Dissingsloth1915

Conclusion In phase III oncology trials, we found no significant differences between the hazard ratios estimated by local investigators and those estimated by blinded independent central reviews. A relatively higher variability, in terms of large CI, was found in trials with biological agents.Purpose To assess whether, in the retrospective assessment of the pragmatic/explanatory features of pragmatic randomized controlled trials (pRCTs), the nine PRECIS-2 domain scores using the information provided in articles were modified after using the information reported in other publicly available sources. Methods This is a cross-sectional study of participant-level pRCTs published in July 2018 to December 2019 in the four highest-impact general medicine journals. The articles described the main results of pRCTs assessing medicines in one or more arms that were not in the pre-licensing phases. The information reported in trial full protocols, published protocols, and other publications, registries, and trial websites were assessed and scored, and compared with that previously obtained after reviewing the information reported in the articles. Results Out of 76 articles on pRCTs, 13 (17%) were included in the analysis. All were two-arm trials, assessing medicines only (n = 7), medicine vs device (n = 2), medopriate retrospective assessment of the pragmatic/explanatory features of a pRCT by authors not involved in the conduct of the trial. To address this issue, editors should require the submission of the original full protocol and final full protocol with the history of amendments to be published as supplementary material to the article.Purpose The aim of this study is to compare the completeness of relevant structured fields such as age, sex, drug and reaction start dates, time to onset, outcome and drug indication, in serious spontaneous cases reported in Spain depending on whether they have been collected by regional pharmacovigilance centres or by the marketing authorization holders. Methods We analyzed the completeness of key variables for causality assessment related to the patient, the reaction and the suspected drug in all serious cases spontaneously reported and registered in the Spanish Pharmacovilance database, called FEDRA, from 1 January 2011 until 31 December 2018. The completeness scores were calculated according to the type of field and taking into account the VigiGrade tool. Cases were classified according to the reporting pathway, that is whether they were received and transmitted by marketing authorization holder or by regional pharmacovigilance centres. Results The completeness score of cases collected by regional pharmacovigilance centres was higher in all the studied variables. The main differences were found in drug and reaction start date, and time to onset. Conclusions This study shows a high completeness score in cases of suspected adverse reactions reported to the regional pharmacovigilance centres with regard to key elements for causality assessment, signal and duplicate detection. In contrast, marketing authorization holder cases show a low completeness score and a decreasing tendency in all the studied variables over the studied period.A novel, Gram-stain-positive bacterium, designated KC615T, was isolated from desert soil which was collected from the Karakum Desert, Turkmenistan. Phylogenetic analysis based on an almost-complete 16S rRNA gene sequence showed that isolate KC615T formed a monophyletic clade with Shimazuella kribbensis KCTC 9933T, sharing 98.2% similarity and polyphasic taxonomic studies confirmed the affiliation of the strain to the genus Shimazuella. The cell-wall peptidoglycan contained meso-diaminopimelic acid. Whole-cell hydrolysates contained ribose and glucose. The major polar lipids were diphosphatidylglycerol, phosphatidylethanolamine and hydroxy-phosphatidylethanolamine. The predominant menaquinones (> 10%) were MK-9(H4) and MK-10(H4). Major fatty acids were anteiso-C150, C200 and C180. The genomic DNA G + C content observed for strain KC615T was 38.5 mol%. Based on 16S rRNA gene similarity, DNA-DNA hybridization value, chemotaxonomic characteristics and differential physiological properties, strain KC615T is considered to represent a novel species within the genus Shimazuella, for which the name Shimazuella alba sp. nov. is proposed. The type strain is KC615T (= JCM 33532T = CGMCC 4.7616T).As a part of studying the effect of deoxygenation, eutrophication and acidification on bacterial diversity, strain HWN-4T was isolated from tube well water and characterized. The draft genome sequencing of strain HWN-4T revealed a genome size of 5,774,764 bp and the annotation indicated 5102 coding sequences including 66 RNA genes. Strain HWN-4T is Gram negative, rod-shaped, motile in the log phase, catalase and oxidase positive, and the major fatty acids and respiratory quinone present are C100 3-OH, C140 3OH/C161 iso I, C161 ω7c/C161 ω6c, C160 and C170 cyclo and ubiquinone-8, respectively. The phylogenetic analyses, based on 16S rRNA gene sequence, indicated that strain HWN-4T is a member of the genus Mitsuaria. The average nucleotide identity (ANI) and genome-to-genome similarity between strain HWN-4T and all other species/strains of the genus Mitsuaria are less than (%) 95.0 and 70.0, respectively. This confirms the status of strain HWN-4T as a novel species. The species status is further confirmed by phenotypic differences exhibited by strain HWN-4T with other members of the same genus. Based on the collective differences exhibited by strain HWN-4T with other members of the genus Mitsuaria, the name Mitsuaria chitinivorans sp. nov. is proposed. Further, the diagnostic signature nucleotides were identified in the 16S rRNA gene sequences of members of the genera Mitsuaria, Pelomonas and Roseateles, that distinctly differentiate them and support an emendation of the genera. Besides, phylogenetic and structural characterization of chitinases from members of the genus Mitsuaria was performed. The type strain of Mitsuaria chitinivorans sp. nov. is HWN-4T = LMG 28685T = KTCC 42483T.The occurrence of multidrug-resistant pathogenic bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA), multidrug-resistant Acinetobacter baumannii (MDRAB), extended-spectrum β-lactamase (ESBL) Escherichia coli, and Pseudomonas aeruginosa, has become a serious problem in animals and public. The objective of this study was to identify and isolate lactic acid bacterial (LAB) strains from the intestinal tracts of pigs and feces of dogs and then characterize them as potential probiotics with antimicrobial activity against multidrug-resistant pathogenic bacteria. AZD9291 In a preliminary isolation screening, 45 of 1167 isolated LAB strains were found to have anti-S. aureus ATCC 27,735 activity. Using 16S rDNA and 16S-23S rDNA intergenic spacer region (ISR) sequences, five of these isolates were further identified as Lactobacillus animalis 30a-2, Lactobacillus reuteri 4-12E, Weissella cibaria C34, Lactococcus lactis 5-12H, and Lactococcus lactis 6-3H. Antimicrobial substance assays suggest that the L. lactis 5-12H, L.