ID

43795

Descripción

Effect on the Electrocardiographic QT Interval Corrected for Heart Rate (QTc) in Healthy Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00979316

Link

https://clinicaltrials.gov/show/NCT00979316

Palabras clave

  1. 1/5/16 1/5/16 -
  2. 20/9/21 20/9/21 -
Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Alzheimer Disease NCT00979316

Eligibility Alzheimer Disease NCT00979316

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
body mass index (bmi) of 18 to 32 kg/m², inclusive.
Descripción

body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) and men, ages 18 to 55
Descripción

contraception status postmenopausal

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0420837
UMLS CUI [1,2]
C0232970
healthy subjects
Descripción

health status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018759
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of cardiac arrhythmias or palpitations associated with presyncope or syncope, or history of unexplained syncope
Descripción

cardiac arrhythmias; presyncope; syncope

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003811
UMLS CUI [2]
C0700200
UMLS CUI [3]
C0039070
sexually active fertile men not using effective birth control (double barrier) if their partners are wocbp
Descripción

men sexually active fertile; birth control

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025266
UMLS CUI [1,2]
C0036899
UMLS CUI [1,3]
C2703065
women who are pregnant or breastfeeding
Descripción

pregnancy; lactating

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of allergy or intolerance to moxifloxacin or any member of the quinolone class of antimicrobial agents
Descripción

hypersensitivity moxifloxacin Microbicides

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0536495
UMLS CUI [1,3]
C1136254
history of hypokalemia, history or family history of prolonged qt interval, or family history of sudden cardiac death at a young age
Descripción

hypokalemia; prolonged qt interval; sudden cardiac death

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020621
UMLS CUI [2]
C0151878
UMLS CUI [3]
C0085298
any clinically significant ecg abnormality
Descripción

ecg abnormality

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0522055
history of seizure disorders
Descripción

seizure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036572
history of drowning survival
Descripción

drowning

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013142

Similar models

Eligibility Alzheimer Disease NCT00979316

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
body mass index
Item
body mass index (bmi) of 18 to 32 kg/m², inclusive.
boolean
C1305855 (UMLS CUI [1])
contraception status postmenopausal
Item
women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) and men, ages 18 to 55
boolean
C0420837 (UMLS CUI [1,1])
C0232970 (UMLS CUI [1,2])
health status
Item
healthy subjects
boolean
C0018759 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
cardiac arrhythmias; presyncope; syncope
Item
history of cardiac arrhythmias or palpitations associated with presyncope or syncope, or history of unexplained syncope
boolean
C0003811 (UMLS CUI [1])
C0700200 (UMLS CUI [2])
C0039070 (UMLS CUI [3])
men sexually active fertile; birth control
Item
sexually active fertile men not using effective birth control (double barrier) if their partners are wocbp
boolean
C0025266 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C2703065 (UMLS CUI [1,3])
pregnancy; lactating
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
hypersensitivity moxifloxacin Microbicides
Item
history of allergy or intolerance to moxifloxacin or any member of the quinolone class of antimicrobial agents
boolean
C0020517 (UMLS CUI [1,1])
C0536495 (UMLS CUI [1,2])
C1136254 (UMLS CUI [1,3])
hypokalemia; prolonged qt interval; sudden cardiac death
Item
history of hypokalemia, history or family history of prolonged qt interval, or family history of sudden cardiac death at a young age
boolean
C0020621 (UMLS CUI [1])
C0151878 (UMLS CUI [2])
C0085298 (UMLS CUI [3])
ecg abnormality
Item
any clinically significant ecg abnormality
boolean
C0522055 (UMLS CUI [1])
seizure
Item
history of seizure disorders
boolean
C0036572 (UMLS CUI [1])
drowning
Item
history of drowning survival
boolean
C0013142 (UMLS CUI [1])

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