{
    "info": {
        "nct_id": "NCT04971473",
        "official_title": "An Open, Single-arm, Self-controlled, Multi-center Phase 3 Study to Compare the Efficacy and Safety of rhTSH as An Adjunctive Diagnostic Tool in Differentiated Thyroid Cancer Patients Who Had Been Thyroidectomized Vs. Patients Who After Thyroid Hormone Withdrawal",
        "inclusion_criteria": "* Subjects voluntarily sign the informed consent form (ICF).\n* Age 18-75 years old, either male or female.\n* Patients with diagnosed differentiated papillary or follicular thyroid carcinoma, including papillary-follicular variant,.\n* Patients with a total or near-total thyroidectomy within 6 weeks prior to administered.\n* Low iodine diet for 4 weeks prior to randomized.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* Pregnant or breast feeding women.\n* Patients with other malignancies (exception for in situ cervix uterine cancer, baso cellular skin cancer or breast cancer in remission)\n* Subjects who are unsuitable to the trial in combination with other serious diseases, as identified by the investigator.\n* Subjects who have participated in another clinical trial of a new drug or medical instrument within 1 months before screening.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Subjects voluntarily sign the informed consent form (ICF).",
            "criterions": [
                {
                    "exact_snippets": "Subjects voluntarily sign the informed consent form (ICF).",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "voluntary",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age 18-75 years old, either male or female.",
            "criterions": [
                {
                    "exact_snippets": "Age 18-75 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "either male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with diagnosed differentiated papillary or follicular thyroid carcinoma, including papillary-follicular variant,.",
            "criterions": [
                {
                    "exact_snippets": "diagnosed differentiated papillary or follicular thyroid carcinoma",
                    "criterion": "thyroid carcinoma type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "differentiated papillary",
                                "follicular"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "including papillary-follicular variant",
                    "criterion": "thyroid carcinoma variant",
                    "requirements": [
                        {
                            "requirement_type": "variant",
                            "expected_value": "papillary-follicular"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a total or near-total thyroidectomy within 6 weeks prior to administered.",
            "criterions": [
                {
                    "exact_snippets": "total or near-total thyroidectomy",
                    "criterion": "thyroidectomy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "total",
                                "near-total"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "within 6 weeks prior",
                    "criterion": "thyroidectomy timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Low iodine diet for 4 weeks prior to randomized.",
            "criterions": [
                {
                    "exact_snippets": "Low iodine diet for 4 weeks prior to randomized.",
                    "criterion": "iodine diet",
                    "requirements": [
                        {
                            "requirement_type": "iodine level",
                            "expected_value": "low"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Pregnant or breast feeding women.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with other malignancies (exception for in situ cervix uterine cancer, baso cellular skin cancer or breast cancer in remission)",
            "criterions": [
                {
                    "exact_snippets": "Patients with other malignancies",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "exception for in situ cervix uterine cancer",
                    "criterion": "in situ cervix uterine cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exception for ... baso cellular skin cancer",
                    "criterion": "baso cellular skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exception for ... breast cancer in remission",
                    "criterion": "breast cancer in remission",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects who are unsuitable to the trial in combination with other serious diseases, as identified by the investigator.",
            "criterions": [
                {
                    "exact_snippets": "unsuitable to the trial in combination with other serious diseases",
                    "criterion": "suitability in combination with other serious diseases",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects who have participated in another clinical trial of a new drug or medical instrument within 1 months before screening.",
            "criterions": [
                {
                    "exact_snippets": "Subjects who have participated in another clinical trial of a new drug or medical instrument within 1 months before screening.",
                    "criterion": "participation in another clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}