5 research outputs found
A survey on the model-centered approaches to conceptual modeling of IoT systems
Internet of Things (IoT) is a system of connected objects, entities, devices, and components which share and transfer data over a network. Many papers are published on the topic of conceptual models in the IoT context, but it is difficult to assess the current status of the conceptual modeling approaches and methods for IoT systems. This paper presents an overview of the state of the art as well as discusses fundamental concepts, challenges and current research gaps with potential future agenda for conceptual modeling of IoT. Search facilities in the selected online repositories were used to identify the most relevant papers. The primary results were scanned and papers were selected according to the inclusion/exclusion criteria. Selected papers were assessed to extract data for the defined attributes. This paper confirms that there is a large body of research related to modeling of IoT systems. However, the results show that there is a lack of commonly agreed approaches and supporting formal methods for conceptual modeling of IoT systems. On the other hand, recent studies that apply model-based or model-driven development principles that use ontology or metamodel based approaches are promising due to systematic use of models as the primary means of a development process enabling for the dissemination of the methods further to the emerging fields such as smart cities, factories, transportation, hospitals, healthcare, hospitality and tourism, etc
Transdisciplinaridade na abordagem da amiloidose
La creciente complejidad en el abordaje de las enfermedades desafía a desarrollar un nuevo paradigma de atención que atraviese los límites disciplinarios, donde profesionales de diferentes especialidades abordan un problema aplicando su expertise, respetando el conocimiento del otro y contribuyendo a la mirada global de la problemática. Las amiloidosis son enfermedades raras. El diagnóstico se basa en la biopsia de aquellos órganos en los que se sospecha de infiltración amiloidea. Existe un aumento del riesgo de sangrado asociado con estos procedimientos. Por ello, la disponibilidad de obtener muestras de determinados sitios con accesos menos invasivos, como las glándulas salivales menores (GSM), representan una alternativa. Objetivos: Describir las experiencias de biopsias GSM como herramienta diagnóstica en la detección de amiloidosis y sus complicaciones intra y postoperatorias. Estimar la performance diagnóstica. El diseño es de cohorte transversal. Se incluyeron consecutivamente todos los pacientes con sospecha de diagnóstico de amiloidosis, entre agosto 2018-septiembre 2020. Resultados: Se efectuaron 23 biopsias con procedimientos mínimamente invasivos. El 60,86 % fueron de sexo masculino y la media de edad 66 años. La prevalencia de amiloidosis fue del 33%. La sensibilidad fue del 55% y la especificidad del 100 %. Un paciente presentó mayor sangrado que lo habitual durante el procedimiento y ninguno presentó complicaciones postoperatorias. Conclusiones: Se describieron las experiencias de biopsia de GSM como herramienta diagnóstica de amiloidosis, reportando una leve complicación intraoperatoria y nula posoperatoria. La prueba alcanzó una sensibilidad del 55 % y una especificidad del 100 %.The increasing complexity in the approach to diseases challenges the development of a new paradigm of care that crosses disciplinary limits, where professionals from different disciplines approach a problem applying their expertise, respecting the knowledge of the other and contributing to the global view of the problem. Amyloidoses are rare diseases. The diagnosis is based on the biopsy of those organs in which amyloid infiltration is suspected. There is an increased risk of bleeding associated with these procedures. Therefore, the availability of obtaining samples from certain sites with less invasive accesses, such as the minor salivary glands (GSM), represent an alternative. Objectives: Describe the experiences of GSM biopsies as a diagnostic tool in the detection of amyloidosis and its intra and postoperative complications. - Estimate the diagnostic performance. The design is a cross-sectional cohort. All patients with a suspected diagnosis of amyloidosis were consecutively included, between August 2018-September 2020. Results: 23 biopsies were performed with minimally invasive procedures. 60.86% were male and the average age was 66 years. The prevalence of amyloidosis was 33%. The sensitivity was 55% and the specificity 100%. One patient had more bleeding than usual during the procedure and none had postoperative complications. Conclusions: GSM biopsy experiences were described as a diagnostic tool for amyloidosis, reporting a slight intraoperative complication and no postoperative complication. The test achieved a sensitivity of 55% and a specificity of 100%.A crescente complexidade na abordagem das doenças desafia o desenvolvimento de um novo paradigma de cuidado que extrapola os limites disciplinares, onde profissionais de diferentes disciplinas abordam um problema aplicando suas competências, respeitando o conhecimento do outro e contribuindo para a visão global do problema. As amiloidoses são doenças raras. O diagnóstico é baseado na biópsia dos órgãos em que há suspeita de infiltração amilóide. Há um risco aumentado de sangramento associado a esses procedimentos. Portanto, a disponibilidade de obtenção de amostras em determinados locais com acessos menos invasivos, como as glândulas salivares menores (GSM), representa uma alternativa. Metas: Descrever as experiências das biópsias GSM como ferramenta diagnóstica na detecção da amiloidose e suas complicações intra e pós-operatórias. - Estimar o desempenho diagnóstico. O desenho é uma coorte transversal. Todos os pacientes com suspeita de diagnóstico de amiloidose foram incluídos consecutivamente, entre agosto de 2018 e setembro de 2020. Resultados: 23 biópsias foram realizadas com procedimentos minimamente invasivos. 60,86% eram do sexo masculino e a idade média era de 66 anos. A prevalência de amiloidose foi de 33%. A sensibilidade foi de 55% e a especificidade de 100%. Um paciente teve mais sangramento que o normal durante o procedimento e nenhum apresentou complicações pós-operatórias. Conclusões: Foram descritas experiências de biópsia GSM como ferramenta diagnóstica para amiloidose, relatando uma leve complicação intra-operatória e nenhuma complicação pós-operatória. O teste atingiu uma sensibilidade de 55% e uma especificidade de 100%.Fil: Alfonsin, Amalia Ernestina. Hospital Italiano. Instituto Universitario. Escuela de Medicina; ArgentinaFil: Escada, Sofia Stephanie. Hospital Italiano. Departamento de Medicina. Servicio de Clínica Médica; ArgentinaFil: Kohan, Dana. Hospital Italiano; ArgentinaFil: Valeo Chulvi, Melina Paula. Hospital Italiano; ArgentinaFil: Posadas Martinez, Maria Lourdes. Hospital Italiano. Departamento de Medicina. Servicio de Clínica Médica; Argentina. Consejo Nacional de Investigaciones Cientificas y Tecnicas. Oficina de Coordinacion Administrativa Houssay. Instituto de Medicina Traslacional E Ingenieria Biomedica. - Hospital Italiano. Instituto de Medicina Traslacional E Ingenieria Biomedica. - Instituto Universitario Hospital Italiano de Buenos Aires. Instituto de Medicina Traslacional E Ingenieria Biomedica.; ArgentinaFil: Aguirre, Maria Adela. Hospital Italiano. Instituto Universitario. Escuela de Medicina; ArgentinaFil: Nucifora, Elsa Mercedes. Hospital Italiano. Departamento de Medicina. Servicio de Clínica Médica; Argentin
History of human occupations during the Late Holocene on a terrace in Barrancas, Jujuy Province
Se presentan los resultados de distintas líneas de evidencia (lítico, fauna, cerámica, arquitectura cronología) procedentes de tres sitios arqueológicos. El área estudiada en este trabajo es una terraza de la Reserva Municipal de Barrancas-Abdón Castro Tolay en la Puna Seca, Provincia de Jujuy. Los estudios presentados aquí corroboran que el lugar habría sido el emplazamiento de un extenso campamento de las últimas poblaciones cazadoras-recolectoras a los inicios del Holoceno tardío, probablemente a continuación de una ocupación del Holoceno medio. Luego de un hiato de ocupaciones, el lugar habría sido utilizado como paradero en el marco del tráfico caravanero llamero durante entre los siglos IX y XIII de nuestra era. Contemporánea y posteriormente a la llegada de los españoles, el sitio habría sido utilizado como vivienda por un grupo poco extenso en el marco de estrategias ganaderas, las cuales se extendieron hasta la actualidad. Los análisis de procesos de formación y tafonómicos evidencian perturbaciones de origen antrópico a partir de ca. 1000 años cal. AP en algunos sectores, aunque se destaca la diferenciación marcada de la depositación de materiales y de la formación de los estratos arqueológicos.This paper presents the results of the analyses of different lines of evidence (lithic, fauna, ceramics, architecture, chronology) from three archaeological sites located on a terrace in the BarrancasAbdón Castro Tolay Municipal Reserve in the Dry Puna, Jujuy Province. The results corroborate that this was the site of a major hunter-gatherer camp at the beginning of the late Holocene period; this was probably a continuance of occupation during the mid-Holocene period. After a hiatus, the place was again occupied as a stopover for llama caravan traffic between the IX and XIII centuries. During and after the arrival of the Spanish, a small group of camelid herders dwelled on the site, which remains the case today. Analysis of formation and taphonomic processes show disturbances of anthropic origin from ca. 1000 years cal BP onwards in some sectors. The marked differentiation in the deposition of materials and the formation of archaeological strata is noteworthy.Fil: Hoguin, Rodolphe Gregory. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Mendoza. Instituto Interdisciplinario de Ciencias Básicas. - Universidad Nacional de Cuyo. Instituto Interdisciplinario de Ciencias Básicas; Argentina. Universidad Nacional de Cuyo. Facultad de Ciencias Exactas y Naturales. Laboratorio de Paleoecología Humana; ArgentinaFil: Samec, Celeste Tamara. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Ciudad Universitaria. Instituto de Geocronología y Geología Isotópica. Universidad de Buenos Aires. Facultad de Ciencias Exactas y Naturales. Instituto de Geocronología y Geología Isotópica; ArgentinaFil: Rouan Sirolli, Mercedes. Universidad de Buenos Aires. Facultad de Filosofía y Letras. Instituto de Arqueología; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Merler Carbajo, Julia. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Ciudad Universitaria. Instituto de Biodiversidad y Biología Experimental y Aplicada. Universidad de Buenos Aires. Facultad de Ciencias Exactas y Naturales. Instituto de Biodiversidad y Biología Experimental y Aplicada; ArgentinaFil: Morales, Marcelo Raul. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Ciudad Universitaria. Instituto de Biodiversidad y Biología Experimental y Aplicada. Universidad de Buenos Aires. Facultad de Ciencias Exactas y Naturales. Instituto de Biodiversidad y Biología Experimental y Aplicada; ArgentinaFil: Oxman, Brenda. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Filosofía y Letras. Instituto de Arqueología; ArgentinaFil: Alvarez, Luciana Sofia. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Filosofía y Letras. Instituto de Arqueología; ArgentinaFil: Castillo, Agustín. Universidad Nacional de Cuyo. Facultad de Filosofía y Letras; ArgentinaFil: Cunietti, Gianni Marcelo. Universidad Nacional de Cuyo. Facultad de Filosofía y Letras; ArgentinaFil: Kohan, Patricio. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Saavedra 15. Instituto Multidisciplinario de Historia y Ciencias Humanas; ArgentinaFil: Mamani, Humberto. Gobierno de la Provincia de Jujuy. Ministerio de Cultura y Turismo. Secretaria de Cultura; ArgentinaFil: Yacobaccio, Hugo Daniel. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Filosofía y Letras. Instituto de Arqueología; Argentin
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Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial
BackgroundSparsentan, a novel, non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist, significantly reduced proteinuria versus irbesartan, an angiotensin II receptor blocker, at 36 weeks (primary endpoint) in patients with immunoglobulin A nephropathy in the phase 3 PROTECT trial's previously reported interim analysis. Here, we report kidney function and outcomes over 110 weeks from the double-blind final analysis.MethodsPROTECT, a double-blind, randomised, active-controlled, phase 3 study, was done across 134 clinical practice sites in 18 countries throughout the Americas, Asia, and Europe. Patients aged 18 years or older with biopsy-proven primary IgA nephropathy and proteinuria of at least 1·0 g per day despite maximised renin–angiotensin system inhibition for at least 12 weeks were randomly assigned (1:1) to receive sparsentan (target dose 400 mg oral sparsentan once daily) or irbesartan (target dose 300 mg oral irbesartan once daily) based on a permuted-block randomisation method. The primary endpoint was proteinuria change between treatment groups at 36 weeks. Secondary endpoints included rate of change (slope) of the estimated glomerular filtration rate (eGFR), changes in proteinuria, a composite of kidney failure (confirmed 40% eGFR reduction, end-stage kidney disease, or all-cause mortality), and safety and tolerability up to 110 weeks from randomisation. Secondary efficacy outcomes were assessed in the full analysis set and safety was assessed in the safety set, both of which were defined as all patients who were randomly assigned and received at least one dose of randomly assigned study drug. This trial is registered with ClinicalTrials.gov, NCT03762850.FindingsBetween Dec 20, 2018, and May 26, 2021, 203 patients were randomly assigned to the sparsentan group and 203 to the irbesartan group. One patient from each group did not receive the study drug and was excluded from the efficacy and safety analyses (282 [70%] of 404 included patients were male and 272 [67%] were White) . Patients in the sparsentan group had a slower rate of eGFR decline than those in the irbesartan group. eGFR chronic 2-year slope (weeks 6–110) was −2·7 mL/min per 1·73 m2 per year versus −3·8 mL/min per 1·73 m2 per year (difference 1·1 mL/min per 1·73 m2 per year, 95% CI 0·1 to 2·1; p=0·037); total 2-year slope (day 1–week 110) was −2·9 mL/min per 1·73 m2 per year versus −3·9 mL/min per 1·73 m2 per year (difference 1·0 mL/min per 1·73 m2 per year, 95% CI −0·03 to 1·94; p=0·058). The significant reduction in proteinuria at 36 weeks with sparsentan was maintained throughout the study period; at 110 weeks, proteinuria, as determined by the change from baseline in urine protein-to-creatinine ratio, was 40% lower in the sparsentan group than in the irbesartan group (−42·8%, 95% CI −49·8 to −35·0, with sparsentan versus −4·4%, −15·8 to 8·7, with irbesartan; geometric least-squares mean ratio 0·60, 95% CI 0·50 to 0·72). The composite kidney failure endpoint was reached by 18 (9%) of 202 patients in the sparsentan group versus 26 (13%) of 202 patients in the irbesartan group (relative risk 0·7, 95% CI 0·4 to 1·2). Treatment-emergent adverse events were well balanced between sparsentan and irbesartan, with no new safety signals.InterpretationOver 110 weeks, treatment with sparsentan versus maximally titrated irbesartan in patients with IgA nephropathy resulted in significant reductions in proteinuria and preservation of kidney function
Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial
Background
Sparsentan, a novel, non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist, significantly reduced proteinuria versus irbesartan, an angiotensin II receptor blocker, at 36 weeks (primary endpoint) in patients with immunoglobulin A nephropathy in the phase 3 PROTECT trial's previously reported interim analysis. Here, we report kidney function and outcomes over 110 weeks from the double-blind final analysis.
Methods
PROTECT, a double-blind, randomised, active-controlled, phase 3 study, was done across 134 clinical practice sites in 18 countries throughout the Americas, Asia, and Europe. Patients aged 18 years or older with biopsy-proven primary IgA nephropathy and proteinuria of at least 1·0 g per day despite maximised renin–angiotensin system inhibition for at least 12 weeks were randomly assigned (1:1) to receive sparsentan (target dose 400 mg oral sparsentan once daily) or irbesartan (target dose 300 mg oral irbesartan once daily) based on a permuted-block randomisation method. The primary endpoint was proteinuria change between treatment groups at 36 weeks. Secondary endpoints included rate of change (slope) of the estimated glomerular filtration rate (eGFR), changes in proteinuria, a composite of kidney failure (confirmed 40% eGFR reduction, end-stage kidney disease, or all-cause mortality), and safety and tolerability up to 110 weeks from randomisation. Secondary efficacy outcomes were assessed in the full analysis set and safety was assessed in the safety set, both of which were defined as all patients who were randomly assigned and received at least one dose of randomly assigned study drug. This trial is registered with ClinicalTrials.gov, NCT03762850.
Findings
Between Dec 20, 2018, and May 26, 2021, 203 patients were randomly assigned to the sparsentan group and 203 to the irbesartan group. One patient from each group did not receive the study drug and was excluded from the efficacy and safety analyses (282 [70%] of 404 included patients were male and 272 [67%] were White) . Patients in the sparsentan group had a slower rate of eGFR decline than those in the irbesartan group. eGFR chronic 2-year slope (weeks 6–110) was −2·7 mL/min per 1·73 m2 per year versus −3·8 mL/min per 1·73 m2 per year (difference 1·1 mL/min per 1·73 m2 per year, 95% CI 0·1 to 2·1; p=0·037); total 2-year slope (day 1–week 110) was −2·9 mL/min per 1·73 m2 per year versus −3·9 mL/min per 1·73 m2 per year (difference 1·0 mL/min per 1·73 m2 per year, 95% CI −0·03 to 1·94; p=0·058). The significant reduction in proteinuria at 36 weeks with sparsentan was maintained throughout the study period; at 110 weeks, proteinuria, as determined by the change from baseline in urine protein-to-creatinine ratio, was 40% lower in the sparsentan group than in the irbesartan group (−42·8%, 95% CI −49·8 to −35·0, with sparsentan versus −4·4%, −15·8 to 8·7, with irbesartan; geometric least-squares mean ratio 0·60, 95% CI 0·50 to 0·72). The composite kidney failure endpoint was reached by 18 (9%) of 202 patients in the sparsentan group versus 26 (13%) of 202 patients in the irbesartan group (relative risk 0·7, 95% CI 0·4 to 1·2). Treatment-emergent adverse events were well balanced between sparsentan and irbesartan, with no new safety signals.
Interpretation
Over 110 weeks, treatment with sparsentan versus maximally titrated irbesartan in patients with IgA nephropathy resulted in significant reductions in proteinuria and preservation of kidney function.</p