri 4 Lubuklinggau pada semester genap tahun ajaran 2018/2019 dengan subjek penelitian guru mata pelajaran sebanyak 6 orang. Teknik pengumpulan data mengunakan lembar observasi, catatan lapangan dan dokumentasi. Data dianalisis menggunakan persentase dan reduksi data. Hasil penelitian menunjukkan bahwa melalui supervisi akademis kepala sekolah terdapat peningkatan kinerja guru dalam pengembangan evaluasi pembelajaran di SMP Negeri 4 Lubuklinggau.
MENINGKATKAN KEMAMPUAN BERPIKIR KREATIF DAN PEMECAHAN MASALAH MATEMATIS SISWA DENGAN PEMBELAJARAN METAKOGNITIF DI KELAS X TKR SMKS 6 PERTIWI CURUP
Authors: Irawan Bayu Putra 
Published: December 2021

ABSTRAK
Jenis penelitian ini adalah Penelitian Tindakan Kelas. Subjek penelitian ini adalah siswa kelas X TKR SMKS 6 Pertiwi Curup yang berjumlah 34 orang. Pengumpulan data dengan menggunakan lembar observasi dan lembar tes. Hasil penelitian menunjukkan bahwa pelaksanaan tindakan kelas dengan pembelajaran metakognitif terlaksana dengan baik. Kemampuan berpikir kreatif matematis siswa meningkat dapat terlihat dari hasil tes yang diberikan, jika pada hasil pre-test hanya 5 orang siswa yang mencapai kategori baik, maka pada hasil post-test sebanyak 24 orang siswa telah mencapai kategori baik, untuk indikator memecahkan masalah dalam kategori kurang pada pre-tes dan pada post-test hasil tes kemampuan pemecahan masalah matematis yang diberikan menunjukkan adanya peningkatan. Jika pada hasil pre-test tidak ada satu siswapun mencapai kategori baik, maka pada hasil post-test untuk siklus I sebanyak 11 orang siswa mencapai kategori baik dan pada hasil post-test siklus II sebanyak 28 orang siswa mampu mencapai kategori baik.
Berdasarkan indikator keberhasilan, maka penelitian ini bisa dikatakan berhasil. Hal ini dilihat berdasarkan pencapaian tiap-tiap indikator berpkir kreatif dan pemecahan masalah matematis siswa dengan kategori baik lebih dari 20 orang. Oleh karena itu, penelitian ini dihentikan sampai siklus II.
Kata Kunci : Kemampuan Berpikir Kreatif, Pemecahan Masalah Matematis Siswa, Pembelajaran Metakognitif
Multi-Parametric Families of Real and Non Singular Solutions of the Kadomtsev-Petviasvili I Equation
Authors: GAİLLARD Pierre 
Published: December 2021

Multi-parametric solutions to the Kadomtsev-Petviashvili equation (KPI) in terms of Fredholm determinants are constructed in function of exponentials. A representation of these solutions as a quotient of wronskians of order $2N$ in terms of trigonometric functions is deduced. All these solutions depend on $2N-1$ real parameters. A third representation in terms of a quotient of two real polynomials depending on $2N-2$ real parameters is given; the numerator is a polynomial of degree $2N(N+1)-2$ in $x$, $y$ and $t$ and the denominator is a polynomial of degree $2N(N+1)$ in $x$, $y$ and $t$. The maximum absolute value is equal to $2(2N+1)^{2}-2$. We explicitly construct the expressions for the first third orders and we study the patterns of their absolute value in the plane $(x,y)$ and their evolution according to time and parameters.\\ It is relevant to emphasize that all these families of solutions are real and non singular.
Creative activity by G. Kkunkin in the context of the development of the military brass band’s culture of the Chernihiv region
Authors: Badalov Oleg 
Published: December 2021

The purpose of the article is to study the activities of the military musician, conductor of the brass band of the Chernihiv Higher Military Aviation College of Pilots, one of the founders of the modern orchestral culture of the Chernihiv region, Major Gryhory Borysovych Kunkin (1927–2009) in the context of the development of military music of Chernihiv region, his contribution to the formation of regional cultural space of the second half of 20th century. The author examines the life of G. Kunkin against the background of the development of the military-musical performance of the Chernihiv region. The methodology is based on historical-chronological, source-study, logical-generalizing, and comparative methods for elucidating the chronology of the development of military musical art of Chernihiv region of the 20th century, the study of G. Kunkin's creative biography, and generalization of information about military conductors of Chernihiv region – his contemporaries, memoirs of G. Kunkin's colleagues, identification of factors influencing his work on the development of the cultural space of Chernihiv region. The scientific novelty of the publication lies in the first domestic musicology study of the life of G. Kunkin as one of the prominent figures of the military-musical culture of the Chernihiv region. Conclusions. The results of the study indicate that G. Kunkin during his career as a military conductor had a significant impact on the development of the military and musical culture of the Chernihiv region. With his activity he revived the regional military-musical life, outlined the main directions of its further development, which were realized in the works of military conductors of Chernihiv region at the beginning of the 21 century; G. Kunkin's concert activity of the military brass band popularized the brass art among the population of the region and, as a result, conditioned the social demand for learning to play wind instruments, intensifying the activity in this direction in art schools of Chernihiv region and music college named after L. Revytsky. The successful combination of musical experience, personal qualities, and organizational abilities allowed G. Kunkin to make a significant contribution to the potential of the spiritual culture of the Chernihiv region, which is worthily presented in Ukraine and abroad by military brass bands of the region.
Traditional socio-cultural values: possibilities of forsite methodology
Authors: Wilchinska Iryna , Oliinyk Oksana 
Published: December 2021

The purpose of the article is to substantiate the possibility of applying foresight methodology for the preservation of traditional socio-cultural values as an important element of innovative development. Given the interdisciplinary nature of the problem, the methodology of the study is based on the complex-integrative combination of theoretical approaches of a number of sciences, in particular, cultural studies, public administration, as well as general scientific methods of system analysis, synthesis, abstraction, generalization, and sub. The scientific novelty is connected with an attempt to outline theoretical and practical aspects of the importance of forsite methodology in preserving the traditions from the projection into practical measures of the state in this sphere. Conclusions. The forsite methodology - as a strategy of public administration of forsite on the basis of forward-thinking - is intended to promote the effectiveness of social development. The actual advance is the innovative mechanism that can, on the one hand, ensure the dynamics of development, on the one hand, and, on the other hand, ensure social stability on the basis of previous achievements and resources, which are analyzed and form (simulate) the idea of ​​a new scenario. At the same time, the results of forsite should be reflected in practical recommendations on the definition of promising directions of the state's cultural policy, in particular regarding the introduction of new forms of support for the activities of various components of the socio-cultural sphere.
Key words: traditional socio-cultural values, transformations, innovations, culture, forsite methodology.
Information-extreme machine training of on-board recognition system with optimization of RGB-component digital images
Authors: Naumenko Igor , Myronenko Mykyta , Savchenko Taras 
Published: December 2021

The research increases the recognition reliability of ground natural and infrastructural objects by use of an autonomous onboard unmanned aerial vehicle (UAV). An information-extreme machine learning method of an autonomous onboard recognition system with the optimization of RGB components of a digital image of ground objects is proposed. The method is developed within the framework of the functional approach to modeling cognitive processes of natural intelligence at the formation and acceptance of classification decisions. This approach, in contrast to the known methods of data mining, including neuro-like structures, provides the recognition system with the properties of adaptability to arbitrary initial conditions of image formation and flexibility in retraining the system. The idea of the proposed method is to maximize the information capacity of the recognition system in the machine learning process. As a criterion for optimizing machine learning parameters, a modified Kullback information measure was used, this informational criterion is the functionality of exact characteristics. As optimization parameters, the geometric parameters of hyperspherical containers of recognition classes and control tolerances for recognition signs were considered, which played the role of input data quantization levels when transforming the input Euclidean training matrix into a working binary training matrix using admissible transformations of a working training matrix the offered machine learning method allows to adapt the input mathematical description of recognition system to the maximum full probability of the correct classification decision acceptance. To increase the depth of information-extreme machine learning, optimization was conducted according to the information criterion of the weight coefficients of the RGB components of the brightness spectrum of ground object images. The results of physical modeling on the example the recognition of terrestrial natural and infrastructural objects confirm the increase in functional efficiency of information-extreme machine learning of on-board system at optimum in information understanding weight coefficients of RGB-components of terrestrial objects image brightness.
Methods and technologies for ensuring cybersecurity of industrial and web-oriented systems and networks
Authors: Morozova Olga , Nicheporuk Andrii , Tetskyi Artem , Tkachov Vitalii 
Published: December 2021

The subject matter of the article is methods and technologies of ensuring the cybersecurity of industrial and web-oriented systems and networks, training of cybersecurity specialists during the acquisition of professional knowledge. The purpose of the article is to ensure the cybersecurity of industrial and web-oriented systems and networks by developing and implementing appropriate methodologies (concepts, principles, set of models, methods) and technologies in the industry, as well as in training the cybersecurity specialists during the acquisition of professional knowledge. The problem of developing models, methods, and technologies for ensuring the cybersecurity of mobile systems, web-oriented systems based on content management systems, virtual networks that provide their interaction, and a methodology for training cybersecurity specialists are formulated. Based on the analysis the particular tasks of developing convolutional neural network model, information technology methods and models for ensuring the cybersecurity of web-oriented systems and networks, a methodological framework of creating information technology, and a model of digital knowledge platform for use in the field of cybersecurity specialists training and security of industrial systems were formulated. The basic theoretical decisions, which underlie the construction of real industrial and web-oriented systems and networks, were described in the article. The results of work are increased reliability value of detecting the malware in the Android operating system, reduced rates of false positives, provided an allowable value of the success rate of attacks at a minimum cost, reduced time spent on building and rebuilding the structure of the virtual network, increased efficiency of cybersecurity specialists training and security of industrial systems. From the above, it is possible to conclude that the obtained results can be used in a line of existing and prospective approaches at designing difficult, complex, hybrid, technical, cyber-physical systems with a web-oriented interface for users and administrators.
NILAI INVESTASI UKM DAN NILAI EKSPOR UKM SERTA PENGARUHNYA TERHADAP ANGKA PRODUK DOMESTIK REGIONAL BRUTO (PDRB) PROVINSI SUMATERA SELATAN
Authors: Pebrianti Yulia 
Published: December 2021

Penelitian ini bertujuan untuk menguji pengaruh nilai investasi dan nilai ekspor UKM terhadap angka produk domestik regional bruto (PDRB) Provinsi Sumatera Selatan. Penelitian ini menggunakan data dari Badan Pusat Statistik tahun 2010-2019. Uji hipotesis menggunakan analisis regresi linier berganda. Hasil penelitian menunjukkan bahwa nilai investasi dan nilai ekspor UKM tidak berpengaruh terhadap PDRB.

Kata kunci: Nilai Investasi, Nilai Ekspor, PDRB.
Survey among Russian doctors on routine electroencephalography
Authors: Bogdanova E. P. , Elshina O. D. , Sinkin M. V. 
Published: December 2021

The aim of the work was to assess how accurately specialists, performing EEG, apply the recommendations in their daily practice.Materials and Methods. An anonymous survey was conducted of 210 specialists in functional diagnostics and neurologists performing routine electroencephalography. The survey consisted of nine mandatory single-choice questions.Results. Only 9 respondents out of 210 (4.3%) perform routine EEG completely in accordance with the Recommendations of the Expert Council of Neurophysiology of the Russian Anti-Epileptic League on performing the routine EEG.' Of these, only three specialists (1.4% of the total number of respondents) answered that a functional diagnostics doctor is present throughout the entire examination.Conclusion: Despite the wide distribution and extensive experience in the use of EEG, there is no uniform practice of its implementation by doctors in the Russian Federation. Standardization of the methodology of its performance will increase confidence in EEG results among doctors of clinical specialties, increase the degree of inter-expert agreement among functional diagnostics physicians, and improve the quality of diagnosis of central nervous system diseases. To do this, it is necessary to develop webinar and educational programs on the methodology of EEG under the auspices of professional associations of doctors of functional diagnostics, neurophysiologists, neurologists.