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- Ruilope, LM, et al.
(författare)
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Design and Baseline Characteristics of the Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease Trial
- 2019
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Ingår i: American journal of nephrology. - : S. Karger AG. - 1421-9670 .- 0250-8095. ; 50:5, s. 345-356
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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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| 2. |
- Day, Louise T., et al.
(författare)
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"Every Newborn-BIRTH" protocol : observational study validating indicators for coverage and quality of maternal and newborn health care in Bangladesh, Nepal and Tanzania
- 2019
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Ingår i: Journal of Global Health. - : International Global Health Society. - 2047-2978 .- 2047-2986. ; 9:1
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Tidskriftsartikel (refereegranskat)abstract
- Background: To achieve Sustainable Development Goals and Universal Health Coverage, programmatic data are essential. The Every Newborn Action Plan, agreed by all United Nations member states and >80 development partners, includes an ambitious Measurement Improvement Roadmap. Quality of care at birth is prioritised by both Every Newborn and Ending Preventable Maternal Mortality strategies, hence metrics need to advance from health service contact alone, to content of care. As facility births increase, monitoring using routine facility data in DHIS2 has potential, yet validation research has mainly focussed on maternal recall surveys. The Every Newborn - Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study aims to validate selected newborn and maternal indicators for routine tracking of coverage and quality of facility-based care for use at district, national and global levels.Methods: EN-BIRTH is an observational study including >20000 facility births in three countries (Tanzania, Bangladesh and Nepal) to validate selected indicators. Direct clinical observation will be compared with facility register data and a pre-discharge maternal recall survey for indicators including: uterotonic administration, immediate newborn care, neonatal resuscitation and Kangaroo mother care. Indicators including neonatal infection management and antenatal corticosteroid administration, which cannot be easily observed, will be validated using inpatient records. Trained clinical observers in Labour/Delivery ward, Operation theatre, and Kangaroo mother care ward/areas will collect data using a tablet-based customised data capturing application. Sensitivity will be calculated for numerators of all indicators and specificity for those numerators with adequate information. Other objectives include comparison of denominator options (ie, true target population or surrogates) and quality of care analyses, especially regarding intervention timing. Barriers and enablers to routine recording and data usage will be assessed by data flow assessments, quantitative and qualitative analyses.Conclusions: To our knowledge, this is the first large, multi-country study validating facility-based routine data compared to direct observation for maternal and newborn care, designed to provide evidence to inform selection of a core list of indicators recommended for inclusion in national DHIS2. Availability and use of such data are fundamental to drive progress towards ending the annual 5.5 million preventable stillbirths, maternal and newborn deaths.
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| 3. |
- Fiorina, B., et al.
(författare)
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Challenging modeling strategies for LES of non-adiabatic turbulent stratified combustion
- 2015
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Ingår i: Combustion and Flame. - : Elsevier BV. - 0010-2180 .- 1556-2921. ; 162:11, s. 4264-4282
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Tidskriftsartikel (refereegranskat)abstract
- Five different low-Mach large eddy simulations are compared to the turbulent stratified flame experiments conducted at the Technical University of Darmstadt (TUD). The simulations were contributed by TUD, the Institute for Combustion Technology (ITV) at Aachen, Lund University (LUND), the EM2C laboratory at Ecole Centrale Paris, and the University of Duisburg-Essen (UDE). Combustion is modeled by a premixed flamelet tabulation with local flame thickening (TUD), a premixed flamelet progress variable approach coupled to a level set method (ITV), a 4-steps mechanism combined with implicit LES (LUND), the F-TACLES model that is based on filtered premixed flamelet tabulation (EM2C), and a flame surface density approach (UDE). An extensive comparison of simulation and experimental data is presented for the first two moments of velocity, temperature, mixture fraction, and major species mass fractions. The importance of heat-losses was assessed by comparing simulations for adiabatic and isothermal boundary conditions at the burner walls. The adiabatic computations predict a flame anchored on the burner lip, while the non-adiabatic simulations show a flame lift-off of one half pilot diameter and a better agreement with experimental evidence for temperature and species concentrations. Most simulations agree on the mean flame brush position, but it is evident that subgrid turbulence must be considered to achieve the correct turbulent flame speed. Qualitative comparisons of instantaneous snapshots of the flame show differences in the size of the resolved flame wrinkling patterns. These differences are (a) caused by the influence of the LES combustion model on the flame dynamics and (b) by the different simulation strategies in terms of grid, inlet condition and numerics. The simulations were conducted with approaches optimized for different objectives, for example low computational cost, or in another case, short turn around. (C) 2015 The Combustion Institute. Published by Elsevier Inc. All rights reserved.
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