Here is the design of a clinical trial:

Official Title: Impact on Mortality of Timing of Dialysis Initiation in Patients With End-stage Renal Disease by a Novel Assessment Based on Fuzzy Mathematics

Included conditions:
- Chronic Kidney Disease

Study Armgroups:
- {'label': 'optimal start dialysis group', 'type': 'EXPERIMENTAL', 'description': 'The DIFE will be used as the assessment of initiation time of dialysis. Patients in this group will start dialysis when their results of the DIFE reaching to 30-35, which defined as the optimal start time.', 'interventionNames': ['Other: optimal start time']}
- {'label': 'late start dialysis group', 'type': 'ACTIVE_COMPARATOR', 'description': 'the DIFE will be used as the assessment of initiation time of dialysis. Patients in this group will start dialysis when their results of the DIFE less than 30, which defined as late start time.', 'interventionNames': ['Other: late start time']}

Interventions:
- {'type': 'OTHER', 'name': 'optimal start time', 'description': 'patients will start hemodialysis when their DIFE reach 35, and can not wait if the DIFE decline to 30.', 'armGroupLabels': ['optimal start dialysis group']}
- {'type': 'OTHER', 'name': 'late start time', 'description': 'patients will start hemodialysis when their DIFE less than 30', 'armGroupLabels': ['late start dialysis group']}

Primary Outcomes:
- {'measure': 'all-cause mortality', 'description': 'proportion of patients who die from any cause', 'timeFrame': 'from the date of enrollment until the end of study, assessed up to 3 years'}
- {'measure': 'cerebro-cardiovascular mortality', 'description': 'proportion of patients who die from cerebro-cardiovascular disease', 'timeFrame': '3 years, from the date of enrollment until the end of study'}

Please estimate the sample size based on the assumption: 
Type I error rate of 5%, 80% power, two-sided test, with p<0.05 considered statistically significant. Assumes 20% withdrawal or dropout rate.
Sample size
        The sample size estimate is mainly based on the primary endpoint of the 3-year all-cause mortality from the previous retrospective cohort DIFE study, which showed that the 3-year mortality of the optimal start dialysis group was 8.38% and that of the late start dialysis group was 19.4%.21 Using PASS V.15 of the Power and Sample Size Calculation program (NCSS, LLC), we estimated a sample size of 154 per group (assuming a type I error rate of 5% with 80% power, two-sided test, with p<0.05 considered statistically significant). Assuming that 20% of the participants would withdraw or drop out, the target sample size was estimated as 388 participants, meaning that 194 participants in each group will be recruited.