Examples of using
Parallel-group
in English and their translations into Croatian
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The design of the studies was parallel-group, double-blind and placebo-controlled.
Ispitivanja su bila s paralelnim skupinama, dvostruko slijepa, kontrolirana placebom.
The effectiveness of tasimelteon in the treatment of Non-24-Hour Sleep-Wake Disorder(Non-24) was established in two randomised, double-masked,placebo-controlled, multicentre, parallel-group studies(SET and RESET) in totally blind patients with Non-24.
Učinkovitost tazimelteona u liječenju poremećaja cirkadijanog ritma budnosti i spavanja koji ne traje 24 sata utvrđena je u dva randomizirana, dvostruko slijepa,placebom kontrolirana ispitivanja s usporednim skupinama(SET i RESET) na potpuno slijepim bolesnicima s poremećajem cirkadijalnog ritma koji ne traje 24 sata.
Two Phase 3 and one Phase 2 double-blind, parallel-group, placebo-controlled studies were performed to assess the indication of sodium oxybate for fibromyalgia.
Provedena su dva dvostruko slijepa, placebom kontrolirana ispitivanja s paralelnim skupinama faze 3 i jedna faze 2 radi ocjene indikacije natrijeva oksibata za fibromijalgiju.
The efficacy of Selincro was alsoevaluated in a randomised, double-blind, parallel-group, placebo-controlled 1-year study.
Djelotvornost Selincra bila je također procijenjena u randomiziranom,dvostruko slijepom, placebom kontroliranom jednogodišnjem ispitivanju paralelnih skupina.
Both studies were randomised, parallel-group, double-blind, multinational trials in patients with symptomatic proximal DVT or symptomatic PE.
Oba ispitivanja bila su randomizirana, dvostruko slijepa, multinacionalna, s paralelnim skupinama, u bolesnika sa simptomatskom proksimalnom dubokom venskom trombozom ili simptomatskom plućnom embolijom.
The effect of selexipag on progression of PAH was demonstrated in a multi-centre, long-term(maximum duration of exposure approximately 4.2 years), double-blind,placebo-controlled, parallel-group, event-driven Phase 3 study in 1,156 patients with symptomatic(WHO FC I-IV) PAH.
Utjecaj seleksipaga na progresiju PAH-a pokazan je u multicentričnom, dugoročnom(najdulje trajanje izloženosti približno 4, 2 godine), dvostruko slijepom,placebom kontroliranom, događajima oblikovanom, ispitivanju paralelnih skupina faze 3 u 1156 bolesnika sa simptomatskim WHO FC I.
AC-052-355 was a multi-centre, randomised,double- blind, parallel-group study of bosentan versus placebo in 33 patients with severe pulmonary arterial hypertension who were receiving concomitant epoprostenol therapy.
AC-052-355 bila je multicentrična, randomizirana,dvostruko slijepa, s paralelnim grupama, studija bosentana u odnosu na placebo na 33 bolesnika s teškom plućnom arterijskom hipertenzijom koji su istodobno dobivali epoprostenol.
The efficacy of mepolizumab in the treatment of a targeted group of patients with severe refractory eosinophilic asthma wasevaluated in 3 randomised, double-blind, parallel-group clinical studies of between 24-52 weeks duration, in patients aged 12 years and older.
Djelotvornost mepolizumaba u liječenju ciljne skupine bolesnika s teškom refraktornom eozinofilnom astmom ocijenjena je u 3 randomizirana,dvostruko slijepa klinička ispitivanja s paralelnim skupinama, u trajanju od 24 do 52 tjedna, s bolesnicima u dobi od 12 i više godina.
Both studies were randomised,double-blind, parallel-group and placebo-controlled, and after 6 months of treatment, patients who received Selincro were re-randomised to receive either placebo or Selincro in a 1-month run-out period.
Oba ispitivanja bila su randomizirana,dvostruko slijepa, paralelnih skupina i placebom kontrolirana, i nakon 6 mjeseci liječenja bolesnici koji su primali Selincro bili su ponovno randomizirani da prime ili placebo ili Selincro u jednomjesečnom završnom razdoblju.
The safety and efficacy of sodium oxybate for the treatment of narcolepsy symptoms was established in four multicentre, randomised,double-blind, placebo-controlled, parallel-group trials in patients with narcolepsy with cataplexy except for one trial where cataplexy was not required for enrolment.
Sigurnost i djelotvornost natrijeva oksibata u liječenju simptoma narkolepsije utvrđena je u četiri multicentrična, randomizirana, dvostruko slijepa,placebom kontrolirana ispitivanja s paralelnim skupinama u bolesnika s narkolepsijom s katapleksijom, osim jednog ispitivanja u kojem katapleksija nije bila uvjet za uključenje.
The DECIDE study was double-blind, randomised, parallel-group, active-controlled with Zinbryta 150 mg every 4 weeks(n=919) versus interferon beta-1a(intramuscular) 30 micrograms weekly(n=922), for a minimum of 2 to a maximum of 3 years 96 to 144 weeks.
DECIDE je bilo dvostruko slijepo, randomizirano, aktivnim lijekom kontrolirano ispitivanje usporednih skupina sa Zinbrytom od 150 mg svaka 4 tjedna(n 919) u odnosu na interferon beta-1a(intramuskularno) 30 mikrograma tjedno(n 922), u trajanju od najmanje 2 do maksimalno 3 godine 96 do 144 tjedna.
The effect of 3.8 g Cholestagel plus 10 mg ezetimibe versus 10 mg ezetimibe alone on LDL-C levels was assessed in a multicentre, randomised,double-blind, placebo-controlled, parallel-group study in 86 patients with primary hypercholesterolaemia over a 6-week treatment period.
Učinak lijeka Cholestagel od 3, 8 g zajedno s 10 mg ezetimiba na vrijednosti LDL kolesterola, u usporedbi s primjenom samo ezetimiba u dozi od 10 mg, ispitan je u multicentričnom, randomiziranom,dvostruko slijepom, placebom kontroliranom ispitivanju s paralelnim skupinama, u 86 bolesnika s primarnom hiperkolesterolemijom tijekom šestotjednog liječenja.
In 2 multicentre, randomised, double-blind, active comparator-controlled, parallel-group phase III clinical studies in adults, aprepitant was compared with ondansetron for the prevention of PONV in 1,658 patients undergoing open abdominal surgery.
U dva multicentrična, randomizirana, dvostruko slijepa ispitivanja faze III u odraslih, s paralelnim skupinama i s aktivnom kontrolom, aprepitant je uspoređens ondanzetronom u sprječavanju PONV-a u 1658 bolesnika podvrgnutih otvorenom abdominalnom kirurškom zahvatu.
An open-label, parallel-group trial in non-iron deficient adult subjects with a pre-treatment haemoglobin of≥ 10 to≤ 13 g/dl who were scheduled for major orthopaedic hip or knee surgery compared epoetin alfa 300 IU/kg subcutaneously daily for 10 days prior to surgery, on the day of surgery and for four days after surgery to epoetin alfa 600 IU/kg subcutaneously once weekly for 3 weeks prior to surgery and on the day of surgery.
U otvorenom ispitivanju na usporedbnim skupinama odraslih ispitanika koji nemaju nedostatak željeza s razinom hemoglobina prije početka liječenja od> 10 do ≤ 13 g/ dl predviđenih za veliki elektivni ortopedski kirurški zahvat na kuku ili koljenu uspoređena je primjena 300 IU/ kg epoetina alfa na dan supkutano tijekom 10 dana prije operacije, na dan operacije i još 4 dana nakon operacije s primjenom 600 IU/ kg epoetina alfa supkutano jednom tjedno, 3 tjedna prije operacije i na dan operacije.
In a 12-week trial of children 4 to 11 years of age[n=203]randomized in a parallel-group study with persistent asthma and who were symptomatic on inhaled corticosteroid, safety was the primary objective.
U 12-tjednom ispitivanju u djece u dobi od 4 do 11 godina[n=203]randomizirane u usporedne skupine koja su imala perzistentnu astmu i simptome uz terapiju inhalacijskim kortikosteroidima, primarni je cilj bila sigurost primjene.
In a double-blind, double-dummy, parallel-group study comparing buprenorphine ethanolic solution to a full agonist active control, 162 subjects were randomized to receive the ethanolic sublingual solution of buprenorphine at 8 mg/day(a dose which is roughly comparable to a dose of 12 mg/day of buprenorphine/naloxone), or two relatively low doses of active control, one of which was low enough to serve as an alternative to placebo, during a 3 to10 day induction phase, a 16-week maintenance phase and a 7-week detoxification phase.
U dvostruko slijepom ispitivanju s dvije kontrole na paralelnim skupinama, u kojem se uspoređivala etanolna otopina buprenorfina s aktivnom kontrolom punog agonista, 162 ispitanika su randomizirana primati sublingvalno 8 mg/dan etanolne otopine buprenorfina(doza koja je ugrubo usporediva s dozom od 12 mg/dan buprenorfina/naloksona), ili dvije relativno niske doze aktivne kontrole, od kojih je jedna bila dovoljno niska da služi kao alternativa placebu, tijekom 3 do 10 dana faze uvođenja, 16 tjedana faze održavanja i 7 tjedana faze detoksikacije.
The efficacy and safety of lenalidomide were evaluated in two Phase III multi-centre, randomised,double- blind, placebo-controlled, parallel-group controlled studies(MM-009 and MM-010) of lenalidomide plus dexamethasone therapy versus dexamethasone alone in previously treated patients with multiple myeloma.
Djelotvornost i sigurnost lenalidomida procijenjene su u dva multicentrična, randomizirana, dvostruko slijepa,placebom kontrolirana ispitivanja faze III u paralelnim skupinama(MM-009 i MM-010) liječenim lenalidomidom i deksametazonom nasuprot primjeni samog deksametazona u prethodno liječenih bolesnika s multiplim mijelomom.
In a multi-centre(US, Canada), parallel-group, double-blind, placebo-controlled study, 539 obese adolescent patients were randomised to receive either 120 mg orlistat(n=357) or placebo(n=182) three times daily as an adjunct to a hypocaloric diet and exercise for 52 weeks.
U multicentričnom(SAD, Kanada), s paralelnim grupama, dvostruko slijepom, placebom kontroliranom ispitivanju, 539 pretilih bolesnika adolescenata randomizirano je da bi tijekom 52 tjedna tri puta dnevno primili 120 mg orlistata(n=357) ili placebo(n=182) uz hipokalorijsku dijetu i vježbanje.
The effectiveness of Numient in patients with early Parkinson's disease wasestablished in a randomized, double-blind, placebo-controlled, fixed-dose, parallel-group, 30-week clinical trial in 381 patients who had a median disease duration of 1 year and limited or no prior exposure to levodopa and dopamine agonists.
Učinkovitost Numienta u bolesnika u ranom stadiju Parkinsonove bolesti ustanovljena je u randomiziranom, dvostruko slijepom,placebom kontroliranom kliničkom ispitivanju fiksne doze, u paralelnim skupinamau trajanju od 30 tjedana, na 381 bolesniku koji je imao medijan trajanja bolesti 1 godinu i ograničenu ili nikakvu prethodnu izloženost levodopi i agonistima dopamina.
In one double-blind, fixed-dose, parallel-group, 3-week placebo controlled trial in subjects with bipolar I disorder experiencing an acute manic or mixed episode involving 367 patients of which 126 received placebo, 122 received asenapine 5 mg twice daily(BID), and 119 received asenapine 10 mg BID, the primary efficacy hypothesis was met.
U jednom trotjednom, dvostruko slijepom, placebom kontroliranom ispitivanju fiksne doze s usporednim skupinama u ispitanika s bipolarnim poremećajem tipa I koji su imali akutnu maničnu ili miješanu epizodu i koje je uključivalo 367 bolesnika od kojih je 126 bolesnika primalo placebo, 122 bolesnika je primalo asenapin u dozi od 5 mg dvaput na dan, a 119 bolesnika je primalo asenapin u dozi od 10 mg dvaput na dan, primarna hipoteza djelotvornosti je zadovoljena.
Study 039 was a 9-month, randomized, double-blind, non-inferiority, active-comparator(imiglucerase) controlled, parallel-group efficacy study in 34 patients aged 2 years and older who were naïve to ERT defined as having not been treated with ERT for at least 12 months prior to study entry.
Ispitivanje 039 bilo je 9-mjesečno, randomizirano, dvostruko slijepo, neinferiornog dizajna,aktivno- kontrolirano( imiglucerazom) ispitivanje djelotvornosti na paralelnim skupinama od 34 bolesnika u dobi od 2 godine i starijim koji nisu bili liječeni enzimskom nadomjesnom terapijom definirano kao neuzimanje enzimske nadomjesne terapije barem 12 mjeseci prije uključenja u ispitivanje.
In a second multicentre, randomised, double-blind, parallel-group, clinical study, the aprepitant regimen was compared with standard therapy in 848 adult patients(652 females, 196 males) receiving a chemotherapy regimen that included any intravenous dose of oxaliplatin, carboplatin, epirubicin, idarubicin, ifosfamide, irinotecan, daunorubicin, doxorubicin; cyclophosphamide intravenously(< 1,500 mg/m2); or cytarabine intravenously> 1 g/m2.
U drugom multicentričnom, randomiziranom, dvostruko slijepom kliničkom ispitivanju s paralelnim skupinama, režim liječenja aprepitantom uspoređen je sa standardnom terapijom u 848 odrasih bolesnika(652 žene, 196 muškaraca) koji su primali kemoterapiju koja je obuhvaćala intravensku primjenu bilo koje doze oksaliplatina, karboplatina, epirubicina, idarubicina, ifosfamida, irinotekana, daunorubicina, doksorubicina; intravenski ciklofosfamid(< 1500 mg/m2); ili intravenski citarabin> 1 g/m2.
The safety and efficacy of infliximab wereassessed in a multicenter, randomised, open-label, parallel-group clinical study(C0168T72) in 60 paediatric patients aged 6 through 17 years(median age 14.5 years) with moderately to severely active ulcerative colitis(Mayo score of 6 to 12; endoscopic subscore≥ 2) with an inadequate response to conventional therapies.
Sigurnost primjene i djelotvornost infliksimaba ispitivane su u multicentričnom,randomiziranom otvorenom kliničkom ispitivanju s paralelnim skupinama( C0168T72), provedenom u 60 pedijatrijskih bolesnika u dobi od 6 do 17 godina( medijan dobi 14, 5 godina) s umjerenim do teškim, aktivnim ulceroznim kolitisom( Mayo rezultat 6-12, endoskopski ≥ 2) koji nisu odgovorili na konvencionalnu terapiju na odgovarajući način.
A two-part phase Ib,multicenter, randomized, open-label, parallel-group trial was conducted in patients with previously untreated CLL, to investigate the non-inferiority of the pharmacokinetic profile, together with efficacy and safety of MabThera subcutaneous formulation in combination with chemotherapy.
U bolesnika s prethodno neliječenim KLL-om provedeno je dvodijelno, multicentrično, randomizirano,otvoreno ispitivanje faze Ib s paralelnim skupinama radi ocjenjivanja neinferiornosti farmakokinetičkog profila te djelotvornosti i sigurnosti lijeka MabThera u formulaciji za supkutanu primjenu u kombinaciji s kemoterapijom.
A phase III, randomised, double-blind, placebo-controlled, parallel-group, 12-month study(POISE) evaluated the safety and efficacy of OCALIVA in 216 patients with PBC who were taking UDCA for at least 12 months(stable dose for≥ 3 months) or who were unable to tolerate UDCA and did not receive UDCA for≥3 months.
U randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju faze III s paralelnim skupinama u trajanju od 12 mjeseci(POISE) procijenjena je sigurnost i djelotvornost lijeka OCALIVA u 216 bolesnika s PBC-om koji su uzimali UDCA tijekom najmanje 12 mjeseci(stabilna doza tijekom ≥ 3 mjeseca) ili koji nisu podnosili UDCA i nisu primali UDCA tijekom ≥ 3 mjeseca.
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