{
    "info": {
        "nct_id": "NCT00125801",
        "official_title": "Breakthrough Cancer Pain: A Randomized Trial Comparing Oral Morphine Immediate Release and Self-Administration of Subcutaneous Hydromorphone Using an Injection Pen",
        "inclusion_criteria": "* Stable cancer pain requiring the equivalent of 60-1000 mg oral morphine/day\n* 1-4 breakthrough pain episodes/day\n* Patients must be able, in the opinion of the investigator, to fully comply with trial requirements\n* Patients who have given written informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Uncontrolled pain\n* Women who are pregnant, lactating or intend to become pregnant\n* Cardiopulmonary disease that would increase the risk of opioids\n* Neurologic or psychiatric disease that would compromise data collection\n* Recently started chemotherapy or radiotherapy in as far as it would be effective in lowering breakthrough pain",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Stable cancer pain requiring the equivalent of 60-1000 mg oral morphine/day",
            "criterions": [
                {
                    "exact_snippets": "Stable cancer pain",
                    "criterion": "cancer pain",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring the equivalent of 60-1000 mg oral morphine/day",
                    "criterion": "oral morphine requirement",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 60,
                                        "unit": "mg"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1000,
                                        "unit": "mg"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 1-4 breakthrough pain episodes/day",
            "criterions": [
                {
                    "exact_snippets": "1-4 breakthrough pain episodes/day",
                    "criterion": "breakthrough pain episodes",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "episodes/day"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "episodes/day"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be able, in the opinion of the investigator, to fully comply with trial requirements",
            "criterions": [
                {
                    "exact_snippets": "Patients must be able, in the opinion of the investigator, to fully comply with trial requirements",
                    "criterion": "compliance with trial requirements",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have given written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Patients who have given written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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": "* Uncontrolled pain",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled pain",
                    "criterion": "pain",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women who are pregnant, lactating or intend to become pregnant",
            "criterions": [
                {
                    "exact_snippets": "Women who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "intend to become pregnant",
                    "criterion": "intention to become pregnant",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cardiopulmonary disease that would increase the risk of opioids",
            "criterions": [
                {
                    "exact_snippets": "Cardiopulmonary disease",
                    "criterion": "cardiopulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "increase the risk of opioids",
                    "criterion": "risk of opioids",
                    "requirements": [
                        {
                            "requirement_type": "increase",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Neurologic or psychiatric disease that would compromise data collection",
            "criterions": [
                {
                    "exact_snippets": "Neurologic ... disease",
                    "criterion": "neurologic disease",
                    "requirements": [
                        {
                            "requirement_type": "impact on data collection",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "psychiatric disease",
                    "criterion": "psychiatric disease",
                    "requirements": [
                        {
                            "requirement_type": "impact on data collection",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recently started chemotherapy or radiotherapy in as far as it would be effective in lowering breakthrough pain",
            "criterions": [
                {
                    "exact_snippets": "Recently started chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": "recently started"
                        }
                    ]
                },
                {
                    "exact_snippets": "Recently started ... radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": "recently started"
                        }
                    ]
                },
                {
                    "exact_snippets": "effective in lowering breakthrough pain",
                    "criterion": "treatment effectiveness",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "lowering breakthrough pain"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}