natgillin/translations-raw huggingface dataset:
The study included a 10 week placebo-controlled acute phase, followed by an 18 week extension treatment period.
Studien inkluderade en 10 veckors placebo- kontrollerad inledningsfas följt av en 18 veckors behandlingsperiod.
The study included observational follow-up for 12 months after the conclusion of treatment.
Studien innefattade observationsuppföljning under 12 månader efter avslutad behandling.
The study included patients over 65 years of age, as well as younger patients who could not be treated with high-dose chemotherapy.
I studien ingick såväl patienter över 65 år som yngre patienter som inte kunde behandlas med höga doser cellgifter.
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.
Studien inkluderade patienter med dokumenterad brist på iduronat-2- sulfatasenzymaktivitet, procentuell predikterad FVC <80 % och stor variation i sjukdomens svårighetsgrad.
The study included patients with and without cirrhosis as well as patients who had not responded to previous therapy.
I studien ingick patienter med cirros liksom patienter som inte hade svarat på tidigare behandling.
The study included patients with renal impairment classified on the basis of creatinine clearance (based on the Cockcroft-Gault formula) as mild (> 50 to ≤ 80 ml/min), moderate (≥ 30 to ≤ 50 ml/min), or severe (< 30 ml/min), as well as patients with ESRD on haemodialysis.
Studien inkluderade patienter med njurfunktionsnedsättning som klassificerades på basis av kreatininclearance (baserad på Cockcroft-Gaults formel) som mild (>50 till ≤80 ml/min), måttlig (≥30 till ≤50 ml/min) eller svår (<30 ml/min), samt patienter med ESRD, vilka får hemodialys.
The study included patients with renal impairment 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 end-stage renal disease (ESRD) on haemodialysis.
I studien inkluderades patienter med nedsatt njurfunktion klassificerade utifrån kreatininclearance som lätt (50 till <80 ml/min), måttlig (30 till <50 ml/min) eller kraftig (<30 ml/min), såväl som patienter med kronisk njursjukdom (ESRD, end-stage renal disease) i hemodialysbehandling.
The study included patients with renal impairment 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 end-stage renal disease (ESRD) on haemodialysis.
I studien inkluderades patienter med nedsatt njurfunktion klassificerade utifrån kreatininclearance som lätt (50 till <80 ml/min), måttlig (30 till <50 ml/min) eller kraftig (<30 ml/min), såväl som patienter med kronisk njursjukdom (ESRD, end-stage renal disease) under hemodialysbehandling.
The study included three treatment arms and was designed to compare each of the palifermin arms (pre- and pre/post-) to placebo.
Studien omfattade tre behandlingsmetoder och var utformad att jämföra var och en av paliderminmetoderna (före- och före/efter-) med placebo.
The study included two simultaneously enrolling cohorts:
Studien inkluderade två samtidigt rekryterande kohorter:
The study inclusion and exclusion criteria as well as the treatment schedule and the co-primary efficacy endpoints were the same as in the pivotal AUX-CC-803 and AUX-CC-804 studies.
Studiens inklusions- och exklusionskriterier samt behandlingsschema och co-primära effektmått var desamma som i de pivotala studierna AUX-CC-803 och AUX-CC-804.
The study involved 39 patients over 6 years of age and compared Kalydeco with placebo.
Studien gjordes på 39 patienter som var över 6 år gamla och Kalydeco jämfördes med placebo.
The study involved over 2,000 adults with cancer who were receiving their first course of chemotherapy including cisplatin.
Studien omfattade drygt 2 000 vuxna med cancer som fick sin första kemoterapibehandling med cisplatin.
The study lasted 12 months, and measured the children’s height at the beginning and the end of the study, and the speed of growth during the study.
Studien pågick i 12 månader och mätte barnens längd i början och i slutet av studien samt tillväxttakten under studiens gång.
The study looked at bodyweight and the amount of chloride in sweat, both of which are reduced in patients with cystic fibrosis.
Studien undersökte kroppsvikten och mängden klorid i svetten, vilka båda minskar hos patienter med cystisk fibros.
The study looked at the ability of the medicine to prevent the progression of disability over three years.
I studien tittade man på läkemedlets förmåga att förhindra utvecklingen av funktionshinder under en period av tre år.
The study looked at the ability of two 7.5 microgram doses of the vaccine, given 21 days apart, to trigger the production of antibodies (‘immunogenicity’).The main measures of effectiveness were the levels of antibodies against the flu virus in the blood before vaccination, on the day of the second injection (day 21), and 21 days after the second vaccination (day 42).
Huvudeffektmåttet var nivåerna av antikroppar mot influensaviruset i blodet före vaccination, dagen då den andra injektionen gavs (dag 21) och 21 dagar efter den andra vaccinationen (dag 42).
The study looked at the blood levels and the safety of Isentress.
I studien tittade man på nivåerna av Isentress i blodet och läkemedlets säkerhet.
The study looked at the duration of severe neutropenia during the patients’ first cycle of cytotoxic chemotherapy.
I studien undersöktes varaktigheten av svår neutropeni under patienternas första cytotoxiska kemoterapicykel.
The study looked at the levels of cortisol in the patients’ blood during a 24 hour period following three months of treatment.
I studien tittade man på nivåerna av kortisol i patienternas blod under ett dygn efter tre månaders behandling.
The study looked at the safety and effectiveness of Aptivus, and at the levels of the medicine in the patients’ blood.
I studien undersöktes Aptivus effekt och säkerhet samt halterna av läkemedlet i patienternas blod.
The study looking at the rapid vaccination course found that a 7-day accelerated vaccination course did not produce lower protection than the standard 4-week vaccination course.
I studien där man undersökte den påskyndade vaccinationen fann man att ett påskyndat vaccinationsschema på sju dagar inte gav lägre skydd än standardschemat på fyra veckor.
The study measured the improvement in exercise capacity by looking at the change in how far the patients could walk in six minutes after 12 to 18 weeks of treatment.
I studien mättes förbättringen av den fysiska funktionsförmågan genom att man undersökte hur mycket längre patienterna kunde gå på sex minuter efter 12 till 18 veckors behandling.
The study measured the number of children who developed an S. pneumoniae invasive disease during the 3.5 years of the study.
I studien mättes antalet barn som utvecklade en invasiv sjukdom med S. pneumoniae under de 3,5 år som studien pågick.
The study measured the time it took for a patient to develop clinically defined MS.
I studien mättes den tid det tog för en patient att utveckla kliniskt definitiv ms.
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).
Studien uppfyllde primärt effektmått och visade en statistiskt signifikant förbättring i progressionsfri överlevnadstid (PFS) i pemetrexed-armen jämfört med placebo-armen (n = 472, oberoende granskning av populationen, medianvärde 3,9 respektive 2,6 månader) riskförhållande = 0,64, 95 % KI: 0,51– 0,81, p = 0,0002).
The study of Extavia in patients with a single demyelinating event involved 487 patients, who received either Extavia or placebo for two years.
Studien av Extavia på patienter med en enda demyeliniseringsepisod omfattade 487 patienter som fick antingen Extavia eller placebo under två år.
The study population comprised patients with technically unresectable disease, patients with low probability of surgical cure and patients aiming at organ preservation.
Studiepopulationen bestod av patienter med kirurgiskt icke resektabel sjukdom, patienter med låg sannolikhet att botas med kirurgi och patienter med möjlighet till organpreservation..
The study population consisted of 497 women with osteoporosis as defined by low vertebral BMD (T-score ≤ 2.5).
Studiepopulationen bestod av 497 kvinnor med osteoporos, som definierats genom lågt BMD i vertebra (T-poäng ≤2,5).
The study population consisted of approximately 48% antimuscarinic treatment naïve patients as well as approximately 52% patients previously treated with antimuscarinic medication.
Studiepopulationen bestod av cirka 48 % antimuskarina behandlingsnaiva patienter samt ca 52 % patienter som tidigare behandlats med antimuskarina läkemedel.
The study population consisted of generally healthy post-menopausal women between 41 to 80 years of age (mean age = 59 years), who at baseline had ≤ 5.0% superficial cells in the vaginal smear, a vaginal pH >5.0 and were required to have at least one moderate or severe VVA symptom, where patients had to choose the symptom that was the most bothersome (MBS).
Studiepopulationen bestod av på det hela taget friska postmenopausala kvinnor mellan 41 och 80 års ålder (genomsnittlig ålder = 59 år), som vid studiestart hade ≤5,0% superficialceller i vaginalutstryk, vaginalt pH >5,0 och som måste ha minst ett måttligt eller svårt VVA-symtom, där patienterna fick välja vilket symtom som var det mest besvärande (MBS).
The study population had an average age of 62 years; the average duration of diabetes was 9.5 years.
Studiepopulationen hade en genomsnittlig ålder på 62 år och de hade i genomsnitt haft diabetes i 9,5 år.
The study population included 2,004 patients ≥ 75 years of age and 3,324 patients with renal impairment (eGFR < 60 mL/min/1.73 m2).
Studiepopulationen omfattade 2 004 patienter 75 år eller äldre och 3 324 patienter med nedsatt njurfunktion (eGFR <60 ml/min/1,73 m2).
The study population included dogs whose tumours contained mutated or normal (‘wild-type’) c-kit receptors.
Både hundar med tumörer som hade muterade c-kit-receptorer och hundar som hade normala receptorer (”vildtypsreceptorer”) ingick.
The study population included those ≥ 65 years (n=8561) and ≥ 75 years (n=2330), with normal or mild renal impairment (n=13,916) as well as moderate (n=2240) or severe (n=336) renal impairment.
Studiepopulationen inkluderade de som var ≥65 år (n=8 561) och ≥75 år (n=2 330) med normal eller lätt nedsatt njurfunktion (13 916) liksom måttligt (n=2 240) eller svårt (n=336) nedsatt njurfunktion.
The study protocol shall be agreed with the CHMP prior to the start of the study and the final results (final study report) provided to the CHMP and EMA by June 2016.
Studieprotokollet ska vara överens med CHMP före starten av studien och de slutliga resultaten (slutlig studierapport) lämnas till CHMP och EMA i juni 2016.
The study protocol, including
Studieprotokollet, inkluderande nyckelsaspekter av DMC-avtalet, måste vara
The study results are summarized in Table 8.
Studieresultaten är summerade i Tabell 8.
The study showed a reduction in the number of cardiovascular events leading to hospitalisations particularly those related to atrial fibrillations.
Studien visade att antalet kardiovaskulära händelser som ledde till sjukhusinläggning minskade, särskilt dem som var kopplade till förmaksflimmer.
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).
Studien visade en signifikant längre tid till återfall hos patienter behandlade med den långverkande injicerbara formuleringen av paliperidon jämfört med placebo (p < 0,001).
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p = 0.025; Alzheimer´s disease cooperative study – activities of daily living (ADCS-ADLsev): p = 0.003; severe impairment battery (SIB): p = 0.002).
Studien visade fördelaktig effekt för memantinbehandling jämfört med placebobehandling vid 6 månader (observed cases analys avseende CIBIC-plus (clinician's interview based impression of change)): p=0,025; ADCS-ADLsev (Alzheimer's disease cooperative study – activities of daily living): p=0,003; SIB (severe impairment battery): p=0,002).
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p = 0.025; Alzheimer´s disease cooperative study – activities of daily living (ADCS-ADLsev): p = 0.003; severe impairment battery (SIB): p = 0.002).
Studien visade fördelaktig effekt för memantinbehandling jämfört med placebobehandling vid 6 månader (observed cases-analys avseende CIBIC-plus (clinician's interview based impression of change)): p=0,025; ADCS-ADLsev (Alzheimer's disease cooperative study – activities of daily living): p=0,003; SIB (severe impairment battery): p=0,002).
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p = 0.025; Alzheimer´s disease cooperative study – activities of daily living (ADCS-ADLsev): p = 0.003; severe impairment battery (SIB): p = 0.002).
Studien visade fördelaktig effekt för memantinbehandling jämfört med placebobehandling vid 6 månader (observed cases-analys avseende CIBIC-plus (clinician's interview based impression of change)): p=0,025; ADCS-ADLsev (Alzheimer's disease cooperative study – activities of daily living): p=0,003;SIB (severe impairment battery): p=0,002).
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p = 0.025; Alzheimer’s disease cooperative study – activities of daily living (ADCS-ADLsev): p = 0.003; severe impairment battery (SIB): p = 0.002).
Studien visade fördelaktig effekt för memantinbehandling jämfört med placebobehandling vid 6 månader (observed cases analys avseende CIBIC-plus (clinician's interview based impression of change)): p=0,025; ADCS-ADLsev (Alzheimer's disease cooperative study - activities of daily living): p=0,003; SIB (severe impairment battery): p=0,002).
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer´s disease cooperative study – activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Studien visade fördelaktig effekt för memantinbehandling jämfört med placebobehandling vid 6 månader (observed cases analys avseende CIBIC-plus (clinician's interview based impression of change)): p=0,025; ADCS-ADLsev (Alzheimer's disease cooperative study - activities of daily living): p=0,003; SIB (severe impairment battery): p=0,002).
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer´s disease cooperative study – activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Studien visade fördelaktig effekt för memantinbehandling jämfört med placebobehandling vid 6 månader (observed cases analys avseende CIBIC-plus (clinician's interview based impression of change)): p=0,025; ADCS-ADLsev (Alzheimer's disease cooperative study – activities of daily living): p=0,003; SIB (severe impairment battery): p=0,002).
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer´s disease cooperative study – activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Studien visade fördelaktig effekt för memantinbehandling jämfört med placebobehandling vid 6 månader (observed cases analys avseende CIBIC-plus (clinician's interview based impression of change): p=0,025; ADCS-ADLsev (Alzheimer's disease cooperative study – activities of daily living): p=0,003; SIB (severe impairment battery): p=0,002).
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer´s disease cooperative study – activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Studien visade fördelaktig effekt för memantinbehandling jämfört med placebobehandling vid 6 månader (observed cases-analys avseende CIBIC-plus (clinician's interview based impression of change)): p=0,025; ADCS-ADLsev (Alzheimer's disease cooperative study – activities of daily living): p=0,003; SIB (severe impairment battery): p=0,002).
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer’s disease cooperative study – activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Studien visade fördelaktig effekt för memantinbehandling jämfört med placebobehandling vid 6 månader (observed cases analys avseende CIBIC-plus (clinician's interview based impression of change)): p=0,025; ADCS-ADLsev (Alzheimer's disease cooperative study – activities of daily living): p=0,003; SIB (severe impairment battery): p=0,002).
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician’s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer´s disease cooperative study- activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Studien visade fördelaktig effekt för memantinbehandling jämfört med placebobehandling vid 6 månader (observed cases-analys avseende CIBIC-plus (clinician's interview based impression of change)): p=0,025; ADCS-ADLsev (Alzheimer's disease cooperative study – activities of daily living): p=0,003; SIB (severe impairment battery): p=0,002).
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician’s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer’s disease cooperative study – activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Studien visade fördelaktig effekt för memantinbehandling jämfört med placebobehandling vid 6 månader (observed cases analys avseende CIBIC-plus (clinician's interview based impression of change)): p=0,025; ADCS-ADLsev (Alzheimer's disease cooperative study – activities of daily living): p=0,003; SIB (severe impairment battery): p=0,002).
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician’s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer’s disease cooperative study – activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Studien visade fördelaktig effekt för memantinbehandling jämfört med placebobehandling vid 6 månader (observed cases-analys avseende CIBIC-plus (clinician's interview based impression of change)): p=0,025; ADCS-ADLsev (Alzheimer's disease cooperative study – activities of daily living): p=0,003; SIB (severe impairment battery): p=0,002).
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician’s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer’s disease cooperative study – activities of the daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Studien visade fördelaktig effekt för memantinbehandling jämfört med placebobehandling vid 6 månader (observed cases analys avseende CIBIC-plus (clinician's interview based impression of change): p=0,025; ADCS-ADLsev (Alzheimer's disease cooperative study – activities of daily living): p=0,003; SIB (severe impairment battery): p=0,002).
The study showed beneficial effects of memantine treatment in comparison to placebo at 6months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p = 0.025; Alzheimer´s disease cooperative study – activities of daily living (ADCS-ADLsev): p = 0.003; severe impairment battery (SIB): p = 0.002).
Studien visade fördelaktig effekt för memantinbehandling jämfört med placebobehandling vid 6 månader (observed cases-analys avseende CIBIC-plus (clinician's interview based impression of change)): p=0,025; ADCS-ADLsev (Alzheimer's disease cooperative study – activities of daily living): p=0,003; SIB (severe impairment battery): p=0,002).
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).
Studien visade signifikant förbättring av PFS för patienter i Kd-armen jämfört med dem i Vd-armen (HR: 0,53; 95 % CI: 0,44, 0,65 [p-värde = 0,0001]) (se figur 3).
The study showed that 15% of patients receiving 0.6 mg Signifor (12 patients out of 82) and 26% of patients receiving 0.9 mg Signifor (21 patients out of 80) had normal urine cortisol levels within six months.
Studien visade att 15 procent av de patienter som fick 0,6 mg Signifor (12 av 82 patienter) och 26 procent av de patienter som fick 0,9 mg Signifor (21 av 80 patienter) hade normala kortisolhalter i urinen inom sex månader.
The study showed that 42.9% (81 out of 189) of patients given Blincyto responded to treatment.
Studien visade att 42,9 procent (81 av 189) av patienterna som fick Blincyto svarade på behandling.
The study showed that a single 150 mg infusion of Ivemend was as effective as a three-day course of Emend in preventing nausea and vomiting.
Studien visade att en enda Ivemend-infusion på 150 mg var lika effektiv som en tredagarsbehandling med Emend för att förhindra illamående och kräkningar.
The study showed that after 6 weeks of treatment average blood sugar levels decreased and clinical signs improved, for example average body weight increased.
I studien visades att efter 6 veckors behandling sjönk de genomsnittliga blodsockernivåerna och de kliniska tecknen förbättrades, till exempel ökade den genomsnittliga kroppsvikten.
The study showed that around 87% (55 out of 63) of patients responded to treatment with Imbruvica.
Studien visade att omkring 87 procent (55 av 63) av patienterna svarade på behandlingen med Imbruvica.
The study showed that doubling the inhalations of each strength of salmeterol/fluticasone propionate for up to 14 days resulted in a small increase in β agonist- related adverse events (tremor - 1 patient [1%] vs 0, palpitations - 6 [3%] vs 1 [<1%], muscle cramps –6 [3%] vs 1 [<1%]) and a similar incidence of inhaled corticosteroid related adverse events (e.g. oral candidiasis - 6 [6%] vs 16 [8%], hoarseness - 2 [2%] vs 4 [2%]) compared with one inhalation twice daily.
Studien visade att en dubblering av inhalationerna för alla styrkor av salmeterol/flutikasonpropionat i upp till 14 dagar gav en liten ökning av β-agonistrelaterade biverkningar (tremor- 1 patient [1 %] mot 0, palpitationer- 6 [3 %] mot 1 [<1 %], muskelkramper- 6 [3 %] mot 1 [<1 %]) och en liknande incidens av biverkningar relaterade till inhalationssteroider (t.ex. oral candidiasis- 6 [6 %] mot 16 [8 %], heshet- 2 [2 %] mot 4 [2 %]) jämfört med en dos två gånger dagligen.