ID

15196

Beschrijving

Pilot Study of the QI Device for Monitoring of Patients With Congestive Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT02343523

Link

https://clinicaltrials.gov/show/NCT02343523

Trefwoorden

Versies (1)
  1. 22-05-16 22-05-16 -
Geüploaded op

22 mei 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02343523

Engels

Eligibility Heart Failure NCT02343523

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
adults over age 18
Beschrijving

Age Adult

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0001675
own, and comfortable using, a home computer with internet access (phase 2 only)
Beschrijving

Personal Computer Access Internet

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162419
UMLS CUI [1,2]
C0444454
UMLS CUI [1,3]
C0282111
acute hospitalization with a primary diagnosis of acute decompensated heart failure (adhf) diagnosed on the basis of all of the following:
Beschrijving

ADHF Hospitalization

Datatype

boolean

Alias
UMLS CUI [1,1]
C1609524
UMLS CUI [1,2]
C0019993
1. symptoms:
Beschrijving

Symptoms

Datatype

boolean

Alias
UMLS CUI [1]
C1457887
onset or worsening of dyspnea within the past 2 weeks
Beschrijving

Dyspnea Onset | Dyspnea Worsening

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013404
UMLS CUI [1,2]
C0332162
UMLS CUI [2,1]
C0013404
UMLS CUI [2,2]
C0332271
2. physical exam (at least 1 present):
Beschrijving

Physical Examination

Datatype

boolean

Alias
UMLS CUI [1]
C0031809
rales/ crackles on auscultation
Beschrijving

Rales | Auscultation

Datatype

boolean

Alias
UMLS CUI [1]
C0034642
UMLS CUI [2]
C0004339
elevated jvp > 10 cmh2o
Beschrijving

Raised jugular venous pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0520861
weight gain
Beschrijving

Weight Gain

Datatype

boolean

Alias
UMLS CUI [1]
C0043094
le edema
Beschrijving

Edema of lower extremity

Datatype

boolean

Alias
UMLS CUI [1]
C0239340
3. diagnostic imaging/ labs (at least 1 present):
Beschrijving

Diagnostic Imaging | Laboratory Diagnostic Procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0011923
UMLS CUI [2]
C1254361
evidence of pulmonary congestion or edema on chest x-ray/ chest ct
Beschrijving

Pulmonary congestion | Pulmonary Edema | Plain chest X-ray | Chest CT

Datatype

boolean

Alias
UMLS CUI [1]
C0242073
UMLS CUI [2]
C0034063
UMLS CUI [3]
C0039985
UMLS CUI [4]
C0202823
elevated bnp or nt-pro-bnp (age-adjusted)
Beschrijving

B-type natriuretic peptide (BNP); Elevated | Amino-terminal pro-brain natriuretic peptide | Adjustment Age

Datatype

boolean

Alias
UMLS CUI [1,1]
C2082356
UMLS CUI [1,2]
C3163633
UMLS CUI [2]
C0754710
UMLS CUI [3,1]
C0456081
UMLS CUI [3,2]
C0001779
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
psychological or social situation that would make the study difficult for the patient
Beschrijving

life circumstances | Clinical Research Difficult Patient

Datatype

boolean

Alias
UMLS CUI [1]
C0680082
UMLS CUI [2,1]
C0008972
UMLS CUI [2,2]
C0332218
UMLS CUI [2,3]
C0030705
inability to consent
Beschrijving

Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
chronic atrial fibrillation or other dysrhythmia with a high (>10%) burden of ectopic beats.
Beschrijving

Chronic atrial fibrillation | Cardiac Arrhythmia | ECG: ectopic beats

Datatype

boolean

Alias
UMLS CUI [1]
C0694539
UMLS CUI [2]
C0003811
UMLS CUI [3]
C0428986
pregnant women
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
pneumonia - currently, or within the past 30 days
Beschrijving

Pneumonia

Datatype

boolean

Alias
UMLS CUI [1]
C0032285
non-cardiogenic pulmonary edema (e.g. ards)
Beschrijving

Non-cardiogenic pulmonary edema | Respiratory Distress Syndrome, Adult

Datatype

boolean

Alias
UMLS CUI [1]
C3241936
UMLS CUI [2]
C0035222
interstitial lung disease
Beschrijving

Lung Diseases, Interstitial

Datatype

boolean

Alias
UMLS CUI [1]
C0206062
end-stage renal disease and on hemodialysis
Beschrijving

Kidney Failure, Chronic | Hemodialysis

Datatype

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0019004
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Similar models

Eligibility Heart Failure NCT02343523

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age Adult
Item
adults over age 18
boolean
C0001779 (UMLS CUI [1,1])
C0001675 (UMLS CUI [1,2])
Personal Computer Access Internet
Item
own, and comfortable using, a home computer with internet access (phase 2 only)
boolean
C0162419 (UMLS CUI [1,1])
C0444454 (UMLS CUI [1,2])
C0282111 (UMLS CUI [1,3])
ADHF Hospitalization
Item
acute hospitalization with a primary diagnosis of acute decompensated heart failure (adhf) diagnosed on the basis of all of the following:
boolean
C1609524 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Symptoms
Item
1. symptoms:
boolean
C1457887 (UMLS CUI [1])
Dyspnea Onset | Dyspnea Worsening
Item
onset or worsening of dyspnea within the past 2 weeks
boolean
C0013404 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C0013404 (UMLS CUI [2,1])
C0332271 (UMLS CUI [2,2])
Physical Examination
Item
2. physical exam (at least 1 present):
boolean
C0031809 (UMLS CUI [1])
Rales | Auscultation
Item
rales/ crackles on auscultation
boolean
C0034642 (UMLS CUI [1])
C0004339 (UMLS CUI [2])
Raised jugular venous pressure
Item
elevated jvp > 10 cmh2o
boolean
C0520861 (UMLS CUI [1])
Weight Gain
Item
weight gain
boolean
C0043094 (UMLS CUI [1])
Edema of lower extremity
Item
le edema
boolean
C0239340 (UMLS CUI [1])
Diagnostic Imaging | Laboratory Diagnostic Procedure
Item
3. diagnostic imaging/ labs (at least 1 present):
boolean
C0011923 (UMLS CUI [1])
C1254361 (UMLS CUI [2])
Pulmonary congestion | Pulmonary Edema | Plain chest X-ray | Chest CT
Item
evidence of pulmonary congestion or edema on chest x-ray/ chest ct
boolean
C0242073 (UMLS CUI [1])
C0034063 (UMLS CUI [2])
C0039985 (UMLS CUI [3])
C0202823 (UMLS CUI [4])
B-type natriuretic peptide (BNP); Elevated | Amino-terminal pro-brain natriuretic peptide | Adjustment Age
Item
elevated bnp or nt-pro-bnp (age-adjusted)
boolean
C2082356 (UMLS CUI [1,1])
C3163633 (UMLS CUI [1,2])
C0754710 (UMLS CUI [2])
C0456081 (UMLS CUI [3,1])
C0001779 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
life circumstances | Clinical Research Difficult Patient
Item
psychological or social situation that would make the study difficult for the patient
boolean
C0680082 (UMLS CUI [1])
C0008972 (UMLS CUI [2,1])
C0332218 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
Informed Consent Unable
Item
inability to consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Chronic atrial fibrillation | Cardiac Arrhythmia | ECG: ectopic beats
Item
chronic atrial fibrillation or other dysrhythmia with a high (>10%) burden of ectopic beats.
boolean
C0694539 (UMLS CUI [1])
C0003811 (UMLS CUI [2])
C0428986 (UMLS CUI [3])
Pregnancy
Item
pregnant women
boolean
C0032961 (UMLS CUI [1])
Pneumonia
Item
pneumonia - currently, or within the past 30 days
boolean
C0032285 (UMLS CUI [1])
Non-cardiogenic pulmonary edema | Respiratory Distress Syndrome, Adult
Item
non-cardiogenic pulmonary edema (e.g. ards)
boolean
C3241936 (UMLS CUI [1])
C0035222 (UMLS CUI [2])
Lung Diseases, Interstitial
Item
interstitial lung disease
boolean
C0206062 (UMLS CUI [1])
Kidney Failure, Chronic | Hemodialysis
Item
end-stage renal disease and on hemodialysis
boolean
C0022661 (UMLS CUI [1])
C0019004 (UMLS CUI [2])
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