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2. Organization and regional distribution of centers for the management of children and adolescents with diabetes in Italy

Author

Giorgetti C., Ferrito L., Zallocco F., Iannilli A., Cherubini V., Maghnie M., Rabbone I., Lera R., De Luna L., Kienberger B., Gualtieri A., Zecchino C., Piccino E., Ortolani F., Zucchini S., Maltoni G., Pasquino B., Reinstadler P., Prandi E., Zattoni V., Gallo F., Morganti G., Guerraggio L., Ripoli C., Frongia M., Pusceddu P., La Loggia A., Scanu P., Cardinale G., Ponzi G., Tomaselli L. G., Rapisarda V., Citriniti F., Soprani T., Tumini S., Lazzaro N., De Donno V., Banin P., Toni S., Lenzi L., Mainetti B., Coccioli M. S., D'Annunzio G., Minuto N., Montani E., Maccioni R., Marongiu U., Beccaria L., Bruzzese M., Mammi F., Pardi D., Lombardo F., Ventrici C., Scaramazza A., Ferrari M., Bonfanti R., Rigamonti A., Iughetti L., Predieri B., Iafusco D., Confetto S., Zanfardino A., Prisco F., Francese A., De Nitto E., Cadario F., Milia A., Piredda G., Mereu L., Soro M., Correddu A., Pipia A., Monciotti C., Cardella F., De Berardinis F., Santoro G., Chiari G., Berioli M. G., Federico G., Zanette G., Marsciani A., Pedini A., Patera I. P., Schiaffini R., Bitti M., Lidano R., Pietrosanti S., Delvecchio M., Trada M., Marinaro A., Meloni G., Galero A., Fichera G., Bulciolu P., Ignaccolo G., Cauvin V., Franceschi R., Faleschini E., Tornese G., Salvatoni A., Cardani R., Maffeis C., Marigliano M., Sabbion A., Arnaldi C., Giorgetti, Chiara, Ferrito, Lucia, Zallocco, Federica, Iannilli, Antonio, Cherubini, Valentino, Maghnie, Mohamad, Rabbone, Ivana, Lera, R., De Luna, L., Kienberger, B., Gualtieri, A., Zecchino, C., Piccino, E., Ortolani, F., Zucchini, S., Maltoni, G., Pasquino, B., Reinstadler, P., Prandi, E., Zattoni, V., Gallo, F., Morganti, G., Guerraggio, L., Ripoli, C., Frongia, M., Pusceddu, P., La Loggia, A., Scanu, P., Cardinale, G., Ponzi, G., Tomaselli, L. G., Rapisarda, V., Citriniti, F., Soprani, T., Tumini, S., Lazzaro, N., De Donno, V., Banin, P., Toni, S., Lenzi, L., Mainetti, B., Coccioli, M. S., D’Annunzio, G., Minuto, N., Montani, E., Maccioni, R., Marongiu, U., Beccaria, L., Bruzzese, M., Mammì, F., Pardi, D., Lombardo, F., Ventrici, C., Scaramazza, A., Ferrari, M., Bonfanti, R., Rigamonti, A., Iughetti, L., Predieri, B., Iafusco, Dario, Confetto, S., Zanfardino, A., Prisco, Francesco, Francese, A., De Nitto, E., Cadario, F., Milia, A., Piredda, G., Mereu, L., Soro, M., Correddu, A., Pipia, A., Monciotti, C., Cardella, F., De Berardinis, F., Santoro, G., Chiari, G., Berioli, M. G., Federico, G., Zanette, G., Marsciani, A., Pedini, A., Patera, I. P., Schiaffini, R., Bitti, M., Lidano, R., Pietrosanti, S., Delvecchio, M., Trada, M., Marinaro, A., Meloni, G., Galero, A., Fichera, G., Bulciolu, P., Rabbone, I., Ignaccolo, G., Cauvin, V., Franceschi, R., Faleschini, E., Tornese, G., Salvatoni, A., Cardani, R., Maffeis, C., Marigliano, M., Sabbion, A., Arnaldi, C., Study Group for Diabetes of, Isped, Tornese, Gianluca, Giorgetti, C., Ferrito, L., Zallocco, F., Iannilli, A., Cherubini, V., Maghnie, M., D'Annunzio, G., Mammi, F., Iafusco, D., and Prisco, F.

Subjects
Male, medicine.medical_specialty, Type 1 diabete, Adolescent, MEDLINE, Staffing, Distribution (economics), Legislation, diabetes, children, T1D, Italy, Pediatrics, Regional Medical Program, Prevalence, Surveys and Questionnaire, Medicine, Regional legislation, Practice Patterns, Physicians', Disease management (health), Child, Organization of care, Pediatric diabetes centers, Type 1 diabetes, Pediatrics, Perinatology and Child Health, business.industry, Incidence, Incidence (epidemiology), Research, Disease Management, Perinatology and Child Health, medicine.disease, Diabetes Mellitus, Type 1, diabete, Family medicine, Female, Organizational structure, Pediatric diabetes center, business, Delivery of Health Care, Human
Abstract

Background: The incidence of type 1 diabetes in childhood is increasing by 3 % per year, placing growing demands on healthcare professionals and medical expenditures. Aim of this study wars to assess the organization of care to children with diabetes in Italy. Methods: During 2012 a structured questionnaire was sent to all of the members of Italian Society of Paediatric Endocrinology and Diabetology (ISPED). Questions examined organizational structure of Centers, personnel dedicated to the care of children with diabetes, number of subjects followed, local legal legislation supporting centres. Results: A total of 68 centers taking care to 15,563 children and adolescents with diabetes under 18 years of age were identified with a prevalence of 1.4 per 1,000 people. A wide variation in the organizational background was also reported. Fourty-four centers were organized as outpatient departments, 17 as simple units, 5 as complex units and 2 as simple departmental structures. Most centers had a multidisciplinary team. Ten out of twenty Italian regions had introduced supportive regional legislation, but it was fully applied only in six of them. Conclusion: Great differences between regions were found in organizational structures, staffing levels and supportive legislation. The national legislation on diabetes was broadly implemented throughout the country regions. Further efforts are needed to improve standards and consistency of pediatric diabetes care in Italy.

Published
2015

3. Erratum: Organization and regional distribution of centers for the management of children and adolescents with diabetes in Italy (Ital J Pediatr (2015) 41 (74) DOI:10.1186/s13052-015-0179-6)

Author

Giorgetti, C., Ferrito, L., Zallocco, F., Iannilli, A., Cherubini, V., Maghnie, M., Rabbone, I., Lera, R., De Luna, L., Kienberger, B., Gualtieri, A., Zecchino, C., Piccino, E., Ortolani, F., Zucchini, S., Maltoni, G., Pasquino, B., Reinstadler, P., Prandi, E., Zattoni, V., Gallo, F., Morganti, G., Guerraggio, L., Ripoli, C., Frongia, M., Pusceddu, P., La Loggia, A., Scanu, P., Cardinale, G., Ponzi, G., Tomaselli, L. G., Rapisarda, V., Citriniti, F., Soprani, T., Tumini, S., Lazzaro, N., De Donno, V., Banin, P., Toni, S., Lenzi, L., Mainetti, B., Coccioli, M. S., D(')Annunzio, G., Minuto, N., Montani, E., Maccioni, R., Marongiu, U., Beccaria, L., Bruzzese, M., Mamm(`i), F., Pardi, D., Lombardo, F., Ventrici, C., Scaramazza, A., Ferrari, M., Bonfanti, R., Rigamonti, A., Iughetti, L., Predieri, B., Iafusco, D., Confetto, S., Zanfardino, A., Prisco, F., Francese, A., De Nitto, E., Cadario, F., Milia, A., Piredda, G., Mereu, L., Soro, M., Correddu, A., Pipia, A., Monciotti, C., Cardella, F., De Berardinis, F., Santoro, G., Chiari, G., Berioli, M. G., Federico, G., Zanette, G., Marsciani, A., Pedini, A., Patera, I. P., Schiaffini, R., Bitti, M., Lidano, R., Pietrosanti, S., Delvecchio, M., Trada, M., Marinaro, A., Meloni, G., Gaiero, A., Fichera, G., Bulciolu, P., Ignaccolo, G., Cauvin, V., Franceschi, R., Faleschini, E., Tornese, G., Salvatoni, A., Cardani, R., Maffeis, C., Marigliano, M., Sabbion, A., and Arnaldi, C.

Subjects
children, type 1 diabetes, children, adolescents, adolescents
Published
2016

4. Stable or improved neurological manifestations during miglustat therapy in patients from the international disease registry for Niemann-Pick disease type C: An observational cohort study

Author

Patterson, M. C, Mengel, E, Vanier, M. T, Schwierin, B, Muller, A, Cornelisse, P, Pineda, M, Amado-Fondo, A, Amraoui, Y, Andria, G, Arellano, M, Audoin, B, Azcona, C, Barr, C, Baruteau, J, Baumgartner, C, Bell, L, Bembi, B, Benneddif, K, Bernard, G, Bobocea, N, Bodzioch, M, Boettcher, T, Bonnan, M, Broue, P, Bruni, A, Caceres, M, Camino, R, Campbell, E, Cances, C, Cannell, P, Cesar, J, Chabrol, B, Chakrapani, A, Colao, R, Collet, A, Corsetti, T, Cousins, A, Covanis, A, Cox, T, Cuisset, J. M, Dardis, A, Das, A, Deegan, P, Dengler, T, Deodato, F, Derralynn, H, Di Donato, I, Di Rocco, M, Dinopoulos, A, Pakiela, D, Eckehard, S, Engelen, M, Eyer, D, Fecarotta, S, Federico, A, Filla, A, Fiumara, A, Fonseca, M. J, Gabrielli, O, Garcia, T, Garrote, J, Gissen, P, Giugliani, L, Greenberg, C, Heron, B, Hertzberg, C, Higgins, F, Hill, A, Hiwot, T, Hlavata, A, Hörbe-Blindt, A, Howley, E, Hussain, N, Illsinger, S, Imrie, J, Jacklin, E, Jones, S, Jovanovic, A, Kaczmarek, V, Kaphan, E, Kibaek, M, Kleinhans, P, Klünemann, Kh, Koch, S. M, Koegl-Wallner, W, Kolnikova, M, Korenke, G. C, Korinthenberg, R, Kumari, S, Lachmann, R, Lee Ann, L, Likopoulou, L, Lilienthal, E, Link, B, Lippold, M, Lopez-Laso, E, Luecke, T, Lundgren, J, Mackrell, M, Madruga, M, Maletta, R, Malinova, V, Manners, J, Marinei, R, Marquardt, T, Martins, E, Martins, A. M, Martins, N, Mcalister, L, Mccabe, A, Mckie, M, Mcmahon, S, Meehan, M, Meldgaard Lund, A, Mendozah, C, Meyer, A, Mielke, S, Milligan, A, Mir, P, Moisa, M, Mombelli, C, Morris, L, Müller Vom Hagen, J, Munoz, B, Murphy, E, Nagarajan, L, Neto, P. B, Nevsimalova, S, Nia, S, Nicolai, J, Niemann, D, Niktari, G, O'Callaghan, M. D. M, Paucar-Arce, M, Peers, K, Peintinger, L, Peralta, M, Pérez, J, Perez-Poyato, M, Petrariu, A, Puschmann, A, Raiman, J, Rask, O, Rataj, J, Raymond-Gaynor, C, Reichelt, G, Ribeiro, E, Riches, V, Roberts, A, Roelants, J, Rohrbach, M, Rokicki, D, Rolfs, A, Russo, C, Rutsch, F, Saleem, R, Santos, M, Schmutz, P, Schwahn, B, Sedel, F, Semotok, J, Sharma, R, Silska, S, Silva, A, Simmons, L, Sivera, R, Skorpen, J, Sole, G, Souza, C, Stadlober-Degwerth, M, Starling, J, Temudo, T, Tomas, M, Tranchant, C, Uziel, G, Valayannopoulous, V, Van Den Hout, H, Van Der Tol, L, Van Spronsen, F, Vellodi, A, Verdu, A, Vilchez, J. J, Vinaixa, A, Visser, G, Voelker, J, Waldek, S, Walter, A, Walterfang, M, Wein, U, Widner, H, Wilcke, C, Wildish, L, Wraith, E, Wright, N, Xaidara, A, Yamamoto, M, Zallocco, F, Zielke, S, Patterson, Mc, Mengel, E, Vanier, Mt, Schwierin, B, Muller, A, Cornelisse, P, Pineda, M, Registry investigators, Npc, Filla, Alessandro, Russo, CINZIA VALERIA, Neurology, Paediatric Neurology, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, ANS - Amsterdam Neuroscience, and Graduate School

Subjects
Male, Pediatrics, Neurology, Cohort Studies, 0302 clinical medicine, Miglustat, Medicine, Enzyme Inhibitor, Genetics(clinical), Pharmacology (medical), Prospective Studies, Young adult, Enzyme Inhibitors, Prospective cohort study, Child, Genetics (clinical), Medicine(all), 0303 health sciences, Medicine (all), Niemann-Pick disease type C, Niemann-Pick Disease, Type C, General Medicine, 3. Good health, Treatment Outcome, Child, Preschool, Cohort, Disease Progression, Female, medicine.drug, Cohort study, Human, Adult, medicine.medical_specialty, Registry, 1-Deoxynojirimycin, Adolescent, 03 medical and health sciences, Young Adult, Disease registry, Swallowing, Humans, 030304 developmental biology, business.industry, Research, Prospective Studie, Cohort Studie, business, 030217 neurology & neurosurgery
Abstract

BACKGROUND: Niemann-Pick disease type C (NP-C) is a rare neurovisceral disease characterised by progressive neurological degeneration, where the rate of neurological disease progression varies depending on age at neurological onset. We report longitudinal data on functional disease progression and safety observations in patients in the international NPC Registry who received continuous treatment with miglustat. METHODS: The NPC Registry is a prospective observational cohort of NP-C patients. Enrolled patients who received ≥1 year of continuous miglustat therapy (for ≥90 % of the observation period, with no single treatment interruption >28 days) were included in this analysis. Disability was measured using a scale rating the four domains, ambulation, manipulation, language and swallowing from 0 (normal) to 1 (worst). Neurological disease progression was analysed in all patients based on: 1) annual progression rates between enrolment and last follow up, and; 2) categorical analysis with patients categorised as 'improved/stable' if ≥3/4 domain scores were lower/unchanged, and as 'progressed' if

Published
2015

7. Effectiveness and Safety of Glecaprevir/Pibrentasvir in Italian Children and Adolescents With Chronic Hepatitis C: A Real-Word, Multicenter Study.

Author

Stinco M, Rubino C, Bartolini E, Nuti F, Paolella G, Nebbia G, Silvestro E, Garazzino S, Nicastro E, D'Antiga L, Zanchi C, Morra L, Iorio R, Di Dato F, Maggiore G, Sartorelli MR, Comparcola D, Stracuzzi M, Giacomet V, Musto F, Pinon M, Calvo P, Carloni I, Zallocco F, Cananzi M, Trapani S, and Indolfi G

Abstract

Background & Aims: Glecaprevir/Pibrentasvir (GLE/PIB) has been approved by the European Medicine Agency (EMA) and by the US Food and Drug Administration (US-FDA) for the treatment of children and adolescents from 3 years of age with chronic hepatitis C virus (CHC) infection. The aim of this study was to confirm the real-world effectiveness and safety of GLE/PIB in children and adolescents (3 to < 18 years old) with CHC., Methods: This prospective, multicentre study involved 11 Italian centres. Children and adolescents (from 3 to < 18 years of age) received a weight-based dose (up to 300/120 mg) of GLE/PIB once daily for 8 weeks. The effectiveness endpoint was sustained virological response 12 weeks after the end of treatment (SVR12). Safety was assessed by adverse events (AE) and clinical/laboratory data., Results: Sixty-one patients (median age 12 years, interquartile range 5) were enrolled and treated between June 2020 and October 2023. Genotype distribution was as follows: 24/61 genotype 1 (39.4%), 13/61 genotype 2 (21.3%), 18/61 genotype 3 (29.5%) and 6/61 genotype 4 (9.8%). Sixty (98.4%) patients completed treatment and follow-up. SVR12 was obtained by 60/61 patients (98.4%). One patient died because of an oncological illness while on treatment. AE occurred in 13.1% of the patients, were mild and no patients prematurely stopped treatment., Conclusions: This study confirmed the real-life effectiveness and safety of the 8-week therapy with GLE/PIB for treatment of CHC in children and adolescents., (© 2024 The Author(s). Liver International published by John Wiley & Sons Ltd.)

Published
2024
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9. Intrapartum use of zidovudine in a large cohort of pregnant women living with HIV in Italy.

Author

Taramasso L, Bovis F, Di Biagio A, Mignone F, Giaquinto C, Tagliabue C, Giacomet V, Genovese O, Chiappini E, Salomè S, Badolato R, Carloni I, Cellini M, Dodi I, Bossi G, Allodi A, Bernardi S, Consolini R, Dedoni M, Banderali G, Mazza A, Pruccoli G, Rampon O, Erba P, Di Pietro G, Montagnani C, Capasso L, Dotta L, Zallocco F, De Martino M, Lisi C, Tovo PA, Bassetti M, Gabiano C, and Galli L

Subjects
Child, Female, Humans, Infant, Newborn, Pregnancy, Pregnant People, Zidovudine therapeutic use, Anti-HIV Agents therapeutic use, HIV Infections drug therapy, HIV Infections epidemiology, HIV Infections prevention & control, Pregnancy Complications, Infectious drug therapy, Pregnancy Complications, Infectious prevention & control
Abstract

Background: Intravenous administration of zidovudine (ZDV) during labour is a key step for vertical HIV transmission (VT) prevention, but there is no evidence of benefit when maternal HIV-RNA at delivery is <50 copies/mL. The aim of this study is evaluating the appropriateness of intrapartum ZDV use in Italy., Methods: Observational study including mother-infant pairs with perinatal HIV exposure during 2002-2019, enrolled in the Italian Register for HIV Infection in Children. Univariable and multivariable logistic regression were used to evaluate factors associated with VT., Results: A total of 3,861 infants, born from 3,791 pregnancies were included. The frequency of ZDV use was 79.9%, 92.1%, 93.7% and 92.8% when HIV-RNA was not available, ≥400 copies, between 50 and 399 copies, and <50 copies/mL. Thirty-three out of 3861 (0.85%) infants were subsequently diagnosed with HIV, 25/3861 (0.6%) of them born to mothers receiving intrapartum ZDV, and 31 (93.9%) to mothers with HIV-RNA ≥50 copies/mL or not available. In women with HIV-RNA < 50 copies/mL, ART discontinuation during pregnancy was the strongest risk factor for VT (odds ratio, OR, 23.1, 95%CI 2.4-219.3), while a higher gestational age (OR 0.6, 95%CI 0.4-0.8) and PEP administration to the newborn (aOR 0.004, 95%CI <0.0001-0.4) were protective factors. Intrapartum ZDV administration did not influence the final outcome in this group., Conclusions: In ART era, more transmission events may occur in utero, limiting value of intrapartum ZDV, particularly for women with suppressed HIV-RNA load. More attention to the HIV-RNA testing of mothers before delivery may avoid unnecessary ZDV use., Competing Interests: Declaration of Competing Interest None of the authors declare conflicts of interest relevant to the present study., (Copyright © 2022. Published by Elsevier Ltd.)

Published
2022
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10. Assessment of clinical outcome of children with sepsis outside the intensive care unit.

Author

Zallocco F, Osimani P, Carloni I, Romagnoli V, Angeloni S, and Cazzato S

Subjects
Biomarkers, Child, Child, Preschool, Female, Hospitalization statistics & numerical data, Humans, Infant, Intensive Care Units, Pediatric, Italy, Length of Stay statistics & numerical data, Male, Prognosis, Retrospective Studies, Sensitivity and Specificity, Sepsis complications, Mass Screening methods, Organ Dysfunction Scores, Risk Assessment methods, Sepsis diagnosis
Abstract

In 2016, in order to identify adult patients with sepsis who are likely to have poor outcomes, the Third International Consensus Definitions Task Force introduced a new bedside index, called the quick Sepsis-related Organ Failure Assessment (qSOFA) score. However, these new criteria have not been validated in the pediatric population. In this study, we sought to assess the qSOFA score for children with sepsis, who are being treated outside the pediatric intensive care units. The qSOFA criteria were revised and applied to a study population of 89 pediatric patients with sepsis, admitted in a pediatric tertiary referral center from 2006 to 2016. The analysis of prognostic performance of qSOFA score for the prediction of severe sepsis showed a sensitivity of 46% (95% CI, 27-67%), a specificity of 74% (95% CI, 62-85%), a positive predictive value of 43% (95% CI, 34-52%), and a negative predictive value of 77% (95% CI, 71-82%). The area under ROC curve for qSOFA score ≥ 2 was 0.602 (95% CI 0.492-0.705).Conclusion: The qSOFA score showed a low accuracy to identify children in the pediatric ward at risk for severe sepsis. Clinical tools are needed to facilitate the diagnosis of impending organ dysfunction in pediatric infection outside of the ICU. What is Known: • One of the major challenges for clinicians is to identify and recognize children with sepsis and impending organ dysfunction, in the emergency and in the pediatric department. • In 2016, members of the Sepsis-3 task force proposed qSOFA, an empirically derived score using simple clinical criteria, to assist clinicians in identifying adult patients with sepsis at risk for poor outcome. What is New: • qSOFA demonstrated insufficient clinical value to be recommended as a screening tool for pediatric sepsis outside ICU. • D-dimer level and blood glucose may be useful biomarkers to identify children at risk for severe sepsis.

Published
2018
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12. Cognitive-motor profile, clinical characteristics and diagnosis of CHARGE syndrome: an Italian experience.

Author

Santoro L, Ficcadenti A, Zallocco F, Del Baldo G, Piraccini F, Gesuita R, Ceccarani P, and Gabrielli O

Subjects
Age Factors, CHARGE Syndrome genetics, Cohort Studies, Female, Humans, Italy epidemiology, Male, Mutation genetics, Surveys and Questionnaires, CHARGE Syndrome diagnosis, CHARGE Syndrome epidemiology, CHARGE Syndrome pathology, Cognition Disorders pathology, Motor Skills Disorders pathology, Phenotype
Abstract

Since 2005, the Pediatric Clinic of Maternal-Infantile Sciences Institute in Ancona, in collaboration with the Lega del Filo d'Oro in Osimo, has been taking care of 35 patients with clinical and molecular diagnosis of CHARGE syndrome. Our investigation is the largest Italian cohort study of CHARGE patients. CHARGE syndrome is a multiple malformation syndrome involving ocular coloboma, heart defects, choanal atresia, retardation of growth and\or development, genital anomalies and\or urinary and ear abnormalities which leads to visual-auditory disabilities, cognitive impairment and behavioral abnormalities. Our purpose is to expand the knowledge of this syndrome by reviewing this group of affected patients in order to delineate in detail the natural history of the disease, and in particular to define the cognitive and motor profiles using an Italian questionnaire called "Progress Guide". Our main results show that Italian CHARGE patients have more delayed development in their physical abilities or skills with respect to normal patients. In particular, the delay is statistically significant in regard to self-care skills (worse toileting, better washing) and the communication skill (language). On the other hand, the expressive skills are still preserved. When patients are considered according to their age (≤3 years) and (>3 years), the older ones have more delayed development than the younger ones when compared with healthy individuals of the same age., (© 2014 Wiley Periodicals, Inc.)

Published
2014
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