ID

30051

Descripción

Transitioning To IV Remodulin From Ventavis in Patients With PAH: Safety, Efficacy and Treatment Satisfaction; ODM derived from: https://clinicaltrials.gov/show/NCT00458042

Link

https://clinicaltrials.gov/show/NCT00458042

Palabras clave

Versiones (1)
  1. 5/5/18 5/5/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

5 de mayo de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hypertension, Pulmonary NCT00458042

Inglés

Eligibility Hypertension, Pulmonary NCT00458042

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Age

Tipo de datos

boolean

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

WHO classification

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Iloprost Inhalation

Tipo de datos

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
Descripción

Iloprost Discontinued

Tipo de datos

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.
Descripción

Capability Administration Remodulin | Use of IV Infusion Pump

Tipo de datos

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
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
be a nursing or pregnant woman
Descripción

Breast Feeding | Pregnancy

Tipo de datos

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.
Descripción

Pulmonary arterial hypertension Pharmaceutical Preparations Discontinued | Exception Iloprost Inhalation

Tipo de datos

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.
Descripción

Epoprostenol | Epoprostenol Analog | Exception Iloprost

Tipo de datos

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
Descripción

Lung disease Parenchymal

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Heart Disease Left sided

Tipo de datos

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.
Descripción

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

Tipo de datos

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
Descripción

Systemic hypertension Uncontrolled | Chronic Kidney Insufficiency

Tipo de datos

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.
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Hypertension, Pulmonary NCT00458042

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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