COMFORT-II was an open-label, randomised study in 219 patients. Another randomised study included 66 patients on tacrolimus versus 67 patients on ciclosporin.
Drugo randomizirano ispitivanje uključilo je 66 bolesnika koji su primali takrolimus i 67 bolesnika koji su primali ciklosporin.Twenty-one female volunteers(aged 22 to 56 years) with oily andshiny facial skin were enrolled in a controlled, randomised study.
Dvadeset i jedna dobrovoljna ispitanica(od 22 do 56 godina) s masnom isjajnom kožom lica prijavila se za sudjelovanje u kontroliranoj, randomiziranoj studiji.A phase III randomised study of Caelyx versus doxorubicin in patients with metastatic breast cancer was completed in 509 patients.
Randomizirano ispitivanje faze III u kojem je Caelyx uspoređivan s doksorubicinom u bolesnica s metastatskim karcinomom dojke dovršilo je 509 bolesnica.None of the patients treated in the osteosarcoma studies were 65 years or older and in the phase III randomised study, only patients up to the age of 30 years were included.
Nijedan od bolesnika s osteosarkomom liječenih u ispitivanjima nije bio u dobi od 65 godina ili stariji, a u randomiziranom ispitivanju faze III bili su uključeni samo bolesnici u dobi do 30 godina.The clinical safety of OZURDEX in patients with inflammation of the posterior segment of the eye presenting as non-infectious uveitis, has been assessed in a single, multicentre,masked, randomised study.
Klinička sigurnost lijekaOZURDEX kod bolesnika s upalom stražnjeg očnog segmenta koji se javlja kao neinfektivni uveitis procijenjena je u jednoj multicentričnoj,maskiranoj, randomiziranoj studiji.This was a double-blind,placebo-controlled, randomised study in pre-term or term neonates(gestational age 36-42 weeks) with PPHN.
FUTURE 4 je bila dvostruko slijepa,placebom kontrolirana, randomizirana studija u nedonoščadi ili donošene novorođenčadi(gestacijske dobi 36-42 tjedna) s PPHN.Using the 17-segment model, the number of segments showing a reversible perfusion defect was calculated for the initial adenosine study and for the randomised study obtained using Rapiscan or adenosine.
Korištenjem modela 17 segmenata izračunat je broj segmenata koji prikazuju reverzibilni defekt perfuzije za inicijalno ispitivanje dobivenih uz primjenu adenozina i za randomizirano ispitivanje dobivenih uz primjenu Rapiscana ili adenozina.The clinical efficacy of OZURDEX has been assessed in a single, multicentre,masked, randomised study for the treatment of non-infectious ocular inflammation of the posterior segment in patients with uveitis.
Klinička djelotvornost lijeka OZURDEX procijenjena je u jednoj multicentričnoj,maskiranoj, randomiziranoj studiji za liječenje neinfektivne upale stražnjeg očnog segmenta kod bolesnika s uveitisom.EMR 62 202-006: This randomised study compared the combination of cetuximab and radiation therapy(211 patients) with radiation therapy alone(213 patients) in patients with locally advanced squamous cell cancer of the head and neck.
EMR 62 202-006: Ovo randomizirano ispitivanje usporedilo je kombinaciju cetuksimaba i zračenja(211 bolesnika) sa zračenjem samim(213 bolesnika) kod bolesnika s lokalno uznapredovalim karcinomom pločastih stanica glave i vrata.In order to address the uncertainties related to the single arm design of the pivotal study supporting the approval of DARZALEX,the MAH should submit the results of study MMY3003, a phase III randomised study investigating lenalidomide and dexamethasone with or without daratumumab in patients with previously treated multiple myeloma.
Kako bi riješio dvojbe vezane uz dizajn pivotalne studije s jednom skupinom bolesnika koja podupire odobrenje lijeka DARZALEX,nositelj odobrenja treba podnijeti rezultate ispitivanja MMY3003, randomiziranog ispitivanja faze III koja istražuje lenalidomid i deksametazon s ili bez daratumumaba u bolesnika s prethodno liječenim multiplim mijelomom.OASIS 6 was a double blind, randomised study assessing the safety and efficacy of fondaparinux 2.5 mg once daily, versus usual care placebo(47%) or UFH(53%) in approximately 12,000 patients with STEMI.
OASIS 6 bilo je dvostruko-slijepo, randomizirano ispitivanje sigurnosti primjene i djelotvornosti fondaparinuksa u dozi od 2, 5 mg jedanput na dan u odnosu na uobičajeno liječenje[placebo(47%) ili nefrakcionirani heparin(53%)] u otprilike 12000 bolesnika sa STEMI.It is likely that these adverse reactions also occurred in the large randomised study, but they were not recorded because only serious and life- threatening adverse reactions were collected in that study..
Vjerojatno je da su se ove nuspojave također javljale u velikom randomiziranom ispitivanju, ali nisu zabilježene, jer su se u tom ispitivanju bilježile samo ozbiljne i po život opasne nuspojave.A three-arm randomised study investigating the combination of everolimus with exemestane versus everolimus alone versus capecitabine in patients with oestrogen-receptor positive metastatic breast cancer after recurrence or progression on letrozole or anastrozole based on a CHMP approved protocol.
Randomizirano ispitivanje u tri kraka kojim se uspoređuje kombinacija everolimusa i eksemestana u odnosu na sam everolimus u odnosu na kapecitabin u bolesnica s metastatskim rakom dojke s pozitivnim estrogenskim receptorima nakon recidiva ili progresije bolesti tijekom uzimanja letrozola ili anastrozola na temelju plana ispitivanja koji je odobrilo Povjerenstvo za humane lijekove CHMP.Submission of the final clinical study report for study 3066K1-4438-WW, a randomised study comparing 2 intravenous temsirolimus regimens in patients with relapsed, refractory Mantle Cell Lymphoma.
Podnijeti konačno izvješće o kliničkom ispitivanju 3066K1-4438-WW, randomiziranom ispitivanju kojim se uspoređuju 2 režima intravenskog temsirolimusa u bolesnika s relapsom/refraktornim limfomom plaštenih stanica.CA225006: This randomised study in patients with metastatic colorectal cancer who had received initial combination treatment with oxaliplatin plus fluoropyrimidine for metastatic disease compared the combination of cetuximab and irinotecan(648 patients) with irinotecan alone 650 patients.
CA225006: Ovo randomizirano ispitivanje kod bolesnika s metastatskim kolorektalnim karcinomom koji su na početku liječenja metastatske bolesti primili kombinaciju oksaliplatina i fluoropirimidina uspoređivalo je kombinaciju cetuksimaba i irinotekana(648 bolesnika) i samo irinotekana 650 bolesnika.The NEFA study is a controlled prospective randomised study which evaluated treatment options for patients who switch from protease inhibitor(PI) based regimen with undetectable load to either nevirapine, efavirenz or abacavir.
NEFA je prospektivno, randomizirano kontrolirano ispitivanje koje je uspoređivalo opcije liječenja za bolesnike koji su s prethodnog liječenja inhibitorima proteaza prebačeni na nevirapin, efavirenz ili abakavir, a pri tome su imali nedetektabilno opterećenje virusa u plazmi.EMR 62 202-007: This randomised study in patients with metastatic colorectal cancer after failure of irinotecan-based treatment for metastatic disease as the last treatment before study entry compared the combination of cetuximab and irinotecan(218 patients) with cetuximab monotherapy 111 patients.
EMR 62 202-007: ovo randomizirano ispitivanje u bolesnika s metastatskim kolorektalnim karcinomom nakon neuspjeha terapije metastatske bolesti bazirane na irinotekanu, kao posljednje terapije davane prije ulaska u ispitivanje, uspoređivalo je kombinaciju cetuksimaba i irinotekana(218 bolesnika) s cetuksimabom u monoterapiji 111 bolesnika.The purpose of the third multicentre,double-blind, randomised study was the assessment of efficacy and safety of 0.03% tacrolimus ointment applied once or twice a day relative to twice daily administration of 1% hydrocortisone acetate ointment in children with moderate to severe atopic dermatitis.
Svrha trećeg multicentričnog,dvostruko slijepog, randomiziranog ispitivanja bila je procjena djelotvornosti i sigurnosti masti s 0,03% takrolimusa koja se nanosila jedanput ili dvaput na dan u odnosu na primjenu masti s 1% hidrokortizon acetata dvaput na dan u djece s umjerenim do teškim atopijskim dermatitisom.CA225025: This randomised study in patients with metastatic colorectal cancer who had received prior oxaliplatin-, irinotecan- and fluoropyrimidine-based treatment for metastatic disease compared the addition of cetuximab as a single agent to best supportive care(BSC)(287 patients) with best supportive care 285 patients.
CA225025: Ovo randomizirano ispitivanje u bolesnika s metastatskim kolorektalnim karcinomom koji su za liječenje metastatske bolesti prethodno primali terapiju baziranu na oksaliplatinu, irinotekanu i fluoropirimidinu uspoređivalo je dodatak cetuksimaba kao samostalnog lijeka najboljoj suportivnoj terapiji(BSC)(287 bolesnika) s najboljom suportivnom terapijom 285 bolesnika.Prophylaxis of influenza in immunocompromised patients: A double-blind,placebo-controlled, randomised study was conducted for seasonal prophylaxis of influenza in 475 immunocompromised patients(388 patients with solid organ transplantation[195 placebo; 193 oseltamivir], 87 patients with haemopoetic stem cell transplantation[43 placebo; 44 oseltamivir], no patient with other immunosuppressant conditions), including 18 children 1 to 12 years of age.
Prevencija gripe u imunokompromitiranih bolesnika: Provedeno je dvostruko-slijepo,placebom kontrolirano, randomizirano ispitivanje profilakse sezonske gripe u 475 imunokompromitiranih bolesnika(388 osoba s presađenim solidnim organom[195 placebo, 193 oseltamivir], 87 osoba s presađenim krvotvornim matičnim stanicama[43 placebo, 44 oseltamivir], nije bilo osoba s drugim imunosuprimirajućim stanjima), uključujući 18 djece u dobi od 1 do 12 godina.A phase III, multicentre, randomised study was conducted to evaluate the safety and efficacy of different dose levels of Signifor over a twelve-month treatment period in Cushing's disease patients with persistent or recurrent disease or de novo patients for whom surgery was not indicated or who refused surgery.
Multicentrično, randomizirano ispitivanje faze III bilo je provedeno da bi se procijenila sigurnost i djelotvornost različitih doza Signifora tijekom razdoblja liječenja od 12 mjeseci kod bolesnika s perzistentnom ili rekurentnom Cushingovom bolešću, ili kod de novo bolesnika u kojih kirurški zahvat nije bio indiciran ili koji su odbili kirurški zahvat.In an open-label randomised study, there were no statistically significant differences between adult patients treated for 52 weeks with 0.2 mg/kg intravenously every other week(n=20) and those treated with 0.2 mg/kg weekly(n=19) in mean change from baseline LVMI or other endpoints cardiac functional status, renal function, and pharmacodynamic activity.
U otvorenom, randomiziranom ispitivanju, nije bilo statistički značajne razlike između odraslih bolesnika liječenih tijekom 52 tjedna s 0, 2 mg/ kg intravenski svaki drugi tjedan( n=20) i bolesnika liječenih s 0, 2 mg/ kg tjedno( n=19) u prosječnoj promjeni u odnosu na početne vrijednosti indeksa mase lijevog ventrikula ili ostale mjere ishoda srčani funkcionalni status, funkcija bubrega i farmakodinamička aktivnost.COIN: This was an open-label, 3-arm, randomised study in 2445 patients with inoperable metastatic or locoregional colorectal cancer who had not received prior treatment for metastatic disease and compared oxaliplatin plus fluoropyrimidines(infusional 5-fluorouracil/folinic acid[OxMdG] or capecitabine[XELOX]) in combination with cetuximab to the same chemotherapy regimen alone.
COIN: To je bilo otvoreno, randomizirano ispitivanje utri- skupine na 2445 bolesnika s neoperabilnim metastatskim ili lokoregionalnim kolorektalnim karcinomom koji nisu primali prethodno liječenje za metastatsku bolest a usporedilo je oksaliplatin i fluoropirimidine infuzijski 5-fluorouracil/ folna kiselina[ OxMdG] ili kapecitabin[ XELOX] u kombinaciji s cetuksimabom s istim režimom kemoterapije kao samostalnim lijekom.Thus, the results were consistent with the results of the pivotal randomised studies.
Stoga su rezultati bili u skladu s rezultatima pivotalnih randomiziranih ispitivanja.All the randomised studies addressing this issue specifically excluded pregnant women, and pregnant women were under-represented in cohort studies as well as in meta-analyses.
Sva randomizirana ispitivanja nevirapina eksplicitno nisu uključivala trudnice, a osim toga, trudnice su tek sporadično zastupljene i u kohortnim ispitivanja i metaanalizama.The evidence is current to 19 January 2015. We included 34 randomised studies in this updated review, with 5121 pregnant women, aged 16 to 45 years.
U ovu obnovljenu verziju Cochrane sustavnog pregleda uključene su 34 randomizirane kontrolirane studije s ukupno 5121 trudnica u dobi od 16 do 45 godina.Pegaptanib was studied in two controlled, double-masked, andidentically designed randomised studies(EOP1003; EOP1004) in patients with neovascular AMD.
Pegaptanib je ispitivan u dva kontrolirana, dvostruko maskirana,identično dizajnirana randomizirana ispitivanja(EOP1003; EOP1004) u kojima su sudjelovali bolesnici s neovaskularnom senilnom makularnom degeneracijom.The most frequent drug-related adverse reactions in double-blind, randomised studies were hot flushes and muscle spasms includes leg cramps.
Najčešće nuspojave povezane s primjenom lijeka u dvostruko slijepim, randomiziranim ispitivanjima bili su valunzi i grčevi mišića uključujući grčeve u nogama.Patients received Cayston at the same frequency(2 or 3 times a day)as they took Cayston or placebo in the randomised studies.
Bolesnici su primali Cayston jednako često(2 ili 3 puta na dan) kao štosu primali Cayston ili placebo u randomiziranim ispitivanjima.
Results: 30,
Time: 0.0339