0 Avaliações

ID

12951

Descrição

A Study to Evaluate the Efficacy and Safety of BRL 49653C in Non-insulin Dependent Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01706211

Link

https://clinicaltrials.gov/show/NCT01706211

Palavras-chave

  1. 07/01/2016 07/01/2016 -
Titular dos direitos

CC BY-NC 3.0

Transferido a

7 de janeiro de 2016

DOI

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Licença

Creative Commons BY-NC 3.0

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    Eligibility Diabetes Mellitus Non Insulin Dependent Oral Agent Therapy NCT01706211

    Eligibility Diabetes Mellitus Non Insulin Dependent Oral Agent Therapy NCT01706211

    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    men or women between 30-80 years of age inclusive at time of enrolment.
    Descrição

    age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    patients who had non-independent diabetes mellitus (niddm) defined by the criteria of the national diabetes data group.
    Descrição

    non-independent diabetes mellitus

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0011849 (Diabetes Mellitus)
    SNOMED
    73211009
    patients who had sulphonylurea therapy for at least 6 months and a constant dose for at least 2 months prior to visit 1.
    Descrição

    sulphonylurea

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0038766 (Sulfonylurea Compounds)
    SNOMED
    34012005
    LOINC
    LP18787-9
    patients who had fasting plasma glucose <= 15.0 mmol/l at screening. hemoglobin a1c >= 7.5%.
    Descrição

    patients who had fasting plasma glucose <= 15.0 mmol/l at screening. hemoglobin a1c >= 7.5%.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0202042 (Plasma Glucose Measurement)
    SNOMED
    72191006
    UMLS CUI [2]
    C0019018 (Glycosylated hemoglobin A)
    LOINC
    LP16413-4
    female patients must be (1) post-menopausal, i.e. > 6 months without menstrual period, surgically sterile, or (2) using hormonal contraceptives or intrauterine contraceptive devices. female patients who were taking hormonal contraceptives must also use an additional barrier form or intrauterine form of birth control.
    Descrição

    contraceptive methods

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    patients who had given their written informed consent to participate.
    Descrição

    written informed consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    female patients who were pregnant, breast feeding or planning a pregnancy during the course of the study.
    Descrição

    female patients who were pregnant, breast feeding or planning a pregnancy during the course of the study.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    patients who had a fasting plasma glucose > 15.0 mmol/l at screening, or severity of diabetes mellitus requiring administration of insulin, or patients with ketonuria.
    Descrição

    patients who had a fasting plasma glucose > 15.0 mmol/l at screening, or severity of diabetes mellitus requiring administration of insulin, or patients with ketonuria.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0202042 (Plasma Glucose Measurement)
    SNOMED
    72191006
    UMLS CUI [2]
    C0021641 (Insulin)
    SNOMED
    39487003
    LOINC
    LP70329-5
    UMLS CUI [3]
    C0162275 (Ketonuria)
    SNOMED
    36815008
    patients who had clinically significant renal or hepatic disease (i.e., patients with serum creatinine > 160 micromol/l (1.8 mg/dl); alt, ast, total bilirubin, gamma gt, or alkaline phosphatase more than 2.5 times the upper limit of the normal laboratory range).
    Descrição

    renal or hepatic disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    UMLS CUI [2]
    C1287351 (Finding of liver enzyme levels)
    SNOMED
    365769003
    any clinically significant abnormality identified on the screening physical examination, laboratory tests, electrocardiogram which in the judgment of the investigator would preclude safe completion of the study.
    Descrição

    any clinically significant abnormality identified on the screening physical examination, laboratory tests, electrocardiogram which in the judgment of the investigator would preclude safe completion of the study.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2348563 (Study Protocol)
    UMLS CUI [1,2]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    UMLS CUI [1,3]
    C0009488 (Comorbidity)
    patients who had leukocyte count < 3000/mm3 or platelet count <120,000/mm3.
    Descrição

    leukocyte count < 3000/mm3 or platelet count <120,000/mm3

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0023508 (White Blood Cell Count procedure)
    SNOMED
    767002
    UMLS CUI [2]
    C0032181 (Platelet Count measurement)
    SNOMED
    61928009
    systolic blood pressure >180mmhg or diastolic blood pressure >114mmhg while on appropriate hypertensive therapy.
    Descrição

    blood pressure

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0005823 (Blood Pressure)
    SNOMED
    75367002
    significant anemia (hemoglobin < 11 g/dl for males or < 10g/dl for females) or diagnosis of porphyria.
    Descrição

    anemia or porphyria

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0002871 (Anemia)
    SNOMED
    271737000
    LOINC
    MTHU020823
    UMLS CUI [2]
    C3463940 (Porphyria <eukaryote>)
    symptomatic diabetic neuropathy of sufficient severity to require treatment for control of symptoms (eg, painful peripheral neuropathy, symptomatic orthostatic hypotension, urinary retention, gastric stasis, pedal ulcers).
    Descrição

    diabetic neuropathy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0011882 (Diabetic Neuropathies)
    SNOMED
    230572002
    diabetic retinopathy imminently requiring treatment for preserving or restoring vision.
    Descrição

    diabetic retinopathy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0011884 (Diabetic Retinopathy)
    SNOMED
    4855003
    body mass index(bmi) < 22 and >38 kg/m2 (formula: bmi= weight, kg ÷height, m2)and variation in body weight of >=5% between screening and visit2.
    Descrição

    body mass index

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1305855 (Body mass index)
    SNOMED
    60621009
    LOINC
    LP35925-4

    Similar models

    Eligibility Diabetes Mellitus Non Insulin Dependent Oral Agent Therapy NCT01706211

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    age
    Item
    men or women between 30-80 years of age inclusive at time of enrolment.
    boolean
    C0001779 (UMLS CUI [1])
    non-independent diabetes mellitus
    Item
    patients who had non-independent diabetes mellitus (niddm) defined by the criteria of the national diabetes data group.
    boolean
    C0011849 (UMLS CUI [1])
    sulphonylurea
    Item
    patients who had sulphonylurea therapy for at least 6 months and a constant dose for at least 2 months prior to visit 1.
    boolean
    C0038766 (UMLS CUI [1])
    patients who had fasting plasma glucose <= 15.0 mmol/l at screening. hemoglobin a1c >= 7.5%.
    Item
    patients who had fasting plasma glucose <= 15.0 mmol/l at screening. hemoglobin a1c >= 7.5%.
    boolean
    C0202042 (UMLS CUI [1])
    C0019018 (UMLS CUI [2])
    contraceptive methods
    Item
    female patients must be (1) post-menopausal, i.e. > 6 months without menstrual period, surgically sterile, or (2) using hormonal contraceptives or intrauterine contraceptive devices. female patients who were taking hormonal contraceptives must also use an additional barrier form or intrauterine form of birth control.
    boolean
    C0700589 (UMLS CUI [1])
    written informed consent
    Item
    patients who had given their written informed consent to participate.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    female patients who were pregnant, breast feeding or planning a pregnancy during the course of the study.
    Item
    female patients who were pregnant, breast feeding or planning a pregnancy during the course of the study.
    boolean
    C0032961 (UMLS CUI [1])
    patients who had a fasting plasma glucose > 15.0 mmol/l at screening, or severity of diabetes mellitus requiring administration of insulin, or patients with ketonuria.
    Item
    patients who had a fasting plasma glucose > 15.0 mmol/l at screening, or severity of diabetes mellitus requiring administration of insulin, or patients with ketonuria.
    boolean
    C0202042 (UMLS CUI [1])
    C0021641 (UMLS CUI [2])
    C0162275 (UMLS CUI [3])
    renal or hepatic disease
    Item
    patients who had clinically significant renal or hepatic disease (i.e., patients with serum creatinine > 160 micromol/l (1.8 mg/dl); alt, ast, total bilirubin, gamma gt, or alkaline phosphatase more than 2.5 times the upper limit of the normal laboratory range).
    boolean
    C0201976 (UMLS CUI [1])
    C1287351 (UMLS CUI [2])
    any clinically significant abnormality identified on the screening physical examination, laboratory tests, electrocardiogram which in the judgment of the investigator would preclude safe completion of the study.
    Item
    any clinically significant abnormality identified on the screening physical examination, laboratory tests, electrocardiogram which in the judgment of the investigator would preclude safe completion of the study.
    boolean
    C2348563 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    leukocyte count < 3000/mm3 or platelet count <120,000/mm3
    Item
    patients who had leukocyte count < 3000/mm3 or platelet count <120,000/mm3.
    boolean
    C0023508 (UMLS CUI [1])
    C0032181 (UMLS CUI [2])
    blood pressure
    Item
    systolic blood pressure >180mmhg or diastolic blood pressure >114mmhg while on appropriate hypertensive therapy.
    boolean
    C0005823 (UMLS CUI [1])
    anemia or porphyria
    Item
    significant anemia (hemoglobin < 11 g/dl for males or < 10g/dl for females) or diagnosis of porphyria.
    boolean
    C0002871 (UMLS CUI [1])
    C3463940 (UMLS CUI [2])
    diabetic neuropathy
    Item
    symptomatic diabetic neuropathy of sufficient severity to require treatment for control of symptoms (eg, painful peripheral neuropathy, symptomatic orthostatic hypotension, urinary retention, gastric stasis, pedal ulcers).
    boolean
    C0011882 (UMLS CUI [1])
    diabetic retinopathy
    Item
    diabetic retinopathy imminently requiring treatment for preserving or restoring vision.
    boolean
    C0011884 (UMLS CUI [1])
    body mass index
    Item
    body mass index(bmi) < 22 and >38 kg/m2 (formula: bmi= weight, kg ÷height, m2)and variation in body weight of >=5% between screening and visit2.
    boolean
    C1305855 (UMLS CUI [1])

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