{
    "info": {
        "nct_id": "NCT06363201",
        "official_title": "Exploratory Study to Evaluate the Effect and Safety of the Use of Ocoxin Oral Solution on the Quality of Life of Paediatric Patients With Advanced Stage Solid Tumours",
        "inclusion_criteria": "* Patient of either sex in the paediatric age group, between 7 and 18 years of age.\n* Father, mother or legal guardian who consents in writing to the minor's participation in the study. Written consent of the minor for ages 12 to 18 years. Verbal consent of the minor for ages 7 to 11 years.\n* Histologically confirmed diagnosis of solid tumour of any location, in advanced stage, with criteria to receive oncospecific therapy.\n* Patients with haematological parameters within normal figures that allow them to receive oncospecific therapy, according to the management protocols for each of the diseases.\nHealthy volunteers allowed\nMust have minimum age of 7 Years\nMust have maximum age of 18 Years",
        "exclusion_criteria": "* Pregnancy or breast-feeding (if less than 3 months have elapsed since delivery, abortion, or breast-feeding prior to the start of treatment).\n* Hypersensitivity to any component of the product under study (Ocoxin®).\n* Any disease or condition that could interfere with the interpretation of the results.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patient of either sex in the paediatric age group, between 7 and 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "either sex",
                    "criterion": "sex",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "paediatric age group, between 7 and 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 7,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Father, mother or legal guardian who consents in writing to the minor's participation in the study. Written consent of the minor for ages 12 to 18 years. Verbal consent of the minor for ages 7 to 11 years.",
            "criterions": [
                {
                    "exact_snippets": "Father, mother or legal guardian who consents in writing",
                    "criterion": "parental or guardian consent",
                    "requirements": [
                        {
                            "requirement_type": "form",
                            "expected_value": "written"
                        }
                    ]
                },
                {
                    "exact_snippets": "Written consent of the minor for ages 12 to 18 years",
                    "criterion": "minor consent (ages 12 to 18)",
                    "requirements": [
                        {
                            "requirement_type": "form",
                            "expected_value": "written"
                        }
                    ]
                },
                {
                    "exact_snippets": "Verbal consent of the minor for ages 7 to 11 years",
                    "criterion": "minor consent (ages 7 to 11)",
                    "requirements": [
                        {
                            "requirement_type": "form",
                            "expected_value": "verbal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed diagnosis of solid tumour of any location, in advanced stage, with criteria to receive oncospecific therapy.",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed diagnosis of solid tumour",
                    "criterion": "solid tumour",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "solid tumour of any location",
                    "criterion": "tumour location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "solid tumour ... in advanced stage",
                    "criterion": "tumour stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "criteria to receive oncospecific therapy",
                    "criterion": "oncospecific therapy eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": "criteria to receive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with haematological parameters within normal figures that allow them to receive oncospecific therapy, according to the management protocols for each of the diseases.",
            "criterions": [
                {
                    "exact_snippets": "haematological parameters within normal figures",
                    "criterion": "haematological parameters",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within normal figures"
                        }
                    ]
                },
                {
                    "exact_snippets": "allow them to receive oncospecific therapy",
                    "criterion": "eligibility for oncospecific therapy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "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 7 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 7 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Pregnancy or breast-feeding (if less than 3 months have elapsed since delivery, abortion, or breast-feeding prior to the start of treatment).",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breast-feeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "less than 3 months have elapsed since delivery",
                    "criterion": "time since delivery",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "less than 3 months have elapsed since ... abortion",
                    "criterion": "time since abortion",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "less than 3 months have elapsed since ... breast-feeding prior to the start of treatment",
                    "criterion": "time since breast-feeding",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hypersensitivity to any component of the product under study (Ocoxin®).",
            "criterions": [
                {
                    "exact_snippets": "Hypersensitivity to any component of the product under study (Ocoxin®)",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any disease or condition that could interfere with the interpretation of the results.",
            "criterions": [
                {
                    "exact_snippets": "Any disease or condition that could interfere with the interpretation of the results.",
                    "criterion": "disease or condition",
                    "requirements": [
                        {
                            "requirement_type": "interference with interpretation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}