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- Thomas, HS, et al.
(author)
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- 2019
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swepub:Mat__t
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2. |
- Ruilope, LM, et al.
(author)
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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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In: American journal of nephrology. - : S. Karger AG. - 1421-9670 .- 0250-8095. ; 50:5, s. 345-356
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Journal article (peer-reviewed)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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3. |
- Weis, J., et al.
(author)
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Sensitivity to change of the EORTC quality of life module measuring cancer-related fatigue (EORTC QlQ-Fa12): Results from the international psychometric validation
- 2019
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In: Psycho-Oncology. - : Wiley. - 1057-9249 .- 1099-1611. ; 28, s. 1753-1761
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Journal article (peer-reviewed)abstract
- Objective The European Organisation for Research and Treatment of Cancer Quality of Life Group (EORTC QLG) has developed a multidimensional instrument measuring cancer-related fatigue, the EORTC QLQ-FA12. The analysis of sensitivity to change is an essential part of psychometric validation. With this study, we investigated the EORTC QLQ-FA12's sensitivity to change. Methods The methodology follows the EORTC guidelines of EORTC QLG for phase IV validation of modules. We included cancer patients undergoing curative and palliative treatment at t1 and followed them up prospectively over the course of their treatment (t2) and 4 weeks after completion of treatment (t3). Data were collected prospectively at 17 sites in 11 countries. Sensitivity to change was investigated using analysis of variance. Results A total sample of 533 patients was enrolled with various tumour types, different stages of cancer, and receiving either curative treatment (n=311) or palliative treatment (n=222). Over time all fatigue scores were significantly higher in the palliative treatment group compared with the curative group (p < .001). Physical fatigue increased with medium effect size over the course of treatment in the curative group (standardized response mean [SRM] (t1,t2) = 0.44]. After treatment physical [SRM (t2,t3) = 0.39], emotional [SRM (t2,t3)= 0.28] and cognitive fatigue (SRM [t2,t3] = 0.22) declined significantly in the curative group. In the palliative group, emotional (SRM [t2,t3] = 0.18) as well as cognitive [SRM [t2,t3] = 0.26) fatigue increases significantly. Conclusions The EORTC-QLQ-FA12 proved to identify clinically significant changes in fatigue in the course of curative and palliative cancer treatment.
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- Mohamed, B., et al.
(author)
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Inter-Annual Variability and Trends of Sea Level and Sea Surface Temperature in the Mediterranean Sea over the Last 25 Years
- 2019
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In: Pure and Applied Geophysics. - : Springer Science and Business Media LLC. - 0033-4553 .- 1420-9136. ; 176:8, s. 3787-3810
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Journal article (peer-reviewed)abstract
- Sea level and sea surface temperature inter-annual variability and trends in the Mediterranean Sea were investigated during the period 1993-2017. These were carried out using gridded absolute dynamic topography from satellite altimetry, tide gauge (TG) time series from 25 stations and gridded sea surface temperature (SST) from advanced very-high-resolution radiometer (AVHRR) data. The coastal TG data were used to verify the satellite derived sea level. Moreover, the contributions of atmospheric pressure and North Atlantic Oscillation (NAO) to sea level changes were also examined. The results revealed that the Mediterranean Sea exhibits inter-annual spatiotemporal coherent variability in both sea level and SST. The spatial variability in sea level is more significant over the Adriatic and Aegean Seas, most of the Levantine basin, and along the Tunisian shelf. Marked spatial variability in SST occurs over the central part of the Mediterranean Sea with maximum amplitude in the Tyrrhenian Sea. The highest temporal variability of sea level and SST was found in 2010 and 2003, respectively. The inter-annual variability of sea level and SST accounts for about 32% and 3% of the total variance of sea level and SST, respectively. An analysis of sea level anomaly reveled large negative values during the extended winter of 2011-2012, which may be attributed to the strong positive phase of NAO index. Satellite altimetry indicated a significant positive sea level trend of 2.7 +/- 0.41 mm/year together with a significant warming of 0.036 +/- 0.003 degrees C/year over the whole Mediterranean Sea for the period 1993-2017.
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