Browsing by Subject "GUIDANCE"

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  • EFSA Panel Dietetic Prod Nutr All (2018)
    Following an application from Unilever NV, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Ireland, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to black tea and improvement of attention. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is black tea. The Panel considers that black tea characterised by its content of tea solids, caffeine and L-theanine, which is the subject of the health claim, is sufficiently characterised in relation to the claimed effect. The claimed effect proposed by the applicant is 'improves attention'. The Panel considers that improvement of attention is a beneficial physiological effect. Three human intervention studies provided by the applicant show an effect of black tea on attention under the conditions of used proposed by the applicant. The applicant proposed that the claimed effect depends on the concerted action of two substances, caffeine and L-theanine, both of which are present in black tea. The Panel considers that the effect of black tea on attention observed in the three human intervention studies provided by the applicant can be explained by its caffeine content. The Panel concludes that a cause and effect relationship has been established between the consumption of black tea and improvement of attention. The Panel considers that the effect of black tea on attention can be explained by its caffeine content. The following wording reflects the scientific evidence: 'Owing to its caffeine content, black tea improves attention'. In order to obtain the claimed effect, 2-3 servings of black tea providing at least 75 mg of caffeine in total should be consumed within 90 min. (C) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
  • Syrjämäki, Marja; Pihlaja, Päivi; Sajaniemi, Nina (2018)
    This article focused on the pedagogy that enhances peer interaction in integrated special groups. In Finland, most children identified as having special educational needs (SEN) attend day-care in mainstream kindergarten groups; the rest are in integrated or segregated early childhood special education (ECSE) groups in public day-care centres [National Institute of Health and Welfare. 2013. "Child Day Care 2013 - Municipal Survey." Accessed March 15, 2016. /116231/Tr16_14.pdf?sequence=4]. An integrated group, which typically consists of seven children without and five with SEN, is supposed to be an inclusive environment that provides an atmosphere in which every child can feel togetherness and be scaffolded [Pihlaja, P. 2009. "Erityisen tuen kaytannot varhaiskasvatuksessa - nakokulmana inkluusio." [The Special Education Practices in Early Childhood Education - Inclusion as Viewpoint.] Kasvatus 2: 146-156]. Our aim was to examine how ECSE professionals' pedagogical practices were used to enhance peer interaction in interactive play. We analysed 14 videotaped sessions of guided play and conceptualized the studied phenomenon by portraying five guidance types in which the identified pedagogical practices were used in different ways.
  • Massinen, Satu; Wang, Jingwen; Laivuori, Krista; Bieder, Andrea; Paez, Isabel Tapia; Jiao, Hong; Kere, Juha (2016)
    Background: The DYX5 locus for developmental dyslexia was mapped to chromosome 3 by linkage study of a large Finnish family, and later, roundabout guidance receptor 1 (ROBO1) was implicated as a candidate gene at DYX5 with suppressed expression from the segregating rare haplotype. A functional magnetoencephalographic study of several family members revealed abnormal auditory processing of interaural interaction, supporting a defect in midline crossing of auditory pathways. In the current study, we have characterized genetic variation in the broad ROBO1 gene region in the DYX5-linked family, aiming to identify variants that would increase our understanding of the altered expression of ROBO1. Methods: We have used a whole genome sequencing strategy on a pooled sample of 19 individuals in combination with two individually sequenced genomes. The discovered genetic variants were annotated and filtered. Subsequently, the most interesting variants were functionally tested using relevant methods, including electrophoretic mobility shift assay (EMSA), luciferase assay, and gene knockdown by lentiviral small hairpin RNA (shRNA) in lymphoblasts. Results: We found one novel intronic single nucleotide variant (SNV) and three novel intergenic SNVs in the broad region of ROBO1 that were specific to the dyslexia susceptibility haplotype. Functional testing by EMSA did not support the binding of transcription factors to three of the SNVs, but one of the SNVs was bound by the LIM homeobox 2 (LHX2) protein, with increased binding affinity for the non-reference allele. Knockdown of LHX2 in lymphoblast cell lines extracted from subjects from the DYX5-linked family showed decreasing expression of ROBO1, supporting the idea that LHX2 regulates ROBO1 also in human. Conclusions: The discovered variants may explain the segregation of dyslexia in this family, but the effect appears subtle in the experimental settings. Their impact on the developing human brain remains suggestive based on the association and subtle experimental support.
  • Darki, Fahimeh; Massinen, Satu; Salmela, Elina; Matsson, Hans; Peyrard-Janvid, Myriam; Klingberg, Torkel; Kere, Juha (2017)
    The axon guidance receptor, Robo1, controls the pathfinding of callosal axons in mice. To determine whether the orthologous ROBO1 gene is involved in callosal development also in humans, we studied polymorphisms in the ROBO1 gene and variation in the white matter structure in the corpus callosum using both structural magnetic resonance imaging and diffusion tensor magnetic resonance imaging. We found that five polymorphisms in the regulatory region of ROBO1 were associated with white matter density in the posterior part of the corpus callosum pathways. One of the polymorphisms, rs7631357, was also significantly associated with the probability of connections to the parietal cortical regions. Our results demonstrate that human ROBO1 may be involved in the regulation of the structure and connectivity of posterior part of corpus callosum.
  • Lepola, Pirkko; Needham, Allison; Mendum, Jo; Sallabank, Peter; Neubauer, David; de Wildt, Saskia (2016)
    Objective Paediatric clinical trials are often conducted as multinational trials. Informed consent or assent is part of the ethics committee approval for clinical trials. The consent requirements vary between countries due to national laws and regulations, which are not harmonised in Europe. These discrepancies can present challenges for paediatric clinical trials. The aim of this study was to assemble these consent and assent requirements across the European Economic Area. The collated national requirements have not been publicly available before, despite a real need for this data. Methods National consent and assent requirements for paediatric clinical trials were analysed and collated for 25 European Union Member States and 2 European Free Trade Association countries until the end of 2014. The data were retrieved from existing databases and through communication with the competent authorities and selected ethics committees. Results from a literature search for international or national guidelines, declarations and conventions and academic societies' publications served as comparison material. Results Consent and assent requirements are heterogeneous across these countries. We compiled our findings in 'The Informed Consent and Assent Tool Kit', a table including 27 national consent and assent requirements listed by individual country. Conclusions Wide variation in paediatric consents and assents presents challenges for multinational paediatric trials in Europe. The toolkit is available for all those involved in paediatric clinical trials and ethics committees, providing a new platform for proactive feedback on informed consent requirements, and may finally lead to a needed harmonisation process, including uniform standards accepted across Europe.
  • EFSA Panel Dietetic Prod Nut (2018)
    Following an application from Lonza Ltd., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No1924/2006 via the Competent Authority of Germany, the EFSA Panelon Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to L-carnitine and normal lipid metabolism. The food that is proposed as the subject of the health claim is L-carnitine. The Panelconsiders that L-carnitine is sufficiently characterised. The claimed effect proposed by the applicant is normal lipid metabolism'. The target population proposed by the applicant is the general population. The Panelconsiders that contribution to normal lipid metabolism is a beneficial physiological effect. The applicant proposes that the claim submitted with this application is based on the essentiality of a nutrient. The Panelconsiders that the evidence provided does not establish that dietary L-carnitine is required to maintain normal lipid metabolism in the target population, for which the claim is intended. The Panelconcludes that a cause and effect relationship has not been established between the consumption of L-carnitine and contribution to normal lipid metabolism in the target population. (c) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
  • Friberg, Kalervo (2013)
    A student self-determination profile of occupational and educational choices was examined through the concepts of Locus of Causality and Locus of Orientation. Research questions associated with respondents’ certainty of occupation and orientation to vocational education were answered. The tested hypotheses were as follows: (a) Independence, initiative, self-guidance, choice of discussion forums, and gender are related to certainty of future occupation choice and choice of vocational education; (b) certainty of occupation relates to choosing vocational education; (c) negatively biased media lessens interest in vocational education; and (d) vocational education choices are related to gender. A survey of ninth-grade students in Finnish comprehensive school was conducted after implementation of a work-orientation program defined in the national comprehensive school curriculum. At the local school system level, 649 subjects of the mean ages of 16.0 years participated in an Internet survey in two school districts in southwestern Finland in 2008. The variables were inserted in Linear Multiple Regression Analysis in IBM SPSS. The means of vocational school choice and certainty of occupation, and vocational school choice and negative media image were compared in SPSS means. An independent-samples ttest for vocational school choice and sex was conducted. Statistically significant regression models of loci of orientation and locus of causality were found. The more the respondents were certain of their occupation choice, the more they expressed their secondary education orientation to be vocational school. When students discussed their choices less at home, their orientation to vocational education weakened. A negative media image was not associated with vocational school choice in this data. The measured means for girls’ and boys’ orientations to vocational school did not show statistically significant differences.
  • Viilo, Marjut; Seitamaa-Hakkarainen, Pirita; Hakkarainen, Kai (2018)
    This explorative case study longitudinally examines teacher orchestration of an inquiry learning process in a technology-enhanced elementary classroom. A 13-month investigative study on cultural artifacts was conducted on 32 fourth grade students who progressed to the fifth grade during the project. The activities were mediated and documented using Knowledge Forum, a technology-enhanced collaborative environment. Data were gathered from video recordings of whole-class sessions and the teacher’s reflective diary entries. The coding scheme for the video analysis focused on identifying the various orchestration events, while drawing on theory and data-driven qualitative content analysis. Six types of orchestration events effectively maintained the process during whole-class sessions. These events supported the advancement of knowledge, reflection on inquiry, and pragmatic organization of inquiry. The study also adopted CORTDRA diagrams that highlighted temporal aspects of the orchestration events throughout the project. Knowledge Forum enabled the longitudinal advancement of the project.
  • Vallejo-Vaz, Antonio J.; Akram, Asif; Seshasai, Sreenivasa Rao Kondapally; Cole, Della; Watts, Gerald F.; Hovingh, G. Kees; Kastelein, John J. P.; Mata, Pedro; Raal, Frederick J.; Santos, Raul D.; Soran, Handrean; Freiberger, Tomas; Abifadel, Marianne; Aguilar-Salinas, Carlos A.; Alnouri, Fahad; Alonso, Rodrigo; Al-Rasadi, Khalid; Banach, Maciej; Bogsrud, Martin P.; Bourbon, Mafalda; Bruckert, Eric; Car, Josip; Ceska, Richard; Corral, Pablo; Descamps, Olivier; Dieplinger, Hans; Do, Can T.; Durst, Ronen; Ezhov, Marat V.; Fras, Zlatko; Gaita, Dan; Gaspar, Isabel M.; Genest, Jaques; Harada-Shiba, Mariko; Jiang, Lixin; Kayikcioglu, Meral; Lam, Carolyn S. P.; Latkovskis, Gustavs; Laufs, Ulrich; Liberopoulos, Evangelos; Lin, Jie; Lin, Nan; Maher, Vincent; Majano, Nelson; Marais, A. David; Maerz, Winfried; Mirrakhimov, Erkin; Miserez, Andre R.; Mitchenko, Olena; Widen, Elisabeth; EAS Familial Hypercholesterolaemia (2016)
    Background: The potential for global collaborations to better inform public health policy regarding major non-hypercholesterolaemia (FH), a common genetic disorder associated with premature cardiovascular disease, is yet to be reliably ascertained using similar approaches. The European Atherosclerosis Society FH Studies Collaboration (EAS FHSC) is a new initiative of international stakeholders which will help establish a global FH registry to generate large-scale, robust data on the burden of FH worldwide. Methods: The EAS FHSC will maximise the potential exploitation of currently available and future FH data (retrospective and prospective) by bringing together regional/national/international data sources with access to individuals with a clinical and/or genetic diagnosis of heterozygous or homozygous FH. A novel bespoke electronic platform and FH Data Warehouse will be developed to allow secure data sharing, validation, cleaning, pooling, harmonisation and analysis irrespective of the source or format. Standard statistical procedures will allow us to investigate cross-sectional associations, patterns of real-world practice, trends over time, and analyse risk and outcomes (e.g. cardiovascular outcomes, all-cause death), accounting for potential confounders and subgroup effects. Conclusions: The EAS FHSC represents an excellent opportunity to integrate individual efforts across the world to tackle the global burden of FH. The information garnered from the registry will help reduce gaps in knowledge, inform best practices, assist in clinical trials design, support clinical guidelines and policies development, and ultimately improve the care of FH patients. (C) 2016 Elsevier Ireland Ltd.
  • EFSA Panel Nutr Novel Foods Food A; Turck, Dominique; Heinonen, Marina (2019)
    Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Allergens (NDA) was asked to deliver an opinion on nicotinamide riboside chloride as a novel food (NF) pursuant to Regulation (EU) 2015/2283, including an evaluation of the safety of its use in food supplements as a source of niacin, and the bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC. The NF, a synthetic form of nicotinamide riboside, is proposed to be used in food supplements for the healthy adult population at levels up to 300 mg/day. The production process, composition, specifications, batch-to-batch variability and stability of the NF do not raise safety concerns. Animal and human data indicate that the NF contributes to the nicotinamide body pool. There are no concerns regarding genotoxicity. Human studies do not raise safety concerns. The proposed maximum use level corresponds to an amount of nicotinamide, which is sixfold lower than the tolerable upper intake level (UL) set for adults, excluding pregnant and lactating women. The margin of exposure (MoE) of 70 derived from repeated dose toxicity studies with rats and dogs is considered sufficient for the adult population, excluding pregnant and lactating women. Regarding these two population groups, the MoE of 76 derived from a developmental toxicity study in rats is considered insufficient in the absence of data which could justify accepting a MoE lower than 100. The Panel concludes that the NF is safe under the proposed conditions of use for the healthy adult population, excluding pregnant and lactating women, and that an intake of the NF up to 230 mg/day is safe for pregnant and lactating women. The Panel also concludes that the NF is a source from which nicotinamide, a form of niacin, is bioavailable. (C) 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
  • Marjosola, Heikki (2022)
    The number and diversity of the European Supervisory Authorities' (ESAs) soft law acts continue to grow. The recent reform of the ESAs' founding regulations added two new instruments to their toolbox, "questions & answers" (Q&A) and "no action letters," both invented and already used by the ESAs in their supervisory practices. The reformed regulations continue to encourage the ESAs to pursue their tasks by developing new instruments and convergence tools. The article assesses the ESAs' rulemaking and regulatory innovation from a broad governance perspective, asking what type of procedural controls and review mechanisms would best facilitate beneficial forms of regulatory innovation while also controlling its excesses. It is argued that the main shortcoming of the present regime is not the lack of adequate procedural controls so much as the incomplete system of legal remedies. Flexibility should be preserved, but more credible judicial controls are needed to check the ability of soft law to bypass legislative processes.
  • Sandström, Niclas; Sjöblom, Kirsi; Mälkki, Kaisu; Lonka, Kirsti (2013)
  • MASK Study Grp; Bedard, A.; Basagana, X.; Anto, J. M.; Haahtela, T.; Toppila-Salmi, S.; Valovirta, E.; Bousquet, J. (2020)
    Background The analysis of mobile health (mHealth) data has generated innovative insights into improving allergic rhinitis control, but additive information is needed. A cross-sectional real-world observational study was undertaken in 17 European countries during and outside the estimated pollen season. The aim was to collect novel information including the phenotypic characteristics of the users. Methods The Allergy Diary-MASK-air-mobile phone app, freely available via Google Play and App, was used to collect the data of daily visual analogue scales (VASs) for overall allergic symptoms and medication use. Fluticasone Furoate (FF), Mometasone Furoate (MF), Azelastine Fluticasone Proprionate combination (MPAzeFlu) and eight oral H1-antihistamines were studied. Phenotypic characteristics were recorded at entry. The ARIA severity score was derived from entry data. This was an a priori planned analysis. Results 9037 users filled in 70,286 days of VAS in 2016, 2017 and 2018. The ARIA severity score was lower outside than during the pollen season. Severity was similar for all treatment groups during the pollen season, and lower in the MPAzeFlu group outside the pollen season. Days with MPAzeFlu had lower VAS levels and a higher frequency of monotherapy than the other treatments during the season. Outside the season, days with MPAzeFlu also had a higher frequency of monotherapy. The number of reported days was significantly higher with MPAzeFlu during and outside the season than with MF, FF or oral H1-antihistamines. Conclusions This study shows that the overall efficacy of treatments is similar during and outside the pollen season and indicates that medications are similarly effective during the year.