natgillin/translations-raw huggingface dataset:
Studierne undersøgte virkningen af Respreeza på progression af emfysem, vurderet ud fra faldet i lungedensitet, målt vha.
The studies investigated the effect of Respreeza on the progression of emphysema, assessed by the decline of lung density, measured by computer tomography (CT).
Studierne viste, at dabigatranetexilat 150 mg 2 gange dagligt er non-inferior til warfarin (non- inferioritet for RE-COVER og RE-COVER II var 3,6 i risiko-forskel og 2,75 for hazard ratio).
The trials, demonstrated that treatment with dabigatran etexilate 150 mg twice daily was non-inferior to the treatment with warfarin (non-inferiority margin for RE-COVER, and RE-COVER II: 3.6 for risk difference and 2.75 for hazard ratio).
Studierne viste, at dabigatranetexilat 150 mg 2 gange dagligt er non-inferior til warfarin non- inferioritet for RE-COVER og RE-COVER II var 3,6 i risiko forskel og 2,75 for hazard ratio
The trials, demonstrated that treatment with dabigatran etexilate 150 mg twice daily was non-inferior to the treatment with warfarin ( non-inferiority margin for RE-COVER and RE-COVER II: 3.6 for risk difference and 2.75 for hazard ratio).
Studierne viste, at glykæmisk kontrol (HbA1c) med Levemir er sammenlignelig med den, der opnås med NPH-insulin og insulin degludec givet som basalbolus-behandling, ved brug af en non-inferioritetsmargin på 0,4%.
The trials demonstrated that glycaemic control (HbA1c) with Levemir is comparable to NPH insulin and insulin degludec when given as basal-bolus therapy, using a non- inferiority margin of 0.4%.
Studiesdesign
Study design
Studiespopulation
Study population
Studiet (dobbeltblindet og placebokontrolleret) evaluerede 24 ugers behandling med ledipasvir/sofosbuvir (sammen med ribavirin – placebo) versus 12 ugers behandling med ledipasvir/sofosbuvir sammen med ribavirin.
The study (double-blind and placebo-controlled) evaluated 24 weeks of treatment ledipasvir/sofosbuvir (with ribavirin placebo) versus 12 weeks of treatment with ledipasvir/sofosbuvir with ribavirin.
Studiet A4001029 er et eksplorativt studie med patienter inficeret med dual/mixed eller CXCR4- tropisme hiv 1 med et lignende design som studierne MOTIVATE 1 og MOTIVATE 2.
Study A4001029 was an exploratory study in patients infected with dual/mixed or CXCR4 tropic HIV- 1 with a similar design as the studies MOTIVATE 1 and MOTIVATE 2.
Studiet anvendte historiske kontroller fra det samme center som patienter, der fik asfotase alfa, og havde gennemgået en lignende protokol for klinisk behandling.
The study employed historical controls from the same centre as patients who received asfotase alfa and who had been subject to a similar protocol of clinical management.
Studiet blev afbrudt, da interimanalysen (n=475) viste en lav incidens af CNS-relaterede hændelser og bedre effekt i armen med trastuzumab plus capecitabin med hensyn til progressionsfri overlevelse og samlet overlevelse (se resultaterne af den endelige analyse i tabel 3).
The study was halted as the interim analysis (N=475) showed a low incidence of CNS events and, superior efficacy of the trastuzumab plus capecitabine arm in terms of progression-free survival and overall survival (see results of final analysis in Table 3).
Studiet blev betegnet som vellykket, hvis mindst ét af de to co-primære endepunkter blev opnået.
The study was declared successful if at least one of the two co-primary endpoint was met.
Studiet blev initieret med en 12 ugers opstartsperiode med liraglutid+metformin, hvoraf 61% nåede et HbA1c <7%.
The trial started with a 12 week run-in period with liraglutide+metformin, where 61% reached an HbA1c <7%.
Studiet blev stoppet tidligere end planlagt, efter 60 uger.
The study was prematurely stopped after 60 weeks.
Studiet blev udført i Nordamerika, Latinamerika, Asien og Stillehavsområdet, samt Europa, og tillod deltagelse af kvinder med en HPV- infektion i anamnesen.
The study was conducted in North America, Latin America, Asia Pacific and Europe, and allowed women with previous history of HPV disease/infection to be enrolled.
Studiet blev udført med deltagelse af 143 rituximab-naive-patienter med recidiverende eller refraktær non-Hodgkin’s lymfom (NHL) eller transformeret B-celle NHL.
The trial was conducted in 143 rituximab-naïve patients with relapsed or refractory low-grade or follicular non-Hodgkin's lymphoma (NHL), or transformed B-cell NHL.
Studiet blev udført, mens der var to andre direkte virkende antivirale midler til stede.
This study was conducted in the presence of another two direct-acting antiviral agents.
Studiet C08-002A/B var et prospektivt, kontrolleret, ikke-blindet studie, hvori der deltog patienter med aHUS i den tidlige fase med tegn på kliniske manifestationer af trombotisk mikroangiopati med et trombocyttal ≤ 150 x 109/l til trods for PE/PI-behandling, og serum-LDH og serum-kreatinin over øvre normalgrænse.
Study C08-002A/B was a prospective, controlled, open-label study which accrued patients in the early phase of aHUS with evidence of clinical thrombotic microangiopathy manifestations with platelet count ≤ 150 x 109/L despite PE/PI, and LDH and serum creatinine above upper limits of normal.
Studiet GS-US-264-0106: Af 469 patienter, som blev behandlet med emtricitabin/rilpivirin/tenofovirdisoproxilfumarat (FTC/RPV/TDF) (317 patienter skiftede ved baseline og 152 patienter skiftede ved uge 24).
Study GS-US-264-0106: Of the 469 emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) -treated patients (317 patients who switched at baseline and 152 patients who switched at Week 24).
Studiet GS-US-264-0106: Virkningen og sikkerheden ved at skifte fra et ritonavir-boostet PI i kombination med to NRTI’er til FTC/RPV/TDF blev evalueret i et randomiseret, åbent studie af virologisk supprimerede hiv 1-inficerede voksne.
Study GS-US-264-0106: The efficacy and safety of switching from a ritonavir-boosted PI in combination with two NRTIs to FTC/RPV/TDF was evaluated in a randomised, open-label study in virologically suppressed HIV-1 infected adults.
Studiet GS-US-264-0111: Indtil uge 48 blev der ikke udviklet nyopstået resistens hos patienter, som skiftede til FTC/RPV/TDF fra efavirenz/emtricitabin/tenofovirdisoproxilfumarat (EFV/FTC/TDF) (0 af 49 patienter).
Study GS-US-264-0111: Through Week 48, no emergent resistance developed among patients that switched to FTC/RPV/TDF from efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) (0 of 49 patients).
Studiet havde ikke nok styrke til overvejelser om virkning.
The study was not powered for efficacy considerations.
Studiet havde to samtidigt indrullerede kohorter:
The study included two simultaneously enrolling cohorts:
Studiet inkluderede kvindelige (72 %) og mandlige (28 %) patienter med en gennemsnitsalder på 59 år (interval 18 – 95 år).
Female (72%) and male (28%) patients with a mean age of 59 years (range 18 – 95 years) were included.
Studiet inkluderede patienter med dokumenteret mangel på iduronat-2-sulfatase-enzym- aktivitet, en forventet FVC på <80% og et bredt spektrum af sværhedsgrad af sygdommen.
The study included patients with a documented deficiency in iduronate-2- sulfatase enzyme activity, a percent predicted FVC <80%, and a broad spectrum of disease severity.
Studiet inkluderede patienter med persisterende, recidiverende eller metastatisk planocellulært karcinom, adenoskvamøst karcinom eller adenokarcinom i cervix, som ikke kunne kureres med operation og/eller strålebehandling, og som ikke tidligere havde fået behandling med bevacizumab, andre VEGF-hæmmere eller VEGF-receptor-målrettede lægemidler.
Eligible patients had persistent, recurrent or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which was not amenable to curative treatment with surgery and/or radiation therapy and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents.
Studiet MEK116513 var et 2-armet, randomiseret, åbent fase III-studie, der sammenlignede kombinationsbehandling med dabrafenib og trametinib med vemurafenib-monoterapi ved BRAF V600-mutationspositivt metastatisk melanom.
Study MEK116513 was a 2-arm, randomised, open-label, Phase III study comparing dabrafenib and trametinib combination therapy with vemurafenib monotherapy in BRAF V600 mutation-positive metastatic melanoma.
Studiet mødte dets primære endepunkt og viste statistisk signifikant forbedring af progressionsfri overlevelse i pemetrexed-armen over for placeboarmen (n=472, uafhængigt evalueret population; median var henholdsvis 3,9 måneder og 2,6 måneder) (hazard ratio = 0,64; 95 % CI = 0,51-0,81; p = 0,0002).
The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (n = 472, independently reviewed population; median of 3.9 months and 2.6 months, respectively) (hazard ratio = 0.64, 95% CI = 0.51-0.81, p = 0.0002).
Studiet nåede ikke sit primære effektendepunkt (progressionsfri overlevelse [PFS]), og interimanalysen af den totale overlevelse (overall survival  OS) favoriserede numerisk armen med placebo plus depot-octreotid.
The study did not meet the primary efficacy endpoint (progression-free-survival [PFS]) and the overall survival (OS) interim analysis numerically favoured the placebo plus depot octreotide arm.
Studiet nåede ingen af de primære mål  at demonstrere en reduktion af risikoen for død (af alle årsager), kardiovaskulær morbiditet eller nyresygdom i slutstadiet (ESRD).
The study did not meet either primary objective of demonstrating a reduction in risk for all-cause mortality, cardiovascular morbidity, or end stage renal disease (ESRD).
Studiet omfattede 168 patienter med type 1-diabetes mellitus som tidligere blev behandlet med det semi- syntetiske human insulin.
The study included 168 patients with type 1 diabetes mellitus, previously treated with the semi-synthetic human insulin.
Studiet omfattede 3 behandlingsarme og var designet til at sammenligne hver palifermin-arm (før og før/efter) med placebo.
The study included three treatment arms and was designed to compare each of the palifermin arms (pre- and pre/post-) to placebo.
Studiet omfattede 5 forsøgspersoner med cirrose hvoraf 4 var i Victrelis-armen.
The study included 5 subjects with cirrhosis and 4 were in the Victrelis arm.
Studiet omfattede 8 personer med normal nyrefunktion (CrCl ≥ 80 ml/min), 8 personer med let nedsat nyrefunktion (CrCl 50 til
The study included 8 subjects with normal renal function (CrCl ≥ 80 mL/min), 8 subjects with mild renal impairment (CrCl 50 mL/min to < 80 mL/min),
Studiet omfattede patienter med 4 til 8 klinisk typiske, synlige, afgrænsede ikke-hypertrofiske og ikke-hyperkeratotiske AK-læsioner indenfor et sammenhængende behandlingsområde på 25 cm2.
The study enrolled patients with 4 to 8 clinically typical, visible, discrete non-hypertrophic and non-hyperkeratotic AK lesions within a 25 cm2 contiguous treatment area.
Studiet omfattede patienter med nedsat nyrefunktion, der ud fra kreatinin-clearance var klassificeret som let (50 til < 80 ml/min.), moderat (30 til < 50 ml/min.) og svær (< 30 ml/min.) samt patienter med terminal nyreinsufficiens (End Stage Renal Disease (ESRD)) i hæmodialyse.
The study included patients with renal insufficiency classified on the basis of creatinine clearance as mild (50 to <80 ml/min), moderate (30 to <50 ml/min), and severe (<30 ml/min), as well as patients with ESRD on hemodialysis.
Studiet omfatter 55 patienter med alvorlige refraktære systemiske Candida-infektioner (herunder candidæmi, dissemineret og andre invasive candidiasis), hvor tidligere antimykotisk behandling, især med fluconazol ikke har været effektivt.
The study comprised 55 patients with serious refractory systemic Candida infections (including candidaemia, disseminated and other invasive candidiasis) where prior antifungal treatment, particularly with fluconazole, had been ineffective.
Studiet opfyldte det primære mål, som var forbedret PFS.
The trial met its primary objective of PFS improvement.
Studiet opfyldte ingen af de primære formål med hensyn til at påvise en reduktion i risikoen for all-cause-mortalitet, for kardiovaskulær morbiditet eller for slutstadie af nyresygdom (ESRD).
The study did not meet either primary objective of demonstrating a reduction in risk for all-cause mortality, cardiovascular morbidity, or end stage renal disease (ESRD).
Studiet opfyldte ingen af de primære formål  påvise en reduktion i risikoen for all-cause-mortalitet, for kardiovaskulær morbiditet eller for slutstadie af nyresygdom (ESRD).
The study did not meet either primary objective of demonstrating a reduction in risk for all-cause mortality, cardiovascular morbidity, or end stage renal disease (ESRD).
Studiet opfyldte sit primære mål med statistisk signifikant forbedret PFS for olaparib- vedligeholdelsesmonoterapi sammenlignet med placebo i den samlede population (HR 0,35;
The study met its primary objective of statistically significantly improved PFS for olaparib maintenance monotherapy compared with placebo in the overall population (HR 0.35; 95% CI
Studiet påviste en klinisk og statistisk signifikant relativ risikoreduktion på 18 % for det primære sammensatte endepunkt, der omfatter kardiovaskulær mortalitet og hospitalsindlæggelse pga. tiltagende hjerteinsufficiens (hazard ratio: 0,82; 95 % KI [0,75;0,90]; p<0,0001), som var åbenbar inden for 3 måneder efter behandlingsstart.
The study demonstrated a clinically and statistically significant relative risk reduction of 18% in the rate of the primary composite endpoint of cardiovascular mortality and hospitalisation for worsening heart failure (hazard ratio: 0.82, 95%CI [0.75;0.90] – p<0.0001) apparent within 3 months of initiation of treatment.
Studiet påviste en signifikant længere tid til recidiv hos patienter, der blev behandlet med den langtidsvirkende injicerbare formulering af paliperidon sammenlignet med placebo (p<0,001).
The study showed a significantly longer time to relapse in patients treated with the long-acting injectable formulation of paliperidone compared to placebo (p<0.001).
Studiet rekrutterede patienter med nyligt diagnosticeret lokalt avanceret (stadium III) eller inflammatorisk tidlig brystkræft.
The study recruited patients with newly diagnosed locally advanced (Stage III) or inflammatory EBC.
Studiet sammenlignede insulin glargin administreret én gang daglig om morgenen med NPH-insulin administreret én eller to gange daglig som basal-insulin.
6 years, comparing insulin glargine given once daily in the morning to NPH insulin given once or twice daily as basal insulin.
Studiet sammenlignede virkningen af to forskellige deferasirox dispergibel tablet- behandlinger (startdoser på 5 og 10 mg/kg/dag, 55 patienter i hver arm) og tilsvarende placebo (56 patienter).
The study compared the efficacy of two different deferasirox dispersible tablet regimens (starting doses of 5 and 10 mg/kg/day, 55 patients in each arm) and of matching placebo (56 patients).
Studiet skal sammenfatte patientkarakteristika ved baseline, herunder PSA og fordoblingstiden for PSA, antallet af patienter, der udvikler metastatisk sygdom, de behandlinger, patienterne får efter diagnosticering af metastatisk sygdom, samt effektparametrene efter de efterfølgende behandlinger, herunder PSA-progression, PSA- progressionsfri overlevelse, tid til anden- eller tredjevalgsbehandling samt samlet overlevelse
PSA doubling time, the number of patients who develop metastatic disease, subsequent therapies received after diagnosis of metastatic disease, and efficacy parameters following subsequent therapies, including PSA progression, PSA progression-free survival, time to next line therapy, and overall survival.
Studiet TMC114HIV3015 evaluerede 200 mg etravirin to gange dagligt i kombination med andre antiretrovirale lægemidler hos 15 gravide kvinder i andet og tredje trimester af graviditeten og post partum.
Study TMC114HIV3015 evaluated etravirine 200 mg b.i.d. in combination with other antiretroviral medicinal products in 15 pregnant women during the second and third trimesters of pregnancy and postpartum.
Studiet undersøgte farmakokinetikken, sikkerhed og tolerabilitet, såvel som virologiske og immunologiske respons gennem 48 uger.
The trial evaluated pharmacokinetics, safety and tolerability, as well as virologic and immunologic responses through 48 weeks.
Studiet var designet til at sammenligne effekten af 13,3 mg/24 timer depotplaster med 9,5 mg/24 timer depotplaster i løbet af en 48-ugers dobbeltblindet behandlingsfase hos patienter med Alzheimers sygdom, som viste funktionel og kognitiv tilbagegang efter en indledende 24-48 ugers åben behandlingsfase med anvendelse af en vedligeholdelsesdosis på 9,5 mg/24 timer depotplaster.
The study was designed to compare the efficacy of the 13.3 mg/24 h transdermal patch against the 9.5 mg/24 h transdermal patch during a 48-week double-blind treatment phase in Alzheimer’s disease patients who demonstrated functional and cognitive decline after an initial 24-48 week open- label treatment phase while on a maintenance dose of 9.5 mg/24 h transdermal patch.
Studiet var designet til at vise SANCUSO’s non-inferioritet i forhold til oral granisetron.
The study was designed to show non-inferiority of SANCUSO to oral granisetron.
Studiet var ikke designet til at demonstrere en forskel mellem vaccine- og placebogruppen for disse endepunkter.
The study was not powered to demonstrate a difference between the vaccine and the control group for these endpoints.
Studiet var primært designet som et farmakokinetisk studie (se pkt.
It was primarily designed as a pharmacokinetic study (see section 5.2).
Studiet vil optage og følge patienter med negativ status for RET-mutation, som ikke får vandetanib på grund af RET-status eller kontraindikation.
RET mutation negative patients who do not receive vandetanib due to RET status or contraindication will be allowed to enrol and followed.
Studiet viste at sammenlignelige og konsistente resultater blev opnået for begge produkter og at NovoEight kan måles stabilt i plasma uden behov for en separat NovoEight standard.
The study showed that comparable and consistent results were obtained for both products and that NovoEight can be reliably measured in plasma without the need of a separate NovoEight standard.
Studiet viste en signifikant forbedret OS for patienter, der blev randomiseret til nivolumab, sammenlignet med docetaxel ved den planlagte interimanalyse, når der var observeret 413 hændelser (93% af det planlagte antal hændelser til endelig analyse).
The trial demonstrated a statistically significant improvement in OS for patients randomised to nivolumab as compared with docetaxel at the prespecified interim analysis when 413 events were observed (93% of the planned number of events for final analysis).
Studiet viste en signifikant forbedring i PFS for patienterne i Kd-armen i forhold til patienterne i Vd-armen (HR 0,53; 95 % CI: 0,44; 0,65 [p-værdi = 0,0001]) (se figur 3).
The study showed significant improvement in PFS for patients in the Kd arm over those in the Vd arm (HR: 0.53, 95% CI: 0.44, 0.65 [p value = 0.0001]) (see figure 3).
Studiet viste en statistisk signifikant forbedret OS for patienter, der blev randomiseret til nivolumab, sammenlignet med everolimus ved den planlagte interimanalyse efter 398 observerede hændelser (70% af det planlagte antal hændelser til endelig analyse) (tabel 9 og figur 7).
The trial demonstrated a statistically significant improvement in OS for patients randomised to nivolumab as compared with everolimus at the prespecified interim analysis when 398 events were observed (70% of the planned number of events for final analysis) (Table 9 and Figure 7).
Studiet viste ingen virkning på varigheden af QT/QTc-intervallet eller noget andet ekg-interval ved doser på op til 2,25 mg.
The study demonstrated no effect on QT/QTc interval duration as well as any other ECG interval at doses up to 2.25 mg.
Studiet viste non-inferioritet af MabThera i forhold til cyclophosphamid med hensyn til fuldstændig remission (CR) ved måned 6 (tabel 14).
The trial demonstrated non-inferiority of MabThera to cyclophosphamide for complete remission (CR) at 6 months (Table 14).
Studiet viste, at fostre, der in utero udsættes for kombinationsbehandlingen, opretholdte et højere niveau af nukleosid-analogt DNA i multiple foetale organer, og udviste også tegn på kortere telomere end dem, der kun fik zidovudin.
The study demonstrated that foetuses exposed in utero to the combination sustained a higher level of nucleoside analogue- DNA incorporation into multiple foetal organs, and showed evidence of more telomere shortening than in those exposed to zidovudine alone.
Studiet viste, at fostre, der in utero udsættes for kombinationsbehandlingen, opretholdte et højere niveau af nukleosid-analogt DNA i multiple føtale organer, og udviste også tegn på kortere telomere end dem, der kun fik zidovudin.
The study demonstrated that foetuses exposed in utero to the combination sustained a higher level of nucleoside analogue- DNA incorporation into multiple foetal organs, and showed evidence of more telomere shortening than in those exposed to zidovudine alone.
Studiets del 1 bestod af en 16-ugers åben fase, hvor de 173 inkluderede børn fik Simponi 30 mg/m2 (højst 50 mg) subkutant hver 4. uge og MTX.
Part 1 of the study consisted of a 16-week open-label phase in which 173 enrolled children received Simponi 30 mg/m2 (maximum 50 mg) subcutaneously every 4 weeks and MTX.
Studiets endemål
Study endpoint
Studiets primæ re endepunkt var kortikosteroidfri klinisk remission i uge 26, defineret som patienter i klinisk remission (CDAI < 150), som i mindst 3 uger ikke havde taget orale systemiske kortikosteroider (prednison eller lignende) eller budesonid i en dosis på > 6 mg/dag.
The primary endpoint of the study was corticosteroid-free clinical remission at week 26, defined as patients in clinical remission (CDAI of < 150) who, for at least 3 weeks, had not taken oral systemic corticosteroids (prednisone or equivalent) or budesonide at a dose > 6 mg/day.
Studiets primære effektendepunkt var post-induktions-responsrate (CR+nCR).
The primary efficacy endpoints of the study were post-induction and post-transplant response rates (CR+nCR).
Studiets primære effektendepunkt var TTP, defineret som tiden fra randomisering til første dokumenterede objektive tumorprogression.
The primary efficacy endpoint of the study was TTP, defined as the time from randomization to first documentation of objective tumour progression.
Studiets primære effektmål var klinisk remission ved uge 26, defineret som PCDAI score  10.
The primary endpoint of the study was clinical remission at Week 26, defined as PCDAI score  10.
Studiets primære endemål var testosteronsuppressionsværdierne efter et års behandling med degarelix eller leuprorelin.
The primary end-point in the study was testosterone suppression rates after one year of treatment with degarelix or leuprorelin.
Studiets primære endepunkt blev mødt og viste en statistisk signifikant forbedring i PFS i ALIMTA- armen over for placebo-armen (n = 472, uafhængigt evalueret population; median på henholdsvis
The study met its primary endpoint and showed a statistically significant improvement in PFS in the ALIMTA arm over the placebo arm (n = 472, independently reviewed population; median of
Studiets primære endepunkt blev mødt og viste en statistisk signifikant forbedring i PFS i ALMITA- armen overfor placebo-armen (n = 472, uafhængigt evalueret population; median på henholdsvis
The study met its primary endpoint and showed a statistically significant improvement in PFS in the ALIMTA arm over the placebo arm (n = 472, independently reviewed population; median of
Studiets primære endepunkt blev mødt og viste en statistisk signifikant forbedring i PFS i ALMITA- armen overfor placebo-armen (n = 472, uafhængigt evalueret population; median på henholdsvis
The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (n = 472, independently reviewed population; median of