natgillin/translations-raw huggingface dataset:
The primary efficacy endpoint was ORR, based on Response Evaluation Criteria in Solid Tumours (RECIST).
Primarna mjera ishoda djelotvornosti bila je stopa objektivnog odgovora na liječenje (ORR) prema Kriterijima za ocjenu odgovora kod solidnih tumora (engl.
The primary efficacy endpoint was OS.
Primarni ishod djelotvornosti bilo je ukupno preživljenje.
The primary efficacy endpoint was Overall Survival (OS).
Primarni ishod djelotvornosti bio je ukupno preživljenje (OS; engl.
The primary efficacy endpoint was progression free survival (PFS) by International Myeloma Working Group (IMWG criteria).
Primarni ishod djelotvornosti bilo je preživljenje bez progresije bolesti (PFS) prema kriterijima međunarodne radne skupine za mijelom (International Myeloma Working Group, IMWG-kriteriji).
The primary efficacy endpoint was progression free survival (PFS).
Primarna mjera ishoda za djelotvornost bilo je preživljenje bez progresije bolesti (engl. progression free survival, PFS).
The primary efficacy endpoint was proportion of subjects achieving ≥35% reduction from baseline in spleen volume at week 24 as measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT).
Primarni ishod djelotvornosti bio je udio ispitanika koji su postigli smanjenje ≥35% od početne vrijednosti u volumenu slezene u 24. tjednu mjereno magnetskom rezonancijom (MR) ili kompjuteriziranom tomografijom (CT).
The primary efficacy endpoint was the change from baseline at Week 12 in 6MWD.
Primarni ishod za djelotvornost bila je promjena početne vrijednosti 6MWD-a u 12. tjednu.
The primary efficacy endpoint was the change from baseline at week 16 in 6-minute walk distance (6MWD).
Primarna mjera ishoda za djelotvornost bila je promjena od početne 6-minutne hodne pruge (6MWD) u 16. tjednu.
The primary efficacy endpoint was the composite of confirmed symptomatic recurrent non-fatal VTE and fatal VTE reported up to Day 97.
Primarna mjera ishoda djelotvornosti bila je kombinacija potvrđenih simptomatskih rekurentnih VTE bez smrtnog ishoda, te VTE sa smrtnim ishodom prijavljenih do 97. dana liječenja.
The primary efficacy endpoint was the CR rate in the delayed phase, 25-120 hours after the start of the chemotherapy administration.
Primarni ishod djelotvornosti bila je stopa potpunog odgovora u odgođenoj fazi, 25 – 120 sati nakon početka primjene kemoterapije.
The primary efficacy endpoint was the patient global assessment of method of pain control at 24 hours used to test equivalence between IONSYS and intravenous PCA morphine using a pre-specified ± 10% equivalence boundary with a 2-sided 95% confidence interval.
Primarna mjera ishoda djelotvornosti bila je globalna procjena bolesnika metode kontrole bola nakon 24 sata korištena za ispitivanje ekvivalencije između sustava IONSYS i intravenskog PCA morfina korištenjem unaprijed definirane ±10%-tne granice ekvivalencije s dvostranim 95%-tnim intervalom pouzdanosti.
The primary efficacy endpoint was the proportion of patients with a reduction of mean GH level to
Mjera primarnog ishoda djelotvornosti bila je udio bolesnika sa smanjenjem srednje razine GH-a na
The primary efficacy endpoints were:
Primarne mjere ishoda za procjenu djelotvornosti bile su:
The primary efficacy measure for both Studies I and II was the frequency of asthma exacerbations for each patient during the 52-week treatment period.
Primarna mjera djelotvornosti u Ispitivanjima I i II bila je učestalost egzacerbacija astme u svakog bolesnika tijekom razdoblja liječenja od 52 tjedna.
The primary efficacy measure in this trial was the frequency of cataplexy attacks.
Primarna mjera djelotvornosti bila je učestalost napadaja katapleksije.
The primary efficacy outcome measure, based on investigator assessed tumour response, was progression-free survival (PFS) of the lenvatinib plus everolimus arm vs the everolimus arm and of the lenvatinib arm vs the everolimus arm.
Primarna mjera ishoda djelotvornosti na temelju ispitivačeve procjene odgovora tumora bilo je preživljenje bez progresije bolesti (engl. progression-free survival, PFS) u skupini koja je primala lenvatinib i everolimus u usporedbi sa skupinom koja je primala samo everolimus, i u skupini koja je primala samo lenvatinib u usporedbi sa skupinom koja je primala samo everolimus.
The primary efficacy outcome was symptomatic recurrent VTE defined as the composite of recurrent DVT or fatal or non-fatal PE.
Primarni ishod djelotvornosti bio je simptomatski ponavljajući VTE definiran kao spoj ponavljajućeg DVT-a ili smrtonosne ili nesmrtonosne plućne embolije.
The primary efficacy parameter of the trial was the duration of progression-free survival.
Primarni parametar djelotvornosti u ispitivanju bilo je preživljenje bez progresije bolesti (engl. progression free survival, PFS).
The primary efficacy parameter was the change from baseline to endpoint in ‘ON Time without troublesome dyskinesia’.
Parametar primarne djelotvornosti bio je promjena od početne vrijednosti do ishoda u „ON razdoblju bez problematične diskinezije“.
The primary efficacy variable was percent change in lumbar spine BMD, fracture efficacy was not evaluated.
Primarna mjera djelotvornosti bila je promjena BMD lumbalne kralježnice u postotcima, djelotvornost s obzirom na frakture nije procjenjivana.
The primary efficacy variable was the patient’s assessment of pain intensity.
Primarna varijabla djelotvornosti bila je bolesnikova procjena intenziteta boli.
The primary efficacy variable was the rate of haematological response, reported as either complete haematological response, no evidence of leukaemia or return to chronic phase CML using the same criteria as for the study in accelerated phase.
Primarna varijabla djelotvornosti bila je stopa hematološkog odgovora, koja je zabilježena ili kao kompletni hematološki odgovor, stanje bez znakova leukemije ili kao vraćanje u kroničnu fazu KML- a, uz primjenu istih kriterija kao i kod ispitivanja u ubrzanoj fazi.
The primary efficacy variable was the rate of haematological response, reported as either complete haematological response, no evidence of leukaemia, or return to chronic phase CML using the same criteria as for the study in accelerated phase.
Primarna varijabla djelotvornosti bila je stopa hematološkog odgovora, koja je zabilježena ili kao kompletni hematološki odgovor, stanje bez znakova leukemije ili kao vraćanje u kroničnu fazu KML- a, uz primjenu istih kriterija kao i kod ispitivanja u ubrzanoj fazi.
The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the percent of patients who achieved an ACR 20 response at Week 24 or 26.
Primarni ishod ispitivanja RA I, II i III te sekundarni ishod ispitivanja RA IV bio je postotak bolesnika u kojih je postignut terapijski odgovor ACR 20 nakon 24, odnosno 26 tjedana liječenja.
The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the percentage of patients who achieved an ACR 20 response at Week 24 or 26.
Primarni ishod ispitivanja RA I, II i III te sekundarni ishod ispitivanja RA IV bio je postotak bolesnika u kojih je postignut terapijski odgovor ACR 20 nakon 24, odnosno 26 tjedana liječenja.
The primary endpoint and other week 48 outcomes (including outcomes by key baseline covariates) for SPRING-2 and SINGLE are shown in Table 3.
Primarna mjera ishoda i ostali ishodi nakon 48 tjedana (uključujući ishode prema ključnim kovarijantama s početka ispitivanja) za ispitivanja SPRING-2 i SINGLE prikazani su u Tablici 3.
The primary endpoint at Day 8 showed that dolutegravir 50 mg twice daily was superior to placebo, with an adjusted mean treatment difference for the change from Baseline in Plasma HIV-1 RNA of -1.2 log10 copies/mL (95% CI -1.5 - - 0.8log10 copies/mL, p<0.001).
Primarna mjera ishoda nakon 8 dana pokazala je da je dolutegravir u dozi od 50 mg dvaput na dan superioran u odnosu na placebo, uz prilagođenu srednju razliku između liječenja s obzirom na promjenu plazmatske koncentracije HIV-1 RNK od -1,2 log10 kopija/ml u odnosu na početnu vrijednost (95% CI -1,5
The primary endpoint for the study was PFS evaluated by RECIST (Response Evaluation Criteria in Solid Tumors).
Primarni ishod ispitivanja bilo je preživljenje bez progresije bolesti ocijenjeno prema RECIST kriterijima.
The primary endpoint for the study was progression-free survival (PFS) evaluated by RECIST (Response Evaluation Criteria in Solid Tumors), based on the investigator’s assessment (local radiology).
Primarni ishod ispitivanja bilo je preživljenje bez progresije bolesti prema RECIST kriterijima (Response Evaluation Criteria in Solid Tumors), na temelju ocjene ispitivača (lokalna radiologija).
The primary endpoint for the two split-thickness skin graft trials was the intra- individual difference in time to wound closure (at least 95% epithelialisation) based on blinded photo evaluations.
Primarni ishod dvaju ispitivanja kožnih presadaka djelomične debljine bila je intraindividualna razlika u vremenu zatvaranja rane (najmanje 95 % epitelizacije) na temelju procjena fotografija na slijepo.
The primary endpoint in both studies was the number of disease exacerbations requiring a “substantial therapeutic intervention” during the DCP, defined as an exacerbation with an IGA of 3-5 (i.e. moderate, severe and very severe disease) on the first day of the flare, and requiring more than 7 days treatment.
Primarni ishod u oba ispitivanja bio je broj egzacerbacija bolesti koje su zahtijevale “znatnu terapijsku intervenciju” tijekom DCP, a bile su definirane kao egzacerbacije s rezultatom na IGA ljestvici od 3 do 5 (tj. umjerena, teška ili jako teška bolest) prvog dana rasplamsavanja bolesti i koju je bilo potrebno liječiti dulje od 7 dana.
The primary endpoint in RA studies VI and VII was injection site pain immediately after injection as measured by a 0-10 cm VAS.
Primarni ishod u ispitivanjima RA VI i VII bila je bol na mjestu injiciranja neposredno nakon injekcije, ocijenjena prema VAS ljestvici od 0-10 cm.
The primary endpoint in RA study V was the percent of patients who achieved an ACR 50 response at Week 52.
Primarni ishod ispitivanja RA V bio je postotak bolesnika u kojih je postignut terapijski odgovor ACR 50 nakon 52 tjedna liječenja.
The primary endpoint in the AP patients was overall confirmed haematological response (HR), defined as either a complete haematological response, no evidence of leukaemia or return to chronic phase.
Primarni ishod u bolesnika u ubrzanoj fazi bio je cjelokupni potvrđeni hematološki odgovor (HR – engl. hematological response), definiran bilo kao kompletan hematološki odgovor, nemogućnost dokazivanja leukemije ili kao povratak u kroničnu fazu.
The primary endpoint in these studies was the proportion of patients who achieved PASI 75 response from baseline at week 12 (see Tables 4 and 5).
Primarni ishod ovih ispitivanja bio je omjer bolesnika koji su u tjednu 12 dostigli odgovor na terapiju PASI 75 u odnosu na početnu vrijednost (vidjeti Tablicu 4 i 5).
The primary endpoint in this study was ORR per investigator assessment.
Primarni ishod u ovom ispitivanju bio je stopa ukupnog odgovora (engl. overall response rate, ORR) prema procjeni ispitivača.
The primary endpoint of safety was evaluated through week 24 (see section 4.8).
Primarni ishod sigurnosti primjene bio je procijenjen do 24. tjedna (vidjeti dio 4.8).
The primary endpoint of the study included progression free survival (PFS) in all patients.
Primarna mjera ishoda ispitivanja uključivala je preživljenje bez progresije bolesti (PFS) u svih bolesnika.
The primary endpoint of the study was clinical remission at Week 26, defined as PCDAI score  10.
Primarni ishod ispitivanja bio je klinička remisija u 26. tjednu, definirana kao PCDAI rezultat ≤ 10.
The primary endpoint of the study was clinical remission at Week 26, defined as PCDAI score  10.
Primarni ishod ispitivanja bio je klinička remisija u 26. tjednu, definirana kao PCDAI rezultat ≤10.
The primary endpoint of the study was met: a statistically significantly higher percentage of subjects in the Resolor group (37.9%) had an average of ≥ 3 SCBMs/week compared with subjects in the placebo treatment group (17.7%) (p<0.0001) over the 12-week double-blind treatment period.
Postignut je primarni ishod ispitivanja: statistički značajno viši postotak ispitanika u skupini liječenoj lijekom Resolor (37,9%) imao je prosječno ≥3 kompletnih pražnjenja crijeva na tjedan, u usporedbi s ispitanicima u skupini koja je liječena placebom (17,7%) (p<0,0001) u 12-tjednom, dvostruko slijepom razdoblju liječenja.
The primary endpoint of the study was overall survival with a key secondary endpoint of PFS.
Mjera primarnog ishoda u ispitivanju bila je ukupno preživljenje uz ključnu mjeru sekundarnog ishoda PFS.
The primary endpoint of the study was overall survival with a key secondary endpoint of PFS.
Mjera primarnog ishoda u ispitivanju bila je ukupno preživljenje uz PFS kao ključnu mjeru sekundarnog ishoda.
The primary endpoint of the study was overall survival.
Primarni ishod ispitivanja bio je sveukupno preživljenje.
The primary endpoint of the study was PFS by investigator assessment.
Primarna mjera ishoda ispitivanja bilo je preživljenje bez progresije bolesti prema ocjeni ispitivača.
The primary endpoint of the study was progression-free survival (PFS) as assessed by an independent review facility (IRF) and defined as the time from the date of randomization to the date of disease progression or death (from any cause) if the death occurred within 18 weeks of the last tumour assessment.
Primarna mjera ishoda ispitivanja bilo je preživljenje bez progresije bolesti prema procjeni neovisnog ocjenjivačkog tijela, a definirana je kao razdoblje od datuma randomizacije do datuma progresije bolesti ili smrti (zbog bilo kojeg uzroka) ako je smrt nastupila unutar 18 tjedana od posljednje procjene tumora.
The primary endpoint of the study was progression-free survival (PFS), with a key secondary endpoint of overall survival (OS).
Mjera primarnog ishoda u ispitivanju bila je preživljenje bez progresije (eng. progression-free survival, PFS), a ključna mjera sekundarnog ishoda ukupno preživljenje (eng. overall survival, OS).
The primary endpoint of the study was recurrence-free survival (RFS), defined as the time from date of randomisation to the date of recurrence or death from any cause.
Primarni ishod ispitivanja bilo je preživljenje bez recidiva bolesti, definirano kao vrijeme od datuma randomizacije do datuma recidiva ili smrti zbog bilo kojeg uzroka.
The primary endpoint of the study was the occurrence of death from any cause or new myocardial infarction (MI) (evaluated by a blinded Clinical Events Committee) within 30 days of randomisation.
Primarna mjera ishoda studije bila je pojava smrti zbog bilo kojeg uzroka ili novog infarkta miokarda (IM) (prema evaluaciji slijepog Povjerenstva za kliničke događaje) unutar 30 dana od randomizacije.
The primary endpoint of the study was the placebo adjusted change from baseline in 6-minute walk distance (6MWD) at the last visit (week 16).
Primarni ishod ispitivanja bila je promjena prevaljenog puta tijekom 6-minutnog hoda (6MWD) kod posljednjeg posjeta (16. tjedan) u odnosu na početnu vrijednost, prilagođena za placebo.
The primary endpoint of the study was to evaluate the efficacy of trametinib compared to chemotherapy with respect to progression-free survival (PFS) in patients with advanced/metastatic BRAF V600E mutation-positive melanoma without a prior history of brain metastases (N = 273) which is considered the primary efficacy population.
Mjera primarnog ishoda ispitivanja bila je ocijeniti djelotvornost trametiniba u usporedbi s kemoterapijom s obzirom na preživljenje bez progresije bolesti (engl. progression-free survival, PFS) u bolesnika s uznapredovalim/metastatskim melanomom pozitivnim na BRAF mutaciju V600E i bez moždanih metastaza u anamnezi (N=273), koji su se smatrali primarnom populacijom za ispitivanje djelotvornosti.
The primary endpoint of this study was the response rate to vaccination, defined as the percentage of patients with a serum bactericidal antibody (SBA) titre ≥ 8 at the week 5 visit.
Primarni ishod u ovom ispitivanju bila je stopa odgovora na cijepljenje, definirana kao stopa bolesnika s titrom baktericidnih protutijela u serumu (SBA) ≥ 8 prilikom posjeta u 5. tjednu.
The primary endpoint of this trial was progression free survival (PFS), based on trial investigators’ assessment of disease progression.
Primarna mjera ishoda ovog ispitivanja bilo je preživljenje bez progresije bolesti, na temelju ispitivačeve procjene progresije bolesti.
The primary endpoint was change in HbA1c from baseline at 52 weeks.
Primarna mjera ishoda bila je promjena vrijednosti HbA1c u 52. tjednu u odnosu na početne vrijednosti.
The primary endpoint was complete patient clearance after 12 weeks following the last photodynamic therapy.
Primarni ishod bio je potpuno uklanjanje lezija kod bolesnika 12 tjedana nakon zadnjeg fotodinamske terapije.
The primary endpoint was complete remission (CR) rate that was assessed by independent expert review.
Primarni ishod ispitivanja bila je stopa kompletne remisije (CR) procijenjen od strane nezavisnih stručnjaka.
The primary endpoint was defined as the percentage decrease in mEASI from the baseline to end of treatment.
Primarni ishod bio je definiran kaostopa smanjenja mEASI od početne vrijednosti do vrijednosti na kraju liječenja.
The primary endpoint was durable response rate (DRR) [defined as the percent of patients with complete response (CR) or partial response (PR) maintained continuously for a minimum of 6 months] per blinded central review.
Primarni ishod je bio učestalost održivog odgovora (eng. durable response rate (DRR)) [definirana kao postotak bolesnika s potpunim odgovorom (CR, od eng. complete response) ili djelomičnim odgovorom (PR, od eng. partial response) održanim kontinuirano kroz najmanje 6 mjeseci] po slijepoj centralnoj procjeni.
The primary endpoint was improvement in lung function as determined by the mean absolute change from baseline at Day 56 in ppFEV1.
Primarni ishod bilo je poboljšanje plućne funkcije određeno kao srednja vrijednost apsolutne promjene vrijednosti ppFEV1 izmjerena 56. dana u odnosu na početak ispitivanja.
The primary endpoint was objective response rate (ORR) as assessed by an independent review facility (IRF) as summarised in Table 2.
Primarni ishod bila je stopa objektivnog odgovora prema procjeni neovisnog ocjenjivačkog tijela, kako je prikazano u Tablici 2.
The primary endpoint was OS and the secondary endpoints included PFS, objective response rate (ORR) and quality of life (QoL) using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30.
Primarna mjera ishoda bio je OS, a sekundarne mjere ishoda uključivale su PFS, stopu objektivnog odgovora (ORR) i kvalitetu života ocijenjenu na temelju upitnika QLQ-C30 Europske organizacije za istraživanje i liječenje raka (engl.
The primary endpoint was PFS as assessed by the investigator using RECIST.
Primarna mjera ishoda ispitivanja bilo je preživljenje bez progresije bolesti po procjeni ispitivača prema RECIST-u.
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.
Primarna mjera ishoda bilo je preživljenje bez progresije bolesti, prema ispitivačevoj procjeni progresije bolesti na temelju radioloških snimaka, razine CA-125 ili simptomatskog pogoršanja po protokolu.
The primary endpoint was PFS.
Primarna završna točka bio je PFS.
The primary endpoint was progression free survival (PFS).
Primarna završna točka bila je preživljenje bez progresije bolesti (PFS, progression free survival).
The primary endpoint was reduction in all-cause mortality at 3 years for salmeterol/fluticasone propionate vs placebo.
Primarni ishod bio je smanjenje smrtnosti svih uzroka nakon 3 godine za salmeterol/flutikazonpropionat naspram placeba.
The primary endpoint was the annualised relapse rate (ARR) over 1 year.
Primarni ishodbila je godišnja stopa recidiva (eng. annualised relapse rate, ARR) tijekom 1 godine.
The primary endpoint was the area-under-the-curve (AUC) of the mEASI as a percentage of baseline averaged over the treatment period.
Primarni ishod bila je površina ispod krivulje (AUC) mEASI-a kao stopa početnih vrijednosti uprosječen za razdoblje liječenja.
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 ).
Superiornost je dokazana primarnim ishodom, razlikom intenziteta bola unutar 15 minuta, koja je u bolesnika liječenih PecFentom iznosila 3,02 u usporedbi s 2,69 u bolesnika liječenih morfin sulfatom s trenutačnim otpuštanjem (p=0,0396).
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.
Primarna mjera ishoda bio je postotak promjene početne vrijednosti do 12. tjedna u broju aktivnih zglobova s artritisom (oticanje koje nije posljedica deformacije ili zglobovi s gubitkom pokretljivosti uz bol i/ili osjetljivost), koji je postignut uz srednji postotak smanjenja od -62,6% (medijan postotka promjene -88,9%) u bolesnika u skupini liječenoj lijekom Humira u usporedbi s -11,6% (medijan postotka promjene -50,0%) u bolesnika u skupini koja je primala placebo.
The primary endpoint was the percent reduction in daily OCS dose (weeks 20-24), whilst maintaining asthma control by defined dose reduction categories (see Table 4).
Primarna mjera ishoda bio je postotak smanjenja dnevne doze OKS-a (20. – 24. tjedan) uz istodobno održanu kontrolu astme prema definiranim kategorijama smanjenja doze (vidjeti Tablicu 4).
The primary endpoint was the percentage of patients achieving American College of Rheumatology (ACR) 20 response at Week 16.
Primarni ishod bio je postotak bolesnika koji prema kriterijima Američkog reumatološkog društva (ACR) postigne odgovor 20 u 16. tjednu.
The primary endpoint was the placebo-corrected percentage change in peak VO2 from baseline to week 16 assessed by CPET in the combined dose groups (Table 2).
Primarni ishod bila je za placebo korigirana postotna promjena vršne vrijednosti VO2 od početka ispitivanja do 16. tjedna, procijenjena CPET testom u skupinama koje su primale kombinirane doze (Tablica 2).
The primary endpoint was the proportion of patients achieving DAS28 remission (DAS28 < 2.6) at week 24.
Primarna mjera ishoda bio je udio bolesnika koji su postigli remisiju DAS28 (DAS28 < 2,6) u 24. tjednu.
The primary endpoint was the proportion of patients in clinical remission at Week 6 in the TNF antagonist failure subpopulation.
Primarni ishod bio je udio bolesnika u kliničkoj remisiji u 6. tjednu u subpopulaciji bolesnika koji nisu reagirali na antagonist TNF.
The primary endpoint was the proportion of patients who achieve a PGA score of cleared (0) or minimal (1) at week 12.
Primarni ishod bio je udio bolesnika koji su u 12. tjednu postigli PGA skor čist (0) ili minimalan (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.
Primarnu mjeru ishoda ispitivanja činio je udio bolesnika koji su pokazali klinički odgovor, definiran kao smanjenje CDAI za ≥ 70 bodova u odnosu na početne vrijednosti nakon 4 tjedna, bez povećanja doza lijekova koji se daju u Crohnovoj bolesti ili kirurškog liječenja Crohnove bolesti.