ID

41388

Beschreibung

Screening for Sleep Hypoxemia in Pulmonary Arterial Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01371669

Link

https://clinicaltrials.gov/show/NCT01371669

Stichworte

Versionen (2)
  1. 19.01.19 19.01.19 -
  2. 28.09.20 28.09.20 -
Rechteinhaber

see on clinicaltrials.gov

Hochgeladen am

28. September 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Sleep Disorders in Pulmonary Arterial Hypertension NCT01371669

Englisch

Eligibility Sleep Disorders in Pulmonary Arterial HypertensionNCT01371669

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient aged 18 to 75 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
patient with ipah or cpeph stable for at least 3 months. stability is defined by the new york heart association classes for dyspnea and the six minutes walking test (6mwt). furthermore, no changes in medical therapy had occured during the last three months.
Beschreibung

Stable ipah or cpeph (NYHA, 6mwt) with no change in medical therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0152171
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C1275491
UMLS CUI [2,1]
C0152171
UMLS CUI [2,2]
C0205360
UMLS CUI [2,3]
C3900190
UMLS CUI [3,1]
C2363973
UMLS CUI [3,2]
C0205360
UMLS CUI [3,3]
C3900190
UMLS CUI [4,1]
C2363973
UMLS CUI [4,2]
C0205360
UMLS CUI [4,3]
C1275491
UMLS CUI [5,1]
C0152171
UMLS CUI [5,2]
C0205360
UMLS CUI [5,3]
C0013227
UMLS CUI [5,4]
C0332185
UMLS CUI [6,1]
C2363973
UMLS CUI [6,2]
C0205360
UMLS CUI [6,3]
C0013227
UMLS CUI [6,4]
C0332185
patients who signed informed consent
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with secondary ph associated with other pathologies outside cpeph (sclerodermia, systemic lupus erythematous, portal hypertension, chronic hiv infection...)
Beschreibung

Secondary pulmonary hypertension other than cpeph

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0264936
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C2363973
patients who had a functional and/or a hemodynamic degradation during the last 3 months or a change in pulmonary hypertension treatment
Beschreibung

Functional or hemodynamic deterioration or treatment change

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C1279889
UMLS CUI [1,3]
C0019010
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C1279889
UMLS CUI [2,3]
C0598463
UMLS CUI [3,1]
C0332185
UMLS CUI [3,2]
C1299575
UMLS CUI [3,3]
C2973725
patients with obstructive or restrictive ventilatory disorder with a ventricular ejection fraction 60 predicted
Beschreibung

Obstructive or restrictive ventilatory disorder with physiological ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0600260
UMLS CUI [2]
C0085581
UMLS CUI [3]
C0428772
women without effective contraception
Beschreibung

No contraception

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C3242229
patients with a body mass index above 35 kg/m2
Beschreibung

BMI

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
patient not affiliated to a social security scheme
Beschreibung

No social security scheme

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037435
UMLS CUI [1,2]
C0332197
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Ähnliche Modelle

Eligibility Sleep Disorders in Pulmonary Arterial HypertensionNCT01371669

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient aged 18 to 75 years
boolean
C0001779 (UMLS CUI [1])
Stable ipah or cpeph (NYHA, 6mwt) with no change in medical therapy
Item
patient with ipah or cpeph stable for at least 3 months. stability is defined by the new york heart association classes for dyspnea and the six minutes walking test (6mwt). furthermore, no changes in medical therapy had occured during the last three months.
boolean
C0152171 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0152171 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C3900190 (UMLS CUI [2,3])
C2363973 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C3900190 (UMLS CUI [3,3])
C2363973 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
C1275491 (UMLS CUI [4,3])
C0152171 (UMLS CUI [5,1])
C0205360 (UMLS CUI [5,2])
C0013227 (UMLS CUI [5,3])
C0332185 (UMLS CUI [5,4])
C2363973 (UMLS CUI [6,1])
C0205360 (UMLS CUI [6,2])
C0013227 (UMLS CUI [6,3])
C0332185 (UMLS CUI [6,4])
Informed consent
Item
patients who signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Secondary pulmonary hypertension other than cpeph
Item
patients with secondary ph associated with other pathologies outside cpeph (sclerodermia, systemic lupus erythematous, portal hypertension, chronic hiv infection...)
boolean
C0264936 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C2363973 (UMLS CUI [1,3])
Functional or hemodynamic deterioration or treatment change
Item
patients who had a functional and/or a hemodynamic degradation during the last 3 months or a change in pulmonary hypertension treatment
boolean
C0332185 (UMLS CUI [1,1])
C1279889 (UMLS CUI [1,2])
C0019010 (UMLS CUI [1,3])
C0332185 (UMLS CUI [2,1])
C1279889 (UMLS CUI [2,2])
C0598463 (UMLS CUI [2,3])
C0332185 (UMLS CUI [3,1])
C1299575 (UMLS CUI [3,2])
C2973725 (UMLS CUI [3,3])
Obstructive or restrictive ventilatory disorder with physiological ventricular ejection fraction
Item
patients with obstructive or restrictive ventilatory disorder with a ventricular ejection fraction 60 predicted
boolean
C0600260 (UMLS CUI [1])
C0085581 (UMLS CUI [2])
C0428772 (UMLS CUI [3])
No contraception
Item
women without effective contraception
boolean
C0700589 (UMLS CUI [1,1])
C3242229 (UMLS CUI [1,2])
BMI
Item
patients with a body mass index above 35 kg/m2
boolean
C1305855 (UMLS CUI [1])
No social security scheme
Item
patient not affiliated to a social security scheme
boolean
C0037435 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
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