{
    "info": {
        "nct_id": "NCT01201694",
        "official_title": "Phase I Study of Surface-Controlled Water Soluble Curcumin (THERACURMIN CR-011L) in Patients With Advanced Malignancies",
        "inclusion_criteria": "1. Patients must have an advanced malignancy that has either failed one or more prior therapies, or for which there is no established standard of care therapy that improves survival by at least 3 months. If standard therapies are available, the informed consent states that patients are forgoing approved therapies proven to prolong life or the time that the patient is alive without growth of their cancer.\n2. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or better (0-3).\n3. Patients must have normal organ and marrow function as defined below: Absolute neutrophil count > 1,000 /uL Platelets > 50,000 /uL Total bilirubin </= 1.5 x upper limit of normal (ULN) (except patients with Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL) and ALT </= 3 x ULN, Creatinine </= 1.5 x ULN or creatinine clearance >/= 40 ml/min\n4. Patients must be able to understand and be willing to sign an Institutional Review Board (IRB) approved written informed consent document.\n5. Women of child-bearing potential (women who are not postmenopausal for at least one year or are not surgically sterile) and men must agree to use adequate contraception (e.g., barrier device) prior to study entry, for the duration of study participation, and for 30 days after the last dose.\n6. Patients may receive palliative radiation therapy immediately before or during the treatment if the radiation therapy is not delivered to the sole target lesions.\n7. Men and women aged >/= 18 years. However, patients who are 13 years or older will be eligible after consultation with their pediatric attending.\nHealthy volunteers allowed\nMust have minimum age of 13 Years",
        "exclusion_criteria": "1. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, active bleeding that requires hospitalization, or psychiatric illness/social situations that would limit compliance with study requirements.\n2. Subject that has not recovered from major surgical procedure, open biopsy, or significant traumatic injury (i.e. subject still needs additional medical care for these issues).\n3. History of gastric or duodenal ulcers, or hyperacidity syndromes.\n4. History of allergic reactions to the study drug or its analogs.\n5. Patient that has received any treatment for tumor specific control within 3 weeks of the start of study drug with investigational drugs and cytotoxic agents, or within 2 weeks of cytotoxic agent given weekly, or within 6 weeks of nitrosoureas or mitomycin C, or within 5 half-lives of biological targeted agents with half-lives and pharmacodynamic effects lasting less than 5 days (that includes, but is not limited to, erlotinib, sorafenib, sunitinib, bortezomib, and other similar agents).\n6. Currently taking therapeutic doses of anticoagulants such as warfarin or antiplatelet agents (any prophylaxis agents are acceptable).\n7. International normalized ratio (INR) > 1.5\n8. Biliary obstruction or cholelithiasis.\n9. Inability to take oral medication (PEG tube is acceptable).\n10. Pregnant or breastfeeding women.\n11. Concurrent enrollment on another therapeutic research study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patients must have an advanced malignancy that has either failed one or more prior therapies, or for which there is no established standard of care therapy that improves survival by at least 3 months. If standard therapies are available, the informed consent states that patients are forgoing approved therapies proven to prolong life or the time that the patient is alive without growth of their cancer.",
            "criterions": [
                {
                    "exact_snippets": "advanced malignancy",
                    "criterion": "malignancy",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "failed one or more prior therapies",
                    "criterion": "prior therapies",
                    "requirements": [
                        {
                            "requirement_type": "outcome",
                            "expected_value": "failed"
                        }
                    ]
                },
                {
                    "exact_snippets": "no established standard of care therapy that improves survival by at least 3 months",
                    "criterion": "standard of care therapy",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "forgoing approved therapies proven to prolong life or the time that the patient is alive without growth of their cancer",
                    "criterion": "approved therapies",
                    "requirements": [
                        {
                            "requirement_type": "decision",
                            "expected_value": "forgoing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or better (0-3).",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 3 or better (0-3)",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients must have normal organ and marrow function as defined below: Absolute neutrophil count > 1,000 /uL Platelets > 50,000 /uL Total bilirubin </= 1.5 x upper limit of normal (ULN) (except patients with Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL) and ALT </= 3 x ULN, Creatinine </= 1.5 x ULN or creatinine clearance >/= 40 ml/min",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count > 1,000 /uL",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1000,
                                "unit": "/uL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelets > 50,000 /uL",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 50000,
                                "unit": "/uL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Total bilirubin </= 1.5 x upper limit of normal (ULN)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL",
                    "criterion": "total bilirubin in patients with Gilbert's syndrome",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 3.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT </= 3 x ULN",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatinine </= 1.5 x ULN",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance >/= 40 ml/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients must be able to understand and be willing to sign an Institutional Review Board (IRB) approved written informed consent document.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be able to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "be willing to sign",
                    "criterion": "willingness to sign consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Institutional Review Board (IRB) approved written informed consent document",
                    "criterion": "IRB approved consent document",
                    "requirements": [
                        {
                            "requirement_type": "approval",
                            "expected_value": "IRB approved"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Women of child-bearing potential (women who are not postmenopausal for at least one year or are not surgically sterile) and men must agree to use adequate contraception (e.g., barrier device) prior to study entry, for the duration of study participation, and for 30 days after the last dose.",
            "criterions": [
                {
                    "exact_snippets": "Women of child-bearing potential (women who are not postmenopausal for at least one year or are not surgically sterile)",
                    "criterion": "women of child-bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "women who are not postmenopausal for at least one year or are not surgically sterile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use adequate contraception (e.g., barrier device)",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "barrier device"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "prior to study entry, for the duration of study participation, and for 30 days after the last dose",
                    "criterion": "contraception use duration",
                    "requirements": [
                        {
                            "requirement_type": "time period",
                            "expected_value": "prior to study entry, for the duration of study participation, and for 30 days after the last dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients may receive palliative radiation therapy immediately before or during the treatment if the radiation therapy is not delivered to the sole target lesions.",
            "criterions": [
                {
                    "exact_snippets": "Patients may receive palliative radiation therapy",
                    "criterion": "palliative radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "immediately before or during the treatment"
                        },
                        {
                            "requirement_type": "target",
                            "expected_value": "not delivered to the sole target lesions"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Men and women aged >/= 18 years. However, patients who are 13 years or older will be eligible after consultation with their pediatric attending.",
            "criterions": [
                {
                    "exact_snippets": "Men and women aged >/= 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who are 13 years or older will be eligible after consultation with their pediatric attending",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 13,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "consultation",
                            "expected_value": "pediatric attending"
                        }
                    ]
                }
            ]
        },
        {
            "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 13 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 13 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 13,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, active bleeding that requires hospitalization, or psychiatric illness/social situations that would limit compliance with study requirements.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... symptomatic congestive heart failure (NYHA Class III or IV)",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "NYHA Class III or IV"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... unstable angina pectoris",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... active bleeding that requires hospitalization",
                    "criterion": "active bleeding",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "requires hospitalization"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... psychiatric illness/social situations that would limit compliance with study requirements",
                    "criterion": "psychiatric illness/social situations",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": "would limit compliance with study requirements"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Subject that has not recovered from major surgical procedure, open biopsy, or significant traumatic injury (i.e. subject still needs additional medical care for these issues).",
            "criterions": [
                {
                    "exact_snippets": "Subject that has not recovered from major surgical procedure",
                    "criterion": "recovery from major surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subject that has not recovered from ... open biopsy",
                    "criterion": "recovery from open biopsy",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subject that has not recovered from ... significant traumatic injury",
                    "criterion": "recovery from significant traumatic injury",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. History of gastric or duodenal ulcers, or hyperacidity syndromes.",
            "criterions": [
                {
                    "exact_snippets": "History of gastric or duodenal ulcers",
                    "criterion": "gastric or duodenal ulcers",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hyperacidity syndromes",
                    "criterion": "hyperacidity syndromes",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. History of allergic reactions to the study drug or its analogs.",
            "criterions": [
                {
                    "exact_snippets": "History of allergic reactions to the study drug",
                    "criterion": "allergic reactions to the study drug",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "allergic reactions to ... its analogs",
                    "criterion": "allergic reactions to analogs of the study drug",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patient that has received any treatment for tumor specific control within 3 weeks of the start of study drug with investigational drugs and cytotoxic agents, or within 2 weeks of cytotoxic agent given weekly, or within 6 weeks of nitrosoureas or mitomycin C, or within 5 half-lives of biological targeted agents with half-lives and pharmacodynamic effects lasting less than 5 days (that includes, but is not limited to, erlotinib, sorafenib, sunitinib, bortezomib, and other similar agents).",
            "criterions": [
                {
                    "exact_snippets": "Patient that has received any treatment for tumor specific control within 3 weeks of the start of study drug with investigational drugs and cytotoxic agents",
                    "criterion": "treatment with investigational drugs and cytotoxic agents",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient that has received any treatment for tumor specific control ... within 2 weeks of cytotoxic agent given weekly",
                    "criterion": "treatment with weekly cytotoxic agents",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient that has received any treatment for tumor specific control ... within 6 weeks of nitrosoureas or mitomycin C",
                    "criterion": "treatment with nitrosoureas or mitomycin C",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient that has received any treatment for tumor specific control ... within 5 half-lives of biological targeted agents with half-lives and pharmacodynamic effects lasting less than 5 days",
                    "criterion": "treatment with biological targeted agents with half-lives and pharmacodynamic effects lasting less than 5 days",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "half-lives"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Currently taking therapeutic doses of anticoagulants such as warfarin or antiplatelet agents (any prophylaxis agents are acceptable).",
            "criterions": [
                {
                    "exact_snippets": "Currently taking therapeutic doses of anticoagulants such as warfarin",
                    "criterion": "therapeutic doses of anticoagulants",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Currently taking ... antiplatelet agents",
                    "criterion": "antiplatelet agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. International normalized ratio (INR) > 1.5",
            "criterions": [
                {
                    "exact_snippets": "International normalized ratio (INR) > 1.5",
                    "criterion": "International normalized ratio (INR)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Biliary obstruction or cholelithiasis.",
            "criterions": [
                {
                    "exact_snippets": "Biliary obstruction",
                    "criterion": "biliary obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cholelithiasis",
                    "criterion": "cholelithiasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Inability to take oral medication (PEG tube is acceptable).",
            "criterions": [
                {
                    "exact_snippets": "Inability to take oral medication",
                    "criterion": "ability to take oral medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "PEG tube is acceptable",
                    "criterion": "PEG tube",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Pregnant or breastfeeding women.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Concurrent enrollment on another therapeutic research study.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent enrollment on another therapeutic research study",
                    "criterion": "concurrent enrollment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}