ID

42999

Description

Effects of Bosentan (Tracleer) in the Course of Pulmonary Artery Hypertension Induced by Hypoxia; ODM derived from: https://clinicaltrials.gov/show/NCT00260819

Link

https://clinicaltrials.gov/show/NCT00260819

Keywords

Versions (2)
  1. 4/11/17 4/11/17 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypoxia-Induced Pulmonary Artery Hypertension NCT00260819

English

Eligibility Hypoxia-Induced Pulmonary Artery Hypertension NCT00260819

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
20 non smoker healthy volunteers : 10 resistant to high-altitude pulmonary oedema and 10 susceptible subjects, without history of cardiac or pulmonary disease or asthma, after a complete clinical examination and safety laboratory measurements prior to randomization, and after giving informed written consent.
Description

Non-smoker | Healthy Volunteers | High altitude pulmonary edema Resistant Patients Quantity | High altitude pulmonary edema susceptible Patients Quantity | Heart Disease Absent | Lung disease Absent | Asthma Absent | Clinical examination Complete | Safety laboratory measurement | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2]
C1708335
UMLS CUI [3,1]
C0340100
UMLS CUI [3,2]
C0332325
UMLS CUI [3,3]
C0030705
UMLS CUI [3,4]
C1265611
UMLS CUI [4,1]
C0340100
UMLS CUI [4,2]
C0220898
UMLS CUI [4,3]
C0030705
UMLS CUI [4,4]
C1265611
UMLS CUI [5,1]
C0018799
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0024115
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C0004096
UMLS CUI [7,2]
C0332197
UMLS CUI [8,1]
C1456356
UMLS CUI [8,2]
C0205197
UMLS CUI [9,1]
C0036043
UMLS CUI [9,2]
C0681902
UMLS CUI [10]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
antecedent of lung disease notably with asthmatic antecedent or htap
Description

Lung diseases | Asthma | Pulmonary Hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C0004096
UMLS CUI [3]
C0020542
antecedent of heart disease
Description

Heart Disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
female genital organ
Description

Female genitalia

Data type

boolean

Alias
UMLS CUI [1]
C0017421
systolic blood pressure < 85 mmhg or > 160 mmhg after 5 minutes of lengthened rest.
Description

Systolic Pressure Post Rest Lengthened

Data type

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0035253
UMLS CUI [1,4]
C0392744
sentimentality in a medicine, in particular in a bosentan or in one of the excipients of the tablet.
Description

Drug Allergy | Hypersensitivity Bosentan | Hypersensitivity Bosentan Tablet Excipient

Data type

boolean

Alias
UMLS CUI [1]
C0013182
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0252643
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1253356
UMLS CUI [3,3]
C0015237
hepatic incapacity moderated to severe correspondent in the class b or c of the classification of child-pugh (cf pharmacokinetics) rate serous hepatic aminotransferases, aspartate aminotransferases( asat) and\or alanine aminotransférases ( alat), superior to 3 times the superior limit of the normal before the started of the treatment.
Description

Hepatic Insufficiency Moderate Child-Pugh Classification | Hepatic Insufficiency Severe Child-Pugh Classification | Pharmacokinetics | Transaminases Hepatic Serous | Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1,1]
C1306571
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C4050412
UMLS CUI [2,1]
C1306571
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C4050412
UMLS CUI [3]
C0031328
UMLS CUI [4,1]
C0002594
UMLS CUI [4,2]
C0205054
UMLS CUI [4,3]
C0440743
UMLS CUI [5]
C0151904
UMLS CUI [6]
C0151905
pointed or chronic systematic diseases.
Description

Systemic disease | Systemic disease chronic

Data type

boolean

Alias
UMLS CUI [1]
C0442893
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0205191
presence of antibody anti-hiv, of anti-hvc antibody, antigens hbs and\or antibody anti-hbc. - active addiction to smoking.
Description

HIV antibody positive | Hepatitis C Antibodies Present | Hepatitis B surface antigen positive | Anti-HBc antibody positive | Smoking (tobacco) addiction

Data type

boolean

Alias
UMLS CUI [1]
C0920548
UMLS CUI [2,1]
C0166049
UMLS CUI [2,2]
C0150312
UMLS CUI [3]
C0149709
UMLS CUI [4]
C0262506
UMLS CUI [5]
C0848323
alcohol abuse and of toxins.
Description

Alcohol abuse | Toxin Abuse

Data type

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2,1]
C0040549
UMLS CUI [2,2]
C1546935
taking of concomitant medicines except those allowed the chapter concomitant treatments.
Description

Concomitant Agent

Data type

boolean

Alias
UMLS CUI [1]
C2347852
signs, symptoms or values of the biological examinations situated except the clinically acceptable values for healthy subjects with or without antecedent of opha.
Description

Physical Examination Signs Abnormal | Physical Examination Symptoms Abnormal | Physical Examination test results abnormal | High altitude pulmonary edema

Data type

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0220912
UMLS CUI [1,3]
C0205161
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C1457887
UMLS CUI [2,3]
C0205161
UMLS CUI [3,1]
C0031809
UMLS CUI [3,2]
C0850610
UMLS CUI [4]
C0340100
common(current) ingestion of excessive quantities of tea, coffee(cafe), chocolate and\or drinks containing some caffeine (> 5 cups / day, is approximately 500 mg of caffeine a day).
Description

Tea intake Excessive | Coffee intake Excessive | CHOCOLATE INGESTION Excessive | Caffeine ingestion Excessive

Data type

boolean

Alias
UMLS CUI [1,1]
C0556161
UMLS CUI [1,2]
C0442802
UMLS CUI [2,1]
C0556160
UMLS CUI [2,2]
C0442802
UMLS CUI [3,1]
C0239052
UMLS CUI [3,2]
C0442802
UMLS CUI [4,1]
C0238877
UMLS CUI [4,2]
C0442802
consumption of juice of grapefruit and\or herb tea on base of st.
Description

GRAPEFRUIT JUICE ST. JOHN'S WORT based | Herbal Tea ST. JOHN'S WORT based

Data type

boolean

Alias
UMLS CUI [1,1]
C0452456
UMLS CUI [1,2]
C0813171
UMLS CUI [1,3]
C1705938
UMLS CUI [2,1]
C0019233
UMLS CUI [2,2]
C0813171
UMLS CUI [2,3]
C1705938
john's wort
Description

ST. JOHN'S WORT

Data type

boolean

Alias
UMLS CUI [1]
C0813171
don of blood in 3 months preceding the study.
Description

Blood Donation

Data type

boolean

Alias
UMLS CUI [1]
C0005794
persons in period of exclusion on the national file of the persons lending itself to the biomedical search(research) without direct individual profit.
Description

Study Subject Participation Status Exclusion

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C2828389
refusal or linguistic or psychic incapacity to sign the lit(enlightened) assent.
Description

Informed Consent Refused | Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
subject which can not submit itself to the constraints of the protocol (for example, not cooperative, incapable to go(surrender) to the visits of follow-up and probably incapable to finish the study
Description

Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Hypoxia-Induced Pulmonary Artery Hypertension NCT00260819

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-smoker | Healthy Volunteers | High altitude pulmonary edema Resistant Patients Quantity | High altitude pulmonary edema susceptible Patients Quantity | Heart Disease Absent | Lung disease Absent | Asthma Absent | Clinical examination Complete | Safety laboratory measurement | Informed Consent
Item
20 non smoker healthy volunteers : 10 resistant to high-altitude pulmonary oedema and 10 susceptible subjects, without history of cardiac or pulmonary disease or asthma, after a complete clinical examination and safety laboratory measurements prior to randomization, and after giving informed written consent.
boolean
C0337672 (UMLS CUI [1])
C1708335 (UMLS CUI [2])
C0340100 (UMLS CUI [3,1])
C0332325 (UMLS CUI [3,2])
C0030705 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
C0340100 (UMLS CUI [4,1])
C0220898 (UMLS CUI [4,2])
C0030705 (UMLS CUI [4,3])
C1265611 (UMLS CUI [4,4])
C0018799 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0024115 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0004096 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C1456356 (UMLS CUI [8,1])
C0205197 (UMLS CUI [8,2])
C0036043 (UMLS CUI [9,1])
C0681902 (UMLS CUI [9,2])
C0021430 (UMLS CUI [10])
Item Group
C0680251 (UMLS CUI)
Lung diseases | Asthma | Pulmonary Hypertension
Item
antecedent of lung disease notably with asthmatic antecedent or htap
boolean
C0024115 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C0020542 (UMLS CUI [3])
Heart Disease
Item
antecedent of heart disease
boolean
C0018799 (UMLS CUI [1])
Female genitalia
Item
female genital organ
boolean
C0017421 (UMLS CUI [1])
Systolic Pressure Post Rest Lengthened
Item
systolic blood pressure < 85 mmhg or > 160 mmhg after 5 minutes of lengthened rest.
boolean
C0871470 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0035253 (UMLS CUI [1,3])
C0392744 (UMLS CUI [1,4])
Drug Allergy | Hypersensitivity Bosentan | Hypersensitivity Bosentan Tablet Excipient
Item
sentimentality in a medicine, in particular in a bosentan or in one of the excipients of the tablet.
boolean
C0013182 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0252643 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1253356 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
Hepatic Insufficiency Moderate Child-Pugh Classification | Hepatic Insufficiency Severe Child-Pugh Classification | Pharmacokinetics | Transaminases Hepatic Serous | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
hepatic incapacity moderated to severe correspondent in the class b or c of the classification of child-pugh (cf pharmacokinetics) rate serous hepatic aminotransferases, aspartate aminotransferases( asat) and\or alanine aminotransférases ( alat), superior to 3 times the superior limit of the normal before the started of the treatment.
boolean
C1306571 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C4050412 (UMLS CUI [1,3])
C1306571 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C4050412 (UMLS CUI [2,3])
C0031328 (UMLS CUI [3])
C0002594 (UMLS CUI [4,1])
C0205054 (UMLS CUI [4,2])
C0440743 (UMLS CUI [4,3])
C0151904 (UMLS CUI [5])
C0151905 (UMLS CUI [6])
Systemic disease | Systemic disease chronic
Item
pointed or chronic systematic diseases.
boolean
C0442893 (UMLS CUI [1])
C0442893 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
HIV antibody positive | Hepatitis C Antibodies Present | Hepatitis B surface antigen positive | Anti-HBc antibody positive | Smoking (tobacco) addiction
Item
presence of antibody anti-hiv, of anti-hvc antibody, antigens hbs and\or antibody anti-hbc. - active addiction to smoking.
boolean
C0920548 (UMLS CUI [1])
C0166049 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
C0149709 (UMLS CUI [3])
C0262506 (UMLS CUI [4])
C0848323 (UMLS CUI [5])
Alcohol abuse | Toxin Abuse
Item
alcohol abuse and of toxins.
boolean
C0085762 (UMLS CUI [1])
C0040549 (UMLS CUI [2,1])
C1546935 (UMLS CUI [2,2])
Concomitant Agent
Item
taking of concomitant medicines except those allowed the chapter concomitant treatments.
boolean
C2347852 (UMLS CUI [1])
Physical Examination Signs Abnormal | Physical Examination Symptoms Abnormal | Physical Examination test results abnormal | High altitude pulmonary edema
Item
signs, symptoms or values of the biological examinations situated except the clinically acceptable values for healthy subjects with or without antecedent of opha.
boolean
C0031809 (UMLS CUI [1,1])
C0220912 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0031809 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C0205161 (UMLS CUI [2,3])
C0031809 (UMLS CUI [3,1])
C0850610 (UMLS CUI [3,2])
C0340100 (UMLS CUI [4])
Tea intake Excessive | Coffee intake Excessive | CHOCOLATE INGESTION Excessive | Caffeine ingestion Excessive
Item
common(current) ingestion of excessive quantities of tea, coffee(cafe), chocolate and\or drinks containing some caffeine (> 5 cups / day, is approximately 500 mg of caffeine a day).
boolean
C0556161 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
C0556160 (UMLS CUI [2,1])
C0442802 (UMLS CUI [2,2])
C0239052 (UMLS CUI [3,1])
C0442802 (UMLS CUI [3,2])
C0238877 (UMLS CUI [4,1])
C0442802 (UMLS CUI [4,2])
GRAPEFRUIT JUICE ST. JOHN'S WORT based | Herbal Tea ST. JOHN'S WORT based
Item
consumption of juice of grapefruit and\or herb tea on base of st.
boolean
C0452456 (UMLS CUI [1,1])
C0813171 (UMLS CUI [1,2])
C1705938 (UMLS CUI [1,3])
C0019233 (UMLS CUI [2,1])
C0813171 (UMLS CUI [2,2])
C1705938 (UMLS CUI [2,3])
ST. JOHN'S WORT
Item
john's wort
boolean
C0813171 (UMLS CUI [1])
Blood Donation
Item
don of blood in 3 months preceding the study.
boolean
C0005794 (UMLS CUI [1])
Study Subject Participation Status Exclusion
Item
persons in period of exclusion on the national file of the persons lending itself to the biomedical search(research) without direct individual profit.
boolean
C2348568 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Informed Consent Refused | Informed Consent Unable
Item
refusal or linguistic or psychic incapacity to sign the lit(enlightened) assent.
boolean
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Protocol Compliance Unable
Item
subject which can not submit itself to the constraints of the protocol (for example, not cooperative, incapable to go(surrender) to the visits of follow-up and probably incapable to finish the study
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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