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  1. Article: Accelerating the transition of new tuberculosis drug combinations from Phase II to Phase III trials: New technologies and innovative designs

    Davies, Geraint

    PLoS medicine, 16(7):e1002851

    2019  

    Abstract: SUMMARY POINTS: (*) Preclinical models of tuberculosis have significant limitations in selecting composition and duration of regimens for tuberculosis. (*) Innovative early-phase clinical trial methodologies and technologies have the potential to reduce ... ...

    Abstract SUMMARY POINTS: (*) Preclinical models of tuberculosis have significant limitations in selecting composition and duration of regimens for tuberculosis. (*) Innovative early-phase clinical trial methodologies and technologies have the potential to reduce risk and accelerate drug development in tuberculosis. (*) Phase IIA monotherapy studies are optional for proof of concept but may be useful for dose-finding in conjunction with pharmacokinetic–pharmacodynamic methods. (*) Innovative Phase IIB designs are increasingly common in tuberculosis drug development, utilising multiarm selection designs, sometimes in an adaptive format. (*) Novel biomarkers including liquid culture and nucleic acid amplification appear capable of replacing conventional solid culture in early-phase development. (*) Phase IIC and ultrashort noninferiority designs attempt to mitigate the problem of estimating duration of treatment regimens from Phase II results alone.
    Keywords Clinical trials ; Drug therapy ; Drug research and development ; Mycobacterium tuberculosis ; Phase II clinical investigation ; Phase III clinical investigation ; Toxicity ; Tuberculosis
    Language English
    Document type Article
    Database Repository for Life Sciences

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  2. Book ; Online: Chapter 9 Which Patient Takes Centre Stage? : Placing Patient Voices in Animal Research

    Davies, Gail / Gorman, Richard / Crudgington, Bentley

    2020  

    Keywords Biomedical engineering ; medicine ; human patients ; animal research ; biomedical research
    Size 1 electronic resource (15 pages)
    Publisher Springer Nature
    Document type Book ; Online
    Note English ; Open Access
    HBZ-ID HT021048349
    ISBN 978-3-030-21406-7 ; 3-030-21406-0
    Database ZB MED Catalogue: Medicine, Health, Nutrition, Environment, Agriculture

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  3. Article ; Online: POLLEN DIAGRAMS FROM NORTHUMBERLAND.

    Davies, G / Turner, J

    The New phytologist

    2022  Volume 82, Issue 3, Page(s) 783–804

    Abstract: Pollen diagrams from four sites in Northumberland have been produced in order to study the impact of prehistoric man on the vegetation of the region since Neolithic times. The major vegetational changes have been radiocarbon dated at Fellend, Steng and ... ...

    Abstract Pollen diagrams from four sites in Northumberland have been produced in order to study the impact of prehistoric man on the vegetation of the region since Neolithic times. The major vegetational changes have been radiocarbon dated at Fellend, Steng and Camp Hill Mosses, but not at Broad Moss. There is evidence at all four sites for small temporary clearances in the woodlands during the Bronze Age and also during the pre-Roman Iron Age. These clearances were mainly for grazing and their frequency at a site accords well with the archaeological evidence for settlement. All the diagrams show a major clearance of forest, primarily for pasture, dated at Fellend and Steng Mosses to the time of the Roman occupation of the north-east of England. At Camp Hill this clearance gave a late medieval date, but there is good reason for suspecting the sample may have been contaminated with
    Language English
    Publishing date 2022-11-04
    Publishing country England
    Document type Journal Article
    ZDB-ID 208885-x
    ISSN 1469-8137 ; 0028-646X
    ISSN (online) 1469-8137
    ISSN 0028-646X
    DOI 10.1111/j.1469-8137.1979.tb01673.x
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Bonn / Germany

    Z 868: Show issues

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  4. Article: Locating the 'culture wars' in laboratory animal research: national constitutions and global competition.

    Davies, Gail

    Studies in history and philosophy of science

    2021  Volume 89, Page(s) 177–187

    Abstract: The increasingly global scope of biomedical research and testing using animals is generating disagreement over the best way to regulate laboratory animal science and care. Despite many common aims, the practices through which political and epistemic ... ...

    Abstract The increasingly global scope of biomedical research and testing using animals is generating disagreement over the best way to regulate laboratory animal science and care. Despite many common aims, the practices through which political and epistemic authority are allocated in the regulations around animal research varies internationally, coming together in what can be identified as different national constitutions. Tensions between these periodically erupt within the laboratory animal research community as a 'cultural war' between those favouring centralised control and those advocating local flexibility. Drawing on long-term engagement with key events and actors in these policy debates, I propose these national differences in the constitution of animal research can be understood through the intersection of two key variables: i) the location of institutional responsibility to permit research projects and ii) the distribution of epistemic authority to shape research practices. These variables are used to explain the development of different policy frameworks in the UK, Europe, and the USA, and identify where there is convergence and divergence in practice. Concluding, I suggest the way these approaches are combined and enacted in different countries reflects different national civic epistemologies, which are coming into conflict in the increasingly global networks of laboratory animal science.
    MeSH term(s) Animal Experimentation ; Animals ; Animals, Laboratory ; Dissent and Disputes ; Europe
    Language English
    Publishing date 2021-08-26
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 202358-1
    ISSN 1879-2510 ; 0039-3681
    ISSN (online) 1879-2510
    ISSN 0039-3681
    DOI 10.1016/j.shpsa.2021.08.010
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Bonn / Germany

    Z 91/732: Show issues

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  5. Article ; Online: Does newborn screening improve early lung function in cystic fibrosis?

    Davies, Gwyneth

    Paediatric respiratory reviews

    2020  Volume 42, Page(s) 17–22

    Abstract: Despite evidence showing an improvement in nutritional outcomes following diagnosis by newborn screening (NBS) for cystic fibrosis (CF), the impact on pulmonary outcomes has been less clear. In this review the approaches to measurement of early lung ... ...

    Abstract Despite evidence showing an improvement in nutritional outcomes following diagnosis by newborn screening (NBS) for cystic fibrosis (CF), the impact on pulmonary outcomes has been less clear. In this review the approaches to measurement of early lung function and knowledge gained from NBS CF cohorts will be described. Studies which have compared outcomes in those diagnosed by NBS to those diagnosed following symptomatic presentation will be presented. Compiling the evidence base used to evaluate the impact of NBS on pulmonary outcomes has been complicated by improvements in clinical management, infection control practices, as well as public health interventions (such as tobacco smoking bans in public places) that have evolved substantially over recent decades. Forced expiratory volumes have been used as the main outcome but it is important not to draw conclusions for 'early lung function' from tests such as spirometry alone, which lack sensitivity in early lung disease. There is, at present, insufficient evidence to draw firm conclusions about the effect of NBS on early lung function. In an era of highly effective treatments targeting the underlying molecular defect responsible for CF, future opportunities for early initiation of treatment may mean that the impact of NBS on early lung function may yet to be realised.
    MeSH term(s) Cystic Fibrosis/complications ; Forced Expiratory Volume ; Humans ; Infant, Newborn ; Lung ; Neonatal Screening ; Treatment Outcome
    Language English
    Publishing date 2020-08-20
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2147664-0
    ISSN 1526-0550 ; 1526-0542
    ISSN (online) 1526-0550
    ISSN 1526-0542
    DOI 10.1016/j.prrv.2020.08.005
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 5919: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

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  6. Article ; Online: Trial emulation with observational data in cystic fibrosis.

    Davies, Gwyneth / Keogh, Ruth H

    The Lancet. Respiratory medicine

    2023  Volume 11, Issue 10, Page(s) 859–861

    MeSH term(s) Humans ; Cystic Fibrosis
    Language English
    Publishing date 2023-09-09
    Publishing country England
    Document type Journal Article
    ZDB-ID 2686754-0
    ISSN 2213-2619 ; 2213-2600
    ISSN (online) 2213-2619
    ISSN 2213-2600
    DOI 10.1016/S2213-2600(23)00328-4
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 7041: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

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  7. Article ; Online: Why is William Sharp's name forgotten when his novel method for treating fractures of the Ankle is still used today?

    Hughes, Sean P / Davies, G Anne

    Journal of medical biography

    2022  Volume 31, Issue 2, Page(s) 85–94

    Abstract: In 1837 Guillaume von Dupuytren (1777-1835) wrote that the innovative method of reducing an ankle fracture by relaxing the calf muscles was due to both William Sharp (1729-1810) and Percivall Pott (1714-1788). While history records the many surgical ... ...

    Abstract In 1837 Guillaume von Dupuytren (1777-1835) wrote that the innovative method of reducing an ankle fracture by relaxing the calf muscles was due to both William Sharp (1729-1810) and Percivall Pott (1714-1788). While history records the many surgical achievements of Percivall Pott, little is known of William Sharp's contribution. He is probably best known as one of a remarkable family portrayed by Johan Zoffany (1733-1810) and exhibited at the Royal Academy in 1781. We review William Sharp's career and contribution as a surgeon to the treatment of fracture/dislocations of the ankle and ask why his concept is not better known today.
    MeSH term(s) Male ; Humans ; Ankle ; Names
    Language English
    Publishing date 2022-03-23
    Publishing country England
    Document type Review ; Journal Article
    ZDB-ID 1159267-9
    ISSN 1758-1087 ; 0967-7720
    ISSN (online) 1758-1087
    ISSN 0967-7720
    DOI 10.1177/09677720221082103
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 3995: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

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  8. Article ; Online: The Epidemic Severity Index: Estimating Relative Local Severity of Novel Disease Outbreaks

    Davies, Gareth

    Abstract: Determining the severity of a novel pathogen in the early stages is difficult in the absence of reliable data. The pattern of outbreaks for COVID-19 across the globe have differed markedly above and below +40N latitudes, suggesting very different levels ... ...

    Abstract Determining the severity of a novel pathogen in the early stages is difficult in the absence of reliable data. The pattern of outbreaks for COVID-19 across the globe have differed markedly above and below +40N latitudes, suggesting very different levels of severity, but countries worldwide have implemented the same lockdown strategies. Existing methods for estimating severity appear not to have been useful in informing strategic decisions, possibly due to mismatches between the data required and those available, overly sophisticated methods with undesirable biases, or perhaps confusion and uncertainly generated by the wide range of estimates these methods produced early on. The Epidemic Severity Index (ESI) is a simple, robust method for estimating the local severity of novel epidemic outbreaks using early and widely-available data and that does not depend on any estimated values. ESI allows rapid, meaningful comparisons across territories that can be tracked as the outbreaks unfold. The ESI quantifies severity relative to a parameterised baseline rather than attempting to estimate values for infection fatality rates, case fatality rates or transmission rates. The relative nature of the ESI sidesteps any problems of confidence associated with absolute rate estimation methods and offers immediate practical strategic value.
    Keywords covid19
    Publisher MedRxiv; WHO
    Document type Article ; Online
    DOI 10.1101/2020.04.23.20077685
    Database COVID19

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  9. Article ; Online: The Epidemic Severity Index: Estimating Relative Local Severity of Novel Disease Outbreaks

    Davies, Gareth

    medRxiv

    Abstract: Determining the severity of a novel pathogen in the early stages is difficult in the absence of reliable data. The pattern of outbreaks for COVID-19 across the globe have differed markedly above and below +40N latitudes, suggesting very different levels ... ...

    Abstract Determining the severity of a novel pathogen in the early stages is difficult in the absence of reliable data. The pattern of outbreaks for COVID-19 across the globe have differed markedly above and below +40N latitudes, suggesting very different levels of severity, but countries worldwide have implemented the same lockdown strategies. Existing methods for estimating severity appear not to have been useful in informing strategic decisions, possibly due to mismatches between the data required and those available, overly sophisticated methods with undesirable biases, or perhaps confusion and uncertainly generated by the wide range of estimates these methods produced early on. The Epidemic Severity Index (ESI) is a simple, robust method for estimating the local severity of novel epidemic outbreaks using early and widely-available data and that does not depend on any estimated values. ESI allows rapid, meaningful comparisons across territories that can be tracked as the outbreaks unfold. The ESI quantifies severity relative to a parameterised baseline rather than attempting to estimate values for infection fatality rates, case fatality rates or transmission rates. The relative nature of the ESI sidesteps any problems of confidence associated with absolute rate estimation methods and offers immediate practical strategic value.
    Keywords covid19
    Language English
    Publishing date 2020-04-29
    Publisher Cold Spring Harbor Laboratory Press
    Document type Article ; Online
    DOI 10.1101/2020.04.23.20077685
    Database COVID19

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  10. Book ; Online: HM Treasury, HM Revenue and Customs

    Davies, Gareth

    implementing employment support schemes in response to the COVID-19 pandemic : report by the Comptroller and Auditor General

    2020  

    Keywords covid19
    Language English
    Publisher National Audit Office
    Publishing country uk
    Document type Book ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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