0 Beoordelingen

ID

17757

Beschrijving

Endothelial Cell Dysfunction in Pulmonary Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00098072

Link

https://clinicaltrials.gov/show/NCT00098072

Trefwoorden

  1. 29-09-16 29-09-16 -
  2. 02-10-16 02-10-16 -
Geüploaded op

2 oktober 2016

DOI

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Licentie

Creative Commons BY 4.0

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    Eligibility Hypertension, Pulmonary NCT00098072

    Eligibility Hypertension, Pulmonary NCT00098072

    Criteria
    Beschrijving

    Criteria

    pilot: the pilot study will enroll two groups of individuals: 1) patients who have either ipah or a secondary form known to have similar histopathology (pah), and 2) age, gender, and race matched control subjects for each patient.
    Beschrijving

    Pilot Project | Idiopathic pulmonary hypertension | Pulmonary arterial hypertension | Age | Gender | Racial group

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0031928
    UMLS CUI [2]
    C0152171
    UMLS CUI [3]
    C2973725
    UMLS CUI [4]
    C0001779
    UMLS CUI [5]
    C0079399
    UMLS CUI [6]
    C0034510
    main: the main study will enroll three groups of individuals: 1) patients who have either ipah or a secondary form known to have similar histopathology (pah), 2) patients with ph ascribed to a nonvascular injury process, and 3) age, gender, and race matched control subjects for each pah patient. subjects must be at least 18 years of age and must be able to provide informed, written consent for participation in this study. there is no exclusion based on race or gender.
    Beschrijving

    Clinical Trial Main | Idiopathic pulmonary hypertension | Pulmonary arterial hypertension | Pulmonary Hypertension Associated with Vascular System Injuries | Age | Gender | Racial group | Informed Consent

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C1542147
    UMLS CUI [2]
    C0152171
    UMLS CUI [3]
    C2973725
    UMLS CUI [4,1]
    C0020542
    UMLS CUI [4,2]
    C0332281
    UMLS CUI [4,3]
    C0178324
    UMLS CUI [5]
    C0001779
    UMLS CUI [6]
    C0079399
    UMLS CUI [7]
    C0034510
    UMLS CUI [8]
    C0021430
    inclusion criteria for pulmonary arterial hypertension patients:
    Beschrijving

    Inclusion criteria Pulmonary arterial hypertension

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C2973725
    the inclusion criteria for this study are as follows:
    Beschrijving

    Inclusion criteria

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1512693
    1. patients diagnosed with ipah
    Beschrijving

    Idiopathic pulmonary hypertension

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0152171
    2. patients diagnosed with secondary pulmonary hypertension known to have histopathology similar to the primary form or pah. clinical conditions causing pulmonary hypertension with histopathology similar to the primary form are listed below.
    Beschrijving

    Secondary pulmonary hypertension | Histopathology Similar Pulmonary Hypertension | Histopathology Similar Pulmonary arterial hypertension

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0264936
    UMLS CUI [2,1]
    C0428093
    UMLS CUI [2,2]
    C2348205
    UMLS CUI [2,3]
    C0020542
    UMLS CUI [3,1]
    C0428093
    UMLS CUI [3,2]
    C2348205
    UMLS CUI [3,3]
    C2973725
    i. eisenmenger syndrome
    Beschrijving

    Eisenmenger Complex

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0013743
    ii. collagen vascular disease
    Beschrijving

    Collagen-vascular disease

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0262428
    iii liver disease with portal hypertension
    Beschrijving

    Liver disease | Portal Hypertension

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0023895
    UMLS CUI [2]
    C0020541
    iv. toxin induced injury (anorexic agents, rapeseed oil)
    Beschrijving

    Injury caused by Toxin | Appetite Depressants | Brassica Napus Oil

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C3263723
    UMLS CUI [1,2]
    C0015127
    UMLS CUI [1,3]
    C0040549
    UMLS CUI [2]
    C0003620
    UMLS CUI [3]
    C0072982
    v. hiv disease
    Beschrijving

    HIV Infection

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    vi. sickle cell disease
    Beschrijving

    Anemia, Sickle Cell

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0002895
    exclusion criteria for patients with pulmonary arterial hypertension:
    Beschrijving

    Exclusion Criteria Pulmonary arterial hypertension

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0680251
    UMLS CUI [1,2]
    C2973725
    1. pregnant women (all women of childbearing age will be required to have a screening urine or blood pregnancy test)
    Beschrijving

    Pregnancy | Childbearing Potential Urine pregnancy test | Childbearing Potential pregnancy blood test

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2,1]
    C3831118
    UMLS CUI [2,2]
    C0430056
    UMLS CUI [3,1]
    C3831118
    UMLS CUI [3,2]
    C0850355
    2. age less than 18 years
    Beschrijving

    Age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    3. inability to provide informed written consent for participation in the study
    Beschrijving

    Informed Consent Unable

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C1299582
    4. mean pa less than or equal to 25mmhg or pvr less than 3 wood units
    Beschrijving

    Mean pulmonary arterial pressure | Pulmonary Vascular Resistance

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3854605
    UMLS CUI [2]
    C0456261
    5. pcw greater than 16 mmhg unless increase accounted for by increased transpulmonary gradient greater than or equal to 10 mmhg
    Beschrijving

    Pulmonary Capillary Wedge Pressure | Increased pulmonary arterial wedge pressure

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0086879
    UMLS CUI [2]
    C0520850
    6. patients receiving more than 1 year of oral therapy or more than 6 months of iv therapy.
    Beschrijving

    Oral administration of treatment | Intravenous therapy

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1273553
    UMLS CUI [2]
    C0455142
    inclusion criteria for patients with nonvascular injury-induced pulmonary hypertension:
    Beschrijving

    Inclusion criteria Pulmonary Hypertension caused by Vascular System Injuries

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C0020542
    UMLS CUI [1,3]
    C0015127
    UMLS CUI [1,4]
    C0178324
    the inclusion criteria are as follows:
    Beschrijving

    Inclusion criteria

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1512693
    patients diagnosed with pulmonary hypertension not known to have histopathology similar to the primary form. etiologies are listed below.
    Beschrijving

    Secondary pulmonary hypertension | Histopathology Similar Pulmonary Hypertension | Etiology aspects

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0264936
    UMLS CUI [2,1]
    C0428093
    UMLS CUI [2,2]
    C2348205
    UMLS CUI [2,3]
    C0020542
    UMLS CUI [3]
    C0015127
    1. congenital or acquired valvular or myocardial disease
    Beschrijving

    Valvular disease | Cardiomyopathies

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3258293
    UMLS CUI [2]
    C0878544
    2. pulmonary parasitic diseases
    Beschrijving

    Lung Diseases, Parasitic

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0024118
    3. arterial hypoxemia with hypercapnea
    Beschrijving

    Hypoxemia | Hypercapnia

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0700292
    UMLS CUI [2]
    C0020440
    4. copd with hypoxemia and forced expiratory volume/forced vital capacity (fev1/fvc) greater than 2 standard deviations from normal
    Beschrijving

    Chronic Obstructive Airway Disease | Hypoxemia | FEV1/FVC ratio abnormal

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0024117
    UMLS CUI [2]
    C0700292
    UMLS CUI [3]
    C0438193
    5. interstitial lung disease with reduced total lung capacity greater than 2 standard deviations from normal and infiltrates on chest x-ray
    Beschrijving

    Lung Diseases, Interstitial | Decreased total lung capacity | Plain chest X-ray Infiltration

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0206062
    UMLS CUI [2]
    C0520829
    UMLS CUI [3,1]
    C0039985
    UMLS CUI [3,2]
    C0332448
    6. pulmonary thromboembolic disease as evidenced by lung perfusion scan or pulmonary angiogram, or intravenous drug abuse
    Beschrijving

    Thromboembolism Pulmonary Evidence | Lung Perfusion Scan | Pulmonary angiogram | Intravenous Drug Abuse

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0040038
    UMLS CUI [1,2]
    C2709248
    UMLS CUI [1,3]
    C3887511
    UMLS CUI [2]
    C1518040
    UMLS CUI [3]
    C0677490
    UMLS CUI [4]
    C0086181
    7. pulmonary hypertension due to congenital abnormalities of the lungs, thorax and diaphragm
    Beschrijving

    Pulmonary Hypertension Due to Lung Congenital Abnormality | Pulmonary Hypertension Due to Chest Congenital Abnormality | Pulmonary Hypertension Due to Diaphragm Congenital Abnormality

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0020542
    UMLS CUI [1,2]
    C0678226
    UMLS CUI [1,3]
    C0024109
    UMLS CUI [1,4]
    C0000768
    UMLS CUI [2,1]
    C0020542
    UMLS CUI [2,2]
    C0678226
    UMLS CUI [2,3]
    C0817096
    UMLS CUI [2,4]
    C0000768
    UMLS CUI [3,1]
    C0020542
    UMLS CUI [3,2]
    C0678226
    UMLS CUI [3,3]
    C0011980
    UMLS CUI [3,4]
    C0000768
    exclusion criteria for patients with nonvascular injury induced pulmonary hypertension:
    Beschrijving

    Exclusion Criteria Pulmonary Hypertension caused by Vascular System Injuries

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0680251
    UMLS CUI [1,2]
    C0020542
    UMLS CUI [1,3]
    C0015127
    UMLS CUI [1,4]
    C0178324
    1. pregnant women (all women of childbearing age will be required to have a screening urine or blood pregnancy test)
    Beschrijving

    Pregnancy | Childbearing Potential Urine pregnancy test | Childbearing Potential pregnancy blood test

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2,1]
    C3831118
    UMLS CUI [2,2]
    C0430056
    UMLS CUI [3,1]
    C3831118
    UMLS CUI [3,2]
    C0850355
    2. age less than 18 years
    Beschrijving

    Age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    3. inability to provide informed written consent for participation in the study
    Beschrijving

    Informed Consent Unable

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C1299582
    4. mean pa less than or equal to 25mmhg or pvr less than 3 wood units
    Beschrijving

    Mean pulmonary arterial pressure | Pulmonary Vascular Resistance

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3854605
    UMLS CUI [2]
    C0456261
    exclusion criteria for mri in subjects with pulmonary hypertension:
    Beschrijving

    Exclusion Criteria MRI Pulmonary Hypertension

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0680251
    UMLS CUI [1,2]
    C0024485
    UMLS CUI [1,3]
    C0020542
    1) implanted cardiac pacemaker or defibrillator
    Beschrijving

    pacemaker implanted | defibrillator implanted

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0848753
    UMLS CUI [2]
    C0850291
    2) central nervous system aneurysm clips
    Beschrijving

    Aneurysm clip Central Nervous System

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0179977
    UMLS CUI [1,2]
    C3714787
    3) cochlear implants
    Beschrijving

    Cochlear Implants

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0009199
    4) neural stimulator
    Beschrijving

    Neurostimulator

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0582124
    5) ocular foreign body (e.g. metal shavings)
    Beschrijving

    Ocular Foreign Body

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3898107
    6) insulin pump
    Beschrijving

    Insulin pump

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1140609
    7) metal shrapnel or bullets
    Beschrijving

    Shrapnel | Bullet

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0522670
    UMLS CUI [2]
    C0336699
    8) claustrophobia.
    Beschrijving

    Claustrophobia

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0008909
    furthermore, the following patient groups will be excluded from studies involving the administration of mri contrast agents:
    Beschrijving

    Involvement with Magnetic resonance imaging contrast media

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1314939
    UMLS CUI [1,2]
    C0180108
    1) lactating women
    Beschrijving

    Breast Feeding

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0006147
    2) renal disease (crcl less than 20 ml/min)
    Beschrijving

    Kidney Diseases | Creatinine clearance measurement

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0022658
    UMLS CUI [2]
    C0373595
    the creatinine clearance (crcl) will be calculated using the cockroft formula where age is in years, kg is weight in kilograms, and cr is the serum creatinine. if there is no history of kidney disease from the patient or referring physician, additional testing will not be performed. if a patient has a history of renal insufficiency, a recent blood cr will be used unless the physician performing the test believes the cr may have changed since the last test. if the cr may have changed, a blood sample will be obtained for cr or the subject will be excluded from receiving gadolinium.
    Beschrijving

    Estimation of creatinine clearance by Cockcroft-Gault formula | Kidney Diseases | Renal Insufficiency | Creatinine measurement | Gadolinium Receive

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2711451
    UMLS CUI [2]
    C0022658
    UMLS CUI [3]
    C1565489
    UMLS CUI [4]
    C0201975
    UMLS CUI [5,1]
    C0016911
    UMLS CUI [5,2]
    C1514756
    crcl = (140-age) (wt in kg)/72 x serum cr (mg/dl) for men
    Beschrijving

    Creatinine clearance | Age | Body Weight | Serum creatinine | Gender

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0812399
    UMLS CUI [2]
    C0001779
    UMLS CUI [3]
    C0005910
    UMLS CUI [4]
    C0600061
    UMLS CUI [5]
    C0079399
    crcl = (0.85) (140-age) (kg)/72 x serum cr (mg/dl) for women
    Beschrijving

    Creatinine clearance | Age | Body Weight | Serum creatinine | Gender

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0812399
    UMLS CUI [2]
    C0001779
    UMLS CUI [3]
    C0005910
    UMLS CUI [4]
    C0600061
    UMLS CUI [5]
    C0079399
    inclusion criteria for control subjects:
    Beschrijving

    Inclusion criteria Control Group

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C0009932
    1. any healthy man or woman who is the appropriate age, race, and gender for matching to a pah patient
    Beschrijving

    Healthy Volunteers | Age | Racial group | Gender | Pulmonary arterial hypertension

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1708335
    UMLS CUI [2]
    C0001779
    UMLS CUI [3]
    C0034510
    UMLS CUI [4]
    C0079399
    UMLS CUI [5]
    C2973725
    2. no history of hiv infection
    Beschrijving

    HIV Infections

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    3. ekg and echocardiogram with no evidence of clinically relevant heart disease
    Beschrijving

    Heart Disease Relevant Clinical Evidence | Electrocardiography | Echocardiography

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0018799
    UMLS CUI [1,2]
    C2347946
    UMLS CUI [1,3]
    C0205210
    UMLS CUI [1,4]
    C3887511
    UMLS CUI [2]
    C1623258
    UMLS CUI [3]
    C0013516
    4. spirometry with no evidence of clinically relevant lung disease
    Beschrijving

    Lung disease Relevant Clinical Evidence | Spirometry

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0024115
    UMLS CUI [1,2]
    C2347946
    UMLS CUI [1,3]
    C0205210
    UMLS CUI [1,4]
    C3887511
    UMLS CUI [2]
    C0037981
    5. no history of causes of pulmonary hypertension such as collagen vascular disease, chronic liver disease with alt or ast greater than 2 times the upper limit of normal or cirrhosis of the liver, chronic thromboembolic disease, congenital heart defects, or pulmonary parenchymal disease with hypoxemia
    Beschrijving

    Pulmonary Hypertension Cause | Collagen-vascular disease | Chronic liver disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Liver Cirrhosis | Thromboembolism chronic | Congenital Heart Defects | Interstitial Lung Diseases | Hypoxemia

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0020542
    UMLS CUI [1,2]
    C0015127
    UMLS CUI [2]
    C0262428
    UMLS CUI [3]
    C0341439
    UMLS CUI [4]
    C0201836
    UMLS CUI [5]
    C0201899
    UMLS CUI [6]
    C0023890
    UMLS CUI [7,1]
    C0040038
    UMLS CUI [7,2]
    C0205191
    UMLS CUI [8]
    C0018798
    UMLS CUI [9]
    C0206062
    UMLS CUI [10]
    C0700292
    6. no history of diseases thought to be related to development of endothelial dysfunction including systemic hypertension or diabetes requiring drug therapy, hypercholesterolemia and obesity
    Beschrijving

    Disease Related Endothelial dysfunction | Hypertensive disease Requirement Pharmacotherapy | Diabetes Mellitus Requirement Pharmacotherapy | Hypercholesterolemia | Obesity

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0439849
    UMLS CUI [1,3]
    C0856169
    UMLS CUI [2,1]
    C0020538
    UMLS CUI [2,2]
    C1514873
    UMLS CUI [2,3]
    C0013216
    UMLS CUI [3,1]
    C0011849
    UMLS CUI [3,2]
    C1514873
    UMLS CUI [3,3]
    C0013216
    UMLS CUI [4]
    C0020443
    UMLS CUI [5]
    C0028754
    7. no history of anemia, thrombocytopenia or coagulopathy
    Beschrijving

    Anemia | Thrombocytopenia | Blood Coagulation Disorders

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0002871
    UMLS CUI [2]
    C0040034
    UMLS CUI [3]
    C0005779
    8. no history of renal insufficiency
    Beschrijving

    Renal Insufficiency

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1565489
    9. no medical conditions requiring chronic medication use with the exception of:
    Beschrijving

    medical condition Requirement Pharmaceutical Preparations chronic

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0013227
    UMLS CUI [1,4]
    C0205191
    a. heartburn, gerd
    Beschrijving

    Heartburn | Gastroesophageal reflux disease

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0018834
    UMLS CUI [2]
    C0017168
    b. environmental allergies, post nasal drip or non-allergic rhinitis
    Beschrijving

    Environmental Illness | Posterior rhinorrhea | Non-allergic rhinitis

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0282504
    UMLS CUI [2]
    C0032781
    UMLS CUI [3]
    C3472698
    c. asthma with no history of oral steroid use, weekly inhaled steroids, or hospitalization for asthma exacerbation
    Beschrijving

    Asthma | Oral steroid therapy | inhaled steroids | Hospitalization Exacerbation of asthma

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0004096
    UMLS CUI [2]
    C0574135
    UMLS CUI [3]
    C2065041
    UMLS CUI [4,1]
    C0019993
    UMLS CUI [4,2]
    C0349790
    d. dermatologic conditions that do not require the use of oral steroids or other immunosuppressants
    Beschrijving

    Dermatologic disorders Requirement Oral steroid therapy | Dermatologic disorders Requirement Immunosuppressive Agents

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0037274
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0574135
    UMLS CUI [2,1]
    C0037274
    UMLS CUI [2,2]
    C1514873
    UMLS CUI [2,3]
    C0021081
    e. treated and stable thyroid disease, depression, or anxiety.
    Beschrijving

    Thyroid Disease Treated Stable | Depressive disorder Treated Stable | Anxiety Treated Stable

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0040128
    UMLS CUI [1,2]
    C1522326
    UMLS CUI [1,3]
    C0205360
    UMLS CUI [2,1]
    C0011581
    UMLS CUI [2,2]
    C1522326
    UMLS CUI [2,3]
    C0205360
    UMLS CUI [3,1]
    C0003467
    UMLS CUI [3,2]
    C1522326
    UMLS CUI [3,3]
    C0205360
    10. no more than 20 cigarettes per years for the previous 2 years and no cigarette use for 30 days prior to the screening evaluation until completion of the study
    Beschrijving

    Cigarette Quantity per year | cigarette use

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0677453
    UMLS CUI [1,2]
    C1265611
    UMLS CUI [1,3]
    C0439508
    UMLS CUI [2]
    C0694535
    exclusion criteria for control subjects:
    Beschrijving

    Exclusion Criteria Control Group

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0680251
    UMLS CUI [1,2]
    C0009932
    1. current pregnancy, lactation or women not currently using medically acceptable birth control. (all women of childbearing age will be required to have a screening urine or blood pregnancy test)
    Beschrijving

    Pregnancy | Breast Feeding | Gender Contraceptive methods Inadequate | Childbearing Potential Urine pregnancy test | Childbearing Potential pregnancy blood test

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3,1]
    C0079399
    UMLS CUI [3,2]
    C0700589
    UMLS CUI [3,3]
    C0205412
    UMLS CUI [4,1]
    C3831118
    UMLS CUI [4,2]
    C0430056
    UMLS CUI [5,1]
    C3831118
    UMLS CUI [5,2]
    C0850355
    2. contraindication to mri scanning including individuals with the following devices:
    Beschrijving

    Medical contraindication Magnetic Resonance Imaging

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0024485
    a) implanted cardiac pacemaker or defibrillator
    Beschrijving

    pacemaker implanted | defibrillator implanted

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0848753
    UMLS CUI [2]
    C0850291
    b) central nervous system aneurysm clips
    Beschrijving

    Aneurysm clip Central Nervous System

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0179977
    UMLS CUI [1,2]
    C3714787
    c) cochlear implants
    Beschrijving

    Cochlear Implants

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0009199
    d) implanted neural stimulator
    Beschrijving

    Implanted Neurostimulators

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2048402
    e) ocular foreign body (e.g. metal shavings)
    Beschrijving

    Ocular Foreign Body

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3898107
    f) insulin pump
    Beschrijving

    Insulin pump

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1140609
    g) metal shrapnel or bullet
    Beschrijving

    Shrapnel | Bullet

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0522670
    UMLS CUI [2]
    C0336699
    h) claustophobia
    Beschrijving

    Claustrophobia

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0008909
    3. contraindications to mri contrast agent administration
    Beschrijving

    Medical contraindication Magnetic resonance imaging contrast media

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0180108
    4. inability to provide informed written consent for participation in the study
    Beschrijving

    Informed Consent Unable

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C1299582
    5. chronic, medically refractory atrial tacharrhythmias
    Beschrijving

    Tachyarrhythmia Atrial refractory chronic

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0080203
    UMLS CUI [1,2]
    C0018792
    UMLS CUI [1,3]
    C0205269
    UMLS CUI [1,4]
    C0205191
    6. symptoms of heart failure.
    Beschrijving

    Heart failure Symptoms

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0018801
    UMLS CUI [1,2]
    C1457887
    7. mean pa greater than 25mmhg or pvr greater than 1.5 wood units, or pcwp greater than 15 mmhg
    Beschrijving

    Pulmonary artery mean pressure | Pulmonary Vascular Resistance | Pulmonary Capillary Wedge Pressure

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0428645
    UMLS CUI [2]
    C0456261
    UMLS CUI [3]
    C0086879
    8. history of recreational drug use with the exception of marijuana. no marijuana use within 3 months of protocol screening through completion of the study.
    Beschrijving

    Drug abuse | Marijuana Smoking

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0013146
    UMLS CUI [2]
    C0024810
    9. intravenous drug abuse.
    Beschrijving

    Intravenous Drug Abuse

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0086181
    volunteers may be excluded if in the opinion of the study investigators they have a condition that may adversely affect the outcome of the study or the safety of the volunteer.
    Beschrijving

    Condition Affecting research results | Condition Affecting patient safety

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0348080
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C0683954
    UMLS CUI [2,1]
    C0348080
    UMLS CUI [2,2]
    C0392760
    UMLS CUI [2,3]
    C1113679

    Similar models

    Eligibility Hypertension, Pulmonary NCT00098072

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Pilot Project | Idiopathic pulmonary hypertension | Pulmonary arterial hypertension | Age | Gender | Racial group
    Item
    pilot: the pilot study will enroll two groups of individuals: 1) patients who have either ipah or a secondary form known to have similar histopathology (pah), and 2) age, gender, and race matched control subjects for each patient.
    boolean
    C0031928 (UMLS CUI [1])
    C0152171 (UMLS CUI [2])
    C2973725 (UMLS CUI [3])
    C0001779 (UMLS CUI [4])
    C0079399 (UMLS CUI [5])
    C0034510 (UMLS CUI [6])
    Clinical Trial Main | Idiopathic pulmonary hypertension | Pulmonary arterial hypertension | Pulmonary Hypertension Associated with Vascular System Injuries | Age | Gender | Racial group | Informed Consent
    Item
    main: the main study will enroll three groups of individuals: 1) patients who have either ipah or a secondary form known to have similar histopathology (pah), 2) patients with ph ascribed to a nonvascular injury process, and 3) age, gender, and race matched control subjects for each pah patient. subjects must be at least 18 years of age and must be able to provide informed, written consent for participation in this study. there is no exclusion based on race or gender.
    boolean
    C0008976 (UMLS CUI [1,1])
    C1542147 (UMLS CUI [1,2])
    C0152171 (UMLS CUI [2])
    C2973725 (UMLS CUI [3])
    C0020542 (UMLS CUI [4,1])
    C0332281 (UMLS CUI [4,2])
    C0178324 (UMLS CUI [4,3])
    C0001779 (UMLS CUI [5])
    C0079399 (UMLS CUI [6])
    C0034510 (UMLS CUI [7])
    C0021430 (UMLS CUI [8])
    Inclusion criteria Pulmonary arterial hypertension
    Item
    inclusion criteria for pulmonary arterial hypertension patients:
    boolean
    C1512693 (UMLS CUI [1,1])
    C2973725 (UMLS CUI [1,2])
    Inclusion criteria
    Item
    the inclusion criteria for this study are as follows:
    boolean
    C1512693 (UMLS CUI [1])
    Idiopathic pulmonary hypertension
    Item
    1. patients diagnosed with ipah
    boolean
    C0152171 (UMLS CUI [1])
    Secondary pulmonary hypertension | Histopathology Similar Pulmonary Hypertension | Histopathology Similar Pulmonary arterial hypertension
    Item
    2. patients diagnosed with secondary pulmonary hypertension known to have histopathology similar to the primary form or pah. clinical conditions causing pulmonary hypertension with histopathology similar to the primary form are listed below.
    boolean
    C0264936 (UMLS CUI [1])
    C0428093 (UMLS CUI [2,1])
    C2348205 (UMLS CUI [2,2])
    C0020542 (UMLS CUI [2,3])
    C0428093 (UMLS CUI [3,1])
    C2348205 (UMLS CUI [3,2])
    C2973725 (UMLS CUI [3,3])
    Eisenmenger Complex
    Item
    i. eisenmenger syndrome
    boolean
    C0013743 (UMLS CUI [1])
    Collagen-vascular disease
    Item
    ii. collagen vascular disease
    boolean
    C0262428 (UMLS CUI [1])
    Liver disease | Portal Hypertension
    Item
    iii liver disease with portal hypertension
    boolean
    C0023895 (UMLS CUI [1])
    C0020541 (UMLS CUI [2])
    Injury caused by Toxin | Appetite Depressants | Brassica Napus Oil
    Item
    iv. toxin induced injury (anorexic agents, rapeseed oil)
    boolean
    C3263723 (UMLS CUI [1,1])
    C0015127 (UMLS CUI [1,2])
    C0040549 (UMLS CUI [1,3])
    C0003620 (UMLS CUI [2])
    C0072982 (UMLS CUI [3])
    HIV Infection
    Item
    v. hiv disease
    boolean
    C0019693 (UMLS CUI [1])
    Anemia, Sickle Cell
    Item
    vi. sickle cell disease
    boolean
    C0002895 (UMLS CUI [1])
    Exclusion Criteria Pulmonary arterial hypertension
    Item
    exclusion criteria for patients with pulmonary arterial hypertension:
    boolean
    C0680251 (UMLS CUI [1,1])
    C2973725 (UMLS CUI [1,2])
    Pregnancy | Childbearing Potential Urine pregnancy test | Childbearing Potential pregnancy blood test
    Item
    1. pregnant women (all women of childbearing age will be required to have a screening urine or blood pregnancy test)
    boolean
    C0032961 (UMLS CUI [1])
    C3831118 (UMLS CUI [2,1])
    C0430056 (UMLS CUI [2,2])
    C3831118 (UMLS CUI [3,1])
    C0850355 (UMLS CUI [3,2])
    Age
    Item
    2. age less than 18 years
    boolean
    C0001779 (UMLS CUI [1])
    Informed Consent Unable
    Item
    3. inability to provide informed written consent for participation in the study
    boolean
    C0021430 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])
    Mean pulmonary arterial pressure | Pulmonary Vascular Resistance
    Item
    4. mean pa less than or equal to 25mmhg or pvr less than 3 wood units
    boolean
    C3854605 (UMLS CUI [1])
    C0456261 (UMLS CUI [2])
    Pulmonary Capillary Wedge Pressure | Increased pulmonary arterial wedge pressure
    Item
    5. pcw greater than 16 mmhg unless increase accounted for by increased transpulmonary gradient greater than or equal to 10 mmhg
    boolean
    C0086879 (UMLS CUI [1])
    C0520850 (UMLS CUI [2])
    Oral administration of treatment | Intravenous therapy
    Item
    6. patients receiving more than 1 year of oral therapy or more than 6 months of iv therapy.
    boolean
    C1273553 (UMLS CUI [1])
    C0455142 (UMLS CUI [2])
    Inclusion criteria Pulmonary Hypertension caused by Vascular System Injuries
    Item
    inclusion criteria for patients with nonvascular injury-induced pulmonary hypertension:
    boolean
    C1512693 (UMLS CUI [1,1])
    C0020542 (UMLS CUI [1,2])
    C0015127 (UMLS CUI [1,3])
    C0178324 (UMLS CUI [1,4])
    Inclusion criteria
    Item
    the inclusion criteria are as follows:
    boolean
    C1512693 (UMLS CUI [1])
    Secondary pulmonary hypertension | Histopathology Similar Pulmonary Hypertension | Etiology aspects
    Item
    patients diagnosed with pulmonary hypertension not known to have histopathology similar to the primary form. etiologies are listed below.
    boolean
    C0264936 (UMLS CUI [1])
    C0428093 (UMLS CUI [2,1])
    C2348205 (UMLS CUI [2,2])
    C0020542 (UMLS CUI [2,3])
    C0015127 (UMLS CUI [3])
    Valvular disease | Cardiomyopathies
    Item
    1. congenital or acquired valvular or myocardial disease
    boolean
    C3258293 (UMLS CUI [1])
    C0878544 (UMLS CUI [2])
    Lung Diseases, Parasitic
    Item
    2. pulmonary parasitic diseases
    boolean
    C0024118 (UMLS CUI [1])
    Hypoxemia | Hypercapnia
    Item
    3. arterial hypoxemia with hypercapnea
    boolean
    C0700292 (UMLS CUI [1])
    C0020440 (UMLS CUI [2])
    Chronic Obstructive Airway Disease | Hypoxemia | FEV1/FVC ratio abnormal
    Item
    4. copd with hypoxemia and forced expiratory volume/forced vital capacity (fev1/fvc) greater than 2 standard deviations from normal
    boolean
    C0024117 (UMLS CUI [1])
    C0700292 (UMLS CUI [2])
    C0438193 (UMLS CUI [3])
    Lung Diseases, Interstitial | Decreased total lung capacity | Plain chest X-ray Infiltration
    Item
    5. interstitial lung disease with reduced total lung capacity greater than 2 standard deviations from normal and infiltrates on chest x-ray
    boolean
    C0206062 (UMLS CUI [1])
    C0520829 (UMLS CUI [2])
    C0039985 (UMLS CUI [3,1])
    C0332448 (UMLS CUI [3,2])
    Thromboembolism Pulmonary Evidence | Lung Perfusion Scan | Pulmonary angiogram | Intravenous Drug Abuse
    Item
    6. pulmonary thromboembolic disease as evidenced by lung perfusion scan or pulmonary angiogram, or intravenous drug abuse
    boolean
    C0040038 (UMLS CUI [1,1])
    C2709248 (UMLS CUI [1,2])
    C3887511 (UMLS CUI [1,3])
    C1518040 (UMLS CUI [2])
    C0677490 (UMLS CUI [3])
    C0086181 (UMLS CUI [4])
    Pulmonary Hypertension Due to Lung Congenital Abnormality | Pulmonary Hypertension Due to Chest Congenital Abnormality | Pulmonary Hypertension Due to Diaphragm Congenital Abnormality
    Item
    7. pulmonary hypertension due to congenital abnormalities of the lungs, thorax and diaphragm
    boolean
    C0020542 (UMLS CUI [1,1])
    C0678226 (UMLS CUI [1,2])
    C0024109 (UMLS CUI [1,3])
    C0000768 (UMLS CUI [1,4])
    C0020542 (UMLS CUI [2,1])
    C0678226 (UMLS CUI [2,2])
    C0817096 (UMLS CUI [2,3])
    C0000768 (UMLS CUI [2,4])
    C0020542 (UMLS CUI [3,1])
    C0678226 (UMLS CUI [3,2])
    C0011980 (UMLS CUI [3,3])
    C0000768 (UMLS CUI [3,4])
    Exclusion Criteria Pulmonary Hypertension caused by Vascular System Injuries
    Item
    exclusion criteria for patients with nonvascular injury induced pulmonary hypertension:
    boolean
    C0680251 (UMLS CUI [1,1])
    C0020542 (UMLS CUI [1,2])
    C0015127 (UMLS CUI [1,3])
    C0178324 (UMLS CUI [1,4])
    Pregnancy | Childbearing Potential Urine pregnancy test | Childbearing Potential pregnancy blood test
    Item
    1. pregnant women (all women of childbearing age will be required to have a screening urine or blood pregnancy test)
    boolean
    C0032961 (UMLS CUI [1])
    C3831118 (UMLS CUI [2,1])
    C0430056 (UMLS CUI [2,2])
    C3831118 (UMLS CUI [3,1])
    C0850355 (UMLS CUI [3,2])
    Age
    Item
    2. age less than 18 years
    boolean
    C0001779 (UMLS CUI [1])
    Informed Consent Unable
    Item
    3. inability to provide informed written consent for participation in the study
    boolean
    C0021430 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])
    Mean pulmonary arterial pressure | Pulmonary Vascular Resistance
    Item
    4. mean pa less than or equal to 25mmhg or pvr less than 3 wood units
    boolean
    C3854605 (UMLS CUI [1])
    C0456261 (UMLS CUI [2])
    Exclusion Criteria MRI Pulmonary Hypertension
    Item
    exclusion criteria for mri in subjects with pulmonary hypertension:
    boolean
    C0680251 (UMLS CUI [1,1])
    C0024485 (UMLS CUI [1,2])
    C0020542 (UMLS CUI [1,3])
    pacemaker implanted | defibrillator implanted
    Item
    1) implanted cardiac pacemaker or defibrillator
    boolean
    C0848753 (UMLS CUI [1])
    C0850291 (UMLS CUI [2])
    Aneurysm clip Central Nervous System
    Item
    2) central nervous system aneurysm clips
    boolean
    C0179977 (UMLS CUI [1,1])
    C3714787 (UMLS CUI [1,2])
    Cochlear Implants
    Item
    3) cochlear implants
    boolean
    C0009199 (UMLS CUI [1])
    Neurostimulator
    Item
    4) neural stimulator
    boolean
    C0582124 (UMLS CUI [1])
    Ocular Foreign Body
    Item
    5) ocular foreign body (e.g. metal shavings)
    boolean
    C3898107 (UMLS CUI [1])
    Insulin pump
    Item
    6) insulin pump
    boolean
    C1140609 (UMLS CUI [1])
    Shrapnel | Bullet
    Item
    7) metal shrapnel or bullets
    boolean
    C0522670 (UMLS CUI [1])
    C0336699 (UMLS CUI [2])
    Claustrophobia
    Item
    8) claustrophobia.
    boolean
    C0008909 (UMLS CUI [1])
    Involvement with Magnetic resonance imaging contrast media
    Item
    furthermore, the following patient groups will be excluded from studies involving the administration of mri contrast agents:
    boolean
    C1314939 (UMLS CUI [1,1])
    C0180108 (UMLS CUI [1,2])
    Breast Feeding
    Item
    1) lactating women
    boolean
    C0006147 (UMLS CUI [1])
    Kidney Diseases | Creatinine clearance measurement
    Item
    2) renal disease (crcl less than 20 ml/min)
    boolean
    C0022658 (UMLS CUI [1])
    C0373595 (UMLS CUI [2])
    Estimation of creatinine clearance by Cockcroft-Gault formula | Kidney Diseases | Renal Insufficiency | Creatinine measurement | Gadolinium Receive
    Item
    the creatinine clearance (crcl) will be calculated using the cockroft formula where age is in years, kg is weight in kilograms, and cr is the serum creatinine. if there is no history of kidney disease from the patient or referring physician, additional testing will not be performed. if a patient has a history of renal insufficiency, a recent blood cr will be used unless the physician performing the test believes the cr may have changed since the last test. if the cr may have changed, a blood sample will be obtained for cr or the subject will be excluded from receiving gadolinium.
    boolean
    C2711451 (UMLS CUI [1])
    C0022658 (UMLS CUI [2])
    C1565489 (UMLS CUI [3])
    C0201975 (UMLS CUI [4])
    C0016911 (UMLS CUI [5,1])
    C1514756 (UMLS CUI [5,2])
    Creatinine clearance | Age | Body Weight | Serum creatinine | Gender
    Item
    crcl = (140-age) (wt in kg)/72 x serum cr (mg/dl) for men
    boolean
    C0812399 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    C0005910 (UMLS CUI [3])
    C0600061 (UMLS CUI [4])
    C0079399 (UMLS CUI [5])
    Creatinine clearance | Age | Body Weight | Serum creatinine | Gender
    Item
    crcl = (0.85) (140-age) (kg)/72 x serum cr (mg/dl) for women
    boolean
    C0812399 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    C0005910 (UMLS CUI [3])
    C0600061 (UMLS CUI [4])
    C0079399 (UMLS CUI [5])
    Inclusion criteria Control Group
    Item
    inclusion criteria for control subjects:
    boolean
    C1512693 (UMLS CUI [1,1])
    C0009932 (UMLS CUI [1,2])
    Healthy Volunteers | Age | Racial group | Gender | Pulmonary arterial hypertension
    Item
    1. any healthy man or woman who is the appropriate age, race, and gender for matching to a pah patient
    boolean
    C1708335 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    C0034510 (UMLS CUI [3])
    C0079399 (UMLS CUI [4])
    C2973725 (UMLS CUI [5])
    HIV Infections
    Item
    2. no history of hiv infection
    boolean
    C0019693 (UMLS CUI [1])
    Heart Disease Relevant Clinical Evidence | Electrocardiography | Echocardiography
    Item
    3. ekg and echocardiogram with no evidence of clinically relevant heart disease
    boolean
    C0018799 (UMLS CUI [1,1])
    C2347946 (UMLS CUI [1,2])
    C0205210 (UMLS CUI [1,3])
    C3887511 (UMLS CUI [1,4])
    C1623258 (UMLS CUI [2])
    C0013516 (UMLS CUI [3])
    Lung disease Relevant Clinical Evidence | Spirometry
    Item
    4. spirometry with no evidence of clinically relevant lung disease
    boolean
    C0024115 (UMLS CUI [1,1])
    C2347946 (UMLS CUI [1,2])
    C0205210 (UMLS CUI [1,3])
    C3887511 (UMLS CUI [1,4])
    C0037981 (UMLS CUI [2])
    Pulmonary Hypertension Cause | Collagen-vascular disease | Chronic liver disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Liver Cirrhosis | Thromboembolism chronic | Congenital Heart Defects | Interstitial Lung Diseases | Hypoxemia
    Item
    5. no history of causes of pulmonary hypertension such as collagen vascular disease, chronic liver disease with alt or ast greater than 2 times the upper limit of normal or cirrhosis of the liver, chronic thromboembolic disease, congenital heart defects, or pulmonary parenchymal disease with hypoxemia
    boolean
    C0020542 (UMLS CUI [1,1])
    C0015127 (UMLS CUI [1,2])
    C0262428 (UMLS CUI [2])
    C0341439 (UMLS CUI [3])
    C0201836 (UMLS CUI [4])
    C0201899 (UMLS CUI [5])
    C0023890 (UMLS CUI [6])
    C0040038 (UMLS CUI [7,1])
    C0205191 (UMLS CUI [7,2])
    C0018798 (UMLS CUI [8])
    C0206062 (UMLS CUI [9])
    C0700292 (UMLS CUI [10])
    Disease Related Endothelial dysfunction | Hypertensive disease Requirement Pharmacotherapy | Diabetes Mellitus Requirement Pharmacotherapy | Hypercholesterolemia | Obesity
    Item
    6. no history of diseases thought to be related to development of endothelial dysfunction including systemic hypertension or diabetes requiring drug therapy, hypercholesterolemia and obesity
    boolean
    C0012634 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    C0856169 (UMLS CUI [1,3])
    C0020538 (UMLS CUI [2,1])
    C1514873 (UMLS CUI [2,2])
    C0013216 (UMLS CUI [2,3])
    C0011849 (UMLS CUI [3,1])
    C1514873 (UMLS CUI [3,2])
    C0013216 (UMLS CUI [3,3])
    C0020443 (UMLS CUI [4])
    C0028754 (UMLS CUI [5])
    Anemia | Thrombocytopenia | Blood Coagulation Disorders
    Item
    7. no history of anemia, thrombocytopenia or coagulopathy
    boolean
    C0002871 (UMLS CUI [1])
    C0040034 (UMLS CUI [2])
    C0005779 (UMLS CUI [3])
    Renal Insufficiency
    Item
    8. no history of renal insufficiency
    boolean
    C1565489 (UMLS CUI [1])
    medical condition Requirement Pharmaceutical Preparations chronic
    Item
    9. no medical conditions requiring chronic medication use with the exception of:
    boolean
    C3843040 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [1,3])
    C0205191 (UMLS CUI [1,4])
    Heartburn | Gastroesophageal reflux disease
    Item
    a. heartburn, gerd
    boolean
    C0018834 (UMLS CUI [1])
    C0017168 (UMLS CUI [2])
    Environmental Illness | Posterior rhinorrhea | Non-allergic rhinitis
    Item
    b. environmental allergies, post nasal drip or non-allergic rhinitis
    boolean
    C0282504 (UMLS CUI [1])
    C0032781 (UMLS CUI [2])
    C3472698 (UMLS CUI [3])
    Asthma | Oral steroid therapy | inhaled steroids | Hospitalization Exacerbation of asthma
    Item
    c. asthma with no history of oral steroid use, weekly inhaled steroids, or hospitalization for asthma exacerbation
    boolean
    C0004096 (UMLS CUI [1])
    C0574135 (UMLS CUI [2])
    C2065041 (UMLS CUI [3])
    C0019993 (UMLS CUI [4,1])
    C0349790 (UMLS CUI [4,2])
    Dermatologic disorders Requirement Oral steroid therapy | Dermatologic disorders Requirement Immunosuppressive Agents
    Item
    d. dermatologic conditions that do not require the use of oral steroids or other immunosuppressants
    boolean
    C0037274 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0574135 (UMLS CUI [1,3])
    C0037274 (UMLS CUI [2,1])
    C1514873 (UMLS CUI [2,2])
    C0021081 (UMLS CUI [2,3])
    Thyroid Disease Treated Stable | Depressive disorder Treated Stable | Anxiety Treated Stable
    Item
    e. treated and stable thyroid disease, depression, or anxiety.
    boolean
    C0040128 (UMLS CUI [1,1])
    C1522326 (UMLS CUI [1,2])
    C0205360 (UMLS CUI [1,3])
    C0011581 (UMLS CUI [2,1])
    C1522326 (UMLS CUI [2,2])
    C0205360 (UMLS CUI [2,3])
    C0003467 (UMLS CUI [3,1])
    C1522326 (UMLS CUI [3,2])
    C0205360 (UMLS CUI [3,3])
    Cigarette Quantity per year | cigarette use
    Item
    10. no more than 20 cigarettes per years for the previous 2 years and no cigarette use for 30 days prior to the screening evaluation until completion of the study
    boolean
    C0677453 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C0439508 (UMLS CUI [1,3])
    C0694535 (UMLS CUI [2])
    Exclusion Criteria Control Group
    Item
    exclusion criteria for control subjects:
    boolean
    C0680251 (UMLS CUI [1,1])
    C0009932 (UMLS CUI [1,2])
    Pregnancy | Breast Feeding | Gender Contraceptive methods Inadequate | Childbearing Potential Urine pregnancy test | Childbearing Potential pregnancy blood test
    Item
    1. current pregnancy, lactation or women not currently using medically acceptable birth control. (all women of childbearing age will be required to have a screening urine or blood pregnancy test)
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C0079399 (UMLS CUI [3,1])
    C0700589 (UMLS CUI [3,2])
    C0205412 (UMLS CUI [3,3])
    C3831118 (UMLS CUI [4,1])
    C0430056 (UMLS CUI [4,2])
    C3831118 (UMLS CUI [5,1])
    C0850355 (UMLS CUI [5,2])
    Medical contraindication Magnetic Resonance Imaging
    Item
    2. contraindication to mri scanning including individuals with the following devices:
    boolean
    C1301624 (UMLS CUI [1,1])
    C0024485 (UMLS CUI [1,2])
    pacemaker implanted | defibrillator implanted
    Item
    a) implanted cardiac pacemaker or defibrillator
    boolean
    C0848753 (UMLS CUI [1])
    C0850291 (UMLS CUI [2])
    Aneurysm clip Central Nervous System
    Item
    b) central nervous system aneurysm clips
    boolean
    C0179977 (UMLS CUI [1,1])
    C3714787 (UMLS CUI [1,2])
    Cochlear Implants
    Item
    c) cochlear implants
    boolean
    C0009199 (UMLS CUI [1])
    Implanted Neurostimulators
    Item
    d) implanted neural stimulator
    boolean
    C2048402 (UMLS CUI [1])
    Ocular Foreign Body
    Item
    e) ocular foreign body (e.g. metal shavings)
    boolean
    C3898107 (UMLS CUI [1])
    Insulin pump
    Item
    f) insulin pump
    boolean
    C1140609 (UMLS CUI [1])
    Shrapnel | Bullet
    Item
    g) metal shrapnel or bullet
    boolean
    C0522670 (UMLS CUI [1])
    C0336699 (UMLS CUI [2])
    Claustrophobia
    Item
    h) claustophobia
    boolean
    C0008909 (UMLS CUI [1])
    Medical contraindication Magnetic resonance imaging contrast media
    Item
    3. contraindications to mri contrast agent administration
    boolean
    C1301624 (UMLS CUI [1,1])
    C0180108 (UMLS CUI [1,2])
    Informed Consent Unable
    Item
    4. inability to provide informed written consent for participation in the study
    boolean
    C0021430 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])
    Tachyarrhythmia Atrial refractory chronic
    Item
    5. chronic, medically refractory atrial tacharrhythmias
    boolean
    C0080203 (UMLS CUI [1,1])
    C0018792 (UMLS CUI [1,2])
    C0205269 (UMLS CUI [1,3])
    C0205191 (UMLS CUI [1,4])
    Heart failure Symptoms
    Item
    6. symptoms of heart failure.
    boolean
    C0018801 (UMLS CUI [1,1])
    C1457887 (UMLS CUI [1,2])
    Pulmonary artery mean pressure | Pulmonary Vascular Resistance | Pulmonary Capillary Wedge Pressure
    Item
    7. mean pa greater than 25mmhg or pvr greater than 1.5 wood units, or pcwp greater than 15 mmhg
    boolean
    C0428645 (UMLS CUI [1])
    C0456261 (UMLS CUI [2])
    C0086879 (UMLS CUI [3])
    Drug abuse | Marijuana Smoking
    Item
    8. history of recreational drug use with the exception of marijuana. no marijuana use within 3 months of protocol screening through completion of the study.
    boolean
    C0013146 (UMLS CUI [1])
    C0024810 (UMLS CUI [2])
    Intravenous Drug Abuse
    Item
    9. intravenous drug abuse.
    boolean
    C0086181 (UMLS CUI [1])
    Condition Affecting research results | Condition Affecting patient safety
    Item
    volunteers may be excluded if in the opinion of the study investigators they have a condition that may adversely affect the outcome of the study or the safety of the volunteer.
    boolean
    C0348080 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C0683954 (UMLS CUI [1,3])
    C0348080 (UMLS CUI [2,1])
    C0392760 (UMLS CUI [2,2])
    C1113679 (UMLS CUI [2,3])

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