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ID

42999

Beschrijving

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

Trefwoorden

Versies (2)
  1. 11-04-17 11-04-17 -
  2. 17-09-21 17-09-21 -
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17 september 2021

DOI

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

    Engels

    Eligibility Hypoxia-Induced Pulmonary Artery Hypertension NCT00260819

    1 Formulieren  
    Inclusion Criteria
    Beschrijving

    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.
    Beschrijving

    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

    Datatype

    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
    Beschrijving

    Exclusion Criteria

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

    Lung diseases | Asthma | Pulmonary Hypertension

    Datatype

    boolean

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

    Heart Disease

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0018799
    female genital organ
    Beschrijving

    Female genitalia

    Datatype

    boolean

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

    Systolic Pressure Post Rest Lengthened

    Datatype

    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.
    Beschrijving

    Drug Allergy | Hypersensitivity Bosentan | Hypersensitivity Bosentan Tablet Excipient

    Datatype

    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.
    Beschrijving

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

    Datatype

    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.
    Beschrijving

    Systemic disease | Systemic disease chronic

    Datatype

    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.
    Beschrijving

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

    Datatype

    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.
    Beschrijving

    Alcohol abuse | Toxin Abuse

    Datatype

    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.
    Beschrijving

    Concomitant Agent

    Datatype

    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.
    Beschrijving

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

    Datatype

    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).
    Beschrijving

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

    Datatype

    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.
    Beschrijving

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

    Datatype

    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
    Beschrijving

    ST. JOHN'S WORT

    Datatype

    boolean

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

    Blood Donation

    Datatype

    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.
    Beschrijving

    Study Subject Participation Status Exclusion

    Datatype

    boolean

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

    Informed Consent Refused | Informed Consent Unable

    Datatype

    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
    Beschrijving

    Protocol Compliance Unable

    Datatype

    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 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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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