ID

39508

Description

Optimization of the Treatment of Acute HF by a Non Invasive Cardiac System-a Randomized Control Trial; ODM derived from: https://clinicaltrials.gov/show/NCT02126254

Link

https://clinicaltrials.gov/show/NCT02126254

Keywords

Versions (1)
  1. 1/20/20 1/20/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 20, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02126254

English

Eligibility Heart Failure NCT02126254

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. hf admitted patient from cardiology and internal medicine departments in our institution.
Description

Patient Admission Heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0030673
UMLS CUI [1,2]
C0018801
3. reduced ef ≤ 40%.
Description

Reduced ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C4022792
4. elevated filling pressures, indicated by one symptom and one physical sign: symptoms
Description

Ventricular filling pressure increased | Symptoms Quantity | Physical signs Quantity

Data type

boolean

Alias
UMLS CUI [1]
C1963871
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0311392
UMLS CUI [3,2]
C1265611
: dyspnea at rest, in the supine position, or immediately upon routine activity, abdominal discomfort, severe anorexia, or nausea without apparent cause other than hepatosplanchnic congestion signs: jugular venous pressure elevation >10 cm above the right atrium, hepatomegaly, ascites, or edema in the absence of other obvious causes, rales greater than 1/3 lung fields, oxygen saturation < 90 % in room air, pulmonary venous congestion determined from chest x-ray films
Description

Resting Dyspnea Supine Position | Resting Dyspnea | Abdominal discomfort | Anorexia Severe | Nausea | Other Coding | Raised jugular venous pressure | Hepatomegaly | Ascites | Edema | Rales | Oxygen saturation measurement on room air | Pulmonary venous congestion Chest X-ray

Data type

boolean

Alias
UMLS CUI [1,1]
C0743330
UMLS CUI [1,2]
C0038846
UMLS CUI [2]
C0743330
UMLS CUI [3]
C0232487
UMLS CUI [4,1]
C0003123
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C0027497
UMLS CUI [6]
C3846158
UMLS CUI [7]
C0520861
UMLS CUI [8]
C0019209
UMLS CUI [9]
C0003962
UMLS CUI [10]
C0013604
UMLS CUI [11]
C0034642
UMLS CUI [12,1]
C0523807
UMLS CUI [12,2]
C2709070
UMLS CUI [13,1]
C0582411
UMLS CUI [13,2]
C0039985
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. severe aortic valve regurgitation and/or aortic stenosis.
Description

Aortic Valve Insufficiency Severe | Aortic Valve Stenosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0003504
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0003507
2. aortic aneurysm.
Description

Aortic Aneurysm

Data type

boolean

Alias
UMLS CUI [1]
C0003486
3. heart rate above 130 beats/min.
Description

Heart rate beats per minute

Data type

boolean

Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0439385
4. intra- and extra-cardiac shunts.
Description

Cardiac shunt

Data type

boolean

Alias
UMLS CUI [1]
C0232180
5. severe peripheral vascular disease.
Description

Peripheral Vascular Disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0085096
UMLS CUI [1,2]
C0205082
6. severe pitting edema.
Description

Pitting edema Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0333243
UMLS CUI [1,2]
C0205082
7. sepsis.
Description

Sepsis

Data type

boolean

Alias
UMLS CUI [1]
C0243026
8. use of hemodialysis.
Description

Use of Hemodialysis

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0019004
9. patients under 18 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
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Similar models

Eligibility Heart Failure NCT02126254

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. written informed consent.
boolean
C0021430 (UMLS CUI [1])
Patient Admission Heart failure
Item
2. hf admitted patient from cardiology and internal medicine departments in our institution.
boolean
C0030673 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
Reduced ejection fraction
Item
3. reduced ef ≤ 40%.
boolean
C4022792 (UMLS CUI [1])
Ventricular filling pressure increased | Symptoms Quantity | Physical signs Quantity
Item
4. elevated filling pressures, indicated by one symptom and one physical sign: symptoms
boolean
C1963871 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0311392 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Resting Dyspnea Supine Position | Resting Dyspnea | Abdominal discomfort | Anorexia Severe | Nausea | Other Coding | Raised jugular venous pressure | Hepatomegaly | Ascites | Edema | Rales | Oxygen saturation measurement on room air | Pulmonary venous congestion Chest X-ray
Item
: dyspnea at rest, in the supine position, or immediately upon routine activity, abdominal discomfort, severe anorexia, or nausea without apparent cause other than hepatosplanchnic congestion signs: jugular venous pressure elevation >10 cm above the right atrium, hepatomegaly, ascites, or edema in the absence of other obvious causes, rales greater than 1/3 lung fields, oxygen saturation < 90 % in room air, pulmonary venous congestion determined from chest x-ray films
boolean
C0743330 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0743330 (UMLS CUI [2])
C0232487 (UMLS CUI [3])
C0003123 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0027497 (UMLS CUI [5])
C3846158 (UMLS CUI [6])
C0520861 (UMLS CUI [7])
C0019209 (UMLS CUI [8])
C0003962 (UMLS CUI [9])
C0013604 (UMLS CUI [10])
C0034642 (UMLS CUI [11])
C0523807 (UMLS CUI [12,1])
C2709070 (UMLS CUI [12,2])
C0582411 (UMLS CUI [13,1])
C0039985 (UMLS CUI [13,2])
Item Group
C0680251 (UMLS CUI)
Aortic Valve Insufficiency Severe | Aortic Valve Stenosis
Item
1. severe aortic valve regurgitation and/or aortic stenosis.
boolean
C0003504 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0003507 (UMLS CUI [2])
Aortic Aneurysm
Item
2. aortic aneurysm.
boolean
C0003486 (UMLS CUI [1])
Heart rate beats per minute
Item
3. heart rate above 130 beats/min.
boolean
C0018810 (UMLS CUI [1,1])
C0439385 (UMLS CUI [1,2])
Cardiac shunt
Item
4. intra- and extra-cardiac shunts.
boolean
C0232180 (UMLS CUI [1])
Peripheral Vascular Disease Severe
Item
5. severe peripheral vascular disease.
boolean
C0085096 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Pitting edema Severe
Item
6. severe pitting edema.
boolean
C0333243 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Sepsis
Item
7. sepsis.
boolean
C0243026 (UMLS CUI [1])
Use of Hemodialysis
Item
8. use of hemodialysis.
boolean
C1524063 (UMLS CUI [1,1])
C0019004 (UMLS CUI [1,2])
Age
Item
9. patients under 18 years of age.
boolean
C0001779 (UMLS CUI [1])
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