bluuebunny/crossref_metadata_2025_split huggingface dataset:
Limits and challenges of the ICH GCP requirements
Authors: Bignamini Angelo A. 
Published: December 2020

Dalla pubblicazione della GCP europea (1991) vi è stato un progressivo spostamento dal primario interesse per la protezione dei diritti del soggetto, verso la garanzia formale della completezza dei dati, a torto confusa con la “credibilità”.
Ciò causa conflitti e ritardi nell'approvazione etica e sembra dovuto allo scollamento fra i criteri di stesura dei protocolli nelle aziende farmaceutiche o i criteri con cui alcune autorità sanitarie emettono raccomandazioni per l'esecuzione di studi clinici, ed i criteri secondo i quali i CdE dovrebbero valutare il protocollo per garantire una reale protezione dei diritti del soggetto: conformità con la legge civile e penale; compatibilità con la pratica terapeutica e con l'etica e la deontologia medica; adeguatezza alla condizione culturale, etica, morale e religiosa localmente prevalente; rispetto dei principi di uguale opportunità e giustizia per l'accesso allo studio.
La GCP e le altre raccomandazioni sono considerate solo in questo contesto. Non sono invece considerati criteri interni allo sponsor (SOPs), né eventuali diversi criteri applicabili in altre sedi.
Si suggerisce quindi a sponsor e autorità sanitarie di incorporare tali considerazioni in protocolli e raccomandazioni; di ricordare che la ricerca clinica è soprattutto un atto terapeutico; che non necessariamente un protocollo deve essere identico dappertutto, purché ne sia rispettata l'integrità. Gli elementi non chiave devono essere considerati suscettibili di adattamento secondo le specifiche caratteristiche locali. Ciò suggerisce di limitare il processo in atto di centralizzazione delle procedure di stesura e approvazione etica dei protocolli, lasciando maggiore autonomia alle realtà operative locali.
Implicazioni etiche e medico-legali nell’utilizzo di placebo nella sperimentazione clinica
Authors: Conti Adelaide , Marniga Brunella 
Published: December 2020

Gli autori, alla luce di un caso clinico riguardante la sperimentazione farmacologica giunto all’esame di un Comitato Etico, espongono alcune considerazioni sugli aspetti etici e medico-legali dell’utilizzo di placebo.
Una volta analizzato il significato del termine placebo, anche dal punto di vista storico, viene descritto l’uso di tali sostanze: sono numerosi infatti gli esempi relativi alla sperimentazione farmacologica per chiarire l’impiego dei placebo.
I problemi etici implicati sono decisamente importanti: in primo luogo il rispetto dei principi di autonomia, beneficialità, non maleficienza, giustizia.
Le opinioni sono contrastanti: a fronte di chi ritiene che non sia corretto né eticamente né metodologicamente sottoporre a placebo alcun paziente, si pongono coloro che ne promuovono l’utilizzo quando non sia nota altra terapia alternativa efficace.
Peraltro un problema rilevante sembra essere la comunicazione al paziente della terapia a lui somministrata, in sostanza la comunicazione della verità al malato, per garantirne la piena autonomia.
Tuttavia sembra che il placebo per esplicare il suo effetto debba dipendere dalla non consapevolezza e dalla suggestionabilità del paziente. Il Codice Deontologico sottolinea il principio di beneficialità e pone alcune direttive per l’uso di placebo.
Il consenso informato rimane anche in questo ambito un elemento basilare, ribadito dalla Costituzione e dal Codice Penale.
Qual è il rischio delle tecniche di fecondazione artificiale?
Authors: Di Pietro Maria Luisa , Minacori Roberta 
Published: December 2020

L’articolo mette a fuoco i rischi che, o per l’imperizia dell’operatore, o per le procedure previste dalla tecnica di fecondazione, sono responsabili della morbilità e mortalità della donna e/o del nascituro. Uno dei rischi per la donna è legato alla stimolazione ovarica che si attua con una induzione farmacologica e che provoca la cosiddetta “iperstimolazione ovarica” e tumori della mammella e dell’ovaio.
Altri rischi sono legati alle complicanze delle procedure di fecondazione artificiale e che riguardano soprattutto la fase di recupero delle ovocellule, la coltura in vitro, il trasferimento dei gameti e degli embrioni nelle vie genitali della donna. Il prelievo degli ovociti viene eseguito sotto controllo ecografico con rischio di dolori pelvici o addominali, infezioni ed emorragie, mentre il trasferimento dei gameti si esegue con la laparoscopia con complicanze legate all’anestesia. Il primo rischio per l’embrione è che non arrivi a vita autonoma per mancato trasferimento nelle vie genitali della donna, il mancato attecchimento nell’utero, l’aborto spontaneo o provocato, la maggiore incidenza di morbilità o di mortalità perinatale.
Altri fattori negativi sono dovuti alla micromanipolazione dei gameti. Inoltre, dall’analisi della letteratura si evince che i nati da fecondazione artificiale presentano maggiori malformazioni congenite e una più elevata incidenza di prematurità. A tutti questi problemi si aggiunge l’inadeguata informazione fornita alle coppie che ricorrono alla fecondazione artificiale sui rischi, sugli effetti collaterali, sulle percentuali di successo.
The use of the condom to prevent the transmission of HIV
Authors: Woodall George J. 
Published: December 2020

The aim of this article is to examine a question which has attracted attention from catholic moral theology, namely whether or not there are any circumstances in which the use of the condom may be legitimate as a protection against the spread of Human Immunodeficiency Virus (HIV). The issue is one of pressing pastoral concern as well as of theological interest, not least as far as it concerns spouses one of whom is HIV-positive.
The scientific effectiveness of the condom as a barrier to the spread of the contagion has been addressed elsewhere. The approach here is a moral theological one. Various principles from the tradition of Catholic moral theology are examined (e.g. follow your conscience’s legitimate defense, double effect, the lesser evil) to see whether a positive response to the question may be given.
The second part of the study reviews these same principles and their application to the question. It is argued that spouses often will have a conditional contraceptive intention to prevent the birth of HIV-positive offspring, while more basically it is asked how an act which exposes the uncontaminated spouse to lethal contagion could be construed as an act of authentic love. More broadly, a careful examination of the criteria for advising the lesser evil queries whether a condom is a lesser evil given its unreliability, but also addresses the danger of scandal where a programmatic policy was to be in view. Particular mention is made of the danger of teachers giving such advice, in the light of their vocation and of their professional ethics.
It is concluded that, however understandable it may appear at first sight to recommend the use of the condom to protect against HIV, from the objective standpoint it does not seem to be justifiable.
L’Italia e la “Dichiarazione di Amsterdam” sui diritti dei pazienti
Authors: Bompiani Adriano 
Published: December 2020

In questo lavoro si compie un’analisi della “Dichiarazione sulla promozione dei diritti dei pazienti in Europa”, redatta da un gruppo di esperti sotto gli auspici dell’Ufficio Regionale Europeo dell’Organizzazione Mondiale della Sanità (OMS) nella riunione tenutasi ad Amsterdam (28-30 marzo 1994). L’iniziativa dell’OMS dimostra il crescente interesse degli Stati appartenenti alla Regione Europea a rendere comparabili le norme degli ordinamenti interni concernenti l’accesso e l’utilizzazione da parte dei pazienti dei servizi sanitari, venendo incontro non solamente ad ormai codificati diritti soggettivi della persona umana, ma anche a legittime aspirazioni di miglioramento della qualità e dei rapporti umani nell’assistenza.
Richiamata la lunga serie delle “Dichiarazioni sui diritti dell’uomo” proclamate in diversi documenti internazionali di alto valore morale, e le parallele dichiarazioni riguardanti i “diritti dei pazienti”, l’analisi prosegue delineando i contenuti fondamentali della Dichiarazione di Amsterdam e valutandoli sotto il profilo etico-giuridico.
Si è cercato anche di verificare - brevemente - le analogie intercorrenti fra detta “Dichiarazione di Amsterdam” e la “Carta dei servizi pubblici sanitari”, strumento che intende attuare l’art. 14 del D. Leg. n. 502/1992 (e successive modificazioni ed integrazioni). “Riordino della disciplina in materia sanitaria, a norma dell’art.1 della legge 23 ottobre 1992 n. 421”. L’art. 14, come è noto, ha per oggetto i “Diritti dei cittadini”.
L’applicazione dei principi solennemente dichiarati nei vari documenti esaminati richiede - ormai - una convinta adesione ai postulati dell’etica della cura, interpretati nella tradizione personalista.
Simulation of a PLC-based Car parking system
Authors: Arowolo Oluwole , Adekunle Adefemi A 
Published: December 2020

Parking is an integral component of the transport system. It plays a crucial role in the management of traffic and congestion. On-street parking constitutes one major problem that makes traffic situation chaotic in Nigeria cities. Most roads in Nigeria cities are narrow and lack pedestrian lanes. As we all know, vehicles are used extensively for transportation. It is also important to have easy and effective system for maintaining the vehicles cleanliness as well which necessitate this simulation experiment. The simulation experiment involves the use of LADDER SIMULATOR which allows the Programmable Computer to simulate a Programmable Logic Controller such that Ladder Logic PLC programs can be developed in a simple ‘Drag and Drop’ manner. The system entails the use of several proximity sensors and components like Timers (On-Delay), Counters (Count-Up and Count-Down), LEDs to control the process of cars moving in to the car park with the proper arrangement of cars entering the car park and the exit of the cars. The sensors transfer the outputs to the PLC (programmable logic controller). This type of setup is an Advanced Parking System (APS) which acquire information any about available parking spaces, process the information and then present it to drivers by means of variable message signs using LADSIM simulation technique. The problem of car parking space is enormous which made this work relevant due to insufficient parking spaces and lack of skilled security men. There is a worldwide and global shift towards the automatic car parking system to calculate accurate space available for car and for revenue collection as parking fees. Opinion statistical analysis sample test with KMO and Bartlett's validity test conducted among fifty students revealed a strong positive significant (0.759) in support of the use of automated car parking system in Nigeria. The significant of this new scheme is that it provides an improvement and reliability in the present car parking system and this system can be implemented easily because it is very economical, dependable and cheap. Keywords— Sensors, PLC (programmable logic controller), Car parking; LADSIM; Ladder Logic.
Restrictions of Fundamental Rights in Private Law Relations in the Special Legal Order, with Exceptional Regard to the Specific Circumstances Caused by the Epidemic
Authors: Josipović Tatjana 
Published: December 2020

In this text, the author analyses the intervention measures within the realm of private law relations that were aimed at alleviating or possibly also eliminating the consequences of the serious epidemic. The author presents and analyses the measures introduced in Croatian law to protect private law entities in their private law relations affected by the consequences of the pandemic and the public health measures. The author’s focus is on the impact of these measures on the protection and restriction of fundamental rights in private law relations to establish whether they met all the necessary requirements when allowing for such restrictions of fundamental rights in private law relations. The aim of this paper is to consider the criteria for the assessment and proportionality of these measures which in private law relations restrict people’s fundamental rights while being imposed to protect people’s health in a serious epidemic.
Book Review: Desain Pendidikan Karakter: Konsepsi dan Aplikasinya dalam Lembaga Pendidikan
Authors: Mawikere Marde Christian Stenly 
Published: December 2020

AbstractThe development of education displayed by the rapid growth in science and technology has become a tremendous blessing and benefit for humans and the universe. However, this is not directly proportional to the attitudes, emotions and dispositions of humans who are held hostage in various evil behaviors that harm fellow humans and the universe. This is realized because there is an imbalance between education which only emphasizes wisdom or controls the human brain, but is not accompanied by the formation of spirituality, character building and life experiences that are consistent with what is learned rationally. Awareness of the significance and urgency of character education in Indonesia, this book was born to revive the importance of the world and nuances of education that touch humans as a whole with the concept of moral, moral attitude, and moral behavior in human self. Thus, it will stimulate the world of education to pay attention to human transformation holistically.AbstrakPerkembangan pendidikan yang ditampilkan dengan pertumbuhan pesat dalam ilmu pengetahuan dan teknologi menjadi berkat dan manfaat yang dahsyat bagi manusia dan alam semesta. Akan tetapi hal itu tidak berbanding lurus dengan sikap, emosi dan watak manusia yang tersandera dalam berbagai perilaku kejahatan yang merugikan sesama manusia dan alam semesta. Hal ini disadari oleh karena adanya ketimpangan antara pendidikan yang hanya menekankan hikmat atau mengasa otak manusia, namun tidak dibarengi dengan formasi spiritualitas, pembentukan karakter dan pengalaman hidup yang konsisten dengan apa yang dipelajari secara rasional. Kesadaran akan siginifikansi dan urgensi pendidikan karakter di Indonesia, maka buku ini lahir untuk membangkitkan kembali pentingnya dunia dan nuansa pendidikan yang menyentuh manusia secara utuh dengan konsep moral (moral knonwing), sikap moral (moral felling), dan perilaku moral (moral behavior) dalam diri manusia. Dengan demikian akan merangsang dunia pendidikan untuk memperhatikan transformasi manusia secara holistik.
Договор лизинга по гражданскому праву Республики Узбекистан: особенности правового регулирования
Authors: Бурхонова Лейла 
Published: December 2020

в статье дано правовое определение договора лизинга на основе норм гражданского законодательства Республики Узбекистан, рассмотрены особенности договора финансовой аренды и форма его заключения; проанализированы существенные условия договора лизинга, а так же права и обязанности сторон – лизингодателя, лизингополучателя и продавца. Рассмотрен вопрос о возможных рисках, связанных с объектом лизинга, - риск случайной гибели или тайной порчи арендованного по лизингу имущества; риски, связанные с несостоятельностью продавца или несоответствием предмета лизинга целям его использования. Определены отношения об уступке лизингодателем и лизингополучателем своих прав третьим лицам. Рассмотрена ответственность сторон по договору лизинга. Сформулированы предложения по совершенствованию гражданского законодательства в области регулирования лизинговых отношений.
Improving of legal regulation of trade secrets in the Republic of Uzbekistan
Authors: Raimova Nargiza 
Published: December 2020

Information, exactly confidential information, is the most important component of the development of society in formative modern world. The current civil society is gradually turning from an informed to the information, so we can fearlessly say that the 21th century is considered to be the age of information. Information is a very important and necessary element of any activity of man, society and the state in the public, social-economic and political spheres.
It is noted in the article that the problems related to the fact that the legislation provides a wide range of powers by government organs in the different tests that may affect the interests of sensitive enterprise because unset concrete facets of government intervention in economic activities of enterprises considered painful for entrepreneurs in many countries.
It is concluded that the commercial valuable information is the right of every establishment for keeping secretness of it's industrial, commercial and financial operations, as well as proper documentation. It presents great interest in securing a wide range of problems related to those which information belong to a commercial secrets, as far as possible lifts the curtain for partners, competitors, government organs not to cause adverse effects on its business.
Based on the study of foreign experience and scientific and theoretical views, ways to improve legislation in the field of regulation of confidential information were investigated. Based on the results of the analysis, relevant conclusions were drawn and proposals were developed for the current legislation
Dos baúles oaxaqueños en el Museo Alma Mater de Zaragoza
Authors: Elisa Ramiro Reglero  
Published: December 2020

Resumen
Estudio de dos baúles realizados en Oaxaca (México) en la colección del Museo Alma Mater de Zaragoza. Estos objetos eran muy apreciados por los altos funcionarios del Virreinato y de vuelta a España, formaron parte de su ajuar como objetos exóticos. Estas piezas están recubiertas de marquetería decorada con incisiones rellenas de una pasta negra realizada con las semillas y la savia del zumaque. Los baúles aquí estudiados pertenecieron a Juan Francisco de Montemayor y Córdoba de Cuenca, oidor de la Real Audiencia de Santo Domingo y años más tarde de la de México, a su vuelta a España compró la villa de Alfocea y construyó una iglesia que dotó con diferentes obras de arte traídas de su estancia en el virreinato, entre ellas las dos piezas del Museo Alma Mater.
Palabras clave: Oaxaca, zumaque, Novohispano, Virreinal, Alfocea, Juan Francisco de Montemayor, muebles, baúl.
Abstract

Study of two trunks made in Oaxaca (Mexico) in the collection of the Alma Mater’s Museum of Zaragoza. These objects were highly appreciated by the senior officials of the Virreinato and once in Spain, were integrated in their trousseau as exotic objects. These pieces are covered by marquetry, which is decorated with incisions filled with a black dough made with the zumaque’s seeds and sap. The trunks belonged to Juan Francisco de Montemayor y Córdoba de Cuenca, “oidor” of the Real Audiencia de Santo Domingo and a few years later “oidor” of the Real Audiencia de México, whom once back in Spain bought the villa de Alfocea and built a church endowed with different art pieces from the virreinato, between them the two Museo Alma Mater’s pieces.
Keywords: Oaxaca, zumaque , Novohispano, Virreinal, Alfocea, Juan Francisco de Montemayor, furniture, trunk.
Dynamic matrix control with input saturation constrained
Authors: C. B. Rego Rosana , Josiran da Silva F. , V. S. Costa Marcus 
Published: December 2020

It is proposed, in this paper a dynamic matrix control (DMC) with an anti-windup (AW) based on linear matrix inequalities (LMI). The DMC-AW control is applied in the ballbeam system, in which the main purpose is to control the ball position on a rotating beam. System modeling was performed, which presented two degrees of freedom. For the mechanical system implementation a microcontroller, an ultrasonic sensor, and a servo motor were used. Theproposed control was implemented both numerically with the software MATLAB and with the microcontroller ATmega328Pu. The simulation results validated the eciency of the proposed DMC-AW and showed that the approach improves the response of the system under input saturation.
Data Analysis and Preprocessing Method of Medium Voltage Distribution Network Feeders
Authors: Ramos Bacalhau João Marcus , F. Fardin Jussara 
Published: December 2020

The investment in the energy sector aims to ensure a continuous, reliable, and quality supply of electrical energy imposed by the electricity regulatory agency with maximum economic-financial balance. This paper discusses the challenges of processing data from medium voltage distribution feeders to use on the distribution network planning. The analysis of missing data and outliers is made on the three-phase voltage, current, and power factor of 459 time series of real feeders. Furthermore, it is proposed a method of preprocessing, and missing data imputation using the unbalanced characteristic between phases, interpolation, and the normalized scaled standard weekday curve. The results show that most missing data are three-phase, however, with a significant amount of single and dual-phase loss that can be filled by the proportion between phases. Hence, the challenge is to fill multiple weeks of missing three-phase data, and for that, it is proposed the use of the standard curve for each day of the week. The method proposed is a promising alternative for data imputation in medium-voltage feeders. The technique is tested using real feeder data degraded by its missing data probability function, and compared with the Naïve approach.
Artistiek onderzoek als een integrerende kracht: Een kritische blik op de rol van het masteronderzoek aan de Nederlandse conservatoria
Authors: Craenen Paul 
Published: December 2020

Abstract
In de nasleep van het Bolognaproces hebben de meeste conservatoria in Europa aanzienlijke inspanningen geleverd om onderzoek te integreren in opleidingen op masterniveau. In formele zin lijkt die integratie vandaag de dag een feit, ook al is in de concrete uitwerking het proces nog lang niet voltooid en zijn alle consequenties ervan nog niet uitgekristalliseerd. Toch verwacht ik dat de aandacht in de komende jaren geleidelijk zal verschuiven van de integratie van onderzoek als dusdanig naar de mogelijkheden om artistiek onderzoek aan te wenden als een kracht die binnen het curriculum zelf integrerend werkt. Om die verschuiving beter te begrijpen, moeten we onze focus richten op de veranderende perceptie van de rol en de mogelijkheden van artistiek onderzoek in kunstopleidingen. In dit artikel sta ik stil bij benaderingen van onderzoek aan Nederlandse conservatoria, waarbij ik me in het bijzonder laat inspireren door actuele curriculumhervormingen aan het Koninklijk Conservatorium Den Haag, waar ik als lector (onderzoeksprofessor) ben aangesteld.
Wanneer politiek onvermijdelijk wordt: Van gemeenschapskunst naar gemene kunst
Authors: Otte Hanka , Gielen Pascal 
Published: December 2020

Abstract
In dit artikel belichten Hanka Otte en Pascal Gielen het onderscheid tussen gemeenschapskunst en gemene kunst, beter bekend als community art en commoning art. Hun stelling is dat gemeenschapskunst, zoals sociaal-artistieke projecten, deels gesubsidieerd worden omdat ze de maatschappelijke status quo bevestigen. Gemene kunst zet daarentegen niet alleen in op het sociale, maar ook op het politieke, en valt daarom vaak tussen de mazen van het vigerende cultuurbeleid. Dat beleid vermijdt volgens de auteurs het politieke, doordat het kunst enkel van publieke waarde acht wanneer het door zoveel mogelijk individuen wordt geconsumeerd. De persoonlijke smaak of persoonlijke werking van kunst staat voorop in het cultuurbeleid, waardoor er wordt voorbijgegaan aan de mogelijkheden die kunst aan een gemeenschap biedt. De auteurs pleiten daarom voor een gemeen cultuurbeleid dat enkel kaders geeft en artistieke ontwikkelingen autonoom hun gang laat gaan.