Examples of using Randomised controlled in English and their translations into Romanian
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Randomised controlled data found no increased risk of CAD in hysterectomised women using oestrogen-only therapy.
Cetuximab as a single agent or in combination with chemotherapy was investigated in 5 randomised controlled clinical studies and several supportive studies.
However, this was not a prospective, randomised controlled study and so all comparisons with the external control group should be viewed with caution.
The frequency category was estimated from a statistical calculation based on the total number of patients exposed to nevirapine in randomised controlled clinical studies(n= 2,718).
Two randomised controlled studies were conducted in 270 haemodialysis patients and 288 patients not yet undergoing dialysis, who were on stable treatment with epoetin beta.
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The safety of Bexsero was evaluated in 14 studies including 10 randomised controlled clinical trials with 8776 subjects(from 2 months of age) who received at least one dose of Bexsero.
This adverse reaction was identified through post-marketingsurveillance for Eviplera(fixed-dose combination) but not observed in randomised controlled clinical studies for Eviplera.
The efficacy and safety of Ryzodeg has been studied in a randomised controlled clinical trial in children and adolescents with diabetes mellitus type 1 for a period of 16 weeks(n=362).
The frequency category was estimated from a statistical calculation based on the total number of patients exposed to Eviplera or all of its components in randomised controlled clinical studies(n= 1,261).
Phase III randomised controlled trials involving 5,239 patients with type 2 diabetes, of which 3,319 were treated with linagliptin were conducted to evaluate efficacy and safety.
It was also identified as an adverse reaction for emtricitabinethrough post-marketing surveillance but was not observed in randomised controlled clinical studies in adults or paediatric HIV clinical studies of emtricitabine.
In an open-label randomised controlled clinical trial pregnant women with type 1 diabetes(n=310) were treated in a basal-bolus treatment regimen with Levemir(n=152) or NPH insulin(n=158) as basal insulin, both in combination with NovoRapid.
The frequency category was estimated from a statistical calculation based on the total number of patients exposed to tenofovir disoproxil fumarate in randomised controlled clinical trials and the expanded access program(n= 7,319).
The efficacy andsafety of Tresiba has been studied in a 1:1 randomised controlled clinical trial in children and adolescents with type 1 diabetes mellitus for a period of 26 weeks(n=350), followed by a 26-week extension period(n=280).
The clinical development programme included one 12-week, two six-month(one of which was extended to one year to evaluate safety and tolerability) andone one-year randomised controlled studies in patients with a clinical diagnosis of COPD.
In a randomised controlled study, the incidence of myeloid malignancy(acute myeloid leukaemia/myelodysplastic syndrome) was the same in patients receiving MEPACT plus chemotherapy as in patients receiving only chemotherapy(2.1%).
This adverse reaction was identified through post-marketing surveillance fortenofovir disoproxil fumarate but not observed in randomised controlled clinical studies or the expanded access program for tenofovir disoproxil fumarate.
It is generally believed that only randomised controlled trials or controlled trials, preferably combined with process evaluation, can establish the efficacy of an intervention and so provide a basis for future practice and policy.
In addition, cetuximab was investigated in combination with chemotherapy in an investigator-initiated randomised controlled phase-III study(COIN, COntinuous chemotherapy plus cetuximab or INtermittent chemotherapy).
Over 9,400 patients were studied in three randomised controlled phase III clinical studies(Einstein DVT, Einstein PE and Einstein Extension) and additionally a predefined pooled analysis of the Einstein DVT and Einstein PE studies was conducted.
This adverse reaction was identified through post-marketingsurveillance for emtricitabine but was not observed in randomised controlled clinical studies in adults or paediatric HIV clinical studies of emtricitabine.
Levemir was studied in an open-label randomised controlled clinical trial pregnant women with type 1 diabetes(n=310) were treated in a basal-bolus treatment regimen with Levemir(n=152) or NPH insulin(n=158) as basal insulin, both in combination with NovoRapid(see section 4.6).
This adverse reaction was identified through post-marketingsurveillance for emtricitabine but was not observed in randomised controlled clinical studies in adults or paediatric HIV clinical studies of emtricitabine.
There was an additional 12-month open-label randomised controlled study(MIP 310) to assess the effect of intraperitoneal insulin administration versus subcutaneous insulin administration on glycaemic control and the frequency of severe hypoglycaemia.
The efficacy of Vectibix in patients with metastatic colorectal cancer(mCRC) who had disease progression during orafter prior chemotherapy was studied in a randomised controlled trial(463 patients) and open-label, single-arm trials(384 patients).
Phase 3 randomised controlled studies 5 In randomised controlled phase 3 clinical studies,> ,1000 patients have been treated with the recommended doses of 80 mg or 120 mg(536 subjects enrolled in a 28 week study and 507 subjects enrolled in a 52 weeks study).
The COPD clinical development programme included a 12-week(HZC113107), two 6-month(HZC112206, HZC112207) andtwo one-year(HZC102970, HZC102871) randomised controlled studies in patients with a clinical diagnosis of COPD.
To conduct a randomised controlled Phase 3 study(PIX306) of pixantrone- rituximab vs gemcitabine-rituximab in patients with aggressive B-cell NHL, who failed front line CHOP-R who are not eligible for autologous stem cell transplant(ASCT)(2nd line) or failed ASCT(3rd or 4th line).
The frequency category was estimated from a statistical calculation based on the total number of patients exposed to tenofovir disoproxil fumarate in randomised controlled clinical studies and the expanded access program(n= 7,319).
This adverse reaction was identifiedthrough post-marketing surveillance but not observed in randomised controlled clinical studies in adults or paediatric HIV clinical studies for emtricitabine or in randomised controlled clinical studies or the tenofovir disoproxil expanded access program for tenofovir disoproxil.