ID

32385

Description

Sleep Disordered Breathing in Patients With Chronic Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00863421

Link

https://clinicaltrials.gov/show/NCT00863421

Keywords

Versions (1)
  1. 10/29/18 10/29/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 29, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Sleep-disordered Breathing NCT00863421

English

Eligibility Sleep-disordered Breathing NCT00863421

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
stable chronic heart failure(nyha ii-iv), defined as
Description

Chronic heart failure Stable New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0264716
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C1275491
a condition diagnosed for at least 6 months prior to inclusion under maximally tolerated medical therapy
Description

Condition Duration | Therapy Maximal

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205289
without any relevant changes to symptoms or medication during the 8 weeks prior to inclusion
Description

Symptoms unchanged | Pharmaceutical Preparations unchanged

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0442739
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0442739
by the absence of any hospitalizations during the previous 3 month
Description

Hospitalization Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0332197
ejection fraction equal or below 35%
Description

Cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232174
age between 18 and 80 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
instable angina pectoris
Description

Angina, Unstable

Data type

boolean

Alias
UMLS CUI [1]
C0002965
acute coronary syndrome within the last 6 months
Description

Acute Coronary Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0948089
cerebrovascular events (tia, prind, stroke) within the last 12 months
Description

Event Cerebrovascular | Transient Ischemic Attack | Prolonged reversible ischemic neurologic deficit | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1880018
UMLS CUI [2]
C0007787
UMLS CUI [3]
C2114798
UMLS CUI [4]
C0038454
primary pulmonary hypertension(systolic pap > 45 mmhg)
Description

Primary pulmonary hypertension | Pulmonary artery systolic pressure

Data type

boolean

Alias
UMLS CUI [1]
C0152171
UMLS CUI [2]
C0428643
congenital heart failure
Description

Congenital cardiac failure

Data type

boolean

Alias
UMLS CUI [1]
C0410933
primary heart valve disease
Description

Heart valve disease Primary

Data type

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0205225
regular use of benzodiazepines, other sedatives, or opiate derivatives
Description

Benzodiazepines Regular | Sedatives Regular | Opiate Derivative Regular

Data type

boolean

Alias
UMLS CUI [1,1]
C0005064
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C0036557
UMLS CUI [2,2]
C0205272
UMLS CUI [3,1]
C0376196
UMLS CUI [3,2]
C1527240
UMLS CUI [3,3]
C0205272
severe renal(s-creatinine > 3 mg/dl) and/or liver disease(gpt > 3xuln)
Description

Kidney Disease Severe | Creatinine measurement, serum | Liver disease Severe | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0201976
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0151905
clinically relevant affections of the central nervous system(e.g.epilepsy, multiple sclerosis,...)
Description

CNS disorder | Epilepsy | Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2]
C0014544
UMLS CUI [3]
C0026769
known moderate to severe chronic obstructive pulmonary disease(fev1/(f)vc < 70% und fev1 < 50% soll) or restrictive lung disease with total lung capacity < 70%
Description

Moderate chronic obstructive pulmonary disease | Severe chronic obstructive pulmonary disease | FEV1/FVC percent | FEV1 | Restrictive lung disease | Total Lung Capacity

Data type

boolean

Alias
UMLS CUI [1]
C0730605
UMLS CUI [2]
C0730607
UMLS CUI [3]
C0730560
UMLS CUI [4]
C0849974
UMLS CUI [5]
C0085581
UMLS CUI [6]
C0040509
untreated hormonal disease(e.g.hypothyreosis,....)
Description

Hormonal disorder untreated | Hypothyroidism

Data type

boolean

Alias
UMLS CUI [1,1]
C3263685
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C0020676
daily alcohol consumption with more than 60g alcohol per day for men and more than 30g alcohol per day for women
Description

Alcohol consumption units/day | Gender

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560578
UMLS CUI [2]
C0079399
implantation of a pacemaker or icd within the previous 6 months
Description

Implantation of cardiac pacemaker | Implantation ICD

Data type

boolean

Alias
UMLS CUI [1]
C0189842
UMLS CUI [2,1]
C0021107
UMLS CUI [2,2]
C0162589
st.p. aortocoronary bypass surgery or lung resection within the previous 12 month
Description

Status post Coronary Artery Bypass Surgery | Status post Lung excision

Data type

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0010055
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0396565
women of child-bearing age
Description

Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1]
C3831118
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Similar models

Eligibility Sleep-disordered Breathing NCT00863421

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic heart failure Stable New York Heart Association Classification
Item
stable chronic heart failure(nyha ii-iv), defined as
boolean
C0264716 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Condition Duration | Therapy Maximal
Item
a condition diagnosed for at least 6 months prior to inclusion under maximally tolerated medical therapy
boolean
C0348080 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0205289 (UMLS CUI [2,2])
Symptoms unchanged | Pharmaceutical Preparations unchanged
Item
without any relevant changes to symptoms or medication during the 8 weeks prior to inclusion
boolean
C1457887 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
Hospitalization Absent
Item
by the absence of any hospitalizations during the previous 3 month
boolean
C0019993 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Cardiac ejection fraction
Item
ejection fraction equal or below 35%
boolean
C0232174 (UMLS CUI [1])
Age
Item
age between 18 and 80 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Angina, Unstable
Item
instable angina pectoris
boolean
C0002965 (UMLS CUI [1])
Acute Coronary Syndrome
Item
acute coronary syndrome within the last 6 months
boolean
C0948089 (UMLS CUI [1])
Event Cerebrovascular | Transient Ischemic Attack | Prolonged reversible ischemic neurologic deficit | Cerebrovascular accident
Item
cerebrovascular events (tia, prind, stroke) within the last 12 months
boolean
C0441471 (UMLS CUI [1,1])
C1880018 (UMLS CUI [1,2])
C0007787 (UMLS CUI [2])
C2114798 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
Primary pulmonary hypertension | Pulmonary artery systolic pressure
Item
primary pulmonary hypertension(systolic pap > 45 mmhg)
boolean
C0152171 (UMLS CUI [1])
C0428643 (UMLS CUI [2])
Congenital cardiac failure
Item
congenital heart failure
boolean
C0410933 (UMLS CUI [1])
Heart valve disease Primary
Item
primary heart valve disease
boolean
C0018824 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Benzodiazepines Regular | Sedatives Regular | Opiate Derivative Regular
Item
regular use of benzodiazepines, other sedatives, or opiate derivatives
boolean
C0005064 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0036557 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
C0376196 (UMLS CUI [3,1])
C1527240 (UMLS CUI [3,2])
C0205272 (UMLS CUI [3,3])
Kidney Disease Severe | Creatinine measurement, serum | Liver disease Severe | Alanine aminotransferase increased
Item
severe renal(s-creatinine > 3 mg/dl) and/or liver disease(gpt > 3xuln)
boolean
C0022658 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
C0023895 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0151905 (UMLS CUI [4])
CNS disorder | Epilepsy | Multiple Sclerosis
Item
clinically relevant affections of the central nervous system(e.g.epilepsy, multiple sclerosis,...)
boolean
C0007682 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
C0026769 (UMLS CUI [3])
Moderate chronic obstructive pulmonary disease | Severe chronic obstructive pulmonary disease | FEV1/FVC percent | FEV1 | Restrictive lung disease | Total Lung Capacity
Item
known moderate to severe chronic obstructive pulmonary disease(fev1/(f)vc < 70% und fev1 < 50% soll) or restrictive lung disease with total lung capacity < 70%
boolean
C0730605 (UMLS CUI [1])
C0730607 (UMLS CUI [2])
C0730560 (UMLS CUI [3])
C0849974 (UMLS CUI [4])
C0085581 (UMLS CUI [5])
C0040509 (UMLS CUI [6])
Hormonal disorder untreated | Hypothyroidism
Item
untreated hormonal disease(e.g.hypothyreosis,....)
boolean
C3263685 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0020676 (UMLS CUI [2])
Alcohol consumption units/day | Gender
Item
daily alcohol consumption with more than 60g alcohol per day for men and more than 30g alcohol per day for women
boolean
C0001948 (UMLS CUI [1,1])
C0560578 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
Implantation of cardiac pacemaker | Implantation ICD
Item
implantation of a pacemaker or icd within the previous 6 months
boolean
C0189842 (UMLS CUI [1])
C0021107 (UMLS CUI [2,1])
C0162589 (UMLS CUI [2,2])
Status post Coronary Artery Bypass Surgery | Status post Lung excision
Item
st.p. aortocoronary bypass surgery or lung resection within the previous 12 month
boolean
C0231290 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0396565 (UMLS CUI [2,2])
Childbearing Potential
Item
women of child-bearing age
boolean
C3831118 (UMLS CUI [1])
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