108 results on '"Morelli, F"'
Search Results
2. A unified approach for fatigue detail categorization applied to rack structures
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Souto, C., Castiglioni, C., Menghini, A., Morelli, F., Piscini, A., Hoffmeister, B., Geers, T., Degée, H., Tzintzos, P., Kraus, O., Frederiks, J., Sesana, S., Figueiredo, M., Gomes, V., Correia, J., and de Jesus, A.
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- 2023
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3. Early visual deprivation disrupts the mental representation of numbers in visually impaired children
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Cappagli, G., Cuturi, L. F., Signorini, S., Morelli, F., Cocchi, E., and Gori, M.
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- 2022
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4. NREM nap differences in children with and without visual impairment: the role of fast sleep spindles
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Vitali, H., primary, Campus, C., additional, Signorini, S., additional, De Giorgis, V., additional, Morelli, F., additional, Varesio, C., additional, Pasca, L., additional, Sammartano, A., additional, and Gori, M., additional
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- 2024
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5. Author Correction: Effects of climate variation on bird escape distances modulate community responses to global change
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Díaz, M., Grim, T., Markó, G., Morelli, F., Ibáñez‑Alamo, J. D., Jokimäki, J., Kaisanlahti‑Jokimäki, M.‑L., Tätte, K., Tryjanowski, P., and Møller, A. P.
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- 2021
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6. Effects of climate variation on bird escape distances modulate community responses to global change
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Díaz, M., Grim, T., Markó, G., Morelli, F., Ibáñez-Alamo, J. D., Jokimäki, J., Kaisanlahti-Jokimäki, M.-L., Tätte, K., Tryjanowski, P., and Møller, A. P.
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- 2021
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7. PROSTATIC ARTERY EMBOLIZATION IN PATIENTS WITH INDWELLING BLADDER CATHETER.
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Secco, S, primary, Campobasso, D, additional, Guarino, G, additional, Maggiorelli, S, additional, Brambillasca, P, additional, De Cinque, A, additional, Paladini, I, additional, Andreone, A, additional, Morelli, F, additional, Olivero, A, additional, Favali, M, additional, Zagnoli, A, additional, Dell’Oglio, P, additional, Ferretti, S, additional, Di Chiacchio, G, additional, Ziglioli, F, additional, Patera, A, additional, Slawitz, M, additional, Di Marco, G, additional, Puliatti, S, additional, Micali, S, additional, Bocciardi, A, additional, Rampoldi, A, additional, Maestroni, U, additional, and Galfano, A, additional
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- 2023
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8. A novel multisensory device for the assessment and rehabilitation of perceptual and attentional competencies
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Morelli, F., primary, Balzarotti, N., additional, Guarischi, M., additional, Cappagli, G., additional, Maviglia, A., additional, Crepaldi, M., additional, Orciari, L., additional, Parmiggiani, A., additional, Catalano, G., additional, Signorini, S., additional, and Gori, M., additional
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- 2023
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9. Transarterial Radioembolization for Unresectable Hepatocellular Carcinoma: A single-center experience
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Mazzarelli, C., primary, Costantino, D., additional, Cesarini, L., additional, Zavaglia, C., additional, Rampoldi, A., additional, Morelli, F., additional, Cabrini, G., additional, Capitanio, S., additional, Zanni, D., additional, Carboni, C., additional, and Belli, L.S., additional
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- 2023
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10. 121 - PROSTATIC ARTERY EMBOLIZATION IN PATIENTS WITH INDWELLING BLADDER CATHETER.
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Secco, S, Campobasso, D, Guarino, G, Maggiorelli, S, Brambillasca, P, De Cinque, A, Paladini, I, Andreone, A, Morelli, F, Olivero, A, Favali, M, Zagnoli, A, Dell’Oglio, P, Ferretti, S, Di Chiacchio, G, Ziglioli, F, Patera, A, Slawitz, M, Di Marco, G, Puliatti, S, Micali, S, Bocciardi, A, Rampoldi, A, Maestroni, U, and Galfano, A
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- 2023
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11. Sleep Architecture Development in Blind and Sighted Children
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Vitali, H., primary, Campus, C., additional, De Giorgis, V., additional, Signorini, S., additional, Morelli, F., additional, Varesio, C., additional, and Gori, M., additional
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- 2022
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12. Efficacy of prostate artery embolization in patients with indwelling bladder catheter
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Secco, S., primary, Brambillasca, P., additional, Morelli, M., additional, Sampogna, G., additional, Alfonsi, A., additional, Morelli, F., additional, Solcia, M., additional, Dell’Oglio, P., additional, Olivero, A., additional, Palagonia, E., additional, Spinelli, M., additional, Bocciardi, A., additional, Rampoldi, A., additional, and Galfano, A., additional
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- 2022
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13. Redefining the zoning of active and capable faults in urban areas: the case of the Mt. Marine fault across the Barete and Pizzoli towns (Central Apennines, Italy)
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Iezzi, F., Boncio, P., Pizzi, A., Piacentini, T., Pace, B., Francescone, M., Morelli, F., Puliti, I., Salvatore, N., Blumetti, A., Di Manna, P., Papasodaro, F., Moro, M., Falcucci, E., Gori, S., Saroli, M., Nicolosi, I., D’Ajello Caracciolo, F., Chiappini, M., Sapia, V., Materni, V., Urbini, S., Caciagli, M., Di Giulio, G., Vassallo, M., Milana, G., Minarelli, L., Pischiutta, M., Cara, F., Sepe, V., and Doglioni, C.
- Published
- 2022
14. Seismic performance of dissipative automated rack supported warehouses
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Natali, A., primary and Morelli, F., additional
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- 2022
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15. The Structural Risk Assessment of Existing Bridges in Tuscany (Italy) a Quick Survey-Based Method
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Buratti, G., Celati, S., Cosentino, A., Gaudioso, D., Mazzatura, I., Morelli, F., Messina, V., and Salvatore, W.
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Bridge inspection ,Defects ,Quick survey ,Risk classification ,Statistical analysis - Published
- 2021
16. 736P Residual masses after salvage chemotherapy in men with metastatic seminoma: The Semi-ResMass multicenter retrospective study
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Baciarello, G., Brard, C., Baumert, H., De Giorgi, U.F.F., Flechon, A., Giannatempo, P., Gravis, G., Morelli, F., Pouessel, D., Vincenzi, B., Oing, C., Secondino, S., Ladoire, S., Crouzet, L., Naoun, N., Foulon, S., and Fizazi, K.
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- 2023
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17. SC154 - Efficacy of prostate artery embolization in patients with indwelling bladder catheter
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Secco, S., Brambillasca, P., Morelli, M., Sampogna, G., Alfonsi, A., Morelli, F., Solcia, M., Dell’Oglio, P., Olivero, A., Palagonia, E., Spinelli, M., Bocciardi, A., Rampoldi, A., and Galfano, A.
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- 2022
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18. Portal Steal Syndrome From a Large Linton’s Splenorenal Shunt after Liver Transplantation: Successful Endovascular Management Through Off-Label Application of a 30 mm Amplatzer Cardiac Plug
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Leonardo Centonze, Ivan Vella, Francesco Morelli, Giuliana Checchini, Riccardo De Carlis, Antonio Rampoldi, Andrea Lauterio, Enzo Andorno, Luciano De Carlis, Centonze, L, Vella, I, Morelli, F, Checchini, G, De Carlis, R, Rampoldi, A, Lauterio, A, Andorno, E, and De Carlis, L
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Adult ,surgical portosystemic shunt ,Liver transplantation ,Portal Vein ,Endovascular Procedures ,Off-Label Use ,General Medicine ,Amplatzer cardiac plug ,Treatment Outcome ,portal steal syndrome ,MED/18 - CHIRURGIA GENERALE ,Humans ,Surgery ,Cardiology and Cardiovascular Medicine ,Splenorenal Shunt, Surgical - Abstract
A 34-year-old patient underwent liver transplantation for progressive hepatic failure in the setting of congenital hepatic fibrosis. In past medical history, the patient had undergone splenectomy with proximal Linton’s splenorenal surgical shunt creation for symptomatic portal hypertension with hypersplenism. The patient developed an early allograft dysfunction, with radiologic evidence of a reduced portal flow associated to portal steal from the patent surgical shunt. The patient was successfully treated through endovascular placement of a 30 mm Amplatzer cardiac plug at the origin of the splenic vein.
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- 2022
19. Evolution of Design Traffic Loads for Italian Road Bridges
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Pasquale Bencivenga, Giovanni Buratti, Antonella Cosentino, Gianfranco De Matteis, Francesco Morelli, Walter Salvatore, Mattia Zizi, C. Pellegrino, F. Faleschini, M. A. Zanini, J. C. Matos, J. R. Casas, A. Strauss, Bencivenga, P., Buratti, G., Cosentino, A., De Matteis, G., Morelli, F., Salvatore, W., and Zizi, M.
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Design criteria, Existing bridges, Italian codes, Structural vulnerability, Traffic loads ,Existing bridges ,Design criteria ,Structural vulnerability ,Italian codes ,Traffic loads - Abstract
The present paper focuses on traffic load definition for road bridge design according to past Italian codes. In particular, starting from the first code of ’33 up to the current Technical Standard for Constructions (NTC2018), several different approaches have been assumed by the codes. Hence, a historical review is firstly proposed and each code is analyzed together with the proposed load schemes. Such a review has allowed the definition of a parametric investigation on typical Italian r.c. decks. In particular, bending moments due to the traffic loads for which the bridges were conceived are investigated, and thus a preliminary estimation of past-to-current design bending moment ratios is carried out with reference to continuous beams.
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- 2022
20. Coexisting conditions and concomitant medications do not affect venetoclax management and survival in chronic lymphocytic leukemia
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Anna Maria Frustaci, Giovanni Del Poeta, Andrea Visentin, Paolo Sportoletti, Alberto Fresa, Candida Vitale, Roberta Murru, Annalisa Chiarenza, Alessandro Sanna, Francesca Romana Mauro, Gianluigi Reda, Massimo Gentile, Marzia Varettoni, Claudia Baratè, Chiara Borella, Antonino Greco, Marina Deodato, Giulia Zamprogna, Roberta Laureana, Alessandra Cipiciani, Andrea Galitzia, Angelo Curto Pelle, Francesca Morelli, Lucio Malvisi, Marta Coscia, Luca Laurenti, Livio Trentin, Marco Montillo, Roberto Cairoli, Alessandra Tedeschi, Frustaci, A, Del Poeta, G, Visentin, A, Sportoletti, P, Fresa, A, Vitale, C, Murru, R, Chiarenza, A, Sanna, A, Mauro, F, Reda, G, Gentile, M, Varettoni, M, Barate, C, Borella, C, Greco, A, Deodato, M, Zamprogna, G, Laureana, R, Cipiciani, A, Galitzia, A, Curto Pelle, A, Morelli, F, Malvisi, L, Coscia, M, Laurenti, L, Trentin, L, Montillo, M, Cairoli, R, and Tedeschi, A
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CIRS ,comorbiditie ,discontinuations ,fitne ,venetoclax ,CLL ,ECOG ,comorbidities ,fitness ,reduction ,targeted therapies ,Hematology ,Settore MED/15 - MALATTIE DEL SANGUE ,MED/15 - MALATTIE DEL SANGUE ,targeted therapie ,discontinuation - Abstract
Background: The question of which parameters may be informative on venetoclax outcome in chronic lymphocytic leukemia (CLL) is still unclear. Furthermore, the choice to treat with venetoclax can be challenging in patients with baseline characteristics or comorbidities that may potentially favor some specific adverse events. Objectives: This study was aimed to evaluate whether age, fitness status, patients’/disease characteristics, or concomitant medications may predict outcomes in CLL patients receiving venetoclax. Design: Retrospective observational study. Methods: Impact of age, presence of Cumulative Illness Rating Scale (CIRS) >6 or severe organ impairment (CIRS3+), Eastern Cooperative Oncology Group–Performance Status (ECOG-PS), renal function, and concomitant medications were retrospectively analyzed on treatment management (definitive discontinuation due to toxicity, discontinuation due to toxicity, Tox-DTD; permanent dose reduction, PDR) and survival [progression free survival (PFS), event free survival (EFS), overall survival (OS)] in unselected patients receiving venetoclax monotherapy in common practice. Results: A total of 221 relapsed/refractory patients were included. Tox-DTD and PDR were reported in 5.9% and 21.7%, respectively, and were not influenced by any fitness parameter, age, number or type of concomitant medication, baseline neutropenia, or impaired renal function. None of these factors were associated with tumor lysis syndrome (TLS) development. Age and coexisting conditions had no influence on PFS and EFS. At univariate analysis, OS was significantly shorter only in patients with ECOG-PS >1 ( p 6 ( p = 0.014) or CIRS3+ ( p = 0.031). ECOG-PS >1 retained an independent role only for EFS and OS. While Tox-DTD affected all survival outcomes, no differences in PFS were reported among patients permanently reducing dose or interrupting venetoclax for > 7 days. Conclusion: Clinical outcome with venetoclax is not influenced by comorbidities, patients’ clinical characteristics, or concomitant medications. Differently from other targeted therapies, this demonstrates that, except ECOG-PS, none of the parameters generally considered for treatment choice, including baseline neutropenia or impaired renal function, should rule the decision process with this agent. Anyway, if clinically needed, a correct drug management does not compromise treatment efficacy and may avoid toxicity-driven discontinuations. Plain Language Summary Chapter 1: Why was this study done? Chapter 2: Which are the main findings of the study? Chapter 3: How these findings may impact on clinical practice? Coexisting conditions and concomitant medications do not affect venetoclax management and survival in chronic lymphocytic leukemia • The question of which parameters may be informative on venetoclax outcome in chronic lymphocytic leukemia is still unclear. Furthermore, the choice to treat with venetoclax can be challenging in patients with baseline characteristics or comorbidities that may potentially favor some specific adverse events (e.g. compromised renal function or baseline neutropenia). • In our large series of patients treated outside of clinical trials, we demonstrated that neither age, fitness, comorbidities nor concomitant medications impact on venetoclax management and survival. Importantly, patients presenting with baseline neutropenia or impaired renal function did not have a higher rate of dose reductions or toxicity-driven discontinuations, thus further underlining that venetoclax may be safely administered even in those categories with no preclusions. • Differently from other targeted agents, our data demonstrate that none of the baseline factors commonly considered in treatment decision process retains a role with venetoclax. Finally, permanent dose reductions and temporary interruptions did not adversely impact PFS suggesting that, if clinically needed, a correct drug management should be adopted with no risk of compromising venetoclax efficacy.
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- 2022
21. GU-CA-COVID: a clinical audit among Italian genitourinary oncologists during the first COVID-19 outbreak
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Sergio Bracarda, Sebastiano Buti, Marco Stellato, Maria Giuseppa Vitale, Giuseppe Procopio, Alessio Cortellini, Ilaria Toscani, Francesco Massari, Carlo Cattrini, Francesco Atzori, Orazio Caffo, Paolo Andrea Zucali, D. Zara, Alessandra Gennari, Mimma Rizzo, Luca Galli, Francesca Corti, Cinzia Baldessari, Melissa Bersanelli, Alberto Dalla Volta, Martina Fanelli, Claudia Mucciarini, Leonardo La Torre, Serena Macrini, Giuseppe Fornarini, Camillo Porta, Angela Gernone, Franco Morelli, Cristina Masini, Alice Gatti, Bersanelli M., Buti S., Rizzo M., Cortellini A., Cattrini C., Massari F., Masini C., Vitale M.G., Fornarini G., Caffo O., Atzori F., Gatti A., Macrini S., Mucciarini C., Galli L., Morelli F., Stellato M., Fanelli M., Corti F., Zucali P.A., Toscani I., Dalla Volta A., Gernone A., Baldessari C., La Torre L., Zara D., Gennari A., Bracarda S., Procopio G., and Porta C.
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Clinical audit ,cancer patient ,medicine.medical_specialty ,Urology ,Population ,Context (language use) ,genitourinary cancer ,Renal cell carcinoma ,Internal medicine ,medicine ,education ,Original Research ,education.field_of_study ,Bladder cancer ,business.industry ,SARS-CoV-2 ,Incidence (epidemiology) ,Cancer ,COVID-19 ,medicine.disease ,genitourinary cancers ,Diseases of the genitourinary system. Urology ,Discontinuation ,renal cancer: urothelial cancer ,bladder cancer ,RC870-923 ,Corrigendum ,business ,cancer patients - Abstract
Background: Considering the growing genitourinary (GU) cancer population undergoing systemic treatment with immune checkpoint inhibitors (ICIs) in the context of the COVID-19 pandemic, we planned a clinical audit in 24 Italian institutions treating GU malignancies. Objective: The primary objective was investigating the clinical impact of COVID-19 in GU cancer patients undergoing ICI-based therapy during the first outbreak of SARS-CoV-2 contagion in Italy. Design, setting, and participants: The included centers were 24 Oncology Departments. Two online forms were completed by the responsible Oncology Consultants, respectively, for metastatic renal cell carcinoma (mRCC) and metastatic urothelial carcinoma (mUC) patients receiving at least one administration of ICIs between 31 January 2020 and 30 June 2020. Results and limitation: In total, 287 mRCC patients and 130 mUC patients were included. The COVID-19 incidence was, respectively, 3.5%, with mortality 1%, in mRCC patients and 7.7%, with mortality 3.1%, in mUC patients. In both groups, 40% of patients developing COVID-19 permanently discontinued anticancer treatment. The pre-test SARS-CoV-2 probability in the subgroup of patients who underwent nasal/pharyngeal swab ranged from 14% in mRCC to 26% in mUC. The main limitation of the work was its nature of audit: data were not recorded at the single-patient level. Conclusion: GU cancer patients undergoing active treatment with ICIs have meaningful risk factors for developing severe events from COVID-19 and permanent discontinuation of therapy after the infection. Treatment delays due to organizational issues during the pandemic were unlikely to affect the treatment outcome in this population.
- Published
- 2021
22. Transjugular intrahepatic portosystemic shunt in patients with splanchnic vein thrombosis: Prevalence and management of patent foramen ovale.
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Becchetti C, De Nicola S, Gallo C, Perricone G, Annoni G, Solcia M, Musca F, Alfonsi A, Morelli F, Barbosa F, Brambillasca PM, Rampoldi A, Airoldi A, and Belli LS
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- Humans, Retrospective Studies, Female, Male, Middle Aged, Adult, Prevalence, Aged, Echocardiography, Splanchnic Circulation, Liver Cirrhosis complications, Liver Cirrhosis surgery, Treatment Outcome, Portasystemic Shunt, Transjugular Intrahepatic adverse effects, Foramen Ovale, Patent complications, Foramen Ovale, Patent surgery, Foramen Ovale, Patent diagnostic imaging, Hypertension, Portal surgery, Hypertension, Portal etiology, Hypertension, Portal complications, Venous Thrombosis etiology, Venous Thrombosis diagnostic imaging, Venous Thrombosis surgery, Portal Vein surgery
- Abstract
Background and Aims: Transjugular intrahepatic portosystemic shunt (TIPS) is an established procedure for the treatment of several complications of portal hypertension (PH), including non-neoplastic portal vein thrombosis (PVT). Selection criteria for TIPS in PVT are not yet well established. Despite anecdotal, cases of thromboembolic events from paradoxical embolism due to the presence of patent foramen ovale (PFO) after TIPS placement have been reported in the literature. Therefore, we aimed at describing our experience in patients with non-neoplastic splanchnic vein thrombosis (SVT) who underwent TIPS following PFO screening., Methods: We conducted a single-centre retrospective study, including consecutive patients who underwent TIPS for the complications of cirrhotic and non-cirrhotic portal hypertension (NCPH) and having SVT., Results: Of 100 TIPS placed in patients with SVT, 85 patients were screened for PFO by bubble-contrast transthoracic echocardiography (TTE) with PFO being detected in 22 (26%) cases. PFO was more frequently detected in patients with non-cirrhotic portal hypertension (NCPH) (23% in the PFO group vs. 6% in those without PFO, p = .04) and cavernomatosis (46% in the PFO group vs. 19% in those without PFO, p = .008). Percutaneous closure was effectively performed in 11 (50%) after multidisciplinary evaluation of anatomical and clinical features. No major complications were observed following closure., Conclusions: PFO screening and treatment may be considered feasible for patients with SVT who undergo TIPS placement., (© 2024 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)
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- 2024
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23. Conservation of more evolutionary unique amphibian communities in Türkiye: The role of protected areas.
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Arslan D, Olivier A, İsfendiyaroğlu SC, Benedetti Y, Akdağ B, Çiçek K, and Morelli F
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- Animals, Phylogeny, Biological Evolution, Amphibians, Conservation of Natural Resources, Biodiversity, Ecosystem
- Abstract
The alarming decline of amphibians, sometimes marked by sudden extinctions, underlines the urgent need for increased conservation efforts. Conservationists recognize that more action, particularly the setting of national targets, is needed to ensure the future persistence and recovery of species and habitats. Protecting habitats that harbor evolutionarily diverse species preserves divergent genetic information within ecosystems. Türkiye holds 36 amphibian species at the intersection of two continents, creating three biodiversity hotspots and phylogenetic transitional areas. In this study, we aimed to determine the hotspot regions and to evaluate the effectiveness of the protected areas in Türkiye in preserving amphibian populations. First, we estimated four community indexes (species richness and three evolutionary distinctiveness measures) for amphibian communities in Türkiye divided into 371 grid cells with a ca 50 × 50 km size. Then, the spatial extent of protected areas is evaluated from two perspectives: current (has a protection status) and candidate protected areas (Key Biodiversity Areas, not protected) coverage in those grid cells. Finally, these two approaches' effectiveness in protecting areas was assessed by modeling four diversity metrics using GLS models. Current protected areas protect about 6% of the total amphibian distribution in Türkiye, while Key Biodiversity Areas would cover 30% if declared protected areas. We estimated that the coastal areas of Türkiye are identified as hotspots based on the four measured amphibian community indexes. Our study also highlights that Key Biodiversity Areas (KBAs) can contribute to conserving high levels of amphibian richness and evolutionary distinctiveness of species across Türkiye. However, existing protected areas (PAs) networks were insufficient to protect amphibians., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)
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- 2024
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24. Prognostic value of type of prior TKI in pretreated metastatic renal cell carcinoma patients receiving nivolumab.
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Damassi A, Cremante M, Signori A, Rebuzzi SE, Malgeri A, Napoli MD, Caffo O, Vignani F, Cavo A, Roviello G, Prati V, Tudini M, Atzori F, Messina M, Morelli F, Prati G, Nolè F, Catalano F, Murianni V, Rescigno P, Banna GL, Fornarini G, and Buti S
- Abstract
Aim: To define the prognostic significance of first-line TKI in mRCC patients receiving nivolumab. Materials and methods: A total of 571 mRCC patients who received ≥second line nivolumab were included in this subanalysis. The correlation between prior TKI (sunitinib vs. pazopanib) and overall response rate (ORR), disease control rate, progression-free survival and overall survival were investigated. Additionally, the impact of TKI choice according to the International Metastatic RCC Database Consortium prognostic score was examined. Results: There was no significant difference between sunitinib and pazopanib groups in terms of mPFS, mOS, overall response rate and disease control rate. Moreover, no difference between sunitinib and pazopanib was found according to the International Metastatic RCC Database Consortium prognostic score. Conclusion: There is no conclusive evidence favoring pazopanib or sunitinib treatment before initiating nivolumab therapy in metastatic renal cell carcinoma patients.
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- 2024
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25. Urban birds' tolerance towards humans was largely unaffected by COVID-19 shutdown-induced variation in human presence.
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Mikula P, Bulla M, Blumstein DT, Benedetti Y, Floigl K, Jokimäki J, Kaisanlahti-Jokimäki ML, Markó G, Morelli F, Møller AP, Siretckaia A, Szakony S, Weston MA, Zeid FA, Tryjanowski P, and Albrecht T
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- Animals, Humans, Fear, Escape Reaction, Pandemics, Cities, COVID-19 epidemiology, SARS-CoV-2, Birds virology
- Abstract
The coronavirus disease 2019 (COVID-19) pandemic and respective shutdowns dramatically altered human activities, potentially changing human pressures on urban-dwelling animals. Here, we use such COVID-19-induced variation in human presence to evaluate, across multiple temporal scales, how urban birds from five countries changed their tolerance towards humans, measured as escape distance. We collected 6369 escape responses for 147 species and found that human numbers in parks at a given hour, day, week or year (before and during shutdowns) had a little effect on birds' escape distances. All effects centered around zero, except for the actual human numbers during escape trial (hourly scale) that correlated negatively, albeit weakly, with escape distance. The results were similar across countries and most species. Our results highlight the resilience of birds to changes in human numbers on multiple temporal scales, the complexities of linking animal fear responses to human behavior, and the challenge of quantifying both simultaneously in situ., (© 2024. The Author(s).)
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- 2024
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26. Sodium levels and immunotherapy efficacy in mRCC patients with bone metastases: sub analysis of Meet-Uro 15 study.
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Catalano M, Rebuzzi SE, Maruzzo M, De Giorgi U, Buti S, Galli L, Fornarini G, Zucali PA, Claps M, Chiellino S, Zampiva I, Pipitone S, Ricotta R, Sorarù M, Mollica V, Tudini M, Fratino L, Prati V, Caffo O, Atzori F, Morelli F, Prati G, Nolè F, Vignani F, Cavo A, Di Napoli M, Malgeri A, Naglieri E, Signori A, Banna GL, Rescigno P, Cerbone L, Antonuzzo L, and Roviello G
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- Humans, Male, Female, Middle Aged, Aged, Retrospective Studies, Nivolumab therapeutic use, Prognosis, Immune Checkpoint Inhibitors therapeutic use, Adult, Treatment Outcome, Aged, 80 and over, Bone Neoplasms secondary, Bone Neoplasms mortality, Bone Neoplasms therapy, Carcinoma, Renal Cell therapy, Carcinoma, Renal Cell mortality, Carcinoma, Renal Cell secondary, Carcinoma, Renal Cell drug therapy, Carcinoma, Renal Cell immunology, Kidney Neoplasms pathology, Kidney Neoplasms therapy, Kidney Neoplasms mortality, Kidney Neoplasms drug therapy, Kidney Neoplasms immunology, Sodium blood, Immunotherapy methods
- Abstract
Background: Immune-checkpoint inhibitors (ICIs) have significantly improved metastatic renal cell carcinoma (mRCC) prognosis, although their efficacy in patients with bone metastases (BMs) remains poorly understood. We investigated the prognostic role of natremia in pretreated RCC patients with BMs receiving immunotherapy., Materials and Methods: This retrospective multicenter study included RCC patients with BMs receiving nivolumab as second-line therapy or beyond. Inclusion criteria involved baseline sodium levels (pre-ICI) and sodium levels after 4 weeks of nivolumab initiation (post-ICI). The population was divided into two groups based on the median value, and response rates, progression-free survival (PFS), and overall survival (OS) were assessed., Results: Among 120 eligible patients, those with pre-treatment sodium levels ≥140 mEq/L showed longer OS (18.7 vs. 12.0 months, p=0.04). Pre-treatment sodium levels ≥140 mEq/L were associated with better OS compared to levels <140 mE/L (18.7 vs. 12.0, p=0.04). Post-treatment sodium levels ≥140 mEq/L were associated with improved PFS (9.6 vs . 3.2 months) and OS (25.1 vs. 8.8 months) (p=0.05 and p<0.01, respectively). Patients with consistent sodium levels ≥140 mEq/L at both time points exhibited the best outcomes compared to those with lower values (PFS 11.5 vs. 3.3 months and OS 42.2 vs. 9.0 months, respectively, p<0.01). Disease control rate was significantly higher in the latter group (p<0.01). Multivariate analysis confirmed the prognostic significance of sodium levels., Conclusion: Elevated sodium levels (≥140 mEq/L) pre- and post-ICI treatment correlate with better survival outcomes in mRCC patients with BMs. This finding suggests sodium level assessment as a potential prognostic factor in these patients and warrants further investigation, particularly in combination immunotherapy settings., Competing Interests: GB: Speaker bureau: Astellas, Astrazeneca, Amgen. Patents: n. 4 patents with ST Microelectronics. Travel, Accommodations for scientific conferences: Merck, Janssen. UG: services as advisory/board member of Astellas, Bayer, BMS, IPSEN, Janssen, Merck, Pfizer, Sanofi, received research grant/funding to the institution from AstraZeneca, Roche, Sanofi and travel/accommodations/expenses from BMS BMS, IPSEN, Janssen, Pfizer. LC: has received honoraria for advisory boards, speaker engagements and scientific consultancy for educational purposes from AstraZeneca, EISAI, MSD, Ipsen, BMS, A.A.A.; past MSD employee in Medical Affairs. MS: honoraria as consultant or advisory role from Janssen; grant for participation at scientific events: Astellas Pharma, Sanofi, Roche Novartis, Ipsen, Janssen, Bristol Myers Squibb, Pfizer; research funding: Roche, Merck, Janssen. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Catalano, Rebuzzi, Maruzzo, De Giorgi, Buti, Galli, Fornarini, Zucali, Claps, Chiellino, Zampiva, Pipitone, Ricotta, Sorarù, Mollica, Tudini, Fratino, Prati, Caffo, Atzori, Morelli, Prati, Nolè, Vignani, Cavo, Di Napoli, Malgeri, Naglieri, Signori, Banna, Rescigno, Cerbone, Antonuzzo and Roviello.)
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- 2024
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27. Long-term responders to nivolumab in previously treated advanced renal cell carcinoma: a sub-analysis of meet-URO15 study.
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Messina C, Catalano M, Roviello G, Gandini A, Maruzzo M, De Giorgi U, Pedrazzoli P, Sbrana A, Zucal PA, Masini C, Naglieri E, Procopio G, Milella M, Catalano F, Fratino L, Pipitone S, Ricotta R, Panni S, Mollica V, Soraru M, Prati V, Atzori F, Di Napoli M, Messina M, Morelli F, Prati G, Nole F, Malgeri A, Tudini M, Vignani F, Cavo A, Signori A, Banna GL, Rescigno P, Buti S, Rebuzzi SE, and Fornarini G
- Subjects
- Humans, Female, Male, Middle Aged, Aged, Adult, Retrospective Studies, Aged, 80 and over, Young Adult, Adolescent, Antineoplastic Agents, Immunological therapeutic use, Follow-Up Studies, Nivolumab therapeutic use, Carcinoma, Renal Cell drug therapy, Carcinoma, Renal Cell mortality, Carcinoma, Renal Cell pathology, Kidney Neoplasms drug therapy, Kidney Neoplasms mortality, Kidney Neoplasms pathology
- Abstract
Background: Although nivolumab prolongs overall survival (OS) in pretreated patients with metastatic renal cell carcinoma (mRCC), underlining clinical and biological features of long-term responses are still to be determined. This study aims to investigate clinical and pathological characteristics of mRCC patients who achieved long-term responses during nivolumab treatment., Materials and Methods: A retrospective analysis was performed on mRCC patients receiving nivolumab as second or further therapy line between May 2016 and January 2019 in 34 Italian Oncology Centres. Outcome assessments and logistic regression were performed to evaluate factors influencing long-term responses., Results: A total of 571 patients with a median age of 61 years (range 17-85) were included in the analysis. With a median follow-up of 22.1 (1.0-89.0) months, 23.1% of patients were 2-year progression-free on treatment with nivolumab, hence they were categorized as long-term responders. Baseline characteristics, including age, gender, and histology, were similar between long- and short-term responders. Karnofsky Performance Status ≥ 80% was significantly associated with long-term response (p = 0.02), while bone metastases (p = 0.03), International mRCC Database Consortium intermediate-poor risk (p < 0.01) and Neutrophil-to-Lymphocyte Ratio ≥ 3.2 (p = 0.02) were associate with short-term responses. Long-term responders exhibited a median progression-free survival of 55.0 months versus 4.0 months of the short-term responders. The median OS was not reached in long-term responders while it was 17.0 months for short*term responders., Conclusion: This retrospective analysis sheds light on factors associated with long-term response to nivolumab in mRCC. Understanding these clinical features will be essential for selecting patients who may mostly benefit from immunotherapy., (© 2024. The Author(s).)
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- 2024
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28. Antibody-Drug Conjugate Made of Zoledronic Acid and the Anti-CD30 Brentuximab-Vedotin Exert Anti-Lymphoma and Immunostimulating Effects.
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Morelli F, Matis S, Benelli R, Salvini L, Zocchi MR, and Poggi A
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- Humans, Cell Line, Tumor, Hodgkin Disease drug therapy, Hodgkin Disease pathology, Hodgkin Disease immunology, Apoptosis drug effects, Cell Proliferation drug effects, Zoledronic Acid pharmacology, Zoledronic Acid therapeutic use, Immunoconjugates pharmacology, Immunoconjugates therapeutic use, Immunoconjugates chemistry, Brentuximab Vedotin pharmacology, Brentuximab Vedotin therapeutic use, Ki-1 Antigen metabolism, Ki-1 Antigen immunology
- Abstract
Relevant advances have been made in the management of relapsed/refractory (r/r) Hodgkin Lymphomas (HL) with the use of the anti-CD30 antibody-drug conjugate (ADC) brentuximab-vedotin (Bre-Ved). Unfortunately, most patients eventually progress despite the excellent response rates and tolerability. In this report, we describe an ADC composed of the aminobisphosphonate zoledronic acid (ZA) conjugated to Bre-Ved by binding the free amino groups of this antibody with the phosphoric group of ZA. Liquid chromatography-mass spectrometry, inductively coupled plasma-mass spectrometry, and matrix-assisted laser desorption ionization-mass spectrometry analyses confirmed the covalent linkage between the antibody and ZA. The novel ADC has been tested for its reactivity with the HL/CD30
+ lymphoblastoid cell lines (KMH2, L428, L540, HS445, and RPMI6666), showing a better titration than native Bre-Ved. Once the HL-cells are entered, the ADC co-localizes with the lysosomal LAMP1 in the intracellular vesicles. Also, this ADC exerted a stronger anti-proliferative and pro-apoptotic (about one log fold) effect on HL-cell proliferation compared to the native antibody Bre-Ved. Eventually, Bre-Ved-ZA ADC, in contrast with the native antibody, can trigger the proliferation and activation of cytolytic activity of effector-memory Vδ2 T-lymphocytes against HL-cell lines. These findings may support the potential use of this ADC in the management of r/r HL.- Published
- 2024
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29. Gaze Orienting in the Social World: An Exploration of the Role Played by Caregiving Vocal and Tactile Behaviors in Infants with Visual Impairment and in Sighted Controls.
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Grumi S, Capelli E, Morelli F, Vercellino L, Mascherpa E, Ghiberti C, Carraro L, Signorini S, and Provenzi L
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Infant attention is a cognitive function that underlines sensory-motor integration processes at the interface between the baby and the surrounding physical and socio-relational environment, mainly with the caregivers. The investigation of the role of non-visual inputs (i.e., vocal and tactile) provided by the caregivers in shaping infants' attention in the context of visual impairment is relevant from both a theoretical and clinical point of view. This study investigated the social attention (i.e., gaze orientation) skills in a group of visually impaired (VI) and age-matched sighted controls (SCs) between 9 and 12 months of age. Moreover, the role of VI severity and maternal vocalizations and touch in shaping the social attention were investigated. Overall, 45 infants and their mothers participated in a video-recorded 4 min interaction procedure, including a play and a still-face episode. The infants' gaze orientation (i.e., mother-directed, object-directed, or unfocused) and the types of maternal vocalizations and touch (i.e., socio-cognitive, affective) were micro-analytically coded. Maternal vocalizations and touch were found to influence gaze orientation differently in VI infants compared SCs. Moreover, the group comparisons during the play episode showed that controls were predominantly oriented to the mothers, while VI infants were less socially oriented. Visual impairment severity did not emerge as linked with social attention. These findings contribute to our understanding of socio-cognitive developmental trajectories in VI infants and highlight the need for tailored interventions to promote optimal outcomes for VI populations.
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- 2024
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30. Sensorimotor Oscillations in Human Infants during an Innate Rhythmic Movement.
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Vitali H, Campus C, De Giorgis V, Signorini S, Morelli F, Fasce M, and Gori M
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The relationship between cerebral rhythms and early sensorimotor development is not clear. In recent decades, evidence revealed a rhythmic modulation involving sensorimotor processing. A widely corroborated functional role of oscillatory activity is to coordinate the information flow across sensorimotor networks. Their activity is coordinated by event-related synchronisation and desynchronisation in different sensorimotor rhythms, which indicate parallel processes may be occurring in the neuronal network during movement. To date, the dynamics of these brain oscillations and early sensorimotor development are unexplored. Our study investigates the relationship between the cerebral rhythms using EEG and a typical rhythmic movement of infants, the non-nutritive sucking (NNS) behaviour. NNS is an endogenous behaviour that originates from the suck central pattern generator in the brainstem. We find, in 17 infants, that sucking frequency correlates with beta synchronisation within the sensorimotor area in two phases: one strongly anticipating (~3 s) and the other encompassing the start of the motion. These findings suggest that a beta synchronisation of the sensorimotor cortex may influence the sensorimotor dynamics of NNS activity. Our results reveal the importance of rapid brain oscillations in infants and the role of beta synchronisation and their possible role in the communication between cortical and deep generators.
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- 2024
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31. Global real-world experiences with pembrolizumab in advanced urothelial carcinoma after platinum-based chemotherapy: the ARON-2 study.
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Massari F, Santoni M, Takeshita H, Okada Y, Tapia JC, Basso U, Maruzzo M, Scagliarini S, Büttner T, Fornarini G, Myint ZW, Galli L, Souza VC, Pichler R, De Giorgi U, Gandur N, Lam ET, Gilbert D, Popovic L, Grande E, Mammone G, Berardi R, Crabb SJ, Kemp R, Molina-Cerrillo J, Freitas M, Luz M, Iacovelli R, Calabrò F, Tural D, Atzori F, Küronya Z, Chiari R, Campos S, Caffo O, Fay AP, Kucharz J, Zucali PA, Rinck JA, Zeppellini A, Bastos DA, Aurilio G, Mota A, Trindade K, Ortega C, Sade JP, Rizzo M, Fiala O, Vau N, Giannatempo P, Barillas A, Monteiro FSM, Dauster B, Mennitto A, Nogueira L, de Carvalho Fernandes R, Seront E, Aceituno LG, Grillone F, Cutuli HJ, Fernandez M, Bassanelli M, Kopp RM, Roviello G, Abahssain H, Procopio G, Milella M, Kopecky J, Martignetti A, Messina C, Caitano M, Inman E, Kanesvaran R, Herchhorn D, Santini D, Bamias A, Bisonni R, Mosca A, Morelli F, Maluf F, Soares A, Nunes F, Pinto A, Zgura A, Incorvaia L, Ansari J, Zabalza IO, Landmesser J, Rizzo A, Mollica V, Marchetti A, Rosellini M, Sorgentoni G, Battelli N, Buti S, Porta C, and Bellmunt J
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- Humans, Adjuvants, Immunologic, Platinum, Retrospective Studies, Antibodies, Monoclonal, Humanized, Carcinoma, Transitional Cell, Urinary Bladder Neoplasms
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Background: Immune checkpoint inhibitors have changed previous treatment paradigm of advanced urothelial carcinoma (UC). The ARON-2 study (NCT05290038) aimed to assess the real-world effectiveness of pembrolizumab in patients recurred or progressed after platinum-based chemotherapy., Patients and Methods: Medical records of patients with documented metastatic UC treated by pembrolizumab as second-line therapy were retrospectively collected from 88 institutions in 23 countries. Patients were assessed for overall survival (OS), progression-free survival (PFS) and overall response rate (ORR). Cox proportional hazards models were adopted to explore the presence of prognostic factors., Results: In total, 836 patients were included: 544 patients (65%) received pembrolizumab after progression to first-line platinum-based chemotherapy in the metastatic setting (cohort A) and 292 (35%) after recurring within < 12 months since the completion of adjuvant or neoadjuvant chemotherapy (cohort B). The median follow-up time was 15.3 months. The median OS and the ORR were 10.5 months and 31% in the overall study population, 9.1 months and 29% in cohort A and 14.6 months and 37% in cohort B. At multivariate analysis, ECOG-PS ≥ 2, bone metastases, liver metastases and pembrolizumab setting (cohort A vs B) proved to be significantly associated with worst OS and PFS. Stratified by the presence of 0, 1-2 or 3-4 prognostic factors, the median OS was 29.4, 12.5 and 4.1 months (p < 0.001), while the median PFS was 12.2, 6.4 and 2.8 months, respectively (p < 0.001)., Conclusions: Our study confirms that pembrolizumab is effective in the advanced UC real-world context, showing outcome differences between patients recurred or progressed after platinum-based chemotherapy., (© 2024. The Author(s).)
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- 2024
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32. Effects of human depopulation and warming climate on bird populations in Japan.
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Katayama N, Fujita T, Ueta M, Morelli F, and Amano T
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- Humans, Animals, Japan, Forests, Biodiversity, Birds, Climate Change, Conservation of Natural Resources, Ecosystem
- Abstract
Quantifying biodiversity trends in economically developed countries, where depopulation, associated secondary succession, and climate warming are ongoing, provides insights for global biodiversity conservation in the 21st century. However, few studies have assessed the impacts of secondary succession and climate warming on species' population trends at a national scale. We estimated the population trends of common breeding bird species in Japan and examined the associations between the overall population trend and species traits with the nationwide bird count data on 47 species collected from 2009 to 2020. The overall population trend varied among species. Four species populations increased moderately, 18 were stable, and 11 declined moderately. Population trends for 13 species were uncertain. The difference in overall trends among the species was associated with their habitat group and temperature niche. Species with relatively low-temperature niches experienced more pronounced declines. Multispecies indicators showed a moderate increase in forest specialists and moderate declines in forest generalists (species that use both forests and open habitats) and open-habitat specialists. Forest generalists and open-habitat specialists also declined more rapidly at sites with more abandoned farmland. All species groups showed an accelerated decline or decelerated increase after 2015. These results suggest that common breeding birds in Japan are facing deteriorating trends as a result of nationwide changes in land use and climate. Future land-use planning and policies should consider the benefits of passive rewilding for forest specialists and active restoration measures (e.g., low-intensive forestry and agriculture) for nonforest specialists to effectively conserve biodiversity in the era of human depopulation and climate warming., (© 2023 The Authors. Conservation Biology published by Wiley Periodicals LLC on behalf of Society for Conservation Biology.)
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- 2024
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33. An extensive database on the traits and occurrences of amphibian species in Turkey.
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Arslan D, Akdağ B, Yaşar Ç, Olivier A, Benedetti Y, Morelli F, and Çiçek K
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- Animals, Biodiversity, Turkey, Databases, Factual, Amphibians, Ecosystem
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Amphibians are the most endangered taxa among vertebrates, and they face many threats during their complex life cycles. The species' life history traits and occurrence database help understand species responses against ecological factors. Consequently, the species-level-trait database has gained more prominence in recent years as a useful tool for understanding the dimensions of communities, assembly processes of communities, and conserving biodiversity at the ecosystem level against environmental changes. However, in Turkey, there are deficiencies in the knowledge of the ecological traits of amphibians compared to other vertebrate taxa, as most studies have focused on their distribution or taxonomic status. Consequently, there is a need to create such a database for future research on all known extant amphibians in Turkey. We compiled a species-level data set of species traits and occurrences for all amphibians in Turkey using 436 literature sources. We completed 36 trait categories with 5611 occurrence data for 37 amphibian species in Turkey. This study provides an open, useful, and comprehensive database for macroecological and conservation studies on amphibians in Turkey., (© 2024. The Author(s).)
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- 2024
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34. Visual function in children with Joubert syndrome.
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Morelli F, Toni F, Saligari E, D'Abrusco F, Serpieri V, Ballante E, Ruberto G, Borgatti R, Valente EM, and Signorini S
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- Child, Humans, Male, Infant, Cerebellum diagnostic imaging, Retina diagnostic imaging, Retrospective Studies, Cross-Sectional Studies, Magnetic Resonance Imaging, Abnormalities, Multiple, Eye Abnormalities complications, Kidney Diseases, Cystic complications, Ocular Motility Disorders genetics
- Abstract
Aim: To describe visual function in children with Joubert syndrome and to investigate its possible association with diagnostic and developmental aspects., Method: This retrospective cross-sectional work included 59 patients (33 male; mean age 9 years 2 months, standard deviation 6 years 3 months, range 4 months to 23 years) diagnosed with Joubert syndrome from January 2002 to December 2020. Data about clinical (neurological, neuro-ophthalmological, developmental/cognitive) and diagnostic (e.g. genetic testing, neuroimaging, systemic involvement) evaluations were collected in a data set during a review of medical records. Clinical and diagnostic variables were described in terms of raw counts and percentages. A χ
2 test was conducted to investigate their association with neuropsychological skills., Results: Ocular motor apraxia was highly represented in our cohort (75%), with a high prevalence of refractive defects and retinal abnormalities. Developmental delay/intellectual disability was frequent (in 69.5% of the sample), associated with retinal dystrophy (p = 0.047) and reduced visual acuity both for near (p = 0.014) and for far distances (p = 0.017)., Interpretation: On the basis of the relevance of oculomotor and perceptual alterations and their impact on overall and cognitive impairment, we encourage early and multidisciplinary assessment and follow-up of visual function in children with Joubert syndrome. This would help in planning a personalized rehabilitation to sustain functional vision. Further studies will be important to explore the link between biological aspects and global functioning in children with Joubert syndrome., What This Paper Adds: Perceptual deficits and oculomotor impairments frequently coexist in Joubert syndrome. Retinal dysfunction may be present despite the absence of funduscopic abnormalities. Both perceptual and oculomotor impairments negatively affect cognitive development in Joubert syndrome., (© 2023 The Authors. Developmental Medicine & Child Neurology published by John Wiley & Sons Ltd on behalf of Mac Keith Press.)- Published
- 2024
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35. Clinical utility of Next Generation Sequencing of plasma cell-free DNA for the molecular profiling of patients with NSCLC at diagnosis and disease progression.
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Del Re M, Luculli GI, Petrini I, Sbrana A, Scotti V, Perez DM, Livi L, Crucitta S, Iannopollo M, Mazzoni F, Ruglioni M, Tibaldi C, Olmetto E, Stasi I, Baldini E, Allegrini G, Antonuzzo L, Morelli F, Pierini A, Panzeri N, Fogli S, Chella A, Rolfo C, and Danesi R
- Abstract
Background: The present study evaluates the utility of NGS analysis of circulating free DNA (cfDNA), which incorporates small amounts of tumor DNA (ctDNA), at diagnosis or at disease progression (PD) in NSCLC patients., Methods: Comprehensive genomic profiling on cfDNA by NGS were performed in NSCLC patients at diagnosis (if tissue was unavailable/insufficient) or at PD to investigate potential druggable molecular aberrations. Blood samples were collected as routinary diagnostic procedures, DNA was extracted, and the NextSeq 550 Illumina platform was used to run the Roche Avenio ctDNA Expanded Kit for molecular analyses. Gene variants were classified accordingly to the ESCAT score., Results: A total of 106 patients were included in this study; 44 % of cases were requested because of tissue unavailability at the diagnosis and 56 % were requested at the PD. At least one driver alteration was observed in 62 % of cases at diagnosis. Driver druggable variants classified as ESCAT level I were detected in 34 % of patients, including ALK-EML4, ROS1-CD74, EGFR, BRAF, KRAS p.G12C, PI3KCA. In the PD group, most patients were EGFR-positive, progressing to a first line-therapy. Sixty-three percent of patients had at least one driver alteration detected in blood and 17 % of patients had a known biological mechanism of resistance allowing further therapeutic decisions., Conclusions: The present study confirms the potential of liquid biopsy to detect tumour molecular heterogeneity in NSCLC patients at the diagnosis and at PD, demonstrating that a significant number of druggable mutations and mechanisms of resistance can be detected by NGS analysis on ctDNA., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023. Published by Elsevier Inc.)
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- 2024
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36. Time to strategy failure and treatment beyond progression in pretreated metastatic renal cell carcinoma patients receiving nivolumab: post-hoc analysis of the Meet-URO 15 study.
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Murianni V, Signori A, Buti S, Rebuzzi SE, Bimbatti D, De Giorgi U, Chiellino S, Galli L, Zucali PA, Masini C, Naglieri E, Procopio G, Milella M, Fratino L, Baldessari C, Ricotta R, Mollica V, Sorarù M, Tudini M, Prati V, Malgeri A, Atzori F, Di Napoli M, Caffo O, Spada M, Morelli F, Prati G, Nolè F, Vignani F, Cavo A, Lipari H, Roviello G, Catalano F, Damassi A, Cremante M, Rescigno P, Fornarini G, and Banna GL
- Abstract
Background: Immunotherapies exhibit peculiar cancer response patterns in contrast to chemotherapy and targeted therapy. Some patients experience disease response after initial progression or durable responses after treatment interruption. In clinical practice, immune checkpoint inhibitors may be continued after radiological progression if clinical benefit is observed. As a result, estimating progression-free survival (PFS) based on the first disease progression may not accurately reflect the actual benefit of immunotherapy., Methods: The Meet-URO 15 study was a multicenter retrospective analysis of 571 pretreated metastatic renal cell carcinoma (mRCC) patients receiving nivolumab. Time to strategy failure (TSF) was defined as the interval from the start of immunotherapy to definitive disease progression or death. This post-hoc analysis compared TSF to PFS and assess the response and survival outcomes between patients treatated beyond progression (TBP) and non-TBP. Moreover, we evaluated the prognostic accuracy of the Meet-URO score versus the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score based on TSF and PFS., Results: Overall, 571 mRCC patients were included in the analysis. Median TSF was 8.6 months (95% CI: 7.0 - 10.1), while mPFS was 7.0 months (95% CI: 5.7 - 8.5). TBP patients (N = 93) had significantly longer TSF (16.3 vs 5.5 months; p < 0.001) and overall survival (OS) (34.8 vs 17.9 months; p < 0.001) but similar PFS compared to non-TBP patients. In TBP patients, a median delay of 9.6 months (range: 6.7-16.3) from the first to the definitive disease progression was observed, whereas non-TBP patients had overlapped median TSF and PFS (5.5 months). Moreover, TBP patients had a trend toward a higher overall response rate (33.3% vs 24.3%; p = 0.075) and disease control rate (61.3% vs 55.5%; p = 0.31). Finally, in the whole population the Meet-URO score outperformed the IMDC score in predicting both TSF (c-index: 0.63 vs 0.59) and PFS (0.62 vs 0.59)., Conclusion: We found a 2-month difference between mTSF and mPFS in mRCC patients receiving nivolumab. However, TBP patients had better outcomes, including significantly longer TSF and OS than non-TBP patients. The Meet-URO score is a reliable predictor of TSF and PFS., Competing Interests: Dr. SB received honoraria as speaker at scientific events and advisory role by BMS, Pfizer, MSD, Ipsen, Roche, Eli Lilly, AstraZeneca, Pierre-Fabre, Novartis, Merck, Gentili, Astellas. Dr. SR received honoraria as speaker at scientific events and travel accommodation from BMS, Amgen, GSK, Ipsen, Astellas, Janssen, MSD. Dr. DB received honoraria as advisory role by Ipsen, Astellas, Janssen, Novartis, BMS, MSD, Pfizer, Merck and travel accommodation from Ipsen, Janssen, MSD, Merck. Dr. UD services as advisory/board member of Astellas, Bayer, BMS, IPSEN, Janssen, Merck, Pfizer, Sanofi, received research grant/funding to the institution from AstraZeneca, Roche, Sanofi and travel/accommodations/expenses from BMS BMS, IPSEN, Janssen, Pfizer. Dr. SC received honoraria as speaker at scientific events/advisory boards and travel accommodation from BMS, Ipsen, MSD, Pierre-Fabre, Bayer, Gentili. Dr. PZ reports outside the submitted work personal fees for advisory role, speaker engagements and travel and accommodation expenses from Merck Sharp & Dohme MSD, Astellas, Janssen, Sanofi, Ipsen, Pfizer, Novartis, Bristol Meyer Squibb, Amgen, Astrazeneca, Roche and Bayer. Dr. GPro services advisory boards/consulting for Astellas, AstraZeneca, BMS, Janssen, IPSEN, Merk, MSD, Novartis, Pfizer. Dr. CB received honoraria from advisory board/clinical trials/conference speaking/travel grant with Astellas, AstraZeneca, Bayer, BMS, Clovis, Exelixis, GSK, Ipsen, Janssen, Merck, MSD, Novartis, Pfizer, Roche, Sanofi. Dr. MSo services advisory boards/consulting for Janssen, received research funding from Janssen, Roche and Merck and received travel accomodation from Ipsen, BMS, Janssen, Pfizer, Novartis, Astellas, Sanofi, Roche. Dr. FM services advisory boards for Pfizer and MSD. Dr. PR services advisory boards for MSD, AstraZeneca and Janssen. Dr. GF services advisory boards for Astellas, Janssen, Pfizer, Bayer, MSD, Merck and received travel accomodation from Astellas, Janssen, Bayer. Dr. GB reports personal fees from AstraZeneca and Astellas for speaker bureau. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (Copyright © 2024 Murianni, Signori, Buti, Rebuzzi, Bimbatti, De Giorgi, Chiellino, Galli, Zucali, Masini, Naglieri, Procopio, Milella, Fratino, Baldessari, Ricotta, Mollica, Sorarù, Tudini, Prati, Malgeri, Atzori, Di Napoli, Caffo, Spada, Morelli, Prati, Nolè, Vignani, Cavo, Lipari, Roviello, Catalano, Damassi, Cremante, Rescigno, Fornarini and Banna.)
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- 2024
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37. Blindness affects the developmental trajectory of the sleeping brain.
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Vitali H, Campus C, Signorini S, De Giorgis V, Morelli F, Varesio C, Pasca L, Sammartano A, and Gori M
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- Child, Humans, Electroencephalography, Cognition, Blindness, Sleep Stages, Sleep, Brain
- Abstract
Sleep plays a crucial role in brain development, sensory information processing, and consolidation. Sleep spindles are markers of these mechanisms as they mirror the activity of the thalamocortical circuits. Spindles can be subdivided into two groups, slow (10-13 Hz) and fast (13-16 Hz), which are each associated with different functions. Specifically, fast spindles oscillate in the high-sigma band and are associated with sensorimotor processing, which is affected by visual deprivation. However, how blindness influences spindle development has not yet been investigated. We recorded nap video-EEG of 50 blind/severely visually impaired (BSI) and 64 sighted children aged 5 months to 6 years old. We considered aspects of both macro- and micro-structural spindles. The BSI children lacked the evolution of developmental spindles within the central area. Specifically, young BSI children presented low central high-sigma and high-beta (25-30 Hz) event-related spectral perturbation and showed no signs of maturational decrease. High-sigma and high-beta activity in the BSI group correlated with clinical indices predicting perceptual and motor disorders. Our findings suggest that fast spindles are pivotal biomarkers for identifying an early developmental deviation in BSI children. These findings are critical for initial therapeutic intervention., Competing Interests: Declaration of competing interest Authors declare no conflict of interest., (Copyright © 2024. Published by Elsevier Inc.)
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- 2024
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38. Ecological filtering shapes the impacts of agricultural deforestation on biodiversity.
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Hua F, Wang W, Nakagawa S, Liu S, Miao X, Yu L, Du Z, Abrahamczyk S, Arias-Sosa LA, Buda K, Budka M, Carrière SM, Chandler RB, Chiatante G, Chiawo DO, Cresswell W, Echeverri A, Goodale E, Huang G, Hulme MF, Hutto RL, Imboma TS, Jarrett C, Jiang Z, Kati VI, King DI, Kmecl P, Li N, Lövei GL, Macchi L, MacGregor-Fors I, Martin EA, Mira A, Morelli F, Ortega-Álvarez R, Quan RC, Salgueiro PA, Santos SM, Shahabuddin G, Socolar JB, Soh MCK, Sreekar R, Srinivasan U, Wilcove DS, Yamaura Y, Zhou L, and Elsen PR
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- Phylogeny, Forests, Agriculture, Conservation of Natural Resources, Biodiversity
- Abstract
The biodiversity impacts of agricultural deforestation vary widely across regions. Previous efforts to explain this variation have focused exclusively on the landscape features and management regimes of agricultural systems, neglecting the potentially critical role of ecological filtering in shaping deforestation tolerance of extant species assemblages at large geographical scales via selection for functional traits. Here we provide a large-scale test of this role using a global database of species abundance ratios between matched agricultural and native forest sites that comprises 71 avian assemblages reported in 44 primary studies, and a companion database of 10 functional traits for all 2,647 species involved. Using meta-analytic, phylogenetic and multivariate methods, we show that beyond agricultural features, filtering by the extent of natural environmental variability and the severity of historical anthropogenic deforestation shapes the varying deforestation impacts across species assemblages. For assemblages under greater environmental variability-proxied by drier and more seasonal climates under a greater disturbance regime-and longer deforestation histories, filtering has attenuated the negative impacts of current deforestation by selecting for functional traits linked to stronger deforestation tolerance. Our study provides a previously largely missing piece of knowledge in understanding and managing the biodiversity consequences of deforestation by agricultural deforestation., (© 2024. The Author(s), under exclusive licence to Springer Nature Limited.)
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- 2024
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39. Real-world Outcome of Patients with Advanced Renal Cell Carcinoma and Intermediate- or Poor-risk International Metastatic Renal Cell Carcinoma Database Consortium Criteria Treated by Immune-oncology Combinations: Differential Effectiveness by Risk Group?
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Santoni M, Buti S, Myint ZW, Maruzzo M, Iacovelli R, Pichler M, Kopecky J, Kucharz J, Rizzo M, Galli L, Büttner T, De Giorgi U, Kanesvaran R, Fiala O, Grande E, Zucali PA, Kopp RM, Fornarini G, Bourlon MT, Scagliarini S, Molina-Cerrillo J, Aurilio G, Matrana MR, Pichler R, Cattrini C, Büchler T, Massari F, Seront E, Calabrò F, Pinto A, Berardi R, Zgura A, Mammone G, Ansari J, Atzori F, Chiari R, Bamias A, Caffo O, Procopio G, Sunela K, Bassanelli M, Ortega C, Grillone F, Landmesser J, Milella M, Messina C, Küronya Z, Mosca A, Bhuva D, Santini D, Vau N, Morelli F, Incorvaia L, Rebuzzi SE, Roviello G, Soares A, Bisonni R, Bimbatti D, Zabalza IO, Rizzo A, Mollica V, Sorgentoni G, Monteiro FSM, Battelli N, Bracarda S, and Porta C
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- Humans, Retrospective Studies, Tyrosine Kinase Inhibitors, Treatment Outcome, Carcinoma, Renal Cell drug therapy, Carcinoma, Renal Cell pathology, Kidney Neoplasms drug therapy
- Abstract
Background: Renal c carcinoma (RCC) is one of the most common urinary cancers worldwide, with a predicted increase in incidence in the coming years. Immunotherapy, as a single agent, in doublets, or in combination with anti-vascular endothelial growth factor receptor tyrosine kinase inhibitors (TKIs), has rapidly become a cornerstone of the RCC therapeutic scenario, but no head-to-head comparisons have been made. In this setting, real-world evidence emerges as a cornerstone to guide clinical decisions., Objective: The objective of this retrospective study was to assess the outcome of patients treated with first-line immune combinations or immune oncology (IO)-TKIs for advanced RCC., Design, Setting, and Participants: Data from 930 patients, 654 intermediate risk and 276 poor risk, were collected retrospectively from 58 centers in 20 countries. Special data such as sarcomatoid differentiation, body mass index, prior nephrectomy, and metastatic localization, in addition to biochemical data such as hemoglobin, platelets, calcium, lactate dehydrogenase, neutrophils, and radiological response by investigator's criteria, were collected., Outcome Measurements and Statistical Analysis: Overall survival (OS) and progression-free survival (PFS) were estimated using the Kaplan-Meier method. The median follow-up was calculated by the inverse Kaplan-Meier method., Results and Limitations: The median follow-up time was 18.7 mo. In the 654 intermediate-risk patients, the median OS and PFS were significantly longer in patients with the intermediate than in those with the poor International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria (38.9 vs 17.3 mo, 95% confidence interval [CI] p < 0.001, and 17.3 vs 11.6 mo, 95% CI p < 0.001, respectively). In the intermediate-risk subgroup, the OS was 55.7 mo (95% CI 31.4-55.7) and 40.2 mo (95% CI 29.6-51.6) in patients treated with IO + TKI and IO + IO combinations, respectively (p = 0.047). PFS was 30.7 mo (95% CI 16.5-55.7) and 13.2 mo (95% CI 29.6-51.6) in intermediate-risk patients treated with IO + TKI and IO + IO combinations, respectively (p < 0.001). In the poor-risk subgroup, the median OS and PFS did not show a statistically significant difference between IO + IO and IO + TKI. Our study presents several limitations, mainly due to its retrospective nature., Conclusions: Our results showed differences between the IO + TKI and IO + IO combinations in intermediate-risk patients. A clear association with longer PFS and OS in favor of patients who received the IO + TKI combinations compared with the IO-IO combination was observed. Instead, in the poor-risk group, we observed no significant difference in PFS or OS between patients who received different combinations., Patient Summary: Renal cancer is one of the most frequent genitourinary tumors. Treatment is currently based on immunotherapy combinations or immunotherapy with tyrosine kinase inhibitors, but there are no comparisons between these.In this study, we have analyzed the clinical course of 930 patients from 58 centers in 20 countries around the world. We aimed to analyze the differences between the two main treatment strategies, combination of two immunotherapies versus immunotherapy + antiangiogenic therapy, and found in real-life data that intermediate-risk patients (approximately 60% of patients with metastatic renal cancer) seem to benefit more from the combination of immunotherapy + antiangiogenic therapy than from double immunotherapy. No such differences were found in poor-risk patients. This may have important implications in daily practice decision-making for these patients., (Copyright © 2023 European Association of Urology. Published by Elsevier B.V. All rights reserved.)
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- 2024
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40. Ultrasound-Assisted, Catheter-Directed Thrombolysis for Acute Intermediate/High-Risk Pulmonary Embolism: Design of the Multicenter USAT IH-PE Registry and Preliminary Results.
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Colombo C, Capsoni N, Russo F, Iannaccone M, Adamo M, Viola G, Bossi IE, Villanova L, Tognola C, Curci C, Morelli F, Guerrieri R, Occhi L, Chizzola G, Rampoldi A, Musca F, De Nittis G, Galli M, Boccuzzi G, Savio D, Bernasconi D, D'Angelo L, Garascia A, Chieffo A, Montorfano M, Oliva F, and Sacco A
- Abstract
Catheter-based revascularization procedures were developed as an alternative to systemic thrombolysis for patients with intermediate-high- and high-risk pulmonary embolisms. USAT IH-PE is a retrospective and prospective multicenter registry of such patients treated with ultrasound-facilitated, catheter-directed thrombolysis, whose preliminary results are presented in this study. The primary endpoint was the incidence of pulmonary hypertension (PH) at follow-up. Secondary endpoints were short- and mid-term changes in the echocardiographic parameters of right ventricle (RV) function, in-hospital and all-cause mortality, and procedure-related bleeding events. Between March 2018 and July 2023, 102 patients were included. The majority were at intermediate-high-risk PE (86%), were mostly female (57%), and had a mean age of 63.7 ± 14.5 years, and 28.4% had active cancer. Echocardiographic follow-up was available for 70 patients, and in only one, the diagnosis of PH was confirmed by right heart catheterization, resulting in an incidence of 1.43% (CI 95%, 0.036-7.7). RV echocardiographic parameters improved both at 24 h and at follow-up. In-hospital mortality was 3.9% (CI 95%, 1.08-9.74), while all-cause mortality was 11% (CI 95%, 5.4-19.2). Only 12% had bleeding complications, of whom 4.9% were BARC ≥ 3. Preliminary results from the USAT IH-PE registry showed a low incidence of PH, improvement in RV function, and a safe profile.
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- 2024
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41. Dense city centers support less evolutionary unique bird communities than sparser urban areas.
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Morelli F, Reif J, Díaz M, Tryjanowski P, Ibáñez-Álamo JD, Suhonen J, Jokimäki J, Kaisanlahti-Jokimäki ML, Møller AP, Jerzak L, Bussière R, Mägi M, Kominos T, Galanaki A, Bukas N, Markó G, Pruscini F, Ciebiera O, and Benedetti Y
- Abstract
Urbanization alters avian communities, generally lowering the number of species and contemporaneously increasing their functional relatedness, leading to biotic homogenization. Urbanization can also negatively affect the phylogenetic diversity of species assemblages, potentially decreasing their evolutionary distinctiveness. We compare species assemblages in a gradient of building density in seventeen European cities to test whether the evolutionary distinctiveness of communities is shaped by the degree of urbanization. We found a significant decline in the evolutionary uniqueness of avian communities in highly dense urban areas, compared to low and medium-dense areas. Overall, communities from dense city centers supported one million years of evolutionary history less than communities from low-dense urban areas. Such evolutionary homogenization was due to a filtering process of the most evolutionarily unique birds. Metrics related to evolutionary uniqueness have to play a role when assessing the effects of urbanization and can be used to identify local conservation priorities., Competing Interests: The authors declare no competing interests., (© 2024 The Author(s).)
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- 2024
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42. Climate change is associated with asynchrony in arrival between two sympatric cuckoos and both host arrival and prey emergence.
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Mikula P, Askeyev OV, Askeyev AO, Askeyev IV, Morelli F, Menzel A, and Tryjanowski P
- Abstract
Matching the timing of spring arrival to the breeding grounds with hosts and prey is crucial for migratory brood parasites such as cuckoos. Previous studies have focused mostly on phenological mismatch between a single cuckoo species and its hosts but information regarding climate-driven mismatch between multiple sympatric cuckoo species and their hosts and invertebrate prey is still lacking. Here, we analysed long-term data (1988-2023) on the first arrival date of two declining migratory cuckoo species and their 14 migratory host species breeding in sympatry and prey emergence date in Tatarstan (southeast Russia). We found that the common cuckoo ( Cuculus canorus ; wintering in Africa) generally arrived on breeding grounds earlier than the oriental cuckoo ( Cuculus optatus ; wintering in southeast Asia and Australia). Both cuckoos have advanced their arrival dates over 36 years but less than their hosts, potentially resulting in an increasing arrival mismatch between cuckoos and their hosts. Moreover, cuckoo arrival advanced less than the emergence date of their prey over time. These observations indicate that climate change may disrupt co-fluctuation in the phenology of important life stages between multiple sympatric brood parasites, their hosts and prey with potential cascading consequences for population dynamics of involved species., Competing Interests: We declare we have no competing interests., (© 2024 The Authors.)
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- 2024
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43. Urban landscape organization is associated with species-specific traits in European birds.
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Ibáñez-Álamo JD, Izquierdo L, Mourocq E, Benedetti Y, Kaisanlahti-Jokimäki ML, Jokimäki J, Morelli F, Rubio E, Pérez-Contreras T, Sprau P, Suhonen J, Tryjanowski P, and Díaz M
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- Animals, Bayes Theorem, Cities, Birds, Ecosystem, Urbanization, Biodiversity
- Abstract
Urbanization is one of the main current drivers of the global biodiversity loss. Cities are usually developed in a gradient between land-sharing (low density housing with small and fragmented green areas) and land-sparing areas (high density housing with large and non-fragmented green patches) depending on the spatial organization of urban attributes. Previous studies have indicated differences in biodiversity between these two urban development types, but mechanisms underlying these differences are inadequately understood. In this context, the landscape features of each urban development type may select for organisms with specific traits. To analyze it, we quantified birds in 9 European cities during the breeding and wintering season, collected species-specific traits and performed Bayesian comparative analyses. We found that birds living in land-sparing areas had a higher reproductive investment and a higher nesting specialization than birds living in land-sharing areas during the breeding season. Typical birds from land-sparing urban areas during winter are fast-lived species. Our results indicate that urban development type could have an important role selecting animal traits and provides useful information on how to build more biodiversity-friendly cities., Competing Interests: Declaration of competing interest The authors declare that there are no competing interests that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier B.V. All rights reserved.)
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- 2024
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44. Little Owl Aggression and Territory in Urban and Rural Landscapes.
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Grzywaczewski G, Morelli F, and Skórka P
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Urbanization is a major land use change across the globe with vast effects on wildlife. In this paper, we studied (1) the territorial displays of Little Owls in urban and rural landscapes, analyzing also (2) the size and habitat composition of the territories, and (3) the factors affecting territory size in both landscapes. To do that, we used t -tests, Principal Components Analysis, and General Linear mixed model procedures. The territory size was smaller in urban than in rural landscapes. Urban territories of Little Owls are characterized by a lower cover of grassland, tall crops, short crops, gardens, and orchards, as well as a higher cover of built-up areas than territories in rural landscapes. Territory size in rural landscapes was negatively correlated with seasonal progress and positively correlated with altitude. The rate of territorial displays was similar between urban and rural territories; however, birds differentially utilized various structures. In urban territories, birds mostly used buildings, whereas in rural territories, birds used electric pylons and trees. The compositional differences between territories in the two landscapes may have important consequences for other behavior types and possibly reproductive output in this species.
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- 2024
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45. Treatment Sequencing and Outcome of Chronic Lymphocytic Leukemia Patients Treated at Fondazione Policlinico Universitario Agostino Gemelli IRCCS: A Thirty-Year Single-Center Experience.
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Innocenti I, Fresa A, Tomasso A, Tarnani M, De Padua L, Benintende G, Pasquale R, Galli E, Morelli F, Giannarelli D, Autore F, and Laurenti L
- Abstract
Background: This monocentric retrospective study describes the treatment patterns and outcomes of chronic lymphocytic leukemia (CLL) patients., Methods: Adult CLL patients treated between 1992 and 2022 were included. The time to next treatment (TTNT) was defined as the time from the treatment's start to the start of a subsequent therapy or death. The time to next treatment failure or death (TTNTF) was defined as the time from treatment discontinuation to the discontinuation of a subsequent therapy or death., Results: Of 637 registered patients, 318 (49.9%) received treatment. We evaluated 157 cBTKi-exposed, 34 BCL2i-exposed cBTKi-naïve, and 26 double-exposed patients. The five-year TTNT values in the cBTKi-exposed patients were 80% (median NR), 40% (median 40 months), and 21% (median 24 months) months in the first line (1L), second line (2L), and beyond the second line (>2L), respectively ( p < 0.0001). The five-year TTNT values in the BCL2i-exposed patients were 83% (median NR), 72% (median NR), 12% (median 28 months) in the 1L, 2L, and >2L, respectively ( p = 0.185). The median TTNTF was 9 months (range 1-87) after cBTKi and 17 months (range 8-49) after both a cBTKi and BCL2i., Conclusions: This study suggests that, in CLL patients, the earlier we used targeted therapies, the better was the outcome obtained. Nonetheless, the poor outcomes in the advanced lines of therapy highlight the need for more effective treatments.
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- 2023
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46. Sodium Levels and Outcomes in Patients With Metastatic Renal Cell Carcinoma Receiving Nivolumab.
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Catalano M, Rebuzzi SE, Maruzzo M, De Giorgi U, Buti S, Galli L, Fornarini G, Zucali PA, Procopio G, Chiellino S, Milella M, Catalano F, Pipitone S, Ricotta R, Sorarù M, Mollica V, Tudini M, Fratino L, Prati V, Caffo O, Atzori F, Morelli F, Prati G, Nolè F, Vignani F, Cavo A, Di Napoli M, Malgeri A, Naglieri E, Signori A, Banna GL, Rescigno P, Antonuzzo L, and Roviello G
- Subjects
- Humans, Male, Aged, Nivolumab therapeutic use, Retrospective Studies, Sodium therapeutic use, Carcinoma, Renal Cell drug therapy, Kidney Neoplasms pathology
- Abstract
Importance: Low sodium levels have been associated with negative outcomes among patients with metastatic renal cell carcinoma (mRCC) receiving therapies other than immune checkpoint inhibitors (ICIs)., Objective: To investigate the role of natremia in patients with mRCC receiving nivolumab as a second-line or subsequent therapy., Design, Setting, and Participants: In this retrospective cohort study, the clinical and biochemical data of patients with mRCC receiving nivolumab were collected from October 2015 to November 2019 as part of a multicenter Italian study. Data analysis was performed from February to March 2023., Exposure: Nivolumab was administered intravenously at a dose of 3 mg/kg every 2 weeks and, since May 2018, at a fixed dose of 240 mg every 2 weeks or 480 mg every 4 weeks. Patients were divided into 2 groups according to their median serum sodium value (<140 or ≥140 mEq/L)., Main Outcomes and Measures: The primary outcomes were the associations of pre-ICI and post-ICI sodium levels with overall survival (OS), progression-free survival (PFS), objective response rate, and disease control rate (DCR). The Kaplan-Meier method was used to estimate PFS and OS, and differences between groups were compared using the log-rank test., Results: A total of 401 patients with mRCC receiving nivolumab as second-line therapy were evaluated, and 355 eligible patients (median [range] age, 76 [44-84] years; 258 male patients [72.7%]) were included in the final cohort. Among patients with pre-ICI sodium greater than or equal to 140 mEq/L compared with those with sodium less than 140 mEq/L, the median PFS was 9.3 months (95% CI, 6.5-11.5 months) vs 7.4 months (95% CI, 4.6-10.1 months; P = .90), and the median OS was 29.2 months (95% CI, 21.8-35.9 months) vs 20.0 months (95% CI, 14.1-26.8 months; P = .03). Patients with post-ICI sodium values greater than or equal to 140 mEq/L had longer PFS (11.1 months [95% CI, 8.5-1.5 months] vs 5.1 months [95% CI, 4.1-7.5 months]; P = .01) and OS (32.9 months [95% CI, 25.1-42.6 months] vs 17.1 months [95% CI, 12.6-24.5 months]; P = .006) compared with patients with sodium values less than 140 mEq/L. Patients with both pre-ICI and post-ICI sodium values greater than or equal to 140 mEq/L exhibited a significant improvement in clinical outcomes compared with those with a value less than 140 mEq/L (PFS, 11.5 months [95% CI, 8.8-16.4 months] vs 5.8 months [95% CI, 4.4-8.3 months]; P = .008); OS, 37.6 months [95% CI, 29.0-49.9 months] vs 19.4 months [95% CI, 14.1-24.5 months]; P = .01). Moreover, sodium levels greater than or equal to 140 mEq/L were associated with significantly better DCR than lower sodium levels., Conclusions and Relevance: In this retrospective cohort study of patients with mRCC receiving nivolumab, sodium values greater than or equal to 140 mEq/L, both before and/or after ICI, were associated with better OS and PFS, as well as a higher DCR, compared with levels less than 140 mEq/L. These findings suggest that sodium levels may be associated with survival outcomes in patients with mRCC and may have potential use as variables to consider in patients' risk scores.
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- 2023
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47. Estimating marksmanship performance during walking while maintaining weapon aim.
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Talarico MK, Morelli F, Yang J, Chaudhari A, and Onate JA
- Subjects
- Humans, Male, Adolescent, Young Adult, Adult, Lower Extremity, Knee Joint, Walking Speed, Biomechanical Phenomena, Walking, Gait
- Abstract
Marksmanship performance while moving is a critical skill among tactical athletes due to the high demands of their occupational duties. Qualifications for dynamic marksmanship performance are not standardized across tactical athlete groups, which may limit comprehensive assessment of tactical athlete performance for situational awareness and adaptability to an unpredictable environment. Although static marksmanship performance provides foundational information on skills and level of ability, research is lacking on factors that influence dynamic marksmanship performance to best prepare tactical athletes for duties. The purpose of this study was to identify whether static marksmanship performance, speed of movement, load carriage, and biomechanical factors while 'shooting on the move' influenced dynamic marksmanship performance. Twenty-four male tactical athletes (22 active-duty Army Soldiers, two civilian SWAT operators; age: 23.83 ± 5.47 years; height: 1.80 ± 0.08 m; weight: 81.04 ± 7.87 kg) participated; final analyses did not include data from the two civilian operators to maintain sample homogeneity. Tactical athletes completed static and dynamic ('shoot on the move') marksmanship tasks under three load conditions: (1) no load (NL), (2) half kit (HK) of 11.34 kg, and (3) full kit (KIT) of 22.68 kg. Dynamic marksmanship was completed under three speed conditions: (1) self-selected slow speed, (2) standard speed, and (3) self-selected fast speed. Hip, knee, and ankle kinematics were collected via wireless inertial measurement units. Spatiotemporal parameters were collected via optical detection system. Marksmanship performance (accuracy) was collected via open-air acoustic target scoring and mean radial error (MRE) was calculated for both static and dynamic marksmanship tasks. Linear mixed-effects models were fit with dynamic MRE as the outcome variable with fixed effects of static MRE, load condition, speed condition, kinematics, and spatiotemporal parameters, adjusting for body mass. Alpha level was set a priori at p ≤ 0.10. The final statistical model included fixed effects of static MRE, load condition, speed condition, and time spent in double limb support. Static MRE (p < 0.01) and time spent in double limb support (p = 0.01) were significant factors. For each 1 cm increase in static MRE there was a 0.66 cm increase in dynamic MRE. For every 1% increase in time spent in double limb support while 'shooting on the move' there was a 0.13 cm increase in dynamic MRE. Findings from this study highlight that tactical athletes who have larger static stance MRE and spend a longer time in double limb support during a gait cycle exhibit an increase in MRE during 'shoot on the move' trials. Overall, dynamic shooting accuracy is not affected by lower extremity joint angles, load carriage, or speed of movement. Although strong relationships are known between gait speed, load, and lower extremity kinematics, the differences in tactical gait compared to normal gait and multi-task paradigm that likely favors marksmanship accuracy seem to present novel movement characteristics unique to occupational gait. Further investigation is warranted to identify other potential factors that may improve or worsen dynamic marksmanship performance., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Published by Elsevier Ltd.)
- Published
- 2023
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48. Use of concomitant proton pump inhibitors, statins or metformin in patients treated with pembrolizumab for metastatic urothelial carcinoma: data from the ARON-2 retrospective study.
- Author
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Fiala O, Buti S, Takeshita H, Okada Y, Massari F, Palacios GA, Dionese M, Scagliarini S, Büttner T, Fornarini G, Myint ZW, Galli L, Souza VC, Pichler R, De Giorgi U, Quiroga MNG, Gilbert D, Popovic L, Grande E, Mammone G, Berardi R, Crabb SJ, Molina-Cerrillo J, Freitas M, Luz M, Iacovelli R, Calabrò F, Tural D, Atzori F, Küronya Z, Chiari R, Campos S, Caffo O, Fay AP, Kucharz J, Zucali PA, Rinck JA, Zeppellini A, Bastos DA, Aurilio G, Mota A, Trindade K, Ortega C, Sade JP, Rizzo M, Vau N, Giannatempo P, Barillas A, Monteiro FSM, Dauster B, Cattrini C, Nogueira L, de Carvalho Fernandes R, Seront E, Aceituno LG, Grillone F, Cutuli HJ, Fernandez M, Bassanelli M, Roviello G, Abahssain H, Procopio G, Milella M, Kopecky J, Martignetti A, Messina C, Caitano M, Inman E, Kanesvaran R, Herchenhorn D, Santini D, Manneh R, Bisonni R, Zakopoulou R, Mosca A, Morelli F, Maluf F, Soares A, Nunes F, Pinto A, Zgura A, Incorvaia L, Ansari J, Zabalza IO, Landmesser J, Rizzo A, Mollica V, Sorgentoni G, Battelli N, Porta C, Bellmunt J, and Santoni M
- Subjects
- Humans, Proton Pump Inhibitors, Retrospective Studies, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Metformin therapeutic use, Carcinoma, Transitional Cell, Urinary Bladder Neoplasms
- Abstract
Background: Concomitant medications may potentially affect the outcome of cancer patients. In this sub-analysis of the ARON-2 real-world study (NCT05290038), we aimed to assess the impact of concomitant use of proton pump inhibitors (PPI), statins, or metformin on outcome of patients with metastatic urothelial cancer (mUC) receiving second-line pembrolizumab., Methods: We collected data from the hospital medical records of patients with mUC treated with pembrolizumab as second-line therapy at 87 institutions from 22 countries. Patients were assessed for overall survival (OS), progression-free survival (PFS), and overall response rate. We carried out a survival analysis by a Cox regression model., Results: A total of 802 patients were eligible for this retrospective study; the median follow-up time was 15.3 months. PPI users compared to non-users showed inferior PFS (4.5 vs. 7.2 months, p = 0.002) and OS (8.7 vs. 14.1 months, p < 0.001). Concomitant PPI use remained a significant predictor of PFS and OS after multivariate Cox analysis. The use of statins or metformin was not associated with response or survival., Conclusions: Our study results suggest a significant prognostic impact of concomitant PPI use in mUC patients receiving pembrolizumab in the real-world context. The mechanism of this interaction warrants further elucidation., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
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- 2023
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49. Potential business model for a European vaccine R&D infrastructure and its estimated socio-economic impact.
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Jungbluth S, Martin W, Slezak M, Depraetere H, Guzman CA, Ussi A, Morrow D, Van Heuverswyn F, Arnouts S, Carrondo MJT, Olesen O, Ottenhoff THM, Dockrell HM, Ho MM, Dobly A, Christensen D, Segalés J, Laurent F, Lantier F, Stockhofe-Zurwieden N, Morelli F, Langermans JAM, Verreck FAW, Le Grand R, Sloots A, Medaglini D, Lawrenz M, and Collin N
- Subjects
- Commerce, Socioeconomic Factors, Biomedical Research, Vaccines
- Abstract
Background: Research infrastructures are facilities or resources that have proven fundamental for supporting scientific research and innovation. However, they are also known to be very expensive in their establishment, operation and maintenance. As by far the biggest share of these costs is always borne by public funders, there is a strong interest and indeed a necessity to develop alternative business models for such infrastructures that allow them to function in a more sustainable manner that is less dependent on public financing., Methods: In this article, we describe a feasibility study we have undertaken to develop a potentially sustainable business model for a vaccine research and development (R&D) infrastructure. The model we have developed integrates two different types of business models that would provide the infrastructure with two different types of revenue streams which would facilitate its establishment and would be a measure of risk reduction. For the business model we are proposing, we have undertaken an ex ante impact assessment that estimates the expected impact for a vaccine R&D infrastructure based on the proposed models along three different dimensions: health, society and economy., Results: Our impact assessment demonstrates that such a vaccine R&D infrastructure could achieve a very significant socio-economic impact, and so its establishment is therefore considered worthwhile pursuing., Conclusions: The business model we have developed, the impact assessment and the overall process we have followed might also be of interest to other research infrastructure initiatives in the biomedical field., Competing Interests: No competing interests were disclosed., (Copyright: © 2023 Jungbluth S et al.)
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- 2023
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50. Visual Function and Neuropsychological Profiling of Idiopathic Infantile Nystagmus.
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Morelli F, Catalano G, Scognamillo I, Balzarotti N, Luparia A, Olivier L, Bertone C, Gori M, and Signorini S
- Abstract
Though considered a benign condition, idiopathic infantile nystagmus (IIN) may be associated with decreased visual acuity and oculo-motor abnormalities, resulting in developmental delays and poor academic performance. Nevertheless, the specific visual function profile of IIN and its possible impact on neuropsychological development have been poorly investigated. To fill this gap, we retrospectively collected the clinical data of 60 children presenting with IIN over a 10-year period (43 male; mean age of 7 years, range of 2 months-17 years, 9 months). The majority of the subjects in our cohort presented with reduced visual acuity for far distances and normal visual acuity for near distances, associated with oculo-motor abnormalities. The overall scores of cognitive and visual-cognitive tests were in the normal range, but revealed peculiar cognitive and visual-cognitive profiles, defined by specific frailties in processing speed and visual-motor integration. The same neuropsychological profiles characterize many neurodevelopmental disorders and may express a transnosographic vulnerability of the dorsal stream. As the first study to explore the neuropsychologic competencies in children with IIN, our study unveils the presence of subclinical frailties that need to be addressed to sustain academic and social inclusion.
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- 2023
- Full Text
- View/download PDF
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