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Minderjährige in klinischen Prüfungen: Ethische Abwägungen ihres Einbezugs am Beispiel der indizierten Prävention psychotischer Erkrankungen
No full textRetrospective, Observational Analysis on the Impact of SARS-CoV-2 Variant Omicron in Hospitalized Immunocompromised Patients in a German Hospital Network: The VISAGE Study
No full textAims: Endemic SARS-CoV-2 infections still burden the healthcare system and represent a considerable threat to vulnerable patient cohorts, in particular immunocompromised (IC) patients. This study aimed to analyze the in-hospital outcome of IC patients with severe SARS-CoV-2 infection in Germany. Methods: This retrospective, observational study, analyzed administrative data from inpatient cases (n = 146,324) in 84 German Helios hospitals between 1 January 2022 and 31 December 2022 with regard to in-hospital outcome and health care burden in IC patients during the first 12 months of Omicron dominance. As the primary objective, in-hospital outcomes of patients with COVID-19-related severe acute respiratory infection (SARI) were analyzed by comparing patients with (n = 2037) and without IC diagnoses (n = 14,772). Secondary analyses were conducted on IC patients with (n = 2037) and without COVID-19-related SARI (n = 129,515). A severe in-hospital outcome as a composite endpoint was defined per the WHO definition if one of the following criteria were met: intensive care unit (ICU) treatment, mechanical ventilation (MV), or in-hospital death. Results: In total, 12% of COVID-related SARI cases were IC patients, accounting for 15% of ICU admissions, 15% of MV use, and 16% of deaths, resulting in a higher prevalence of severe in-hospital courses in IC patients developing COVID-19-related SARI compared to non-IC patients (Odds Ratio, OR = 1.4, p < 0.001), based on higher in-hospital mortality (OR = 1.4, p < 0.001), increased need for ICU treatment (OR = 1.3, p < 0.001) and mechanical ventilation (OR = 1.2, p < 0.001). Among IC patients, COVID-19-related SARI profoundly increased the risk for severe courses (OR = 4.0, p < 0.001). Conclusions: Our findings highlight the vulnerability of IC patients to severe COVID-19. The persistently high prevalence of severe outcomes in these patients in the Omicron era emphasizes the necessity for continuous in-hospital risk assessment and monitoring of IC patients
A free boundary problem-in time-for the spread of Covid-19
No full textIn this paper we deal with two aspects of the Covid epidemic. The first is a phase
change during the epidemic. The empirical observation is that once a certain threshold
of active infections is reached, the rate of infection is increasing significantly. This
threshold depends, among others, also on the season. We model this phenomenon
as a jump in the coefficient of the virus exposition, giving the force of infection.
In a chemical mass action law this coefficient corresponds to the reaction rate. We
get a free boundary problem in time, which exhibits deterministic ‘metastability’. In
a population which is in a state of herd immunity, still, if the number of imported
infections is large enough, an epidemic wave can start. The second aspect is the two
scale nature of the infection network. On one hand side, there is always a finite number
of reoccuring–deterministic–contacts, and on the other hand there is a large number
of possible random contacts. We present a simple example, where the group size of
deterministic contacts is two, and the graph of random contacts is complete
A note on the cost of capital with fixed payout ratios
No full textThe insights of Modigliani and Miller (Am Econ Rev 53:433–443, 1963) and Miles and Ezzell (15:719–730, https://doi.org/10.2307/2330405 [Titel anhand dieser DOI in Citavi-Projekt übernehmen] , 1980) on the cost of capital of firms rank among the most important results in financial theory. The underlying assumptions regarding the financial policy, however, can hardly be reconciled with empirical findings. We investigate the implications of an alternative approach that is characterized by a fixed payout ratio. By introducing additional assumptions about investment opportunities, we find relationships between the cost of equity of levered and unlevered firms. The results contribute to explaining empirical findings and open the possibility to base valuation techniques on realistic and yet practicable assumptions
Safety of User-Initiated Intensification of Insulin Delivery Using Cambridge Hybrid Closed-Loop Algorithm
No full textObjective:
Many hybrid closed-loop (HCL) systems struggle to manage unusually high glucose levels as experienced with intercurrent illness or pre-menstrually. Manual correction boluses may be needed, increasing hypoglycemia risk with overcorrection. The Cambridge HCL system includes a user-initiated algorithm intensification mode (“Boost”), activation of which increases automated insulin delivery by approximately 35%, while remaining glucose-responsive. In this analysis, we assessed the safety of “Boost” mode.
Methods:
We retrospectively analyzed data from closed-loop studies involving young children (1-7 years, n = 24), children and adolescents (10-17 years, n = 19), adults (≥24 years, n = 13), and older adults (≥60 years, n = 20) with type 1 diabetes. Outcomes were calculated per participant for days with ≥30 minutes of “Boost” use versus days with no “Boost” use. Participants with <10 “Boost” days were excluded. The main outcome was time spent in hypoglycemia <70 and <54 mg/dL.
Results:
Eight weeks of data for 76 participants were analyzed. There was no difference in time spent 300 mg/dL was 1.39 percentage points (1.01 to 1.77; P < .001) higher on “Boost” days, with higher mean glucose and lower time in target range (P < .001).
Conclusions:
Use of an algorithm intensification mode in HCL therapy is safe across all age groups with type 1 diabetes. The higher time in hyperglycemia observed on “Boost” days suggests that users are more likely to use algorithm intensification on days with extreme hyperglycemic excursions
Preparation of consolidated exposure scenarios for mixtures under REACh
No full textUnder REACh, formulators of dangerous mixtures need to include substance-related information into extended safety data sheets (eSDS), by consolidating exposure scenarios (ESs). Here different methods (the critical component approach (CCA) the DPD+ method based on the Dangerous Preparation Directive, 1999/45/EC), and risk assessment of the complete mixture) for the development of mixtures´ ESs are compared.
The work presents the results of application of DPD+ and the CCA approaches in identifying the risk determining substances of mixtures and of the risk assessment conducted for the risk determining substances and for the complete mixtures. In conclusion it t can be concluded that conducting the risk assessment to the whole mixture can contribute to improve the preparation of the ESs for mixtures
(How) Would You Continue Working?: A Comparison of Responses to the Lottery Question and a Basic Income Question
No full textThe introduction of a basic income (BI) is a controversial topic. A key psychological question is whether most employees would stop or, as suggested by lottery question research, continue working. We addressed this question through two surveys with 268 and 640 employees, examining their plans regarding working if they won the lottery (lottery question) or received a monthly BI (BI question) as well as their reasons for continuing to work. More than 90 % (Study 1) and more than 80 % (Study 2) of respondents planned to continue working in both scenarios. In response to the BI question, more participants indicated they would continue working as before and fewer planned to pursue a different kind of work or to stop working. Financial reasons to continue working were reported more frequently in response to the BI question. Our findings suggest that the generalizability of lottery question research to the BI is limited, which necessitates specific research on the BI.Die Einführung eines Bedingungslosen Grundeinkommens (engl. Basic Income; BI) wird kontrovers diskutiert. Eine zentrale psychologische Frage ist, ob die meisten Beschäftigten wegen des BI aufhören würden zu arbeiten oder dies, entsprechend der Forschung zur „Lotteriefrage“ (Lottery Question), nicht zu erwarten ist. Wir untersuchten diese Frage in zwei Befragungen mit 268 und 640 Beschäftigten, in der wir ihre Pläne bezüglich Erwerbstätigkeit im Fall eines Lottogewinns („Lotteriefrage“) oder der monatlichen Auszahlung eines BI (BI Frage) sowie ihre Gründe weiterzuarbeiten erfassten. Mehr als 90 % (Studie 1) und mehr als 80 % (Studie 2) der Teilnehmenden planten in beiden Szenarien weiterzuarbeiten. Auf die BI Frage gaben mehr Teilnehmende an, dass sie wie zuvor weiterarbeiten würden und weniger planten, eine andere Arbeit aufzunehmen oder nicht weiterzuarbeiten. Finanzielle Gründe weiterzuarbeiten wurden beim BI häufiger berichtet. Unsere Ergebnisse zeigen, dass die Übertragbarkeit der Forschung zur „Lotteriefrage“ auf das BI begrenzt ist und es spezifischer Forschung zum BI bedarf
Analysis of the Effects of Environmental Chemicals on Human Adipocyte Function and Metabolism by using Metabolomics and 13C Metabolic Tracing
No full textGrowing evidence suggests that, apart from changes in lifestyle factors such as reduced physical activity, exposure to certain environmental chemicals may promote the development of obesity and related metabolic diseases. These chemicals are termed metabolism-disrupting chemicals and include phthalate plasticizers, which are a particularly well-characterized group of concern given their widespread use. Due to the ban of several phthalates in specific applications, including in toys, in the EU and the US, they have been replaced by safer declared substitutes, such as the plasticizer DINCH. However, previous research has shown that the primary metabolite of DINCH, MINCH, induces adipogenesis in human adipocytes, while no obesogenic effects were observed in application studies in vivo, suggesting that the safety regarding metabolic effects remains underexplored. The aim of this PhD project was to analyse the potential of DINCH and its metabolite MINCH to affect adipocyte metabolism and function by using metabolomics and 13C metabolic tracing as new assessment strategies in human SGBS adipocytes. In preadipocytes during differentiation, MINCH induced lipid accumulation and promoted adipogenesis by rewiring the TCA cycle toward lipid synthesis, comparable to the peroxisome proliferator-activated receptor gamma (PPARγ)-agonist rosiglitazone. In mature adipocytes, metabolic analysis revealed that MINCH induces a white-to-brite conversion (browning) of adipocytes. The results highlight that metabolomics and 13C metabolic tracing in human adipocytes are sensitive approaches for detecting adipogenic effects and subtle metabolic alterations caused by environmental chemicals. This underscores their potential as New Approach Methodologies for chemical risk assessment, which are particularly needed given that the existing internationally applied OECD guidelines for testing chemicals do not specifically address metabolism-disrupting properties
