{
    "info": {
        "nct_id": "NCT01735955",
        "official_title": "An Open Label, Multi-center Nilotinib Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Nilotinib Study and Are Judged by the Investigator to Benefit From Continued Nilotinib Treatment",
        "inclusion_criteria": "-Patient is currently enrolled in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs study receiving nilotinib and has fulfilled all their requirements in the parent study -Patient is currently benefiting from the treatment with nilotinib, as determined by the investigator -Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements -Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures -Written informed consent obtained prior to enrolling in roll-over study\nHealthy volunteers allowed",
        "exclusion_criteria": "- Patient has been permanently discontinued from nilotinib treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason - Patient has participated in a Novartis sponsored combination trial where nilotinib was dispensed in combination with another study medication and patient is still receiving combination therapy -Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval or inducing Torsade de Pointes and the treatment cannot be either safely discontinued at least one week prior to nilotinib treatment or switched to a different medication prior to start of nilotinib treatment and for the duration of the study -Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcG laboratory test. -Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study and for 30 days after the final dose of nilotinib.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "-Patient is currently enrolled in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs study receiving nilotinib and has fulfilled all their requirements in the parent study -Patient is currently benefiting from the treatment with nilotinib, as determined by the investigator -Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements -Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures -Written informed consent obtained prior to enrolling in roll-over study",
            "criterions": [
                {
                    "exact_snippets": [
                        "currently enrolled in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs study"
                    ],
                    "criterion": "enrollment in Novartis-sponsored study",
                    "requirement_type": "status",
                    "expected_value": "currently enrolled"
                },
                {
                    "exact_snippets": [
                        "receiving nilotinib"
                    ],
                    "criterion": "nilotinib treatment",
                    "requirement_type": "status",
                    "expected_value": "receiving"
                },
                {
                    "exact_snippets": [
                        "fulfilled all their requirements in the parent study"
                    ],
                    "criterion": "requirements in parent study",
                    "requirement_type": "fulfillment",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "currently benefiting from the treatment with nilotinib"
                    ],
                    "criterion": "benefit from nilotinib treatment",
                    "requirement_type": "status",
                    "expected_value": "currently benefiting"
                },
                {
                    "exact_snippets": [
                        "demonstrated compliance",
                        "with the parent study protocol requirements"
                    ],
                    "criterion": "compliance with parent study protocol",
                    "requirement_type": "status",
                    "expected_value": "demonstrated"
                },
                {
                    "exact_snippets": [
                        "Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures"
                    ],
                    "criterion": "compliance with study procedures",
                    "requirement_type": "willingness and ability",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Written informed consent obtained prior to enrolling in roll-over study"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "status",
                    "expected_value": "obtained"
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "- Patient has been permanently discontinued from nilotinib treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason - Patient has participated in a Novartis sponsored combination trial where nilotinib was dispensed in combination with another study medication and patient is still receiving combination therapy -Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval or inducing Torsade de Pointes and the treatment cannot be either safely discontinued at least one week prior to nilotinib treatment or switched to a different medication prior to start of nilotinib treatment and for the duration of the study -Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcG laboratory test. -Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study and for 30 days after the final dose of nilotinib.",
            "criterions": [
                {
                    "exact_snippets": [
                        "permanently discontinued from nilotinib treatment"
                    ],
                    "criterion": "nilotinib treatment",
                    "requirement_type": "discontinuation",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "unacceptable toxicity"
                    ],
                    "criterion": "toxicity",
                    "requirement_type": "acceptability",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "non-compliance to study procedures"
                    ],
                    "criterion": "study procedures compliance",
                    "requirement_type": "compliance",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "withdrawal of consent"
                    ],
                    "criterion": "consent",
                    "requirement_type": "withdrawal",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "participated in a Novartis sponsored combination trial"
                    ],
                    "criterion": "Novartis sponsored combination trial participation",
                    "requirement_type": "participation",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "still receiving combination therapy"
                    ],
                    "criterion": "combination therapy",
                    "requirement_type": "receipt",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "currently receiving treatment with any medications that have the potential to prolong the QT interval or inducing Torsade de Pointes"
                    ],
                    "criterion": "medications with potential to prolong QT interval or induce Torsade de Pointes",
                    "requirement_type": "current treatment",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "treatment cannot be either safely discontinued at least one week prior to nilotinib treatment or switched to a different medication prior to start of nilotinib treatment and for the duration of the study"
                    ],
                    "criterion": "medication treatment",
                    "requirement_type": "discontinuation or switch",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "Pregnant or nursing (lactating) women"
                    ],
                    "criterion": "pregnancy or nursing",
                    "requirement_type": "status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Women of child-bearing potential"
                    ],
                    "criterion": "women of child-bearing potential",
                    "requirement_type": "status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "using highly effective methods of contraception during the study and for 30 days after the final dose of nilotinib"
                    ],
                    "criterion": "contraception use",
                    "requirement_type": "method",
                    "expected_value": "highly effective"
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}