ID

29443

Beschrijving

A Study To Evaluate The Effect Of WELLBUTRIN XL On Intraocular Pressure; ODM derived from: https://clinicaltrials.gov/show/NCT00439868

Link

https://clinicaltrials.gov/show/NCT00439868

Trefwoorden

Versies (1)
  1. 24-03-18 24-03-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

24 maart 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Healthy Subjects NCT00439868

Engels

Eligibility Healthy Subjects NCT00439868

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy males or females.
Beschrijving

Healthy

Datatype

boolean

Alias
UMLS CUI [1]
C3898900
non-smokers
Beschrijving

Non-smoker

Datatype

boolean

Alias
UMLS CUI [1]
C0337672
agree to remain in the clinic for the time defined in the protocol.
Beschrijving

Hospital Stay Agreement

Datatype

boolean

Alias
UMLS CUI [1,1]
C3489408
UMLS CUI [1,2]
C0680240
normal ecg.
Beschrijving

ECG normal

Datatype

boolean

Alias
UMLS CUI [1]
C0522054
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
any serious medical disorder or condition.
Beschrijving

Disease Serious | Condition Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0205404
any history of an endocrine disorder.
Beschrijving

Endocrine System Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0014130
any clinically significant laboratory abnormality.
Beschrijving

Laboratory test result abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C0438215
history of psychiatric illness.
Beschrijving

Mental disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0004936
any history of suicidal attempts or behavior.
Beschrijving

Suicide attempt | Suicidal behavior

Datatype

boolean

Alias
UMLS CUI [1]
C0038663
UMLS CUI [2]
C1760428
risk factors for precipitation of angle closure glaucoma or elevated iop.
Beschrijving

Risk factors Angle Closure Glaucoma | Risk factors Raised intraocular pressure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0017605
UMLS CUI [2,1]
C0035648
UMLS CUI [2,2]
C0234708
inability to refrain from use of contact lenses during the study days, if correction is required.
Beschrijving

Contact Lenses Avoidance Unable | Correction Required

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009836
UMLS CUI [1,2]
C0870186
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C1947976
UMLS CUI [2,2]
C1514873
self-administered beck depression inventory ii scale total score greater than 9, and a suicide question score of greater than zero.
Beschrijving

Beck depression inventory | Suicide intent score scale

Datatype

boolean

Alias
UMLS CUI [1]
C0451022
UMLS CUI [2]
C0560334
current or past history of seizure disorder or brain injury (traumatic or disease-related); or any condition which, in the opinion of the investigator, predisposes to seizure - women having a positive serum hcg pregnancy test at screening, a positive urine pregnancy test before admission to the unit during the in-house periods, who are not willing to use acceptable methods of contraception or who are lactating or planning to become pregnant within the three months following the screening visit.
Beschrijving

Epilepsy | Traumatic Brain Injury | Brain Injury Disease Related | Condition predisposing Seizure | Serum pregnancy test (B-HCG) Positive | Urine pregnancy test positive | Pregnancy Contraceptive methods Unwilling | Breast Feeding | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C0876926
UMLS CUI [3,1]
C0270611
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0439849
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0231203
UMLS CUI [4,3]
C0036572
UMLS CUI [5,1]
C0430060
UMLS CUI [5,2]
C1514241
UMLS CUI [6]
C0430059
UMLS CUI [7,1]
C0032961
UMLS CUI [7,2]
C0700589
UMLS CUI [7,3]
C0558080
UMLS CUI [8]
C0006147
UMLS CUI [9]
C0032992
Terug naar het begin van de pagina

Similar models

Eligibility Healthy Subjects NCT00439868

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Healthy
Item
healthy males or females.
boolean
C3898900 (UMLS CUI [1])
Non-smoker
Item
non-smokers
boolean
C0337672 (UMLS CUI [1])
Hospital Stay Agreement
Item
agree to remain in the clinic for the time defined in the protocol.
boolean
C3489408 (UMLS CUI [1,1])
C0680240 (UMLS CUI [1,2])
ECG normal
Item
normal ecg.
boolean
C0522054 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease Serious | Condition Serious
Item
any serious medical disorder or condition.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0348080 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Endocrine System Disease
Item
any history of an endocrine disorder.
boolean
C0014130 (UMLS CUI [1])
Laboratory test result abnormal
Item
any clinically significant laboratory abnormality.
boolean
C0438215 (UMLS CUI [1])
Mental disorders
Item
history of psychiatric illness.
boolean
C0004936 (UMLS CUI [1])
Suicide attempt | Suicidal behavior
Item
any history of suicidal attempts or behavior.
boolean
C0038663 (UMLS CUI [1])
C1760428 (UMLS CUI [2])
Risk factors Angle Closure Glaucoma | Risk factors Raised intraocular pressure
Item
risk factors for precipitation of angle closure glaucoma or elevated iop.
boolean
C0035648 (UMLS CUI [1,1])
C0017605 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2,1])
C0234708 (UMLS CUI [2,2])
Contact Lenses Avoidance Unable | Correction Required
Item
inability to refrain from use of contact lenses during the study days, if correction is required.
boolean
C0009836 (UMLS CUI [1,1])
C0870186 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1947976 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Beck depression inventory | Suicide intent score scale
Item
self-administered beck depression inventory ii scale total score greater than 9, and a suicide question score of greater than zero.
boolean
C0451022 (UMLS CUI [1])
C0560334 (UMLS CUI [2])
Epilepsy | Traumatic Brain Injury | Brain Injury Disease Related | Condition predisposing Seizure | Serum pregnancy test (B-HCG) Positive | Urine pregnancy test positive | Pregnancy Contraceptive methods Unwilling | Breast Feeding | Pregnancy, Planned
Item
current or past history of seizure disorder or brain injury (traumatic or disease-related); or any condition which, in the opinion of the investigator, predisposes to seizure - women having a positive serum hcg pregnancy test at screening, a positive urine pregnancy test before admission to the unit during the in-house periods, who are not willing to use acceptable methods of contraception or who are lactating or planning to become pregnant within the three months following the screening visit.
boolean
C0014544 (UMLS CUI [1])
C0876926 (UMLS CUI [2])
C0270611 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0231203 (UMLS CUI [4,2])
C0036572 (UMLS CUI [4,3])
C0430060 (UMLS CUI [5,1])
C1514241 (UMLS CUI [5,2])
C0430059 (UMLS CUI [6])
C0032961 (UMLS CUI [7,1])
C0700589 (UMLS CUI [7,2])
C0558080 (UMLS CUI [7,3])
C0006147 (UMLS CUI [8])
C0032992 (UMLS CUI [9])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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