• Molina Jernigan opublikował 5 miesięcy, 2 tygodnie temu

    Our findings present a platform for further genetic epidemiological studies for Arab patients with β-thal.Background BI 695501 is an approved biosimilar to Humira® reference product (RP). Research design and methods In this randomized Phase III trial (VOLTAIRE-PSO), patients with moderate-to-severe chronic plaque psoriasis received BI 695501 or adalimumab RP (24-week treatment). Primary efficacy endpoint the proportion of patients with ≥75% reduction in Psoriasis Area and Severity Index (PASI 75) response at week 16 (±18% equivalence limits for two-sided 95% confidence interval between treatment groups). Safety, pharmacokinetics, and immunogenicity were also assessed. Results Baseline characteristics were balanced between treated groups (BI 695501, n = 159; adalimumab RP, n = 158). PASI 75 response rates (full analysis set, n = 158; n = 157) were 68.2% (BI 695501) and 70.4% (adalimumab RP) at week 16 (95% CI -14.4%, 8.7%), and 75.3% and 72.4%, at week 24, respectively. At week 24, 41.5% (BI 695501) and 44.9% (adalimumab RP) of treated patients had treatment-emergent adverse events (AEs), 3.1% and 4.4% had serious AEs, and 0.0% and 1.9% had AEs of special interest. Of treated patients, 75.3% (BI 695501) and 77.9% (adalimumab RP) were anti-drug antibody-positive. Conclusion These data demonstrate equivalent efficacy and highly similar safety and immunogenicity between BI 695501 and adalimumab RP in patients with chronic plaque psoriasis. Study identifier NCT02850965.Purpose To assess the correlation between the choriocapillaris (CC) on optical coherence tomography (OCT) angiography and the inner choroid (IC) on structural OCT. Methods In this prospective, cross-sectional, observational, pilot study, consecutive healthy subjects were imaged with a 6x6mm macular scan using OCTA PlexElite. Angiographic images of the CC were isolated using 10 μm-thick slab starting 21 μm posterior to the automatically segmented retinal pigment epithelium (RPE) band centerline. The structural en face OCT images of the IC were isolated using five 10 μm-thick slabs starting 11 to 51 μm posterior to the automatically segmented RPE band centerline. Retinal vessels masking was obtained by two methods automated OCTA superficial vessel slab and automated structural OCT outer retina to CC (ORCC) slab. The en face OCT images were binarized for computation of the stromal index (SI). The flow deficits (FD) of the angiographic CC were correlated with the SI of the structural en face OCTs of the IC. Results Twenty eyes of 20 subjects were enrolled. The strongest correlation was observed between the CC FD and the inner choroid SI of the 31-41 slab (IC SI31-41) using the ORCC mask (R = 0.603, p = .005). Similar results were observed when the analysis was repeated when using IC SI31-41 values obtained with the superficial vessels mask (R = 0.561, p = .01). Conclusions The angiographic CC FD was significantly correlated with the structural inner choroidal stromal index. These findings suggest that there may be an opportunity to use structural OCT data to analyze the CC, which may allow longitudinal assessment from historical structural OCT datasets.Background To investigate the effects of insulin glargine injection given with a QS-P jet injector on the glucose profile using a professional mode flash glucose monitoring (FGM) system in patients with type 2 diabetes mellitus (T2DM). Research design and methods In this randomized, controlled, cross-sectional study, 66 patients with T2DM who received insulin glargine (12-18 IU/day) injection were enrolled. The patients were randomly divided into group A (jet injector before insulin pen) and group B (insulin pen before jet injector). Each subject injected insulin daily before breakfast. We analyzed the changes in the glucose profile using a professional mode FGM system. Results Treatment with a jet injector led to significantly lower 24-h mean glucose, maximum blood glucose, area under the curve (AUC) > 10.0 mmol/L, time above range and increased AUC less then 3.9 mmol/L and time below range than those when using an insulin pen. There was no difference in glycemic variability between the two groups. We observed that patients using a jet injector had significantly lower mean glucose between 1200 to 2200. Conclusions Needle-free jet injection of insulin glargine was more effective than use of an insulin pen for good glycemic control in patients with T2DM. Clinical trial registration http://www.clinicaltrials.gov identifier is NCT04093284.Aim Multicenter study to investigate the safety of mite extract product Novo-Helisen Depot, Strengths 1 to 3 (NHD3), as subcutaneous immunotherapy (SCIT), in Chinese children and adolescents with allergic rhinitis (AR) and allergic asthma (AA). Patients & methods We evaluated SCIT-related adverse events (AEs) during NHD3 14-week initial therapy in children (5-11 years) and adolescents (12-17 years) with perennial symptomatic AR and AA. Results Among 3600 injections in 250 patients, 361/3600 (10.0%) injections caused SCIT-related AEs in 96/250 (38.4%) patients, 321/3600 injections (8.9%) caused local reactions in 89/250 (35.6%) and 40/3600 injections (1.1%) caused systemic reactions in 23/250 (9.2%). Conclusion Initial SCIT treatment using NHD3 was safe and well tolerated in Chinese children and adolescents with AR and AA.Animal and human studies demonstrate anatomical and functional links between the vestibular nuclei and the circadian timing system. This promotes the hypothesis of a circadian rhythm of vestibular function. The objective of this study was to evaluate the vestibular function through the vestibulo-ocular reflex using a rotatory chair at different times of the day to assess circadian rhythmicity of vestibular function. Two identical studies evaluating temporal variation of the vestibulo-ocular reflex (VOR) were performed, the first in young adults (age 22.4 ± 1.5 y), and the second in older adults (70.7 ± 4.7 y). The slow phase velocity and time constant of the VOR were evaluated in six separate test sessions, i.e., 0200, 0600, 1000, 1400, 1800, and 2200 h. In both studies, markers of circadian rhythmicity (temperature, fatigue, and sleepiness) displayed expected usual temporal variation. In young adults, the time constant of the VOR showed variation throughout the day (p less then .005), being maximum 1225 h (0600 h test session) before the acrophase of temperature circadian rhythm. In older adults, the slow phase velocity and time constant also displayed temporal variation (p less then .05). Maximum values were recorded at 1035 h (0600 h test session) before the acrophase of temperature circadian rhythm. The present study demonstrates that vestibular function is not constant throughout the day. The implication of the temporal variation in vestibular system in equilibrium potentially exposes the elderly, in particular, to differential risk during the 24 h of losing balance and falling.There are many synthetic drugs in literature have been utilized in healing of the wounds although the natural product specially antioxidants can offer similar if not better biological activity in that regard. Genus Sophora is well known to contain flavonoids and phenolic compounds which have antioxidant and inflammatory effects. So, the aim of the current study was to develop and evaluate chitosan/gelatin based Sophora gibbosa extract-loaded microemulsion as wound dressing. Sophora gibbosa extract (SGE) contained 16 major compounds which have reasonable antioxidant activity. The developed microemulsion showed that Tween 80 produced significant (p  less then  0.05) lower particle size than Pluronic F127 at the same SGE concentration whereas high concentration of extract results in large particle size. Thermodynamic stability studies showed that using higher concentration of the extract produced less stable formulations. The selected formulation was impregnated in the dressing base (chitosan/gelatin; 21 w/w ratio) which exhibited more water absorption. In vivo evaluation revealed that the dressing displayed superior wound repair compared to the control in terms histological examination and determination of alpha smooth muscle actin (α-SMA) and proliferating cell nuclear antigen (PCNA). Thus, SGE-loaded microemulsion-impregnated gelatin/chitosan could be a potential candidate for the wound healing.

    To determine the cost-effectiveness of 2 strategies for post-discharge suicide prevention, an Enhanced Contact intervention based on repeated in-person and telephone contacts, and an individual 2-month long problem-solving Psychotherapy program, in comparison to facilitated access to outpatient care following a suicide attempt.

    We conducted a cost-effectiveness analysis based on a decision tree between January and December 2019. Comparative effectiveness estimates were obtained from an observational study conducted between 2013 and 2017 in Madrid, Spain. Electronic health care records documented resource use (including extra-hospital emergency care, mortality, inpatient admission, and disability leave). Direct cost data were derived from Madrid’s official list of public health care prices. Indirect cost data were derived from Spain’s National Institute of Statistics.

    Both augmentation strategies were more cost-effective than a single priority outpatient appointment considering reasonable thresholds of wmpared to psychotherapy.This study investigated the weekly prevalence of groin problems over a 3-week football pre-season, compared to a 39-week competitive in-season. We registered time-loss groin injuries, and self-reported weekly groin-pain in 17 amateur male football teams (386 players). The average weekly prevalence of groin problems (prevalence ratio (PR)) was 1.8 times higher (95% CI 1.6 to 2.0) during pre-season (21%) compared to in-season (12%). We found a higher weekly prevalence (PR 1.8; 95% CI 1.6 to 2.1) of groin problems without time loss, during the pre-season (19%) compared to the in-season (10%), but no significant difference in the weekly prevalence of groin problems with time loss (PR 1.5; 95% CI 1.0 to 2.4). Attention should be given to optimal load progression, and early implementation of preventive measures during the football pre-season to reduce the prevalence of groin problems in both pre- and in-season.Older adults are at an elevated risk for passive suicide ideation. The interpersonal theory of suicide and the 3-step theory may provide a framework to better understand factors that contribute to passive suicide ideation among older adults. Specifically, this study aimed to test components of prominent suicide theories and examine the role of meaning in life in the associations between hopelessness, thwarted belongingness, perceived burdensomeness and passive suicide ideation among older adults. Participants were 243 adults aged 60 and older recruited from primary care settings in the southwest United States. We hypothesized that high meaning in life would weaken the associations between hopelessness, thwarted belongingness, perceived burdensomeness and passive suicide ideation. Results from moderation analyses indicate that meaning in life was a significant moderator of the associations between hopelessness and passive suicide ideation, thwarted belongingness and passive suicide ideation, and perceived burdensomeness and passive suicide ideation.

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