bluuebunny/crossref_metadata_2025 huggingface dataset:
Precision-Panc Master Protocol: Personalizing treatment for pancreatic cancer ISRCTN14879538—Part of Precision-Panc United Kingdom.
Authors: Valle Juan W. , Evans T.R. Jeffry , McKay Colin J , Dixon-Hughes Judith , Paul James , Stobo Jamie , Cooke Susie , Willshire Christine , Williams Nicola , Duthie Fraser , Biankin Andrew , Chang David Kuang-Fu
Published: January 2019

TPS460

Background: A major challenge of lower incidence cancer types is that to make significant advances a network approach is required to coordinate research, generate greater clinical capacity and recruit sufficient patients. This is particularly the case for pancreatic cancer (PC). To address this, we established Precision-Panc, a synergistic and dynamic platform aligning “discovery”, “preclinical” and “clinical” therapeutic development. Methods: Central to the clinical development is the Precision-Panc Master Protocol, a multi-centre “portal” protocol recruiting patients with known or suspected PC, to enable enrolment into PRIMUS (Pancreatic canceR Individualised Multi-arm Umbrella Study), examining different treatment regimens and/or biomarker development. Eligible patients are identified prior to the diagnostic biopsy to obtain Stage 1 (Screening) Consent for extra tissue to be taken in the same biopsy setting. Patients who already have a diagnosis are asked to provide additional research biopsy. Once the PC diagnosis is made, Stage 2 (Registration) Consent is obtained for molecular profiling at the central reference laboratory using Precision-Panc NGS Diagnostic (bespoke clinical grade assay), including germline testing of 12 PC predisposition genes. The results may inform eligibility for a PRIMUS study. There is no sample size calculation due to the nature of the Master Protocol; however, individual PRIMUS studies will be appropriately powered according to their study design and primary endpoint. Results: Adults (aged >16 years) with either a hypodense pancreatic mass highly suspicious of PC (+/- distant metastases) or histologically/cytologically confirmed PC and its variants; willing and able to undergo tumour biopsy to obtain sufficient tissue for molecular profiling; deemed suitable to receive chemotherapy and/or radiotherapy and/or surgery pending stage of disease; must give both Stage 1 and 2 informed consent. Conclusions: The study opened on 28 Dec 2017; by 25 Sep 2018, 67 patients have been screened for Precision-Panc, 43 of whom have gone on to be registered and 19 have then been randomised to the PRIMUS-001 study (first-line metastatic). Clinical trial information: ISRCTN14879538.
Trial design for a phase 3 study evaluating pemigatinib (INCB054828) versus gemcitabine plus cisplatin chemotherapy in first-line treatment of patients with cholangiocarcinoma with FGFR2 rearrangement.
Authors: Bekaii-Saab Tanios S. , Valle Juan W. , Borad Mitesh J. , Melisi Davide , Vogel Arndt , Féliz Luis , Lihou Christine Francis , Zhen Huiling , Abou-Alfa Ghassan K.
Published: January 2019

TPS462

Background: Dysregulation of fibroblast growth factor receptor (FGFR) signaling by FGFR genetic alterations is implicated in many cancers, including cholangiocarcinoma (CCA). FGFR2 translocations with fusion partners occur in ≈10% to 20% of intrahepatic CCA tumors. Pemigatinib is a selective oral inhibitor of FGFR-1, 2, 3. Preliminary data from the ongoing phase 2 study show efficacy and tolerable safety in patients (pts) with CCA with FGFR2 translocations. We present the design for a phase 3, open-label, randomized trial investigating pemigatinib monotherapy versus gemcitabine plus cisplatin chemotherapy in the first-line treatment of pts with advanced/metastatic or unresectable CCA with FGFR2 rearrangement. Methods: Eligible pts (target, N = 432) are ≥ 18 years (≥ 20 years for Japanese pts) and have ECOG performance status ≤ 1 and histologically confirmed advanced (locally advanced, metastatic, or recurrent) CCA with a documented FGFR2 rearrangement. Key exclusion criteria include prior systemic therapy, excluding adjuvant/neoadjuvant treatment completed ≥ 6 months before enrollment; current evidence of clinically significant corneal or retinal disorder; history of calcium and phosphate homeostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues; and known, untreated CNS metastases or history of uncontrolled seizures. Pts are randomized 1:1 and stratified by geographic region and tumor burden into 2 treatment groups: pemigatinib starting dose 13.5 mg once daily continuously on a 3-week cycle; or gemcitabine (1000 mg/m2) and cisplatin (25 mg/m2) administered intravenously on days 1 and 8 of every 3-week cycle for up to 8 cycles until disease progression or unacceptable toxicity. Crossover to pemigatinib may be allowed once progressive disease is confirmed. The primary endpoint is progression-free survival (based on independent central review using RECIST v1.1). Secondary endpoints include overall response rate, overall survival, duration of response, disease control rate, safety and tolerability, and impact on quality of life. Clinical trial information: NCT03656536.
Celiac plexus radiosurgery for pain management in advanced cancer patients: An international phase II trial.
Authors: Lawrence Yaacov Richard , Meron Tikva , Dicker Adam P. , Zimmermann Camilla , Ben-Ayun Maoz , Hausner David , Golan Talia , Morag Ofir , Ackerstein Aliza , Pfeffer Raphael M. , Dawson Laura A. , Shlomo Nir , Ohri Nitin , Narayana Ashwatha , Gaya Andrew , Diaz Pardo Dayssy Alexandra , Yanovsky Inessa , Fluss Ronen , Freedman Laurence S , Symon Zvi
Published: January 2019

TPS466

Background: Many cancer patients, especially those with pancreatic cancer, suffer from severe back/epigastric pain. Contemporary approaches (opioids, celiac blocks, systemic chemotherapy) are often inadequate. This clinical trial investigates a new approach in which high-dose radiation (radiosurgery) is focused on the retroperitoneal celiac plexus nerve bundle. Preliminary results from a single institution pilot trial NCT02356406 are promising: pain relief is substantial and side effects minimal. The main aim of the trial is to establish safety/efficacy in the setting of an international multicenter study. Exploratory analyses will examine the relationship between pain reduction and subjects’ quality-of-life, functionality, and caregiver burden. Methods: Eligibility criteria include a diagnosis of metastatic/unresectable malignancy, uncontrolled pain defined as ≥ 5 on 11-point BPI-SF scale despite analgesic use, typical retroperitoneal pain syndrome, prognosis > 8 weeks, ECOG 0-2, anatomical involvement of the celiac plexus (e.g. any pancreatic cancer, or any other cancer involving the celiac trunk). Exclusion criteria include previous upper abdo. radiation. The intervention consists of a single 25 Gy radiation fraction delivered to the celiac plexus, using anterolateral aspect of the aorta from the 12th thoracic to 2nd lumbar vertebral body as a surrogate structure. The primary tumour may be irradiated at physicians’ discretion. Dose-painting technique limits dose to organs at risk. Pain intensity will be measured using Brief Pain Inventory Short Form (BPI-SF), and quality of life with FACT-Hep. The primary endpoint is complete or partial pain response, defined as a decrease between the score immediately before treatment and 3 weeks’ post-treatment. A change of two or more on the BPI 11-point pain scale is defined as clinically significant. Secondary endpoints include other BPI pain endpoints, pain at 6 weeks, analgesic use, toxicity (CTCAE v4.03), quality of life and functional measures. Analgesia is not restricted. Expected accrual is 100 subjects over three years. Supported by Gateway for Cancer Research, additional support from Israel Cancer Association. Clinical trial information: NCT03323489.
A phase Ib trial of anti-VEGFR/PDGFR vorolanib combined with immune checkpoint inhibitors (CPIs) in solid tumors.
Authors: Bagegni Nusayba Ali , Tan Benjamin R. , Park Haeseong , Kraft Katlyn , Amin Manik A. , Lim Kian-Huat , Morgensztern Daniel , Pedersen Katrina , Suresh Rama , Trikalinos Nikolaos , Wang-Gillam Andrea
Published: January 2019

TPS472

Background: Immune CPIs have become a standard treatment option for many advanced malignancies, including gastric (G)/GE junction (GEJ) and hepatocellular cancer (HCC), but resistance is inevitable. Data suggests angiogenesis plays a key role in tumor-mediated immune regulation. Vascular endothelial growth factor (VEGF) can inhibit intra-tumor T cell trafficking, while anti-VEGF therapy can improve T cell infiltration, potentially enhancing response to CPIs to overcome resistance. Vorolanib (V), a potent oral VEGFR/PDGFR inhibitor, has anti-angiogenic properties with a favorable toxicity profile. This phase 1b study is aimed to assess the safety and efficacy of V + CPIs, pembrolizumab (P) or nivolumab (N), in pts with advanced solid tumors. Methods: The primary objective is to determine the recommended phase 2 dose (RP2D) of V + CPIs. Secondary objectives include safety, toxicity and objective response rate (ORR) and survival outcomes. Correlatives include analysis of angiogenic factors and tumor infiltrating lymphocytes as response biomarkers in archived tumor tissue and peripheral blood. Key eligibility for dose escalation cohort includes pts with solid tumors who can receive standard P or N, and for dose expansion cohort includes pts with PD-L1+ G/GEJ cancer who progressed on one or two lines of chemo, refused or are not candidates for chemo; or HCC Child-Pugh A treated with or refused sorafenib, ECOG PS 0-1 and adequate organ function. Key exclusions include prior CPI, significant bleeding, thrombosis, autoimmune disease or condition requiring corticosteroid use. A 3+3 design will be utilized to determine maximum tolerated dose and RP2D. V starts at 300 mg PO daily, pts receive N 480 mg IV Q 28-day cycle or P 200 mg IV Q 21-day cycle (max 36 pts). Dose level advancement occurs when all pts complete cycle 1 of assessed level. 20 additional pts (10 HCC, 10 G/GEJ cancer) will be treated at RP2D. Response assessment by RECIST v1.1 occurs Q 3 cycles on P or Q 2 cycles on N. ORR of 20% or greater warrants further investigation. Enrollment is ongoing. Clinical trial information: NCT03511222.
A phase II, open-label pilot study evaluating the safety and activity of nal-IRI in combination with 5-FU and oxaliplatin in preoperative treatment of pancreatic adenocarcinoma (NEO-Nal-IRI study).
Authors: Parekh Hiral D. , DeRemer David L. , Hitchcock Kathryn , McGorray Susan P. , Allegra Allison , Daniels Alisha , Fan Z. Hugh , Allegra Carmen Joseph , Zlotecki Robert , Hughes Steven J. , Cioffi Jessica L , Trevino Jose Gilberto , George Thomas J.
Published: January 2019

TPS476

Background: Neoadjuvant treatment for borderline resectable pancreatic cancer (PCa) is increasing in acceptability, but a standard regimen has yet to be established. Multiple studies have demonstrated feasibility and effectiveness of the FOLFIRINOX (5-fluorouracil, leucovorin, oxaliplatin and irinotecan) regimen in the perioperative setting. However, FOLFIRINOX often requires dose modifications, delays and growth factor support due to excessive toxicity which can complicate care delivery when given neoadjuvantly. Irinotecan liposomal injection (Nal-IRI) is FDA approved with a very tolerable safety profile in refractory metastatic PCa. The current study aims to substitute Nal-IRI for traditional irinotecan in the standard FOLFIRINOX regimen and demonstrate safe and effective delivery in the neoadjuvant setting. Methods: This phase II, open-label, single-arm study targets patients with borderline resectable PCa without metastatic disease. Other key eligibility criteria include age ≥ 18 years, measurable disease by RECIST v1.1, adequate cardiac, renal, hepatic function, and Eastern Cooperative Oncology Group performance status of 0 to 1. Patients receive FOLFNal-IRINOX regimen as per table every two weeks for four months followed by disease reassessment. Patients who remain surgical candidates will undergo surgical resection within four to eight weeks following last dose of therapy. The primary endpoint is to assess safety and feasibility of regimen in perioperative setting. Secondary endpoints include R0 resection rate, clinical, biochemical and radiological response rate and patient-reported quality of life as measured by the NCI validated FACT-G scale. Enrollment continues to a maximum of 28 evaluable patients to demonstrate a reduction in historical 30 day postoperative complication rate. FOLFNal-IRINOX regimen. Clinical trial information: NCT03483038. [Table: see text]
The Global POLAR program: Calmangafodipir used on top of modified FOLFOX6 (5-FU/FA and oxaliplatin) to prevent chemotherapy induced peripheral neuropathy (CIPN).
Authors: Pfeiffer Per , Qvortrup Camilla , Muro Kei , Lustberg Maryam B. , Nagahama Fumiko , Sonehara Yusuke , Bengtson Marie Helene , Nittve Malin , Sonesson Christian , Carlsson Carl Stefan
Published: January 2019

TPS722

Background: Oxaliplatin (OXA), is approved in combination with 5-FU/FA (5-fluorouracil/folinic acid; FOLFOX) for metastatic as well as in adjuvant colo-rectal cancer (CRC) treatment. CIPN is a common adverse event, after OXA treatment. The incidence of chronic CIPN is approximately 15% after a cumulative dose of 780 to 850 mg/m² and 50% after a cumulative dose of 1170 mg/m². OXA induced neuropathy, results in greatly reduced nitrated manganese superoxide dismutase (MnSOD) activity. Treatment with a superoxide dismutase mimetic, such as calmangafodipir (CAL), prevents and reverses oxaliplatin-induced neuropathies. This has been demonstrated in the PLIANT study (Glimelius et al. 2017). Methods: The POLAR program is a phase III, multicenter, placebo (PLC)-controlled program of CAL to prevent CIPN, initiated in US, Europe and Asia: POLAR A patients with CRC, treatment of patients with stage III or high-risk stage II who are indicated for adjuvant modified FOLFOX6 (mFOLFOX6) chemotherapy for up to 6 months, randomized in a 1:1 ratio, each arm n = 140: A: CAL (5 µmol/kg) + mFOLFOX6 chemotherapy B: PLC + mFOLFOX6 chemotherapy POLAR M Patients with metastatic colorectal cancer (mCRC), who are indicated for first-line mFOLFOX6 chemotherapy for at least 3 months, without any pre-planned treatment breaks and will be randomized in a 1:1:1 ratio, each arm n = 140: A: CAL (2 µmol/kg) + mFOLFOX6 chemotherapy B: CAL (5 µmol/kg) + mFOLFOX6 chemotherapy C: PLC + mFOLFOX6 chemotherapy. Primary objective is to compare CAL versus PLC with respect to the proportion of patients with moderate or severe chronic CIPN. The primary endpoint is; patient reported symptoms as proportion of patients scoring 3 or 4 in at least 1 of the first 4 items of the FACT/GOG-NTX-13 (i.e., FACT/GOG-NTX-4), targeting numbness, tingling or discomfort in hands and/or feet, assessed 9 months after the first dose of chemotherapy. In addition to conventional safety endpoints, Progressive Free Survival and Overall Survival are assessed in the POLAR M study. In the POLAR A study Disease Free Survival is one additional safety endpoint assessed. Results are expected during second half of 2020. Clinical trial information: NCT03654729.
CO.28: Neoadjuvant Chemotherapy, Excision and Observation (NEO) for early rectal cancer.
Authors: Kennecke Hagen F. , Brown Carl J , Auer Rebecca , Drolet Sebastien , Eng Cathy , Gordon Vallerie Lynn , Hochman David J , Moloo Hussein , Wei Alice C , Chan Kelvin , Montenegro Alexander , Loree Jonathan M. , Tu Dongsheng , Jonker Derek J.
Published: January 2019

TPS724

Background: CO.28 is a phase II study which aims to determine if patients with stage I/II rectal cancer can be treated with induction chemotherapy (FOLFOX/CAPOX) and organ-preserving transanal microsurgery. Prior studies have explored the use of pelvic chemoradiation followed by transanal microsurgery as a means to increase organ preservation. However, pre-operative radiation may have acute and prolonged impacts such as wound complications and adverse on sphincter, sexual and urinary function. Moreover, patients who develop recurrence following this strategy are difficult to salvage as re-irradiation is not usually an option. There is virtually no prospective experience of neoadjuvant FOLFOX/CAPOX chemotherapy and excision for early rectal tumors. Methods: The primary objective is to determine the rate of organ preservation and the trial will be successful if more than 65% of patients avoid a formal rectal resection. In this two-staged phase II trial, patients are eligible if they have clinical N0 and T1-T3a/bN0M0 rectal tumors and no pathologic high risk features. After 6 cycles of q2weekly FOLFOX or 4 cycles of CAPOX, rectal endoscopy and pelvic MRI are repeated and if there is evidence of tumor response, patients proceed to tumor excision by Transanal Endoscopic Microsurgery (TEMS) or Transanal Minimally Invasive Surgery (TAMIS). It is required that participating surgeons have a minimum experience of 20 TEMS/TAMIS procedures and they are asked to submit an unedited video for central review. Pathologic ypT0 or ypT1N0 tumors are assigned to observation while ypT2+ or any ypN+ tumors are treated with radical surgery and total mesorectal excision (TME). Pre-operative pelvic radiation is suggested only for ypT3+ or node positive tumors. Endoscopic and cross-sectional imaging is repeated every 4-6 months for 36 months. Circulating tumor DNA (ctDNA) will be correlated with tumor response and relapse. A total of 58 patients will be accrued. Study Progress: The study was activated in Canada in late 2017 and at select US Cancer Centers in 2018, with total accrual to date of 4 patients. (NCT03259035) Clinical trial information: NCT03259035.
Morphogenesis of neurons and glia within an epithelium
Authors: Low Isabel I. C. , Williams Claire R. , Chong Megan K. , McLachlan Ian G. , Wierbowski Bradley M. , Kolotuev Irina , Heiman Maxwell G.
Published: January 2019

To sense the outside world, some neurons protrude across epithelia, the cellular barriers that line every surface of our bodies. To study the morphogenesis of such neurons, we examined the C. elegans amphid, in which dendrites protrude through a glial channel at the nose. During development, amphid dendrites extend by attaching to the nose via DYF-7, a type of protein typically found in epithelial apical ECM. Here, we show that amphid neurons and glia exhibit epithelial properties, including tight junctions and apical-basal polarity, and develop in a manner resembling other epithelia. We find that DYF-7 is a fibril-forming apical ECM component that promotes formation of the tube-shaped glial channel, reminiscent of roles for apical ECM in other narrow epithelial tubes. We also identify a requirement for FRM-2, a homolog of EPBL15/moe/Yurt that promotes epithelial integrity in other systems. Finally, we show that other environmentally exposed neurons share a requirement for DYF-7. Together, our results suggest that these neurons and glia can be viewed as part of an epithelium continuous with the skin, and are shaped by mechanisms shared with other epithelia.
Drilling Like There’s No Tomorrow: Bankruptcy, Insurance, and Environmental Risk
Authors: Boomhower Judson
Published: January 2019

This paper measures the effects of bankruptcy protection on industry structure and environmental outcomes in oil and gas extraction. Using administrative data from Texas, I exploit variation in an insurance requirement that reduced firms’ ability to avoid liability through bankruptcy. Among small firms, the policy substantially improved environmental outcomes and reduced production. Most production was reallocated to larger firms with better environmental records, but high-cost production where social cost may have exceeded social benefit decreased. These results suggest that incomplete internalization of environmental costs due to bankruptcy is an important determinant of industry structure and safety effort in hazardous industries. (JEL G22, G33, L25, L71, Q35, Q52)
Learning to Coordinate: A Study in Retail Gasoline
Authors: Byrne David P. , de Roos Nicolas
Published: January 2019

This paper studies equilibrium selection in the retail gasoline industry. We exploit a unique dataset that contains the universe of station-level prices for an urban market for 15 years, and that encompasses a coordinated equilibrium transition mid-sample. We uncover a gradual, three-year equilibrium transition, whereby dominant firms use price leadership and price experiments to create focal points that coordinate market prices, soften price competition, and enhance retail margins. Our results inform the theory of collusion, with particular relevance to the initiation of collusion and equilibrium selection. We also highlight new insights into merger policy and collusion detection strategies. (JEL G34, L12, L13, L71, L81, Q35)
Recovery from the Great Depression: The Farm Channel in Spring 1933
Authors: Hausman Joshua K. , Rhode Paul W. , Wieland Johannes F.
Published: January 2019

From March to July 1933, US industrial production rose 57 percent. We show that an important source of recovery was the effect of dollar devaluation on farm prices, incomes, and consumption. Devaluation immediately raised traded crop prices, and auto sales grew more rapidly in states and counties most exposed to these price increases. The response was amplified in counties with more severe farm debt burdens. For plausible assumptions about farmers’ relative MPC, the incidence of higher farm prices, and the aggregate multiplier, this redistribution to farmers accounted for a substantial portion of spring 1933 growth. This farm channel thus provides an example of how the distributional consequences of macroeconomic policies can have large aggregate effects. That recovery in 1933 benefited from redistribution to farmers suggests an important limitation to the use of 1933 as a guide to the effects of monetary regime changes in other circumstances. (JEL E32, E65, N12, N52, Q11, Q12)
Study protocol for the Anesthesiology Control Tower—Feedback Alerts to Supplement Treatments (ACTFAST-3) trial: a pilot randomized controlled trial in intraoperative telemedicine
Authors: Gregory Stephen , Murray-Torres Teresa M. , Fritz Bradley A. , Ben Abdallah Arbi , Helsten Daniel L. , Wildes Troy S. , Sharma Anshuman , Avidan Michael S. ,   ACTFAST Study Group
Published: January 2019

Background: Each year, over 300 million people undergo surgical procedures worldwide. Despite efforts to improve outcomes, postoperative morbidity and mortality are common. Many patients experience complications as a result of either medical error or failure to adhere to established clinical practice guidelines. This protocol describes a clinical trial comparing a telemedicine-based decision support system, the Anesthesiology Control Tower (ACT), with enhanced standard intraoperative care.

Methods: This study is a pragmatic, comparative effectiveness trial that will randomize approximately 12,000 adult surgical patients on an operating room (OR) level to a control or to an intervention group. All OR clinicians will have access to decision support software within the OR as a part of enhanced standard intraoperative care. The ACT will monitor patients in both groups and will provide additional support to the clinicians assigned to intervention ORs. Primary outcomes include blood glucose management and temperature management. Secondary outcomes will include surrogate, clinical, and economic outcomes, such as incidence of intraoperative hypotension, postoperative respiratory compromise, acute kidney injury, delirium, and volatile anesthetic utilization.

Ethics and dissemination: The ACTFAST-3 study has been approved by the Human Resource Protection Office (HRPO) at Washington University in St. Louis and is registered at clinicaltrials.gov (NCT02830126). Recruitment for this protocol began in April 2017 and will end in December 2018. Dissemination of the findings of this study will occur via presentations at academic conferences, journal publications, and educational materials.
The Convergence of Knowledge to Human Capital Management in Enterprises in Management Theory
Authors: Ширинкина Елена , Shirinkina Elena
Published: January 2019

The article presents a study of the theory of the value of human capital in the context of the development of economic thought and management, provides an explication of tools for managing the human capital of an enterprise. Analysis of the formation of the theory of human capital allows us to form a system of principles of human capital management with the goal of its effective management and planning.
Leaders of Russia as a Recruitment Tool for State Managers of a New Generation
Authors: Опарина Наталья , Oparina Natalya , Панова Е. , Panova E.
Published: January 2019

The article is focused on the analysis of the substantive aspect of the first competition “Leaders of Russia”, implemented in 2017–2018 as a special program identifying the leaders of the new generation and launching the mechanism of social elevators for the development and promotion of young leaders-managers. In the article the methods of selection (remote testing), development (case analysis, business games, interaction with mentors, etc.), promotion of participants, finalists and winners (attraction to leadership positions in the system of public administration) are examined. The motivational tools of the competition (training grants, attachment of mentors for career counseling, etc.) are analyzed. The main results of the first competition on the number of participants, geographical coverage, distribution by level of management and representation of industries among the finalists and winners of the competition are presented. From the angle of identification of possible zones for programs’ optimizing, the authors reviewed the mechanisms of assessing and developing the leadership and managerial competencies of the participants. According to the results of the analysis, expert recommendations for improving the competition procedure were proposed.
Staff Engagement as the Factor of Effective Change Management at the Space and Rocket Enterprises
Authors: Подвербных О. , Podverbnykh O. , Остроушенко М. , Ostroushenko M. , Соколова Е. , Sokolova E. , Самохвалова С. , Samohvalova S.
Published: January 2019

In the article the need of increased stuff engagement in organization and technology changes at the space and rocket enterprises is justified. The prerequisites of research and creation of engagement growth conditions at one of the leading space and rocket enterprise are identified. The set of modern views about stuff engagement, is described, the general approaches to analyze and measurement of engagement. The results of the stuff survey with Gallup questionnaire concluded the need of growth of some stuff engagement parameters are presented. The concept of the stuff engagement management in conditions of organization and technology changes at space and rocket enterprise is formed. The scientific novelty of the research consists in Roskosmos corporative competences and Gallup engagement assessment model adaptation to Kano’s product attribute model. The conclusion about need of priority of some managers’ corporative competences development, aimed at organization and technology changes stuff engagement growth is made.
The Image of the Employee of Personnel Service in Representations of Students and Its Role in the Process of Their Professional Formation
Authors: Романова И. , Romanova I. , Лобачева А. , Lobacheva A.
Published: January 2019

The article describes the results of the study of the views of students of GUU (future personnel officers) about the subject of their professional activities. It is shown how the ideas of students about the ideal image of the personnel officer have a significant formative impact on their personality and are associated with the process of professionalization. Comparison of students ‘answers with experts’ opinions on functions, methods and techniques, professional and important qualities of HR-managers is given.
Problems of Implementation of the Professional Standard «Specialist in the Field of Labour Protection»
Authors: Бутова С. , Butova S. , Несоленая О. , Nesolenaya O.
Published: January 2019

Problems and prospects for the implementation of professional standards in the Russian reality is one of the most urgent topics for discussion in the professional community. The professional standard «Specialist in the field of labour protection» defines the qualification requirements, among which are the requirements for education. The number of specialists with higher education in the field of «Technosphere safety» is limited due to the fact that such training of bachelors began in Russia only in 2009. In addition to the qualification requirements, the professional standard also establishes the labour functions of workers occupying the position of labour protection specialist, which should be reflected in the employment contract. And the name of the position should coincide with the names presented in the professional standard. The authors analyse the necessity and problems of implementing the professional standard «Specialist in the field of labour protection».
Predição da definição da escolha vocacional a partir de variáveis familiares
Authors: Ambiel Rodolfo , Ferraz Adriana , Pereira Edson , Simões Natália , Silva Jasiele
Published: January 2019

Na adolescência, a participação da família é considerada como um importante fator no processo de escolha profissional. Objetivou-se a investigação do nível de predição dos estilos parentais, congruência entre pais e filhos e autoeficácia dos filhos em relação à definição da escolha vocacional numa amostra de 140 alunos doensino médio. As idades variaram de 15 a 18 anos (M = 16,14), sendo a maioria do sexo feminino (58%). Os instrumentos utilizados foram: Questionário  sociodemográfico, Escala de Responsividade e Exigência Parental-EREP, Escala de Congruência entre Pais e Filhos  sobre Escolha Profissional-ECPF-EP e Escala de Autoeficácia para Escolha Profissional-EAE-EP. Por meio da análise de regressão hierárquica, os instrumentos foram agrupados em três blocos. O modelo formado a partir do último bloco foi o melhor, sendo que as variáveis responsividade materna, congruência complementar e autoeficácia para busca de informação profissionalprática foram os preditores significativos. Sugere-se a continuidade dos estudos.Palavras-chave: autoeficácia para escolha profissional, relações familiares, estilos parentais, orientação profissional
Melancolia: literatura
Authors: De Freitas Eduardo Da Silva
Published: January 2019

Resenha do livro Melancolia, de Luiz Costa Lima, publicado em 2017.
Un suelo que no deja de moverse. Temporalidades no-humanas de Nuno Ramos
Authors: Giorgi Gabriel
Published: January 2019

Perhaps some of the most significant investigations in contemporary literature and art from Brazil revolve around  the question of temporality , the  threshold between the living and the dead and the ways in which conflicting temporalities and  anachronism articulate a critique of the present.  In this context,  Nuno Ramos’ installations and writings, working on the unstable terrain between the living and the dead, the organic and the inorganic, the fossilized and the spectral, represent a decisive intervention. In Ramos’ works memory is never entirely human; it is irreducible to the domain of subjectivity nor to the shared narratives of the collective. From books such as Cujo or Junco   to the the fossilized matter present in many of his works, the relationship between life and death is both political, technological and non-anthropomorphic —it is, in other words, biopolitical. This paper analyzes the ways in which  the configuration of such critical perspective in Nuno Ramos’ work interrogates and reformulates the ways in which temporality and the political interface there where the very notion of life — the bios that articulates the biopolitical— is at stake.
A circulação da literatura brasileira nos Estados Unidos: o caso da série literatura brasileira em tradução da Tagus Press
Authors: Antunes Maria Alice Gonçalves
Published: January 2019

Artigos publicados em diversos jornais e revistas virtuais revelam os primeiros anos do século XXI como um período de especial importância para a circulação da literatura brasileira em tradução para a língua inglesa nos Estados Unidos, em especial. Parece-nos também que o cenário de lamentação constante causado pelo número limitado de traduções de literatura brasileira publicadas em inglês começou a sofrer alteração expressiva nos dezessete primeiros anos do século XXI. Neste artigo, procuramos compreender melhor a circulação da literatura brasileira no mundo anglófono, nos primeiros anos deste século. Para tal, tomaremos as ideias dos estudiosos André Lefevere e Johan Heilbron para examinar o caso da Brazilian Literature in Translation Series publicada pela Tagus Press, entre 2013 e 2014, nos Estados Unidos.
Brazuca negão e sebento
Authors: Wolff Joca
Published: January 2019

Resenha de:GODDARD, Jean-Christophe. São Paulo: n-1 edições, 2017
Take cover!
Authors: Weinstein Nicole
Published: January 2019

An outdoor setting in the Scottish Highlands is giving children the resources and autonomy to take their den-building to a new level, Nicole Weinstein discovers
Mechanical Compression of Coverslipped Tissue Sections During Heat-induced Antigen Retrieval Prevents Section Detachment and Preserves Tissue Morphology
Authors: Eckhard Andreas H. , O’Malley Jennifer T. , Nadol Joseph B. , Adams Joe C.
Published: January 2019

Heat-induced antigen retrieval (HIAR) is routinely employed on aldehyde-fixed tissue sections to enhance the reactivity of antibodies that exhibit weak or no specific interactions with tissue antigens when applied in conventional immunohistochemical protocols. A major drawback of HIAR protocols is, however, the heat-induced detachment of sections from the microscope slide with resultant impaired tissue morphology or loss of the section. We developed a method in which tissue sections mounted on glass slides are temporally coverslipped, and a clamp is used to compress the sections on the microscope slide during HIAR treatment. This “pressurized coverslipping” during HIAR was tested on various formalin-fixed tissues (murine kidneys and temporal bones, human tonsils and temporal bones) that were embedded in paraffin or celloidin. The method reliably kept the sections adherent to the slide, preserved the tissue morphology, and effectively retrieved tissue antigens for improved results in immunohistochemical labeling, even for exceptionally delicate, large, and poorly adhering sections, that is, decalcified human temporal bone sections. In summary, we present a simple method for improved slide adherence and morphological preservation of tissue sections during HIAR treatment that can be combined with all HIAR protocols and that requires only basic lab equipment.
Contamination of Streptococcus suis in pork and edible pig organs in central Thailand
Authors: Boonyong Nuchjaree , Kaewmongkol Sarawan , Khunbutsri Duangdaow , Satchasataporn Khomsan , Meekhanon Nattakan
Published: January 2019

Background and Aim: Streptococcus suis is an important zoonotic pathogen that can cause serious diseases in both swine and humans worldwide, especially in Asian countries. Since the majority of human cases reported in Thailand were infected by the consumption of a raw pork dish, the microbial food safety hazard associated with raw meat has been a matter of concern. Therefore, this study aimed to investigate the contamination by S. suis in pork and edible pig organs sold in central Thailand.

Materials and Methods: In total, 88 raw pork and pig organ samples were purchased from markets, butcher shops, and supermarkets in central Thailand. The samples were examined using the loop-mediated isothermal amplification (LAMP) technique. LAMP reactions used for the detection of the DNA of S. suis (LAMPSS) and S. suis serotype 2 or 1/2 (LAMPSS2) were carried out according to previous studies.

Results: The percentage of LAMPSS-positive samples was as high as 85.23% (75/88) while the percentage of LAMPSS2- positive samples was 17.05% (15/88). The percentages of LAMPSS- and LAMPSS2-positive samples were relatively high in both pig organs (lung and heart) and meat (sliced pork and minced pork) compared with the previous report. Except one supermarket, LAMPSS-positive samples were found in all sources investigated in this study. The pork and pig organs obtained from the markets and the butcher shops additionally gave positive results for LAMPSS2.

Conclusion: Using LAMP techniques, high rate contamination of S. suis was found in raw pork and edible pig organs sold at different sources in central Thailand. The cross-contamination could have occurred through slaughtering, meat cutting, and meat handling processes. Therefore, consumers and people involved in the pig production industry should be aware of the potential hazards of S. suis infection; food safety education is crucial to prevent further infection.
Detection of invA gene of Salmonella from milkfish (Chanos chanos) at Sidoarjo wet fish market, Indonesia, using polymerase chain reaction technique
Authors: Yanestria Sheila Marty , Rahmaniar Reina Puspita , Wibisono Freshinta Jellia , Effendi Mustofa Helmi
Published: January 2019

Aim: The study aimed to detect the invA gene in Salmonella isolated from milkfish in the Sidoarjo wet fish market.

Materials and Methods: A total of 84 samples were prepared in enrichment media and isolated on the surface of Salmonella Shigella Agar. Salmonella growth produces transparent colonies with blackish color in the middle due to H2S gas formation. Samples were identified as Salmonella based on macroscopic colony morphology. Presumptive Salmonella sp. was put on Bismuth Sulfite Agar media. Salmonella was determined based on the results of the biochemical test that has been carried out using Microbact identification kits from negative gram staining.

Results: The results of this study indicate that 32 of 84 samples (38.09%) were Salmonella bacteria. Furthermore, the invA gene detection was carried out using the polymerase chain reaction technique. Electrophoresis results showed four positive samples contained invA gene with a length of 284 bp.

Conclusion: Results in this study indicate that contamination of milkfish with Salmonella needs strict hygienic measures to prevent their transmission to human.
From the Editor
Authors: Goss David A.
Published: January 2019

The Optometric Historical Society (OHS) celebrates its 50th Anniversary in 2019. The editor, Dr. David Goss, celebrates his 25th year as editor of Hindsight. Dr. Goss thanks OHS members, introduces the anniversary issue and encourages readers to submit their own work for publication.
Hindsight is 2020
Authors: Goss David A.
Published: January 2019

This paper gives an account of the history of the Optometric Historical Society (OHS), based on material in its quarterly publication, variously named Newsletter of the Optometric Historical Society (1970-1991), Hindsight (1992-2006), and Hindsight: Journal of Optometry History (2007-present).  Operated as an independent organization for many years from its founding in 1969, the OHS became a part of Optometry Cares – The AOA Foundation in 2012.  In addition to its publication, now totaling more than 3,300 pages since its inception, the OHS has also held meetings referred to as Reminisce-ins or Blasts from the Past, in association with annual meetings of the American Optometric Association and the American Academy of Optometry.  Officers and participants in the OHS have included many significant individuals in optometry.
The Year OHS Began
Authors: Bennett Irving
Published: January 2019

The year 1969 was a time of tremendous change in American society as well as in the profession of optometry. In the broader culture, academics, students and community activists organized grassroots campaigns to change institutions from the bottom up. For optometry, this movement began with the January 1968 “LaGuardia” meeting, when a small group of optometrists planned a campaign to transform the profession by agitating for the American Optometric Association (AOA) to advocate for the expansion of the scope of practice. Ripe for change, the AOA membership began to respond. In June of 1968, despite early opposition, OHS founder Henry W Hofstetter was the first full-time academic to serve as president of the AOA. Only one year after La Guardia in February of 1969, the AOA held the Airlie House Conference which set a new course for the profession. When the movement to change optometry gained traction, the keepers of the culture began to recognize the need to document the past. In December of 1969, Hofstetter and the AOA Librarian Maria Dablemont founded the Optometric Historical Society to ensure the history of optometry would not be lost. This first-person reminiscence by Irving Bennett, O.D. recounts his recollections of the individuals and events instrumental in the formation of the OHS.
The Origins of the Optometric Historical Society
Authors: Myers Raymond I.
Published: January 2019

This article is a first-person account of the historical development of the Optometric Historical Society (OHS) which includes a description of the pivotal roles played by Head Librarian Maria Dablemont of the International Library, Archives and Museum of Optometry and Henry W Hofstetter, O.D., Ph.D., and the conditions that contributed to the need for a historical society. The author was a student, colleague and contemporary of Dr. Hofstetter and Ms. Dablemont during his education and employment in St. Louis, MO.
Founding Members and Presidents of the Optometric Historical Society
Authors: Goss David A.
Published: January 2019

A list of founding members and presidents of the Optometric Historical Society
Optometric Historical Society Award Recipients
Authors: Goss David A.
Published: January 2019

List of award recipients from the Optometric Historical Society with dates of award.
Keragaman Cendawan Pascapanen pada Umbi Bawang Merah Varietas Bima Brebes
Authors: Dharmaputra Okky Setyawati , Listiyowati Sri , Nurwulansari Ira Zahara
Published: January 2019

Diversity of Postharvest Fungi on Shallot Bulbs Variety Bima BrebesIn Indonesia, shallot (Allium ascalonicum) is horticultural main commodity after hot pepper. Significant yield losses can be caused by postharvest fungi infection. Research on the diversity of postharvest fungi on shallot bulbs has been conducted in some countries, unfortunately little is done in Indonesia. The study was aimed to obtain information on the diversity of postharvest fungi infecting shallot bulbs variety Bima Brebes from several traditional markets in Bogor City. Shallot bulbs were collected in January and February 2016. The study consisted of fungal isolation from shallot bulbs, fungal pathogenicity test, and identification of pathogenic fungi based on morphological and molecular characteristics. Morphology identification was based on the color of fungal colony, growth pattern, as well as somatic and reproduction structures. Several species of pathogenic fungi were successfully identified from shallot bulbs i.e. Alternaria alternata, Aspergillus niger, Colletotrichum gloeosporioides species complex, Fusarium fujikuroi species complex, F. oxysporum, F. solani, Penicillium citrinum and P. pinophilum.  Among these fungi, the highest pathogenicity was shown by C.  gloeosporioides species complex.
Numerical Simulation of Gas-Liquid Dispersion in A Stirred Tank Agitated by Punched Rigid-Flexible Impeller
Authors: Gu Deyin , Liu Zuohua , Tao Changyuan , Li Jun , Wang Yundong
Published: January 2019

The hydrodynamics of gas-liquid dispersion process in a stirred tank with rigid impellers, rigid-flexible impellers, and punched rigid-flexible impellers were investigated using a combined computational fluid dynamics (CFD) and population balance model (PBM) approach. A classical Eulerian-Eulerian approach coupled with standard k-e turbulence model was employed to simulate gas-liquid turbulent flow in the stirred tank. The multiple reference frame (MRF) approach was used to simulate impeller rotation. The effects of impeller type, flexible connection piece length, aperture size/ratio, impeller speed and superficial gas velocity on the local gas holdup and bubble size distribution for the gas-liquid dispersion process were investigated. Results showed that a long flexible connection piece length was conductive to the gas-liquid dispersion process. The optimum aperture ratio and aperture diameter were 12 % and 8 mm, respectively, for the gas-liquid dispersion process. Punched rigid-flexible impeller could reduce the differential pressure ahead and behind the impeller blade, decrease the size of low-pressure zone, and improve the water shear strain rate compared with rigid impeller and rigid-flexible impeller at the same Pg,v. It was found that punched rigid-flexible impeller was more efficient in terms of gas dispersibility than rigid impeller and rigid-flexible impeller.
Comparative evaluation of neuroendocrine dysfunction in children with craniopharyngiomas before and after mass effects are removed
Authors: Guo Ying , Wang Yonggang , Ni Ming , Zhang Yazhuo , Zhong Liyong
Published: January 2019

Objective

To compare the effects of mass effects in situ (MEIS) and after neurosurgery (ANS) on neuroendocrine function in children with craniopharyngioma.

Methods

We retrospectively investigated 185 cases of children with craniopharyngioma who underwent neurosurgical treatment at the Beijing Tiantan Hospital from 2011 to 2016. The neuroendocrine function of patients was compared before and after tumor removal.

Results

Compared with the MEIS, the incidence of growth hormone insulin-like growth factor 1 axis dysfunction (47.03% vs. 57.30%), pituitary-thyroid axis dysfunction (20.00% vs. 50.27%), pituitary-adrenal axis dysfunction (18.38% vs. 43.78%) and diabetes insipidus (26.49% vs. 44.86%) was significantly increased in the ANS status. The incidence of hyperprolactinemia significantly decreased from 28.11% in the MEIS status to 20.54% in the ANS status. Compared with the MEIS group, changes in appetite, development of diabetes insipidus, body temperature dysregulation, sleeping disorders, personality abnormalities and cognitive abnormalities were more frequent after ANS, yet no statistically significant differences were found.

Conclusions

Endocrine dysfunction is common in children with craniopharyngioma. Both MEIS and ANS can be harmful to neuroendocrine function, and neurosurgical treatment may increase the level of neuroendocrine dysfunction.
The Ideal Character of the General Will and Popular Sovereignty in Kant
Authors: Marey Macarena
Published: January 2019

In this paper, I examine Kant’s reception of and solution to the problem of the unity of the political will. I propose that Kant distances himself from the modern paradigmatic foundations of sovereignty principally with his theses of the ideality of the general will (section II) and of the apriority of the justification of popular sovereignty (section III). My interpretative hypothesis is that Kant solves the problem by grounding sovereignty in a conceptual element which is new in the history of political philosophy, i. e. the a priori unified omnilateral will. In section IV, I explain why my reading of the ideality of the general will can respond to seemingly plausible objections arising from Kant’s own texts and how it works in the face of concrete political states of affairs.