A survey on methodological issues of clinical research studies reviewed by independent ethic committees during the COVID-19 pandemic in Italy

The struggle for information and the hasty search for answers caused by the COVID-19 pandemic threatened the possibility of lowering study quality, as well as ethical committees’ review standards during the outbreak. Our investigation aimed to assess the impact of COVID-19 on the quality of clinical research studies submitted to Italian Ethics Committees in the period between April and July 2020. All 91 Italian ethics committees were contacted via email in order to collect anonymized information on the type and quality of COVID-19-related studies submitted to each committee during the study period. The present study summarizes the characteristics of the 184 study applications collected, pointing out, especially, how the quality of the study population and statistical analysis are crucial variables in determining the study approval. Nevertheless, despite the need for high-quality and open scientific information, especially exacerbated by this particular historical period, only a minority of the ethics committees (20.9%) agreed to share their data; such scarce participation, beyond biasing the representativeness of the results obtained by the present study, more importantly, hinders the broader goal of creating trust between researchers and the general public

Experimental and computational investigation of co production and dispersion in an automotive repair shop

Carbon monoxide (CO), a highly toxic gas, is produced during the incomplete combustion of carbon-based fuels. In indoor environments, high CO concentrations constitute a serious occupational health hazard; this is especially true in the case of automotive repair shop (ARS) employees who are exposed on a daily basis to vehicle exhaust streams. The present study focuses on the experimental investigation and numerical simulation of CO production and dispersion inside an ARS facility. Detailed measurements of CO concentration, vehicle traffic and ventilation system velocities are performed; the obtained data are appropriately formulated to provide quantitative information for modelling purposes. A detailed Computational Fluid Dynamics simulation of the developing transient flow-field is performed. The numerical results are validated using the experimental data; an overall good qualitative and quantitative agreement is achieved. Aiming to improve the energy efficiency of the mechanical ventilation system, three alternative scenarios are investigated; it is shown that the utilization of a dynamic ventilation system may result in significant energy consumption benefits, while, at the same time, CO concentrations remain below the values suggested by current occupational health legislation. The obtained results may be utilized to assist the design of mechanical ventilation systems for ARS facilities

Effects of microplastics and drought on soil ecosystem functions and multifunctionality

1. Microplastics in soils have become an important threat for terrestrial systems as they may potentially alter the geochemical/biophysical soil environment and can interact with drought. As microplastics may affect soil water content, this could exacerbate the well-known negative effects of drought on ecosystem functionality. Thus, functions including litter decomposition, soil aggregation or those related with nutrient cycling can be altered. Despite this potential interaction, we know relatively little about how microplastics, under different soil water conditions, affect ecosystem functions and multifunctionality. 2. To address this gap, we performed an experiment using grassland plant communities growing in microcosms. Microplastic fibres (absent, present) and soil water conditions (well-watered, drought) were applied in a fully factorial design. At harvest, we measured soil ecosystem functions related to nutrient cycling (beta-glucosaminidase, beta-D-cellobiosidase, phosphatase, beta-glucosidase enzymes), respiration, nutrient retention, pH, litter decomposition and soil aggregation (water stable aggregates). As terrestrial systems provide these functions simultaneously, we also assessed ecosystem multifunctionality, an index that encompasses the array of ecosystem functions measured here. 3. We found that the interaction between microplastic fibres and drought affected ecosystem functions and multifunctionality. Drought had negatively affected nutrient cycling by decreasing enzymatic activities by up to similar to 39%, while microplastics increased soil aggregation by similar to 18%, soil pH by similar to 4% and nutrient retention by up to similar to 70% by diminishing nutrient leaching. Microplastic fibres also impacted soil enzymes, respiration and ecosystem multifunctionality, but importantly, the direction of these effects depended on soil water status. That is, under well-watered conditions, these functions decreased with microplastic fibres by up to similar to 34% while under drought they had similar values irrespective of the microplastic presence, or tended to increase with microplastics. Litter decomposition had a contrary pattern increasing with microplastics by similar to 6% under well-watered conditions while decreasing to a similar percentage under drought. 4. Synthesis and applications. Single ecosystem functions can be positively or negatively affected by microplastics fibres depending on soil water status. However, our results suggest that microplastic fibres may cause negative effects on ecosystem soil multifunctionality of a similar magnitude as drought. Thus, strategies to counteract this new global change factor are necessary

An evacuation model for risk analysis in Spanish road tunnels

In this paper we present EvacTunnel 3.0 an evacuation model design specifically for road tunnels. The model combines coarse network (space discretization) and a microscopic approach for modeling individual behaviors. Based on Monte Carlo methods, the model has the capability to perform multiple simulations by changing random variables of tunnel users such as pre-movement times and walking speeds. The proposed model allows the user to incorporate the effects of fire into the evacuation simulation (importing fire data/results from another model) and, therefore, predicts the number of people directly affected by the smoke (victims). Three verification cases of the proposed model are shown in this paper: 1) risk analysis application, 2) comparison with other evacuation models and 3) a real case application

Improved behavioral indices of welfare in continuous compared to intermittent pair-housing in adult female rhesus macaques (Macaca mulatta).

Limiting opportunities for captive non-human primates (NHPs) to express species-specific social behaviors may disrupt the adaptive drive for social companionship and may lead to increases in coping behaviors and inactivity. While captive NHPs show improved welfare when moving to pair-housing from single-housing, the impact of daily separation of pair-mates, as is implemented in intermittent pair-housing, is not fully understood. We compared behavioral indices of welfare exhibited by adult female rhesus macaques (Macaca mulatta) in two conditions: (1) intermittent pair-housing, involving daily overnight separation of pair-mates, and (2) continuous pair-housing, involving little separation of pair-mates. A within-subjects study design tested two groups of females experiencing both pairing conditions in an alternate order, switching either from continuous to intermittent pair-housing, or from intermittent to continuous pair-housing. Behavioral observations, recording activity state, self-directed, abnormal, and social behaviors, were conducted at midday when all females were paired, and in the afternoon when intermittent pairs were separated. Females exhibited higher levels of inactivity and self-directed behavior when separated due to intermittent pair-housing in comparison to continuous pair-housing. In addition, intermittently paired females showed higher levels of grooming and other types of affiliation when paired, than during the same time frame when they were continuously paired. These results suggest that females in the continuous presence of a social partner experience improved levels of activity and do not need to elevate levels of behavioral coping mechanisms (e.g., self-scratching, increased affiliation) as they receive the benefits associated with social companionship consistently throughout the day. Overall, this study provides the first evidence that continuous pair-housing affords better welfare than intermittent pair-housing in adult female rhesus macaques. Pair-housing options, such as continuous pairing, that reduce reliance on behavioral coping mechanisms and promote adaptive social behavior throughout the entirety of the day should be prioritized over husbandry care scheduled for convenience

Novel microbiological system for antibiotic detection in ovine milk

[EN] This article presents a microbiological system composed of a " BT" bioassay (Beta-lactams and Tetracyclines) and a " QS" bioassay (Quinolones and Sulfonamides). The " BT" bioassay contains spores of Geobacillus stearothermophilus, bromocresol purple and cloramphenicol in a culture medium (incubation time: 2.45h), while the " QS" bioassay uses spores of Bacillus subtilis, trifenyltetrazolium - toluidine blue and trimethoprim in a suitable culture medium (incubation time: 5.5h). The detection capability (CC ß) of 27 antimicrobial agents in ovine milk were determined by logistic regression models. Thus, the " BT" bioassay detects amoxycillin, ampicillin, penicillin " G" , cloxacillin, oxacillin, cephalexin, cefoperazone, ceftiofur, chlortetracycline, oxytetracycline, tetracycline, neomycin, gentamycin and tylosin, while " QS" bioassay detects: ciprofloxacin, enrofloxacin, marbofloxacin, sulfadiazine, sulfadimethoxine, sulfamerazine, sulfamethazine, sulfamethoxazole, sulfathiazole, erythromycin, lincomycin and spiramycin at levels close to their respective Maximum Residue Limits. The simultaneous use of both bioassays detects a large number of antibiotics in milk given each method's adequate complementary sensitivity. © 2011 Elsevier B.V..This research work has been carried out as part of the CAI+D'09/12 Projects (No. 033-173 Res. H.C.D. No. 100/09, Universidad Nacional del Litoral, Santa Fe, Argentina) and AGL2009-11524 (Ministry of Science and Innovation, Spain).Nagel, OG.; Beltrán Martínez, MC.; Molina Pons, MP.; Lisandro Althaus, R. (2012). Novel microbiological system for antibiotic detection in ovine milk. Small Ruminant Research. 102(1):26-31. https://doi.org/10.1016/j.smallrumres.2011.11.018S2631102

Fundamental spray and combustion measurements of soy methyl-ester biodiesel

Although biodiesel has begun to penetrate the fuel market, its effect on injection processes, combustion and emission formation under diesel engine conditions remains somewhat unclear. Typical exhaust measurements from engines running biodiesel indicate that particulate matter, carbon monoxide and unburnt hydrocarbons are decreased, whereas nitrogen oxide emissions tend to be increased. However, these observations are the result of complex interactions between physical and chemical processes occurring in the combustion chamber, for which understanding is still needed. To characterize and decouple the physical and chemical influences of biodiesel on spray mixing, ignition, combustion and soot formation, a soy methyl-ester (SME) biodiesel is injected into a constant-volume combustion facility under diesel-like operating conditions. A range of optical diagnostics is performed, comparing biodiesel to a conventional #2 diesel at the same injection and ambient conditions. Schlieren high-speed imaging shows virtually the same vapour-phase penetration for the two fuels, while simultaneous Mie-scatter imaging shows that the maximum liquid-phase penetration of biodiesel is higher than diesel. Differences in the liquid-phase penetration are expected because of the different boiling-point temperatures of the two fuels. However, the different liquid-phase penetration does not affect overall mixing rate and downstream vapour-phase penetration because each fuel spray has similar momentum and spreading angle. For the biodiesel and diesel samples used in this study, the ignition delay and lift-off length are only slightly less for biodiesel compared to diesel, consistent with the fuel cetane number (51 for biodiesel, 46 for diesel). Because of the similarity in lift-off length, the differences in equivalence ratio distribution at the lift-off length are mainly affected by the oxygen content of the fuels. For biodiesel, the equivalence ratio is reduced, which, along with the fuel molecular structure and oxygen content, significantly affects soot formation downstream. Spatially resolved soot volume fraction measurements obtained by combining line-of-sight laser extinction measurements with planar laser-induced incandescence imaging show that the soot concentration can be reduced by an order of magnitude for biodiesel. These integrated measurements of spray mixing, combustion and quantitative soot concentration provide new validation data for the development of computational fluid dynamics spray, combustion and soot formation models suitable for the latest biofuels.This work was supported by the Spanish Ministry of Science and Innovation for Jean-Guillaume Nerva's visiting research, through the OPTICOMB project [TRA2007-67961-C03-01].Nerva, J.; Genzale, CL.; Kook, S.; García Oliver, JM.; Pickett, LM. (2013). Fundamental spray and combustion measurements of soy methyl-ester biodiesel. International Journal of Engine Research. 14(4):373-390. https://doi.org/10.1177/1468087412456688S373390144(2009). World Energy Outlook 2009. World Energy Outlook. doi:10.1787/weo-2009-enMonyem, A., & H. Van Gerpen, J. (2001). The effect of biodiesel oxidation on engine performance and emissions. Biomass and Bioenergy, 20(4), 317-325. doi:10.1016/s0961-9534(00)00095-7LAPUERTA, M., ARMAS, O., & RODRIGUEZFERNANDEZ, J. (2008). Effect of biodiesel fuels on diesel engine emissions. Progress in Energy and Combustion Science, 34(2), 198-223. doi:10.1016/j.pecs.2007.07.001Fisher, B. T., Knothe, G., & Mueller, C. J. (2010). Liquid-Phase Penetration under Unsteady In-Cylinder Conditions: Soy- and Cuphea-Derived Biodiesel Fuels Versus Conventional Diesel. Energy & Fuels, 24(9), 5163-5180. doi:10.1021/ef100594pFang, T., Lin, Y.-C., Foong, T. M., & Lee, C. (2009). Biodiesel combustion in an optical HSDI diesel engine under low load premixed combustion conditions. Fuel, 88(11), 2154-2162. doi:10.1016/j.fuel.2009.02.033Pastor, J. V., García-Oliver, J. M., Nerva, J.-G., & Giménez, B. (2011). Fuel effect on the liquid-phase penetration of an evaporating spray under transient diesel-like conditions. Fuel, 90(11), 3369-3381. doi:10.1016/j.fuel.2011.05.006Fisher, B. T., & Mueller, C. J. (2010). Liquid penetration length of heptamethylnonane and trimethylpentane under unsteady in-cylinder conditions. Fuel, 89(10), 2673-2696. doi:10.1016/j.fuel.2010.04.024Kim, H. J., Park, S. H., Suh, H. K., & Lee, C. S. (2009). Atomization and Evaporation Characteristics of Biodiesel and Dimethyl Ether Compared to Diesel Fuel in a High-Pressure Injection System. Energy & Fuels, 23(3), 1734-1742. doi:10.1021/ef800811gSuh, H. K., Roh, H. G., & Lee, C. S. (2008). Spray and Combustion Characteristics of Biodiesel∕Diesel Blended Fuel in a Direct Injection Common-Rail Diesel Engine. Journal of Engineering for Gas Turbines and Power, 130(3). doi:10.1115/1.2835354Pickett, L. M., & Siebers, D. L. (2006). Soot Formation in Diesel Fuel Jets Near the Lift-Off Length. International Journal of Engine Research, 7(2), 103-130. doi:10.1243/146808705x57793Pickett, L. M., Kook, S., Persson, H., & Andersson, Ö. (2009). Diesel fuel jet lift-off stabilization in the presence of laser-induced plasma ignition. Proceedings of the Combustion Institute, 32(2), 2793-2800. doi:10.1016/j.proci.2008.06.082Yoo, C. S., Richardson, E. S., Sankaran, R., & Chen, J. H. (2011). A DNS study on the stabilization mechanism of a turbulent lifted ethylene jet flame in highly-heated coflow. Proceedings of the Combustion Institute, 33(1), 1619-1627. doi:10.1016/j.proci.2010.06.147Pastor, J. V., Payri, R., Gimeno, J., & Nerva, J. G. (2009). Experimental Study on RME Blends: Liquid-Phase Fuel Penetration, Chemiluminescence, and Soot Luminosity in Diesel-Like Conditions. Energy & Fuels, 23(12), 5899-5915. doi:10.1021/ef9007328Benajes, J., Molina, S., Novella, R., & Amorim, R. (2010). Study on Low Temperature Combustion for Light-Duty Diesel Engines. Energy & Fuels, 24(1), 355-364. doi:10.1021/ef900832cPickett, L. M., & Siebers, D. L. (2002). An investigation of diesel soot formation processes using micro-orifices. Proceedings of the Combustion Institute, 29(1), 655-662. doi:10.1016/s1540-7489(02)80084-0Siebers, D. L., & Pickett, L. M. (2004). Injection Pressure and Orifice Diameter Effects on Soot in DI Diesel Fuel Jets. Thermo- and Fluid Dynamic Processes in Diesel Engines 2, 109-132. doi:10.1007/978-3-662-10502-3_7Pickett, L. M., & Siebers, D. L. (2004). Soot in diesel fuel jets: effects of ambient temperature, ambient density, and injection pressure. Combustion and Flame, 138(1-2), 114-135. doi:10.1016/j.combustflame.2004.04.006Cheng, A. S., Upatnieks, A., & Mueller, C. J. (2006). Investigation of the impact of biodiesel fuelling on NOx emissions using an optical direct injection diesel engine. International Journal of Engine Research, 7(4), 297-318. doi:10.1243/14680874jer05005Cheng, A. S. (Ed), Upatnieks, A., & Mueller, C. J. (2007). Investigation of Fuel Effects on Dilute, Mixing-Controlled Combustion in an Optical Direct-Injection Diesel Engine. Energy & Fuels, 21(4), 1989-2002. doi:10.1021/ef0606456Klein-Douwel, R. J. H., Donkerbroek, A. J., van Vliet, A. P., Boot, M. D., Somers, L. M. T., Baert, R. S. G., … ter Meulen, J. J. (2009). Soot and chemiluminescence in diesel combustion of bio-derived, oxygenated and reference fuels. Proceedings of the Combustion Institute, 32(2), 2817-2825. doi:10.1016/j.proci.2008.06.140Fang, T., & Lee, C. F. (2009). Bio-diesel effects on combustion processes in an HSDI diesel engine using advanced injection strategies. Proceedings of the Combustion Institute, 32(2), 2785-2792. doi:10.1016/j.proci.2008.07.031Payri, F., Pastor, J. V., Nerva, J.-G., & Garcia-Oliver, J. M. (2011). Lift-Off Length and KL Extinction Measurements of Biodiesel and Fischer-Tropsch Fuels under Quasi-Steady Diesel Engine Conditions. SAE International Journal of Engines, 4(2), 2278-2297. doi:10.4271/2011-24-0037Kook, S., & Pickett, L. M. (2012). Liquid length and vapor penetration of conventional, Fischer–Tropsch, coal-derived, and surrogate fuel sprays at high-temperature and high-pressure ambient conditions. Fuel, 93, 539-548. doi:10.1016/j.fuel.2011.10.004Settles, G. S. (2001). Schlieren and Shadowgraph Techniques. doi:10.1007/978-3-642-56640-0Pickett, L. M., Manin, J., Genzale, C. L., Siebers, D. L., Musculus, M. P. B., & Idicheria, C. A. (2011). Relationship Between Diesel Fuel Spray Vapor Penetration/Dispersion and Local Fuel Mixture Fraction. SAE International Journal of Engines, 4(1), 764-799. doi:10.4271/2011-01-0686MUSCULUS, M., & PICKETT, L. (2005). Diagnostic considerations for optical laser-extinction measurements of soot in high-pressure transient combustion environments. Combustion and Flame, 141(4), 371-391. doi:10.1016/j.combustflame.2005.01.013Williams, T. C., Shaddix, C. R., Jensen, K. A., & Suo-Anttila, J. M. (2007). Measurement of the dimensionless extinction coefficient of soot within laminar diffusion flames. International Journal of Heat and Mass Transfer, 50(7-8), 1616-1630. doi:10.1016/j.ijheatmasstransfer.2006.08.024Kook, S., & Pickett, L. M. (2011). Soot volume fraction and morphology of conventional and surrogate jet fuel sprays at 1000-K and 6.7-MPa ambient conditions. Proceedings of the Combustion Institute, 33(2), 2911-2918. doi:10.1016/j.proci.2010.05.073De Francqueville, L., Bruneaux, G., & Thirouard, B. (2010). Soot Volume Fraction Measurements in a Gasoline Direct Injection Engine by Combined Laser Induced Incandescence and Laser Extinction Method. SAE International Journal of Engines, 3(1), 163-182. doi:10.4271/2010-01-0346Musculus, M. P. B., & Kattke, K. (2009). Entrainment Waves in Diesel Jets. 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High-pressure processing of Manuka honey: brown pigment formation, improvement of antibacterial activity and hydroxymethylfurfural content

This work was undertaken to assess the effects of high-pressure processing on brown pigment formation, antibacterial activity and hydroxymethylfurfural (HMF) content in Manuka honey. The honey was subjected to different pressures (200–600 MPa) at ambient temperatures (25–33 °C) and with moderate temperatures (53–74 °C) for holding times (10–30 min). The brown pigment formation in high-pressuretreated sample showed a significant increase (0.16–0.17, P 0.05). Thus, high-pressure processing has no adverse effect on the honey quality because it can control HMF concentration during process. Increasing brown pigment formation is associated with the enhancement of antibacterial activity

Challenges in the assessment of medical devices: the MedtecHTA project

Assessing medical devices (MDs) raises challenges which require us to reflect on whether current methods are adequate. Major features of devices are: (i) device–operator interaction can generate learning curve effects; (ii) incremental nature of innovation needs to be addressed by careful identification of the alternatives for comparative and incremental costeffectiveness analysis; and (iii) broader organizational impact in terms of training and infrastructure, coupled with dynamic pricing, requires a more flexible approach to costing. The objective of the MedtecHTA project was to investigate improvements in HTA methods to allow for more comprehensive evaluation of MDs. It consisted of several work packages concerning (i) the available evidence on the currently adopted approaches for regulation and HTA of medical devices; (ii) the geographical variation in access to MDs; (iii) the development of methodological frameworks for conducting comparative effectiveness research and economic evaluation of MDs; and (iv) the organizational impact of MDs. This introductory paper summarizes the main results of the project and draws out the main overarching themes. This supplement represents a comprehensive report of all the main findings of the MedtecHTA project, and it is intended to be the main source for researchers and policy makers wanting information on the project

Air Pollution, Aeroallergens, and Emergency Room Visits for Acute Respiratory Diseases and Gastroenteric Disorders among Young Children in Six Italian Cities

Past studies reported evidence of associations between air pollution and respiratory symptoms and morbility for children. Few studies examined associations between air pollution and emergency room (ER) visits for wheezing, and even fewer for gastroenteric illness. We conducted a multicity analysis of the relationship between air pollution and ER visits for wheezing and gastroenteric disorders in children 0-2 years of age.BACKGROUND: Past studies reported evidence of associations between air pollution and respiratory symptoms and morbidity for children. Few studies examined associations between air pollution and emergency room (ER) visits for wheezing, and even fewer for gastroenteric illness. We conducted a multicity analysis of the relationship between air pollution and ER visits for wheezing and gastroenteric disorder in children 0-2 years of age. METHODS: We obtained ER visit records for wheezing and gastroenteric disorder from six Italian cities. A cityspecific case-crossover analysis was applied to estimate effects of particulate matter (PM), nitrogen dioxide, sulfur dioxide, ozone, and carbon monoxide, adjusting for immediate and delayed effects of temperature. Lagged effects of air pollutants up to 6 prior days were examined. The cityspecific results were combined using a random-effect meta-analysis. RESULTS: CO and SO2 were most strongly associated with wheezing, with a 2.7% increase [95% confidence interval (CI), 0.5-4.9] for a 1.04 \u3bcg/m3 increase in 7day average CO and a 3.4% (95% CI, 1.5-5.3) increase for an 8.0 \u3bcg/m3 increase in SO2. Positive associations were also found for PM with aerodynamic diameter 64 10 \u3bcg and NO2. We found a significant association between the 3day moving average CO and gastroenteric disorders [3.8% increase (95% CI, 1.0-6.8)]. When data were stratified by season, the associations were stronger in summer for wheezing and in winter for gastroenteric disorders. CONCLUSION: Air pollution is associated with triggering of wheezing and gastroenteric disorders in children 0-2 years of age; more work is needed to understand the mechanisms to help prevent wheezing in children