0 Avaliações

ID

16054

Descrição

The PK/PD, Efficacy, Safety and Tolerability Study of SHR3824 in Type 2 Diabetes Mellitus Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02366351

Link

https://clinicaltrials.gov/show/NCT02366351

Palavras-chave

  1. 27/06/2016 27/06/2016 -
Transferido a

27 de junho de 2016

DOI

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Licença

Creative Commons BY 4.0

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    Eligibility Type 2 Diabetes Mellitus NCT02366351

    Eligibility Type 2 Diabetes Mellitus NCT02366351

    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    patients must have a diagnosis of type 2 diabetes mellitus;
    Descrição

    Diabetes Mellitus, Non-Insulin-Dependent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0011860
    hemoglobin a1c levels >=7.5% and <=10.5%;
    Descrição

    Hemoglobin A1c measurement

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0474680
    body mass index (bmi) 25 to 45 kg/m2;
    Descrição

    Body mass index

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    patient either has not been previously treated with antihyperglycemic medication or has not been treated with antihyperglycemic in the last 10 weeks.
    Descrição

    Hypoglycemic Agents Patient untreated | Therapeutic procedure Hypoglycemic Agents Duration

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020616
    UMLS CUI [1,2]
    C0030705
    UMLS CUI [1,3]
    C0332155
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C0020616
    UMLS CUI [2,3]
    C0449238
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    type i diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, cushing's syndrome, etc.);
    Descrição

    Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus Due to Pancreatic Diseases | Secondary diabetes mellitus | Acromegaly | Cushing Syndrome

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0011854
    UMLS CUI [2,1]
    C0011849
    UMLS CUI [2,2]
    C0678226
    UMLS CUI [2,3]
    C0030286
    UMLS CUI [3]
    C0271640
    UMLS CUI [4]
    C0001206
    UMLS CUI [5]
    C0010481
    past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage iii or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy);
    Descrição

    Complications of Diabetes Mellitus Severe | Proliferative diabetic retinopathy | Kidney Disease Staging of disease | Diabetic Ketoacidosis | Diabetic Neuropathies Serious

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0342257
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [2]
    C0154830
    UMLS CUI [3,1]
    C0022658
    UMLS CUI [3,2]
    C0449385
    UMLS CUI [4]
    C0011880
    UMLS CUI [5,1]
    C0011882
    UMLS CUI [5,2]
    C0205404
    systolic blood pressure of ≥160 mmhg or diastolic blood pressure of ≥100 mmhg on the start or end day of the run-in period;
    Descrição

    Systolic Pressure | Diastolic blood pressure

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0871470
    UMLS CUI [2]
    C0428883
    history of myocardial infarction, unstable angina, or cerebrovascular disorder within 6 months before the start of the run-in period;
    Descrição

    Myocardial Infarction | Angina, Unstable | Cerebrovascular Disorders

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    UMLS CUI [2]
    C0002965
    UMLS CUI [3]
    C0007820
    past or current history of malignant tumor;
    Descrição

    Malignant Neoplasms

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;
    Descrição

    Drug Allergy | anaphylaxis | Drug-induced anaphylactoid reaction

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0013182
    UMLS CUI [2]
    C0002792
    UMLS CUI [3]
    C0344178
    pregnant women, lactating mothers, or women of childbearing potential;
    Descrição

    Pregnancy | Breast Feeding | Childbearing Potential

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3]
    C3831118
    any condition that subjects are assessed to be ineligible by the investigator (sub investigator).
    Descrição

    Condition Study Subject Participation Status Limited

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0348080
    UMLS CUI [1,2]
    C2348568
    UMLS CUI [1,3]
    C0439801

    Similar models

    Eligibility Type 2 Diabetes Mellitus NCT02366351

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Diabetes Mellitus, Non-Insulin-Dependent
    Item
    patients must have a diagnosis of type 2 diabetes mellitus;
    boolean
    C0011860 (UMLS CUI [1])
    Hemoglobin A1c measurement
    Item
    hemoglobin a1c levels >=7.5% and <=10.5%;
    boolean
    C0474680 (UMLS CUI [1])
    Body mass index
    Item
    body mass index (bmi) 25 to 45 kg/m2;
    boolean
    C1305855 (UMLS CUI [1])
    Hypoglycemic Agents Patient untreated | Therapeutic procedure Hypoglycemic Agents Duration
    Item
    patient either has not been previously treated with antihyperglycemic medication or has not been treated with antihyperglycemic in the last 10 weeks.
    boolean
    C0020616 (UMLS CUI [1,1])
    C0030705 (UMLS CUI [1,2])
    C0332155 (UMLS CUI [1,3])
    C0087111 (UMLS CUI [2,1])
    C0020616 (UMLS CUI [2,2])
    C0449238 (UMLS CUI [2,3])
    Item Group
    C0680251 (UMLS CUI)
    Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus Due to Pancreatic Diseases | Secondary diabetes mellitus | Acromegaly | Cushing Syndrome
    Item
    type i diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, cushing's syndrome, etc.);
    boolean
    C0011854 (UMLS CUI [1])
    C0011849 (UMLS CUI [2,1])
    C0678226 (UMLS CUI [2,2])
    C0030286 (UMLS CUI [2,3])
    C0271640 (UMLS CUI [3])
    C0001206 (UMLS CUI [4])
    C0010481 (UMLS CUI [5])
    Complications of Diabetes Mellitus Severe | Proliferative diabetic retinopathy | Kidney Disease Staging of disease | Diabetic Ketoacidosis | Diabetic Neuropathies Serious
    Item
    past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage iii or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy);
    boolean
    C0342257 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0154830 (UMLS CUI [2])
    C0022658 (UMLS CUI [3,1])
    C0449385 (UMLS CUI [3,2])
    C0011880 (UMLS CUI [4])
    C0011882 (UMLS CUI [5,1])
    C0205404 (UMLS CUI [5,2])
    Systolic Pressure | Diastolic blood pressure
    Item
    systolic blood pressure of ≥160 mmhg or diastolic blood pressure of ≥100 mmhg on the start or end day of the run-in period;
    boolean
    C0871470 (UMLS CUI [1])
    C0428883 (UMLS CUI [2])
    Myocardial Infarction | Angina, Unstable | Cerebrovascular Disorders
    Item
    history of myocardial infarction, unstable angina, or cerebrovascular disorder within 6 months before the start of the run-in period;
    boolean
    C0027051 (UMLS CUI [1])
    C0002965 (UMLS CUI [2])
    C0007820 (UMLS CUI [3])
    Malignant Neoplasms
    Item
    past or current history of malignant tumor;
    boolean
    C0006826 (UMLS CUI [1])
    Drug Allergy | anaphylaxis | Drug-induced anaphylactoid reaction
    Item
    past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;
    boolean
    C0013182 (UMLS CUI [1])
    C0002792 (UMLS CUI [2])
    C0344178 (UMLS CUI [3])
    Pregnancy | Breast Feeding | Childbearing Potential
    Item
    pregnant women, lactating mothers, or women of childbearing potential;
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C3831118 (UMLS CUI [3])
    Condition Study Subject Participation Status Limited
    Item
    any condition that subjects are assessed to be ineligible by the investigator (sub investigator).
    boolean
    C0348080 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C0439801 (UMLS CUI [1,3])

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