bluuebunny/crossref_metadata_2025_split huggingface dataset:
Die nationale Begleitgesetzgebung zum Genehmigungsverfahren klinischer Prüfungen mit Humanarzneimitteln im Rahmen der Verordnung (EU) Nr. 536/2014
Authors: Frech Marion , Dexel Florian , Burgard Margareta , Seibel Yvonne 
Published: December 2022

ZusammenfassungDie Verordnung (EU) Nr. 536/2014 (Clinical Trials Regulation [CTR]) über klinische Prüfungen mit Humanarzneimitteln stellt nicht nur die Sponsoren, sondern auch die Behörden und Ethik-Kommissionen vor Herausforderungen. So waren grundlegende strukturelle Veränderungen für die Etablierung des neuartigen Genehmigungsverfahrens erforderlich. Die dazu notwendige Begleitgesetzgebung wurde 2016 mit dem Vierten Gesetz zur Änderung arzneimittelrechtlicher und anderer Vorschriften (4. AMGÄndG) sowie 2017 mit der Klinische Prüfung-Bewertungsverfahren-Verordnung (KPBV) geschaffen.Das 4. AMGÄndG sah Änderungen des Arzneimittelgesetzes (AMG) vor, die bereits vor Geltungsbeginn der CTR in Kraft getreten sind. Ganz wesentlich betrifft das die Einführung einer Registrierungspflicht für Ethik-Kommissionen beim Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). Daneben enthält das 4. AMGÄndG Regelungen, die parallel zum Geltungsbeginn der CTR Anfang 2022 in Kraft getreten sind. Die Verordnung über die Anwendung der guten klinischen Praxis bei der Durchführung von klinischen Prüfungen mit Arzneimitteln zur Anwendung an Menschen (GCP-Verordnung) wurde aufgehoben. Der 6. Abschnitt des AMG über den Schutz des Menschen bei klinischen Prüfungen wurde neu gefasst, um die Vorgaben der CTR zu ergänzen und den Verfahrensablauf in das nationale Rechtssystem einzupassen. Insbesondere betrifft das Regelungen über die Zusammenarbeit zwischen Bundesoberbehörden und Ethik-Kommissionen, wie zu Zuständigkeiten, Fristen, Verfahrensabläufen und auch Gebühren. Auch wurden Regelungen für das nationale Verfahren der Freisetzungsgenehmigung bei klinischen Prüfungen mit Arzneimitteln, die gentechnisch veränderte Organismen (GVO) enthalten, getroffen sowie besondere Schutzvorschriften für spezielle Teilnehmergruppen geschaffen.
Land-use Suitability is Not an Intrinsic Property of a Land Parcel
Authors: Snelder Ton , Lilburne Linda , Booker Doug , Whitehead Amy , Harris Simon , Larned Scott , Semadeni-Davies Anette , Plew David , McDowell Richard 
Published: December 2022

AbstractAgricultural production has economic, environmental, social and cultural consequences beyond farm boundaries, but information about these impacts is not readily available to decision makers. This study applied the land use suitability concept by carrying out an assessment of a region that has the potential for intensification of agricultural production, but where eutrophication of river and estuary receiving environments due to nitrogen enrichment is a significant issue. The assessment evaluated three indicators for each farmable land parcel in the region: productive potential (the inherent productive and economic potential of the parcel), relative contribution (the potential for the parcel to contribute nitrogen to receiving environments compared to other land parcels), and pressure (the load of nitrogen delivered to receiving environments compared to the loads that ensure environmental objectives are achieved). The assessment indicated that land with high suitability for land-use intensification in Southland is limited because areas with high productive potential and low relative contribution rarely coincide with receiving environments with low pressure. Existing data, methods and models can be used to calculate the indicators under different choices for regional land-use intensity and receiving environment objectives. However, the spatial resolution and accuracy that is achievable may preclude using assessment outputs to make land use decisions at small spatial scales such as individual farms. The study highlighted that land use suitability is not an intrinsic property of a land parcel because it is dependent on choices about land use elsewhere in the landscape and the environmental objectives, and that land use suitability is inherently subjective because of decisions that concern how indicators are combined and weighted.
Impact of physical activity on postural stability and coordination in children with posterior fossa tumor: randomized control phase III trial
Authors: Usama Mahmoud , Abdelaziem Faten , Rashed Wafaa M. , Maher Eslam , El Beltagy Mohamed , Zekri Wael 
Published: December 2022

Abstract
Background
Posterior fossa tumor is a type of brain tumor that is located at the borders of both the brain stem and cerebellum. The cerebellum is the brain region in charge of balance and coordination. Pediatric patients diagnosed with posterior fossa tumor have been reported to fall frequently.

Objectives
The aim of this study is to investigate the effectiveness of balance and coordination training in these children.

Methods
This randomized control clinical trial (ClinicalTrials.gov Identifier: NCT04528316) was carried out between September 2020 and April 2021 at Children’s Cancer Hospital-57357. The inclusion criteria were patients with posterior fossa tumor in maintenance phase and, age between 5 and 12 years. The exclusion criteria were patients who had a genetic disorder or suffer from mental retardation, a chronic lung disease, severe cardiomyopathy, or a neuromuscular disease that does not relate to tumor. The study participants were randomly assigned into three groups: Group I/Control group: they received Pilates core stability exercises program, Group II/Postural stability group: they received the same program plus HUMAC balance program, and Group III/Coordination group: they received the same program plus coordination exercises of BOT-2. The semi-parametric proportional odds model was used to compare follow-up scores of the Postural stability group vs Control, and Coordination group vs Control, while adjusting for baseline values. All tests were two sided, with alpha set to 0.05.

Results
Sixty children including 38 boys and 22 girls were enrolled in this study. In all three groups, postural stability and coordination improved significantly in terms of modified clinical test of sensory integration of balance, center of pressure, limits of stability, bilateral coordination, and upper-limb coordination.

Conclusion
The current study supports the value of adding postural stability and coordination training to the physiotherapy plan for children with posterior fossa tumor.

Trial registration number and date of registration
ClinicalTrials.gov Identifier: NCT04528316 on August 27, 2020.
Social Support, social ties, and cognitive function of women with breast cancer: findings from the Women’s Health Initiative (WHI) Life and Longevity After Cancer (LILAC) Study
Authors: Yang Yesol , McLaughlin Eric M. , Naughton Michelle J. , Lustberg Maryam B. , Nolan Timiya S. , Kroenke Candyce H. , Weitlauf Julie C. , Saquib Nazmus , Shadyab Aladdin H. , Follis Shawna , Pan Kathy , Paskett Electra D. 
Published: December 2022

Abstract

Purpose
This study examined associations between self-reported cognitive functioning and social support as well as social ties among women with breast cancer.

Methods
The study included 3351 women from the Women’s Health Initiative Life and Longevity After Cancer cohort who were diagnosed with breast cancer stages I–III. Social support was assessed using a modified Medical Outcomes Study (MOS) Social Support Survey, and marital status was obtained from the baseline questionnaire. We also assessed social ties (e.g., number of friends, relatives, living children) and cognitive function (Functional Assessment of Cancer Therapy-Cognitive Function [FACT-COG]) on the year-1-follow up questionnaire. Multivariable quantile regression was used to estimate the changes in median cognitive scores. Kruskal–Wallis tests were used to assess the association of cognitive function with social ties.

Results
The majority of participants were non-Hispanic White (93.3%), presently married (49%), with at least a 4-year college degree (53.2%), and had been diagnosed with localized breast cancer (79%). A 10-point higher social support score correlated to a 0.32 higher (better) median cognitive score (p < 0.001). Women who were presently married tended to have better cognition than women who were divorced/separated or widowed (p = 0.01). Significant associations were also present for having close relatives (p < 0.001) or friends (p < 0.001), with cognitive scores being higher in those with at least one close relative or friend compared to none.

Conclusion
Women reporting higher social support and greater numbers of friends or relatives have higher cognitive functioning. Compared to divorced or separated women, married women were likely to have higher cognitive functioning. These findings suggest that social support assessments have the potential to help identify women at higher risk of cognitive decline.
Untersuchungen zur Vergleichbarkeit der statischen und dynamischen Überdruckprüfung von druckfesten Kapselungen
Authors: Spörhase Stefanie , Brombach Falk Marian , Eckhardt Felix , Krause Tim , Markus Detlev , Küstner Bernd , Walch Otto 
Published: December 2022

ZusammenfassungDer Einsatz von elektrischen Geräten in explosionsgefährdeten Bereichen erfordert besondere Schutzmaßnahmen, um eine Zündung der explosionsfähigen Atmosphäre zu verhindern. Eine mögliche Schutzmaßnahme ist die Zündschutzart „Druckfeste Kapselung“. Hierfür müssen die Gehäuse nach den Vorgaben der Norm IEC 60079‑1 ausgelegt und geprüft werden. Neben anderen Prüfungen muss das Gehäuse entweder einer statischen oder einer dynamischen Überdruckprüfung unterzogen werden. Diese basieren auf dem maximalen Druck einer Explosion, dem sogenannten Bezugsdruck. Auf Grundlage der Überdruckprüfung wird die Festigkeit des Gehäuses beurteilt.Dieser Beitrag beschäftigt sich mit der Frage, ob eine dieser beiden Prüfmethoden das Material stärker beansprucht als die andere. Es wurden Gehäuse aus verschiedenen Materialien und Wandstärken statisch und dynamisch belastet. Die dynamischen Explosionsversuche wurden mit verschiedenen Gasen, Vordrücken und Gehäusegeometrien durchgeführt. Hierbei wurden der Innendruck mit piezoelektrischen Drucksensoren und die Dehnung des Materials mit Hilfe von Dehnungsmessstreifen gemessen und die Ergebnisse verglichen.Bei einfachen Geometrien treten unterhalb der Dehn- bzw. Streckgrenze bei der dynamischen und bei der statischen Prüfung vergleichbar große Dehnungen des Materials auf. Bei Geometrien, bei denen Drucküberhöhungen, pressure piling, auftreten, kommt es zusätzlich zu einer Schwingungsanregung, welches sich in erhöhten Dehnungswerten zeigt. Es kann dennoch in diesem Fall keine Aussage darüber getroffen werden, welche Prüfmethode zu einer höheren Belastung des Prüfmusters führt.
Multi-fidelity Surrogate Modelling of Wall Mounted Cubes
Authors: Mole Andrew , Skillen Alex , Revell Alistair 
Published: December 2022

AbstractThis paper focuses on the application of multi-fidelity surrogate modelling to characteristics of a flow as it changes with a parameter. This provides insight into the potential of combining multi-fidelity modelling approaches with varying fidelities of computational fluid dynamics methods to a parameter space exploration. A limited number of trusted high-fidelity large eddy simulation data points, in combination with an extended study using lower-fidelity Reynolds averaged Navier–Stokes modelling is used as the input for the surrogate model. Multi-fidelity surrogate models are implemented to bridge the low-fidelity and high-fidelity models providing an improved surrogate model over using a single fidelity alone. The flow around tandem wall mounted cubes at varying inlet yaw angle is used as an aerodynamic test case for this methodology. Results presented show that the multi-fidelity surrogate modelling provides a significant improvement over single fidelity modelling for the prediction of global flow properties. This methodology is then extended to combine multiple local flow features into the multi-fidelity model to build up fuller descriptions of the flow at angles not included in the training data for the model. The results of this are presented for both one-dimensional line plots at a range of locations along the center line of the flow and for two-dimensional slices of the velocity field. The multi-fidelity surrogate model produces results at locations in the parameter space away from the high fidelity training data that match closely to large eddy simulation results.
Robust and continuous metric subregularity for linear inequality systems
Authors: Camacho J. , Cánovas M. J. , López M. A. , Parra J. 
Published: December 2022

AbstractThis paper introduces two new variational properties, robust and continuous metric subregularity, for finite linear inequality systems under data perturbations. The motivation of this study goes back to the seminal work by Dontchev, Lewis, and Rockafellar (2003) on the radius of metric regularity. In contrast to the metric regularity, the unstable continuity behavoir of the (always finite) metric subregularity modulus leads us to consider the aforementioned properties. After characterizing both of them, the radius of robust metric subregularity is computed and some insights on the radius of continuous metric subregularity are provided.
Extracellular adenosine 5ʹ-diphosphate promotes MCP-1/CCL2 expression via the P2Y13 purinergic receptor/ERK signaling axis in temporomandibular joint-derived mouse fibroblast-like synoviocytes
Authors: Yokota Seiji , Chosa Naoyuki , Matsumoto Shikino , Satoh Kazuro , Ishisaki Akira 
Published: December 2022

Abstract
Background
Temporomandibular joint osteoarthritis (TMJ-OA) causes cartilage degeneration, bone cavitation, and fibrosis of the TMJ. However, the mechanisms underlying the fibroblast-like synoviocyte (FLS)-mediated inflammatory activity in TMJ-OA remain unclear.

Methods and results
Reverse transcription-quantitative polymerase chain reaction analysis revealed that the P2Y1, P2Y12, and P2Y13 purinergic receptor agonist adenosine 5ʹ-diphosphate (ADP) significantly induces monocyte chemotactic protein 1 (MCP-1)/ C–C motif chemokine ligand 2 (CCL2) expression in the FLS1 synovial cell line. In contrast, the uracil nucleotide UTP, which is a P2Y2 and P2Y4 agonist, has no significant effect on MCP-1/CCL2 production in FLS1 cells. In addition, the P2Y13 antagonist MRS 2211 considerably decreases the expression of ADP-induced MCP-1/CCL2, whereas ADP stimulation enhances extracellular signal-regulated kinase (ERK) phosphorylation. Moreover, it was found that the mitogen-activated protein kinase/ERK kinase (MEK) inhibitor U0126 reduces ADP-induced MCP-1/CCL2 expression.

Conclusion
ADP enhances MCP-1/CCL2 expression in TMJ FLSs via P2Y13 receptors in an MEK/ERK-dependent manner, thus resulting in inflammatory cell infiltration in the TMJ. Collectively, the findings of this study contribute to a partial clarification of the signaling pathway underlying the development of inflammation in TMJ-OA and can help identify potential therapeutic targets for suppressing ADP-mediated purinergic signaling in this disease.
Quality of life outcomes in incidental and operated meningiomas (QUALMS): a cross-sectional cohort study
Authors: Keshwara Sumirat M. , Gillespie Conor S. , Mustafa Mohammad A. , George Alan M. , Richardson George E. , Clynch Abigail L. , Wang Justin Z. , Lawson David D. A. , Gilkes Catherine E. , Farah J. Osman , Yousaf Jawad , Chavredakis Emmanuel , Mills Samantha J. , Brodbelt Andrew R. , Zadeh Gelareh , Millward Christopher P. , Islim Abdurrahman I. , Jenkinson Michael D. 
Published: December 2022

Abstract
Introduction:
Few studies have evaluated meningioma patients’ longer-term health-related quality of life (HRQoL) following diagnosis and treatment, particularly in those with incidental, actively monitored tumours.

Methods:
A single-center, cross-sectional study was completed. Adult patients with surgically managed or actively monitored meningioma with more than five years of follow-up were included. The patient-reported outcome measures RAND SF-36, EORTC QLQ-C30 and QLQ-BN20 were used to evaluate HRQoL. HRQoL scores were compared to normative population data. Outcome determinants were evaluated using multivariate linear regression analysis.

Results:
243 patient responses were analyzed, and the mean time from diagnosis was 9.8 years (range 5.0–40.3 years). Clinically relevant, statistically significant HRQoL impairments were identified across several SF-36 and QLQ-C30 domains. Increasing education level (β = 2.9, 95% CI 0.9 to 4.9), P = .004), employment (β = 7.7, 95% CI 2.2 to 13.1, P = .006) and absence of postoperative complications (β=-6.7, 95% CI -13.2 to (-)0.3, P = .041) were associated with a better QLQ-C30 summary score. Other tumour and treatment variables were not.

Conclusion:
This study highlights the longer-term disease burden of patients with meningioma nearly one decade after diagnosis or surgery. Patients with actively monitored meningioma have similar HRQoL to operated meningioma patients. Healthcare professionals should be mindful of HRQoL impairments and direct patients to sources of support as needed.
Lava-ice interactions during historical eruptions of Veniaminof Volcano, Alaska and the potential for meltwater floods and lahars
Authors: Waythomas Christopher F. , Edwards Benjamin R. , Miller Thomas P. , McGimsey Robert G. 
Published: December 2022

AbstractVeniaminof Volcano on the Alaska Peninsula of southwest Alaska is one of a small group of ice-clad volcanoes globally that erupts lava flows in the presence of glacier ice. Here, we describe the nature of lava-ice-snow interactions that have occurred during historical eruptions of the volcano since 1944. Lava flows with total volumes on the order of 0.006 km3have been erupted in 1983–1984, 1993–1994, 2013, and 2018. Smaller amounts of lava (1 × 10−4 km3or less) were generated during eruptions in 1944 and 2021. All known historical eruptions have occurred at a 300-m-high cinder cone (informally named cone A) within the 8 × 10-km-diameter ice-filled caldera that characterizes Veniaminof Volcano. Supraglacial lava flows erupted at cone A, resulted in minor amounts of melting and did not lead to any significant outflows of water in nearby drainages. Subglacial effusion of lava in 1983–1984, 2021 and possibly in 1944 and 1993–1994 resulted in more significant melting including a partially water-filled melt pit, about 0.8 km2in area, that developed during the 1983–1984 eruption. The 1983–1984 event created an impression that meltwater floods from Mount Veniaminof’s ice-filled caldera could be significant and hazardous given the large amount of glacier ice resident within the caldera (ice volume about 8 km3). To date, no evidence supporting catastrophic outflow of meltwater from lava-ice interactions at cone A has been found. Analysis of imagery from the 1983–1984 eruption shows that the initial phase erupted englacial lavas that melted ice/snow/firn from below, producing surface subsidence outward from the cone with no discernable surface connection to the summit vent on cone A. This also happened during the 2021 eruption, and possibly during the 1993–1994 eruption although meltwater lakes did not form during these events. Thus, historical eruptions at Veniaminof Volcano appear to have two different modes of effusive eruptive behavior, where lava reaches the ice subglacially from flank vents, or where lava flows are erupted subaerially from vents near the summit of cone A and flow down the cone on to the ice surface. When placed in the context of global lava-ice eruptions, in cases where lava flows melt the ice from the surface downward, the main hazards are from localized phreatic explosions as opposed to potential flood/lahar hazards. However, when lava effusion/emplacement occurs beneath the ice surface, melting is more rapid and can produce lakes whose drainage could plausibly produce localized floods and lahars.
Semi-parametric modelling of inefficiencies in stochastic frontier analysis
Authors: Forchini Giovanni , Theler Raoul 
Published: December 2022

Abstract
We propose a novel penalized splines method to estimate a stochastic frontier model in which the frontier is linear and the inefficiency has a single index structure with unknown link function and a linear index. The approach is more flexible than the traditional methodology requiring a parametric link function and, at the same time, it does not incur the curse of dimensionality as a fully non-parametric approach. The procedure can be easily implemented using existing software. We give conditions for the model to be identified and provide some asymptotic results. We also use Monte Carlo simulations to show that the approach works well in finite samples in many situations when compared to the well specified maximum likelihood estimator. An application to the residential energy demand of US states is considered. In this case, the penalized splines approach estimates inefficiency functions that deviate substantially from those resulting from parametric maximum likelihood methods previously implemented.
New ventures fighting the war for talents: the impact of product innovativeness and entrepreneurs’ passion on applicant attraction
Authors: Piva Evila , Stroe Silvia 
Published: December 2022

AbstractAn unanswered question in studies on recruiting in new ventures is how entrepreneurs can persuasively communicate to job seekers information about their ventures’ unique features to attract applicants. By building on nonverbal communication research, we investigate how verbally communicated product innovativeness and entrepreneurs’ nonverbal displays of passion affect applicant attraction both separately and in combination. We find applicant attraction is positively related to both communicated product innovativeness and entrepreneurs’ displays of moderate passion and negatively related to excessive displays of passion. Moreover, our findings suggest that displays of high passion distract job seekers from processing the semantic content of recruitment messages.
Project to Adapt: Domain Adaptation for Depth Completion from Noisy and Sparse Sensor Data
Authors: Lopez-Rodriguez Adrian , Busam Benjamin , Mikolajczyk Krystian 
Published: December 2022

AbstractDepth completion aims to predict a dense depth map from a sparse depth input. The acquisition of dense ground-truth annotations for depth completion settings can be difficult and, at the same time, a significant domain gap between real LiDAR measurements and synthetic data has prevented from successful training of models in virtual settings. We propose a domain adaptation approach for sparse-to-dense depth completion that is trained from synthetic data, without annotations in the real domain or additional sensors. Our approach simulates the real sensor noise in an RGB + LiDAR set-up, and consists of three modules: simulating the real LiDAR input in the synthetic domain via projections, filtering the real noisy LiDAR for supervision and adapting the synthetic RGB image using a CycleGAN approach. We extensively evaluate these modules in the KITTI depth completion benchmark.