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Evaluation of the virus clearance capacity and robustness of the manufacturing process for the recombinant factor VIII protein, turoctocog alfa
No full textAbstractTuroctocog alfa is a B-domain-truncated recombinant factor VIII protein produced in a Chinese hamster ovary (CHO) cell line. The aim of this study was to evaluate the virus clearance capacity and robustness of the turoctocog alfa purification process. Virus clearance evaluation studies were conducted utilising a scaled-down version of the manufacturing process. Total virus clearance was evaluated using the ecotropic murine leukaemia virus (eMuLV) as a model for non-infectious retrovirus-like particles (RVLPs) and certain enveloped viruses. Other viruses utilised included: infectious bovine rhinotracheitis (IBRV), minute virus of mice (MVM), bovine enterovirus (BEV) and Reo-3 virus (Reo-3). Robust clearance of all model viruses was demonstrated with either new or reused resins. Overall, virus reduction factors were: >18.0 log10 (eMuLV); 11.0 log10 (MVM); >11.8 log10 (Reo-3; >5.0 log10 using nanofiltration); >15.3 log10 (BEV) and >12.7 log10 (IBRV). Taken together, these values demonstrate that the purification process for turoctocog alfa effectively removes a range of enveloped and non-enveloped viruses of different physicochemical properties and sizes
Cellular electron cryo tomography and in situ sub-volume averaging reveal the context of microtubule-based processes
No full textAbstractElectron cryo-tomography (cryoET) is currently the only technique that allows the direct observation of proteins in their native cellular environment. Sub-volume averaging of electron tomograms offers a route to increase the signal-to-noise of repetitive biological structures, such improving the information content and interpretability of tomograms. We discuss the potential for sub-volume averaging in highlighting and investigating specific processes in situ, focusing on microtubule structure and viral infection. We show that (i) in situ sub-volume averaging from single tomograms can guide and complement segmentation of biological features, (ii) the in situ determination of the structure of individual viruses is possible as they infect a cell, and (iii) novel, transient processes can be imaged with high levels of detail
Comparative performance of five Mexican plancha-type cookstoves using water boiling tests
No full textAbstractWhile plancha-type cookstoves are very popular and widely disseminated in Latin America, few peer review articles exist documenting their detailed technical performance. In this paper we use the standard Water Boiling Tests (WBT) to assess the energy and emission performance of five plancha-type cookstoves disseminated in about 450 thousand Mexican rural homes compared to the traditional 3-stone fire (TSF). In the high-power phase, average modified combustion efficiencies (MCE) for plancha-type stoves were 97±1% which was higher than TSF 93±4%, and reductions in CO and PM2.5 total emissions were on average 44%. Time to boil and specific fuel consumption, however, were increased in plancha-type stoves compared to the open fire as a result of the reduced overall thermal efficiency of the plancha during WBT. In the simmering phase, plancha-type stoves showed much more consistent performance reductions compared to the TSF. MCE for plancha stoves were on average 98±1% and 95±3% for the TSF, while reductions in CO and PM2.5 total emissions were on average 55%. In this phase 27% average savings in fuel use are achieved by plancha-type stoves. Removal of the plancha rings resulted in savings of specific fuel consumption (SFC), thermal efficiency (TE), and time to boil; however, CO and PM2.5 emissions increased significantly as flue air is drawn through the comal surface rather than through the combustion zone, resulting in suboptimal combustion conditions.International Workshop Agreement (IWA) energy performance Tiers for plancha-type stoves ranged from 0 to 1. However, these results contrast sharply with the well documented reductions in fuel consumption during daily cooking activities achieved by these stoves. IWA indoor emissions Tiers are 4 for both PM2.5 and CO using locally measured values for fugitive emissions. Optimization of combustion chamber design on these stoves in Mexico is desirable to further reduce indoor emissions and to reduce the impacts of neighborhood pollution that can re-infiltrate kitchens. Comparison of performance between plancha-type stoves and unvented stoves should reflect the substantial gains that are made by reducing indoor air pollution and exposures by venting pollutants
Nonparametric estimation of a latent variable model
No full textAbstractIn this paper a nonparametric latent variable model is estimated without specifying the underlying distributions. The main idea is to estimate in a first step a common factor analysis model under the assumption that each manifest variable is influenced by at most one of the latent variables. In a second step nonparametric regression is used to analyze the relation between the latent variables. Theoretical results concerning consistency of the estimates are presented, and the finite sample size performance of the estimates is illustrated by applying them to simulated data
Dorsalis Pedis Artery-based Flap to Cover Nonhealing Wounds Over the Tendo Achillis—A Case Series 用足背動脈蒂皮瓣來覆蓋非癒合的跟腱手術傷口—系列病例報告
No full textAbstractBackground/PurposeSoft tissue necrosis after the repair of a ruptured tendo Achillis is a difficult problem commonly encountered by orthopaedic surgeons. Such wounds are difficult to manage because of the tenuous blood supply and the characteristic anatomical features of the area. Flaps such as the reverse sural flap, medial plantar flap, gastrocnemius flap and free flaps cover such wounds with a good success rate. The aim of our study was to investigate the use of a dorsalis pedis artery (DPA)-based flap to cover a wound over the tendo Achillis insertion area.MethodsWe report a series of 11 patients in whom wounds over the tendo Achillis insertion area were covered with a DPA-based flap. Between 1995 and 2012, 11 patients (nine men and two women), who were referred to us with a nonhealing wound over the tendo Achillis because of soft tissue necrosis after the open repair of a ruptured tendon, were selected for soft tissue coverage of the wound by using a DPA-based flap.ResultsThe average follow-up period was 2.4 years (range, 1–6 years). The mean operative time was 1.7 hours (range, 1.5–2.0 hours). At the latest follow-up examination, the flaps had survived in all patients.ConclusionA DPA-based flap is a good and relatively less complex procedure to use to cover defects over the tendo Achillis with minimum donor site morbidity
An efficient one-pot multi component synthesis of polyhydroquinoline derivatives through Hantzsch reaction catalysed by Gadolinium triflate
No full textAbstractGadolinium(III) trifluoromethanesulfonate (Gadolinium triflate) Gd(OTf)3 catalysed efficient Hantzsch reaction via four-component coupling reactions of aldehydes, 5,5-dimethyl-1,3-cyclohexaedione (dimedone), ethyl acetoacetate and ammonium acetate at ambient temperature was described as the preparation of polyhydroquinoline derivatives. The process presented here is operationally simple, environmentally benign and has excellent yield. Furthermore, the catalyst can be recovered conveniently and reused efficiently
Biological evaluation and simple method for the synthesis of tetrahydrobenzo[a]xanthenes-11-one derivatives
No full textAbstractA simple method for the synthesis of Tetrahydrobenzo[a]xanthenes-11-one derivatives in the presence of BF3.SiO2, and its antibacterial activity was assessed against Pseudomonas syringae, Xanthomonas citi and Pectobacterium carotovorum. The structure of the isolated compounds has been determined by means of 1H/13C NMR and FT-IR spectroscopy. The reactions were carried out in water at room temperature for 5h. This method has some advantages such as good to excellent yield, mild reaction condition, ease of operation and workup, high product purity and green process
Situational determinants of cognitive, affective, and compassionate empathy in naturalistic digital interactions
No full textAbstractEmpathy is apparent in computer-mediated communication (CMC), yet little is known about the situational predictors of empathic responses when interacting digitally. We used a diary methodology to explore: (1) the degree three types of empathy (cognitive, affective, and compassionate) are experienced in students' everyday (text- and image-based) dyadic digital interactions; (2) which situational factors are important for (different types of) empathy in CMC; and (3) how empathy reported in everyday CMC affects participants' perceptions of their empathy in CMC and face-to-face (FtF) contexts. One hundred student volunteers (50 women, Mage = 22.57 years) completed a “digital interaction diary” for three consecutive days, yielding 1939 observations. Participants reported significantly more cognitive than affective empathy, and significantly greater affective than compassionate empathy. Several situational variables (e.g., number of communications, recipient) were related to empathy overall, while others (e.g., subject, mood) contributed to discrete contextual profiles for the empathy subtypes. Empathy reported in the diaries predicted a more favourable ratio of perceived CMC to FtF empathy, particularly for those lower in baseline trait empathy. These findings help elucidate the multidimensional experience of empathy in CMC interactions
Long-term safety, efficacy, pharmacokinetics and pharmacodynamics of omalizumab in children with severe uncontrolled asthma
No full textAbstractBackgroundOmalizumab is effective and well-tolerated in children with moderate to severe allergic asthma. However, the effects of long-term treatment with omalizumab in this population haven't been well investigated. The objective of this study is to evaluate the long-term safety, efficacy, pharmacokinetics and pharmacodynamics of omalizumab in children with uncontrolled severe asthma.MethodsThirty-eight Japanese children (aged 7–16 years) who completed the 24-week treatment core study were included in an uncontrolled extension study, in which treatment with omalizumab continued until the pediatric indication was approved in Japan (ClinicalTrials.gov number: NCT01328886).ResultsThirty-five patients (92.1%) completed the extension study. The median exposure throughout the core and extension studies was 116.6 weeks (range, 46.9–151.1 weeks). The most common adverse events were nasopharyngitis, influenza, upper respiratory tract infection, and asthma. Serious adverse events developed in 10 patients (26.3%), but resolved completely with additional treatments. Incidence of adverse events didn't increase with extended exposure with omalizumab. Twenty-nine patients (76.3%) achieved completely- or well-controlled asthma compared with 9 patients (23.7%) at the start of the extension study. QOL scores, the rates (per year) of hospitalizations and ER visits were significantly improved compared with the baseline of the core study [39.0 vs 48.0 (median), p < 0.001 for QOL, 1.33 vs 0.16, p < 0.001 for hospitalization, 0.68 vs 0.15, p = 0.002 for ER visits]. Remarkably, the mean total IgE level showed a decreasing trend while exposure to omalizumab remained at steady-state.ConclusionsLong-term treatment with omalizumab is well-tolerated and effective in children with uncontrolled severe allergic asthma. No new safety findings were identified
Determinant Effects of Average Fasting Plasma Glucose on Mortality in Diabetic End-Stage Renal Disease Patients on Maintenance Hemodialysis
No full textIntroductionDiabetic kidney disease is an increasingly frequent cause of end-stage renal disease. However, mixed results were shown between glycated hemoglobin and mortality.MethodsWe used the average fasting plasma glucose (FPG) levels to predict mortality rates in long-term hemodialysis patients. We enrolled 46,332 hemodialysis patients with diabetes mellitus, who were registered in the Taiwan Renal Registry Data System between January 2005 and December 2012. The patients were stratified based on the quartiles of average FPG levels measured for the first (1-year FPG) and third years (3-year FPG) of hemodialysis. Survival analysis was conducted via multivariable Cox regression.ResultsAfter the first year of hemodialysis, the mean FPG levels were 103.5 ± 14.5, 144.7 ± 11.5, 189.6 ± 15.2, and 280.8 ± 1.2 mg/dl for the first, second, third, and fourth quartile, respectively. The Kaplan-Meier curve showed an incremental reduction in the survival as FPG levels increased (P < 0.0001). In the Cox regression model, the adjusted hazard ratios were 1.15 (95% CI: 1.10–1.20), 1.30 (95% CI: 1.25–1.36), and 1.45 (95% CI: 1.39–1.51) for the pairwise comparisons between the first quartile and the second, third, and fourth quartile, respectively. Similar trends were observed by 3-year FPG. Patients whose FPG levels increased had a 22% increased risk (95% CI: 1.16–1.29) for all-cause mortality compared with patients whose FPG levels decreased.DiscussionOur results suggest that the average FPG levels are useful predictors of all-cause mortality in dialysis patients. In addition, an increasing trend in average FPG levels indicates poor survival