{
    "info": {
        "nct_id": "NCT05099562",
        "official_title": "Precision Acupuncture in the Treatment of Peripheral Neuropathy After Taxanes Chemotherapy in Breast Cancer",
        "inclusion_criteria": "1. The patient was at least 18 years old and had reported grade 1 or higher neuropathic symptoms for more than 2 weeks;\n2. Patients were screened for eligibility by the investigator prior to enrollment, including verification of baseline neuropathic symptoms.\n3. Patients had a diagnosis of stage I, II, or IIIA breast cancer;\n4. Have completed at least 2 weeks of chemotherapy;\n5. Higher scores indicate more severe symptoms;\n6. Voluntarily participate in the clinical trial and sign the informed consent form after informed consent (patients voluntarily accept the treatment and give informed consent);\n7. Eastern Cooperative Oncology Group (ECOG ) score of physical condition (0-1);\n8. Patients with previous local recurrence were eligible;\n9. The basic indexes were consistent, and the blood routine and ECG were normal.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. patients with needle phobia;\n2. Low platelet count (<50 000); co-morbidity with a bleeding disorder; comorbidity with thyroid dysfunction; pregnancy; haemoglobin levels <10 g/dl and haematocrit <30; anaemia on active pharmacological treatment or receiving blood transfusion or steroids;\n3. having metastatic or recurrent disease, history of preexisting peripheral neuropa- thy prior to chemotherapy, uncontrolled seizure disorder, unstable cardiac disease or myocardial infarction within 6 months prior to study entry;\n4. Being pregnant or nursing, or having used acupuncture for peripheral neuropathy within 6 months prior to study entry;\n5. Life expectancy <6 months;\n6. Lymphedema of limbs;",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. The patient was at least 18 years old and had reported grade 1 or higher neuropathic symptoms for more than 2 weeks;",
            "criterions": [
                {
                    "exact_snippets": "at least 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "reported grade 1 or higher neuropathic symptoms",
                    "criterion": "neuropathic symptoms",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "neuropathic symptoms for more than 2 weeks",
                    "criterion": "duration of neuropathic symptoms",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients were screened for eligibility by the investigator prior to enrollment, including verification of baseline neuropathic symptoms.",
            "criterions": [
                {
                    "exact_snippets": "verification of baseline neuropathic symptoms",
                    "criterion": "neuropathic symptoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients had a diagnosis of stage I, II, or IIIA breast cancer;",
            "criterions": [
                {
                    "exact_snippets": "diagnosis of stage I, II, or IIIA breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "I",
                                "II",
                                "IIIA"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Have completed at least 2 weeks of chemotherapy;",
            "criterions": [
                {
                    "exact_snippets": "completed at least 2 weeks of chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Higher scores indicate more severe symptoms;",
            "criterions": [
                {
                    "exact_snippets": "Higher scores indicate more severe symptoms",
                    "criterion": "symptom severity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "higher scores"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Voluntarily participate in the clinical trial and sign the informed consent form after informed consent (patients voluntarily accept the treatment and give informed consent);",
            "criterions": [
                {
                    "exact_snippets": "Voluntarily participate in the clinical trial",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sign the informed consent form",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Eastern Cooperative Oncology Group (ECOG ) score of physical condition (0-1);",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG ) score of physical condition (0-1)",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients with previous local recurrence were eligible;",
            "criterions": [
                {
                    "exact_snippets": "Patients with previous local recurrence",
                    "criterion": "previous local recurrence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. The basic indexes were consistent, and the blood routine and ECG were normal.",
            "criterions": [
                {
                    "exact_snippets": "basic indexes were consistent",
                    "criterion": "basic indexes",
                    "requirements": [
                        {
                            "requirement_type": "consistency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "blood routine ... normal",
                    "criterion": "blood routine",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "ECG ... normal",
                    "criterion": "ECG",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. patients with needle phobia;",
            "criterions": [
                {
                    "exact_snippets": "patients with needle phobia",
                    "criterion": "needle phobia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Low platelet count (<50 000); co-morbidity with a bleeding disorder; comorbidity with thyroid dysfunction; pregnancy; haemoglobin levels <10 g/dl and haematocrit <30; anaemia on active pharmacological treatment or receiving blood transfusion or steroids;",
            "criterions": [
                {
                    "exact_snippets": "Low platelet count (<50 000)",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 50000,
                                "unit": ""
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "co-morbidity with a bleeding disorder",
                    "criterion": "bleeding disorder",
                    "requirements": [
                        {
                            "requirement_type": "comorbidity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "comorbidity with thyroid dysfunction",
                    "criterion": "thyroid dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "comorbidity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "haemoglobin levels <10 g/dl",
                    "criterion": "haemoglobin levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "g/dl"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "haematocrit <30",
                    "criterion": "haematocrit",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": ""
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "anaemia on active pharmacological treatment or receiving blood transfusion or steroids",
                    "criterion": "anaemia",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "active pharmacological treatment",
                                "receiving blood transfusion",
                                "receiving steroids"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Being pregnant or nursing, or having used acupuncture for peripheral neuropathy within 6 months prior to study entry;",
            "criterions": [
                {
                    "exact_snippets": "Being pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "having used acupuncture for peripheral neuropathy within 6 months prior to study entry",
                    "criterion": "acupuncture for peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Life expectancy <6 months;",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy <6 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Lymphedema of limbs;",
            "criterions": [
                {
                    "exact_snippets": "Lymphedema of limbs",
                    "criterion": "lymphedema",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "limbs"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "3. having metastatic or recurrent disease, history of preexisting peripheral neuropa- thy prior to chemotherapy, uncontrolled seizure disorder, unstable cardiac disease or myocardial infarction within 6 months prior to study entry;",
            "criterions": [
                {
                    "exact_snippets": "having metastatic or recurrent disease",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "metastatic",
                                "recurrent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "history of preexisting peripheral neuropathy prior to chemotherapy",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled seizure disorder",
                    "criterion": "seizure disorder",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within 6 months prior to study entry",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}