natgillin/translations-raw huggingface dataset:
The primary endpoint was PFS (progression-free survival) based on investigator assessment using RECIST 1.0. Secondary efficacy endpoints included OS (overall survival), DCR (disease control rate) defined as confirmed CR/PR + SD (stable disease), HRQoL (health related quality of life), and disease related symptoms.
Primarni cilj študije je bilo preživetje brez napredovanja (PFS – progression-free survival) na podlagi raziskovalčeve ocene in z uporabo RECIST 1.0. Sekundarni cilji študije so obsegali celokupno preživetje (OS – overall survival), delež obvladanja bolezni (DCR – disease control rate), opredeljen kot potrjeni CR/PR + SD (stabilna bolezen), zdravstveno kakovost življenja in z boleznijo povezane simptome.
The primary endpoint was PFS as assessed by the investigator using RECIST.
Primarni cilj študije je bilo preživetje brez napredovanja bolezni, ocenjeno s strani raziskovalca z uporabo kriterija RECIST (Response Evaluation Criteria In Solid Tumors).
The primary endpoint was PFS based on investigator’s assessment of disease progression based on radiological scans or CA 125 levels, or symptomatic deterioration per protocol.
Primarni cilj študije je bil preživetje brez napredovanja bolezni, ki temelji na oceni raziskovalca o napredovanju bolezni glede na radiološki posnetek ali določitvi vrednosti CA 125 oziroma na simptomatsko poslabšanje glede na protokol.
The primary endpoint was PFS.
Primarna končna točka je bilo PFS.
The primary endpoint was PFS.
Primarni opazovani dogodek je bilo PFS.
The primary endpoint was progression free survival (PFS).
Primarni opazovani dogodek je bilo preživetje brez napredovanja bolezni (PFS, progression free survival).
The primary endpoint was progression-free survival (PFS) as assessed by an independent review committee (IRC) based on the intent-to-treat (ITT) population and tested by histology.
Primarni opazovani dogodek je bilo preživetje brez napredovanja bolezni (progression-free survival – PFS), kar je ocenila neodvisna komisija (independent review committee – IRC) na podlagi podatkov za populacijo ITT (intent-to-treat ) in kot so pokazale histološke preiskave.
The primary endpoint was progression-free survival based on investigator assessment using modified RECIST 1.0. Additional endpoints included objective response, duration of response, overall survival and safety.
Primarni cilj preskušanja je bilo preživetje brez napredovanja bolezni, glede na oceno raziskovalca, z uporabo kriterija RECIST 1.0. Ostali cilji so vključevali objektiven odgovor, trajanje odgovora, celokupno preživetje in varnost.
The primary endpoint was reduction in all-cause mortality at 3 years for salmeterol/fluticasone propionate vs placebo.
Primarni cilj študije je bil ugotoviti zmanjšanje umrljivosti zaradi vseh vzrokov po 3 letih uporabe salmeterola/flutikazonpropionata v primerjavi s placebom.
The primary endpoint was the change from baseline over 16 weeks in FEV1.
Primarni opazovani dogodek je bila sprememba FEV1 od izhodišča čez 16 tednov.
The primary endpoint was the comparison between the summed pain intensity difference at 30 minutes after dosing (SPID30), which was 6.57 in the PecFent-treated episodes compared to 4.45 for placebo (p<0.0001 ).
Primarni cilj študije je bila primerjava med vsoto razlik intenzivnosti bolečine 30 minut po odmerku (summed pain intensity difference – SPID30), ki je bila 6,57 v epizodah, zdravljenih z zdravilom PecFent, v primerjavi s 4,45 pri placebu (p<0,0001 ).
The primary endpoint was the ORR defined as the proportion of subjects who achieved a CR or PR (based on the Revised Response Criteria for Malignant Lymphoma [Cheson]), and, for subjects with Waldenström macroglobulinaemia, a minor response (MR) (based on the Response Assessment for Waldenström macroglobulinaemia [Owen]).
Primarni opazovani dogodek je bila vrednost ORR, opredeljena kot delež oseb, ki je dosegel CR ali PR (na podlagi Revidiranih kriterijev odziva za maligni limfom - Revised Response Criteria for Malignant Lymphoma [Cheson]), in, za osebe z Waldenströmovo makroglobulinemijo, manjši odziv (MR, minor response) (na podlagi Ocene odziva za Waldenströmovo makroglobulinemijo - Response Assessment for Waldenström macroglobulinaemia [Owen]).
The primary endpoint was the percent change from Baseline to Week 12 in the number of active joints with arthritis (swelling not due to deformity or joints with loss of motion plus pain and/or tenderness), which was achieved with mean percent decrease of -62.6% (median percent change -88.9%) in patients in the Humira group compared to -11.6% (median percent change -50.0%) in patients in the placebo group.
Primarni opazovani dogodek je bil odstotek spremembe od izhodiščne vrednosti do 12. tedna v številu aktivnih sklepov z artritisom (oteklina, ki ni nastala zaradi deformacije ali sklepi z zmanjšano gibljivostjo ter bolečino in/ali občutljivostjo); slednji je bil dosežen s povprečnim zmanjšanjem za -62,6 % (mediana sprememba -88,9 %) pri skupini bolnikov, ki je prejemala Humiro v primerjavi z -11,6 % (mediana sprememba -50,0 %) v skupini bolnikov, ki je prejemala placebo.
The primary endpoint was the percentage of patients achieving American College of Rheumatology (ACR) 20 response at Week 16.
Primarni končni opazovani dogodek je bil odstotni delež bolnikov, ki so v 16. tednu dosegli odziv 20 po American College of Rheumatology (ACR).
The primary endpoint was the percentage of patients who achieved American College of Rheumatology (ACR) 20 response at week 24.
Primarni končni rezultat je bil delež bolnikov, ki so po 24. tednih dosegli odziv 20 po merilih Ameriškega revmatološkega združenja (ACR-American College of Rheumatology criteria).
The primary endpoint was the proportion of patients achieving by Month 6 at least a two- grade improvement in keratitis (CFS) and a 30% improvement in symptoms, measured with the Ocular Surface Disease Index (OSDI).
Primarni opazovani dogodek je bil delež bolnikov, ki je do 6. meseca doseglo izboljšanje keratitisa (CFS) za vsaj dve stopnji in 30 % izboljšanje simptomov, izmerjeno z indeksom bolezni očesne površine (OSDI - Ocular Surface Disease Index).
The primary endpoint was the proportion of patients in clinical remission at Week 6 in the TNF antagonist failure subpopulation.
Primarni opazovani dogodek je bil delež bolnikov v klinični remisiji v 6. tednu v podpopulaciji bolnikov brez odziva na zdravljenje z zaviralcem TNFα.
The primary endpoint was the proportion of patients who achieve a PGA score of cleared (0) or minimal (1) at week 12.
Primarni cilj je bil delež bolnikov, ki so v 12. tednu dosegli oceno PGA čisto (0) ali minimalno (1).
The primary endpoint was the proportion of patients who experienced a clinical response, defined as a decrease in CDAI by ≥ 70 points from baseline at the 4-week evaluation and without an increase in the use of medicinal products or surgery for Crohn’s disease.
Primarni cilj študije je bil odstotek bolnikov s kliničnim odzivom, opredeljenim kot zmanjšanje CDAI za ≥ 70 točk od izhodiščne vrednosti ob pregledu v 4. tednu zdravljenja, z nespremenjeno potrebo po zdravilih ali operativnih posegih za zdravljenje Crohnove bolezni.
The primary endpoint was the proportion of patients who experienced a clinical response, defined as a decrease in CDAI by ≥70 points from baseline at the 4-week evaluation and without an increase in the use of medicinal products or surgery for Crohn’s disease.
Primarni cilj študije je bil odstotek bolnikov s kliničnim odzivom, opredeljenim kot zmanjšanje CDAI za ≥ 70 točk od izhodiščne vrednosti ob pregledu v 4. tednu zdravljenja, z nespremenjeno potrebo po zdravilih ali operativnih posegih za zdravljenje Crohnove bolezni.
The primary endpoint was the proportion of patients who experienced a clinical response, defined as ≥ 50% reduction from baseline in the number of fistulae draining upon gentle compression on at least two consecutive visits (4 weeks apart), without an increase in the use of medicinal products or surgery for Crohn’s disease.
Primarni cilj študije je bil odstotek bolnikov s kliničnim odzivom, ki je bil opredeljen kot ≥ 50 % zmanjšanje števila aktivnih fistul, iz katerih je ob rahlem pritisku iztekala črevesna vsebina, ob najmanj dveh zaporednih pregledih (v presledku 4 tednov) v primerjavi z izhodiščnim številom, brez povečanja odmerka zdravil ali potrebe po operaciji za zdravljenje Crohnove bolezni.
The primary endpoint was the proportion of patients who experienced a clinical response, defined as ≥50% reduction from baseline in the number of fistulae draining upon gentle compression on at least two consecutive visits (4 weeks apart), without an increase in the use of medicinal products or surgery for Crohn’s disease.
Primarni cilj študije je bil odstotek bolnikov s kliničnim odzivom, ki je bil opredeljen kot ≥ 50 % zmanjšanje števila aktivnih fistul, iz katerih je ob rahlem pritisku iztekala črevesna vsebina, ob najmanj dveh zaporednih pregledih (v presledku 4 tednov) v primerjavi z izhodiščnim številom, brez povečanja odmerka zdravil ali potrebe po operaciji za zdravljenje Crohnove bolezni.
The primary endpoint was the rate of confirmed complete cytogenetic response (cCCyR) within 12 months.
Primarni opazovani dogodek je bil delež potrjenega popolnega citogenetskega odziva (cCCyR; “confirmed complete cytogenetic response”) v 12 mesecih.
The primary endpoint was the responder rate in walking speed as measured by the Timed 25-foot Walk (T25FW).
Primarna končna točka je bila stopnja odziva v hitrosti hoje, izmerjena s časovno omejeno hojo na 25 čevljev (= 7,62 m) (T25FW – Timed 25 Foot Walk).
The primary endpoint was the time to first occurrence of a clinical failure event, defined as:
Primarni opazovani dogodek je bil čas do prvega pojava dogodka kliničnega neuspeha, opredeljenega kot:
The primary endpoint was the time to first occurrence of a morbidity or mortality event, up to the end of double-blind treatment, defined as death, or atrial septostomy, or lung transplantation, or initiation of intravenous (i.v.) or subcutaneous (s.c.) prostanoids, or other worsening of PAH.
Primarni opazovani dogodek je bil čas do prvega pojava dogodka obolevnosti ali smrtnosti, do konca dvojno slepega zdravljenja, ki je bil opredeljen kot smrt ali atrijska septostomija ali presaditev pljuč ali uvedba intravenskih (i.v.) ali subkutanih (s.c.) prostanoidov ali drugo poslabšanje PAH.
The primary endpoint, a composite of death or cardiogenic shock or congestive heart failure or re-infarction within 30 days, was observed in 12.4% (116/939) of the pharmaco-invasive arm versus 14.3% (135/943) in the primary PCI arm (relative risk 0.86 (0.68-1.09)).
Pogostnost primarnega sestavljenega opazovanega dogodka, ki je zajemal smrt ali kardiogeni šok ali zastojno srčno popuščanje ali ponovni infarkt v 30 dneh, je bila v skupini s farmakoinvazivno strategijo 12,4 % (116/939), v skupini s primarno perkutano koronarno intervencijo pa 14,3 % (135/943) (relativno tveganje 0,86 (0,68–1,09)).
The primary endpoint, progression-free survival (PFS), was assessed using a blinded independent central review.
Primarni opazovani dogodek, preživetje brez napredovanja bolezni (PFS), so ocenjevali s slepim, neodvisnim, centralnim ocenjevanjem.
The primary endpoint, the composite of the occurrence or time to first occurrence of CV death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for unstable angina, was non-significantly lower for linagliptin versus combined active and placebo comparators [Hazard ratio 0.78 (95% confidence interval 0.55;1.12)].
Primarni cilj, ki je zajemal pojav ali čas do prve smrti zaradi srčnožilnega dogodka, neusodnega miokardnega infarkta, neusodne možganske kapi ali hospitalizacije zaradi nestabilne angine pektoris, je bil ne-pomembno manjši v skupini z linagliptinom kot pri primerjalni kombinaciji zdravila in placeba [razmerje tveganja 0,78 (95-odstotni IZ: 0,55; 1,12].
The primary endpoint, the composite of: the occurrence or time to first occurrence of CV death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for unstable angina, was non-significantly lower for linagliptin versus combined active and placebo comparators [Hazard ratio 0.78 (95% confidence interval 0.55;1.12)].
Primarni opazovani dogodek, sestavljen iz pojava ali časa do prvega pojava srčno-žilne smrti, neusodnega miokardnega infarkta, neusodne možganske kapi ali sprejema v bolnišnico zaradi nestabilne angine pektoris, je bil pri linagliptinu v primerjavi s kombiniranimi aktivnimi in placebnimi komparatorji ne-značilno manjši [razmerje tveganja 0,78 (95-odstotni interval zaupanja 0,55; 1,12)].
The primary endpoints of this study, progression-free survival (PFS), as assessed by hazard ratio, and overall response rate (ORR) were determined based on assessments made by a blinded Independent Review Committee.
Primarna opazovana dogodka te študije sta bila preživetje brez napredovanja bolezni (PFS, progression-free survival), ovrednoteno z razmerjem ogroženosti, in delež celokupnega odziva (ORR, overall response rate) na osnovi vrednotenja, ki ga je izvedel neodvisen odbor za pregled.
The primary enzyme involved in the biotransformation of simeprevir is CYP3A4 (see section 5.2) and clinically relevant effects of other medicinal products on simeprevir pharmacokinetics via CYP3A4 may occur.
Poglavitni encim, ki sodeluje pri biotransformaciji simeprevirja, je CYP3A4 (glejte poglavje 5.2), zato lahko zaradi vpliva na CYP3A4 pride do klinično pomembnih učinkov drugih zdravil na farmakokinetiko simeprevirja.
The primary evidence of efficacy was based on objective response rates.
Primarni dokaz učinkovitosti je temeljil na objektivni odzivnosti.
The primary faecal and urinary metabolites in dog were identified as glucuronide conjugates of milbemycin A3 or A4 5-oximes, dealkylated milbemycin A3 or A4 5-oximes, and hydroxylated milbemycin A4 5-oxime.
Glavne presnovke v blatu in urinu pri psih so opredelili kot glukuronidne konjugate milbemicina A3 ali A4 5-oksima, dealkiliranega milbemicin A3 ali A4 5-oksima in hidroksiliranega milbemicin A4 5- oksima.
The primary immunisation should be completed at least one week prior to potential exposure to Japanese encephalitis virus (JEV) (see section 4.4).
Primarno cepljenje je treba dopolniti vsaj en teden pred morebitno izpostavljenostjo virusu japonskega encefalitisa (JEV) (glejte poglavje 4.4).
The primary infant series consists of three doses with the first dose given at 2 months of age and with an interval of at least 1 month between doses.
Primarno zaporedje za dojenčke obsega tri odmerke, pri čemer je prvi odmerek uporabljen pri 2 mesecih starosti, presledek med odmerki pa je vsaj 1 mesec.
The primary infant series consists of three doses with the first dose usually given at 2 months of age and with an interval of at least 1 month between doses.
Primarno zaporedje za dojenčke obsega tri odmerke, pri čemer je prvi odmerek po navadi uporabljen pri 2 mesecih starosti, presledek med odmerki pa je vsaj 1 mesec.
The primary infant series consists of three doses, each of 0.5 ml, the first dose usually given at 2 months of age and with an interval of at least 1 month between doses.
Primarno zaporedje za dojenčke sestavljajo trije odmerki po 0,5 ml; prvi odmerek običajno pri mesecih, med ostalima odmerkoma mora biti najmanj enomesečni presledek.
The primary measure of effectiveness was the responder rate (percent of patients with ≥ 50 % reduction from baseline in average daily partial onset seizure frequency) assessed by a blinded central reader using a 48-hour video EEG.
Osnovno merilo učinkovitosti je bila reakcijska stopnja (odstotek bolnikov z ≥ 50 % znižanjem povprečnih pogostosti napadov parcialnega izvora na dan glede na začetne vrednosti), ki jo je na 48-urnem EEG posnetku določil ocenjevalec, ki ni vedel kdo je prejemal placebo in kdo zdravilo.
The primary measure of effectiveness was the responder rate (percent of patients with ≥ 50 % reduction from baseline in average daily partial onset seizure frequency) assessed by a blinded central reader using a 48-hour video EEG.
Osnovno merilo učinkovitosti je bila stopnja odziva (odstotek bolnikov z ≥ 50 % znižanjem povprečnih pogostosti napadov parcialnega izvora na dan glede na začetne vrednosti), ki jo je na 48- urnem EEG posnetku določil ocenjevalec, ki ni vedel kdo je prejemal placebo in kdo zdravilo.
The primary measure of effectiveness was the responder rate (percent of patients with ≥ 50 % reduction from baseline in average daily partial onset seizure frequency) assessed by a blinded central reader using a 48-hour video EEG.
Osnovno merilo učinkovitosti je bila stopnja odziva (odstotek bolnikov z ≥ 50 % znižanjem povprečnih pogostosti parcialnih napadov na dan glede na začetne vrednosti), ki jo je na
The primary measure of effectiveness was the responder rate (percent of patients with ≥ 50% reduction from baseline in average daily partial onset seizure frequency) assessed by a blinded central reader using a 48-hour video EEG.
Osnovno merilo učinkovitosti je bila stopnja odziva (odstotek bolnikov z ≥ 50 % znižanjem povprečnih pogostosti parcialnih napadov na dan glede na začetne vrednosti), ki jo je na
The primary measure of efficacy (ASAS 20) was a ≥ 20% improvement in at least 3 of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains (patient global assessments, back pain, BASFI, and inflammation) and absence of deterioration in the remaining domain.
Primarno merilo učinkovitosti (ASAS 20) je bilo ≥ 20 % izboljšanje pri vsaj 3 od 4 domen lestvice Ocenjevanje pri ankilozirajočem spondilitisu (ASAS - Assessment in Ankylosing Spondylitis) (bolnikova splošna ocena, bolečina v hrbtenici, BASFI in vnetje) ter odsotnost poslabšanja pri četrti domeni.
The primary measure of efficacy (ASAS 20) was a 20% improvement in at least 3 of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains (patient global assessments, back pain, BASFI, and inflammation) and absence of deterioration in the remaining domain.
Primarno merilo učinkovitosti (ASAS 20) je bilo  20 % izboljšanje pri vsaj 3 od 4 domen lestvice Ocenjevanje pri ankilozirajočem spondilitisu (ASAS - Assessment in Ankylosing Spondylitis) (bolnikova splošna ocena, bolečina v hrbtenici, BASFI in vnetje) ter odsotnost poslabšanja pri četrti domeni.
The primary measures of efficacy were changes in excessive daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS), and the change in the overall severity of the patient’s narcolepsy symptoms as assessed by the investigator using the Clinical Global Impressions of Change (CGI-c) measure.
Primarno merilo učinkovitosti so bile spremembe v pretirani dnevni zaspanosti, ki so bile izmerjene z Epworthovo lestvico zaspanosti (ESS), in sprememba celotne resnosti bolnikovih simptomov narkolepsije, ki jo je preiskovalec ocenil z uporabo lestvice celostnega kliničnega odziva (CGI-c).
The primary mechanism of action of Zalmoxis relies on its ability to engraft and stimulate immune- reconstitution.
Primarni mehanizem delovanja zdravila Zalmoxis temelji na njegovi sposobnosti, da se "prime" in stimulira imunsko reaktivacijo.
The primary metabolic pathway for riluzole is initial oxidation by cytochrome P450 1A2 producing N-hydroxy-riluzole (RPR112512), the major active metabolite of riluzole.
Primarna presnovna pot riluzola je uvodna oksidacija s citokromom P450 1A2, s čimer nastane N- hidroksiriluzol (RPR112512), glavni aktivni presnovek riluzola.
The primary metabolite is N-desethylbrinzolamide followed by the N-desmethoxypropyl and O-desmethyl metabolites as well as an N-propionic acid analog formed by oxidation of the N-propyl side chain of O-desmethyl brinzolamide.
Njegov glavni presnovek je N-desetilbrinzolamid, sledijo pa mu N- desmetoksipropil in O-desmetilni presnovki, poleg tega pa tudi analog N-propionske kisline, ki nastane z oksidacijo N-propilne stranske verige O-desmetilbrinzolamida.
The primary metabolite resulting from the cleavage of Arg3-Pro4 bond of the N- terminal sequence by thrombin is not active because of the loss of affinity to the catalytic active site of thrombin.
Osnovni presnovek, ki nastane kot posledica cepitve vezi Arg3-Pro4 N-terminalnega zaporedja s trombinom ni aktiven zaradi izgube afinitete do katalitično aktivnega mesta trombina.
The primary mode of action of the fluoroquinolones involves interaction with enzymes essential for major DNA functions such as replication, transcription and recombination.
Primarno delovanje flourokinolonov temelji na interakciji z encimi, ki sodelujejo pri podvojevanju, obnovi in prepisu dezoksiribonukleinske kisline (DNK) v bakterijski celici.
The primary mode of action of voriconazole is the inhibition of fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylation, an essential step in fungal ergosterol biosynthesis.
Glavni mehanizem delovanja vorikonazola je zavrtje 14α- lanosterolske demetilacije, katero posreduje glivični citokrom P450 in ki je ključni korak v glivični biosintezi ergosterola.
The primary objective for this study was to evaluate the efficacy of dabrafenib compared to DTIC with respect to progression-free survival (PFS) per investigator assessment.
Primarni cilj študije je bila ocena učinkovitosti dabrafeniba v primerjavi z DTIC, kar zadeva preživetje brez napredovanja (PFS – progression-free survival) po raziskovalčevi oceni.
The primary objective in this study was to determine if dabigatran etexilate was non-inferior to warfarin in reducing the occurrence of the composite endpoint stroke and SEE.
Primarni cilj raziskave je bil ugotoviti, ali je dabigatran eteksilat enakovreden varfarinu pri zmanjšanju pojavnosti sestavljenega opazovanega dogodka, ki je zajemal možgansko kap in sistemske embolične dogodke.
The primary objective of the study was to assess the antiviral efficacy of INCIVO, peginterferon alfa-2a, and ribavirin in HCV-infected liver transplant recipients as measured by SVR12.
Primarni cilj te študije je bil s pomočjo SVR12 oceniti protivirusno učinkovitost zdravila INCIVO, peginterferona alfa 2a in ribavirina pri s HCV-1 okuženih bolnikih.
The primary objective of the study was to assess the duration of the improvement following IKERVIS treatment discontinuation once the patient was improved with respect to the baseline of the SANSIKA study (i.e. at least 2 grade improvement on the modified Oxford scale).
Primarni cilj študije je bilo oceniti trajanje izboljšanja po prekinitvi zdravljenja z zdravilom IKERVIS po izboljšanju stanja bolnika, ob upoštevanju izhodišča študije SANSIKA (tj. vsaj 2-stopenjsko izboljšanje na prilagojeni lestvici Oxford).
The primary objective of the study was to compare the CCyR at 1 year in patients with newly diagnosed Ph+ CP CML who received bosutinib compared with those who received imatinib.
Primarni opazovani dogodek v študiji je bila primerjava popolnega citogenetičnega odziva (CCyR) po 1 letu pri bolnikih z novo odkrito Ph+ KML v kronični fazi, ki so prejemali bosutinib, v primerjavi s tistimi, ki so prejemali imatinib.
The primary objective of the study was to compare the effects of tolvaptan + SC with placebo + SC on the time to all-cause mortality and on the time to first occurrence of cardiovascular (CV) mortality or hospitalisation for HF.
Primarni cilj študije je bil primerjati učinke tolvaptana + SO s placebom + SO časa do umrljivosti zaradi vseh vzrokov in časa do prvega pojava kardiovaskularne (KV) umrljivosti ali hospitalizacije zaradi SP.
The primary objective of the study was to evaluate and compare the two treatment arms for progression-free survival (PFS) and the principle secondary endpoint is overall survival (OS).
Primarni cilj študije je bil ovrednotiti čas preživetja brez napredovanja bolezni (PFS; “progression-free survival”) in ga primerjati med obema skupinama zdravljenja, glavni sekundarni opazovani dogodek pa skupno preživetje (OS; “overall survival”).