{
    "info": {
        "nct_id": "NCT03435120",
        "official_title": "Quality of Life Study in Patients With Breakthrough Cancer Pain Treated in Medical Oncology Services",
        "inclusion_criteria": "* Patients > 18 years\n* Patients with histologically confirmed neoplasia\n* Patients attended in medical oncology consultations\n* Life expectancy > 3 months\n* Patients with baseline controlled cancer pain with opioids who are diagnosed of breakthrough cancer pain by Davies algorithm\n* Written informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Untreated patients with opioids for baseline pain\n* Patients who are not opioid tolerant\n* Serious psychiatric disorder or any disease or condition that prevents the collection of data\n* Patients with evidence of opioid addiction or history of drug or alcohol abuse",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients > 18 years",
            "criterions": [
                {
                    "exact_snippets": "Patients > 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with histologically confirmed neoplasia",
            "criterions": [
                {
                    "exact_snippets": "histologically confirmed neoplasia",
                    "criterion": "neoplasia",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients attended in medical oncology consultations",
            "criterions": [
                {
                    "exact_snippets": "attended in medical oncology consultations",
                    "criterion": "attendance in medical oncology consultations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy > 3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy > 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with baseline controlled cancer pain with opioids who are diagnosed of breakthrough cancer pain by Davies algorithm",
            "criterions": [
                {
                    "exact_snippets": "baseline controlled cancer pain with opioids",
                    "criterion": "baseline cancer pain control",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "controlled with opioids"
                        }
                    ]
                },
                {
                    "exact_snippets": "diagnosed of breakthrough cancer pain by Davies algorithm",
                    "criterion": "breakthrough cancer pain diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis method",
                            "expected_value": "Davies algorithm"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "form",
                            "expected_value": "written"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Untreated patients with opioids for baseline pain",
            "criterions": [
                {
                    "exact_snippets": "Untreated patients",
                    "criterion": "treatment status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "opioids for baseline pain",
                    "criterion": "opioid use for baseline pain",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are not opioid tolerant",
            "criterions": [
                {
                    "exact_snippets": "Patients who are not opioid tolerant",
                    "criterion": "opioid tolerance",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious psychiatric disorder or any disease or condition that prevents the collection of data",
            "criterions": [
                {
                    "exact_snippets": "Serious psychiatric disorder",
                    "criterion": "psychiatric disorder",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "any disease or condition that prevents the collection of data",
                    "criterion": "disease or condition",
                    "requirements": [
                        {
                            "requirement_type": "impact on data collection",
                            "expected_value": "prevents"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with evidence of opioid addiction or history of drug or alcohol abuse",
            "criterions": [
                {
                    "exact_snippets": "evidence of opioid addiction",
                    "criterion": "opioid addiction",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of drug or alcohol abuse",
                    "criterion": "drug or alcohol abuse",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}