ID

13042

Descripción

Observational Study to Assess a 6-months Treatment With Gladem; ODM derived from: https://clinicaltrials.gov/show/NCT02231268

Link

https://clinicaltrials.gov/show/NCT02231268

Palabras clave

  1. 12/1/16 12/1/16 -
Subido en

12 de enero de 2016

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Depressive Disorder NCT02231268

Eligibility Depressive Disorder NCT02231268

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women at least 18 years old
Descripción

gender, age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
de novo prescription of gladem
Descripción

gladem

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1564118
treatment with gladem intended for at least 6 months
Descripción

gladem

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1564118
depressive disorders
Descripción

depressive disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011581
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
known hypersensitivity against sertraline
Descripción

hypersensitivity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0074393
concomitant treatment with monoamine oxidase (mao)-inhibitors, selegiline, moclobemide (washout for at least 14 days necessary)
Descripción

concomitant treatment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707479
concomitant treatment with other serotoninergic substances like tryptophan or fenfluramine
Descripción

concomitant treatment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707479
instable epilepsy
Descripción

epilepsy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0014544
UMLS CUI [1,2]
C0443343
according to product information (october 1998) gladem prescription was possible with precautions in the following cases:
Descripción

precaution

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1882442
patients with stable epilepsy
Descripción

epilepsy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0014544
UMLS CUI [1,2]
C0205360
patients with restricted liver functions
Descripción

liver dysfunction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086565
suicidal patients
Descripción

suicidal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0438696
patients in emotional state and marked sleeping disorders
Descripción

sleeping disorders, emotional state

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0037317
UMLS CUI [2]
C0935620
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.
Descripción

pregnancy, lactation, contraception

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589

Similar models

Eligibility Depressive Disorder NCT02231268

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
gender, age
Item
men and women at least 18 years old
boolean
C0079399 (UMLS CUI [1])
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])
Item Group
C0680251 (UMLS CUI)
hypersensitivity
Item
known hypersensitivity against sertraline
boolean
C0020517 (UMLS CUI [1,1])
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])
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])
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])
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])

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