{
    "info": {
        "nct_id": "NCT06855680",
        "official_title": "The EMIRATES Study - Development and Evaluation of Thyroid Cancer Patient Decision Aid (PDA-TC) - Pilot Study",
        "inclusion_criteria": "* Aged over 18\n* Both genders\n* Patients who are diagnosed of low-risk well-differentiated thyroid carcinoma (papillary thyroid carcinoma or follicular carcinoma) with size of 1-4cm. This is either:\n\n  1. Diagnosed pre-operatively by fine-needle aspiration cytology (FNAC) with Thy5 grade [see appendix for the Thy classification] or\n  2. Confirmed following diagnostic hemithyroidectomy\n* Able to communicate in spoken and written English\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients who are diagnosed with thyroid cancer with adverse features (i.e. poor differentiated cytology or tall cell, columnar cell, Hurthle cell, and solid variant cytology)\n* Patients who are diagnosed with thyroid cancer which is multifocal, bilateral, with extrathyroidal extension, with perineural invasion or angioinvasion.\n* Patients who are diagnosed with thyroid cancer with clinically or radiologically involved nodes or distant metastases\n* Patients who are diagnosed with thyroid cancer which is of a familial disease\n* Patient who is either Pregnant or breast-feeding\n* Patient with hyper- or hypothyroidism who is a candidate for surgery\n* Patient who is concurrently diagnosed with any medullary, anaplastic, lymphoma, or parathyroid disease\n* Patients who had previous thyroidectomy for reasons other than diagnostic hemithyroidectomy for their recent cancer diagnosis.\n* Patients who are cognitively impaired or have a mental health condition and are therefore unable to give consent\n* Patient who is not able to read write and speak English",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Aged over 18",
            "criterions": [
                {
                    "exact_snippets": "Aged over 18",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Both genders",
            "criterions": [
                {
                    "exact_snippets": "Both genders",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are diagnosed of low-risk well-differentiated thyroid carcinoma (papillary thyroid carcinoma or follicular carcinoma) with size of 1-4cm. This is either:",
            "criterions": [
                {
                    "exact_snippets": "diagnosed of low-risk well-differentiated thyroid carcinoma",
                    "criterion": "thyroid carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "low-risk well-differentiated"
                        }
                    ]
                },
                {
                    "exact_snippets": "papillary thyroid carcinoma or follicular carcinoma",
                    "criterion": "thyroid carcinoma type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "papillary",
                                "follicular"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "size of 1-4cm",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "cm"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "cm"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Diagnosed pre-operatively by fine-needle aspiration cytology (FNAC) with Thy5 grade [see appendix for the Thy classification] or",
            "criterions": [
                {
                    "exact_snippets": "Diagnosed pre-operatively by fine-needle aspiration cytology (FNAC)",
                    "criterion": "diagnosis method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "fine-needle aspiration cytology (FNAC)"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "pre-operatively"
                        }
                    ]
                },
                {
                    "exact_snippets": "Thy5 grade",
                    "criterion": "Thy classification",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": "Thy5"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Confirmed following diagnostic hemithyroidectomy",
            "criterions": [
                {
                    "exact_snippets": "Confirmed following diagnostic hemithyroidectomy",
                    "criterion": "diagnostic hemithyroidectomy",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to communicate in spoken and written English",
            "criterions": [
                {
                    "exact_snippets": "Able to communicate in spoken and written English",
                    "criterion": "English communication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "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": "* Patients who are diagnosed with thyroid cancer with adverse features (i.e. poor differentiated cytology or tall cell, columnar cell, Hurthle cell, and solid variant cytology)",
            "criterions": [
                {
                    "exact_snippets": "diagnosed with thyroid cancer",
                    "criterion": "thyroid cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adverse features",
                    "criterion": "adverse features",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "poor differentiated cytology",
                    "criterion": "poor differentiated cytology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tall cell, columnar cell, Hurthle cell, and solid variant cytology",
                    "criterion": "cytology type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "tall cell",
                                "columnar cell",
                                "Hurthle cell",
                                "solid variant"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are diagnosed with thyroid cancer which is multifocal, bilateral, with extrathyroidal extension, with perineural invasion or angioinvasion.",
            "criterions": [
                {
                    "exact_snippets": "diagnosed with thyroid cancer",
                    "criterion": "thyroid cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "multifocal",
                    "criterion": "multifocal",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bilateral",
                    "criterion": "bilateral",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "extrathyroidal extension",
                    "criterion": "extrathyroidal extension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "perineural invasion",
                    "criterion": "perineural invasion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "angioinvasion",
                    "criterion": "angioinvasion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are diagnosed with thyroid cancer with clinically or radiologically involved nodes or distant metastases",
            "criterions": [
                {
                    "exact_snippets": "diagnosed with thyroid cancer",
                    "criterion": "thyroid cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically or radiologically involved nodes",
                    "criterion": "involved nodes",
                    "requirements": [
                        {
                            "requirement_type": "detection method",
                            "expected_value": [
                                "clinical",
                                "radiological"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "distant metastases",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are diagnosed with thyroid cancer which is of a familial disease",
            "criterions": [
                {
                    "exact_snippets": "diagnosed with thyroid cancer",
                    "criterion": "thyroid cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "familial disease",
                    "criterion": "familial disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient who is either Pregnant or breast-feeding",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient with hyper- or hypothyroidism who is a candidate for surgery",
            "criterions": [
                {
                    "exact_snippets": "Patient with hyper- or hypothyroidism",
                    "criterion": "thyroid condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "hyperthyroidism",
                                "hypothyroidism"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "candidate for surgery",
                    "criterion": "surgery candidacy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient who is concurrently diagnosed with any medullary, anaplastic, lymphoma, or parathyroid disease",
            "criterions": [
                {
                    "exact_snippets": "concurrently diagnosed with any medullary",
                    "criterion": "medullary disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "concurrently diagnosed with any ... anaplastic",
                    "criterion": "anaplastic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "concurrently diagnosed with any ... lymphoma",
                    "criterion": "lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "concurrently diagnosed with any ... parathyroid disease",
                    "criterion": "parathyroid disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who had previous thyroidectomy for reasons other than diagnostic hemithyroidectomy for their recent cancer diagnosis.",
            "criterions": [
                {
                    "exact_snippets": "previous thyroidectomy",
                    "criterion": "previous thyroidectomy",
                    "requirements": [
                        {
                            "requirement_type": "reason",
                            "expected_value": "other than diagnostic hemithyroidectomy for their recent cancer diagnosis"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are cognitively impaired or have a mental health condition and are therefore unable to give consent",
            "criterions": [
                {
                    "exact_snippets": "cognitively impaired",
                    "criterion": "cognitive impairment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "mental health condition",
                    "criterion": "mental health condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to give consent",
                    "criterion": "ability to give consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient who is not able to read write and speak English",
            "criterions": [
                {
                    "exact_snippets": "not able to read",
                    "criterion": "ability to read English",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not able to ... write",
                    "criterion": "ability to write English",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not able to ... speak English",
                    "criterion": "ability to speak English",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}