{
    "info": {
        "nct_id": "NCT05088876",
        "official_title": "Paracetamol in Addition to WHO Step III Opioids in Chronic Cancer Pain Control - a Randomized, Double-blind, Placebo-controlled, Non-inferiority Study",
        "inclusion_criteria": "* Male and female patients receiving a WHO step III opioid (i.e. morphine, oxycodone, methadone, fentanyl, hydromorphone, or buprenorphine) in combination with paracetamol (minimum dose 1.5 g/day)\n* Age ≥ 18 at screening\n* Ability to understand the study procedures and to provide written informed consent\n* Stable analgesia before randomisation, defined as no required changes in the analgesic treatment during the previous 7 days\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Participation in another interventional trial within 30 days prior to randomisation, with the exception of cancer treatment trials\n* Changes of the dosage or start of other (co-)analgesics (e.g. tricyclic antidepressants, neuroleptics, nonsteroidal anti-inflammatory drugs (NSAIDs), dipyrone), within the last 7 days preceding randomisation\n* Surgery within the 14 days preceding randomisation or surgery planned within the duration of the study\n* Any circumstances, comorbidities or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the study protocol",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Male and female patients receiving a WHO step III opioid (i.e. morphine, oxycodone, methadone, fentanyl, hydromorphone, or buprenorphine) in combination with paracetamol (minimum dose 1.5 g/day)",
                "criterions": [
                    {
                        "exact_snippets": "Male and female patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "receiving a WHO step III opioid (i.e. morphine, oxycodone, methadone, fentanyl, hydromorphone, or buprenorphine)",
                        "criterion": "opioid medication",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "receiving a WHO step III opioid (i.e. morphine, oxycodone, methadone, fentanyl, hydromorphone, or buprenorphine)",
                        "criterion": "opioid medication",
                        "requirement": {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "morphine",
                                "oxycodone",
                                "methadone",
                                "fentanyl",
                                "hydromorphone",
                                "buprenorphine"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "in combination with paracetamol (minimum dose 1.5 g/day)",
                        "criterion": "paracetamol dosage",
                        "requirement": {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "g/day"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "receiving a WHO step III opioid (i.e. morphine, oxycodone, methadone, fentanyl, hydromorphone, or buprenorphine)",
                                "criterion": "opioid medication",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "receiving a WHO step III opioid (i.e. morphine, oxycodone, methadone, fentanyl, hydromorphone, or buprenorphine)",
                                "criterion": "opioid medication",
                                "requirement": {
                                    "requirement_type": "allowed_values",
                                    "expected_value": [
                                        "morphine",
                                        "oxycodone",
                                        "methadone",
                                        "fentanyl",
                                        "hydromorphone",
                                        "buprenorphine"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Male and female patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "in combination with paracetamol (minimum dose 1.5 g/day)",
                        "criterion": "paracetamol dosage",
                        "requirement": {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "g/day"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Age ≥ 18 at screening",
                "criterions": [
                    {
                        "exact_snippets": "Age ≥ 18",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age ≥ 18",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Stable analgesia before randomisation, defined as no required changes in the analgesic treatment during the previous 7 days",
                "criterions": [
                    {
                        "exact_snippets": "Stable analgesia before randomisation, defined as no required changes in the analgesic treatment during the previous 7 days",
                        "criterion": "analgesia",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Stable analgesia before randomisation, defined as no required changes in the analgesic treatment during the previous 7 days",
                        "criterion": "analgesia",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Stable analgesia before randomisation, defined as no required changes in the analgesic treatment during the previous 7 days",
                        "criterion": "analgesia",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Stable analgesia before randomisation, defined as no required changes in the analgesic treatment during the previous 7 days",
                        "criterion": "analgesia",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Ability to understand the study procedures and to provide written informed consent",
                "criterions": [
                    {
                        "exact_snippets": "Ability to understand the study procedures",
                        "criterion": "understanding of study procedures",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "ability ... to provide written informed consent",
                        "criterion": "ability to provide written informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Ability to understand the study procedures",
                        "criterion": "understanding of study procedures",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "ability ... to provide written informed consent",
                        "criterion": "ability to provide written informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Participation in another interventional trial within 30 days prior to randomisation, with the exception of cancer treatment trials",
                "criterions": [
                    {
                        "exact_snippets": "Participation in another interventional trial within 30 days prior to randomisation",
                        "criterion": "participation in another interventional trial",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "with the exception of cancer treatment trials",
                        "criterion": "cancer treatment trials",
                        "requirement": {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Participation in another interventional trial within 30 days prior to randomisation",
                    "criterion": "participation in another interventional trial",
                    "requirement": {
                        "requirement_type": "time frame",
                        "expected_value": {
                            "operator": "<=",
                            "value": 30,
                            "unit": "days"
                        }
                    }
                },
                "then_criteria": {
                    "not_criteria": {
                        "exact_snippets": "with the exception of cancer treatment trials",
                        "criterion": "cancer treatment trials",
                        "requirement": {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Changes of the dosage or start of other (co-)analgesics (e.g. tricyclic antidepressants, neuroleptics, nonsteroidal anti-inflammatory drugs (NSAIDs), dipyrone), within the last 7 days preceding randomisation",
                "criterions": [
                    {
                        "exact_snippets": "Changes of the dosage ... within the last 7 days preceding randomisation",
                        "criterion": "dosage changes",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within the last 7 days preceding randomisation"
                        }
                    },
                    {
                        "exact_snippets": "start of other (co-)analgesics ... within the last 7 days preceding randomisation",
                        "criterion": "start of other (co-)analgesics",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within the last 7 days preceding randomisation"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Changes of the dosage ... within the last 7 days preceding randomisation",
                                "criterion": "dosage changes",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "within the last 7 days preceding randomisation"
                                }
                            },
                            {
                                "exact_snippets": "start of other (co-)analgesics ... within the last 7 days preceding randomisation",
                                "criterion": "start of other (co-)analgesics",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "within the last 7 days preceding randomisation"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Surgery within the 14 days preceding randomisation or surgery planned within the duration of the study",
                "criterions": [
                    {
                        "exact_snippets": "Surgery within the 14 days preceding randomisation",
                        "criterion": "surgery",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "surgery planned within the duration of the study",
                        "criterion": "surgery",
                        "requirement": {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Surgery within the 14 days preceding randomisation",
                                "criterion": "surgery",
                                "requirement": {
                                    "requirement_type": "timing",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "surgery planned within the duration of the study",
                                "criterion": "surgery",
                                "requirement": {
                                    "requirement_type": "planned",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any circumstances, comorbidities or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the study protocol",
                "criterions": [
                    {
                        "exact_snippets": "Any circumstances, comorbidities or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the study protocol",
                        "criterion": "circumstances, comorbidities or conditions",
                        "requirement": {
                            "requirement_type": "impact on participation",
                            "expected_value": "may affect full participation in the study or compliance with the study protocol"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Any circumstances, comorbidities or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the study protocol",
                        "criterion": "circumstances, comorbidities or conditions",
                        "requirement": {
                            "requirement_type": "impact on participation",
                            "expected_value": "may affect full participation in the study or compliance with the study protocol"
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}