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1. Long-term impact of COVID-19 pandemic on ART-mediated births in Lombardy, Italy

Author

Esposito, G, Somigliana, E, Vigano, P, Filippi, F, Franchi, M, Corrao, G, Parazzini, F, Esposito G., Somigliana E., Vigano P., Filippi F., Franchi M., Corrao G., Parazzini F., Esposito, G, Somigliana, E, Vigano, P, Filippi, F, Franchi, M, Corrao, G, Parazzini, F, Esposito G., Somigliana E., Vigano P., Filippi F., Franchi M., Corrao G., and Parazzini F.

Abstract

ART-mediated births declined between December 2020 and February 2021, followed by a rapid recovery to 2019 levels. In 2022, ART-mediated births exceeded pre-pandemic rates.

Published
2024

2. The neglected emotional drawbacks of the prioritization of embryos to transfer

Author

Spinelli, G., Somigliana, E., Micci, L. G., Vigano, P., Facchin, Federica, Gramegna, M. G., Facchin F. (ORCID:0000-0001-8944-1440), Spinelli, G., Somigliana, E., Micci, L. G., Vigano, P., Facchin, Federica, Gramegna, M. G., and Facchin F. (ORCID:0000-0001-8944-1440)

Abstract

In recent years, increasing efforts have been made to develop advanced techniques that could predict the potential of implantation of each single embryo and prioritize the transfer of those at higher chance. The most promising include non-invasive preimplantation genetic testing for aneuploidy and artificial intelligence-based algorithms using time lapse images. The psychological effect of these add-ons is neglected. One could speculate that embarking on another transfer after one or more failures with the prospect of receiving an embryo of lower potential may be distressing for the couple. In addition, the symbolic and mental representation of an embryo with ‘lower capacity to implant’ is currently unknown but could affect couples’ choices and wellbeing. These emotional responses may also undermine adherence to the programme and, ultimately, its real effectiveness. Future trials aimed at evaluating the validity of prioritization procedures must also consider the emotional burden on the couples.

Published
2023

3. Effects of the early phase of the COVID-19 pandemic on natural and ART-mediated birth rates in Lombardy Region, Northern Italy

Author

Somigliana, E, Esposito, G, Vigano, P, Franchi, M, Corrao, G, Parazzini, F, Somigliana E., Esposito G., Vigano P., Franchi M., Corrao G., Parazzini F., Somigliana, E, Esposito, G, Vigano, P, Franchi, M, Corrao, G, Parazzini, F, Somigliana E., Esposito G., Vigano P., Franchi M., Corrao G., and Parazzini F.

Abstract

Research question: What effects did the early phase of the COVID-19 pandemic have on natural and assisted reproductive technology (ART)-mediated birth rates? Design: Regional registries were consulted with permission from the Health Authorities of Lombardy Region, Northern Italy, an area particularly affected by the early phase of the epidemic. Deliveries occurring in the area between 1 January 2019 and 31 December 2020 from women beneficiaries of the National Health System and resident in Lombardy were identified. Comparisons mainly focused on December 2020, when women who conceived after 8 March (the start of the stringent lockdown imposed by the authorities) were expected to deliver. Results: When comparing the periods January to November in 2019 and 2020, a 5.1% reduction of monthly general birth rate (from 5732 in 2019 to 5438 in 2020) was observed. The contribution of ART births was similar in 2019 and 2020, being 4.4% and 4.5%, respectively. In December 2020, a notable drop in natural (–17.8%), ART-mediated (–86.6%) and overall (–21.0%) births was observed compared with December 2019. After adjusting for the expected 5.1% reduction, the inferred effect of the COVID-19 crisis corresponded to a 16.7% reduction in birth rate, of which 76% was related to natural (707 births) and 24% to ART (218 births) conceptions. Conclusions: This is the first study providing population-based evidence on the effects of COVID-19 and its related stringent restrictions on birth rates. The birth rate was dramatically reduced following the critical period, and the closure of ART centres played only a marginal role (24%) in the overall detrimental effect.

Published
2021

4. High rates of sustained virological response despite premature discontinuation of directly acting antivirals in HCV-infected patients treated in a real-life setting

Author

Fabbiani, M, Lombardi, A, Colaneri, M, Del Poggio, P, Perini, P, D'Ambrosio, R, Degasperi, E, Dibenedetto, C, Giorgini, A, Pasulo, L, Maggiolo, F, Castelli, F, Brambilla, P, Spinelli, O, Re, T, Lleo, A, Rumi, M, Uberti-Foppa, C, Soria, A, Aghemo, A, Lampertico, P, Baiguera, C, Schiavini, M, Fagiuoli, S, Bruno, R, Borghi, M, Soffredini, R, Perbellini, R, Gori, A, Ferroni, V, Colpani, M, Manini, M, Cologni, G, Lazzaroni, S, Vinci, M, De Nicola, S, Mazzarelli, C, Angelini Zucchetti, T, Picciotto, V, Puoti, M, Rossotti, R, Landonio, S, Magni, C, Rizzardini, G, Colella, E, Columpsi, P, Gambaro, A, Spolti, A, Magnani, C, Vigano, P, Mena, M, Villa, M, Caramma, I, Basilico, C, Capelli, F, Biagiotti, S, Mazzone, A, Saladino, V, Baldacci, M, Gatti, F, Varalli, L, Morini, L, Menzaghi, B, Farinazzo, M, Meli, R, Plaz Torres, M, Fanetti, I, Orellana, D, Zermiani, P, Zuin, M, De Bona, A, D'Arminio Monforte, A, Capretti, A, Taddei, M, Soncini, M, Spinetti, A, Zaltron, S, Pigozzi, M, Rossini, A, Pan, A, Dal Zoppo, S, Zoncada, A, Memoli, M, Salpietro, S, Hamid, H, Messina, E, Colombo, A, Giglio, O, Bonfanti, P, Molteni, C, Terreni, N, Spinzi, G, Conforti, S, Clerici, E, Menozzi, F, Buscarini, E, Centenaro, R, Corbellini, A, Noventa, F, Gritti, S, Giani, P, Fabbiani M., Lombardi A., Colaneri M., Del Poggio P., Perini P., D'Ambrosio R., Degasperi E., Dibenedetto C., Giorgini A., Pasulo L., Maggiolo F., Castelli F., Brambilla P., Spinelli O., Re T., Lleo A., Rumi M., Uberti-Foppa C., Soria A., Aghemo A., Lampertico P., Baiguera C., Schiavini M., Fagiuoli S., Bruno R., Borghi M., Soffredini R., Perbellini R., Gori A., Ferroni V., Colpani M., Manini M., Cologni G., Lazzaroni S., Vinci M., De Nicola S., Mazzarelli C., Angelini Zucchetti T., Picciotto V., Puoti M., Rossotti R., Landonio S., Magni C. F., Rizzardini G., Colella E., Columpsi P., Gambaro A., Spolti A., Magnani C., Vigano P., Mena M., Villa M., Caramma I., Basilico C., Capelli F., Biagiotti S., Mazzone A., Saladino V., Baldacci M. P., Gatti F., Varalli L., Morini L., Menzaghi B., Farinazzo M., Meli R., Plaz Torres M. C., Fanetti I., Orellana D., Zermiani P., Zuin M., De Bona A., D'Arminio Monforte A., Capretti A., Taddei M. T., Soncini M., Spinetti A., Zaltron S., Pigozzi M. G., Rossini A., Pan A., Dal Zoppo S., Zoncada A., Memoli M., Salpietro S., Hamid H., Messina E., Colombo A. E., Giglio O., Bonfanti P., Molteni C., Terreni N., Spinzi G., Conforti S., Clerici E., Menozzi F., Buscarini E., Centenaro R., Corbellini A., Noventa F., Gritti S., Giani P., Fabbiani, M, Lombardi, A, Colaneri, M, Del Poggio, P, Perini, P, D'Ambrosio, R, Degasperi, E, Dibenedetto, C, Giorgini, A, Pasulo, L, Maggiolo, F, Castelli, F, Brambilla, P, Spinelli, O, Re, T, Lleo, A, Rumi, M, Uberti-Foppa, C, Soria, A, Aghemo, A, Lampertico, P, Baiguera, C, Schiavini, M, Fagiuoli, S, Bruno, R, Borghi, M, Soffredini, R, Perbellini, R, Gori, A, Ferroni, V, Colpani, M, Manini, M, Cologni, G, Lazzaroni, S, Vinci, M, De Nicola, S, Mazzarelli, C, Angelini Zucchetti, T, Picciotto, V, Puoti, M, Rossotti, R, Landonio, S, Magni, C, Rizzardini, G, Colella, E, Columpsi, P, Gambaro, A, Spolti, A, Magnani, C, Vigano, P, Mena, M, Villa, M, Caramma, I, Basilico, C, Capelli, F, Biagiotti, S, Mazzone, A, Saladino, V, Baldacci, M, Gatti, F, Varalli, L, Morini, L, Menzaghi, B, Farinazzo, M, Meli, R, Plaz Torres, M, Fanetti, I, Orellana, D, Zermiani, P, Zuin, M, De Bona, A, D'Arminio Monforte, A, Capretti, A, Taddei, M, Soncini, M, Spinetti, A, Zaltron, S, Pigozzi, M, Rossini, A, Pan, A, Dal Zoppo, S, Zoncada, A, Memoli, M, Salpietro, S, Hamid, H, Messina, E, Colombo, A, Giglio, O, Bonfanti, P, Molteni, C, Terreni, N, Spinzi, G, Conforti, S, Clerici, E, Menozzi, F, Buscarini, E, Centenaro, R, Corbellini, A, Noventa, F, Gritti, S, Giani, P, Fabbiani M., Lombardi A., Colaneri M., Del Poggio P., Perini P., D'Ambrosio R., Degasperi E., Dibenedetto C., Giorgini A., Pasulo L., Maggiolo F., Castelli F., Brambilla P., Spinelli O., Re T., Lleo A., Rumi M., Uberti-Foppa C., Soria A., Aghemo A., Lampertico P., Baiguera C., Schiavini M., Fagiuoli S., Bruno R., Borghi M., Soffredini R., Perbellini R., Gori A., Ferroni V., Colpani M., Manini M., Cologni G., Lazzaroni S., Vinci M., De Nicola S., Mazzarelli C., Angelini Zucchetti T., Picciotto V., Puoti M., Rossotti R., Landonio S., Magni C. F., Rizzardini G., Colella E., Columpsi P., Gambaro A., Spolti A., Magnani C., Vigano P., Mena M., Villa M., Caramma I., Basilico C., Capelli F., Biagiotti S., Mazzone A., Saladino V., Baldacci M. P., Gatti F., Varalli L., Morini L., Menzaghi B., Farinazzo M., Meli R., Plaz Torres M. C., Fanetti I., Orellana D., Zermiani P., Zuin M., De Bona A., D'Arminio Monforte A., Capretti A., Taddei M. T., Soncini M., Spinetti A., Zaltron S., Pigozzi M. G., Rossini A., Pan A., Dal Zoppo S., Zoncada A., Memoli M., Salpietro S., Hamid H., Messina E., Colombo A. E., Giglio O., Bonfanti P., Molteni C., Terreni N., Spinzi G., Conforti S., Clerici E., Menozzi F., Buscarini E., Centenaro R., Corbellini A., Noventa F., Gritti S., and Giani P.

Abstract

In routine clinical practice, hepatitis C virus-infected patients can prematurely discontinue the prescribed regimen for several reasons. The aim of our study was to investigate sustained virological response (SVR12) rates in patients who prematurely discontinued directly acting antiviral (DAA) regimens and to assess the shortest effective duration of DAA able to lead to SVR12. We retrospectively collected the SVR rates of patients, registered in the NAVIGATORE-Lombardia Network database from January 2015, who discontinued DAAs before the predefined end of treatment. Overall, we included 365 patients, males were the majority (213, 58.4%), mean age was 60.5 years, and 53 (14.5%) patients were HIV-co-infected. Liver cirrhosis was observed in 251 (68.8%) subjects, and the most represented genotypes were 1b (n = 168, 46%) and 3 (n = 59, 16.2%). DAA was discontinued a median of 1 (IQR 1–4) weeks before the predefined EOT, with 164 (44.9%) patients stopping DAAs at least 2 weeks before the planned schedule. In patients with F0–F3 liver fibrosis, lower rates of SVR12 were observed in patients treated for <4 weeks: 50% (n = 2/4) vs. 99.1% (n = 109/110) for ≥4 weeks, p = 0.003. In patients with liver cirrhosis, lower rates of SVR12 were observed in patients treated <8 weeks: 83.3% (n = 25/30) vs. 94.6% (n = 209/221) for ≥8 weeks, p = 0.038. Despite premature discontinuation of DAA, high SVR12 rates were observed in a real-life setting for treatment lasting at least 4 weeks in patients with liver fibrosis F0–F3 and 8 weeks in those with liver cirrhosis. On this basis, feasibility of reducing DAA treatment duration should be explored in randomized clinical trials.

Published
2021

5. Clinical management of imported malaria in Italy: Results from a national cross-sectional survey in 2015

Author

Lepore, L, Vairo, F, D'Abramo, A, Grilli, E, Corpolongo, A, Scorzolini, L, Nisii, C, Calleri, G, Castelli, F, Chirianni, A, Ippolito, G, Nicastri, E, Andreoni, M, Angarano, G, Anselmo, M, Ascoli Bartoli, T, Bartoloni, A, Bassi, P, Bevilacqua, N, Bisoffi, Z, Cacopardo, B, Caligaris, S, Calzetti, C, Casolari, S, Cassola, G, Chianura, L, Chiodera, A, Conforto, M, Coppola, N, De Luca, A, Feasi, M, Ferrari, C, Filippini, P, Foti, G, Francavilla, E, Fusco, F, Tekle, S, Giancola, M, Giammario, A, Giobbia, M, Giordani, M, Gobbi, F, Gori, A, Grossi, P, Iacobello, C, Iannetta, M, Libanore, M, Luzzati, R, Magnani, G, Manfrin, V, Mariano, A, Mastroianni, C, Mazzotta, F, Mecocci, L, Mondardini, V, Montineri, A, Nicolini, L, Oliva, A, Palazzolo, C, Pasquale, G, Portelli, V, Puoti, M, Quirino, T, Santantonio, T, Sarmati, L, Sciotti, M, Scotton, P, Tomasoni, L, Toscanini, F, Tunesi, S, Vanino, E, Viale, P, Vigano, P, Viscoli, C, Vullo, V, Lepore L., Vairo F., D'Abramo A., Grilli E., Corpolongo A., Scorzolini L., Nisii C., Calleri G., Castelli F., Chirianni A., Ippolito G., Nicastri E., Andreoni M., Angarano G., Anselmo M., Ascoli Bartoli T., Bartoloni A., Bassi P., Bevilacqua N., Bisoffi Z., Cacopardo B., Caligaris S., Calzetti C., Casolari S., Cassola G., Chianura L., Chiodera A., Conforto M., Coppola N., De Luca A., Feasi M., Ferrari C., Filippini P., Foti G., Francavilla E., Fusco F. M., Tekle S. G., Giancola M. L., Giammario A., Giobbia M., Giordani M. T., Gobbi F., Gori A., Grossi P., Iacobello C., Iannetta M., Libanore M., Luzzati R., Magnani G., Manfrin V., Mariano A., Mastroianni C., Mazzotta F., Mecocci L., Mondardini V., Montineri A., Nicolini L. A., Oliva A., Palazzolo C., Pasquale G., Portelli V., Puoti M., Quirino T., Santantonio T. A., Sarmati L., Sciotti M. P., Scotton P., Tomasoni L. R., Toscanini F., Tunesi S., Vanino E., Viale P., Vigano P., Viscoli C., Vullo V., Lepore, L, Vairo, F, D'Abramo, A, Grilli, E, Corpolongo, A, Scorzolini, L, Nisii, C, Calleri, G, Castelli, F, Chirianni, A, Ippolito, G, Nicastri, E, Andreoni, M, Angarano, G, Anselmo, M, Ascoli Bartoli, T, Bartoloni, A, Bassi, P, Bevilacqua, N, Bisoffi, Z, Cacopardo, B, Caligaris, S, Calzetti, C, Casolari, S, Cassola, G, Chianura, L, Chiodera, A, Conforto, M, Coppola, N, De Luca, A, Feasi, M, Ferrari, C, Filippini, P, Foti, G, Francavilla, E, Fusco, F, Tekle, S, Giancola, M, Giammario, A, Giobbia, M, Giordani, M, Gobbi, F, Gori, A, Grossi, P, Iacobello, C, Iannetta, M, Libanore, M, Luzzati, R, Magnani, G, Manfrin, V, Mariano, A, Mastroianni, C, Mazzotta, F, Mecocci, L, Mondardini, V, Montineri, A, Nicolini, L, Oliva, A, Palazzolo, C, Pasquale, G, Portelli, V, Puoti, M, Quirino, T, Santantonio, T, Sarmati, L, Sciotti, M, Scotton, P, Tomasoni, L, Toscanini, F, Tunesi, S, Vanino, E, Viale, P, Vigano, P, Viscoli, C, Vullo, V, Lepore L., Vairo F., D'Abramo A., Grilli E., Corpolongo A., Scorzolini L., Nisii C., Calleri G., Castelli F., Chirianni A., Ippolito G., Nicastri E., Andreoni M., Angarano G., Anselmo M., Ascoli Bartoli T., Bartoloni A., Bassi P., Bevilacqua N., Bisoffi Z., Cacopardo B., Caligaris S., Calzetti C., Casolari S., Cassola G., Chianura L., Chiodera A., Conforto M., Coppola N., De Luca A., Feasi M., Ferrari C., Filippini P., Foti G., Francavilla E., Fusco F. M., Tekle S. G., Giancola M. L., Giammario A., Giobbia M., Giordani M. T., Gobbi F., Gori A., Grossi P., Iacobello C., Iannetta M., Libanore M., Luzzati R., Magnani G., Manfrin V., Mariano A., Mastroianni C., Mazzotta F., Mecocci L., Mondardini V., Montineri A., Nicolini L. A., Oliva A., Palazzolo C., Pasquale G., Portelli V., Puoti M., Quirino T., Santantonio T. A., Sarmati L., Sciotti M. P., Scotton P., Tomasoni L. R., Toscanini F., Tunesi S., Vanino E., Viale P., Vigano P., Viscoli C., and Vullo V.

Abstract

In Italy, malaria continues to be one of the most common imported parasitoses; therefore, continuous surveillance of epidemiological data and clinical management is needed. In 2016, the National Institute for Infectious Diseases 'Lazzaro Spallanzani' in Rome promoted a retrospective questionnaire-based survey to assess the clinical management of imported malaria cases in Italy in 2015. The questionnaire was sent to 104 Tropical and/or Infectious Diseases Units in the country, and 37 of them filled out and returned the questionnaires. A total of 399 malaria cases were reported in 2015, mostly caused by Plasmodium falciparum and imported from Africa. Malaria chemoprophylaxis was correctly used by a minority of patients. Most patients presented with uncomplicated malaria and were treated orally. In severe cases, intravenous artesunate or quinine alone or in combination were administered, although one third of these severe cases received oral treatment. This retrospective survey reveals a lack of homogeneity in management of malaria-imported cases in Italy. Improvement of malaria chemoprophylaxis, standardization of clinical management of malaria cases and harmonization of oral and intravenous drug availability are needed throughout the country.

Published
2020

6. Comparison of three therapeutic regimens for genotype-3 hepatitis C virus infection in a large real-life multicentre cohort

Author

Soria, A, Fava, M, Bernasconi, D, Lapadula, G, Colella, E, Valsecchi, M, Migliorino, G, D'Ambrosio, R, Landonio, S, Schiavini, M, Spinetti, A, Carriero, C, Degasperi, E, Cologni, G, Gatti, F, Vigano, P, Hasson, H, Uberti-Foppa, C, Pasulo, L, Baiguera, C, Rossotti, R, Vinci, M, Puoti, M, Giorgini, A, Menzaghi, B, Lombardi, A, Pan, A, Aghemo, A, Grossi, P, Boldizzoni, R, Colombo, S, Vigano, M, Rumi, M, Del Poggio, P, Valenti, L, Giglio, O, De Bona, A, d'Arminio Monforte, A, Colombo, A, Spinelli, O, Pigozzi, M, Molteni, C, Bonfanti, P, Terreni, N, Perini, P, Capretti, A, Bella, D, Liani, C, Polo, S, Aimo, G, Pagnucco, L, Bhoori, S, Centenaro, R, Graffeo, M, Ciaccio, A, Dionigi, E, Lazzaroni, S, Carderi, I, Di Marco, M, Rizzardini, G, Noventa, F, Lampertico, P, Fagiuoli, S, Soria A., Fava M., Bernasconi D. P., Lapadula G., Colella E., Valsecchi M. G., Migliorino G. M., D'Ambrosio R., Landonio S., Schiavini M., Spinetti A., Carriero C., Degasperi E., Cologni G., Gatti F., Vigano P., Hasson H., Uberti-Foppa C., Pasulo L., Baiguera C., Rossotti R., Vinci M., Puoti M., Giorgini A., Menzaghi B., Lombardi A., Pan A., Aghemo A., Grossi P. A., Boldizzoni R., Colombo S., Vigano M., Rumi M. G., Del Poggio P., Valenti L., Giglio O., De Bona A., d'Arminio Monforte A., Colombo A., Spinelli O., Pigozzi M. G., Molteni C., Bonfanti P., Terreni N., Perini P., Capretti A., Bella D., Liani C., Polo S., Aimo G., Pagnucco L., Bhoori S., Centenaro R., Graffeo M., Ciaccio A., Dionigi E., Lazzaroni S., Carderi I., Di Marco M., Rizzardini G., Noventa F., Lampertico P., Fagiuoli S., Soria, A, Fava, M, Bernasconi, D, Lapadula, G, Colella, E, Valsecchi, M, Migliorino, G, D'Ambrosio, R, Landonio, S, Schiavini, M, Spinetti, A, Carriero, C, Degasperi, E, Cologni, G, Gatti, F, Vigano, P, Hasson, H, Uberti-Foppa, C, Pasulo, L, Baiguera, C, Rossotti, R, Vinci, M, Puoti, M, Giorgini, A, Menzaghi, B, Lombardi, A, Pan, A, Aghemo, A, Grossi, P, Boldizzoni, R, Colombo, S, Vigano, M, Rumi, M, Del Poggio, P, Valenti, L, Giglio, O, De Bona, A, d'Arminio Monforte, A, Colombo, A, Spinelli, O, Pigozzi, M, Molteni, C, Bonfanti, P, Terreni, N, Perini, P, Capretti, A, Bella, D, Liani, C, Polo, S, Aimo, G, Pagnucco, L, Bhoori, S, Centenaro, R, Graffeo, M, Ciaccio, A, Dionigi, E, Lazzaroni, S, Carderi, I, Di Marco, M, Rizzardini, G, Noventa, F, Lampertico, P, Fagiuoli, S, Soria A., Fava M., Bernasconi D. P., Lapadula G., Colella E., Valsecchi M. G., Migliorino G. M., D'Ambrosio R., Landonio S., Schiavini M., Spinetti A., Carriero C., Degasperi E., Cologni G., Gatti F., Vigano P., Hasson H., Uberti-Foppa C., Pasulo L., Baiguera C., Rossotti R., Vinci M., Puoti M., Giorgini A., Menzaghi B., Lombardi A., Pan A., Aghemo A., Grossi P. A., Boldizzoni R., Colombo S., Vigano M., Rumi M. G., Del Poggio P., Valenti L., Giglio O., De Bona A., d'Arminio Monforte A., Colombo A., Spinelli O., Pigozzi M. G., Molteni C., Bonfanti P., Terreni N., Perini P., Capretti A., Bella D., Liani C., Polo S., Aimo G., Pagnucco L., Bhoori S., Centenaro R., Graffeo M., Ciaccio A., Dionigi E., Lazzaroni S., Carderi I., Di Marco M., Rizzardini G., Noventa F., Lampertico P., and Fagiuoli S.

Abstract

Background & Aims: In the direct-acting antiviral era, treatment of genotype-3 HCV (HCV-GT3) is still challenging. Real-life comparisons between recommended regimens, sofosbuvir (SOF)+daclatasvir (DAC), SOF/velpatasvir (VEL), glecaprevir/pibrentasvir (GLE/PIB), are scarce. We aimed at filling this data gap. Methods: Sustained virological response 12 weeks after treatment completion (SVR12) was assessed for all HCV-GT3 patients consecutively treated within the Lombardia web-based Navigatore HCV-Network; differences in SVR12 across regimens were evaluated by logistic regression. Results: Of the 2082 subjects with HCV-GT3, 1544 were evaluable for comparisons between regimens: SOF + DAC (1023, 66.2%), SOF/VEL (369, 23.9%), GLE/PIB (152, 9.8%). Patients treated with former regimens were more frequently male, cirrhotic, HIV-positive, pretreated, used ribavirin in their regimen, and had lower baseline HCV-RNA. SVR12 was similar across groups: 94.8% in SOF + DAC, 97.6% in SOF/VEL, 96.7% in GLE/PIB (P =.065). At univariate analysis, SVR12 was associated with female gender (97.9% vs 94.8%, P =.007) and lower median pretreatment Log10HCV-RNA (5.87 vs 6.20, P =.001). At multivariate logistic regression analysis, treatment with SOF/VEL was associated with a higher likelihood of SVR12 than SOF + DAC, but only in the absence of ribavirin (98% vs 90.3%). Female gender and lower pretreatment HCV-RNA were independently associated with SVR12. Conclusions: In a large real-life setting of HCV-GT3-infected patients with a high proportion of cirrhosis, the success rate was remarkable. The slight advantage of SOF/VEL on SOF + DAC was significant only without ribavirin. The current prescription shift towards novel regimens (ie SOF/VEL and GLE/PIB) in easier-to-treat patients allows ribavirin-free and shorter schedules without mining SVR12 in this <> genotype.

Published
2020

7. Renal safety in 3264 HCV patients treated with DAA-based regimens: Results from a large Italian real-life study

Author

D'Ambrosio, R, Pasulo, L, Giorgini, A, Spinetti, A, Messina, E, Fanetti, I, Puoti, M, Aghemo, A, Vigano, P, Vinci, M, Menzaghi, B, Lombardi, A, Pan, A, Pigozzi, M, Grossi, P, Lazzaroni, S, Spinelli, O, Invernizzi, P, Maggiolo, F, Terreni, N, Monforte, A, Poggio, P, Taddei, M, Colombo, S, Pozzoni, P, Molteni, C, Brocchieri, A, Bhoori, S, Buscarini, E, Centenaro, R, Mendeni, M, Colombo, A, Di Marco, M, Dionigi, E, Bella, D, Borghi, M, Zuin, M, Zaltron, S, Noventa, F, Annalisa, D, Lampertico, P, Fagiuoli, S, D'Ambrosio R., Pasulo L., Giorgini A., Spinetti A., Messina E., Fanetti I., Puoti M., Aghemo A., Vigano P., Vinci M., Menzaghi B., Lombardi A., Pan A., Pigozzi M. G., Grossi P., Lazzaroni S., Spinelli O., Invernizzi P., Maggiolo F., Terreni N., Monforte A. D., Poggio P. D., Taddei M. T., Colombo S., Pozzoni P., Molteni C., Brocchieri A., Bhoori S., Buscarini E., Centenaro R., Mendeni M., Colombo A. E., Di Marco M., Dionigi E., Bella D., Borghi M., Zuin M., Zaltron S., Noventa F., Annalisa D. S., Lampertico P., Fagiuoli S., D'Ambrosio, R, Pasulo, L, Giorgini, A, Spinetti, A, Messina, E, Fanetti, I, Puoti, M, Aghemo, A, Vigano, P, Vinci, M, Menzaghi, B, Lombardi, A, Pan, A, Pigozzi, M, Grossi, P, Lazzaroni, S, Spinelli, O, Invernizzi, P, Maggiolo, F, Terreni, N, Monforte, A, Poggio, P, Taddei, M, Colombo, S, Pozzoni, P, Molteni, C, Brocchieri, A, Bhoori, S, Buscarini, E, Centenaro, R, Mendeni, M, Colombo, A, Di Marco, M, Dionigi, E, Bella, D, Borghi, M, Zuin, M, Zaltron, S, Noventa, F, Annalisa, D, Lampertico, P, Fagiuoli, S, D'Ambrosio R., Pasulo L., Giorgini A., Spinetti A., Messina E., Fanetti I., Puoti M., Aghemo A., Vigano P., Vinci M., Menzaghi B., Lombardi A., Pan A., Pigozzi M. G., Grossi P., Lazzaroni S., Spinelli O., Invernizzi P., Maggiolo F., Terreni N., Monforte A. D., Poggio P. D., Taddei M. T., Colombo S., Pozzoni P., Molteni C., Brocchieri A., Bhoori S., Buscarini E., Centenaro R., Mendeni M., Colombo A. E., Di Marco M., Dionigi E., Bella D., Borghi M., Zuin M., Zaltron S., Noventa F., Annalisa D. S., Lampertico P., and Fagiuoli S.

Abstract

Background: Sofosbuvir (SOF)-based regimens have been associated with renal function worsening in HCV patients with estimated glomerular filtration rate (eGFR) ≤ 45 ml/min, but further investigations are lacking. Aim: To assess renal safety in a large cohort of DAA-treated HCV patients with any chronic kidney disease (CKD). Methods: All HCV patients treated with DAA in Lombardy (December 2014–November 2017) with available kidney function tests during and off-treatment were included. Results: Among 3264 patients [65% males, 67% cirrhotics, eGFR 88 (9–264) ml/min], CKD stage was 3 in 9.5% and 4/5 in 0.7%. 79% and 73% patients received SOF and RBV, respectively. During DAA, eGFR declined in CKD-1 (p < 0.0001) and CKD-2 (p = 0.0002) patients, with corresponding rates of CKD stage reduction of 25% and 8%. Conversely, eGFR improved in lower CKD stages (p < 0.0001 in CKD-3a, p = 0.0007 in CKD-3b, p = 0.024 in CKD-4/5), with 33–45% rates of CKD improvement. Changes in eGFR and CKD distribution persisted at SVR. Baseline independent predictors of CKD worsening at EOT and SVR were age (p < 0.0001), higher baseline CKD stages (p < 0.0001) and AH (p = 0.010 and p < 0.0001, respectively). Conclusions: During DAA, eGFR significantly declined in patients with preserved renal function and improved in those with lower CKD stages, without reverting upon drug discontinuation.

Published
2020

8. HIV clinical pathway: A new approach to combine guidelines and sustainability of anti-retroviral treatment in Italy

Author

Croce, D, Lazzarin, A, Rizzardini, G, Gianotti, N, Scolari, F, Foglia, E, Garagiola, E, Ricci, E, Bini, T, Quirino, T, Vigano, P, Re, T, Monforte, A, Bonfanti, P, Croce D., Lazzarin A., Rizzardini G., Gianotti N., Scolari F., Foglia E., Garagiola E., Ricci E., Bini T., Quirino T., Vigano P., Re T., Monforte A. D., Bonfanti P., Croce, D, Lazzarin, A, Rizzardini, G, Gianotti, N, Scolari, F, Foglia, E, Garagiola, E, Ricci, E, Bini, T, Quirino, T, Vigano, P, Re, T, Monforte, A, Bonfanti, P, Croce D., Lazzarin A., Rizzardini G., Gianotti N., Scolari F., Foglia E., Garagiola E., Ricci E., Bini T., Quirino T., Vigano P., Re T., Monforte A. D., and Bonfanti P.

Abstract

The present article describes the case study of a "real world" HIV practice within the debate concerning the strategic role of Clinical Governance (CG) tools in the management of a National Healthcare System's sustainability. The study aimed at assessing the impact of a Clinical Pathway (CP) implementation, required by the Regional Healthcare Service, in terms of effectiveness (virological and immunological conditions) and efficiency (economic resources absorption), from the budget holder perspective. Data derived from a multi-centre cohort of patients treated in 6 Hospitals that provided care to approximately 42% of the total HIV+ patients, in Lombardy Region, Italy. Two phases were compared: Pre-CP (2009-2010) vs. Post-CP implementation (2011-2012). All HIV infected adults, observed in the participating hospitals during the study periods, were enrolled and stratified into the 3 categories defined by the Regional CP: first-line, switch for toxicity/other, and switch for failure. The study population was composed of 1,284 patients (Pre-CP phase) and 1,135 patients (Post-CP phase). The results showed that the same level of virological and immunological effectiveness was guaranteed to HIV+ patients: 81.2% of Pre-CP phase population and 83.2% of Post-CP phase population had undetectable HIV-RNA (defined as <50 copies/mL) at 12-month follow up. CD4+ cell counts increased by 28 ± 4 cells/mm3 in Pre-CP Phase and 39 ± 5 cells/mm3 in Post-CP Phase. From an economic point of view, the CP implementation led to a substantial advantage: the mean total costs related to the management of the HIV disease (ART, hospital admission and laboratory tests) decreased (-8.60%) in the Post-CP phase (p-value < 0.0001). Results confirmed that the CP provided appropriateness and quality of care, with a cost reduction for the budget holder.

Published
2016

9. HIV clinical pathway: A new approach to combine guidelines and sustainability of anti-retroviral treatment in Italy

Author

Croce, D, Lazzarin, A, Rizzardini, G, Gianotti, N, Scolari, F, Foglia, E, Garagiola, E, Ricci, E, Bini, T, Quirino, T, Vigano, P, Re, T, Monforte, A, Bonfanti, P, Croce D., Lazzarin A., Rizzardini G., Gianotti N., Scolari F., Foglia E., Garagiola E., Ricci E., Bini T., Quirino T., Vigano P., Re T., Monforte A. D., Bonfanti P., Croce, D, Lazzarin, A, Rizzardini, G, Gianotti, N, Scolari, F, Foglia, E, Garagiola, E, Ricci, E, Bini, T, Quirino, T, Vigano, P, Re, T, Monforte, A, Bonfanti, P, Croce D., Lazzarin A., Rizzardini G., Gianotti N., Scolari F., Foglia E., Garagiola E., Ricci E., Bini T., Quirino T., Vigano P., Re T., Monforte A. D., and Bonfanti P.

Abstract

The present article describes the case study of a "real world" HIV practice within the debate concerning the strategic role of Clinical Governance (CG) tools in the management of a National Healthcare System's sustainability. The study aimed at assessing the impact of a Clinical Pathway (CP) implementation, required by the Regional Healthcare Service, in terms of effectiveness (virological and immunological conditions) and efficiency (economic resources absorption), from the budget holder perspective. Data derived from a multi-centre cohort of patients treated in 6 Hospitals that provided care to approximately 42% of the total HIV+ patients, in Lombardy Region, Italy. Two phases were compared: Pre-CP (2009-2010) vs. Post-CP implementation (2011-2012). All HIV infected adults, observed in the participating hospitals during the study periods, were enrolled and stratified into the 3 categories defined by the Regional CP: first-line, switch for toxicity/other, and switch for failure. The study population was composed of 1,284 patients (Pre-CP phase) and 1,135 patients (Post-CP phase). The results showed that the same level of virological and immunological effectiveness was guaranteed to HIV+ patients: 81.2% of Pre-CP phase population and 83.2% of Post-CP phase population had undetectable HIV-RNA (defined as <50 copies/mL) at 12-month follow up. CD4+ cell counts increased by 28 ± 4 cells/mm3 in Pre-CP Phase and 39 ± 5 cells/mm3 in Post-CP Phase. From an economic point of view, the CP implementation led to a substantial advantage: the mean total costs related to the management of the HIV disease (ART, hospital admission and laboratory tests) decreased (-8.60%) in the Post-CP phase (p-value < 0.0001). Results confirmed that the CP provided appropriateness and quality of care, with a cost reduction for the budget holder.

Published
2016

10. “Metabolic pathways in clear cell renal cell carcinoma: possible therapeutic targets

Author

Bianchi, C, Meregalli, C, DI STEFANO, V, Cattaneo, E, Torsello, B, Bombelli, S, Bovo, G, Vigano’, P, Strada, G, Perego, R, BIANCHI, CRISTINA, MEREGALLI, CRISTINA, DI STEFANO, VITALBA, TORSELLO, BARBARA ROSA, BOMBELLI, SILVIA, PEREGO, ROBERTO, CATTANEO, E, BOVO, G, VIGANO’, P, STRADA, G, Bianchi, C, Meregalli, C, DI STEFANO, V, Cattaneo, E, Torsello, B, Bombelli, S, Bovo, G, Vigano’, P, Strada, G, Perego, R, BIANCHI, CRISTINA, MEREGALLI, CRISTINA, DI STEFANO, VITALBA, TORSELLO, BARBARA ROSA, BOMBELLI, SILVIA, PEREGO, ROBERTO, CATTANEO, E, BOVO, G, VIGANO’, P, and STRADA, G

Published
2014

11. Role of specific metabolic pathways in clear cell renal cell carcinoma (ccRCC)

Author

Bianchi, C, DI STEFANO, V, Cattaneo, E, Meregalli, C, Torsello, B, Bombelli, S, Bovo, G, Vigano’, P, Strada, G, Perego, R, BIANCHI, CRISTINA, DI STEFANO, VITALBA, TORSELLO, BARBARA ROSA, BOMBELLI, SILVIA, PEREGO, ROBERTO, CATTANEO, E, MEREGALLI, C, BOVO, G, VIGANO’, P, STRADA, G, Bianchi, C, DI STEFANO, V, Cattaneo, E, Meregalli, C, Torsello, B, Bombelli, S, Bovo, G, Vigano’, P, Strada, G, Perego, R, BIANCHI, CRISTINA, DI STEFANO, VITALBA, TORSELLO, BARBARA ROSA, BOMBELLI, SILVIA, PEREGO, ROBERTO, CATTANEO, E, MEREGALLI, C, BOVO, G, VIGANO’, P, and STRADA, G

Published
2014

13. Endogenous lysyl-oxidase in clear cell renal cell carcinoma promotes tumor progression and collagen stiffness

Author

Torsello, B, Di Stefano, V, Bianchi, C, Battaglia, C, Cifola, I, Mangano, E, Bovo, G, Cassina, V, De Marco, S, Corti, R, Meregalli, C, Bombelli, S, Vigano’, P, Strada, G, Perego, R, TORSELLO, BARBARA ROSA, BIANCHI, CRISTINA, CASSINA, VALERIA, CORTI, ROBERTA, MEREGALLI, CHIARA, BOMBELLI, SILVIA, STRADA, GUIDO RAFFAELE, PEREGO, ROBERTO, Torsello, B, Di Stefano, V, Bianchi, C, Battaglia, C, Cifola, I, Mangano, E, Bovo, G, Cassina, V, De Marco, S, Corti, R, Meregalli, C, Bombelli, S, Vigano’, P, Strada, G, Perego, R, TORSELLO, BARBARA ROSA, BIANCHI, CRISTINA, CASSINA, VALERIA, CORTI, ROBERTA, MEREGALLI, CHIARA, BOMBELLI, SILVIA, STRADA, GUIDO RAFFAELE, and PEREGO, ROBERTO

Published
2016

14. World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonisation Project: IV. Tissue collection, processing, and storage in endometriosis research

Author

Fassbender, A, Rahmioglu, N, Vitonis, AF, Vigano, P, Giudice, LC, D'Hooghe, TM, Hummelshoj, L, Adamson, GD, Becker, CM, Missmer, SA, Zondervan, KT, Fassbender, A, Rahmioglu, N, Vitonis, AF, Vigano, P, Giudice, LC, D'Hooghe, TM, Hummelshoj, L, Adamson, GD, Becker, CM, Missmer, SA, and Zondervan, KT

Abstract

OBJECTIVE: To harmonize standard operating procedures (SOPs) and standardize the recording of associated data for collection, processing, and storage of human tissues relevant to endometriosis. DESIGN: An international collaboration involving 34 clinical/academic centers and three industry collaborators from 16 countries on five continents. SETTING: In 2013, two workshops were conducted followed by global consultation, bringing together 54 leaders in endometriosis research and sample processing from around the world. PATIENT(S): None. INTERVENTION(S): Consensus SOPs were based on: 1) systematic comparison of SOPs from 24 global centers collecting tissue samples from women with and without endometriosis on a medium or large scale (publication on >100 cases); 2) literature evidence where available, or consultation with laboratory experts otherwise; and 3) several global consultation rounds. MAIN OUTCOME MEASURE(S): Standard recommended and minimum required SOPs for tissue collection, processing, and storage in endometriosis research. RESULT(S): We developed "recommended standard" and "minimum required" SOPs for the collection, processing, and storage of ectopic and eutopic endometrium, peritoneum, and myometrium, and a biospecimen data collection form necessary for interpretation of sample-derived results. CONCLUSION(S): The EPHect SOPs allow endometriosis research centers to decrease variability in tissue-based results, facilitating between-center comparisons and collaborations. The procedures are also relevant to research into other gynecologic conditions involving endometrium, myometrium, and peritoneum. The consensus SOPs are based on the best available evidence; areas with limited evidence are identified as requiring further pilot studies. The SOPs will be reviewed based on investigator feedback and through systematic triannual follow-up. Updated versions will be made available at: http://endometriosisfoundation.org/ephect.

Published
2014

15. Molecular and functional characterization of cancer stem-like cells isolated from human renal cell carcinoma tissue

Author

Bombelli, S, Zipeto, M, Torsello, B, Meregalli, C, DI STEFANO, V, Bovo, G, Vigano’, P, Strada, G, Bianchi, C, Perego, R, BOMBELLI, SILVIA, ZIPETO, MARIA ANNA, TORSELLO, BARBARA ROSA, DI STEFANO, VITALBA, BIANCHI, CRISTINA, PEREGO, ROBERTO, Bombelli, S, Zipeto, M, Torsello, B, Meregalli, C, DI STEFANO, V, Bovo, G, Vigano’, P, Strada, G, Bianchi, C, Perego, R, BOMBELLI, SILVIA, ZIPETO, MARIA ANNA, TORSELLO, BARBARA ROSA, DI STEFANO, VITALBA, BIANCHI, CRISTINA, and PEREGO, ROBERTO

Published
2014

16. Nephrospheres from human kidney contain cells with regenerative abilities

Author

Bombelli, S, Bovo, G, Torsello, B, Meregalli, C, V, D, Vigano’, P, Strada, G, Bianchi, C, Perego, R, DI STEFANO, V, BOMBELLI, SILVIA, TORSELLO, BARBARA ROSA, BIANCHI, CRISTINA, PEREGO, ROBERTO, DI STEFANO, VITALBA, Bombelli, S, Bovo, G, Torsello, B, Meregalli, C, V, D, Vigano’, P, Strada, G, Bianchi, C, Perego, R, DI STEFANO, V, BOMBELLI, SILVIA, TORSELLO, BARBARA ROSA, BIANCHI, CRISTINA, PEREGO, ROBERTO, and DI STEFANO, VITALBA

Published
2014

17. Effect of specific metabolic pathway inhibition on in vitro viability of ccRCC cells

Author

Bianchi, C, DI STEFANO, V, Cattaneo, E, Torsello, B, Bombelli, S, Meregalli, C, Bovo, G, Vigano’, P, Strada, G, Perego, R, BIANCHI, CRISTINA, DI STEFANO, VITALBA, TORSELLO, BARBARA ROSA, BOMBELLI, SILVIA, PEREGO, ROBERTO, Bianchi, C, DI STEFANO, V, Cattaneo, E, Torsello, B, Bombelli, S, Meregalli, C, Bovo, G, Vigano’, P, Strada, G, Perego, R, BIANCHI, CRISTINA, DI STEFANO, VITALBA, TORSELLO, BARBARA ROSA, BOMBELLI, SILVIA, and PEREGO, ROBERTO

Published
2013

18. Cancer Stem Cell characteristics may be correlated to the renal cell carcinoma intratumoral heterogeneity

Author

Bombelli, S, Zipeto, M, Bianchi, C, Torsello, B, DI STEFANO, V, Vigano’, P, Bovo, G, Cattoretti, G, Strada, G, Perego, R, BOMBELLI, SILVIA, ZIPETO, MARIA ANNA, BIANCHI, CRISTINA, TORSELLO, BARBARA ROSA, DI STEFANO, VITALBA, CATTORETTI, GIORGIO, PEREGO, ROBERTO, Bombelli, S, Zipeto, M, Bianchi, C, Torsello, B, DI STEFANO, V, Vigano’, P, Bovo, G, Cattoretti, G, Strada, G, Perego, R, BOMBELLI, SILVIA, ZIPETO, MARIA ANNA, BIANCHI, CRISTINA, TORSELLO, BARBARA ROSA, DI STEFANO, VITALBA, CATTORETTI, GIORGIO, and PEREGO, ROBERTO

Published
2013

19. Stem-like cells in nephrospheres present multilineage differentiative abilities

Author

Bombelli, S, Zipeto, M, Bianchi, C, Torsello, B, DI STEFANO, V, Bovo, G, Vigano’, P, Strada, G, Cattoretti, G, Perego, R, BOMBELLI, SILVIA, ZIPETO, MARIA ANNA, BIANCHI, CRISTINA, TORSELLO, BARBARA ROSA, DI STEFANO, VITALBA, CATTORETTI, GIORGIO, PEREGO, ROBERTO, Bombelli, S, Zipeto, M, Bianchi, C, Torsello, B, DI STEFANO, V, Bovo, G, Vigano’, P, Strada, G, Cattoretti, G, Perego, R, BOMBELLI, SILVIA, ZIPETO, MARIA ANNA, BIANCHI, CRISTINA, TORSELLO, BARBARA ROSA, DI STEFANO, VITALBA, CATTORETTI, GIORGIO, and PEREGO, ROBERTO

Published
2012

20. Characterization of cancer stem-like cells by detecting chromosomal aberrations in bladder cancer

Author

Bentivegna, A, Panzeri, E, Conconi, D, Redaelli, S, Baronchelli, S, Antolini, L, Valsecchi, M, Bovo, G, Pallotti, F, Vigano, P, Strada, G, Dalpra', L, BENTIVEGNA, ANGELA, PANZERI, ELENA, CONCONI, DONATELLA, REDAELLI, SERENA, BARONCHELLI, SIMONA, ANTOLINI, LAURA, VALSECCHI, MARIA GRAZIA, DALPRA', LEDA, Bentivegna, A, Panzeri, E, Conconi, D, Redaelli, S, Baronchelli, S, Antolini, L, Valsecchi, M, Bovo, G, Pallotti, F, Vigano, P, Strada, G, Dalpra', L, BENTIVEGNA, ANGELA, PANZERI, ELENA, CONCONI, DONATELLA, REDAELLI, SERENA, BARONCHELLI, SIMONA, ANTOLINI, LAURA, VALSECCHI, MARIA GRAZIA, and DALPRA', LEDA

Abstract

Th e capability of a tumor to grow and propagate seems to depend on a small sub-population of cells, called cancer stem cells (CSCs) [1]. We isolated and characterized putative bladder CSCs populations from primary Transitional Cell Carcinomas (TCCs). Th ese cells proliferated as urospheres and had abilities for extensive proliferation and self-renewal. Their positivity for stem cell markers and their potential to diff erentiate were assessed. Urospheres gradually showed loss of proliferation, adherence to the substrate, and morphological changes, which might refl ect their progressive loss of self-renewal ability. Conventional cytogenetic analysis was carried out on fresh chromosome spreads immediately aft er the isolation and aft er one week of culture. Th e data indicated important karyotype selection and the loss of complexity present in fresh tumors. Another purpose was to evaluate the performance of a targeted test (UroVysion assay) widely used for the detection of TCCs [2], on Formalin Fixed Paraffi n Embedded (FFPE) tissues and interphasic nuclei of urospheres: comparing tissue and aft er-culture data, we observed a great heterogeneity also among samples with the same histotype. The comparison between array-CGH and UroVysion assay evidenced the same heterogeneity on two different types of material derived from the same tumor: FFPE and Freshly Isolated interphasic Nuclei (FIN). Our results confi rmed the importance of use complementary techniques such array-CGH and FISH, as the former is able to detect alterations at the genome level, but the latter is able to maintain the individual data at the level of single cells, even if it focuses on few genomic regions.

Published
2011

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