Exact(2)
This study was a prospective, randomized, open-label, blinded end point design, employing simple randomization.
The insulin glargine arm of the study used a prospective, randomized, open, blinded end point design (PROBE), so that study participants and site investigators were not blinded but all personnel at the Core CUS Laboratory and all other study personnel and investigators involved in event adjudication and data analysis were blinded to treatment assignment.
Similar(58)
A subanalysis of the NORDIL study addressed the effect of age, sex, severity of hypertension and heart rate on outcome in a prospective, randomized, open label, blinded end point designed (PROBE) trial comparing the calcium channel blocker diltiazem with diuretic/beta-blocker based treatment.
It was an 8-week prospective, randomized, open, blinded end points design study.
Knowledge of genetic variation in metabolism has many applications of biomedical and pharmaceutical interests, including the functional understanding of genetic associations with clinical end points, design of strategies to correct dysregulations in metabolic disorders and the identification of genetic effect modifiers of metabolic disease biomarkers.
The study followed a prospective randomized end-point design.
The study design was based on the multinomial end-point design as in Zee et al (1999) and allowed for early study termination after 15 patients if (1) one or less responses and 11 or more early progressions, or (2) 12 or more early progressions were observed.
All participants were followed up at Niigata-Rousai Hospithe using the prospective randomized open blinded end point (PROBE) design, which aims to create conditions similar to routine clinical practice (9).
Alternatives to traditional phase II trial design including alternative end points, randomized designs, biomarkers, and imaging tools are discussed.
Given the controversies in IBS pathophysiology, patient heterogeneity, or lack of clear, reproducible evidence for gut microbiota abnormalities in patients with IBS, additional RCTs with appropriate end points and design are needed to determine the extent to which (and in which IBS subpopulations) certain probiotics are useful therapeutic strategies in the management of IBS symptoms.
Apart from these established roles in routine practice, PCT represents an interesting research tool which allows investigators to: (1) test new regimens with a validated short-term end point (pCR); (2) design tailored treatments based on the observed response; (3) identify tumour biomarkers with prognostic and/or predictive value.
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