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Assessment of genetically modified maize NK603 x MON810 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐007)
2018
Efsa Panel On Genetically Modified Organisms (gmo)Scientific opinionRequestor:European Commission (DG SANTE)Question number:EFSA-Q-2017-00028; Following the submission of application EFSA-GMO-RX-007 under Regulation (EC) No 1829/2003 from Monsanto, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application of the herbicide-tolerant and insect-resistant genetically modified maize NK603 x MON810. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic searc…
Validation of Using Smartphone Built-In Accelerometers to Estimate the Active Energy Expenditures of Full-Time Manual Wheelchair Users with Spinal Co…
2021
[EN] This study aimed to investigate the validity of using built-in smartphone accelerometers to estimate the active energy expenditures of full-time manual wheelchair users with spinal cord injury (SCI). Twenty participants with complete SCI completed 10 5-min daily activities that involved the upper limbs, during which their oxygen consumption and upper limb activity were registered using a portable gas analyzer and a smartphone (placed on the non-dominant arm), respectively. Time series of 1-min averaged oxygen consumption and 55 accelerometer variables (13 variables for each of the four axes and three additional variables for the correlations between axes) were used to estimate three mu…
Impact of COVID-19 on the self-reported physical activity of people with complete thoracic spinal cord injury full-time manual wheelchair users
2021
Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Activitat física; Lesió medul·lar Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Actividad física; Lesión de la médula espinal Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Physical activity; Spinal cord injury Context The emergence of COVID-19 caused a new public health crisis, leading to major changes in daily life routines, often including physical activity (PA) levels. The main goal of this study was to analyze the differences in self-reported physical activity of people with complete spinal cord injuries between the time prior to the COVID-19 lockdown and the lockdown period itself. Methods A sample of 20 participants with complete thoracic spi…
Assessment of genetically modified sugar beet H7‐1 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐006)
2017
Efsa Panel On Genetically Modified Organisms (gmo)Scientific opinionRequestor: European Commission (DG SANTE)Question number: EFSA-Q-2017-00026; Following the submission of application EFSA-GMO-RX-006 under Regulation (EC) No 1829/2003 fromKWS SAAT SE and Monsanto Company, the Panel on Genetically Modified Organisms of the EuropeanFood Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the datasubmitted in the context of the renewal of authorisation application for the herbicide-tolerantgenetically modified sugar beet H7-1. The data received in the context of this renewal applicationcontained a systematic search and evaluation of literature, updated bioinforma…
Scientific Opinion on application EFSA‐GMO‐BE‐2013‐118 for authorisation of genetically modified maize MON 87427 × MON 89034 × 1507 × MON 88017 × 591…
2017
Abstract In this opinion, the GMO Panel assessed the five‐event stack maize MON 87427 × MON 89034 ×1507 × MON 88017 × 59122 and its 25 subcombinations, independently of their origin. The GMO Panel has previously assessed the five single events combined to produce this five‐event stack maize and 11 subcombinations of these events and did not identify safety concerns. No new data on the single events or their previously assessed subcombinations, leading to modification of the original conclusions were identified. The combination of the single events and of the newly expressed proteins in the five‐event stack maize did not give rise to issues – based on the molecular, agronomic/phenotypic or c…
The effects of 8-weeks Mindfulness-Based Stress Reduction program on cognitive control: an EEG study
2019
Objectives: Mindfulness practice can enhance different aspects of attentional functions, such as the ability to sustain the attentional focus over time. However, it is still unclear whether this practice might indeed impact higher cognitive functions, such as control mechanisms that allow the appropriate and flexible allocation of attentional resources. In this longitudinal study, changes associated with a mindfulness-based stress reduction (MBSR) program were investigated, with a focus on proactive and reactive cognitive control mechanisms, namely, the ability to maintain task-relevant information and to prepare in advance the response, and the ability to promptly adjust overlearned behavi…
The impact of direct acting antivirals on hepatitis C virus disease burden and associated costs in four European countries
2021
Eliminació del VHC; Punt d'equilibri; Infecció d'hepatitis C Eliminación del VHC; Punto de equilibrio; Infección de hepatitis C HCV elimination; Break-even; Hepatitis C infection Background and Aims We assessed the clinical and economic impact of direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) in England, Italy, Romania and Spain. Methods An HCV progression Markov model was developed considering DAA eligibility and population data during the years 2015-2019. The period of time to recover the investment in DAAs was calculated as the cost saved by avoiding estimated clinical events for 1000 standardized treated patients. A delayed treatment scenario because of coronavirus di…
Self-reported antibiotic stewardship and infection control measures from 57 intensive care units: An international ID-IRI survey
2022
Infection control; Multidrug resistance; Stewardship Control de infección; Resistencia a múltiples fármacos; Administración Control d'infecció; Resistència a múltiples fàrmacs; Administració We explored the self-reported antibiotic stewardship (AS), and infection prevention and control (IPC) activities in intensive care units (ICUs) of different income settings. A cross-sectional study was conducted using an online questionnaire to collect data about IPC and AS measures in participating ICUs. The study participants were Infectious Diseases–International Research Initiative (IDI-IR) members, committed as per their institutional agreement form. We analyzed responses from 57 ICUs in 24 countri…
International BEAT-PCD Consensus Statement for Infection Prevention and Control for Primary Ciliary Dyskinesia in collaboration with ERN-LUNG PCD Cor…
2021
Introduction In primary ciliary dyskinesia (PCD) impaired mucociliary clearance leads to recurrent airway infections and progressive lung destruction, and concern over chronic airway infection and patient-to-patient transmission is considerable. So far, there has been no defined consensus on how to control infection across centres caring for patients with PCD. Within the BEAT-PCD network, COST Action and ERS CRC together with the ERN-Lung PCD core a first initiative has now been taken towards creating such a consensus statement. Methods A multidisciplinary international PCD expert panel was set up to create a consensus statement for infection prevention and control (IP&C) for PCD, covering …
Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation and Study of Diabetic Nephropathy with Atrasentan : what …
2019
Albuminuria; Atrasentan; Canagliflozin Albuminuria; Atrasentan; Canagliflozina Albuminúria; Atrasentan; Canagliflozina In April 2019, two major Phase 3 randomized clinical trials were published that assessed primary renal outcomes in diabetic kidney disease (DKD) in type 2 diabetes mellitus (T2DM). The Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) tested an already available antidiabetic drug, canagliflozin, and the Study of Diabetic Nephropathy with Atrasentan (SONAR) tested a novel molecule, the endothelin-1 receptor blocker atrasentan, both on top of renin-angiotensin system blockade. Both trials demonstrated significant nephroprot…