{
    "info": {
        "nct_id": "NCT02386800",
        "official_title": "Open Label, Multi-center, Phase IV Study of Ruxolitinib or Ruxolitinib and Panobinostat Combination, for Patients Who Have Completed Prior Global Novartis or Incyte Sponsored Studies",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 1 Month\nMust have maximum age of 100 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Key Inclusion criteria:\n\n1. Patient is currently enrolled in a Novartis GDD or GMA-sponsored or Incyte-sponsored clinical study, are receiving either ruxolitinib or combination of ruxolitinib and panobinostat, and fulfilled all of the requirements of the parent protocol.\n2. Patient is currently benefiting from the treatment with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat, as determined by the investigator\n3. Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements\n4. Patient currently has no evidence of progressive disease, as determined by the investigator, following previous treatment with ruxolitinib or combination of ruxolitinib and panobinostat\n\nKey Exclusion criteria:\n\n1. Patient has been permanently discontinued from study treatment in the parent study due to any reason.\n2. Patient's indication is currently approved and reimbursed in the corresponding country for ruxolitinib monotherapy or combination of ruxolitinib and panobinostat.\n3. Pregnant or nursing (lactating) women.\n4. Female patients of childbearing potential (e.g. are menstruating) who do not agree to abstinence or, if sexually active, do not agree to the use of highly effective contraception, throughout the study and for up to 30 days after stopping study treatment.\n\nOther protocol-defined Inclusion / Exclusion criteria may apply."
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 1 Month",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 1 Month"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 1
                    }
                }
            ]
        },
        {
            "line": "Must have maximum age of 100 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "maximum age of 100 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "maximum",
                    "expected_value": {
                        "operator": "<=",
                        "value": 100
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "1. Patient is currently enrolled in a Novartis GDD or GMA-sponsored or Incyte-sponsored clinical study, are receiving either ruxolitinib or combination of ruxolitinib and panobinostat, and fulfilled all of the requirements of the parent protocol.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patient is currently enrolled in a Novartis GDD or GMA-sponsored or Incyte-sponsored clinical study"
                    ],
                    "criterion": "enrollment in specific clinical study",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "are receiving either ruxolitinib or combination of ruxolitinib and panobinostat"
                    ],
                    "criterion": "treatment",
                    "requirement_type": "type",
                    "expected_value": [
                        "ruxolitinib",
                        "combination of ruxolitinib and panobinostat"
                    ]
                },
                {
                    "exact_snippets": [
                        "fulfilled all of the requirements of the parent protocol"
                    ],
                    "criterion": "requirements of the parent protocol",
                    "requirement_type": "fulfillment",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "2. Patient is currently benefiting from the treatment with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat, as determined by the investigator",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patient is currently benefiting from the treatment with ruxolitinib monotherapy"
                    ],
                    "criterion": "ruxolitinib monotherapy",
                    "requirement_type": "benefit",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Patient is currently benefiting from the treatment with",
                        "combination of ruxolitinib and panobinostat"
                    ],
                    "criterion": "combination of ruxolitinib and panobinostat",
                    "requirement_type": "benefit",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "3. Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patient has demonstrated compliance",
                        "parent study protocol requirements"
                    ],
                    "criterion": "compliance with parent study protocol",
                    "requirement_type": "demonstration",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "4. Patient currently has no evidence of progressive disease, as determined by the investigator, following previous treatment with ruxolitinib or combination of ruxolitinib and panobinostat",
            "criterions": [
                {
                    "exact_snippets": [
                        "no evidence of progressive disease"
                    ],
                    "criterion": "progressive disease",
                    "requirement_type": "evidence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "previous treatment with ruxolitinib"
                    ],
                    "criterion": "ruxolitinib treatment",
                    "requirement_type": "previous",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "combination of ruxolitinib and panobinostat"
                    ],
                    "criterion": "ruxolitinib and panobinostat treatment",
                    "requirement_type": "previous",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "1. Patient has been permanently discontinued from study treatment in the parent study due to any reason.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patient has been permanently discontinued from study treatment"
                    ],
                    "criterion": "study treatment",
                    "requirement_type": "discontinuation",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "in the parent study"
                    ],
                    "criterion": "parent study",
                    "requirement_type": "association",
                    "expected_value": "true"
                }
            ]
        },
        {
            "line": "2. Patient's indication is currently approved and reimbursed in the corresponding country for ruxolitinib monotherapy or combination of ruxolitinib and panobinostat.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patient's indication is currently approved"
                    ],
                    "criterion": "indication",
                    "requirement_type": "approval",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "reimbursed in the corresponding country"
                    ],
                    "criterion": "indication",
                    "requirement_type": "reimbursement",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "ruxolitinib monotherapy"
                    ],
                    "criterion": "treatment",
                    "requirement_type": "type",
                    "expected_value": "ruxolitinib monotherapy"
                },
                {
                    "exact_snippets": [
                        "combination of ruxolitinib and panobinostat"
                    ],
                    "criterion": "treatment",
                    "requirement_type": "type",
                    "expected_value": "combination of ruxolitinib and panobinostat"
                }
            ]
        },
        {
            "line": "3. Pregnant or nursing (lactating) women.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "nursing (lactating)"
                    ],
                    "criterion": "nursing",
                    "requirement_type": "status",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "4. Female patients of childbearing potential (e.g. are menstruating) who do not agree to abstinence or, if sexually active, do not agree to the use of highly effective contraception, throughout the study and for up to 30 days after stopping study treatment.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Female patients"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specificity",
                    "expected_value": "female"
                },
                {
                    "exact_snippets": [
                        "childbearing potential",
                        "e.g. are menstruating"
                    ],
                    "criterion": "childbearing potential",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "do not agree to abstinence"
                    ],
                    "criterion": "abstinence",
                    "requirement_type": "agreement",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "if sexually active, do not agree to the use of highly effective contraception"
                    ],
                    "criterion": "contraception",
                    "requirement_type": "agreement",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "Other protocol-defined Inclusion / Exclusion criteria may apply.",
            "criterions": [
                {
                    "exact_snippets": [
                        "protocol-defined Inclusion / Exclusion criteria"
                    ],
                    "criterion": "protocol-defined criteria",
                    "requirement_type": "applicability",
                    "expected_value": true
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Key Inclusion criteria:",
            "criterions": []
        },
        {
            "line": "Key Exclusion criteria:",
            "criterions": []
        }
    ]
}