The European framework surrounding clinical trials on medicinal products for human use is going to change as demonstrated by the large debate at European institutional level. One of the major challenges is to overcome the lack of harmonisation of clinical trial procedures among countries. This aspect is gaining more and more importance, considering the increasing number of multicentre and multinational studies. In this work, the actual European rules governing the Clinical Trial Application have been analysed throughout the different steps including (...) the registration of the trial in the European database; the preparation of documents to be submitted and their contents; the preparation of documents related to the information and consent process; the submission to competent bodies. Specific issues related to paediatric research and trials involving non EU/EEA countries have been addressed as well. Results reveal that the European legislation offers a well defined set of European rules covering different aspects of a Clinical Trial Application. However, these are not suitable to meet the challenges from multicentre and multinational clinical studies. A stronger set of rules, such as is available in a composite European Regulation has been adopted and is expected to harmonise practices and enable sponsors to carry out well conducted trials. But will the new regulation overcome the existing criticisms of Directive 2001/20/EC? (shrink)

This study aims to open a critical scenario on the current paradigm of reference for teaching sports techniques by pointing to a methodological perspective that is more in keeping with the theoretical reference framework of the ecological-dynamic approach. Currently, the Constraints-led Approach is considered very useful for teaching sports techniques; however, the transition from pure theory to practice is not so simple and consistent with the heuristic learning paradigm. The purpose is to highlight, starting from the theoretical lines, the methodological (...) applications of the different ways of applying the reference paradigm, analyzing the contrasts of the significant aspects and the uniqueness and unrepeatability of heuristic learning. For this purpose, an in-depth review of the scientific literature was conducted, highlighting the main critical points of the approach, also defined as nonlinear, with the consequent elaboration of operational proposals for the various macro-families of sports. (shrink)

The aim of the present study was to investigate the association between attachment dimensions and neural correlates in response to the Rorschach inkblots. Twenty-seven healthy volunteers were recruited for the electroencephalographic registration during a visual presentation of the Rorschach inkblots and polygonal shapes. The Attachment Style Questionnaire was administered to participants. Correlations between the ASQ scores and standardized low-resolution brain electromagnetic tomography intensities were performed. The Rorschach inkblots elicited several projective responses greater than the polygonal shapes. Only during the Rorschach (...) inkblots presentation, discomfort with closeness and relationships as secondary subscales were negatively correlated with the activation of right hippocampus, parahippocampus, amygdala, and insula; need for approval subscale was negatively correlated with the activation of orbital and prefrontal cortex and left hippocampus. Moreover, the correlations between attachment dimensions and neural activation during the Rorschach inkblots were significantly higher compared to the same correlations in response to polygonal shapes. These findings suggest that attachment style can modulate brain activation during the projective activity of the Rorschach inkblots. (shrink)

A team of young scholars from the University of Babes-Bolyai, Cluj-Napoca, Romania, has received funding to edit Book I of the commentary on the Sentences by the Cistercian Iacobus de Altavilla, or James of Eltville, who is attested as lecturing on the Sentences at Paris in 1369. The project has made it possible to correct Friedrich Stegmüller's findings, removing from his list several wrongly attributed manuscripts and adding to the list a number of authentic copies or fragments. The present (...) article provides an inventory with short descriptions of the twenty-one manuscripts that preserve the whole or parts of James of Eltville's commentary, and presents new information about the manuscript tradition based on the preliminary results of the Romanian project. (shrink)