ID

17757

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00098072

Stichworte

  1. 29.09.16 29.09.16 -
  2. 02.10.16 02.10.16 -
Hochgeladen am

2. Oktober 2016

DOI

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Lizenz

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Eligibility Hypertension, Pulmonary NCT00098072

Eligibility Hypertension, Pulmonary NCT00098072

Criteria
Beschreibung

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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:
Beschreibung

Inclusion criteria Pulmonary arterial hypertension

Datentyp

boolean

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

Inclusion criteria

Datentyp

boolean

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

Idiopathic pulmonary hypertension

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Eisenmenger Complex

Datentyp

boolean

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

Collagen-vascular disease

Datentyp

boolean

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

Liver disease | Portal Hypertension

Datentyp

boolean

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

Injury caused by Toxin | Appetite Depressants | Brassica Napus Oil

Datentyp

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
Beschreibung

HIV Infection

Datentyp

boolean

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

Anemia, Sickle Cell

Datentyp

boolean

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

Exclusion Criteria Pulmonary arterial hypertension

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

Age

Datentyp

boolean

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

Informed Consent Unable

Datentyp

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
Beschreibung

Mean pulmonary arterial pressure | Pulmonary Vascular Resistance

Datentyp

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
Beschreibung

Pulmonary Capillary Wedge Pressure | Increased pulmonary arterial wedge pressure

Datentyp

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.
Beschreibung

Oral administration of treatment | Intravenous therapy

Datentyp

boolean

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

Inclusion criteria Pulmonary Hypertension caused by Vascular System Injuries

Datentyp

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:
Beschreibung

Inclusion criteria

Datentyp

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.
Beschreibung

Secondary pulmonary hypertension | Histopathology Similar Pulmonary Hypertension | Etiology aspects

Datentyp

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
Beschreibung

Valvular disease | Cardiomyopathies

Datentyp

boolean

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

Lung Diseases, Parasitic

Datentyp

boolean

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

Hypoxemia | Hypercapnia

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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:
Beschreibung

Exclusion Criteria Pulmonary Hypertension caused by Vascular System Injuries

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

Age

Datentyp

boolean

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

Informed Consent Unable

Datentyp

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
Beschreibung

Mean pulmonary arterial pressure | Pulmonary Vascular Resistance

Datentyp

boolean

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

Exclusion Criteria MRI Pulmonary Hypertension

Datentyp

boolean

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

pacemaker implanted | defibrillator implanted

Datentyp

boolean

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

Aneurysm clip Central Nervous System

Datentyp

boolean

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

Cochlear Implants

Datentyp

boolean

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

Neurostimulator

Datentyp

boolean

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

Ocular Foreign Body

Datentyp

boolean

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

Insulin pump

Datentyp

boolean

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

Shrapnel | Bullet

Datentyp

boolean

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

Claustrophobia

Datentyp

boolean

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

Involvement with Magnetic resonance imaging contrast media

Datentyp

boolean

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

Breast Feeding

Datentyp

boolean

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

Kidney Diseases | Creatinine clearance measurement

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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:
Beschreibung

Inclusion criteria Control Group

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

HIV Infections

Datentyp

boolean

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

Heart Disease Relevant Clinical Evidence | Electrocardiography | Echocardiography

Datentyp

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
Beschreibung

Lung disease Relevant Clinical Evidence | Spirometry

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Anemia | Thrombocytopenia | Blood Coagulation Disorders

Datentyp

boolean

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

Renal Insufficiency

Datentyp

boolean

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

medical condition Requirement Pharmaceutical Preparations chronic

Datentyp

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
Beschreibung

Heartburn | Gastroesophageal reflux disease

Datentyp

boolean

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

Environmental Illness | Posterior rhinorrhea | Non-allergic rhinitis

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Cigarette Quantity per year | cigarette use

Datentyp

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:
Beschreibung

Exclusion Criteria Control Group

Datentyp

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)
Beschreibung

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

Datentyp

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:
Beschreibung

Medical contraindication Magnetic Resonance Imaging

Datentyp

boolean

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

pacemaker implanted | defibrillator implanted

Datentyp

boolean

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

Aneurysm clip Central Nervous System

Datentyp

boolean

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

Cochlear Implants

Datentyp

boolean

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

Implanted Neurostimulators

Datentyp

boolean

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

Ocular Foreign Body

Datentyp

boolean

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

Insulin pump

Datentyp

boolean

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

Shrapnel | Bullet

Datentyp

boolean

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

Claustrophobia

Datentyp

boolean

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

Medical contraindication Magnetic resonance imaging contrast media

Datentyp

boolean

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

Informed Consent Unable

Datentyp

boolean

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

Tachyarrhythmia Atrial refractory chronic

Datentyp

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.
Beschreibung

Heart failure Symptoms

Datentyp

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
Beschreibung

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

Datentyp

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.
Beschreibung

Drug abuse | Marijuana Smoking

Datentyp

boolean

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

Intravenous Drug Abuse

Datentyp

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.
Beschreibung

Condition Affecting research results | Condition Affecting patient safety

Datentyp

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

Ähnliche Modelle

Eligibility Hypertension, Pulmonary NCT00098072

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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