natgillin/translations-raw huggingface dataset:
Det primære endepunkt var andelen af patienter, der opnåede HbA1c <7 % uden bekræftet eller alvorlig hypoglykæmi.
Primary endpoint was the proportion of patients reaching HbA1c <7% without confirmed or severe hypoglycaemia.
Det primære endepunkt var andelen af patienter, der ved måned 6 havde opnået mindst to graders forbedring i keratitis (CFS) og en 30% forbedring i symptomer, målt vha.Ocular Surface Disease Index (OSDI).
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).
Det primære endepunkt var andelen af patienter, som var i live og fri for invasiv ventilations-
The primary endpoint was the proportion of patients who were alive and free of invasive ventilator support.
Det primære endepunkt var bedste bekræftede respons på genbehandling vurderet ud fra EBMT- kriterierne.
The primary endpoint was best confirmed response to retreatment as assessed by EBMT criteria.
Det primære endepunkt var bedste bekræftede respons på genbehandling, vurderet ud fra EBMT- kriterierne.
The primary endpoint was best confirmed response to retreatment as assessed by EBMT criteria.
Det primære endepunkt var den procentvise ændring i antallet af led med aktiv artrit (hævelse, som ikke skyldes deformitet, eller led med tab af bevægelse plus smerte og/eller ømhed) fra baseline til uge 12, som blev opnået med et mediant fald på -62,6 % (median procentvise ændring -88,9 %) hos patienter i Humira-gruppen sammenlignet med et fald på - 11,6 % (median procentvise ændring -50,0 %) hos patienter i placebo-gruppen.
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.
Det primære endepunkt var død, progression af det erhvervede immundefektsyndrom eller en stigning i hiv-1-RNA niveau til 200 kopier eller mere pr. ml. endepunkt
The primary study endpoint was death, progression to the acquired immunodeficiency syndrome, or an increase in HIV-1 RNA levels to 200 copies or more per millilitre.
Det primære endepunkt var forekomsten af en kombination af okkluderede arterier, der var relateret til infarkt, på angiogrammet før patienten blev udskrevet, dødsfald eller ved gentaget MI før koronarangiografi.
The primary endpoint was the occurrence of the composite of an occluded infarct-related artery on the predischarge angiogram, or death or recurrent MI before coronary angiography.
Det primære endepunkt var gennemsnitlig progressionsfri overlevelse (PFS) som vurderet af en blændet uafhængig vurderingskomité (IRC) ved brug af International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines (2008).
The primary endpoint was median progression-free survival (PFS) as assessed by a blinded Independent Review Committee (IRC) using the International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines (2008).
Det primære endepunkt var investigatorvurderet PFS.
The primary endpoint was investigator assessed PFS.
Det primære endepunkt var nedsat hyppighed af klinisk signifikante astma- eksacerbationer, og reduktionerne i begge behandlingsarme med mepolizumab var statistisk signifikante sammenlignet med placebo (p < 0,001).
The primary endpoint was the frequency of clinically significant exacerbations of asthma and the reductions for both mepolizumab treatment arms compared to placebo were statistically significant (p<0.001).
Det primære endepunkt var OS i ipilimumab+ gp100–gruppen versus gp100–gruppen.
The primary endpoint was OS in the ipilimumab+ gp100 group vs. the gp100 group.
Det primære endepunkt var overlevelse (OS).
The primary efficacy endpoint was Overall Survival (OS).
Det primære endepunkt var PFS (progressionsfri overlevelse) baseret på investigators vurdering under anvendelse af RECIST 1.0. Sekundære virkningsendepunkter omfattede OS (samlet overlevelse), DCR (sygdomskontrolrate) defineret som bekræftet CR/PR + SD (stabil sygdom), HRQoL (helbredsrelateret livskvalitet) og sygdomsrelaterede symptomer.
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.
Det primære endepunkt var PFS, baseret på investigators vurdering af sygdomsprogression baseret på radiologiske scanninger eller CA-125-niveauer, eller symptomatisk forværring per protokol.
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.
Det primære endepunkt var procentdelen af patienter i klinisk remission i uge 52.
Primary endpoint was the proportion of patients in clinical remission at Week 52.
Det primære endepunkt var procentdelen af patienter med klinisk respons (defineret som en reduktion af det totale Mayo-score på 3 point og
Primary endpoint was the proportion of patients with clinical response (defined as reduction in complete Mayo score of
Det primære endepunkt var procentdelen af patienter, der opnåede et respons i henhold til American College of Rheumatology (ACR) 20 efter uge 16.
The primary endpoint was the percentage of patients achieving American College of Rheumatology (ACR) 20 response at Week 16.
Det primære endepunkt var procentvis ændring i maksimalt iltforbrug (VO2) fra baseline til uge 16 bestemt ved CPET-test af forsøgspersonerne i de kombinerede doseringsgrupper (se tabel 2).
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).
Det primære endepunkt var progressionfri overlevelse vurderet af investigator ved brug af modificeret RECIST 1.0. Yderligere endepunkter inkluderede objektivt respons, responsvarighed, samlet overlevelse og sikkerhed.
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.
Det primære endepunkt var reduktion i mortalitet uanset årsag efter 3 år for salmeterol/fluticasonpropionat vs. placebo.
The primary endpoint was reduction in all-cause mortality at 3 years for salmeterol/fluticasone propionate vs placebo.
Det primære endepunkt var tiden til første tilfælde af klinisk behandlingssvigt, defineret som:
The primary endpoint was the time to first occurrence of a clinical failure event, defined as:
Det primære endepunkt var ændring fra baseline i Simplified Endoscopic Disease Severity Score for Crohns Disease (SES-CD), en sammensat score for 5 segmenter i ileum-colon for tilstedeværelse/størrelse af sår, andel af mucosa dækket af sår, andel af mucosa påvirket af eventuelle andre læsioner og tilstedeværelse/type af forsnævringer/strikturer.
The primary endpoint was change from baseline in Simplified Endoscopic Disease Severity Score for Crohn’s Disease (SES-CD), a composite score across 5 ileo- colonic segments of presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions and presence/type of narrowing/strictures.
Det primære endepunkt var ændringen i HbA1c efter 52 uger i forhold til baseline.
The primary endpoint was change in HbA1c from baseline at 52 weeks.
Det primære endepunkt ved ge 24 var andelen af patienter, som opnåede et ACR 20-respons.
The primary endpoint at week 24 was the proportion of patients who achieved an ACR 20 response.
Det primære endepunkt viste non-inferioritet (prædefineret margen på 12%) for ACR-20-respons efter 12 måneders behandling, 64,8% (206/318) for abatacept-s.c.-gruppen og 63,4% (208/328) for adalimumab-s.c.-gruppen; behandlingsforskel 1,8% [95% konfidensinterval (CI): -5,6; 9,2], med sammenlignelige responser i løbet af 24-måneders-perioden.
The primary endpoint showed non- inferiority (predefined margin of 12%) of ACR 20 response after 12 months of treatment, 64.8% (206/318) for the abatacept SC group and 63.4% (208/328) for the adalimumab SC group; treatment difference was 1.8% [95% confidence interval (CI): -5.6, 9.2], with comparable responses throughout the 24-month period.
Det primære endepunkt viste non-inferioritet (prædefineret margen på 12%) for ACR-20-respons efter 12 måneders behandling, 64,8% (206/318) for abatacept-s.c.-gruppen og 63,4% (208/328) for adalimumab-s.c.-gruppen; behandlingsforskel var 1,8% [95% konfidensinterval (CI): -5,6, 9,2], med sammenlignelige responser i løbet af 24-måneders-perioden.
The primary endpoint showed non- inferiority (predefined margin of 12%) of ACR20 response after 12 months of treatment, 64.8% (206/318) for the abatacept SC group and 63.4% (208/328) for the adalimumab SC group; treatment difference was 1.8% [95% confidence interval (CI): -5.6, 9.2], with comparable responses throughout the 24-month period.
Det primære endepunkt, behandlingssvigt, var defineret som mindre end 1 log10 fald i plasma hiv- 1-RNA i de første 12 uger eller mere end 50 kopier/ml i to på hinanden følgende målinger efter uge 24, eller sygdomsprogression.
The primary endpoint, treatment failure, was defined as less than 1 log10 decline in plasma HIV-1 RNA in the first 12 weeks, or two consecutive measurements of more than 50 copies/ ml from week 24 onwards, or disease progression.
Det primære endepunkt, behandlingssvigt, var defineret som mindre end 1 log10-fald i plasma hiv-1- RNA i de første 12 uger eller mere end 50 kopier/ml i to på hinanden følgende målinger efter uge 24, eller sygdomsprogression.
The primary endpoint, treatment failure, was defined as less than 1 log10 decline in plasma HIV-1 RNA in the first 12 weeks, or two consecutive measurements of more than 50 copies/ ml from week 24 onwards, or disease progression.
Det primære endepunkt, der var sammensat af: forekomsten af eller tiden til første forekomst af kardiovaskulær mortalitet, ikke- dødeligt myokardieinfarkt, ikke-dødelig apopleksi eller indlæggelse på grund af ustabil angina pectoris, var ikke signifikant lavere for linagliptin sammenlignet med en kombination af aktive- og placebokomparatorer [hazard ratio 0,78 (95 % konfidensinterval 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)].
Det primære endepunkt, der var sammensat af: forekomsten af eller tiden til første forekomst af kardiovaskulær mortalitet, ikke-dødeligt myokardieinfarkt, ikke-dødelig apopleksi eller indlæggelse på grund af ustabil angina pectoris, var ikke signifikant lavere for linagliptin sammenlignet med en kombination af aktive- og placebokomparatorer [hazard ratio 0,78 (95 % konfidensinterval 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)].
Det primære endepunkt, hastigheden af forværring i FVC i løbet af 52 uger, var lavere i nintedanib- gruppen (-0,060 l/år, N=84) end i placebogruppen (-0,190 l/år, N=83).
The primary endpoint, rate of decline in FVC over 52 weeks was lower in the nintedanib arm (-0.060 L/year, N=84) than the placebo arm (-0.190 L/year, N=83).
Det primære endepunkt, sammensat af død, kardiogent shock, kongestivt hjertesvigt og re- infarkt indenfor 30 dage, blev observeret hos 12,4 % (116/939) i den farmako-invasive arm versus 14,3 % (135/943) i den primære PCI-arm (relativ risiko 0,86 (0,68-1,09)).
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)).
Det primære endepunkti RA-studie I, II og III og det sekundære endepunkt i RA-studie IV var den procentdel af patienter, som fik ACR 20-respons i uge 24 eller 26.
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.
Det primære endpoint evaluerede effekten af ataluren på evnen til at gå vurderet ved ændringen i gangafstand (6MWD) under en 6MWT.
The primary efficacy endpoint evaluated the effect of ataluren on ambulation as assessed by the change in distance (6MWD) walked during a 6MWT.
Det primære endpoint for disse studier var den gennemsnitlige daglige AUC for ændring i serum- natrium fra baseline til dag 4 og fra baseline til dag 30.
The primary endpoint for these trials was the average daily AUC for change in serum sodium from baseline to Day 4 and baseline to Day 30.
Det primære endpoint var attakkfrekvensen på årsbasis (ARR) over 1 år.
The primary endpoint was the annualised relapse rate (ARR) over 1 year.
Det primære fokus for sygdommen var kolon (62%) eller rektum (38%).
The primary site of disease was colon (62%) or rectum (38%).
Det primære formål blev ikke nået.
The primary objective was not met.
Det primære formål med denne undersøgelse var at påvise en forbedring i progressionsfri overlevelse (PFS) med vandetanib sammenlignet med placebo.
The primary objective of this study was to demonstrate an improvement in progression-free survival (PFS) with vandetanib compared to placebo.
Det primære formål med dette studie var at udelukke en effekt større end 10 msek (dvs. påvise manglende effekt) på QTc- intervallet med en enkelt oral dosis på 80 mg vardenafil sammenlignet med placebo, målt som ændringen i Fridericia’s korrektionsformel (QTcF=QT/RR1/3) en time efter dosering, sammenlignet med udgangsværdien.
The primary objective of this study was to rule out a greater than 10 msec effect (i.e., to demonstrate lack of effect) of a single 80 mg oral dose of vardenafil on QTc interval compared to placebo, as measured by the change in Fridericia's correction formula (QTcF=QT/RR1/3) from baseline at the 1 hour post-dose time point.
Det primære formål med dette studie var at udelukke en effekt større end 10 msek (dvs. påvise manglende effekt) på QTc-intervallet med en enkelt oral dosis på 80 mg vardenafil sammenlignet med placebo, målt som ændringen i Fridericia’s korrektionsformel (QTcF=QT/RR1/3) en time efter dosering, sammenlignet med udgangsværdien.
The primary objective of this study was to rule out a greater than 10 msec effect (i.e. to demonstrate lack of effect) of a single 80 mg oral dose of vardenafil on QTc interval compared to placebo, as measured by the change in Fridericia's correction formula (QTcF=QT/RR1/3) from baseline at the 1 hour post-dose time point.
Det primære formål med dette studie var at vurdere effekten af dabrafenib sammenlignet med DTIC med hensyn til progressionsfri overlevelse (PFS), hvor tidspunktet for progression blev bestemt af investigators vurdering.
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.
Det primære formål med forsøget var at sammenligne virkningen af tolvaptan + standardbehandling med placebo + standardbehandling i forhold til tiden til mortalitet af alle årsager og tiden til første forekomst af kardiovaskulær mortalitet eller indlæggelse for hjertesvigt.
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.
Det primære formål med studiet var at sammenligne CCyR efter 1 år hos patienter med nydiagnosticeret Ph+ CP CML, som fik bosutinib, i forhold til patienter, der fik imatinib.
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.
Det primære formål med studiet var at sammenligne virkningen af tolvaptan + standardbehandling med placebo + standardbehandling i forhold til tiden til mortalitet af alle årsager og tiden til første forekomst af kardiovaskulær mortalitet eller indlæggelse for hjertesvigt.
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.
Det primære formål med studiet var at vurdere varigheden af forbedringen efter seponering af behandling med IKERVIS, når først patienten var forbedret med hensyn til baseline for SANSIKA- studiet (dvs. mindst 2 grader forbedring på den modificerede Oxford-skala).
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).
Det primære formål var at påvise non-inferioritet af T12(b.i.d.)/PR i forhold til T12(q8h)/PR.
The primary objective was to demonstrate the noninferiority of T12(b.i.d.)/PR over T12(q8h)/PR.
Det primære forudbestemte endepunkt, dvs. ændringen i FEV1 (ml) i forhold til baseline i den modificerede ITT-population (mITT) (henholdsvis n=269 og 297 i undersøgelse DPM-CF-301 og DPM-CF-302), sammenlignet med kontrolgruppen over de 26 uger er vist i tabel 1 sammen med FEV1, der er angivet som forventet absolut og relativ ændring i %.
The primary pre-specified endpoint i.e. the change from baseline in FEV1 (ml) in the modified ITT (mITT) population (n=269 and 297 in studies DPM-CF-301 and DPM-CF-302, respectively) compared to control over the 26 weeks period is provided in Table 1 alongside FEV1 presented as absolute and relative change % predicted.
Det primære mål for behandlingens virkning var antallet af attakker hos patienterne.
The main measure of effectiveness was the number of relapses that the patients had.
Det primære mål for effekt (ASAS 20) var en ≥ 20 % forbedring i mindst 3 af 4 af responskriterierne i Assessment in Ankylosing Spondylitis (ASAS) (patientens helhedsvurdering, rygsmerter, BASFI og inflammation) og ingen forringelse i det sidste af kriterierne.
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.
Det primære mål for effekt (ASAS 20) var en 20 % forbedring i mindst 3 af 4 af responskriterierne i Assessment in Ankylosing Spondylitis (ASAS) (patientens helhedsvurdering, rygsmerter, BASFI og inflammation) og ingen forringelse i det sidste af kriterierne.
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.
Det primære mål for effekt var baseret på, hvor meget man kunne afkorte den tid, hvor patienterne havde svær neutropeni.
The main measure of effectiveness was based on the reduction in the length of time that the patients had severe neutropenia.
Det primære mål for virkning blev baseret på, hvor mange patienter der opnåede "komplet respons" defineret som ingen opkastning eller opkastningsfornemmelser og intet behov for andre lægemidler mod kvalme og opkastning 25-120 timer efter påbegyndelse af kemoterapien (forsinket fase).Det blev også undersøgt, hvor mange patienter der opnåede komplet respons i de første 24 timer efter kemoterapi (akut fase).
The main measure of effectiveness was based on how many patients had a ‘complete response’, which was defined as no vomiting, retching or dry heaves and no need for any other medication to control nausea and vomiting 25 to 120 hours after the start of chemotherapy (delayed phase).The study also looked at how many patients achieved a complete response in the first 24 hours after chemotherapy (acute phase).
Det primære mål for virkning var andelen af patienter, der udviste fuld eller delvis respons på behandlingen (som målt ved eliminering eller en reduktion på mindst 50 % af et protein, der findes i store mængder i myelomatose-celler).
The main measure of effectiveness was the proportion of patients who responded completely or partially to treatment (as measured by the disappearance of or at least a 50% reduction in a protein found in excess in multiple myeloma cells).
Det primære mål for virkning var antallet af patienter, hvis tarm åbnede sig inden for fire timer efter den første dosis, og procentdelen af injektioner, som medførte en tarmtømning.
The main measures of effectiveness were the number of patients whose bowels opened within four hours of the first dose, and the percentage of injections that were successful in producing a bowel movement.
Det primære mål for virkning var mængden af antistoffer i blodet mod viraene i vaccinen.
The main measure of effectiveness was the level of antibodies in the blood against the viruses in the vaccine.
Det primære mål for virkning var tiden til sygdomsforværring eller, for så vidt angår Kaposis sarkom, antallet af patienter, der opnåede positiv respons på behandlingen.
The main measure of effectiveness was time until the disease got worse or, for Kaposi’s sarcoma, the number of patients who responded to treatment.
Det primære mål for virkningen var andelen af patienter, der reagerede på behandlingen, og hvis hjernetumor skrumpede til mindst halv størrelse efter 6 måneders behandling.
The main measure of effectiveness was the proportion of patients who responded to treatment and whose brain tumour shrank by at least half after six months of treatment.
Det primære mål for virkningen var andelen af patienter, der reagerede på behandlingen, og hvis nyretumor skrumpede til mindst halv størrelse.
The main measure of effectiveness was the proportion of patients who responded to treatment and whose kidney tumour shrank by at least half.
Det primære mål for virkningen var andelen af personer, der udviklede antistoffer mod hepatitis A og B.
The main measure of effectiveness was the proportion of the people who had developed antibodies against hepatitis A and B.
Det primære mål for virkningen var antallet af patienter, hos hvem der efter behandling ikke fandtes påviselige mængder af hiv-1 i blodet (under 400 kopier/ml)
The main measure of effectiveness was the number of patients who had undetectable levels of HIV-1 in their blood (below 400 copies/ml) after treatment.
Det primære mål for virkningen var antallet af patienter, som oplevede mindst én ny knoglerelateret hændelse i en periode på 13 måneder.
The main measure of effectiveness was the number of patients who developed at least one new ‘skeletal event’ over 13 months.
Det primære mål for virkningen var baseret på det antal patienter, hvis sygdom forværredes, eller som døde i løbet af behandlingen eller kort tid efter behandlingsstop.
The main measure of effectiveness was based on the number of patients whose disease worsened or who died during treatment or shortly after treatment had ended.
Det primære mål for virkningen var baseret på muskelstyrke og mindskelsen af patientens invaliditet.
The main measures of effectiveness were based on muscle strength and the reduction in patients’ disability.