{
    "info": {
        "nct_id": "NCT01088750",
        "official_title": "First International Inter-Group Study for Nodular Lymphocyte-Predominant Hodgkin's Lymphoma in Children and Adolescents",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have maximum age of 17 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion criteria:\n\n* nodular lymphocyte-predominant Hodgkin's lymphoma confirmed by reference pathology.\n* initial stage IA/IIA (according to local staging) or relapse stage IA or IIA and residual tumour after relapse biopsy and no additional surgery planned in nLP patients relapsing after surgery alone\n* patient aged under 18 years at time of diagnosis\n* written informed consent of the patient and/or the patient's parents or guardian according to national laws\n\nExclusion criteria\n\n* pre-treatment of Hodgkin's lymphoma differing from study protocol\n* Any extra-nodal involvement\n* Inability to fulfil protocol requirements for imaging (CT, MRI, FDG-PET) at staging and response assessment\n* known hypersensitivity or contraindication to study drugs\n* prior chemotherapy or radiotherapy\n* Current or recent therapy (within 30 days prior to the start of trial treatment) with steroids\n* Current or recent (within 30 days prior to the start of trial treatment) treatment with another investigational drug or participation in another investigational trial\n* other (simultaneous) malignancies\n* severe concomitant diseases (e.g. immune deficiency syndrome)\n* known HIV positivity\n* pregnancy and / or lactation\n* females who are sexually active refusing to use effective contraception (oral contraception, intrauterine devices, barrier method of contraception in conjunction with spermicidal jelly or surgical sterile) (except for surgery only)"
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have maximum age of 17 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "maximum age of 17 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "maximum",
                    "expected_value": {
                        "operator": "<=",
                        "value": 17
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "* nodular lymphocyte-predominant Hodgkin's lymphoma confirmed by reference pathology.",
            "criterions": [
                {
                    "exact_snippets": [
                        "nodular lymphocyte-predominant Hodgkin's lymphoma"
                    ],
                    "criterion": "nodular lymphocyte-predominant Hodgkin's lymphoma",
                    "requirement_type": "confirmation",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "confirmed by reference pathology"
                    ],
                    "criterion": "reference pathology",
                    "requirement_type": "confirmation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* initial stage IA/IIA (according to local staging) or relapse stage IA or IIA and residual tumour after relapse biopsy and no additional surgery planned in nLP patients relapsing after surgery alone",
            "criterions": [
                {
                    "exact_snippets": [
                        "initial stage IA/IIA"
                    ],
                    "criterion": "cancer stage",
                    "requirement_type": "initial",
                    "expected_value": [
                        "IA",
                        "IIA"
                    ]
                },
                {
                    "exact_snippets": [
                        "relapse stage IA or IIA"
                    ],
                    "criterion": "cancer stage",
                    "requirement_type": "relapse",
                    "expected_value": [
                        "IA",
                        "IIA"
                    ]
                },
                {
                    "exact_snippets": [
                        "residual tumour after relapse biopsy"
                    ],
                    "criterion": "residual tumour",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "no additional surgery planned"
                    ],
                    "criterion": "additional surgery",
                    "requirement_type": "planned",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "nLP patients relapsing after surgery alone"
                    ],
                    "criterion": "nLP patients",
                    "requirement_type": "relapse after surgery alone",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* patient aged under 18 years at time of diagnosis",
            "criterions": [
                {
                    "exact_snippets": [
                        "patient aged under 18 years"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 18
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* written informed consent of the patient and/or the patient's parents or guardian according to national laws",
            "criterions": [
                {
                    "exact_snippets": [
                        "written informed consent of the patient"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "written",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "patient's parents or guardian according to national laws"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "written",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* pre-treatment of Hodgkin's lymphoma differing from study protocol",
            "criterions": [
                {
                    "exact_snippets": [
                        "pre-treatment of Hodgkin's lymphoma differing from study protocol"
                    ],
                    "criterion": "pre-treatment of Hodgkin's lymphoma",
                    "requirement_type": "conformity",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Any extra-nodal involvement",
            "criterions": [
                {
                    "exact_snippets": [
                        "extra-nodal involvement"
                    ],
                    "criterion": "extra-nodal involvement",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Inability to fulfil protocol requirements for imaging (CT, MRI, FDG-PET) at staging and response assessment",
            "criterions": [
                {
                    "exact_snippets": [
                        "Inability to fulfil protocol requirements for imaging"
                    ],
                    "criterion": "imaging protocol requirements",
                    "requirement_type": "fulfillment",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "CT"
                    ],
                    "criterion": "CT imaging",
                    "requirement_type": "availability",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "MRI"
                    ],
                    "criterion": "MRI imaging",
                    "requirement_type": "availability",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "FDG-PET"
                    ],
                    "criterion": "FDG-PET imaging",
                    "requirement_type": "availability",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* known hypersensitivity or contraindication to study drugs",
            "criterions": [
                {
                    "exact_snippets": [
                        "known hypersensitivity",
                        "study drugs"
                    ],
                    "criterion": "hypersensitivity",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "contraindication",
                        "study drugs"
                    ],
                    "criterion": "contraindication",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Current or recent therapy (within 30 days prior to the start of trial treatment) with steroids",
            "criterions": [
                {
                    "exact_snippets": [
                        "Current or recent therapy",
                        "with steroids"
                    ],
                    "criterion": "steroid therapy",
                    "requirement_type": "recency",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 30
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Current or recent (within 30 days prior to the start of trial treatment) treatment with another investigational drug or participation in another investigational trial",
            "criterions": [
                {
                    "exact_snippets": [
                        "Current or recent (within 30 days prior to the start of trial treatment) treatment with another investigational drug"
                    ],
                    "criterion": "treatment with another investigational drug",
                    "requirement_type": "recency",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 30
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "participation in another investigational trial"
                    ],
                    "criterion": "participation in another investigational trial",
                    "requirement_type": "current",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* other (simultaneous) malignancies",
            "criterions": [
                {
                    "exact_snippets": [
                        "other (simultaneous) malignancies"
                    ],
                    "criterion": "other malignancies",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* severe concomitant diseases (e.g. immune deficiency syndrome)",
            "criterions": [
                {
                    "exact_snippets": [
                        "severe concomitant diseases"
                    ],
                    "criterion": "concomitant diseases",
                    "requirement_type": "severity",
                    "expected_value": "severe"
                },
                {
                    "exact_snippets": [
                        "immune deficiency syndrome"
                    ],
                    "criterion": "immune deficiency syndrome",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* known HIV positivity",
            "criterions": [
                {
                    "exact_snippets": [
                        "known HIV positivity"
                    ],
                    "criterion": "HIV",
                    "requirement_type": "positivity",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* pregnancy and / or lactation",
            "criterions": [
                {
                    "exact_snippets": [
                        "pregnancy"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "lactation"
                    ],
                    "criterion": "lactation",
                    "requirement_type": "presence",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* females who are sexually active refusing to use effective contraception (oral contraception, intrauterine devices, barrier method of contraception in conjunction with spermicidal jelly or surgical sterile) (except for surgery only)",
            "criterions": [
                {
                    "exact_snippets": [
                        "females"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specificity",
                    "expected_value": "female"
                },
                {
                    "exact_snippets": [
                        "sexually active"
                    ],
                    "criterion": "sexual activity",
                    "requirement_type": "status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "refusing to use effective contraception"
                    ],
                    "criterion": "contraception use",
                    "requirement_type": "willingness",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "oral contraception",
                        "intrauterine devices",
                        "barrier method of contraception in conjunction with spermicidal jelly",
                        "surgical sterile"
                    ],
                    "criterion": "contraception methods",
                    "requirement_type": "types",
                    "expected_value": [
                        "oral contraception",
                        "intrauterine devices",
                        "barrier method of contraception in conjunction with spermicidal jelly",
                        "surgical sterile"
                    ]
                },
                {
                    "exact_snippets": [
                        "except for surgery only"
                    ],
                    "criterion": "treatment type",
                    "requirement_type": "exclusion",
                    "expected_value": "surgery only"
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion criteria:",
            "criterions": []
        },
        {
            "line": "Exclusion criteria",
            "criterions": []
        },
        {
            "line": "* prior chemotherapy or radiotherapy",
            "criterions": [
                {
                    "exact_snippets": [
                        "prior chemotherapy"
                    ],
                    "criterion": "chemotherapy",
                    "requirement_type": "prior treatment",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "prior radiotherapy"
                    ],
                    "criterion": "radiotherapy",
                    "requirement_type": "prior treatment",
                    "expected_value": true
                }
            ]
        }
    ]
}