ID

29443

Descrição

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

Palavras-chave

Versões (1)
  1. 24/03/2018 24/03/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

24 de março de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Healthy Subjects NCT00439868

Inglês

Eligibility Healthy Subjects NCT00439868

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy males or females.
Descrição

Healthy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3898900
non-smokers
Descrição

Non-smoker

Tipo de dados

boolean

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

Hospital Stay Agreement

Tipo de dados

boolean

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

ECG normal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0522054
Exclusion Criteria
Descrição

Exclusion Criteria

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

Disease Serious | Condition Serious

Tipo de dados

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.
Descrição

Endocrine System Disease

Tipo de dados

boolean

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

Laboratory test result abnormal

Tipo de dados

boolean

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

Mental disorders

Tipo de dados

boolean

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

Suicide attempt | Suicidal behavior

Tipo de dados

boolean

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

Risk factors Angle Closure Glaucoma | Risk factors Raised intraocular pressure

Tipo de dados

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.
Descrição

Contact Lenses Avoidance Unable | Correction Required

Tipo de dados

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.
Descrição

Beck depression inventory | Suicide intent score scale

Tipo de dados

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.
Descrição

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

Tipo de dados

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
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Similar models

Eligibility Healthy Subjects NCT00439868

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
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