bluuebunny/crossref_metadata_2025_split huggingface dataset:
Oncology Drugs: Evolution, Comparative study of Global Drug Regulatory approval process and various measures to improve availability and accessibility
Authors: Sharma Shagun , Sharma Khushbu , Verma Pooja , Rahi Shivali , Rana Arpana 
Published: January 2023

Cancer is the leading cause of death worldwide and is a well-known fact that it can be cured if detected and treated early. Cancer treatment has evolved from conventional therapies like vinca alkaloids, photodynamic and radiation therapy, chemotherapy to immunotherapy. Recent advances in tumour agnostic therapies based on cancer genetics and molecular features has led to a single drug treating different types of cancers. Next Generation sequencing (NGS) represents an effective way to gather large amount of genomic information about a cancer. The concept of precision medicine goes along with an understanding of the cancer genome as determined by NGS. Thus with an array of cancer diagnosis and treatment options the marketing approval process globally is challenging. This is mainly due to lack of harmonization of guidelines. This review evaluates the approval process of oncology drugs in US, EU and India. Recent USFDA initiatives like Project Orbis involving multi country collaboration and real time oncology review while EU PRIME and WHO proposed reliance pathway are several global initiatives which accelerates assessment process.
New NDCT rules introduced in India in 2019 is one of the key step towards faster availability and accessibility of Cancer drugs in the country.
Countries with high resource settings like USA and EU have recognized this and have made several initiatives to provide early access to patients. USA has several pathways for speeding up the regulatory approval process for oncology drugs. India has recently came up with New Drugs and Clinical Trial rules, 2019 (NDCT rules 2019) which laid down the provisions of Provisions of Accelerated approval, Expedited review and Clinical trial waivers ensures faster availability and accessibility of cancer drugs in the country.
Although a lot of initiatives have already been taken in this direction still there is a strong need to harmonize the requirements globally for faster availability and accessibility of drug in the country for the much-needed patients.
Survey of the Jan Pariyojana Scheme in India and its impact on citizens during the previous decade
Authors: Kaul Evesh , Gupta Priyanka 
Published: January 2023

It is a well-known fact that Branded medicines are sold at significantly higher prices in India. Making affordable, high-quality pharmaceuticals available on the market will help everyone, but mainly the underprivileged and destitute given the country's pervasive poverty. The Indian government has always been quite concerned about this. The Ministry of Chemicals and Fertilizers' Department of Pharmaceutical has periodically implemented a number of regulatory and financial initiatives to achieve this goal.
The "Pradhan Mantri Bhartiya Jan Aushadhi Pariyojana" is a wonderful project started by the Indian government back in 2008 for the worthy purpose of providing high quality medications at accessible prices to all.
The Pariyojana involved selling inexpensive generic medications through upscale retailers called "Pradhan Mantri Bhartiya Jan Oshadhi Kendra" in different regions of the nation. On November 25, 2008, the first "Pradhan Mantri Bhartiya Jan Oshadhi Kendra" in Punjab's Amritsar city was inaugurated.
At first, it was planned that the "Pradhan Mantri Bhartiya Jan Oshadhi Pariyojana" would be implemented during the 11th Five-Year Plan period, beginning in 2008-2009, with the goal of establishing at least each Pradhan Mantri Bhartiya Jan Oshadhi Kendra in each of the firm's 630 regions, and then expanding to sub divisional levels as well as major town and village centers by 2012.
After garnering early support, the concept was planned to be self-sustaining and not rely on government subsidies or assistance. It was to be run on the basis of "No Profit, No Loss."
A study of Regulatory aspects on Registration of Orphan Drugs in US and EU
Authors: S. Vasantha Mounika  , P. Ramya  , M.S.L. Divya  , S. Naga Swaroopa  , Raju K. Venkateswara , N.L. Prasanthi  
Published: January 2023

The medicinal products used in the treatment, prevention, and diagnosis of rare disease like Myoclonus disease, Huntington's disease, Tourette syndrome are called as Orphan drugs, when it comes to defining rare disease and approving them as “Orphan designations.” The Criteria varies from country to country based on severity, prevalence of the disease and alternative therapies available.
In 1983, the US government brought the Orphan Drug Act to facilitate and encourage pharmaceutical company to develop orphan drugs without which they show reduced interest in the research and development of these drugs. The reason being their low market value and sales of orphan a drug is so miniscule that it will not enable them to even recover a fraction of the investment made in them.
After the inception of “Orphan Drugs” act 4500 orphan designations have been approved, 730 biologic drug products have been approved to treat 250 Orphan designations.
In the past decades, orphan designations have doubled in number when compared to its preceding decade but only 1/5th of the developed medications to treat them and received regulatory approval.
Analysis of emergency Drug Approval System in China and the United States under Public Health emergencies and its enlightenment to China
Authors: Chen Wei , Liang Yi 
Published: January 2023

Objective: Public health emergencies, such as COVID-19, put forward a severe test to the response system of countries all over the world, including China. Especially under such conditions, the establishment and operation of the emergency drug approval system is particularly important. The purpose of this paper is to compare and analyze the emergency drug approval system between China and the United States, and learn from the experience of developed countries to improve China's drug review capability in response to public health emergencies.
This paper mainly analyzes the emergency drug approval system of China and the United States under public health emergencies through literature research and comparative analysis theory. Although there are four channels to accelerate the approval of drugs for listing in China, none of them can solve the problem of emergency drug use in the face of public health emergencies, and cannot become the policy basis for the use of unlisted drugs or drugs beyond the instructions.
Conclusion: On the basis of maintaining China's own institutional advantages and drawing on foreign experience, this paper puts forward relevant policy recommendations to improve China's emergency drug approval system in the event of public health emergencies.
ANALISIS TANGGUNG JAWAB PEMERINTAH DAERAH DALAM PEMANTAUAN ORANG ASING
Authors: Maria Diana , Ansorullah Ansorullah 
Published: January 2023

Penelitian ini bertujuan 1) untuk mengetahui dan menganalisis pengaturan terhadap tanggung jawab pemerintah daerah dalam pemantauan orang asing; 2) untuk mengetahui dan menganalisis implikasi hukum terhadap tanggung jawab pemerintah daerah dalam pemantauan orang asing. Metode penelitian yang digunakan adalah tipe penelitian yuridis normatif. Hasil penelitian menunjukkan bahwa 1) pengaturan terhadap tanggung jawab pemerintah daerah dalam pemantauan orang asing bahwa Undang-Undang Nomor 23 Tahun 2014 tentang Pemerintahan Daerah tidak diketemukan mengenai ketentuan tanggung jawab pemerintah daerah dalam pemantauan orang asing. Dalam Pasal 4 Permendagri Nomor 49 Tahun 2010 tentang Pedoman Pemantauan Orang Asing dan Organisasi Masyarakat Asing di Daerah, tidak ditentukan secara jelas dan tegas ruang lingkup atau tugas yang dimaksud apakah disesuaikan dengan tugas dan fungsi gubernur dan tugas fungsi Badan Kesatuan Bangsa dan Perlindungan Masyarakat Provinsi; 2) implikasi hukum terhadap tanggung jawab pemerintah daerah dalam pemantauan orang asing mengacu 3 (tiga) aspek yaitu pendekatan konsep dan yuridis, kelembagaan dan aspek administrasi.

Kata Kunci: Tanggung Jawab, Pemerintah Daerah, Pemantauan Orang Asing.
Effect of Using Beluntas Leaf Flour (Pluchea indica Less) on the Performance of Arabic Chicken (Gallus turcicus)
Authors: Tantu Rizal Y. , Setiawan Neno , Sulistiawati Dwi 
Published: January 2023

Ketersediaan ransum merupakan faktor yang sangat menentukan keberhasilan suatu usaha peternakan. Ayam mengkonsumsi ransum untuk memenuhi kebutuhan energi bagi berlangsungnya proses-proses biologis untuk pertumbuhan. Daun beluntas yang mudah tumbuh dan banyak terdapat di Indonesia dapat menjadi alternatif yang dapat dimasukkan dalam komposisi pakan untuk ayam. Pemanfaatan daun beluntas secara tradisional pada umumnya sebagai penambah nafsu makan dan membantu pencernaan. Penelitian ini bertujuan untuk mengetahui performa ayam arab (Gallus turcicus) umur 48 minggu setelah diberikan tambahan tepungdaun beluntas (Pluchea indica Less) dalam ransum. Penelitian ini menggunakan Rancangan Acak Lengkap (RAL) dengan 5 perlakuan dan 4 ulangan dengan rincian R0 = 100% ransum kontrol (0% tepung daun beluntas), R1 = R0 + 2,5% tepung daun beluntas, R2 = R0 +5% tepung daun beluntas, R3 = R0 +7,5% tepung daun beluntas, R4 = R0 +10% tepung daun beluntas. Parameter yang diukur yaitu, pertambahan bobot badan, konsumsi ransum, dan konversi ransum. Hasil Analisis ragam menunjukkan bahwa penambahan tepung daun beluntas (Pluchea indica Less) dalam ransum ayam arab (Gallus turcicus) berpengaruh tidak nyata (p>0,05) terhadap pertambahan bobot badan, konsumsi ransum dan konversi ransum. Hasil konversi ransum terendah diperoleh pada perlakuan R1 dengan nilai konversi ransum 12,4 yang mengandung tepung daun beluntas 2,5%. Kemudian, berdasarkan hasil perhitungan feed cost, pemberian ransum yang terdiri dari ransum basal 97,5% dan tepung daun beluntas 2,5% memiliki cost yang paling rendah.
Konsep Kafā’ah dalam Pernikahan Syarifah dengan Non Sayyid
Authors: Safiul Anam  , Mokh. Yahya  
Published: January 2023

There are hundreds of families of the grandchildren of the Prophet Muhammad. who live in Pasar Kliwon, Surakarta. Among them are the Habib Ali al Habsy Family, such as Habib Anis al Habsyi, and his father Habib Alwi bin Ali al Habsy. In Pasar Kliwon District there are sharif and syarifah associations, from the data obtained in the field in the last 5 years there have been 25 marriages between syarifah and nonsyarif. Besides that, in Kliwon Market there is also an organization of the Rabithah Alawiyah Branch Leadership Council. This study aims to identify and describe the conditions or cases of marriage between sharifah and non-syarif in the Kliwon market in Surakarta and to describe the implementation of kafā’ah in the prohibition of marriage between sharifah and non-syarif according to Habaib Pasar Kliwon Surakarta and to explain Islamic law and positive law reviews of the concept kafā’ah towards the Alawiyyin family which was carried out by the people of Pasar Kliwon District, Surakarta. This type of research is a type of field research using primary and secondary data. The data collection technique was carried out using observation, interviews, documentation studies and literature studies, all of which answered research problems regarding the implementation of kafā’ah in the prohibition of marriage between sharifah and non-syarif. According to the majority view of Habaib, Pasar Kliwon sub-district, a sharifah is not allowed to marry a non-syarif because they are considered not to be in the same league and for her, the descendants of Rasulullah SAW have the glory and virtue that not everyone has. Therefore, the kafā’ah problem is of great concern to the habaib of Pasar Kliwon.
The Identification of Arabic Teaching Models in Aliy Ma'had l Tahdid Anwau’ Ta’lim al-Lugah al-'Arabiyah fi al-Ma’had al-‘Aliy
Authors: Kaharuddin Kaharuddin , Nawas Kamaluddin Abu , Bahri Ratni Bt. Hj. , Hussin MD Noor Bin 
Published: January 2023

The study of teaching Arabic models in Aliy Ma’had was necessary to be conducted. It could make contribution in designing Arabic teaching. The purpose of this research was to analyze the models of Arabic teaching. This research was field research which the researcher obtained and collected data from the research location. Two types of data were used in this research namely primary data and secondary data. Primary data was obtained from sheikh of Ma'had, 3 chiefs of Ma'had, 10 teachers, and 30 students. Secondary data was obtained from alumni, documents, and online news that was related to the topic. In collecting data, observation, interview, documentation, and FGD were used. Miles and Huberman model was used in this research. The results showed that the teaching Arabic in Aliy Ma’had consisted of four models. First, teaching Arabic with a conventional model: teaching that took place in official classes. Second, teaching Arabic with an extracurricular model: teaching that takes place outside the classroom and is supported by conventional teaching to improve both Arabic language skills. Third, teaching Arabic with the halaqiyah model: students learnt classical Islamic sciences by sitting on the floor in front of the teacher, which took place in the mosque after every evening and dawn prayers. Fourth, teaching Arabic with visiting teacher’s house where students studied further to strengthen scientific and spiritual connections. This research suggested the teacher and the institution in improving this topic to contribute Arabic teaching development in Aliy Ma’had.
Translating Poetry – An Impossible Task?
Authors: Ajtony Zsuzsanna 
Published: January 2023

Abstract
Poetry is often claimed to be untranslatable. More specifically, rendering light verse, i.e. poetic humour in another language poses serious challenges for the translator to encounter. In spite of these alleged obstacles, T. S. Eliot’s Old Possum’s Book of Practical Cats has been translated and lately retranslated into Hungarian in the form of inventive and jocular texts for children. After summarizing the theoretical aspects of poetry translation and providing a brief overview of Eliot’s collection of poems about cats, the present study aims to approach the English source text by highlighting its foregrounded elements: titles, names, and cultural realia and their Hungarian counterparts in the latest translation by Attila Havasi and Dániel Varró.
Speaking Properly: Language Ideologies of Hungarian Interpreters from Transylvania
Authors: Fazakas Noémi 
Published: January 2023

Abstract
The paper presents the results of a research project that aimed to identify the explicit and implicit language ideologies of a group of Hungarian interpreters from Transylvania or of Transylvanian origin, now living and working in Romania and in Hungary. During the online focus group meetings, the participants reflected on their own professional and linguistic practices and experiences, talking about their stories of individual language socialization and providing detailed career narratives. The study seeks to identify the interpreters’ explicit and implicit language ideologies in the context of their working languages, their attitudes towards these languages, towards the standard and the non-standard varieties, as well as their experiences connected to these languages in the light of the quality assurance expectations formulated regarding their activities as professional language service providers.
Spotting Acronyms and Initialisms with the Help of Informatics
Authors: Imre Attila 
Published: January 2023

Abstract
The growing popularity of streaming services has led to innumerable audiovisual material available for the audience. As movies, documentaries, or TV shows are part of the entertainment industry, they aim at reaching viewers worldwide with the help of dubbed and subtitled versions. Our aim is to collect the acronyms used in the transcripts/subtitles of several American political TV shows (24, Designated Survivor, House of Cards, and The West Wing) and analyse their translated versions into Hungarian. However, the strenuous activity of opening each subtitle file one by one and browsing through them to spot and collect the acronyms and initialisms would result in countless mouse clicks. Hence, a specific software (SRT Manager) was designed to speed up the process. As the majority of definitions regarding acronyms and initialisms focus on the fact that they result from the combination of at least two capital letters, once the software gets the input (multiple subtitle files of entire seasons), it provides all the consecutive two- or more capital letter instances (with or without periods) found in the raw data, such as AA or A.A. Further statistical data (the source file of each instance, counting all unique values and numbering occurrences, and adding sample lines from the subtitle) also saves a lot of time and energy, as it can easily be exported to spreadsheet programs for further data analysis.
Hungary and Transylvania in Women’s Travel Writing in the 19th Century
Authors: Bökös Borbála 
Published: January 2023

Abstract
Travel narratives written in the mid-nineteenth century served as valuable sources of information for the Western society regarding remote and exotic places as well as different cultures. Hungary and Transylvania became increasingly interesting and challenging destinations for British and American travellers, especially in the pre- and post-revolutionary periods. Julia Pardoe’s The City of the Magyar, or Hungary and Her Institutions in 1839–1840 (1840) and Nina Elizabeth Mazuchelli’s memoir, Magyarland (1881), provided extensive accounts of a multi-ethnic Hungary, discussing various populations as being distinct from the mainstream society, as well as their folklore, history, manners, and customs. In analysing Pardoe’s and Mazuchelli’s memoirs, I am interested in the ways in which they portray Hungarian otherness as contrasted to Western, more precisely British national ideals. Making use of the theories of imagology, I will argue that the perceptions of a national character (hetero-images) as well as the defining of the (travellers’) self against the Other (auto-images) are determined and perpetuated by cultural distinctions and by the various forms of cultural clash of the British and the East-Central European. Moreover, through a comparative approach, I will also look at the differences in the travellers’ perception of the same country but in two very different historical and political time periods: Pardoe’s journey in Hungary took place in 1840, before the War of Independence, while Mazuchelli visited the country in 1881, long after the Austro-Hungarian Compromise in 1867. The findings will indicate that the main features of the image of Hungarian national identity, as it is represented in the travelogues, are generated by the historical, cultural, and socio-political developments before and after the Hungarian War of Independence (1848–49).1
From Proletarian Internationalism to Transnational Consciousness
Authors: Szilveszter László Szilárd 
Published: January 2023

Abstract
Following the Treaty of Trianon, in Transylvania, which had been detached from historical Hungary and attached to Romania, besides the Romanian majority, there lived a considerable Hungarian- and German-speaking minority. Although in the last two decades of the communist dictatorship – in the 70s and 80s – as a consequence of emigration to Germany, the number of ethnic Germans decreased substantially, the number of Hungarian speakers is over one million even today. Regarding the characteristics of the post-World War II literary discourse and cultural policy, in the second half of the forties, the communist power gained control over all manifestations of community life in Romania. It regulated culture and the arts, banned, abolished, or restructured all forums that had enjoyed some kind of independence, and completely revised the literary and artistic canon. In this era, the discourse emphasizing the aspects of revolutionary transformation and radical policy change decisively builds on the enemy image; the fault-line between past and present and the necessity of continuous political struggle prevail in both poetry and prose. In order to achieve the intended social goals, this kind of communist sacrifice ethics regards the annihilation of resisters, protesters, and even of the internal opposition not only as a possibility but as an assumed necessity. This paper aims to present the ideological/political and aesthetic/poetic tendencies that determined Transylvanian Hungarian literature and cultural policy from the mid-40s until the end of 20th century.
Change of Direction Deficit: A Promising Method to Measure a Change of Direction Ability in Adolescent Basketball Players
Authors: Lazić Anja , Andrašić Slobodan , Stanković Mima , Milanović Zoran , Trajković Nebojša 
Published: January 2023

Abstract
The aims of this study were to determine the relationship between vertical jumping performance, linear speed, change of direction speed (CODs) time and the COD deficit (CODD) in adolescent basketball players and to analyze the CODD between faster and slower players based on linear speed performance. Thirty-eight male basketball players (age: 15.47 ± 0.51 years; body height: 185.19 ± 5.67 cm; body mass: 71.87 ± 7.29 kg) completed countermovement jumps (CMJ) with and without an arm swing, squat jumps (SJs), linear sprints at 20 m with split times at 5 and 10 m, the pro–agility test and the zig-zag tests. Furthermore, the CODD was calculated as the difference between the 20 m linear speed result and CODs time in both COD tests. Pearson and Spearman analyses were used to determine the correlations between power-speed-related variables and the CODD. Moreover, independent t-tests and Cohen’s d effect size (ES) were used to analyze the differences between the faster and slower players in the CODD. Moderate to strong significant negative correlations were observed between the CODD in the pro-agility test and linear speed at 5 m, 10 m, and 20 m (r = –0.55 to –0.46), while moderate negative significant correlation was found between the zig-zag CODD and SJs (r = –0.37) as well as small positive significant correlation between the CODD in the zig–zag test and the eccentric utilization ratio (EUR) (r = 0.23). Additionally, faster basketball players displayed significantly higher CODD values performing the pro-agility test. In summary, these findings underline the complexity of COD performance and the importance of remodeling traditional training programs in basketball players.