{
    "info": {
        "nct_id": "NCT02324231",
        "official_title": "SPOG 2015 FN Definition. A Swiss Pediatric Oncology Group (SPOG) Initiated Multi-center Open-label Randomized Controlled Multiple Crossover Non-inferiority Trial on Safety of a High Versus Low Temperature Limit Defining Fever in Pediatric Patients With Cancer at Risk for Fever in Chemotherapy-induced Neutropenia (FN)",
        "inclusion_criteria": "* Chemotherapy treatment because of any malignancy for at least 2 months at time of recruitment for myelosuppressive therapy, or at least 1 cycle of myeloablative chemotherapy followed by autologous hematopoietic stem cell transplantation\n* Age ≥12 months and <18 years at time of recruitment\n* Written informed consent from patients and/or parents\nHealthy volunteers allowed\nMust have minimum age of 1 Year\nMust have maximum age of 18 Years",
        "exclusion_criteria": "* Infants <1 years old (reason: differences in temperature measurement method)\n* Past allogeneic hematopoietic stem cell transplantation\n* Denied written informed consent from patients and/or parents",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Chemotherapy treatment because of any malignancy for at least 2 months at time of recruitment for myelosuppressive therapy, or at least 1 cycle of myeloablative chemotherapy followed by autologous hematopoietic stem cell transplantation",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy treatment because of any malignancy for at least 2 months",
                    "criterion": "chemotherapy treatment duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "myelosuppressive therapy",
                    "criterion": "myelosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 1 cycle of myeloablative chemotherapy",
                    "criterion": "myeloablative chemotherapy cycles",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cycle"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "autologous hematopoietic stem cell transplantation",
                    "criterion": "autologous hematopoietic stem cell transplantation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥12 months and <18 years at time of recruitment",
            "criterions": [
                {
                    "exact_snippets": "Age ≥12 months and <18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 12,
                                        "unit": "months"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Written informed consent from patients and/or parents",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent from patients and/or parents",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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 1 Year",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 1 Year",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "Year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Infants <1 years old (reason: differences in temperature measurement method)",
            "criterions": [
                {
                    "exact_snippets": "Infants <1 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 1,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Past allogeneic hematopoietic stem cell transplantation",
            "criterions": [
                {
                    "exact_snippets": "Past allogeneic hematopoietic stem cell transplantation",
                    "criterion": "allogeneic hematopoietic stem cell transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Denied written informed consent from patients and/or parents",
            "criterions": [
                {
                    "exact_snippets": "Denied written informed consent from patients",
                    "criterion": "written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Denied written informed consent from ... parents",
                    "criterion": "written informed consent from parents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}