ID

15196

Description

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

Lien

https://clinicaltrials.gov/show/NCT02343523

Mots-clés

  1. 22/05/2016 22/05/2016 -
Téléchargé le

22 mai 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Heart Failure NCT02343523

Eligibility Heart Failure NCT02343523

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adults over age 18
Description

Age Adult

Type de données

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)
Description

Personal Computer Access Internet

Type de données

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:
Description

ADHF Hospitalization

Type de données

boolean

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

Symptoms

Type de données

boolean

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

Dyspnea Onset | Dyspnea Worsening

Type de données

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):
Description

Physical Examination

Type de données

boolean

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

Rales | Auscultation

Type de données

boolean

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

Raised jugular venous pressure

Type de données

boolean

Alias
UMLS CUI [1]
C0520861
weight gain
Description

Weight Gain

Type de données

boolean

Alias
UMLS CUI [1]
C0043094
le edema
Description

Edema of lower extremity

Type de données

boolean

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

Diagnostic Imaging | Laboratory Diagnostic Procedure

Type de données

boolean

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

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

Type de données

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)
Description

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

Type de données

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
Description

Exclusion Criteria

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

life circumstances | Clinical Research Difficult Patient

Type de données

boolean

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

Informed Consent Unable

Type de données

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.
Description

Chronic atrial fibrillation | Cardiac Arrhythmia | ECG: ectopic beats

Type de données

boolean

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

Pregnancy

Type de données

boolean

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

Pneumonia

Type de données

boolean

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

Non-cardiogenic pulmonary edema | Respiratory Distress Syndrome, Adult

Type de données

boolean

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

Lung Diseases, Interstitial

Type de données

boolean

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

Kidney Failure, Chronic | Hemodialysis

Type de données

boolean

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

Similar models

Eligibility Heart Failure NCT02343523

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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