ID

17452

Beskrivning

Dose Escalation Study of KW-3902 on Diuresis in Subjects With Congestive Heart Failure (CHF).; ODM derived from: https://clinicaltrials.gov/show/NCT00159627

Länk

https://clinicaltrials.gov/show/NCT00159627

Nyckelord

  1. 2016-09-15 2016-09-15 -
Uppladdad den

15 september 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Heart Failure, Congestive NCT00159627

Eligibility Heart Failure, Congestive NCT00159627

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
history of chf for greater than 3 months,
Beskrivning

Congestive heart failure disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0872146
receiving oral/iv diuretic therapy
Beskrivning

Diuretic therapy Oral | Diuretic therapy Intravenous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0948575
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0948575
UMLS CUI [2,2]
C1522726
hospitalized for therapy for hf and edema that has not responded to diuretic therapy.
Beskrivning

Hospitalization Therapeutic procedure Heart failure | Hospitalization Therapeutic procedure Edema | Diuretic therapy Unresponsive to Treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0018801
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0013604
UMLS CUI [3,1]
C0948575
UMLS CUI [3,2]
C0205269
signs and symptoms of ongoing volume overload
Beskrivning

Fluid overload Continuous Signs and Symptoms

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0546817
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C0037088
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
myocardial infarction in past 14 days
Beskrivning

Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
clinical evidence of acute coronary syndrome causing worsening of hf,
Beskrivning

Acute Coronary Syndrome Evidence Clinical | Acute Coronary Syndrome Causing Worsening Heart failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0948089
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0205210
UMLS CUI [2,1]
C0948089
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0332271
UMLS CUI [2,4]
C0018801
pregnant or breast-feeding,
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
severe, uncorrected primary valvular disease, constrictive pericarditis, restrictive or hypertrophic cardiomyopathy,
Beskrivning

Valvular disease Primary uncorrected Severe | Pericarditis, Constrictive | Restrictive cardiomyopathy | Hypertrophic Cardiomyopathy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3258293
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C4072785
UMLS CUI [1,4]
C0205082
UMLS CUI [2]
C0031048
UMLS CUI [3]
C0007196
UMLS CUI [4]
C0007194
automated implanted cardiac defibrillator (aicd) or synchronization device implanted within the preceding 7 days,
Beskrivning

Automatic Implantable Cardioverter-Defibrillator | Cardiac Resynchronization Therapy Device

Datatyp

boolean

Alias
UMLS CUI [1]
C0972395
UMLS CUI [2]
C2936377
require mechanical ventilation, ultrafiltration, or hemodialysis at the time of enrollment,
Beskrivning

Mechanical ventilation Patient need for | Ultrafiltration Patient need for | Hemodialysis Patient need for

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0199470
UMLS CUI [1,2]
C0686904
UMLS CUI [2,1]
C0041612
UMLS CUI [2,2]
C0686904
UMLS CUI [3,1]
C0019004
UMLS CUI [3,2]
C0686904
deterioration due to an acute or superimposed condition requiring therapy other than diuretics
Beskrivning

Deterioration Due to Acute Disease | Therapeutic procedure Patient need for | Diuretics

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1279889
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0001314
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0686904
UMLS CUI [3]
C0012798
symptomatic ventricular tachycardia,
Beskrivning

VENTRICULAR TACHYCARDIA SYMPTOMATIC

Datatyp

boolean

Alias
UMLS CUI [1]
C0750198
severe concomitant primary hepatic disease,
Beskrivning

Liver disease Primary Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0205082
severe pulmonary disease,
Beskrivning

Lung disease Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205082
any other concomitant life-threatening disease,
Beskrivning

Comorbidity Life Threatening

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2826244
cva in the preceding 6 months,
Beskrivning

Cerebrovascular accident

Datatyp

boolean

Alias
UMLS CUI [1]
C0038454
hypotension,
Beskrivning

Hypotension

Datatyp

boolean

Alias
UMLS CUI [1]
C0020649
participated in another clinical trial within 30 days,
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
acute contrast nephropathy,
Beskrivning

Contrast - Induced Nephropathy

Datatyp

boolean

Alias
UMLS CUI [1]
C4055183
admitted for heart transplant surgery or have had a heart transplant.
Beskrivning

Admission Heart Transplantation | Heart Transplantation Previous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030673
UMLS CUI [1,2]
C0018823
UMLS CUI [2,1]
C0018823
UMLS CUI [2,2]
C0205156

Similar models

Eligibility Heart Failure, Congestive NCT00159627

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Congestive heart failure disease length
Item
history of chf for greater than 3 months,
boolean
C0018802 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Diuretic therapy Oral | Diuretic therapy Intravenous
Item
receiving oral/iv diuretic therapy
boolean
C0948575 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0948575 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
Hospitalization Therapeutic procedure Heart failure | Hospitalization Therapeutic procedure Edema | Diuretic therapy Unresponsive to Treatment
Item
hospitalized for therapy for hf and edema that has not responded to diuretic therapy.
boolean
C0019993 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C0019993 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0013604 (UMLS CUI [2,3])
C0948575 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
Fluid overload Continuous Signs and Symptoms
Item
signs and symptoms of ongoing volume overload
boolean
C0546817 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Myocardial Infarction
Item
myocardial infarction in past 14 days
boolean
C0027051 (UMLS CUI [1])
Acute Coronary Syndrome Evidence Clinical | Acute Coronary Syndrome Causing Worsening Heart failure
Item
clinical evidence of acute coronary syndrome causing worsening of hf,
boolean
C0948089 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0948089 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0332271 (UMLS CUI [2,3])
C0018801 (UMLS CUI [2,4])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding,
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Valvular disease Primary uncorrected Severe | Pericarditis, Constrictive | Restrictive cardiomyopathy | Hypertrophic Cardiomyopathy
Item
severe, uncorrected primary valvular disease, constrictive pericarditis, restrictive or hypertrophic cardiomyopathy,
boolean
C3258293 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C4072785 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])
C0031048 (UMLS CUI [2])
C0007196 (UMLS CUI [3])
C0007194 (UMLS CUI [4])
Automatic Implantable Cardioverter-Defibrillator | Cardiac Resynchronization Therapy Device
Item
automated implanted cardiac defibrillator (aicd) or synchronization device implanted within the preceding 7 days,
boolean
C0972395 (UMLS CUI [1])
C2936377 (UMLS CUI [2])
Mechanical ventilation Patient need for | Ultrafiltration Patient need for | Hemodialysis Patient need for
Item
require mechanical ventilation, ultrafiltration, or hemodialysis at the time of enrollment,
boolean
C0199470 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0041612 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C0019004 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
Deterioration Due to Acute Disease | Therapeutic procedure Patient need for | Diuretics
Item
deterioration due to an acute or superimposed condition requiring therapy other than diuretics
boolean
C1279889 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0001314 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C0012798 (UMLS CUI [3])
VENTRICULAR TACHYCARDIA SYMPTOMATIC
Item
symptomatic ventricular tachycardia,
boolean
C0750198 (UMLS CUI [1])
Liver disease Primary Severe
Item
severe concomitant primary hepatic disease,
boolean
C0023895 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Lung disease Severe
Item
severe pulmonary disease,
boolean
C0024115 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Comorbidity Life Threatening
Item
any other concomitant life-threatening disease,
boolean
C0009488 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
Cerebrovascular accident
Item
cva in the preceding 6 months,
boolean
C0038454 (UMLS CUI [1])
Hypotension
Item
hypotension,
boolean
C0020649 (UMLS CUI [1])
Study Subject Participation Status
Item
participated in another clinical trial within 30 days,
boolean
C2348568 (UMLS CUI [1])
Contrast - Induced Nephropathy
Item
acute contrast nephropathy,
boolean
C4055183 (UMLS CUI [1])
Admission Heart Transplantation | Heart Transplantation Previous
Item
admitted for heart transplant surgery or have had a heart transplant.
boolean
C0030673 (UMLS CUI [1,1])
C0018823 (UMLS CUI [1,2])
C0018823 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

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