European regulators' views on a wearable-derived performance measurement of Ambulation for Duchenne Muscular Dystrophy regulatory trials

Abstract Development of novel therapies for Duchenne muscular dystrophy (DMD) are driving the need for more efficient ways of detecting changes in disease- progression in DMD [1] . However, medicines' approval must be based on outcome measures that are acceptable from a regulatory perspective. In this article, European regulators provide an update on the recent regulatory consideration of a new endpoint (Stride Velocity 95th Centile (SV95C)) that could be used in therapeutic DMD trials. This new endpoint aims to quantify a patient's ambulation directly, reliably and continuously in a home environment with a wearable device

Effects of clinical decision topic on patients’ involvement in and satisfaction with decisions and their subsequent implementation

Clinical decision-making is the vehicle for mental health care delivery, and predictors of decision-making experience and adherence are under-researched. The aim was to investigate the relationship between decision topic and kind of involvement in the decision, satisfaction and subsequent implementation, from both staff and patient perspectives

Avanços e aplicações da bioengenharia tecidual

Bioengineering compiles knowledge of major areas of science such as biology and engineering, which are currently used in restorative medicine. Recent advances in tissue engineering have enabled the development and improvement of new biomaterials. These should encourage adherence, differentiation and proliferation, and yet promote the production of specific molecules of the target tissue. The cells used in therapy can be the bone marrow’s mesenchymal cells, specific adult cells from the patient, as well as the embryonic stem cells which have the capacity to differentiate themselves into multiple lineages in vitro. Stem cells have been used in several areas of health. Mesenchymal cells and dental pulp are sources of stem cells that can differentiate themselves into fibroblasts, cementoblasts and osteoblasts. In order to obtain such differentiation some signs are necessary to direct the development’s and the tissue’s regeneration’s steps. One of the major challenges of tissue engineering is to discover these signs and steps with the purpose of understanding the necessary signals for the tissue’s reproduction. Advances in research on stem cells and on tissue bioengineering offer opportunities to develop new therapies such as gene therapy, as well as studies related to angiogenesis. Nowadays, it is known that the adult stem cells are present in blood vessels, pancreas, liver, brain, dental pulp, among other tissues, however the bone marrow cells are the most studied in the context of many diseases, especially the cardiovascular ones. After the embryonic stem cells, the most questionable biological treatment is the gene therapy. In order to correct genetic defects, it is necessary to insert genes into the cells which, most of the times, are introduced by means of virus. This article has the scope of approaching the role of the stem cells, the angiogenesis, the gene therapy in tissue bioengineering and the cell’s interaction associated with biomaterials.A bioengenharia compila conhecimentos de grandes áreas da ciência, como a biologia e a engenharia, que são aplicados atualmente na medicina reparadora. Recentes avanços na área da engenharia tecidual possibilitaram o desenvolvimento e aperfeiçoamento de novos biomateriais. Estes devem estimular a adesão, diferenciação e proliferação celular, e ainda promover a produção de moléculas específicas do tecido-alvo. As células usadas na terapia podem ser mesenquimais de medula óssea, células adultas específicas do próprio paciente e também as células-tronco embrionárias, as quais têm capacidade de se diferenciar em múltiplas linhagens in vitro. As células-tronco têm sido empregadas em diversas áreas da saúde. Células mesenquimais e polpa dental são fontes de células-tronco que podem se diferenciar em fibroblastos, cementoblastos e osteoblastos. Para que ocorra tal diferenciação, são necessários alguns sinais para direcionar as etapas do desenvolvimento e da regeneração tecidual. Um dos grandes desafios da engenharia tecidual é desvendar esses sinais e etapas para tentar entender as sinalizações necessárias à reprodução do tecido. Os avanços das pesquisas com células-tronco e a bioengenharia tecidualabrem oportunidades para desenvolver novas terapias, como a terapia gênica e os estudos relacionados com a angiogênese. Hoje em dia, sabe-se que as células-tronco adultas estão presentes nos vasos sanguíneos, no pâncreas, no fígado, no cérebro, na polpa dentária, entre outros tecidos, mas são as células da medula óssea as mais estudadas no contexto de muitas doenças, especialmente as cardiovasculares. Depois das células-tronco embrionárias, o tratamento biológico mais questionado é a terapia gênica. Para corrigir defeitos genéticos, é preciso inserir genes na célula que, na maioria das vezes, são introduzidos por meio de vírus. Este artigo tem como escopo abordar a atuação das células-tronco, a angiogênese, a terapia gênica na bioengenharia tecidual e a interação celular associada aos biomateriais

CONDIÇÕES DE TRABALHO NO CONTEXTO DE CATADORAS DE MATERIAIS RECICLÁVEIS: DESAFIOS E PERSPECTIVAS PARA O TRABALHO SEGURO

RESUMO O estudo objetivou descrever as condições de trabalho segundo a percepção de catadoras de materiais recicláveis associadas, destacando os desafios e perspectivas para o trabalho seguro a partir da ação assistencial de enfermagem. Trata-se de estudo qualitativo, fundamentado na Pesquisa Convergente-Assistencial, realizado com 11 catadoras de materiais recicláveis de uma associação do Sul do Brasil. Os dados foram produzidos por meio de observação participante, entrevistas semiestruturadas e grupo de convergência. A análise foi realizada por meio dos passos estabelecidos pelo método: apreensão, síntese, teorização e transferência. Como resultados emergiram três categorias: “Organização do trabalho como elemento agravante das condições de trabalho: desencontros no processo de comunicação e colaboração”; “As condições de trabalho agravadas pelo rodízio de atividades e sobrecarga laboral”; e “Perspectivas para o trabalho seguro: problematizando as condições de trabalho”. Os dados evidenciam que as catadoras vivenciam precárias condições de trabalho relacionadas, principalmente, à execução das tarefas, dificultada por falhas nos processo de comunicação e colaboração entre os membros da equipe e com os fornecedores de materiais recicláveis. As precárias condições de trabalho culminam em sobrecarga, dor, automedicação e acidentes. A problematização das condições trabalho mostrou-se uma exitosa prática assistencial para a promoção do trabalho seguro. Concluiu-se que a mediação de um espaço de diálogo e pactuação pode oferecer perspectivas para a otimização do trabalho seguro

FORTALECIMIENTO MUTUO ENTRE LA ECONOMÍA CIRCULAR Y HERRAMIENTAS DE CICLO DE VIDA

Introducción: Para dar respuesta a los objetivos de la Agenda 2030, se requiere que los patrones de consumo y producción dejen de ser lineales y se cambien al modelo de la economía circular (EC). La circularidad de los flujos de materiales y recursos deben ser medibles y pueden apoyarse de herramientas de ciclo de vida para la toma de decisiones, que permitan evaluar los impactos ambientales, sociales y de costos de productos o servicios. Objetivo: Mostrar que las herramientas de ciclo de vida y los indicadores de circularidad se fortalecen mutuamente, para lograr un modelo de producción y consumo más sostenible. Materiales y Métodos: Se realizó la búsqueda de publicaciones entre 2018-2022, que integraran metodologías de Análisis de Ciclo de Vida (ACV), Costo del Ciclo de Vida (CCV) y el Análisis de Ciclo de Vida Social (ACV-S) con indicadores de circularidad. Se analizaron clasificándolos conforme a los indicadores de Circularidad de Materiales (ICM), Análisis de Flujo de Materiales (AFM) y otros. Resultados y Discusión: Los indicadores de circularidad tienen limitaciones en cuanto a factores de calidad de reciclaje de materiales, aspectos ambientales y estandarización, por lo que requieren de ACV, CCV y ACV-S. Por su parte estas metodologías requieren de indicadores para garantizar el grado de circularidad de las alternativas evaluadas y recomendadas como mejores. Conclusiones: La aplicación de herramientas de ciclo de vida e indicadores de circularidad, permitió constatar que son complementarios y se fortalecen mutuamente, lo que redunda en evaluaciones que cumplen con los pilares de la sostenibilidad

The variable finesse locking technique

Virgo is a power recycled Michelson interferometer, with 3 km long Fabry-Perot cavities in the arms. The locking of the interferometer has been obtained with an original lock acquisition technique. The main idea is to lock the instrument away from its working point. Lock is obtained by misaligning the power recycling mirror and detuning the Michelson from the dark fringe. In this way, a good fraction of light escapes through the antisymmetric port and the power build-up inside the recycling cavity is extremely low. The benefit is that all the degrees of freedom are controlled when they are almost decoupled, and the linewidth of the recycling cavity is large. The interferometer is then adiabatically brought on to the dark fringe. This technique is referred to as variable finesse, since the recycling cavity is considered as a variable finesse Fabry-Perot. This technique has been widely tested and allows us to reach the dark fringe in few minutes, in an essentially deterministic way

Evaluation of polygenic risk scores for breast and ovarian cancer risk prediction in BRCA1 and BRCA2 mutation carriers

Background: Genome-wide association studies (GWAS) have identified 94 common single-nucleotide polymorphisms (SNPs) associated with breast cancer (BC) risk and 18 associated with ovarian cancer (OC) risk. Several of these are also associated with risk of BC or OC for women who carry a pathogenic mutation in the high-risk BC and OC genes BRCA1 or BRCA2. The combined effects of these variants on BC or OC risk for BRCA1 and BRCA2 mutation carriers have not yet been assessed while their clinical management could benefit from improved personalized risk estimates. Methods: We constructed polygenic risk scores (PRS) using BC and OC susceptibility SNPs identified through population-based GWAS: for BC (overall, estrogen receptor [ER]-positive, and ER-negative) and for OC. Using data from 15 252 female BRCA1 and 8211 BRCA2 carriers, the association of each PRS with BC or OC risk was evaluated using a weighted cohort approach, with time to diagnosis as the outcome and estimation of the hazard ratios (HRs) per standard deviation increase in the PRS. Results: The PRS for ER-negative BC displayed the strongest association with BC risk in BRCA1 carriers (HR = 1.27, 95% confidence interval [CI] = 1.23 to 1.31, P = 8.2 x 10(53)). In BRCA2 carriers, the strongest association with BC risk was seen for the overall BC PRS (HR = 1.22, 95% CI = 1.17 to 1.28, P = 7.2 x 10(-20)). The OC PRS was strongly associated with OC risk for both BRCA1 and BRCA2 carriers. These translate to differences in absolute risks (more than 10% in each case) between the top and bottom deciles of the PRS distribution; for example, the OC risk was 6% by age 80 years for BRCA2 carriers at the 10th percentile of the OC PRS compared with 19% risk for those at the 90th percentile of PRS. Conclusions: BC and OC PRS are predictive of cancer risk in BRCA1 and BRCA2 carriers. Incorporation of the PRS into risk prediction models has promise to better inform decisions on cancer risk management

Virgo calibration and reconstruction of the gravitational wave strain during VSR1

Virgo is a kilometer-length interferometer for gravitational waves detection located near Pisa. Its first science run, VSR1, occured from May to October 2007. The aims of the calibration are to measure the detector sensitivity and to reconstruct the time series of the gravitational wave strain h(t). The absolute length calibration is based on an original non-linear reconstruction of the differential arm length variations in free swinging Michelson configurations. It uses the laser wavelength as length standard. This method is used to calibrate the frequency dependent response of the Virgo mirror actuators and derive the detector in-loop response and sensitivity within ~5%. The principle of the strain reconstruction is highlighted and the h(t) systematic errors are estimated. A photon calibrator is used to check the sign of h(t). The reconstructed h(t) during VSR1 is valid from 10 Hz up to 10 kHz with systematic errors estimated to 6% in amplitude. The phase error is estimated to be 70 mrad below 1.9 kHz and 6 micro-seconds above.Comment: 8 pages, 8 figures, proceedings of Amaldi 8 conference, to be published in Journal of Physics Conference Series (JPCS). Second release: correct typo

A Cross-correlation method to search for gravitational wave bursts with AURIGA and Virgo

We present a method to search for transient GWs using a network of detectors with different spectral and directional sensitivities: the interferometer Virgo and the bar detector AURIGA. The data analysis method is based on the measurements of the correlated energy in the network by means of a weighted cross-correlation. To limit the computational load, this coherent analysis step is performed around time-frequency coincident triggers selected by an excess power event trigger generator tuned at low thresholds. The final selection of GW candidates is performed by a combined cut on the correlated energy and on the significance as measured by the event trigger generator. The method has been tested on one day of data of AURIGA and Virgo during September 2005. The outcomes are compared to the results of a stand-alone time-frequency coincidence search. We discuss the advantages and the limits of this approach, in view of a possible future joint search between AURIGA and one interferometric detector.Comment: 11 pages, 6 figures, submitted to CQG special issue for Amaldi 7 Proceeding