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Background Biological drugs have improved the management of immune-mediated inflammatory diseases (IMIDs) despite being associated with important safety issues such as immunogenicity, infections, and malignancies in real-world settings. Objective The aim of this study was to explore the potential of a large Italian multi-database distributed network for use in the postmarketing surveillance of biological drugs, including biosimilars, in patients with IMID. Methods A retrospective cohort study was conducted using 13 Italian regional claims databases during 2010–2019. A tailor-made R-based tool developed for distributed analysis of claims data using a study-specific common data model was customized for this study. We measured the yearly prevalence of biological drug users and the frequency of switches between originator and biosimilars for infliximab, etanercept, and adalimumab separately and stratified them by calendar year and region. We then calculated the cumulative number of users and person-years (PYs) of exposure to individual biological drugs approved for IMIDs. For a number of safety outcomes (e.g., severe acute respiratory syndrome coronavirus 2 [SARS-COV-2] infection), we conducted a sample power calculation to estimate the PYs of exposure required to investigate their association with individual biological drugs approved for IMIDs, considering different strengths of association. Results From a total underlying population of almost 50 million inhabitants from 13 Italian regions, we identified 143,602 (0.3%) biological drug users, with a cumulative exposure of 507,745 PYs during the entire follow-up. The mean age ± standard deviation of biological drug users was 49.3 ± 16.3, with a female-to-male ratio of 1.2. The age-adjusted yearly prevalence of biological drug users increased threefold from 0.7 per 1000 in 2010 to 2.1 per 1000 in 2019. Overall, we identified 40,996 users of biosimilars of tumor necrosis factor (TNF)-α inhibitors (i.e., etanercept, adalimumab, and infliximab) in the years 2015–2019. Of these, 46% (N = 18,845) switched at any time between originator and biosimilars or vice versa. To investigate a moderate association (incidence rate ratio 2) between biological drugs approved for IMIDs and safety events of interest, such as optic neuritis (lowest background incidence rate 10.4/100,000 PYs) or severe infection (highest background incidence rate 4312/100,000 PYs), a total of 43,311 PYs and 104 PYs of exposure to individual biological drugs, respectively, would be required. As such, using this network, of 15 individual biological drugs approved for IMIDs, the association with those adverse events could be investigated for four (27%) and 14 (93%), respectively. Conclusion The VALORE project multi-database network has access to data on more than 140,000 biological drug users (and > 0.5 million PYs) from 13 Italian regions during the years 2010–2019, which will be further expanded with the inclusion of data from other regions and more recent calendar years. Overall, the cumulated amount of person-time of exposure to biological drugs approved for IMIDs provides enough statistical power to investigate weak/moderate associations of almost all individual compounds and the most relevant safety outcomes. Moreover, this network may offer the opportunity to investigate the interchangeability of originator and biosimilars of several TNFα inhibitors in different therapeutic areas in real-world settings. Supplementary Information The online version contains supplementary material available at 10.1007/s40259-021-00498-3.

The archaeological area of Pompeii is known throughout the world for having been submerged for sixteen centuries and for still being the subject of excavation works to highlight it, as well as to ensure that rain and rainwater can conceal or damage what has emerged from the subsoil again. Pozzuoli and the entire Flegrean area since ancient times have a constantly evolving geographical outline. The phenomenon of bradyseism mainly affects the relationship between land and sea. The raising and lowering of the water and the consequent human intervention over the centuries lead to focus the attention on the current actions to safeguard the several testimonies of the past exposed to these risks. Instead, more recent is the casual discovery of traces of a prehistoric hut settlement, on the suburbs of the ancient city of Nola, during the excavation phase for the foundations of a shopping centre. The cavities identified in the preliminary geological investigation phase, have made possible to obtain the shape and size of some huts and the connection spaces between them. Again, the burial of the entire village would have been caused by water. The aim of the contribution is to investigate these three cases, in the Neapolitan metropolitan area, where large parts of ancient architectural sites had been obliterated due to or with the help of rainwater, as for Pompeii. The conditions that generated the burial of the three sites will be compared with those that the discovery has produced, highlighting the problems and critical issues as well as the solutions adopted to prevent water from damaging the undisclosed assets. The issue of water governance in archaeological sites is therefore considered crucial to ensure the protection and to contain the degradation of the assets highlighted and the solutions adopted up to now will be presented.

Architecture is not just a container or a place in which it is possible to perform functions; architecture is everything that surrounds us, it is the space in which we immerse ourselves and with which we communicate. It is not the shape of the project that first influences our perception of space, whether it is open or closed, but the colours and materials that characterise and define it, making it harmonious and pleasant or, in the opposite way, hostile and inhospitable. In 1981 the UNI 8289:1981 "Construction. Needs of the final user. Classification" defined the term "well-being" as "the set of conditions relating to states of the building system appropriate to life, to health, to the performance of the users' activities", how do colours and materials contribute to the conditions of well-being? Which are the targets that can be achieved through the wise use of these elements? The aim of this work is to analyse the application of colours and materials in famous architectures in order to determinate the impact at urban and human level, how they dialogue with the context and how they dialogue with human perceptions, identifying three directions of intervention: colour and materials as anthropomorphic relation, colours and materials as pictorial support, colour and materials as function.

Demolizione o ristrutturazione? La scelta può essere un compito complesso, dovendo considerare l'iniziale condizioni e prevedere il futuro Scenari. Anche se la rigenerazione degli organismi edilizi potenziale è molteplici, la tecnologia e sistema di costruzione può svolgere un ruolo decisivo la determinazione della fine del loro ciclo di vita, a causa di i costi di ristrutturazione e strutturale l'adattamento all'energia. Oltre all'economia valutazioni, politiche, storiche e sociali motivazioni sono coinvolte, o in alcuni casi sono mettere al primo posto. Pertanto, la fase finale di un la vita dell'edificio non è sempre indiscutibilmente determinabile; Esistono due scenari possibili che sono spesso delineati in una condizione di inefficienza funzionale: Demolire o Ristrutturare. Attraverso l'applicazione di due approcci, il progetto di demolizione e progetto di ristrutturazione Per stesso caso di studio a Pozzuoli, è possibile evidenziare le potenzialità, i vantaggi e le conseguenze dei due diversi modi di Azione.

L’Ayuntamiento de Madrid, fin dal 2016, ha stanziato dei finanziamenti per la conversione dei tetti verdi, indirizzando così gli interventi di manutenzione e progettazione delle coperture verso gli obiettivi di sostenibilità ambientale ed incentivando economicamente la creazione di tetti giardino con un nuovo uso green delle superfici di copertura. Le idee qui sinteticamente presentate si riferiscono ad una tesi sperimentale, sviluppata in collaborazione tra l’Universidad Politécnica de Madrid, con il prof. José Ballesteros, e l’Università Federico II di Napoli, con la prof. Marina Fumo, e si riferiscono ad un caso studio concreto che ne evidenzia l’applicabilità ed il potenziale su un recente edificio a torre per uffici di buona qualità architettonica. Il progetto architettonico, declinato sulla scala urbana, ha bisogno dell’interazione tra questa, l’ambiente naturale e l’oggetto stesso. Questo approccio integrato fa sì che tutti i parametri del progetto vengano considerati in ogni sua fase traducendosi in una ottimizzazione che sarebbe complessa da affrontare con i classici strumenti progettuali, e mette in evidenza le potenzialità della modellazione parametrica attraverso un approccio matematico al progetto, con analisi e simulazioni in tempo reale che portano vantaggi immediati in termini di velocità ed efficienza. L’intervento proposto, parte di un più ampio progetto, riguarda lo sviluppo di una struttura verde in bamboo posta sul terrazzo di copertura di un grattacielo di Madrid. L’idea nasce da un’analisi sul campo, svolta durante un periodo di ricerca a Madrid, dalla quale è emersa l’importanza delle terrazze di copertura usate, sia nel privato che nel pubblico, come luoghi nei quali poter godere di spazi verdi. Dalla razionalizzazione della forma complessa, al form finding, alle istallazioni reattive, tutto si può sintetizzare nella volontà di progettare al di là della logica della standardizzazione per ottimizzare e differenziare gli elementi costruttivi.

Across history, continuous socioeconomic changes have largely affected the evolution of the defensive systems of fortified cities, leaving them fragmented today. With a focus of such key elements as city walls, gates, moats and towers of fortified cities, this research is aimed to investigate how to manage the existing defensive systems in a way to simultaneously preserve their historic and cultural values and generate sociocultural benefits to meet contemporary needs. Based on literature review and using Xi’an (China) and Naples (Italy) as cases, the research first briefly looks into the evolution and the status quo of the defensive systems of the two cities. Then, it examines how the defensive systems are protected both at legislative and technical levels, referring to local, national and international provisions and practices. Finally, the research casts light on the value-adding of the defensive systems, focusing on creative interpretation, utilization and community participation. The research also tries to draw lessons from the existing protection and value-adding mechanisms. It is concluded that multilevel legislative system, knowledge sharing, and a people-centered, community-led value-adding approach are critical to a sustainable management of defensive systems of fortified cities.

Gli edifici pubblici destinati all’educazione scolastica dovrebbero costituire un obiettivo prioritario nelle strategie di sviluppo nazionale, regionale e locale, ma anche in passato è accaduto che venissero varate leggi inerenti nuovi metodi di insegnamento e di formazione senza considerare che alle nuove modalità didattiche e alle nuove attività dovessero corrispondere nuovi differenti spazi. Se la più evoluta pedagogia ci annuncia da molti decenni che l’istruzione e la formazione non avvengono solo ed esclusivamente tramite lezioni frontali ex catedra, ciò dovrebbe significare che gli spazi scolastici dovrebbero essere strutturalmente innovati e subire una reale metamorfosi funzionale. L’edilizia scolastica dovrebbe essere al centro delle azioni politiche strategiche nazionali se non può esserci polis senza la scuola come veicolo di trasmissione culturale tra generazioni, nella consapevole partecipazione delle nuove generazioni al processo di cambiamento della società urbana. Le nostre scuole pubbliche devono trasformarsi in Civic Center, come ci indica chiaramente il Decreto Ministeriale del 2013, appropriandosi del ruolo associativo ed identitario che nel nostro cattolico Paese è stato troppo a lungo delegato ai soli enti religiosi che hanno assolto questa carenza dell’istituzione laica, con lodevole spirito di servizio pubblico. Scuole come ‘incubatori civici’, ovvero scuole educanti ovvero edifici scolastici educanti. Come realizzare questo obiettivo se non attraverso la percezione di un progetto rispettoso delle risorse ambientali?

Over fourteen thousand and up to twelve thousand years ago, due to a serious food supply crisis, homo sapiens implemented a new model of survival based on agriculture, starting to sow, man became more sedentary. Nowadays, we rely on a new adaptation process to bring us closer to farm and craft activities, reviving small scale settlement systems. Knowing the peculiar features of a natural or urban artificial landscape and identifying in it with a feeling of belonging, as a place bearing culture and traditions, has always linked the human beings to their territory, to a geographical context. In the current global environmental crisis, the rural landscape is once again considered an asset for man, especially for its cultural and spiritual values, as a fundamental scenario to build individual and collective life. Therefore, for every human community, the whole landscape becomes a place where to reside, live, build, produce, sell, pass on, it participates in the whole cycle.

The most appropriate use of materials and construction techniques has characterized whole historical periods and defined specific physical and geographical human habitat. Re­thinking deeply on architectural features of the historical buildings and the most appropriate technologies, in order to interpret by design each need of transformation, is the precondition to spread awareness of the intimate connection between local resources and "Technological Footprint" , which is the result of all structural and social processes producing the built historical and layered context. This approach should guide all project actions of retrofit, rehabilitation and restoration. Especially in the case of minor historical centers, having important historical, archaeological and landscape quality, the design action taken with ancient materials in order to meet modern needs, can enhance the particular characteristics, limiting the critical issues and improving performance. This paper illustrates teaching methodologies and educational experience carried out by students of the Course: "Project of building rehabilitation", together with Erasmus students of Polytechnic University of Madrid and Polytechnic University din Timisoara, as part of the project actions for preservation of Campi Flegrei, conducted by the Department DICEA of the University of Naples “Federico II”. The project experience on field, outside the university classrooms, in an international comparison (group work with colleagues from other universities and nationality) is a major strength of this experimental teaching. In relation to the specific issues dealt, the didactic methodology combined/alternated front lessons, direct and participatory debate with students and lab activities. The lab phase allowed a close examination of the issues faced, applying them to a real case study: the identity recovery and urban regeneration of the rural village of Cappella in Bacoli (NA). The workshop was divided into three phases: 1) Specialized Seminars, which provided the basic technical knowledge; front lessons gave the necessary knowledge mainly concerning logics at the base of integrated national and international strategies about rehabilitation and restoration. 2) Design on field, during which the students, divided into 17 groups, were involved in the analysis of architectural (construction features, identity of architectural elements, …) and social issue (population needs and local tradition). 3) Dissemination, which is the verify phase during which the groups submit and describe to local administrators and associations the design proposals. The didactic approach of the Lab activities is linked with the key competences reported in the European recommendations, linked not only with knowledge, but also with being able to be and do. The methods, such as drawing from life, interview, technological relief in sight and instrumental analysis, led the groups to develop project proposals presented in the final day. “Honour the past, but welcome the future” (E.E. Cummings)

Gli spazi pubblici, che rappresentano importanti elementi all'interno del paesaggio storico urbano, spesso hanno funzioni monotone e si presentano come non-luoghi privi di vita. Considerando i processi dinamici urbani attuali e i possibili processi di degrado del paesaggio nelle aree storiche a seguito della urbanizzazione e della globalizzazione, il contributo sostiene che la diversità incrementa la vitalità degli spazi pubblici nelle aree storico-urbane, le quali richiedono una innovativa rigenerazione spaziale. In tal modo si potrebbe coadiuvare la diversità culturale e allo stesso tempo arricchire lo stesso HUL. Con questo obiettivo, il contributo dapprima fa una disamina sugli strumenti internazionali in relazione alla diversità e al paesaggio urbano, focalizzando l'attenzione sulla loro applicabilità nel contesto socio-culturale e in quello del paesaggio urbano. Su questa base, si analizzano i significati e i problemi degli spazi pubblici in relazione all'HUL e si evidenzia il ruolo della diversità come soluzione reale sia per il livello socio-culturale, sia per quello relativo al paesaggio. Infine, per conformare gli spazi pubblici della diversità e in senso dinamico, il contributo propone una metodologia di rigenerazione degli spazi cioè HUL-guided, diversity-based a innovation-driven. Per meglio illustrare le questioni riguardanti diversità e innovazione, saranno argomentate delle good practices, di Milano, Parigi e Barcellona.

International audience

International audience

The implementation of the principles and methods towards a Sustainable Construction varies across different countries in Europe. In some countries, the sustainability of the construction sector has been effectively taken into consideration over the last years, while in other its implementation is at an initial stage. Many reasons may be pointed out for this situation. Different countries have different understandings of what is entailed in Sustainable Construction. Different cultural and educational backgrounds, along with different priorities in each country, are also contributing for the lack of a common European approach. General frameworks, aiming to cover every aspect of Sustainable Construction and to provide a consistent and integrated approach, such as Agenda 21 for Sustainable Construction, gave a major advance in the search for a common approach for the construction sector. However, general agreed methodologies and tools to make this common approach operational are still missing., European Science Foundation - COST Action C25

An ultra-high-temperature ZrB2-SiC ceramic nose cone was tested in an arcjet plasma torch facility for 10 min at temperatures above 2000°C. The nose cone model was obtained from a hot-pressed billet via electrical discharge machining. The relevant portions of the models directly exposed to the hot stream were analyzed by scanning electron microscopy and energy-dispersive spectroscopy. The post test cross sectioning of the model showed a non negligible surface recession on the tip of the nose. Nonetheless, the material exhibited a promising potential to withstand severe reentry conditions with temperatures exceeding 2000°C in a single-use application. Spectral directional emissivity evaluations were performed on the fly during the test by means of thermography coupled with dual-color pyrometer. The numerical calculations, which simulated the chemical nonequilibrium flow around the model assuming a low catalytic surface behavior, are in good accordance with the experimental results