Informatie:
Fout:
ID
17757
Beschrijving
Endothelial Cell Dysfunction in Pulmonary Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00098072
Link
https://clinicaltrials.gov/show/NCT00098072
Trefwoorden
Versies (2)
- 29-09-16 29-09-16 -
- 02-10-16 02-10-16 -
Geüploaded op
2 oktober 2016
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 4.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Eligibility Hypertension, Pulmonary NCT00098072
Eligibility Hypertension, Pulmonary NCT00098072
- StudyEvent: Eligibility
Similar models
Eligibility Hypertension, Pulmonary NCT00098072
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
Geen commentaren