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- 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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| 2. |
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| 3. |
- Konold, Patrick E., et al.
(author)
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3D-printed sheet jet for stable megahertz liquid sample delivery at X-ray free-electron lasers
- 2023
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In: IUCrJ. - : International Union Of Crystallography. - 2052-2525. ; 10, s. 662-670
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Journal article (peer-reviewed)abstract
- X-ray free-electron lasers (XFELs) can probe chemical and biological reactions as they unfold with unprecedented spatial and temporal resolution. A principal challenge in this pursuit involves the delivery of samples to the X-ray interaction point in such a way that produces data of the highest possible quality and with maximal efficiency. This is hampered by intrinsic constraints posed by the light source and operation within a beamline environment. For liquid samples, the solution typically involves some form of high-speed liquid jet, capable of keeping up with the rate of X-ray pulses. However, conventional jets are not ideal because of radiation-induced explosions of the jet, as well as their cylindrical geometry combined with the X-ray pointing instability of many beamlines which causes the interaction volume to differ for every pulse. This complicates data analysis and contributes to measurement errors. An alternative geometry is a liquid sheet jet which, with its constant thickness over large areas, eliminates the problems related to X-ray pointing. Since liquid sheets can be made very thin, the radiation-induced explosion is reduced, boosting their stability. These are especially attractive for experiments which benefit from small interaction volumes such as fluctuation X-ray scattering and several types of spectroscopy. Although their use has increased for soft X-ray applications in recent years, there has not yet been wide-scale adoption at XFELs. Here, gas-accelerated liquid sheet jet sample injection is demonstrated at the European XFEL SPB/SFX nano focus beamline. Its performance relative to a conventional liquid jet is evaluated and superior performance across several key factors has been found. This includes a thickness profile ranging from hundreds of nanometres to 60 nm, a fourfold increase in background stability and favorable radiation-induced explosion dynamics at high repetition rates up to 1.13 MHz. Its minute thickness also suggests that ultrafast single-particle solution scattering is a possibility.
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| 4. |
- Kumar, S, et al.
(author)
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In Vivo Lentiviral Gene Delivery of HLA-DR and Vaccination of Humanized Mice for Improving the Human T and B Cell Immune Reconstitution
- 2021
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In: Biomedicines. - : MDPI AG. - 2227-9059. ; 9:8
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Journal article (peer-reviewed)abstract
- Humanized mouse models generated with human hematopoietic stem cells (HSCs) and reconstituting the human immune system (HIS-mice) are invigorating preclinical testing of vaccines and immunotherapies. We have recently shown that human engineered dendritic cells boosted bonafide human T and B cell maturation and antigen-specific responses in HIS-mice. Here, we evaluated a cell-free system based on in vivo co-delivery of lentiviral vectors (LVs) for expression of a human leukocyte antigen (HLA-DRA*01/ HLA-DRB1*0401 functional complex, “DR4”), and a LV vaccine expressing human cytokines (GM-CSF and IFN-α) and a human cytomegalovirus gB antigen (HCMV-gB). Humanized NOD/Rag1null/IL2Rγnull (NRG) mice injected by i.v. with LV-DR4/fLuc showed long-lasting (up to 20 weeks) vector distribution and expression in the spleen and liver. In vivo administration of the LV vaccine after LV-DR4/fLuc delivery boosted the cellularity of lymph nodes, promoted maturation of terminal effector CD4+ T cells, and promoted significantly higher development of IgG+ and IgA+ B cells. This modular lentigenic system opens several perspectives for basic human immunology research and preclinical utilization of LVs to deliver HLAs into HIS-mice.
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| 5. |
- Weni, Woro Mustika, et al.
(author)
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Psychometric evaluation of the Indonesian version of the Person-centered Care Assessment Tool
- 2023
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In: International Journal of Older People Nursing. - : John Wiley & Sons. - 1748-3735 .- 1748-3743. ; 18:6
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Journal article (peer-reviewed)abstract
- Background: The number of Indonesian care staff working in hospitals and long-term care facilities caring for persons with dementia in Japan is increasing; however, there is no instrument available in the Indonesian language to assess their dementia care practice.Objectives: This study aimed to translate the Person-centered Care Assessment Tool (P-CAT) and evaluate its psychometric properties in a sample of Indonesian care staff working in dementia care and long-term care facilities in Japan.Methods: This is a descriptive, methodological, and cross-sectional study. The P-CAT was translated into the Indonesian language. The draft was administered to Indonesian care staff (n = 218) working at long-term care facilities in Japan. Data were analysed using exploratory factor analysis (EFA), confirmatory factor analysis (CFA), known-group validity, internal consistency, and test-retest reliability.Results: EFA showed three-factor and CFA of the three-factor indicated that the model had an acceptable fit (chi-squared statistics/degree of freedom = 1.78, comparative fit index = 0.94, root mean square error of approximation = 0.06) with a slightly different structure compared to the original P-CAT. Regarding known-group validity, the P-CAT total score was significantly higher for those who had training in dementia, who knew about person-centred care, and who showed satisfaction in the job. Internal consistency (Cronbach's a) of the total scale was 0.68 which is considered acceptable, and the test-retest reliability intraclass correlation coefficient was 0.61 which is considered moderate.Conclusion: The Indonesian P-CAT indicated sound validity and reliability to measure person-centred care among Indonesian care staff working in dementia care and long-term care facilities in Japan.Implication for Practice: The development of Indonesian P-CAT allows the evaluation of dementia care, promotes and further improves person-centred care for persons with dementia provided by Indonesian care staff working in long-term care facilities in Japan.
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