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53 result(s) for "Lema, Laura"
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Estimation of glucose rate of appearance in portal vein circulation using a phenomenological-based model
The joint work of the stomach and the small intestine plays a fundamental role in human digestion. In the stomach, food is turned into a semi-fluid mixture that is slowly released into the small intestine, where most enzymatic reactions occur, and nutrients are absorbed as they become available. This whole process is closely related to glucose homeostasis, mainly because of the appearance of glucose in the portal system and the energetic expenditure of the process itself. The current phenomenological-based model describes such effects of the digestive process on blood glucose concentration. It considers enzymatic and mechanical transformations, energetic expenditure, and the impact of macro-nutrients, fiber, and water on overall digestion and glucose absorption. The model estimates the rate of glucose appearance in the portal vein and is intended to be further integrated into existing models for other human organs and used in model-based systems such as an artificial pancreas with automated insulin delivery.
Estimation of glucose rate of appearance in portal vein circulation using a phenomenological-based model
The joint work of the stomach and the small intestine plays a fundamental role in human digestion. In the stomach, food is turned into a semi-fluid mixture that is slowly released into the small intestine, where most enzymatic reactions occur, and nutrients are absorbed as they become available. This whole process is closely related to glucose homeostasis, mainly because of the appearance of glucose in the portal system and the energetic expenditure of the process itself. The current phenomenological-based model describes such effects of the digestive process on blood glucose concentration. It considers enzymatic and mechanical transformations, energetic expenditure, and the impact of macro-nutrients, fiber, and water on overall digestion and glucose absorption. The model estimates the rate of glucose appearance in the portal vein and is intended to be further integrated into existing models for other human organs and used in model-based systems such as an artificial pancreas with automated insulin delivery.
A digital twin-enhanced decision support system improves time-in-range in type 1 diabetes: a randomized clinical trial
Most individuals with type 1 diabetes (T1D) worldwide continue to be managed with multiple daily injections or sensor-augmented pumps. Decision-support systems (DSSs) have emerged as cost-effective tools to enhance treatment adherence and glucose control. We conducted a randomized, open-label, parallel-group study to evaluate STUDIA, a DSS incorporating a digital twin-enabled simulation-assisted bolus calculator. Twenty-eight participants with T1D used either the simulation-assisted calculator or traditional carbohydrate counting for prandial insulin dosing, with glucose monitored using Freestyle Libre. After four weeks, the group using the simulation-assisted calculator showed a 7% increase in time in the target glucose range (70–180 mg/dL) compared to the control ( p  < 0.001), along with a lower hypoglycemia incidence rate (RR 0.31, p  = 0.022). Model performance yielded a mean absolute percentage error at 60 min of 19.2 ± 6.7%, increasing at longer horizons, with most discrepancies between simulation and sensor falling into no-risk or slight-risk zones. These findings support the safety, feasibility, and potential clinical utility of the STUDIA system in people with T1D.
La paz como mediación: aportes de Sanaduría a los estudios de paz desde la historia conceptual y la museología crítica
Objetivo: demostrar que el proyecto museográfico “Sanaduría, mediaciones para tejer sentidos plurales de la paz” enriquece los estudios de paz a través de un trabajo colaborativo y participativo que ha explorado sentidos plurales de paz situados territorial, histórica y epistemológicamente. Para llevar a cabo este propósito, se da cuenta del proyecto Sanaduría, el cual, sustentado en la escucha, conversaciones constantes y trabajo de campo, ha buscado entender cómo miembros de los pueblos indígenas nasa, murui, wayúu, pasto y camëntsá y sobrevivientes del conflicto armado de la Asociación de Víctimas y Sobrevivientes del Nordeste Antioqueño piensan la paz. Metodología: el texto articula la historia conceptual, la museología crítica y los diálogos interculturales, lo que hace de Sanaduría un laboratorio metodológico que se propone construir nuevas formas de conocimiento y trazar nuevos caminos para entender la conflictividad que atraviesa el concepto de paz. Originalidad: al constituirse en laboratorio metodológico y pedagógico, el artículo muestra que Sanaduría ha descentrado la discusión sobre la paz desde un punto de vista territorial, cultural y epistemológico y constituye un aporte a los estudios de paz. Conclusiones: al hacer la traducción museográfica de sentidos plurales de la paz, como “juntanza”, “abrir caminos”, “mediar pa-labrar”, “enfriar la palabra” y “trenzar comunidad”, se evidencia el trabajo constante que implica el establecimiento de formas de convivencia que no conciben el conflicto como algo que debe ser resuelto o eliminado, sino como algo que se puede transformar, lo que demuestra que la paz no es un concepto universal ni un estado al que se llega, ya que invoca procesos continuos y negociados.
Everolimus plus endocrine therapy beyond CDK4/6 inhibitors progression for HR+ /HER2− advanced breast cancer: a real-world evidence cohort
Purpose Everolimus in combination with endocrine therapy (ET) was formerly approved as 2nd-line therapy in HR(+)/HER2(−) advanced breast cancer (aBC) patients (pts) progressing during or after a non-steroidal aromatase inhibitor (NSAI). Since this approval, the treatment landscape of aBC has changed dramatically, particularly with the arrival of CDK 4–6 inhibitors. Endocrine monotherapy after progression to CDK4/6 inhibitors has shown a limited progression-free survival (PFS), below 3 months. Evidence of the efficacy of everolimus plus ET after CDK4/6 inhibitors is scarce. Methods A retrospective observational study of patients with aBC treated with everolimus and ET beyond CDK4/6-i progression compiled from February 2015 to December 2022 in 4 Spanish hospitals was performed. Clinical and demographic data were collected from medical records. The main objective was to estimate the median progression-free survival (mPFS). Everolimus adverse events (AE) were registered. Quantitative variables were summarized with medians; qualitative variables with proportions and the Kaplan–Meier method were used for survival estimates. Results One hundred sixty-one patients received everolimus plus ET (exemestane: 96, fulvestrant: 54, tamoxifen: 10, unknown: 1) after progressing on a CDK4/6 inhibitor. The median follow-up time was 15 months (interquartile range: 1–56 months). The median age at diagnosis was 49 years (range: 35–90 years). The estimated mPFS was 6.0 months (95%CI 5.3–7.8 months). PFS was longer in patients with previous CDK4/6 inhibitor therapy lasting for > 18 months (8.7 months, 95%CI 6.6–11.3 months), in patients w/o visceral metastases (8.0 months, 95%CI 5.8–10.5 months), and chemotherapy-naïve in the metastatic setting (7.2 months, 95%CI 5.9–8.4 months). Conclusion This retrospective analysis cohort of everolimus plus ET in mBC patients previously treated with a CDK4/6 inhibitor suggests a longer estimated mPFS when compared with the mPFS with ET monotherapy obtained from current randomized clinical data. Everolimus plus ET may be considered as a valid control arm in novel clinical trial designs.
Proactive assessment of patient reported outcomes in ovarian cancer studies: a systematic review and call for action in future studies
ObjectiveThis systematic review aims to evaluate the proactive or real-time assessment of patient reported outcomes in studies involving patients with ovarian cancer undergoing systemic therapy.MethodsPubMed, Embase, and Cochrane databases were searched (from database inception until February 2022), and prospective ovarian cancer studies (experimental or observational) that incorporated patient reported outcomes, including quality of life, were included. The primary objective was to assess the ratio of studies incorporating real-time use of patient reported outcomes among those studies performing patient reported outcomes. A secondary objective was to describe the patient reported outcome reporting. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2020 checklist was followed. Descriptive statistics were used.Results3071 articles were screened, with 117 included in the final analysis. Studies were published between 1990 and 2022, and consisted of 35 735 patients (median 140 patients per study; interquartile range 58–415). Median time from patient enrollment initiation to study publication was 7 years (range 1–15). Most studies were experimental/clinical trials (n=93, 79%) followed by observational (n=23, 20%). Therapeutic strategies were assessed in 98% (91/93) of experimental studies, most frequently chemotherapy (n=53, 58%), followed by antiangiogenics or poly-ADP ribose polymerase (PARP) inhibitors (n=8, 9%, each). Patient reported outcomes were the primary endpoint in 7.5% (7/93) and 83% (19/23) of experimental and observational studies, respectively. The ratio of real-time patient reported outcomes assessment/evaluation was 0.9% (1/117).ConclusionsCompletion of patient reported outcome questionnaires involves time and effort for patients with ovarian cancer. Responses to these questionnaires were only assessed in real time in <1% of analyzed studies. Efforts should be made to incorporate proactive assessment of patient reported outcomes to optimize patient care and safety.
STUDIA: una aplicación para apoyar el conteo de carbohidratos simulando la dinámica de la glucosa
Contexto: El conteo de carbohidratos se ha considerado la forma ideal de calcular la insulina prandial, por ende se han propuesto varias formas de mejorarlo. Objetivo: Proponemos refinar el conteo de carbohidratos utilizando una simulación, la cual se presenta en una aplicación móvil, STUDIA, que simula en tiempo real la glucosa postprandial.Métodos: Utilizamos un fenomenológico del tracto gastrointestinal, acoplado al modelo mínimo para la glucosa postprandial en personas con diabetes mellitus tipo 1 (DM1). Las funciones y requisitos técnicos se definieron mediante un sistema de adquisición de requerimientos. Para la caracterización de usuarios, utilizamos una aproximación basada en el individuo. El ecosistema de datos se evaluó mediante el criterio UX/UI, la curva de aprendizaje, flexibilidad y la posibilidad de ejecutar modelos matemáticos. Utilizamos datos de un paciente con DM1 para ejemplificar el uso de la aplicación y los datos del monitoreo continuo de glucosa para comparación.Resultados: STUDIA fue construida en Android Studio® con una interfaz de usuario y un módulo administrativo basado en la web conectado a AWS®. Permite similar la glucosa basado en el conteo de carbohidratos para su refinamiento. Se utilizan los parámetros del paciente y los datos históricos de la glucosa para el ajuste de la aplicación. Esta aplicación puede ser utilizada tanto por los pacientes para comparar diferentes escenarios al igual que en la investigación clínica. Conclusiones: Presentamos la primera aplicación para simular la glucosa postprandial basada en un modelo fenomenológico del tracto gastrointestinal para pacientes con DM1. STUDIA se probará con datos históricos de pacientes y en un ensayo clínico.
Niraparib Plus Aromatase Inhibitors for Hormone Receptor-Positive/HER2-Negative Advanced Breast Cancer with a Germline BRCA Mutation
Background: Niraparib is an oral poly (adenosine diphosphate-ribose) polymerase inhibitor with promising activity for patients with advanced breast cancer harboring germline BRCA1/2 mutations. Methods: LUZERN (NCT04240106) was a multicenter, open-label, Simon’s two-stage, phase II clinical trial evaluating the efficacy and safety of niraparib with aromatase inhibitors (AIs) for patients with HR-positive/HER2-negative advanced breast cancer with either a germline BRCA1/2 mutation (cohort A) or germline BRCA1/2 wild-type and homologous recombination deficiency (exploratory cohort B). Eligible patients received ≤1 line of chemotherapy and 1–2 prior lines of endocrine therapy for advanced disease with secondary resistance to the last AI-based regimen. Patients received niraparib (300 mg or 200 mg) plus an AI. The primary endpoint was the clinical benefit rate (CBR) in cohort A. Results: Between June 2020 and November 2022, 14 patients were enrolled in cohort A (n = 6 for stage I, n = 8 for stage II) and no patients were enrolled in cohort B. One patient was excluded from the efficacy analysis due to no prior AI treatment. Nearly all patients (92.9%) previously received a cyclin-dependent kinase 4/6 inhibitor, but no patients had received prior platinum-based chemotherapy. Median follow-up was 16.7 months (range: 13.2–18.2). The CBR was 46.2% (95% CI: 19.2–74.9), meeting the primary endpoint. Median progression-free survival was 5.5 months (95% CI: 1.9–8.5), and median overall survival was 18.1 months (95% CI: 9.7–NE). The safety profile was consistent with the known toxicity of both drugs. Conclusions: Niraparib combined with an AI has encouraging antitumor activity and a manageable safety profile in patients with AI-resistant HR-positive/HER2-negative advanced breast cancer with germline BRCA1/2 mutations.
La paz como mediación: aportes de Sanaduría a los estudios de paz desde la historia conceptual y la museología crítica
Objetivo: demostrar que el proyecto museográfico “Sanaduría, mediaciones para tejer sentidos plurales de la paz” enriquece los estudios de paz a través de un trabajo colaborativo y participativo que ha explorado sentidos plurales de paz situados territorial, histórica y epistemológicamente. Para llevar a cabo este propósito, se da cuenta del proyecto Sanaduría, el cual, sustentado en la escucha, conversaciones constantes y trabajo de campo, ha buscado entender cómo miembros de los pueblos indígenas nasa, murui, wayúu, pasto y camëntsá y sobrevivientes del conflicto armado de la Asociación de Víctimas y Sobrevivientes del Nordeste Antioqueño piensan la paz. Metodología: el texto articula la historia conceptual, la museología crítica y los diálogos interculturales, lo que hace de Sanaduría un laboratorio metodológico que se propone construir nuevas formas de conocimiento y trazar nuevos caminos para entender la conflictividad que atraviesa el concepto de paz. Originalidad: al constituirse en laboratorio metodológico y pedagógico, el artículo muestra que Sanaduría ha descentrado la discusión sobre la paz desde un punto de vista territorial, cultural y epistemológico y constituye un aporte a los estudios de paz. Conclusiones: al hacer la traducción museográfica de sentidos plurales de la paz, como “juntanza”, “abrir caminos”, “mediar pa-labrar”, “enfriar la palabra” y “trenzar comunidad”, se evidencia el trabajo constante que implica el establecimiento de formas de convivencia que no conciben el conflicto como algo que debe ser resuelto o eliminado, sino como algo que se puede transformar, lo que demuestra que la paz no es un concepto universal ni un estado al que se llega, ya que invoca procesos continuos y negociados.