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ArticlesPeer ReviewedFull Text
Orphan medicinal products in Europe and United States to cover needs of patients with rare diseases: an increased common effort is to be foreseen
Author / Creator:Giannuzzi, Viviana ; Conte, Rosa ; Landi, Annalisa ; Ottomano, Serena Antonella ; Bonifazi, Donato ; Baiardi, Paola ; Bonifazi, Fedele ; Ceci, Adriana
Publisher:England: BioMed Central
Journal title:Orphanet journal of rare diseases, 2017-04, Vol.12 (1), p.64-64, Article 64
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Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical trials in and outside the European Union: the challenging experience of the DEEP project
Author / Creator:Giannuzzi, Viviana ; Felisi, Mariagrazia ; Bonifazi, Donato ; Devlieger, Hugo ; Papanikolaou, George ; Ragab, Lamis ; Fattoum, Slaheddine ; Tempesta, Bianca ; Reggiardo, Giorgio ; Ceci, Adriana
Publisher:England: BioMed Central
Journal title:BMC medical ethics, 2021-04, Vol.22 (1), p.49-49, Article 49
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Optimizing the World Health Organization algorithm for HIV vertical transmission risk assessment by adding maternal self-reported antiretroviral therapy adherence
Author / Creator:Fernández-Luis, Sheila ; Lain, Maria Grazia ; Serna-Pascual, Miquel ; Domínguez-Rodríguez, Sara ; Kuhn, Louise ; Liberty, Afaaf ; Barnabas, Shaun ; Lopez-Varela, Elisa ; Otwombe, Kennedy ; Danaviah, Siva ; Nastouli, Eleni ; Palma, Paolo ; Cotugno, Nicola ; Spyer, Moira ; Giannuzzi, Viviana ; Giaquinto, Carlo ; Violari, Avy ; Cotton, Mark F. ; Nhampossa, Tacilta ; Klein, Nigel ; Ramsagar, Nastassja ; van Rensburg, Anita Janse ; Behuhuma, Osee ; Vaz, Paula ; Maiga, Almoustapha Issiaka ; Oletto, Andrea ; Naniche, Denise ; Rossi, Paolo ; Rojo, Pablo ; Tagarro, Alfredo ; Faggion, Silvia ; Pena, Daniel Gomez ; Rossi, Inger Lindfors ; James, William ; Nardone, Alessandra ; Zangari, Paola ; Paganin, Carla ; Spyer, Moira J ; Marcelin, Anne-Genevieve ; Calvez, Vincent ; Dominguez, Sara ; Munoz, Maria Angeles ; Foster, Caroline ; Pahwa, Savita ; De Rossi, Anita ; Cotton, Mark ; Persaud, Deborah ; De Boer, Rob J. ; Schroeter, Juliane ; Ceci, Adriana ; Luzuriaga, Kathrine ; Chomont, Nicolas ; Yates, Andrew ; López-Varela, Elisa ; Nhamposssa, Tacilta ; Levy, Ofer ; Goulder, Philip ; Lichterfeld, Mathias ; Peay, Holly ; Sylla, Pr Mariam ; Maiga, Almoustapha
Publisher:England: BioMed Central Ltd
Journal title:BMC public health, 2022-07, Vol.22 (1), p.1312-1312, Article 1312
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PedCRIN tool for the biosamples management in pediatric clinical trials
Author / Creator:Giannuzzi, Viviana ; Ruggieri, Lucia ; Conte, Rosa ; Manfredi, Cristina ; Felisi, Mariagrazia ; Kubiak, Christine ; Matei, Mihaela ; Malik, Salma ; Demotes, Jacques ; Ceci, Adriana ; Bonifazi, Donato
Publisher:United States: John Wiley & Sons, Inc
Journal title:Clinical and translational science, 2023-05, Vol.16 (5), p.797-809
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Erratum to: Review and evaluation of the methodological quality of the existing guidelines and recommendations for inherited neurometabolic disorders
Author / Creator:Cassis, Linda ; Cortès-Saladelafont, Elisenda ; Molero-Luis, Marta ; Yubero, Delia ; González, Maria Julieta ; Ormazábal, Aida ; Fons, Carme ; Jou, Cristina ; Sierra, Cristina ; Ponce, Esperanza Castejon ; Ramos, Federico ; Armstrong, Judith ; O’Callaghan, M. Mar ; Casado, Mercedes ; Montero, Raquel ; Meavilla-Olivas, Silvia ; Artuch, Rafael ; Barić, Ivo ; Bartoloni, Franco ; Bellettato, Cinzia Maria ; Bonifazi, Fedele ; Ceci, Adriana ; Cvitanović-Šojat, Ljerka ; Dali, Christine I. ; D’Avanzo, Francesca ; Fumic, Ksenija ; Giannuzzi, Viviana ; Lampe, Christina ; Scarpa, Maurizio ; Garcia-Cazorla, Ángels
Publisher:England: BioMed Central
Journal title:Orphanet journal of rare diseases, 2016-11, Vol.11 (1), p.147-147, Article 147
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Informed consent and assent guide for paediatric clinical trials in Europe
Author / Creator:Lepola, Pirkko ; Kindred, Maxine ; Giannuzzi, Viviana ; Glosli, Heidi ; Dehlinger-Kremer, Martine ; Dalrymple, Harris ; Neubauer, David ; Boylan, Geraldine B ; Conway, Jean ; Dewhurst, Jo ; Hoffman, Diane
Publisher:England: BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health
Journal title:Archives of disease in childhood, 2022-06, Vol.107 (6), p.582-590
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Ethical, Legal and Regulatory Issues of Paediatric Translational Research. Call for an Adequate Model of Governance
Author / Creator:Altavilla, Annagrazia ; Giannuzzi, Viviana ; Lupo, Mariangela ; Bonifazi, Donato ; Ceci, Adriana
Publisher:Leiden | Boston: Brill | Nijhoff
Journal title:European journal of health law, 2020-05, Vol.27 (3), p.213-231
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ArticlesPeer ReviewedFull Text
Clinical Trial Application in Europe: What Will Change with the New Regulation?
Author / Creator:Giannuzzi, Viviana ; Altavilla, Annagrazia ; Ruggieri, Lucia ; Ceci, Adriana
Publisher:Dordrecht: Springer Netherlands
Journal title:Science and engineering ethics, 2016-04, Vol.22 (2), p.451-466
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ArticlesPeer ReviewedFull Text
The “A” of FAIR – As Open as Possible, as Closed as Necessary
Author / Creator:Landi, Annalisa ; Thompson, Mark ; Giannuzzi, Viviana ; Bonifazi, Fedele ; Labastida, Ignasi ; da Silva Santos, Luiz Olavo Bonino ; Roos, Marco
Publisher:One Rogers Street, Cambridge, MA 02142-1209, USA: MIT Press
Journal title:Data intelligence, 2020-01, Vol.2 (1-2), p.47-55
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Effective early antiretroviral therapy in perinatal-HIV infection reduces subsequent plasma inflammatory profile
Author / Creator:Nguyen, Athena N. ; Plotkin, Alec L. ; Odumade, Oludare A. ; De Armas, Lesley ; Pahwa, Savita ; Morrocchi, Elena ; Cotugno, Nicola ; Rossi, Paolo ; Foster, Caroline ; Domínguez-Rodríguez, Sara ; Tagarro, Alfredo ; Syphurs, Caitlin ; Diray-Arce, Joann ; Fatou, Benoit ; Ozonoff, Al ; Levy, Ofer ; Palma, Paolo ; Smolen, Kinga K.
Publisher:New York: Nature Publishing Group US
Journal title:Pediatric research, 2023-11, Vol.94 (5), p.1667-1674
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ArticlesPeer ReviewedFull Text
Sharing Data and Transferring Samples Within Pediatric Clinical Studies: How to Overcome Challenges and Make Them a Science Opportunity
Author / Creator:Landi, Annalisa ; D’Ambrosio, Federica ; Faggion, Silvia ; Rocchi, Francesca ; Paganin, Carla ; Lain, Maria Grazia ; Ceci, Adriana ; Giannuzzi, Viviana
Publisher:Switzerland: MDPI AG
Journal title:Healthcare (Basel), 2024-12, Vol.12 (23), p.2473
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ArticlesPeer ReviewedFull Text
Machine Learning Systems Applied to Health Data and System
Author / Creator:Bonifazi, Fedele ; Volpe, Elisabetta ; Digregorio, Giuseppe ; Giannuzzi, Viviana ; Ceci, Adriana
Publisher:Leiden | Boston: Brill | Nijhoff
Journal title:European journal of health law, 2020-05, Vol.27 (3), p.242-258
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ArticlesPeer ReviewedFull Text
Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs
Author / Creator:Giannuzzi, Viviana ; Landi, Annalisa ; Bosone, Enrico ; Giannuzzi, Floriana ; Nicotri, Stefano ; Torrent-Farnell, Josep ; Bonifazi, Fedele ; Felisi, Mariagrazia ; Bonifazi, Donato ; Ceci, Adriana
Publisher:England: BMJ Publishing Group LTD
Journal title:BMJ open, 2017-09, Vol.7 (9), p.e017358-e017358
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The ethical framework for performing research with rare inherited neurometabolic disease patients
Author / Creator:Giannuzzi, Viviana ; Devlieger, Hugo ; Margari, Lucia ; Odlind, Viveca Lena ; Ragab, Lamis ; Bellettato, Cinzia Maria ; D’Avanzo, Francesca ; Lampe, Christina ; Cassis, Linda ; Cortès-Saladelafont, Elisenda ; Cazorla, Ángels Garcia ; Barić, Ivo ; Cvitanović-Šojat, Ljerka ; Fumić, Ksenija ; Dali, Christine I ; Bartoloni, Franco ; Bonifazi, Fedele ; Scarpa, Maurizio ; Ceci, Adriana
Publisher:Berlin/Heidelberg: Springer Berlin Heidelberg
Journal title:European journal of pediatrics, 2017-03, Vol.176 (3), p.395-405
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The CLOSED trial; CLOnidine compared with midazolam for SEDation of paediatric patients in the intensive care unit: study protocol for a multicentre randomised controlled trial
Author / Creator:Neubert, Antje ; Baarslag, Manuel Alberto ; Dijk, Monique van ; Rosmalen, Joost van ; Standing, Joseph F ; Sheng, Yucheng ; Rascher, Wolfgang ; Roberts, Deborah ; Winslade, Jackie ; Rawcliffe, Louise ; Hanning, Sara M ; Metsvaht, Tuuli ; Giannuzzi, Viviana ; Larsson, Peter ; Pokorná, Pavla ; Simonetti, Alessandra ; Tibboel, Dick
Publisher:England: BMJ Publishing Group LTD
Journal title:BMJ open, 2017-06, Vol.7 (6), p.e016031
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ArticlesPeer ReviewedFull Text
Review and evaluation of the methodological quality of the existing guidelines and recommendations for inherited neurometabolic disorders
Author / Creator:Cassis, Linda ; Cortès-Saladelafont, Elisenda ; Molero-Luis, Marta ; Yubero, Delia ; González, Maria Julieta ; Ormazábal, Aida ; Fons, Carme ; Jou, Cristina ; Sierra, Cristina ; Castejon Ponce, Esperanza ; Ramos, Federico ; Armstrong, Judith ; O’Callaghan, M. Mar ; Casado, Mercedes ; Montero, Raquel ; Meavilla-Olivas, Silvia ; Artuch, Rafael ; Barić, Ivo ; Bartoloni, Franco ; Bellettato, Cinzia Maria ; Bonifazi, Fedele ; Ceci, Adriana ; Cvitanović-Šojat, Ljerka ; Dali, Christine I ; D’Avanzo, Francesca ; Fumic, Ksenija ; Giannuzzi, Viviana ; Lampe, Christina ; Scarpa, Maurizio ; Garcia-Cazorla, Ángels
Publisher:England: BioMed Central Ltd
Journal title:Orphanet journal of rare diseases, 2015-12, Vol.10 (1), p.164-164, Article 164
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Early inflammation as a footprint of increased mortality risk in infants living with HIV from three African countries
Author / Creator:Morrocchi, Elena ; Pascucci, Giuseppe R. ; Cotugno, Nicola ; Pighi, Chiara ; Dominguez-Rodriguez, Sara ; Petrara, Maria Raffaella ; Tagarro, Alfredo ; Kuhn, Louise ; Cotton, Mark F. ; Otwombe, Kennedy ; Lain, Maria G. ; Vaz, Paula ; Barnabas, Shaun L. ; Spyer, Moira J. ; Lopez, Elisa ; Fernández-Luis, Sheila ; Nhampossa, Tacilta ; Maiga, Almoustapha I. ; Dolo, Oumar ; De Rossi, Anita ; Rojo, Pablo ; Giaquinto, Carlo ; Lichterfeld, Mathias ; Violari, Avy ; Smit, Theresa ; Behuhuma, Osee ; Klein, Nigel ; De Armas, Lesley ; Pahwa, Savita ; Rossi, Paolo ; Palma, Paolo
Publisher:London: Nature Publishing Group UK
Journal title:Scientific reports, 2024-10, Vol.14 (1), p.25792-11, Article 25792
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Orphan medicinal products in Europe and United States to cover needs of patients with rare diseases: an increased common effort is to be foreseen

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Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical trials in and outside the European Union: the challenging experience of the DEEP project

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Optimizing the World Health Organization algorithm for HIV vertical transmission risk assessment by adding maternal self-reported antiretroviral therapy adherence

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PedCRIN tool for the biosamples management in pediatric clinical trials

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Erratum to: Review and evaluation of the methodological quality of the existing guidelines and recommendations for inherited neurometabolic disorders

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Informed consent and assent guide for paediatric clinical trials in Europe

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Ethical, Legal and Regulatory Issues of Paediatric Translational Research. Call for an Adequate Model of Governance

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Clinical Trial Application in Europe: What Will Change with the New Regulation?

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The “A” of FAIR – As Open as Possible, as Closed as Necessary

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Effective early antiretroviral therapy in perinatal-HIV infection reduces subsequent plasma inflammatory profile

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Sharing Data and Transferring Samples Within Pediatric Clinical Studies: How to Overcome Challenges and Make Them a Science Opportunity

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Machine Learning Systems Applied to Health Data and System

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Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs

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The ethical framework for performing research with rare inherited neurometabolic disease patients

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The CLOSED trial; CLOnidine compared with midazolam for SEDation of paediatric patients in the intensive care unit: study protocol for a multicentre randomised controlled trial

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Review and evaluation of the methodological quality of the existing guidelines and recommendations for inherited neurometabolic disorders

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Early inflammation as a footprint of increased mortality risk in infants living with HIV from three African countries

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