ID

32360

Descrição

Treatment of Outpatients With Severe Asthma and Moderate or Severe Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00621946

Link

https://clinicaltrials.gov/show/NCT00621946

Palavras-chave

Versões (1)
  1. 27/10/2018 27/10/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

27 de outubro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Severe Asthma NCT00621946

Inglês

Eligibility Severe Asthma NCT00621946

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
current ham-d score of ≥ 20
Descrição

Hamilton rating scale for depression

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0451203
patients with severe asthma (defined as asthma requiring three or more course of oral corticosteroids in the past year).
Descrição

Severe asthma | Course Quantity Adrenal Cortex Hormones Oral

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0581126
UMLS CUI [2,1]
C0750729
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0001617
UMLS CUI [2,4]
C1527415
no changes in asthma medications, oral corticosteroid use, or treatment for respiratory tract infections in the past week
Descrição

Asthma Pharmaceutical Preparations unchanged | Adrenal Cortex Hormones Oral unchanged | Treatment unchanged Respiratory Tract Infections

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0442739
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0442739
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0442739
UMLS CUI [3,3]
C0035243
needs to have taken ≥ 3 courses of oral corticosteroids, for asthma, in the past 12 months.
Descrição

Course Quantity Adrenal Cortex Hormones Oral | Asthma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0001617
UMLS CUI [1,4]
C1527415
UMLS CUI [2]
C0004096
both male and female
Descrição

Gender

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
english- or spanish-speaking
Descrição

Able to speak English Language | Able to speak Spanish Language

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0564215
UMLS CUI [2,2]
C0037750
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
current substance or alcohol abuse/dependence
Descrição

Substance Use Disorders | Substance Dependence

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
mdd with psychotic features (delusions, hallucinations, disorganized thought processes)
Descrição

Major depression with psychotic features | Delusions | Hallucinations | Disorganized thinking

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4518519
UMLS CUI [2]
C0011253
UMLS CUI [3]
C0018524
UMLS CUI [4]
C1855263
bipolar disorder
Descrição

Bipolar Disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005586
schizophrenia or schizoaffective disorder
Descrição

Schizophrenia | Schizoaffective Disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
substance-induced mood disorder and mood disorder secondary to a general medical condition
Descrição

Substance-induced mood disorder | Mood Disorder Secondary to Medical condition General

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3267135
UMLS CUI [2,1]
C0525045
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C3843040
UMLS CUI [2,4]
C0205246
mental retardation or other severe cognitive impairment
Descrição

Mental Retardation | Severe cognitive impairment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0025362
UMLS CUI [2]
C3554639
prison or jail inmates
Descrição

Prisoners

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0033167
pregnant or nursing women or women of childbearing age who will not use the university of texas southwestern medical center - institutional review board (utsw irb) approved methods of birth control or abstinence during the study
Descrição

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Sexual Abstinence Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0036899
UMLS CUI [4,3]
C0558080
treatment-resistant depressed persons defined as having failed two adequate trials of antidepressants
Descrição

Persons Depressed Unresponsive to Treatment | Antidepressive Agents Quantity failed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027361
UMLS CUI [1,2]
C0344315
UMLS CUI [1,3]
C0205269
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0231175
current antipsychotic or antidepressant therapy or psychotherapy
Descrição

Antipsychotic drug therapy | Antidepressant therapy | Psychotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1319421
UMLS CUI [2]
C1096649
UMLS CUI [3]
C0033968
initiation of other psychotropic medications or psychotherapy within past 2 weeks (e.g., anxiolytics, hypnotics)
Descrição

Psychotropic Drugs | Psychotherapy | Anti-Anxiety Agents | Hypnotics

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0033978
UMLS CUI [2]
C0033968
UMLS CUI [3]
C0040616
UMLS CUI [4]
C0020591
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Similar models

Eligibility Severe Asthma NCT00621946

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Hamilton rating scale for depression
Item
current ham-d score of ≥ 20
boolean
C0451203 (UMLS CUI [1])
Severe asthma | Course Quantity Adrenal Cortex Hormones Oral
Item
patients with severe asthma (defined as asthma requiring three or more course of oral corticosteroids in the past year).
boolean
C0581126 (UMLS CUI [1])
C0750729 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0001617 (UMLS CUI [2,3])
C1527415 (UMLS CUI [2,4])
Asthma Pharmaceutical Preparations unchanged | Adrenal Cortex Hormones Oral unchanged | Treatment unchanged Respiratory Tract Infections
Item
no changes in asthma medications, oral corticosteroid use, or treatment for respiratory tract infections in the past week
boolean
C0004096 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0442739 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C0442739 (UMLS CUI [3,2])
C0035243 (UMLS CUI [3,3])
Course Quantity Adrenal Cortex Hormones Oral | Asthma
Item
needs to have taken ≥ 3 courses of oral corticosteroids, for asthma, in the past 12 months.
boolean
C0750729 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0001617 (UMLS CUI [1,3])
C1527415 (UMLS CUI [1,4])
C0004096 (UMLS CUI [2])
Gender
Item
both male and female
boolean
C0079399 (UMLS CUI [1])
Able to speak English Language | Able to speak Spanish Language
Item
english- or spanish-speaking
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0564215 (UMLS CUI [2,1])
C0037750 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Substance Use Disorders | Substance Dependence
Item
current substance or alcohol abuse/dependence
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Major depression with psychotic features | Delusions | Hallucinations | Disorganized thinking
Item
mdd with psychotic features (delusions, hallucinations, disorganized thought processes)
boolean
C4518519 (UMLS CUI [1])
C0011253 (UMLS CUI [2])
C0018524 (UMLS CUI [3])
C1855263 (UMLS CUI [4])
Bipolar Disorder
Item
bipolar disorder
boolean
C0005586 (UMLS CUI [1])
Schizophrenia | Schizoaffective Disorder
Item
schizophrenia or schizoaffective disorder
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
Substance-induced mood disorder | Mood Disorder Secondary to Medical condition General
Item
substance-induced mood disorder and mood disorder secondary to a general medical condition
boolean
C3267135 (UMLS CUI [1])
C0525045 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C3843040 (UMLS CUI [2,3])
C0205246 (UMLS CUI [2,4])
Mental Retardation | Severe cognitive impairment
Item
mental retardation or other severe cognitive impairment
boolean
C0025362 (UMLS CUI [1])
C3554639 (UMLS CUI [2])
Prisoners
Item
prison or jail inmates
boolean
C0033167 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Sexual Abstinence Unwilling
Item
pregnant or nursing women or women of childbearing age who will not use the university of texas southwestern medical center - institutional review board (utsw irb) approved methods of birth control or abstinence during the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0036899 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Persons Depressed Unresponsive to Treatment | Antidepressive Agents Quantity failed
Item
treatment-resistant depressed persons defined as having failed two adequate trials of antidepressants
boolean
C0027361 (UMLS CUI [1,1])
C0344315 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
C0003289 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
Antipsychotic drug therapy | Antidepressant therapy | Psychotherapy
Item
current antipsychotic or antidepressant therapy or psychotherapy
boolean
C1319421 (UMLS CUI [1])
C1096649 (UMLS CUI [2])
C0033968 (UMLS CUI [3])
Psychotropic Drugs | Psychotherapy | Anti-Anxiety Agents | Hypnotics
Item
initiation of other psychotropic medications or psychotherapy within past 2 weeks (e.g., anxiolytics, hypnotics)
boolean
C0033978 (UMLS CUI [1])
C0033968 (UMLS CUI [2])
C0040616 (UMLS CUI [3])
C0020591 (UMLS CUI [4])
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