bluuebunny/crossref_metadata_2025_split huggingface dataset:
CheckMate 436: A phase 1-2 study to evaluate safety and efficacy of nivolumab plus brentuximab vedotin in patients with CD30-expressing relapsed/refractory non-Hodgkin lymphomas.
Authors: Barr Paul M. , Carson Kenneth Robert , Brody Joshua , Shustov Andrei R. , Moskowitz Alison J. , Kline Justin Paul , Savage Kerry J. , Kuruvilla John , Campbell Mary S. , Zinzani Pier Luigi , Salles Gilles A. , Masood Aisha , Ansell Stephen Maxted 
Published: September 2018

TPS7577 Background: Nivolumab (nivo) is a PD-1 immune checkpoint inhibitor that augments T-cell activation and host anti-tumor responses. PD-1 blockade has shown promise in B- and T-cell non-Hodgkin lymphoma (NHL),1 but many patients (pts) with NHL do not respond or progress after response. Combination therapy using anti-tumor agents with complementary mechanisms of action and low immunosuppressive impact may result in more frequent and durable responses. Brentuximab vedotin (BV) is an anti-CD30 antibodydrug conjugate that induces cell cycle arrest and apoptosis, with activity in a range of NHL tumors.2,3 Tumor cells undergoing BV-induced apoptosis have shown subsequent immune-mediated anti-tumor cytotoxicity.4 Therefore, nivo and BV may synergize if combined for relapsed/refractory (RR) NHL. Methods: CheckMate 436 (NCT02581631) is a phase 12, open-label, international, single-arm study evaluating nivo + BV for CD30-expressing RR NHL (study start: Dec 2015) in pts with RR diffuse large B-cell lymphoma, peripheral T-cell lymphoma (excluding anaplastic large cell lymphoma), and cutaneous T-cell lymphoma (mycosis fungoides/Sézary syndrome); cohorts with primary mediastinal B-cell lymphoma (PMBL) and mediastinal gray zone lymphoma were made eligible in Sept 2016. Pts with PMBL must be aged ≥15 y (≥18 y for other histologies). All pts must have CD30-expressing disease, defined by CD30 on ≥1% of tumor cells or tumor-infiltrating lymphocytes by immunohistochemistry. In the phase 1 component, 6 pts will receive nivo and BV until disease progression or unacceptable toxicity. In the phase 2 component, ~130 more pts across the 5 histologies will be enrolled and treated at the recommended dose. Primary endpoints: safety, tolerability, and investigator-assessed objective response rate; secondary endpoints: duration of response and complete response (CR), CR rate, and progression-free and overall survival. Accrual is ongoing. References: 1. Lesokhin A et al. JCO 2016;34:2698704 2. Jacobsen E et al. Blood 2015;125:1394402 3. Horwitz S et al. Blood 2014;123:3095100 4. Gardai S et al. Cancer Res 2015;75(15 Suppl):2469 [abstract]. Clinical trial information: NCT02581631.
Early rebiopsy to identify mechanisms and biomarkers of tumor cell survival following epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy.
Authors: McCoach Caroline Elizabeth , Merrick Dan , Aisner Dara L. , Bunn Paul A. , Camidge D. Ross , Gao Dexiang , Kondo Kimi , Doebele Robert Charles 
Published: September 2018

TPS9100 Background: Significant advances in the clinical outcomes of lung cancer patients have been achieved in part due to the identification of targetable driver mutations. The success of targeting oncogenic drivers with TKIs has allowed for improvements in response rates, progression free survival and overall survival. Despite these improvements, patients ultimately relapse. Acquired resistance has been evaluated in post-progression tumor samples and is caused by a variety of mechanisms including secondary resistance mutations, gene copy number gains, gene amplification, or bypass pathway activation. Residual tumor burden with surviving cancer cells are the origin of the ultimate tumor progression. Studies analyzing signaling pathways and other markers of these tumor cells or microenvironmental cells in tumor samples before clinical resistance develops are needed to determine how best to target this compartment. Methods: Eligible patients will have a new diagnosis of advanced NSCLC with an EGFR TKI sensitizing mutation. Additional inclusion criteria include ECOG 0-2, a tumor measurable by RECIST 1.1 and at least 2cm in one dimension, and tumor site that is accessible and safe to biopsy. Patients will undergo a pretreatment target lesion biopsy, begin treatment with an EGFR TKI then receive a second biopsy of the same target lesion after two weeks of therapy. Our primary objective is to identify differences between pretreatment and early treatment tumor samples. To do this we will be using a combination of RNA seq, multiplex protein expression analysis and proximity ligation assays. Secondary objectives include identification of predictive markers that can be used to determine which tumors will undergo epithelial to mesenchymal transition or activate other survival pathways and determination of the success rate and adverse event rate of repeat biopsy. Patients are currently being enrolled at a single academic institution however, additional clinical site openings are pending. Our goal enrollment for this study is 47 patients to achieve 20 paired biopsy samples. We will present updated enrollment and demographic information. Clinical trial information: NCT03042221.
An open-label, uncontrolled, single arm phase II trial of the PI3K inhibitor buparlisib in patients with melanoma brain metastases.
Authors: Meier Friedegund Elke , Forschner Andrea , Garzarolli Marlene , Rauschenberg Ricarda , Beissert Stefan , Garbe Claus , Eigentler Thomas K. 
Published: September 2018

TPS9595 Background: The approval of effective BRAF +/- MEK inhibitors and immune checkpoint inhibitors has revolutionized the treatment of metastatic melanoma. However, available therapies appear to be less effective on cerebral than extracerebral metastases. Hyperactivation of the PI3K-AKT survival pathway is a prominent feature of melanoma brain metastases (MBM). This trial aims to determine the activity and safety of the PI3K inhibitor buparlisib in patients (pts) with MBM. Methods: The study enrolls adults suffering from MBM not eligible for neurosurgery or/and radiosurgery. Patients must have failed prior treatment with BRAF +/- MEK Inhibitors (BRAF-V600E mutated population) and anti-PD-1 or/and anti-CTLA-4 antibodies (BRAF wild-type population), respectively. Patients are treated with buparlisib 100 mg PO daily until disease progression or unacceptable toxicity. The Simon-Two-Step design for phase 2 studies was used to determine sample size. Assuming a response rate of 12.5% in comparison to historical 10% for chemotherapy 22 (8/14) pts would be required. If there are one or fewer responses in the first 8 pts the study would stop. Prespecified activity goal for the first stage of accrual was met; currently 11/22 pts are enrolled. Clinical trial information: NCT02452294.
PENGARUH IMPLEMENTASI PRINSIP-PRINSIP GOOD CORPORATE GOVERNANCE TERHADAP KINERJA MANAJERIAL PADA BANK PEMBANGUNAN DAERAH (BPD) DAERAH ISTIMEWA YOGYAKARTA
Authors: Hidayah Nur , Ariesanti Alia 
Published: September 2018

Implementation of good corporate governance in banks is expected to eliminate mismanagement, forming a system of checks and balances that guarantee effective and all-powerful corporation in line with improving corporate performance through the creation process of making better decisions, improve operational efficiency and further improve services to stakeholders. The study was conducted to provide empirical evidence of the influence of the implementation of good corporate governance on managerial performance in Yogyakarta BPD Bank. Research object is the middle and lower level managers in the Regional Development Bank (BPD) Special Region of Yogyakarta. The data used are the primary data from respondents' answers, the manager at the Bank BPD DIY. This study uses multiple linear regression analysis. The results showed that: (1) Transparency affect managerial performance. (2) Accountability affect managerial performance. (3) Responsibility affect managerial performance. (4) independency affect managerial performance. (5) Fairness does not affect managerial performance
KINERJA KEUANGAN PADA KOPERASI PENERIMA DANA BERGULIR MODAL KERJA DI DAERAH ISTIMEWA YOGYAKARTA Studi Kasus pada Koperasi Serba Usaha (KSU) BMT An Ni’mah Kotagede
Authors: Mubiroh Siti , Winarso Beni Suhendra 
Published: September 2018

Empowerment of cooperatives is part of poverty reduction through the expansion of employment opportunities and the increase of society incomes. In the framework of economic empowerment and cooperatives income increasing in DIY, the provincial government provide Dana Bergulir Modal Kerja to increase the production capacity of the cooperative.The objective of this research is to analyze the financial performance of cooperatives before and after receiving Dana Bergulir Modal Kerja. The main data that was collected is secondary data. The financial data was analyzed using quantitave analysis using financial ratio analysis and different t-test (paired sample t test) .Result of analysis showed that there are some increases in debt to total asset ratio and there is no increase in current ratio, cash ratio, net profit margin ratio, return on asset ratio and return on equity ratio in KSU BMT An Ni’mah Kotagede after receiving Dana Bergulir Modal Kerja.
How do modern parents deal with cultural beliefs about breastfeeding? A qualitative study
Authors: Anggraeni Mekar Dwi , Aji Budi , Setiyani Rahmi , Kartikasari Aprilia , Rahmawati Eni 
Published: September 2018

Background Cultural beliefs strongly affect the practice of breastfeeding. Interpretations of cultural beliefs change over time, particularly among modern parents; however, knowledge of these changes is limited. Aim To explore cultural beliefs related to breastfeeding and modern Indonesian parents' perceptions. Methods This article reports on the cultural beliefs about breastfeeding from an ethnographic study of 23 participants. Data were collected using focus group discussions, in-depth interviews and observations, and analysed using thematic analysis. Findings Analysis revealed four main themes: ‘suggested food and behaviour’; ‘restricted food and behaviour’; ‘consequences of avoiding taboos’ and ‘the dynamic change in cultural beliefs’. Conclusions Healthcare providers can use the results of this study to develop a culturally sensitive educational programmes that are congruent with modern parents' needs.
Early and Accurate Sex Determination by qPCR of Y Chromosome Repetitive Sequence (YRS) In Cell-Free Fetal DNA from Maternal Plasma
Authors: Jacobsen Ditte , Krog Grethe Risum , Clausen Frederik Banch 
Published: September 2018

Abstract

Background
Circulating cell-free fetal DNA (cffDNA) provides the opportunity for noninvasive prenatal diagnosis. Early knowledge of the fetal sex is essential in cases with a risk of a sex-linked genetic disease. A reliable and highly sensitive sex determination test is required for first trimester testing because of the low amounts of cffDNA.

Methods
First trimester blood samples from 326 pregnant women were analyzed by real-time quantitative polymerase chain reaction (qPCR) for the presence of Y chromosome repetitive sequence (YRS). Blood samples were collected from gestational weeks 4–12. Fetal sex was predicted on the basis of results from the YRS assay of cffDNA extracted from maternal plasma. The predicted sex was compared with the phenotypic sex of the newborn baby (n = 294).

Results
There was high concordance between the test results from the YRS assay and the actual sex at birth. There were no false-positive results, indicating agreement between male YRS results and male sex at birth. Two results were false negative (from gestational weeks 4 and 6) predicting female fetuses, when the actual sex at birth was male. Overall, the sensitivity of the YRS assay was 98.6% (95% CI, 95.1%–99.8%), specificity was 100% (95% CI, 97.5%–100%), and accuracy was 99.3% (95% CI, 97.5%–99.9%). From 7 weeks of gestation, sensitivity, specificity, and accuracy were 100%.

Conclusions
This study shows that qPCR can be used to detect and quantify repetitive DNA sequences from 0.3 genome equivalents per milliliter of plasma. Prenatal sex determination by qPCR of YRS in cffDNA from maternal plasma was reliable and robust with cffDNA extracted from 1 mL of nonhemolyzed plasma, with a plasma equivalent per PCR of 167 μL. The YRS assay can be used for early noninvasive prenatal sex determination from a gestational age of 7 weeks.
Characterization of an acidophilic α-amylase from Aspergillus niger RBP7 and study of catalytic potential in response to nutritionally important heterogeneous compound
Authors: Mukherjee Riddha , Paul Tanmay , Halder Suman Kumar , Soren Jyoti Prakash , Banerjee Amrita , Mondal Keshab Chandra , Pati Bikash Ranjan , Mohapatra Pradeep Kumar Das 
Published: September 2018

An acidophilic α-amylase from Aspergillus niger RBP7 was purified after solid state fermentation on potato peel substrate. Molecular mass of the purified α-amylase was 37.5 kDa and it exhibited 1.4 mg/ml and 0.992 μ/mol/min Km and Vmax values, respectively. The enzyme was stable in the pH range from 2.0 to 6.0, at high NaCl concentration (3 M) and at temperatures between 40 °C and 70 °C. The enzyme showed an optimal activity at pH 3.0 and at 45 °C. The enzyme was inhibited by Hg2+ and was stable in the presence of different surfactants (Tween 60, Tween 80, and SDS at 1% level) and different inhibitory reagents (β-mercaptoethanol, phenylmethylsulfonyl fluoride, and sodium azide). This acidophilic amylase enzyme can digest heterogeneous food materials, i.e. the mixture of rice, fish, bread and curry with comparable activity to the commercial diastase enzymes available.
Analysis of Innovation Activity of Enterprises in Modern Business Environment
Authors: AKHMETSHIN Elvir , DANCHIKOV Evgeniy , POLYANSKAYA Tatyana , PLASKOVA Nataliya , PRODANOVA Natalia , ZHILTSOV Sergey 
Published: September 2018

The article discusses the question of the possibility of the business community to implement mechanisms for the development of its structure. The authors show that in the process of historical transformation are implemented opportunities for market entry and process of improvement activities. The authors show that every company can produce a range of innovative products and its innovative principles transform of striving for improvement in the need to innovate. The subject of research is itself innovative activity of the organization, and the possibility of its integration in market conditions.
The novelty of this study is the assumption that the innovation activity of the enterprise does not depend on the amount of goods produced and the number of shipped innovative products. The main indicator is the amount of revenue from goods that are produced on the basis of a new technological cycle. In the course of the work are analyzed the statistics and formed the algorithmization of actions to increase the share of innovative products
The authors show and this is the basis for further research that the advancement and increase of the share of innovative products determines the possibility of development of a qualitatively new setting and identifies opportunities for technological and, consequently, the social capital of a certain territory.
Averroes and the essential reinterpretation of Aristotle’s metaphysics
Authors: Kokoć Damian 
Published: September 2018

Question of relation between an essence and an existence was one of major medieval philosophical problems. The first ones who started considerate this issue were Muslim thinkers, especially Avicenna and Averroes. The latter of them was one of the main figure in this debate. Étienne Gilson claims that on ground of Averroes’ thought Aristotle struggles with problem of existence. Averroes claimed that this two components differ only in logical manner. In reality an essence and an existence are identical and an existence is something which flows from essence of being. That is why Averroes did not agree with Avicenna that existence is only a accident of essence, because such claim is contradictory with Aristotle’s theory of being. According to this Greek thinker, all accidents can be described by one of the categories (except a category of substance which is the subject on which other categories are predicated) and an existence is not one of them. For Averroes, Avicenna‘s conception is example of contamination of Aristotle’s thought by theological components. That is why he tried to purify interpretations of Aristotle’s philosophy from this ideas, foreign to his thought. According to Averroes problem of relation between an essence and an existence is wrongly formulated because when we want explain why the being is, we must only point on it cause and we don’t need to search answer about an existence of being.
Law and values in the theory of law of Józef Nowacki
Authors: Tkacz Sławomir 
Published: September 2018

The contents of the paper present the basic assumptions of Józef Nowacki’s theory of law. The author was a proponent of Hans Kelsen’s theory. The characteristic of Józef Nowacki’s views was the conviction that the foundations of the study of the aw should be their „purity”. It is understood by him as freedom from any ideological assumption. This approach is consistently presented in his works dealing with issues of a specific nature. In the course of deliberations, the problem of the concept of law was discussed, as understood by Józef Nowacki. His works on the issues of the rule of law were also analyzed. Moreover, they presented his critical attention devoted to the jurisdiction of the Polish Constitutional Court. The conclusions highlight the validity of the author’s view that the consideration of the law should be free of any ideological assumptions
Using computerized virtual cases to explore diagnostic error in practicing physicians
Authors: Trowbridge Robert L. , Reilly James B. , Clauser Jerome C. , Durning Steven J. 
Published: September 2018

Abstract

Background
Diagnostic errors are a significant cause of patient harm. Cognitive processes often contribute to diagnostic errors but studying and mitigating the effects of these errors is challenging. Computerized virtual patients may provide insight into the diagnostic process without the potential for patient harm, but the feasibility and utility of using such cases in practicing physicians has not been well described.

Methods
We developed a series of computerized virtual cases depicting common presentations of disease that included contextual factors that could result in diagnostic error. Cases were piloted by practicing physicians in two phases and participant impressions of the case platform and cases were recorded, as was outcome data on physician performance.

Results
Participants noted significant challenges in using the case platform. Participants specifically struggled with becoming familiar with the platform and adjusting to the non-adaptive and constraining processes of the model. Although participants found the cases to be typical presentations of problems commonly encountered in practice, the correct diagnosis was identified in less than 33% of cases.

Conclusions
The development of virtual patient cases for use by practicing physicians requires substantial resources and platforms that account for the non-linear and adaptive nature of reasoning in experienced clinicians. Platforms that are without such characteristics may negatively affect diagnostic performance. The novelty of such platforms may also have the potential to increase cognitive load. Nonetheless, virtual cases may have the potential to be a safe and robust means of studying clinical reasoning performance.
Liability for Means of Mass Transportation in Scandinavia
Authors: Askeland Bjarte 
Published: September 2018

Abstract
The article presents an overview of Norwegian law with regard to damages caused by means of mass transportation by buses, railways and airplanes. The author explains why and how in Norway, as elsewhere in Scandinavia, there is strict liability for damages caused by means of mass transportation. Also the assessment of damages in the mentioned categories is discussed. For personal injuries there are no caps for trains or buses, partly because a greater part of the loss of income is covered by social security benefits, something which is typical of the ‘Nordic model’. Along the same lines, the rules on contributory negligence favour the victim somewhat more than in other parts of Europe, with regard to accidents caused by both buses and trains. Hence the law is all in all rather friendly to the victim. As for damage caused by air traffic, there are tensions between the ‘victim-friendly’ attitude and the relevant EU regulations which make the Montreal Convention applicable to Scandinavian law. These tensions are discussed towards the end of the article. Thus the article highlights and illustrates how the Scandinavian legal culture with the ‘Nordic Model’ as its special hallmark endorses solutions that somewhat contradict the common solutions in continental Europe and in the UK.
It Is Impossible That There Could Have Been Nothing: New Support for Cosmological Arguments for the Existence of God
Authors: Ottesen Søvik Atle 
Published: September 2018

Summary
Cosmological arguments for the existence of God defend God as a necessary being against (among others) the alternative that the universe came from nothing. “Nothing” is an ambiguous term, but when clarified it can be argued that a strong sense of the term is self-contradictory and thus impossible. This article discusses the arguments Lorenz B. Puntel has put forth in favour of this conclusion. The arguments herein rely on Puntel’s understanding of theoretical frameworks in explanations, which is also discussed. This article finds that there are good arguments against the possibility of nothing in a strong sense of the term, ending by considering this argument’s relevance to cosmological arguments for the existence of God.
A meta-analysis on residential exposure to magnetic fields and the risk of amyotrophic lateral sclerosis
Authors: Röösli Martin , Jalilian Hamed 
Published: September 2018

Abstract
Amyotrophic lateral sclerosis (ALS) is caused by the gradual degeneration and death of motor neurons, with mostly unknown etiology. Some risk factors have been suggested for this disease including extremely low frequency magnetic fields (ELF-MF) exposure. This meta-analysis assesses the association of residential exposure to ELF-MF with the risk of ALS. Five studies have addressed the risk of ALS in relation to overhead power lines. A pooled relative risk (RR) of 0.71 [95% confidence interval (CI): 0.48, 1.07] for the most exposed population group (either <200 m distance from high voltage power lines or >0.1 μT) was found. Little heterogeneity (I2=0.00%, p=0.67) and indication for publication bias (PBegg’s test=0.22; PEgger’s test=0.19) was seen. Overall, we found no evidence for an association between residential exposure to ELF-MF and the risk of ALS, although the number of exposed cases is low.
Three-component condensation reaction of various aldehydes, dimedone and malononitrile catalyzed by boric acid in water in comparison with multifunctional ionic liquids as green catalytic systems
Authors: Khazaei Ardeshir , Nik Heidar Ali Alavi , Moosavi-Zare Ahmad Reza , Afshar-Hezarkhani Hadis 
Published: September 2018

Abstract
Triethanol ammonium acetate ([TEAH]+[OAc]−) and triethanol ammonium formate ([TEAH]+[HCOO]−) as multifunctional ionic liquids and catalysts were successfully applied for the preparation of tetrahydrobenzo[b]pyrans by the one-pot three-component condensation reaction of various aldehydes, dimedone and malononitrile under solvent-free conditions. These reactions were also tested using boric acid in water. In this catalytic system, by the reaction of water with boric acid, the hydronium ion caused by water separation can catalyze the reaction.