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As there is little long-term evidence, this pragmatic randomised trial, known as Comparison Of iNfliximab and ciclosporin in STeroid Resistant Ulcerative Colitis: a Trial (CONSTRUCT), aims to compare the clinical and cost-effectiveness of infliximab and ciclosporin for steroid-resistant UC.
Thus the policy question is clear: should we make a subsequent move from ciclosporin to infliximab.' Hence we have designed Comparison Of iNfliximab and ciclosporin in STeroid Resistant Ulcerative Colitis: a Trial (CONSTRUCT) to achieve a rigorous and comprehensive comparison of these costly therapies.
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Based on these results, we performed a single arm open labeled clinical trial, constructed along a conventional Simon 2-step phase II study design [ 14], to evaluate the safety and clinical activity of olaparib in adult patients with advanced Ewing sarcoma following failure of conventional chemotherapy.
Further, the assessment did not capture comprehensive data on access and use of adherence resources outside of the trial, a construct that is gaining attention in adherence research [ 45].
The same process was applied to the trial criteria to construct the trial pattern vector (Step 3).
After averaging, the power was determined in two frequency bands, alpha (8 13 Hz) and beta (13 25 Hz) by a fast Fourier transformation using Frequency Trend (Yokogawa Electric Corporation) for each participant and the contrast images of (after the n-back test trials)/(before the n-back test trials) was constructed for each frequency band.
Neural activity was averaged in 20-ms bins, shifted by 1 ms, and averaged across trials to construct the peri-event histogram (PETH).
Enrolment criteria for the proposed trial were constructed to ensure that only women who were addicted to nicotine were likely to be enrolled in the study.
The trial is constructed with independent research and services teams that are responsible for data collection needed to analyze outcomes, and the implementation of the interventions, respectively.
Stopping rules for a single-arm, two-stage trial were constructed using simulations performed in TreeAge Pro Healthcare software (Version 1.0.2, 2009, Williamstown, Massachusetts) (program available on request).
To examine the relationship between expression of FGF biomarkers and PFS, a tissue microarray representing clear cell RCC specimens from patients with available tumor and enrolled on the trial was constructed.
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