Patient Information and Informed Consent for Research in the Elderly : lessons Learned from a Randomized Controlled Trial

The informed consent (IC) of subjects participating in experimental studies is the mainstay to comply with the ethical principle of autonomy to ensure that the participation is voluntary. This experience was performed within the context of a single-center randomized clinical trial in elective prosthetic surgery. Obtaining IC in clinical trials is not without difficulties, and especially in the case of vulnerable populations it can be very challenging. This work aimed to identify the difficulties during the IC process for a clinical trial in subjects older than 65 years old and quantify and describe the use of IC in front of a witness. Methods: This is a mixed methodology study with a qualitative part (focus group with 4 nurses involved in the inclusion of subjects) and a quantitative part describing the characteristics of patients who signed IC forms. Results: The main difficulties identified are related to comprehension, sensory impairments, education level, and time. IC in front of witnesses was used in 20 patients out of 508. Conclusions: The participation of subjects older than 65 years old in clinical trials requires an adaptation of the process. The use of IC in front of a witness should always be considered in studies including elderly subjects

La implementación de un modelo de Proyecto Emprendedor Grupal de Aula, fomentando el uso de las nuevas tecnologías y el desarrollo de competencias transversales y emprendedoras aplicadas al campo profesional.

Utilizar el Proyecto Emprededor de Aula como una fuente de aprendizaje y emprendimiento entre los jóvenes dentro del aula

“Micropíldoras” educativas para la formación práctica en las asignaturas de la Unidad Docente de Terapia Celular del Departamento de Medicina

Memoria ID-047 Ayudas de la Universidad de Salamanca para la innovación docente, curso 2020-2021

A Case Study of available methodology for the identification of Vulnerable Ecosystems/Habitats in bottom deep-sea fisheries: Possibilities to apply this method in the NAFO Regulatory Area in order to select Marine Protected Areas

Information is critical to Ecosystem Approach and to research about Vulnerable Marine Ecosystems/Habitats (VME/Hs), fishing impacts on habitats and ad-hoc management measures are high-priority. Therefore, this paper presents the ECOVUL/ARPA Interdisciplinary Approach, a case study of methodology for the identification of VME/Hs in order to advise on conservation measures such as marine protected areas (MPAs). By means of an interactive process involving Conventional Fisheries Science, Geomorphology, Sedimentology and Benthic Ecology, the methodology developed under the ECOVUL/ARPA project, has been useful in order to contribute to define practical criteria to the identification of VME/Hs, to improve the knowledge about VME/Hs distribution and the adverse impacts of bottom trawl fisheries and to produce high quality advice on habitat protection. Applying an interdisciplinary approach, the project identified the deep-water bottom trawl fishery footprint on the Hatton Bank Western slope (NEAFC Regulatory Area), mapped the main fishing grounds and related seabed habitats and studied the interactions between fishing and cold-water corals. This approach was used to suggest, with high level of precision, the spatial limits of an area closed to bottom fishing, as an essential conservation measure to protect the cold-water corals in the framework of the Ecosystem Approach to Fisheries management. We present here the methods used, the main results obtained and discuss on the utility of this approach and the possibilities to apply it in the NAFO Regulatory Area, with the aim to advise on measures for reducing the interactions of bottom fishing with sensitive high-seas habitats and to contribute to implement the UNGA recommendations about habitat conservation

Concordance of the risk of neonatal respiratory morbidity assessed by quantitative ultrasound lung texture analysis in fetuses of twin pregnancies

To evaluate the concordance of the risk of neonatal respiratory morbidity (NRM) assessed by quantitative ultrasound lung texture analysis (QuantusFLM) between twin fetuses of the same pregnancy. Prospective study conducted in twin pregnancies. There was good concordance of the risk of NRM between twins 34.0 weeks. From 30.0 to 33.6 weeks 26.5% of the twin pairs had discordant results, with moderate concordance of the risk of NRM

Evaluación competencial en lengua extranjera y en otras competencias transversales del alumnado de la Facultad de Educación

El presente estudio preliminar pretende evaluar el perfil competencial en las áreas de lengua extranjera (inglés) y otras transversales como la alfabetización digital y la gestión de la información del alumnado de la Facultad de Educación. Se eligieron las áreas a evaluar, se elaboraron los ítems correspondientes y se diseñaron dos cuestionarios de evaluación sobre la herramienta Google Formularios. Después de su aplicación y en relación a los resultados obtenidos, se hace necesario ampliar la recogida de información, con la finalidad de fortalecer y profundizar los datos obtenidos

Ethnobotany in Rayones, Nuevo León, México

Trough collections of plants and interviews with 110 individuals, an ethnobotanical study was conducted in order to determine the knowledge and use plant species in Rayones, Nuevo Leon, Mexico. The aim of this study was to record all useful plants and their uses, to know whether differences exist in the knowledge about the number of species and uses between women and men, and to know if there is a correlation between the age of individuals and knowledge of species and their uses

Autologous stem-cell transplantation as consolidation of first-line chemotherapy in patients with peripheral T-cell lymphoma : a multicenter GELTAMO/FIL study

Peripheral T-cell lymphomas (PTCL) are a heterogeneous group of rare lymphoid malignancies that mostly have poor prognoses with currently available treatments. Upfront consolidation with autologous stem cell transplantation (ASCT) is frequently carried out, but its efficacy has never been investigated in randomized trials. We designed a multicenter, international, retrospective study with the main objective of comparing progression-free survival and overall survival of patients with PTCL who underwent ASCT in complete remission (CR) after first-line chemotherapy with a control group who did not undergo ASCT. From the initial population of 286 registered patients, 174 patients with PTCL other than anaplastic large cell lymphoma, ALK-positive, deemed fit for ASCT at the time of diagnosis, and who were in CR or uncertain CR after induction therapy (CR1) were included in our analysis. one hundred and three patients underwent ASCT, whereas 71 did not, in most cases (n=53) because the physician decided against it. With a median follow-up of 65.5 months, progression-free survival was significantly better in the transplanted patients than in the non-transplanted group: 63% versus 48% at 5 years (P =0.042). Overall survival was significantly longer for ASCT patients in the subgroup with advanced stage at diagnosis (5-year overall survival: 70% vs. 50%, P =0.028). In the multivariate analysis, first-line ASCT was associated with significantly prolonged progression-free survival (HR=0.57, 95% CI: 0.35-0.93) and overall survival (HR=0.57, 95% CI: 0.33-0.99). In conclusion, our study supports the use of ASCT as a consolidation strategy for patients with PTCL in CR1. These results should be confirmed in a prospective randomized study

Adipose-derived mesenchymal stromal cells for the treatment of patients with severe SARS-CoV-2 pneumonia requiring mechanical ventilation. A proof of concept study

Background: Identification of effective treatments in severe cases of COVID-19 requiring mechanical ventilation represents an unmet medical need. Our aim was to determine whether the administration of adipose-tissue derived mesenchymal stromal cells (AT-MSC) is safe and potentially useful in these patients. Methods: Thirteen COVID-19 adult patients under invasive mechanical ventilation who had received previous antiviral and/or anti-inflammatory treatments (including steroids, lopinavir/ritonavir, hydroxychloroquine and/or tocilizumab, among others) were treated with allogeneic AT-MSC. Ten patients received two doses, with the second dose administered a median of 3 days (interquartile range-IQR- 1 day) after the first one. Two patients received a single dose and another patient received 3 doses. Median number of cells per dose was 0.98 × 106 (IQR 0.50 × 106) AT-MSC/kg of recipient's body weight. Potential adverse effects related to cell infusion and clinical outcome were assessed. Additional parameters analyzed included changes in imaging, analytical and inflammatory parameters. Findings: First dose of AT-MSC was administered at a median of 7 days (IQR 12 days) after mechanical ventilation. No adverse events were related to cell therapy. With a median follow-up of 16 days (IQR 9 days) after the first dose, clinical improvement was observed in nine patients (70%). Seven patients were extubated and discharged from ICU while four patients remained intubated (two with an improvement in their ventilatory and radiological parameters and two in stable condition). Two patients died (one due to massive gastrointestinal bleeding unrelated to MSC therapy). Treatment with AT-MSC was followed by a decrease in inflammatory parameters (reduction in C-reactive protein, IL-6, ferritin, LDH and d-dimer) as well as an increase in lymphocytes, particularly in those patients with clinical improvement. Interpretation: Treatment with intravenous administration of AT-MSC in 13 severe COVID-19 pneumonia under mechanical ventilation in a small case series did not induce significant adverse events and was followed by clinical and biological improvement in most subjects. Funding: None.We would like to acknowledge the Instituto de Salud Carlos III (ISCIII) through the project “RD16/0011: Red de Terapia Celular”, from the sub-program RETICS, integrated in the “Plan Estatal de I+D+I 2013-2016” and co-financed by the European Regional Development Fund “A way to make Europe”, groups RD16/0011/0001, -/0002, -/005, -/0013, -/0015, -/0029), the Centro en Red de Medicina Regenerativa y Terapia Celular de Castilla y León, Spain and AvanCell-CM (Red de Investigación de Terapia Celular de la Comunidad de Madrid, Spain), for supporting some personnel and networking activities

Predicting bee community responses to land-use changes: Effects of geographic and taxonomic biases

Land-use change and intensification threaten bee populations worldwide, imperilling pollination services. Global models are needed to better characterise, project, and mitigate bees' responses to these human impacts. The available data are, however, geographically and taxonomically unrepresentative; most data are from North America and Western Europe, overrepresenting bumblebees and raising concerns that model results may not be generalizable to other regions and taxa. To assess whether the geographic and taxonomic biases of data could undermine effectiveness of models for conservation policy, we have collated from the published literature a global dataset of bee diversity at sites facing land-use change and intensification, and assess whether bee responses to these pressures vary across 11 regions (Western, Northern, Eastern and Southern Europe; North, Central and South America; Australia and New Zealand; South East Asia; Middle and Southern Africa) and between bumblebees and other bees. Our analyses highlight strong regionally-based responses of total abundance, species richness and Simpson's diversity to land use, caused by variation in the sensitivity of species and potentially in the nature of threats. These results suggest that global extrapolation of models based on geographically and taxonomically restricted data may underestimate the true uncertainty, increasing the risk of ecological surprises