ID

23812

Descripción

Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults; ODM derived from: https://clinicaltrials.gov/show/NCT00581087

Link

https://clinicaltrials.gov/show/NCT00581087

Palabras clave

Versiones (1)
  1. 14/7/17 14/7/17 -
Subido en

14 de julio de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Chronic Obstructive Pulmonary Disease NCT00581087

Inglés

Eligibility Chronic Obstructive Pulmonary Disease NCT00581087

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 years old and ≤ 75 years old (*)
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
chronic obstructive pulmonary disease with fevs/vc < 70% (**)
Descripción

Chronic Obstructive Airway Disease | Forced expired volume in one second/vital capacity ratio

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0429744
respiratory pulmonary hypertension with mean pulmonary arterial pressure ≥ 25 mmhg (**) related to normal pulmonary capillary pressure assessed by catheterization of the right side of the heart (pulmonary capillary wedge pressure ≤12mmhg)
Descripción

Pulmonary Hypertension respiratory | Pulmonary artery mean pressure | Pulmonary artery pressure Normal | Catheterization of right heart | Pulmonary Capillary Wedge Pressure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0521346
UMLS CUI [2]
C0428645
UMLS CUI [3,1]
C0428642
UMLS CUI [3,2]
C0205307
UMLS CUI [4]
C0189896
UMLS CUI [5]
C0086879
po2 ≤ 60 mmhg assessed by arterial gazometry at ease (**) or po2 > 60 mmhg, but related with high hypoxemia after exercise (six-minute walk test )
Descripción

Oxygen measurement, partial pressure, arterial | PO2 measurement | Hypoxemia Post Exercise | Hypoxemia Post 6-minute walk test

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202155
UMLS CUI [2]
C1283004
UMLS CUI [3,1]
C0700292
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C0015259
UMLS CUI [4,1]
C0700292
UMLS CUI [4,2]
C0687676
UMLS CUI [4,3]
C0430515
oxygenotherapy more than 6 months before pre-screening
Descripción

Oxygen Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0184633
written informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
(*) inclusion of young adults concerns copd related to asthma or cystic fibrosis (**) criteria assessed from last health check or the last exams for copd diagnosis
Descripción

Young Adult | Chronic Obstructive Airway Disease Related Asthma | Cystic Fibrosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0238598
UMLS CUI [2,1]
C0024117
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0004096
UMLS CUI [3]
C0010674
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinical instability and/or respiratory exacerbation within the previous three months
Descripción

Instability Clinical | Exacerbation respiratory

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1444783
UMLS CUI [1,2]
C0205210
UMLS CUI [2,1]
C4086268
UMLS CUI [2,2]
C0521346
clinical instability and/or respiratory exacerbation dangerous for catheterization
Descripción

Instability Clinical | Exacerbation respiratory At risk Catheterization

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1444783
UMLS CUI [1,2]
C0205210
UMLS CUI [2,1]
C4086268
UMLS CUI [2,2]
C0521346
UMLS CUI [2,3]
C1444641
UMLS CUI [2,4]
C0007430
pregnancy (ßhcg > 20 ui /l) or breastfeeding on going
Descripción

Pregnancy Human chorionic gonadotropin measurement | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0428402
UMLS CUI [2]
C0006147
general corticotherapy > 0,5 mg/kg/day prédnisolone equivalent
Descripción

Adrenal Cortex Hormones U/day | Prednisolone Equivalent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0456683
UMLS CUI [2,1]
C0032950
UMLS CUI [2,2]
C0205163
hepatic insufficiency (tp < 50%) or renal insufficiency (creatininemia > 130 µmol/l) or diabetes mellitus type i or ii (treated by oral antidiabetic or insulin)
Descripción

Hepatic Insufficiency | Total protein measurement | Renal Insufficiency | Creatinine measurement | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral | Insulin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1306571
UMLS CUI [2]
C0555903
UMLS CUI [3]
C1565489
UMLS CUI [4]
C0201975
UMLS CUI [5]
C0011854
UMLS CUI [6]
C0011860
UMLS CUI [7,1]
C0935929
UMLS CUI [7,2]
C1527415
UMLS CUI [8]
C0021641
left-heart failure (coronary heart disease and/or left valvulopathy)
Descripción

Left-Sided Heart Failure | Coronary heart disease | Heart valve disease Left

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023212
UMLS CUI [2]
C0010068
UMLS CUI [3,1]
C0018824
UMLS CUI [3,2]
C0205091
high level of prostatic specific antigen (psa) (> 2,5ng/ml)
Descripción

Raised prostate specific antigen

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0178415
cancer antecedent or treatment on going
Descripción

Malignant Neoplasms | Cancer treatment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0920425
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Similar models

Eligibility Chronic Obstructive Pulmonary Disease NCT00581087

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 18 years old and ≤ 75 years old (*)
boolean
C0001779 (UMLS CUI [1])
Chronic Obstructive Airway Disease | Forced expired volume in one second/vital capacity ratio
Item
chronic obstructive pulmonary disease with fevs/vc < 70% (**)
boolean
C0024117 (UMLS CUI [1])
C0429744 (UMLS CUI [2])
Pulmonary Hypertension respiratory | Pulmonary artery mean pressure | Pulmonary artery pressure Normal | Catheterization of right heart | Pulmonary Capillary Wedge Pressure
Item
respiratory pulmonary hypertension with mean pulmonary arterial pressure ≥ 25 mmhg (**) related to normal pulmonary capillary pressure assessed by catheterization of the right side of the heart (pulmonary capillary wedge pressure ≤12mmhg)
boolean
C0020542 (UMLS CUI [1,1])
C0521346 (UMLS CUI [1,2])
C0428645 (UMLS CUI [2])
C0428642 (UMLS CUI [3,1])
C0205307 (UMLS CUI [3,2])
C0189896 (UMLS CUI [4])
C0086879 (UMLS CUI [5])
Oxygen measurement, partial pressure, arterial | PO2 measurement | Hypoxemia Post Exercise | Hypoxemia Post 6-minute walk test
Item
po2 ≤ 60 mmhg assessed by arterial gazometry at ease (**) or po2 > 60 mmhg, but related with high hypoxemia after exercise (six-minute walk test )
boolean
C0202155 (UMLS CUI [1])
C1283004 (UMLS CUI [2])
C0700292 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C0015259 (UMLS CUI [3,3])
C0700292 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C0430515 (UMLS CUI [4,3])
Oxygen Therapy
Item
oxygenotherapy more than 6 months before pre-screening
boolean
C0184633 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Young Adult | Chronic Obstructive Airway Disease Related Asthma | Cystic Fibrosis
Item
(*) inclusion of young adults concerns copd related to asthma or cystic fibrosis (**) criteria assessed from last health check or the last exams for copd diagnosis
boolean
C0238598 (UMLS CUI [1])
C0024117 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0004096 (UMLS CUI [2,3])
C0010674 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Instability Clinical | Exacerbation respiratory
Item
clinical instability and/or respiratory exacerbation within the previous three months
boolean
C1444783 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C4086268 (UMLS CUI [2,1])
C0521346 (UMLS CUI [2,2])
Instability Clinical | Exacerbation respiratory At risk Catheterization
Item
clinical instability and/or respiratory exacerbation dangerous for catheterization
boolean
C1444783 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C4086268 (UMLS CUI [2,1])
C0521346 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0007430 (UMLS CUI [2,4])
Pregnancy Human chorionic gonadotropin measurement | Breast Feeding
Item
pregnancy (ßhcg > 20 ui /l) or breastfeeding on going
boolean
C0032961 (UMLS CUI [1,1])
C0428402 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
Adrenal Cortex Hormones U/day | Prednisolone Equivalent
Item
general corticotherapy > 0,5 mg/kg/day prédnisolone equivalent
boolean
C0001617 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0032950 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
Hepatic Insufficiency | Total protein measurement | Renal Insufficiency | Creatinine measurement | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral | Insulin
Item
hepatic insufficiency (tp < 50%) or renal insufficiency (creatininemia > 130 µmol/l) or diabetes mellitus type i or ii (treated by oral antidiabetic or insulin)
boolean
C1306571 (UMLS CUI [1])
C0555903 (UMLS CUI [2])
C1565489 (UMLS CUI [3])
C0201975 (UMLS CUI [4])
C0011854 (UMLS CUI [5])
C0011860 (UMLS CUI [6])
C0935929 (UMLS CUI [7,1])
C1527415 (UMLS CUI [7,2])
C0021641 (UMLS CUI [8])
Left-Sided Heart Failure | Coronary heart disease | Heart valve disease Left
Item
left-heart failure (coronary heart disease and/or left valvulopathy)
boolean
C0023212 (UMLS CUI [1])
C0010068 (UMLS CUI [2])
C0018824 (UMLS CUI [3,1])
C0205091 (UMLS CUI [3,2])
Raised prostate specific antigen
Item
high level of prostatic specific antigen (psa) (> 2,5ng/ml)
boolean
C0178415 (UMLS CUI [1])
Malignant Neoplasms | Cancer treatment
Item
cancer antecedent or treatment on going
boolean
C0006826 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
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