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In view of the approaching application date of Regulation (EU) 2017/746 („IVDR“) and the resulting EU-wide, harmonized requirements for in-vitro diagnostic medical devices (IVD) manufactured and used within European health institutions, the Ad hoc Commission IVD of the German Association of the Scientific Medical Societies (AWMF) takes a national position on the details of the requirements and conditions related to the use of these IVD products.The Ad hoc Commission IVD emphasizes the relevance of examination procedures developed in medical laboratories, especially in the field of orphan diseases and new diagnostic markers. The IVDR sets an adequate regulatory framework for IVD manufactured and used within health institutions as long as these requirements are fulfilled with reliability and in accordance with the current state of the art in medical laboratory sciences. At the same time, the IVDR requirements have to be regarded under a pragmatic view and in accordance with the quality management systems approved within the different EU Member States. On the one hand, the mandatory requirements of the RiLiBÄK play an essential role in Germany. On the other hand, elements of voluntarily applicable international standards may support the fulfilment of product requirements for safety and performance according to Annex I of the IVDR. Both the complexity and possible solutions for the implementation of the IVDR requirements are discussed on the basis of examples such as the required documentation, performance evaluation and software validation.The Ad hoc Commission IVD recommends that, while aiming at a preferably EU-wide harmonized interpretation of the IVDR requirements, the flexibility in medical laboratory diagnostics necessary for patient care, including the use of IVD from in-house production, should be emphasized.

BackgroundMental health is an emerging topic on university campuses, with students reporting higher levels of psychological distress than the general population of the same age. Increasing physical activity and reducing sedentary time have been proved promising measures to promote mental health in the general population. However, to derive and implement effective measures to promote mental health among university students, further exploration of the associations between physical activity, sedentary time, and perceived stress in this specific setting is needed. ObjectiveThis study aims to identify associations between physical activity, sedentary time, and perceived stress after controlling for sociodemographic and behavioral variables among university students in Germany. We hypothesize that perceived stress is inversely related to physical activity and positively associated with sedentary time. Furthermore, we hypothesize that combined associations of concurrently high physical activity and low sedentary time on perceived stress are stronger compared with either alone and that the association between physical activity and perceived stress depends on activity intensity. MethodsWe conducted cross-sectional analyses from a large-scale internet-based student health survey (n=4189; response rate=10.0%). Physical activity, sedentary time, and engaging in moderate and vigorous activity intensities were assessed using the International Physical Activity Questionnaire Short Form with categorization into low, intermediate, and high levels. We measured perceived stress using the 10-item Perceived Stress Scale (range 0-40). ResultsThe results indicate that higher physical activity and lower sedentary time are associated with reduced levels of perceived stress. Following adjustment for gender, BMI, income, fruit and vegetable intake, alcohol consumption, and sleep quality, perceived stress scores were lower for students reporting high physical activity levels and low sedentary time compared with the least active and highly sedentary students (Perceived Stress Scale –2.2, 95% CI –2.9 to –1.5, P

The re-emergence of competitive elections in Africa has sparked new interest in political mobilization on the continent. Much of this literature focusses on political actors and the strategies they use to mobilize. If the campaign activists are reviewed at all, they are often categorized by their ethnic or religious affiliation. Thereby, abilities and potentials for political participation, which are important within conceptual literature on political mobilization, are side-lined. This article uses an activist-centered perspective to review the political mobilization of motorcycle taxi drivers, eastern Congo. Based on empirical research in 2020 and 2021, it evaluates the mobilization potentials of the so-called motards and their deployment during political action. The article finds that motards possess unique potentials for participating in political campaigns due to their mobility and large social networks but only partially deploy them. While their mobility potential is widely utilized, the mobilization of their social networks is hampered by a lack of allegiances and infrequent contacts with politicians. Based on the research findings, the article advocates expanding the perception of political mobilization in Africa by reflecting on the preconditions of mobilizability such as enabling potentials, interactions with activists and aligned political strategies. [ABSTRACT FROM AUTHOR]

Apple cultivars 'Annurca' and 'Limoncella' are grown locally in the Campania region of Italy and are valued for their distinctive flavour and characteristics, including a high content of nutritionally important bioactive compounds. However, apples are typically stored chilled for several months before consumption, so it is important to assess if the valuable characteristics are still present after postharvest storage. Here, we compare the quality, nutritional parameters, and aroma of these two cultivars with two widely grown international cultivars, 'Golden Delicious' and 'Fuji', after 60 days of storage. The aroma profiles of all four apples were analysed using thermal desorption and gas chromatography–time-of-flight mass spectrometry. We show that the local cultivars are distinct from the international cultivars in their bioactive compound content and their antioxidant activity. 'Limoncella' shows high sugar content, which may be acting as a cryoprotectant during storage, and high total phenolics in the flesh, which is of nutritional interest. We identified 104 volatile organic compounds (VOCs) and showed that the overall aroma profile is distinct for each cultivar, containing 11 published odorant compounds. The 'Annurca' profile is uniquely low in esters. Seven VOCs retain good discrimination across the four cultivars and, together with the quality and nutritional data, separate the two local cultivars from the international cultivars by hierarchical clustering. Overall, the data emphasize the unique characteristics of the two local cultivars and their value. [ABSTRACT FROM AUTHOR]

We present the motivation, experience, and learnings from a data challenge conducted at a large pharmaceutical corporation on the topic of subgroup identification. The data challenge aimed at exploring approaches to subgroup identification for future clinical trials. To mimic a realistic setting, participants had access to 4 Phase III clinical trials to derive a subgroup and predict its treatment effect on a future study not accessible to challenge participants. A total of 30 teams registered for the challenge with around 100 participants, primarily from Biostatistics organization. We outline the motivation for running the challenge, the challenge rules, and logistics. Finally, we present the results of the challenge, the participant feedback as well as the learnings. We also present our view on the implications of the results on exploratory analyses related to treatment effect heterogeneity. [ABSTRACT FROM AUTHOR]

Objectives: Midostaurin is an oral multitargeted tyrosine kinase inhibitor for the treatment of acute myeloid leukemia (AML). Therapeutic drug monitoring of midostaurin may support its safe use when suspecting toxicity or combined with strong CYP3A4 inhibitors. Methods: A stable isotope dilution liquid chromatography–tandem mass spectrometry method was developed and validated for the determination and quantification of midostaurin in human plasma and serum. Midostaurin serum concentrations were analyzed in 12 patients with FMS‐like tyrosine kinase 3 (FLT3)‐mutated AML during induction chemotherapy with cytarabine, daunorubicin, and midostaurin. Posaconazole was used as prophylaxis of invasive fungal infections. Results: Linear quantification of midostaurin was demonstrated across a concentration range of 0.01–8.00 mg/L. Inter‐ and intraday imprecisions of the proposed method were well within ±10%. Venous blood samples were taken in nine and three patients in the first and second cycle of induction chemotherapy. Median (range) midostaurin serum concentration was 7.9 mg/L (1.5–26.1 mg/L) as determined in 37 independent serum specimens. Conclusion: In a real‐life cohort of AML patients, interindividual variability in midostaurin serum concentrations was high, highlighting issues concerning optimal drug dosing in AML patients. A personalized dosage approach may maximize the safety of midostaurin. Prospective studies and standardization of analytical methods to support such an approach are needed. [ABSTRACT FROM AUTHOR]

Radical trifluoromethoxylation is an attractive approach to prepare compounds featuring the important OCF3 group, however most existing methods have focused on aromatic substrates. Here, we report novel methodologies with alkenyl substrates employing bis(trifluoromethyl)peroxide (BTMP) as a practical and comparatively atom economical trifluoromethoxylating reagent. With silyl enol ether substrates, switching reaction solvent allows for the synthesis of either α‐(trifluoromethoxy)ketone products or unprecedented alkenyl‐OCF3 species. Furthermore, allyl silanes have been employed as substrates for the first time, affording allyl(trifluoromethyl)ether products in good yields. In each case, the methods operate at room temperature without large excesses of the alkene substrate while, in contrast to previous radical trifluoromethoxylation reactions, no catalyst, light or other activators are required. [ABSTRACT FROM AUTHOR]