11 research outputs found

    Design and baseline characteristics of the finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease trial

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    Background: 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. Patients and Methods: 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(2) 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 alpha = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Conclusions: 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

    Canagliflozin and renal outcomes in type 2 diabetes and nephropathy

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    BACKGROUND Type 2 diabetes mellitus is the leading cause of kidney failure worldwide, but few effective long-term treatments are available. In cardiovascular trials of inhibitors of sodium–glucose cotransporter 2 (SGLT2), exploratory results have suggested that such drugs may improve renal outcomes in patients with type 2 diabetes. METHODS In this double-blind, randomized trial, we assigned patients with type 2 diabetes and albuminuric chronic kidney disease to receive canagliflozin, an oral SGLT2 inhibitor, at a dose of 100 mg daily or placebo. All the patients had an estimated glomerular filtration rate (GFR) of 30 to &lt;90 ml per minute per 1.73 m2 of body-surface area and albuminuria (ratio of albumin [mg] to creatinine [g], &gt;300 to 5000) and were treated with renin–angiotensin system blockade. The primary outcome was a composite of end-stage kidney disease (dialysis, transplantation, or a sustained estimated GFR of &lt;15 ml per minute per 1.73 m2), a doubling of the serum creatinine level, or death from renal or cardiovascular causes. Prespecified secondary outcomes were tested hierarchically. RESULTS The trial was stopped early after a planned interim analysis on the recommendation of the data and safety monitoring committee. At that time, 4401 patients had undergone randomization, with a median follow-up of 2.62 years. The relative risk of the primary outcome was 30% lower in the canagliflozin group than in the placebo group, with event rates of 43.2 and 61.2 per 1000 patient-years, respectively (hazard ratio, 0.70; 95% confidence interval [CI], 0.59 to 0.82; P=0.00001). The relative risk of the renal-specific composite of end-stage kidney disease, a doubling of the creatinine level, or death from renal causes was lower by 34% (hazard ratio, 0.66; 95% CI, 0.53 to 0.81; P&lt;0.001), and the relative risk of end-stage kidney disease was lower by 32% (hazard ratio, 0.68; 95% CI, 0.54 to 0.86; P=0.002). The canagliflozin group also had a lower risk of cardiovascular death, myocardial infarction, or stroke (hazard ratio, 0.80; 95% CI, 0.67 to 0.95; P=0.01) and hospitalization for heart failure (hazard ratio, 0.61; 95% CI, 0.47 to 0.80; P&lt;0.001). There were no significant differences in rates of amputation or fracture. CONCLUSIONS In patients with type 2 diabetes and kidney disease, the risk of kidney failure and cardiovascular events was lower in the canagliflozin group than in the placebo group at a median follow-up of 2.62 years

    Studentų emocinės būklės testavimo metu tyrimas panaudojant biometrines technologijas

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    The dissertation investigates the issues of creating a computer system that uses voice signal features to determine person’s emotional state. In addition presented system of measuring pupil diameter.The main objects of research include emotion recognition from speech and dynamics of eye pupil size change.The main purpose of this dissertation is employing suitable methodologies and algorithms to automatically process and analyse human voice parameters. Created algorithms can be used in Stress Management System software. The dissertation also focuses on researching the possibilities of identification of speaker’s psychoemotional state: applying the analysis of speaker’s voice parameters and the analysis of dynamics of eye pupil size change. The dissertation consists of four parts including Introduction, 4 chapters, Conclusions and References. The introduction reveals the investigated problem, importance of the thesis and the object of research and describes the purpose and tasks of the paper, research methodology, scientific novelty, the practical significance of results examined in the paper and defended statements. The introduction ends in presenting the author’s publications on the subject of the defended dissertation, offering the material of made presentations in conferences and defining the structure of the dissertation. Chapter 1- the Recommended Biometric Stress Management System founded on the speech analysis. The System can assist in determining the level of negative stress and resolve the problem for lessening it and can help to manage current stressful situation and to minimize future stress by making the level of future need satisfaction more rational. Chapter 2 investigates the possibilities of detecting trends of microtremor frequency (Pitch phase modulation). Suggested methodology and the algorithm microtremor detect and show that when a person experiences stress, the value microtremor can reach 12 Hz. Besides suggested methodology and the algorithm determine the preparation grade students for the examination and evaluation of knowledge based on his speech analysis. Chapter 3 investigates the possibilities of detecting trends of voice signal parameters. Suggested methodology and the algorithm voice signal parameters detect and show, that when a person is in anger state Pitch in-creases by 30-50 percent compared to a neutral state. Chapter 4 investigates the possibilities of detecting trends of pupil size change depending on person’s psychoemotional state. Suggested methodology and the algorithm detecting psychoemotional state based on measurements pupil size change. Presented hardware system to measure the pupil size change. Shows relationship between pupil size and person's emo-tional state

    Investigation of students’ knowledge and iris interrelationship

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    The developers of computer systems intended for detection of pupil size variation in different human states investigates the following two types of the response: response of a pupil to the psychoemotional state; and pupils response in relation with human‘s intellectual activity performed . During the research we have been analyzing pupil size variation induced by students’ reaction when they know the answer and do not. Image capture device with video camera has been designed in order to execute experiments and record eye images. Delivered image has been processed with the help of specially made Video processing software. Gained results are presented in a form of diagrams which shows that response of students’ pupil within the first minute upon question reading varies when a student knows the answer and does not. If the answer is unknown – the pupil remains widened after first minute of the response

    Research on Human Emotion while Playing a Computer Game using Pupil Recognition Technology

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    The article presents the results of an experiment during which the participants were playing an online game (poker), and while playing the game, a special video cam was recording the diameters of the player’s eye pupils. Diameter data and calculations were based on these records with the aid of a computer program; then, diagrams of the diameter changes in the players’ pupils were created (built) depending on the game situation. The study was conducted in a real life situation, when the players were playing online poker. The results of the study point out the connection between the changes in the psycho-emotional state of the players and the changes in their pupil diameters, where the emotional state is a critical factor affecting the operation of such systems

    Biometric and Intelligent Self-Assessment of Student Progress System

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    All distance learning participants (students, professors, instructors, mentors, tutors and the rest) would like to know how well the students have assimilated the study materials being taught. The analysis and assessment of the knowledge students have acquired over a semester are an integral part of the independent studies process at the most advanced universities worldwide. A formal test or exam during the semester would cause needless stress for students. To resolve this problem, the authors of this article have developed a Biometric and Intelligent Self-Assessment of Student Progress (BISASP) System. The obtained research results are comparable with the results from other similar studies. This article ends with two case studies to demonstrate practical operation of the BISASP System. The first case study analyses the interdependencies between microtremors, stress and student marks. The second case study compares the marks assigned to students during the e-self-assessment, prior to the e-test and during the e-test. The dependence, determined in the second case study, between the student marks scored for the real examination and the marks based on their self-evaluation is statistically significant (the significance >0.99%). The original contribution of this article, compared to the research results published earlier, is as follows: the BISASP System developed by the authors is superior to the traditional self-assessment systems due to the use of voice stress analysis and a special algorithm, which permits a more detailed analysis of the knowledge attained by a student

    Effects of once-weekly exenatide on cardiovascular outcomes in type 2 diabetes

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    BACKGROUND: The cardiovascular effects of adding once-weekly treatment with exenatide to usual care in patients with type 2 diabetes are unknown. METHODS: We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly. The primary composite outcome was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The coprimary hypotheses were that exenatide, administered once weekly, would be noninferior to placebo with respect to safety and superior to placebo with respect to efficacy. RESULTS: In all, 14,752 patients (of whom 10,782 [73.1%] had previous cardiovascular disease) were followed for a median of 3.2 years (interquartile range, 2.2 to 4.4). A primary composite outcome event occurred in 839 of 7356 patients (11.4%; 3.7 events per 100 person-years) in the exenatide group and in 905 of 7396 patients (12.2%; 4.0 events per 100 person-years) in the placebo group (hazard ratio, 0.91; 95% confidence interval [CI], 0.83 to 1.00), with the intention-to-treat analysis indicating that exenatide, administered once weekly, was noninferior to placebo with respect to safety (P<0.001 for noninferiority) but was not superior to placebo with respect to efficacy (P=0.06 for superiority). The rates of death from cardiovascular causes, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, hospitalization for heart failure, and hospitalization for acute coronary syndrome, and the incidence of acute pancreatitis, pancreatic cancer, medullary thyroid carcinoma, and serious adverse events did not differ significantly between the two groups. CONCLUSIONS: Among patients with type 2 diabetes with or without previous cardiovascular disease, the incidence of major adverse cardiovascular events did not differ significantly between patients who received exenatide and those who received placebo
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