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1. Angiogenesis inhibition in lung cancer: emerging novel strategies

Author

Vanesa Gregorc, Aurora Mirabile, Giuseppe Damiano, Alessandra Bulotta, Giulia Veronesi, M. G. Vigano, Chiara Lazzari, Lazzari, C., Bulotta, A., Damiano, G., Mirabile, A., Vigano, M., Veronesi, G., and Gregorc, V.

Subjects
Vascular Endothelial Growth Factor A, Cancer Research, Lung Neoplasms, Immune checkpoint inhibitors, chemistry.chemical_compound, Immune system, Carcinoma, Non-Small-Cell Lung, medicine, Humans, Epidermal growth factor receptor, Lung cancer, Immune Checkpoint Inhibitors, Protein Kinase Inhibitors, biology, Nonsmall cell lung cancer, business.industry, Cancer, medicine.disease, Molecular medicine, ErbB Receptors, Vascular endothelial growth factor, Clinical trial, Oncology, chemistry, Cancer research, biology.protein, Angiogenesis, business, Tyrosine kinase, Epidermal growth factor receptor-tyrosine kinase inhibitors
Abstract

Purpose of review In the current review, we will explore the molecular bases that have determined the design of clinical trials exploring the efficacy of antivascular agents in combination with chemotherapy, immune check point inhibitors and epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) in patients with advanced nonsmall cell lung cancer. Recent findings Recent clinical trials have demonstrated the synergistic effect of antivascular agents with immune checkpoint inhibitors and EGFR-TKIs, despite no molecular marker has been identified yet to select patients. Summary Lung cancer remains one of the first causes of cancer-related death. However, thanks to the development of stratified molecular medicine and the introduction of immune checkpoint inhibitors, patients' survival has significantly improved. Due to the critical role of pro-angiogenic factors in cancer progression, antivascular agents targeting the vascular endothelial growth factor (VEGF) and its receptor (VEGFR) have been developed. Their efficacy has been explored in combination with chemotherapy, and immune checkpoint inhibitors, with promising but not definitive conclusions about their impact on prolonging patients' survival.

Published
2021

2. Perspectives from Italy during the COVID-19 pandemic: nationwide survey-based focus on minimally invasive HPB surgery

Author

Aldrighetti, aEmail Author, L., Boggi, U. b., Falconi, M. c., Giuliante, F. d., Cipriani, F. a., Ratti, Torzilli, G. e., Abu, Hilal, Andrianello, Anselmo, Ardito, Gian, L. B., Banchini, Barabino, Barberis, Bassi, Batignani, Battiston, Belli, Berti, Bianco, Brolese, Brozzetti, Butturini, Calise, Carabott, Capretti, Casadei, Cescon, Cesaretti, Cillo, Cinardi, Colledan, Coppola, Cotsoglou, Crippa, Bona, E. D., Valle, R. D., Angelis, De, Carlis, De, Benedetto, Di, Sebastiano, Di, Dova, Ercolani, Esposito, Giuseppe, M. E., Fabris, Ferrero, Frena, Frigerio, Gianotti, Giuliani, Grazi, Gringeri, Griseri, Gruttadauria, Guglielmi, Izzo, Jovine, Lanza, Malleo, Manzini, Massani, Mazzaferro, Memeo, Minni, Morelli, Nappo, Nardo, Orlando, Partelli, Patriti, Patrone, Percivale, Piccolo, Ravaioli, Reggiani, Risaliti, Rocca, A, Romagnoli, Romano, Russolillo, Ruzzenente, Saladino, Salvia, Santambrogio, Tarchi, Troci, Troisi, Urbani, Veneroni, Vennarecci, Vigano, Viola, Vistoli, Vivarelli, Zanello, Zanus, Zerbi, Italian Association of HepatoBilioPancreatic Surgeons-AICEP, Aldrighetti, L., Boggi, U., Falconi, M., Giuliante, F., Cipriani, F., Ratti, F., Torzilli, G., Abu Hilal, M., Andrianello, S., Anselmo, A., Ardito, F., Gian, L. B., Banchini, F., Barabino, M., Barberis, A., Bassi, C., Batignani, G., Battiston, C., Belli, A., Berti, S., Bianco, P., Brolese, A., Brozzetti, S., Butturini, G., Calise, F., Carabott, K., Capretti, G., Casadei, R., Cescon, M., Cesaretti, M., Cillo, U., Cinardi, N., Colledan, M., Coppola, A., Cotsoglou, C., Crippa, S., Bona, E. D., Valle, R. D., De Angelis, M., De Carlis, L., Di Benedetto, F., Di Sebastiano, P., Dova, L., Ercolani, G., Esposito, A., Giuseppe, M. E., Fabris, A., Ferrero, A., Frena, A., Frigerio, I., Gianotti, L., Giuliani, A., Grazi, G., Gringeri, E., Griseri, G., Gruttadauria, S., Guglielmi, A., Izzo, F., Jovine, E., Lanza, E., Malleo, G., Manzini, L., Massani, M., Mazzaferro, V., Memeo, R., Minni, F., Morelli, L., Nappo, G., Nardo, B., Orlando, F., Partelli, S., Patriti, A., Patrone, R., Percivale, A., Piccolo, G., Ravaioli, M., Reggiani, P., Risaliti, M., Rocca, A., Romagnoli, R., Romano, F., Russolillo, N., Ruzzenente, A., Saladino, E., Salvia, R., Santambrogio, R., Tarchi, P., Troci, A., Troisi, R., Urbani, L., Veneroni, L., Vennarecci, G., Vigano, L., Viola, M., Vistoli, F., Vivarelli, M., Zanello, M., Zanus, G., Zerbi, A., Aldrighetti L., Boggi U., Falconi M., Giuliante F., Cipriani F., Ratti F., Torzilli G., Abu Hilal M., Andrianello S., Anselmo A., Ardito F., Gian L.B., Banchini F., Barabino M., Barberis A., Bassi C., Batignani G., Battiston C., Belli A., Berti S., Bianco P., Brolese A., Brozzetti S., Butturini G., Calise F., Carabott K., Capretti G., Casadei R., Cescon M., Cesaretti M., Cillo U., Cinardi N., Colledan M., Coppola A., Cotsoglou C., Crippa S., Bona E.D., Valle R.D., De Angelis M., De Carlis L., Di Benedetto F., Di Sebastiano P., Dova L., Ercolani G., Esposito A., Giuseppe M.E., Fabris A., Ferrero A., Frena A., Frigerio I., Gianotti L., Giuliani A., Grazi G., Gringeri E., Griseri G., Gruttadauria S., Guglielmi A., Izzo F., Jovine E., Lanza E., Malleo G., Manzini L., Massani M., Mazzaferro V., Memeo R., Minni F., Morelli L., Nappo G., Nardo B., Orlando F., Partelli S., Patriti A., Patrone R., Percivale A., Piccolo G., Ravaioli M., Reggiani P., Risaliti M., Rocca A., Romagnoli R., Romano F., Russolillo N., Ruzzenente A., Saladino E., Salvia R., Santambrogio R., Tarchi P., Troci A., Troisi R., Urbani L., Veneroni L., Vennarecci G., Vigano L., Viola M., Vistoli F., Vivarelli M., Zanello M., Zanus G., and Zerbi A.

Subjects
Future studies, Settore MED/18 - CHIRURGIA GENERALE, Crisis management, Nationwide survey, 0302 clinical medicine, Pandemic, Pancrea, Medicine, Viral, Minimally invasive procedures, Liver Disease, Liver Diseases, COVID-19, Liver, Minimally invasive, Pancreas, Biliary Tract Diseases, Health Care Surveys, Humans, Italy, Pancreatic Diseases, Coronavirus Infections, Minimally Invasive Surgical Procedures, Pandemics, Pneumonia, Viral, 030220 oncology & carcinogenesis, Esophagus Resection, Original Article, 030211 gastroenterology & hepatology, Biliary Tract Disease, Human, Prioritization, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), NO, 03 medical and health sciences, High Volume Hospital, Centralization, LS7_4, Coronavirus Infection, business.industry, Minimally Invasive Surgical Procedure, Pneumonia, Surgery, Health Care Survey, Invasive surgery, Pancreatic Disease, business
Abstract

The safety of minimally invasive procedures during COVID pandemic remains hotly debated, especially in a country, like Italy, where minimally invasive techniques have progressively and pervasively entered clinical practice, in both the hepatobiliary and pancreatic community. A nationwide snapshot of the management of HPB minimally invasive surgery activity during COVID-19 pandemic is provided: a survey was developed and conducted within AICEP (Italian Association of HepatoBilioPancreatic Surgeons) with the final aim of conveying the experience, knowledge, and opinions into a unitary report enabling more efficient crisis management. Results from the survey (81 respondents) show that, in Italian hospitals, minimally invasive surgery maintains its role despite the COVID-19 pandemic, with the registered reduction of cases being proportional to the overall reduction of the HPB surgical activity. Respondents agree that the switch from minimally invasive to open technique can be considered as a valid option for cases with a high technical complexity. Several issues merit specific attention: screening for virus positivity should be universally performed; only expert surgical teams should operate on positive patients and specific technical measures to lower the biological risk of contamination during surgery must be followed. Future studies specifically designed to establish the true risks in minimally invasive surgery are suggested. Furthermore, a standard and univocal process of prioritization of patients from Regional Healthcare Systems is advisable. Electronic supplementary material The online version of this article (10.1007/s13304-020-00815-5) contains supplementary material, which is available to authorized users.

Published
2020

3. Overview of Prognostic Systems for Hepatocellular Carcinoma and ITA.LI.CA External Validation of MESH and CNLC Classifications

Author

Vitale, A, Farinati, F, Finotti, M, Di Renzo, C, Brancaccio, G, Piscaglia, F, Cabibbo, G, Caturelli, E, Missale, G, Marra, F, Sacco, R, Giannini, Eg, Trevisani, F, Cillo, U, Bhoori, S, Borzio, M, Burra, P, Casadei Gardini, A, Carrai, P, Conti, F, Cozzolongo, R, Cucchetti, A, D'Ambrosio, R, Dell'Unto, C, De Matthaeis, N, Di Costanzo, Gg, Di Sandro, S, Famularo, S, Foschi, Fg, Fucilli, F, Galati, G, Gambato, M, Gasbarrini, A, Giuliante, F, Ghinolfi, D, Grieco, A, Gruttadauria, S, Guarino, M, Iavarone, M, Kostandini, A, Lai, Q, Lenci, I, Levi Sandri, Gv, Losito, F, Lupo, Lg, Marasco, G, Manzia, Tm, Mazzocato, S, Masarone, M, Melandro, F, Mescoli, C, Miele, L, Morisco, F, Muley, M, Nicolini, D, Pagano, D, Persico, M, Pompili, M, Ponziani, Fr, Pravisani, R, Rapaccini, Gl, Rendina, M, Renzulli, M, Romano, F, Rossi, M, Rreka, E, Russo, Fp, Sangiovanni, A, Sessa, A, Simonetti, N, Sposito, C, Tortora, R, Vigano, L, Vigano, M, Villa, E, Vincenzi, V, Violi, P, Azzaroli, F, Brunetto, Mr, Di Marco, A, Masotto, A, Mega, A, Nardone, G, Oliveri, F, Raimondo, G, Svegliati Baroni, G, Vidili, G, Zoli, M, Vitale A., Farinati F., Finotti M., Di Renzo C., Brancaccio G., Piscaglia F., Cabibbo G., Caturelli E., Missale G., Marra F., Sacco R., Giannini E.G., Trevisani F., Cillo U., Bhoori S., Borzio M., Burra P., Casadei Gardini A., Carrai P., Conti F., Cozzolongo R., Cucchetti A., D'ambrosio R., Dell'unto C., De Matthaeis N., Di Costanzo G.G., Di Sandro S., Famularo S., Foschi F.G., Fucilli F., Galati G., Gambato M., Gasbarrini A., Giuliante F., Ghinolfi D., Grieco A., Gruttadauria S., Guarino M., Iavarone M., Kostandini A., Lai Q., Lenci I., Levi Sandri G.V., Losito F., Lupo L.G., Marasco G., Manzia T.M., Mazzocato S., Masarone M., Melandro F., Mescoli C., Miele L., Morisco F., Muley M., Nicolini D., Pagano D., Persico M., Pompili M., Ponziani F.R., Pravisani R., Rapaccini G.L., Rendina M., Renzulli M., Romano F., Rossi M., Rreka E., Russo F.P., Sangiovanni A., Sessa A., Simonetti N., Sposito C., Tortora R., Vigano L., Vigano M., Villa E., Vincenzi V., Violi P., Azzaroli F., Brunetto M.R., Di Marco A., Masotto A., Mega A., Nardone G., Oliveri F., Raimondo G., Svegliati Baroni G., Vidili G., Zoli M., Vitale, A., Farinati, F., Finotti, M., Di Renzo, C., Brancaccio, G., Piscaglia, F., Cabibbo, G., Caturelli, E., Missale, G., Marra, F., Sacco, R., Giannini, E. G., Trevisani, F., Cillo, U., Bhoori, S., Borzio, M., Burra, P., Casadei Gardini, A., Carrai, P., Conti, F., Cozzolongo, R., Cucchetti, A., D'Ambrosio, R., Dell'Unto, C., De Matthaeis, N., Di Costanzo, G. G., Di Sandro, S., Famularo, S., Foschi, F. G., Fucilli, F., Galati, G., Gambato, M., Gasbarrini, A., Giuliante, F., Ghinolfi, D., Grieco, A., Gruttadauria, S., Guarino, M., Iavarone, M., Kostandini, A., Lai, Q., Lenci, I., Levi Sandri, G. V., Losito, F., Lupo, L. G., Marasco, G., Manzia, T. M., Mazzocato, S., Masarone, M., Melandro, F., Mescoli, C., Miele, L., Morisco, F., Muley, M., Nicolini, D., Pagano, D., Persico, M., Pompili, M., Ponziani, F. R., Pravisani, R., Rapaccini, G. L., Rendina, M., Renzulli, M., Romano, F., Rossi, M., Rreka, E., Russo, F. P., Sangiovanni, A., Sessa, A., Simonetti, N., Sposito, C., Tortora, R., Vigano, L., Vigano, M., Villa, E., Vincenzi, V., Violi, P., Azzaroli, F., Brunetto, M. R., Di Marco, A., Masotto, A., Mega, A., Nardone, G., Oliveri, F., Raimondo, G., Svegliati Baroni, G., Vidili, G., and Zoli, M.

Subjects
Cancer Research, medicine.medical_specialty, Review, lcsh:RC254-282, Prognostic score, 03 medical and health sciences, 0302 clinical medicine, medicine, In patient, Medical physics, Staging system, monotonicity of gradients, Settore MED/12 - Gastroenterologia, discrimination ability, hepatocellular carcinoma, homogeneity, prognostic performance, prognostic system, business.industry, External validation, Mono-tonicity of gradient, medicine.disease, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Settore MED/18, Oncology, 030220 oncology & carcinogenesis, Hepatocellular carcinoma, Population data, 030211 gastroenterology & hepatology, General health, Liver dysfunction, business
Abstract

Simple Summary This review proposes a comprehensive overview of the main prognostic systems for HCC classified as prognostic scores, staging systems, or combined systems. Prognostic systems for HCC are usually compared in terms of homogeneity, monotonicity of gradients, and discrimination ability. However, despite the great number of published studies comparing HCC prognostic systems, it is rather difficult to identify a system that could be universally accepted as the best prognostic scheme for all HCC patients encountered in clinical practice. In order to give a contribute in this topic, we conducted a study aimed at externally validate the MESH score and the CNLC classification using the ITA.LI.CA database. Abstract Prognostic assessment in patients with HCC remains an extremely difficult clinical task due to the complexity of this cancer where tumour characteristics interact with degree of liver dysfunction, patient general health status, and a large span of available treatment options. Several prognostic systems have been proposed in the last three decades, both from the Asian and European/North American countries. Prognostic scores, such as the CLIP score and the recent MESH score, have been generated on a solid statistical basis from real life population data, while staging systems, such as the BCLC scheme and the recent CNLC classification, have been created by experts according to recent HCC prognostic evidences from the literature. A third category includes combined prognostic systems that can be used both as prognostic scores and staging systems. A recent example is the ITA.LI.CA prognostic system including either a prognostic score and a simplified staging system. This review focuses first on an overview of the main prognostic systems for HCC classified according to the above three categories, and, second, on a comprehensive description of the methodology required for a correct comparison between different systems in terms of prognostic performance. In this second section the main studies in the literature comparing different prognostic systems are described in detail. Lastly, a formal comparison between the last prognostic systems proposed for each of the above three categories is performed using a large Italian database including 6882 HCC patients in order to concretely apply the comparison rules previously described.

Published
2021

4. IntravaScular Lithotripsy for the Management of UndILatable Coronary StEnt: The SMILE Registry

Author

Gabriele Tumminello, Paolo Calabrò, Achille Gaspardone, Piergiuseppe Greco Lucchina, Luca Testa, Francesco Arioli, Fabrizio Ugo, Bindo Missiroli, Fabrizio Tomai, Mauro Maioli, Massimo Leoncini, Bernardo Cortese, Elisabetta Moscarella, Salvatore Colangelo, Alfonso Ielasi, Francesco Bedogni, Maurizio Tespili, Stefano Benedetto, Matteo Pennesi, Gaetano Morabito, Mario Bollati, Gaetano Gioffrè, Elena Vigano, Ielasi, A., Moscarella, E., Testa, L., Gioffre, G., Morabito, G., Cortese, B., Colangelo, S., Tomai, F., Arioli, F., Maioli, M., Leoncini, M., Tumminello, G., Benedetto, S., Lucchina, P. G., Pennesi, M., Ugo, F., Vigano, E., Bollati, M., Missiroli, B., Gaspardone, A., Calabro, P., Bedogni, F., and Tespili, M.

Subjects
medicine.medical_specialty, Percutaneous coronary interventions, medicine.medical_treatment, 030204 cardiovascular system & hematology, Lithotripsy, Coronary Angiography, Balloon, 03 medical and health sciences, 0302 clinical medicine, Refractory, Coronary stent, medicine, Clinical endpoint, Humans, In patient, Registries, 030212 general & internal medicine, Vascular Calcification, Retrospective Studies, business.industry, Intravascular lithotripsy, stent underexpansion, drug eluting stent, Stent, Retrospective cohort study, General Medicine, Surgery, Treatment Outcome, Stents, Cardiology and Cardiovascular Medicine, business
Abstract

Background: Intravascular lithotripsy (IVL) showed to be effective in dilating heavily calcified de novo coronary lesions but little is known about its performance in under-expanded stents management. Aim of this study was to assess the feasibility, effectiveness and safety of IVL for the treatment of stent underexpansion refractory to balloon dilatation. Methods: A multicentre, retrospective cohort analysis was performed in patients undergoing IVL to treat under-expanded stents following non-compliant balloon expansion failure. Primary endpoint was successful IVL dilatation defined as IVL balloon delivery and application at the target site followed by an increase of at least 1 mm2 in minimal stent cross-sectional area (MSA) on intracoronary imaging or an increase of at least 20% in minimal stent diameter (MSD) by quantitative coronary analysis (QCA). Results: Thirty-nine under-expanded stents (34 patients) were included. Two cases (5.1%) of multiple stent layers and one (2.5%) acutely under-expanded stent were treated. The median IVL balloon diameter was 3.1 mm (IQR: 2.5–3.5 mm) while the number of pulses emitted was 56.7 (IQR: 30–80). IVL was successful in 34 cases (87.1%), with significant improvement in MSD (post: 3.23 mm [IQR: 3–3.5 mm] vs. pre: 0.81 mm [IQR: 0.35–1.2], p < 0.00001) and MSA (post: 7.61mm2 [IQR: 6.43–7.79mm2] vs. pre: 3.35 [IQR: 2.8–4 mm2], p < 0.00001). Non-fatal peri-procedural ST-elevation myocardial infarction occurred in one case (2.5%) due to IVL balloon rupture. No cardiac death, target lesion revascularization and stent thrombosis occurred in-hospital and at 30-day follow-up. Conclusions: Bailout IVL was feasible, efficacious and safe to improve refractory stent under-expansion.

Published
2020

5. The economic impact of two diagnostic strategies in the management of restorations in primary teeth: a health economic analysis plan for a trial-based economic evaluation

Author

Raiza Dias Freitas, Bruna Lorena Pereira Moro, Laura Regina Antunes Pontes, Haline Cunha Maia, Ana Laura Passaro, Rodolfo Carvalho Oliveira, Jonathan Rafael Garbim, Maria Eduarda Vigano, Cristopher Deery, Daniela Prócida Raggio, Maximiliano Sergio Cenci, Fausto Medeiros Mendes, Tamara Kerber Tedesco, Mariana Minatel Braga, and collaborative group CARDEC

Subjects
Medicine (General), Cost-Benefit Analysis, Psychological intervention, Medicine (miscellaneous), Time horizon, Study Protocol, Quality of life (healthcare), R5-920, Humans, Medicine, Pharmacology (medical), Operations management, Economic impact analysis, Tooth, Deciduous, Child, Cost–utility analysis, Data collection, business.industry, Cost-effectiveness analysis, Cost-utility analysis, Molar, Economic evaluation, Quality of Life, Dental caries, Quality-Adjusted Life Years, business
Abstract

Background Different approaches have been used by dentists to base their decision. Among them, there are the aesthetical issues that may lead to more interventionist approaches. Indeed, using a more interventionist strategy (the World Dental Federation - FDI), more replacements tend to be indicated than using a minimally invasive one (based on the Caries Around Restorations and Sealants—CARS). Since the resources related to the long-term health effects of these strategies have not been explored, the economic impact of using the less-invasive strategy is still uncertain. Thus, this health economic analysis plan aims to describe methodologic approaches for conducting a trial-based economic evaluation that aims to assess whether a minimally invasive strategy is more efficient in allocating resources than the conventional strategy for managing restorations in primary teeth and extrapolating these findings to a longer time horizon. Methods A trial-based economic evaluation will be conducted, including three cost-effectiveness analyses (CEA) and one cost-utility analysis (CUA). These analyses will be based on the main trial (CARDEC-03/NCT03520309), in which children aged 3 to 10 were included and randomized to one of the diagnostic strategies (based on FDI or CARS). An examiner will assess children’s restorations using the randomized strategy, and treatment will be recommended according to the same criteria. The time horizon for this study is 2 years, and we will adopt the societal perspective. The average costs per child for 24 months will be calculated. Three different cost-effectiveness analyses (CEA) will be performed. For CEAs, the effects will be the number of operative interventions (primary CEA analysis), the time to these new interventions, the percentage of patients who did not need new interventions in the follow-up, and changes in children’s oral health-related quality of life (secondary analyses). For CUA, the effect will be tooth-related quality-adjusted life years (QALYs). Intention-to-treat analyses will be conducted. Finally, we will assess the difference when using the minimally invasive strategy for each health effect (∆effect) compared to the conventional strategy (based on FDI) as the reference strategy. The same will be calculated for related costs (∆cost). The discount rate of 5% will be applied for costs and effects. We will perform deterministic and probabilistic sensitivity analyses to handle uncertainties. The net benefit will be calculated, and acceptability curves plotted using different willingness-to-pay thresholds. Using Markov models, a longer-term economic evaluation will be carried out with trial results extrapolated over a primary tooth lifetime horizon. Discussion The main trial is ongoing, and data collection is still not finished. Therefore, economic evaluation has not commenced. We hypothesize that conventional strategy will be associated with more need for replacements of restorations in primary molars. These replacements may lead to more reinterventions, leading to higher costs after 2 years. The health effects will be a crucial aspect to take into account when deciding whether the minimally invasive strategy will be more efficient in allocating resources than the conventional strategy when considering the management of restorations in primary teeth. Finally, patients/parents preferences and consequent utility values may also influence this final conclusion about the economic aspects of implementing the minimally invasive approach for managing restorations in clinical practice. Therefore, these trial-based economic evaluations may bring actual evidence of the economic impact of such interventions. Trial registration NCT03520309. Registered May 9, 2018. Economic evaluations (the focus of this plan) are not initiated at the moment.

Published
2021

6. THE IMPACT OF TIMELY ACCESS TO AN ASSISTED THERAPY CENTER

Author

Roberta de Almeida Pernambuco, Paula Regina Toche dos Santos, Karina Gatz Capobianco, Vanessa Hax, Luciana Paula Dardin, Ana Carolina Fragoso Motta, Maria Lúcia Lemos Lopes, Virginia Fernandes Moça Trevisani, Valeria Valim, Aiessa Zanchett Fedrigo, Samira Tatiyama Miyamoto, Juliana Markus, Aysa César Pinheiro, Érica Vieira Serrano, Giovanna Sant’Ana Petterle, Fernanda Lourenço Macagnan, Ricardo Machado Xavier, Maria Clara Cardoso Gomes Zampirolli, Alisson Aliel Vigano Pugliesi, Sandra Lúcia Euzébio Ribeiro, Simone Appenzeller, Licia Maria Henrique Mota, Eduardo Rosa, Ketty Lisie Libardi Machado, Gustavo Pafume de Sá, Nathália de Carvalho Sacilotto, Fabiola Reis de Oliveira, Leandro Augusto Tanure, and Laura Caldas

Subjects
medicine.medical_specialty, business.industry, medicine, Disease, Sjogren s, business, Dermatology
Published
2022

7. Taste and smell disturbances in cancer patients: a scoping review of available treatments

Author

Popi Kasvis, MariaLuisa Vigano, Antonio Vigano, and Olga Sevryugin

Subjects
medicine.medical_specialty, Palliative care, business.industry, Pain medicine, Nursing research, MEDLINE, Cancer, CINAHL, medicine.disease, Dysgeusia, 03 medical and health sciences, 0302 clinical medicine, Quality of life (healthcare), Oncology, 030220 oncology & carcinogenesis, medicine, 030212 general & internal medicine, medicine.symptom, Intensive care medicine, business
Abstract

Taste and smell disturbances in patients affected by cancer are very common, but often under-recognized symptoms. If not addressed properly, they may impact nutritional status, food enjoyment, and quality of life. Treatment tools available for clinicians to manage chemosensory alterations are limited and are often based on personal clinical experiences. The aim of this study was to assess current oncological and palliative care literature through a scoping review, in order to identify available treatments for taste and smell alterations in cancer patients. Medline, Embase, CINAHL, ProQuest Dissertations and Theses, and Google Scholar were searched from inception until January 2020, with subject headings relevant to the domains of chemosensory alterations, palliative, and cancer care. A total of 10,718 English and French language publications were reviewed, yielding 43 articles on the researched topic. The heterogeneity of selected articles led to difficulties in interpretation and analysis of the available evidence. Included publications differed in study design, population sample, anticancer treatments, and measures of assessment for taste and smell disturbances. A broad variety of treatment options were described including zinc and polaprezinc, radio-protectors, vitamins and supplements, anti-xerostomia agents, active swallowing exercises, nutritional interventions, delta-9-tetrahydrocannabinol, and photobiomodulation. This scoping review identifies the current state of knowledge regarding chemosensory alterations within supportive cancer care. Despite not reaching firm conclusions, this article offers therapeutic venues to further explore in larger and more methodologically sound studies.

Published
2020

8. A Snapshot of Elective Oncological Surgery in Italy During COVID-19 Emergency

Author

Torzilli G., Vigano L., Galvanin J., Castoro C., Quagliuolo V., Spinelli A., Zerbi A., Donadon M., Montorsi M., de Manzini N, Torzilli, G., Vigano, L., Galvanin, J., Castoro, C., Quagliuolo, V., Spinelli, A., Zerbi, A., Donadon, M., Montorsi, M., and de Manzini, N

Subjects
medicine.medical_specialty, Referral, medicine.medical_treatment, Pneumonia, Viral, MEDLINE, Medical Oncology, surgery, Betacoronavirus, 03 medical and health sciences, 0302 clinical medicine, Interquartile range, Surgical oncology, Neoplasms, medicine, Humans, Viral, Prospective Studies, Prospective cohort study, Pandemics, Neoadjuvant therapy, COVID-19, emergency, Italy, Coronavirus Infections, Patient Selection, Elective Surgical Procedures, Betacoronaviru, Pandemic, Coronavirus Infection, business.industry, General surgery, Pneumonia, medicine.disease, Prospective Studie, 030220 oncology & carcinogenesis, Neoplasm, 030211 gastroenterology & hepatology, Surgery, Sarcoma, Elective Surgical Procedure, business, Human
Abstract

OBJECTIVE: To analyze the impact of COVID-19 emergency on elective oncological surgical activity in Italy. SUMMARY OF BACKGROUND DATA: COVID-19 emergency shocked national health systems, subtracting resources from treatment of other diseases. Its impact on surgical oncology is still to elucidate. METHODS: A 56-question survey regarding the oncological surgical activity in Italy during the COVID-19 emergency was sent to referral centers for hepato-bilio-pancreatic, colorectal, esophago-gastric, and sarcoma/soft-tissue tumors. The survey portrays the situation 5 weeks after the first case of secondary transmission in Italy. RESULTS: In total, 54 surgical Units in 36 Hospitals completed the survey (95%). After COVID-19 emergency, 70% of Units had reduction of hospital beds (median -50%) and 76% of surgical activity (median -50%). The number of surgical procedures decreased: 3.8 (interquartile range 2.7-5.4) per week before the emergency versus 2.6 (22-4.4) after (P = 0.036). In Lombardy, the most involved district, the number decreased from 3.9 to 2 procedures per week. The time interval between multidisciplinary discussion and surgery more than doubled: 7 (6-10) versus 3 (3-4) weeks (P < 0.001). Two-third (n = 34) of departments had repeated multidisciplinary discussion of patients. The commonest criteria to prioritize surgery were tumor biology (80%), time interval from neoadjuvant therapy (61%), risk of becoming unresectable (57%), and tumor-related symptoms (52%). Oncological hub-and-spoke program was planned in 29 departments, but was active only in 10 (19%). CONCLUSIONS: This survey showed how surgical oncology suffered remarkable reduction of the activity resulting in doubled waiting-list. The oncological hub-and-spoke program did not work adequately. The reassessment of healthcare systems to better protect the oncological path seems a priority.

Published
2020

9. Protocol for a phase II, multicenter, open-label, randomized controlled trial to compare the efficacy of gamification using Nintendo Switch Ring Fit Adventure game versus standard exercise in the treatment of fibromyalgia

Author

Carla Darrás Ismael, Michelle Menon Miyake, Romelia Barba Bernal, Aline Zimmermann de Azambuja, Luís Fábio Barbosa Botelho, Antonio Vaz de Macedo, Alisson Aliel Vigano Pugliesi, Manasa Kotte, Sara Saeed Ibrahim Mohamed, Maria Fe Velarde-Alvarez, Thiago Ramos Grigio, Cristina Lemos Barbosa Furia, Katharina Requião Barretto Bezerra, Letícia Araujo Pinholato, Franciely Jesus Guedes, Natália Prado Boris, Sofia Leonardo, and Vivian Henriques do Amaral

Subjects
Chronic condition, medicine.medical_specialty, business.industry, Dysfunctional family, medicine.disease, law.invention, Superiority Trial, Randomized controlled trial, Quality of life, law, Fibromyalgia, Physical therapy, Medicine, Anxiety, medicine.symptom, business, Depression (differential diagnoses)
Abstract

Background: Fibromyalgia (FM) is a chronic condition related to dysfunctional central pain processing mechanisms, which affects 3-6% of the world population, leading to widespread pain, stiffness, and tenderness of the muscles, tendons, and joints, as well as restless sleep, fatigue, depression, and anxiety. Exercise is the most effective way of reducing pain and improving global well-being in people with FM, but such patients present an important limitation to exercise adherence. Objective: We aim to evaluate whether a home-based gamification strategy will improve the Fibromyalgia Impact Questionnaire Revised (FIQR) scores in female patients aged 18-60 years old as an alternative to traditional exercise. Methods: The proposed trial is a multicenter, phase II, open-label, parallel, randomized, superiority trial. Female patients ranging from 18 to 60 years old with a diagnosis of FM will be randomized to the intervention group, designed to play the Nintendo Switch Ring Fit Adventure game on three home-based weekly sessions, or to the control group, which will receive general educational guidance through videos and pamphlets provided by the study staff for a total of 12 weeks. The primary outcome will be the mean change in FIQR score results. Discussion: The development of new strategies to increase exercise adherence can enhance the control of symptoms such as pain, depression, low quality of sleep, and physical limitation in FM patients, thereby improving their quality of life. We believe that gamification strategies such as the one used here can make physical activity more playful, accessible, and dynamic, motivating patients and increasing their physical function compared to those seeking center-based or conventional exercises.

Published
2021

10. How radical prostatectomy procedures have changed over the last 10 years in Italy: a comparative analysis based on more than 1500 patients participating in the MIRROR-SIU/LUNA and the Pros-IT CNR study

Author

Gacci, M., Artibani, W., Bassi, P., Bertoni, F., Bracarda, S., Briganti, A., Carmignani, G., Carmignani, L., Conti, G., Corvo, R., De Nunzio, C., Fusco, F., Graziotti, P., Greco, I., Maggi, S., Magrini, S. M., Mirone, V., Montironi, R., Morgia, G., Muto, G., Noale, M., Pecoraro, S., Porreca, A., Ricardi, U., Russi, E., Russo, G., Salonia, A., Simonato, A., Serni, S., Tomasini, D., Tubaro, A., Zagonel, V., Crepaldi, G., Conti, G. N., Alitto, A. R., Ambrosi, E., Antonelli, A., Aristei, C., Bardari, F., Bardoscia, L., Barra, S., Bartoncini, S., Basso, U., Becherini, C., Bellavita, R., Bergamaschi, F., Berlingheri, S., Berruti, A., Borghesi, M., Bortolus, R., Borzillo, V., Bosetti, D., Bove, G., Bove, P., Brausi, M., Bruni, A., Bruno, G., Brunocilla, E., Buffoli, A., Buglione, M., Buttigliero, C., Cacciamani, G., Caldiroli, M., Cardo, G., Carrieri, G., Castelli, E., Castrezzati, E., Catalano, G., Cattarino, S., Catucci, F., Cavallini Francolini, D., Ceccarini, O., Celia, A., Chiancone, F., Chini, T., Cianci, C., Cisternino, A., Collura, D., Corbella, F., Corinti, M., Corsi, P., Cortese, F., Corti, L., Decosimo, N., Cristiano, O., Rolando, D. A., Da Pozzo, L., D'Agostino, D., D'Elia, C., Dandrea, M., De Angelis, M., De Angelis, P., De Cobelli, O., De Concilio, B., De Lisa, A., De Luca, S., De Stefani, A., Deantoni, C. L., Degli Esposti, C., Destito, A., Detti, B., Di Muzio, N., Di Stasio, A., Di Stefano, C., Di Trapani, D., Difino, G., Falivene, S., Farullo, G., Fedelini, P., Ferrari, I., Ferrau, F., Ferro, M., Fodor, A., Fontana, F., Francesca, F., Francolini, G., Frata, P., Frezza, G., Gabriele, P., Galeandro, M., Garibaldi, E., Gennari, P. G., Gentilucci, A., Giacobbe, A., Giussani, L., Giusti, G., Gontero, P., Guarneri, A., Guida, C., Gurioli, A., Huqi, D., Imbimbo, C., Ingrosso, G., Iotti, C., Italia, C., La Mattina, P., La Rocca, R., Lamanna, E., Lastrucci, L., Lazzari, G., Liberale, F., Liguori, G., Lisi, R., Lohr, F., Lombardo, R., Lovisolo, J. A., Ludovico, G. M., Macchione, N., Maggio, F., Malizia, M., Manasse, G., Mandoliti, G., Mantini, G., Marafioti, L., Marciello, L., Marconi, A. M., Martilotta, A., Marzano, S., Masciullo, S., Maso, G., Massenzo, A., Mazzeo, E., Mearini, L., Medoro, S., Mole, R., Monesi, G., Montanari, E., Montefiore, F., Montesi, G., Moro, G., Muscas, G., Musio, D., Muto, P., Muzzonigro, G., Napodano, G., Negro, C. L. A., Nidini, M., Ntreta, M., Orsatti, M., Palazzolo, C., Palumbo, I., Parisi, A., Parma, P., Pavan, N., Pericolini, M., Pinto, F., Pistone, A., Pizzuti, V., Platania, A., Polli, C., Pomara, G., Ponti, E., Porcaro, A. B., Porpiglia, F., Pugliese, D., Pycha, A., Raguso, G., Rampini, A., Randone, D. F., Roboldi, V., Roscigno, M., Ruggieri, M. P., Ruoppo, G., Sanseverino, R., Santacaterina, A., Santarsieri, M., Santoni, R., Scagliarini, S., Scagliotti, G. V., Scanzi, M., Scarcia, M., Schiavina, R., Sciarra, A., Sciorio, C., Scolaro, T., Scuzzarella, S., Selvaggio, O., Serao, A., Signor, M. A., Silvani, M., Silvano, G., Silvestris, F., Simeone, C., Simone, V., Spagnoletti, G., Spinelli, M. G., Squillace, L., Tombolini, V., Toninelli, M., Triggiani, L., Trinchieri, A., Trodella, L., Luca, E., Trombetta, C., Tronnolone, L., Tucci, M., Urzi, D., Valdagni, R., Valeriani, M., Vanoli, M., Vitali, E., Volpe, A., Zaramella, S., Zeccolini, G., Zini, G., Acanfora, F., Aiello, E., Alchiede, S., Altieri, V., Anceschi, C., Aragona, F., Balloni, F., Barasolo, E., Barba, G., Bartoletti, R., Bigazzi, B., Belgrano, E., Salvatore, S., Battaglia, M., Bellei, L., Bettin, A., Bianchi, G., Bombieri, L., Brancato, T., Breda, G., Caggiano, S., Calabro, A., Caldironi, M., Campo, B., Capobianco, S., Capparelli, F., Carbone, A., Carlo, D., Catanzaro, F., Ciaraldi, F., Cicalese, V., Corbu, C., Cosciani Cunico, S., Cosentino, V., Crimi, A., Cucchiarale, G., Cuscuna, D., Damiano, R., D'Armiento, M., De Dominicis, C., De Grande, G., Del Boca, C., D'Elia, A., De Mayo, E., De Martin, M., Di Clemente, L., Di Meo, S., Di Monaco, G., Di Nicola, G., Di Silverio, A., Di Silverio, F., Fabri, F., Falsaperla, M., Fanciullacci, F., Ferrari, G., Fiaccavento, G., Filoni, A., Fontana, D., Fontana, G., Ghabin, H., Frea, B., Gaboardi, F., Gentile, V., Giandotti, M., Grasso, M., Grosso, G., Guazzieri, S., Isaia, A., Landi, G., Landolfi, R., Larcher, P., Laurenti, C., Lavelli, D., Leidi, G. L., Lembo, A., Leoni, S., Maffei, N., Maffezzini, M., Martinengo, C., Manieri, C., Martorana, G., Mazza, R., Medica, M., Melloni, D., Miano, L., Micheli, E., Milesi, R., Minervini, M. S., Minocci, D., Molon, A., Morello, P., Motta, M., Narcisi, F., Nicita, G., Palermo, S., Paoluzzi, M., Pompa, P., Porena, M., Raciti, G., Rizzotto, A., Rocco, F., Romano, M., Rossini, L., Russo, G. R., Salvioni, R., Sandri, S., Savoca, G., Selli, C., Selvaggi, F. P., Sercia, F., Tallarigo, C., Tanello, M., Tasca, A., Tenaglia, R., Tensi, M., Terrone, C., Tralce, L., Vagge, A., Valenti, P., Varaldo, M., Vespasiani, G., Vicentini, C., Vicirca, F., Vigano, P., Zaccone, V., Zartar, C., Gacci, M., Artibani, W., Bassi, P., Bertoni, F., Bracarda, S., Briganti, A., Carmignani, G., Carmignani, L., Conti, G., Corvo, R., De Nunzio, C., Fusco, F., Graziotti, P., Greco, I., Maggi, S., Magrini, S. M., Mirone, V., Montironi, R., Morgia, G., Muto, G., Noale, M., Pecoraro, S., Porreca, A., Ricardi, U., Russi, E., Russo, G., Salonia, A., Simonato, A., Serni, S., Tomasini, D., Tubaro, A., Zagonel, V., Crepaldi, G., Conti, G. N., Alitto, A. R., Ambrosi, E., Antonelli, A., Aristei, C., Bardari, F., Bardoscia, L., Barra, S., Bartoncini, S., Basso, U., Becherini, C., Bellavita, R., Bergamaschi, F., Berlingheri, S., Berruti, A., Borghesi, M., Bortolus, R., Borzillo, V., Bosetti, D., Bove, G., Bove, P., Brausi, M., Bruni, A., Bruno, G., Brunocilla, E., Buffoli, A., Buglione, M., Buttigliero, C., Cacciamani, G., Caldiroli, M., Cardo, G., Carrieri, G., Castelli, E., Castrezzati, E., Catalano, G., Cattarino, S., Catucci, F., Cavallini Francolini, D., Ceccarini, O., Celia, A., Chiancone, F., Chini, T., Cianci, C., Cisternino, A., Collura, D., Corbella, F., Corinti, M., Corsi, P., Cortese, F., Corti, L., Decosimo, N., Cristiano, O., Rolando, D. A., Da Pozzo, L., D'Agostino, D., D'Elia, C., Dandrea, M., De Angelis, M., De Angelis, P., De Cobelli, O., De Concilio, B., De Lisa, A., De Luca, S., De Stefani, A., Deantoni, C. L., Degli Esposti, C., Destito, A., Detti, B., Di Muzio, N., Di Stasio, A., Di Stefano, C., Di Trapani, D., Difino, G., Falivene, S., Farullo, G., Fedelini, P., Ferrari, I., Ferrau, F., Ferro, M., Fodor, A., Fontana, F., Francesca, F., Francolini, G., Frata, P., Frezza, G., Gabriele, P., Galeandro, M., Garibaldi, E., Gennari, P. G., Gentilucci, A., Giacobbe, A., Giussani, L., Giusti, G., Gontero, P., Guarneri, A., Guida, C., Gurioli, A., Huqi, D., Imbimbo, C., Ingrosso, G., Iotti, C., Italia, C., La Mattina, P., La Rocca, R., Lamanna, E., Lastrucci, L., Lazzari, G., Liberale, F., Liguori, G., Lisi, R., Lohr, F., Lombardo, R., Lovisolo, J. A., Ludovico, G. M., Macchione, N., Maggio, F., Malizia, M., Manasse, G., Mandoliti, G., Mantini, G., Marafioti, L., Marciello, L., Marconi, A. M., Martilotta, A., Marzano, S., Masciullo, S., Maso, G., Massenzo, A., Mazzeo, E., Mearini, L., Medoro, S., Mole, R., Monesi, G., Montanari, E., Montefiore, F., Montesi, G., Moro, G., Muscas, G., Musio, D., Muto, P., Muzzonigro, G., Napodano, G., Negro, C. L. A., Nidini, M., Ntreta, M., Orsatti, M., Palazzolo, C., Palumbo, I., Parisi, A., Parma, P., Pavan, N., Pericolini, M., Pinto, F., Pistone, A., Pizzuti, V., Platania, A., Polli, C., Pomara, G., Ponti, E., Porcaro, A. B., Porpiglia, F., Pugliese, D., Pycha, A., Raguso, G., Rampini, A., Randone, D. F., Roboldi, V., Roscigno, M., Ruggieri, M. P., Ruoppo, G., Sanseverino, R., Santacaterina, A., Santarsieri, M., Santoni, R., Scagliarini, S., Scagliotti, G. V., Scanzi, M., Scarcia, M., Schiavina, R., Sciarra, A., Sciorio, C., Scolaro, T., Scuzzarella, S., Selvaggio, O., Serao, A., Signor, M. A., Silvani, M., Silvano, G., Silvestris, F., Simeone, C., Simone, V., Spagnoletti, G., Spinelli, M. G., Squillace, L., Tombolini, V., Toninelli, M., Triggiani, L., Trinchieri, A., Trodella, L., Luca, E., Trombetta, C., Tronnolone, L., Tucci, M., Urzi, D., Valdagni, R., Valeriani, M., Vanoli, M., Vitali, E., Volpe, A., Zaramella, S., Zeccolini, G., Zini, G., Acanfora, F., Aiello, E., Alchiede, S., Altieri, V., Anceschi, C., Aragona, F., Balloni, F., Barasolo, E., Barba, G., Bartoletti, R., Bigazzi, B., Belgrano, E., Salvatore, S., Battaglia, M., Bellei, L., Bettin, A., Bianchi, G., Bombieri, L., Brancato, T., Breda, G., Caggiano, S., Calabro, A., Caldironi, M., Campo, B., Capobianco, S., Capparelli, F., Carbone, A., Carlo, D., Catanzaro, F., Ciaraldi, F., Cicalese, V., Corbu, C., Cosciani Cunico, S., Cosentino, V., Crimi, A., Cucchiarale, G., Cuscuna, D., Damiano, R., D'Armiento, M., De Dominicis, C., De Grande, G., Del Boca, C., D'Elia, A., De Mayo, E., De Martin, M., Di Clemente, L., Di Meo, S., Di Monaco, G., Di Nicola, G., Di Silverio, A., Di Silverio, F., Fabri, F., Falsaperla, M., Fanciullacci, F., Ferrari, G., Fiaccavento, G., Filoni, A., Fontana, D., Fontana, G., Ghabin, H., Frea, B., Gaboardi, F., Gentile, V., Giandotti, M., Grasso, M., Grosso, G., Guazzieri, S., Isaia, A., Landi, G., Landolfi, R., Larcher, P., Laurenti, C., Lavelli, D., Leidi, G. L., Lembo, A., Leoni, S., Maffei, N., Maffezzini, M., Martinengo, C., Manieri, C., Martorana, G., Mazza, R., Medica, M., Melloni, D., Miano, L., Micheli, E., Milesi, R., Minervini, M. S., Minocci, D., Molon, A., Morello, P., Motta, M., Narcisi, F., Nicita, G., Palermo, S., Paoluzzi, M., Pompa, P., Porena, M., Raciti, G., Rizzotto, A., Rocco, F., Romano, M., Rossini, L., Russo, G. R., Salvioni, R., Sandri, S., Savoca, G., Selli, C., Selvaggi, F. P., Sercia, F., Tallarigo, C., Tanello, M., Tasca, A., Tenaglia, R., Tensi, M., Terrone, C., Tralce, L., Vagge, A., Valenti, P., Varaldo, M., Vespasiani, G., Vicentini, C., Vicirca, F., Vigano, P., Zaccone, V., Zartar, C., Gacci M., Artibani W., Bassi P., Bertoni F., Bracarda S., Briganti A., Carmignani G., Carmignani L., Conti G., Corvo R., De Nunzio C., Fusco F., Graziotti P., Greco I., Maggi S., Magrini S.M., Mirone V., Montironi R., Morgia G., Muto G., Noale M., Pecoraro S., Porreca A., Ricardi U., Russi E., Russo G., Salonia A., Simonato A., Serni S., Tomasini D., Tubaro A., Zagonel V., Crepaldi G., Conti G.N., Alitto A.R., Ambrosi E., Antonelli A., Aristei C., Bardari F., Bardoscia L., Barra S., Bartoncini S., Basso U., Becherini C., Bellavita R., Bergamaschi F., Berlingheri S., Berruti A., Borghesi M., Bortolus R., Borzillo V., Bosetti D., Bove G., Bove P., Brausi M., Bruni A., Bruno G., Brunocilla E., Buffoli A., Buglione M., Buttigliero C., Cacciamani G., Caldiroli M., Cardo G., Carrieri G., Castelli E., Castrezzati E., Catalano G., Cattarino S., Catucci F., Cavallini Francolini D., Ceccarini O., Celia A., Chiancone F., Chini T., Cianci C., Cisternino A., Collura D., Corbella F., Corinti M., Corsi P., Cortese F., Corti L., deCosimo N., Cristiano O., Rolando D.A., Da Pozzo L., D'Agostino D., D'Elia C., Dandrea M., De Angelis M., De Angelis P., De Cobelli O., De Concilio B., De Lisa A., De Luca S., De Stefani A., Deantoni C.L., Degli Esposti C., Destito A., Detti B., Di Muzio N., Di Stasio A., Di Stefano C., Di Trapani D., Difino G., Falivene S., Farullo G., Fedelini P., Ferrari I., Ferrau F., Ferro M., Fodor A., Fontana F., Francesca F., Francolini G., Frata P., Frezza G., Gabriele P., Galeandro M., Garibaldi E., Gennari P.G., Gentilucci A., Giacobbe A., Giussani L., Giusti G., Gontero P., Guarneri A., Guida C., Gurioli A., Huqi D., Imbimbo C., Ingrosso G., Iotti C., Italia C., La Mattina P., La Rocca R., Lamanna E., Lastrucci L., Lazzari G., Liberale F., Liguori G., Lisi R., Lohr F., Lombardo R., Lovisolo J.A., Ludovico G.M., Macchione N., Maggio F., Malizia M., Manasse G., Mandoliti G., Mantini G., Marafioti L., Marciello L., Marconi A.M., Martilotta A., Marzano S., Masciullo S., Maso G., Massenzo A., Mazzeo E., Mearini L., Medoro S., Mole R., Monesi G., Montanari E., Montefiore F., Montesi G., Moro G., Muscas G., Musio D., Muto P., Muzzonigro G., Napodano G., Negro C.L.A., Nidini M., Ntreta M., Orsatti M., Palazzolo C., Palumbo I., Parisi A., Parma P., Pavan N., Pericolini M., Pinto F., Pistone A., Pizzuti V., Platania A., Polli C., Pomara G., Ponti E., Porcaro A.B., Porpiglia F., Pugliese D., Pycha A., Raguso G., Rampini A., Randone D.F., Roboldi V., Roscigno M., Ruggieri M.P., Ruoppo G., Sanseverino R., Santacaterina A., Santarsieri M., Santoni R., Scagliarini S., Scagliotti G.V., Scanzi M., Scarcia M., Schiavina R., Sciarra A., Sciorio C., Scolaro T., Scuzzarella S., Selvaggio O., Serao A., Signor M.A., Silvani M., Silvano G., Silvestris F., Simeone C., Simone V., Spagnoletti G., Spinelli M.G., Squillace L., Tombolini V., Toninelli M., Triggiani L., Trinchieri A., Trodella L., Luca E., Trombetta C., Tronnolone L., Tucci M., Urzi D., Valdagni R., Valeriani M., Vanoli M., Vitali E., Volpe A., Zaramella S., Zeccolini G., Zini G., Acanfora F., Aiello E., Alchiede S., Altieri V., Anceschi C., Aragona F., Balloni F., Barasolo E., Barba G., Bartoletti R., Bigazzi B., Belgrano E., Salvatore S., Battaglia M., Bellei L., Bettin A., Bianchi G., Bombieri L., Brancato T., Breda G., Caggiano S., Calabro A., Caldironi M., Campo B., Capobianco S., Capparelli F., Carbone A., Carlo D., Catanzaro F., Ciaraldi F., Cicalese V., Corbu C., Cosciani Cunico S., Cosentino V., Crimi A., Cucchiarale G., Cuscuna D., Damiano R., D'Armiento M., De Dominicis C., De Grande G., Del Boca C., D'Elia A., De Mayo E., De Martin M., Di Clemente L., Di Meo S., Di Monaco G., Di Nicola G., Di Silverio A., Di Silverio F., Fabri F., Falsaperla M., Fanciullacci F., Ferrari G., Fiaccavento G., Filoni A., Fontana D., Fontana G., Ghabin H., Frea B., Gaboardi F., Gentile V., Giandotti M., Grasso M., Grosso G., Guazzieri S., Isaia A., Landi G., Landolfi R., Larcher P., Laurenti C., Lavelli D., Leidi G.L., Lembo A., Leoni S., Maffei N., Maffezzini M., Martinengo C., Manieri C., Martorana G., Mazza R., Medica M., Melloni D., Miano L., Micheli E., Milesi R., Minervini M.S., Minocci D., Molon A., Morello P., Motta M., Narcisi F., Nicita G., Palermo S., Paoluzzi M., Pompa P., Porena M., Raciti G., Rizzotto A., Rocco F., Romano M., Rossini L., Russo G.R., Salvioni R., Sandri S., Savoca G., Selli C., Selvaggi F.P., Sercia F., Tallarigo C., Tanello M., Tasca A., Tenaglia R., Tensi M., Terrone C., Tralce L., Vagge A., Valenti P., Varaldo M., Vespasiani G., Vicentini C., Vicirca F., Vigano P., Zaccone V., Zartar C., Gacci, Mauro, Artibani, Walter, Bassi, Pierfrancesco, Bertoni, Filippo, Bracarda, Sergio, Briganti, Alberto, Carmignani, Giorgio, Carmignani, Luca, Conti, Giario, Corvò, Renzo, De Nunzio, Cosimo, Fusco, Ferdinando, Graziotti, Pierpaolo, Greco, Isabella, Maggi, Stefania, Magrini, Stefano Maria, Mirone, Vincenzo, Montironi, Rodolfo, Morgia, Giuseppe, Muto, Giovanni, Noale, Marianna, Pecoraro, Stefano, Porreca, Angelo, Ricardi, Umberto, Russi, Elvio, Russo, Giorgio, Salonia, Andrea, Simonato, Alchiede, Serni, Sergio, Tomasini, Davide, Tubaro, Andrea, Zagonel, Vittorina, and Crepaldi, Gaetano

Subjects
Male, Nephrology, medicine.medical_specialty, Time Factors, Urology, medicine.medical_treatment, 030232 urology & nephrology, Lymph node dissection, Logistic regression, 03 medical and health sciences, Prostate cancer, 0302 clinical medicine, Internal medicine, LUNA study, Biopsy, Humans, Medicine, Prospective Studies, Nerve sparing, Lymph node, Aged, Prostatectomy, medicine.diagnostic_test, business.industry, MIRROR SIU/LUNA study, Lymph node dissection, MIRROR SIU/LUNA study, Nerve sparing, Pros-IT CNR study, Prostate cancer, Robotic procedures, Prostatic Neoplasms, Cancer, Pros-IT CNR study, Middle Aged, medicine.disease, MIRROR SIU, Dissection, Robotic procedures, Logistic Models, medicine.anatomical_structure, Italy, 030220 oncology & carcinogenesis, business
Abstract

Purpose Therapeutic strategies for prostate cancer (PCa) have been evolving dramatically worldwide. The current article reports on the evolution of surgical management strategies for PCa in Italy. Methods The data from two independent Italian multicenter projects, the MIRROR-SIU/LUNA (started in 2007, holding data of 890 patients) and the Pros-IT-CNR project (started in 2014, with data of 692 patients), were compared. Differences in patients' characteristics were evaluated. Multivariable logistic regression models were used to identify characteristics associated with robot-assisted (RA) procedure, nerve sparing (NS) approach, and lymph node dissection (LND). Results The two cohorts did not differ in terms of age and prostate-specific antigen (PSA) levels at biopsy. Patients enrolled in the Pros-IT-CNR project more frequently were submitted to RA (58.8% vs 27.6%,p < 0.001) and NS prostatectomy (58.4% vs. 52.9%,p = 0.04), but received LND less frequently (47.7% vs. 76.7%,p < 0.001), as compared to the MIRROR-SIU/LUNA patients. At multivariate logistic models, Lower Gleason Scores (GS) and PSA levels were significantly associated with RA prostatectomy in both cohorts. As for the MIRROR-SIU/LUNA data, clinical T-stage was a predictor for NS (OR = 0.07 for T3, T4) and LND (OR = 2.41 for T2) procedures. As for Pros-IT CNR data, GS >= (4 + 3) and positive cancer cores >= 50% were decisive factors both for NS (OR 0.29 and 0.30) and LND (OR 7.53 and 2.31) strategies. Conclusions PCa management has changed over the last decade in Italian centers: RA and NS procedures without LND have become the methods of choice to treat newly medium-high risk diagnosed PCa.

Published
2021

11. Technical feasibility and short-term outcomes of laparoscopic isolated caudate lobe resection: an IgoMILS (Italian Group of Minimally Invasive Liver Surgery) registry-based study

Author

Ruzzenente A., Ciangherotti A., Aldrighetti L., Ettorre G. M., De Carlis L., Ferrero A., Dalla Valle R., Tisone G., Guglielmi A., Ratti F., Gringeri E., Russolillo N., Campagnaro T., Conci S., Sandri G. B. L., Ardito F., Boggi U., Gruttadauria S., Vigano L., Di Benedetto F., Rossi G. E., Berti S., Ceccarelli G., Vincenti L., Cillo U., Giuliante F., Mazzaferro V., Jovine E., Calise F., Belli G., Zamboni F., Coratti A., Mezzatesta P., Santambrogio R., Navarra G., Giuliani A., Ferla F., Pinna A. D., Parisi A., Colledan M., Slim A., Antonucci A., Grazi G. L., Frena A., Sgroi G., Brolese A., Morelli L., Floridi A., Patriti A., Veneroni L., Boni L., Maida P., Griseri G., Filauro M., Guerriero S., Romito R., Tedeschi U., Zimmitti G., Ruzzenente, A., Ciangherotti, A., Aldrighetti, L., Ettorre, G. M., De Carlis, L., Ferrero, A., Dalla Valle, R., Tisone, G., Guglielmi, A., Ratti, F., Gringeri, E., Russolillo, N., Campagnaro, T., Conci, S., Sandri, G. B. L., Ardito, F., Boggi, U., Gruttadauria, S., Vigano, L., Di Benedetto, F., Rossi, G. E., Berti, S., Ceccarelli, G., Vincenti, L., Cillo, U., Giuliante, F., Mazzaferro, V., Jovine, E., Calise, F., Belli, G., Zamboni, F., Coratti, A., Mezzatesta, P., Santambrogio, R., Navarra, G., Giuliani, A., Ferla, F., Pinna, A. D., Parisi, A., Colledan, M., Slim, A., Antonucci, A., Grazi, G. L., Frena, A., Sgroi, G., Brolese, A., Morelli, L., Floridi, A., Patriti, A., Veneroni, L., Boni, L., Maida, P., Griseri, G., Filauro, M., Guerriero, S., Romito, R., Tedeschi, U., Zimmitti, G., Ruzzenente, A, Ciangherotti, A, Aldrighetti, L, Ettorre, G, De Carlis, L, Ferrero, A, Dalla Valle, R, Tisone, G, Guglielmi, A, Ratti, F, Gringeri, E, Russolillo, N, Campagnaro, T, Conci, S, Sandri, G, Ardito, F, Boggi, U, Gruttadauria, S, Vigano, L, Di Benedetto, F, Rossi, G, Berti, S, Ceccarelli, G, Vincenti, L, Cillo, U, Giuliante, F, Mazzaferro, V, Jovine, E, Calise, F, Belli, G, Zamboni, F, Coratti, A, Mezzatesta, P, Santambrogio, R, Navarra, G, Giuliani, A, Ferla, F, Pinna, A, Parisi, A, Colledan, M, Slim, A, Antonucci, A, Grazi, G, Frena, A, Sgroi, G, Brolese, A, Morelli, L, Floridi, A, Patriti, A, Veneroni, L, Boni, L, Maida, P, Griseri, G, Filauro, M, Guerriero, S, Romito, R, Tedeschi, U, and Zimmitti, G

Subjects
medicine.medical_specialty, Carcinoma, Hepatocellular, Settore MED/18 - CHIRURGIA GENERALE, Article, NO, Cohort Studies, 03 medical and health sciences, Liver disease, 0302 clinical medicine, Postoperative Complications, Caudate lobe, Open Resection, Internal medicine, medicine, Hepatectomy, Humans, Multi-institutional, Prospective Studies, Registries, Propensity Score, Contraindication, Retrospective Studies, LS7_4, Intrahepatic, business.industry, Carcinoma, Liver Neoplasms, Minimally invasive liver surgery, Hepatocellular, Perioperative, Hepatology, Length of Stay, medicine.disease, Surgery, Settore MED/18, Bile Ducts, Intrahepatic, Bile Duct Neoplasms, 030220 oncology & carcinogenesis, Hepatocellular carcinoma, Propensity score matching, Feasibility Studies, 030211 gastroenterology & hepatology, Laparoscopy, Bile Ducts, business, Propensity score matched, Abdominal surgery
Abstract

Background Although isolated caudate lobe (CL) liver resection is not a contraindication for minimally invasive liver surgery (MILS), feasibility and safety of the procedure are still poorly investigated. To address this gap, we evaluate data on the Italian prospective maintained database on laparoscopic liver surgery (IgoMILS) and compare outcomes between MILS and open group. Methods Perioperative data of patients with malignancies, as colorectal liver metastases (CRLM), hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), non-colorectal liver metastases (NCRLM) and benign liver disease, were retrospectively analyzed. A propensity score matching (PSM) analysis was performed to balance the potential selection bias for MILS and open group. Results A total of 224 patients were included in the study, 47 and 177 patients underwent MILS and open isolated CL resection, respectively. The overall complication rate was comparable between the two groups; however, severe complication rate (Dindo–Clavien grade ≥ 3) was lower in the MILS group (0% versus 6.8%, P = ns). In-hospital mortality was 0% in both groups and mean hospital stay was significantly shorter in the MILS group (P = 0.01). After selection of 42 MILS and 43 open CL resections by PSM analysis, intraoperative and postoperative outcomes remained similar except for the hospital stay which was not significantly shorter in MILS group. Conclusions This multi-institutional cohort study shows that MILS CL resection is feasible and safe. The surgical procedure can be technically demanding compared to open resection, whereas good perioperative outcomes can be achieved in highly selected patients.

Published
2021

12. Inflammatory Bowel Disease and Oral Radiological Manifestions

Author

Cinzia Casu, Viola Vigano, Grendele Marta, Luca Viganò, Moneta Alessandra, Hazbiu Sea, Riva Giulia, and Pasqual Giorgia

Subjects
medicine.medical_specialty, business.industry, Radiological weapon, Internal medicine, medicine, General Medicine, medicine.disease, business, Gastroenterology, Inflammatory bowel disease
Published
2021

13. Treatment with tenofovir disoproxil fumarate or entecavir in chronic hepatitis B virus-infected patients with renal impairment: results from a 7-year, multicentre retrospective cohort study

Author

Lampertico P., Berg T., Buti M., Pathil A., Petersen J., Ryder S. D., Zoulim F., Botros I., Flaherty J. F., Jump B., Op den Brouw M. L., van Troostenburg A., Ramroth H., Bourliere M., De Ledinghen V., Riachi G., Loustaud-Ratti V., Tran A., Larrey D., Dumortier J., Leroy V., Metivier S., Sellier P., Mauss S., Peterson J., Schiefke I., Niederau C., Teuber G., Goeser T., Jung M. C., Grambihler A., Pathil-Warth A., Sprinzl K., Von der Ohe M., Antoni C., Weigand K., Andreone P., Di Marco V., Madonia S., Puoti M., Santantonio T., Vigano M., Ciancio A., D'Offizi G., Pirisi M., Suarez Garcia E., Pascasio Acevedo J. M., Andrade R., Gea F., Serra Desfilis M. A., Molina Perez E., Manzano Alonso M., Carrion J. A., Aoufi Rabih S., Planas M. M., Ryder S., Agarwal K., Ustianowski A., Aspinall R., Kennedy P., Geretti A. M., McCorry R., Foxton M., Healy B., Lampertico P., Berg T., Buti M., Pathil A., Petersen J., Ryder S.D., Zoulim F., Botros I., Flaherty J.F., Jump B., Op den Brouw M.L., van Troostenburg A., Ramroth H., Bourliere M., De Ledinghen V., Riachi G., Loustaud-Ratti V., Tran A., Larrey D., Dumortier J., Leroy V., Metivier S., Sellier P., Mauss S., Peterson J., Schiefke I., Niederau C., Teuber G., Goeser T., Jung M.C., Grambihler A., Pathil-Warth A., Sprinzl K., Von der Ohe M., Antoni C., Weigand K., Andreone P., Di Marco V., Madonia S., Puoti M., Santantonio T., Vigano M., Ciancio A., D'Offizi G., Pirisi M., Suarez Garcia E., Pascasio Acevedo J.M., Andrade R., Gea F., Serra Desfilis M.A., Molina Perez E., Manzano Alonso M., Carrion J.A., Aoufi Rabih S., Planas M.M., Ryder S., Agarwal K., Ustianowski A., Aspinall R., Kennedy P., Geretti A.M., McCorry R., Foxton M., Healy B., Lampertico, P, Berg, T, Buti, M, Pathil, A, Petersen, J, Ryder, S, Zoulim, F, Botros, I, Flaherty, J, Jump, B, Op den Brouw, M, van Troostenburg, A, Ramroth, H, Bourliere, M, De Ledinghen, V, Riachi, G, Loustaud-Ratti, V, Tran, A, Larrey, D, Dumortier, J, Leroy, V, Metivier, S, Sellier, P, Mauss, S, Peterson, J, Schiefke, I, Niederau, C, Teuber, G, Goeser, T, Jung, M, Grambihler, A, Pathil-Warth, A, Sprinzl, K, Von der Ohe, M, Antoni, C, Weigand, K, Andreone, P, Di Marco, V, Madonia, S, Puoti, M, Santantonio, T, Vigano, M, Ciancio, A, D'Offizi, G, Pirisi, M, Suarez Garcia, E, Pascasio Acevedo, J, Andrade, R, Gea, F, Serra Desfilis, M, Molina Perez, E, Manzano Alonso, M, Carrion, J, Aoufi Rabih, S, Planas, M, Agarwal, K, Ustianowski, A, Aspinall, R, Kennedy, P, Geretti, A, Mccorry, R, Foxton, M, and Healy, B

Subjects
Male, Adult, medicine.medical_specialty, Guanine, Tenofovir, MEDLINE, Antiviral Agents, Virus, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Hepatitis B, Chronic, Retrospective Studie, Internal medicine, 80 and over, HBV, Medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, Renal Insufficiency, Young adult, Aged, Aged, 80 and over, Female, Middle Aged, Retrospective Studies, Treatment Outcome, Chronic, Antiviral Agent, Hepatology, business.industry, Gastroenterology, virus diseases, Retrospective cohort study, Entecavir, Hepatitis B, medicine.disease, Cohort, 030211 gastroenterology & hepatology, business, medicine.drug, Human
Abstract

BackgroundLimited data exist regarding tenofovir disoproxil fumarate (TDF) safety and effectiveness in chronic hepatitis B virus-infected (CHB) patients with renal impairment (RI).AimsTo compare real-world data on renal safety and effectiveness of TDF vs entecavir (ETV) in CHB patients with moderate-to-severe RI.MethodsRetrospective, non-interventional, cohort study analysing medical records for TDF/ETV-treated CHB patients (54 European centres). Included patients experienced moderate-to-severe RI (creatinine clearance 20-60 mL/min [Cockcroft-Gault]) either before TDF/ETV initiation ('before' subgroup [baseline = treatment initiation]) or after TDF/ETV initiation ('after' subgroup [baseline = first RI occurrence]). The primary objective was TDF safety, particularly renal-related adverse events of special interest (AESI). TDF and ETV safety and effectiveness were compared and multivariate analyses were performed using inverse probability treatment weighting.Results'Before' subgroup included 107 TDF- and 91 ETV-treated patients; 'after' subgroup included 212 TDF- and 77 ETV-treated patients. Mean baseline creatinine clearance was higher for TDF- vs ETV-treated patients (both subgroups). Median follow-up was 3.1 years (both treatments). AESI were more frequent with TDF vs ETV ('before': 18.7% vs 8.8%; 'after': 9.9% vs 3.9%); however, differences were not significant by multivariate analysis. Only TDF-treated patients experienced renal tubular dysfunction (6.5% 'before'; 1.9% 'after') as well as renal adverse events leading to treatment discontinuation (8.4% 'before'; 7.1% 'after'). Effectiveness was similar between treatments.ConclusionsOverall safety was similar for TDF vs ETV (both subgroups). Given that renal tubular dysfunction occurred with TDF and not with ETV, renal safety concerns may be greater with TDF in CHB patients with RI.

Published
2020

14. HeartWare Explant After Recovery 6 Years After Implant in a 3-Year-Old Child: Has the Game Changed?

Author

Fabrizio De Rita, Stephan Schueler, Gaia Vigano, Nicholas Chilvers, Iain McPherson, Tommaso Generali, Zdenka Reinhardt, Mohamed Nassar, and Asif Hasan

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, business.industry, medicine.medical_treatment, Cardiomyopathy, 030204 cardiovascular system & hematology, medicine.disease, Surgery, 03 medical and health sciences, 0302 clinical medicine, 030228 respiratory system, Quality of life, Ventricular assist device, medicine, Implant, Cardiology and Cardiovascular Medicine, business
Abstract

The use of continuous-flow mechanical circulatory support in preschool children remains anecdotal. This case report describes the sequel to the implantation with a HeartWare HVAD system (Medtronic, Minneapolis, MN) in a 3-year old child. A 3-year-old boy with myocarditis-related cardiomyopathy underwent implantation with a HeartWare device. After an uncomplicated postoperative course, the patient was discharged home. Serial echocardiography showed progressive left ventricular recovery. After 6 months, the device was decommissioned, and the outflow graft was tied off. Six years after insertion, the device was explanted uneventfully. The HeartWare ventricular assist device offers viable long-term mechanical circulatory support in selected children that results in sustainable care and good quality of life.

Published
2021

15. Long‐Term Survival and Risk of Institutionalization in Onco‐Geriatric Surgical Patients: Long‐Term Results of the PREOP Study

Author

Isacco Montroni, Geertruida H. de Bock, Giampaolo Ugolini, Roberto Cirocchi, Eriberto Farinella, Barbara L. van Leeuwen, Federico Ghignone, Grigory Sidorenkov, Antonio Vigano, Nicola de Liguori Carino, Riccardo A. Audisio, M. G. Huisman, ​Basic and Translational Research and Imaging Methodology Development in Groningen (BRIDGE), Life Course Epidemiology (LCE), Damage and Repair in Cancer Development and Cancer Treatment (DARE), Clinical Cognitive Neuropsychiatry Research Program (CCNP), and Guided Treatment in Optimal Selected Cancer Patients (GUTS)

Subjects
Male, onco‐geriatric patients, Time Factors, Regular Issue Content, postoperative outcome, COLORECTAL-CANCER, Postoperative Complications, 0302 clinical medicine, QUALITY-OF-LIFE, Interquartile range, Neoplasms, ABDOMINAL-SURGERY, Longitudinal Studies, Prospective Studies, Prospective cohort study, ELDERLY-PATIENTS, Aged, 80 and over, COMPLICATIONS, Framingham Risk Score, INDEPENDENCE, Hazard ratio, risk assessment, Survival Rate, Elective Surgical Procedures, FUNCTIONAL STATUS, 030220 oncology & carcinogenesis, Cohort, institutionalization, Female, 030211 gastroenterology & hepatology, Risk assessment, medicine.medical_specialty, Clinical Investigations, survival, 03 medical and health sciences, Internal medicine, MANAGEMENT, medicine, Humans, Clinical Investigation, Elective surgery, Geriatric Assessment, Aged, OLDER PATIENTS, business.industry, Odds ratio, Geriatrics and Gerontology, FOLLOW-UP, business, onco-geriatric patients
Abstract

OBJECTIVES: To evaluate long-term survival and institutionalization in onco-geriatric surgical patients, and to analyze the association between these outcomes and a preoperative risk score. DESIGN: Prospective cohort study with long-term follow-up. SETTING: International and multicenter locations. PARTICIPANTS: Patients aged 70 years or older undergoing elective surgery for a malignant solid tumor at five centers (n = 229). MEASUREMENTS: We assessed long-term survival and institutionalization using the Preoperative Risk Estimation for Onco-geriatric Patients (PREOP) score, developed to predict the 30-day risk of major complications. The PREOP score collected data about sex, type of surgery, and the American Society for Anesthesiologists classification, as well as the Timed Up & Go test and the Nutritional Risk Screening results. An overall score higher than 8 was considered abnormal. RESULTS: We included 149 women and 80 men (median age = 76 y; interquartile range = 8). Survival at 1, 2, and 5 years postoperatively was 84%, 77%, and 56%, respectively. Moreover, survival at 1 year was worse for patients with a PREOP risk score higher than 8 (70%) compared with 8 or lower (91%). Of those alive at 1 year, 43 (26%) were institutionalized, and by 2 years, almost half of the entire cohort (46%) were institutionalized or had died. A PREOP risk score higher than 8 was associated with increased mortality (hazard ratio = 2.6; 95% confidence interval [CI] = 1.7-4.0), irrespective of stage and age, but not with being institutionalized (odds ratios = 1 y, 1.6 [95% CI =.7-3.8]; 2 y, 2.2 [95% CI =.9-5.5]). CONCLUSION: A high PREOP score is associated with mortality but not with remaining independent. Despite acceptable survival rates, physical function may deteriorate after surgery. It is imperative to discuss treatment goals and expectations preoperatively to determine if they are feasible. Using the PREOP risk score can provide an objective measure on which to base decisions. J Am Geriatr Soc 68:1235–1241, 2020.

Published
2020

16. Burden and attitude to resistant and refractory migraine: a survey from the European Headache Federation with the endorsement of the European MigraineHeadache Alliance

Author

Sacco S., Lampl C., Maassen van den Brink A., Caponnetto V., Braschinsky M., Ducros A., Little P., Pozo-Rosich P., Reuter U., Ruiz de la Torre E., Sanchez Del Rio M., Sinclair A. J., Martelletti P., Katsarava Z., Cakciri G., Djamandi P., Grabova S., Halili G., Kruja J., Kuqo A., Naco D., Quka A., Stefanidhi L., Vyshka G., Zekja I., Bruera O., Gomez D., Guitian B., Roma J. C., Chen I. L., Bashirova S., Linkov M., Van Den Abbeele D., Vanderschueren G., Araujo R., Arruda R., Catharino A., Ciriaco J., Dalla Corte A., Dornas R., Felsenfeld B., Fonseca Taufner A., Fragoso Y., Hurtado R., Isoni Martins D., Londero R., Melo L., Mignoni K. S., Sgobbi De Souza P. V., Souza M. N., Osman S., Baltzer V., Pacheco Mosquera L. F., Dubroja I., Hucika Z., Lisak M., Lovrencic-Huzjan A., Lusic I., Mahovic Lakusic D., Mikulenka P., Rehulka P., Amin F. M., Antic S., Fakhril-Din Z., Moeller-Hansen J., Munksgaard S., Nan A. M., Pellesi L., Schytz H., Vides M., Braschinsky K., Krikmann U., Roos C., Cauchie A., Christian L., Guegan-Massardier E., Demarquay G., Gilles G., Mawet J., Kuhn E., Lanteri Minet M., Bustuchina Vlaicu M., Moisset X., Muresan M., Najjar-Ravan M., Giraud P., Simonin S., De Gaalon S., Chakhava G., Demuria M., Gegelashvili G., Kapanadze N., Antonakakis A., Gaul C., Forderreuther S., Huhn J. -I., Ibragimov S., Kamm K., Raffaelli B., Czaniera R., Ruscheweyh R., Gavanozi E., Karagiorgis G., Mavridism T., Ertsey C., Shubham D., Callista Tanowi A. D., Erdana Putra S., Hadi D. W., Kurnia L., Nasrul M., Albanese M., Antonaci F., Asioli G. M., Baschi R., Bentivegna E., Brunelli N., Caratozzolo S., Catarci T., Cherchi A., Corbelli I., Costa A., De Luca C., Doretti A., Favoni V., Ghiotto N., Giamberardino M. A., Giani L., Zanchin G., Govone F., Grillo G., Mampreso E., Negro A., Ornello R., Pasculli M., Pensato U., Prudenzano M. P. A., Quintana S., Rapisarda R., Romoli M., Russo A., Russo M., Spuntarelli V., Tiseo C., Torrente A., Vacca A., Vaula G., Vigano A., Vigneri S., Freimane A., Slosberga E., Zvaune L., Tan H. J., Fenech C., Cobilt-Catana R., De La Garza Neme Y., Martinez M., Proano Narvaez J. V., Rodriguez Herrera A., Vazquez D., Grosu O., Jakupi A., Kristoffersen E. S., Tronvik E., Winsvold B. S., Azhar M., Reyes Alvarez M. T., Vilchez Fernandez L., Dayrit G. D., Czapinska-Ciepiela E. K., Fila M., Gryglas-Dworak A., Couto M., Esperanca P., Ferreira A., Gil-Gouveia R., Goncalves A., Lopes M., Lourenco M., Machado J., Marinho M., Miranda M. A., Palavra F., Parreira E., Pavao Martins I., Pereira L., Pereira Monteiro J. M., Leahu P., Aloman S., Abramova E., Akhmadeeva L., Belopasova A., Bogdanova I., Chernyak M., Epifanova M., Fedorova E., Felbush A., Karpova M., Korobkova D., Korotkova D., Latysheva N., Makeeva T., Mikhalkina K., Osipova V., Roshchina O., Serga A., Serousova O. V., Sidorova Y., Skiba I., Skorobogatykh K., Vashchenko N., Apostolski S., Buder N., Kopitovic A., Mirjana J., Podgorac A., Rakic D., Simic S., Zarko M., Trajkovic J. Z., Beltran-Blasco I., Calabria Gallego M. D., Diaz Insa S., Ezpeleta D., Fernandez M., Garcia-Azorin D., Gonzalez-Garcia N., Guerrero A. L., Guillamon E., Herreros Rodriguez J., Layos-Romero A., Medrano V., Minguez-Olaondo A., Navarro Munoz S., Pare Curell M., Ruibal M., Sanchez Alvarez J. M., Santos S., Soler R., Viguera J., Zabalza R., Abdelrahman T., Abobaker Hamza S. B., Mustafa M. N., Edvinsson L., Gantenbein A., Maraffi I., Couturier E., Dirkx T., Hoebert M., Van Oosterhout W., Wim M., Zwartbol R., Bakir M., Demirel H., Erdemoglu A. K., Ertem D. H., Gonullu S., Ilgaz Aydinlar E., Inan L. E., Olmez B., Ozbenli T., Ozge A., Uluduz D., Uyar Cankay T., Yalinay Dikmen P., Saxena A. B., Bozhenko M., Bozhenko N., Bubnov R., Tsurkalenko O., Abu-Arafeh I., Idrovo L., Miller S., Nirmalananthan N., Sinclair A., Taleti E., Valori A., Whitehouse W., Zermansky A., Thura M., Institut Català de la Salut, [Sacco S, Caponnetto V] Neuroscience section – Department of Biotechnological and Applied Clinical Sciences and (Edificio Coppito 2), University of L’Aquila, Via Vetoio, 67100 L’Aquila, Italy. Regional Referral Headache Center of the Abruzzo Region, ASL Avezzano-Sulmona-L’Aquila, L’Aquila, Italy. [Lampl C] Department of Neurology, Headache Medical Centre Linz, Hospital Barmherzige Brüder, Centre of Integrative Medicine (ZiAM) Ordensklinikum Linz, Linz, Austria. [Maassen van den Brink A] Division of Pharmacology, Department of Internal Medicine, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands. [Braschinsky M] Headache Clinic, Department of Neurology, Tartu University Clinics, Tartu, Estonia. [Ducros A] Headache Unit, Neurology Department, Montpellier University Hospital and Montpellier University, Montpellier, France. [Pozo-Rosich P] Unitat de Cefalea, Servei de Neurologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. Grup d'Investigació en Cefalees i Dolors Neurològics, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus, Sacco, S., Lampl, C., Maassen van den Brink, A., Caponnetto, V., Braschinsky, M., Ducros, A., Little, P., Pozo-Rosich, P., Reuter, U., Ruiz de la Torre, E., Sanchez Del Rio, M., Sinclair, A. J., Martelletti, P., Katsarava, Z., Cakciri, G., Djamandi, P., Grabova, S., Halili, G., Kruja, J., Kuqo, A., Naco, D., Quka, A., Stefanidhi, L., Vyshka, G., Zekja, I., Bruera, O., Gomez, D., Guitian, B., Roma, J. C., Chen, I. L., Bashirova, S., Linkov, M., Van Den Abbeele, D., Vanderschueren, G., Araujo, R., Arruda, R., Catharino, A., Ciriaco, J., Dalla Corte, A., Dornas, R., Felsenfeld, B., Fonseca Taufner, A., Fragoso, Y., Hurtado, R., Isoni Martins, D., Londero, R., Melo, L., Mignoni, K. S., Sgobbi De Souza, P. V., Souza, M. N., Osman, S., Baltzer, V., Pacheco Mosquera, L. F., Dubroja, I., Hucika, Z., Lisak, M., Lovrencic-Huzjan, A., Lusic, I., Mahovic Lakusic, D., Mikulenka, P., Rehulka, P., Amin, F. M., Antic, S., Fakhril-Din, Z., Moeller-Hansen, J., Munksgaard, S., Nan, A. M., Pellesi, L., Schytz, H., Vides, M., Braschinsky, K., Krikmann, U., Roos, C., Cauchie, A., Christian, L., Guegan-Massardier, E., Demarquay, G., Gilles, G., Mawet, J., Kuhn, E., Lanteri Minet, M., Bustuchina Vlaicu, M., Moisset, X., Muresan, M., Najjar-Ravan, M., Giraud, P., Simonin, S., De Gaalon, S., Chakhava, G., Demuria, M., Gegelashvili, G., Kapanadze, N., Antonakakis, A., Gaul, C., Forderreuther, S., Huhn, J. -I., Ibragimov, S., Kamm, K., Raffaelli, B., Czaniera, R., Ruscheweyh, R., Gavanozi, E., Karagiorgis, G., Mavridism, T., Ertsey, C., Shubham, D., Callista Tanowi, A. D., Erdana Putra, S., Hadi, D. W., Kurnia, L., Nasrul, M., Albanese, M., Antonaci, F., Asioli, G. M., Baschi, R., Bentivegna, E., Brunelli, N., Caratozzolo, S., Catarci, T., Cherchi, A., Corbelli, I., Costa, A., De Luca, C., Doretti, A., Favoni, V., Ghiotto, N., Giamberardino, M. A., Giani, L., Zanchin, G., Govone, F., Grillo, G., Mampreso, E., Negro, A., Ornello, R., Pasculli, M., Pensato, U., Prudenzano, M. P. A., Quintana, S., Rapisarda, R., Romoli, M., Russo, A., Russo, M., Spuntarelli, V., Tiseo, C., Torrente, A., Vacca, A., Vaula, G., Vigano, A., Vigneri, S., Freimane, A., Slosberga, E., Zvaune, L., Tan, H. J., Fenech, C., Cobilt-Catana, R., De La Garza Neme, Y., Martinez, M., Proano Narvaez, J. V., Rodriguez Herrera, A., Vazquez, D., Grosu, O., Jakupi, A., Kristoffersen, E. S., Tronvik, E., Winsvold, B. S., Azhar, M., Reyes Alvarez, M. T., Vilchez Fernandez, L., Dayrit, G. D., Czapinska-Ciepiela, E. K., Fila, M., Gryglas-Dworak, A., Couto, M., Esperanca, P., Ferreira, A., Gil-Gouveia, R., Goncalves, A., Lopes, M., Lourenco, M., Machado, J., Marinho, M., Miranda, M. A., Palavra, F., Parreira, E., Pavao Martins, I., Pereira, L., Pereira Monteiro, J. M., Leahu, P., Aloman, S., Abramova, E., Akhmadeeva, L., Belopasova, A., Bogdanova, I., Chernyak, M., Epifanova, M., Fedorova, E., Felbush, A., Karpova, M., Korobkova, D., Korotkova, D., Latysheva, N., Makeeva, T., Mikhalkina, K., Osipova, V., Roshchina, O., Serga, A., Serousova, O. V., Sidorova, Y., Skiba, I., Skorobogatykh, K., Vashchenko, N., Apostolski, S., Buder, N., Kopitovic, A., Mirjana, J., Podgorac, A., Rakic, D., Simic, S., Zarko, M., Trajkovic, J. Z., Beltran-Blasco, I., Calabria Gallego, M. D., Diaz Insa, S., Ezpeleta, D., Fernandez, M., Garcia-Azorin, D., Gonzalez-Garcia, N., Guerrero, A. L., Guillamon, E., Herreros Rodriguez, J., Layos-Romero, A., Medrano, V., Minguez-Olaondo, A., Navarro Munoz, S., Pare Curell, M., Ruibal, M., Sanchez Alvarez, J. M., Santos, S., Soler, R., Viguera, J., Zabalza, R., Abdelrahman, T., Abobaker Hamza, S. B., Mustafa, M. N., Edvinsson, L., Gantenbein, A., Maraffi, I., Couturier, E., Dirkx, T., Hoebert, M., Van Oosterhout, W., Wim, M., Zwartbol, R., Bakir, M., Demirel, H., Erdemoglu, A. K., Ertem, D. H., Gonullu, S., Ilgaz Aydinlar, E., Inan, L. E., Olmez, B., Ozbenli, T., Ozge, A., Uluduz, D., Uyar Cankay, T., Yalinay Dikmen, P., Saxena, A. B., Bozhenko, M., Bozhenko, N., Bubnov, R., Tsurkalenko, O., Abu-Arafeh, I., Idrovo, L., Miller, S., Nirmalananthan, N., Sinclair, A., Taleti, E., Valori, A., Whitehouse, W., Zermansky, A., Thura, M., and Internal Medicine

Subjects
Investigative Techniques::Epidemiologic Methods::Data Collection::Surveys and Questionnaires [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], medicine.medical_specialty, Pediatrics, Neurology, Consensus, enfermedades del sistema nervioso::enfermedades del sistema nervioso central::enfermedades cerebrales::trastornos con cefaleas::cefaleas primarias::trastornos migrañosos [ENFERMEDADES], migraine, migraine care, refractory migraine, resistant migraine, consensus, cross-sectional studies, headache, humans, surveys and questionnaires, migraine disorders, Pain medicine, Moderate confidence, Migraine Disorders, Medizin, Consensu, Migranya - Tractament, Qüestionaris, Refractory, Surveys and Questionnaires, medicine, Surveys and Questionnaire, Humans, Clinical significance, Nervous System Diseases::Central Nervous System Diseases::Brain Diseases::Headache Disorders::Headache Disorders, Primary::Migraine Disorders [DISEASES], Otros calificadores::/terapia [Otros calificadores], Migraine, Cross-Sectional Studie, business.industry, Headache, técnicas de investigación::métodos epidemiológicos::recopilación de datos::encuestas y cuestionarios [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], General Medicine, Other subheadings::/therapy [Other subheadings], medicine.disease, Refractory migraine, Anesthesiology and Pain Medicine, Cross-Sectional Studies, Burden, Medicine, Neurology (clinical), Level of care, business, Resistant migraine, Migraine care, Human, Research Article
Abstract

Background New treatments are currently offering new opportunities and challenges in clinical management and research in the migraine field. There is the need of homogenous criteria to identify candidates for treatment escalation as well as of reliable criteria to identify refractoriness to treatment. To overcome those issues, the European Headache Federation (EHF) issued a Consensus document to propose criteria to approach difficult-to-treat migraine patients in a standardized way. The Consensus proposed well-defined criteria for resistant migraine (i.e., patients who do not respond to some treatment but who have residual therapeutic opportunities) and refractory migraine (i.e., patients who still have debilitating migraine despite maximal treatment efforts). The aim of this study was to better understand the perceived impact of resistant and refractory migraine and the attitude of physicians involved in migraine care toward those conditions. Methods We conducted a web-questionnaire-based cross-sectional international study involving physicians with interest in headache care. Results There were 277 questionnaires available for analysis. A relevant proportion of participants reported that patients with resistant and refractory migraine were frequently seen in their clinical practice (49.5% for resistant and 28.9% for refractory migraine); percentages were higher when considering only those working in specialized headache centers (75% and 46% respectively). However, many physicians reported low or moderate confidence in managing resistant (8.1% and 43.3%, respectively) and refractory (20.7% and 48.4%, respectively) migraine patients; confidence in treating resistant and refractory migraine patients was different according to the level of care and to the number of patients visited per week. Patients with resistant and refractory migraine were infrequently referred to more specialized centers (12% and 19%, respectively); also in this case, figures were different according to the level of care. Conclusions This report highlights the clinical relevance of difficult-to-treat migraine and the presence of unmet needs in this field. There is the need of more evidence regarding the management of those patients and clear guidance referring to the organization of care and available opportunities.

Published
2021

18. 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. 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, Massimiliano, Lombardi, Andrea, Colaneri, Marta, Del Poggio, Paolo, Perini, Paolo, D'Ambrosio, Roberta, Degasperi, Elisabetta, Dibenedetto, Clara, Giorgini, Alessia, Pasulo, Luisa, Maggiolo, Franco, Castelli, Francesco, Brambilla, Paola, Spinelli, Ombretta, Tiziana, Re, Lleo, Ana, Rumi, Mariagrazia, Uberti-Foppa, Caterina, Soria, Alessandro, Aghemo, Alessio, Lampertico, Pietro, Baiguera, Chiara, Schiavini, Monica, Fagiuoli, Stefano, Bruno, Raffaele, 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, and Giani, P

Subjects
Simeprevir, Male, medicine.medical_specialty, Cirrhosis, SVR, Sofosbuvir, Sustained Virologic Response, liver cirrhosis, antiviral treatment, Hepacivirus, Antiviral Agents, law.invention, Randomized controlled trial, law, Virology, Internal medicine, Medicine, Humans, chronic hepatitis C, Prospective cohort study, DAA, Retrospective Studies, Hepatology, liver cirrhosi, business.industry, Hepatitis C, Hepatitis C, Chronic, Middle Aged, medicine.disease, Discontinuation, Regimen, Infectious Diseases, Treatment Outcome, business, medicine.drug
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 60.5years, 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 2weeks before the planned schedule. In patients with F0–F3 liver fibrosis, lower rates of SVR12 were observed in patients treated for

Published
2021

19. Optical coherence tomography, intravascular ultrasound or angiography guidance for distal left main coronary stenting. The ROCK cohort II study

Author

Massimo Fineschi, Alfonso Ielasi, Magdalena Lanocha, Jose A. Linares, Francesco Burzotta, Fernando Alfonso, Oleg Krestianinov, Alexander Sozykin, Pieter R. Stella, José M. de la Torre Hernández, Bernardo Cortese, Francesco Giannini, Gianluca Campo, Fabrizio D'Ascenzo, Carlo Trani, Tamara Garcia Camarero, Francesco Prati, Elena Vigano, Adrian Wlodarczak, Roberto Latini, and Gennaro Sardella

Subjects
intravascular imaging ultrasound, medicine.medical_specialty, medicine.medical_treatment, Coronary Artery Disease, Revascularization, Coronary Angiography, NO, Percutaneous Coronary Intervention, Optical coherence tomography, Angioplasty, Intravascular ultrasound, medicine, Humans, Radiology, Nuclear Medicine and imaging, Myocardial infarction, Ultrasonography, Interventional, Retrospective Studies, optical coherence tomography, medicine.diagnostic_test, business.industry, Ultrasound, General Medicine, medicine.disease, Coronary Vessels, left main coronary artery stenting, Treatment Outcome, Settore MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE, Angiography, Cohort, Radiology, Cardiology and Cardiovascular Medicine, business, Tomography, Optical Coherence
Abstract

Objectives to test the safety and efficacy of intravascular imaging and specifically optical coherence tomography (OCT) as a diagnostic tool for left main angioplasty and analyze the mid-term outcome accordingly. Background Clinical data and international guidelines recommend the use of intravascular imaging ultrasound (IVUS) to guide left main (LM) angioplasty. Despite early experience using OCT in this setting is encouraging, the evidence supporting its use is still limited. Methods ROCK II is a multicenter, investigator-driven, retrospective European study to compare the performance of IVUS and OCT versus angiography in patients undergoing distal-LM stenting. The primary study endpoint was target-lesion failure (TLF) including cardiac death, target-vessel myocardial infarction and target-lesion revascularization. We designed this study hypothesizing the superiority of intravascular imaging over angiographic guidance alone, and the non-inferiority of OCT versus IVUS. Results A total of 730 patients, 377 with intravascular-imaging guidance (162 OCT, 215 IVUS) and 353 with angiographic guidance, were analyzed. The one-year rate of TLF was 21.2% with angiography and 12.7% with intravascular-imaging (p = 0.039), with no difference between OCT and IVUS (p = 0.26). Intravascular-imaging was predictor of freedom from TLF (HR 0.46; 95% CI 0.23-0.93: p = 0.03). Propensity-score matching identified three groups of 100 patients each with no significant differences in baseline characteristics. The one-year rate of TLF was 16% in the angiographic, 7% in the OCT and 6% in the IVUS group, respectively (p = 0.03 for IVUS or OCT vs. angiography). No between-group significant differences in the rate of individual components of TLF were found. Conclusions Intravascular imaging was superior to angiography for distal LM stenting, with no difference between OCT and IVUS.

Published
2021

21. Personality profile and health-related quality of life in adults with previous continuous spike-waves during slow sleep syndrome

Author

Maria Margherita Mancardi, Livia Pisciotta, Monica Vigano, Maria Grazia Calevo, Maria Giuseppina Baglietto, Edvige Veneselli, Roberto Gaggero, G. Prato, Giovanna Lenci, and Elisa De Grandis

Subjects
Adult, Male, Sleep Wake Disorders, Psychological General Well-Being Index (PGWBI), Pediatrics, medicine.medical_specialty, Continuous Spike-Waves During Slow-Wave Sleep Syndrome (CSWSS), media_common.quotation_subject, Spike-Wave Index (SWI), Electroencephalography, Sleep, Slow-Wave, 03 medical and health sciences, Epilepsy, 0302 clinical medicine, Developmental Neuroscience, Minnesota Multiphasic Personality Inventory, Minnesota Multiphasic Personality Inventory-2 (MMPI-2), Outcome, Young adult, Humans, Medicine, Personality, Prospective Studies, Prospective cohort study, media_common, medicine.diagnostic_test, business.industry, Neuropsychology, Syndrome, General Medicine, medicine.disease, Italy, Pediatrics, Perinatology and Child Health, Structured interview, Quality of Life, Female, Neurology (clinical), Sleep, business, 030217 neurology & neurosurgery
Abstract

Introduction Epilepsy with continuous spike-waves during slow sleep syndrome (CSWSS) is characterized by various seizure types, a characteristic EEG pattern and neuropsychological disorders. The main purpose of this study was to evaluate the long-term outcome of CSWSS occurred in childhood and to evaluate the variables that could influence the quality of social adaptation and the personality profile. Material and methods This is a prospective study on 24 young adults with previous CSWSS (median age 24.5 yrs) who were enrolled between January and July 2011 at the G. Gaslini Children’s Hospital, Genoa, Italy. Patients were divided into two groups: twelve with previous spike-wave index (SWI > 85%) defined as typical CSWSS (T-CSWSS) and twelve with previous SWI = 50–85% defined as atypical CSWSS (A-CSWSS). All the subjects were submitted to Minnesota Multiphasic Personality Inventory-2 (MMPI-2), Psychological General Well-Being Index (PGWBI), and to a structured interview. Results A correlation was observed with the severity of EEG abnormalities expressed by the SWI and outcome. The T-CSWSS group showed a significantly lower perceived well-being. Similarly in the T-CSWSS group the percentage of MMPI-2 clinical scales with T-scores ≥65 was higher than in the A-CSWSS group. Finally, a significant lower schooling in the T-CSWSS group was observed. Conclusion There seem to be two forms of the same disease, with similar onset and clinical evolution but a different outcome regarding the social and psychological conditions. The outcome of the social adaptation and of the personality consciousness was related with the severity of the EEG abnormalities: more favorable in patients with less intense SWI activity (A-CSWSS) compared those with a more severe EEG impairment (T-CSWSS).

Published
2019

22. Prospective Review of Clinical Hypersensitivity Reactions After Administration of 5% Human Serum Albumin in 40 Critically Ill Cats

Author

Costanza Blasi, Nike Carminati, Fabio Vigano, and Elisabetta Giudice

Subjects
Male, medicine.medical_specialty, Critical Illness, Serum Albumin, Human, Cat Diseases, Gastroenterology, Internal medicine, Hypersensitivity, Animals, Medicine, Prospective Studies, Infusions, Intravenous, Small Animals, Prospective cohort study, cat, hypoalbuminenia, hypersensitive reactions, critical care, CATS, Critically ill, business.industry, Human serum albumin, body regions, Underlying disease, embryonic structures, Cats, Female, business, Hypoalbuminemia, medicine.drug
Abstract

This prospective study assesses the presence of immediate and delayed clinical hypersensitivity reactions in 40 hypoalbuminemic critically ill cats during and after an intravenous administration of 5% human serum albumin (HSA). Twenty hypoalbuminemic critically ill cats with no known exposure to HSA (control group) were also checked in order to highlight any clinical signs related to the underlying disease which could mimic hypersensitivity reactions. The administration of 10-20 mL/kg of 5% HSA at 2 mL/kg/h in critically ill cats did not lead to clinical signs of types I and III hypersensitivity reactions at days 0, 7, 14, 21, and 28, unlike previous findings with 25% HSA in this species.

Published
2019

23. High-risk Fontan completion patients achieve low perioperative risk and benefit from cavopulmonary connection 7 years out†

Author

Orla Franklin, Colin J. McMahon, Jonathan McGuinness, John M Redmond, John S Byrne, Paul Oslizlok, Lars Nolke, Gaia Vigano, and Kevin Walsh

Subjects
Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Time Factors, Vena Cava, Superior, Adolescent, medicine.medical_treatment, Hemodynamics, Pulmonary Artery, 030204 cardiovascular system & hematology, Fontan Procedure, Risk Assessment, Fontan procedure, 03 medical and health sciences, Postoperative Complications, 0302 clinical medicine, Internal medicine, medicine.artery, medicine, Humans, Child, Retrospective Studies, business.industry, Postoperative complication, General Medicine, Perioperative, Catheter, Exact test, Treatment Outcome, 030228 respiratory system, Child, Preschool, Pulmonary artery, Cardiology, Female, Surgery, Cardiology and Cardiovascular Medicine, Fenestration, business, Follow-Up Studies
Abstract

OBJECTIVES: Our unit has pursued Fontan completion in all patients except those with immobility or combined poor ventricular function and high pulmonary artery pressures. We assessed retrospectively whether conventional high-risk criteria would predict patients with a poorer outcome. METHODS: One hundred and thirty-three consecutive children who underwent extracardiac Fontan completion (2004–2012) had their outcomes recorded (mean follow-up of 7 years). Three groups were analysed: those with 1 of 6 historical risk factors (outside 6 commandments), those with 1 of reduced systemic ventricular function or pulmonary artery pressure >15 mmHg (outside 2 commandments) versus those with no contraindications. The Fischer’s exact test examined frequency differences, with the χ2 test to look for outcome associations. RESULTS: There were no differences in postoperative complication rates between the outside 6 commandments (n = 105) or outside 2 commandments (n = 49) versus the low-risk no-contraindication group (n = 28): arrhythmias [18% (P = 0.3) or 18% (P = 0.3) vs 25%], infection [22% (P = 0.6) or 33% (P = 0.2) vs 21%], cerebrovascular accident [6% (P = 0.5) or 10% (P = 0.3) vs 4%], length of stay [20 days (P = 0.4) or 23 days (P = 0.2) vs 21 days] and duration of chest drainage (P = 0.5). There was 1 predischarge mortality in each group. Long term, the majority of patients in each group had suitable haemodynamics for fenestration closure [95% (P = 0.7) or 95% (P = 0.7) vs 92%]. Long term, there was no difference in the rate of arrhythmias [11% (P = 0.5) or 12.5% (P = 0.3) vs 7%], protein-losing enteropathy [1% (P = 0.1) or 2% (P = 0.3) vs 7%] or moderate or more ventricular dysfunction on echocardiography [2% (P = 0.7) or 4% (P = 0.7) vs 4%]. Notably, there was a higher rate of catheter reinterventions in the high-risk groups [22% (P CONCLUSIONS The medium-term benefits of Fontan completion can be achieved for high-risk patients, suggesting that historical selection criteria should be re-examined.

Published
2019

24. Haptic Augmented Reality (HapticAR) for assembly guidance

Author

Gilberto Osorio-Gómez, Roberto Vigano, and Juan Carlos Arbeláez

Subjects
0209 industrial biotechnology, Focus (computing), business.industry, Computer science, 02 engineering and technology, Augmented Reality · Haptic · Assembly guidance · User interaction · Object recognition, Industrial and Manufacturing Engineering, 03 medical and health sciences, Task (computing), 020901 industrial engineering & automation, 0302 clinical medicine, Software, Human–computer interaction, Industrial design, Modeling and Simulation, Gestalt psychology, Augmented reality, business, Engineering design process, 030217 neurology & neurosurgery, Haptic technology
Abstract

The use of Augmented Reality (AR) to support assembly tasks has been an area of interest from its origins in the 90s. Since then, the benefits that this technology could bring to assembly-related tasks have been shown. And, although several advances have been done in different areas such as software, hardware, and human interaction, there are still some problems that have not allowed AR to expand and reach its full potential. Thereby, authors propose a real-time vibrotactile guidance method based on the Gestalt continuity principle and developed a Haptic Augmented Reality application with a low-cost configuration to evaluate the support of the proposed method in assembly tasks. Thus, it potentially overcomes the existing visual issues of AR allowing the user to focus on the task and avoid over-reliance into the technology. The proposed system recognizes the different parts and sub-assemblies, generates the instructions to perform the assembly based on the target position and rotation of each part and verifies the assembly. Additionally, a test was conducted to guide the user in positioning a part, obtaining a high accuracy of rotation and location placement. Also, different functions of the application were tested and the results are suitable for supporting the user guidance.

Published
2019

25. HIGH PREVALENCE OF CANCER AMONG PRIMARY SJÖGREN’S SYNDROME: DATA FROM BRAZILIAN SJÖGREN’S SYNDROME REGISTRY (RE-BRASS)

Author

Fabiola Reis de Oliveira, Rafael Coradin, Paula Regina Toche dos Santos, Maria Clara Cardoso Gomes Zampirolli, Fernanda Lourenço Macagnani, Aysa César Pinheiro, Ketty Lisie Libardi Machado, Laura Caldas, Barbara Seabra Carneiro, Gustavo Pafume de Sá, Giovanna Sant’Ana Petterle, Bianca Barbosa Rosa, Juliana Markus, Valeria Valim, Vanessa Hax, Virginia Fernandes Moça Trevisani, Roberta de Almeida Pernambuco, Ricardo Machado Xavier, Alisson Aliel Vigano Pugliesi, Leandro Augusto Tanure, Samira Tatiyama Miyamoto, Raíssa Dudienas Domingues Pereira, Ana Carolina Pereira Nunes Pinto, Nathália de Carvalho Sacilotto, Camila Avila Megda Cabianca, Thais Ferreira Costa, Karina Gatz Capobianco, Maria Lúcia Lemos Lopes, and Aiessa Zanchett Fedrigo

Subjects
medicine.medical_specialty, High prevalence, business.industry, medicine, Cancer, Sjogren s, medicine.disease, business, Dermatology
Published
2021

26. D2 dissection improves disease-specific survival in advanced gastric cancer patients: 15-year follow-up results of the Italian Gastric Cancer Study Group D1 versus D2 randomised controlled trial

Author

Antonio Ponti, L. Vigano, Mario Morino, Maurizio Degiuli, P. Mello Teggia, D. Scaglione, Mitsuru Sasako, M. Garino, Mariano Tomatis, Fabrizio Rebecchi, Rossella Reddavid, and L. Locatelli

Subjects
0301 basic medicine, Male, Cancer Research, medicine.medical_specialty, Time Factors, medicine.medical_treatment, Population, Clinical Decision-Making, Risk Assessment, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Informed consent, Gastrectomy, Risk Factors, Stomach Neoplasms, Internal medicine, medicine, Humans, education, Lymph node, Aged, Neoplasm Staging, education.field_of_study, Intention-to-treat analysis, business.industry, Cancer, medicine.disease, Dissection, 030104 developmental biology, medicine.anatomical_structure, Treatment Outcome, Oncology, Italy, 030220 oncology & carcinogenesis, Lymphatic Metastasis, Lymph Node Excision, Lymphadenectomy, Female, Lymph Nodes, business
Abstract

Background The extended lymphadenectomy (D2) was recently introduced in several guidelines as the optimal treatment for gastric cancer, based only on the 15-year follow-up results of the Dutch randomised trial, while the British Medical Research Council (MRC) study failed to demonstrate a survival benefit over the more limited D1 dissection. The Italian Gastric Cancer Study Group randomised controlled trial (RCT) was also undertaken to compare D1 versus D2 gastrectomy, and a tendency to improve survival in patients with advanced resectable disease (pT > 1N+) was documented despite negative results in the entire patient population. Now we present the 15-year follow-up results of survival and gastric cancer-related mortality. Methods Between June 1998 and December 2006, eligible patients with gastric cancer who signed the informed consent were randomised at 5 centres to either D1 or D2 gastrectomy. Intraoperative randomisation was implemented centrally by phone call. Primary outcome was overall survival (OS); secondary end-points were disease-specific survival, postoperative morbidity and mortality. Analyses were by intention to treat. Strict quality control measures for surgery, lymph node removal, pathology and patient follow-up were implemented and monitored. Registration number: ISRCTN11154654 ( http://www.controlled-trials.com ). Findings A total of 267 eligible patients were assigned to either D1 (133 patients) or D2 (134) procedure. Median follow-up time was 16.76 years. Analyses were done both in overall patient population and in pT > 1N+. One hundred patients (38.5) were alive without recurrence. OS and disease-specific survival (DSS) were very high in both arms. In overall population, they were not different between D1 and D2 arm (51.3% vs. 46.8% and 65% vs. 67% respectively, p = 0.31 and p = 0.94). DSS was significantly higher after D2 in pT > 1N+ patients (29.4% vs. 51.4%, p = 0.035). OS and DSS were better after D1 in patients older than 70 years (p = 0.003 and p = 0.006). DSS was higher after D1 also in early stages (p = 0.01). Interpretation After 15-year follow up, despite no relevant difference in overall population, DSS and gastric cancer-related mortality of patients with advanced disease and lymph node metastases are improved by D2 procedure. Further data available from this trial suggest that D1 procedure should be preferably used in older patients and in early disease. As accurate detection of advanced diseases can be currently provided by adequate preoperative workup in referral centres, D2 procedure should be recommended in these cases. Funding Piedmont Regional fund for Finalized Healthy Research Project, Application 2003 for data collection.

Published
2021

27. Compared efficacy of rituximab, abatacept, and tocilizumab in patients with rheumatoid arthritis refractory to methotrexate or anti-TNF agents: a systematic review and network

Author

Manoel Barros Bertolo, Ricardo Machado Xavier, Luiz Sérgio F. de Carvalho, Alisson Aliel Vigano Pugliesi, Miguel Angel Gonzalez-Gay, Licia Maria Henrique Mota, Gustavo Citera, and Amanda Borges de Oliveira

Subjects
Oncology, medicine.medical_specialty, business.industry, Abatacept, medicine.disease, chemistry.chemical_compound, Tocilizumab, Refractory, chemistry, Rheumatoid arthritis, Internal medicine, medicine, Tumor necrosis factor alpha, Methotrexate, In patient, Rituximab, business, medicine.drug
Published
2021

28. PRIMARY BILIARY CHOLANGITIS IN A PATIENT WITH DIFFUSE SYSTEMIC SCLEROSIS

Author

Júlia Guimarães Fernandes Costa, Marlone Cunha da Silva, Alisson Aliel Vigano Pugliesi, Marília Bulhões Calheiros, Aloma Guinami Scabora, Ana Paula Toledo Del Rio, Zoraida Sachetto, Marília Paula Souza dos Santos, Camille Constanza Codogno Postigo Castro, and Vani Abreu de Souza Filho

Subjects
medicine.medical_specialty, Primary (chemistry), business.industry, Internal medicine, medicine, business, Gastroenterology
Published
2021

29. Therapies for inflammatory bowel disease do not pose additional risks for adverse outcomes of SARS-CoV 2 infection: an IG-IBD study

Author

Bezzio, C., Armuzzi, A., Furfaro, F., Ardizzone, S., Milla, M., Carparelli, S., Orlando, A., Caprioli, F. A., Castiglione, F., Vigano, C., Ribaldone, D. G., Zingone, F., Monterubbianesi, R., Imperatore, N., Festa, S., Daperno, M., Scucchi, L., Ferronato, A., Pastorelli, L., Balestrieri, P., Ricci, C., Cappello, M., Felice, C., Fiorino, G., Saibeni, S., Coppini, F., Alvisi, P., Gerardi, V., Variola, A., Mazzuoli, S., Lenti, M. V., Pugliese, D., Allocca, M., Ferretti, F., Roselli, J., Bossa, F., Giuliano, A., Piazza, N., Manes, G., Sartini, A., Buda, A., Micheli, F., Ciardo, V., Casella, G., Viscido, A., Bodini, G., Casini, V., Soriano, A., Amato, A., Grossi, L., Onali, S., Rottoli, M., Spagnuolo, R., Baroni, S., Cortelezzi, C. C., Baldoni, M., Vernero, M., Scaldaferri, F., Maconi, G., Guarino, A. D., Palermo, A., D'Inca, R., Scribano, M. L., Biancone, L., Carrozza, L., Ascolani, M., Costa, F., Di Sabatino, A., Zammarchi, I., Gottin, M., Conforti, F. S., Bezzio, Cristina, Armuzzi, Alessandro, Furfaro, Federica, Ardizzone, Sandro, Milla, Monica, Carparelli, Sonia, Orlando, Ambrogio, Caprioli, Flavio Andrea, Castiglione, Fabiana, Viganò, Chiara, Ribaldone, Davide Giuseppe, Zingone, Fabiana, Monterubbianesi, Rita, Imperatore, Nicola, Festa, Stefano, Daperno, Marco, Scucchi, Ludovica, Ferronato, Antonio, Pastorelli, Luca, Balestrieri, Paola, Ricci, Chiara, Cappello, Maria, Felice, Carla, Fiorino, Gionata, Saibeni, Simone, and Francesca Coppini, Patrizia Alvisi, Viviana Gerardi, Angela Variola, Silvia Mazzuoli, Marco Vincenzo Lenti, Daniela Pugliese, Mariangela Allocca, Francesca Ferretti, Jenny Roselli, Fabrizio Bossa, Alessandra Giuliano, Nicole Piazza, Gianpiero Manes, Alessandro Sartini, Andrea Buda, Federica Micheli, Valeria Ciardo, Giovanni Casella, Angelo Viscido, Giorgia Bodini, Valentina Casini, Alessandra Soriano, Arnaldo Amato, Laurino Grossi, Sara Onali, Matteo Rottoli, Rocco Spagnuolo, Stefania Baroni, Claudio Cortelezzi, Monia Baldoni, Marta Vernero, Franco Scaldaferri, Giovanni Maconi, Alessia Dalila Guarino, Andrea Palermo, Renata D'Incà, Maria Lia Scribano, Livia Biancone, Lucio Carrozza, Marta Ascolani, Francesco Costa, Antonio Di Sabatino, Irene Zammarchi, Matteo Gottin, Francesco Simone Conforti

Subjects
medicine.medical_specialty, Settore MED/12 - GASTROENTEROLOGIA, IBD, Population, Ulcerative, Disease, Lower risk, Asymptomatic, Inflammatory bowel disease, Aged, Humans, SARS-CoV-2, Tumor Necrosis Factor Inhibitors, COVID-19, Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases, IBD Treatments and Sars‐cov‐2 Infection, Internal medicine, medicine, biologics, Pharmacology (medical), education, therapy, education.field_of_study, Hepatology, business.industry, INFLAMMATORY BOWEL DISEASE, Gastroenterology, medicine.disease, Colitis, Ulcerative colitis, Pneumonia, Original Article, medicine.symptom, business, Cohort study
Abstract

Summary Background Older age and comorbidities are the main risk factors for adverse COVID‐19 outcomes in patients with inflammatory bowel disease (IBD). The impact of IBD medications is still under investigation. Aims To assess risk factors for adverse outcomes of COVID‐19 in IBD patients and use the identified risk factors to build risk indices. Methods Observational cohort study. Univariable and multivariable logistic regression was used to identify risk factors associated with pneumonia, hospitalisation, need for ventilatory support, and death. Results Of the 937 patients (446 with ulcerative colitis [UC]) evaluated, 128 (13.7%) had asymptomatic SARS‐CoV‐2 infection, 664 (70.8%) had a favourable course, and 135 (15.5%) had moderate or severe COVID‐19. In UC patients, obesity, active disease and comorbidities were significantly associated with adverse outcomes. In patients with Crohn's disease (CD), age, obesity, comorbidities and an additional immune‐mediated inflammatory disease were identified as risk factors. These risk factors were incorporated into two indices to identify patients with UC or CD with a higher risk of adverse COVID‐19 outcomes. In multivariable analyses, no single IBD medication was associated with poor COVID‐19 outcomes, but anti‐TNF agents were associated with a lower risk of pneumonia in UC, and lower risks of hospitalisation and severe COVID‐19 in CD. Conclusion The course of COVID‐19 in patients with IBD is similar to that in the general population. IBD patients with active disease and comorbidities are at greater risk of adverse COVID‐19 outcomes. IBD medications do not pose additional risks. The risk indices may help to identify patients who should be prioritised for COVID‐19 re‐vaccination or for therapies for SARS‐CoV‐2 infection., The course of COVID‐19 in patients with IBD patients is similar to that in the general population. IBD patients with active disease and comorbidities are at greater risk of adverse COVID‐19 outcomes. IBD medications do not pose additional risks.

Published
2021

30. DRUG-INDUCED LIVER INJURY AS A DIFFERENTIAL DIAGNOSIS OF HEPATIC MANIFESTATIONS ASSOCIATED WITH SYSTEMIC LUPUS ERYTHEMATOSUS

Author

Marlone Cunha da Silva, Simone Appenzeller, Marcelo Gustavo Lopes, Walace Magalhães Barbosa, Alisson Aliel Vigano Pugliesi, Marília Bulhões Calheiros, Lilian Tereza Lavras Costallat, Lais Naziozeno Santos, and Mariana Frason Fernandes

Subjects
Liver injury, Drug, Pathology, medicine.medical_specialty, business.industry, media_common.quotation_subject, medicine, Differential diagnosis, medicine.disease, business, media_common
Published
2021

31. A Dielectric Dome Antenna with Reduced Profile and Wide Scanning Capability

Author

Fabrizio Silvestri, Stefano Maci, Giovanni Toso, M. C. Vigano, Enrica Martini, Erio Gandini, A. Benini, Giampiero Gerini, and Stefania Monni

Subjects
Dome antenna, phased array antenna, lens antenna, Materials science, Phased array, business.industry, 020206 networking & telecommunications, 02 engineering and technology, Dielectric, Physical optics, Directivity, phased array antenna, law.invention, Lens (optics), Optics, law, Dome antenna, 0202 electrical engineering, electronic engineering, information engineering, Ray tracing (graphics), Electrical and Electronic Engineering, Antenna (radio), Driven element, business, lens antenna
Abstract

The design and experimental validation of a wide scanning dome antenna with reduced profile is presented. The antenna is based on the combination of a planar phased array with limited scanning capabilities and a dielectric lens which allows to broaden the field of view. The angular variation of the scan loss can be almost arbitrarily designed if no constraint is imposed on the size of the dielectric lens. However, the focus of this article is on the size minimization of the dome as required for applications where the form factor is critical. Therefore, a lower boundary of the height of the dome is derived and imposed as a design constraint. The antenna is analyzed using in-house ray tracing and physical optics software tools. It is shown that, when the array is combined with the dielectric dome, a significant directivity enhancement can be achieved for wide scanning. A demonstrator of the lens is designed, manufactured and combined with an available phased array working in $Ku$ -band. The experimental tests confirm the theoretical predictions, validating the analysis tools, and show a scanning range of 70° in all scanning planes over a 15% bandwidth. The directivity is enhanced by approximately 2 dB at the limits of the scanning range compared to the standalone illuminating array. The active element pattern is rotationally symmetric, thus, the radiation performance is almost independent on the scanning plane. Moreover, the dielectric lens allows to preserve the cross-polarization performance of the illuminating array without adding a significant contribution.

Published
2021

32. Longitudinally extensive transverse myelitis as a presentation of SLE flare after COVID-19 infection

Author

Julia Manara Martins, Yasmin Algazal, Alisson Aliel Vigano Pugliesi, Carlos Eduardo Garcez Teixeira, Simone Appenzeller, Lilian Tereza Lavras Costallat, Thiago Bezerra Matias, Marina Ferreira Simões, Isabela Tambelli Pires Cardoso, and Daniela Gomes Chicre Oliveira

Subjects
medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), law, business.industry, medicine, Radiology, Presentation (obstetrics), medicine.disease, business, Transverse myelitis, Flare, law.invention
Published
2021

33. Risdiplam-Treated Infants with Type 1 Spinal Muscular Atrophy versus Historical Controls

Author

Darras, Basil T, Masson, Riccardo, Mazurkiewicz-Bełdzińska, Maria, Rose, Kristy, Xiong, Hui, Zanoteli, Edmar, Baranello, Giovanni, Bruno, Claudio, Vlodavets, Dmitry, Wang, Yi, El-Khairi, Muna, Gerber, Marianne, Gorni, Ksenija, Khwaja, Omar, Kletzl, Heidemarie, Scalco, Renata S, Fontoura, Paulo, Servais, Laurent, Joseph J, Volpe, John, Posner, Armin, Koch, Ulrich, Kellner, Rosaline, Quinlivan, Nicolas, Deconinck, Irina, Balikova, Patricia, Delbeke, Inge, Joniau, Valentine, Tahon, Sylvia, Wittevrongel, Elke De Vos, Rodrigo de Holanda Mendonça, Ciro Matsui Jr, Ana Letícia Fornazieri Darcie, Cleide, Machado, Maria Kiyoko Oyamada, Daniel de Souza Costa, Joyce, Martini, Graziela, Polido, Juliana Rodrigues Iannicelli, Juliana Caires de Oliveira Achili Ferreira, Chaoping, Hu, Yiyun, Shi, Shuizhen, Zhou, Xiaomei, Zhu, Chen, Qian, Shen, Li, Ying, Xiao, Zhenxuan, Zhou, Hui, Li, Sujuan, Wang, Tian, Sang, Cuijie, Wei, Jing, Wen, Yiwen, Cao, Wenzhu, Li, Lun, Qin, Nina, Barisic, Ivan, Celovec, Martina, Martina, Galiot, Delic, Petra Kristina Ivkić, Nenad, Vukojević, Ivana, Kern, Boris, Najdanovic, Marin, Skugor, Odile, Boespflug-Tanguy, Teresa, Gidaro, Andrea, Seferian, Emmanuel, Barreau, Elodie Da Cunha, Céline, Lambotin, Nabila, Mnafek, Helene, Peche, Stephanie, Gilabert, Allison, Grange, Charlotte, Lilien, Darko, Milascevic, Ariadna, Perticari, Shotaro, Tachibana, Emanuela, Pagliano, Stefania Bianchi Marzoli, Diletta, Santarsiero, Myriam Garcia Sierra, Gemma, Tremolada, Maria Teresa Arnoldi, Marta, Vigano, Riccardo, Zanin, Noemi, Brolatti, Marina, Pedemonte, Enrico, Priolo, Giuseppe, Rao, Enrica, Spaletra, Lorenza, Sposetti, Elisa, Tassara, Simone, Morando, Paola, Tacchetti, Giacomo Pietro Comi, Alessandra, Govoni, Silvia Gabriella Osnaghi, Valeria, Minorini, Francesca, Abbati, Federica, Fassini, Michaela, Foa, Amalia, Lopopolo, Elisa, Minuti, Mercuri, Eugenio Maria, Pane, Marika, Concetta, Palermo, Pera, Maria Carmela, Amorelli, Giulia Maria, Costanza, Barresi, Gugliemo, D'Amico, Orazi, Lorenzo, Coratti, Giorgia, De Sanctis, Roberto, Yasuhiro, Takeshima, Fumi, Gomi, Naoki, Kimura, Takanobu, Morimatsu, Mana, Okamoto, Toru, Furukawa, Mateusz, Koberda, Natalia, Kubiak, Urszula, Stodolska-Koberda, Agnieszka, Waśkowska, Jagoda, Kolendo, Agnieszka, Sobierajska-Rek, Svetlana, Artemyeva, Evgenia, Melnik, Natalya, Leppenen, Nataliya, Yupatova, Elena, Litvinova, Anastasya, Monakhova, Yulia, Papina, Olga, Shidlovsckaia, Andrea, Klein, Cornelia, Enzmann, Elea, Galiart, Konstantin, Gugleta, Patricia, Siems, Verena, Kreiliger, Christine Wondrusch Haschke, Haluk, Topaloglu, Ibrahim, Oncel, Didem, Ardicli, Nesibe Eroglu Ertugrul, Hizal, Gharibzadeh, Ceren, Gunbey, Bahadir, Konuskan, Selen Serel Arslan, Elams Ebru Yalcin, Fatma Gokcem Yildiz Sarikaya, Bora, Eldem, Sibel, Kadayıfçılar, Ipek, Alemdaroglu, Aynur Ayse Karaduman, Oznur Tunca Yilmaz, Robert, J Graham, Partha, Ghosh, David, Casavant, Brian, Snyder, Alexis, Levine, Rachael, Titus, Amanda, Engelbrekt, Lucia, Ambrosio, Anne, Fulton, Anna Maria Baglieri, Courtney, Dias, Elizabeth, Maczek, Elizabeth, Mirek, Amy, Pasternak, John, W Day, Shannon, Beres, Tina, Duong, Richard, Gee, Sally, Young, Darras, Basil T, Masson, Riccardo, Mazurkiewicz-Bełdzińska, Maria, Rose, Kristy, Xiong, Hui, Zanoteli, Edmar, Baranello, Giovanni, Bruno, Claudio, Vlodavets, Dmitry, Wang, Yi, El-Khairi, Muna, Gerber, Marianne, Gorni, Ksenija, Khwaja, Omar, Kletzl, Heidemarie, Scalco, Renata S, Fontoura, Paulo, Servais, Laurent, and Ambrosio, Lucia

Subjects
Male, medicine.medical_specialty, Neuromuscular disease, Risdiplam, Type 1 Spinal Muscular Atrophy, treated infants, historical controls, MEDLINE, Spinal Muscular Atrophies of Childhood, Severity of Illness Index, Text mining, Settore MED/39 - NEUROPSICHIATRIA INFANTILE, Internal medicine, Severity of illness, medicine, Humans, Progression-free survival, 610 Medicine & health, business.industry, Historically Controlled Study, Infant, General Medicine, Spinal muscular atrophy, SMA, medicine.disease, Progression-Free Survival, Settore MED/26 - NEUROLOGIA, Pyrimidines, Neuromuscular Agents, Motor Skills, Female, business, Azo Compounds
Abstract

BACKGROUND Type 1 spinal muscular atrophy (SMA) is a progressive neuromuscular disease characterized by an onset at 6 months of age or younger, an inability to sit without support, and deficient levels of survival of motor neuron (SMN) protein. Risdiplam is an orally administered small molecule that modifies SMN2 pre-messenger RNA splicing and increases levels of functional SMN protein in blood. METHODS We conducted an open-label study of risdiplam in infants with type 1 SMA who were 1 to 7 months of age at enrollment. Part 1 of the study (published previously) determined the dose to be used in part 2 (reported here), which assessed the efficacy and safety of daily risdiplam as compared with no treatment in historical controls. The primary end point was the ability to sit without support for at least 5 seconds after 12 months of treatment. Key secondary end points were a score of 40 or higher on the Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND; range, 0 to 64, with higher scores indicating better motor function), an increase of at least 4 points from baseline in the CHOP-INTEND score, a motor-milestone response as measured by Section 2 of the Hammersmith Infant Neurological Examination (HINE-2), and survival without permanent ventilation. For the secondary end points, comparisons were made with the upper boundary of 90% confidence intervals for natural-history data from 40 infants with type 1 SMA. RESULTS A total of 41 infants were enrolled. After 12 months of treatment, 12 infants (29%) were able to sit without support for at least 5 seconds, a milestone not attained in this disorder. The percentages of infants in whom the key secondary end points were met as compared with the upper boundary of confidence intervals from historical controls were 56% as compared with 17% for a CHOP-INTEND score of 40 or higher, 90% as compared with 17% for an increase of at least 4 points from baseline in the CHOP-INTEND score, 78% as compared with 12% for a HINE-2 motor-milestone response, and 85% as compared with 42% for survival without permanent ventilation (P

Published
2021

34. Adjunctive Brivaracetam in Focal Epilepsy: Real-World Evidence from the BRIVAracetam add-on First Italian netwoRk STudy (BRIVAFIRST)

Author

Lattanzi, S., Canafoglia, L., Canevini, M. P., Casciato, S., Chiesa, V., Dainese, F., De Maria, G., Didato, G., Falcicchio, G., Fanella, M., Ferlazzo, E., Fisco, G., Gangitano, M., Giallonardo, A. T., Giorgi, F. S., La Neve, A., Mecarelli, O., Montalenti, E., Piazza, F., Pulitano, P., Quarato, P. P., Ranzato, F., Rosati, E., Tassi, L., Di Bonaventura, C., Alicino, A., Ascoli, M., Assenza, G., Avorio, F., Badioni, V., Banfi, P., Bartolini, E., Basili, L. M., Belcastro, V., Beretta, S., Berto, I., Biggi, M., Billo, G., Boero, G., Bonanni, P., Bongorno, J., Brigo, F., Caggia, E., Cagnetti, C., Calvello, C., Irelli, E. C., Cesnik, E., Chianale, G., Ciampanelli, D., Ciuffini, R., Cocito, D., Colella, D., Contento, M., Costa, C., Cumbo, E., D'Aniello, A., Deleo, F., Difrancesco, J. C., Di Gennaro, G., Di Giacomo, R., Di Liberto, A., Domina, E., Donato, F., Dono, F., Durante, V., Elia, M., Estraneo, A., Evangelista, G., Faedda, M. T., Failli, Y., Fallica, E., Fattouch, J., Ferrari, A., Ferreri, F., Fonti, D., Fortunato, F., Foschi, N., Francavilla, T., Galli, R., Gazzina, S., Giuliano, L., Habetswallner, F., Izzi, F., Kassabian, B., Labate, A., Luisi, C., Magliani, M., Maira, G., Mari, L., Marino, D., Mascia, A., Mazzeo, A., Meletti, S., Morano, A., Nilo, A., Orlando, B., Paladin, F., Pascarella, M. G., Pastori, C., Pauletto, G., Peretti, A., Perri, G., Pezzella, M., Piccioli, M., Pignatta, P., Pilolli, N., Pisani, F., Pisani, L. R., Placidi, F., Pollicino, P., Porcella, V., Pradella, S., Puligheddu, M., Quadri, S., Quintas, R., Renna, R., Rossi, J., Rum, A., Salamone, E. M., Savastano, E., Sessa, M., Stokelj, D., Tartara, E., Tombini, M., Tumminelli, G., Ventura, M., Vigano, I., Viglietta, E., Vignoli, A., Villani, F., Zambrelli, E., Zummo, L., Lattanzi S., Canafoglia L., Canevini M.P., Casciato S., Chiesa V., Dainese F., De Maria G., Didato G., Falcicchio G., Fanella M., Ferlazzo E., Fisco G., Gangitano M., Giallonardo A.T., Giorgi F.S., La Neve A., Mecarelli O., Montalenti E., Piazza F., Pulitano P., Quarato P.P., Ranzato F., Rosati E., Tassi L., and Di Bonaventura C.

Subjects
medicine.medical_specialty, business.industry, Context (language use), Brivaracetam, medicine.disease, Discontinuation, law.invention, Psychiatry and Mental health, Epilepsy, Randomized controlled trial, Tolerability, focal epilepsy, add-on therapy, seizure, law, Concomitant, Internal medicine, Medicine, Pharmacology (medical), Neurology (clinical), Levetiracetam, Original Research Article, business, medicine.drug
Abstract

Background: In randomized controlled trials, add-on brivaracetam (BRV) reduced seizure frequency in patients with drug-resistant focal epilepsy. Studies performed in a naturalistic setting are a useful complement to characterize the drug profile. Objective: This multicentre study assessed the effectiveness and tolerability of adjunctive BRV in a large population of patients with focal epilepsy in the context of real-world clinical practice. Methods: The BRIVAFIRST (BRIVAracetam add-on First Italian netwoRk STudy) was a retrospective, multicentre study including adult patients prescribed adjunctive BRV. Patients with focal epilepsy and 12-month follow-up were considered. Main outcomes included the rates of seizure‐freedom, seizure response (≥50% reduction in baseline seizure frequency), and treatment discontinuation. The incidence of adverse events (AEs) was also considered. Analyses by levetiracetam (LEV) status and concomitant use of strong enzyme-inducing antiseizure medications (EiASMs) and sodium channel blockers (SCBs) were performed. Results: A total of 1029 patients with a median age of 45years (33–56) was included. At 12 months, 169 (16.4%) patients were seizure-free and 383 (37.2%) were seizure responders. The rate of seizure freedom was 22.3% in LEV-naive patients, 7.1% in patients with prior LEV use and discontinuation due to insufficient efficacy, and 31.2% in patients with prior LEV use and discontinuation due to AEs (p&nbsp

Published
2021

35. Ethical Orientation in Banks - Original Roots in Bank Governance and Current Challenges

Author

Laura Vigano

Subjects
Marginal clientele, Ethical banks, Settore SECS-P/11 - Economia degli Intermediari Finanziari, business.industry, Corporate governance, Financial intermediary, Ethical financial products, Accounting, Alternative banks, Cooperative banks, Transparency, Social impact, Business economics, Transparency (graphic), Financial crisis, Business, Product (category theory), Market share, Privilege (social inequality)
Abstract

Over the past 30 years, the banking sector has been characterized by increasing attention to ethics, which intensified as a consequence of the global financial crisis. Banks have the privilege and responsibility of directly interacting with a wide and diversified clientele and are supposed to base their long-lasting relationship with this clientele on trust, transparency, and proper behavior. Special types of banks, “alternative” to traditional banks in what they consider ethical behavior, have been increasingly present in the market. While alternative banks still cover a limited market share in terms of intermediated funds, awareness on their values and operational choices has been spreading throughout the financial community. The concept of social impact finance, currently permeating the financial sector, is a product of such a process. One interesting question, therefore, emerges: are these banks truly special and clearly distinguished from traditional banking? A second concern focuses on the role that these banks may play in the financial system due to a more intense ethical orientation. To answer these questions, it is necessary to outline a suitable analytical framework. Differently from the common approach, which is purely based on banks’ investment choices, this contribution draws from some cornerstone work on ethical business and is enriched by the original view of a classical author of the Italian business economics academic community. The resulting holistic approach bases banks’ ethical orientation on the institutional nature of financial intermediaries, their ultimate strategic goals, and their role in the economy and in society. To make the analysis more concrete, the suggested theoretical framework is used to study two types of banks that are commonly considered particularly ethically oriented: cooperative and alternative banks. It emerges that a small size may be critical in facilitating the achievement of a high degree of ethical orientation. The conclusions drawn based on these cases are used to offer some critical perspectives on the role of ethics in the current overall banking system.

Published
2021

36. Whipple´s disease mimicking undifferentiated arthritis and fibromyalgia

Author

Vinícius Verlangieri Soubihe, Michel Alexandre Yazbek, Diego de Paula Ferreira Nunes, Lilian Tiemi Hirata, Caio Rustichelli Cardoso, Raíssa Dudienas Domingues Pereira, Juliana Zonzini Gaino, Manoel Barros Bertolo, and Alisson Aliel Vigano Pugliesi

Subjects
medicine.medical_specialty, Undifferentiated arthritis, business.industry, Fibromyalgia, medicine, Whipple's disease, medicine.disease, business, Dermatology
Published
2021

37. Consensus recommendations on dosing and administration of medical cannabis to treat chronic pain: results of a modified Delphi process

Author

Matthew R.D. Brown, Malcolm Hogg, Dustin Sulak, Claude Cyr, Caroline A. MacCallum, Hance Clarke, Arun Bhaskar, Wellington Briques, Ricardo Ferreira de Oliveira Silva, Colleen O'Connell, Antonio Vigano, Peter Georgius, Tina Ingrid Horsted, Aaron Sihota, Alan Bell, Dwight E. Moulin, Robert Sealey, Elon Eisenberg, Marc Seibolt, Kirsten R. Müller-Vahl, Michael Boivin, Eva Frohlich, and Brennan K Smith

Subjects
THC, medicine.medical_treatment, Chronic pain, Medical cannabis, law.invention, SB1-1110, 03 medical and health sciences, 0302 clinical medicine, Pharmacy and materia medica, Randomized controlled trial, law, Medicine, Cannabidiol, 030212 general & internal medicine, Dosing, Tetrahydrocannabinol, Original Research, business.industry, Plant culture, medicine.disease, RS1-441, Anesthesia, CBD, Delphi process, Psychopharmacology, Cannabinoid, business, 030217 neurology & neurosurgery, medicine.drug
Abstract

Background Globally, medical cannabis legalization has increased in recent years and medical cannabis is commonly used to treat chronic pain. However, there are few randomized control trials studying medical cannabis indicating expert guidance on how to dose and administer medical cannabis safely and effectively is needed. Methods Using a multistage modified Delphi process, twenty global experts across nine countries developed consensus-based recommendations on how to dose and administer medical cannabis in patients with chronic pain. Results There was consensus that medical cannabis may be considered for patients experiencing neuropathic, inflammatory, nociplastic, and mixed pain. Three treatment protocols were developed. A routine protocol where the clinician initiates the patient on a CBD-predominant variety at a dose of 5 mg CBD twice daily and titrates the CBD-predominant dose by 10 mg every 2 to 3 days until the patient reaches their goals, or up to 40 mg/day. At a CBD-predominant dose of 40 mg/day, clinicians may consider adding THC at 2.5 mg and titrate by 2.5 mg every 2 to 7 days until a maximum daily dose of 40 mg/day of THC. A conservative protocol where the clinician initiates the patient on a CBD-predominant variety at a dose of 5 mg once daily and titrates the CBD-predominant dose by 10 mg every 2 to 3 days until the patient reaches their goals, or up to 40 mg/day. At a CBD-predominant dose of 40 mg/day, clinicians may consider adding THC at 1 mg/day and titrate by 1 mg every 7 days until a maximum daily dose of 40 mg/day of THC. A rapid protocol where the clinician initiates the patient on a balanced THC:CBD variety at 2.5–5 mg of each cannabinoid once or twice daily and titrates by 2.5–5 mg of each cannabinoid every 2 to 3 days until the patient reaches his/her goals or to a maximum THC dose of 40 mg/day. Conclusions In summary, using a modified Delphi process, expert consensus-based recommendations were developed on how to dose and administer medical cannabis for the treatment of patients with chronic pain.

Published
2021
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38. Amyloid Arthropathy (Shoulder Pad Sign) in a patient on dialysis due to Multiple Myeloma

Author

Luísa Becker Savastano, Eliane Maria Ingrid Amstalden, Manoel Barros Bertolo, Alisson Aliel Vigano Pugliesi, Daniela Gomes Chicre Oliveira, Lilian Tiemi Hirata, Carlos Eduardo Garcez Teixeira, Luã Portela Carvalho, Ana Carolina Armiliato Bogoevich, Isabela Tambelli Pires Cardoso, and Marina Ferreira Simões

Subjects
medicine.medical_specialty, business.industry, medicine.medical_treatment, Medicine, business, medicine.disease, Multiple myeloma, Dialysis, Shoulder-pad sign, Amyloid arthropathy, Surgery
Published
2021

39. Risdiplam in Type 1 Spinal Muscular Atrophy

Author

Baranello, Giovanni, Darras, Basil T, Day, John W, Deconinck, Nicolas, Klein, Andrea, Masson, Riccardo, Mercuri, Eugenio Maria, Rose, Kristy, El-Khairi, Muna, Gerber, Marianne, Gorni, Ksenija, Khwaja, Omar, Kletzl, Heidemarie, Scalco, Renata S, Seabrook, Timothy, Fontoura, Paulo, Servais, Laurent, FIREFISH Working Group: Joseph, J Volpe, John, Posner, Armin, Koch, Ulrich, Kellner, Rosaline, Quinlivan, Irina, Balikova, Patricia, Delbeke, Inge, Joniau, Valentine, Tahon, Sylvia, Wittevrongel, Elke De Vos, Edmar, Zanoteli, Rodrigo de Holanda Mendonça, Ciro Matsui Jr, Ana Letícia Fornazieri Darcie, Cleide, Machado, Maria Kiyoko Oyamada, Daniel de Souza Costa, Joyce, Martini, Graziela, Polido, Juliana Rodrigues Iannicelli, Juliana Caires de Oliveira Achili Ferreira, Wang, Yi, Chaoping, Hu, Yiyun, Shi, Shuizhen, Zhou, Xiaomei, Zhu, Chen, Qian, Shen, Li, Ying, Xiao, Zhenxuan, Zhou, Hui, Li, Sujuan, Wang, Hui, Xiong, Tian, Sang, Cuijie, Wei, Jing, Wen, Yiwen, Cao, Wenzhu, Li, Lun, Qin, Nina, Barisic, Ivan, Celovec, Martina Galiot Delic, Petra Kristina Ivkić, Nenad, Vukojević, Ivana, Kern, Boris, Najdanovic, Marin, Skugor, Odile, Boespflug-Tanguy, Teresa, Gidaro, Andrea, Seferian, Emmanuel, Barreau, Elodie Da Cunha, Céline, Lambotin, Nabila, Mnafek, Helene, Peche, Stephanie, Gilabert, Allison, Grange, Charlotte, Lilien, Darko, Milascevic, Ariadna, Perticari, Shotaro, Tachibana, Emanuela, Pagliano, Bianchi Marzoli, Stefania, Diletta, Santarsiero, Myriam Garcia Sierra, Gemma, Tremolada, Maria Teresa Arnoldi, Marta, Vigano, Riccardo, Zanin, Bissoli, Claudio Bruno, Noemi, Brolatti, Marina, Pedemonte, Enrico, Priolo, Giuseppe, Rao, Enrica, Spaletra, Lorenza, Sposetti, Elisa, Tassara, Simone, Morando, Paola, Tacchetti, Giacomo Pietro Comi, Alessandra, Govoni, Silvia Gabriella Osnaghi, Valeria, Minorini, Francesca, Abbati, Federica, Fassini, Michaela, Foa, Amalia, Lopopolo, Elisa, Minuti, Pane, Marika, Concetta, Palermo, Pera, Maria Carmela, Amorelli, Giulia Maria, Costanza, Barresi, Gugliemo, D'Amico, Orazi, Lorenzo, Coratti, Giorgia, De Sanctis, Roberto, Yasuhiro, Takeshima, Fumi, Gomi, Naoki, Kimura, Takanobu, Morimatsu, Mana, Okamoto, Toru, Furukawa, Maria, Mazurkiewicz-Bełdzińska, Mateusz, Koberda, Natalia, Kubiak, Urszula, Stodolska-Koberda, Agnieszka, Waśkowska, Jagoda, Kolendo, Agnieszka, Sobierajska-Rek, Dmitry, Vlodavets, Svetlana, Artemyeva, Evgenia, Melnik, Natalya, Leppenen, Nataliya, Yupatova, Elena, Litvinova, Anastasya, Monakhova, Yulia, Papina, Olga, Shidlovsckaia, Cornelia, Enzmann, Elea, Galiart, Konstantin, Gugleta, Patricia, Siems, Verena, Kreiliger, Christine Wondrusch Haschke, Haluk, Topaloglu, Ibrahim, Oncel, Didem, Ardicli, Nesibe Eroglu Ertugrul, Hizal, Gharibzadeh, Ceren, Gunbey, Bahadir, Konuskan, Selen Serel Arslan, Elams Ebru Yalcin, Fatma Gokcem Yildiz Sarikaya, Bora, Eldem, Sibel, Kadayıfçılar, Ipek, Alemdaroglu, Aynur Ayse Karaduman, Oznur Tunca Yilmaz, Lucia, Ambrosio, Anne, Fulton, Anna Maria Baglieri, Courtney, Dias, Elizabeth, Maczek, Elizabeth, Mirek, Amy, Pasternak, Shannon, Beres, Tina, Duong, Richard, Gee, Sally, Young, Giovanni, Baranello, Basil T, Darra, John W, Day, Nicolas, Deconinck, Andrea, Klein, Riccardo, Masson, Eugenio, Mercuri, Kristy, Rose, Muna, El-Khairi, Marianne, Gerber, Ksenija, Gorni, Omar, Khwaja, Heidemarie, Kletzl, Renata S, Scalco, Timothy, Seabrook, Paulo, Fontoura, Laurent, Servai, and Ambrosio, Lucia

Subjects
Male, Oral, Neuromuscular disease, RNA Splicing, Administration, Oral, 030204 cardiovascular system & hematology, Spinal Muscular Atrophies of Childhood, Bioinformatics, Dose-Response Relationship, 03 medical and health sciences, 0302 clinical medicine, Settore MED/39 - NEUROPSICHIATRIA INFANTILE, medicine, Humans, Risdiplam, Type 1 Spinal Muscular Atrophy, 030212 general & internal medicine, Progression-free survival, 610 Medicine & health, Respiratory Tract Infections, Dose-Response Relationship, Drug, business.industry, Infant, Survival of motor neuron, General Medicine, Spinal muscular atrophy, medicine.disease, Survival of Motor Neuron 1 Protein, Progression-Free Survival, Clinical trial, Dose–response relationship, Settore MED/26 - NEUROLOGIA, Pyrimidines, nervous system, Neuromuscular Agents, RNA splicing, Administration, Female, Drug, business, Respiratory Insufficiency, Azo Compounds
Abstract

Background: Type 1 spinal muscular atrophy is a rare, progressive neuromuscular disease that is caused by low levels of functional survival of motor neuron (SMN) protein. Risdiplam is an orally administered, small molecule that modifies SMN2 pre-messenger RNA splicing and increases levels of functional SMN protein. Methods: We report the results of part 1 of a two-part, phase 2-3, open-label study of risdiplam in infants 1 to 7 months of age who had type 1 spinal muscular atrophy, which is characterized by the infant not attaining the ability to sit without support. Primary outcomes were safety, pharmacokinetics, pharmacodynamics (including the blood SMN protein concentration), and the selection of the risdiplam dose for part 2 of the study. Exploratory outcomes included the ability to sit without support for at least 5 seconds. Results: A total of 21 infants were enrolled. Four infants were in a low-dose cohort and were treated with a final dose at month 12 of 0.08 mg of risdiplam per kilogram of body weight per day, and 17 were in a high-dose cohort and were treated with a final dose at month 12 of 0.2 mg per kilogram per day. The baseline median SMN protein concentrations in blood were 1.31 ng per milliliter in the low-dose cohort and 2.54 ng per milliliter in the high-dose cohort; at 12 months, the median values increased to 3.05 ng per milliliter and 5.66 ng per milliliter, respectively, which represented a median of 3.0 times and 1.9 times the baseline values in the low-dose and high-dose cohorts, respectively. Serious adverse events included pneumonia, respiratory tract infection, and acute respiratory failure. At the time of this publication, 4 infants had died of respiratory complications. Seven infants in the high-dose cohort and no infants in the low-dose cohort were able to sit without support for at least 5 seconds. The higher dose of risdiplam (0.2 mg per kilogram per day) was selected for part 2 of the study. Conclusions: In infants with type 1 spinal muscular atrophy, treatment with oral risdiplam led to an increased expression of functional SMN protein in the blood. (Funded by F. Hoffmann-La Roche; ClinicalTrials.gov number, NCT02913482.).

Published
2021

40. Spondylodiscitis and wrist arthritis caused by Tuberculosis in a patient with Sjogren Syndrome

Author

Daniela Gomes Chicre Oliveira, Ana Paula Toledo Del Rio, Carlos Eduardo Garcez Teixeira, Alisson Aliel Vigano Pugliesi, Zoraida Sachetto, Marina Ferreira Simões, and Isabela Tambelli Pires Cardoso

Subjects
Spondylodiscitis, medicine.medical_specialty, Wrist arthritis, Tuberculosis, business.industry, Medicine, Sjögren syndrome, business, medicine.disease, Dermatology
Published
2021

41. Using GIS to assess the impact of electric vehicles on electrical distribution networks: a study applied to the city of Brescia

Author

Chiara Michelangeli, Diana Moneta, Alessandro Bosisio, Andrea Morotti, Daniele Clerici, Pasetti Caterina, Giacomo Vigano, and Bartolomeo Greco

Subjects
Electric power distribution, Electric vehicles, Computer science, Emerging technologies, business.industry, Photovoltaic systems , Power engineering , Substations , Databases , Urban areas , Distribution networks , Electric vehicles, Substations, Fossil fuel, Photovoltaic system, Power engineering, Power distribution networks, Groundwater recharge, Geographic information systems, Network topology, Renewable energy, Transport engineering, Charging stations, Databases, Distribution networks, Decarbonisation, business, Urban areas, Photovoltaic systems
Abstract

The local environmental concerns and the need to replace fossil fuels with renewable sources to decrease carbon dioxide emissions, are driving the spread of new technologies, such as electric heating/cooling systems, residential photovoltaic generators, and electric mobility. These new equipment will be mostly connected to the electricity distribution networks, managed by distribution system operators. The definition of realistic future scenarios, in terms of network topology and user characteristics, is essential to determine the impact of these resources. This paper shows a methodology for integrating the network data with external public databases information to forecast the future impact of electromobility. In particular, the electromobility scenario is defined by exploiting public information regarding the position of public parking areas and the Origin-Destination (O-D) matrixes. This information, together with a georeferenced description of the distribution network, can be used to determine the impact on the network of electric vehicles recharge. The methodology is applied to the distribution network of Brescia, a city in Northern Italy.

Published
2021

42. Arteritic Anterior Ischemic Optic Neuropathy (AION) as a Manifestation of Rheumatoid Vasculitis: Case Report

Author

Vani Abreu de Souza Filho, Matheus Schwengber Gasparini, Frederico Castelo Moura, João Artur Santos, Raíssa Dudienas Domingues Pereira, Caio Rustichelli Cardoso, Roberto dos Reis, Vinicius Verlangieri Soubihe, Diego de Paula Ferreira Nunes, Nivaldo Adolfo da Silva Junior, Manoel Barros Bertolo, Alisson Aliel Vigano Pugliesi, and Thiago Bezerra Matias

Subjects
Arteritic anterior ischemic optic neuropathy, medicine.medical_specialty, business.industry, Ophthalmology, medicine, Rheumatoid vasculitis, business, medicine.disease
Published
2021

43. BUDD-CHIARI SYNDROME AS INITIAL MANIFESTATION OF BEHÇET'S DISEASE

Author

Alisson Alien Vigano Pugliesi, Carla Jerônimo Peres Fingerhut, Vani Abreu de Souza Filho, Daniel Ferraz de Campos Mazo, Heloisa Sisconeto Bisinotto, Zoraida Sachetto, Camille Constanza Codogno Postigo Castro, and Flávia Carolina Oliveira

Subjects
medicine.medical_specialty, business.industry, medicine, Budd–Chiari syndrome, Behcet's disease, medicine.disease, business, Dermatology
Published
2021

44. HIV Antibody Fc N-Linked Glycosylation Is Associated with Viral Rebound

Author

Ole Schmeltz Søgaard, Saheli Sadanand, Zelda Euler, Dan H. Barouch, Galit Alter, Douglas A. Lauffenburger, Caitlyn Linde, Jessica K. Sassic, Thomas A Rasmussen, Stephanie Fischinger, Martin Tolstrup, Madeleine F. Jennewein, Todd J. Suscovich, Giuseppe Lofano, Richelle C. Charles, Eileen P. Scully, Selena Vigano, Lu Zheng, Rasmus Offersen, Boris Julg, Lars Østergaard, Kathryn E. Stephenson, Mathias Lichterfeld, Marcus Altfeld, Erik S. Rosenberg, Dario Garcia-Dominguez, Wen-Han Yu, and Todd M. Allen

Subjects
0301 basic medicine, Glycosylation, Fc-receptors, glycosylation, viral host response, Human immunodeficiency virus (HIV), Inflammation, HIV Antibodies, medicine.disease_cause, HIV reservoir, General Biochemistry, Genetics and Molecular Biology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, N-linked glycosylation, medicine, Humans, antibodies, lcsh:QH301-705.5, B cells, biology, business.industry, biomarkers, HIV, Viral Load, cure, Discontinuation, Vaccination, 030104 developmental biology, lcsh:Biology (General), chemistry, HIV remission, Immunology, biology.protein, Biomarker (medicine), Antibody, medicine.symptom, business, 030217 neurology & neurosurgery
Abstract

Summary: Changes in antibody glycosylation are linked to inflammation across several diseases. Alterations in bulk antibody galactosylation can predict rheumatic flares, act as a sensor for immune activation, predict gastric cancer relapse, track with biological age, shift with vaccination, change with HIV reservoir size on therapy, and decrease in HIV and HCV infections. However, whether changes in antibody Fc biology also track with reservoir rebound time remains unclear. The identification of a biomarker that could forecast viral rebound time could significantly accelerate the downselection and iterative improvement of promising HIV viral eradication strategies. Using a comprehensive antibody Fc-profiling approach, the level of HIV-specific antibody Fc N-galactosylation is significantly associated with time to rebound after treatment discontinuation across three independent cohorts. Thus virus-specific antibody glycosylation may represent a promising, simply measured marker to track reservoir reactivation.

Published
2020

45. TSO-DSO coordination to acquire services from distribution grids : simulations, cost benefit analysis and regulatory conclusions from the SmartNet project

Author

Gianluigi Migliavacca, Andrei Z. Morch, Giacomo Vigano, Ivana Kockar, Dario Siface, Marco Rossi, Carlos Madina, and Inés Gómez

Subjects
Flexibility (engineering), Cost–benefit analysis, Aggregation of distribution resources, Computer science, business.industry, 020209 energy, TK, 020208 electrical & electronic engineering, Network simulation, Electricity system, Ancillary services market, Energy Engineering and Power Technology, Distribution (economics), 02 engineering and technology, 7. Clean energy, Demand response, Risk analysis (engineering), Order (exchange), Distributed generation, 0202 electrical engineering, electronic engineering, information engineering, Network operators coordination schemes, Electrical and Electronic Engineering, business
Abstract

The continuously growing distributed generation and the business potential for demand response are gradually enabling significant provision of flexibility and reserve towards distribution networks. For this reason, transmission and distribution system operators need to coordinate their operation in order to develop efficient market arrangements that can help utilize all the resources capable of providing ancillary services. SmartNet project investigated the potential interaction schemes between network operators, together with the possible new services devoted to the optimal distribution grid management. This paper summarizes the main challenges in simulating complex electricity systems and flexibility markets for three European countries (Italy, Denmark and Spain) in 2030 scenarios. The simulation results are then analyzed using cost-benefit analysis and regulatory conclusions are deduced. European Commission's H2020 under grant agreement No 691405.

Published
2020

46. Direct-acting antivirals and hepatocellular carcinoma in chronic hepatitis C: A few lights and many shadows

Author

Guarino, Maria, Sessa, Anna, Cossiga, Valentina, Morando, Federica, Caporaso, Nicola, Morisco, Filomena, Luca, Viganó, Romana, Ponziani Francesca, Maurizio, Pompili, Cillo, Umberto, Burra, Patrizia, Mescoli, Claudia, Gambato, Martina, Russo, FRANCESCO PAOLO, Vitale, Alessandro, Giuseppe, Cabibbo, Mauro, Vigano', Giovanni, Galati, Erica, Villa, Lupo, Luigi G., Maria, Rendina, Losito, Francesco, Fucilli, Fabio, Persico, Marcello, D'Ambrosio, Roberta, Sangiovanni, Angelo, Massimo, Iavarone, Brancaccio, Giuseppina, Cucchetti, Alessandro, Renzulli, Matteo, Franco, Trevisani, Miele, Luca, Grieco, Antonio, Rapaccini, Gianlodovico, Gasbarrini, Antonio, Sandri, Giovanni Battisa Levi, Melandro, Fabio, Rossi, Massimo, Quirino, Lai, Lenci, Ilaria, Manzia, Tommaso Maria, Tortora, Raffaella, Di Costanzo, Giovan Giuseppe, Ghinolfi, Davide, Rreka, Erion, Carrai, Paola, Simonetti, Natalia, Rodolfo, Sacco, Sposito, Carlo, Bhoori, Sherrie, Di Sandro, Stefano, Foschi, Francesco Giuseppe, Gardini, Andrea Casadei, Nicolini, Daniele, Mazzocato, Susanna, Alba, Kostandini, Violi, Paola, Baccarani, Umberto, Pravisani, Riccardo, Vincenzi, Valter, Maria, Guarino, Anna, Sessa, Valentina, Cossiga, Federica, Morando, Nicola, Caporaso, Filomena, Morisco, Viganó, Luca, Ponziani Francesca, Romana, Pompili, Maurizio, Umberto, Cillo, Patrizia, Burra, Claudia, Mescoli, Martina, Gambato, Russo Francesco, Paolo, Vitale, Alessandro, Cabibbo, Giuseppe, Vigano', Mauro, Galati, Giovanni, Villa, Erica, Luigi G., Lupo, Rendina, Maria, Francesco, Losito, Fabio, Fucilli, Marcello, Persico, Roberta, D'Ambrosio, Angelo, Sangiovanni, Iavarone, Massimo, Brancaccio, Giuseppina, Alessandro, Cucchetti, Matteo, Renzulli, Trevisani, Franco, Luca, Miele, Antonio, Grieco, Gianlodovico, Rapaccini, Antonio, Gasbarrini, Giovanni Battisa Levi, Sandri, Fabio, Melandro, Massimo, Rossi, Lai, Quirino, Ilaria, Lenci, Tommaso Maria, Manzia, Raffaella, Tortora, Giovan Giuseppe, Di Costanzo, Davide, Ghinolfi, Erion, Rreka, Paola, Carrai, Natalia, Simonetti, Sacco, Rodolfo, Carlo, Sposito, Sherrie, Bhoori, Stefano, Di Sandro, Francesco Giuseppe, Foschi, Andrea Casadei, Gardini, Daniele, Nicolini, Susanna, Mazzocato, Kostandini, Alba, Paola, Violi, Umberto, Baccarani, Riccardo, Pravisani, Valter, Vincenzi, Guarino, Maria, Sessa, Anna, Cossiga, Valentina, Morando, Federica, Caporaso, Nicola, Morisco, Filomena, Luca, Viganó, Romana, Ponziani Francesca, Maurizio, Pompili, Cillo, Umberto, Burra, Patrizia, Mescoli, Claudia, Gambato, Martina, Paolo, Russo Francesco, Alessandro, Vitale, Giuseppe, Cabibbo, Mauro, Vigano', Giovanni, Galati, Erica, Villa, Lupo, Luigi G., Maria, Rendina, Losito, Francesco, Fucilli, Fabio, Persico, Marcello, D'Ambrosio, Roberta, Sangiovanni, Angelo, Massimo, Iavarone, Giuseppina, Brancaccio, Cucchetti, Alessandro, Renzulli, Matteo, Franco, Trevisani, Miele, Luca, Grieco, Antonio, Rapaccini, Gianlodovico, Gasbarrini, Antonio, Sandri, Giovanni Battisa Levi, Melandro, Fabio, Rossi, Massimo, Quirino, Lai, Lenci, Ilaria, Manzia, Tommaso Maria, Tortora, Raffaella, Di Costanzo, Giovan Giuseppe, Ghinolfi, Davide, Rreka, Erion, Carrai, Paola, Simonetti, Natalia, Rodolfo, Sacco, Sposito, Carlo, Bhoori, Sherrie, Di Sandro, Stefano, Foschi, Francesco Giuseppe, Gardini, Andrea Casadei, Nicolini, Daniele, Mazzocato, Susanna, Alba, Kostandini, Violi, Paola, Baccarani, Umberto, Pravisani, Riccardo, and Vincenzi, Valter

Subjects
Oncology, Cirrhosis, Direct-acting antiviral agent, Sustained Virologic Response, Direct-acting antiviral agents, Hepatitis C virus, Hepatocellular carcinoma, Occurrence, Recurrence, Antiviral Agents, Carcinoma, Hepatocellular, Disease Progression, Hepacivirus, Hepatitis C, Chronic, Humans, Incidence, Liver, Liver Neoplasms, Neoplasm Recurrence, Local, Risk Factors, Treatment Outcome, Gastroenterology, medicine.disease_cause, DIRECT ACTING ANTIVIRALS, 0302 clinical medicine, Chronic, biology, Incidence (epidemiology), Minireviews, General Medicine, Hepatitis C, Local, Liver Neoplasm, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Human, medicine.medical_specialty, Interferon therapy, 03 medical and health sciences, Chronic hepatitis, Internal medicine, medicine, Antiviral Agent, Hepaciviru, business.industry, Risk Factor, Carcinoma, Hepatocellular, medicine.disease, biology.organism_classification, digestive system diseases, Settore MED/18 - Chirurgia Generale, Neoplasm Recurrence, business, Hepatitis C viru
Abstract

With the introduction of direct-acting antiviral agents (DAA), the rate of sustained virological response (SVR) in the treatment of hepatitis C virus (HCV) has radically improved to over 95%. Robust scientific evidence supports a beneficial role of SVR after interferon therapy in the progression of cirrhosis, resulting in a decreased incidence of hepatocellular carcinoma (HCC). However, a debate on the impact of DAAs on the development of HCC is ongoing. This review aimed to analyse the scientific literature regarding the risk of HCC in terms of its recurrence and occurrence after the use of DAAs to eradicate HCV infection. Among 11 studies examining HCC occurrence, the de novo incidence rate ranged from 0 to 7.4% (maximum follow-up: 18 mo). Among 18 studies regarding HCC recurrence, the rate ranged from 0 to 54.4% (maximum "not well-defined" followup: 32 mo). This review highlights the major difficulties in interpreting data and reconciling the results of the included studies. These difficulties include heterogeneous cohorts, potential misclassifications of HCC prior to DAA therapy, the absence of an adequate control group, short follow-up times and different kinds of follow-up. Moreover, no clinical feature-based scoring system accounts for the molecular characteristics and pathobiology of the tumours. Nonetheless, this review does not suggest that there is a higher rate of de novo HCC occurrence or recurrence after DAA therapy in patients with previous HCV infection. © 2018 The Author(s). Published by Baishideng Publishing Group Inc. All rights reserved.

Published
2018

47. The potential of CSR to support the implementation of the EU sustainability strategy: editorial introduction

Author

Moon, Jeremy, Anastasiadis, Stephanos, and Vigano, Federica

Subjects
Sustainable development, Corporate social responsibility, Business, Business, international, Economics
Abstract

To authenticate to the full-text of this article, please visit this link: http://dx.doi.org/10.1111/j.1467-8608.2009.01562.x Byline: Jeremy Moon ([dagger]), Stephanos Anastasiadis ([dagger]), Federica Vigano (*) Author Affiliation: ([dagger])Nottingham University Business School, Nottingham, UK (*)Fondazione Eni Enrico Mattei, Milan, Italy.

Published
2009

48. Use of Historical Data for the Estimation of Distribution Network Expansion in Future Decarbonization Scenarios

Author

Chiara Michelangeli, Diana Moneta, Marco Rossi, and Giacomo Vigano

Subjects
Electric power distribution, Computer science, business.industry, 020209 energy, 020208 electrical & electronic engineering, Energy mix, 02 engineering and technology, Environmental economics, Renewable energy, Electric power system, Distributed generation, Greenhouse gas, 0202 electrical engineering, electronic engineering, information engineering, Key (cryptography), Scenario analysis, business
Abstract

The reduction of greenhouse emissions will require that renewable energy sources represent a significant portion of the generation energy mix. An important contribution is expected by resources installed at the distribution network level, such as photovoltaic generators. The distribution networks will then play a key role for the decarbonisation of the power system and they will require both conventional reinforcements and innovative control solutions. These issues are not new, since in the past years some countries already faced the problem of combining network refurbishment and advanced control strategies to install a significant share of distributed generation. The objective of this paper consists of showing how historical data can be used to estimate the future evolution of the power system. The analysis is focused on the Italian electricity distribution system, where the distributed generation already represents a large percentage of the energy mix.

Published
2020

49. 52 Incidence and outcomes of bailout stenting following use of sirolimus drug coated balloon

Author

Elena Vigano, Kaeng W. Lee, Richard Watkin, Beth Freestone, Sampath Athukorala, Jerome Ment, Sophia Khattak, Boyang Liu, Mohammed Ishaq, Michael K. Pitt, George Pulikal, and Gurbir Bhatia

Subjects
Target lesion, medicine.medical_specialty, Drug coated balloon, Double dose, business.industry, Incidence (epidemiology), medicine.medical_treatment, Stent, Surgery, Sirolimus, medicine, Clinical endpoint, business, Mace, medicine.drug
Abstract

Introduction Bailout stenting post-Paclitaxcel drug coated balloon use (DCB) is done with Limus eluting stent as we don’t use Paclitaxcel eluting stent anymore. However, when using Sirolimus DCB, bailout stenting is done with Limus eluting stent, but this raises the issue of drug toxicity with double dose of Limus to the vessel wall. In this study, we evaluate all patients treated with Limus DCB that required bailout stenting for safety and clinical outcomes. Methods and Results We evaluated all patients who were treated with MagicTouch Sirolimus eluting DCB (Concept Medical limited, India) March 2018-June 2019. Bailout stenting per lesion were identified and studied for endpoints which included cardiac death, target vessel MI, stent thrombosis, target lesion revascularisation and MACE. Between the study period; 406 patients (477-lesions) with a mean age of 66 ± 11.2 years (range; 37-90) were treated with MagicTouch DCB. Bailout stenting was required in 39 lesions (8%) and of which 22 were due to dissections and 17 were due to >50% recoil following DCB use. During a median follow-up of 302 days; there were no cases of cardiac death, 1-case of target vessel MI (2.6%) and 3-cases (7%) of TLR. The MACE rate was 7%. There were no cases of stent thrombosis as per the ARC definition. Conclusion One of the highlighting features of our study is low-rates of bailout stenting (9%). This may be due to our criteria of not stenting mild dissections (unless they are flow limiting) and not to expect stent like results. The outcomes in the bailout stenting group is excellent with very low hard clinical endpoints indicating there may not be any toxic effect from double dose of Limus drug (DCB + DES). Conflict of Interest None

Published
2020

50. 37 Shockwave intravascular lithotripsy in calcified coronary lesions: a retrospective, observational, international multi-centre analysis

Author

Bernardo Cortese, Luca Testa, Rami Mokdad, Amir Aziz, Alfonso Lelasi, Sophia Khattak, Sandeep Basavarajaiah, Elena Vigano, and Michael K. Pitt

Subjects
Target lesion, medicine.medical_specialty, business.industry, medicine.medical_treatment, Perforation (oil well), Stent, medicine.disease, Surgery, Restenosis, Right coronary artery, medicine.artery, medicine, Complication, business, Mace, Kidney disease
Abstract

Introduction Sub-optimal stent expansion due to coronary calcification augments the risk of restenosis and stent thrombosis. Calcium modification is generally achieved by rotational atherectomy or specialized balloons (scoring and cutting balloons), which carries risk of complications. Intravascular lithotripsy (IVL) appears safe and also aids in cracking deep seated adventitial calcium. Although, there are reported studies on this novel technology, there is a lack of real-world data. In this study, we report the experience from 4 centres that undertake high-volume complex coronary interventions. Methods We enrolled all patients treated with IVL between September 2018 and October 2019 at 4 centres (1 in UK and 3 in Italy). Procedural success and complication were assessed. The clinical outcomes evaluated were; cardiovascular death, target vessel MI (TVMI), target lesion revascularisation (TLR) and MACE (composite of cardiovascular death, TVMI and TLR). Results During the study period, 100 lesions (in 94 patients) with a mean age of 71±9.7 years (range;30 - 88) were treated using IVL. 70% (n=70) were male, 85% (n=80) had hypertension, 51% (n=48) had diabetes and 20% (n=19) had chronic kidney disease. Acute coronary syndromes accounted for 40% of patients (n=38). De-novo lesions accounted for 66% of cases (n=66) and the remaining 34% (n=34) were restenotic lesions. Left anterior descending artery (56%) accounted for most cases followed by right coronary artery (22%), left circumflex artery (21%), left main (17%) and saphenous vein grafts (3%) procedures. Upfront use of IVL occurred in 18% of cases whilst the rest were bail-out procedures due to inadequate pre-dilatation with conventional balloons. Adjuvant rotational atherectomy (Rota-tripsy) was used in 10 cases (10%) prior to the use of IVL. The mean diameter of IVL balloon was 3.3 ± 0.5mm. Intravascular imaging (IVUS) was used in 19% of cases. Procedural success was achieved in 100% of cases with a complication rate of 2% (2-cases of coronary perforation and one of them resulted in in-hospital mortality). During the median follow-up of 150 days, there were no clinical events including cardiac death, TVMI and TLR. Conclusion Initial experience and short-term clinical follow-up from IVL use appears safe and effective PCI strategy for dealing with calcified coronary lesions. A high success rate was observed with low event rates and procedural complications. We are enrolling more patients from other centres as part of a larger multi-centre registry and will be able to report this with higher numbers and longer follow-up at BCS 2020. Conflict of Interest nil

Published
2020

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