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Sökning: WFRF:(Mihaylova S.)

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  • Ruilope, LM, et al. (författare)
  • Design and Baseline Characteristics of the Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease Trial
  • 2019
  • Ingår i: American journal of nephrology. - : S. Karger AG. - 1421-9670 .- 0250-8095. ; 50:5, s. 345-356
  • Tidskriftsartikel (refereegranskat)abstract
    • <b><i>Background:</i></b> Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. <b><i>Patients and</i></b> <b><i>Methods:</i></b> The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate ≥25 mL/min/1.73 m<sup>2</sup> and albuminuria (urinary albumin-to-creatinine ratio ≥30 to ≤5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level α = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. <b><i>Conclusions:</i></b> FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049.
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  • Ruperto, N., et al. (författare)
  • The Pediatric Rheumatology International Trials Organization/American College of Rheumatology provisional criteria for the evaluation of response to therapy in juvenile systemic lupus erythematosus : prospective validation of the definition of improvement
  • 2006
  • Ingår i: Arthritis and Rheumatism. - : Wiley. - 0004-3591 .- 1529-0131. ; 55:3, s. 355-363
  • Tidskriftsartikel (refereegranskat)abstract
    • OBJECTIVE: To use the Pediatric Rheumatology International Trials Organization (PRINTO) core set of outcome measures to develop a validated definition of improvement for the evaluation of response to therapy in juvenile systemic lupus erythematosus (SLE).METHODS: Thirty-seven experienced pediatric rheumatologists from 27 countries, each of whom had specific experience in the assessment of juvenile SLE patients, achieved consensus on 128 patient profiles as being clinically improved or not improved. Using the physicians' consensus ratings as the gold standard measure, the chi-square, sensitivity, specificity, false-positive and false-negative rates, area under the receiver operating characteristic curve, and kappa level of agreement for 597 candidate definitions of improvement were calculated. Only definitions with a kappa value greater than 0.7 were retained. The top definitions were selected based on the product of the content validity score multiplied by its kappa statistic.RESULTS: The definition of improvement with the highest final score was at least 50% improvement from baseline in any 2 of the 5 core set measures, with no more than 1 of the remaining worsening by more than 30%.CONCLUSION: PRINTO proposes a valid and reproducible definition of improvement that reflects well the consensus rating of experienced clinicians and that incorporates clinically meaningful change in core set measures in a composite end point for the evaluation of global response to therapy in patients with juvenile SLE. The definition is now proposed for use in juvenile SLE clinical trials and may help physicians to decide whether a child with SLE responded adequately to therapy.
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  • Ruperto, N., et al. (författare)
  • PRINTO/PRES international website for families of children with rheumatic diseases: www.pediatric-rheumatology.printo.it
  • 2005
  • Ingår i: Ann Rheum Dis. - : BMJ. - 0003-4967. ; 64:7, s. 1101-6
  • Tidskriftsartikel (refereegranskat)abstract
    • OBJECTIVE: To prepare a website for families and health professionals containing up to date information about paediatric rheumatic diseases (PRD). METHODS: Firstly, paediatric rheumatology centres and family self help associations were surveyed to characterise current clinical practice of physicians providing care for children with PRD, research activities, and training facilities of each centre. Secondly, international consensus was reached on the content of the website. Finally, the website was developed and the texts translated. RESULTS: The web page contains three main sections: (a) description for families of the characteristics of 15 PRD; (b) list of paediatric rheumatology centres; (c) contact information for family self help associations. A version for 45 countries in 52 languages (with another three in progress) is now available on the web. 291 surveys from 171 centres and 102 family associations were received from 42 countries. The median proportion of time spent in paediatric practice in the centres examined was 100%, with 70% of this time dedicated to paediatric rheumatology. 90% of the centres were willing to perform clinical trials in the future. CONCLUSIONS: The PRINTO/PRES website provides a well defined and competent set of information about PRD, with appropriate multiple translated versions and easy web navigational direction.
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  • Hernández-Durán, S., et al. (författare)
  • European women in neurosurgery: I – A chronology of trailblazers
  • 2021
  • Ingår i: Journal of Clinical Neuroscience. - : Elsevier BV. - 0967-5868. ; 86, s. 316-323
  • Tidskriftsartikel (refereegranskat)abstract
    • Neurosurgery as a distinct speciality has been around for 100 years. Some of the earliest women neurosurgeons were European, emerging from the 1920′s onwards. Here we detail the rise of women in neurosurgery across Europe with a decade by decade account of big events and firsts across the continent. The emerging themes are seen in stories of pioneers with enormous resilience, camaraderie, trailblazing and triumphing in a system with great obstacles and challenges. Our journey through this chronology brings us to the modern day, where most European countries have or have had a woman neurosurgeon and the future for women in neurosurgery in the continent is very bright. © 2021
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  • Murphy, M., et al. (författare)
  • European women in neurosurgery: II – Historical characters and living legends
  • 2021
  • Ingår i: Journal of Clinical Neuroscience. - : Elsevier BV. - 0967-5868. ; 86, s. 324-331
  • Tidskriftsartikel (refereegranskat)abstract
    • A collaborative global working group of women neurosurgeons in multiple countries at different stages of their neurosurgical careers undertook the task of researching the history of European women in neurosurgery. While doing so, we happened upon many remarkable female neurosurgeons who overcame great adversity, made tremendous contributions to society and institutional neurosurgery, and displayed numerous talents beyond the operating room. In the first part of this paper, we recounted a chronology of female neurosurgeons in Europe, highlighting the most remarkable achievements of women in every decade, from the 1920’s to 2020. In this paper, we honor fascinating women in European neurosurgery, both historical characters and living legends. These women have overcome great adversity and have also excelled in a huge variety of pursuits. While some were themselves refugees, we also have uncovered noteworthy examples of women who immersed themselves in humanitarian missions and who tried to better the world through political action. There are stories of women beating the odds, taking on biased institutions and proving their worth, in spite of the prevailing system. Most inspirational, we have discovered through our comprehensive research on the history of women in European neurosurgery that the future is increasingly female. © 2021 Elsevier Ltd
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  • Castellani, Joëlle, et al. (författare)
  • Impact of Improving Community-Based Access to Malaria Diagnosis and Treatment on Household Costs.
  • 2016
  • Ingår i: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. - : Oxford University Press (OUP). - 1537-6591. ; 63:suppl 5
  • Tidskriftsartikel (refereegranskat)abstract
    • Community health workers (CHWs) were trained in Burkina Faso, Nigeria, and Uganda to diagnose febrile children using malaria rapid diagnostic tests, and treat positive malaria cases with artemisinin-based combination therapy (ACT) and those who could not take oral medicines with rectal artesunate. We quantified the impact of this intervention on private household costs for childhood febrile illness.Households with recent febrile illness in a young child in previous 2 weeks were selected randomly before and during the intervention and data obtained on household costs for the illness episode. Household costs included consultation fees, registration costs, user fees, diagnosis, bed, drugs, food, and transport costs. Private household costs per episode before and during the intervention were compared. The intervention's impact on household costs per episode was calculated and projected to districtwide impacts on household costs.Use of CHWs increased from 35% of illness episodes before the intervention to 50% during the intervention (P < .0001), and total household costs per episode decreased significantly in each country: from US Dollars (USD) $4.36 to USD $1.54 in Burkina Faso, from USD $3.90 to USD $2.04 in Nigeria, and from USD $4.46 to USD $1.42 in Uganda (all P < .0001). There was no difference in the time used by the child's caregiver to care for a sick child (59% before intervention vs 51% during intervention spent ≤2 days). Using the most recent population figures for each study district, we estimate that the intervention could save households a total of USD $29 965, USD $254 268, and USD $303 467, respectively, in the study districts in Burkina Faso, Nigeria, and Uganda.Improving access to malaria diagnostics and treatments in malaria-endemic areas substantially reduces private household costs. The key challenge is to develop and strengthen community human resources to deliver the intervention, and ensure adequate supplies of commodities and supervision. We demonstrate feasibility and benefit to populations living in difficult circumstances.ISRCTN13858170.
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  • Gutierrez-Suarez, R., et al. (författare)
  • Health-related quality of life of patients with juvenile idiopathic arthritis coming from 3 different geographic areas. The PRINTO multinational quality of life cohort study
  • 2007
  • Ingår i: Rheumatology (Oxford). - : Oxford University Press (OUP). - 1462-0324 .- 1462-0332. ; 46:2, s. 314-320
  • Tidskriftsartikel (refereegranskat)abstract
    • OBJECTIVES: To compare health-related quality of life (HRQL) and to identify clinical determinants for poor HRQL of patients with juvenile idiopathic arthritis (JIA) coming from three geographic areas.METHODS: The HRQL was assessed through the Child Health Questionnaire (CHQ). A total of 30 countries were included grouped in three geographic areas: 16 countries in Western Europe; 10 in Eastern Europe; and four in Latin America. Potential determinants of poor HRQL included demographic data, physician's and parent's global assessments, measures of joint inflammation, disability as measured by Childhood Health Assessment Questionnaire (CHAQ) and erythrocyte sedimentation rate. Poor HRQL was defined as a CHQ physical summary score (PhS) or psychosocial summary score (PsS) <2 S.D. from that of healthy children.RESULTS: A total of 3167 patients with JIA, younger than 18 yrs, were included in this study. The most affected health concepts (<2 S.D. from healthy children) that differentiate the three geographic areas include physical functioning, bodily pain/discomfort, global health, general health perception, change in health with respect to the previous year, self-esteem and family cohesion. Determinants for poor HRQL were similar across geographic areas with physical well-being mostly affected by the level of disability while the psychosocial well-being by the intensity of pain.CONCLUSION: We found that patients with JIA have a significant impairment of their HRQL compared with healthy peers, particularly in the physical domain. Disability and pain are the most important determinants of physical and psychosocial well-being irrespective of the geographic area of origin.
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  • Mihaylova, Sashka A, et al. (författare)
  • Analyses of clinically-relevant isolates of Stenotrophomonas spp.
  • 2007
  • Ingår i: Proceedings of the 26th Annual General Meeting of the European Culture Collections’ Organization; A0264.
  • Konferensbidrag (refereegranskat)abstract
    • Objectives: The identification of clinical isolates of Stenotrophomonas spp. to the species level, using a polyphasic approach of phenotypic and genotypic methods, and the determination and comparison of the in vitro responses to various classes of antimicrobial agents by these isolates. Previous studies have suggested a marked diversity among clinical, as well as environmental, isolates of Stenotrophomonas spp. and they represent a significant threat within hospital settings, particularly for patients in ICUs and other immunocompromised conditions. Isolates characterised as putative Stenotrophomonas spp. from Pleven University Hospital were analysed in detail. The predominant source of the isolates was respiratory tract and two thirds of patients were admitted to ICUs. Isolates were examined, using the VITEK 2 compact system, CCUG phenotypic characterisation panels and sequencing and analyses of the genes for 16S rRNA and gyrB. The in vitro responses of isolates to 10 antibiotics (azlocillin, piperacillin, ceftazidime, imipenem, meropenem, ampicillin-sulbactam, piperacillin-tazobactam, gentamicin, amikacin and ciprofloxacin) were evaluated, using the disc diffusion method, according to guidelines of the Clinical and Laboratory Standards Institute. The commercial VITEK 2 system defined all isolates as S. maltophilia, with probabilities of identifications varying from 92 to 99%, and “good”, “very good” or “excellent” confidence. Results from conventional phenotypic testing confirmed identifications for isolates as S. maltophilia or S. rhizophila. DNA sequencing and analyses further defined the species affiliations of isolates of the genus Stenotrophomonas. Previous reports have indicated that Stenotrophomonas spp. exhibit resistance to a broad range of antibiotics. More than 90% of examined isolates were observed to be resistant to imipenem, meropenem and ampicillin-sulbactam, more than 80% were resistant to azlocillin, piperacillin and piperacillin-tazobactam. The only beta-lactam antibiotic with an indication of better activity was ceftazidime. Among the ten antimicrobial agents tested, ciprofloxacin demonstrated the highest activity, as evaluated by diameter zone of growth inhibition. Conclusions: The VITEK 2 compact system identified all isolates to the genus level. However, conventional phenotypic testing may be more effective for species differentiation. Analysis of DNA gene sequencing allows further precise taxonomic identification. Ciprofloxacin could be a drug of choice for therapy of infections caused by Stenotrophomonas spp.
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  • Mihaylova, Sashka A, et al. (författare)
  • In vitro activity of antimicrobial agents against extended-spectrum-beta-lactamase-producing enteric bacteria isolated from urine specimens
  • 2009
  • Ingår i: FEMS 2009 - 3rd Congress of European Microbiologists.
  • Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
    • Objectives: To apply detailed phenotypic and genotypic analyses on extended-spectrum-beta-lactamase (ESBL)-producing clinical isolates. To determine in vitro activities of 14 antimicrobial agents and access these data with respect to treatment choice. Methods: One hundred strains were collected from urine samples of patients from Pleven University Hospital, Bulgaria, from January to December 2008. Patient ages: one month to 85 years. Two thirds were male. At the time of sampling, 50 patients were in Urology department, 23 were in Nephrology department, 8 were in Pediatric department, and 19 were in other departments. Double disc and Combination disc tests were applied for ESBL confirmation. ESBL-types were determined, using a multiplex PCR assay for CTX, TEX, SHV and OXA types. In vitro activities of fosfomycin, imipenem, meropenem, ertapenem, amoxicillin/clavulanic acid, piperacillin/tazobactam, gentamicin, amikacin, tigecycline, colistin, nalidixic acid, nitrofurantoin, ciprofloxacin and levofloxacin were determined by the disk diffusion method, according to guidelines of the CLSI. Results: All strains were confirmed to be members of the Enterobacteriaceae and to be ESBL producers. All strains were susceptible to the three carbapenems tested. Eighty-eight percent of the strains were susceptible to tigecycline, 74% were susceptible to amikacin, 64% were susceptible to piperacillin/tazobactam and 63% were susceptible to nitrofurantoin. More than 70% of the strains tested were resistant or intermediately susceptible to amoxicillin/clavulanic acid, gentamicin, nalidixic acid, ciprofloxacin and levofloxacin. Conclusions: Correlation was found between phenotypic and genotypic methods for detection of ESBL-producing bacteria. Carbapenems demonstrated excellent in vitro activity against strains of ESBL-positive enteric bacteria isolated in a Bulgarian university hospital. Tigecycline, amikacin, piperacillin/tazobactam, nitrofurantoin should also be considered as treatment options.
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  • Mihaylova, S., et al. (författare)
  • Susceptibility of environmental strains of Rhizobium radiobacter to antimicrobial agents
  • 2014
  • Ingår i: World Applied Sciences Journal. - : International Digital Organization for Scientific Information. - 1818-4952. ; 31:5, s. 859-862
  • Tidskriftsartikel (refereegranskat)abstract
    • The objective of the present study was to evaluate the in vitro activities of antimicrobial agents against Rhizobium radiobacter strains, in order to identify the most effective antibiotics for the elimination and control of this bacterium from different biological systems. Carbenicillin, imipenem, meropenem, gentamicin, amikacin, polymyxin B, ciprofloxacin and levofloxacin were determined to be applicable for transformation of the plants with these bacteria. Carbenicillin, carbapenems and fluoroquinolones would be suggested for treatment of human infections. © IDOSI Publications, 2014.
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  • Moore, Edward R.B. 1954, et al. (författare)
  • The family cardiobacteriaceae
  • 2014
  • Ingår i: The Prokaryotes: Gammaproteobacteria. - Berlin, Heidelberg : Springer. - 9783642389221 ; 9783642389221, s. 135-146
  • Bokkapitel (refereegranskat)abstract
    • Cardiobacteriaceae, within the order, Cardiobacteriales, in the class, Gammaproteobacteria, was described as a novel family, based upon the 16S rRNA sequence-based relationships of Cardiobacterium hominis, Dichelobacter nodosus, and Suttonella indologenes, representing distinct lineages within a common phylogenetic cluster. The two species of Cardiobacterium, one species of Dichelobacter, and two species of Suttonella are Gram-negative, rod-shaped, fastidious, facultatively anaerobic, strictly anaerobic or microaerophilic chemoorganotrophs, manifesting pathogenicity in humans and animals. Strains of the species are isolated from human and animal samples. C. hominis, C. valvarum, and S. indologenes are typically recovered from the blood cultures of patients with endocarditis. D. nodosus is a causative agent for foot-rot disease in cloven-hoofed animals, and S. ornithocola is implicated in pulmonary necrosis in birds of the tit family. Rarely are bacteria of the Cardiobacteriaceae detected in nonclinical samples. © 2014 Springer-Verlag Berlin Heidelberg. All rights are reserved.
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  • Saad-Magalhaes, C., et al. (författare)
  • Does removal of aids/devices and help make a difference in the Childhood Health Assessment Questionnaire disability index?
  • 2010
  • Ingår i: Annals of the Rheumatic Diseases. - : BMJ Publishing Group Ltd. - 0003-4967 .- 1468-2060. ; 69:1, s. 82-87
  • Tidskriftsartikel (refereegranskat)abstract
    • OBJECTIVE: To assess whether the removal of aids/devices and/or help from another person in the Childhood Health Assessment Questionnaire (C-HAQ) leads to a significant change in the disability index (DI) score and responsiveness in juvenile idiopathic arthritis (JIA).METHODS: Changes in the C-HAQ DI score in a cross-sectional sample of 2663 children with JIA and in 530 active patients with JIA in a trial of methotrexate (MTX) were compared.RESULTS: Patients in the MTX trial had higher disease activity and disability than the cross-sectional sample. The frequency of aids/devices (range 1.2-10.2%) was similar between the two samples, while help (range 5.3-38.1%) was more frequently used in the MTX group. Correlation between disease severity variables and the two different C-HAQ DI scoring methods did not change substantially. There was a decrease in the C-HAQ DI score for both the cross-sectional (mean score from 0.64 with the original method to 0.54 without aids/devices and help, p<0.0001) and the MTX sample (mean score from 1.23 to 1.07, p<0.0001). A linear regression analysis of the original C-HAQ DI score versus the score without aids/devices and help demonstrated the substantial overlap of the different scoring methods. Responsiveness in the responders to MTX treatment did not change with the different C-HAQ DI scoring methods (range 0.86-0.82).CONCLUSION: The removal of aids/devices and help from the C-HAQ does not alter the interpretation of disability at a group level. The simplified C-HAQ is a more feasible and valid alternative for the evaluation of disability in patients with JIA.
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  • Zhao, Yuxin, 1986-, et al. (författare)
  • Gaussian processes for RSS fingerprints construction in indoor localization
  • 2018
  • Ingår i: 21st International Conference on Information Fusion (FUSION). - : IEEE. - 9780996452762 ; , s. 1377-1384
  • Konferensbidrag (refereegranskat)abstract
    • Location-based applications attract more and more attention in recent years. Examples of such applications include commercial advertisements, social networking software and patient monitoring. The received signal strength (RSS) based location fingerprinting is one of the most popular solutions for indoor localization. However, there is a big challenge in collecting and maintaining a relatively large RSS fingerprint database. In this work, we propose and compare two algorithms namely, the Gaussian process (GP) and Gaussian process with variogram, to estimate and construct the RSS fingerprints with incomplete data. The fingerprint of unknown reference points is estimated based on measurements at a limited number of surrounding locations. To validate the effectiveness of both algorithms, experiments using Bluetooth-low-energy (BLE) infrastructure have been conducted. The constructed RSS fingerprints are compared to the true measurements, and the result is analyzed. Finally, using the constructed fingerprints, the localization performance of a probabilistic fingerprinting method is evaluated.
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