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Article ; Online: Further disorientation in the hall of mirrors.

Wynne, Brian

Public understanding of science (Bristol, England)

2014 Volume 23, Issue 1, Page(s) 60–70

Abstract: This paper reviews some changes and continuities in science-society relations which have shaped this journal's birth and development. I argue that the main focus on publics has been developed with insufficient primary attention to problematising what is ... ...

Abstract	This paper reviews some changes and continuities in science-society relations which have shaped this journal's birth and development. I argue that the main focus on publics has been developed with insufficient primary attention to problematising what is meant by 'science' in its variable public forms, including discourses. We cannot understand 'publics' in relation to 'science', unless we also ask, searchingly, what is it that they experience as such, in all its multiple self-contradictions and confusions? Thus I reiterate the point made in the inaugural issue, still neglected in mainstream science and policy, that 'science' needs to be critically addressed in several dimensions, as part of public understanding of science research. First, instrumental pragmatic scientific meanings, useful in their own parochial situations, should not be given automatic sovereignty in public issues. Second, public concerns where they exist should not be interpreted and judged against this presumptively entrenched scientistic normative baseline.
MeSH term(s)	Community Participation ; Hermeneutics ; Humans ; Politics ; Public Opinion ; Public Policy ; Science/organization & administration
Language	English
Publishing date	2014-01
Publishing country	England
Document type	Journal Article
ZDB-ID	1421272-9
ISSN	1361-6609 ; 0963-6625
ISSN (online)	1361-6609
ISSN	0963-6625
DOI	10.1177/0963662513505397
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Article ; Online: Dolutegravir + Lamivudine vs. Dolutegravir + Tenofovir Disoproxil Fumarate/Emtricitabine: Very-Low-Level HIV-1 Replication through 144 Weeks in the GEMINI-1 and GEMINI-2 Studies.

Underwood, Mark / Urbaityte, Rimgaile / Wang, Ruolan / Horton, Joe / Oyee, James / Wynne, Brian / Fox, Dainielle / Jones, Bryn / Man, Choy / Sievers, Jörg

Viruses

2024 Volume 16, Issue 3

Abstract: In GEMINI-1/-2, dolutegravir + lamivudine was non-inferior to dolutegravir + tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in achieving viral suppression (viral load [VL] < 50 copies/mL) in treatment-naive adults. Abbott's RealTime HIV-1 assay ... ...

Abstract	In GEMINI-1/-2, dolutegravir + lamivudine was non-inferior to dolutegravir + tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in achieving viral suppression (viral load [VL] < 50 copies/mL) in treatment-naive adults. Abbott's RealTime HIV-1 assay provides quantitative VL (40-10,000,000 copies/mL) and qualitative target detected or target not detected (TND) for VL < 40 copies/mL. This post hoc analysis assessed very-low-level viremia and "blips" through Week 144. Proportions with VL < 40 copies/mL and TND are presented overall and by baseline VL and CD4+ cell count. "Blips" (single VL ≥ 50 to <200 copies/mL with adjacent values < 50 copies/mL) were assessed from Day 1 after VL suppression and from Weeks 48 through to 144. Proportions with TND increased through Week 48 and were similar between groups at all visits (Week 144: dolutegravir + lamivudine, 451/716 [63%]; dolutegravir + TDF/FTC, 465/717 [65%]). By observed analysis, TND rates were similar between groups across baseline subgroups. Through Week 144, proportions with ≥1 "blip" were generally comparable for dolutegravir + lamivudine vs. dolutegravir + TDF/FTC from Day 1 (15% vs. 20%) and from Week 48 (7% vs. 11%). Through 144 weeks, the proportions with TND or "blips" were similar between dolutegravir + lamivudine and the three-drug comparator, reinforcing the efficacy and durability of dolutegravir + lamivudine.
MeSH term(s)	Adult ; Humans ; Lamivudine/therapeutic use ; Emtricitabine/therapeutic use ; Tenofovir/therapeutic use ; HIV Infections/drug therapy ; Anti-HIV Agents/therapeutic use ; HIV-1 ; Drug Therapy, Combination ; Heterocyclic Compounds, 3-Ring/therapeutic use ; HIV Seropositivity ; Viral Load ; Virus Replication ; Oxazines ; Piperazines ; Pyridones
Chemical Substances	Lamivudine (2T8Q726O95) ; Emtricitabine (G70B4ETF4S) ; Tenofovir (99YXE507IL) ; dolutegravir (DKO1W9H7M1) ; Anti-HIV Agents ; Heterocyclic Compounds, 3-Ring ; Oxazines ; Piperazines ; Pyridones
Language	English
Publishing date	2024-03-06
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2516098-9
ISSN	1999-4915 ; 1999-4915
ISSN (online)	1999-4915
ISSN	1999-4915
DOI	10.3390/v16030405
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Article: Efficacy and Safety of Switching to Dolutegravir/Lamivudine Versus Continuing a Tenofovir Alafenamide-Based Regimen in Virologically Suppressed Adults With Human Immunodeficiency Virus Type 1: Subgroup Analysis of Participants With Elvitegravir as Baseline Third Agent From the TANGO Study.

Ait-Khaled, Mounir / Oyee, James / Ooi, Adrian Yit Reen / Wynne, Brian / Maldonado, Andres / Jones, Bryn / Wang, Tao

Open forum infectious diseases

2024 Volume 11, Issue 5, Page(s) ofae227

Abstract: TANGO results have established the durable efficacy of dolutegravir/lamivudine in virologically suppressed individuals who switched from 3- or 4-drug tenofovir alafenamide (TAF)-based regimens. In this post hoc subgroup analysis, 144-week efficacy and ... ...

Abstract	TANGO results have established the durable efficacy of dolutegravir/lamivudine in virologically suppressed individuals who switched from 3- or 4-drug tenofovir alafenamide (TAF)-based regimens. In this post hoc subgroup analysis, 144-week efficacy and tolerability of dolutegravir/lamivudine in participants who switched from elvitegravir/cobicistat/emtricitabine/TAF were consistent with the overall switch population. Clinical trials registration: NCT03446573.
Language	English
Publishing date	2024-05-02
Publishing country	United States
Document type	Clinical Trial
ZDB-ID	2757767-3
ISSN	2328-8957
ISSN	2328-8957
DOI	10.1093/ofid/ofae227
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Article: GMO regulations and their interpretation: how EFSA’s guidance on risk assessments of GMOs is bound to fail

Hilbeck, Angelika / Meyer, Hartmut / Wynne, Brian / Millstone, Erik

Environmental sciences Europe. 2020 Dec., v. 32, no. 1

2020

Abstract: We identify the origins, and key characteristics, of the current regulatory framework for genetically modified organisms (GMOs) in the European Union (EU). We focus on the approach of the European Food Safety Authority (EFSA) to assessing GMO risks to ... ...

Abstract	We identify the origins, and key characteristics, of the current regulatory framework for genetically modified organisms (GMOs) in the European Union (EU). We focus on the approach of the European Food Safety Authority (EFSA) to assessing GMO risks to public and environmental health. An historical account informs our critical appraisal of the current practices of EFSA’s GMO panel, and helps to explain how and why it fails to satisfy the objectives of the EU’s GMO legislation. While those legislative texts set appropriate objectives, their concrete implementation has fallen far short of the legislative goals. EFSA’s prevailing approach to GM crop and food risk assessment starts from what it terms a ‘comparative safety assessment’. Those comparisons require the scrutiny of sets of molecular, chemical and phenotypic data from GM plants and non-GM varieties (many of which may be only remotely related to the GM variety). Those data are, however, inadequate for predicting adverse biological, toxicological and ecological effects. EFSA’s ‘comparative safety assessments’ draw over-optimistic conclusions from too little data from too few studies. When GM products are deemed to have passed a ‘comparative safety assessment’, EFSA has interpreted that as grounds for conducting only very narrowly circumscribed risk assessments, which have not required meaningful data from studies of ecological or eco-toxicological impacts. This is a reductionist approach to risk assessment, when a more inclusive and comprehensive approach, which we outline, is scientifically available, and also more likely to meet the specified legislative aims. Instead, however, the reductionist choice is systematically applied, but never justified nor acknowledged as such. Indeed, it is concealed, by EFSA and by its main policy client the European Commission, as if it were only for specialist expert scientific deliberation. Thus, key questions that sound scientific assessments should ask about potential harm are not even posed, let alone answered—or at least, they are ‘answered’ only by default, given that the implicit burden of proof requires harm to be demonstrated. Furthermore, and a key point of this paper, we show how the problematic features of EFSA’s approach have been premised on a set of evaluative policy judgements, rather than purely scientific considerations. Responsibility for selecting how EFSA frames its scientific approach should however lie with European Commission risk managers, and not with EFSA. These problems might have been and could be avoided if explicit commitments entered into by the EU at the Codex Alimentarius Commission were implemented by the European Commission and EFSA were instructed accordingly.
Keywords	Codex Alimentarius ; European Union ; concrete ; environmental health ; environmental impact ; food safety ; genetically modified plants ; issues and policy ; objectives ; paper ; phenotype ; prediction ; risk ; risk assessment ; risk managers ; safety assessment ; toxicology ; varieties ; Europe
Language	English
Dates of publication	2020-12
Size	p. 54.
Publishing place	Springer Berlin Heidelberg
Document type	Article
Note	NAL-light ; Review
ZDB-ID	2593962-2
ISSN	2190-4715 ; 2190-4707
ISSN (online)	2190-4715
ISSN	2190-4707
DOI	10.1186/s12302-020-00325-6
Database	NAL-Catalogue (AGRICOLA)

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Article: GMO regulations and their interpretation: how EFSA’s guidance on risk assessments of GMOs is bound to fail

Hilbeck, Angelika / Meyer, Hartmut / Wynne, Brian / Millstone, Erik

Environmental sciences Europe. 2020 Dec., v. 32, no. 1

2020

Abstract	We identify the origins, and key characteristics, of the current regulatory framework for genetically modified organisms (GMOs) in the European Union (EU). We focus on the approach of the European Food Safety Authority (EFSA) to assessing GMO risks to public and environmental health. An historical account informs our critical appraisal of the current practices of EFSA’s GMO panel, and helps to explain how and why it fails to satisfy the objectives of the EU’s GMO legislation. While those legislative texts set appropriate objectives, their concrete implementation has fallen far short of the legislative goals. EFSA’s prevailing approach to GM crop and food risk assessment starts from what it terms a ‘comparative safety assessment’. Those comparisons require the scrutiny of sets of molecular, chemical and phenotypic data from GM plants and non-GM varieties (many of which may be only remotely related to the GM variety). Those data are, however, inadequate for predicting adverse biological, toxicological and ecological effects. EFSA’s ‘comparative safety assessments’ draw over-optimistic conclusions from too little data from too few studies. When GM products are deemed to have passed a ‘comparative safety assessment’, EFSA has interpreted that as grounds for conducting only very narrowly circumscribed risk assessments, which have not required meaningful data from studies of ecological or eco-toxicological impacts. This is a reductionist approach to risk assessment, when a more inclusive and comprehensive approach, which we outline, is scientifically available, and also more likely to meet the specified legislative aims. Instead, however, the reductionist choice is systematically applied, but never justified nor acknowledged as such. Indeed, it is concealed, by EFSA and by its main policy client the European Commission, as if it were only for specialist expert scientific deliberation. Thus, key questions that sound scientific assessments should ask about potential harm are not even posed, let alone answered—or at least, they are ‘answered’ only by default, given that the implicit burden of proof requires harm to be demonstrated. Furthermore, and a key point of this paper, we show how the problematic features of EFSA’s approach have been premised on a set of evaluative policy judgements, rather than purely scientific considerations. Responsibility for selecting how EFSA frames its scientific approach should however lie with European Commission risk managers, and not with EFSA. These problems might have been and could be avoided if explicit commitments entered into by the EU at the Codex Alimentarius Commission were implemented by the European Commission and EFSA were instructed accordingly.
Keywords	Codex Alimentarius ; European Union ; concrete ; environmental health ; environmental impact ; food safety ; genetically modified plants ; issues and policy ; phenotype ; prediction ; risk assessment ; risk managers ; safety assessment ; toxicology
Language	English
Dates of publication	2020-12
Size	p. 54.
Publishing place	Springer Berlin Heidelberg
Document type	Article
Note	Review
ZDB-ID	2593962-2
ISSN	2190-4715 ; 2190-4707
ISSN (online)	2190-4715
ISSN	2190-4707
DOI	10.1186/s12302-020-00325-6
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Intolerance: science informs, not defines.

Wynne, Brian

Nature

2011 Volume 471, Issue 7338, Page(s) 305

MeSH term(s)	Humans ; Policy Making ; Public Relations ; Science ; United Kingdom
Language	English
Publishing date	2011-03-17
Publishing country	England
Document type	Letter
ZDB-ID	120714-3
ISSN	1476-4687 ; 0028-0836
ISSN (online)	1476-4687
ISSN	0028-0836
DOI	10.1038/471305b
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Lab work goes social, and vice versa: strategising public engagement processes : commentary on: "What happens in the lab does not stay in the lab: applying midstream modulation to enhance critical reflection in the laboratory".

Wynne, Brian

Science and engineering ethics

2011 Volume 17, Issue 4, Page(s) 791–800

Abstract: Midstream modulation is a form of public engagement with science which benefits from strategic application of science and technology studies (STS) insights accumulated over nearly 20 years. These have been developed from STS researchers' involvement in ... ...

Abstract	Midstream modulation is a form of public engagement with science which benefits from strategic application of science and technology studies (STS) insights accumulated over nearly 20 years. These have been developed from STS researchers' involvement in practical engagement processes and research with scientists, science funders, policy and other public stakeholders. The strategic aim of this specific method, to develop what is termed second-order reflexivity amongst scientist-technologists, builds upon and advances earlier more general STS work. However this method is focused and structured so as to help generate such reflexivity-over the 'upstream' questions which have been identified in other STS research as important public issues for scientific research, development and innovation-amongst practising scientists-technologists in their specialist contexts (public or private, in principle). This is a different focus from virtually all such previous work, and offers novel opportunities for those key broader issues to be opened up. The further development of these promising results depends on some important conditions such as identifying and engaging research funders and other stakeholders like affected publics in similar exercises. Implementing these conditions could connect the productive impacts of midstream modulation with wider public engagement work, including with 'uninvited' public engagement with science. It would also generate broader institutional and political changes in the larger networks of institutional actors which constitute contemporary technoscientific innovation and governance processes. All of these various broader dimensions, far beyond the laboratory alone, need to be appropriately open, committed to democratic needs, and reflexive, for the aims of midstream modulation to be achieved, whilst allowing specialists to work as specialists.
MeSH term(s)	Cooperative Behavior ; Engineering/ethics ; Ethics, Research ; Humans ; Laboratories/ethics ; Science/ethics ; Social Responsibility ; Social Values
Language	English
Publishing date	2011-10-21
Publishing country	England
Document type	Journal Article ; Comment
ZDB-ID	2136491-6
ISSN	1471-5546 ; 1353-3452
ISSN (online)	1471-5546
ISSN	1353-3452
DOI	10.1007/s11948-011-9316-9
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Article ; Online: Editorial.

Rommetveit, Kjetil / Wynne, Brian

Public understanding of science (Bristol, England)

2017 Volume 26, Issue 2, Page(s) 128–132

MeSH term(s)	Communication ; Europe ; Information Dissemination ; Public Opinion ; Science ; Technology
Language	English
Publishing date	2017-02-06
Publishing country	England
Document type	Editorial ; Introductory Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1421272-9
ISSN	1361-6609 ; 0963-6625
ISSN (online)	1361-6609
ISSN	0963-6625
DOI	10.1177/0963662516685666
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Article ; Online: Technoscience, imagined publics and public imaginations.

Rommetveit, Kjetil / Wynne, Brian

Public understanding of science (Bristol, England)

2017 Volume 26, Issue 2, Page(s) 133–147

Abstract: This essay begins from the intensified entanglements of technoscientific innovation with miscellaneous societal and public fields of interest and action over recent years. This has been accompanied by an apparent decline in the work of purification of ... ...

Abstract	This essay begins from the intensified entanglements of technoscientific innovation with miscellaneous societal and public fields of interest and action over recent years. This has been accompanied by an apparent decline in the work of purification of discourses of natural and human agency, which Latour observed in 1993. Replacing such previous discursive purifications, we increasingly find technoscientific visions of the imagined-possible as key providers of public meanings and policies. This poses the question of what forms of legitimation are constituted by these sciences, including the ways in which they enter into articulations of public matters. Revisiting historical and contemporary theories of imagination and science, this essay proposes a joint focus on imagination, publics and technoscience and their mutual co-production over time. This focus is then directed towards recent reconfigurations of technosciences with their imagined publics and towards how public issues may become constituted by social actors as active imaginations-exercising agents.
MeSH term(s)	Imagination ; Public Opinion ; Public Policy ; Science ; Technology
Language	English
Publishing date	2017-02-07
Publishing country	England
Document type	Journal Article
ZDB-ID	1421272-9
ISSN	1361-6609 ; 0963-6625
ISSN (online)	1361-6609
ISSN	0963-6625
DOI	10.1177/0963662516663057
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Article ; Online: Effects of the HIV-1 maturation inhibitor GSK3640254 on QT interval in healthy participants.

Zhang, Ying / Bush, Mark / Yazdani, Parto / Zhan, Joyce / Wen, Bo / Bainbridge, Veronica / Wynne, Brian R / Joshi, Samit / Lataillade, Max

Pharmacology research & perspectives

2023 Volume 11, Issue 6, Page(s) e01151

Abstract: GSK3640254 (GSK'254) is a novel HIV-1 maturation inhibitor with pharmacokinetics supporting once-daily (QD) therapy for HIV-1 treatment. This thorough QT/corrected QT (QTc) study evaluated the effect of GSK'254 on cardiac repolarization. In this two-part, ...

Abstract	GSK3640254 (GSK'254) is a novel HIV-1 maturation inhibitor with pharmacokinetics supporting once-daily (QD) therapy for HIV-1 treatment. This thorough QT/corrected QT (QTc) study evaluated the effect of GSK'254 on cardiac repolarization. In this two-part, randomized study, healthy participants received GSK'254 or placebo QD for 7 days (part 1) to determine safety and pharmacokinetics of a 500-mg supratherapeutic dose. Four sequential treatment periods composed the main QTc study (part 2): GSK'254 100 mg, GSK'254 500 mg, placebo QD for 7 days, or placebo QD for 6 days with a 400-mg moxifloxacin dose on Day 7 (all with a moderate-fat meal). Concentration-QTc analyses modeled the relationship between GSK'254 plasma concentrations and placebo-adjusted change from baseline in QT interval corrected with Fridericia's formula (ΔΔQTcF). Of 50 participants enrolled, 48 completed the study (part 1, 8/8; part 2, 40/42). Least-squares (LS) mean change from baseline in QTcF for GSK'254 100 mg followed the placebo pattern across time points (maximum LS mean ΔΔQTcF, 1.7 ms); the upper bound of the 90% CI remained <10 ms. Maximum LS mean ΔΔQTcF for GSK'254 500 mg exceeded the 10-ms threshold: 10.6 ms (90% CI 7.75-13.38). Neither GSK'254 dose had clinically relevant effects on heart rate or cardiac conduction. By concentration-QTc analysis, no effect on ΔΔQTcF >10 ms is expected up to GSK'254 concentrations of ~3070 ng mL
MeSH term(s)	Humans ; HIV-1 ; Electrocardiography ; Fluoroquinolones ; Healthy Volunteers ; Double-Blind Method
Chemical Substances	Fluoroquinolones ; GSK3640254
Language	English
Publishing date	2023-11-14
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	2740389-0
ISSN	2052-1707 ; 2052-1707
ISSN (online)	2052-1707
ISSN	2052-1707
DOI	10.1002/prp2.1151
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