natgillin/translations-raw huggingface dataset:
Study 138 is an international randomised, open-label, multicenter, prospective trial of treatment naïve patients comparing REYATAZ/ritonavir (300 mg/100 mg once daily) to lopinavir/ritonavir (400 mg/100 mg twice daily), each in combination with fixed dose tenofovir disoproxil fumarate/emtricitabine (300 mg/200 mg tablets once daily).
Ispitivanje 138 međunarodno je, randomizirano, multicentrično, prospektivno ispitivanje otvorenog tipa u bolesnika koji prethodno nisu bili liječeni u kojem se REYATAZ/ritonavir (300 mg/100 mg jedanput na dan) uspoređivao s lopinavirom/ritonavirom (400 mg/100 mg dvaput na dan), gdje su obje te kombinacije bile davane zajedno s fiksnom dozom tenofovirdizoproksilfumarata/emtricitabina (300 mg/200 mg tablete, jedanput na dan).
Study 1468 (LEPTON)
Ispitivanje 1468 (LEPTON)
Study 174-0103 (HBeAg positive)
Ispitivanje 174-0103 (HbeAg-pozitivni)
Study 1899 was a randomised, evaluator-blinded study of posaconazole oral suspension (200 mg three times a day) versus fluconazole suspension (400 mg once daily) or itraconazole oral solution (200 mg twice a day) in neutropenic patients who were receiving cytotoxic chemotherapy for acute myelogenous leukaemia or myelodysplastic syndromes.
Ispitivanje 1899 bilo je randomizirano ispitivanje posakonazol oralne suspenzije (200 mg triput na dan) naspram flukonazol suspenzije (400 mg jedanput na dan) ili itrakonazol oralnom otopinom (200 mg dvaput na dan) u neutropeničnih bolesnika koji su primali citotoksičnu kemoterapiju za liječenje akutne mijeloične leukemije ili mijelodisplastičkog sindroma.
Study 1: living and standard criteria deceased donors
Ispitivanje 1: živi darivatelji i preminuli koji zadovoljavaju standardne kriterije
Study 1: Recipients of Living Donor and Standard Criteria Deceased Donor Kidneys
Ispitivanje 1: Primatelji bubrega sa živih darivatelja i preminulih donora prema standardnim kriterijima
Study 2
Ispitivanje
Study 2
Ispitivanje 2.
Study 2
Istraživanje 2
Study 2 (BD)2
Ispitivanje 2 (BD)2
Study 2 (n=1023)
Ispitivanje 2 (n=1023)
Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C who were co- infected with HIV.
Ispitivanje 2 (P02080) bilo je randomizirano ispitivanje provedeno u jednom centru, u koje je uključeno 95 prethodno neliječenih odraslih bolesnika s kroničnim hepatitisom C koji su istodobno bili zaraženi HIV-om.
Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C who were co- infected with HIV.
Ispitivanje 2 (P02080) bilo je randomizirano, monocentrično ispitivanje, u koje je uključeno 95 prethodno neliječenih odraslih bolesnika s kroničnim hepatitisom C koji su istodobno bili zaraženi HIV-om.
Study 2 also had a drug withdrawal period during which patients who achieved a PASI improvement of at least 50% at week 24 had treatment stopped.
U ispitivanju 2također je postojao period bez primjene lijeka za vrijeme kojeg je, u bolesnika s postignutim PASI poboljšanjem od najmanje 50% u 24. tjednu, primjena lijeka obustavljena.
Study 2 contained a rater-blinded (i.e. study physician/ investigator assessing the response to study treatment was blinded) reference comparator of glatiramer acetate.
Ispitivanje 2 bilo je slijepo za ocjenjivača (tj. liječnik/ispitivač koji procjenjuje odgovor na liječenje u ispitivanju ne zna koju tvar uzima ispitanik) i uključivalo je za usporedbu referentni lijek glatiramer acetat.
Study 2 shows that 37% of the patients treated with linaclotide compared with 19% of the patients treated with placebo showed response to IBS degree of relief (p<0.0001) and 55% of the patients treated with linaclotide compared with 42% of the patients treated with placebo showed response to abdominal pain/discomfort (p=0.0002).
Ispitivanje 2 je pokazalo da je 37% bolesnika liječenih linaklotidom u usporedbi s 19% bolesnika liječenih placebom pokazalo odgovor s obzirom na stupanj olakšanja IBS-a (p< 0,0001), dok je 55% bolesnika liječenih linaklotidom u usporedbi s 42% bolesnika liječenih placebom pokazalo odgovor s obzirom na bolove/nelagodu u abdomenu (p= 0,0002).
Study 2**
Ispitivanje 2
Study 2--------------
Ispitivanje 2
Study 205 (n=396; n=303)
Ispitivanje 205 (n=396; n=303)
Study 206207-010
Ispitivanje 206207-010
Study 206207-011
Ispitivanje 206207-011
Study 2301: Vildagliptin 50 mg twice daily (N=90)
Ispitivanje 2301: vildagliptin 50 mg dvaput na dan (N=90)
Study 2384: Vildagliptin 50 mg twice daily (N=79)
Ispitivanje 2384: vildagliptin 50 mg dvaput na dan (N=79)
Study 2: Recipients of Extended Criteria Donor Kidneys
Ispitivanje 2: Primatelji organa darivatelja prema proširenim kriterijima
Study 3 (phase 2 study CAMMS223) evaluated the safety and efficacy of LEMTRADA in patients with RRMS over the course of 5 years.
U Ispitivanju 3 (ispitivanje faze 2 CAMMS223) ocjenjivala se sigurnost i djelotvornost lijeka LEMTRADA u bolesnika oboljelih od RRMS-a tijekom razdoblja od 5 godina.
Study 3 was 14 days in duration and Study 4 was 10 days in duration.
Ispitivanje 3 trajalo je 14 dana, a Ispitivanje 4 trajalo je 10 dana.
Study 3 was a single arm study of 30 patients with relapsed or refractory low-grade, follicular, or transformed B-cell NHL who had mild thrombocytopenia (platelet count 100,000 to 149,000 cells/mm3).
Ispitivanje 3 bilo je ispitivanje na jednoj skupini od 30 bolesnika s recidivirajućim/refraktornim, folikularnim ili transformiranim B-NHL-om niskog stupnja s blagom trombocitopenijom (broj trombocita u rasponu od 100 000 do 149 000 stanica/mm3).
Study 3*
Ispitivanje 3
Study 3------------
Ispitivanje 3
Study 301 (n=305; n=256)
Ispitivanje 301 (n=305; n=256)
Study 301 (patients who had received prior chemotherapy)
Ispitivanje 301 (bolesnici koji su prethodno primili kemoterapiju)
Study 301 - Overall Survival (ITT Population)
Ispitivanje 301 – ukupno preživljenje u populaciji predviđenoj za liječenje (ITT)
Study 301 enrolled patients who had received prior docetaxel.
Ispitivanje 301 uključilo je bolesnike koji su prethodno primili docetaksel.
Study 301 Overall Survival ITT Population
Ispitivanje 301 – ukupno preživljenje u populaciji predviđenoj za liječenje (ITT)
Study 305 - Updated Overall Survival ( ITT Population)
Ispitivanje 305 – kasnija analiza ukupnog preživljenja u populaciji predviđenoj za liječenje (ITT)
Study 305 Updated Overall Survival ITT Population
Ispitivanje 301 – ukupno preživljenje u populaciji predviđenoj za liječenje (ITT)
Study 309 - Overall Survival in the Liposarcoma Subgroup
Ispitivanje 309 – Ukupno preživljenje u podskupini bolesnika s liposarkomom
Study 309 ITT Population
Ispitivanje 309 Populacija predviđena za liječenje (ITT)
Study 309 – Progression Free Survival in the Liposarcoma Subgroup
Ispitivanje 309 – Preživljenje bez progresije bolesti u podskupini bolesnika s liposarkomom
Study 316
Ispitivanje 316
Study 316 was a randomised, double-blind trial of posaconazole oral suspension (200 mg three times a day) versus fluconazole capsules (400 mg once daily) in allogeneic hematopoietic stem cell transplant recipients with graft-versus-host disease (GVHD).
Ispitivanje 316 bilo je randomizirano, dvostruko slijepo ispitivanje primjene posakonazol oralne suspenzije (200 mg triput na dan) naspram flukonazol kapsula (400 mg jedanput na dan) u primatelja alogeničnih hematopoetskih matičnih stanica koji su imali reakciju presatka protiv primatelja (engl. graft versus host disease, GVHD).
Study 316 was a randomised, double-blind trial of posaconazole oral suspension (200 mg three times a day) versus fluconazole capsules (400 mg once daily) in allogeneic hematopoietic stem cell transplant recipients with graft-versus-host disease (GVHD).
Ispitivanje 316 bilo je randomizirano, dvostruko slijepo ispitivanje primjene posakonazol oralne suspenzije (200 mg triput na dan) naspram flukonazol kapsula (400 mg jedanput na dan) u primatelja alogeničnih hematopoetskih matičnih stanica koji su imali reakciju presatka protiv primatelja (GVHD).
Study 3356 compared 4-week treatment regimens of methylnaltrexone bromide 12 mg once daily and methylnaltrexone bromide 12 mg every other day with placebo.
U ispitivanju 3356 uspoređena su 4-tjedni režimi liječenja metilnaltreksonbromidom u dozi od 12 mg jedanput dnevno i metilnaltreksonbromidom u dozi od 12 mg svaki drugi dan s placebom.
Study 396
tudija 396
Study 3a
Ispitivanje 3a
Study 4 enrolled 37 adult patients with histologically confirmed unresectable or recurrent giant cell tumour of bone.
Ispitivanje 4 uključilo je 37 odraslih bolesnika s histološki potvrđenim neresektabilnim ili rekurentnim gigantocelularnim tumorom kosti.
Study 4------------
Ispitivanje 4
Study 5 enrolled 507 adult or skeletally mature adolescents with giant cell tumour of bone and evidence of measurable active disease.
Ispitivanje 5 uključilo je 507 odraslih bolesnika ili koštano sazrelih adolescenata s gigantocelularnim tumorom kosti i dokazanom mjerljivom aktivnom bolesti.
Study 5520 enrolled a total of 279 subjects, including 268 receiving at least one dose of posaconazole concentrate for solution for infusion.
U Ispitivanje 5520 bilo je uključeno ukupno 279 ispitanika, uključujući 268 bolesnika koji su primili najmanje jednu dozu posakonazol koncentrata za otopinu za infuziju.
Study 5615 was a non-comparative multi-center study performed to evaluate the pharmacokinetic properties, safety, and tolerability of posaconazole tablet.
Ispitivanje 5615 bilo je nekomparativno, multicentrično ispitivanje provedeno kako bi se procjenila farmakokinetička svojstva, sigurnost i podnošljivost posakonazol tableta.
Study 6 evaluated 69 patients who were 6 years of age or older; 53 (76.8%) of patients had the F508del mutation in the second allele.
U ispitivanju 6 procijenjeno je 69 bolesnika u dobi od 6 i više godina; 53 (76,8%) bolesnika imalo je mutaciju F508del na drugom alelu.
Study 6: study in patients with CF with an R117H mutation in the CFTR gene
Ispitivanje 6: ispitivanje u bolesnika s cističnom fibrozom i mutacijom R117H gena CFTR
Study 7 was a placebo-controlled trial which included a specific subgroup (n=235) of patients as defined in the present indication, who were treated with high-dose inhaled corticosteroids (≥500 µg/day fluticasone equivalent) plus long-acting beta agonist.
Studija 7 bila je placebom kontrolirano ispitivanje koje je uključivalo specifičnu podskupinu bolesnika (n=235), kao što je definirano u trenutnoj indikaciji, koji su bili liječeni visokim dozama inhalacijskih kortikosteroida (što odgovara ≥500 µg/dan flutikazona) i dugodjelujućim beta- agonistom.
Study 734
Ispitivanje 734
Study 735
Ispitivanje 735
Study A ceritinib 750 mg
Ispitivanje A ceritinib 750 mg
Study A was a phase 1 study which included a dose-escalation phase and an expansion phase, at the recommended dose of 750 mg.
Ispitivanje A bilo je ispitivanje faze 1 koje je uključivalo fazu eskalacije doze i fazu proširenja, pri preporučenoj dozi od 750 mg.
Study A: Responses assessed using RECIST 1.0 Study B: Responses assessed using RECIST 1.1
Ispitivanje A: Odgovori procijenjeni koristeći RECIST 1.0 Ispitivanje B: Odgovori procijenjeni koristeći RECIST 1.1
Study AC-052-356 [BREATHE-3]) evaluated the pharmacokinetics of single and multiple oral doses of the film-coated tablet formulation of bosentan in 19 children aged from 3 to 15 years with pulmonary arterial hypertension (PAH) who were dosed on the basis of body weight with 2 mg/kg twice daily.
Studija AC-052-356 [BREATHE-3] procijenila je farmakokinetiku pojedinačnih i višekratnih oralnih doza bosenatana u obliku filmom obloženih tableta u 19 djece u dobi od 3 do 15 godina s plućnom arterijskom hipertenzijom (PAH) koji su dobivali dozu na temelju njihove tjelesne težine od 2 mg/kg dvaput dnevno.
Study AC-052-356 [BREATHE-3]) evaluated the pharmacokinetics of single and multiple oral doses of the film-coated tablet formulation of bosentan in 19 children aged from 3 to 15 years with pulmonary arterial hypertension (PAH) who were dosed on the basis of body weight with 2 mg/kg twice daily.
Studija AC-052-356 [BREATHE-3] procijenila je farmakokinetiku pojedinačnih i višekratnih oralnih doza bosentana u obliku filmom obloženih tableta u 19 djece u dobi od 3 do 15 godina s plućnom arterijskom hipertenzijom (PAH) koji su dobivali dozu na temelju njihove tjelesne težine od 2 mg/kg dvaput dnevno.
Study AC-052-516: Disease characteristics and outcomes of pulmonary arterial hypertension in children and adolescents in real-world clinical settings to collect further data on long-term safety and outcomes in paediatric patients with PAH (Systematic review of prospective observational registries)
Ispitivanje AC-052-516: obilježja bolesti i ishodi plućne arterijske hipertenzije u djece i adolescenata u stvarnom kliničkom okruženju s ciljem daljnjeg prikupljanja podataka o dugoročnoj sigurnosti i ishodima u pedijatrijskih pacijenata s PAH (sistematski pregled prospektivnih opservacijskih registara)
Study ACTG 364
Ispitivanje ACTG
Study ACTG 364
Ispitivanje ACTG 364
Study ACTG 364 enrolled 196 patients who had been treated with NRTIs but not with PIs or NNRTIs.
U ispitivanje ACTG 364 uključeno je 196 bolesnika koji su već primali NRTI-je, ali ne i inhibitore proteaze ili
Study ADE10
Studija ADE10
Study AI266073 was a 48-week open-label randomised clinical study in HIV infected patients comparing the efficacy of Atripla to antiretroviral therapy consisting of at least two nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs) with a protease inhibitor or non-nucleoside reverse transcriptase inhibitor; however not a regimen containing all Atripla components (efavirenz, emtricitabine and tenofovir disoproxil fumarate).
Ispitivanje AI266073 bilo je otvoreno randomizirano kliničko ispitivanje od 48 tjedana na pacijentima inficiranima virusom HIV-a u kojem je učinkovitost Atriple uspoređivana s učinkovitošću antiretrovirusne terapije koja se sastoji od najmanje dva nukleozidna ili nukleotidna inhibitora reverzne transkriptaze (NRTI) s inhibitorom proteaze ili ne-nukleozidnim inhibitorom reverzne transkriptaze, ali ne i s režimom koji bi sadržavao sve komponente Atriple (efavirenz, emtricitabin i tenofovirdizoproksil fumarat).
Study AI455-096 was a 48-week, randomised, double-blind study with Zerit (40 mg twice daily), in combination with lamivudine (150 mg twice daily) plus efavirenz (600 mg once daily), in 76 treatment-naive patients, with a median CD4 cell count of 261 cells/mm3 (range 63 to 962 cells/mm3) and a median plasma HIV-1 RNA of 4.63 log10 copies/ml (range 3.0 to 5.9 log10 copies/ml) at baseline.
Ispitivanje AI455-096 je trajalo 48 tjedana, bilo je randomizirano, dvostruko slijepo ispitivanje s lijekom Zerit (40 mg dva puta dnevno), u kombinaciji s lamivudinom (150 mg dva puta dnevno) i efavirenzom (600 mg jednom dnevno), u 76 bolesnika koji prethodno nisu bili liječeni, s početnim medijanom vrijednosti CD4 stanica od 261 stanica/mm3 (raspon od 63 do 962 stanica/mm3) i početnim medijanom vrijednosti HIV-1 RNA u plazmi od 4,63 log10 kopija/ml (raspon 3,0 do 5,9 log10 kopija/ml).
Study AI455-096 was a 48-week, randomised, double-blind study with Zerit (40 mg twice daily), in combination with lamivudine (150 mg twice daily) plus efavirenz (600 mg once daily), in 76 treatment-naive patients, with a median CD4 cell count of 261 cells/mm3 (range 63 to 962 cells/mm3) and a median plasma HIV-1 RNA of 4.63 log10 copies/ml (range 3.0 to 5.9 log10 copies/ml) at baseline.
Ispitivanje AI455-096 je trajalo 48 tjedana, bilo je randomizirano, dvostruko slijepo ispitivanje s lijekom Zerit (40 mg dva puta dnevno), u kombinaciji s lamivudinom (150 mg dva puta dnevno) i efavirenzom (600 mg jednom dnevno), u 76 bolesnika koji prethodno nisu bili liječeni, s početnim medijanom vrijednosti CD4 stanica od 261 stanica/mm3 (raspon od 63 do 962 stanica/mm3) i početnim medijanom vrijednosti HIV-1 RNA u plazmi od 4,63 log10 kopija/ml (raspon 3,0do 5,9 log10 kopija/ml).
Study AI455-099 was a 48-week, randomised, double-blind study with Zerit (40 mg twice daily), in combination with lamivudine (150 mg twice daily) plus efavirenz (600 mg once daily), in 391 treatment-naive patients, with a median CD4 cell count of 272 cells/mm3 (range 61 to 1,215 cells/mm3) and a median plasma HIV-1 RNA of 4.80 log10 copies/ml (range 2.6 to 5.9 log 10 copies/ml) at baseline.
Ispitivanje AI455-099 je trajalo 48 tjedana, bilo je randomizirano, dvostruko slijepo ispitivanje s lijekom Zerit (40 mg dva puta dnevno) u kombinaciji s lamivudinom (150 mg dva puta dnevno) i efavirenzom (600 mg jednom dnevno), u 391 bolesnika koji prethodno nisu bili liječeni, s početnim medijanom vrijednosti CD4 stanica od 272 stanica/mm3 (raspon od 61 do 1215 stanica/mm3) i početnim medijanom vrijednosti HIV-1 RNA u plazmi od 4,80 log10 kopija/ml (raspon 2,6 do 5,9 log10 kopija/ml).
Study AI455-099 was a 48-week, randomised, double-blind study withZerit (40 mg twice daily), in combination with lamivudine (150 mg twice daily) plus efavirenz (600 mg once daily), in 391 treatment-naive patients, with a median CD4 cell count of 272 cells/mm3 (range 61 to 1,215 cells/mm3) and a median plasma HIV-1 RNA of 4.80 log10 copies/ml (range 2.6 to 5.9 log 10 copies/ml) at baseline.
Ispitivanje AI455-099 je trajalo 48 tjedana, bilo je randomizirano, dvostruko slijepo ispitivanje s lijekom Zerit (40 mg dva puta dnevno) u kombinaciji s lamivudinom (150 mg dva puta dnevno) i efavirenzom (600 mg jednom dnevno), u 391 bolesnika koji prethodno nisu bili liječeni, s početnim medijanom vrijednosti CD4 stanica od 272 stanica/mm3 (raspon od 61 do 1215 stanica/mm3) i početnim medijanom vrijednosti HIV-1 RNA u plazmi od 4,80 log10 kopija/ml (raspon 2,6 do 5,9 log10 kopija/ml).
Study AMD3100-3101 efficacy results - CD34+ cell mobilisation in non-Hodgkin’s lymphoma patients
Rezultati djelotvornosti u ispitivanju AMD3100-3101 – mobilizacija CD34+ stanica u bolesnika s ne-Hodgkinovim limfomom
Study AMD3100-3101 – Proportion of patients who achieved ≥ 5 x 106 CD34+ cells/kg by apheresis day in non-Hodgkin’s lymphoma patients
Ispitivanje AMD3100-3101 – Udio bolesnika s ne-Hodgkinovim limfomom koji su postigli ≥ 5 x 106 CD34+ stanica/kg po danu afereze
Study AMD3100-3102 efficacy results – CD34+ cell mobilisation in multiple myeloma patients
Rezultati djelotvornosti u ispitivanju AMD3100-3102 – mobilizacija CD34+ stanica u bolesnika s multiplim mijelomom
Study arms
Skupine ispitivanja
Study Arms and Duration (Number of Subjects Treated)
Ispitivane skupine i trajanje (broj liječenih ispitanika)
Study AVF3694g (capecitabine)
Ispitivanje AVF3694g (kapecitabin)
Study AVF3694g was a Phase III, multicentre, randomised, placebo-controlled trial designed to evaluate the efficacy and safety of Avastin in combination with chemotherapy compared to chemotherapy plus placebo as first-line treatment for patients with HER2-negative metastatic or locally recurrent breast cancer.
Ispitivanje AVF3694g bilo je multicentrično, randomizirano, placebom kontrolirano kliničko ispitivanje faze III u kojemu se ispitivala djelotvornost i sigurnost primjene lijeka Avastin u kombinaciji s kemoterapijom u odnosu na kemoterapiju plus placebo, u prvoj liniji liječenja bolesnika s HER2 negativnim metastatskim ili lokalno recidivirajućim karcinomom dojke.
Study B ceritinib 750 mg
Ispitivanje B ceritinib 750 mg
Study B involved 140 patients who had been previously treated with 1-3 lines of cytotoxic chemotherapy followed by treatment with crizotinib, and who had then progressed on crizotinib.
Ispitivanje B uključivalo je 140 bolesnika koji su prethodno bili liječeni s 1-3 linije citotoksične kemoterapije, a nakon toga krizotinibom, i koji su zatim imali progresiju na krizotinibu.
Study B was a phase 2 study to evaluate the efficacy and safety of 750 mg ceritinib in patients with locally advanced or metastatic ALK-positive NSCLC.
Ispitivanje B bilo je ispitivanje faze 2 za ocjenjivanje djelotvornosti i sigurnosti 750 mg ceritiniba u bolesnika s lokalno uznapredovalim ili metastatskim ALK-pozitivnim NSCLC-om.
Study BCIRG 006 study was designed to investigate combining Herceptin treatment with docetaxel either following AC chemotherapy or in combination with docetaxel and carboplatin in patients with HER2 positive EBC following surgery.
Ispitivanje BCIRG 006 s ciljem istraživanja kombiniranog liječenja lijekom Herceptin i docetakselom nakon AC kemoterapije ili u kombinaciji s docetakselom i karboplatinom u bolesnica s HER2 pozitivnim ranim rakom dojke nakon kirurškog zahvata.
Study BO15935
Ispitivanje BO15935
Study BO16348 was designed to compare one and two years of three-weekly Herceptin treatment versus observation in patients with HER2 positive EBC following surgery, established chemotherapy and radiotherapy (if applicable).
Ispitivanje BO16348 s ciljem usporedbe liječenja lijekom Herceptin u trotjednim ciklusima tijekom jedne i dvije godine i opservacije u bolesnica s HER2 pozitivnim tumorom dojke u ranom stadiju nakon kirurškog zahvata, završene kemoterapije i radioterapije (ako su provedeni).
Study BO16348 was designed to compare one and two years of three-weekly Herceptin treatment versus observation in patients with HER2 positive EBC following surgery, established chemotherapy and radiotherapy (if applicable).
Ispitivanje BO16348 s ciljem usporedbe skupine liječene lijekom Herceptin u trotjednim ciklusima tijekom jedne i dvije godine i opservacijske skupine u bolesnica s HER2 pozitivnim tumorom dojke u ranom stadiju nakon kirurškog zahvata, završene kemoterapije i radioterapije (ako su provedeni).
Study C-2000-007 evaluated patients after undergoing abdominal, thoracic, or orthopedic surgeries; Study CAPSS-319 evaluated patients after undergoing total hip replacement; Study CAPSS-320 assessed IONSYS in patients following abdominal and pelvic surgeries; and Study FEN-PPA-401 assessed patients following major abdominal or orthopedic surgery.
Ispitivanje C-2000-007 procjenjivalo je bolesnike nakon što su podvrgnuti abdominalnom, torakalnom ili ortopedskom kirurškom zahvatu; ispitivanje CAPSS-319 procjenjivalo je bolesnike nakon što su podvrgnuti potpunoj zamjeni kuka; ispitivanje CAPSS-320 procjenjivalo je sustav IONSYS u bolesnika nakon kirurškog zahvata abdomena i zdjelice; a ispitivanje FEN-PPA-401 procjenjivalo je bolesnike nakon velikog abdominalnog ili ortopedskog kirurškog zahvata.
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.
Ispitivanje C08-002A/B bilo je prospektivno, kontrolirano ispitivanje otvorenog tipa koje je uključilo bolesnike u ranoj fazi aHUS-a s dokazanim kliničkim manifestacijama trombotične mikroangiopatije, brojem trombocita ≤150 x 109/l usprkos PE/PI i vrijednostima LDH i kreatinina u serumu iznad gornje granice normale.
Study C2305, patients who had no prior medical treatment
Ispitivanje C2305, bolesnici bez prethodne terapije lijekovima
Study C2402 was a phase III, multicentre, randomised, parallel-group, three-arm study of double-blind pasireotide intramuscular use 40 mg and 60 mg versus open-label octreotide intramuscular use 30 mg or lanreotide deep subcutaneous injection 120 mg in patients with inadequately controlled acromegaly.
Ispitivanje C2402 bilo je multicentrično, randomizirano ispitivanje faze III s tri paralelne skupine u kojem se ispitivao dvostruko slijepi pasireotid 40 mg i 60 mg primijenjen intramuskularno u usporedbi s otvorenim ispitivanjem u kojem se primjenjivao oktreotid 30 mg intramuskularno ili lanreotid 120 mg dubokom supkutanom injekcijom u bolesnika s neodgovarajuće kontroliranom akromegalijom.
Study C2402, inadequately controlled patients
Ispitivanje C2402, neodgovarajuće kontrolirani bolesnici