bluuebunny/crossref_metadata_2025_split huggingface dataset:
Analysis of the pan-Asian subgroup of patients in the NALA Trial: a randomized phase III NALA Trial comparing neratinib+capecitabine (N+C) vs lapatinib+capecitabine (L+C) in patients with HER2+metastatic breast cancer (mBC) previously treated with two or more HER2-directed regimens
Authors: Dai Ming Shen , Feng Yin Hsun , Chen Shang Wen , Masuda Norikazu , Yau Thomas , Chen Shou Tung , Lu Yen Shen , Yap Yoon Sim , Ang Peter C. S. , Chu Sung Chao , Kwong Ava , Lee Keun Seok , Ow Samuel , Kim Sung Bae , Lin Johnson , Chung Hyun Cheol , Ngan Roger , Kok Victor C. , Rau Kun Ming , Sangai Takafumi , Ng Ting Ying , Tseng Ling Ming , Bryce Richard , Bebchuk Judith , Chen Mei Chieh , Hou Ming Feng 
Published: September 2021

Abstract
Purpose
Neratinib, an irreversible pan-HER tyrosine kinase inhibitor, has demonstrated systemic efficacy and intracranial activity in various stages of HER2+breast cancer. NALA was a phase III randomized trial that assessed the efficacy and safety of neratinib+capecitabine (N+C) against lapatinib+capecitabine (L+C) in HER2+ metastatic breast cancer (mBC) patients who had received ≥ 2 HER2-directed regimens. Descriptive analysis results of the Asian subgroup in the NALA study are reported herein.

Methods
621 centrally assessed HER2+ mBC patients were enrolled, 202 of whom were Asian. Those with stable, asymptomatic brain metastases (BM) were eligible for study entry. Patients were randomized 1:1 to N (240 mg qd) + C (750 mg/m2 bid, day 1–14) with loperamide prophylaxis or to L (1250 mg qd) + C (1000 mg/m2 bid, day 1–14) in 21-day cycles. Co-primary endpoints were centrally assessed progression-free survival (PFS) and overall survival (OS). Secondary endpoints included time to intervention for central nervous system (CNS) disease, objective response rate, duration of response (DoR), clinical benefit rate, and safety.

Results
104 and 98 Asian patients were randomly assigned to receive N+C or L+C, respectively. Median PFS of N+C and L+C was 7.0 and 5.4 months (P = 0.0011), respectively. Overall cumulative incidence of intervention for CNS disease was lower with N+C (27.9 versus 33.8%; P = 0.039). Both median OS (23.8 versus 18.7 months; P = 0.185) and DoR (11.1 versus 4.2 months; P < 0.0001) were extended with N+C, compared to L+C. The incidences of grade 3/4 treatment emergent adverse events (TEAEs) and TEAEs leading to treatment discontinuation were mostly comparable between the two arms. Diarrhea and palmar-plantar erythrodysesthesia were the most frequent TEAEs in both arms, similar to the overall population in incidence and severity.

Conclusion
Consistent with the efficacy profile observed in the overall study population, Asian patients with HER2+ mBC, who had received ≥ 2 HER2-directed regimens, may also benefit from N+C. No new safety signals were noted.

Clinical trial registration
NCT01808573
Low temperature super ductility and threshold stress of an ultrafine-grained Al–Zn–Mg–Zr alloy processed by equal-channel angular pressing
Authors: Boldizsár Bálint , Jenei Péter , Ahmed Anwar Q. , Murashkin Maxim Yu. , Valiev Ruslan Z. , Chinh Nguyen Q. 
Published: September 2021

AbstractLow temperature tensile and impression creep tests were carried out on an ultrafine-grained 7xxx series Al–4.8Zn–1.2 Mg–0.14Zr (wt%) alloy, which can be deformed for maximum elongation of about 200% at 150 °C. The characteristics of the deformation process, such as the strain rate sensitivity (SRS) and activation energy (Q) were determined by considering also the effect of threshold stress. Relatively high SRS of$$\sim$$∼0.35 and low activation energy of$$\sim$$∼92 kJ/mole were obtained, confirming the super ductility of the investigated ultrafine-grained alloy in the low temperature region between 140 and 160 °C.Graphical abstract
Integration of Cognitive and Emotional Processing Predicts Poor and Good Outcomes of Psychotherapy
Authors: de Felice Giulio , Giuliani Alessandro , Andreassi Silvia , Orsucci Franco , Schöller Helmut , Aichhorn Wolfgang , Kratzer Leonhard , Schiepek Günter 
Published: September 2021

Abstract
With the aim of investigating analogies and differences between psychotherapeutic processes, ten good-outcome and ten poor-outcome cases were selected from a sample of patients treated at the University Hospital of Psychiatry, Salzburg, Austria, and the Department of Psycho-Traumatology of the Clinic St. Irmingard, Prien am Chiemsee, Germany. They were monitored daily using the Therapy Process Questionnaire (TPQ), and their evolution over time was analyzed by means of Principal Components Analysis and Linear Discriminant Analysis. The results highlight that poor-outcome patients show a separation between cognitive processes (Principal Component 1) and relational-emotional processes (Principal Component 2) (r = − 0.25; p = n.s.), while in the good-outcome patients these aspects are well integrated (r = 0.70; p = 0.02). These results corroborate the validity of the daily monitoring procedure and also indicate the need for greater attention to the relational and emotional aspects of the patients rather than merely to their cognitive functioning and well-being.

Key Message
In poor-outcome cases, burdensome emotions and interpersonal experiences on the one hand and cognitive/well-being aspects of the mental processing on the other, stay unrelated. Successful therapeutic processing, as in good-outcome cases, requires an integration of cognitive and affective components.
Deep state-space Gaussian processes
Authors: Zhao Zheng , Emzir Muhammad , Särkkä Simo 
Published: September 2021

AbstractThis paper is concerned with a state-space approach to deep Gaussian process (DGP) regression. We construct the DGP by hierarchically putting transformed Gaussian process (GP) priors on the length scales and magnitudes of the next level of Gaussian processes in the hierarchy. The idea of the state-space approach is to represent the DGP as a non-linear hierarchical system of linear stochastic differential equations (SDEs), where each SDE corresponds to a conditional GP. The DGP regression problem then becomes a state estimation problem, and we can estimate the state efficiently with sequential methods by using the Markov property of the state-space DGP. The computational complexity scales linearly with respect to the number of measurements. Based on this, we formulate state-space MAP as well as Bayesian filtering and smoothing solutions to the DGP regression problem. We demonstrate the performance of the proposed models and methods on synthetic non-stationary signals and apply the state-space DGP to detection of the gravitational waves from LIGO measurements.
Either with us or against us: experimental evidence on partial cartels
Authors: Clemens Georg , Rau Holger A. 
Published: September 2021

AbstractThis paper analyzes the coordination challenge a partial cartel faces when payoff asymmetries between potential cartel insiders and potential cartel outsiders are large. We introduce two experimental treatments: a standard treatment where a complete cartel can be supported in a Nash equilibrium and a modified treatment where a complete cartel and a partial cartel can both be supported in a Nash equilibrium. To assess the role of communication both treatments are additionally run with a “chat option,” yielding four treatments in total. Our results show that subjects frequently reject the formation of partial cartels in the modified treatments. In all treatments with communication subjects are more likely to form complete cartels than partial cartels. The implications of these results are important for antitrust: payoff asymmetries between cartel members and outsiders may jeopardize the formation of partial cartels. Yet complete cartels may be formed instead, if institutional mechanisms with frequent communication are used to form cartels.
First-Class but not for Long: Heterogeneous Infrastructure and Water Bricolage in Accra’s Kiosk Compounds
Authors: Alba Rossella , Bruns Antje 
Published: September 2021

AbstractThis paper explores the micro-geographies of water access in the context of a first-class residential neighborhood of Accra served by the city’s networked infrastructure. We focus our analyses on how water is accessed and supplied to six kiosk compounds—privately owned, walled plots of land provisionally inhabited by urban dwellers living in kiosk-like structures with the (tacit) knowledge of the plot-owners. We document how kiosk inhabitants access pipe-born water, despite not being directly connected to the city’s network, through diverse configurations of actors, practices, and material set ups. Our findings suggest more attention should be paid to the micro-geographies of water distribution in networked neighborhoods as this contributes to more nuanced understandings of the uneven and diverse ways through which water is distributed in the context of Accra’s incremental urbanization. To analyze this diversity, we suggest combining the heuristic of heterogenous infrastructure configurations with the concept of water bricolage and using the plot as a unit of analysis.
Migration and cultural integration in the early medieval cemetery of Finglesham, Kent, through stable isotopes
Authors: Leggett Sam 
Published: September 2021

AbstractDebate over migrations to Britain during the fifth and sixth centuries AD is still rampant in archaeological discourse. Stable carbon, nitrogen and oxygen isotope values from multiple tissues in individuals buried at Finglesham in Kent during the first millennium AD demonstrate not only migration of individuals to the region but also highlight community integration through foodways and refute previous models of ‘invasion’ and replacement. This case study community suggests gendered differences in mobility into early medieval England, with males more likely to be migrants from cooler regions than women. It also challenges traditional narratives of social status in these furnished cemeteries being linked to diet or migrant status with no clear correlations found between funerary treatment and isotopic signatures. This multi-tissue and multi-isotope study tracks dietary changes in this multi-origin community throughout their lives and shows that they may have even changed their diets to adapt to Christianising influences in the region.
Decision Making for Managing Community Flood Risks: Perspectives of United States Floodplain Managers
Authors: Tyler Jenna , Sadiq Abdul-Akeem , Noonan Douglas S. , Entress Rebecca M. 
Published: September 2021

AbstractTo reduce flood losses, floodplain managers make decisions on how to effectively manage their community’s flood risks. While there is a growing body of research that examines how individuals and households make decisions to manage their flood risks, far less attention has been directed at understanding the decision-making processes for flood management at the community level. This study aimed to narrow this research gap by examining floodplain managers’ perceptions of the quality of their community’s flood management decision-making processes. Data gathered from interviews with 200 floodplain managers in the United States indicate that most floodplain managers perceive their community’s flood management decision-making processes to be good. The results also indicate that communities participating in the Federal Emergency Management Agency’s Community Rating System, as well as communities with a higher level of concern for flooding and a lower poverty rate, are significantly more likely to report better flood management decision-making processes.
Angeborene Adipositasformen und Therapien
Authors: Beghini Marianna , Scherer Thomas 
Published: September 2021

ZusammenfassungEtwa 5 % der Fälle schwerer Adipositas sind auf eine Mutation in einem einzigen Gen zurückzuführen. Diese genetischen Adipositasformen werden in monogene und syndromische Adipositas eingeteilt. Monogene Adipositas wird häufig durch Mutationen im Leptin-Melanocortin-Signalweg, der den Appetit reguliert, verursacht und ist durch frühkindlich auftretendes schweres Übergewicht gekennzeichnet. Bei syndromischer Adipositas (z. B. Prader-Willi‑, Bardet-Biedl- und Alström-Syndrom) liegen neben dem Übergewicht häufig auch Entwicklungsstörungen, dysmorphe Merkmale und Organanomalien vor. Die richtige Diagnose ist von Bedeutung, da es bereits medikamentöse Therapiemöglichkeiten gibt und eine Indikation zur bariatrischen Chirurgie nur mit großer Vorsicht getroffen werden sollte. Demzufolge sollte man in ausgewählten Fällen ein genetisches Screening anfordern. Warnsignale für eine genetische Ursache sind frühkindliche, ausgeprägte Adipositas, schwere Hyperphagie, normaler BMI der Eltern und Angehörigkeit zu Ethnien mit höherer Prävalenz von Konsanguinität (z. B. Pakistan, Türkei). Das genetische Screening sollte in erfahrenen Zentren mittels Gen-Panel erfolgen. Akkreditierte medizinisch-genetische Labore werden in den Datenbanken von Orphanet und Genetic Testing Registry (GTR) aufgelistet. In der EU liegt die klinische Zulassung für das Medikament Metreleptin bei LEP-Mutationen, so wie für das MC4R-Agonisten Setmelanotid bei LEPR-, POMC- und PCSK1-Mutationen vor. Bei MC4R-Mutationen, der häufigsten Ursache monogener Adipositas, scheint Liraglutid wirksam zu sein. Verschiedenste Medikamente für Prader-Willi‑, Bardet-Biedl- und Alström-Syndrom werden gerade in klinischen Studien untersucht.
Ten-Year Outcomes of Children and Adolescents Who Underwent Sleeve Gastrectomy: Weight Loss, Comorbidity Resolution, Adverse Events, and Growth Velocity
Authors: Alqahtani Aayed R. , Elahmedi Mohamed , Abdurabu Hanan Y. , Alqahtani Sultan 
Published: September 2021

Background
To date, there are insufficient data on long-term outcomes of weight loss surgery in children and adolescents with obesity beyond 5 years of follow-up. This study aimed to analyze durability of weight loss and comorbidity resolution, growth velocity, and adverse events associated with laparoscopic sleeve gastrectomy (LSG) in children and adolescents with severe obesity.

Study Design
In this prospective cohort study, 2,504 children and adolescents with class II/III obesity who were enrolled in a multidisciplinary, family-based pediatric obesity management program underwent LSG between 2008 and 2021. Weight loss, growth, comorbidity resolution, and adverse event data during the first 10 years after LSG were analyzed.

Results
The cohort age was 5 to 21 years at the time of operation, and 55% were female. Mean ± SD percentage of excess weight lost during short- (1 to 3 years; n = 2,051), medium- (4 to 6 years; n = 1,268), and long-term (7 to 10 years; n = 632) follow-up was 82.3% ± 20.5%, 76.3% ± 29.1%, and 71.1% ± 26.9%, respectively. Complete comorbidity remission at long-term follow-up was observed in 74%, 59%, and 64% of type 2 diabetes, dyslipidemia, and hypertension cases, respectively. Mean ± SD height z-score change at short-, medium-, and long-term follow-up was 0.1 ± 0.5, 0.1 ± 1.2, and 0.0 ± 0.8, respectively, representing no significant change in growth velocity. There were 27 adverse events (1%) with no procedure-related mortality.

Conclusions
Long-term follow-up after LSG in children and adolescents demonstrates durable weight loss, maintained comorbidity resolution, and unaltered growth.

Visual Abstract
Energy expenditure and nutrient intake after spinal cord injury: a comprehensive review and practical recommendations
Authors: Farkas Gary J. , Sneij Alicia , McMillan David W. , Tiozzo Eduard , Nash Mark S. , Gater David R. 
Published: September 2021

AbstractMany persons with spinal cord injury (SCI) have one or more preventable chronic diseases related to excessive energetic intake and poor eating patterns. Appropriate nutrient consumption relative to need becomes a concern despite authoritative dietary recommendations from around the world. These recommendations were developed for the non-disabled population and do not account for the injury-induced changes in body composition, hypometabolic rate, hormonal dysregulation and nutrition status after SCI. Because evidence-based dietary reference intake values for SCI do not exist, ensuring appropriate consumption of macronutrient and micronutrients for their energy requirements becomes a challenge. In this compressive review, we briefly evaluate aspects of energy balance and appetite control relative to SCI. We report on the evidence regarding energy expenditure, nutrient intake and their relationship after SCI. We compare these data with several established nutritional guidelines from American Heart Association, Australian Dietary Guidelines, Dietary Guidelines for Americans, Institute of Medicine Dietary Reference Intake, Public Health England Government Dietary Recommendations, WHO Healthy Diet and the Paralyzed Veterans of America (PVA) Clinical Practice Guidelines. We also provide practical assessment and nutritional recommendations to facilitate a healthy dietary pattern after SCI. Because of a lack of strong SCI research, there are currently limited dietary recommendations outside of the PVA guidelines that capture the unique nutrient needs after SCI. Future multicentre clinical trials are needed to develop comprehensive, evidence-based dietary reference values specific for persons with SCI across the care continuum that rely on accurate, individual assessment of energy need.
Are Populists Sore Losers? Explaining Populist Citizens' Preferences for and Reactions to Referendums
Authors: Werner Hannah , Jacobs Kristof 
Published: September 2021

AbstractCan referendums help increase perceived legitimacy among citizens with populist attitudes? Indeed, public opinion surveys show that populist citizens are especially in favour of referendums. However, we do not know whether this support reflects a principled desire for different decision-making procedures or an instrumental one (that is, because they expect referendums to yield favourable outcomes). We study this question on a real-life case: the Dutch 2018 referendum on the Intelligence and Security Services Act 2017. Using high-quality survey data from both before and after the referendum, we find that, counter to conventional wisdom and our hypotheses, populists' support for referendums is less driven by instrumental motives compared to that of non-populists, and that populists are more likely than non-populists to accept the outcome of a referendum, even when this outcome is unfavourable.
Impaired self-awareness of cognitive deficits in Parkinson's disease relates to cingulate cortex dysfunction
Authors: Maier Franziska , Greuel Andrea , Hoock Marius , Kaur Rajbir , Tahmasian Masoud , Schwartz Frank , Csoti Ilona , Jessen Frank , Drzezga Alexander , van Eimeren Thilo , Timmermann Lars , Eggers Carsten 
Published: September 2021

AbstractBackgroundImpaired self-awareness of cognitive deficits (ISAcog) has rarely been investigated in Parkinson's disease (PD). ISAcog is associated with poorer long-term outcome in other diseases. This study examines ISAcog in PD with and without mild cognitive impairment (PD-MCI), compared to healthy controls, and its clinical-behavioral and neuroimaging correlates.MethodsWe examined 63 PD patients and 30 age- and education-matched healthy controls. Cognitive state was examined following the Movement Disorder Society Level II criteria. ISAcog was determined by subtracting z-scores (based on controls' scores) of objective tests and subjective questionnaires. Neural correlates were assessed by structural magnetic resonance imaging (MRI) and 2-[fluorine-18]fluoro-2-deoxy-d-glucose-positron emission tomography (FDG-PET) in 47 patients (43 with MRI) and 11 controls. We analyzed whole-brain glucose metabolism and cortical thickness in regions where FDG-uptake correlated with ISAcog.ResultsPD-MCI patients (N = 23) showed significantly more ISAcog than controls and patients without MCI (N = 40). When all patients who underwent FDG-PET were examined, metabolism in the bilateral superior medial frontal gyrus, anterior and midcingulate cortex negatively correlated with ISAcog (FWE-corrected p < 0.001). In PD-MCI, ISAcog was related to decreased metabolism in the right superior temporal lobe and insula (N = 13; FWE-corrected p = 0.023) as well as the midcingulate cortex (FWE-corrected p = 0.002). Cortical thickness was not associated with ISAcog in these regions. No significant correlations were found between ISAcog and glucose metabolism in controls and patients without MCI.ConclusionsSimilar to Alzheimer's disease, the cingulate cortex seems to be relevant in ISAcog in PD. In PD-MCI patients, ISAcog might result from a disrupted network that regulates awareness of cognition and error processes.
Independent contribution of polygenic risk for schizophrenia and cannabis use in predicting psychotic-like experiences in young adulthood: testing gene × environment moderation and mediation
Authors: Elkrief Laurent , Lin Bochao , Marchi Mattia , Afzali Mohammad H , Banaschewski Tobias , Bokde Arun L. W. , Quinlan Erin Burke , Desrivières Sylvane , Flor Herta , Garavan Hugh , Gowland Penny , Heinz Andreas , Ittermann Bernd , Martinot Jean-Luc , Martinot Marie-Laure Paillère , Nees Frauke , Orfanos Dimitri Papadopoulos , Paus Tomáš , Poustka Luise , Hohmann Sarah , Fröhner Juliane H. , Smolka Michael N. , Walter Henrik , Whelan Robert , Schumann Gunter , Luykx Jurjen , Boks Marco P. , Conrod Patricia J. ,   the IMAGEN consortium
Published: September 2021

AbstractBackgroundIt has not yet been determined if the commonly reported cannabis–psychosis association is limited to individuals with pre-existing genetic risk for psychotic disorders.MethodsWe examined whether the relationship between polygenic risk score for schizophrenia (PRS-Sz) and psychotic-like experiences (PLEs), as measured by the Community Assessment of Psychic Experiences-42 (CAPE-42) questionnaire, is mediated or moderated by lifetime cannabis use at 16 years of age in 1740 of the individuals of the European IMAGEN cohort. Secondary analysis examined the relationships between lifetime cannabis use, PRS-Sz and the various sub-scales of the CAPE-42. Sensitivity analyses including covariates, including a PRS for cannabis use, were conducted and results were replicated using data from 1223 individuals in the Dutch Utrecht cannabis cohort.ResultsPRS-Sz significantly predicted cannabis use (p = 0.027) and PLE (p = 0.004) in the IMAGEN cohort. In the full model, considering PRS-Sz and covariates, cannabis use was also significantly associated with PLE in IMAGEN (p = 0.007). Results remained consistent in the Utrecht cohort and through sensitivity analyses. Nevertheless, there was no evidence of a mediation or moderation effects.ConclusionsThese results suggest that cannabis use remains a risk factor for PLEs, over and above genetic vulnerability for schizophrenia. This research does not support the notion that the cannabis–psychosis link is limited to individuals who are genetically predisposed to psychosis and suggests a need for research focusing on cannabis-related processes in psychosis that cannot be explained by genetic vulnerability.