Safety and efficacy of ribociclib plus letrozole in patients with HR+, HER2– advanced breast cancer: Results from the Spanish sub-population of the phase 3b CompLEEment-1 trial

Advanced breast cancer; CDK4/6 inhibitor; PostmenopausalCáncer de mama avanzado; Inhibidor de CDK4/6; PosmenopáusicaCàncer de mama avançat; Inhibidor de CDK4/6; PostmenopàusicaBackground Breast cancer is the most common malignancy and the second leading cause of cancer-related mortality in Spanish women. Ribociclib in combination with endocrine therapy (ET) has shown superiority in prolonging survival in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (ABC) vs. ET alone. Methods CompLEEment-1 is a single-arm, open-label phase 3b trial evaluating ribociclib plus letrozole in a broad population of patients with HR+, HER2– ABC. The primary endpoints were safety and tolerability. Here we report data for Spanish patients enrolled in CompLEEment-1. Results A total of 526 patients were evaluated (median follow-up: 26.97 months). Baseline characteristics showed a diverse population with a median age of 54 years. At study entry, 56.5% of patients had visceral metastases and 8.7% had received prior chemotherapy for advanced disease. Rates of all-grade and Grade ≥3 adverse events (AEs) were 99.0% and 76.2%, respectively; 21.3% of patients experienced a serious AE, and 15.8% of AEs led to treatment discontinuation. AEs of special interest of neutropenia, increased alanine aminotransferase, increased aspartate aminotransferase and QTcF prolongation occurred in 77.8%, 14.8%, 11.4% and 4.0% of patients, respectively. Patients aged >70 years experienced increased rates of all-grade and Grade ≥3 neutropenia and anemia. Efficacy results were consistent with the global study. Conclusions Results from Spanish patients enrolled in CompLEEment-1 are consistent with global data showing efficacy and a manageable safety profile for ribociclib plus letrozole treatment in patients with HR+, HER2− ABC, including populations of interest (NCT02941926).This study was funded by Novartis Pharmaceuticals. The sponsor was involved in the study design, the collection, analysis, and interpretation of data, and the writing of the manuscript

Bayesian Networks for Decision-Making and Causal Analysis under Uncertainty in Aviation

Most decisions in aviation regarding systems and operation are currently taken under uncertainty, relaying in limited measurable information, and with little assistance of formal methods and tools to help decision makers to cope with all those uncertainties. This chapter illustrates how Bayesian analysis can constitute a systematic approach for dealing with uncertainties in aviation and air transport. The chapter addresses the three main ways in which Bayesian networks are currently employed for scientific or regulatory decision-making purposes in the aviation industry, depending on the extent to which decision makers rely totally or partially on formal methods. These three alternatives are illustrated with three aviation case studies that reflect research work carried out by the authors

Efectos de los ejercicios pliométricos en pacientes postoperatorio de rotura del tendón calcáneo

It is known about the rupture of the Achilleus tendon since ancient Greece, which has been increasing in recent years, therefore, it seeks to implement better tools for its treatment, one of them being plyometric exercises. Meta-analysis type studies, randomized and experimental controlled trials observed that the application of plyometric exercises in most of the participants improved the quality of the tendon, increasing elasticity and decreasing its stiffness (p <0.01) in 14 studies and in the remaining 3 studies. , did not improve the structure of the tendon, however, it did improve its symptoms and functionality in late studies (p <0.01). The application of plyometric exercises is an additional tool to treat subjects undergoing an operation to rupture the Achilles tendon, which must be applied in the final stages of rehabilitation, improving tissue stiffness, increasing functionality and reducing chronic pain.De la ruptura del tendón Aquileo se tiene conocimiento desde la antigua Grecia, la cual ha ido en aumento en los últimos años, por ende, se busca implementar mejores herramientas para el tratamiento de la misma, siendo una de ellas los ejercicios pliométricos. Estudios tipo meta-análisis, ensayos controlados aleatorizados y experimentales observaron que la aplicación de ejercicios pliométricos en la mayoría de los participantes mejoraba la calidad del tendón, aumentando elasticidad y disminuyendo su rigidez  (p<0.01) en 14 estudios y en los 3 estudios restantes, no mejoraba la estructura del tendón, sin embargo, mejoraba la sintomatología y funcionalidad del mismo en estudios tardíos (p<0.01). La aplicación de ejercicios pliométricos es una herramienta adicional para tratar a los sujetos sometidos a una operación de ruptura de tendón Aquileo, el cual debe ser aplicado en estadios finales en rehabilitación, mejorando la rigidez del tejido, aumentando la funcionalidad y disminuyendo el dolor crónico

A single bout of whole-body vibration improves hamstring flexibility in university athletes: A randomized controlled trial

Hamstring muscle injuries are one of most frequent injuries in team sports. Whole-body vibration (WBV) has an important effect on flexibility that could prevent shortening of the hamstrings. To investigate both acute and residual effect of a single bout of WBV on hamstring flexibility in a group of university athletes from team sports 70 athletes (81% men, age 21 ± 1.9 years old) were separated into three groups; control group (CG; n=24), hamstring flexibility group without vibration (-V; n=23), and hamstring flexibility group with vibration (+V; n=23). Both -V and +V groups performed the same experimental protocol, composed of 6 sets of 30 seconds of passive hamstring flexibility over a vibration platform with both legs alternately (full-length 6 minutes; 3 minutes per leg). A high-magnitude vibration loading was applied only in +V group (40 Hz and 4 mm). Hamstring flexibility was evaluated through the Modified Sit and Reach (MSR) and Passive Straight Leg Raise (PSLR) test before (baseline), immediately after (acute effect), and after 72 h (residual effect) intervention. Both experimental groups showed a significant improvement in flexibility compared to CG in all measures (p<0.05). No statistical differences were found between +V and –V, however, MSR, right PSLR, and left PSLR residual effect size (Cohen's d) were greater in +V. In conclusion, adding a WBV stimulus to flexibility training improves acute and residual hamstring flexibility in university athletes from team sports

Study protocol and rationale of the “Cogniaction project” a cross-sectional and randomized controlled trial about physical activity, brain health, cognition, and educational achievement in schoolchildren

Background: Education and health are crucial topics for public policies as both largely determine the future wellbeing of the society. Currently, several studies recognize that physical activity (PA) benefits brain health in children. However, most of these studies have not been carried out in developing countries or lack the transference into the education field. The Cogni-Action Project is divided into two stages, a cross-sectional study and a crossover-randomized trial. The aim of the first part is to establish the associations of PA, sedentarism, and physical fitness with brain structure and function, cognitive performance and academic achievement in Chilean schoolchildren (10–13 years-old). The aim of the second part is to determinate the acute effects of three PA protocols on neuroelectric indices during a working memory and a reading task. Methods: PA and sedentarism will be self-reported and objectively-assessed with accelerometers in a representative subsample, whilst physical fitness will be evaluated through the ALPHA fitness test battery. Brain structure and function will be assessed by magnetic resonance imaging (MRI) in a randomized subsample. Cognitive performance will be assessed through the NeuroCognitive Performance Test, and academic achievement by school grades. In the second part 32 adolescents (12–13 year-old) will be cross-over randomized to these condition (i) “Moderate-Intensity Continuous Training” (MICT), (ii) “Cooperative High-Intensity Interval Training” (C-HIIT), and (iii) Sedentary condition. Neuroelectric indices will be measures by electroencephalogram (EEG) and eye-tracking, working memory by n-back task and reading comprehension by a reading task

Qué necesitan los estudiantes de Periodismo para su inserción laboral. Análisis de la demanda del mercado laboral de las empresas de comunicación.

PIMCD nº 176, realizado por el grupo Research and Learning of Media and Communications Management. Investigación y Enseñanza de la Gestión de los Medios y la Comunicación (MediaCom UCM) www.ccinf.es/mediacom/Primera fase de trabajo para fijar descriptores que identifiquen comportamientos formativos de entrada en el mercado laboral. En esta fase se han encontrado 442 oferentes de contratos en prácticas para estudiantes de Periodismo. Los datos obtenidos se articulan de acuerdo a dos subsecciones: sectores empresariales y empresas; a su vez, cada subsector, atendiendo al índice de recepción de alumnos y la descripción cualitativa de los puestos.Depto. de Periodismo y Comunicación GlobalFac. de Ciencias de la InformaciónFALSEsubmitte

Plan de mercadeo para el lanzamiento de un nuevo producto “FRUTIMIEL”

El presente plan de mercadeo de Frutimiel se desarrollo con el fin de identificar la viabilidad para el lanzamiento de un producto natural e innovador a un segmento de mercado definido a partir de investigaciones previas. Se busca que el consumidor utilice el producto como sustituto en relación con los productos endulzantes artificiales, al igual que se pretende brindar la información necesaria y relevante sobre los momentos de consumo de Frutimiel a nuestros potenciales consumidores y así incrementar la demanda del producto. El mercado de la miel de abejas en Colombia no ha sido explotado de forma efectiva, las fincas apícolas tienen una producción baja debido a la falta de recursos financieros y tecnológicos que permitan un adecuado desarrollo del sector, sumado a estos antecedentes tenemos el poco desarrollo del mercado por el bajo consumo, sin embargo en el nuevo milenio se identifican tendencias conductuales que conllevan a reemplazar el consumo de productos sintéticos por naturales, recuperando así la importancia de la ingesta de uno de los néctares más antiguos y nobles: la miel

Plan de mercadeo para el lanzamiento de un nuevo producto “FRUTIMIEL”

El presente plan de mercadeo de Frutimiel se desarrollo con el fin de identificar la viabilidad para el lanzamiento de un producto natural e innovador a un segmento de mercado definido a partir de investigaciones previas. Se busca que el consumidor utilice el producto como sustituto en relación con los productos endulzantes artificiales, al igual que se pretende brindar la información necesaria y relevante sobre los momentos de consumo de Frutimiel a nuestros potenciales consumidores y así incrementar la demanda del producto. El mercado de la miel de abejas en Colombia no ha sido explotado de forma efectiva, las fincas apícolas tienen una producción baja debido a la falta de recursos financieros y tecnológicos que permitan un adecuado desarrollo del sector, sumado a estos antecedentes tenemos el poco desarrollo del mercado por el bajo consumo, sin embargo en el nuevo milenio se identifican tendencias conductuales que conllevan a reemplazar el consumo de productos sintéticos por naturales, recuperando así la importancia de la ingesta de uno de los néctares más antiguos y nobles: la miel

Implementación de la Simulación Clínica como método de aprendizaje, evaluación y análisis de puntos de mejora para alumnos de 4º curso del Grado de Enfermería en el contexto de los seminarios de Enfermería Clínica III

EL proyecto trata de la implementación de la metodología formativa de la "Simulación Clínica" en el contexto de la asignatira "Enfermería Clínica III". Esta metodología permite un aprendizaje no solo teórico, si no desarrollar competencias prácticas en cuanto habilidades técnicas y no técnicas. El resultado del proyecto es positivo, ya que se consigue implementar dicha metodología con unos resultados bastante buenos y una satisfacción general por parte de los alumnos muy elevada

Safety and efficacy of ribociclib plus letrozole in patients with HR+, HER2– advanced breast cancer: Results from the Spanish sub-population of the phase 3b CompLEEment-1 trial

Background: Breast cancer is the most common malignancy and the second leading cause of cancer-related mortality in Spanish women. Ribociclib in combination with endocrine therapy (ET) has shown superiority in prolonging survival in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) vs. ET alone.Methods: CompLEEment-1 is a single-arm, open-label phase 3b trial evaluating ribociclib plus letrozole in a broad population of patients with HR+, HER2- ABC. The primary endpoints were safety and tolerability. Here we report data for Spanish patients enrolled in CompLEEment-1.Results: A total of 526 patients were evaluated (median follow-up: 26.97 months). Baseline characteristics showed a diverse population with a median age of 54 years. At study entry, 56.5% of patients had visceral metastases and 8.7% had received prior chemotherapy for advanced disease. Rates of all-grade and Grade >= 3 adverse events (AEs) were 99.0% and 76.2%, respectively; 21.3% of patients experienced a serious AE, and 15.8% of AEs led to treatment discontinuation. AEs of special interest of neutropenia, increased alanine aminotransferase, increased aspartate aminotransferase and QTcF prolongation occurred in 77.8%, 14.8%, 11.4% and 4.0% of patients, respectively. Patients aged >70 years experienced increased rates of all-grade and Grade >= 3 neutropenia and anemia. Efficacy results were consistent with the global study.Conclusions: Results from Spanish patients enrolled in CompLEEment-1 are consistent with global data showing efficacy and a manageable safety profile for ribociclib plus letrozole treatment in patients with HR+, HER2-ABC, including populations of interest (NCT02941926).Trial registration: ClinicalTrials.gov NCT0294192