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  • Arildsen Gertsen posted an update 3 hours, 44 minutes ago

    The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be low. Overall, the Panel cannot conclude on the safety of the food enzyme isoamylase produced with Dyella sp.The food enzyme β-cyclodextrin glucanotransferase ((1→4)-α-d-glucan 4-α-d-[(1→4)-α-d-glucano]-transferase; EC 2.4.1.19) is produced with a genetically modified Escherichia coli strain WCM105xpCM6420 by Wacker Chemie GmbH. The production strain harbours a self-replicating multicopy plasmid which contains genes conferring resistance to two highly important antimicrobials for human and veterinary medicine. The food enzyme is free from viable cells of the production organism, but not of its recombinant DNA. Therefore, the food enzyme poses a risk of promoting the spread of antimicrobial resistance genes. It is intended to be used in starch processing for the production of γ-cyclodextrin. Residual amounts of total organic solids are removed by the purification steps applied during the production of γ-cyclodextrin; consequently, dietary exposure was not calculated. A bacterial reverse mutation test was not considered, because the representativeness of the test material could not be established. No other toxicological tests were provided. In the absence of information about the sequence homology of this β-cyclodextrin glucanotransferase with known allergens, the Panel could not complete the assessment on the allergenicity of the food enzyme. 2-D08 price concludes that the food enzyme β-cyclodextrin glucanotransferase produced with the genetically modified E. coli strain WCM105xpCM6420 cannot be considered safe.The food enzyme α-cyclodextrin glucanotransferase ((1→4)-α-d-glucan 4-α-d-[(1→4)-α-d-glucano]-transferase; EC 2.4.1.19) is produced with a genetically modified Escherichia coli strain WCM105xpCM703 by Wacker Chemie GmbH. The production strain harbours a self-replicating multicopy plasmid which contains genes conferring resistance to two highly important antimicrobials for human and veterinary medicine. #link# The food enzyme is free from viable cells of the production organism, but not of its recombinant DNA. link2 Therefore, the food enzyme poses a risk of promoting the spread of antimicrobial resistance genes. It is intended to be used in starch processing for the production of α-cyclodextrin. Residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of α-cyclodextrin; consequently, dietary exposure was not calculated. Genotoxicity tests, although not raising a safety concern, did not comply with the EFSA guideline. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The study was not supplied as a full report. The Panel identified the highest dose tested as the No Observed Adverse Effect Level, which according to the authors of the study corresponds to 260 mg TOS/kg body weight per day. In the absence of information about the sequence homology of this α-cyclodextrin glucanotransferase with known allergens, the Panel could not complete the assessment on the allergenicity of the food enzyme. The Panel concludes that the food enzyme α-cyclodextrin glucanotransferase produced with the genetically modified E. coli strain WCM105xpCM703 cannot be considered safe.

    With the interruption of elective activity during the coronavirus disease 2019 (COVID-19) pandemic, a reorganisation of health care for patients with inflammatory bowel disease (IBD) was warranted. We aimed to investigate the effectiveness of a dedicated contact centre service (CCS) on the reorganization of a high-volume IBD centre and on the continuity of care during the COVID-19 outbreak.

    We compared the CCS services provided to 3680 IBD patients and clinical outcomes before (January-February 2020) and during (March-April 2020) the COVID-19 period. We further included, as comparator, data from March to April of the previous year (2019).

    During the outbreak, the CCS received an increase of 10.2% of contacts, from 881, in January-February 2020, to 971 (

     = 0.02). An increase of 6% in CCS activities was also reported in comparison with March-April 2019 (from 914 to 971 in March-April 2020,

     = 0.71). Before COVID-19, in both periods most contacts (67% in January-February 2020 and 60% in March-April 201n the reorganization of the IBD centre. Scheduled visits were replaced by phone calls. The main clinical outcomes were maintained in the COVID-19 period. Virtual follow-up using the CCS could be implemented after the pandemic to optimise the resources of the IBD centre.

    The recent shelter-in-place order issued by the Spanish government (due to the outbreak of the COVID-19) forced the Spanish population to self-isolate at home. The psychological and social effects of this new situation are unknown. link3 Therefore, this study aimed to examine the impact of such scenario on citizens’ resilience, as well as the connections between resilience, physical activity (PA), gender, weight and body mass index (BMI) before and after confinement, and COVID-19-related information.

    A total of 1795 people answered an online questionnaire conducted on March 21st

    , 2020, seven days after the mandatory shelter-in-place health order was issued.

    Results showed that individuals who regularly engaged in Vigorous PA during the first week of confinement reported higher resilience in terms of higher locus of control, higher self-efficacy, and higher optimism. Moreover, inter-personal resilience differences were observed based on gender, age groups, BMI, weight, and people living with dependent persons or under health risk conditions.

    To the best of our knowledge, these findings are the first quantitative evidence pointing towards a link between engagement in Vigorous PA and resilience within the COVID-19 restrictions in Spain. These findings may have important implications for general population during the course of this pandemic, or future ones.

    To the best of our knowledge, these findings are the first quantitative evidence pointing towards a link between engagement in Vigorous PA and resilience within the COVID-19 restrictions in Spain. These findings may have important implications for general population during the course of this pandemic, or future ones.

    The objective of the present study was to assess nation-wide, representative prevalence estimates for symptom-defined posttraumatic stress disorder (PTSD) within populations of refugee minors from Afghanistan, Syria and Iraq resettled in Sweden.

    A nation-wide, cross-sectional, questionnaire study with a stratified sample of refugee minors, aged 16-18 years, from Afghanistan, Iraq and Syria, resettled in Sweden between 2014 and 2018 (

    = 5071) was conducted. The response rate was 22.3%, leaving

    = 1129 refugee minors (boys 53.1% / girls 46.9%) in the final sample. Symptom-defined prevalences of PTSD were measured using CRIES-8 with ≥17 as cut-off. Data were analyzed using frequency distributions, and strata-specific PTSD prevalences with 95% confidence intervals (95% CIs), were estimated. The association between migratory status on arrival (unaccompanied vs. accompanied) and PTSD was estimated using crude and adjusted odds ratios (OR)utilizing logistic regression analyses with 95% CIs.

    Overall, the weightedPTSD prevalence was 42% (95% CI 38.9-45.1), with minors from Afghanistan presenting the highest prevalence (56.9, 95% CI 51.5-62.2), compared to minors from Iraq (36.8, 95% CI 28.9-45.4) and Syria (33.4, 95% CI 29.4-37.6). Unaccompanied minors from Afghanistan had higher odds of PTSD compared to accompanied minors from Afghanistan (OR = 1.92, 95% CI 1.08-3.40). Gender differences were non-significant.

    High prevalences of symptom-defined PTSD among refugee minors in general and in unaccompanied minors from Afghanistan in particular, were revealed. Findings calls for continued efforts to support this especially vulnerable group.

    High prevalences of symptom-defined PTSD among refugee minors in general and in unaccompanied minors from Afghanistan in particular, were revealed. Findings calls for continued efforts to support this especially vulnerable group.

    Galectin-3 promotes the proliferation of neural progenitor cells and is engaged in cell-cell adhesion, cell-matrix interactions, and macrophage activation. In addition, in patients with heart failure this carbohydrate-binding protein is a known prognostic marker for cardiovascular mortality. However, its association with psychological variables has not been investigated so far.

    Using data from the multicenter, observational Diast-CHF (Diagnostic Trial on Prevalence and Clinical Course of Diastolic Dysfunction and Heart Failure) trial, we studied in participants with cardiovascular risk factors (

     = 1260, age 66.7 ± 8.0 years, males 51%, left ventricular ejection fraction 60.0 ± 8.1%) the relationship between serum concentrations of galectin-3 and anxiety. Galectin-3 levels were measured by means of a sandwich enzyme-linked immunosorbent assay, and anxiety was assessed using the Hospital Anxiety and Depression Scale (HADS).

    In univariate analysis, there was a weak but significant inverse correlation between galectin-3 and HADS anxiety (rho = - 0.076;

     = 0.008). Linear regression models adjusted for sex, age, body-mass index, estimated glomerular filtration rate, left ventricular ejection fraction, 6-min walking distance, the 36-item Short-Form Health Survey (SF-36) subscale physical functioning, and known biomarkers for heart failure confirmed that serum galectin-3 significantly and independently predicted self-rated anxiety (B = -2.413; 95%CI = -2.413–4.422;

     = 0.019).

    In patients with cardiovascular risk factors, serum concentrations of galectin-3 showed an inverse association with anxiety, which was independent of both the severity of physical impairment and established risk factors for the progression of heart failure.

    In patients with cardiovascular risk factors, serum concentrations of galectin-3 showed an inverse association with anxiety, which was independent of both the severity of physical impairment and established risk factors for the progression of heart failure.

    Screening of unvaccinated women remains essential to mitigate the high morbidity/mortality of cervical cancer. Here, we compared visual inspection with acetic acid (VIA), recommended by WHO as the most cost-effective screening approach in LMICs, with HPV-based screening, and usage of p16

    /Ki-67 dual stain cytology.

    We prospectively enrolled women participating in a VIA-based cervical cancer screening program in two peri-urban health centers of Kenya. Consenting women had a VIA examination preceded by collection of a liquid-based cytology sample from the cervix stored in PreservCyt medium (Hologic®). Analysis of all samples included a hrHPV DNA test and evaluation of a p16

    /Ki-67 (CINtecPLUS®) dual stained slide that was prepared using the ThinPrep® 2000 Processor and evaluated by a pathologist trained in the methodology.

    In 701 of a total of 800 women aged 18-64 years, all three investigations were performed and data could be analyzed. The HPV, VIA and dual stain cytology positivity were 33%, 7%, and 2% respectively.