Search results for "vigilance"
showing 10 items of 154 documents
New European legislation on pharmacovigilance
2011
TheEuropeanParliament and theCouncil of the EuropeanUnion have recently adoptedRegulation (EU) No 1235/20101 and Directive 2010/84/EU2 concerning the pharmacovigilance of medicinal products for human use. These and other European institutions have been laying down rules on the subject for decades, but this is the first time they have enacted legislation specifically and (almost) exclusively regulating pharmacovigilance. This paper analyzes the context, causes, objectives, key points and challenges of the new legislation.
Cardiorespiratory information dynamics during mental arithmetic and sustained attention
2015
An analysis of cardiorespiratory dynamics during mental arithmetic, which induces stress, and sustained attention was conducted using information theory. The information storage and internal information of heart rate variability (HRV) were determined respectively as the self-entropy of the tachogram, and the self-entropy of the tachogram conditioned to the knowledge of respiration. The information transfer and cross information from respiration to HRV were assessed as the transfer and cross-entropy, both measures of cardiorespiratory coupling. These information-theoretic measures identified significant nonlinearities in the cardiorespiratory time series. Additionally, it was shown that, alt…
Phasic and tonic alerting in mild cognitive impairment: A preliminary study.
2013
In this preliminary study we assessed the functioning of the different attentional networks in mild cognitive impairment (MCI) patients, taking as theoretical framework the Posner's cognitive neuroscience approach. Two groups of participants were tested in a single short experiment: 20 MCI patients (6 amnestic, 6 non-amnestic and 8 multiple-domain) and 18 healthy matched controls (HC). For attentional assessment we used a version of the Attention Network Test (the ANTI-V) that provided not only a score of the orienting, the executive, and the alerting networks and their interactions, but also an independent measure of vigilance (tonic alerting). The results showed that all subtypes of MCI p…
French organization for the pharmacovigilance of COVID-19 vaccines: A major challenge.
2021
International audience; In this special issue, we present the main highlights of the first weeks of pharmacovigilance monitoring of coronavirus disease 2019 (COVID-19) vaccines in this unprecedented situation in France: the deployment of a vaccination during an epidemic period with the aim of vaccinating the entire population and the intense pharmacovigilance and surveillance of these vaccines still under conditional marketing authorizations. In this unprecedented situation, the cross approach and interaction between the French pharmacovigilance network and French National Agency for the Safety of Medicines and Health Products (ANSM) has been optimized to provide a real-time safety related …
Cognitive-behavioral screening in elderly patients with new-onset epilepsy before treatment
2014
Objectives Cognitive comorbidity at epilepsy onset reflects disease severity and provides a baseline estimate of reserve capacities with regard to the effects of epilepsy and its treatment. Given the high incidence of epilepsy at an older age, this study analyzed objective and subjective cognition as well as quality of life in elderly patients with new-onset focal epilepsy before initiation of anti-epileptic treatment. Materials and methods A total of 257 untreated patients (60–95 years of age) with new-onset epilepsy underwent objective assessment of executive function (EpiTrack) and performed subjective ratings of cognition (Portland Neurotoxicity Scale) and quality of life (QoL; QOLIE-31…
The effect of alertness and attention on the modulation of the beta rhythm to tactile stimulation
2021
Abstract Beta rhythm modulation has been used as a biomarker to reflect the functional state of the sensorimotor cortex in both healthy subjects and patients. Here, the effect of reduced alertness and active attention to the stimulus on beta rhythm modulation was investigated. Beta rhythm modulation to tactile stimulation of the index finger was recorded simultaneously with MEG and EEG in 23 healthy subjects (mean 23, range 19–35 years). The temporal spectral evolution method was used to obtain the peak amplitudes of beta suppression and rebound in three different conditions (neutral, snooze, and attention). Neither snooze nor attention to the stimulus affected significantly the strength of…
Risk of bleeding related to selective and non-selective serotonergic antidepressants: a case/non-case approach using data from two pharmacovigilance …
2014
There is increasing evidence for an association between treatment with selective serotonin reuptake inhibitors (SSRI) and an increased risk of bleeding events. The most important underlying mechanism appears to be inhibition of serotonin uptake in platelets, an effect that is also present in antidepressants with non-selective serotonin-reuptake inhibition (NSRI). Accordingly, also NSRI may be associated with an increased risk of bleeding. However, there is little data in this regard.Based on data (spontaneous reports of adverse drug reactions) from 2 pharmacovigilance databases (WHO-database/Vigibase™; BfArM/AkdÄ-database in Germany) we used a case/non-case approach and calculated reporting…
Sleep and alertness in shift work disorder: findings of a field study
2018
Purpose Although shift work disorder (SWD) affects a major part of the shift working population, little is known about its manifestation in real life. This observational field study aimed to provide a detailed picture of sleep and alertness among shift workers with a questionnaire-based SWD, by comparing them to shift workers without SWD during work shifts and free time. Methods SWD was determined by a questionnaire. Questionnaires and 3-week field monitoring, including sleep diaries, actigraphy, the Karolinska Sleepiness Scale (KSS), EEG-based sleep recordings, and Psychomotor Vigilance Tasks (PVT), were used to study 22 SWD cases and 9 non-SWD workers. Results The SWD group had a shorter …
Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee
2020
Background: To derive a list of opportunistic infections (OI) through the analysis of the juvenile idiopathic arthritis (JIA) patients in the Pharmachild registry by an independent Safety Adjudication Committee (SAC). Methods: The SAC (3 pediatric rheumatologists and 2 pediatric infectious disease specialists) elaborated and approved by consensus a provisional list of OI for use in JIA. Through a 5 step-procedure, all the severe and serious infections, classified as per MedDRA dictionary and retrieved in the Pharmachild registry, were evaluated by the SAC by answering six questions and adjudicated with the agreement of 3/5 specialists. A final evidence-based list of OI resulted by matching …
Functioning of the Attentional Networks at Rest vs. During Acute Bouts of Aerobic Exercise
2011
The present study explored the effects of three different activity conditions on three attentional functions: alerting, orienting, and executive control. A group of highly experienced cyclists performed the Attention Network Test–Interactions (Callejas, Lupiáñez, & Tudela, 2004) at rest, during moderate aerobic exercise, and during intense aerobic exercise. Results indicated that aerobic exercise accelerated reaction time and reduced the alerting effect compared with the rest condition. However, aerobic exercise did not modulate the functioning of either the orienting or the executive control attentional networks. No differences in reaction time or attentional functioning were observed …