scholarly journals The DataCite MDC Stack

Author(s):  
Martin Fenner

In May, the Make Data Count team announced that we have received additional funding from the Alfred P. Sloan Foundation for work on the Make Data Count (MDC) initiative. This will enable DataCite to do additional work in two important areas:Implement ...

Author(s):  
Valeriy S. Gerasimov ◽  
Vladimir I. Ignatov ◽  
Konstantin G. Sovin

According to forecasts for 2022, the number of self-propelled agricultural machinery that will fail will be about 100 thousand units. This will have a significant impact on the overall productivity in the field of agricultural production and will require additional financial costs for effective resource-saving environmental-oriented utilization of agricultural machinery with the maximum recovery of secondary resources in the processing of its components. (Research purpose) The research purpose is considering the main life cycles of machinery, including agricultural, and determining the possibility of obtaining secondary resources in the recycling of components of machinery and equipment. (Materials and methods) The authors found that the establishment of an industry-wide recycling system would allow the reuse of usable and recovered parts obtained from decommissioned equipment, as well as receive additional funding from the sale of secondary resources. The authors have found that for the functioning of the whole system, it is necessary to work with a large amount of data related to the ongoing recycling processes, as well as constantly monitor changes in the state and properties of materials. They also found that the maximum use of digital technology is the only way to combine all these requirements and make the system work. (Results and discussion) The article reviews the key points of the use of life cycle method for equipment, including agricultural, reviews the state of machine and tractor park of agro-industrial complex, shows the possibility of using resource-saving ecologically oriented branch system of recycling of agricultural machinery, as well as the movement of waste and material flows in the processing components of utilized machines. (Conclusion) The article presents recommendations on the possibility of efficient disposal of equipment, including agricultural, with the maximum recovery of secondary resources from recycled waste.


Author(s):  
Virginia Ronco ◽  
Myriam Dilecce ◽  
Elena Lanati ◽  
Pier Luigi Canonico ◽  
Claudio Jommi

Abstract Background Advanced therapy medicinal products (ATMPs) represent an important cornerstone for innovation in healthcare. However, uncertainty on the value, the high average cost per patient and their one-shot nature has raised a debate on their assessment and appraisal process for pricing and reimbursement (P&R) purposes. This debate led experts providing for recommendations on this topic. Our primary objective is to investigate the ATMPs P&R process in the main five European countries and to understand if this process is consistent with published P&R expert recommendations. We also investigated the current ATMP pipelines to understand if future ATMPs will create challenges for their P&R process. Methods P&R framework for ATMPs in the European Major five (EU5) countries was investigated through a literature search on PubMed, institutional websites of National Health Authorities and grey literature. The ATMPs pipeline database was populated from a clinical trial database (clinicaltrials.gov), relying on inclusion and exclusion criteria retrieved from the literature. Results Reimbursement status of ATMPs is different across the EU5 countries, with the exception of CAR-Ts which are reimbursed in all countries. Standard P&R process in place for other medicinal products is extended to ATMPs, with the exception of some cases in Germany. List prices, where available, are high and, tend to be aligned across countries. Outcome-based Managed Entry Agreements (MEAs) have been extensively used for ATMPs. Extra-funds for hospitals managing ATMPs were provided only in Germany and, as additional fund per episode, in France. The accreditation process of hospitals for ATMPs management was in most countries managed by the national authorities. As far as ATMPs pipeline is concerned, ATMPs in development are mostly targeting non-rare diseases. Conclusions Expert recommendations for ATMPs P&R were partially applied: the role of outcome-based MEAs has increased and the selection process of the centres authorized to use these treatments has been enhanced; additional funding for ATMPs management to accredited centres has not been completely considered and annuity payment and broader perspective in cost considerations are far from being put in place. These recommendations should be considered for future P&R negotiations to pursue rational resource allocation and deal with budget constraints.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Dena R. Howard ◽  
Anna Hockaday ◽  
Julia M. Brown ◽  
Walter M. Gregory ◽  
Susan Todd ◽  
...  

Abstract Background The FLAIR trial in chronic lymphocytic leukaemia has a randomised, controlled, open-label, confirmatory, platform design. FLAIR was successfully amended to include an emerging promising experimental therapy to expedite its assessment, greatly reducing the time to reach the primary outcome compared to running a separate trial and without compromising the validity of the research or the ability to recruit to the trial and report the outcomes. The methodological and practical issues are presented, describing how they were addressed to ensure the amendment was a success. Methods FLAIR was designed as a two-arm trial requiring 754 patients. In stage 2, two new arms were added: a new experimental arm and a second control arm to protect the trial in case of a change in practice. In stage 3, the original experimental arm was closed as its planned recruitment target was reached. In total, 1516 participants will be randomised to the trial. Results The changes to the protocol and randomisation to add and stop arms were made seamlessly without pausing recruitment. The statistical considerations to ensure the results for the original and new hypotheses are unbiased were approved following peer review by oversight committees, Cancer Research UK, ethical and regulatory committees and pharmaceutical partners. These included the use of concurrent comparators in case of any stage effect, appropriate control of the type I error rate and consideration of analysis methods across trial stages. The operational aspects of successfully implementing the amendments are described, including gaining approvals and additional funding, data management requirements and implementation at centres. Conclusions FLAIR is an exemplar of how an emerging experimental therapy can be assessed within an existing trial structure without compromising the conduct, reporting or validity of the trial. This strategy offered considerable resource savings and allowed the new experimental therapy to be assessed within a confirmatory trial in the UK years earlier than would have otherwise been possible. Despite the clear efficiencies, treatment arms are rarely added to ongoing trials in practice. This paper demonstrates how this strategy is acceptable, feasible and beneficial to patients and the wider research community. Trial registration ISRCTN Registry ISRCTN01844152. Registered on August 08, 2014


Author(s):  
Samit N. Unadkat ◽  
Alfonso Luca Pendolino ◽  
Deborah Auer ◽  
Sadie Khwaja ◽  
Premjit S. Randhawa ◽  
...  

AbstractEver since the introduction of the concept of Procedures of Limited Clinical Value (PoLCV), procedures such as functional septorhinoplasty have been subject to additional funding restrictions within the British National Health Service. Recent publications have suggested that 10% of Clinical Commissioning Groups in the United Kingdom no longer fund septorhinoplasty surgery irrespective of the indications, including congenital malformations or post-trauma, and despite the strong evidence available in the literature in treating a range of health conditions. Thus, inequity exists across the country. At present functional septorhinoplasty surgery is frequently but incorrectly grouped together with aesthetic rhinoplasty, both of which are deemed to be cosmetic interventions. Moreover, as we exit the peak of the current coronavirus disease 2019 (COVID-19) pandemic, procedures deemed to be of lower clinical priority will potentially be at risk throughout Europe. The purpose of this review is twofold; the first is to put forward the evidence to commissioners in favor of functional septorhinoplasty surgery on patient well-being and mental health; the second is to demonstrate why functional septorhinoplasty surgery is a distinct procedure from aesthetic rhinoplasty and why it ought not to be classified as a procedure of limited clinical value.


1983 ◽  
Vol 92 (6_suppl) ◽  
pp. 30-30
Author(s):  
R. A. Friedman ◽  
W. J. Doyle ◽  
J. Fagin ◽  
C. D. Bluestone ◽  
P. Fireman

Allergic and other immune mechanisms have been suggested as important in the etiology and pathogenesis of OME, and both humoral and cellular components of the immune response have been identified in MEEs obtained from patients with OME. Yet, specific and direct documentation of an immune basis for OME has not been forthcoming. To establish a causal relationship between an immune hypersensitivity and middle ear pathophysiology, a provocative intranasal antigen challenge test has been designed using the nine-step inflation-deflation tympanometric test for ET dysfunction. These initial studies were undertaken by OMRC personnel in association with the allergy and immunology service. Subsequently, on the basis of the preliminary observations additional funding was obtained (NIAID AI 19262) to confirm and extend these studies to document antigen-induced ET dysfunction in allergic adults and children, and to establish a clinical relevance for antigen-induced ET dysfunction. Because questions concerning the etiology and pathogenesis required invasive techniques and are not suitable in humans, a monkey animal model has also been developed. Our future plans will be to further develop the monkey model of OME employing IgE and other immune reactions in monkeys with normal ET function, or with compromised, surgically created ET function. The experimental MEE will be assayed for immune components, including IgA and its secretory piece; IgG, IgM, and IgE, total complement; C3, C4, and cells including polymorphonuclear leukocytes, eosinophils, and lymphocytes (both T and B cells). Since OME is mainly a disease of the young child, it is essential that age-related differences be explored in each aspect of our experimental model. The reversal and prevention of ET dysfunction and/or OME with several drugs, including cromolyn, steroids, and antihistamines, will be studied in humans and in the monkey model.


2014 ◽  
Vol 23 (3) ◽  
pp. 373 ◽  
Author(s):  
Eva Marino ◽  
Carmen Hernando ◽  
Rosa Planelles ◽  
Javier Madrigal ◽  
Mercedes Guijarro ◽  
...  

Spain is one of the Mediterranean countries most severely affected by wildfires during the last 30 years, despite enhanced fire suppression efforts. At present, forest area is increasing more in Spain than in any other European country, and also has one of the highest densities of fire ignitions. However, forest management plans have been developed for only 13% of Spanish forest areas. The objective of the present study was to assess the role of forest fuel management for wildfire prevention in Spain. Different fuel management techniques, including mechanical treatments, prescribed burning and controlled grazing, were considered. A quantitative SWOT (Strengths, Weaknesses, Opportunities and Threats) analysis was performed, based on a thorough documentation review and on the opinions of forest fire experts. Results enabled the identification of obstacles that hinder the implementation of effective fuel management, and suggested strategic recommendations to overcome them. New opportunities related to rural development activities (e.g. promotion of ‘FIRESMART’ products) would be highly relevant in fire-prone forest areas. These opportunities should provide additional funding for sustainable forest management and could foster fuel management activities that would directly involve and benefit rural populations.


2018 ◽  
Vol 33 (2) ◽  
pp. 70-76 ◽  
Author(s):  
Joanne Copeland

The Pupil Premium Grant was introduced in 2011 with the aim to ‘close’ the attainment gap within education between children classified as disadvantaged and their peers. However, recent research has shown that this gap appears to be widening across the education sector. This article explores the reasons why the Pupil Premium Grant was introduced, giving commentary on the political rationale behind the additional funding. It asks whether the Pupil Premium Grant can ever hope to counteract the impact of a child’s socioeconomic background, especially when successive governments have continually changed political educational interventions. Parental engagement is also discussed, and the influence of a home learning environment demonstrated. The impact socioeconomic background has on cognitive development is also highlighted. Finally, successful strategies for using the Pupil Premium Grant are debated. It is suggested that currently there is no way to determine whether the Pupil Premium Grant is counteracting such a deep-rooted educational issue.


Author(s):  
Svend Larsen

In December 2004 the Danish parliament passed a new act on legal deposit which brought together all regulations concerning the collection and preservation of works published in Denmark, irrespective of type and format. The act covers works published in a physical format, works published on the Internet, radio and television broadcasts, and motion pictures. The responsibility for collecting and preserving this material (apart from motion pictures) is shared by the Royal Library and the State and University Library, and the article describes the procedures by which this responsibility will be discharged. Additional funding was secured to develop a system to meet the challenges of Internet harvesting and web archiving, and the new Danish Net Archive was ready to operate when the new law came into force on 1 July 2005. The article also considers the requirement for long-term preservation of digital material and the regulation of access to it, since both are seen as essential components in Denmark's initiatives to safeguard the nation's cultural heritage and to increase access to it.


Author(s):  
Christopher R. Martin

This paper describes a method using electrical characteristics of the torch, flame, and work piece to replace active sensing elements most commonly used for mechanized oxyfuel cutting applications; height, fuel/oxygen ratio, work temperature, and preheat flow rate. Calibrations are given for the torch under test for standoff accurate to ±1/32 in (0.8 mm) and F/O ratio accurate to ±.008. Methods are proposed for balancing flow across multi-torch systems, and detecting the work kindling temperature. Additional work is needed if calibrated flow and work temperatures are to be measured electrically.


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