ID

29443

Beschreibung

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

Stichworte

Versionen (1)
  1. 24.03.18 24.03.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

24. März 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Healthy Subjects NCT00439868

Englisch

Eligibility Healthy Subjects NCT00439868

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy males or females.
Beschreibung

Healthy

Datentyp

boolean

Alias
UMLS CUI [1]
C3898900
non-smokers
Beschreibung

Non-smoker

Datentyp

boolean

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

Hospital Stay Agreement

Datentyp

boolean

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

ECG normal

Datentyp

boolean

Alias
UMLS CUI [1]
C0522054
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Disease Serious | Condition Serious

Datentyp

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.
Beschreibung

Endocrine System Disease

Datentyp

boolean

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

Laboratory test result abnormal

Datentyp

boolean

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

Mental disorders

Datentyp

boolean

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

Suicide attempt | Suicidal behavior

Datentyp

boolean

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

Risk factors Angle Closure Glaucoma | Risk factors Raised intraocular pressure

Datentyp

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.
Beschreibung

Contact Lenses Avoidance Unable | Correction Required

Datentyp

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.
Beschreibung

Beck depression inventory | Suicide intent score scale

Datentyp

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.
Beschreibung

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

Datentyp

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
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Healthy Subjects NCT00439868

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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