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70 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #658859

    IATE #3574880
    triail chliniciúil dearaidh oiriúnaithigh Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    triail oiriúnaitheach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    adaptive klinische Prüfung
    de
    adaptive design clinical trial | adaptive design clinical study | adaptive clinical trial | adaptive trial
    en
    Definition clinical trial that includes a prospectively planned opportunity for modification of one or more specified aspects of the study design and hypotheses based on analysis of data (usually interim data) from subjects in the study Reference "COM-EN, based on:J.R. Yates, J. Seoane, C. Le Tourneau et al., 'Precision Medicine Glossary', European Society for Medical Oncology: Annals of Oncology, Vol. 29, Issue 1, p.30-35, 1 January 2018. "
    Comment The term prospective here means that the adaptation was planned (and details specified) before data were examined in an unblinded manner by any personnel involved in planning the revision.
    essai clinique adaptatif | essai clinique de type adaptatif | essai adaptatif | schéma adaptatif | design adaptatif | stratégie adaptative
    fr
    Definition essai clinique dans le cadre duquel les données accumulées permettent de modifier et d’adapter certains aspects de l’étude au cours du temps (nombre de patients, dose et durée du traitement, fréquence des analyses, critères d’évaluation, etc.) afin de rendre l’essai plus précis et efficace Reference "COM-FR, d’après: 1. le site BioPharmAnalyses, «Design adaptatif: un concept qui se prête bien aux besoins médicaux non couverts» (23.4.2020), A.-L. Berthier2. le site du laboratoire Roche > Les chercheurs de Roche réveillent le système immunitaire > Découverte: les essais cliniques s’adaptent (23.4.2020)"
    Comment "Voir aussi: -
  3. SOCIAL QUESTIONS|health

    #633410

    IATE #1638698
    measúnú cliniciúil Reference "Rialachán (AE) 2021/2282 maidir le measúnú ar theicneolaíocht sláinte"
    ga
    Context 'ciallaíonn “measúnú cliniciúil comhpháirteach” ar theicneolaíocht sláinte tiomsú eolaíoch agus tuairisc ar anailís chomparáideach ar an bhfianaise chliniciúil atá ar fáil maidir le teicneolaíocht sláinte i gcomparáid le ceann amháin nó níos mó de theicneolaíochtaí sláinte eile nó nósanna imeachta atá ann cheana, i gcomhréir le raon feidhme measúnaithe arna chomhaontú de bhun an Rialacháin seo agus atá bunaithe ar ghnéithe eolaíocha réimsí cliniciúla HTA' Reference "Rialachán (AE) 2021/2282 maidir le measúnú ar theicneolaíocht sláinte"
    klinische Bewertung
    de
    Definition Zusammenstellung und Prüfung der verfügbaren wissenschaftlichen Nachweise über eine Gesundheitstechnologie im Vergleich zu einer oder mehreren anderen Gesundheitstechnologien, die sich auf folgende klinische Bereiche der Bewertung von Gesundheitstechnologien stützt: Beschreibung des gesundheitlichen Problems, bei dem die Gesundheitstechnologie angewandt wird, sowie anderer Gesundheitstechnologien, die derzeit bei diesem Gesundheitsproblem angewandt werden, Beschreibung und technische Charakterisierung der Gesundheitstechnologie, relative klinische Wirksamkeit sowie relative Sicherheit der Gesundheitstechnologie Reference "Vorschlag für eine Verordnung über die Bewertung von Gesundheitstechnologien und zur Änderung der Richtlinie 2011/24/EU COM/2018/051 final - 2018/018 (COD) CELEX:52018PC0051/DE"
    clinical assessment | relative effectiveness assessment | REA
    en
    Definition "evaluation of the available scientific evidence on the clinical aspects (e.g. safety, clinical effectiveness) of a health technology in comparison with one or more other health technologies" Reference "COM-Terminology Coordination, based on: - Proposal for a Regulation on health technology assessment and amending Directive 2011/24/EU, COM(2018) 51 final 2018/0018(COD), (explanatory memorandum)- Regulation (EU) 2021/2282 on health technology assessment and amending Directive 2011/24/EU"
    Comment 1) The four clinical domains of assessment concern the identification of a health problem and current health technology, the examination of the technical characteristics of the health technology under assessment, its relative safety, and its relative clinical effectiveness.2) REA/clinical assessment (assessment carried out by an individual HTA body) must not be confused with joint REA/Joint clinical assessment (assessment carried out at EU level by the coordination group via its sub-group dedicated to JCAs)
    évaluation clinique | évaluation de l'efficacité relative
    fr
    Definition compilation et évaluation des données probantes scientifiques disponibles concernant une technologie de la santé par comparaison avec une ou plusieurs autres technologies de la santé sur la base des domaines cliniques d’évaluation des technologies de la santé suivants:1. la description du problème de santé traité par la technologie de la santé et l’utilisation actuelle d’autres technologies de la santé pour ce problème, 2. la description et les caractéristiques techniques de la technologie de la santé, 3. l’efficacité clinique relative et4. la sécurité relative de la technologie de la santé Reference "COM-FR, d’après la proposition de règlement du Parlement européen et du Conseil concernant l’évaluation des technologies de la santé et modifiant la directive 2011/24/UE, CELEX:52018PC0051/FR [9.2.2018]"
    Comment "Voir aussi: -
  4. SOCIAL QUESTIONS|health|illness|epidemic · SOCIAL QUESTIONS|health|medical science|epidemiology

    #619350

    IATE #1108831
    ráta ruaige Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Anfallsrate
    de
    attack rate | clinical attack rate | incidence proportion
    en
    Definition proportion of an initially disease-free population that develops disease, becomes injured, or dies during a specified (usually limited) period of time Reference "CDC. Principles of Epidemiology in Public Health Practice, Third Edition An Introduction to Applied Epidemiology and Biostatistics > 'Lesson 3: Measures of Risk Section 2: Morbidity Frequency Measures' (3.8.2020)"
    Comment "It is a measure of the risk of disease or the probability of developing the disease during the specified period. As a measure of incidence, it includes only new cases of disease in the numerator. The denominator is the number of persons in the population at the start of the observation period. Because all of the persons with new cases of disease (numerator) are also represented in the denominator, a risk is also a proportion.Numerator: Number of new cases of disease during specified time interval.Denominator: Population at start of time interval.(while the denominator for the calculation of the incidence rate is ""Summed person-years of observation or average population during time interval"")"
    taux d'attaque
    fr
    Definition proportion de la population qui développera les signes de la maladie durant une épidémie Reference ---
  5. SOCIAL QUESTIONS|health|medical science · SCIENCE|natural and applied sciences|physical sciences

    #624614

    IATE #1269693
    iniúchadh cliniciúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    klinische Kontrolle
    de
    Definition systematische Untersuchung oder Überprüfung der medizinisch-radiologischen Verfahren, mit der die Qualität und das Ergebnis der Patientenversorgung durch strukturierte Überprüfung verbessert werden soll und bei der medizinisch-radiologische Tätigkeiten, Verfahren und Ergebnisse anhand vereinbarter Normen für gute medizinisch-radiologische Verfahren untersucht werden, wobei die Praxis geändert wird, wenn dies angezeigt ist, und neue Normen angewandt werden, falls dies erforderlich ist Reference "RL 2013/59/EURATOM zur Festlegung grundlegender Sicherheitsnormen für den Schutz vor den Gefahren einer Exposition gegenüber ionisierender Strahlung, Art.4 Nr.12 (ABl. L_13/2014, S.1) CELEX:32013L0059/DE"
    Comment DIV: do, 18.12.2014
    clinical audit
    en
    Definition a systematic examination or review of medical radiological procedures which seeks to improve the quality and outcome of patient care through structured review, whereby medical radiological practices, procedures and results are examined against agreed standards for good medical radiological procedures, with modification of practices where indicated and the application of new standards if necessary Reference "EC Multilingual Glossary of Terms relating to Quality Assurance and Radiation Protection in Diagnostic Radiology, p.252 ftp://ftp.cordis.europa.eu/pub/fp5-euratom/docs/glossary99-diagnostic-radiology.pdf (31.07.2014)"
    audit clinique
    fr
    Definition examen ou passage en revue systématique des procédures radiologiques médicales, qui vise à améliorer la qualité et le résultat des soins administrés au patient grâce à un examen structuré dans le cadre duquel les pratiques, les procédures et les résultats radiologiques sont comparés à des référentiels convenus de bonnes procédures radiologiques médicales et qui donne lieu à la modification des pratiques, si cela s'impose, et à l'application de nouveaux référentiels en cas de nécessité Reference "«Glossaire multilingue d'assurance de qualité et de radioprotection en radiodiagnostic», Commission européenne, juillet 1999, Office des publications de l'Union européenne, ISBN 92-828-1540-4, ftp://ftp.cordis.europa.eu/pub/fp5-euratom/docs/glossary99-diagnostic-radiology.pdf [21.10.2014]"
    Comment "Voir aussi:procédure radiologique médicale [IATE:1269705 ]"
  6. SOCIAL QUESTIONS|health|pharmaceutical industry

    #643821

    IATE #3517476
    brisphointe cliniciúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    tiúchan antaibheathach an bhrisphointe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Grenzkonzentration | Break-Point
    de
    breakpoint | breakpoints | breakpoint antibiotic concentration | concentrations | clinical breakpoint
    en
    Definition discriminating concentration used in the interpretation of results of susceptibility testing to define isolates as susceptible, intermediate or resistant Reference "British Society for Antimicrobial Chemotherapy (BSAC) website > Alasdair P. MacGowana and Richard Wise. Establishing MIC breakpoints and the interpretation of in vitro susceptibility tests, http://bsac.org.uk/wp-content/uploads/2012/02/Chapter-3-Establishing-MIC-bps-2005updated.pdf [9.3.2010]"
    Comment "These concentrations range from x mg/L (low) to y mg/L (high) and an isolate is characterised as:- susceptible (S), if at a concentration < less than x mg/L there is a high likelihood of therapeutic success- intermediate (I), if at a concentration more than x and less than y mg/L the therapeutic effect is uncertain, and- resistant (R), if at a concentration more than y mg/L there a high likelihood of therapeutic failure.For more information, see also: EUCAST definitions of clinical breakpoints and epidemiological cut-off values, http://www.srga.org/Eucastwt/eucastdefinitions.htm [22.11.2013]"
    valeur seuil | concentration critique
    fr
    Definition valeur numérique utilisée pour restituer qualitativement les résultats d'un antibiogramme en deux ou trois catégories cliniques: sensible, intermédiaire, résistant Reference "COM-FR, d'après:Définitions de la résistance aux antibiotiques en médecine vétérinaire: épidémiologique ou pronostique, P. Sanders et M. Laurentie, http://documents.irevues.inist.fr/bitstream/handle/2042/48416/AVF_2012_3_261.pdf?sequence=1 [18.3.2015]"
  8. SOCIAL QUESTIONS|health|medical science

    #649418

    IATE #3545917
    sonraí cliniciúla Reference "Rialachán (AE) 2017/745 maidir le feistí leighis, lena leasaítear Treoir 2001/83/CE, Rialachán (CE) Uimh. 178/2002 agus Rialachán (CE) Uimh. 1223/2009 agus lena n-aisghairtear Treoir 90/385/CEE ón gComhairle agus Treoir 93/42/CEE ón gComhairle, CELEX:32017R0745/GA ; Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Definition faisnéis a bhaineann le sábháilteacht agus le feidhmíocht a ghineann úsáid na feiste agus arb iad na nithe seo a leanas a foinse: — imscrúdú cliniciúil nó imscrúduithe cliniciúla ar an bhfeiste lena mbaineann, — imscrúdú cliniciúil nó imscrúdaithe cliniciúla nó staidéir eile a bhfuil trácht orthu i litríocht eolaíoch, ar fheiste den chineál céanna ar féidir a coibhéis leis an bhfeiste atá i gceist a thaispeáint, — tuarascálacha a fhoilsítear i litríocht eolaíochta a ndéantar athbhreithniú piaraí uirthi ar thaithí chliniciúil eile a bhaineann leis an bhfeiste atá i gceist nó le feiste eile den chineál céanna ar féidir a coibhéis leis an bhfeiste atá i gceist a thaispeáint, — faisnéis atá ábhartha go cliniciúil agus a thagann as faireachas iarmhargaidh, go háirithe an measúnú leantach cliniciúil iarmhargaidh Reference "Rialachán (AE) Uimh. 745/2017 maidir le feistí leighis, lena leasaítear Treoir 2001/83/CE, Rialachán (CE) Uimh. 178/2002 agus Rialachán (CE) Uimh. 1223/2009 agus lena n-aisghairtear Treoir 90/385/CEE ón gComhairle agus Treoir 93/42/CEE ón gComhairle, CELEX:32017R0745/GA"
    klinische Daten
    de
    Definition Angaben zur Sicherheit oder Leistung eines Medizinprodukts, die im Rahmen seiner Verwendung gewonnen werden und aus den bestimmten Quellen stammen Reference "vgl. Vorschlag für eine Verordnung über Medizinprodukte, Art.2 Nr.36; COM(2012)0542 final CELEX:52012PC0542/DE"
    clinical data
    en
    Definition information concerning safety or performance that is generated from the use of a device and is sourced from the following: — clinical investigation(s) of the device concerned, — clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated, — reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated, — clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up Reference "Article 2(48) of Regulation (EU) 2017/745 on medical devices, amending Directive 2001/83/EC"
    données cliniques
    fr
    Definition informations relatives à la sécurité ou aux performances obtenues dans le cadre de l'utilisation d'un dispositif et qui proviennent des sources suivantes: - la ou les investigations cliniques du dispositif concerné, - la ou les investigations cliniques ou d'autres études citées dans des publications scientifiques d'un dispositif dont l'équivalence avec le dispositif concerné peut être démontrée, - les rapports figurant dans des publications scientifiques à comité de lecture relatifs à toute autre expérimentation clinique du dispositif concerné ou d'un dispositif dont l'équivalence avec le dispositif concerné peut être démontrée, - des informations pertinentes sur le plan clinique provenant de la surveillance après commercialisation, en particulier le suivi clinique après commercialisation. Reference "Règlement (UE) 2017/745 relatif aux dispositifs médicaux, article 2, point 48)"
  9. SOCIAL QUESTIONS|health|pharmaceutical industry · EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency · PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|research

    #668092

    IATE #3629891
    forbairt chliniciúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'forbairt chliniciúil, bailíochtú agus iontráil sa mhargadh i réimse na ngalar tógálach, na ngalar neamhchoitianta aimpléiseach, na ngalar néarmheathlúcháin agus eile...' Reference "Rialachán Tarmligthe (AE) 2021/1078 lena bhforlíontar Rialachán (AE) 2021/523 ó Pharlaimint na hEorpa agus ón gComhairle lena leagtar amach na treoirlínte infheistíochta maidir le Ciste InvestEU,CELEX:32021R1078/GA"
    taighde cliniciúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Chuir rialálaithe idirnáisiúnta in iúl go raibh gá leis an gclár oibre taighde cliniciúil a fheabhsú chun fianaise láidir ar cháilíocht, sábháilteacht agus éifeachtúlacht táirgí íocshláinte a ghiniúint.' Reference "Rialachán (AE) 2022/123 maidir le ról atreisithe don Ghníomhaireacht Leigheasra Eorpach in ullmhacht agus bainistiú géarchéimeanna do tháirgí íocshláinte agus d’fheistí leighis,CELEX:32022R0123/GA"
    clinical development | clinical research
    en
    Definition studies in human subjects, either patients or healthy volunteers, including clinical trials designed to determine human pharmacology (PK/PD), and exploratory or confirmatory safety and efficacy studies, for pre- or post-authorisation activities including risk-management programmes Reference "EMA. 'European Medicines Agency Guidance for Applicants seeking scientific advice and protocol assistance' (14.11.2022). 14 October 2022 EMA/4260/2001 Rev. 14 Scientific Evidence Generation Department"
  10. SOCIAL QUESTIONS|health|illness

    #648234

    IATE #3541287
    galar cliniciúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    clinical disease
    en
    Definition stage in the history of a pathologic condition that begins with anatomic or physiologic changes that are sufficient to produce recognizable signs and symptoms of a disease Reference "The Free Dictionary, http://medical-dictionary.thefreedictionary.com/clinical+disease [07.02.2012]"
    maladie clinique
    fr
    Definition "une maladie est dite ""clinique"" à partir du moment où les symptômes anatomiques et/ou physiologiques décelés correspondent à une pathologie définie" Reference Conseil-FR
    Comment "La maladie est dite ""préclinique"" ou ""asymptomatique"" avant l'apparition des premiers symptômes."
  11. SOCIAL QUESTIONS|health|pharmaceutical industry

    #616122

    IATE #930980
    críochphointe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Endpunkt
    de
    Definition festgelegtes Ziel einer klinischen Studie, anhand dessen festgestellt wird, ob eine angewendete Maßnahme (i.d.R. eine medizinische Behandlung) erfolgreich war Reference "vgl. Wikipedia http://de.wikipedia.org/wiki/Prim%C3%A4rer_Endpunkt (13.10.2009)"
    Comment "Es wird unterschieden zwischen primären Endpunkten (Hauptziel einer Studie - z.B. Überlebensrate oder Rückfallrisiko, i.d.R. messbare Größen) und sekundären Endpunkten (zweitrangiges Ziel einer Studie, oftmals nicht messbare Größen wie Schmerzen, Lebensqualität). [ vgl. Wikipedia http://de.wikipedia.org/wiki/Sekund%C3%A4rer_Endpunkt , 13.10.2009]"
    clinical endpoint | clinical trial endpoint | endpoint | end point | end-point
    en
    Definition clinically relevant outcome, accepted in medical practice (e.g. by regulatory guidance or professional society guidelines) and sufficiently sensitive and specific to detect the anticipated effect of the treatment Reference "COM-Terminology Coordination, based on:European Medicines Agency (EMA). 'ICH guideline E17 on general principles for planning and design of multi-regional clinical trials Step 5' (14.12.2023)"
    Comment "A clinical trial might use a clinical endpoint or a surrogate endpoint. A clinical endpoint is an outcome that represents direct clinical benefit, such as survival, decreased pain, or the absence of disease."
    critère d'évaluation principal | critère d'efficacité | critère de jugement
    fr
    Definition paramètre par lequel on évalue, au cours d'un essai clinique, les effets d'une intervention thérapeutique chez des sujets Reference "Office québecois de la langue française > Grand dictionnaire terminologique > critère d'évaluation (21.9.2023)"
  12. SOCIAL QUESTIONS|health|health policy · SOCIAL QUESTIONS|health|medical science

    #649165

    IATE #3545137
    meastóireacht chliniciúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Ba cheart neartú go mór ar phríomhghnéithe den chur chuige rialála atá ann faoi láthair, amhail faireachán ar chomhlachtaí dá dtugtar fógra, nósanna imeachta um measúnú comhréireachta, imscrúduithe cliniciúla agus meastóireacht chliniciúil, aireachas agus faireachas margaidh a neartú go mór, agus ba cheart forálacha lena n-áirithítear trédhearcacht agus inrianaitheacht maidir le feistí leighis a thabhairt isteach chun sláinte agus sábháilteacht a fheabhsú.' Reference "Rialachán (AE) 2017/745 maidir le feistí leighis, lena leasaítear Treoir 2001/83/CE, Rialachán (CE) Uimh. 178/2002 agus Rialachán (CE) Uimh. 1223/2009 agus lena n-aisghairtear Treoir 90/385/CEE ón gComhairle agus Treoir 93/42/CEE ón gComhairle"
    Definition próiseas córasach, pleanáilte chun na sonraí cliniciúla a bhaineann le feiste a ghiniúint agus a bhailiú ar bhonn leanúnach agus anailís agus measúnú leanúnach a dhéanamh orthu chun sábháilteacht agus feidhmíocht na feiste, lena n-áirítear sochair chliniciúla, a fhíorú agus í á húsáid mar a bhí beartaithe ag an monaróir Reference "Rialachán (AE) 2017/745 maidir le feistí leighis, lena leasaítear Treoir 2001/83/CE, Rialachán (CE) Uimh. 178/2002 agus Rialachán (CE) Uimh. 1223/2009 agus lena n-aisghairtear Treoir 90/385/CEE ón gComhairle agus Treoir 93/42/CEE ón gComhairle"
    klinische Bewertung
    de
    Definition Beurteilung und Analyse klinischer Daten zu einem Produkt, mit denen Sicherheit und Leistung des Produkts bei bestimmungsgemäßem Einsatz nach Angabe des Herstellers überprüft werden Reference "Vorschlag für eine Verordnung über Medizinprodukte und zur Änderung der Richtlinie 2001/83/EG, der Verordnung (EG) Nr. 178/2002 und der Verordnung (EG) Nr. 1223/2009, Art.2 Abs.1Nr.32; COM(2012) 0542 final CELEX:52012PC0542/DE"
    Comment "Nicht zu verwechseln mit der klinischen Studie IATE:3543172 oder der klinischen Prüfung IATE:1686971"
    clinical evaluation
    en
    Definition systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer Reference "Regulation (EU) 2017/745 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Directives 90/385/EEC and 93/42/EEC"
    Comment "This is a specific form of 'clinical evaluation' and other types of evaluation are made in different contexts1.Should be distinguished from clinical assessment, which refers - again in the specific context in which the term is used - to a comparison of health technologies."
    évaluation clinique
    fr
    Definition processus systématique et planifié visant à produire, collecter, analyser et évaluer en continu les données cliniques relatives à un dispositif afin de vérifier la sécurité et les performances, y compris les bénéfices cliniques, de celui-ci lorsqu'il est utilisé conformément à la destination prévue par le fabricant Reference "art. 2, point 44, du règlement (UE) 2017/745 du Parlement européen et du Conseil relatif aux dispositifs médicaux (7.2.2022)"
  13. SOCIAL QUESTIONS|health|medical science

    #649301

    IATE #3545445
    fianaise chliniciúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    klinischer Nachweis
    de
    Definition Information, mit denen die wissenschaftliche Validität und Leistung eines Produkts bei der vom Hersteller vorgesehenen Verwendung belegt wird Reference "Vorschlag für eine Verordnung über In-Vitro-Diagnostika, COM(2012)0541 final - COD(2012)0267 CELEX:52012PC0541/DE"
    clinical evidence
    en
    Definition "clinical data and clinical evaluation/performance evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer" Reference "Council-EN, based on:- Regulation (EU) 2017/746 on in vitro diagnostic medical devices- Regulation (EU) 2017/745 on medical devices"
    preuve clinique
    fr
    Definition données cliniques et résultats de l'évaluation des performances relatifs à un dispositif, dont le volume et la qualité sont suffisants pour permettre d'évaluer, en connaissance de cause, si le dispositif est sûr et offre le ou les bénéfices cliniques attendus lorsqu'il est utilisé conformément à la destination prévue par le fabricant. Reference "Règlement (UE) 2017/745 relatif aux dispositifs médicaux, article 2, point 51)"
  14. SOCIAL QUESTIONS|health|medical science · AGRICULTURE, FORESTRY AND FISHERIES|agricultural activity|animal health

    #634653

    IATE #1687525
    scrúdú cliniciúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Ní eiseofar oideas tréidliachta le haghaidh beatha íocleasaithe ach amháin i ndiaidh scrúdú cliniciúil nó aon mheasúnú ceart eile a bheith déanta ag tréidlia ar stádas sláinte an ainmhí nó an ghrúpa ainmhithe agus ní eiseofar é ach amháin le haghaidh galar diagnóisithe.' Reference "Rialachán (AE) 2019/452 lena gcuirtear ar bun creat maidir le hinfheistíochtaí díreacha coigríche isteach san Aontas a scagadh, CELEX:32019R0452/GA"
    clinical examination
    en
    Definition examination of a patient including taking the history, physical examination by palpation, auscultation and percussion, clinicopathological examination and examination of the environment Reference Blood, Studdert, Gay, 'Saunders Comprehensive Veterinary Dictionary', Third edition (2007)
  15. SOCIAL QUESTIONS|health|medical science · AGRICULTURE, FORESTRY AND FISHERIES|agricultural activity|animal health

    #661041

    IATE #3581119
    stair chliniciúil Reference "Rialachán (CE) uimh. 1272/2008 maidir le haicmiú, lipéadú agus pacáistiú substaintí agus meascán, agus lena leasaítear agus lena n-aisghairtear Treoir 67/548/CEE agus Treoir 1999/45/CE, agus lena leasaítear Rialachán (CE) Uimh. 1907/2006, CELEX:32008R1272/GA ;Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    clinical history
    en
    Definition "medical information on an individual based on clinical signs [ 261853 & 1615755 ] obtained during a clinical examination [ 1687525 ]" Reference "COM-Terminology Coordination, based on: 1) National Institute for Health and Care Excellence (NICE) > NICE Guidance > Conditions and diseases > Neurological conditions > Transient loss of consciousness > Transient loss of consciousness ('blackouts') in over 16s (4.6.2019)"
    Comment "Not to be confused with medical history [ 771554 ] which also includes information gained by asking the patient specific questions and thus also includes symptoms [ 1489022 ]."
  16. SOCIAL QUESTIONS|health|medical science|medicine · SOCIAL QUESTIONS|health|medical science|medicine|medical diagnosis

    #660817

    IATE #3580577
    medizinisches Bild
    de
    Definition mithilfe eines bildgebenden Verfahrens erzeugte visuelle Darstellung von Körperstrukturen Reference "Council-DE nach DocCheck: Bildgebendes Verfahren (13.9.2023)"
    health image | medical image | clinical image
    en
    Definition image produced by techniques that enable the inside of a body to be viewed Reference "Council-Terminology Coordination, based on:The Science and Applications of Medical Imaging | PostDICOM"
    Comment Such images are mainly used for diagnostic purposes.
    image médicale
    fr
    Definition matérialisation sous forme d'images de parties (organes, tissus, cellules) du corps humain, montrant la distribution dans l'espace de paramètres biophysiques, et obtenues pour répondre à un besoin médical grâce à des moyens techniques d'imagerie Reference "Conseil-FR, d'après: site de l'Académie nationale de médecine, Qu'est-ce qu'une image médicale? Considérations médico-économiques (4.8.2023), Daniel Le Bihan"
  17. AGRICULTURE, FORESTRY AND FISHERIES|agricultural activity|animal health

    #577507

    IATE #3522554
    cigireacht chliniciúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    clinical inspection
    en
    Definition visual examination of a patient for detection of features or qualities perceptible to the eye Reference Blood, Studdert, Gay, 'Saunders Comprehensive Veterinary Dictionary', Third edition (2007)
  18. SOCIAL QUESTIONS|health|medical science · PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|research

    #648838

    IATE #3544151
    imscrúdú cliniciúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    klinische Untersuchung | klinische Prüfung
    de
    Definition systematische Untersuchung an einem oder mehreren menschlichen Probanden, die zwecks Bewertung der Sicherheit oder Leistung eines Produkts durchgeführt wird Reference "Vorschlag für eine Verordnung über Medizinprodukte, Art.2 Nr.33; COM(2012)0542 final CELEX:52012PC0542/DE"
    Comment "entspricht der klinischen Prüfung (EN clinical trial) bei Arzneimitteln IATE:1686971 ; NICHT dasselbe wie ""klinische Bewertung"" (EN ""clinical evaluation"") IATE:3545137"
    clinical investigation
    en
    Definition any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device Reference "Regulation (EU) 2017/745 on medical devices"
    Comment Please note that in general usage, clinical investigation is a broader concept which in addition to medical devices covers also, e.g. in the USA, investigational new drug and investigational device exemption studies.
    investigation clinique
    fr
    Definition toute investigation systématique impliquant un ou plusieurs participants humains destinée à évaluer la sécurité ou les performances d'un dispositif Reference "Règlement (UE) 2017/745 relatif aux dispositifs médicaux (art. 2, point 45)"
  19. SOCIAL QUESTIONS|health|medical science

    #649427

    IATE #3545962
    plean don imscrúdú cliniciúil Reference "Rialachán (AE) 2017/745 maidir le feistí leighis, lena leasaítear Treoir 2001/83/CE, Rialachán (CE) Uimh. 178/2002 agus Rialachán (CE) Uimh. 1223/2009 agus lena n-aisghairtear Treoir 90/385/CEE ón gComhairle agus Treoir 93/42/CEE ón gComhairle, CELEX:32017R0745/GA ;Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Definition doiciméad ina dtugtar tuairisc ar réasúnaíocht, ar chuspóirí, ar dhearadh, ar mhodheolaíocht, ar ghnéithe staidrimh, ar eagrú agus ar stiúradh imscrúdaithe chliniciúil agus ar an bhfaireachán a rinneadh air Reference "Rialachán (AE) 2017/745 maidir le feistí leighis, lena leasaítear Treoir 2001/83/CE, Rialachán (CE) Uimh. 178/2002 agus Rialachán (CE) Uimh. 1223/2009 agus lena n-aisghairtear Treoir 90/385/CEE ón gComhairle agus Treoir 93/42/CEE ón gComhairle, CELEX:32017R0745/GA"
    klinischer Prüfplan
    de
    Definition "Unterlagen, in denen die Begründung, die Ziele, die Konzeption und vorgeschlagene Analyse, die Methodik, die Überwachung und Durchführung einer klinischen Prüfung IATE:3544151 sowie die diesbezüglichen Aufzeichnungspflichten dargelegt sind" Reference "Vorschlag für eine Verordnung über Medizinprodukte, Art.2 Nr.33; COM(2012)0542 final CELEX:52012PC0542/DE"
    clinical investigation plan
    en
    Definition "document that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation" Reference "Article 2(47) of Regulation (EU) 2017/745 on medical devices"
    protocole d'investigation clinique
    fr
    Definition "document qui décrit la justification, les objectifs, la conception, la méthodologie, le contrôle, les aspects statistiques, l'organisation et la conduite d'une investigation clinique" Reference "Règlement (UE) 2017/745 relatif aux dispositifs médicaux, article 2, point 46)"
  20. SOCIAL QUESTIONS|health|medical science

    #668770

    IATE #3638794
    bainistiú cliniciúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context '... bearnaí, neamhréireachtaí nó easnaimh shuntasacha sna bearta a glacadh nó atá le glacadh a aithint agus a mhaolú, agus an bhagairt shonrach a bhainistiú agus a tionchar a shárú, lena n-áirítear maidir le bainistiú agus cóireáil chliniciúil, frithbhearta neamhchógaisíochta agus riachtanais taighde sláinte poiblí...' Reference "Rialachán (AE) 2022/2371 maidir le bagairtí tromchúiseacha trasteorann ar an tsláinte, agus lena n-aisghairtear Cinneadh Uimh. 1082/2013/AE, CELEX:32022R2371/GA"
    Comment <<<_not_supplied_>>>
    klinisches Management
    de
    clinical management
    en
    Definition clinical tasks and decisions that are aimed at managing a patient with a specific presentation (disease) Reference "'Clinical Management Workflow' (7.3.2023). IGI-Global. Encyclopedia of E-Health and Telemedicine (2 Volumes)"