NeuroEPO plus (NeuralCIM®) in mild-to-moderate Alzheimer's clinical syndrome: the ATHENEA randomized clinical trial.

BACKGROUND: NeuroEPO plus is a recombinant human erythropoietin without erythropoietic activity and shorter plasma half-life due to its low sialic acid content. NeuroEPO plus prevents oxidative damage, neuroinflammation, apoptosis and cognitive deficit in an Alzheimer's disease (AD) models. The aim of this study was to assess efficacy and safety of neuroEPO plus. METHODS: This was a double-blind, randomized, placebo-controlled, phase 2-3 trial involving participants ≥ 50 years of age with mild-to-moderate AD clinical syndrome. Participants were randomized in a 1:1:1 ratio to receive 0.5 or 1.0 mg of neuroEPO plus or placebo intranasally 3 times/week for 48 weeks. The primary outcome was change in the 11-item cognitive subscale of the AD Assessment Scale (ADAS-Cog11) score from baseline to 48 weeks (range, 0 to 70; higher scores indicate greater impairment). Secondary outcomes included CIBIC+, GDS, MoCA, NPI, Activities of Daily Living Scales, cerebral perfusion, and hippocampal volume. RESULTS: A total of 174 participants were enrolled and 170 were treated (57 in neuroEPO plus 0.5 mg, 56 in neuroEPO plus 1.0 mg and 57 in placebo group). Mean age, 74.0 years; 121 (71.2%) women and 85% completed the trial. The median change in ADAS-Cog11 score at 48 weeks was -3.0 (95% CI, -4.3 to -1.7) in the 0.5 mg neuroEPO plus group, -4.0 (95% CI, -5.9 to -2.1) in the 1.0 mg neuroEPO plus group and 4.0 (95% CI, 1.9 to 6.1) in the placebo group. The difference of neuroEPO plus 0.5 mg vs. placebo was 7.0 points (95% CI, 4.5-9.5) P = 0.000 and between the neuroEPO plus 1.0 mg vs. placebo was 8.0 points (95% CI, 5.2-10.8) P = 0.000. NeuroEPO plus treatment induced a statistically significant improvement in some of clinical secondary outcomes vs. placebo including CIBIC+, GDS, MoCA, NPI, and the brain perfusion. CONCLUSIONS: Among participants with mild-moderate Alzheimer's disease clinical syndrome, neuroEPO plus improved the cognitive evaluation at 48 weeks, with a very good safety profile. Larger trials are warranted to determine the efficacy and safety of neuroEPO plus in Alzheimer's disease. TRIAL REGISTRATION: https://rpcec.sld.cu Identifier: RPCEC00000232.

Automated generation of decision-tree models for the economic assessment of interventions for rare diseases using the RaDiOS ontology.

OBJECTIVE: The development of decision models to assess interventions for rare diseases require huge efforts from research groups, especially regarding collecting and synthesizing the knowledge to parameterize the model. This article presents a method to reuse the knowledge collected in an ontology to automatically generate decision tree models for different contexts and interventions. MATERIAL AND METHODS: We updated the reference ontology (RaDiOS) to include more knowledge required to generate a model. We implemented a transformation tool (RaDiOS-MTT) that uses the knowledge stored in RaDiOS to automatically generate decision trees for the economic assessment of interventions on rare diseases. RESULTS: We used a case study to illustrate the potential of the tool, and automatically generate a decision tree that reproduces an actual study on newborn screening for profound biotinidase deficiency. CONCLUSIONS: RaDiOS-MTT allows research groups to reuse the evidence collected, and thus speeding up the development of health economics assessments for interventions on rare diseases.

Towards the automated economic assessment of newborn screening for rare diseases.

OBJECTIVE: Economic assessments of newborn screening programs for rare diseases involve the use of models and require huge efforts to synthesize information from different sources. Sharing and automatically or semi-automatically reusing this information for new assessments would be desirable, but it is not possible nowadays due to the lack of suitable tools. MATERIAL AND METHODS: We designed and implemented the Rare Diseases Ontology for Simulation (RaDiOS) after performing two reviews, and critically appraising the existing data repositories on rare diseases. The first review involved previous published economic assessments, and served to identify the main parameters required to model newborn screening. The second review aimed at locating existing data repositories potentially available to inform these parameters. RESULTS: We found key model parameters on epidemiology, screening methods, diagnose methods, pathogenesis, treatment and follow-up tests. We also identified seven data repositories directly related to rare diseases. None of such repositories was well-suited for the automated generation of simulation models. We incorporated the identified parameters as structured classes and properties of the new ontology (RaDiOS). We carefully set the relationships among the parameters so to allow automated inference from the ontology. CONCLUSIONS: RaDiOS is an ontology that serves as a data repository to automatically build simulation models for the economic assessment of newborn screening for rare diseases.

Kinetic studies of complex biomedical process by magnetic resonance: Cuban experiences.

The potentials of the magnetic resonance (MR) methods in the research of biomedical systems have been demonstrated during the 70 years of its existence. It is presented that the Cuban experience in quantitative magnetic resonance associated with molecular, preclinical and clinical studies of significant diseases and drugs development. MR "in vitro" and "in vivo" studies of sickle cell disease, the diabetic foot ulcer, the brain tumor response and the magnetic nano-particle pharmacokinetics, are presented as example. Furthermore, contributions and restrictions of magnetic resonance to diagnostic and optimization of therapeutic pathways are discussed in some concrete cases.

A neuro-fuzzy system for extracting environment features based on ultrasonic sensors.

In this paper, a method to extract features of the environment based on ultrasonic sensors is presented. A 3D model of a set of sonar systems and a workplace has been developed. The target of this approach is to extract in a short time, while the vehicle is moving, features of the environment. Particularly, the approach shown in this paper has been focused on determining walls and corners, which are very common environment features. In order to prove the viability of the devised approach, a 3D simulated environment has been built. A Neuro-Fuzzy strategy has been used in order to extract environment features from this simulated model. Several trials have been carried out, obtaining satisfactory results in this context. After that, some experimental tests have been conducted using a real vehicle with a set of sonar systems. The obtained results reveal the satisfactory generalization properties of the approach in this case.

Participación popular y actividades de salud / Popular participation and health activities

La participación popular y las actividades de salud, se abordan teniendo en cuenta los aspectos sociohistóricos de la participación, la participación y la salud en general, y la participación y la salud en Cuba específicamente: Sobre los aspectos socio-históricos de la participación se analiza la vinculación de ésta con las estrategias de desarrollo nacional o local surgidas en América Latina. Se hace evidente la necesidad de precisar los términos de "Comunidad" y "participación", y destacar la determinación histórica de esta última y la función de los objetivos y clases sociales en la forma que adopta. En la participación y la slud en general se analiza la función de la participación en las estrategias que tratan de dar solución a la insuficiente cobertura de los servicios de salud, las limitaciones político-ideológicas de estas concepciones en el contexto de un orden social injusto, y destacar que la participación de la comunidad en el sector saluld debe considerarse como parte del proceso de transformaciones que ha expermentado la sociedad en el curso de su desarrollo histórico, al garantizar su continuidad mediante la comunidad organizada. Por último, en la participación y la salud en Cuba, se destaca que la participación constituye un fundamento político, social y económico del Estado Cubano, lo cual es el resultado del desarrollo histórico de la sociedad cubana, que alcanz

Un enfoque de estudio de los puestos de trabajo de dirección / A study on direction cadres.

Se presenta un estudio de puestos de trabajo orientado hacia los de dirección administrativa, diferenciándolos brevemente de los de la dirección política. Se hace un paralelo entre las direcciones comunistas y capitalistas, basado en las funciones de la masa trabajadora en cada una de ellas; seplantea la necesidad existente en nuestro país, de cómo organizar y dirigir a los hombres en la porducción, de lo que se hace una descripción a partir del triunfo de la Revolución, momento en que se nacionalizan las grandes empresas nacionales y extrajeras y el Estado participa directamente en la economía del país. También se señala el éxodo de profesionales hacia países capitalistas, lo que fácilmente puede suponerse significó una gran tarea que enfrentó la nación; asimismo se expresa el camino seguido hasta el momento en cuanto a política de cuadros, de la que se consideran sus elementos básicos y se exponen criterios en cada uno. Se señalan, además, las características y responsabilidades del dirigente administrativo, y la relación de la dirección con las demás funciones de la administración. Se incluye un esbozo sobre el análisis de los puestos de trabajo y del trabajador: de éste, se exponen distintos métodos y criterios para su aplicación, y se finaliza con lo que puede ser un plan de análisis de puesto de trabajo y las conclusiones generales del tema (AU)