{
    "info": {
        "nct_id": "NCT02410382",
        "official_title": "A Phase II Randomized Study of Short-Term Dexamethasone Versus Placebo for Fatigue in Patients Receiving Radiation Alone or Radiation and Chemotherapy for the Treatment of Head and Neck and Non-Small Cell Lung Cancers",
        "inclusion_criteria": "* confirmation of head & neck cancer (stage I-IV) or non-small cell lung cancer (stage II & III)\n* Undergoing treatment with either radiation alone or in combination with chemotherapy\n* Normal cognition and willingness to complete fatigue and quality of life forms, patient observation form, and pill diary\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Hypersensitivity to dexamethasone or corticosteroids or Equal sugar substitute\n* Corticosteroid within the past 30 days prior to study enrollment for greater than one week duration\n* Planned Stereotactic Body Radiation Therapy (SBRT)\n* Active psychosis\n* Current pregnancy\n* Active peptic ulcer disease or evidence of gastrointestinal bleed\n* Current active tuberculosis or systemic fungal infection\n* Previous diagnosis of diabetes mellitus\n* Acute febrile illness\n* Known human immunodeficiency virus or acquired immunodeficiency syndrome\n* Major surgery within two weeks of study enrollment of which the patient has not recovered\n* Psychostimulant use in the past 30 days prior to registration\n* History of phenylketonuria (PKU)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* confirmation of head & neck cancer (stage I-IV) or non-small cell lung cancer (stage II & III)",
            "criterions": [
                {
                    "exact_snippets": "confirmation of head & neck cancer (stage I-IV)",
                    "criterion": "head & neck cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "stage"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmation of ... non-small cell lung cancer (stage II & III)",
                    "criterion": "non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "II",
                                "III"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Undergoing treatment with either radiation alone or in combination with chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Undergoing treatment with either radiation",
                    "criterion": "treatment type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "radiation"
                        }
                    ]
                },
                {
                    "exact_snippets": "Undergoing treatment with ... in combination with chemotherapy",
                    "criterion": "treatment type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "radiation and chemotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Normal cognition and willingness to complete fatigue and quality of life forms, patient observation form, and pill diary",
            "criterions": [
                {
                    "exact_snippets": "Normal cognition",
                    "criterion": "cognition",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to complete fatigue and quality of life forms, patient observation form, and pill diary",
                    "criterion": "willingness to complete forms and diary",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Hypersensitivity to dexamethasone or corticosteroids or Equal sugar substitute",
            "criterions": [
                {
                    "exact_snippets": "Hypersensitivity to dexamethasone",
                    "criterion": "hypersensitivity to dexamethasone",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity to ... corticosteroids",
                    "criterion": "hypersensitivity to corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity to ... Equal sugar substitute",
                    "criterion": "hypersensitivity to Equal sugar substitute",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Corticosteroid within the past 30 days prior to study enrollment for greater than one week duration",
            "criterions": [
                {
                    "exact_snippets": "Corticosteroid within the past 30 days prior to study enrollment for greater than one week duration",
                    "criterion": "corticosteroid use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the past 30 days prior to study enrollment"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Planned Stereotactic Body Radiation Therapy (SBRT)",
            "criterions": [
                {
                    "exact_snippets": "Planned Stereotactic Body Radiation Therapy (SBRT)",
                    "criterion": "Stereotactic Body Radiation Therapy (SBRT)",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active psychosis",
            "criterions": [
                {
                    "exact_snippets": "Active psychosis",
                    "criterion": "psychosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current pregnancy",
            "criterions": [
                {
                    "exact_snippets": "Current pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "current"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active peptic ulcer disease or evidence of gastrointestinal bleed",
            "criterions": [
                {
                    "exact_snippets": "Active peptic ulcer disease",
                    "criterion": "peptic ulcer disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of gastrointestinal bleed",
                    "criterion": "gastrointestinal bleed",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current active tuberculosis or systemic fungal infection",
            "criterions": [
                {
                    "exact_snippets": "Current active tuberculosis",
                    "criterion": "tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic fungal infection",
                    "criterion": "systemic fungal infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous diagnosis of diabetes mellitus",
            "criterions": [
                {
                    "exact_snippets": "Previous diagnosis of diabetes mellitus",
                    "criterion": "diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Acute febrile illness",
            "criterions": [
                {
                    "exact_snippets": "Acute febrile illness",
                    "criterion": "febrile illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "acute"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known human immunodeficiency virus or acquired immunodeficiency syndrome",
            "criterions": [
                {
                    "exact_snippets": "Known human immunodeficiency virus",
                    "criterion": "human immunodeficiency virus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "acquired immunodeficiency syndrome",
                    "criterion": "acquired immunodeficiency syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgery within two weeks of study enrollment of which the patient has not recovered",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within two weeks of study enrollment",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "of which the patient has not recovered",
                    "criterion": "recovery from surgery",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Psychostimulant use in the past 30 days prior to registration",
            "criterions": [
                {
                    "exact_snippets": "Psychostimulant use in the past 30 days prior to registration",
                    "criterion": "psychostimulant use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "past 30 days prior to registration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of phenylketonuria (PKU)",
            "criterions": [
                {
                    "exact_snippets": "History of phenylketonuria (PKU)",
                    "criterion": "phenylketonuria (PKU)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}