What is the translation of " ACTIVE-CONTROLLED STUDY " in Slovenian?

• aktivno kontrolirani študiji
• študiji kontrolirani z zdravilno učinkovino
• z aktivno učinkovino kontrolirana študija
• z zdravilno učinkovino nadzorovani študiji

Examples of using Active-controlled study in English and their translations into Slovenian

Active-controlled study versus insulin glargine as add-on to metformin sulphonylurea.
Z aktivno učinkovino kontrolirana študija v primerjavi z insulinom glarginom kot dodatkom metforminu  sulfonilsečnini.

Table 4: Change in HbA1c(%) from baseline with alogliptin 25 mg by active-controlled study(PPS, LOCF).
Tabela 4: Sprememba vrednosti HbA1c(%) od izhodišča pri uporabi alogliptina v odmerku 25 mg v z zdravilno učinkovino nadzorovani študiji(PPS, LOCF).

Active-controlled study versus sitagliptin in patients with type 2 diabetes and different degrees of renal impairment.
Z aktivno učinkovino kontrolirana študija v primerjavi s sitagliptinom pri bolnikih s sladkorno boleznijo tipa 2 in različnimi stopnjami okvare ledvic.

The safety and efficacy of Oncaspar was evaluated in an open-label, multicenter, randomized, active-controlled study(Study 1).
Varnost in učinkovitost zdravila Oncaspar so ocenili v odprti, multicentrični, randomizirani, aktivno kontrolirani študiji(1. študija)..

In the active-controlled study, audiology testing was performed in selected centres accounting for about a quarter of the study population.
V aktivno kontrolirani študiji so preiskave sluha izvajali v izbranih študijskih centrih, opravila jih je približno četrtina bolnikov vključenih v študijo..

Years, including 231 patients treated with LIFMIOR in combination with methotrexate in the 2-year active-controlled study.
Let, vključno z 231 bolniki, ki so bili zdravljeni s kombinacijo zdravila LIFMIOR in metotreksata v dvoletni študiji, nadzorovani z učinkovino.

Table 5: Active-controlled study in combination with basal insulin with or without metformin(26-week results)-(mITT) and safety population.
Preglednica 5: Z zdravilno učinkovino kontrolirana študija v kombinaciji z bazalnim insulinom(z metforminom ali brez njega)(26-tedenski rezultati)-(mZNZ) in varnostna populacija.

No effect on QT interval was reported in a randomised, double-blind, placebo, and active-controlled study using standard and Holter electrocardiography.
V randomizirani, dvojno slepi, s placebom in aktivno kontrolirani študiji, v kateri so uporabljali standardno in Holter elektrokardiografijo, niso opažali učinka na QT interval.

Active-controlled study versus liraglutide in combination with metformin, thiazolidinedione, or sulphonylurea(as monotherapy or dual therapy).
Z aktivno učinkovino kontrolirana študija v primerjavi z liraglutidom v kombinaciji z metforminom, tiazolidindionom ali sulfonilsečnino(kot monoterapija ali dvotirno zdravljenje).

The efficacy and safety of empagliflozin as monotherapy was evaluated in a double-blind, placebo- and active-controlled study of 24 weeks duration in treatment-naïve patients.
Učinkovitost in varnost empagliflozina pri samostojnem zdravljenju so pri predhodno še nezdravljenih bolnikih ocenili v dvojno slepi, s placebom in zdravilno učinkovino nadzorovani študiji, ki je trajala 24 tednov.

In one double-masked, randomised, vehicle and active-controlled study, patients treated with NEVANAC had significantly less inflammation than those treated with vehicle.
V eni dvojno slepi, randomizirani in z vehiklom ter drugim zdravilom nadzorovani študiji so imeli bolniki, zdravljeni z zdravilom NEVANAC, bistveno manj vnetja kot tisti, ki so se zdravili z vehiklom.

One hundred and twenty-nine(129) new malignancies of various types were observed in 4,114 rheumatoid arthritis patients treated in clinical trials with Enbrel for up to approximately 6 years, including 231 patients treated with Enbrel in combination with methotrexate in the 2-year active-controlled study.
Sto devetindvajset(129) novih malignih obolenj različnih tipov so ugotovili pri 4.114 bolnikih z revmatoidnim artritisom, zdravljenih v kliničnih preskušanjih z zdravilom Enbrel do približno 6 let, vključno z 231 bolniki, ki so bili zdravljeni s kombinacijo zdravila Enbrel in metotreksata v dvoletni študiji, nadzorovani z zdravilno učinkovino.

HbA1c at week 24 in active-controlled study comparing the combination of saxagliptin and dapagliflozin added concurrently to metformin with either saxagliptin or dapagliflozin added to metformin.
Teden v študiji, kontrolirani z zdravilno učinkovino, ki je primerjala kombinacijo saksagliptina in dapagliflozina, dodano metforminu, s saksagliptinom ali dapagliflozinom, dodanem metforminu.

Efficacy of INVEGA over a flexible dose range of 3 mg/day to 9 mg/day in adolescent subjects(12 years and older) with schizophrenia(INVEGA N= 112, aripiprazole N= 114) was also evaluated in a randomised, double-blind, active-controlled study that included an 8-week, double-blind acute phase and an 18-week, double-blind maintenance phase.
Učinkovitost zdravila INVEGA pri prilagodljivih odmerkih v razponu od 3 mg/dan do 9 mg/dan pri mladostnikih s shizofrenijo(starih 12 let in več)(zdravilo INVEGA N= 112, aripiprazol N= 114) so ocenili tudi v randomizirani, dvojno slepi, aktivno nadzorovani študiji, ki je vključevala 8-tedensko dvojno slepo akutno fazo in 18-tedensko, dvojno slepo vzdrževalno fazo.

In a 24-week active-controlled study of Cayston therapy, no increases in P. aeruginosa MIC50(± 2 dilution change) were observed, whereas MIC90 increased to 4 times the initial MIC.
V 24-tedenski aktivno kontrolirani študiji zdravljenja z zdravilom Cayston niso opazili povečanja MIK50 za povzročitelja P. aeruginosa(± 2 spremembi v redčenju), pri čemer se je povečanje MIK90 pokazalo v 4-kratnem povečanju začetne MIK.

Efficacy of Adlyxin was also assessed in two randomised, open-label, active-controlled study(versus exenatide or versus insulin glulisine) and in a meal time study(in total 1,067 patients randomised to lixisenatide).
Učinkovitost zdravila Lyxumia so ocenili tudi v dveh randomiziranih, odprtih, z zdravilno učinkovino kontroliranih študijah(v primerjavi z eksenatidom ali v primerjavi z insulinom glulisinom) in v študiji ob obroku(skupno 1.067 bolnikov randomiziranih na liksisenatid).

In the 2-year active-controlled study where patients were treated with either Enbrel alone, methotrexate alone or Enbrel in combination with methotrexate, the rates of serious infections were similar among the treatment groups.
V dveletni študiji, nadzorovani z zdravilno učinkovino, v kateri so bili bolniki zdravljeni z zdravilom Enbrel, metotreksatom ali kombinacijo zdravila Enbrel in metotreksata, je bila stopnja pogostnosti resnih okužb v treh skupinah podobna.

In a randomized, parallel, double-blind, active-controlled study, IVEMEND 150 mg(N=1,147) was compared with a 3-day aprepitant regimen(N=1,175) in patients receiving a HEC regimen that included cisplatin(≥70 mg/m2).
V randomizirani, vzporedni, dvojno slepi, z zdravilno učinkovino nadzorovani študiji so primerjali zdravilo IVEMEND 150 mg(N= 1.147) s 3-dnevnim režimom zdravljenja z aprepitantom(N= 1.175) pri bolnikih, ki so prejemali zelo emetogeno kemoterapijo, ki je vključevala cisplatin( 70 mg/m2).

In the active-controlled study, at least 89% of patients had P. aeruginosa isolates with MICs at least 15 times lower than mean post-dose sputum concentration, both at baseline and at the end of the third active treatment cycle.
V aktivno kontrolirani študiji je imelo najmanj 89% bolnikov izolate bakterije P. aeruginosa z MIK, ki je bila vsaj 15-krat nižja od povprečne koncentracije zdravila v slini po odmerjanju, in sicer tako ob izhodišču kot ob koncu tretjega aktivnega ciklusa zdravljenja.

The efficacy of etanercept was compared to methotrexate in a randomised, active-controlled study with blinded radiographic evaluations as a primary endpoint in 632 adult patients with active rheumatoid arthritis(< 3 years duration) who had never received treatment with methotrexate.
V randomizirani študiji, nadzorovani z učinkovino, so s slepo radiografsko oceno kot primarnim opazovanim dogodkom primerjali učinkovitost etanercepta z učinkovitostjo metotreksata pri 632 odraslih bolnikih z aktivnim revmatoidnim artritisom(trajanje bolezni manj kot 3 leta), ki se pred tem nikoli niso zdravili z metotreksatom.

In the active-controlled study(the DECIDE study), 919 patients received Zinbryta(150 mg, every 4 weeks) and 922 patients received interferon beta-1a intramuscular,(30 microgram weekly) for a minimum of 2 years and up to 3 years.
V študiji, nadzorovani z zdravilno učinkovino(študija DECIDE), je vsaj 2 leti in največ 3 leta 919 bolnikov prejemalo zdravilo Zinbryta(150 mg, vsake 4 tedne), 922 bolnikov pa je prejemalo interferon beta-1a intramuskularno(30 mikrogramov na teden).

BRIGHTER was a 3-arm randomised active-controlled study that compared 0.5 mg ranibizumab given as monotherapy or in combination with adjunctive laser photocoagulation to laser photocoagulation alone.
Študija BRIGHTER je bila randomizirana, aktivno kontrolirana študija s tremi študijskimi skupinami, v kateri so zdravljenje z ranibizumabom 0,5 mg v monoterapiji ali v kombinaciji z dodatno lasersko fotokoagulacijo primerjali z zdravljenjem s samo lasersko fotokoagulacijo.

In the 52-week active-controlled study, the mean pre-dose FEV1 was statistically significant in favour of Ulunar Breezhaler at all visits up to week 52 compared to fluticasone/salmeterol(LS mean treatment difference 62-86 ml, p<0.001).
V 52-tedenski aktivno kontrolirani študiji je bilo povprečje vrednosti FEV1 pred odmerjanjem statistično značilno boljše pri uporabi zdravila Ulunar Breezhaler kot pri uporabi kombinacije flutikazon/salmeterol pri vseh obiskih do 52. tedna(razlika med obema načinoma zdravljenja po metodi najmanjših kvadratov: 62-86 ml, p<0,001).

In addition, a randomised, blinded assessor, active-controlled study compared ustekinumab and etanercept in patients with moderate to severe plaque psoriasis who had had an inadequate response to, intolerance to, or contraindication to ciclosporin, MTX, or PUVA.
Dodatno so učinkovitost ustekinumaba in etanercepta primerjali v randomizirani, dvojno slepi, z učinkovino nadzorovani študiji pri bolnikih z zmerno do hudo psoriazo s plaki, ki se na zdravljenje s ciklosporinom, MTX ali PUVA niso odzvali v zadostni meri, ga niso prenašali ali je bilo le-to kontraindicirano.

Active-controlled studies.
Aktivno nadzorovane študije.

T/LAIV has demonstrated superiority in 3 active-controlled studies with injectable influenza vaccine.
V 3 študijah, kontroliranih z aktivno učinkovino, se je T/LAIV izkazalo za superiorno glede na cepivo proti gripi za injiciranje.

The efficacy and safety of IONSYS for treatment of acute, moderate to severe postoperative pain was evaluated in seven controlled studies in 1763 IONSYS patients: three placebo-controlled studies and four active-controlled studies.
Učinkovitost in varnost zdravila IONSYS pri zdravljenju akutnih, zmernih do hudih pooperativnih bolečin so ocenili v sedmih nadzorovanih študijah pri 1763 bolnikih: treh s placebom nadzorovanih študijah in štirih z zdravilno učinkovino nadzorovanih študijah.

A higher dose of umeclidinium/vilanterol(113/22 micrograms) was also studied in a 24-week placebo controlled clinical study and in two of the three 24-week active-controlled studies.
Višji odmerek kombinacije umeklidinij/vilanterol(113/22 mikrogramov) so prav tako preučili v 24-tedenski klinični študiji, kontrolirani s placebom, in v dveh od treh 24-tedenskih študij, kontroliranih z zdravilno učinkovino.