9 results on '"Iveli, Pablo"'
Search Results
2. Hepatotoxicidad en el lactante sano expuesto a nevirapina durante el embarazo
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Iveli, Pablo, Noguera-Julian, Antoni, Soler-Palacín, Pere, Martín-Nalda, Andrea, Rovira-Girabal, Núria, Fortuny-Guasch, Clàudia, and Figueras-Nadal, Concepció
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- 2016
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3. Effect of Intravitreal Aflibercept vs Laser Photocoagulation on Treatment Success of Retinopathy of Prematurity: The FIREFLEYE Randomized Clinical Trial.
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Stahl, Andreas, Sukgen, Emine A., Wu, Wei-Chi, Lepore, Domenico, Nakanishi, Hidehiko, Mazela, Jan, Moshfeghi, Darius M., Vitti, Robert, Athanikar, Aditya, Chu, Karen, Iveli, Pablo, Zhao, Fei, Schmelter, Thomas, Leal, Sergio, Koefuencue, Evra, Azuma, Noriyuki, FIREFLEYE Study Group, and Köfüncü, Evra
- Abstract
Importance: Laser photocoagulation, which is the standard treatment for retinopathy of prematurity (ROP), can have adverse events. Studies of anti-vascular endothelial growth factor injections have suggested efficacy in the treatment of ROP, but few studies have directly compared them with laser treatments.Objective: To compare intravitreal aflibercept vs laser photocoagulation in infants with ROP requiring treatment.Design, Setting, and Participants: This noninferiority, phase 3, 24-week, randomized clinical trial was conducted in 27 countries (64 hospital sites) throughout Asia, Europe, and South America. Overall, 118 infants (gestational age ≤32 weeks at birth or birth weight ≤1500 g) with ROP severity (zone I stage 1+ [stage 1 plus increased disease activity], zone I stage 2+, zone I stage 3, zone I stage 3+, zone II stage 2+, or zone II stage 3+) requiring treatment or with aggressive posterior ROP in at least 1 eye were enrolled between September 25, 2019, and August 28, 2020 (the last visit occurred on February 12, 2021).Interventions: Infants were randomized 2:1 to receive a 0.4-mg dose of intravitreal aflibercept (n = 75) or laser photocoagulation (n = 43) at baseline. Additional treatment was allowed as prespecified.Main Outcomes and Measures: The primary outcome was the proportion of infants without active ROP and unfavorable structural outcomes 24 weeks after starting treatment (assessed by investigators). The requirement for rescue treatment was considered treatment failure. Intravitreal aflibercept was deemed noninferior if the lower limit of the 1-sided 95% bayesian credible interval for the treatment difference was greater than -5%.Results: Among 118 infants randomized, 113 were treated (mean gestational age, 26.3 [SD, 1.9] weeks; 53 [46.9%] were female; 16.8% had aggressive posterior ROP, 19.5% had zone I ROP, and 63.7% had zone II ROP) and 104 completed the study. Treatment (intravitreal aflibercept: n = 75; laser photocoagulation: n = 38) was mostly bilateral (92.9%), and 82.2% of eyes in the intravitreal aflibercept group received 1 injection per eye. Treatment success was 85.5% with intravitreal aflibercept vs 82.1% with laser photocoagulation (between-group difference, 3.4% [1-sided 95% credible interval, -8.0% to ∞]). Rescue treatment was required in 4.8% (95% CI, 1.9% to 9.6%) of eyes in the intravitreal aflibercept group vs 11.1% (95% CI, 4.9% to 20.7%) of eyes in the laser photocoagulation group. The serious adverse event rates were 13.3% (ocular) and 24.0% (systemic) in the intravitreal aflibercept group compared with 7.9% and 36.8%, respectively, in the laser photocoagulation group. Three deaths, which occurred 4 to 9 weeks after intravitreal aflibercept treatment, were considered unrelated to aflibercept by the investigators.Conclusions and Relevance: Among infants with ROP, intravitreal aflibercept compared with laser photocoagulation did not meet criteria for noninferiority with respect to the primary outcome of the proportion of infants achieving treatment success at week 24. Further data would be required for more definitive conclusions regarding the comparative effects of intravitreal aflibercept and laser photocoagulation in this population.Trial Registration: ClinicalTrials.gov Identifier: NCT04004208. [ABSTRACT FROM AUTHOR]- Published
- 2022
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4. Improving clinical paediatric research and learning from COVID-19: recommendations by the Conect4Children expert advice group.
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Ramanan, Athimalaipet V., Modi, Neena, de Wildt, Saskia N., c4c Learning from COVID-19 Group, Aurich, Beate, Bakhtadze, Sophia, Sirvent, Francisco J. Bautista, Cabañas, Fernando, Campbell, Lisa, Casanova, Michaela, Charlton, Philippa, Crandall, Wallace, Eichler, Irmgard, Fregonese, Laura, Hawcutt, Daniel B., Iveli, Pablo, Jaki, Thomas, Jocic-Jakubi, Bosanka, Johnson, Mats, and Kaguelidou, Florentina
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- 2022
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5. Intravitreal Aflibercept vs Laser Therapy for Retinopathy of Prematurity: Two-Year Efficacy and Safety Outcomes in the Nonrandomized Controlled Trial FIREFLEYE next.
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Stahl, Andreas, Nakanishi, Hidehiko, Lepore, Domenico, Wu, Wei-Chi, Azuma, Noriyuki, Jacas, Carlos, Vitti, Robert, Athanikar, Aditya, Chu, Karen, Iveli, Pablo, Zhao, Fei, Leal, Sergio, Schlief, Sarah, Schmelter, Thomas, Miller, Thomas, Köfüncü, Evra, and Fielder, Alistair
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- 2024
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6. Correction: Improving clinical paediatric research and learning from COVID-19: recommendations by the Conect4Children expert advice group.
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Ramanan, Athimalaipet V., Modi, Neena, de Wildt, Saskia N., Aurich, Beate, Bakhtadze, Sophia, Sirvent, Francisco J. Bautista, Cabañas, Fernando, Campbell, Lisa, Casanova, Michaela, Charlton, Philippa, Crandall, Wallace, Eichler, Irmgard, Fregonese, Laura, Hawcutt, Daniel B., Iveli, Pablo, Jaki, Thomas, Jocic-Jakubi, Bosanka, Johnson, Mats, Kaguelidou, Florentina, and Karadag, Bülent
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- 2023
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7. Off-label prescriptions in child and adolescent psychiatry. Why, when and how?
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Iveli MF, Monti M, Benito ME, and Iveli P
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- Adolescent, Humans, Child, Prescriptions, Argentina, Practice Patterns, Physicians', Off-Label Use, Adolescent Psychiatry
- Abstract
In the paediatric population, paticulary in the field of child and adolescent psychiatry, off-label indications are the rule rather than the exception. This may occur when a drug is indicated for a pathology, age, route of administration or treatment length other than those described in the product label. Argentina, unlike other countries, has no explicit regulation on off-label prescribing. Therefore, the prescription of a medicine in a manner different from that approved by the National Administration of Medicines, Food and Medical Technology (ANMAT) does not have a regulatory framework regarding the conditions that must be met at the time of treatment. Although off-label use is not prohibited, it carries an additional risk. In order to encourage research in paediatrics, regulatory agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have introduced legislative reform. The following paper will review the current framework of the regulatory agencies that are relevant to the paediatric population and will analyse criteria to guide physicians in the rational use of off-label pharmacotherapy., Competing Interests: The authors have no conflicts of interest to declare., (Creative Commons BY-NC-ND 4.0)
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- 2022
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8. Thirty-Day Outcomes of Children and Adolescents With COVID-19: An International Experience.
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Duarte-Salles T, Vizcaya D, Pistillo A, Casajust P, Sena AG, Lai LYH, Prats-Uribe A, Ahmed WU, Alshammari TM, Alghoul H, Alser O, Burn E, You SC, Areia C, Blacketer C, DuVall S, Falconer T, Fernandez-Bertolin S, Fortin S, Golozar A, Gong M, Tan EH, Huser V, Iveli P, Morales DR, Nyberg F, Posada JD, Recalde M, Roel E, Schilling LM, Shah NH, Shah K, Suchard MA, Zhang L, Zhang Y, Williams AE, Reich CG, Hripcsak G, Rijnbeek P, Ryan P, Kostka K, and Prieto-Alhambra D
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- Adolescent, Age Distribution, Child, Child, Preschool, Cohort Studies, Comorbidity, Databases, Factual, Diagnosis, Differential, Female, France epidemiology, Germany epidemiology, Hospitalization statistics & numerical data, Humans, Infant, Infant, Newborn, Influenza, Human complications, Influenza, Human diagnosis, Influenza, Human epidemiology, Male, Republic of Korea epidemiology, Spain epidemiology, Symptom Assessment, Time Factors, Treatment Outcome, United States epidemiology, COVID-19 complications, COVID-19 diagnosis, COVID-19 epidemiology, COVID-19 Drug Treatment
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Objectives: To characterize the demographics, comorbidities, symptoms, in-hospital treatments, and health outcomes among children and adolescents diagnosed or hospitalized with coronavirus disease 2019 (COVID-19) and to compare them in secondary analyses with patients diagnosed with previous seasonal influenza in 2017-2018., Methods: International network cohort using real-world data from European primary care records (France, Germany, and Spain), South Korean claims and US claims, and hospital databases. We included children and adolescents diagnosed and/or hospitalized with COVID-19 at age <18 between January and June 2020. We described baseline demographics, comorbidities, symptoms, 30-day in-hospital treatments, and outcomes including hospitalization, pneumonia, acute respiratory distress syndrome, multisystem inflammatory syndrome in children, and death., Results: A total of 242 158 children and adolescents diagnosed and 9769 hospitalized with COVID-19 and 2 084 180 diagnosed with influenza were studied. Comorbidities including neurodevelopmental disorders, heart disease, and cancer were more common among those hospitalized with versus diagnosed with COVID-19. Dyspnea, bronchiolitis, anosmia, and gastrointestinal symptoms were more common in COVID-19 than influenza. In-hospital prevalent treatments for COVID-19 included repurposed medications (<10%) and adjunctive therapies: systemic corticosteroids (6.8%-7.6%), famotidine (9.0%-28.1%), and antithrombotics such as aspirin (2.0%-21.4%), heparin (2.2%-18.1%), and enoxaparin (2.8%-14.8%). Hospitalization was observed in 0.3% to 1.3% of the cohort diagnosed with COVID-19, with undetectable ( n < 5 per database) 30-day fatality. Thirty-day outcomes including pneumonia and hypoxemia were more frequent in COVID-19 than influenza., Conclusions: Despite negligible fatality, complications including hospitalization, hypoxemia, and pneumonia were more frequent in children and adolescents with COVID-19 than with influenza. Dyspnea, anosmia, and gastrointestinal symptoms could help differentiate diagnoses. A wide range of medications was used for the inpatient management of pediatric COVID-19., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2021 by the American Academy of Pediatrics.)
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- 2021
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9. Baseline characteristics, management, and outcomes of 55,270 children and adolescents diagnosed with COVID-19 and 1,952,693 with influenza in France, Germany, Spain, South Korea and the United States: an international network cohort study.
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Duarte-Salles T, Vizcaya D, Pistillo A, Casajust P, Sena AG, Lai LYH, Prats-Uribe A, Ahmed WU, Alshammari TM, Alghoul H, Alser O, Burn E, You SC, Areia C, Blacketer C, DuVall S, Falconer T, Fernandez-Bertolin S, Fortin S, Golozar A, Gong M, Tan EH, Huser V, Iveli P, Morales DR, Nyberg F, Posada JD, Recalde M, Roel E, Schilling LM, Shah NH, Shah K, Suchard MA, Zhang L, Zhang Y, Williams AE, Reich CG, Hripcsak G, Rijnbeek P, Ryan P, Kostka K, and Prieto-Alhambra D
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Objectives To characterize the demographics, comorbidities, symptoms, in-hospital treatments, and health outcomes among children/adolescents diagnosed or hospitalized with COVID-19. Secondly, to describe health outcomes amongst children/adolescents diagnosed with previous seasonal influenza. Design International network cohort. Setting Real-world data from European primary care records (France/Germany/Spain), South Korean claims and US claims and hospital databases. Participants Diagnosed and/or hospitalized children/adolescents with COVID-19 at age <18 between January and June 2020; diagnosed with influenza in 2017-2018. Main outcome measures Baseline demographics and comorbidities, symptoms, 30-day in-hospital treatments and outcomes including hospitalization, pneumonia, acute respiratory distress syndrome (ARDS), multi-system inflammatory syndrome (MIS-C), and death. Results A total of 55,270 children/adolescents diagnosed and 3,693 hospitalized with COVID-19 and 1,952,693 diagnosed with influenza were studied. Comorbidities including neurodevelopmental disorders, heart disease, and cancer were all more common among those hospitalized vs diagnosed with COVID-19. The most common COVID-19 symptom was fever. Dyspnea, bronchiolitis, anosmia and gastrointestinal symptoms were more common in COVID-19 than influenza. In-hospital treatments for COVID-19 included repurposed medications (<10%), and adjunctive therapies: systemic corticosteroids (6.8% to 37.6%), famotidine (9.0% to 28.1%), and antithrombotics such as aspirin (2.0% to 21.4%), heparin (2.2% to 18.1%), and enoxaparin (2.8% to 14.8%). Hospitalization was observed in 0.3% to 1.3% of the COVID-19 diagnosed cohort, with undetectable (N<5 per database) 30-day fatality. Thirty-day outcomes including pneumonia, ARDS, and MIS-C were more frequent in COVID-19 than influenza. Conclusions Despite negligible fatality, complications including pneumonia, ARDS and MIS-C were more frequent in children/adolescents with COVID-19 than with influenza. Dyspnea, anosmia and gastrointestinal symptoms could help differential diagnosis. A wide range of medications were used for the inpatient management of pediatric COVID-19.
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- 2020
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