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1
Folegatti, Pedro M., Duncan Bellamy, Amy Flaxman, Catherine Mair, Chris Ellis, Raquel L. Ramon, Fernando Ramos Lopez, et al. "Safety and Immunogenicity of the Heterosubtypic Influenza A Vaccine MVA-NP+M1 Manufactured on the AGE1.CR.pIX Avian Cell Line." Vaccines 7, no. 1 (March 22, 2019): 33. http://dx.doi.org/10.3390/vaccines7010033.
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Seasonal influenza infections have a significant global impact leading to increased health and economic burden. The efficacy of currently available seasonal influenza vaccines targeting polymorphic surface antigens has historically been suboptimal. Cellular immune responses against highly conserved Influenza A virus antigens, such as nucleoprotein (NP) and matrix protein-1 (M1), have previously been shown to be associated with protection from disease, whilst viral-vectored vaccines are an effective strategy to boost cell-mediated immunity. We have previously demonstrated that MVA encoding NP and M1 can induce potent and persistent T cell responses against influenza. In this Phase I study, we evaluated the safety and immunogenicity of MVA-NP+M1, which was newly manufactured on an immortalized cell line, in six healthy adult participants. The vaccine was well-tolerated with only mild to moderate adverse events that resolved spontaneously and were comparable to previous studies with the same vaccine manufactured in chick embryo fibroblasts. A significant increase in vaccine-specific T cell responses was detected seven days after immunization and was directed against both antigens in the vector insert. This small Phase I study supports progression of this vaccine to a Phase IIb study to assess immunogenicity and additional protective efficacy in older adults receiving licensed seasonal influenza vaccines.
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Jordan, Ingo, Deborah Horn, Kristin Thiele, Lars Haag, Katharina Fiddeke, and Volker Sandig. "A Deleted Deletion Site in a New Vector Strain and Exceptional Genomic Stability of Plaque-Purified Modified Vaccinia Ankara (MVA)." Virologica Sinica 35, no. 2 (December 12, 2019): 212–26. http://dx.doi.org/10.1007/s12250-019-00176-3.
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AbstractVectored vaccines based on highly attenuated modified vaccinia Ankara (MVA) are reported to be immunogenic, tolerant to pre-existing immunity, and able to accommodate and stably maintain very large transgenes. MVA is usually produced on primary chicken embryo fibroblasts, but production processes based on continuous cell lines emerge as increasingly robust and cost-effective alternatives. An isolate of a hitherto undescribed genotype was recovered by passage of a non-plaque-purified preparation of MVA in a continuous anatine suspension cell line (CR.pIX) in chemically defined medium. The novel isolate (MVA-CR19) replicated to higher infectious titers in the extracellular volume of suspension cultures and induced fewer syncytia in adherent cultures. We now extend previous studies with the investigation of the point mutations in structural genes of MVA-CR19 and describe an additional point mutation in a regulatory gene. We furthermore map and discuss an extensive rearrangement of the left telomer of MVA-CR19 that appears to have occurred by duplication of the right telomer. This event caused deletions and duplications of genes that may modulate immunologic properties of MVA-CR19 as a vaccine vector. Our characterizations also highlight the exceptional genetic stability of plaque-purified MVA: although the phenotype of MVA-CR19 appears to be advantageous for replication, we found that all genetic markers that differentiate wildtype and MVA-CR19 are stably maintained in passages of recombinant viruses based on either wildtype or MVA-CR.
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V. S., Harish Kumar, Sindhura Reddy Baleed, Pradeep A. N., Kiran L. J., Shivashankaramurthy K. G., and Raghu Prasada M. S. "Safety evaluation of chromium picolinate in experimental rats." International Journal of Basic & Clinical Pharmacology 9, no. 1 (December 24, 2019): 113. http://dx.doi.org/10.18203/2319-2003.ijbcp20195772.
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Background: Chromium, an essential trace mineral plays an important role in the metabolism of carbohydrate, fat and proteins. Chromium picolinate (Cr.Pic) is used in alternative medicine to treat chromium deficiency. Though Cr.Pic is increasingly used to treat diabetes and obesity, studies on its safety profile is limited.Methods: Acute toxicity study was conducted by oral administration of Cr.Pic (2000 mg/kg body weight). The animals were maintained another 14 days with once a day observation. For sub-chronic studies, test groups were treated with Cr.Pic 10 mg/kg/day for 90 days. Tests for hepatic and renal function were conducted. Effect of Cr.Pic on behavioural changes and motor co-ordination was done on every week. Histopathological studies were conducted on day 90 at the end of the experiment.Results: Acute toxicity study of Cr.Pic showed no signs of toxicity and mortality. Absence of any behavioural alteration or mortality during the period of 14 days indicates that Cr.Pic has no latent effect. Similar results were obtained with sub-chronic studies suggesting safety of Cr.Pic. Cr.Pic treated groups showed no changes in learning and motor co-ordination compared to the untreated group. No gross histopathological changes were seen in any group indicating safety of Cr.Pic.Conclusions: The present study conferred safety profile of Cr.Pic from normal results obtained in hepatic function, renal function, behavioural and histopathological studies, suggesting its safety.
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Alhifany, Abdullah A., Nisrin Bifari, Yasser Alatawi, Saad Ullah Malik, and Thamer Almangour. "465. Comparative Efficacy of Double vs. Single Antibiotic Regimens for the Empiric Treatment of MRSA-Induced Acute Bacterial Skin and Skin Structure Infection." Open Forum Infectious Diseases 6, Supplement_2 (October 2019): S227—S228. http://dx.doi.org/10.1093/ofid/ofz360.538.
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Abstract Background The initial management of Acute bacterial skin and skin structure infection (ABSSSI) is burdensome. It requires empirical antibiotic therapy that covers both gram-positive and gram-negative bacteria. Vancomycin plus aztreonam are the most commonly used antibiotic combination, nonetheless, they have many limitations which limits their use. Hence, many new single agents with MRSA and gram-negative coverage, oral options, and/or good safety profile have been developed to be a potential alternative such as: ceftaroline, ceftobiprole, tigecycline and the recent FDA approved antibiotic (delafloxacin). In the absence of head-to-head trials comparing these agents, we decided to conduct a network meta-analysis for these therapeutic regimens. Methods A Bayesian network meta-analysis of randomized clinical trials identified in PubMed/Medline and Embase databases was conducted. We performed both fixed and random effect models for clinical cure as the primary outcome of interest. Additionally, rankograms were generated using the surface under the cumulative ranking curve (SUCRA) to obtain the treatment ranking probabilities in relation to their relative effect. Results We identified 10 eligible studies involving 4,914 patients. The indirect comparison demonstrated that delafloxacin showed no difference in terms of clinical cure compared with ceftaroline (OR, 0.82, 95% Cr.I 0.39–1.8), ceftobiprole (OR, 0.79, 95% Cr.I 0.32–1.9), SOC (OR, 1.2, 95% Cr.I 0.62–2.4) and tigecycline (OR, 1.0, 95% Cr.I 0.45–2.2) in the fixed effect analysis, nor in the random-effect analysis (OR, 0.8, 95% Cr.I 0.26–2.2; OR, 0.78, 95% Cr.I 0.2–3.0; OR, 1.2, 95% Cr.I 0.51–3.1; and OR, 0.96, 95% Cr.I 0.30–3.0), respectively. Furthermore, the ranking probabilities in the fixed-effect and random-effect analysis showed that ceftaroline was ranked the first in terms of clinical cure (SUCRA, 40.02%) followed by ceftobiprole (SUCRA, 22.80%), delafloxacin (SUCRA, 16.60%), SOC (SUCRA, 13.80%), and then tigecycline (SUCRA, 6.70%). Conclusion Ceftaroline, ceftbiprole, delafoxacin, SOC and tigecycline are similarly effective. However, delafloxacin provides better convenience. Further comparative studies regarding their safety are needed. Disclosures All authors: No reported disclosures.
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Matos, Felipe de Souza, Thaís Christina Cunha, Ayla Macyelle de Oliveira Correia, João Paulo Mendes Tribst, Taciana Marco Ferraz Caneppele, and Alexandre Luiz Souto Borges. "Impact of different restorative techniques on the stress distribution of endodontically-treated maxillary first premolars: a 2-dimensional finite element analysis." JOURNAL OF RESEARCH AND KNOWLEDGE SPREADING 1, no. 1 (December 30, 2020): e11761. http://dx.doi.org/10.20952/jrks1111761.
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The aim of this study was to investigate, through finite element analysis, the impact of different restorative techniques on stress distribution in endodontically-treated maxillary first premolars. A human maxillary first premolar was modeled following the real anatomical dimensions, through a periapical radiography, using the Rhinoceros software, version 4.0SR8. The model was then replicated to compose the groups according to the coronary restorative technique: C (coltosol), GI.C (glass ionomer + coltosol), GI (glass ionomer), CR.GI (conventional resin + glass ionomer), and BR.GI (Bulk Fill resin + glass ionomer). After the models were finished, they were imported as IGES files into ANSYS software, version 17.2. Fixation was defined at the base of the cortical bone and the load was applied with 300 N axially to the buccal and palatal cusps. The results generated were in maximum principal stress (MPS), with the CR.GI and BR.GI groups presenting the lowest values of tension concentration and more homogeneous stress distribution, followed by GI, GI.C and C. All restorative techniques affected the stress distribution in endodontically-treated maxillary first premolars, promoting greater tension in the occlusal third, at the interface with the buccal wall, and in the cervical third. Conventional or Bulk Fill resins associated with a glass ionomer base have a superior biomechanical behavior in relation to coltosol or glass ionomer.
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Christoff, Ana Paula, Giuliano Netto Flores Cruz, Aline Fernanda Rodrigues Sereia, Dellyana Rodrigues Boberg, Daniela Carolina de Bastiani, Laís Eiko Yamanaka, Gislaine Fongaro, et al. "Swab pooling: A new method for large-scale RT-qPCR screening of SARS-CoV-2 avoiding sample dilution." PLOS ONE 16, no. 2 (February 4, 2021): e0246544. http://dx.doi.org/10.1371/journal.pone.0246544.
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To minimize sample dilution effect on SARS-CoV-2 pool testing, we assessed analytical and diagnostic performance of a new methodology, namely swab pooling. In this method, swabs are pooled at the time of collection, as opposed to pooling of equal volumes from individually collected samples. Paired analysis of pooled and individual samples from 613 patients revealed 94 positive individuals. Having individual testing as reference, no false-positives or false-negatives were observed for swab pooling. In additional 18,922 patients screened with swab pooling (1,344 pools), mean Cq differences between individual and pool samples ranged from 0.1 (Cr.I. -0.98 to 1.17) to 2.09 (Cr.I. 1.24 to 2.94). Overall, 19,535 asymptomatic patients were screened using 4,400 RT-qPCR assays. This corresponds to an increase of 4.4 times in laboratory capacity and a reduction of 77% in required tests. Therefore, swab pooling represents a major alternative for reliable and large-scale screening of SARS-CoV-2 in low prevalence populations.
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Tripathi, Mahesh A., Anand Kumartripathi, and Shahanshah Gulpham. "Negligence Vis-À-Vis Ignorance Of Fact With Reference To Responsibilities Of Investigative Officers." American Journal of Political Science Law and Criminology 03, no. 08 (August 25, 2021): 33–39. http://dx.doi.org/10.37547/tajpslc/volume03issue08-07.
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An investigative officer is the first stake holder of the criminal justice system who is responsible to bring each and every fact of the crime and to bring accused before the court of law. Sec- 328,Cr.P.C. emphasis on the inquiry of unsoundness of mind of an accused that believe to be suffering from any mental illness and a magistrate immediately directs prosecution for the a medical examination. If Magistrate is convinced that the person is of unsound mind and consequently incapable of making his defence, he shall postpone proceedings and referred the accused to the hospital for the treatment. Section- 100 to 105 of Mental Health Care Act, 2017 also laid down procedures to deal with mentally ill people who come in contact with law. However, it is found that investigative officers are either not aware of these criminal procedures or showing negligence towards it. Few cases of insanity were cometo notice by the Hon’ble High Courts where investigative officer’s negligence resulted into miscarriage of judgments by lower courts. In this research article authors discussed few cases where Court has found lacuna’s in investigative process and by setting past judgments aside deliver fresh judgment in the favour of an insane defendant. Researcher also explores the issue of human right violation by the criminal justice system itself. In conclusion some deliberations are made to eliminate such issues from criminal justice system.
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Feng, Xian-Chao, Lin Chen, Su Zhuang, Xing-Lian Xu, and Guang-Hong Zhou. "The effect of intake of lamb meat on energy metabolism of Sprague-Dawley rats: possible role of carnitine." Animal Production Science 54, no. 7 (2014): 886. http://dx.doi.org/10.1071/an12307.
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The purpose of the present study was to determine whether carnitine was responsible for the increased energy metabolism observed in Sprague-Dawley rats following inclusion of lamb meat in their diet. This was tested by feeding one of the following three diets: a control diet (control) based on a standard formulation (AIN-93G), a carnitine-supplemented control diet (CD) and a lamb meat diet (LD). All diets were isocaloric (15.46 kJ/g DM) and contained 18.3% protein, 7.1% fat and 58.3% carbohydrate. The carnitine concentrations in the control diet, CD and LD were 29, 984 and 953 mg/kg, respectively. The expression of carnitine palmitoyltransferase-I(CPT-I)α and CTP-Iβ genes, Na,K-ATPase activities and the contents of fat, ATP and creatine phosphate (Cr.P) in liver and skeletal muscle tissues were measured on Days 7 and 14. Bodyweights, bodyweight gains and oxygen consumption rates (OCR) of rats were also measured. The rats fed the LD had higher OCR, ATP and Cr.P concentrations, expressions of CPT-I gene, Na,K-ATPase activities, and lower fat contents, bodyweights and bodyweight gains (P < 0.05) than did the control-group rats. However, rats fed the CD were not significantly different from those fed the control diet, except for the higher CPT-Iα expression, ATP concentrations and lower fat contents in liver (P < 0.05). We conclude that carnitine intake from lamb was not the main factor accounting for the significant effects of lamb consumption on energy metabolism. However, it is likely that carnitine intake by consumption of lamb meat in the LD partly contributed to lowering fat contents in liver, compared with the CD and the control diet groups.
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Varotto, Leonardo, Gianni Bregolin, Mariemma Paccanaro, Antonella De Boni, Carlo Bonanno, and Francesco Perini. "The Closure of Patent Foramen Ovale in Preventing Subsequent Neurological Events: A Bayesian Network Meta-Analysis to Identify the Best Device." Cerebrovascular Diseases 49, no. 2 (2020): 124–34. http://dx.doi.org/10.1159/000507317.
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Background: Randomized-controlled trials (RCTs) reported a finding on the safety and efficacy of percutaneous patent foramen ovale (PFO) closure to prevent stroke recurrence. It showed that the Amplatzer (AMP) device appears to be superior to medical therapy (MT) in preventing strokes and episodes of atrial fibrillation (AF), than other devices. We performed a network meta-analysis (NMA) to evaluate the closure of PFO in preventing subsequent neurological events while investigating the results obtained by specific devices. Methods: We searched 3 databases (MEDLINE, EMBASE, CENTRAL/CCTR) and identified 6 RCTs until March 2019. We performed an NMA and used pooled ORs. Analyses were done in NetMetaXL1.6-WinBUGS1.4. Results: Six RCTs with 3,560 patients (mean age 45.2–46.2 years) were included in the present NMA. Depending on the device, 4 groups of patients were compared with MT: 1,889 patients undergoing PFO closure were significantly less likely to experience a stroke than 1,671 patients treated with MT (ORs 0.41; 95% Cr.I. 0.27–0.60 with fixed-effects model and ORs 0.22; 95% Cr.I. 0.05–0.70 with random-effects model). The patients with AMP showed a similar risk than those treated with Helex/Cardioform (HLX/CF) or with a group of 11 multiple devices. This suggests the equality between the 2 most currently used devices. When assessing TIA and, for the safety analysis, major bleeding, both models confirm no significant difference between any devices and MT. PFO closure increased the risk of new-onset AF: MT induces AF significantly less than all the devices. In favor of the AMP, there is a reduced number of cases of AF versus MT; however, no device superiority has been established in comparing HLX/CF and other devices in a random effect model. Conclusions: Our NMA provides evidence in favor of PFO closure with all the devices currently in use. We can conclude that these devices are better than MT, but not that 1 device is better than the rest in reducing stroke recurrences and AF episodes in the follow-up.
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Kučera, Miloš. "Land category in the National Forest Inventory of the Czech Republic." Acta Universitatis Agriculturae et Silviculturae Mendelianae Brunensis 58, no. 5 (2010): 223–32. http://dx.doi.org/10.11118/actaun201058050223.
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The article deals with the land categorization with special focus on the definition of category FOREST in the National Forest Inventory of the Czech Republic (NFI CR). Definitions of land categories used in the first cycle of forest inventory in 2001–2004 are evaluated. The first task is to assess the appropriateness of existing land categorization and definition of category FOREST in terms of suitability of used parameters defining individual categories and their values. Their compatibility with international definitions of category FOREST is also assessed. The second task is, based on data from the first cycle of NFI CR, to calculate the area of category FOREST according to the international definition of European National Forest Inventory Network (ENFIN) and to determine whether the area of category FOREST is the same or varies from the area according to the definition FOREST defined in NFI CR.In the first part there is a list of used land classifications in the Czech Republic and there are also described used international classifications. Land categorization and definitions according ENFIN are presented. Further the parameters are chosen in the national definition of NFI CR, which are compared with analogous parameters defined by ENFIN, indicating differences. Subsequently, the area of category FOREST is calculated according to the parameters of national definition and ENFIN definition. Finally, suggestions are given for the land classification into categories for the second cycle of NFI CR, including the appropriate parameters and their values for the definition of category FOREST. Possible ways of their implementation into the methodology of NFI CR are listed.
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Lohr, Verena, Oliver Hädicke, Yvonne Genzel, Ingo Jordan, Heino Büntemeyer, Steffen Klamt, and Udo Reichl. "The avian cell line AGE1.CR.pIX characterized by metabolic flux analysis." BMC Biotechnology 14, no. 1 (July 30, 2014). http://dx.doi.org/10.1186/1472-6750-14-72.
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Lohr, Verena, Yvonne Genzel, Ingo Jordan, Dietmar Katinger, Stefan Mahr, Volker Sandig, and Udo Reichl. "Live attenuated influenza viruses produced in a suspension process with avian AGE1.CR.pIX cells." BMC Biotechnology 12, no. 1 (October 30, 2012). http://dx.doi.org/10.1186/1472-6750-12-79.
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Tipu, Umar Farooq. "Appeals under Cr.P.C 1908." SSRN Electronic Journal, 2021. http://dx.doi.org/10.2139/ssrn.3811411.
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Varghese, C., S. Bhat, T. H. H. Wang, G. O’Grady, and S. Pandanaboyana. "Impact of gastric resection and enteric anastomotic configuration on delayed gastric emptying after pancreaticoduodenectomy: a network meta-analysis of randomized trials." BJS Open 5, no. 3 (May 2021). http://dx.doi.org/10.1093/bjsopen/zrab035.
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Abstract Introduction Delayed gastric emptying (DGE) is frequent after pancreaticoduodenectomy (PD). Several RCTs have explored operative strategies to minimize DGE, however, the optimal combination of gastric resection approach, anastomotic route, configuration and the use of enteroenterostomy remains unclear. Methods MEDLINE, Embase and CENTRAL databases were systematically searched for RCTs comparing gastric resection (classic Whipple, pylorus-resecting, pylorus-preserving), anastomotic route (antecolic, retrocolic), configuration (loop gastroenterostomy/Billroth II, Roux-en-Y), and use of enteroenterostomy (Braun). A random-effects, Bayesian network meta-analysis with non-informative priors was conducted to determine the optimal combination of approaches to PD for minimizing DGE. Results Twenty-four RCTs, including 2526 patients and 14 approaches were included. There was some heterogeneity, although inconsistency was low. The overall incidence of DGE was 25.6 per cent (647 patients). Pylorus-resecting, antecolic, Billroth II with Braun enteroenterostomy was associated with the lowest rates of DGE and ranked the best in 35 per cent of comparisons. Classic Whipple, retrocolic, Billroth II with Braun ranked the worst for DGE in 32 per cent of comparisons. Pairwise meta-analysis of retrocolic versus antecolic route for gastrojejunostomy found increased risk of DGE with the retrocolic route (odds ratio 2.10, 95 per cent credibility interval (cr.i.) 0.92 to 4.70). Pairwise meta-analysis of enteroenterostomy found a trend towards lower DGE rates when this was used (odds ratio 1.90, 95 per cent cr.i. 0.92 to 3.90). Having a Braun enteroenterostomy ranked the best in 96 per cent of comparisons. Conclusion Based on existing RCT evidence, a pylorus-resecting, antecolic, Billroth II with Braun enteroenterostomy seems to be associated with the lowest rates of DGE. Preregistration PROSPERO submitted 23 December 2020. CRD42021227637
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Otiende, Verrah, Thomas Achia, and Henry Mwambi. "Bayesian modeling of spatiotemporal patterns of TB-HIV co-infection risk in Kenya." BMC Infectious Diseases 19, no. 1 (October 28, 2019). http://dx.doi.org/10.1186/s12879-019-4540-z.
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Abstract Background Tuberculosis (TB) and Human Immunodeficiency Virus (HIV) diseases are globally acknowledged as a public health challenge that exhibits adverse bidirectional relations due to the co-epidemic overlap. To understand the co-infection burden we used the case notification data to generate spatiotemporal maps that described the distribution and exposure hypotheses for further epidemiologic investigations in areas with unusual case notification levels. Methods We analyzed the TB and TB-HIV case notification data from the Kenya national TB control program aggregated for forty-seven counties over a seven-year period (2012–2018). Using spatiotemporal poisson regression models within the Integrated Nested Laplace Approach (INLA) paradygm, we modeled the risk of TB-HIV co-infection. Six competing models with varying space-time formulations were compared to determine the best fit model. We then assessed the geographic patterns and temporal trends of coinfection risk by mapping the posterior marginal from the best fit model. Results Of the total 608,312 TB case notifications, 194,129 were HIV co-infected. The proportion of TB-HIV co-infection was higher in females (39.7%) than in males (27.0%). A significant share of the co-infection was among adults aged 35 to 44 years (46.7%) and 45 to 54 years (42.1%). Based on the Bayesian Defiance Information (DIC) and the effective number of parameters (pD) comparisons, the spatiotemporal model allowing space-time interaction was the best in explaining the geographical variations in TB-HIV coinfection. The model results suggested that the risk of TB-HIV coinfection was influenced by infrastructure index (Relative risk (RR) = 5.75, Credible Interval (Cr.I) = (1.65, 19.89)) and gender ratio (RR = 5.81e−04, Cr. I = (1.06e−04, 3.18e−03). The lowest and highest temporal relative risks were in the years 2016 at 0.9 and 2012 at 1.07 respectively. The spatial pattern presented an increased co-infection risk in a number of counties. For the spatiotemporal interaction, only a few counties had a relative risk greater than 1 that varied in different years. Conclusions We identified elevated risk areas for TB/HIV co-infection and fluctuating temporal trends which could be because of improved TB case detection or surveillance bias caused by spatial heterogeneity in the co-infection dynamics. Focused interventions and continuous TB-HIV surveillance will ensure adequate resource allocation and significant reduction of HIV burden amongst TB patients.