0 Avaliações

ID

43874

Descrição

Lilly's Emotional and Physical Symptoms of Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00479453

Link

https://clinicaltrials.gov/show/NCT00479453

Palavras-chave

  1. 19/10/2016 19/10/2016 -
  2. 20/09/2021 20/09/2021 -
Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0

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    Eligibility Major Depressive Disorder NCT00479453

    Eligibility Major Depressive Disorder NCT00479453

    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    meet criteria for major depressive disorder according to the dsm-iv diagnostic criteria
    Descrição

    Major Depressive Disorder

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1269683 (Major Depressive Disorder)
    SNOMED
    370143000
    outpatients at lease 18 years of age
    Descrição

    Outpatients | Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0029921 (Outpatients)
    SNOMED
    373864002
    UMLS CUI [2]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    sign the informed consent
    Descrição

    Informed Consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    all females must test negative for a urine pregnancy test at visit 1. females of child bearing potential must agree to utilize medically acceptable and reliable means of birth control
    Descrição

    Gender Urine pregnancy test negative | Childbearing Potential Contraceptive methods

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    UMLS CUI [1,2]
    C0430057 (Urine pregnancy test negative)
    SNOMED
    167254001
    UMLS CUI [2,1]
    C3831118 (Childbearing Potential)
    UMLS CUI [2,2]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    have a level of understanding sufficient to communicate with the investigator and are able to complete all patient self-rated scales in the study
    Descrição

    Able to communicate Investigator | Depression self rating scale Completion Ability

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2364293 (Able to communicate)
    SNOMED
    288575003
    UMLS CUI [1,2]
    C0035173 (Research Personnel)
    SNOMED
    769038007
    LOINC
    LA23773-7
    UMLS CUI [2,1]
    C0451108 (Depression self rating scale)
    SNOMED
    273403004
    UMLS CUI [2,2]
    C0205197 (Complete)
    SNOMED
    255594003
    LOINC
    LA13937-0
    UMLS CUI [2,3]
    C0085732 (Ability)
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    are investigator site personnel directly affiliated with the study or immediate family
    Descrição

    Research Personnel Affiliated Clinical Trial Family | Research Personnel Affiliated Immediate family

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0035173 (Research Personnel)
    SNOMED
    769038007
    LOINC
    LA23773-7
    UMLS CUI [1,2]
    C1510826 (Affiliated)
    UMLS CUI [1,3]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,4]
    C0015576 (Family)
    SNOMED
    35359004
    LOINC
    LP76012-1
    UMLS CUI [2,1]
    C0035173 (Research Personnel)
    SNOMED
    769038007
    LOINC
    LA23773-7
    UMLS CUI [2,2]
    C1510826 (Affiliated)
    UMLS CUI [2,3]
    C2371717 (Immediate family)
    are employed by eli lilly and company
    Descrição

    Employee Eli Lilly & Co Ltd

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0599987 (Employee)
    SNOMED
    224528001
    UMLS CUI [1,2]
    C0470942 (Eli Lilly & Co Ltd)
    have received treatment within the last 30 days or are currently enrolled in a study with a drug that has not received regulatory approval for any indication at time of study entry
    Descrição

    Study Subject Participation Status | Therapeutic procedure Drug Approval Lacking

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [2,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [2,2]
    C0162696 (Drug Approval)
    UMLS CUI [2,3]
    C0332268 (Lacking)
    SNOMED
    41277001
    current substance dependence, excluding nicotine and caffeine
    Descrição

    Substance Dependence | Nicotine Dependence | Caffeine dependence

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0038580 (Substance Dependence)
    UMLS CUI [2]
    C0028043 (Nicotine Dependence)
    SNOMED
    56294008
    UMLS CUI [3]
    C1386553 (Caffeine dependence)
    SNOMED
    428219007
    treatment with a monoamine oxidase inhibitor within 14 days prior to visit 1 or potential need to use an maoi within 5 days after discontinuation of study drug
    Descrição

    Monoamine Oxidase Inhibitors

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0026457 (Monoamine Oxidase Inhibitors)
    SNOMED
    373281001
    acute liver injury or severe (child-pugh class c) cirrhosis
    Descrição

    Injury of liver | Liver Cirrhosis Severe | Child-Pugh Classification

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0160390 (Injury of liver)
    SNOMED
    39400004
    UMLS CUI [2,1]
    C0023890 (Liver Cirrhosis)
    SNOMED
    19943007
    UMLS CUI [2,2]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    UMLS CUI [3]
    C4050412 (Child-Pugh Clinical Classification)
    SNOMED
    3191000175106

    Similar models

    Eligibility Major Depressive Disorder NCT00479453

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Major Depressive Disorder
    Item
    meet criteria for major depressive disorder according to the dsm-iv diagnostic criteria
    boolean
    C1269683 (UMLS CUI [1])
    Outpatients | Age
    Item
    outpatients at lease 18 years of age
    boolean
    C0029921 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    Informed Consent
    Item
    sign the informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Gender Urine pregnancy test negative | Childbearing Potential Contraceptive methods
    Item
    all females must test negative for a urine pregnancy test at visit 1. females of child bearing potential must agree to utilize medically acceptable and reliable means of birth control
    boolean
    C0079399 (UMLS CUI [1,1])
    C0430057 (UMLS CUI [1,2])
    C3831118 (UMLS CUI [2,1])
    C0700589 (UMLS CUI [2,2])
    Able to communicate Investigator | Depression self rating scale Completion Ability
    Item
    have a level of understanding sufficient to communicate with the investigator and are able to complete all patient self-rated scales in the study
    boolean
    C2364293 (UMLS CUI [1,1])
    C0035173 (UMLS CUI [1,2])
    C0451108 (UMLS CUI [2,1])
    C0205197 (UMLS CUI [2,2])
    C0085732 (UMLS CUI [2,3])
    Item Group
    C0680251 (UMLS CUI)
    Research Personnel Affiliated Clinical Trial Family | Research Personnel Affiliated Immediate family
    Item
    are investigator site personnel directly affiliated with the study or immediate family
    boolean
    C0035173 (UMLS CUI [1,1])
    C1510826 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    C0015576 (UMLS CUI [1,4])
    C0035173 (UMLS CUI [2,1])
    C1510826 (UMLS CUI [2,2])
    C2371717 (UMLS CUI [2,3])
    Employee Eli Lilly & Co Ltd
    Item
    are employed by eli lilly and company
    boolean
    C0599987 (UMLS CUI [1,1])
    C0470942 (UMLS CUI [1,2])
    Study Subject Participation Status | Therapeutic procedure Drug Approval Lacking
    Item
    have received treatment within the last 30 days or are currently enrolled in a study with a drug that has not received regulatory approval for any indication at time of study entry
    boolean
    C2348568 (UMLS CUI [1])
    C0087111 (UMLS CUI [2,1])
    C0162696 (UMLS CUI [2,2])
    C0332268 (UMLS CUI [2,3])
    Substance Dependence | Nicotine Dependence | Caffeine dependence
    Item
    current substance dependence, excluding nicotine and caffeine
    boolean
    C0038580 (UMLS CUI [1])
    C0028043 (UMLS CUI [2])
    C1386553 (UMLS CUI [3])
    Monoamine Oxidase Inhibitors
    Item
    treatment with a monoamine oxidase inhibitor within 14 days prior to visit 1 or potential need to use an maoi within 5 days after discontinuation of study drug
    boolean
    C0026457 (UMLS CUI [1])
    Injury of liver | Liver Cirrhosis Severe | Child-Pugh Classification
    Item
    acute liver injury or severe (child-pugh class c) cirrhosis
    boolean
    C0160390 (UMLS CUI [1])
    C0023890 (UMLS CUI [2,1])
    C0205082 (UMLS CUI [2,2])
    C4050412 (UMLS CUI [3])

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