ID

28379

Beschrijving

Phase 2b Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency; ODM derived from: https://clinicaltrials.gov/show/NCT00709865

Link

https://clinicaltrials.gov/show/NCT00709865

Trefwoorden

  1. 09-01-18 09-01-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

9 januari 2018

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Congestive Heart Failure NCT00709865

Eligibility Congestive Heart Failure NCT00709865

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
previous diagnosis of heart failure.
Beschrijving

Heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0018801
must have adhf, requiring hospitalization, with clinical evidence for volume overload
Beschrijving

ADHF | Hospitalization Required | Volume overload

Datatype

boolean

Alias
UMLS CUI [1]
C1609524
UMLS CUI [2]
C1708385
UMLS CUI [3]
C0546817
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of an allergic reaction to any xanthine-containing substance.
Beschrijving

Xanthine allergy

Datatype

boolean

Alias
UMLS CUI [1]
C0571073
history of seizure
Beschrijving

Epilepsy

Datatype

boolean

Alias
UMLS CUI [1]
C0014544
history of stroke
Beschrijving

Cerebrovascular accident

Datatype

boolean

Alias
UMLS CUI [1]
C0038454
myocardial infarction
Beschrijving

Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
uncorrected hemodynamically significant primary valvular disease or known obstructive or restrictive cardiomyopathy.
Beschrijving

Primary valvular heart disease Hemodynamic Significant uncorrected | Obstructive Cardiomyopathy | Restrictive cardiomyopathy

Datatype

boolean

Alias
UMLS CUI [1,1]
C2064629
UMLS CUI [1,2]
C0019010
UMLS CUI [1,3]
C0750502
UMLS CUI [1,4]
C4072785
UMLS CUI [2]
C0007194
UMLS CUI [3]
C0007196
serious systemic infection
Beschrijving

Sepsis Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C0205404
major surgical procedures within 30 days
Beschrijving

Major surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0679637
acute coronary syndrome
Beschrijving

Acute Coronary Syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0948089
cardiogenic shock
Beschrijving

Shock, Cardiogenic

Datatype

boolean

Alias
UMLS CUI [1]
C0036980
baseline body weight >150 kg
Beschrijving

Body Weight

Datatype

boolean

Alias
UMLS CUI [1]
C0005910
participation in any other investigational study of drugs or devices within 30 days prior to screening
Beschrijving

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
nursing mothers, pregnant women, or women planning on becoming pregnant during the study
Beschrijving

Breast Feeding | Pregnancy | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0032992
presence of any clinically significant condition that might interfere with optimal safe participation in this study
Beschrijving

Medical condition Interferes with Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568

Similar models

Eligibility Congestive Heart Failure NCT00709865

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure
Item
previous diagnosis of heart failure.
boolean
C0018801 (UMLS CUI [1])
ADHF | Hospitalization Required | Volume overload
Item
must have adhf, requiring hospitalization, with clinical evidence for volume overload
boolean
C1609524 (UMLS CUI [1])
C1708385 (UMLS CUI [2])
C0546817 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Xanthine allergy
Item
history of an allergic reaction to any xanthine-containing substance.
boolean
C0571073 (UMLS CUI [1])
Epilepsy
Item
history of seizure
boolean
C0014544 (UMLS CUI [1])
Cerebrovascular accident
Item
history of stroke
boolean
C0038454 (UMLS CUI [1])
Myocardial Infarction
Item
myocardial infarction
boolean
C0027051 (UMLS CUI [1])
Primary valvular heart disease Hemodynamic Significant uncorrected | Obstructive Cardiomyopathy | Restrictive cardiomyopathy
Item
uncorrected hemodynamically significant primary valvular disease or known obstructive or restrictive cardiomyopathy.
boolean
C2064629 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C4072785 (UMLS CUI [1,4])
C0007194 (UMLS CUI [2])
C0007196 (UMLS CUI [3])
Sepsis Serious
Item
serious systemic infection
boolean
C0243026 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Major surgery
Item
major surgical procedures within 30 days
boolean
C0679637 (UMLS CUI [1])
Acute Coronary Syndrome
Item
acute coronary syndrome
boolean
C0948089 (UMLS CUI [1])
Shock, Cardiogenic
Item
cardiogenic shock
boolean
C0036980 (UMLS CUI [1])
Body Weight
Item
baseline body weight >150 kg
boolean
C0005910 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
participation in any other investigational study of drugs or devices within 30 days prior to screening
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Breast Feeding | Pregnancy | Pregnancy, Planned
Item
nursing mothers, pregnant women, or women planning on becoming pregnant during the study
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Medical condition Interferes with Study Subject Participation Status
Item
presence of any clinically significant condition that might interfere with optimal safe participation in this study
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])

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