ID

13042

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02231268

Nyckelord

  1. 2016-01-12 2016-01-12 -
Uppladdad den

12 januari 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Depressive Disorder NCT02231268

Eligibility Depressive Disorder NCT02231268

Inclusion Criteria
Beskrivning

Inclusion Criteria

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

gender, age

Datatyp

boolean

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

gladem

Datatyp

boolean

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

gladem

Datatyp

boolean

Alias
UMLS CUI [1]
C1564118
depressive disorders
Beskrivning

depressive disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0011581
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
known hypersensitivity against sertraline
Beskrivning

hypersensitivity

Datatyp

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)
Beskrivning

concomitant treatment

Datatyp

boolean

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

concomitant treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C1707479
instable epilepsy
Beskrivning

epilepsy

Datatyp

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:
Beskrivning

precaution

Datatyp

boolean

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

epilepsy

Datatyp

boolean

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

liver dysfunction

Datatyp

boolean

Alias
UMLS CUI [1]
C0086565
suicidal patients
Beskrivning

suicidal

Datatyp

boolean

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

sleeping disorders, emotional state

Datatyp

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.
Beskrivning

pregnancy, lactation, contraception

Datatyp

boolean

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

Similar models

Eligibility Depressive Disorder NCT02231268

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial