8 research outputs found

    Проблематика и методология языковой локализации продукта

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    This article is devoted to reviewing important components of globalization such as localization and internationalization. The article presents the main concepts of these processes and establishes the basic differences between language localization and translation. The text also concerns the systematization of problems in the process of working on the localization of a product, methods of performing localization, theoretical methods of internationalization and localization.Данная статья посвящена ознакомлению с такими важными составляющими глобализации как локализация и интернационализация. В статье приведены основные понятия данных процессов и установлены базовые различия между языковой локализацией и переводом. Так же текст касается систематизации проблематик в процессе работы над локализацией продукта, способах выполнения локализации и теоретических методах интернационализации и локализации

    Algorithm for determining the authenticity of biomedical cell preparations containing mesenchymal stem cells

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    The use of mesenchymal stem cells (MSCs), which have a pronounced immunomodulatory activity, is a promising direction in the development of biomedical cell preparations (BMCPs). In oncohematology, the use of BMCPs containing MSCs is aimed at supporting hematopoiesis during cotransplantation with hematopoietic stem cells (HSCs) and suppressing immune conflicts during allogeneic unrelated transplantation and severe autoimmune processes. An obligatory stage of registration of BMCPs is confirmation of the identity of the MSC cell line (CL), which includes the establishment of morphological characteristics, evaluation of the expression of specific markers and proteins, and confirmation of the genetic stability of CL during cultivation. Determination of markers of genetic stability is possible using various methods, however, according to the recommendations of the American National Standardization Institute, the standard is the analysis of short tandem repeats (STR analysis). The purpose of the study is to develop an algorithm for determining the authenticity of BMCPs containing MSCs, including STR analysis. Material and methods. Identification of MSC cells in BMCP was performed according to the criteria of the International Society for Cell Therapy. Viable cells were counted in a Goryaev chamber. Immunophenotypic characteristics of MSCs were determined by flow cytometry. The level of production of specific proteins was assessed using enzyme immunoassay. Genetic stability markers were identified by STR analysis. Results and discussion. The methods were tested in triplicate for ten BMCP samples to confirm the reproducibility and reliability of the results. The developed algorithm for determining the authenticity of BMCP has a high accuracy, as it includes the STR analysis technique, which makes it possible to identify 19 polymorphic STR markers located on different alleles. Using the method will allow BMCP manufacturers to go through the procedure of state registration of drugs

    Cytokines and autologic bone marrow mononuclears in postmyocardial infarction regeneration

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    Aim. To study safety and effectiveness of autologic bone marrow mononuclears (BMM) transplantation in acute myocardial infarction (AMI) patients. Material and methods. This open, randomized, controlled study included 44 AMI patients: 22 in intervention group (I) and 22 in control group (II). AMI-related coronary artery (AMI-CA) recanalization was performed by stenting. At Day 7-21 of AMI, 100 millions of autologic BMM were infused into AMI-CA in Group I. BMM distribution was studied by radionuclide 99mТс-HMPAO indication method. Clinical status, physical stress tolerance, quality of life were assessed; echocardiography, 24-hour electrocardiography monitoring, myocardial perfusion scintigraphy with 199Tl and ATP were performed. Plasma levels of fatty acid-binding protein, tumor necrosis factor)alpha (TNF)alpha), interleukin 1-beta (IL-1beta), insulin-like growth factor (ILGF), and basic fibroblast growth factor (FGF) were measured. Results. Intracoronary BMM infusion resulted in myocardial BMM fixation. There was no inter-group difference in volume parameters and left ventricular (LV) ejection fraction. In intervention group, local LV contractility improved earlier. Transient perfusion defect remained at 6 months in control group only. In Group I, at Days 1 and 5, the levels of IL-1-beta and TNF-alpha were significantly lower, and ILGF-1 - significantly higher than in controls. BMM quantity directly correlated with basic FGF levels. Conclusion. Cell cardiomyoplastics facilitates myocardial cell fixation, without damaging myocardium, triggering malignant arrhythmias or affecting global LV contractility, reduces IL-1-beta and TNF-alpha levels, increases ILGF-1 and basic FGF concentration

    Rivaroxaban with or without aspirin in stable cardiovascular disease

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    BACKGROUND: We evaluated whether rivaroxaban alone or in combination with aspirin would be more effective than aspirin alone for secondary cardiovascular prevention. METHODS: In this double-blind trial, we randomly assigned 27,395 participants with stable atherosclerotic vascular disease to receive rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg once daily). The primary outcome was a composite of cardiovascular death, stroke, or myocardial infarction. The study was stopped for superiority of the rivaroxaban-plus-aspirin group after a mean follow-up of 23 months. RESULTS: The primary outcome occurred in fewer patients in the rivaroxaban-plus-aspirin group than in the aspirin-alone group (379 patients [4.1%] vs. 496 patients [5.4%]; hazard ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.86; P<0.001; z=−4.126), but major bleeding events occurred in more patients in the rivaroxaban-plus-aspirin group (288 patients [3.1%] vs. 170 patients [1.9%]; hazard ratio, 1.70; 95% CI, 1.40 to 2.05; P<0.001). There was no significant difference in intracranial or fatal bleeding between these two groups. There were 313 deaths (3.4%) in the rivaroxaban-plus-aspirin group as compared with 378 (4.1%) in the aspirin-alone group (hazard ratio, 0.82; 95% CI, 0.71 to 0.96; P=0.01; threshold P value for significance, 0.0025). The primary outcome did not occur in significantly fewer patients in the rivaroxaban-alone group than in the aspirin-alone group, but major bleeding events occurred in more patients in the rivaroxaban-alone group. CONCLUSIONS: Among patients with stable atherosclerotic vascular disease, those assigned to rivaroxaban (2.5 mg twice daily) plus aspirin had better cardiovascular outcomes and more major bleeding events than those assigned to aspirin alone. Rivaroxaban (5 mg twice daily) alone did not result in better cardiovascular outcomes than aspirin alone and resulted in more major bleeding events

    Global variations in heart failure etiology, management, and outcomes

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    Importance: Most epidemiological studies of heart failure (HF) have been conducted in high-income countries with limited comparable data from middle- or low-income countries. Objective: To examine differences in HF etiology, treatment, and outcomes between groups of countries at different levels of economic development. Design, Setting, and Participants: Multinational HF registry of 23 341 participants in 40 high-income, upper–middle-income, lower–middle-income, and low-income countries, followed up for a median period of 2.0 years. Main Outcomes and Measures: HF cause, HF medication use, hospitalization, and death. Results: Mean (SD) age of participants was 63.1 (14.9) years, and 9119 (39.1%) were female. The most common cause of HF was ischemic heart disease (38.1%) followed by hypertension (20.2%). The proportion of participants with HF with reduced ejection fraction taking the combination of a β-blocker, renin-angiotensin system inhibitor, and mineralocorticoid receptor antagonist was highest in upper–middle-income (61.9%) and high-income countries (51.1%), and it was lowest in low-income (45.7%) and lower–middle-income countries (39.5%) (P &lt; .001). The age- and sex- standardized mortality rate per 100 person-years was lowest in high-income countries (7.8 [95% CI, 7.5-8.2]), 9.3 (95% CI, 8.8-9.9) in upper–middle-income countries, 15.7 (95% CI, 15.0-16.4) in lower–middle-income countries, and it was highest in low-income countries (19.1 [95% CI, 17.6-20.7]). Hospitalization rates were more frequent than death rates in high-income countries (ratio = 3.8) and in upper–middle-income countries (ratio = 2.4), similar in lower–middle-income countries (ratio = 1.1), and less frequent in low-income countries (ratio = 0.6). The 30-day case-fatality rate after first hospital admission was lowest in high-income countries (6.7%), followed by upper–middle-income countries (9.7%), then lower–middle-income countries (21.1%), and highest in low-income countries (31.6%). The proportional risk of death within 30 days of a first hospital admission was 3- to 5-fold higher in lower–middle-income countries and low-income countries compared with high-income countries after adjusting for patient characteristics and use of long-term HF therapies. Conclusions and Relevance: This study of HF patients from 40 different countries and derived from 4 different economic levels demonstrated differences in HF etiologies, management, and outcomes. These data may be useful in planning approaches to improve HF prevention and treatment globally
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