bluuebunny/crossref_metadata_2025 huggingface dataset:
Treatment modalities, adverse events, and survival outcomes in older patients with head and neck squamous cell carcinoma
Authors: Amr Sania , Ioffe Dina , Suzuki Ikumi , Mehra Ranee , Cullen Kevin , Goloubeva Olga
Published: October 2021

Background

Chemoradiation with curative intent in older adults with locally advanced head and neck squamous cell carcinoma (HNSCC) has been a challenge, because of its potential toxicities.

Methods

We selected primary HNSCC cases from the SEER‐Medicare linked database, assessed overall survival (OS) and adverse events and their associations with different treatments, across four age groups including the youngest (66–69 years) and the oldest (≥80 years).

Results

Better OS was associated with chemoradiation compared to radiation alone, not only in all patients (N = 5879) (hazard ratio [HR] = 0.82, p < 0.001), but also in the oldest group (N = 1380) (HR = 0.77, p = 0.006) in whom the adverse events rates were not higher than those in the youngest (N = 1562); more of the latter (26%–30%) than the former (14%–19%) received chemoradiation, regardless of their comorbidity indices.

Conclusions

Our findings provide evidence that patients' characteristics, other than chronological age, should be equally considered in selecting the best therapy for older patients with HNSCC.
Gut microbiome features associated with liver fibrosis in Hispanics, a population at high risk for fatty liver disease
Authors: Kwan Suet‐Ying , Jiao Jingjing , Joon Aron , Wei Peng , Petty Lauren E. , Below Jennifer E. , Daniel Carrie R. , Wu Xiaogang , Zhang Jianhua , Jenq Robert R. , Futreal P. Andrew , Hawk Ernest T. , McCormick Joseph B. , Fisher‐Hoch Susan P. , Beretta Laura
Published: October 2021

Background and Aims

Hispanics are disproportionately affected by NAFLD, liver fibrosis, cirrhosis, and HCC. Preventive strategies and noninvasive means to identify those in this population at high risk for liver fibrosis, are urgently needed. We aimed to characterize the gut microbiome signatures and related biological functions associated with liver fibrosis in Hispanics and identify environmental and genetic factors affecting them.

Approach and Results

Subjects of the population‐based Cameron County Hispanic Cohort (CCHC; n = 217) were screened by vibration‐controlled transient elastography (FibroScan). Among them, 144 (66.7%) had steatosis and 28 (13.0%) had liver fibrosis. The gut microbiome of subjects with liver fibrosis was enriched with immunogenic commensals (e.g., Prevotella copri, Holdemanella, Clostridiaceae 1) and depleted of Bacteroides caccae, Parabacteroides distasonis, Enterobacter, and Marinifilaceae. The liver fibrosis‐associated metagenome was characterized by changes in the urea cycle, L‐citrulline biosynthesis and creatinine degradation pathways, and altered synthesis of B vitamins and lipoic acid. These metagenomic changes strongly correlated with the depletion of Parabacteroides distasonis and enrichment of Prevotella and Holdemanella. Liver fibrosis was also associated with depletion of bacterial pathways related to L‐fucose biosynthesis. Alcohol consumption, even moderate, was associated with high Prevotella abundance. The single‐nucleotide polymorphisms rs3769502 and rs7573751 in the NCK adaptor protein 2 (NCK2) gene positively associated with high Prevotella abundance.

Conclusion

Hispanics with liver fibrosis display microbiome profiles and associated functional changes that may promote oxidative stress and a proinflammatory environment. These microbiome signatures, together with NCK2 polymorphisms, may have utility in risk modeling and disease prevention in this high‐risk population.
Exposure monitoring toward environmental justice
Authors: Racz LeeAnn , Rish William
Published: October 2021

Executive Order 14008, signed on 27 January 2021, established environmental justice (EJ) as a core priority of the Biden Administration. There is a need for state and federal regulators, as well as industry, to enhance risk assessment methods and exposure monitoring approaches to be more inclusive of EJ community involvement and more representative of EJ community exposures. Cumulative risk assessment models are critical for understanding the unique interaction between chemical exposures and nonchemical stressors that EJ communities encounter daily. Enhanced environmental monitoring with personal and portable sensors, especially when deployed using community partnerships, can capture chemical exposures with sufficient resolution to characterize exposures down to the neighborhood level. Use of internet-linked sensors will also require thoughtful advances in management of big data to inform meaningful and time-sensitive decisions. Integr Environ Assess Manag 2022;18:858–862. © 2021 SETAC

KEY POINTS

There is a need for regulators and industry to enhance risk assessment methods and exposure monitoring approaches to be more inclusive of environmental justice community involvement and more representative of EJ community exposures. Cumulative risk assessment models are critical for understanding the unique interaction between chemical exposures and non-chemical stressors  faced by environmental justice communities. Enhanced environmental monitoring with personal and portable sensors, especially when deployed using community partnerships, can capture chemical exposures with sufficient resolution to characterize exposures down to the neighborhood level. Use of internet-linked sensors will also require thoughtful advances in management of big data to inform meaningful and time-sensitive decisions.
Modeling-Based Bone Formation After 2 Months of Romosozumab Treatment: Results From the FRAME Clinical Trial
Authors: Eriksen Erik F , Chapurlat Roland , Boyce Rogely Waite , Shi Yifei , Brown Jacques P , Horlait Stéphane , Betah Donald , Libanati Cesar , Chavassieux Pascale
Published: October 2021

The bone-forming agent romosozumab is a monoclonal antibody that inhibits sclerostin, leading to increased bone formation and decreased resorption. The highest levels of bone formation markers in human patients are observed in the first 2 months of treatment. Histomorphometric analysis of bone biopsies from the phase 3 FRAME trial (NCT01575834) showed an early significant increase in bone formation with concomitant decreased resorption. Preclinical studies demonstrated that most new bone formation after romosozumab treatment was modeling-based bone formation (MBBF). Here we analyzed bone biopsies from FRAME to assess the effect of 2 months of romosozumab versus placebo on the surface extent of MBBF and remodeling-based bone formation (RBBF). In FRAME, postmenopausal women aged ≥55 years with osteoporosis were randomized 1:1 to 210 mg romosozumab or placebo sc every month for 12 months, followed by 60 mg denosumab sc every 6 months for 12 months. Participants in the bone biopsy substudy received quadruple tetracycline labeling and underwent transiliac biopsies at month 2. A total of 29 biopsies were suitable for histomorphometry. Using fluorescence microscopy, bone formation at cancellous, endocortical, and periosteal envelopes was classified based on the appearance of underlying cement lines as modeling (smooth) or remodeling (scalloped). Data were compared using the Wilcoxon rank-sum test, without multiplicity adjustment. After 2 months, the median percentage of MBBF referent to the total bone surface was significantly increased with romosozumab versus placebo on cancellous (18.0% versus 3.8%; p = 0.005) and endocortical (36.7% versus 3.0%; p = 0.001), but not on periosteal (5.0% versus 2.0%; p = 0.37) surfaces, with no significant difference in the surface extent of RBBF on all three bone surfaces. These data show that stimulation of bone formation in the first 2 months of romosozumab treatment in postmenopausal women with osteoporosis is predominately due to increased MBBF on endocortical and cancellous surfaces. © 2021 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

Abstract

Bone biopsies from the FRAME trial were analyzed to evaluate MBBF and RBBF after romosozumab treatment. After 2 months, the median percentage of MBBF referent to the total bone surface was significantly increased with romosozumab vs placebo on cancellous and endocortical, but not periosteal surfaces, with no significant difference in the surface extent of RBBF on all three bone surfaces. MBBF, modeling-based bone formation; RBBF, remodeling-based bone formation
Clearance of Senescent Cells From Injured Muscle Abrogates Heterotopic Ossification in Mouse Models of Fibrodysplasia Ossificans Progressiva
Authors: Wang Haitao , Zhang Qiang , Kaplan Frederick S. , Pignolo Robert J.
Published: October 2021

Fibrodysplasia ossificans progressiva (FOP) is a rare genetic disease caused by mutations in activin A receptor type I/activin-like kinase 2 (ACVR1/ALK2), a bone morphogenetic protein (BMP) type I receptor, resulting in the formation of extraskeletal or heterotopic ossification (HO) and other features consistent with premature aging. During the first decade of life, episodic bouts of inflammatory swellings (flare-ups) occur, which are typically triggered by soft tissue trauma. Through an endochondral process, these exacerbations ultimately result in skeletal muscles, tendons, ligaments, fascia, and aponeuroses transforming into ectopic bone, rendering movement impossible. We have previously shown that soft tissue injury causes early FOP lesions characterized by cellular hypoxia, cellular damage, and local inflammation. Here we show that muscle injury in FOP also results in senescent cell accumulation, and that senescence promotes tissue reprogramming toward a chondrogenic fate in FOP muscle but not wild-type (WT) muscle. Using a combination of senolytic drugs we show that senescent cell clearance and reduction in the senescence associated secretory phenotype (SASP) ameliorate HO in mouse models of FOP. We conclude that injury-induced senescent cell burden and the SASP contribute to FOP lesion formation and that tissue reprogramming in FOP is mediated by cellular senescence, altering myogenic cell fate toward a chondrogenic cell fate. Furthermore, pharmacological removal of senescent cells abrogates tissue reprogramming and HO formation. Here we provide proof-of-principle evidence for senolytic drugs as a future therapeutic strategy in FOP. © 2021 American Society for Bone and Mineral Research (ASBMR).
An efficient synthesis of 4,6‐diarylnicotinonitrile‐acetamide hybrids via 1,2,3‐triazole linker as multitarget microbial inhibitors
Authors: El‐Sayed Hassan A. , Moustafa Ahmed H. , Masry Asmaa A. , Amer Atef M. , Mohammed Samar M.
Published: October 2021

An efficient and smart approach for design and synthesis of a novel series of nicotinonitrile‐1,2,3‐triazole‐acetamide hybrids was described. The synthetic methodology was commenced with preparation of acetylene derivatives via alkynylation of 2‐oxonicotinonitrile with propargyl bromide under mild basic catalyst (pot. carbonate). The facile click cycloaddition reaction of alkynes 2a‐f and azido‐acetamides 3‐5 in the presence of catalytic Cu(I) in H2O/tetrahydrofuran (THF) was utilized for the synthesis of target molecules 6a‐l. Triazoles 6c, d, f, and 6i have highly activity against the four pathogenic bacteria (Escherichia coli, Pseudomonas aeruginosa, Bacillus subtilis, and Staphylococcus aureus) and two pathogenic fungi (Candida albicans and Aspergillus flavus) with minimum inhibitory concentration (MIC) in between 0.5 and 4 μg/ml for bacteria and 0.5 and 8 μg/ml for fungi.
Effective synthesis of new benzo‐fused macrocyclic and thiamacrocyclic dilactams and related pyrazolo‐fused macrocycles
Authors: Ahmed Ahmed A. M. , Mekky Ahmed E. M. , Sanad Sherif M. H.
Published: October 2021

In the current study, we examined the synthetic potential of new bis(aldehydes), linked to aliphatic spacers via phenoxy linkage, as versatile building blocks for the synthesis of new macrocyclic dilactams. The target macrocycles were prepared, in 65%–72% yields, by the cyclocondensation ofN,N′‐(alkane‐1,ω‐diyl)bis(2‐cyanoacetamide) with the appropriate bis(aldehydes) in dioxane in the presence of few drops of piperidine at reflux for 4 h. Using the precursors for bis(2‐cyanoacetamide), linked to aliphatic cores via thioethers, a new series of thiamacrocyclic dilactams were prepared, in 60%–66% yields, under the previous reaction conditions and at reflux for 5 h. Next, we examined the synthetic potential of the new dilactams derivatives as key synthons for the preparation of new dipyrazolo‐fused macrocycles. After treating the appropriate dilactams with hydrazine hydrate in DMF at reflux for 6 h, the previous macrocycles were prepared in 50%–57% yields.
Discrepancy between frequent occurrence of COVID‐19‐like symptoms and low seroconversion rates among healthcare workers
Authors: Dehnen Dorothea , Dehnen Katja , Trilling Mirko , Fiedler Melanie , Drexler Julia , Goralski Marcel , Le‐Trilling Vu Thuy Khanh , Schöler Lara , Jöckel Karl‐Heinz , Heßbrügge Martina
Published: October 2021

During the first wave of the pandemic, we compared the occurrence of subjectively experienced COVID‐19‐like symptoms and true severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) seroconversion rates among medical personnel in general practices. This cross‐sectional study determined the SARS‐CoV‐2‐specific immunoglobulin G (IgG) antibody status of medical staff from 100 outpatient practices in Germany. Study cohort characteristics and COVID‐19‐like symptoms were obtained by questionnaires. The initial screening for SARS‐CoV‐2‐recognizing antibodies was performed using a commercial chemiluminescence microparticle immunoassay. Positive results were controlled with another approved test. Samples with discrepant results were subjected to a third IgG‐binding assay and a neutralization test. A total of 861 participants were included, 1.7% (n = 15) of whom tested positive for SARS‐CoV‐specific IgG in the initial screening test. In 46.6% (n = 7) of positive cases, test results were confirmed by an independent test. In the eight samples with discrepant results, neither spike‐specific antibodies nor in vitro neutralizing capacity were detectable, resulting in a genuine seroprevalence rate of 0.8%. 794 participants completed the questionnaire. Intriguingly, a total of 53.7% (n = 426) of them stated episodes of COVID‐19‐like symptoms. Except for smell and taste dysfunction, there were no significant differences between the groups with and without laboratory‐confirmed SARS‐CoV‐2 seroconversion. Our results demonstrated that only 0.8% of participants acquired SARS‐CoV‐2 even though 53.7% of participants reportedly experienced COVID‐19‐like symptoms. Thus, even among medical staff, self‐diagnosis based on subjectively experienced symptoms does not have a relevant predictive value.
Tradeoffs between soil conservation and soil‐water retention: The role of vegetation pattern and density
Authors: Wei Wei , Pan Daili , Feng Jing
Published: October 2021

Balancing erosion control and the water conservation service is the primary goal of intensive revegetation in water‐limited conditions. In this study, a field experiment was conducted in the dryland Chinese Loess Plateau (CLP), to investigate the role of vegetation pattern and density in their tradeoff between soil conservation (SC) and soil water retention (SWR). Five vegetation patterns (up‐slope covered, downslope covered, low and high uniformly covered, no coverage) with three levels of grass density (220 g m−2, 110 g m−2, and 0) were designed and implemented. A novel indicator EEW (the exchange between erosion reduction and water consumption), as the cost of any extra depletion of soil water to improve each unit of soil conservation, was used to represent the tradeoff during a complete dry‐wet‐dry soil water convert cycle. The higher EEW, the poorer tradeoff between SC and SWR. It was illustrated that higher vegetation density could promote SC but not inevitably suppress EEW. The present typical grass density in CLP, round 220 g m−2, was redundant in optimizing the SC‐SWR tradeoff. A concentrated and centralized vegetation distribution mainly in the downslope obtained an EEW at 11.6 mm m2 kg−1 and was confirmed as a favoured vegetation pattern. The simulated typical density and spatial pattern in CLP (about 220 g m−2 and uniformly distribution) had EEW at 20.5 mm m2 kg−1, by reducing the density to about 110 g m−2 and a downslope centralized vegetation redistribution, the EEW was reduced by 43.4%. Under long‐term drought conditions at dry‐wet‐dry cycles, soil water decreased more sharply in the Full‐covered plots, due to more evapotranspiration and vertical water loss caused by higher plant density, compared with half‐covered and bare soil plots. The present study confirmed that planted density and vegetation pattern can manipulate SC‐SWR tradeoff and it was thus possible to optimize it by adjusting revegetation's intensity and structures in practice.
β‐Carotene Bioavailability and Conversion Efficiency Are Significantly Affected by Sex in Rats
Authors: Borel Patrick , Troadec Romane , Damiani Morgane , Halimi Charlotte , Nowicki Marion , Guichard Philippe , Margier Marielle , Astier Julien , Grino Michel , Reboul Emmanuelle , Landrier Jean‐François
Published: October 2021

Scope

To study the effect of variation in dietary vitamin A (VA) content on its hepatic and intestinal metabolism.

Methods and Results

Adult female and male rats are fed with diets containing 400, 2300, or 9858 IU kg−1 VA for 31–33 weeks. VA concentrations are measured in plasma and liver. Bioavailability and intestinal conversion efficiency of β‐carotene to VA are assessed by measuring postprandial plasma β‐carotene and retinyl palmitate concentrations after force‐feeding rats with β‐carotene. Expression of genes involved in VA metabolism, together with concentrations of RBP4, BCO1, and SR‐BI proteins, are measured in the intestine and liver of female rats. Plasma retinol concentrations are lower and hepatic free retinol concentrations are higher in females than in males. There is no effect of dietary VA content on β‐carotene bioavailability and its conversion efficiency, but bioavailability is higher and conversion efficiency is lower in females than in males. The expression of most genes exhibited a U‐shaped dose response curve depending on VA intake.

Conclusions

β‐Carotene bioavailability and conversion efficiency to VA are affected by the sex of rats. Results of gene expression suggest a hormetic regulation of VA metabolism in female rats.
A rare case of visceral leishmaniasis misdiagnosed as systemic lupus erythematosus
Authors: Zheng Mai , Liu Shuang , Wang Xiangyu , Li XingJun , Wang Nan , Guo Yulong , Yang Jingyi , Upreti Bibhuti , Cui Ruomei , Xu Jian
Published: October 2021

Visceral leishmaniasis (VL) is an infectious disease caused by Leishmania donovani and transmitted by sandflies. It can be life‐threatening if not treated. Common clinical features of VL include recurrent fever, pancytopenia, splenomegaly, and a variety of positive autoantibodies, which can lead to a misdiagnosis of systemic lupus erythematosus (SLE). We report the case of a 25‐year‐old woman with VL misdiagnosed as SLE to add to the existing literature on this subject.
Comparing the sensitivities of two screening tests in nonblinded randomized paired screen‐positive trials with differential screening uptake
Authors: van de Ven Peter M. , Bassi Andrea , Berkhof Johannes
Published: October 2021

Before a new screening test can be used in routine screening, its performance needs to be compared to the standard screening test. This comparison is generally done in population screening trials with a screen‐positive design where participants undergo one or both screening tests after which disease verification takes place for those positive on at least one screening test. We consider the randomized paired screen‐positive design of Alonzo and Kittelson where participants are randomized to receive one of the two screening tests and only participants with a positive screening test subsequently receive the other screening test followed by disease verification. The tests are usually offered in an unblinded fashion in which case the screening uptake may differ between arms, in particular when one test is more burdensome than the other. When uptake is associated with disease, the estimator for the relative sensitivity derived by Alonzo and Kittelson may be biased and the type I error of the associated statistical test is no longer guaranteed to be controlled. We present methods for comparing sensitivities of screening tests in randomized paired screen‐positive trials that are robust to differential screening uptake. In a simulation study, we show that our methods adequately control the type I error when screening uptake is associated with disease. We apply the developed methods to data from the IMPROVE trial, a nonblinded cervical cancer screening trial comparing the accuracy of HPV testing on self‐collected versus provider‐collected samples. In this trial, screening uptake was higher among participants randomized to self‐collection.
Band tunable X‐ray flat crystal spectrometer for laser‐produced plasma spectroscopy measurements
Authors: Rui‐Rong Wang , Guo Jia , Hong‐Hai An , Zhi‐Yong Xie , Wei Wang
Published: October 2021

An updated design of a band‐tunable flat crystal spectrometer is presented. The new configuration contributes to a broad spectral coverage with greater resolving power, a strong rejection of hard X‐ray backgrounds, and decreased sensitivity to source broadening for an extended source. To verify the performance of the spectrometer, spectral lines were measured using a potassium acid phthalate crystal for highly ionized species of aluminum or silicon, and the results were compared by measuring H‐ and He‐like Al and Si lines by rotating the crystal to selected Bragg angles, at the Shenguang II laser facility. The observed energy‐coverage range is consistent with the theoretical predictions, as well as with the measured spectral resolution of ~300.
Analysis, Quantification and Evaluation of Uncertainty
Authors: Schaeffner Maximilian , Abele Eberhard , Anderl Reiner , Bölling Christian , Brötz Johannes , Dietrich Ingo , Feldmann Robert , Gehb Christopher M. , Geßner Felix , Hartig Jakob , Hedrich Philipp , Hoppe Florian , Kersting Sebastian , Kohler Michael , Lenz Jonathan , Martin Daniel , Matei Alexander , Melz Tobias , Öztürk Tuğrul , Pelz Peter F. , Pfetsch Marc E. , Platz Roland , Rexer Manuel , Staudter Georg , Ulbrich Stefan , Weber Moritz , Weigold Matthias
Published: October 2021

This chapter describes the various approaches to analyse, quantify and evaluate uncertainty along the phases of the product life cycle. It is based on the previous chapters that introduce a consistent classification of uncertainty and a holistic approach to master the uncertainty of technical systems in mechanical engineering. Here, the following topics are presented: the identification of uncertainty by modelling technical processes, the detection and handling of data-induced conflicts, the analysis, quantification and evaluation of model uncertainty as well as the representation and visualisation of uncertainty. The different approaches are discussed and demonstrated on exemplary technical systems.
Big Data and the Threat to Moral Responsibility in Healthcare
Authors: Tigard Daniel W.
Published: October 2021

Technological innovations in healthcare, perhaps now more than ever, are posing decisive opportunities for improvements in diagnostics, treatment, and overall quality of life. The use of artificial intelligence and big data processing, in particular, stands to revolutionize healthcare systems as we once knew them. But what effect do these technologies have on human agency and moral responsibility in healthcare? How can patients, practitioners, and the general public best respond to potential obscurities in responsibility? In this paper, I investigate the social and ethical challenges arising with newfound medical technologies, specifically the ways in which artificially intelligent systems may be threatening moral responsibility in the delivery of healthcare. I argue that if our ability to locate responsibility becomes threatened, we are left with a difficult choice of trade-offs. In short, it might seem that we should exercise extreme caution or even restraint in our use of state-of-the-art systems, but thereby lose out on such benefits as improved quality of care. Alternatively, we could embrace novel healthcare technologies but in doing so we might need to loosen our commitment to locating moral responsibility when patients come to harm; for even if harms are fewer – say, as a result of data-driven diagnostics – it may be unclear who or what is responsible when things go wrong. What is clear, at least, is that the shift toward artificial intelligence and big data calls for significant revisions in expectations on how, if at all, we might locate notions of responsibility in emerging models of healthcare.
Sekundärnutzung klinischer Daten in datensammelnden, nicht-interventionellen Forschungs- oder Lernaktivitäten – Begriff, Studientypen und ethische Herausforderungen
Authors: Jungkunz Martin , Köngeter Anja , Winkler Eva C. , Mehlis Katja , Schickhardt Christoph
Published: October 2021

Der Sekundärnutzung klinischer Daten wird großes Potenzial für den wissenschaftlichen Fortschritt der Biomedizin und Krankenversorgung zugesprochen, welches im Rahmen von datensammelnden, nicht-interventionellen Forschungs- oder Lernaktivitäten ausgeschöpft werden könnte. Doch was kann man unter dieser Art von Forschungs- oder Lernaktivitäten verstehen? Welche Potenziale und Herausforderungen bergen sie konkret? Welche Risiken gehen mit diesen Aktivitäten einher und wie können diese Risiken reduziert werden? Diesen Fragen widmet sich der vorliegende Artikel.
Im ersten Abschnitt wird zunächst mit einem begriffsanalytischen Ansatz Klarheit bzgl. des Begriffs der Sekundärnutzung klinischer Daten in datensammelnden, nicht-interventionellen Forschungs- oder Lernaktivitäten geschaffen, um danach anhand konkreter Studientypen die Vielfalt dieser Aktivitäten zu illustrieren und in drei Anwendungsfelder zu kategorisieren. Im nächsten Abschnitt werden forschungsökonomische, forschungsmethodische und forschungsethische Nutzenpotenziale analysiert, sowie solche für die Erforschung einzelner Erkrankungen. Die Herausforderungen für datensammelnde, nicht-interventionelle Forschungs- oder Lernaktivitäten werden im Bereich der Datenqualität- und Vollständigkeit, der Interoperationalisierbarkeit und in möglichen, den Daten inhärenten, Verzerrungen (Bias) identifiziert. Im Anschluss werden mögliche Risiken für Patienten genannt, insbesondere Risiken der Re-Identifikation und des Datenmissbrauchs, Gefahren für das Vertrauen in der Arzt-Patientenbeziehung und das Wecken falscher Hoffnungen. Mögliche Risiken für Ärzte und Institutionen hingegen bestehen in einem möglicherweise erhöhten Dokumentationsaufwand und in der Gefahr eines (unfairen) Vergleiches von Leistungs- und Kostendaten unterschiedlicher Behandler oder Institutionen. Der letzte Abschnitt geht auf mögliche Maßnahmen zur Verringerung der genannten Risiken ein: eine systematischen Risikoabschätzung, welche darauffolgende technisch-organisatorische Maßnahmen zur Risikoreduktion informiert; die Einrichtung von Use and Access Committees; Patientenaufklärung und Widerspruchsmöglichkeit.
Die im Artikel aufgezeigten Aspekte können und sollten von Gremien bzw. Personen in Betracht gezogen werden, die sich mit der ethischen Prüfung oder Bewertung möglicher Sekundärnutzungen klinischer Daten in datensammelnden, nicht-interventionellen Forschungs- oder Lernaktivitäten beschäftigen.
Datenverarbeitung zu medizinischen Forschungszwecken im internationalen Kontext – Neue juristische Herausforderungen unter der DSGVO
Authors: Schrader Leonie F.
Published: October 2021

Die DSGVO sieht an vielen Stellen Öffnungsklauseln vor, die den Mitgliedstaaten Gestaltungsspielräume für nationale Regelungen eröffnen. Bei grenzüberschreitenden Datenverarbeitungen, die besonders im Kontext medizinischer Forschung von Bedeutung sind, stellt sich somit die Frage des jeweils anwendbaren mitgliedstaatlichen Datenschutzrechts. Die Bestimmung dieses nationalen Anpassungsrechts wird unter der Rechtslage der DSGVO vor allem durch das Fehlen einer allgemeinen Kollisionsnorm erschwert. Der Beitrag analysiert in seinem ersten Teil mögliche Lösungsansätze und stellt Bestrebungen auf europäischer Ebene vor, dieser Thematik zu begegnen.

Bei der Datenübermittlung in Drittstaaten ergeben sich darüber hinaus zusätzliche, anders gelagerte Fragestellungen. Neben der Betrachtung der in der DSGVO aufgestellten Anforderungen für internationale Datenübermittlungen wird im zweiten Teil des Beitrags insbesondere auch das Zusammenspiel zwischen den Vorschriften für die Datenübermittlung in Drittstaaten im Kapitel V der DSGVO und dem räumlichen Anwendungsbereich nach Art. 3 DSGVO diskutiert.
Informierte Einwilligung, häusliche Altenpflege und soziale Robotik – Ein Konzept zur Konkretisierung der Zweckangabe bei Social-Compagnion-Robotern
Authors: Loh Wulf , Wierling Anne
Published: October 2021

Mit dem Einsatz von sozialer Robotik im Bereich der Pflege und Betreuung älterer Menschen ist eine große Vielfalt an Sensorik verbunden, mit der eine enorme Menge sensibler Daten potenziell rund um die Uhr aufgenommen werden kann – und dies gerade im häuslichen Nahbereich der Pflegebedürftigen. Gleichzeitig stellen ältere Menschen aufgrund ihrer mangelnden Technikaffinität eine besonders vulnerable Gruppe dar. Dieser Beitrag beschäftigt sich mit den Schwierigkeiten einer DSGVO-konformen und ethisch akzeptablen Einwilligungskonzeption in diesen Kontexten, da hier medizinische wie auch medizinisch relevante Daten in erheblichem Umfang verarbeitet werden. Wir schlagen eine „Privacy Interference Matrix“ vor, bei der Kriterien für die Ermittlung der Eingriffstiefe in die Privatsphäre entwickelt und mit der Konkretheit der Zweckangabe in Beziehung gesetzt werden: Je tiefer der Eingriff in die Privatsphäre, desto konkreter muss der Zweck angegeben werden. Im Ergebnis formulieren wir einige Designvorschläge für die Einwilligung, bspw. die Dynamisierung und Wiederholung der Einwilligung, Rahmenbedingungen zur Herabsetzung der kognitiven Belastung.
Studienübergreifende Harmonisierung datenschutzrechtlicher und ethischer Gesichtspunkte in Patientenunterlagen: Eine Praxisanalyse
Authors: Kraus Monika , Nauck Matthias , Stahl Dana , Blumentritt Arne , Anton Gabriele , Wichmann H.-Erich , Peters Annette
Published: October 2021

Im Rahmen des Deutschen Zentrums für Herz-Kreislauf-Forschung e. V. (DZHK) wurden die klinische Forschungsplattform des DZHK für die Erhebung von standardisierten Daten und Bioproben aus DZHK-finanzierten klinischen Studien sowie ein Antrags- und Zugangsprozess unter Einbeziehung eines Use and Access Komitees für weitere medizinische Forschungsprojekte aufgebaut.

Die Sammlung dieser Forschungsressourcen erfolgt auf Basis eines DZHK-weit harmonisierten Broad Consent. Entsprechend ergänzte Patienteninformations- und Einwilligungsunterlagen der DZHK-Studien wurden seit 2013 bereits von über 50 Ethikkommissionen deutschlandweit positiv begutachtet. Inhalte von 43 Ethikvoten aus den Jahren 2017 und 2018 wurden ausgewertet sowie eine Ist-Analyse (Q4/2019) der Anzahl beteiligter Studienzentren und der Anzahl verwalteter Einwilligungsversionen durchgeführt.

Die Auswertungen spiegeln die erhöhten Herausforderungen wider, die sich seit verbindlich werden der EU-Datenschutzgrundverordnung (EU-DSGVO) im Mai 2018 ergaben. Durch Forderungen und Änderungswünsche einzelner Ethikkommissionen werden derzeit (Q4/2019) 75 unterschiedliche, die Daten- und Biomaterialsammlung betreffende Patienteninformations- und Einwilligungsunterlagen für 19 klinische Studien verwaltet.

Trotz eines, im Verhältnis zur Anzahl der teilnehmenden Studien und Studienzentren, hohen Harmonisierungsgrades bestehen aufgrund von Forderungen aus den Ethikvoten deutliche Unterschiede in den Formulierungen der DZHK-Patientenunterlagen, die u. a. kritische Aspekte wie Speicherzeitbegrenzung, Widerruf und Weitergabe von Daten für die Forschung betreffen. Der Artikel soll die Schwierigkeiten, mit denen wir  und andere übergreifende Forschungsverbünde im Alltagsbetrieb bei Ethikeinreichungen konfrontiert werden, strukturiert darlegen und den Umgang des DZHK e. V. damit beschreiben um Wünsche für eine zukünftige Vorgehensweise zu formulieren.
Ernst Weiss: Die Kunst des Erzählens. Fragen der Assimilation am Beispiel des „deutschen“ Mozart
Authors: Neumann Bernd
Published: October 2021

Karl figuriert bei Kafka als der einzige, der noch über einen vollen Namen, seinen „christian name“, verfügt. Danach wird Verkürzung zum Programm. „Josef K.“ im „Process“ gerät zum „K.“ des Schlosses.
Ein (gemeinsamer?) „chinesischer“ Mozart
Authors: Neumann Bernd
Published: October 2021

Ein weiterer, entscheidender Punkt der 1913 geschlossenen Freundschaft zwischen den beiden böhmischen Schriftstellern war deren Sicht auf Mozart. Unter den Essays zur Kunst des Erzählens, mithin im Band 16 der Suhrkamp’schen Gesamtausgabe, findet sich ein einziger Text, die Musik betreffend. Wie bereits referiert, ist er ist überschrieben mit Mozart, ein Meister des Ostens. Geht auf jene Eindrücke zurück, die sein Autor als weltreisender Schiffsarzt in Asien erhalten hatte.
Taoismus, Hermeneutik und moderne Physik. Noch ein notwendiger Exkurs
Authors: Neumann Bernd
Published: October 2021

Noch in den 80er Jahren des vorigen Jahrhunderts gab es eine breit rezipierte, sehr bald ins „Modische“ zerlaufene „New Age“-Bewegung, die weniger einen „fernöstlichen“ Mozart statuieren, als gleich die gesamte moderne Teilchen-Physik mit altchinesischen Lehren und Weisheiten zu den zwei Seiten einer gleichen Münze zu verbinden trachtete. Deren Erfolg kann heute, bis hinein in die allgegenwärtigen Angebote „fernöstlicher Meditationstechniken“, in zahlreichen Fitness-Studios besichtigt werden. Ein entscheidender bestseller-Autor war in diesem Zusammenhang Fritjof Capra mit Wendezeit.
Kafkas Blumfeld-Erzählung im Rahmen von Kafkas „Neutönertum“. Eine Entdeckung
Authors: Neumann Bernd
Published: October 2021

„Wo keine Götter sind da walten Gespenster“ (Novalis in seinen Fragmenten)
Eine epochale „Verwandlung“ und mitten darin: Hans Magnus Enzensbergers Geniestreich
Authors: Neumann Bernd
Published: October 2021

Der direkt „physikalische“ Blumberg ein älterer Junggeselle wird geschrieben im frühen Jahr 1915. Mithin zeitgleich mit der endgültigen (und geradezu erleichterten) Aufgabe aller Hochzeitspläne, mit der Wiederaufnahme der Wehrdienstabsichten (Kafka will an die Front, sein Mentor, der Chef der Anstalt, lässt das nicht zu, weil er einen seinen vertrautesten Mitarbeiter nicht verlieren will).
Kafkas „mesmeristischer“ Kleist, ein artverwandtes Geschöpf im Geiste noch früher Romantik. Von Ritter zu Brecht und Dürrenmatt, oder: Die Spaltkraft der Atombombe
Authors: Neumann Bernd
Published: October 2021

Alle Forschung zum elektromagnetischen Feld, wie sie bei Maxwell vorliegt und sich dann beim frühen Einstein fortsetzte, begann eigentlich mit dem Mesmerismus.
Noch einmal Theoretisches, nunmehr mit Blick auf Friedrich Nietzsche und Botho Strauβ. Ein notwendiger Exkurs mitten ins Herz einer vermeintlichen Finsternis
Authors: Neumann Bernd
Published: October 2021

Wie es ausschaut, herrscht derzeit auf dem Gebiet der Literaturwissenschaft, und noch entschiedener auf dem der Kafka-Deutung, so etwas wie die „Stunde zwischen Hund und Wolf“ (wie sie einst von Christa Wolf in ihrem Geteilten Himmel als weltanschaulicher Lackmustest geschildert worden ist; lang ist das her, der Autorin stand damals die Erkenntnis noch bevor, die ihr Gesinnungsgenosse Georg Lukács im Jahr 1956 bereits gemacht hatte: Dass Kafka doch tatsächlich ein Realist war) – und wie sie heute im neueren Novellenwerk des Botho Strauβ zu finden ist, seitdem der Mann im Jahr 2007 seine erste klassische, und, wie sich zeigen wird, ihrerseits Kleistisch-„electrische“ Novelle geschrieben hat.
Botho Strauβ’ „elektrische“ Novellen
Authors: Neumann Bernd
Published: October 2021

Im Jahr 1994 (Strauβ publizierte noch im Hanser Verlag, war noch nicht zu Rowohlt gewechselt wie vor ihn bereits Martin Walser), erschien in Wohnen. Dämmern. Lügen das später dann klar „elektromagnetische“ Erzählen des Botho Strauβ’ noch in einen mystisch-metaphysischen Kokon eingehüllt. Wiewohl es bereits mit Himmelskörpern, „Zeit und Raum“, Meteoriten und anderen in’s Auge fallenden (früh)romantischen Requisiten ausstaffiert auftrat – wobei der, als einsam Erwählte sich präsentierende, Erzähler interessanterweise überall das „Chinesische“ nach Art des damals „angesagten“ Bestsellerautors Fritjof Capra suchte.
Integrated Strategies for the Management of Wadi Flash Floods in the Middle East and North Africa (MENA) Arid Zones: The ISFF Project
Authors: Kantoush Sameh A. , Saber Mohamed , Abdel-Fattah Mohammed , Sumi Tetsuya
Published: October 2021

Sustainable management of wadi flash flood (WFF) risks is desperately needed to secure development in wadi systems. Due to rapid flow generation with sudden high flood peaks, spatiotemporal variability of rainfall occurrence, and poorly sited rapid development, most Middle East and North Africa (MENA) region have no comprehensive proper protection from WFFs. In arid regions, single mitigation measures, including storage dams, recharge dams, artificial lakes and embankments, are implemented, although soft mitigation measures are not dominant, such as early warning systems. The single management strategy under climate change impacts is not adequate to reduce flash flood risks; an integrated strategy is required. The objective of the international symposium on flash floods (ISFF) project has been to develop scientific understanding of WFFs in wadi systems; monitor, model, and mitigate; issue warnings; and plan urban development by discussing and networking the strategies in the MENA region. To achieve this goal, the project defines priorities for future research challenges and potential projects for WFFs. This chapter provides a state-of-the-art scientific basis in terms of integrated flash flood management. Further, priorities are defined for the main research gaps, and the emerging research methodologies can contribute to guide the management of WFFs in such regions.
The Role of Urban Planning and Landscape Tools Concerning Flash Flood Risk Reduction Within Arid and Semiarid Regions
Authors: Abdrabo Karim I. , Kantosh Sameh A. , Saber Mohamed , Sumi Tetsuya , Elleithy Dina , Habiba Omar M. , Alboshy Bahaa
Published: October 2021

This chapter highlights some substantial questions inquired by researchers to comprehend the flood risks (FRs) that occur in their cities as follows: (1) What is the impact of flooding on urban areas? (2) what effect does urbanization have on FR? (3) What are the existing nonstructural and structural mitigation measures for urban flooding? and (4) What is the role of urban planning and landscape tools in flood risk reduction (FRR) for cities as well as their inhabitants? The main messages in this chapter could be summarized as follows: (1) Comprehension of both the sources and types of flooding is vital if proper FRR measures are to be determined, (2) Unplanned urban growth could seriously put lives and properties at high risk (3) Land use planning and regulation, and Sustainable infrastructure for stormwater management through landscape architecture are fundamental measures for future FRR (4) The application of the urban planning approach for FRR in arid and semiarid regions has not yet received adequate attention and facing many challenges for its implementation, and finally (5) the combination of structural and nonstructural mitigation measures in spatial planning could be much more effective than using one type of measure alone.
Measuring Vulnerability to Flash Flood of Urban Dwellers
Authors: Huq Md. Enamul , Shao Zhenfeng , Al Dughairi Ahmed Abdullah , Sarker Md. Nazirul Islam , Bowen Cai , Al Mamun Abdullah , Saleem Nayyer , Javed Akib , Rahman Md. Mahabubur
Published: October 2021

Flash floods are unexpected, localized flood events that occur when an exceptional amount of rain falls happens over a short period of time. In South Asia, it is mostly disastrous, for example, in 2017 flash floods killed approximately 1200 people from India, Nepal, and Bangladesh. However, it is also common in Dhaka megacity, Bangladesh due to its geographic location, monsoon climatic condition and surrounding rivers. Though it is impossible to avoid them, the losses and damages of hazards can be reduced effectively by using appropriate techniques. This study aims to determine the responsible factors and measure the household vulnerability to flash flood as a tool of mitigation. The study has been conducted based on primary data. Therefore, data were collected from both slum and non-slum population to cover the entire urban habitats. Data were collected with a structured questionnaire based on five factors (social, economic, institutional, structural, and environmental) of vulnerability to flash flood. The key feature of this paper is to provide an insight into real picture of vulnerability to flash flood for urban habitants. Moreover, this practical approach is useful to quantify hazard-induced vulnerabilities not only for Dhaka megacity but also for other cities of the globe.
Sediment Transport in Shallow Waters as a Multiphysics Approach
Authors: Holzbecher Ekkehard , Hadidi Ahmed
Published: October 2021

Suspended particle and bed-load transport are usually high during flooding events. For that reason, sediment transport is an important feature to be taken into account when studying floods. Measures that aim to mitigate the negative impacts of floods depend on such studies. Sediment transport phenomena are complex due to their coupling behavior with fluid flow. Due to the erosion and sedimentation of particulate matter, the ground surface changes during the passing of a flood. The courses of unregulated rivers and wadis after floods are different than those before floods. Flowing water transports sediments, and vice versa; sediment redistribution affects the flow of water due to changes in the ground surface and other factors. Computer simulations of sediment transport must take the coupling between water flow and transport processes into account. Here, a multiphysics approach in such a coupled model is presented. Shallow water equations (SWE) representing water height and velocity are coupled with equations for suspended particulate matter and bed loads. Using COMSOL Multiphysics software, an implementation is presented that demonstrates the capability and feasibility of the proposed approach. The approach is applied to the problems of scouring and sedimentation at obstacles, which are particularly important for ensuring the stability of bridges across rivers and wadis.
Determining the Precipitation Intensity Threshold of Debris Flood Occurrence
Authors: Banihabib Mohammad Ebrahim , Tanhapour Mitra
Published: October 2021

In this chapter, the precipitation threshold at which debris floods occur was evaluated experimentally, and the factors that influence debris flood occurrence, including the bed slope, sediment layer thickness, sediment grain size, length of alluvial flow direction, precipitation intensity, and time of debris flood occurrence, were examined. The impacts of these factors on debris flood initiation were investigated through dimensional analysis. Then, a method was developed to estimate the precipitation intensity threshold based on a set of laboratory tests. Furthermore, different methods for determining the precipitation intensity threshold at which debris floods are initiated were assessed and discussed. The results of the experiments showed that the effect of the sediment layer thickness on debris flood occurrence can be ignored. Moreover, by independently evaluating the effect of each factor on debris flood occurrence, it was found that the sediment length and average diameter of sediments are influential to debris flood initiation. The results of this research provide a better understanding of debris flood mechanisms and occurrence thresholds of debris floods and can be employed to prepare a forecasting model.
Renewed Patronage and Strengthened Authority of Chiefs Under the Scarcity of Customary Land in Zambia
Authors: Oyama Shuichi
Published: October 2021

The Zambian government enacted the 1995 Lands Act with the aim of stimulating investment and agricultural productivity. This Act strengthened the role and power of traditional leaders, particularly chiefs, as it empowered them to allocate customary land to individuals and companies, including foreign investors. In the Bembachiefdom of northern Zambia, a new chief issued new land rights and invalidated the land rights issued by the old chiefs. As a result, land owners with documents in the old formats were required to obtain new certification from the new chief. Concerned about the land within his territory, this chief also decided to invalidate the title deeds issued by the central government so that he could release the protected land to local people. Alongside their historical and cultural power, the chiefs strengthened their patronage over land distribution as well as their authority over the residents in their territories. With high demand for land, anxiety among local people due to land scarcity has created political power and authority for the chiefs.
Traversing State, Agribusinesses, and Farmers’ Land Discourse in Kenyan Commercial Intensive Agriculture
Authors: Narh Peter
Published: October 2021

From a qualitative study of sugarcane production in Chemelil(western Kenya) and insights drawn from the Kenyan land reform enacted in 2012, this study contends that the goal of land reform to provide farmers with certainty of rights to land to invest in and benefit from agriculture is heavily weakened by the farmers’ lack of control over agricultural inputs. Land reform and intensive agriculture, such as sugarcane production, share the same market-based land discourse, where land is considered an environmental asset to be harnessed efficiently for high productivity. Although this discourse supports the application of high inputs for maximum agricultural outputs, it has also eroded farmers’ power and control over their lands. This loss of power and control occurs through the supply of high-cost agricultural inputs from external sources, such as state research agencies and the Chemelil Sugar Company. The control of inputs by sources external to farmers stifles possible farm-based innovations that could reduce farming costs. The chapter, thus, contends that, although land reform aims at farmers’ utmost benefit from land, the farmer’s lack of control over agricultural inputs limits the benefits they derive from land use for intensive agriculture; this is especially true in the case of small-scale farmers.
Fermion mass hierarchy and g − 2 anomalies in an extended 3HDM Model
Authors: Hernández A. E. Cárcamo , Kovalenko Sergey , Maniatis M. , Schmidt Ivan
Published: October 2021

Abstract

We propose an extension of the three-Higgs-doublet model (3HDM), where the Standard Model (SM) particle content is enlarged by the inclusion of two inert SU2L scalar doublets, three inert and two active electrically neutral gauge singlet scalars, charged vector like fermions and Majorana neutrinos. These additional particles are introduced to generate the SM fermion mass hierarchy from a sequential loop suppression mechanism. In our model the top and exotic fermion masses appear at tree level, whereas the remaining fermions get their masses radiatively. Specifically, bottom, charm, tau and muon masses appear at 1-loop; the masses for the light up, down and strange quarks as well as for the electron at 2-loop and masses for the light active neutrinos at 3-loop. Our model successfully accounts for SM fermion masses and mixings and accommodates the observed Dark Matter relic density, the electron and muon anomalous magnetic moments, as well the constraints arising from charged Lepton Flavor Violating (LFV) processes. The proposed model predicts charged LFV decays within the reach of forthcoming experiments.