Informações:
Falhas:
ID
13042
Descrição
Observational Study to Assess a 6-months Treatment With Gladem; ODM derived from: https://clinicaltrials.gov/show/NCT02231268
Link
https://clinicaltrials.gov/show/NCT02231268
Palavras-chave
Versões (1)
- 12/01/2016 12/01/2016 -
Transferido a
12 de janeiro de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Depressive Disorder NCT02231268
Eligibility Depressive Disorder NCT02231268
- StudyEvent: Eligibility
Similar models
Eligibility Depressive Disorder NCT02231268
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
gender, age
Item
men and women at least 18 years old
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])
gladem
Item
de novo prescription of gladem
boolean
C1564118 (UMLS CUI [1])
gladem
Item
treatment with gladem intended for at least 6 months
boolean
C1564118 (UMLS CUI [1])
depressive disorders
Item
depressive disorders
boolean
C0011581 (UMLS CUI [1])
hypersensitivity
Item
known hypersensitivity against sertraline
boolean
C0020517 (UMLS CUI [1,1])
C0074393 (UMLS CUI [1,2])
C0074393 (UMLS CUI [1,2])
concomitant treatment
Item
concomitant treatment with monoamine oxidase (mao)-inhibitors, selegiline, moclobemide (washout for at least 14 days necessary)
boolean
C1707479 (UMLS CUI [1])
concomitant treatment
Item
concomitant treatment with other serotoninergic substances like tryptophan or fenfluramine
boolean
C1707479 (UMLS CUI [1])
epilepsy
Item
instable epilepsy
boolean
C0014544 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,2])
precaution
Item
according to product information (october 1998) gladem prescription was possible with precautions in the following cases:
boolean
C1882442 (UMLS CUI [1])
epilepsy
Item
patients with stable epilepsy
boolean
C0014544 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,2])
liver dysfunction
Item
patients with restricted liver functions
boolean
C0086565 (UMLS CUI [1])
suicidal
Item
suicidal patients
boolean
C0438696 (UMLS CUI [1])
sleeping disorders, emotional state
Item
patients in emotional state and marked sleeping disorders
boolean
C0037317 (UMLS CUI [1])
C0935620 (UMLS CUI [2])
C0935620 (UMLS CUI [2])
pregnancy, lactation, contraception
Item
according to product information (october 1998) gladem should only be prescribed during pregnancy and lactation period, if the expected benefit was greater than the risk. women of childbearing age should use gladem only in combination with sufficient contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])