bluuebunny/crossref_metadata_2025_split huggingface dataset:
A double-blind, placebo-controlled randomized phase II study: Evaluating the effect of curcumin for treatment of cancer anorexia-cachexia syndrome in solid cancer patients.
Authors: Prasongsook Naiyarat , Sitalarom Kasarn , Saichaemchan Siriwimon , Peechatanan Khunthong , Chaiworramukkul Aornchuma 
Published: May 2019

e23151 Background: Cancer anorexia–cachexia syndrome (CACS) is common among patients with advanced solid cancer and associated with poor prognosis. CACS is a hypercatabolic state, which comprises adipose tissue and skeletal muscle loss, which is characterized by negative protein and energy balance, loss of lean body mass and adipose tissue. Also, CACS increase systemic inflammation. The treatment of CACS is still unclear. Curcumin has been shown anti-cancer and anti-inflammatory effects, including attenuation of CACS in animal models. Therefore, clinical study of curcumin for CACS is required. Methods: This is randomized, double-blind, placebo-controlled phase ll study, 52 patients with CACS in solid malignancy were enrolled and randomized in 1:1 to receive oral curcumin (at a dose of 400 mg twice daily) or placebo for 8 weeks. The primary end point was body tissue composition and the secondary end points were body weight and body mass index, Hand grip muscle strengthening, safety and toxicity. Results: All parameters of body compositions were not statistically significant different between two groups: curcumin group and placebo group, which were consist body fat mass -0.9, SEM = 0.94 versus –1.65, SEM = 1 ( p-value = 0.58), skeletal muscle mass -0.17, SEM = 0.49 versus +0.4, SEM = 0.52 ( p-value = 0.42) and percent body fat –1.0, SEM = 0.65 versus -0.1, SEM = 0.68 ( p-value = 0.3) including with basal metabolic rate -5.3, SEM = 18 versus +18.3, SEM = 19 ( p-value = 0.37). The average of weight loss was also not statistically significant different between two groups, -1.04, SEM = 0.63 in curcumin group versus –1.15, SEM = 0.61 in placebo group, ( p-value = 0.9). Notably, patient with curcumin had less reduction of hand-grip muscle strength on both hands [right hand: -2.09 in curcumin versus -3.68 in placebo; p = 0.46], [left hand: -1.24 versus -5.04; p-value = 0.12], and basal metabolic rate than placebo group. Most adverse events were grade 1 on both groups similarly. Conclusions: Curcumin was not shown to be superior to placebo with regard to increasing the body composition in cancer patients with CACS. However, curcumin might show some clinical benefits, including slow progression of hand-grip muscle strength loss and basal metabolic rate. Further investigations should be explored.
Non-invasive assessment of chemotherapy-induced peripheral neuropathy using neuromuscular ultrasound in breast cancer patients.
Authors: Lycan Thomas , Thomas Alexandra , Hsu Fang-Chi , Cartwright Michael Stephen , Walker Francis O , Ahn Christine , Sangueza Omar P , Shiozawa Yusuke , Park Sun Hee , Peters Christopher Michael , Romero-Sandoval Edgar Alfonso , Melin Susan Anitra , Sorscher Steven , Ansley Katherine Cox , Lesser Glenn Jay , Strowd Roy E. 
Published: May 2019

e23152 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a dose-limiting toxicity for breast cancer patients that leads to early treatment discontinuation and worse outcomes. Neuromuscular ultrasound (NMUS) is a non-invasive assessment of peripheral nerves that has not been studied in taxane CIPN. Methods: This cross-sectional study enrolled breast cancer patients with subjective complaints of CIPN symptoms during or after taxane chemotherapy and compared nerve cross-sectional area (CSA) by NMUS with historical values in 120 healthy adults. Findings were correlated with self-reported symptom scale (EORTC-QLQ CIPN20, range 0-72, higher more severe); nerve conduction studies; and skin biopsies for intraepidermal nerve fiber density (IENF). Results: We evaluated 20 participants (mean 55.4 ± 10.5 yrs) with NMUS at 74 nerve sites after median 3.7 months (IQR 1.0-6.1) since last taxane (paclitaxel 10, docetaxel 8, nab-paclitaxel 2). Participants reported moderate-to-severe CIPN symptoms which were predominantly sensory (19.1 ±4.9, max 32) as opposed to motor (15.6 ±5.8, max 32) or autonomic (3.3 ±1.6, max 8). Sural sensory nerve CSA was 1.2 mm2 smaller than in historical controls (4.1 vs. 5.3 mm2, 2-sample t-test p = 0.005) and decreased with more days from last taxane (Spearman’s r -0.46, p = 0.04). Tibial motor nerve was not significantly different from controls (p = 0.35). Median nerve CSA was enlarged at the distal wrist crease entrapment site (12.5 vs 10.1, p = 0.03). Older age was associated with smaller sural CSA (r = -0.72, p < 0.001). When controlling for age and days from last taxane, for each 1mm2 decrease in sural CSA, distal IENF reduced by 2.1 nerve/mm2 (p = 0.04, R2 = 0.30). Conclusions: NMUS showed expected sensory predominant distal axonopathy in taxane CIPN. Evaluation of nerve CSA by non-invasive NMUS may serve as an objective point-of-care assessment to risk-stratify women with taxane CIPN prior to the development of debilitating symptoms. Clinical trial information: NCT03139435. [Table: see text]
Direct oral factor Xa inhibitors for the treatment of acute cancer-associated venous thromboembolism: A systematic review and network meta-analysis.
Authors: Fuentes Harry E , McBane Robert , Wysokinski Waldemar , Tafur Alfonso Javier , Loprinzi Charles L. , Murad M. Hassan , Riaz Irbaz Bin 
Published: May 2019

e23156 Background: A direct meta-analysis was performed to explore the efficacy and safety of direct oral factor Xa inhibitors with dalteparin in patients with cancer associated acute venous thromboembolism (VTE). Also, the comparative efficacy and safety of apixaban, rivaroxaban, and edoxaban was assessed with a network meta-analysis. Methods: MEDLINE, CENTRAL, and EMBASE were searched for trials comparing direct oral anticoagulants (DOACs) to dalteparin for the management of cancer associated acute VTE. A network meta-analysis using both frequentist and Bayesian methods was performed to analyze VTE recurrence, major and clinically relevant non-major bleeding (CRNMB). Results: Three randomized control trials, at low risk of bias, enrolled 1,739 patients with cancer associated VTE. Direct comparison showed a lower rate of VTE recurrence in DOAC compared to dalteparin groups (odds Ratio [OR]:0.48, 95% Confidence interval [CI]:0.24-0.96; I2:46%). Indirect comparison suggested that apixaban had greater reduction in VTE recurrence compared to dalteparin (OR: 0.10; 95% CI: 0.01–0.82), but not rivaroxaban or edoxaban. Apixaban also had the highest probability of being ranked most effective. By direct comparisons, there was an increased likelihood of major bleeding in the DOAC group compared to dalteparin (OR: 1.70; 95% CI: 1.04–2.78). CRNMB did not differ. Indirect estimates were imprecise. Subgroup analyses in gastrointestinal cancers suggested that dalteparin may have the lowest risk of bleeding whereas estimates in urothelial cancer were imprecise. Conclusions: DOACs appear to lower the risk of VTE recurrence compared to daltaparin while increasing major bleeding. Apixaban may be associated with the lowest risk of VTE recurrence compared to the other DOACs.
Phase 2 study of brigatinib in patients (pts) with anaplastic lymphoma kinase (ALK)−positive, advanced non–small cell lung cancer (NSCLC) that progressed on alectinib or ceritinib.
Authors: Kim Edward S. , Ou Sai-Hong Ignatius , Barlesi Fabrice , Mok Tony S. K. , Ahn Myung-Ju , Bunn Veronica , Zhang Pingkuan 
Published: May 2019

TPS9115 Background: Second-generation ALK tyrosine kinase inhibitors (TKIs) alectinib and ceritinib have demonstrated efficacy and acceptable safety in ALK TKI-pretreated and TKI-naive NSCLC. However, as with crizotinib, resistance to alectinib and ceritinib eventually develops, with secondary resistance mutations detected in approximately 50% of pts. Brigatinib is a next-generation ALK TKI designed to have potent and broad activity against ALK mutants. Post-crizotinib, brigatinib demonstrated high systemic and CNS objective response rates (ORR) and the longest reported median progression-free survival (PFS) of any ALK inhibitor in this setting (16.3–16.7 mo) (Huber. J Clin Oncol 2018;36; Bazhenova. Ann Oncol 2017;28); efficacy was demonstrated regardless of mutations. Based on nonclinical and clinical data, brigatinib may show efficacy in ALK+ NSCLC that has developed resistance or failed to respond to alectinib/ceritinib. This trial was designed to assess efficacy and safety of brigatinib in pts with ALK+ NSCLC that has progressed on alectinib or ceritinib. Methods: This is a phase 2, open-label, single-arm, multicenter, international trial (NCT03535740) in pts (≥18 y) with locally advanced/metastatic NSCLC and disease progression on alectinib or ceritinib (± prior crizotinib; ≤3 different systemic regimens for locally advanced/metastatic disease). Pts receive oral brigatinib 180 mg QD with 7-day lead-in at 90 mg QD. Treatment beyond progression or escalation to brigatinib 240 mg QD is permitted. Primary endpoint: independent review committee (IRC)−assessed confirmed ORR (cORR) per RECIST v1.1. Secondary endpoints: investigator (INV)-assessed cORR, duration of response (INV- and IRC-assessed), PFS, disease control rate, and time to response; in pts with baseline brain metastases: IRC-assessed intracranial cORR, duration of intracranial response, and intracranial PFS; OS; safety/tolerability; and HRQoL. Exploratory endpoints include biomarker analyses. The study was initiated in Dec 2018 at 78 sites (North America, Europe, Asia), with a planned sample size of 103 pts. Accrual is ongoing. Clinical trial information: NCT03535740.
A multicenter, open label, randomized phase II study of osimertinib plus ramucirumab versus osimertinib alone as initial chemotherapy for EGFR mutation-positive non-squamous non-small cell lung cancer: TORG1833.
Authors: Nakahara Yoshiro , Kato Terufumi , Isomura Reiko , Seki Nobuhiko , Furuya Naoki , Naoki Katsuhiko , Yamanaka Takeharu , Okamoto Hiroaki 
Published: May 2019

TPS9120 Background: Vascular endothelial growth factor (VEGF) and epidermal growth factor receptor (EGFR) pathways are shown to be interrelated in several preclinical studies. Furthermore, recent clinical studies have shown the adding effect of an anti VEGF monoclonal antibody with an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) for the non-small-cell lung cancer (NSCLC) patients with EGFR mutation. Thus, osimertinib plus ramucirumab would be the promising candidate for the new standard treatment in EGFR mutation positive NSCLC. Methods: This study is an investigator initiated trial. Previously untreated EGFR mutation positive advanced non squamous NSCLC patients aged 20 years or older with a performance status of 0 or 1 are randomized at a 1:1 ratio to receive osimertinib (80mg) every day either without or with ramucirumab (10mg/kg) every 2 weeks until evidence of disease progression or development of unacceptable toxicity. The primary endpoint of the study is progression free survival (PFS) assessed by the central image reviewer. Secondly endpoints include PFS (assessed by an attending physician), objective response rate (ORR), disease control rate (DCR), duration of response (DOR), overall survival (OS), safety and toxicity profile. Stratification factors are gender and the type of EGFR mutation (exon 19 deletion, Leu858Arg point mutation in exon 21). We determined that, with a sample size of 120 patients (60 in each arm), the trial will have 80% power to show a hazard ratio for disease progression or death of 0.667 at a one-sided alpha level of 0.2 (as calculated on the basis of 80 such events) for comparison between the two arms with 1.5-year accrual and 2-year follow-up periods. Study enrollment began in November 2018 and is continued for 3.5 years among 20 sites of Thoracic Oncology Research Group (TORG). Seven patients were enrolled at time of submission. Clinical trial information: 184146.
Debt Heterogeneity and Covenants
Authors: Lou Yun , Otto Clemens A. 
Published: May 2019

Coordination failure among owners of heterogeneous debt types increases distress costs. Covenants reduce expected distress costs by lowering the probability of liquidity shortages, increasing liquidation values, and incentivizing creditor monitoring. We predict and find that new debt contracts include more covenants when borrowers’ existing debt structures are more heterogeneous. Our findings suggest that covenants are not only used to address creditor–shareholder conflicts but also to reduce the expected costs of coordination failure among creditors. Furthermore, our results indicate a dynamic component missing from static debt structure models: Debt heterogeneity entails additional covenants (i.e., constraints) when raising future debt. This paper was accepted by Lauren Cohen, finance.
Coordination Is Hard: Electronic Auction Mechanisms for Increased Efficiency in Transportation Logistics
Authors: Karaenke Paul , Bichler Martin , Minner Stefan 
Published: May 2019

The lack of coordination among carriers leads to substantial inefficiencies in logistics. Such coordination problems constitute fundamental problems in supply chain management for their computational and strategic complexity. We consider the problem of slot booking by independent carriers at several warehouses and investigate recent developments in the design of electronic market mechanisms promising to address both types of complexity. Relax-and-round mechanisms describe a class of approximation mechanisms that is truthful in expectation and runs in polynomial time. Whereas the solution quality of these mechanisms is low, we introduce a variant able to solve real-world problem sizes with high solution quality while still being incentive compatible. We compare these mechanisms to core-selecting auctions, which are not incentive compatible but provide stable outcomes with respect to the bids. In addition to a theoretical analysis we report results from extensive numerical experiments based on field data. The experimental results yield a clear ranking of the mechanisms in terms of waiting time reductions and computation times. This paper was accepted by Anandhi Bharadwaj, information systems.
How to prepare and manage a systematic review and meta-analysis of clinical studies
Authors: Berstock James R. , Whitehouse Michael R. 
Published: May 2019

Use the PICO framework to formulate a specific clinical question. Formulate a search strategy. Prospectively register the review protocol. Execute the literature search. Apply eligibility criteria to exclude irrelevant studies. Extract data and appraise each study for risk of bias and external validity. Provide a narrative review. If appropriate data are available, perform a meta-analysis. Report the review findings in the context of the risk of bias assessment, any sensitivity analyses and the analysis of risk of publication bias. Useful resources include the Cochrane Handbook, PROSPERO, GRADE and PRISMA. Cite this article: EFORT Open Rev 2019;4:213-220. DOI: 10.1302/2058-5241.4.180049
Dairy Intake and Body Composition and Cardiometabolic Traits among Adults: Mendelian Randomization Analysis of 182041 Individuals from 18 Studies
Authors:   Mendelian Randomization of Dairy Consumption Working Group,   the CHARGE consortium, Huang Tao , Sun Dianjianyi , Heianza Yoriko , Bergholdt Helle K M , Gao Meng , Fang Zhe , Ding Ming , Frazier-Wood Alexis C , North Kari E , Marouli Eirini , Graff Mariaelisa , Smith Caren E , Varbo Anette , Lemaitre Rozenn N , Corella Dolores , Wang Carol A , Tjønneland Anne , Overvad Kim , Sørensen Thorkild I A , Feitosa Mary F , Wojczynski Mary K , Kähönen Mika , Mikkilä Vera , Bartz Traci M , Psaty Bruce M , Siscovick David S , Danning Rebecca D , Dedoussis George , Pedersen Oluf , Hansen Torben , Havulinna Aki S , Männistö Satu , Rotter Jerome I , Sares-Jäske Laura , Allison Mathew A , Rich Stephen S , Sorlí Jose V , Coltell Oscar , Pennell Craig E , Eastwood Peter , Ridker Paul M , Viikari Jorma , Raitakari Olli , Lehtimäki Terho , Helminen Mika , Wang Yujie , Deloukas Panagiotis , Knekt Paul , Kanerva Noora , Kilpeläinen Tuomas O , Province Michael A , Mozaffarian Dariush , Chasman Daniel I , Nordestgaard Børge G , Ellervik Christina , Qi Lu 
Published: May 2019

Abstract

BACKGROUND
Associations between dairy intake and body composition and cardiometabolic traits have been inconsistently observed in epidemiological studies, and the causal relationship remains ill-defined.

METHODS
We performed Mendelian randomization analysis using an established genetic variant located upstream of the lactase gene (LCT-13910 C/T, rs4988235) associated with dairy intake as an instrumental variable (IV). The causal effects of dairy intake on body composition and cardiometabolic traits (lipids, glycemic traits, and inflammatory factors) were quantified by IV estimators among 182041 participants from 18 studies.

RESULTS
Each 1 serving/day higher dairy intake was associated with higher lean mass [β (SE) = 0.117 kg (0.035); P = 0.001], higher hemoglobin A1c [0.009% (0.002); P &lt; 0.001], lower LDL [−0.014 mmol/L (0.006); P = 0.013], total cholesterol (TC) [−0.012 mmol/L (0.005); P = 0.023], and non-HDL [−0.012 mmol/L (0.005); P = 0.028]. The LCT-13910 C/T CT + TT genotype was associated with 0.214 more dairy servings/day (SE = 0.047; P &lt; 0.001), 0.284 cm higher waist circumference (SE = 0.118; P = 0.017), 0.112 kg higher lean mass (SE = 0.027; P = 3.8 × 10−5), 0.032 mmol/L lower LDL (SE = 0.009; P = 0.001), and 0.032 mmol/L lower TC (SE = 0.010; P = 0.001). Genetically higher dairy intake was associated with increased lean mass [0.523 kg per serving/day (0.170); P = 0.002] after correction for multiple testing (0.05/18). However, we find that genetically higher dairy intake was not associated with lipids and glycemic traits.

CONCLUSIONS
The present study provides evidence to support a potential causal effect of higher dairy intake on increased lean mass among adults. Our findings suggest that the observational associations of dairy intake with lipids and glycemic traits may be the result of confounding.
Поиск многомерной связи категориальных признаков: сравнение CHAID, логлинейного анализа и множественного анализа соответствий
Authors: Жучкова Светлана Васильевна , Ротмистров Алексей Николаевич 
Published: May 2019

В работе затрагивается проблема отсутствия разработанных концепций анализа многомерных связей между категориальными признаками при том, что такие признаки и многомерные связи между ними довольно распространены в социологических исследованиях. Об этом свидетельствует ряд методологических работ, в которых делается вывод о необходимости анализа многомерных связей, а не только парных, поскольку многомерные связи не сводятся к набору парных связей. Тем не менее опыт изучения многомерных связей между категориальными признаками в социологии остается довольно ограничен и практически отсутствует его теоретическое обобщение. Настоящим исследованием авторы попытались восполнить этот пробел через сравнение трех методов, подходящих для поиска многомерной связи между категориальными признаками: дерева решений CHAID, логлинейного анализа и множественного анализа соответствий. Сравнение методов происходило на теоретическом и эмпирическом уровнях. Содержательной задачей эмпирического этапа выступило составление портрета типичного представителя электората различных российских политических партий на основе базы восьмой волны Европейского социального исследования, проведенного в 2016 г., и социологического теоретико-методологического подхода к изучению электорального поведения. Результаты применения этих методов приведены к форме комбинаций категорий; введены числовые критерии сравнения, благодаря чему выделен наиболее эффективный метод в двух типах аналитических задач: описании и прогнозировании. Согласно результатам исследования, в описательных задачах наиболее эффективен множественный анализ соответствий, а в задачах прогноза — логлинейный анализ. Последний вывод противоречит сложившемуся мнению о преимуществе CHAID в случаях наличия в данных какого-либо целевого признака и в связи с этим обладает высокой практической значимостью для дальнейшего развития идеи построения высокоточных прогностических моделей в социологических исследованиях.
Благодарность. Публикация подготовлена в ходе проведения исследования «Обоснование преимуществ поиска эффектов взаимодействия и их учета в социологических регрессионных моделях» (№18-05-0031) в рамках Программы «Научный фонд Национального исследовательского университета «Высшая школа экономики» (НИУ ВШЭ)» в 2018 г. и в рамках государственной поддержки ведущих университетов Российской Федерации «5-100».
Переезд из Таджикистана в Россию: мифы и реальность
Authors: Лисицын Павел Петрович , Степанов Александр Михайлович 
Published: May 2019

В статье представлены результаты исследования, проведенного в России и Таджикистане в 2017—2018 гг. Целью исследования было сопоставление ожиданий мигрантов с реальностью принимающей стороны. Метод исследования — глубинное интервью с четырьмя группами информантов: трудовыми мигрантами (N=40, Самара, Иваново, Москва) и посредниками, обеспечивающими их официальными документами и работой на территории России (N=12, Самара, Иваново, Москва), готовящимися к отъезду в Россию гражданами Таджикистана (N=20, Душанбе) и представителями профсоюзов и работодателей Таджикистана (N=4, Душанбе, Худжанд, Бохтар (Курган-Тюбе)).
Благодарность. Статья подготовлена при поддержке Российского научного фонда, проект № 17-78-20107.
Блокчейн для науки: революционные возможности, перспективы внедрения, потенциальные проблемы
Authors: Космарский Артем Анатольевич 
Published: May 2019

В статье рассматриваются перспективы применения технологии блокчейна (распределенного реестра) в сфере науки. Объясняется, чем ключевые свойства технологии (децентрализация, гарантия неизменности данных, доверие среди не доверяющих друг другу субъектов) могут быть полезны в организации науки. Подробно рассказывается о том, насколько реально работающие проекты в Европе, США и России смогли воплотить в жизнь обещания новой технологии. Описываются четыре области, где применение блокчейна идет наиболее активно: работа с первичными данными и выход из кризиса воспроизводимости исследований; оптимизация издательских процессов и рецензирования; снижение пристрастности, коррумпированности и бюрократизма в экспертизе и финансировании науки; выстраивание более комплексной, гибкой и «низовой» наукометрии. Наконец, автор обсуждает главные сложности и проблемы, возникающие при интеграции блокчейна в повседневные практики ученых: конфликт между демократическим потенциалом новой технологии и ее использованием в новых инструментах отчетности и контроля над исследователями; опасность исключительно денежной мотивации для ученых (токенизация); плюсы и минусы анархической, коммерческой и государственной «блокчейнизации» науки.
Благодарность. Статья подготовлена при финансовой поддержке Российского фонда фундаментальных исследований (РФФИ) в рамках научного проекта «Сетевые договоры (смарт-контракты) как способ регулирования и организации научной деятельности» (№ 18-29-16184).
Автор выражает благодарность Ивану Тарханову (ГАУГН) за ценные советы, высказанные при обсуждении рукописи статьи.
НЕМОСКВА: практики управления на основе социологических данных в регионах. По материалам секции на IХ Грушинской социологической конференции
Authors: Петрова Лариса Евгеньевна , Бурлуцкая Мария Георгиевна 
Published: May 2019

Материал не аннотирован.
Благодарность. Авторы выражают благодарность Программному комитету IX Грушинской социологической конференции и лично Наталье Седовой, руководителю Департамента науки и образования ВЦИОМ, заместителю председателя Программного комитета, за внимание к проблеме и предоставленную возможность обсудить ее на конференции.