Eligibility Hypertension, Pulmonary NCT00458042

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
be between 18 years and 65 years of age
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
who class ii-iii
Description

WHO classification

Type de données

boolean

Alias
UMLS CUI [1]
C4267671
diagnosis of one of the following group i who clinical classifications: idiopathic or familial pulmonary arterial hypertension (pah) or pah associated with a collagen vascular disease or pah associated with congenital systemic-to-pulmonary shunt repaired greater than 5 years prior to study entry or pah associated with portal hypertension with mild or moderate hepatic dysfunction or pah associated with drugs or toxins.
Description

WHO classification | Idiopathic pulmonary arterial hypertension | Familial pulmonary arterial hypertension | Pulmonary arterial hypertension Associated with Collagen-vascular disease | Pulmonary arterial hypertension Associated with Systemic to pulmonary arterial shunt | Pulmonary arterial hypertension associated with portal hypertension | Pulmonary arterial hypertension Associated with Mild liver dysfunction | Pulmonary arterial hypertension Associated with Liver Dysfunction Moderate | Pulmonary arterial hypertension Associated with Pharmaceutical Preparations | Pulmonary arterial hypertension Associated with Toxins

Type de données

boolean

Alias
UMLS CUI [1]
C4267671
UMLS CUI [2]
C3203102
UMLS CUI [3]
C1701939
UMLS CUI [4,1]
C2973725
UMLS CUI [4,2]
C0332281
UMLS CUI [4,3]
C0262428
UMLS CUI [5,1]
C2973725
UMLS CUI [5,2]
C0332281
UMLS CUI [5,3]
C0190388
UMLS CUI [6]
C1868851
UMLS CUI [7,1]
C2973725
UMLS CUI [7,2]
C0332281
UMLS CUI [7,3]
C3279149
UMLS CUI [8,1]
C2973725
UMLS CUI [8,2]
C0332281
UMLS CUI [8,3]
C0086565
UMLS CUI [8,4]
C0205081
UMLS CUI [9,1]
C2973725
UMLS CUI [9,2]
C0332281
UMLS CUI [9,3]
C0013227
UMLS CUI [10,1]
C2973725
UMLS CUI [10,2]
C0332281
UMLS CUI [10,3]
C0040549
receiving inhaled iloprost for at least two months prior to screening or prior to treatment discontinuation.
Description

Iloprost Inhalation

Type de données

boolean

Alias
UMLS CUI [1,1]
C0079594
UMLS CUI [1,2]
C0205535
may have discontinued iloprost treatment against medical advice up to thirty days prior to screening
Description

Iloprost Discontinued

Type de données

boolean

Alias
UMLS CUI [1,1]
C0079594
UMLS CUI [1,2]
C1444662
be mentally and physically capable of learning to administer remodulin using an intravenous infusion pump.
Description

Capability Administration Remodulin | Use of IV Infusion Pump

Type de données

boolean

Alias
UMLS CUI [1,1]
C2698977
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C1101501
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0777049
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
be a nursing or pregnant woman
Description

Breast Feeding | Pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
have any pah medication, other than inhaled iloprost, discontinued within the week prior to study entry.
Description

Pulmonary arterial hypertension Pharmaceutical Preparations Discontinued | Exception Iloprost Inhalation

Type de données

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1444662
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0079594
UMLS CUI [2,3]
C0205535
received any prostacyclin or prostacyclin analog except iloprost in the past 3 months.
Description

Epoprostenol | Epoprostenol Analog | Exception Iloprost

Type de données

boolean

Alias
UMLS CUI [1]
C0033567
UMLS CUI [2,1]
C0033567
UMLS CUI [2,2]
C0243071
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0079594
previous history of significant parenchymal lung disease
Description

Lung disease Parenchymal

Type de données

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C4277702
have any other type of pah including but not limited to pah related to thrombotic or embolic disease
Description

Pulmonary arterial hypertension Type Other | Pulmonary arterial hypertension Relationship Thrombotic vascular disease | Pulmonary arterial hypertension Relationship Embolism

Type de données

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0205394
UMLS CUI [2,1]
C2973725
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C4049573
UMLS CUI [3,1]
C2973725
UMLS CUI [3,2]
C0439849
UMLS CUI [3,3]
C0013922
have evidence of left-sided heart disease
Description

Heart Disease Left sided

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0443246
musculoskeletal disorder (e.g. arthritis, artificial leg, etc.) or any other disease, which is thought to limit ambulation, or be connected to a machine, which is not portable.
Description

Musculoskeletal Diseases | Arthritis | Leg Prosthesis | Disease Limiting Ambulation | Disease Connection Machine

Type de données

boolean

Alias
UMLS CUI [1]
C0026857
UMLS CUI [2]
C0003864
UMLS CUI [3]
C0524491
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0439801
UMLS CUI [4,3]
C0080331
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0449379
UMLS CUI [5,3]
C0336779
uncontrolled systemic hypertension or chronic renal insufficiency
Description

Systemic hypertension Uncontrolled | Chronic Kidney Insufficiency

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0403447
use of an investigational drug within the past 30 days.
Description

Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0013230

Similar models

Eligibility Hypertension, Pulmonary NCT00458042

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
be between 18 years and 65 years of age
boolean
C0001779 (UMLS CUI [1])
WHO classification
Item
who class ii-iii
boolean
C4267671 (UMLS CUI [1])
WHO classification | Idiopathic pulmonary arterial hypertension | Familial pulmonary arterial hypertension | Pulmonary arterial hypertension Associated with Collagen-vascular disease | Pulmonary arterial hypertension Associated with Systemic to pulmonary arterial shunt | Pulmonary arterial hypertension associated with portal hypertension | Pulmonary arterial hypertension Associated with Mild liver dysfunction | Pulmonary arterial hypertension Associated with Liver Dysfunction Moderate | Pulmonary arterial hypertension Associated with Pharmaceutical Preparations | Pulmonary arterial hypertension Associated with Toxins
Item
diagnosis of one of the following group i who clinical classifications: idiopathic or familial pulmonary arterial hypertension (pah) or pah associated with a collagen vascular disease or pah associated with congenital systemic-to-pulmonary shunt repaired greater than 5 years prior to study entry or pah associated with portal hypertension with mild or moderate hepatic dysfunction or pah associated with drugs or toxins.
boolean
C4267671 (UMLS CUI [1])
C3203102 (UMLS CUI [2])
C1701939 (UMLS CUI [3])
C2973725 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C0262428 (UMLS CUI [4,3])
C2973725 (UMLS CUI [5,1])
C0332281 (UMLS CUI [5,2])
C0190388 (UMLS CUI [5,3])
C1868851 (UMLS CUI [6])
C2973725 (UMLS CUI [7,1])
C0332281 (UMLS CUI [7,2])
C3279149 (UMLS CUI [7,3])
C2973725 (UMLS CUI [8,1])
C0332281 (UMLS CUI [8,2])
C0086565 (UMLS CUI [8,3])
C0205081 (UMLS CUI [8,4])
C2973725 (UMLS CUI [9,1])
C0332281 (UMLS CUI [9,2])
C0013227 (UMLS CUI [9,3])
C2973725 (UMLS CUI [10,1])
C0332281 (UMLS CUI [10,2])
C0040549 (UMLS CUI [10,3])
Iloprost Inhalation
Item
receiving inhaled iloprost for at least two months prior to screening or prior to treatment discontinuation.
boolean
C0079594 (UMLS CUI [1,1])
C0205535 (UMLS CUI [1,2])
Iloprost Discontinued
Item
may have discontinued iloprost treatment against medical advice up to thirty days prior to screening
boolean
C0079594 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
Capability Administration Remodulin | Use of IV Infusion Pump
Item
be mentally and physically capable of learning to administer remodulin using an intravenous infusion pump.
boolean
C2698977 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C1101501 (UMLS CUI [1,3])
C1524063 (UMLS CUI [2,1])
C0777049 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Breast Feeding | Pregnancy
Item
be a nursing or pregnant woman
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Pulmonary arterial hypertension Pharmaceutical Preparations Discontinued | Exception Iloprost Inhalation
Item
have any pah medication, other than inhaled iloprost, discontinued within the week prior to study entry.
boolean
C2973725 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0079594 (UMLS CUI [2,2])
C0205535 (UMLS CUI [2,3])
Epoprostenol | Epoprostenol Analog | Exception Iloprost
Item
received any prostacyclin or prostacyclin analog except iloprost in the past 3 months.
boolean
C0033567 (UMLS CUI [1])
C0033567 (UMLS CUI [2,1])
C0243071 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0079594 (UMLS CUI [3,2])
Lung disease Parenchymal
Item
previous history of significant parenchymal lung disease
boolean
C0024115 (UMLS CUI [1,1])
C4277702 (UMLS CUI [1,2])
Pulmonary arterial hypertension Type Other | Pulmonary arterial hypertension Relationship Thrombotic vascular disease | Pulmonary arterial hypertension Relationship Embolism
Item
have any other type of pah including but not limited to pah related to thrombotic or embolic disease
boolean
C2973725 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2973725 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C4049573 (UMLS CUI [2,3])
C2973725 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0013922 (UMLS CUI [3,3])
Heart Disease Left sided
Item
have evidence of left-sided heart disease
boolean
C0018799 (UMLS CUI [1,1])
C0443246 (UMLS CUI [1,2])
Musculoskeletal Diseases | Arthritis | Leg Prosthesis | Disease Limiting Ambulation | Disease Connection Machine
Item
musculoskeletal disorder (e.g. arthritis, artificial leg, etc.) or any other disease, which is thought to limit ambulation, or be connected to a machine, which is not portable.
boolean
C0026857 (UMLS CUI [1])
C0003864 (UMLS CUI [2])
C0524491 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0080331 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C0449379 (UMLS CUI [5,2])
C0336779 (UMLS CUI [5,3])
Systemic hypertension Uncontrolled | Chronic Kidney Insufficiency
Item
uncontrolled systemic hypertension or chronic renal insufficiency
boolean
C0020538 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0403447 (UMLS CUI [2])
Investigational New Drugs
Item
use of an investigational drug within the past 30 days.
boolean
C0013230 (UMLS CUI [1])