ID

25140

Descripción

Safety Study of Gleevec® in Children With Pulmonary Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00583115

Link

https://clinicaltrials.gov/show/NCT00583115

Palabras clave

Versiones (1)
  1. 27/08/2017 27/08/2017 -
Subido en

27 août 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Eligibility Pulmonary Hypertension NCT00583115

Inglés

Eligibility Pulmonary Hypertension NCT00583115

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male and female patients between the ages of 8 -18 years of age.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. diagnosis of idiopathic (or primary) pulmonary arterial hypertension according to the venice classification system (2003).54, 55
Descripción

Idiopathic pulmonary arterial hypertension | Primary pulmonary hypertension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3203102
UMLS CUI [2]
C0152171
3. functional classification of who class iii - iv.
Descripción

Pulmonary arterial hypertension WHO classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C4267671
4. pulmonary vascular resistance (pvr) >300 dynes / sec / cm5.
Descripción

Pulmonary Vascular Resistance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0456261
5. ipah medications stable for at least 3 mo prior to baseline visit.
Descripción

IPAH Pharmaceutical Preparations Stable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0152171
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0205360
6. female patients of child bearing potential who are sexually active must have negative pregnancy test within 7 days prior to initiation of study drug and use a double-barrier local contraception, i.e., intra-uterine device plus condom, or spermicidal gel plus condom up to the study completion visit.
Descripción

Childbearing Potential Sexually active Pregnancy test negative | Childbearing Potential Sexually active Barrier Contraception Double | Intrauterine Devices | Female Condoms | Vaginal Spermicides

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0004764
UMLS CUI [2,4]
C0205173
UMLS CUI [3]
C0021900
UMLS CUI [4]
C0221829
UMLS CUI [5]
C0087145
7. able to communicate well with the investigator, to understand and comply with the requirements of the study. able to verbalize understanding and sign the written informed assent.
Descripción

Protocol Compliance | Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
8. parents, or legal guardians, must be able to communicate well with the investigator, to understand and comply with the requirements of the study. they must verbalize understanding and sign the written informed consent statement.
Descripción

Protocol Compliance Parent | Informed Consent Parent | Protocol Compliance Legal Guardians | Informed Consent Legal Guardians

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030551
UMLS CUI [3,1]
C0525058
UMLS CUI [3,2]
C0023226
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C0023226
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pre-existing lung disease including parasitic diseases affecting lungs, bronchial asthma, congenital abnormalities of the lungs, thorax and diaphragm.
Descripción

Lung disease Pre-existing | Parasitic Diseases Affecting Lungs | Asthma | Congenital anomaly of lung | Congenital anomaly of thorax | Congenital anomaly of diaphragm

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C0030499
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0024109
UMLS CUI [3]
C0004096
UMLS CUI [4]
C0158644
UMLS CUI [5]
C1285210
UMLS CUI [6]
C0158782
2. congenital heart disease, left ventricular failure, or left-sided obstructive lesion (pulmonary venous hypertension with pulmonary capillary wedge pressure > 12 mmhg) detected at right heart catheterization.
Descripción

Congenital heart disease | Left-Sided Heart Failure | Obstructive lesion Left sided | Pulmonary Hypertension Venous | Pulmonary Capillary Wedge Pressure | Catheterization of right heart

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0152021
UMLS CUI [2]
C0023212
UMLS CUI [3,1]
C3872566
UMLS CUI [3,2]
C0443246
UMLS CUI [4,1]
C0020542
UMLS CUI [4,2]
C0348013
UMLS CUI [5]
C0086879
UMLS CUI [6]
C0189896
3. chronic thromboembolic pulmonary hypertension, congenital or acquired deficiencies of blood coagulation, deficient thrombocyte function, thrombocytopenia < 40,000/μl, or sickle cell anemia.
Descripción

Chronic thromboembolic pulmonary hypertension | Blood Coagulation Disorders, Inherited | Blood Coagulation Disorders Acquired | Blood Platelet Disorders | Thrombocytopenia | Anemia, Sickle Cell

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2363973
UMLS CUI [2]
C0852077
UMLS CUI [3,1]
C0005779
UMLS CUI [3,2]
C0439661
UMLS CUI [4]
C0005818
UMLS CUI [5]
C0040034
UMLS CUI [6]
C0002895
4. pregnancy, breast feeding, or lack of safe contraception (hormonal contraception, iud, bilateral tubal ligation, hysterectomy) in premenopausal women.
Descripción

Pregnancy | Breast Feeding | Premenopausal state Contraceptive methods Lacking | Hormonal contraception | IUD | Bilateral tubal ligation | Hysterectomy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0232969
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332268
UMLS CUI [4]
C2985296
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0589114
UMLS CUI [7]
C0020699
5. hepatic insufficiency with transaminase levels >4-fold the upper limit of normal, or a bilirubin > 2-fold the upper limit of normal.
Descripción

Hepatic Insufficiency | Transaminases increased | Elevated total bilirubin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1306571
UMLS CUI [2]
C0438717
UMLS CUI [3]
C0741494
6. renal insufficiency (serum creatinine > 200 μmol/l).
Descripción

Renal Insufficiency | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
7. history of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). a known hypersensitivity to the study drug, or drugs similar to the study drug.
Descripción

Drug Allergy | Atopy | Asthma | Urticaria | Eczema | Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Similar

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013182
UMLS CUI [2]
C0392707
UMLS CUI [3]
C0004096
UMLS CUI [4]
C0042109
UMLS CUI [5]
C0013595
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0013230
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0013227
UMLS CUI [7,3]
C2348205
8. previous therapeutic radiation of lungs or mediastinum.
Descripción

Radiotherapy to lung | Radiotherapy to mediastinum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948315
UMLS CUI [2]
C4049191
9. participation in any treatment studies within 3 months prior to dosing, or longer if required by local regulations, and for any other limitation of participation based on local regulations.
Descripción

Study Subject Participation Status | Participation Limitation Due to Regulation Local

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C0449295
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0851285
UMLS CUI [2,5]
C0205276
10. history of immunodeficiency diseases, including a positive hiv (elisa and western blot) test result, or a positive hepatitis b surface antigen (hbsag), or positive hepatitis c test result.
Descripción

Immunologic Deficiency Syndromes | HIV Seropositivity ELISA | HIV Seropositivity Western blot for HIV | Hepatitis B surface antigen positive | Hepatitis C test positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021051
UMLS CUI [2,1]
C0019699
UMLS CUI [2,2]
C0014441
UMLS CUI [3,1]
C0019699
UMLS CUI [3,2]
C0860963
UMLS CUI [4]
C0149709
UMLS CUI [5]
C1609517
11. any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs, such as a history of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding, or a history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection.
Descripción

Surgical aspects Changing Drug absorption | Surgical aspects Changing Drug distribution | Surgical aspects Changing Drug metabolism | Surgical aspects Changing Drug elimination | Medical condition Changing Drug absorption | Medical condition Changing Drug distribution | Medical condition Changing Drug metabolism | Medical condition Changing Drug elimination | Inflammatory Bowel Diseases | Gastritis | Ulcer | Gastrointestinal Hemorrhage | Rectal hemorrhage | Operation on gastrointestinal tract Major | Gastrectomy | Gastroenterostomy | Bowel resection

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0038895
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C0038895
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0699903
UMLS CUI [3,1]
C0038895
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C0683140
UMLS CUI [4,1]
C0038895
UMLS CUI [4,2]
C0392747
UMLS CUI [4,3]
C0683141
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0392747
UMLS CUI [5,3]
C0678745
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0392747
UMLS CUI [6,3]
C0699903
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C0392747
UMLS CUI [7,3]
C0683140
UMLS CUI [8,1]
C3843040
UMLS CUI [8,2]
C0392747
UMLS CUI [8,3]
C0683141
UMLS CUI [9]
C0021390
UMLS CUI [10]
C0017152
UMLS CUI [11]
C0041582
UMLS CUI [12]
C0017181
UMLS CUI [13]
C0267596
UMLS CUI [14,1]
C0399610
UMLS CUI [14,2]
C0205164
UMLS CUI [15]
C0017118
UMLS CUI [16]
C0017164
UMLS CUI [17]
C0741614
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Similar models

Eligibility Pulmonary Hypertension NCT00583115

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. male and female patients between the ages of 8 -18 years of age.
boolean
C0001779 (UMLS CUI [1])
Idiopathic pulmonary arterial hypertension | Primary pulmonary hypertension
Item
2. diagnosis of idiopathic (or primary) pulmonary arterial hypertension according to the venice classification system (2003).54, 55
boolean
C3203102 (UMLS CUI [1])
C0152171 (UMLS CUI [2])
Pulmonary arterial hypertension WHO classification
Item
3. functional classification of who class iii - iv.
boolean
C2973725 (UMLS CUI [1,1])
C4267671 (UMLS CUI [1,2])
Pulmonary Vascular Resistance
Item
4. pulmonary vascular resistance (pvr) >300 dynes / sec / cm5.
boolean
C0456261 (UMLS CUI [1])
IPAH Pharmaceutical Preparations Stable
Item
5. ipah medications stable for at least 3 mo prior to baseline visit.
boolean
C0152171 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Childbearing Potential Sexually active Pregnancy test negative | Childbearing Potential Sexually active Barrier Contraception Double | Intrauterine Devices | Female Condoms | Vaginal Spermicides
Item
6. female patients of child bearing potential who are sexually active must have negative pregnancy test within 7 days prior to initiation of study drug and use a double-barrier local contraception, i.e., intra-uterine device plus condom, or spermicidal gel plus condom up to the study completion visit.
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0427780 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0004764 (UMLS CUI [2,3])
C0205173 (UMLS CUI [2,4])
C0021900 (UMLS CUI [3])
C0221829 (UMLS CUI [4])
C0087145 (UMLS CUI [5])
Protocol Compliance | Informed Consent
Item
7. able to communicate well with the investigator, to understand and comply with the requirements of the study. able to verbalize understanding and sign the written informed assent.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Protocol Compliance Parent | Informed Consent Parent | Protocol Compliance Legal Guardians | Informed Consent Legal Guardians
Item
8. parents, or legal guardians, must be able to communicate well with the investigator, to understand and comply with the requirements of the study. they must verbalize understanding and sign the written informed consent statement.
boolean
C0525058 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3,1])
C0023226 (UMLS CUI [3,2])
C0021430 (UMLS CUI [4,1])
C0023226 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Lung disease Pre-existing | Parasitic Diseases Affecting Lungs | Asthma | Congenital anomaly of lung | Congenital anomaly of thorax | Congenital anomaly of diaphragm
Item
1. pre-existing lung disease including parasitic diseases affecting lungs, bronchial asthma, congenital abnormalities of the lungs, thorax and diaphragm.
boolean
C0024115 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0030499 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0024109 (UMLS CUI [2,3])
C0004096 (UMLS CUI [3])
C0158644 (UMLS CUI [4])
C1285210 (UMLS CUI [5])
C0158782 (UMLS CUI [6])
Congenital heart disease | Left-Sided Heart Failure | Obstructive lesion Left sided | Pulmonary Hypertension Venous | Pulmonary Capillary Wedge Pressure | Catheterization of right heart
Item
2. congenital heart disease, left ventricular failure, or left-sided obstructive lesion (pulmonary venous hypertension with pulmonary capillary wedge pressure > 12 mmhg) detected at right heart catheterization.
boolean
C0152021 (UMLS CUI [1])
C0023212 (UMLS CUI [2])
C3872566 (UMLS CUI [3,1])
C0443246 (UMLS CUI [3,2])
C0020542 (UMLS CUI [4,1])
C0348013 (UMLS CUI [4,2])
C0086879 (UMLS CUI [5])
C0189896 (UMLS CUI [6])
Chronic thromboembolic pulmonary hypertension | Blood Coagulation Disorders, Inherited | Blood Coagulation Disorders Acquired | Blood Platelet Disorders | Thrombocytopenia | Anemia, Sickle Cell
Item
3. chronic thromboembolic pulmonary hypertension, congenital or acquired deficiencies of blood coagulation, deficient thrombocyte function, thrombocytopenia < 40,000/μl, or sickle cell anemia.
boolean
C2363973 (UMLS CUI [1])
C0852077 (UMLS CUI [2])
C0005779 (UMLS CUI [3,1])
C0439661 (UMLS CUI [3,2])
C0005818 (UMLS CUI [4])
C0040034 (UMLS CUI [5])
C0002895 (UMLS CUI [6])
Pregnancy | Breast Feeding | Premenopausal state Contraceptive methods Lacking | Hormonal contraception | IUD | Bilateral tubal ligation | Hysterectomy
Item
4. pregnancy, breast feeding, or lack of safe contraception (hormonal contraception, iud, bilateral tubal ligation, hysterectomy) in premenopausal women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0232969 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
C2985296 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0589114 (UMLS CUI [6])
C0020699 (UMLS CUI [7])
Hepatic Insufficiency | Transaminases increased | Elevated total bilirubin
Item
5. hepatic insufficiency with transaminase levels >4-fold the upper limit of normal, or a bilirubin > 2-fold the upper limit of normal.
boolean
C1306571 (UMLS CUI [1])
C0438717 (UMLS CUI [2])
C0741494 (UMLS CUI [3])
Renal Insufficiency | Creatinine measurement, serum
Item
6. renal insufficiency (serum creatinine > 200 μmol/l).
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Drug Allergy | Atopy | Asthma | Urticaria | Eczema | Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Similar
Item
7. history of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). a known hypersensitivity to the study drug, or drugs similar to the study drug.
boolean
C0013182 (UMLS CUI [1])
C0392707 (UMLS CUI [2])
C0004096 (UMLS CUI [3])
C0042109 (UMLS CUI [4])
C0013595 (UMLS CUI [5])
C0020517 (UMLS CUI [6,1])
C0013230 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0013227 (UMLS CUI [7,2])
C2348205 (UMLS CUI [7,3])
Radiotherapy to lung | Radiotherapy to mediastinum
Item
8. previous therapeutic radiation of lungs or mediastinum.
boolean
C0948315 (UMLS CUI [1])
C4049191 (UMLS CUI [2])
Study Subject Participation Status | Participation Limitation Due to Regulation Local
Item
9. participation in any treatment studies within 3 months prior to dosing, or longer if required by local regulations, and for any other limitation of participation based on local regulations.
boolean
C2348568 (UMLS CUI [1])
C0679823 (UMLS CUI [2,1])
C0449295 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0851285 (UMLS CUI [2,4])
C0205276 (UMLS CUI [2,5])
Immunologic Deficiency Syndromes | HIV Seropositivity ELISA | HIV Seropositivity Western blot for HIV | Hepatitis B surface antigen positive | Hepatitis C test positive
Item
10. history of immunodeficiency diseases, including a positive hiv (elisa and western blot) test result, or a positive hepatitis b surface antigen (hbsag), or positive hepatitis c test result.
boolean
C0021051 (UMLS CUI [1])
C0019699 (UMLS CUI [2,1])
C0014441 (UMLS CUI [2,2])
C0019699 (UMLS CUI [3,1])
C0860963 (UMLS CUI [3,2])
C0149709 (UMLS CUI [4])
C1609517 (UMLS CUI [5])
Surgical aspects Changing Drug absorption | Surgical aspects Changing Drug distribution | Surgical aspects Changing Drug metabolism | Surgical aspects Changing Drug elimination | Medical condition Changing Drug absorption | Medical condition Changing Drug distribution | Medical condition Changing Drug metabolism | Medical condition Changing Drug elimination | Inflammatory Bowel Diseases | Gastritis | Ulcer | Gastrointestinal Hemorrhage | Rectal hemorrhage | Operation on gastrointestinal tract Major | Gastrectomy | Gastroenterostomy | Bowel resection
Item
11. any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs, such as a history of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding, or a history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection.
boolean
C0038895 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0038895 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0699903 (UMLS CUI [2,3])
C0038895 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0683140 (UMLS CUI [3,3])
C0038895 (UMLS CUI [4,1])
C0392747 (UMLS CUI [4,2])
C0683141 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C0392747 (UMLS CUI [5,2])
C0678745 (UMLS CUI [5,3])
C3843040 (UMLS CUI [6,1])
C0392747 (UMLS CUI [6,2])
C0699903 (UMLS CUI [6,3])
C3843040 (UMLS CUI [7,1])
C0392747 (UMLS CUI [7,2])
C0683140 (UMLS CUI [7,3])
C3843040 (UMLS CUI [8,1])
C0392747 (UMLS CUI [8,2])
C0683141 (UMLS CUI [8,3])
C0021390 (UMLS CUI [9])
C0017152 (UMLS CUI [10])
C0041582 (UMLS CUI [11])
C0017181 (UMLS CUI [12])
C0267596 (UMLS CUI [13])
C0399610 (UMLS CUI [14,1])
C0205164 (UMLS CUI [14,2])
C0017118 (UMLS CUI [15])
C0017164 (UMLS CUI [16])
C0741614 (UMLS CUI [17])
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