433 research outputs found

    Value Assessments of Novel Medicines in the US and Europe, 2018-2019

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    Individuals' quality of life linked to major life events, perceived social support, and personality traits.

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    PURPOSE: The aim of this study was to investigate the relationship between major recent life events that occurred during the last 5 years, social and personal resources, and subjective quality of life (QoL). METHODS: A total of 1801 participants from the general population (CoLaus/PsyCoLaus study) completed the Life Events Questionnaire, the Social Support Questionnaire, the NEO Five-Factor Inventory Revised, and the Manchester Short Assessment of Quality of Life. RESULTS: Major life events were modestly associated with the QoL (about 5 % of the explained variance). However, QoL was significantly related to perceived social support and personality traits (about 37 % of the explained variance). Particularly, perceived social support, extraversion and conscientiousness personality dimensions were positively linked to life satisfaction, whereas a high level of neuroticism was negatively associated with QoL. CONCLUSION: This study highlights the negative but temporary association between critical events and QoL. However, a combination of high conscientiousness and extraversion, and positive social support may explain better variances for a high-perceived QoL

    Personality, tobacco consumption, physical inactivity, obesity markers, and metabolic components as risk factors for cardiovascular disease in the general population.

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    The aim of this study was to investigate the relationship between personality traits, tobacco consumption, physical inactivity, obesity markers and metabolic components as cardiovascular risk factors (CVRFs). A total of 2543 participants from the general population (CoLaus|PsyCoLaus) had provided complete information on physical health and unhealthy behaviors and completed the Revised NEO Five-Factor Inventory. Our results show a strong cross-correlation between obesity markers and metabolic components suggesting that their combination could represent an important CVRF. Moreover, socio-demographic characteristics, tobacco consumption, and physical inactivity were associated with both obesity markers and metabolic components latent traits. The conscientiousness personality trait was significantly associated with obesity markers, but played a modest role. Indeed, higher conscientiousness was associated with lower level of obesity indicators. However, no link between personality and metabolic components were found. In sum, our data suggest that health related behaviours have more effect on the development of cardiovascular diseases than personality traits

    Full NLO QCD predictions for Higgs-pair production in the 2-Higgs-doublet model

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    After the discovery of the Higgs boson in 2012 at the CERN Large Hadron Collider (LHC), the study of its properties still leaves room for an extended Higgs sector with more than one Higgs boson. 2-Higgs doublet models (2HDMs) are well-motivated extensions of the Standard Model (SM) with five physical Higgs bosons: two CP-even states h and H, one CP-odd state A, and two charged states H±H^{\pm}. In this letter, we present the calculation of the full next-to-leading order (NLO) QCD corrections to hH and AA production at the LHC in the 2HDM at small values of the ratio of the vacuum expectation values, tan βtan\space\beta, including the exact top-mass dependence everywhere in the calculation. Using techniques applied in the NLO QCD SM Higgs pair production calculation, we present results for the total cross section as well as for the Higgs-pair-mass distribution at the LHC. We also provide the top-quark scale and scheme uncertainties which are found to be sizeable

    Gluon fusion into Higgs pairs at NLO QCD and the top mass scheme

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    We present the calculation of the full next-to-leading order (NLO) QCD corrections to Higgs boson pair production via gluon fusion at the LHC, including the exact top-mass dependence in the two-loop virtual and one-loop real corrections. This is the first independent cross-check of the NLO QCD corrections presented in the literature before. Our calculation relies on numerical integrations of Feynman integrals, stabilised with integration-by-parts and a Richardson extrapolation to the narrow width approximation. We present results for the total cross section as well as for the invariant Higgs-pair-mass distribution at the LHC, including for the first time a study of the uncertainty due to the scheme and scale choice for the top mass in the loops

    Therapeutic Value of Drugs Granted Accelerated Approval or Conditional Marketing Authorization in the US an Europe From 2007 to 2021

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    IMPORTANCE: The number of drugs approved through the accelerated approval or conditional marketing authorization pathways has increased with unclear evidence of their therapeutic value. OBJECTIVES: To assess the therapeutic value of drug indications granted accelerated approval in the US or conditional marketing authorization in the European Union (EU) overall and for cancer indications. DESIGN, SETTING, AND PARTICIPANTS: This cohort study used the public databases of the US Food and Drug Administration and the European Medicines Agency to identify all drugs (initial and supplemental indications) granted accelerated approval in the US or conditional marketing authorization (initial indications only) in the EU between January 1, 2007, and December 31, 2021. Therapeutic value ratings were obtained from national health authorities in Germany, France, and Canada. MAIN OUTCOMES AND MEASURES: Descriptive statistics were used to assess the proportion of accelerated approvals and conditional marketing authorizations overall and for cancer vs noncancer indications rated as having high added therapeutic value. RESULTS: The cohort included 146 drug indications (94 first indications, 52 supplemental indications) in the US and 58 (all first indications) in the EU. Most drugs were approved for cancer (122 [83.6%] in the US; 40 [69.0%] in the EU). Therapeutic value ratings were available for 90 drug indications (61.6%) in the US and 56 (96.6%) in the EU. Overall, 35 drug indications granted accelerated approval (38.9%) and 21 granted conditional marketing authorization (37.5%) had high added therapeutic value in the US and EU, respectively, at the time of approval. The proportions of indications rated as having high added therapeutic value were 36.0% (27 of 75) for cancer vs 53.3% (8 of 15) for noncancer indications in the US and 30.8% (12 of 39) for cancer vs 52.9% (9 of 17) for noncancer indications in the EU. CONCLUSIONS AND RELEVANCE: In this cohort study, among new drug indications approved through the accelerated approval or conditional marketing authorization pathways in the US and Europe from 2007 to 2021, 38.9% and 37.5%, respectively, demonstrated high therapeutic value. A substantially lower proportion of cancer indications than noncancer indications were rated as having high therapeutic value. Policy makers and regulators should increase enforcement of timely postapproval study completion for drugs qualifying for these pathways

    Efficacy of long-term oral telmisartan treatment in cats with hypertension: Results of a prospective European clinical trial

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    BACKGROUND: Efficacy of telmisartan in treating hypertension (HT) in cats has not been largely investigated. OBJECTIVE: Telmisartan oral solution effectively controls systolic arterial blood pressure (SABP) in hypertensive cats. ANIMALS: Two-hundred eighty-five client-owned cats with systemic HT. METHODS: Prospective, multicenter, placebo-controlled, randomized, double-blinded study. Hypertensive cats diagnosed with SABP ≥160 mmHg and ≤200 mmHg without target-organ-damage were randomized (2 : 1 ratio) to receive 2 mg/kg telmisartan or placebo q24 PO. A 28-day efficacy phase was followed by a 120-day extended use phase. Efficacy was defined as significant difference in mean SABP reduction between telmisartan and placebo on Day 14 and group mean reduction in SABP of > 20 mmHg by telmisartan on Day 28 compared to baseline. RESULTS: Two-hundred fifty-two cats completed the efficacy and 144 cats the extended use phases. Mean SABP reduction at Day 14 differed significantly between groups (P < .001). Telmisartan reduced baseline SABP of 179 mmHg by 19.2 (95% confidence interval [CI]: 15.92-22.52) and 24.6 (95% CI: 21.11-28.14) mmHg at Days 14 and 28. The placebo group baseline SABP of 177 mmHg was reduced by 9.0 (95% CI: 5.30-12.80) and 11.4 (95% CI: 7.94-14.95) mmHg, respectively. Of note, 52% of telmisartan-treated cats had SABP <150 mmHg at Day 28. Mean SABP reduction by telmisartan in severe (≥180 mmHg) and moderate HT (160-179 mmHg) was comparable and persistent over time. CONCLUSIONS AND CLINICAL IMPORTANCE: Telmisartan solution (PO) was effective in reducing SABP in hypertensive cats with SABP ≥160 mmHg and ≤200 mmHg

    NLO QCD corrections to Higgs boson pair production

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    In this contribution the next-to-leading (NLO) QCD corrections to Higgs boson pair production are discussed. A brief sketch of the calculation is given. The differential cross section as a function of the invariant Higgs pair mass and the total hadronic cross section are presented. Furthermore, the uncertainties not only from the renormalisation and factorisation scales but also the uncertainties due to the scheme-and-scale choice of the top mass are shown. In addition, the effects of varying the Higgs self-coupling strength on the cross section are investigated

    Full NLO QCD corrections to Higgs-pair production in the Standard Model and beyond

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    Higgs-pair production is one of the targets of the high-luminosity LHC and of future hadron colliders, as it allows for a direct probe of the trilinear Higgs coupling and hence of the mechanism behind electroweak symmetry breaking. This contribution focuses on the impact of the full next- to-leading order QCD corrections to Higgs-pair production via gluon fusion, the main production mechanism at hadron colliders, in the Standard Model and in Two-Higgs-Doublet models. The uncertainties due to the top-mass scale-and-scheme choice will be discussed

    The impact of disease severity on the psychological well-being of youth affected by an inborn error of metabolism and their families: A one-year longitudinal study.

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    Inborn errors of metabolism (IEMs) refer to rare heterogeneous genetic disorders with various clinical manifestations that can cause serious physical and psychological sequelae. Results of previous studies on the impact of an IEM on health-related quality of life (HR-QoL) were incongruent and only few studies considered more broadly the psychological well-being of children with IEM and their families. Our objectives were to examine: (1) the impact of the IEM severity on the HR-QoL and psychological functioning of patients and their parents at baseline; and (2) its evolution over time; and (3) the correlation between parental and children's perspectives. Methods: The sample included 69 pediatric patients (mean age = 7.55 y, SD = 4.59) with evaluations at baseline and after one year. We collected data on HR-QoL, child mental health and emotional regulation as well as on parental mood and stress using different validated questionnaires. IEM severity was rated by a clinician through the biological subdomain of the pediatric INTERMED instrument. Results: Two groups of patients based on IEM severity scores were created (n = 31 with low and n = 38 with moderate/high IEM severity). The two groups differed with respect to age, diet and supplement intake. IEM severity had an impact on HR-QoL and behavioral symptoms in children, as well as on HR-QoL and stress in parents. For patients with moderate/high IEM severity, child and parental HR-QoL improved after 1-year of follow-up. We did not observe any significant difference between evaluations by patients versus parents. Conclusions: Our findings demonstrate that moderate/high IEM severity altered child and parental psychological well-being, but also revealed a significant improvement after one-year follow-up. This observation suggests that patients with a moderate/high IEM severity and their families benefit from the care of an interdisciplinary team including a child psychologist specialized in IEMs. Moreover, in patients with higher IEM severity there may also be more room for improvement compared to patients with low IEM severity. Future studies should focus on observations over a larger time span, particularly during adolescence, and should include objective measurements
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