{
    "info": {
        "nct_id": "NCT00874731",
        "official_title": "A Clinical Trial to Assess the Effect of Ridaforolimus (AP23573; MK-8669) on QTc Interval in Patients",
        "inclusion_criteria": "* Participant must have metastatic or locally advanced cancer which has failed to respond to standard therapy or no therapy exists.\n* If the participant is a female, she must be postmenopausal or if she is of childbearing potential she must have blood pregnancy tests during the study and be willing to use 2 methods of contraception.\n* If the participant is male and has female partners of child-bearing potential, he must agree to use a medically acceptable method of contraception during the study and for 30 days after the last dose of study drug.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Participant has had chemotherapy, radiotherapy or biological therapy within the past 4 weeks.\n* Participant is currently receiving other anti-cancer therapy.\n* Participant is currently participating or has participated in a study with an investigation drug or device within the last 30 days.\n* Participant has a primary central nervous system tumor or active brain metastases.\n* Participant has a psychiatric disorder.\n* Participant uses illegal drugs.\n* Participant is pregnant or breastfeeding.\n* Participant is known to be human immunodeficiency virus (HIV) positive.\n* Participant has a known history of Hepatitis B or C.\n* Participant has newly diagnosed diabetes.\n* Participant has an active infection.\n* Participant is unable to swallow capsules.\n* Participant has received a blood transfusion with one week of study entry.\n* Participant has a history of cardiac problems including heart failure, myocardial infarction, unstable angina, congestive heart failure or cardiac arrhythmia.\n* Participant has a known sensitivity to the components of the study drug.\n* Participant has not adequately recovered from any prior surgical procedure.\n* Participant does not agree to refrain from use of herbal remedies and consumption of grapefruit juice for 2 weeks prior to and during the study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Participant must have metastatic or locally advanced cancer which has failed to respond to standard therapy or no therapy exists.",
            "criterions": [
                {
                    "exact_snippets": "metastatic or locally advanced cancer",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "metastatic",
                                "locally advanced"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "failed to respond to standard therapy",
                    "criterion": "response to standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no therapy exists",
                    "criterion": "availability of standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If the participant is a female, she must be postmenopausal or if she is of childbearing potential she must have blood pregnancy tests during the study and be willing to use 2 methods of contraception.",
            "criterions": [
                {
                    "exact_snippets": "participant is a female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "postmenopausal",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "potential",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "blood pregnancy tests during the study",
                    "criterion": "pregnancy tests",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": "during the study"
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to use 2 methods of contraception",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "methods",
                            "expected_value": ">= 2"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If the participant is male and has female partners of child-bearing potential, he must agree to use a medically acceptable method of contraception during the study and for 30 days after the last dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "participant is male",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "female partners of child-bearing potential",
                    "criterion": "partner's child-bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "child-bearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "agree to use a medically acceptable method of contraception",
                    "criterion": "contraception agreement",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "during the study and for 30 days after the last dose of study drug",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the study and for 30 days after the last dose of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "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 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Participant has had chemotherapy, radiotherapy or biological therapy within the past 4 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Participant has had chemotherapy ... within the past 4 weeks.",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Participant has had ... radiotherapy ... within the past 4 weeks.",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Participant has had ... biological therapy within the past 4 weeks.",
                    "criterion": "biological therapy",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant is currently receiving other anti-cancer therapy.",
            "criterions": [
                {
                    "exact_snippets": "currently receiving other anti-cancer therapy",
                    "criterion": "anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "current status",
                            "expected_value": "receiving"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant is currently participating or has participated in a study with an investigation drug or device within the last 30 days.",
            "criterions": [
                {
                    "exact_snippets": "Participant is currently participating ... in a study with an investigation drug or device",
                    "criterion": "current participation in a study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has participated in a study with an investigation drug or device within the last 30 days",
                    "criterion": "past participation in a study",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has a primary central nervous system tumor or active brain metastases.",
            "criterions": [
                {
                    "exact_snippets": "primary central nervous system tumor",
                    "criterion": "primary central nervous system tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active brain metastases",
                    "criterion": "active brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has a psychiatric disorder.",
            "criterions": [
                {
                    "exact_snippets": "psychiatric disorder",
                    "criterion": "psychiatric disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant uses illegal drugs.",
            "criterions": [
                {
                    "exact_snippets": "Participant uses illegal drugs.",
                    "criterion": "illegal drug use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant is pregnant or breastfeeding.",
            "criterions": [
                {
                    "exact_snippets": "Participant is pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant is known to be human immunodeficiency virus (HIV) positive.",
            "criterions": [
                {
                    "exact_snippets": "Participant is known to be human immunodeficiency virus (HIV) positive.",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has a known history of Hepatitis B or C.",
            "criterions": [
                {
                    "exact_snippets": "known history of Hepatitis B",
                    "criterion": "Hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known history of ... C",
                    "criterion": "Hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has newly diagnosed diabetes.",
            "criterions": [
                {
                    "exact_snippets": "newly diagnosed diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis status",
                            "expected_value": "newly diagnosed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has an active infection.",
            "criterions": [
                {
                    "exact_snippets": "Participant has an active infection.",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant is unable to swallow capsules.",
            "criterions": [
                {
                    "exact_snippets": "Participant is unable to swallow capsules.",
                    "criterion": "ability to swallow capsules",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has received a blood transfusion with one week of study entry.",
            "criterions": [
                {
                    "exact_snippets": "Participant has received a blood transfusion",
                    "criterion": "blood transfusion",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has a history of cardiac problems including heart failure, myocardial infarction, unstable angina, congestive heart failure or cardiac arrhythmia.",
            "criterions": [
                {
                    "exact_snippets": "history of cardiac problems including heart failure",
                    "criterion": "cardiac problems",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has a known sensitivity to the components of the study drug.",
            "criterions": [
                {
                    "exact_snippets": "known sensitivity to the components of the study drug",
                    "criterion": "sensitivity to study drug components",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has not adequately recovered from any prior surgical procedure.",
            "criterions": [
                {
                    "exact_snippets": "Participant has not adequately recovered from any prior surgical procedure.",
                    "criterion": "recovery from prior surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant does not agree to refrain from use of herbal remedies and consumption of grapefruit juice for 2 weeks prior to and during the study.",
            "criterions": [
                {
                    "exact_snippets": "Participant does not agree to refrain from use of herbal remedies",
                    "criterion": "use of herbal remedies",
                    "requirements": [
                        {
                            "requirement_type": "agreement to refrain",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Participant does not agree to refrain from ... consumption of grapefruit juice",
                    "criterion": "consumption of grapefruit juice",
                    "requirements": [
                        {
                            "requirement_type": "agreement to refrain",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for 2 weeks prior to and during the study",
                    "criterion": "timeframe for refraining",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "2 weeks prior to and during the study"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}