BACKGROUND: Monoamine oxidase (MAO) inhibitors can interact with selective serotonin reuptake inhibitors (SSRIs)/serotonin-norepinephrine reuptake inhibitors (SNRIs). There is clinical interest surrounding use of ozanimod with SSRIs/SNRIs because the major metabolites of ozanimod are weak inhibitors of MAO-B in vitro. OBJECTIVE: To evaluate the incidence of treatment-emergent adverse events (TEAEs) potentially related to serotonin accumulation (SA) during concomitant ozanimod and SSRI/SNRI use by performing analyses of data from an open-label, oral ozanimod 0.92 mg trial (DAYBREAK; NCT02576717). METHODS: SA narrow (serotonin syndrome, neuroleptic malignant syndrome, and hyperthermia malignant) and broad (terms potentially associated with SA) MedDRA v24.0 searches were performed using TEAE data from participants with relapsing multiple sclerosis who entered DAYBREAK from phase 3 studies (cutoff February 1, 2022). Incidences of TEAEs matching terms from each search were stratified by SSRI/SNRI use. RESULTS: Of 2257 DAYBREAK participants, 274 (12.1%) used an SSRI/SNRI. No participants had TEAEs matching the SA narrow search terms. There was no significant difference in the percentage of participants with ⩾1 TEAE matching the SA broad search for those on versus off SSRIs/SNRIs (on: 12.4%, n = 34/274; off: 15.6%, n = 310/1982, nominal p = 0.1630). CONCLUSION: MedDRA searches showed no increase in TEAEs potentially associated with SA with concomitant SSRI/SNRI and ozanimod use.
- MeSH
- antidepresiva škodlivé účinky MeSH
- indany * MeSH
- inhibitory zpětného vychytávání serotoninu a noradrenalinu * škodlivé účinky MeSH
- lidé MeSH
- oxadiazoly * MeSH
- roztroušená skleróza * chemicky indukované MeSH
- selektivní inhibitory zpětného vychytávání serotoninu škodlivé účinky MeSH
- serotonin MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
OBJECTIVE: To investigate the serologic response, predictors of response, and clinical outcomes associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination and infection in ozanimod-treated participants with relapsing multiple sclerosis (RMS) from DAYBREAK. METHODS: DAYBREAK (ClinicalTrials.gov-NCT02576717), an open-label extension study of oral ozanimod 0.92 mg, enrolled participants aged 18-55 years with RMS who completed phase 1-3 ozanimod trials. Participants who were fully vaccinated against SARS-CoV-2 with mRNA or non-mRNA vaccines, were unvaccinated, and/or had COVID-19-related adverse events (AEs, with or without vaccination) and postvaccination serum samples were included (n = 288). Spike receptor binding domain (RBD) antibody levels (seroconversion: ≥0.8 U/mL) and serologic evidence of SARS-CoV-2 infection (nucleocapsid IgG: ≥1 U/mL) were assessed (Roche Elecsys/Cobas e411 platform). RESULTS: In fully vaccinated participants (n = 148), spike RBD antibody seroconversion occurred in 90% (n = 98/109) of those without serologic evidence of prior SARS-CoV-2 exposure (100% [n = 80/80] seroconversion after mRNA vaccination) and in 100% (n = 39/39) of participants with serologic evidence of viral exposure. mRNA vaccination predicted higher spike RBD antibody levels, whereas absolute lymphocyte count (ALC), age, body mass index, and sex did not. COVID-19-related AEs were reported in 10% (n = 15/148) of fully vaccinated participants-all were nonserious and not severe; all participants recovered. INTERPRETATION: Most ozanimod-treated participants with RMS mounted a serologic response to SARS-CoV-2 vaccination and infection, regardless of participant characteristics or ALC levels. In this analysis, all COVID-19-related AEs post-full vaccination in participants taking ozanimod were nonserious and not severe.
BACKGROUND: Patients with obstructive sleep apnoea (OSA) are at increased risk of severe course of COVID-19. Vaccination remains to be the most effective prevention of complicated courses of infection. The best contemporary conservative treatment of OSA is continuous positive airway pressure (CPAP) therapy. PURPOSE: To compare vaccination acceptance and outcomes of COVID-19 infection between OSA patients adhering to the CPAP therapy and those who rejected CPAP and surgical therapy. PATIENTS AND METHODS: Subjects were divided into two groups: group A (N = 167) were individuals with sufficient CPAP adherence (more than 4 hours per night on average) over the last 10 years. Group B (N = 106) were individuals who did not use the CPAP therapy at all and had no indications to surgical therapy. RESULTS: Three patients in group B died, and one had a severe course of COVID-19. None of the patients in group A died or experienced a severe course of COVID-19. Group A had a significantly higher proportion of males (77.8% compared to 66% in group B) and all parameters of OSA severity. The vaccination status was similar among both groups, with a complete triple dose vaccination rate of 69.5% and 67.9% in groups A and B, respectively. CONCLUSION: The results show that the patients with OSA adherent to CPAP therapy were less likely to experience a severe course of COVID-19 or death than the OSA patients non-compliant with therapy, despite the former group having more severe OSA. This result underlines the importance of adherence to CPAP therapy in OSA.
- Publikační typ
- časopisecké články MeSH
The present study examined the influence of the individual and sequential combination of the key components of OPTIMAL (Optimizing Performance Through Intrinsic Motivation and Attention for Learning) theory (i.e., enhanced expectancies, autonomy support, and external focus), on the performance of a laser-pistol shooting task. In addition to shooting accuracy, intra-trial variability in the sway of forearm/pistol motion prior to movement execution (pulling the trigger) was the primary variable of interest. In a between-within-subject design, thirty-six participants (Mage = 21.27 ± 1.75 years) were randomized into either a control or an optimized group. Enhanced expectancies, autonomy support, and an external focus were implemented via sequential blocks of trials for participants in the optimized group. Participants in the control group performed all trials under "neutral" conditions. Our results showed that motor performance was enhanced for participants in the optimized group compared to those in the control group. Moreover, greater reductions in forearm sway leading up to the trigger pull were observed for the optimized group compared to the control group. These findings suggest higher movement effectiveness and efficiency, potentially through better attunement to task and environmental constraints, when implementing optimized instructions in a self-initiated fine motor task.
- Publikační typ
- časopisecké články MeSH
BACKGROUND: The monoclonal antibody ublituximab enhances antibody-dependent cellular cytolysis and produces B-cell depletion. Ublituximab is being evaluated for the treatment of relapsing multiple sclerosis. METHODS: In two identical, phase 3, double-blind, double-dummy trials (ULTIMATE I and II), participants with relapsing multiple sclerosis were randomly assigned in a 1:1 ratio to receive intravenous ublituximab (150 mg on day 1, followed by 450 mg on day 15 and at weeks 24, 48, and 72) and oral placebo or oral teriflunomide (14 mg once daily) and intravenous placebo. The primary end point was the annualized relapse rate. Secondary end points included the number of gadolinium-enhancing lesions on magnetic resonance imaging (MRI) by 96 weeks and worsening of disability. RESULTS: A total of 549 participants were enrolled in the ULTIMATE I trial, and 545 were enrolled in the ULTIMATE II trial; the median follow-up was 95 weeks. In the ULTIMATE I trial, the annualized relapse rate was 0.08 with ublituximab and 0.19 with teriflunomide (rate ratio, 0.41; 95% confidence interval [CI], 0.27 to 0.62; P<0.001); in the ULTIMATE II trial, the annualized relapse rate was 0.09 and 0.18, respectively (rate ratio, 0.51; 95% CI, 0.33 to 0.78; P = 0.002). The mean number of gadolinium-enhancing lesions was 0.02 in the ublituximab group and 0.49 in the teriflunomide group (rate ratio, 0.03; 95% CI, 0.02 to 0.06; P<0.001) in the ULTIMATE I trial and 0.01 and 0.25, respectively (rate ratio, 0.04; 95% CI, 0.02 to 0.06; P<0.001), in the ULTIMATE II trial. In the pooled analysis of the two trials, 5.2% of the participants in the ublituximab group and 5.9% in the teriflunomide group had worsening of disability at 12 weeks (hazard ratio, 0.84; 95% CI, 0.50 to 1.41; P = 0.51). Infusion-related reactions occurred in 47.7% of the participants in the ublituximab group. Serious infections occurred in 5.0% in the ublituximab group and in 2.9% in the teriflunomide group. CONCLUSIONS: Among participants with relapsing multiple sclerosis, ublituximab resulted in lower annualized relapse rates and fewer brain lesions on MRI than teriflunomide over a period of 96 weeks but did not result in a significantly lower risk of worsening of disability. Ublituximab was associated with infusion-related reactions. (Funded by TG Therapeutics; ULTIMATE I and II ClinicalTrials.gov numbers, NCT03277261 and NCT03277248.).
- MeSH
- antiflogistika nesteroidní terapeutické užití MeSH
- dvojitá slepá metoda MeSH
- gadolinium terapeutické užití MeSH
- hydroxybutyráty MeSH
- imunosupresiva terapeutické užití MeSH
- krotonáty MeSH
- lidé MeSH
- magnetická rezonanční tomografie MeSH
- monoklonální protilátky * terapeutické užití MeSH
- nitrily MeSH
- relabující-remitující roztroušená skleróza * komplikace diagnostické zobrazování farmakoterapie patologie MeSH
- roztroušená skleróza komplikace diagnostické zobrazování farmakoterapie patologie MeSH
- toluidiny MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- randomizované kontrolované studie MeSH
The purpose of this study was to examine whether conditions that provide performers with a sense of autonomy, by giving them choices, would increase movement efficiency. We evaluated neuromuscular activation as a function of choice, using surface electromyography (EMG), during isometric force production. Participants (N = 16) were asked to perform plantar flexions at each of three target torques (80%, 50%, 20% of maximum voluntary contractions) under both choice and control conditions. In the choice condition, they were able to choose the order of target torques, whereas the order was pre-determined in the control condition. Results demonstrated that while similar torques were produced under both conditions, EMG activity was lower in the choice relative to the control condition. Thus, providing performers with a choice led to reduced neuromuscular activity, or an increase in movement efficiency. This finding is in line with the notion that autonomy support readies the motor system for task execution by contributing to the coupling of goals and actions (Wulf and Lewthwaite, Psychon Bull Rev 23:1382-1414, 2016).
- MeSH
- dospělí MeSH
- isometrická kontrakce fyziologie MeSH
- kosterní svaly fyziologie MeSH
- lidé MeSH
- mladý dospělý MeSH
- osobní autonomie * MeSH
- pohyb fyziologie MeSH
- psychomotorický výkon fyziologie MeSH
- svalová síla fyziologie MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
The HEXACO Personality Inventory-Revised (HEXACO-PI-R) has become one of the most heavily applied measurement tools for the assessment of basic personality traits. Correspondingly, the inventory has been translated to many languages for use in cross-cultural research. However, formal tests examining whether the different language versions of the HEXACO-PI-R provide equivalent measures of the 6 personality dimensions are missing. We provide a large-scale test of measurement invariance of the 100-item version of the HEXACO-PI-R across 16 languages spoken in European and Asian countries (N = 30,484). Multigroup exploratory structural equation modeling and confirmatory factor analyses revealed consistent support for configural and metric invariance, thus implying that the factor structure of the HEXACO dimensions as well as the meaning of the latent HEXACO factors is comparable across languages. However, analyses did not show overall support for scalar invariance; that is, equivalence of facet intercepts. A complementary alignment analysis supported this pattern, but also revealed substantial heterogeneity in the level of (non)invariance across facets and factors. Overall, results imply that the HEXACO-PI-R provides largely comparable measurement of the HEXACO dimensions, although the lack of scalar invariance highlights the necessity for future research clarifying the interpretation of mean-level trait differences across countries.
- MeSH
- dospělí MeSH
- lidé MeSH
- osobnostní dotazník normy MeSH
- psychometrie normy MeSH
- srovnání kultur MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
Variability in practice has been shown to enhance motor skill learning. Benefits of practice variability have been attributed to motor schema formation (variable versus constant practice), or more effortful information processing (random versus blocked practice). We hypothesized that, among other mechanisms, greater practice variability might promote an external focus of attention on the intended movement effect, while less variability would be more conducive to a less effective internal focus on body movements. In Experiment 1, the learning of a throwing task was enhanced by variable versus constant practice, and variable group participants reported focusing more on the distance to the target (external focus), while constant group participants focused more on their posture (internal focus). In Experiment 2, golf putting was learned more effectively with a random compared with a blocked practice schedule. Furthermore, random group learners reported using a more effective distal external focus (i.e., distance to the target) to a greater extent, whereas blocked group participants used a less effective proximal focus (i.e., putter) more often. While attentional focus was assessed through questionnaires in the first two experiments, learners in Experiment 3 were asked to report their current attentional focus at any time during practice. Again, the learning of a throwing task was more effective after random relative to blocked practice. Also, random practice learners reported using more external focus cues, while in blocked practice participants used more internal focus cues. The findings suggest that the attentional foci induced by different practice schedules might be at least partially responsible for the learning differences.
- MeSH
- golf fyziologie MeSH
- kognice fyziologie MeSH
- lidé MeSH
- mladý dospělý MeSH
- motorické dovednosti fyziologie MeSH
- podněty MeSH
- pohyb fyziologie MeSH
- postura těla fyziologie MeSH
- pozornost fyziologie MeSH
- praxe (psychologie) MeSH
- průzkumy a dotazníky MeSH
- učení fyziologie MeSH
- Check Tag
- lidé MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
INTRODUCTION: Noise is one of the most extensive environmental factors affecting the general population. The present study is focused on the association between discomfort caused by noise and the incidence of certain diseases (ischaemic heart disease, stroke and hypertension). MATERIALS AND METHODS: This cross-sectional questionnaire study, conducted in 10 cities in the Czech Republic, comprises two stages with 3592 obtained questionnaires in the first phase and 762 in the second phase. Twelve variables describe subjective responses to noise from different sources at different times of day. The intensity of the associations between variables was measured by correlation coefficient. Logistic regression was used for fitting models of morbidity, and confounders such as age and socio-economic status were included. The hypotheses from the first phase were independently validated using data from the second phase. RESULTS: The general rates of noise annoyance/sleep disturbance had greater correlation with traffic noise variables than with neighbourhood noise variables. Factors significantly associated with diseases are: for hypertension - annoyance by traffic noise (the elderly, odds ratio (OR) 1.4) and sleep disturbance by traffic and neighbourhood noise (the elderly, OR 1.6); for ischaemic heart disease - the general rate of noise annoyance (all respondents, OR 1.5 and the adults 30-60 years, OR 1.8) and the general rate of annoyance and sleep disturbance (all respondents, OR 1.3); for stroke - annoyance and sleep disturbance by traffic and neighbourhood noise (all respondents, OR 1.8). CONCLUSION: Factors that include multiple sources of noise or non-specific noise are associated with the studied diseases more frequently than the source-specific factors.
- MeSH
- dospělí MeSH
- hluk škodlivé účinky MeSH
- kardiovaskulární nemoci epidemiologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- logistické modely MeSH
- poruchy spánku a bdění epidemiologie MeSH
- průřezové studie MeSH
- průzkumy a dotazníky MeSH
- psychický stres epidemiologie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- socioekonomické faktory MeSH
- věkové faktory MeSH
- vystavení vlivu životního prostředí škodlivé účinky MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Česká republika MeSH
