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6. List of contributors

Author

Artusi, Carlo Alberto, primary, Balachandar, Arjun, additional, Bhidayasiri, Roongroj, additional, Bordallo López, Miguel, additional, Bouça-Machado, Raquel, additional, Cacho, Ricardo, additional, Choudhury, Supriyo, additional, Del Din, Silvia, additional, Deuschl, Günther, additional, Espay, Alberto J., additional, Fasano, Alfonso, additional, Ferreira, Joaquim J., additional, Gandolfi, Marialuisa, additional, Goetz, Christopher G., additional, Imbalzano, Gabriele, additional, Kauppila, Linda Azevedo, additional, Kumar, Hrishikesh, additional, Lage Cañellas, Manuel, additional, Leitão, Mariana, additional, Leyens, Lada, additional, Maetzler, Walter, additional, Mancini, Martina, additional, Mari, Zoltan, additional, Mathur, Soania, additional, Mirelman, Anat, additional, Monje, Mariana H.G., additional, Nguyen, Le, additional, Nobbs, David, additional, Oyama, Genko, additional, Padovani, Alessandro, additional, Paul, Serene S., additional, Phokaewvarangkul, Onanong, additional, Pilotto, Andrea, additional, Prasertpan, Tittaya, additional, Ray Chaudhuri, K., additional, Rehman, Rana Zia Ur, additional, Rizzardi, Andrea, additional, Salaorni, Francesca, additional, Schönberg, Laura, additional, Simuni, Tanya, additional, Sánchez-Ferro, Álvaro, additional, Susarla, Praneeth, additional, Tinazzi, Michele, additional, Álvarez Casado, Constantino, additional, Tönges, Lars, additional, van Wamelen, Daniel J., additional, Virameteekul, Sasivimol, additional, Vizcarra, Joaquin A., additional, and Zatti, Cinzia, additional

Published
2024
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7. Risk of recurrence after discontinuing anticoagulation in patients with COVID-19- associated venous thromboembolism: a prospective multicentre cohort studyResearch in context

Author

Luis Jara-Palomares, Behnood Bikdeli, David Jiménez, Alfonso Muriel, Pablo Demelo-Rodríguez, Farès Moustafa, Aurora Villalobos, Patricia López-Miguel, Luciano López-Jiménez, Sonia Otálora, María Luisa Peris, Cristina Amado, Romain Chopard, Francisco Rivera-Cívico, Manuel Monreal, María Dolores Adarraga, Ana Alberich Conesa, Jesús Aibar, Alicia Alda Lozano, Joaquín Alfonso, Jesús Alonso Carrillo, María Angelina García, Juan Ignacio Arcelus, Aitor Ballaz, Raquel Barba, María Barca Hernando, Cristina Barbagelata, Manuel Barrón, Belén Barrón Andrés, Fahd Beddar Chaib, María Ángeles Blanco Molina, Juan Carlos Caballero, Gonzalo Castellanos, Leyre Chasco, Juan Criado, Cristina de Ancos, Jorge del Toro, Pablo Demelo Rodríguez, Cristina de Juana Izquierdo, Ana María Díaz Brasero, José Antonio Díaz Peromingo, Álvaro Dubois Silva, Juan Carlos Escribano, Concepción Falgá, Ana Isabel Farfán Sedano, Cleofe Fernández Aracil, Carmen Fernández Capitán, Begoña Fernández Jiménez, José Luis Fernández Reyes, María Ángeles Fidalgo, Iria Francisco, Cristina Gabara, Francisco Galeano Valle, Francisco García Bragado, Alberto García Ortega, Olga Gavín Sebastián, María Allende Gil de Gómez, Aída Gil Díaz, Covadonga Gómez Cuervo, Adriana González Munera, Enric Grau, Leticia Guirado, Javier Gutiérrez, Luis Hernández Blasco, Luis Jara Palomares, María Jesús Jaras, Rafael Jiménez, Inés Jou, María Dolores Joya, Sara Lainez Justo, Antonio Lalueza, Ramón Lecumberri, José Manuel León Ramírez, Pilar Llamas, José Luis Lobo, Luciano López Jiménez, Patricia López Miguel, Juan José López Núñez, Antonio López Ruiz, Juan Bosco López Sáez, Alicia Lorenzo, Marina Lumbierres, Olga Madridano, Ana Maestre, Pablo Javier Marchena, María Marcos, Mar Martín del Pozo, Francisco Martín Martos, Jorge Manuel Maza, Elisabeth Mena, Maria Isabel Mercado, Jorge Moisés, María del Valle Morales, Maria Sierra Navas, José Antonio Nieto, Manuel Jesús Núñez Fernández, Mónica Olid, Lucía Ordieres Ortega, María Ortiz, Jeisson Osorio, Remedios Otero, Nazaret Pacheco Gómez, Javier Pagán, Andrea Catalina Palomeque, Ezequiel Paredes, Pedro Parra Caballero, José María Pedrajas, Cristina Pérez Ductor, Montserrat Pérez Pinar, María Lourdes Pesce, José Antonio Porras, Ramón Puchades, Francisco Rivera Cívico, Ana Rodríguez Cobo, Vladimir Rosa, Marta Romero Brugera, Pedro Ruiz Artacho, Nuria Ruiz Giménez, Justo Ruiz Ruiz, Georgina Salgueiro, Teresa Sancho, Vanesa Sendín, Patricia Sigüenza, Silvia Soler, Susana Suárez Fernández, Raimundo Tirado, Ana Torrents Vilar, María Isabel Torres, Javier Trujillo Santos, Fernando Uresandi, Reina Valle, José Felipe Varona, Paula Villares, Cihan Ay, Stephan Nopp, Ingrid Pabinger, Matthias Engelen, Thomas Vanassche, Peter Verhamme, Hugo Hyung Bok Yoo, Ana Cristina Montenegro, Silvia Natalia Morales, Jairo Roa, Jana Hirmerova, Radovan Malý, Laurent Bertoletti, Alessandra Bura-Riviere, Judith Catella, Francis Couturaud, Olivier Espitia, Claire Grange, Barbara Leclercq, Raphael Le Mao, Isabelle Mahé, Ludovic Plaisance, Gabrielle Sarlon Bartoli, Pierre Suchon, Edouard Versini, Sebastian Schellong, Benjamin Brenner, Najib Dally, Inna Tzoran, Parham Sadeghipour, Fahrid Rashidi, Alessia Abenante, Giovanni Barillari, Manuela Basaglia, Franca Bilora, Daniele Bissacco, Cristiano Bortoluzzi, Barbara Brandolin, Renato Casana, Maurizio Ciammaichella, Donatella Colaizzo, Francesco Dentali, Pierpaolo Di Micco, Elvira Grandone, Egidio Imbalzano, Daniela Lambertenghi Deliliers, Federica Negro, Raffaele Pesavento, Alessandra Poz, Paolo Prandoni, Paolo Scarinzi, Carmine Siniscalchi, Beldisa Taflaj, Antonella Tufano, Adriana Visonà, Ngoc Vo Hong, Beniamino Zalunardo, Andris Skride, Dana Kigitovica, Samuel Fonseca, Rafael Marques, José Meireles, Sara Barbosa Pinto, Marijan Bosevsky, Aleksandra Eftimova, Marijan Zdraveska, Henri Bounameaux, Lucia Mazzolai, Avinash Aujayeb, Joseph Caprini, Ido Weinberg, and Hanh My Bui

Subjects
Pulmonary embolism, Venous thromboembolism, Anticoagulation, COVID-19, SARS-CoV-2, Medicine (General), R5-920
Abstract

Summary: Background: The clinical relevance of recurrent venous thromboembolism (VTE) after discontinuing anticoagulation in patients with COVID-19-associated VTE remains uncertain. We estimated the incidence rates and mortality of VTE recurrences developing after discontinuing anticoagulation in patients with COVID-19-associated VTE. Methods: A prospective, multicenter, non-interventional study was conducted between March 25, 2020, and July 26, 2023, including patients who had discontinued anticoagulation after at least 3 months of therapy. All patients from the registry were analyzed during the study period to verify inclusion criteria. Patients with superficial vein thrombosis, those who did not receive at least 3 months of anticoagulant therapy, and those who were followed for less than 15 days after discontinuing anticoagulation were excluded. Outcomes were: 1) Incidence rates of symptomatic VTE recurrences, and 2) fatal PE. The rate of VTE recurrences was defined as the number of patients with recurrent VTE divided by the patient-years at risk of recurrent VTE during the period when anticoagulation was discontinued. Findings: Among 1106 patients with COVID-19-associated VTE (age 62.3 ± 14.4 years; 62.9% male) followed-up for 12.5 months (p25-75, 6.3–20.1) after discontinuing anticoagulation, there were 38 VTE recurrences (3.5%, 95% confidence interval [CI]: 2.5–4.7%), with a rate of 3.1 per 100 patient-years (95% CI: 2.2–4.2). No patient died of recurrent PE (0%, 95% CI: 0–7.6%). Subgroup analyses showed that patients with diagnosis in 2021–2022 (vs. 2020) (Hazard ratio [HR] 2.86; 95% CI 1.45–5.68) or those with isolated deep vein thrombosis (vs. pulmonary embolism) (HR 2.31; 95% CI 1.19–4.49) had significantly higher rates of VTE recurrences. Interpretation: In patients with COVID-19-associated VTE who discontinued anticoagulation after at least 3 months of treatment, the incidence rate of recurrent VTE and the case-fatality rate was low. Therefore, it conceivable that long-term anticoagulation may not be required for many patients with COVID-19-associated VTE, although further research is needed to confirm these findings. Funding: Sanofi and Rovi, Sanofi Spain.

Published
2024
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8. Chronic kidney disease progression in diabetic patients: Real world data in general practice

Author

Michelangelo Rottura, Selene Francesca Anna Drago, Viviana Maria Gianguzzo, Antonino Molonia, Giovanni Pallio, Riccardo Scoglio, Sebastiano Marino, Angela Alibrandi, Egidio Imbalzano, Francesco Squadrito, Natasha Irrera, and Vincenzo Arcoraci

Subjects
Diabetes, Chronic kidney disease, General practice, Real world data, Appropriateness of prescriptions, Science (General), Q1-390, Social sciences (General), H1-99
Abstract

Aims: the aim of the study was to analyze glomerular filtration ratio (GFR) changes in diabetic patients assisted by General Practitioners (GPs) evaluating the risk factors related to glomerular function. Methods: patients with diabetes with at least three recorded values of creatinine were recruited in the study and GFR values were estimated. The quarterly percentage change in GFR for each patient was estimated. Nephrotoxic drugs were identified, and glucose-lowering drugs use was described. Linear regression analyses were performed to identify eGFR changes predictors. Results: a total of 545 patients with diabetes were selected. According to the last eGFR values 64 (11.7 %) patients were classified in G1 stage, 277 (50,8 %) in G2, 175 (32.1 %) in G3a, 25 (4.6 %) in G3b and only 4 (0.7 %) in G4. Patients treated with at least one glucose-lowering drugs were 479 (87.9 %), most of them with biguanides (67.0 %). At least one nephrotoxic drug prescription was recorded in 524 (96.1 %) patients; proton pump inhibitors (74.7 %) and NSAIDs (71.6 %) were the most prescription classes. Heart failure, diabetes duration and preserved GFR values were related to reduced eGFR values. Conclusions: patients with diabetes should be more carefully observed regardless of kidney risk factors and GFR values in clinical practice.

Published
2024
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9. Venous thromboembolism characteristics and outcomes among RIETE patients tested and untested for inherited thrombophilia

Author

Adarraga, MD, Alberich-Conesa, A, Aibar, J, Alda-Lozano, A, Alfonso, J, Amado, C, Angelina-García, M, Arcelus, JI, Ballaz, A, Barba, R, Barbagelata, C, Barrón, M, Barrón-Andrés, B, Beddar-Chaib, F, Blanco-Molina, A, Caballero, JC, Castellanos, G, Criado, J, De Ancos, C, Del Toro, J, Demelo-Rodríguez, P, De Juana-Izquierdo, C, Díaz-Peromingo, JA, Dubois-Silva, A, Escribano, JC, Falgá, C, Farfán-Sedano, AI, Fernández-Aracil, C, Fernández-Capitán, C, Fernández-Jiménez, B, Fernández-Reyes, JL, Fidalgo, MA, Francisco, I, Gabara, C, Galeano-Valle, F, García-Bragado, F, García-Ortega, A, Gavín-Sebastián, O, Gil-Díaz, A, Gómez-Cuervo, C, González-García, C, González-Munera, A, Grau, E, Guirado, L, Gutiérrez-Guisado, J, Hernández-Blasco, L, Herreros, M, Jara-Palomares, L, Jaras, MJ, Jiménez, D, Jou, I, Joya, MD, Lecumberri, R, Llamas, P, Lobo, JL, López-Jiménez, L, López-Miguel, P, López-Brull, H, López-Núñez, JJ, López-Ruiz, A, López-Sáez, JB, Lorenzo, A, Lumbierres, M, Madridano, O, Maestre, A, Marchena, PJ, Marcos, M, Martín del Pozo, M, Martín-Martos, F, Martínez-Prado, R, Maza, JM, Mena, E, Mercado, MI, Moisés, J, Molino, A, Monreal, M, Morales, MV, Navas, MS, Nieto, JA, Núñez-Fernández, MJ, Olid, M, Ordieres-Ortega, L, Ortiz, M, Osorio, J, Otálora, S, Otero, R, Pacheco-Gómez, N, Pagán, J, Palomeque, AC, Paredes, E, Parra-Caballero, P, Pedrajas, JM, Pérez-Ductor, C, Pérez-Pinar, M, Peris, ML, Pesce, ML, Porras, JA, Puchades, R, Rivera-Cívico, F, Rodríguez-Cobo, A, Romero-Brugera, M, Ruiz-Artacho, P, Ruiz-Giménez, N, Ruiz-Ruiz, J, Salgueiro, G, Sancho, T, Sendín, V, Sigüenza, P, Soler, S, Steinherr, A, Suárez-Fernández, S, Tirado, R, Torrents-Vilar, A, Torres, MI, Trujillo-Santos, J, Uresandi, F, Valle, R, Varona, JF, Villalobos, A, Villares, P, Ay, C, Nopp, S, Pabinger, I, Vanassche, T, Verhamme, P, Verstraete, A, Yoo, HHB, Montenegro, AC, Morales, SN, Roa, J, Hirmerova, J, Malý, R, Bertoletti, L, Bura-Riviere, A, Catella, J, Chopard, R, Couturaud, F, Espitia, O, Grange, C, Le Mao, R, Leclercq, B, Mahé, I, Morange, P, Moustafa, F, Plaisance, L, Sarlon-Bartoli, G, Suchon, P, Versini, E, Schellong, S, Brenner, B, Dally, N, Kenet, G, Tzoran, I, Sadeghipour, P, Rashidi, F, Abenante, A, Barillari, G, Basaglia, M, Bertoni, M, Bilora, F, Brandolin, B, Ciammaichella, M, Colaizzo, D, Dentali, F, Di Micco, P, Grandone, E, Imbalzano, E, Negro, F, Pesavento, R, Poz, A, Prandoni, P, Siniscalchi, C, Taflaj, B, Tufano, A, Visonà, A, Zalunardo, B, Skride, A, Kigitovica, D, Zicans, M, Fonseca, S, Marques, R, Meireles, J, Pinto, S, Bosevski, M, Trajkova, M, Zdraveska, M, Bounameaux, H, Mazzolai, L, Aujayeb, A, Caprini, JA, Weinberg, I, Bui, HM, Cohen, Omri, Waldman Radinsky, Liat, Kenet, Gili, Mahé, Isabelle, Barillari, Giovanni, Soler, Silvia, Sigüenza, Patricia, Del Valle Morales, María, Villares, Paula, and Monreal, Manuel

Published
2024
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10. Physical exercise in hypertensive heart disease: From the differential diagnosis to the complementary role of exercise

Author

Pastore, Maria Concetta, Cavigli, Luna, Olivoni, Gabriele, Morrone, Francesco, Amati, Francesca, Imbalzano, Egidio, Rinaldi, Andrea, Liga, Riccardo, Mattioli, Anna Vittoria, Scicchitano, Pietro, Curcio, Antonio, Barillà, Francesco, Ciccarelli, Michele, Maestrini, Viviana, Perrone Filardi, Pasquale, D'Ascenzi, Flavio, and Cameli, Matteo

Published
2024
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11. Clinical outcomes after discontinuing anticoagulant therapy in patients with first unprovoked venous thromboembolism

Author

Agudo, P., Aibar, J., Alberich-Conesa, A., Alda-Lozano, A., Alfonso, J., Amado, C., Angelina-García, M., Arcelus, J.I., Ballaz, A., Barba, R., Barbagelata, C., Barreiro, B., Barrón, M., Barrón-Andrés, B., Bascuñana, J., Beddar-Chaib, F., Blanco-Molina, A., Caballero, J.C., Cañas, I., Castellanos, G., Chasco, L., Claver, G., Criado, J., De Juana-Izquierdo, C., Del Toro, J., Demelo-Rodríguez, P., Díaz-Pedroche, M.C., Díaz-Peromingo, J.A., Dubois-Silva, A., Escribano, J.C., Falgá, C., Fernández-Aracil, C., Fernández-Capitán, C., Fernández-Jiménez, B., Fernández-Reyes, J.L., Fidalgo, M.A., Francisco, I., Gabara, C., Galeano-Valle, F., García-Bragado, F., García-Ortega, A., Gavín-Sebastián, O., Gil-Díaz, A., Gómez-Cuervo, C., González-Munera, A., Grau, E., Guirado, L., Gutiérrez-Guisado, J., Hernández-Blasco, L., Hernández-Molina, A., Hernández-Vidal, M.J., Jara-Palomares, L., Jiménez, D., Jou, I., Joya, M.D., Lalueza, A., Lecumberri, R., Llamas, P., Lobo, J.L., López-Brull, H., López-De la Fuente, M., López-Jiménez, L., López-Miguel, P., López-Núñez, J.J., López-Ruiz, A., López-Sáez, J.B., Lorente, M.A., Lorenzo, A., Lumbierres, M., Madridano, O., Maestre, A., Marchena, P.J., Marcos, M., Martín del Pozo, M., Martín-Martos, F., Martínez-Prado, R., Maza, J.M., Mercado, M.I., Moisés, J., Molino, A., Monreal, M., Monzón, L., Morales, M.V., Muñoz-Gamito, G., Navas, M.S., Nieto, J.A., Núñez-Fernández, M.J., Olid, M., Ordieres-Ortega, L., Ortiz, M., Osorio, J., Otálora, S., Otero, R., Pacheco-Gómez, N., Pagán, J., Palomeque, A.C., Paredes, E., Parra-Rosado, P., Pedrajas, J.M., Pérez-Ductor, C., Pérez-Pinar, M., Peris, M.L., Pesce, M.L., Porras, J.A., Puchades, R., Rivas, A., Rivera-Cívico, F., Rivera-Gallego, A., Rodríguez-Cobo, A., Romero-Bruguera, M., Ruiz-Artacho, P., Salgueiro, G., Sancho, T., Sendín, V., Sigüenza, P., Soler, S., Steinherr, A., Suárez-Fernández, S., Tirado, R., Torrents-Vilar, A., Torres, M.I., Trujillo-Santos, J., Uresandi, F., Valle, R., Varona, J.F., Villalobos, A., Villares, P., Ay, C., Nopp, S., Pabinger, I., Vanassche, T., Verhamme, P., Verstraete, A., Yoo, H.H.B., Montenegro, A.C., Morales, S.N., Roa, J., Hirmerova, J., Malý, R., Varhaník, F., Bertoletti, L., Bura-Riviere, A., Catella, J., Chopard, R., Couturaud, F., Espitia, O., Le Mao, R., Leclerq, B., Mahé, I., Moustafa, F., Plaisance, L., Sarlon-Bartoli, G., Suchon, P., Versini, E., Schellong, S., Brenner, B., Dally, N., Kenet, G., Tzoran, I., Rashidi, F., Sadeghipour, P., Tahmasbi, F., Abenante, A., Barillari, G., Bilora, F., Bissacco, D., Brandolin, B., Casana, R., Ciammaichella, M., Colaizzo, D., Dentali, F., Di Micco, P., Giorgi-Pierfranceschi, M., Grandone, E., Imbalzano, E., Lambertenghi-Deliliers, D., Martini, R., Meschi, T., Negro, F., Poz, A., Prandoni, P., Simioni, P., Siniscalchi, C., Taflaj, B., Ticinesi, A., Tufano, A., Visonà, A., Zalunardo, B., Kalnina, P., Kigitovica, D., Skride, A., Zicans, M., Nishimoto, Y., Yamashita, Y., Tazi-Mezalek, Z., Fonseca, S., Marques, R., Meireles, J., Pinto, S., Bosevski, M., Zdraveska, M., Bounameaux, H., Mazzolai, L., Aujayeb, A., Bikdeli, B., Caprini, J.A., Khalil, A., Tafur, J., Weinberg, I., Bui, H.M., Nguyen, S.T., Pham, K.Q., Tran, G.B., Gabara, Cristina, Aibar, Jesus, Nishimoto, Yuji, Yamashita, Yugo, Prandoni, Paolo, Barnes, Geoffrey D., Bikdeli, Behnood, Jiménez, David, Demelo-Rodríguez, Pablo, Peris, Ma Luisa, Nguyen, Son Truong, and Monreal, Manuel

Published
2024
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13. Telemedicine and Digital Medicine in the Clinical Management of Hypertension and Hypertension-Related Cardiovascular Diseases: A Position Paper of the Italian Society of Arterial Hypertension (SIIA)

Author

Minuz, Pietro, Albini, Fabio Lucio, Imbalzano, Egidio, Izzo, Raffaele, Masi, Stefano, Pengo, Martino F., Pucci, Giacomo, Scalise, Filippo, Salvetti, Massimo, Tocci, Giuliano, Cicero, Arrigo, Iaccarino, Guido, Savoia, Carmine, Sechi, Leonardo, Parati, Gianfranco, Borghi, Claudio, Volpe, Massimo, Ferri, Claudio, Grassi, Guido, and Muiesan, Maria Lorenza

Published
2023
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15. Effects of SGLT2-Inhibitors on Comprehensive Geriatric Assessment, Biomarkers of Oxidative Stress, and Platelet Activation in Elderly Diabetic Patients with Heart Failure with Preserved Ejection Fraction

Author

Marcello Magurno, Velia Cassano, Francesco Maruca, Carlo Alberto Pastura, Marcello Divino, Federica Fazio, Giandomenico Severini, Elvira Clausi, Giuseppe Armentaro, Sofia Miceli, Raffaele Maio, Egidio Imbalzano, Francesco Andreozzi, Marta Letizia Hribal, and Angela Sciacqua

Subjects
SGLT2i, T2DM, cognitive impairment, elderly, oxidative stress, Biology (General), QH301-705.5, Chemistry, QD1-999
Abstract

Background: Heart failure (HF) with preserved ejection fraction (HFpEF) represents a major comorbidity in the elderly and is associated with cognitive impairment (CoI) and type 2 diabetes mellitus (T2DM). In this context, there is an increase in oxidative stress and platelet activation biomarkers. The aim of this study was to evaluate the effects of 6 months’ treatment with SGLT2i on functional, mood-related, and cognitive aspects, assessed by performing a comprehensive geriatric assessment (CGA), and on oxidative stress and platelet activation biomarkers, in a cohort of HFpEF elderly patients with T2DM. We recruited 150 elderly outpatients (mean age 75.8 ± 7.4 years). Results: At six-month follow-up, there was a significant improvement in MMSE (p < 0.0001), MoCA (p < 0.0001), GDS score (p < 0.0001), and SPPB (p < 0.0001). Moreover, we observed a significant reduction in Nox-2 (p < 0.0001), 8-Isoprostane (p < 0.0001), Sp-Selectin (p < 0.0001), and Gp-VI (p < 0.0001). Considering ΔMMSE as the dependent variable, ΔE/e’, ΔNox-2, ΔHOMA, Δ8-Isoprostane, and ΔUricemia were associated for 59.6% with ΔMMSE. When ΔMoCA was considered as the dependent variable, ΔHOMA, ΔE/e’, Δ8-Isoprostane, ΔNox-2 and ΔUricemia were associated for 59.2%. Considering ΔGDS as the dependent variable, ΔHOMA, ΔNox-2, Δ8-Isoprostane, and ΔUricemia were associated with 41.6% of ΔGDS variation. Finally, ΔHOMA was the main predictor of ΔSPPB, which was associated with 21.3% with ΔSPPB, Δ8-Isoprostane, ΔNox-2, ΔE/e’, and ΔUricemia added another 24.1%. Conclusion: The use of SGLT2i in elderly patients with T2DM and HFpEF significantly contributes to improving CGA scales and biomarkers of OS and PA.

Published
2024
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16. Bacterial Porins and Their Procoagulant Role: Implication in the Pathophysiology of Several Thrombotic Complications during Sepsis

Author

Carmine Siniscalchi, Alessandro Perrella, Ugo Trama, Francesca Futura Bernardi, Egidio Imbalzano, Giuseppe Camporese, Vincenzo Russo, Olga Scudiero, Tiziana Meschi, and Pierpaolo Di Micco

Subjects
porins, thromboembolism, bacteria, sepsis, Medicine
Abstract

The association between sepsis and thrombotic complications is still not well known. Different mechanisms have been shown to be involved in the sepsis-induced prothrombotic state, but clinical scenarios may differ. In this review, we have summarized the role that bacterial products such as porins and toxins can have in the induction of the prothrombotic state during sepsis and the interaction that they can have with each other. Furthermore, the above-mentioned mechanisms might be involved in the pattern of the clinical presentation of thrombotic events during bacterial sepsis, which would secondarily explain the association between sepsis and venous thromboembolism, the association between sepsis and disseminated intravascular coagulation, and the association between sepsis and microangiopathic venous thromboembolism.

Published
2024
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17. Risk of recurrence after discontinuing anticoagulation in patients with COVID-19- associated venous thromboembolism: a prospective multicentre cohort study

Author

Adarraga, María Dolores, Conesa, Ana Alberich, Aibar, Jesús, Lozano, Alicia Alda, Alfonso, Joaquín, Carrillo, Jesús Alonso, Amado, Cristina, García, María Angelina, Arcelus, Juan Ignacio, Ballaz, Aitor, Barba, Raquel, Hernando, María Barca, Barbagelata, Cristina, Barrón, Manuel, Andrés, Belén Barrón, Chaib, Fahd Beddar, Blanco Molina, María Ángeles, Caballero, Juan Carlos, Castellanos, Gonzalo, Chasco, Leyre, Criado, Juan, de Ancos, Cristina, Toro, Jorge del, Rodríguez, Pablo Demelo, de Juana Izquierdo, Cristina, Díaz Brasero, Ana María, Díaz Peromingo, José Antonio, Silva, Álvaro Dubois, Escribano, Juan Carlos, Falgá, Concepción, Farfán Sedano, Ana Isabel, Aracil, Cleofe Fernández, Capitán, Carmen Fernández, Jiménez, Begoña Fernández, Fernández Reyes, José Luis, Fidalgo, María Ángeles, Francisco, Iria, Gabara, Cristina, Valle, Francisco Galeano, Bragado, Francisco García, Ortega, Alberto García, Sebastián, Olga Gavín, Gil de Gómez, María Allende, Díaz, Aída Gil, Cuervo, Covadonga Gómez, Munera, Adriana González, Grau, Enric, Guirado, Leticia, Gutiérrez, Javier, Blasco, Luis Hernández, Palomares, Luis Jara, Jaras, María Jesús, Jiménez, David, Jiménez, Rafael, Jou, Inés, Joya, María Dolores, Justo, Sara Lainez, Lalueza, Antonio, Lecumberri, Ramón, León Ramírez, José Manuel, Llamas, Pilar, Lobo, José Luis, Jiménez, Luciano López, Miguel, Patricia López, López Núñez, Juan José, Ruiz, Antonio López, López Sáez, Juan Bosco, Lorenzo, Alicia, Lumbierres, Marina, Madridano, Olga, Maestre, Ana, Marchena, Pablo Javier, Marcos, María, Martín del Pozo, Mar, Martos, Francisco Martín, Maza, Jorge Manuel, Mena, Elisabeth, Mercado, Maria Isabel, Moisés, Jorge, Monreal, Manuel, Morales, María del Valle, Navas, Maria Sierra, Nieto, José Antonio, Núñez Fernández, Manuel Jesús, Olid, Mónica, Ortega, Lucía Ordieres, Ortiz, María, Osorio, Jeisson, Otálora, Sonia, Otero, Remedios, Gómez, Nazaret Pacheco, Pagán, Javier, Palomeque, Andrea Catalina, Paredes, Ezequiel, Caballero, Pedro Parra, Pedrajas, José María, Ductor, Cristina Pérez, Pinar, Montserrat Pérez, Peris, María Luisa, Pesce, María Lourdes, Porras, José Antonio, Puchades, Ramón, Cívico, Francisco Rivera, Cobo, Ana Rodríguez, Rosa, Vladimir, Brugera, Marta Romero, Artacho, Pedro Ruiz, Giménez, Nuria Ruiz, Ruiz, Justo Ruiz, Salgueiro, Georgina, Sancho, Teresa, Sendín, Vanesa, Sigüenza, Patricia, Soler, Silvia, Fernández, Susana Suárez, Tirado, Raimundo, Vilar, Ana Torrents, Torres, María Isabel, Santos, Javier Trujillo, Uresandi, Fernando, Valle, Reina, Varona, José Felipe, Villalobos, Aurora, Villares, Paula, Ay, Cihan, Nopp, Stephan, Pabinger, Ingrid, Engelen, Matthias, Vanassche, Thomas, Verhamme, Peter, Bok Yoo, Hugo Hyung, Montenegro, Ana Cristina, Morales, Silvia Natalia, Roa, Jairo, Hirmerova, Jana, Malý, Radovan, Bertoletti, Laurent, Bura-Riviere, Alessandra, Catella, Judith, Chopard, Romain, Couturaud, Francis, Espitia, Olivier, Grange, Claire, Leclercq, Barbara, Le Mao, Raphael, Mahé, Isabelle, Moustafa, Farès, Plaisance, Ludovic, Bartoli, Gabrielle Sarlon, Suchon, Pierre, Versini, Edouard, Schellong, Sebastian, Brenner, Benjamin, Dally, Najib, Tzoran, Inna, Sadeghipour, Parham, Rashidi, Fahrid, Abenante, Alessia, Barillari, Giovanni, Basaglia, Manuela, Bilora, Franca, Bissacco, Daniele, Bortoluzzi, Cristiano, Brandolin, Barbara, Casana, Renato, Ciammaichella, Maurizio, Colaizzo, Donatella, Dentali, Francesco, Di Micco, Pierpaolo, Grandone, Elvira, Imbalzano, Egidio, Deliliers, Daniela Lambertenghi, Negro, Federica, Pesavento, Raffaele, Poz, Alessandra, Prandoni, Paolo, Scarinzi, Paolo, Siniscalchi, Carmine, Taflaj, Beldisa, Tufano, Antonella, Visonà, Adriana, Hong, Ngoc Vo, Zalunardo, Beniamino, Skride, Andris, Kigitovica, Dana, Fonseca, Samuel, Marques, Rafael, Meireles, José, Pinto, Sara Barbosa, Bosevsky, Marijan, Eftimova, Aleksandra, Zdraveska, Marijan, Bounameaux, Henri, Mazzolai, Lucia, Aujayeb, Avinash, Bikdeli, Behnood, Caprini, Joseph, Weinberg, Ido, Bui, Hanh My, Jara-Palomares, Luis, Muriel, Alfonso, Demelo-Rodríguez, Pablo, López-Miguel, Patricia, López-Jiménez, Luciano, and Rivera-Cívico, Francisco

Published
2024
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18. Unmet needs and barriers in venous thromboembolism education and awareness among people living with cancer: a global survey

Author

Potere, Nicola, Mahé, Isabelle, Angchaisuksiri, Pantep, Cesarman-Maus, Gabriela, Tan, Chee Wee, Rashid, Anila, AlGahtani, Farjah H., Imbalzano, Egidio, van Es, Nick, Leader, Avi, Olayemi, Edeghonghon, Porreca, Ettore, Ní Áinle, Fionnuala, Okoye, Helen C., Candeloro, Matteo, Mayeur, Didier, Valerio, Luca, Clark, R. Cary, Castellucci, Lana A., Barco, Stefano, and Di Nisio, Marcello

Published
2024
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20. Effectiveness of biosimilar pegfilgrastim in patients with multiple myeloma after high-dose melphalan and autologous stem cell transplantation

Author

Martino, Massimo, Gori, Mercedes, Porto, Gaetana, Pellicano, Maria, Santoro, Ludovica, Verduci, Chiara, Canale, Filippo Antonio, Loteta, Barbara, Moscato, Tiziana, Alati, Caterina, Ieracitano, Maria Consuelo, Cuzzocrea, Amelia, Altomonte, Maria, Florenzano, Maria Teresa, Morabito, Antonella, Irrera, Giuseppe, Naso, Virginia, Pugliese, Marta, Console, Giuseppe, Ferreri, Anna, Imbalzano, Lucrezia, Tripepi, Giovanni, and Pitino, Annalisa

Published
2023
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21. Age-Related Differences in the Presentation, Management, and Clinical Outcomes of 100,000 Patients With Venous Thromboembolism in the RIETE Registry

Author

Adarraga, M.D., Alberich-Conesa, A., Aibar, J., Alda-Lozano, A., Alfonso, J., Amado, C., Angelina-García, M., Arcelus, J.I., Ballaz, A., Barba, R., Barbagelata, C., Barrón, M., Barrón-Andrés, B., Bascuñana, J., Beddar-Chaib, F., Blanco-Molina, A., Caballero, J.C., Castellanos, G., Chasco, L., Criado, J., De Ancos, C., Del Toro, J., Demelo-Rodríguez, P., De Juana-Izquierdo, C., Díaz-Brasero, A.M., Díaz-Peromingo, J.A., Dubois-Silva, A., Escribano, J.C., Falgá, C., Farfán-Sedano, A.I., Fernández-Aracil, C., Fernández-Capitán, C., Fernández-Jiménez, B., Fernández-Reyes, J.L., Fidalgo, M.A., Francisco, I., Gabara, C., Galeano-Valle, F., García-Bragado, F., García-Ortega, A., Gavín-Sebastián, O., Gil De Gómez, M.A., Gil-Díaz, A., Gómez-Cuervo, C., González-Munera, A., Grau, E., Guirado, L., Gutiérrez, J., Hernández-Blasco, L., Jara-Palomares, L., Jaras, M.J., Jiménez, D., Jiménez, R., Jou, I., Joya, M.D., Lainez-Justo, S., Lecumberri, R., León-Ramírez, J.M., Llamas, P., Lobo, J.L., López-Jiménez, L., López-Miguel, P., López-Núñez, J.J., López-Ruiz, A., López-Sáez, J.B., Lorenzo, A., Lumbierres, M., Madridano, O., Maestre, A., Marchena, P.J., Marcos, M., Martín del Pozo, M., Martín-Martos, F., Maza, J.M., Mena, E., Mercado, M.I., Moisés, J., Monreal, M., Morales, M.V., Navas, M.S., Nieto, J.A., Núñez-Fernández, M.J., Olid, M., Ordieres-Ortega, L., Ortiz, M., Osorio, J., Otálora, S., Otero, R., Pacheco-Gómez, N., Pagán, J., Palomeque, A.C., Paredes, E., Parra-Caballero, P., Parra-Rosado, P., Pedrajas, J.M., Pérez-Ductor, C., Pérez-Pinar, M., Peris, M.L., Pesce, M.L., Porras, J.A., Puchades, R., Rivera-Cívico, F., Rodríguez-Cobo, A., Rosa, V., Romero-Brugera, M., Ruiz-Artacho, P., Ruiz-Giménez, N., Ruiz-Ruiz, J., Salgueiro, G., Sancho, T., Sendín, V., Sigüenza, P., Soler, S., Suárez-Fernández, S., Tirado, R., Torrents-Vilar, A., Torres, M.I., Trujillo-Santos, J., Uresandi, F., Valle, R., Varona, J.F., Villalobos, A., Villares, P., Ay, C., Nopp, S., Pabinger, I., Vanassche, T., Verhamme, P., Verstraete, A., Yoo, H.H.B., Montenegro, A.C., Morales, S.N., Roa, J., Hirmerova, J., Malý, R., Bertoletti, L., Bura-Riviere, A., Catella, J., Chopard, R., Couturaud, F., Espitia, O., Grange, C., Leclercq, B., Le Mao, R., Mahé, I., Moustafa, F., Plaisance, L., Sarlon-Bartoli, G., Suchon, P., Versini, E., Schellong, S., Brenner, B., Dally, N., Tzoran, I., Sadeghipour, P., Rashidi, F., Abenante, A., Barillari, G., Basaglia, M., Bilora, F., Bissacco, D., Bortoluzzi, C., Brandolin, B., Casana, R., Ciammaichella, M., Colaizzo, D., Dentali, F., Di Micco, P., Grandone, E., Imbalzano, E., Lambertenghi-Deliliers, D., Negro, F., Pesavento, R., Poz, A., Prandoni, P., Scarinzi, P., Siniscalchi, C., Taflaj, B., Tufano, A., Visonà, A., Vo Hong, N., Zalunardo, B., Paluga, R., Skride, A., Kigitovica, D., Fonseca, S., Marques, R., Meireles, J., Pinto, S., Bosevski, M., Trajkova, M., Zdraveska, M., Bounameaux, H., Mazzolai, L., Aujayeb, A., Caprini, J.A., Weinberg, I., Bui, H.M., Ortega, Alberto García, Jiménez, David, Pedro-Tudela, Ana, Pérez-Ductor, Cristina, Fernández-Capitán, Carmen, Falgá, Conxita, Skride, Andris, Siniscalchi, Carmine, Weinberg, Ido, and Monreal, Manuel

Published
2024
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22. Modeling the Ga/As binary system across temperaturesand compositions from first principles

Author

imbalzano, Giulio and Ceriotti, Michele

Subjects
Condensed Matter - Materials Science
Abstract

Materials composed of elements from the third and fifth columns of the periodic table display a very rich behavior, with the phase diagram usually containing a metallic liquid phase and a polar semiconducting solid. As a consequence, it is very hard to achieve transferable empirical models of interactions between the atoms that can reliably predict their behavior across the temperature and composition range that is relevant to the study of the synthesis and properties of III/V nanostructures and devices. We present a machine-learning potential trained on density functional theory reference data that provides a general-purpose model for the Ga$_x$As$_{1-x}$ system. We provide a series of stringent tests that showcase the accuracy of the potential, and its applicability across the whole binary phase space, computing with ab initio accuracy a large number of finite-temperature properties as well as the location of phase boundaries. We also show how a committe model can be used to reliably determine the uncertainty induced by the limitations of the ML model on its predictions, to identify regions of phase space that are predicted with insufficient accuracy, and to iteratively refine the training set to achieve consistent, reliable modeling.

Published
2021
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24. Statins during Anticoagulation for Emergency Life-Threatening Venous Thromboembolism: A Review

Author

Carmine Siniscalchi, Egidio Imbalzano, Tiziana Meschi, Andrea Ticinesi, Beatrice Prati, Manuela Basaglia, Giuseppe Camporese, Alessandro Perrella, Andreev Viorica, Elisa Eletto, Vincenzo Russo, and Paolo Simioni

Subjects
venous thromboembolism, deep vein thrombosis, pulmonary embolism, statin, blood clotting, Medicine (General), R5-920
Abstract

Venous thromboembolism (VTE) is the leading cause of morbidity and death worldwide, after cancer and cardiovascular diseases. VTE is defined to include pulmonary embolism (PE) and/or deep vein thrombosis (DVT). Approximately 25% of PE patients experience sudden death as an initial symptom of VTE, and between 10% and 30% of patients die within the first month after diagnosis. Currently, the only drugs approved for the treatment of both acute and chronic VTE are vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs). However, their effectiveness is limited due to their associated risk of bleeding. Ideally, therapy should be able to treat VTE and limit the risk of VTE recurrence without increasing the risk of bleeding. Several studies have shown that the use of statins during anticoagulation for VTE reduces the risk of death and VTE recurrence. However, to date, there are conflicting data on the impact of statins during anticoagulation for VTE. A biological protective function of statins during anticoagulation has also been reported. Statins affect D-dimer levels; tissue factor (TF) gene expression; and VIII, VII, and Von Willebrand clotting factors—the major clotting factors they are able to affect. However, the usefulness of statins for the treatment and prevention of VTE is currently under debate, and they should not be substituted for guideline-recommended VTE prophylaxis or anticoagulation treatment. In this review of the literature, we illustrate the advances on this topic, including data on the role of statins in primary VTE prevention and secondary VTE prevention, related biological mechanisms, the risk of bleeding during their use, and their ability to reduce the risk of death.

Published
2024
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25. Effects of Heart Failure Therapies on Atrial Fibrillation: Biological and Clinical Perspectives

Author

Alfredo Mauriello, Antonia Ascrizzi, Anna Selvaggia Roma, Riccardo Molinari, Alfredo Caturano, Egidio Imbalzano, Antonello D’Andrea, and Vincenzo Russo

Subjects
atrial fibrillation, heart failure, empagliflozin, dapagliflozin, vericiguat, sacubitril/valsartan, Therapeutics. Pharmacology, RM1-950
Abstract

Heart failure (HF) and atrial fibrillation (AF) are prevalent cardiovascular diseases that contribute significantly to morbidity, mortality, hospitalisation, and healthcare costs. It is not uncommon for these conditions to coexist and have mutually reinforcing effects. A critical factor in the aetiology of these conditions is oxidative stress, driven by reactive oxygen species (ROS), which contributes to atrial remodelling and fibrosis. The recent introduction of new drugs for the treatment of heart failure has also had an impact on the management of atrial fibrillation due to their influence on oxidative stress. The objective of this review is to analyse the effects of these therapies, including their role in mitigating ROS, on the prevention and treatment of AF in HF patients.

Published
2024
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26. Hypertriglyceridemia: Molecular and Genetic Landscapes

Author

Pietro Scicchitano, Francesca Amati, Marco Matteo Ciccone, Flavio D’Ascenzi, Egidio Imbalzano, Riccardo Liga, Stefania Paolillo, Maria Concetta Pastore, Andrea Rinaldi, Anna Vittoria Mattioli, and Matteo Cameli

Subjects
molecular mechanisms, genetics, physiopathology, triglycerides, cardiovascular diseases, Biology (General), QH301-705.5, Chemistry, QD1-999
Abstract

Lipid disorders represent one of the most worrisome cardiovascular risk factors. The focus on the impact of lipids on cardiac and vascular health usually concerns low-density lipoprotein cholesterol, while the role of triglycerides (TGs) is given poor attention. The literature provides data on the impact of higher plasma concentrations in TGs on the cardiovascular system and, therefore, on the outcomes and comorbidities of patients. The risk for coronary heart diseases varies from 57 to 76% in patients with hypertriglyceridemia. Specifically, the higher the plasma concentrations in TGs, the higher the incidence and prevalence of death, myocardial infarction, and stroke. Nevertheless, the metabolism of TGs and the exact physiopathologic mechanisms which try to explain the relationship between TGs and cardiovascular outcomes are not completely understood. The aims of this narrative review were as follows: to provide a comprehensive evaluation of the metabolism of triglycerides and a possible suggestion for understanding the targets for counteracting hypertriglyceridemia; to describe the inner physiopathological background for the relationship between vascular and cardiac damages derived from higher plasma concentrations in TGs; and to outline the need for promoting further insights in therapies for reducing TGs plasma levels.

Published
2024
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27. Effects of a Dietary Supplement Composed of Baicalin, Bromelain and Escin for Venous Chronic Insufficiency Treatment: Insights from a Retrospective Observational Study

Author

Selene Francesca Anna Drago, Michelangelo Rottura, Antonino Molonia, Viviana Maria Gianguzzo, Giovanni Pallio, Natasha Irrera, Luana Orlando, Marianna Gigliotti De Fazio, Marilena Isgrò, Natalia Zirilli, Vincenzo Arcoraci, and Egidio Imbalzano

Subjects
chronic venous insufficiency, dietary supplement, baicalin, bromelain, escin, graduated compression stockings, Medicine, Pharmacy and materia medica, RS1-441
Abstract

Chronic venous insufficiency (CVI) represents a risk factor for cardiovascular events. The first-line treatment includes the use of compression stockings and lifestyle changes. Natural products, such as flavonoids, could be used to improve the effects of compression therapy due to their anti-inflammatory and anti-oxidant properties. This study aims to evaluate the effects of a dietary supplement containing baicalin, bromeline and escin in CVI patients. A retrospective cohort study was performed by using the medical records of CVI affected outpatients. Patients treated with the dietary supplement were defined as “users”. A modified Venous Clinical Severity Score (VCSS) was calculated, including pain, inflammation, vessels induration and skin pigmentation. All clinical variables were evaluated at baseline (T0), after 30 (T1) and 90(T2) days in “users” and “non-users”. Out of 62 patients, 30 (48.4%) were “users”. No difference was observed between groups at baseline. A lower VCSS value was recorded in “users” than that observed in “non-users” at T2 (7.0 (4.0–9.0) vs. 9.0 (5.0–10.0); p = 0.025). Vessels’ induration and pain significantly reduced in 53.3% and 43.3% of “users” and in 18.8% and 9.4% of “non-users”. Only “users” (33.3%) showed a reduction of the inflammatory signs as well as a decrease in malleolar circumference, from 29.0 (26.5–30.0) to 27.5 (26.0–28.5) (p < 000.1). A reduction of C-reactive Protein levels was found in “users” compared to “non-users” at T2 (1.0 (0.9–1.2) vs. 1.3 (1.0–1.5); p = 0.006). These findings suggest that implementation of a dietary supplement could improve the clinical outcomes of CVI patients.

Published
2024
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28. Botulinum Toxin for Axial Postural Abnormalities in Parkinson’s Disease: A Systematic Review

Author

Marialuisa Gandolfi, Carlo Alberto Artusi, Gabriele Imbalzano, Serena Camozzi, Mauro Crestani, Leonardo Lopiano, Michele Tinazzi, and Christian Geroin

Subjects
axial postural abnormality, Parkinson’s disease, botulinum toxin, physiotherapy, disability, pain, Medicine
Abstract

Axial postural abnormalities (APAs), characterized by their frequency, disabling nature, and resistance to pharmacological treatments, significantly impact Parkinson’s disease and atypical Parkinsonism patients. Despite advancements in diagnosing, assessing, and understanding their pathophysiology, managing these complications remains a significant challenge. Often underestimated by healthcare professionals, these disturbances can exacerbate disability. This systematic review assesses botulinum toxin treatments’ effectiveness, alone and with rehabilitation, in addressing APAs in Parkinson’s disease, utilizing MEDLINE (PubMed), Web of Science, and SCOPUS databases for source material. Of the 1087 records retrieved, 16 met the selection criteria. Most research has focused on botulinum toxin (BoNT) as the primary treatment for camptocormia and Pisa syndrome, utilizing mostly observational methods. Despite dose and injection site variations, a common strategy was using electromyography-guided injections, occasionally enhanced with ultrasound. Patients with Pisa syndrome notably saw consistent improvements in APAs and pain. However, studies on the combined effects of botulinum toxin and rehabilitation are limited, and antecollis is significantly under-researched. These findings recommend precise BoNT injections into hyperactive muscles in well-selected patients by skilled clinicians, avoiding compensatory muscles, and underscore the necessity of early rehabilitation. Rehabilitation is crucial in a multidisciplinary approach to managing APAs, highlighting the importance of a multidisciplinary team of experts.

Published
2024
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29. Uncertainty estimation for molecular dynamics and sampling

Author

Imbalzano, Giulio, Zhuang, Yongbin, Kapil, Venkat, Rossi, Kevin, Engel, Edgar A., Grasselli, Federico, and Ceriotti, Michele

Subjects
Physics - Chemical Physics, Computer Science - Machine Learning, Physics - Computational Physics
Abstract

Machine learning models have emerged as a very effective strategy to sidestep time-consuming electronic-structure calculations, enabling accurate simulations of greater size, time scale and complexity. Given the interpolative nature of these models, the reliability of predictions depends on the position in phase space, and it is crucial to obtain an estimate of the error that derives from the finite number of reference structures included during the training of the model. When using a machine-learning potential to sample a finite-temperature ensemble, the uncertainty on individual configurations translates into an error on thermodynamic averages, and provides an indication for the loss of accuracy when the simulation enters a previously unexplored region. Here we discuss how uncertainty quantification can be used, together with a baseline energy model, or a more robust although less accurate interatomic potential, to obtain more resilient simulations and to support active-learning strategies. Furthermore, we introduce an on-the-fly reweighing scheme that makes it possible to estimate the uncertainty in the thermodynamic averages extracted from long trajectories. We present examples covering different types of structural and thermodynamic properties, and systems as diverse as water and liquid gallium., Comment: 17 pages, 9 figures

Published
2020
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32. Metabolic and vascular effect of a new standardized bergamot phytocomplex: a three-arm, placebo controlled, double-blind clinical trial

Author

Federica Fogacci, Marina Giovannini, Edigio Imbalzano, Elisa Grandi, Elisabetta Rizzoli, Sergio D'Addato, and Arrigo F.G. Cicero

Subjects
bergamot, metabolic syndrome, randomized clinical trial, tg/hdl index, c reactive protein, Medicine
Abstract

Introduction In addition to healthy lifestyle and balanced diet, nutraceutical supplementation may be useful to maintain overall metabolic wellness. The aim of the present study was to assess the metabolic and vascular effects of a new, highly standardized bergamot phytocomplex supplement in healthy volunteers with the features of metabolic syndrome. Material and methods We carried out a double-blind, randomized, placebo-controlled, three-arm, parallel-group clinical trial in 90 adult subjects (30 per group) treated for 12 weeks with two different dosages of a highly standardized bergamot phytocomplex (Endoberg by AKHYNEX and Kalita by Giellepi) or placebo. Lipid plasma levels, glycemia, plasma hs-CRP, HOMA-IR, body fat, endothelial reactivity and fatty liver index were assessed at baseline, after 6 weeks and at the end of treatment in all subjects. Results At the end of treatment, both tested bergamot extract doses were able to significantly improve atherogenic dyslipidemia and insulin sensitivity (p < 0.05) compared to placebo. In the high-dose treated group, total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), non high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG) improved versus placebo (p < 0.05) just after 6 weeks of treatment. After 12 weeks of treatment, TC decreased by 13.2 ±2.1%, LDL-C by 17.7 ±3.2%, non-HDL-C by 17.5 ±3.1%, TG by 16.6 ±3.3%, TG/HDL-C by 22.5 ±4.4%, homeostasis insulin resistance index (HOMA-IR) by 12.2 ±2.1%, -glutamyl transferase (GGT) by 22.2 ±4.6%, and high-sensitivity C-reactive protein (hs-CRP) by 17.9 ±3.4% versus baseline (p < 0.05) and vs. placebo (p < 0.05). Percentage body fat and endothelial reactivity improved versus baseline, but not versus placebo, in the high-dose treatment only (p < 0.05). Conclusions The tested bergamot phytocomplex was able to significantly improve glucose and lipid metabolism, as well as inflammation, and might represent a novel multi-target approach to control metabolic syndrome.

Published
2023
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33. Treatment of axial postural abnormalities in parkinsonism disorders: A systematic review of pharmacological, rehabilitative and surgical interventions

Author

Marialuisa Gandolfi, Christian Geroin, Gabriele Imbalzano, Serena Camozzi, Zoe Menaspà, Michele Tinazzi, and Carlo Alberto Artusi

Subjects
Axial Postural Abnormalities, Parkinson disease, Drug, Deep brain stimulation, Rehabilitation, Disability, Neurology. Diseases of the nervous system, RC346-429
Abstract

Axial postural abnormalities (PA) are frequent, highly disabling, and drug-refractory motor complications affecting patients with Parkinson’s disease (PD) or atypical parkinsonism. Over the past few years, advances have been reached across diagnosis, assessment, and pathophysiological mechanisms of PA. Nonetheless, their management remains a challenge, and these disturbances are generally overlooked by healthcare professionals, potentially resulting in their worsening and impact on patients’ disabilities. From shared consensus-based assessment and diagnostic criteria, PA calls for interdisciplinary management based on the complexity and multifactorial pathogenesis. In this context, we conducted a systematic literature review to analyze the available pharmacological and non-pharmacological treatment options for PA in PD according to the new expert-based classification of axial PA in Parkinsonism. Different multidisciplinary approaches, including dopaminergic therapy adjustment, physiotherapy, botulinum toxin injection, and deep brain stimulation, can improve PA depending on its type and severity. An early, interdisciplinary approach is recommended in PD patients to manage PA.

Published
2024
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34. The role of feature space in atomistic learning

Author

Goscinski, Alexander, Fraux, Guillaume, Imbalzano, Giulio, and Ceriotti, Michele

Subjects
Physics - Computational Physics, Condensed Matter - Materials Science, Statistics - Machine Learning
Abstract

Eficient, physically-inspired descriptors of the structure and composition of molecules and materials play a key role in the application of machine-learning techniques to atomistic simulations. The proliferation of approaches, as well as the fact that each choice of features can lead to very different behavior depending on how they are used, e.g. by introducing non-linear kernels and non-Euclidean metrics to manipulate them, makes it difficult to objectively compare different methods, and to address fundamental questions on how one feature space is related to another. In this work we introduce a framework to compare different sets of descriptors, and different ways of transforming them by means of metrics and kernels, in terms of the structure of the feature space that they induce. We define diagnostic tools to determine whether alternative feature spaces contain equivalent amounts of information, and whether the common information is substantially distorted when going from one feature space to another. We compare, in particular, representations that are built in terms of n-body correlations of the atom density, quantitatively assessing the information loss associated with the use of low-order features. We also investigate the impact of different choices of basis functions and hyperparameters of the widely used SOAP and Behler-Parrinello features, and investigate how the use of non-linear kernels, and of a Wasserstein-type metric, change the structure of the feature space in comparison to a simpler linear feature space.

Published
2020

35. Increasingly transformed MCF-10A cells have a progressively tumor-like phenotype in three-dimensional basement membrane culture

Author

Imbalzano Anthony N, Tatarkova Iva, Imbalzano Karen M, and Nickerson Jeffrey A

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282, Cytology, QH573-671
Abstract

Abstract Background MCF-10A cells are near diploid and normal human mammary epithelial cells. In three-dimensional reconstituted basement membrane culture, they undergo a well-defined program of proliferation, differentiation, and growth arrest, forming acinar structures that recapitulate many aspects of mammary architecture in vivo. The pre-malignant MCF-10AT cells and malignant MCF-10CA1a lines were sequentially derived from the MCF-10A parental cell line first by expression of a constitutively active T24 H-Ras generating the MCF-10AT cell line. This was followed by repeated selection for increasingly aggressive tumor formation from cells recovered from xenograft tumors in immuno-compromised mice, generating the MCF-10CA1a cell line. When inoculated subcutaneously into the flanks of immuno-compromised mice, MCF-10AT cells occasionally form tumors, whereas MCF-10CA1a cells invariably form tumors with a shorter latency than MCF-10AT derived tumors. Results MCF-10AT cells grown in three-dimensional basement membrane culture form complex multi-acinar structures that produce a basement membrane but undergo delayed cell cycle arrest and have incomplete luminal development. MCF-10CA1a cells grown in three-dimensional basement membrane culture form large, hyper-proliferative masses, that retain few characteristics of MCF10A acini and more closely resemble tumors. Conclusion Here we report on the growth and differentiation properties of these three matched cell lines in three-dimensional basement membrane culture. Features of tissue morphogenesis were assessed, including proliferation, basement membrane formation, polarization of alpha-6 beta-4 integrin to the basement membrane, formation of cell:cell junctions, and apoptosis for luminal clearance. The matched series of normal MCF-10A, pre-malignant MCF-10AT, and malignant MCF-10CA1a cells offers a unique opportunity to study the mechanisms of malignant progression both in a three-dimensional microenvironment and in the same cell background.

Published
2009
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36. A prognostic score to identify women at increased risk for abnormal uterine bleeding during anticoagulation for venous thromboembolism

Author

Gabrielle Sarlon-Bartoli, Juan Criado, Saskia Middeldorp, José Antonio Nieto, María del Carmen Díaz-Pedroche, Farès Moustafa, Nuria Ruiz-Giménez, Benjamin Brenner, Manuel Monreal, Pierpaolo DI Micco, Paolo Prandoni, Dominique Farge-Bancel, Raquel Barba, Pierpaolo Di Micco, Laurent Bertoletti, Sebastian Schellong, Inna Tzoran, Abilio Reis, Marijan Bosevski, Henri Bounameaux, Radovan Malý, Peter Verhamme, Joseph A. Caprini, Hanh My Bui, M.D. Adarraga, P. Agudo, C. Amado, J.I. Arcelus, A. Ballaz, J. Bascuñana, R. Barba, C. Barbagelata, M. Barrón, B. Barrón-Andrés, A. Blanco-Molina, F. Beddar Chaib, E. Botella, I. Cañas, R. Carrero-Arribas, I. Casado, P. Cerdá, L. Chasco, J. Criado, C. de Ancos, J. de Miguel, J. del Toro, P. Demelo-Rodríguez, A.M. Díaz-Brasero, M.C. Díaz-Pedroche, J.A. Díaz-Peromingo, I.M. Domínguez, A. Dubois-Silva, J.C. Escribano, F. Espósito, A.I. Farfán-Sedano, C. Falgá, C. Fernández-Capitán, B. Fernández-Jiménez, J. Fernández-Muixi, J.L. Fernández-Reyes, C. Font, I. Francisco, F. Galeano-Valle, M.A. García, F. García-Bragado, M. García de Herreros, O. Gavín-Blanco, A. Gil-Díaz, C. Gómez-Cuervo, A.M. Gómez-Mosquera, M. Gonzalez-Moreno, E. Grau, L. Guirado, J. Gutiérrez, L. Hernández-Blasco, L. Jara-Palomares, M.J. Jaras, D. Jiménez, I. Jou, M.D. Joya, B. Lacruz, S. Lainez-Justo, Latorre A, Lima J, Lobo Jl, M. López-De la Fuente, L. López-Jiménez, M. López-Meseguer, P. López-Miguel, J.J. López-Núñez, R. López-Reyes, J.B. López-Sáez, M.A. Lorente, A. Lorenzo, O. Madridano, A. Maestre, P.J. Marchena, J.M. Martín-Guerra, F. Martín-Martos, M. Mellado, E. Mena, J. Moisés, M.I. Mercado, M. Monreal, A. Muñoz-Blanco, G. Muñoz-Gamito, M.V. Morales, J.A. Nieto, E. Noguera-Gras, M.J. Núñez-Fernández, M. Olid-Velilla, J. Osorio, S. Otalora, R. Otero, D. Paredes-Ruiz, P. Parra, V. Parra, J.M. Pedrajas, M. Pérez-López, M.L. Peris, M.L. Pesce, J.A. Porras, J. Poyo-Molina, R. Puchades, A. Riera-Mestre, F. Rivera-Civico, A. Rivera-Gallego, M. Roca, V. Rosa, A. Rodríguez-Cobo, C. Rodríguez-Matute, P. Ruiz-Artacho, N. Ruiz-Giménez, J. Ruiz-Ruiz, G. Salgueiro, T. Sancho, V. Sendín, P. Sigüenza, S. Soler, B. Suárez-Rodríguez, J.M. Suriñach, G. Tiberio, M.I. Torres, A. Torres-Sánchez, J. Trujillo-Santos, F. Uresandi, E. Usandizaga, R. Valle, J.F. Varona, L. Vela, J.R. Vela, A. Villalobos, P. Villares, C. Ay, S. Nopp, I. Pabinger, M.M. Engelen, C. Martens, P. Verhamme, H.H.B. Yoo, J.D. Arguello, A.C. Montenegro, J. Roa, J. Hirmerova, R. Malý, S. Accassat, L. Bertoletti, A. Bura-Riviere, J. Catella, R. Chopard, F. Couturaud, O. Espitia, S. El Harake, R. Le Mao, I. Mahé, F. Moustafa, L. Plaisance, G. Sarlon-Bartoli, P. Suchon, E. Versini, S. Schellong, A. Braester, B. Brenner, G. Kenet, I. Tzoran, P. Sadeghipour, M. Basaglia, F. Bilora, C. Bortoluzzi, B. Brandolin, M. Ciammaichella, A. De Angelis, F. Dentali, P. Di Micco, E. Imbalzano, S. Merla, R. Pesavento, P. Prandoni, C. Siniscalchi, A. Tufano, A. Visonà, N. Vo Hong, B. Zalunardo, D. Kigitovica, E. Rusa, A. Skride, S. Fonseca, M. Manuel, J. Meireles, M. Bosevski, A. Eftimova, M. Zdraveska, H. Bounameaux, L. Mazzolai, A. Aujayeb, J.A. Caprini, I. Weinberg, and H.M. Bui

Subjects
Anticoagulants, Venous thromboembolism, Uterine bleeding, Prognostic score, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Introduction: Little is known about the clinical characteristics of women at increased risk for abnormal uterine bleeding (UB) during anticoagulation for venous thromboembolism (VTE). Methods: We used the RIETE registry to identify the baseline characteristics of women developing abnormal UB during anticoagulation. We used logistic regression analysis to identify independent predictors for abnormal UB. Then, we built a prognostic score to identify at-risk women. Results: From March 2001 through October 2022, there were 54,372 women with VTE. During anticoagulation (median, 181 days), 318 (0.6%) developed abnormal UB (major bleeding = 88, clinically relevant non-major (CRNM) = 230). On multivariable analysis, women aged 70 kg, with uterine cancer, recent UB, anemia, estrogen-related VTE, or receiving rivaroxaban or apixaban were at increased risk for abnormal UB. Using the prognostic score, 42,273 women (78%) were at low-risk, 8,828 (16%) intermediate-, and 3,271 (6.1%) at high-risk for abnormal UB. Their rates of abnormal UB were: 0.28 (95%CI: 0.23–0.35), 1.32 (95%CI: 1.07–1.61) and 7.12 (95%CI: 5.98–8.41) bleeds per 100 patient-years, respectively. The c-statistic was 0.80 (95%CI: 0.77–0.83). The rates of major UB were: 0.06 (95%CI: 0.04–0.09), 0.43 (95%CI: 0.30–0.60) and 1.85 (95%CI: 1.31–2.53) per 100 patient-years, respectively (c-statistic: 0.84; 95%CI: 0.80–0.89). The rates of CRNM uterine bleeding were: 0.21 (95%CI: 0.17–0.26), 0.85 (95%CI: 0.65–1.08), and 5.02 (95%CI: 4.09–6.10) bleeds per 100 patient-years, respectively (c-statistic: 0.78; 95%CI: 0.75–0.82). Conclusions: Using 7 variables easily available at admission, we built a prognostic score that reliably identified women with VTE at increased risk for abnormal UB during anticoagulation.

Published
2023
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37. A prognostic score to identify women at increased risk for abnormal uterine bleeding during anticoagulation for venous thromboembolism

Author

Monreal, Manuel, Prandoni, Paolo, Brenner, Benjamin, Farge-Bancel, Dominique, Barba, Raquel, Di Micco, Pierpaolo, Bertoletti, Laurent, Schellong, Sebastian, Tzoran, Inna, Reis, Abilio, Bosevski, Marijan, Bounameaux, Henri, Malý, Radovan, Verhamme, Peter, Caprini, Joseph A., Bui, Hanh My, Adarraga, M.D., Agudo, P., Amado, C., Arcelus, J.I., Ballaz, A., Bascuñana, J., Barba, R., Barbagelata, C., Barrón, M., Barrón-Andrés, B., Blanco-Molina, A., Beddar Chaib, F., Botella, E., Cañas, I., Carrero-Arribas, R., Casado, I., Cerdá, P., Chasco, L., Criado, J., de Ancos, C., de Miguel, J., del Toro, J., Demelo-Rodríguez, P., Díaz-Brasero, A.M., Díaz-Pedroche, M.C., Díaz-Peromingo, J.A., Domínguez, I.M., Dubois-Silva, A., Escribano, J.C., Espósito, F., Farfán-Sedano, A.I., Falgá, C., Fernández-Capitán, C., Fernández-Jiménez, B., Fernández-Muixi, J., Fernández-Reyes, J.L., Font, C., Francisco, I., Galeano-Valle, F., García, M.A., García-Bragado, F., García de Herreros, M., Gavín-Blanco, O., Gil-Díaz, A., Gómez-Cuervo, C., Gómez-Mosquera, A.M., Gonzalez-Moreno, M., Grau, E., Guirado, L., Gutiérrez, J., Hernández-Blasco, L., Jara-Palomares, L., Jaras, M.J., Jiménez, D., Jou, I., Joya, M.D., Lacruz, B., Lainez-Justo, S., A, Latorre, J, Lima, Jl, Lobo, López-De la Fuente, M., López-Jiménez, L., López-Meseguer, M., López-Miguel, P., López-Núñez, J.J., López-Reyes, R., López-Sáez, J.B., Lorente, M.A., Lorenzo, A., Madridano, O., Maestre, A., Marchena, P.J., Martín-Guerra, J.M., Martín-Martos, F., Mellado, M., Mena, E., Moisés, J., Mercado, M.I., Monreal, M., Muñoz-Blanco, A., Muñoz-Gamito, G., Morales, M.V., Nieto, J.A., Noguera-Gras, E., Núñez-Fernández, M.J., Olid-Velilla, M., Osorio, J., Otalora, S., Otero, R., Paredes-Ruiz, D., Parra, P., Parra, V., Pedrajas, J.M., Pérez-López, M., Peris, M.L., Pesce, M.L., Porras, J.A., Poyo-Molina, J., Puchades, R., Riera-Mestre, A., Rivera-Civico, F., Rivera-Gallego, A., Roca, M., Rosa, V., Rodríguez-Cobo, A., Rodríguez-Matute, C., Ruiz-Artacho, P., Ruiz-Giménez, N., Ruiz-Ruiz, J., Salgueiro, G., Sancho, T., Sendín, V., Sigüenza, P., Soler, S., Suárez-Rodríguez, B., Suriñach, J.M., Tiberio, G., Torres, M.I., Torres-Sánchez, A., Trujillo-Santos, J., Uresandi, F., Usandizaga, E., Valle, R., Varona, J.F., Vela, L., Vela, J.R., Villalobos, A., Villares, P., Ay, C., Nopp, S., Pabinger, I., Engelen, M.M., Martens, C., Verhamme, P., Yoo, H.H.B., Arguello, J.D., Montenegro, A.C., Roa, J., Hirmerova, J., Malý, R., Accassat, S., Bertoletti, L., Bura-Riviere, A., Catella, J., Chopard, R., Couturaud, F., Espitia, O., El Harake, S., Le Mao, R., Mahé, I., Moustafa, F., Plaisance, L., Sarlon-Bartoli, G., Suchon, P., Versini, E., Schellong, S., Braester, A., Brenner, B., Kenet, G., Tzoran, I., Sadeghipour, P., Basaglia, M., Bilora, F., Bortoluzzi, C., Brandolin, B., Ciammaichella, M., De Angelis, A., Dentali, F., Di Micco, P., Imbalzano, E., Merla, S., Pesavento, R., Prandoni, P., Siniscalchi, C., Tufano, A., Visonà, A., Vo Hong, N., Zalunardo, B., Kigitovica, D., Rusa, E., Skride, A., Fonseca, S., Manuel, M., Meireles, J., Bosevski, M., Eftimova, A., Zdraveska, M., Bounameaux, H., Mazzolai, L., Aujayeb, A., Caprini, J.A., Weinberg, I., Bui, H.M., Sarlon-Bartoli, Gabrielle, Criado, Juan, Middeldorp, Saskia, Nieto, José Antonio, Díaz-Pedroche, María del Carmen, Moustafa, Farès, Ruiz-Giménez, Nuria, and DI Micco, Pierpaolo

Published
2023
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38. COVID-19–associated venous thromboembolism: risk of recurrence and major bleeding

Author

Adarraga, M.D., Alberich-Conesa, A., Amado, C., Amorós, S., Arcelus, J.I., Ballaz, A., Barba, R., Barbagelata, C., Barrón, M., Barrón-Andrés, B., Blanco-Molina, A., Botella, E., Carrero, R., Casado, I., Criado, J., del Toro, J., De Ancos, C., De Juana-Izquierdo, C., Demelo-Rodríguez, P., Díaz-Brasero, A.M., Díaz-Pedroche, M.C., Díaz-Peromingo, J.A., Dubois-Silva, A., Escribano, J.C., Espósito, F., Falgá, C., Farfán-Sedano, A.I., Fernández-Capitán, C., Fernández-Jiménez, B., Fernández-Muixi, J., Fernández-Reyes, J.L., Font, C., Francisco, I., Galeano-Valle, F., García, M.A., García de Herreros, M., García-Bragado, F., García-Ortega, A., Gavín-Sebastián, O., Gil-Díaz, A., Gil-Hernández, A., Gómez-Cuervo, C., Gómez-Mosquera, A.M., González-Martínez, J., Grau, E., Guirado, L., Gutiérrez, J., Hernández-Blasco, L., Jara-Palomares, L., Jaras, M.J., Jiménez, D., Jou, I., Joya, M.D., Lacruz, B., Lalueza, A., Lainez-Justo, S., Lecumberri, R., León-Ramírez, J.M., Lobo, J.L., López-De la Fuente, M., López-Jiménez, L., López-Miguel, P., López-Núñez, J.J., López-Reyes, R., López-Ruiz, A., López-Sáez, J.B., Lorente, M.A., Lorenzo, A., Lumbierres, M., Madridano, O., Maestre, A., Mas-Maresma, L., Marcos, M., Martín-Guerra, J.M., Martín-Martos, F., Mellado, M., Mena, E., Mercado, M.I., Moisés, J., Monreal, M., Muñoz-Blanco, A., Muñoz-Gamito, G., Nieto, J.A., Núñez-Fernández, M.J., Osorio, J., Otalora, S., Pacheco-Gómez, N., Paredes-Ruiz, D., Parra, P., Pedrajas, J.M., Pérez-Ductor, C., Pérez-Jacoiste, A., Pérez-Pérez, J.L., Peris, M.L., Pesce, M.L., Porras, J.A., Poyo-Molina, J., Puchades, R., Riera-Mestre, A., Rivera-Civico, F., Rivera-Gallego, A., Roca, M., Rubio, C.M., Rosa, V., Rodríguez-Cobo, A., Ruiz-Giménez, N., Ruiz-Ruiz, J., Salgueiro, G., Sancho, T., Sendín, V., Sigüenza, P., Soler, S., Suriñach, J.M., Tiberio, G., Tolosa, C., Torres, M.I., Trujillo-Santos, J., Uresandi, F., Usandizaga, E., Valle, R., Varona, J.F., Vela, J.R., Vela, L., Vidal, G., Villalobos, A., Villares, P., Ay, C., Nopp, S., Pabinger, I., Engelen, M., Martens, C., Verhamme, P., Yoo, H.H.B., Arguello, J.D., Montenegro, A.C., Roa, J., Hirmerova, J., Malý, R., Accassat, S., Bertoletti, L., Bura-Riviere, A., Catella, J., Chopard, R., Couturaud, F., Espitia, O., Grange, C., Leclercq, B., Le Mao, R., Mahé, I., Moustafa, F., Plaisance, L., Poenou, G., Sarlon-Bartoli, G., Suchon, P., Versini, E., Schellong, S., Braester, A., Brenner, B., Kenet, G., Najib, D., Tzoran, I., Farrashi, M., Sadeghipour, P., Basaglia, M., Bilora, F., Bortoluzzi, C., Brandolin, B., Ciammaichella, M., Colaizzo, D., Dentali, F., Di Micco, P., Grandone, E., Imbalzano, E., Merla, S., Pesavento, R., Prandoni, P., Scarinzi, P., Siniscalchi, C., Taflaj, B., Tufano, A., Visonà, A., Vo Hong, N., Zalunardo, B., Fonseca, S., Manuel, M., Meireles, J., Bosevski, M., Eftimova, A., Zdraveska, M., Bounameaux, H., Mazzolai, L., Aujayeb, A., Caprini, J.A., Weinberg, I., Bui, H.M., Demelo-Rodriguez, Pablo, Alonso-Beato, Rubén, Jara-Palomares, Luis, Galeano-Valle, Francisco, Bura-Riviere, Alessandra, Visonà, Adriana, Francisco, Iria, Vidal, Gemma, López-Ruiz, Antonio, and Monreal, Manuel

Published
2023
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39. Venous thromboembolism characteristics, treatment and outcomes in young adults: findings from the Registro Informatizado de Enfermedad TromboEmbólica registry

Author

Monreal, Manuel, Prandoni, Paolo, Brenner, Benjamin, Farge-Bancel, Dominique, Barba, Raquel, Di Micco, Pierpaolo, Bertoletti, Laurent, Schellong, Sebastian, Tzoran, Inna, Reis, Abilio, Bosevski, Marijan, Bounameaux, Henri, Malý, Radovan, Verhamme, Peter, Caprini, Joseph A., Bui, Hanh My, Adarraga, M.D., Alberich-Conesa, A., Alonso-Carrillo, J., Amado, C., Amorós, S., Arcelus, J.I., Ballaz, A., Barba, R., Barbagelata, C., Barrón, M., Barrón-Andrés, B., Blanco-Molina, A., Botella, E., Casado, I., Chasco, L., Cerdà, P., Criado, J., del Toro, J., De Juana-Izquierdo, C., Demelo-Rodríguez, P., Díaz-Brasero, A.M., Díaz-Pedroche, M.C., Díaz-Peromingo, J.A., Dubois-Silva, A., Escribano, J.C., Espósito, F., Falgá, C., Fernández-Capitán, C., Fernández-Jiménez, B., Fernández-Muixi, J., Fernández-Reyes, J.L., Fidalgo, M.A., Font, C., Francisco, I., Galeano-Valle, F., García, M.A., García de Herreros, M., García-Bragado, F., García-Ortega, A., Gavín-Sebastián, O., Gil-Díaz, A., Gómez-Cuervo, C., Gómez-Mosquera, A.M., González-Martínez, J., González-Moreno, M., Grau, E., Guirado, L., Gutiérrez, J., Hernández-Blasco, L., Jaras, M.J., Jiménez, D., Jou, I., Joya, M.D., Lacruz, B., Lainez-Justo, S., Lalueza, A., Latorre, A., Lecumberri, R., Lobo, J.L., López-De la Fuente, M., López-Jiménez, L., López-Miguel, P., López-Núñez, J.J., López-Ruiz, A., López-Sáez, J.B., Lorenzo, A., Lumbierres, M., Madridano, O., Maestre, A., Marcos, M., Martín-Martos, F., Mellado, M., Mena, E., Mercado, M.I., Moisés, J., Monreal, M., Muñoz-Blanco, A., Muñoz-Gamito, G., Morales, M.V., Nieto, J.A., Noguera-Gras, E., Núñez-Fernández, M.J., Osorio, J., Otalora, S., Pacheco-Gómez, N., Paredes-Ruiz, D., Parra, P., Pedrajas, J.M., Pérez-Ductor, C., Pérez-Jacoiste, M.A., Pérez-Pérez, J.L., Peris, M.L., Porras, J.A., Poyo-Molina, J., Puchades, R., Riera-Mestre, A., Rivera-Civico, F., Rivera-Gallego, A., Roca, M., Rosa, V., Rodríguez-Cobo, A., Ruiz-Giménez, N., Salgueiro, G., Sancho, T., Sendín, V., Sigüenza, P., Soler, S., Suriñach, J.M., Tiberio, G., Torres, M.I., Trujillo-Santos, J., Uresandi, F., Usandizaga, E., Valle, R., Varona, J.F., Vela, L., Vela, J.R., Villalobos, A., Villares, P., Ay, C., Nopp, S., Pabinger, I., Engelen, M.M., Martens, C., Verhamme, P., Yoo, H.H.B., Arguello, J.D., Montenegro, A.C., Roa, J., Hirmerova, J., Malý, R., Accassat, S., Bertoletti, L., Bura-Riviere, A., Catella, J., Chopard, R., Couturaud, F., Espitia, O., Leclercq, B., Le Mao, R., Mahé, I., Moustafa, F., Plaisance, L., Poenou, G., Sarlon-Bartoli, G., Suchon, P., Versini, E., Schellong, S., Braester, A., Brenner, B., Kenet, G., Tzoran, I., Sadeghipour, P., Basaglia, M., Bilora, F., Bortoluzzi, C., Brandolin, B., Ciammaichella, M., Colaizzo, D., De Angelis, A., Dentali, F., Di Micco, P., Grandone, E., Imbalzano, E., Merla, S., Pesavento, R., Prandoni, P., Scarinzi, P., Siniscalchi, C., Tufano, A., Visonà, A., Vo Hong, N., Zalunardo, B., Gibietis, V., Kigitovica, D., Skride, A., Fonseca, S., Manuel, M., Meireles, J., Bosevski, M., Bounameaux, H., Mazzolai, L., Aujayeb, A., Caprini, J.A., Weinberg, I., Bui, H.M., Cohen, Omri, Barg, Assaf A., Nowak-Göttl, Ulrike, Amado-Fernández, Cristina, Mazzolai, Lucia, Tiberio, Gregorio, Skride, Andris, Morales, María del Valle, and Kenet, Gili

Published
2023
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41. Gene Therapy in Movement Disorders: A Systematic Review of Ongoing and Completed Clinical Trials

Author

Merola, Aristide, Kobayashi, Noelle, Romagnolo, Alberto, Wright, Brenton A, Artusi, Carlo Alberto, Imbalzano, Gabriele, Litvan, Irene, Van Laar, Amber D, and Bankiewicz, Krystof

Subjects
Biotechnology, Neurodegenerative, Clinical Trials and Supportive Activities, Gene Therapy, Orphan Drug, Parkinson's Disease, Genetics, Clinical Research, Neurosciences, Rare Diseases, Brain Disorders, Huntington's Disease, 5.2 Cellular and gene therapies, Development of treatments and therapeutic interventions, Neurological, movement disorder, multiple system atrophy, amino acid decarboxylase deficiency, ataxia, Huntington, Parkinson, gene therapy, Clinical Sciences, Psychology
Abstract

Introduction: We sought to provide an overview of the published and currently ongoing movement disorders clinical trials employing gene therapy, defined as a technology aiming to modulate the expression of one or more genes to achieve a therapeutic benefit. Methods: We systematically reviewed movement disorders gene therapy clinical trials from PubMed and ClinicalTrials.gov using a searching strategy that included Parkinson disease (PD), Huntington disease (HD), amino acid decarboxylase (AADC) deficiency, multiple system atrophy (MSA), progressive supranuclear palsy (PSP), dystonia, tremor, ataxia, and other movement disorders. Data extracted included study characteristics, investigational product, route of administration, safety/tolerability, motor endpoints, and secondary outcomes (i.e., neuroimaging, biomarkers). Results: We identified a total of 46 studies focusing on PD (21 published and nine ongoing), HD (2 published and 5 ongoing), AADC deficiency (4 published and 2 ongoing), MSA (2 ongoing), and PSP (1 ongoing). In PD, intraparenchymal infusion of viral vector-mediated gene therapies demonstrated to be safe and showed promising preliminary data in trials aiming at restoring the synthesis of dopamine, enhancing the production of neurotrophic factors, or modifying the functional interaction between different nodes of the basal ganglia. In HD, monthly intrathecal delivery of an antisense oligonucleotide (ASO) targeting the huntingtin protein (HTT) mRNA proved to be safe and tolerable, and demonstrated a dose-dependent reduction of the cerebrospinal fluid levels of mutated HTT, while a small phase-I study testing implantable capsules of cells engineered to synthesize ciliary neurotrophic factor failed to show consistent drug delivery. In AADC deficiency, gene replacement studies demonstrated to be relatively safe in restoring catecholamine and serotonin synthesis, with promising outcomes. Ongoing movement disorders clinical trials are focusing on a variety of gene therapy approaches including alternative viral vector serotypes, novel recombinant genes, novel delivery techniques, and ASOs for the treatment of HD, MSA, and distinct subtypes of PD (LRRK2 mutation or GBA1 mutation carriers). Conclusion: Initial phase-I and -II studies tested the safety and feasibility of gene therapy in PD, HD, and AADC deficiency. The ongoing generation of clinical trials aims to test the efficacy of these approaches and explore additional applications for gene therapy in movement disorders.

Published
2021

44. Unveiling the Unpredictable in Parkinson’s Disease: Sensor-Based Monitoring of Dyskinesias and Freezing of Gait in Daily Life

Author

Alessandro Zampogna, Luigi Borzì, Domiziana Rinaldi, Carlo Alberto Artusi, Gabriele Imbalzano, Martina Patera, Leonardo Lopiano, Francesco Pontieri, Gabriella Olmo, and Antonio Suppa

Subjects
Parkinson’s disease, dyskinesias, freezing of gait, wearable sensors, long-term monitoring, Technology, Biology (General), QH301-705.5
Abstract

Background: Dyskinesias and freezing of gait are episodic disorders in Parkinson’s disease, characterized by a fluctuating and unpredictable nature. This cross-sectional study aims to objectively monitor Parkinsonian patients experiencing dyskinesias and/or freezing of gait during activities of daily living and assess possible changes in spatiotemporal gait parameters. Methods: Seventy-one patients with Parkinson’s disease (40 with dyskinesias and 33 with freezing of gait) were continuously monitored at home for a minimum of 5 days using a single wearable sensor. Dedicated machine-learning algorithms were used to categorize patients based on the occurrence of dyskinesias and freezing of gait. Additionally, specific spatiotemporal gait parameters were compared among patients with and without dyskinesias and/or freezing of gait. Results: The wearable sensor algorithms accurately classified patients with and without dyskinesias as well as those with and without freezing of gait based on the recorded dyskinesias and freezing of gait episodes. Standard spatiotemporal gait parameters did not differ significantly between patients with and without dyskinesias or freezing of gait. Both the time spent with dyskinesias and the number of freezing of gait episodes positively correlated with the disease severity and medication dosage. Conclusions: A single inertial wearable sensor shows promise in monitoring complex, episodic movement patterns, such as dyskinesias and freezing of gait, during daily activities. This approach may help implement targeted therapeutic and preventive strategies for Parkinson’s disease.

Published
2024
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46. The Lipid-Lowering Efficacy of a Nutraceutical Combination Including Leucoselect Phytosome, Red Yeast Rice, Policosanol and Folic Acid in Dyslipidaemia Patients: Real-World Insights

Author

Vincenzo Russo, Nicola Napolitano, Antonia Ascrizzi, Silvia Leonardi, Filomena Pisacane, Pierpaolo Di Micco, Egidio Imbalzano, Ferdinando Carlo Sasso, Antonello D’Andrea, Alfredo Caturano, and Alfredo Mauriello

Subjects
cardiovascular risk, cholesterol, nutraceuticals, adherence, leucoselect phytosome, red yeast rice, Medicine, Pharmacy and materia medica, RS1-441
Abstract

Background: Cardiovascular disease is a global health concern and reducing plasma LDL-C levels is a major goal in cardiovascular prevention. Our study aimed to evaluate the effectiveness of a nutraceutical formulation including leucoselect® phytosome®, red yeast rice, policosanol and folic acid on LDL-c levels in patients at low cardiovascular risk with dyslipidemia. Materials and Methods: We prospectively enrolled all consecutive patients with dyslipidemia at low cardiovascular risk who were unresponsive to diet and physical activity. Clinical assessments and laboratory analyses, encompassing lipid profile, hepatic function, and CPK levels, were performed at baseline prior to initiating treatment and repeated at the 12-week mark following administration of the study nutraceutical. Results: Sixty (60) consecutive patients (mean age 48.02 ± 10.1 years; 60% male) were included. At the 12-week follow-up, a statistically significant reduction in Total Cholesterol (13.1%) and LDL-c serum level (20.4%) was observed. Hepatic and muscular function remain stable over the time. The adherence to therapy was 99% and the persistence was maximum. Conclusions: The nutraceutical formulation including leucoselect® phytosome® red yeast rice, policosanol and folic acid significantly reduced the LDL-c plasma levels, consistent with previous research showing that the bioactive component in red yeast rice—lovastatin—is effective in addressing problems with lipid metabolism. Importantly, it was safe and well-tolerated among patients with dyslipidemia in a real-world setting.

Published
2024
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47. Correction to: Effectiveness of biosimilar pegfilgrastim in patients with multiple myeloma after high‑dose melphalan and autologous stem cell transplantation

Author

Martino, Massimo, Gori, Mercedes, Porto, Gaetana, Pellicano, Maria, Santoro, Ludovica, Verduci, Chiara, Canale, Filippo Antonio, Loteta, Barbara, Moscato, Tiziana, Alati, Caterina, Ieracitano, Maria Consuelo, Cuzzocrea, Amelia, Altomonte, Maria, Florenzano, Maria Teresa, Morabito, Antonella, Irrera, Giuseppe, Naso, Virginia, Pugliese, Marta, Console, Giuseppe, Ferreri, Anna, Imbalzano, Lucrezia, Tripepi, Giovanni, and Pitino, Annalisa

Published
2023
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48. Prescriptive behavior of non-vitamin K oral anticoagulants in patients affected by atrial fibrillation in general practice

Author

M. Rottura, S.F.A. Drago, A. Molonia, N. Irrera, S. Marino, R. Scoglio, L. Orlando, M. Gigliotti De Fazio, F. Squadrito, V. Arcoraci, and E. Imbalzano

Subjects
Atrial fibrillation, NOAC, Drug prescriptions, Appropriateness, General Practitioners, Therapeutics. Pharmacology, RM1-950
Abstract

Atrial fibrillation (AF) is the most common cardiac arrhythmia worldwide and in recent years the pharmacological approach has been strongly implemented; in Italy, the prescription of the non-vitamin K oral anticoagulants (NOAC) was also extended to General Practitioners (GPs) since 2020. The aim of the present study was to investigate the GPs prescribing behaviour of NOACs. An observational study was performed by using the computerized medical record of 14 GPs in Sicily: patients affected by AF were selected and stratified according to the prescribed antithrombotic drugs. Patients were considered inadequately managed if antithrombotic treatment was not adherent to recent ESC guidelines. A total of 467 (2.7 %) patients were affected by AF, 276 (59.1 %) were treated with an oral anticoagulant (OAC) regardless the high stroke risk (OR 1.64; 95 %CI 0.74–3.62; p = 0.226). The NOAC users were 236 patients as follow: Rivaroxaban 33.5 %, Apixaban 33,1 %, Dabigatran 17,4 %, Edoxaban 16.1 %. In 7 patients an inappropriate NOAC treatment was observed. Among Vitamin-K antagonist users, 25.0 % were considered inappropriate. Patients not treated with OAC were 191, of them 81.7 % were at high stroke risk and did not receive any OAC despite the indication to treat. In addition, the probability to be not properly managed significantly increased in older and in patients with atherosclerosis. Conversely, patients with at least one reported cardiology counselling significantly reduced the likelihood to be not properly managed (OR 0.38, 95 %CI 0.25–0.58; p 0.01). Our results suggest the need to optimize the management of real-life AF patients by improving prescribing adherence to ESC guidelines.

Published
2023
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