{
    "info": {
        "nct_id": "NCT01669460",
        "official_title": "A Phase II, Open Label Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy",
        "inclusion_criteria": "* Histologically confirmed prostate cancer\n* Currently receiving LHRH-agonist therapy for greater than 6 months\n* Measurable fatigue, defined as a score of ≥ 2 on the Bruera global fatigue severity scale\n* Able to swallow Red Bull™ Sugar-Free Drink\n* Life expectancy of at least 1 year\n* Able to read and write in English\n* Willing to limit consumption of alcohol to one drink per day\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 85 Years",
        "exclusion_criteria": "* Current malignancy or received treatment for a previous malignancy within the last 3 years other than prostate cancer (exceptions are superficial bladder cancer or non-melanoma skin cancer)\n* Myocardial infarction within past 6 months\n* Any unstable serious co-existing medical condition(s) including but not limited to unstable or poorly controlled coronary artery disease, chronic atrial fibrillation, uncontrolled hypertension, uncontrolled diabetes, severe bleeding diseases or immune disorders\n* Evidence of drug or alcohol abuse\n* Known hypersensitivity to caffeine\n* Known history of liver and kidney insufficiencies\n* Known contraindications to Red Bull™ use",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically confirmed prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently receiving LHRH-agonist therapy for greater than 6 months",
            "criterions": [
                {
                    "exact_snippets": "Currently receiving LHRH-agonist therapy",
                    "criterion": "LHRH-agonist therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "greater than 6 months",
                    "criterion": "duration of LHRH-agonist therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable fatigue, defined as a score of ≥ 2 on the Bruera global fatigue severity scale",
            "criterions": [
                {
                    "exact_snippets": "Measurable fatigue, defined as a score of ≥ 2 on the Bruera global fatigue severity scale",
                    "criterion": "fatigue",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Bruera global fatigue severity scale"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to swallow Red Bull™ Sugar-Free Drink",
            "criterions": [
                {
                    "exact_snippets": "Able to swallow Red Bull™ Sugar-Free Drink",
                    "criterion": "ability to swallow Red Bull™ Sugar-Free Drink",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of at least 1 year",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 1 year",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to read and write in English",
            "criterions": [
                {
                    "exact_snippets": "Able to read and write in English",
                    "criterion": "English literacy",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing to limit consumption of alcohol to one drink per day",
            "criterions": [
                {
                    "exact_snippets": "limit consumption of alcohol to one drink per day",
                    "criterion": "alcohol consumption",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "drink per day"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 85 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 85 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 85,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Current malignancy or received treatment for a previous malignancy within the last 3 years other than prostate cancer (exceptions are superficial bladder cancer or non-melanoma skin cancer)",
            "criterions": [
                {
                    "exact_snippets": "Current malignancy",
                    "criterion": "current malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "received treatment for a previous malignancy within the last 3 years",
                    "criterion": "treatment for previous malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other than prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exceptions are superficial bladder cancer or non-melanoma skin cancer",
                    "criterion": "superficial bladder cancer or non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Myocardial infarction within past 6 months",
            "criterions": [
                {
                    "exact_snippets": "Myocardial infarction within past 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any unstable serious co-existing medical condition(s) including but not limited to unstable or poorly controlled coronary artery disease, chronic atrial fibrillation, uncontrolled hypertension, uncontrolled diabetes, severe bleeding diseases or immune disorders",
            "criterions": [
                {
                    "exact_snippets": "unstable serious co-existing medical condition(s)",
                    "criterion": "serious co-existing medical condition",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable or poorly controlled coronary artery disease",
                    "criterion": "coronary artery disease",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic atrial fibrillation",
                    "criterion": "atrial fibrillation",
                    "requirements": [
                        {
                            "requirement_type": "chronicity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "severe bleeding diseases",
                    "criterion": "bleeding diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "immune disorders",
                    "criterion": "immune disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of drug or alcohol abuse",
            "criterions": [
                {
                    "exact_snippets": "Evidence of drug or alcohol abuse",
                    "criterion": "drug abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Evidence of drug or alcohol abuse",
                    "criterion": "alcohol abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known hypersensitivity to caffeine",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to caffeine",
                    "criterion": "hypersensitivity to caffeine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known history of liver and kidney insufficiencies",
            "criterions": [
                {
                    "exact_snippets": "Known history of liver ... insufficiencies",
                    "criterion": "liver insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known history of ... kidney insufficiencies",
                    "criterion": "kidney insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known contraindications to Red Bull™ use",
            "criterions": [
                {
                    "exact_snippets": "Known contraindications to Red Bull™ use",
                    "criterion": "contraindications to Red Bull™ use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}