bluuebunny/crossref_metadata_2025_split huggingface dataset:
Are clinical trial results transferable in the real life?
Authors: Natale Enrico , Marsocci Alfiera 
Published: June 2016

Generally in the clinical practice patients are more complex in comparison with those included in the clinical trials. In this article, we discuss three relevant items, which may implement the transferability of the clinical trial results in the real world. The observational studies have fewer restrictions on the number of patients included, due to more relaxed inclusion and exlusion criteria than in randomized clinical trials. The absence of randomization however may lead to potential for bias. The recurrent event analysis may extend the positive results of clinical trials regarding the reductions of the first primary endpoint event to total events, including those beyond the first event. This analysis is of great interest in the clinical practice, where recurrent events are common. Finally the reliability of subgroup analysis is discussed. Pre-specified subgroup analyses are more credible and valuable than post-hoc analyses.RiassuntoNella pratica clinica i pazienti sono generalmente piÃ¹ complessi rispetto alle popolazioni studiate nei trial clinici. Si rendono necessari pertanto strumenti di analisi che integrino i trial clinici. In questo articolo vengono esaminati alcuni punti di rilevante importanza nella definizione di una corretta applicabilitÃ dei risultati dei trial clinici al mondo reale. Il primo punto riguarda il ruolo e i limiti degli studi osservazionali. Il secondo tratta delle analisi degli eventi ricorrenti, una modalitÃ di analisi dei trial clinici che rende i risultati piÃ¹ aderenti alla vita reale, nella consapevolezza che limitare i dati di outcome al primo evento sia riduttivo rispetto alla necessitÃ di stabilire che lâ€™intervento studiato nel trial confermi la sua efficacia anche sugli eventi successivi al primo. Il terzo punto riguarda la controversa questione delle analisi per sottogruppi, uno strumento utile per generare ipotesi, ma discutibile quando impiegato per rimediare a trial con risultati negativi o estendere i risultati di trial positivi a sottopopolazioni particolari di pazienti.Â
Quality of anticoagulation therapy in neurological patients in a tertiary care hospital in north India
Authors: Singh Prabhat , Kalita J. , Misra U.K. 
Published: June 2016

Background & objectives:
There is paucity of studies on the quality of anticoagulation in neurological patients from India. This study evaluates the quality of oral anticoagulation therapy in neurology patients.

Methods:
Consecutive patients attending a tertiary care neurology service in north India who were prescribed oral anticoagulant (OAC), were included. Their international normalized ratio (INR) values were prospectively monitored and the earlier INR values of the patients who were already on OAC were retrospectively analyzed. The patients with multi-organ dysfunction, pregnancy and those below 18 yr of age were excluded. The therapeutic INR range was defined as per standard recommendations. The level of anticoagulation, factors interfering with OAC and complications were noted.

Results:
The results were based on 77 patients with median age 40 yr. Fifty one patients received OAC for secondary stroke prevention, 23 for cerebral venous sinus thrombosis (CVST) and three for deep vein thrombosis (DVT). A total 167.9 person-years of follow up was done with a median of 1.2 (0.3-9.3) years. Of the 1287 INR reports, 505 (39.3%) reports were in the therapeutic range, 496 (38.5%) were below and 282 (21.91%) were above the therapeutic level. Stable INR was obtained in 33 (42.86%) patients only. INR level was improved by dose adjustment in 20 (26%), drug modification in two (2.6%), and dietary adjustment in six (7.8%) patients. Three patients were sensitive and five were resistant to OAC. Complications were noted in 28 instances; thromboembolic in 16 and haemorrhagic stroke in 12. The overall complication rate was 16.7 per 100 person-years.

Interpretation & conclusions:
It may be concluded that stable therapeutic INR is difficult to maintain in neurological patients. Optimal modification of diet, drug and dose of oral anticoagulant may help in stabilization of INR.
The Theatre of Caryl Churchill
Authors: Gobert R. Darren 
Published: June 2016

The Theatre of Caryl Churchill documents and analyses the major plays and productions of one of Britain's greatest and most innovative playwrights. Drawing on hundreds of never-before-seen archival sources from the US and the UK, it provides an essential guide to Churchill's groundbreaking work for students and theatregoers.
Each chapter illuminates connections across plays and explores major scripts alongside unpublished and unfinished projects. Each considers the rehearsal room, the stage, and the printed text. Each demonstrates how Churchill has pushed the boundaries of dramatic aesthetics while posing urgent political and theoretical questions. But since each maps Churchill's work in a different way, each deploys a different reading practice - for many approaches are necessary to characterise such a restlessly imaginative and prolific career.
Through its five interlocking parts, The Theatre of Caryl Churchill tells a story about the playwright, her work, and its place in contemporary drama.
Rainfall erosivity in catchments contaminated with fallout from the Fukushima Daiichi nuclear power plant accident
Authors: Laceby J. Patrick , Chartin Caroline , Evrard Olivier , Onda Yuichi , Garcia-Sanchez Laurent , Cerdan Olivier 
Published: June 2016

Abstract. The Fukushima Daiichi nuclear power plant (FDNPP) accident in March 2011 resulted in the fallout of significant quantities of radiocesium over the Fukushima region. After reaching the soil surface, radiocesium is quickly bound to fine soil particles. Thereafter, rainfall and snowmelt run-off events transfer particle-bound radiocesium downstream. Characterizing the precipitation regime of the fallout-impacted region is thus important for understanding post-deposition radiocesium dynamics. Accordingly, 10 min (1995–2015) and daily precipitation data (1977–2015) from 42 meteorological stations within a 100 km radius of the FDNPP were analyzed. Monthly rainfall erosivity maps were developed to depict the spatial heterogeneity of rainfall erosivity for catchments entirely contained within this radius. The mean average precipitation in the region surrounding the FDNPP is 1420 mm yr−1 (SD 235) with a mean rainfall erosivity of 3696 MJ mm ha−1 h−1 yr−1 (SD 1327). Tropical cyclones contribute 22 % of the precipitation (422 mm yr−1) and 40 % of the rainfall erosivity (1462 MJ mm ha−1 h−1 yr−1 (SD 637)). The majority of precipitation (60 %) and rainfall erosivity (82 %) occurs between June and October. At a regional scale, rainfall erosivity increases from the north to the south during July and August, the most erosive months. For the remainder of the year, this gradient occurs mostly from northwest to southeast. Relief features strongly influence the spatial distribution of rainfall erosivity at a smaller scale, with the coastal plains and coastal mountain range having greater rainfall erosivity than the inland Abukuma River valley. Understanding these patterns, particularly their spatial and temporal (both inter- and intraannual) variation, is important for contextualizing soil and particle-bound radiocesium transfers in the Fukushima region. Moreover, understanding the impact of tropical cyclones will be important for managing sediment and sediment-bound contaminant transfers in regions impacted by these events.
Evaluation of Oriental Pickling Melon (Cucumis melo L. Var. conomon) Genotypes for Pest and Disease Reaction under Northern Dry Zone of Karnataka
Authors: Gondi Shruti Prakash. , Ganiger V. M. , G Bhuvaneshwari. , Madalageri M. B. , Kotikal Y. K. , G Manjunatha. 
Published: June 2016

<p>Cucurbits are the group of vegetables belongs to the family Cucurbitaceae. Oriental pickling melon (<em>Cucumis melo </em>var. <em>conomon)</em> is one among the melon group vegetables belongs to <em>Cucurbitaceae</em> family<em> </em>with a chromosomal number 2n=24. It is also called as golden melon or culinary melon in English. In Karnataka it is called by local names as <em>Sambar Southe, Mogghe kayi or Mangalore southe</em>. A field experiment was carried out at University of Horticultural Sciences Bagalkot, Karnataka to study the reaction of oriental pickling melon to fruit fly pest, diseases like powdery mildew and downy mildew disease. The results revealed that least infestation of fruit fly was recorded in Sirsi Local (40.00 %) followed by BCMCO-01 (41.30 %), BCMCO-02 and BCMSO-03 (41.75 % each). Highest infestation of fruit fly was recorded in Sirsi-2-13 (65.07 %) followed by BCMSO-04 (59.90 %). Among the genotypes, none of them had showed resistant to infestation and found susceptible to fruit fly attack in unsprayed condition. Least infestation of powdery mildew was found in Mysore Local (37.71 %) followed by Sirsi Local (37.99 %) and BCMSO-03 (39.76 %). Whereas highest mildew in GR-3 (46.08 %) followed by Sirsi-1-13 (45.81 %) and BCMCO-02 (45.75 %). Least infestation of downy mildew was observed in BCMCO-02 (14.00 %) followed by Sirsi Local (16.29 %) and BCMSO-03 (17.43%). Highest infestation was found in GR-2-1 (27.07%) followed by GR-4 (26.58 %) and GR-4-1 (26.23 %). Most of the genotypes were moderately susceptible to downy mildew disease.</p>
Erfaringer med intervensjonsforsøk i yrkesepidemiologi: Basert på studier av miljøtiltak for å forbedre inneklima i kontormiljø
Authors: Skyberg Knut , Skulberg Knut 
Published: June 2016

SAMMENDRAGBasert på to intervensjonsforsøk rettet mot helseeffekter i hud og øvre luftveier før og etter inneklimatiltak,drøftes erfaringer med design, metoder og analyse av data. Intervensjonene som ble prøvet ut varantistatisk behandling av dataskjerm (n=117) og storrengjøring i kontormiljø (n=104). Det ble måltstøvkonsentrasjon under vanlig arbeid med direktevisende partikkelteller. Ved støvkonsentrasjoner > 50μg/m 3 hadde tiltakene effekt. Antistatisk behandling av skjermen førte til reduserte hudplager i ansiktet.Kolorimetrisk måling av rødfarge i ansiktet viste ingen forskjeller mellom intervensjon og placebo.Rengjøring av enkeltkontorer førte til reduserte slimhinneplager i øvre luftveier. Personer med tendenstil redusert nesepassasje viste økning av hulmål-parametre, målt med akustisk rhinometri. I beggeforsøk ble endring i helsevariabler før-etter i intervensjonsgruppen sammenlignet med endring ikontrollgruppen. Det konkluderes med at intervensjon som metode i arbeidsmedisinsk forskning erressurskrevende, men har en rekke fordeler som metoden deler med klinisk kontrollerte forsøk.Skyberg K, Skulberg K. Experiences from intervention trials in occupational epidemiology,based on studies of measures to improve indoor air in offices.Nor J Epidemiol ENGLISH SUMMARYBased on two intervention trials on health effects in skin and upper airways, before and after indoor airquality measures, experience with design, methods and data analysis are discussed. Applied interventionswere antistatic treatment of VDU (n=117) and comprehensive cleaning of the office (n=104). Dustconcentrations during usual work were measured, using a particle counter. The interventions showedeffect when the dust concentration was > 50 μg/m 3. Antistatic treatment of the VDU lead to reducedfacial skin symptoms. Colorimetric measurements, however, showed no differences between the interventionand control groups. Cleaning of single offices lead to a reduction of mucosal complaints in theupper airways. Persons with a tendency to reduced nasal passage showed an increase in nasal volumeparameters, measured by acoustic rhinometry. In both trials the differences in health indicators beforeand after in the intervention group were compared to differences in the control group. It is concludedthat intervention methods used in occupational health research are resource demanding, but have anumber of advantages that this method shares with controlled clinical trials.1999; 9 (1): 71-77.
Menns overdødelighet
Authors: Waaler Hans Th. 
Published: June 2016

SAMMENDRAGForventet levealder for kvinner er ca. 6 år lenger enn for menn, en forskjell som svarer til en livsvarigdobbel dødelighet for menn. Ratioen mellom kvinners og menns forventede levealder var konstant fra1840 til 1950. I de siste 50 år har ratioen økt betydelig og varierende med alderen. De siste ti årene harigjen ratioen vært fallende. I NOU 13:1999 om Kvinners helse i Norge framheves en langvarig diskrimineringmot kvinner i forskning og i helsetjenestens møte med kvinner som et problem. Hvis det erriktig så kan man neppe si at det har gitt mennene en fordel mht. helse.Waaler HT. The excess mortality of men in Norway. Nor J Epidemiol 1999; 9 (2): 97-100. ENGLISH SUMMARYThe excess mortality of men has been observed for a long time and figures are presented from Norwaysince 1850. The ratio between females and males as to life expectancy was rather constant from themiddle of the last century up to about 1950. For the last 50 years the ratio has increased conciderablyand differently for the varying age groups. A recent Official Report on Females' Health in Norwayunderscores the discrimination against women from the medical research and the health services overthe generations. The increasing gap in life expectancy between females and males doesn’t support thisclaim or at least doesn’t seem to have given the males an advantage. One consequence of the differencein mortality is the widow/widower ratio which takes the value of about four in all adult age groups.
The Principle of Indifference Does Not Lead to Contradictions
Authors: Tschirk Wolfgang 
Published: June 2016

The Principle of Indifference says that if there are a finite number of propositions and a state of knowledge according to which none of the propositions is more plausible than any other, then, conditional on that knowledge, all of them have the same probability. Most researchers reject the principle because there exist counterexamples believed to prove that it leads to contradictions. We analyse three examples representative of the objections to the principle and show that, rather than disproving it, they suffer from a common error in applying it. From this and the fact that the Principle of Indifference complies with plausible reasoning we conclude that it does not lead to contradictions.
Using Arbitration for Resolving Foreign Investment Disputes: A Comparative Study of Laws on Arbitration in Ghana and China
Authors: Ayangbah Shirley 
Published: June 2016

<p>International Investment in recent times is seen as one of the fastest-developing areas of international law. In the past decades, there has been a dramatic increase in the number of bilateral investment treaties and other agreements with investment related provisions that grant foreign investors important substantive and procedural rights, including, most importantly, the right to sue individuals, organizations and even the state hosting their investment for violations of customary international law and treaty obligations. Dispute becomes an inevitable phenomenon as individuals, organizations and countries continue to engage in foreign investment and as such there is the need for dispute solving mechanism to resolve such disputes as and when they arises. Even though there are several dispute solving mechanisms, arbitration seems to be a well-established and widely used mechanism to end dispute probably due to the efficiency and flexibility nature of it. The laws governing arbitration differ from one country to the other and it is for this reason that investors need to be abreast with the different arbitration laws so as to enable them make inform decisions as to whether to resort to arbitration or not. This paper analyses the arbitration laws of The Republic of Ghana and Peoples Republic of China in a comparative manner by drawing on the similarities and difference with respect to arbitration laws and procedure in these two countries. The paper is divided into three parts. The first part of this paper gives a brief background as well as the characteristics of the concept of arbitration. The second part looks as the similarities and difference of arbitration between the selected countries, and the final part looks at the arbitration phase and post arbitration phase of the two countries.</p>
Adapting Preclinical Benchmarks for First-in-Human Trials of Human Embryonic Stem Cell-Based Therapies
Authors: Barazzetti Gaia , Hurst Samia A. , Mauron Alexandre 
Published: June 2016

Abstract

As research on human embryonic stem cell (hESC)-based therapies is moving from the laboratory to the clinic, there is an urgent need to assess when it can be ethically justified to make the step from preclinical studies to the first protocols involving human subjects. We examined existing regulatory frameworks stating preclinical requirements relevant to the move to first-in-human (FIH) trials and assessed how they may be applied in the context of hESC-based interventions to best protect research participants. Our findings show that some preclinical benchmarks require rethinking (i.e., identity, purity), while others need to be specified (i.e., potency, viability), owing to the distinctive dynamic heterogeneity of hESC-based products, which increases uncertainty and persistence of safety risks and allows for limited predictions of effects in vivo. Rethinking or adaptation of how to apply preclinical benchmarks in specific cases will be required repeatedly for different hESC-based products. This process would benefit from mutual learning if researchers included these components in the description of their methods in publications.

Significance
To design translational research with an eye to protecting human participants in early trials, researchers and regulators need to start their efforts at the preclinical stage. Existing regulatory frameworks for preclinical research, however, are not really adapted to this in the case of stem cell translational medicine. This article reviews existing regulatory frameworks for preclinical requirements and assesses how their underlying principles may best be applied in the context of human embryonic stem cell-based interventions for the therapy of Parkinson's disease. This research will help to address the question of when it is ethically justified to start first-in-human trials in stem cell translational medicine.
Importance de mieux connaître les mécanismes de transport des métaux pour la prédiction de l’accumulation et de la toxicité des métaux dissous chez le phytoplancton : récentes avancées et défis pour le développement du modèle du ligand biotique
Authors: Lavoie Michel , Campbell Peter G.C. , Fortin Claude 
Published: June 2016

L’accumulation et la toxicité (aigüe) des métaux dissous chez plusieurs organismes aquatiques peuvent être prédites adéquatement à l’aide du modèle du ligand biotique (MLB), même si quelques exceptions existent. Lors d’expositions chroniques aux métaux, des interactions physiologiques complexes entre les organismes et les métaux essentiels et non essentiels modulent le taux de transport des métaux et leur toxicité. La présente revue de littérature aborde les récentes avancées en chimie de l’environnement, en biologie moléculaire et en physiologie cellulaire touchant aux mécanismes de régulation du transport membranaire des métaux essentiels chez le phytoplancton eucaryote et leurs impacts sur l’accumulation et la toxicité d’un métal habituellement non essentiel, le cadmium. Cette revue évalue finalement la possibilité d’inclure des éléments de physiologie algale dans la présente version du MLB afin d’améliorer le potentiel de ce modèle à prédire l’accumulation et la toxicité des métaux pour des expositions chroniques. Les résultats disponibles dans la littérature suggèrent que l’inclusion des rétroactions négatives et positives des métaux sur les paramètres cinétiques (Vmax : vitesse maximale de transport transmembranaire; KM : affinité des transporteurs pour le métal) des multiples systèmes de transport membranaire des métaux a le potentiel d’améliorer les prédictions de l’accumulation et de la toxicité des métaux à long terme chez le phytoplancton. Le développement d’un MLB capable de prédire adéquatement la toxicité chronique des métaux dans des conditions physicochimiques variables représentatives de celles retrouvées en milieu naturel bénéficiera des avancées récentes et futures en toxicologie, biologie et chimie de l’environnement. Ces connaissances pourraient permettre à long terme d’atteindre l’objectif ambitieux d’un MLB capable de réaliser des prédictions fiables à l’intérieur de milieux naturels complexes de différentes compositions chimiques.
Le réalisme avec degrés de certitude
Authors: Prosperi Oliver 
Published: June 2016

Dans le contexte de l’utilisation des degrés de certitude avec des QCM (questions à choix multiples), l’évaluateur désire mesurer l’adéquation entre la façon dont les personnes évaluées (souvent les étudiants) utilisent les degrés de certitude et les instructions fournies pour les utiliser. Cette mesure est appelée « réalisme du sujet ». Actuellement, le calcul du réalisme, quoiqu’élémentaire, présente quelques inconvénients de types calculatoire, conceptuel ou probabiliste. Une nouvelle approche de type probabiliste correspondant mieux à la définition des degrés de certitude et à la façon avec laquelle les étudiants doivent les utiliser est décrite ici. Cette approche aboutira à de nouvelles définitions et méthodes de calcul du réalisme basées sur des arguments statistiquement justifiés. Cette nouvelle définition est plus précise que la précédente, et décrit mieux la capacité de s’autoévaluer et d’utiliser correctement les degrés de certitude. Enfin, elle permettra d’améliorer la fiabilité des indices de qualité liés aux questions utilisant le réalisme, par exemple le rpbisSCT de Gilles (2002).
Problématiques et enjeux du tourisme de chasse
Authors: Leclerc Vincent , Vachon Marc-Antoine 
Published: June 2016

La chasse est une activité importante tant au niveau économique que pour la conservation de la faune. À partir d’une revue extensive de la littérature, cet article documente cinq problématiques majeures entourant le tourisme de chasse : les conflits entre usagers, l’image négative de la chasse, la méconnaissance du marché, les difficultés de promotion de la chasse et le manque de relève. Afin d’assurer la présence d’un bassin suffisant de chasseurs touristiques, l’article propose de concentrer les efforts dans l’amélioration de la connaissance du marché, ce qui aura un effet direct ou indirect sur les autres problématiques. Les auteurs concluent avec des suggestions d’axes de recherches appliquées afin de remédier aux cinq problématiques majeures. L’article vise à aider les gestionnaires privés, publics, associatifs et les citoyens dans leurs efforts pour assurer la pérennité du tourisme de chasse dans un esprit de développement durable.
Des représentations aux incidences socio-spatiales du tourisme de routard
Authors: Delmas Antoine 
Published: June 2016

À travers l’exemple du Groenland, cet article propose d’explorer toute la complexité des relations qui existent entre les expériences touristiques traditionnelles et routardes. L’appréhension conjointe de ces deux formes de tourisme dévoile des singularités mais révèle aussi de nombreux points communs. L’article invite alors à repenser la distinction usuelle qui oppose ces expériences. Outre la compréhension des comportements du routard et de ses motivations, le parti pris scientifique de cet article est également de révéler les incidences spatiales de cette expérience touristique. En raison de la marginalité des flux, l’analyse des effets spatiaux a souvent été délaissée. À partir d’une étude de cas sur le tourisme de routard au Groenland, l’article montre comment cette clientèle représente la fréquentation historique et comment elle joue un rôle déclencheur dans la dynamique de mise en tourisme. Encore aujourd’hui, elle est la principale instigatrice du processus de touristification et ouvre la voie à un tourisme plus conventionnel.