FEM Consulting (Czechia)

The World Health Organization declared COVID-19 a pandemic on 12 March 2020. One of the strategies to combat the pandemic was the development of novel COVID-19 vaccines. Once these vaccines were deployed, immunizations followed. The objective of this study was to identify the characteristics of case reports of adverse events following immunization (AEFIs) with COVID-19 vaccines based on Individual Case Safety Reports (ICSRs) in VigiBase, submitted by four CARICOM countries: Barbados, Haiti, Jamaica and St. Vincent and the Grenadines. A review of the publicly available data on AEFIs with COVID-19 vaccines based on ICSRs in VigiBase was conducted from March 1, 2021 to December 14, 2022. A total of 1,582 AEFI case reports were identified for this period. Most of these were non-serious events, involving persons under 65 years (84.9%), and females (74.1%); 19% were classified as serious events. The top age group reported for AEFIs in VigiBase were 18-44 years (46.6%). The most frequently reported reactions were headache (29.3%), pyrexia (19.3%), dizziness (19.3%). Altogether for the four countries, the AEFIs per 100,000 doses was 64.1 and 12.2 serious AEFIs per 100,000 doses. Recommended actions identified were strengthening national pharmacovigilance regulatory frameworks, establishing robust national pharmacovigilance centres, capacity building of professionals, enhancing communication with key stakeholders and consider relying in a regional pharmacovigilance system.

This study aimed to develop a method for producing human recombinant insulin-like growth factor (IGF-1) based on a prokaryotic expression system and to characterize the highly purified protein.
 To achieve the study’s goal, the following methods were conducted: we performed automated chemical synthesis of DNA, constructed the expression plasmid, obtained Escherichia coli cell-producers of human recombinant IGF-1, cultivated the obtained producer cells with the induction of recombinant protein synthesis by isopropyl-β-D-1-thiogalactopyranoside and lactose, and purified human recombinant IGF-1 with affinity and cation exchange chromatography.
 The recombinant protein IGF-1 forms inclusion bodies during synthesis in Escherichia coli BL21 cells that contain plasmid pET28-IGF-1. Purified recombinant protein was obtained with a purity of 98% using affinity and cation exchange chromatography methods. The protein yield was 6 mg of human recombinant IGF-1 from 1 g of raw biomass. The resulting protein has the ability to protect Neuro 2a neuroblastoma cells from death caused by the deprivation of serum in the culture medium and can stimulate the differentiation of cells into neurons.
 Thus, a highly purified human recombinant IGF-1 was obtained. This protein has biological activity and is suitable for preclinical studies.

The investigation of reactor pressure vessel (RPV) material from the decommissioned Greifswald nuclear power plant representing the first generation of Russian-type WWER-440/V-230 reactors offers the opportunity to evaluate the real toughness response. This paper presents test results measured on trepans taken from the multilayer beltline welding seam SN0.1.4 and forged base metal ring 0.3.1 located in the reactor core region of the Unit 4 RPV. This unit was shut down after 11 years of operation. The characterization of the irradiation response was based on the measurement of the hardness, the tensile strength, the master curve reference temperature, T0, and the Charpy-V transition temperature through the thickness of multilayer beltline welding seam SN0.1.4 and the forged base metal ring 0.3.1. For the beltline welding seam we observed a large variation in the through-thickness master curve T0 values. The T0 values measured with the T-S-oriented Charpy size SE(B) specimens strongly depended on the intrinsic welding bead microstructure along the crack tip. The progression of the T0 values through the thickness-forged base metal ring 0.3.1 ranged from −121 to −130°C and indicated no irradiation-induced embrittlement within the fluence range of 5.38 to 1.20 × 1019 n/cm2 (E > 0.5 MeV) through the thickness of the RPV wall. More than the allowed 2 % of the specimen size-adjusted fracture toughness values, KJc-1T, were below the fracture toughness curve for 2 % fracture probability. The reason for the occurrence of very low KJc-1T values was seen in the intergranular planes detected on the fractured surfaces of the specimens. Modified master curve-based evaluation methods indicated the material to be nonhomogeneous. This investigation shows that the measured irradiation response of the investigated RPV materials does not correspond to the forecast according to the current Russian code.

PURPOSE: In order to quantify the acceleration due to physical activity from an accelerometer signal, the gravity component of acceleration is typically removed from the signal. Yet, when inactive, the orientation of the gravity vector of a triaxial accelerometer provides valuable information, particularly when the monitor is worn on the wrist as utilised in the Sedentary Sphere. We aimed to further explore use of the gravity vector to 1) identify accelerometer wear-site and 2) classify posture using the Sedentary Sphere in data from two brands of wrist-worn accelerometer. METHODS: 1) Wear-site: 22 children, aged 10-12 y, wore a GENEActiv at the wrist and at the hip for 7 days. The angle between the forearm and vertical for the wrist-worn monitor and between the pelvis and the vertical for the hip-worn monitor was calculated for each 5 s epoch. The standard deviation of this angle (SDangle) was calculated over time for windows of varying lengths (1-720 min). We hypothesised that the wrist angle would be more variable than the hip angle. 2) Posture: 34 adults, aged 20-40 y, wore a GENEActiv and an ActiGraph GT3X+ on their non-dominant wrist and an activPAL3 on their thigh for 24 h. Posture (sitting/lying vs upright) was estimated based on the orientation of the gravity vector for both the GENEActiv and ActiGraph and compared with the activPAL. RESULTS: 1) Wear-site: Wear site could be discriminated based on SDangle; the shorter the time window the lower the optimal threshold and area under the receiver-operating-characteristic curve (AUROC) for discrimination of wear-site (AUROC = 0.833 (1 min) - 0.952 (12 h)). Classification accuracy was good for time windows >15 min (sensitivity > 92%, specificity > 88%, AUROC > 0.93). 2) Posture: Time estimated sitting/lying was 534±144 min/d (activPAL), 523±143 min/d (GENEActiv) and 528±137 min/d (ActiGraph). Strong intra-class correlations were evident between the activPAL and accelerometer posture classifications, irrespective of brand (>0.93, 95% confidence interval ≈ 0.84-0.97). CONCLUSION: The gravity component of the acceleration signal of a triaxial accelerometer provides valuable information on the orientation of the monitor. This can be exploited to distinguish between hip and wrist wear-sites and to estimate posture from a wrist-worn accelerometer, independent of brand.

PURPOSE: Determining the factors that limit endurance performance has received considerable attention. Secher and Amman propose that afferent feedback from the fatigued skeletal muscle is the primary determinant of endurance performance. By contrast, Marcora proposes a psychobiological model in which factors such as the perception of effort are principal. Developing methods to distinguish the effect of peripheral vs. central factors would provide insight into this debate. Selectively cooling the head during exercise is one way to potentially provide disparate signals from the brain and the periphery. Therefore, the effects of head cooling on exercise performance in the heat were evaluated in this study. METHODS: Twenty-two young, non-obese (BMI=23.8 kg/m2) men between the ages of 18 and 23 years participated in the study (19.8 +/-1.6 yr). Baseline VO2 peak testing in the heat (35.0 +/- 0.1°C) was followed by a counter-balanced repeated measures design in which participants cycled in the heat (35.0 +/- 0.3°C) for 40 minutes at 65% relative VO2 peak. After 40 minutes of aerobic exercise, participants rested for seven minutes with head cooling (or sham cooling) then performed a final VO2 peak test. Profile of Mood States (POMS) and tympanic temperature were recorded four times: before and after the 40-minute bout of aerobic exercise, as well as before and after the final VO2 peak test. In addition, peak power, VO2, lactate, RPE, and HR were recorded during and at the end of each VO2 peak test. RESULTS: Head-cooling significantly attenuated the heat-induced reduction in power by 50% (-11.8 +/- 19.9 watts) when compared to sham (-24.3 +/- 23.3 watts) (p = 0.002) which translated to a time to exhaustion that was 32 seconds longer after head cooling compared to sham. By contrast, there was no difference between cool-cap and sham for core body temperature (p = 0.91; 38.3 0.3 and 38.7 0.4, respectively), tympanic temperature (p = 0.68, 0.17 +/- 0.44 and 0.22 +/- 0.48), or changes in energy (p=0.864; 0.18 +/-4.91) and fatigue (p=0.54; 0.45 +/- 3.4) as measured by the POMS. DISCUSSION: Our initial results suggest that neither peripheral nor central signals significantly contributed to the increased performance that resulted from head cooling. Future studies could evaluate alterations to efficiency or utilize other measures of energy and fatigue.

The 2009 NEHRP Provisions modified the definition of horizontal ground motion from the geometric mean of spectral accelerations for two components to the peak response of a single lumped mass oscillator regardless of direction. These maximum‐direction (MD) ground motions operate under the assumption that the dynamic properties of the structure (e.g., stiffness, strength) are identical in all directions. This assumption may be true for some in‐plan symmetric structures, however, the response of most structures is dominated by modes of vibration along specific axes (e.g., longitudinal and transverse axes in a building), and often the dynamic properties (especially stiffness) along those axes are distinct. In order to achieve structural designs consistent with the collapse risk level given in the NEHRP documents, we argue that design spectra should be compatible with expected levels of ground motion along those principal response axes. The use of MD ground motions effectively assumes that the azimuth of maximum ground motion coincides with the directions of principal structural response. Because this is unlikely, design ground motions have lower probability of occurrence than intended, with significant societal costs. We recommend adjustments to make design ground motions compatible with target risk levels.

Objective functional performance assessment has recently been added to the 4th edition of the recommended pre-participation examination (PPE) sports physical examination. Clinical postural control assessments conducted in the pre-season have been associated with identifying individuals at risk for lower extremity injury. PURPOSE: The purpose of this study was to evaluate gender and injury occurrence differences in a clinical postural control assessment on ankle injury occurrence in collegiate soccer athletes. METHODS: Postural control assessments were completed on 51 injured vs. 51 non-injured matched-control subjects based on school, gender, height, weight, and history of ankle injury. A total sample of 342 (19.4±1.2yrs, 172.7±12.97cm, 69.3±10.01kg) collegiate U.S. soccer players were tested during the pre-season. Subjects performed three trials of the Star Excursion Balance Test (SEBT) for the anterior (ANT), posterolateral (PL), and posteromedial (PM) directions. Dependent variables consisted of reach distance normalized to % leg length for the mean of each direction and a composite score for all three directions. Separate univariate ANOVA's were conducted for gender and each reach direction normalized score with an alpha level set at.05. RESULTS: There were no significant differences noted between matched-control subjects on each of the SEBT reach directions and composite score (p values ranged.315 to.464). Overall, females had significantly higher anterior reach (p=.018) and composite scores (p=.039) as compared to males. CONCLUSION: Clinical postural control assessment utilizing components of the SEBT were not statistically different in a group of injured vs. matched-control collegiate soccer players for ankle injury. Future research evaluating the SEBT battery as a predictor of ankle injury in physically active populations warrants further study. National Institutes of Health RO3: PA 04-002 NIAMS Small Grant Program for New Investigators: 1R03AR054031-01