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ID

43931

Description

Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021); ODM derived from: https://clinicaltrials.gov/show/NCT00087516

Lien

https://clinicaltrials.gov/show/NCT00087516

Mots-clés

  1. 30/08/2016 30/08/2016 -
  2. 20/09/2021 20/09/2021 -
Téléchargé le

20 septembre 2021

DOI

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Licence

Creative Commons BY 4.0

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    Eligibility Diabetes Mellitus, Type 2 NCT00087516

    Eligibility Diabetes Mellitus, Type 2 NCT00087516

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    patients with type 2 diabetes mellitus
    Description

    Diabetes Mellitus, Non-Insulin-Dependent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0011860
    patient is not pregnant or breastfeeding
    Description

    Pregnancy | Breast Feeding

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    male or female patient unlikely to conceive
    Description

    Gender Fertility Unlikely

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0079399
    UMLS CUI [1,2]
    C0015895
    UMLS CUI [1,3]
    C0750558
    patient not on an antihyperglycemic drug
    Description

    Hypoglycemic Agents

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0020616
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patient has history of type 1 diabetes mellitus
    Description

    Diabetes Mellitus, Insulin-Dependent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0011854
    patient has history of ketoacidosis
    Description

    Diabetic Ketoacidosis

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0011880
    patient requires insulin within 8 weeks prior to start of study
    Description

    Insulin Patient need for

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0021641
    UMLS CUI [1,2]
    C0686904
    patient on weight loss program and is not in maintenance phase
    Description

    Weight Reduction Program | Maintenance Phase

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C3179079
    UMLS CUI [2,1]
    C0024501
    UMLS CUI [2,2]
    C0205390
    patient taking weight loss medication within 8 weeks prior to start of study
    Description

    Weight-Loss Agents

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0376606
    patient on or likely to require = 14 days or repeated courses of corticosteroids
    Description

    Adrenal Cortex Hormones | Adrenal Cortex Hormones Course Repeated

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001617
    UMLS CUI [2,1]
    C0001617
    UMLS CUI [2,2]
    C0750729
    UMLS CUI [2,3]
    C0205341
    patient taking immunosuppressive/immunomodulating medication
    Description

    Immunosuppressive Agents | immunomodulating agent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021081
    UMLS CUI [2]
    C0005525
    patient taking digoxin or other cardiac medication
    Description

    Digoxin | Cardiac agent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0012265
    UMLS CUI [2]
    C0007220
    patient has undergone surgical general anesthesia within 30 days prior to start of study
    Description

    General Anesthesia Related Operative Surgical Procedure

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0002915
    UMLS CUI [1,2]
    C0439849
    UMLS CUI [1,3]
    C0543467
    patient taking investigational drug within 8 weeks prior to start of study
    Description

    Investigational New Drugs

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    patient is diagnosed with liver disease
    Description

    Liver disease

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0023895
    patient has chronic myopathy, progressive neurological/neuromuscular disorder
    Description

    Myopathy chronic | nervous system disorder Progressive | Neuromuscular Disease Progressive

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0026848
    UMLS CUI [1,2]
    C0205191
    UMLS CUI [2,1]
    C0027765
    UMLS CUI [2,2]
    C0205329
    UMLS CUI [3,1]
    C0027868
    UMLS CUI [3,2]
    C0205329
    patient has with severe cardiac conditions within the last 6 months
    Description

    Heart Diseases Severe

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0018799
    UMLS CUI [1,2]
    C0205082
    patient is human immunodeficiency virus (hiv) positive
    Description

    HIV Seropositivity

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    patient has hematological disorder
    Description

    Hematological Disease

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0018939
    patient has history of malignancy
    Description

    Malignant Neoplasms

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    patient has history of alcohol or drug abuse within the past 3 years
    Description

    Substance Use Disorders

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0038586

    Similar models

    Eligibility Diabetes Mellitus, Type 2 NCT00087516

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Diabetes Mellitus, Non-Insulin-Dependent
    Item
    patients with type 2 diabetes mellitus
    boolean
    C0011860 (UMLS CUI [1])
    Pregnancy | Breast Feeding
    Item
    patient is not pregnant or breastfeeding
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Gender Fertility Unlikely
    Item
    male or female patient unlikely to conceive
    boolean
    C0079399 (UMLS CUI [1,1])
    C0015895 (UMLS CUI [1,2])
    C0750558 (UMLS CUI [1,3])
    Hypoglycemic Agents
    Item
    patient not on an antihyperglycemic drug
    boolean
    C0020616 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Diabetes Mellitus, Insulin-Dependent
    Item
    patient has history of type 1 diabetes mellitus
    boolean
    C0011854 (UMLS CUI [1])
    Diabetic Ketoacidosis
    Item
    patient has history of ketoacidosis
    boolean
    C0011880 (UMLS CUI [1])
    Insulin Patient need for
    Item
    patient requires insulin within 8 weeks prior to start of study
    boolean
    C0021641 (UMLS CUI [1,1])
    C0686904 (UMLS CUI [1,2])
    Weight Reduction Program | Maintenance Phase
    Item
    patient on weight loss program and is not in maintenance phase
    boolean
    C3179079 (UMLS CUI [1])
    C0024501 (UMLS CUI [2,1])
    C0205390 (UMLS CUI [2,2])
    Weight-Loss Agents
    Item
    patient taking weight loss medication within 8 weeks prior to start of study
    boolean
    C0376606 (UMLS CUI [1])
    Adrenal Cortex Hormones | Adrenal Cortex Hormones Course Repeated
    Item
    patient on or likely to require = 14 days or repeated courses of corticosteroids
    boolean
    C0001617 (UMLS CUI [1])
    C0001617 (UMLS CUI [2,1])
    C0750729 (UMLS CUI [2,2])
    C0205341 (UMLS CUI [2,3])
    Immunosuppressive Agents | immunomodulating agent
    Item
    patient taking immunosuppressive/immunomodulating medication
    boolean
    C0021081 (UMLS CUI [1])
    C0005525 (UMLS CUI [2])
    Digoxin | Cardiac agent
    Item
    patient taking digoxin or other cardiac medication
    boolean
    C0012265 (UMLS CUI [1])
    C0007220 (UMLS CUI [2])
    General Anesthesia Related Operative Surgical Procedure
    Item
    patient has undergone surgical general anesthesia within 30 days prior to start of study
    boolean
    C0002915 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    C0543467 (UMLS CUI [1,3])
    Investigational New Drugs
    Item
    patient taking investigational drug within 8 weeks prior to start of study
    boolean
    C0013230 (UMLS CUI [1])
    Liver disease
    Item
    patient is diagnosed with liver disease
    boolean
    C0023895 (UMLS CUI [1])
    Myopathy chronic | nervous system disorder Progressive | Neuromuscular Disease Progressive
    Item
    patient has chronic myopathy, progressive neurological/neuromuscular disorder
    boolean
    C0026848 (UMLS CUI [1,1])
    C0205191 (UMLS CUI [1,2])
    C0027765 (UMLS CUI [2,1])
    C0205329 (UMLS CUI [2,2])
    C0027868 (UMLS CUI [3,1])
    C0205329 (UMLS CUI [3,2])
    Heart Diseases Severe
    Item
    patient has with severe cardiac conditions within the last 6 months
    boolean
    C0018799 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    HIV Seropositivity
    Item
    patient is human immunodeficiency virus (hiv) positive
    boolean
    C0019699 (UMLS CUI [1])
    Hematological Disease
    Item
    patient has hematological disorder
    boolean
    C0018939 (UMLS CUI [1])
    Malignant Neoplasms
    Item
    patient has history of malignancy
    boolean
    C0006826 (UMLS CUI [1])
    Substance Use Disorders
    Item
    patient has history of alcohol or drug abuse within the past 3 years
    boolean
    C0038586 (UMLS CUI [1])

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