Here is the design of a clinical trial:

Official Title: Dexamethasone for the Treatment of Traumatic Brain Injured Patients With Brain Contusions and Pericontusional Edema: Study Protocol for a Prospective, Randomized and Double Blind Trial.

Included conditions:
- Traumatic Brain Injury
- Cerebral Edema

Study Armgroups:
- {'label': 'Dexamethasone', 'type': 'EXPERIMENTAL', 'description': 'Dexamethasone will be a short and descending course: 4mg/6 hours (2 days); 4 mg/8 hours (2 days); 2 mg/6 hours (2 days); 2 mg/8 hours (2 days); 1 mg/8 hours (2 days); 1 mg/12 hours (2 days).\n\nDexamethasone (Fortecortin®) will be acquired from ERN, SA. Laboratories (Barcelona, Spain). The Son Espases Pharmacy Department will be in charge of developing and conditioning the 4mg, 2mg and 1mg dexamethasone / placebo capsules needed for 12 days of treatment, keeping the researchers blind', 'interventionNames': ['Drug: Dexamethasone Oral']}
- {'label': 'Control', 'type': 'PLACEBO_COMPARATOR', 'description': 'The preparation and conditioning of the capsules will be carried out following the standardized work procedures of the pharmaceutical laboratory and its quality controls, previously authorized by the Agencia Española del Medicamento (AEMPS).\n\nThe Son Espases Pharmacy Department will be responsible for identifying the containers and sending them by courier to the participating hospitals. A record of the dispensing of test samples will be kept and will be sent in acknowledgment of receipt for control', 'interventionNames': ['Drug: Placebo oral tablet']}

Interventions:
- {'type': 'DRUG', 'name': 'Dexamethasone Oral', 'description': 'It will be a short and descending course of oral dexamethasone: 4mg/6 hours (2 days); 4 mg/8 hours (2 days); 2 mg/6 hours (2 days); 2 mg/8 hours (2 days); 1 mg/8 hours (2 days); 1 mg/12 hours (2 days).', 'armGroupLabels': ['Dexamethasone']}
- {'type': 'DRUG', 'name': 'Placebo oral tablet', 'description': 'The preparation and conditioning of the placebo capsules will be carried out following the standardized work procedures of the pharmaceutical laboratory and its quality controls, previously authorized by the Agencia Española del Medicamento (AEMPS).', 'armGroupLabels': ['Control']}

Primary Outcomes:
- {'measure': 'Glasgow Scale Outcome Extended (GOSE).', 'timeFrame': 'one month'}

Please estimate the sample size based on the assumption: 
80% power, 2-sided alpha = 5%, 10% inflation due to non-adherence
3.10
        Sample size and treatment effect size that should be detectable
        Since the data available in this type of patients with this treatment is scarce and inconclusive, we will perform a randomized, triple-blind, placebo controlled trial with an interim futility analysis (interim analysis). The primary endpoint for the DEXCON TBI trial is the good recovery (GOSE 7â8) one month after the TBI.
        A study with 600 patients would have about 80% power (2 sided alphaâ=â5%) to detect a 12% absolute increased (from 50% to 62%) in good recovery (GOSE 7â8). It includes an inflation of 10% due to non-adherence (withdrawal of consent, loss to follow-up, cross-over or change of treatment).