ID

22861

Beschreibung

Dose Determination Safety and Activity Study of Inhaled NX1011 to Treat Pulmonary Arterial Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00323024

Link

https://clinicaltrials.gov/show/NCT00323024

Stichworte

Versionen (1)
  1. 13.06.17 13.06.17 -
Hochgeladen am

13. Juni 2017

DOI

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Creative Commons BY 4.0
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Eligibility Pulmonary Hypertension NCT00323024

Englisch

Eligibility Pulmonary Hypertension NCT00323024

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient must either:
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
meet the pah diagnostic criteria at screening (based on a documented history of diagnosis as outlined in the american college of chest physicians [accp] 2004 evidence-based clinical practices guidelines)15; or
Beschreibung

Pulmonary arterial hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C2973725
have elevated pulmonary pressure with a suspected pah diagnosis based on a clinical referral at screening for a rhc.
Beschreibung

Pulmonary arterial pressure elevated | Pulmonary arterial hypertension Suspected | Clinical referral Catheterization of right heart

Datentyp

boolean

Alias
UMLS CUI [1]
C3670875
UMLS CUI [2,1]
C2973725
UMLS CUI [2,2]
C0332147
UMLS CUI [3,1]
C1545725
UMLS CUI [3,2]
C0189896
patient must have pah as defined by a mean pulmonary artery pressure (pap) > 25 mmhg.
Beschreibung

Pulmonary arterial hypertension | Pulmonary artery mean pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C2973725
UMLS CUI [2]
C0428645
patient must have symptoms of pulmonary hypertension (ph) according to the world health organization (who) functional classification of pulmonary hypertension class ii through iv.
Beschreibung

Symptoms Pulmonary Hypertension | WHO Pulmonary arterial hypertension Class Functional

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0020542
UMLS CUI [2,1]
C0043237
UMLS CUI [2,2]
C2973725
UMLS CUI [2,3]
C0456387
UMLS CUI [2,4]
C0205245
patient must consent to, be able to tolerate, and have adequate venous and arterial access for swan-ganz catheterization (sgc) and an arterial line.
Beschreibung

Venous access Swan-Ganz Catheterization | Access Arterial Swan-Ganz Catheterization | Arterial Line

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3164222
UMLS CUI [1,2]
C0007438
UMLS CUI [2,1]
C0444454
UMLS CUI [2,2]
C0221464
UMLS CUI [2,3]
C0007438
UMLS CUI [3]
C0003835
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically significant right-to-left intracardiac shunts based on doppler echocardiography with bubble study.
Beschreibung

Shunt right-left intracardiac Doppler Echocardiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0489644
UMLS CUI [1,2]
C0013520
history of pulmonary veno-occlusive disease or clinically significant aortic or mitral stenosis.
Beschreibung

Pulmonary Veno-Occlusive Disease | Aortic Valve Stenosis | Mitral Valve Stenosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0034091
UMLS CUI [2]
C0003507
UMLS CUI [3]
C0026269
history of sustained ventricular tachycardia (vt-s) or ventricular fibrillation (vf) and cardiac arrest, or presence of atrial fibrillation.
Beschreibung

Sustained ventricular tachycardia | Ventricular Fibrillation | Cardiac Arrest | Atrial Fibrillation

Datentyp

boolean

Alias
UMLS CUI [1]
C0750197
UMLS CUI [2]
C0042510
UMLS CUI [3]
C0018790
UMLS CUI [4]
C0004238
active cardiac disease meeting the following criteria:
Beschreibung

Heart Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
patient with elevated pulmonary capillary wedge pressures (pcwps) > 25 mmhg.
Beschreibung

Increased pulmonary arterial wedge pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0520850
patient with a history of myocardial infarction or coronary intervention within the last 60 days.
Beschreibung

Myocardial Infarction | Percutaneous Coronary Intervention

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C1532338
patient with a history of pacemaker, cardiac defibrillator, or biventricular pacemaker insertion within 4 weeks of baseline.
Beschreibung

Artificial cardiac pacemaker | Cardiac defibrillator | Biventricular pacemaker insertion

Datentyp

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C1391956
UMLS CUI [3]
C3805138
patient who cannot be withdrawn from nitrate therapy.
Beschreibung

Nitrates therapy Withdrawal Unsuccessful

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0028125
UMLS CUI [1,2]
C0039798
UMLS CUI [1,3]
C2349954
UMLS CUI [1,4]
C1272705
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Ähnliche Modelle

Eligibility Pulmonary Hypertension NCT00323024

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
patient must either:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Pulmonary arterial hypertension
Item
meet the pah diagnostic criteria at screening (based on a documented history of diagnosis as outlined in the american college of chest physicians [accp] 2004 evidence-based clinical practices guidelines)15; or
boolean
C2973725 (UMLS CUI [1])
Pulmonary arterial pressure elevated | Pulmonary arterial hypertension Suspected | Clinical referral Catheterization of right heart
Item
have elevated pulmonary pressure with a suspected pah diagnosis based on a clinical referral at screening for a rhc.
boolean
C3670875 (UMLS CUI [1])
C2973725 (UMLS CUI [2,1])
C0332147 (UMLS CUI [2,2])
C1545725 (UMLS CUI [3,1])
C0189896 (UMLS CUI [3,2])
Pulmonary arterial hypertension | Pulmonary artery mean pressure
Item
patient must have pah as defined by a mean pulmonary artery pressure (pap) > 25 mmhg.
boolean
C2973725 (UMLS CUI [1])
C0428645 (UMLS CUI [2])
Symptoms Pulmonary Hypertension | WHO Pulmonary arterial hypertension Class Functional
Item
patient must have symptoms of pulmonary hypertension (ph) according to the world health organization (who) functional classification of pulmonary hypertension class ii through iv.
boolean
C1457887 (UMLS CUI [1,1])
C0020542 (UMLS CUI [1,2])
C0043237 (UMLS CUI [2,1])
C2973725 (UMLS CUI [2,2])
C0456387 (UMLS CUI [2,3])
C0205245 (UMLS CUI [2,4])
Venous access Swan-Ganz Catheterization | Access Arterial Swan-Ganz Catheterization | Arterial Line
Item
patient must consent to, be able to tolerate, and have adequate venous and arterial access for swan-ganz catheterization (sgc) and an arterial line.
boolean
C3164222 (UMLS CUI [1,1])
C0007438 (UMLS CUI [1,2])
C0444454 (UMLS CUI [2,1])
C0221464 (UMLS CUI [2,2])
C0007438 (UMLS CUI [2,3])
C0003835 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Shunt right-left intracardiac Doppler Echocardiography
Item
clinically significant right-to-left intracardiac shunts based on doppler echocardiography with bubble study.
boolean
C0489644 (UMLS CUI [1,1])
C0013520 (UMLS CUI [1,2])
Pulmonary Veno-Occlusive Disease | Aortic Valve Stenosis | Mitral Valve Stenosis
Item
history of pulmonary veno-occlusive disease or clinically significant aortic or mitral stenosis.
boolean
C0034091 (UMLS CUI [1])
C0003507 (UMLS CUI [2])
C0026269 (UMLS CUI [3])
Sustained ventricular tachycardia | Ventricular Fibrillation | Cardiac Arrest | Atrial Fibrillation
Item
history of sustained ventricular tachycardia (vt-s) or ventricular fibrillation (vf) and cardiac arrest, or presence of atrial fibrillation.
boolean
C0750197 (UMLS CUI [1])
C0042510 (UMLS CUI [2])
C0018790 (UMLS CUI [3])
C0004238 (UMLS CUI [4])
Heart Disease
Item
active cardiac disease meeting the following criteria:
boolean
C0018799 (UMLS CUI [1])
Increased pulmonary arterial wedge pressure
Item
patient with elevated pulmonary capillary wedge pressures (pcwps) > 25 mmhg.
boolean
C0520850 (UMLS CUI [1])
Myocardial Infarction | Percutaneous Coronary Intervention
Item
patient with a history of myocardial infarction or coronary intervention within the last 60 days.
boolean
C0027051 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
Artificial cardiac pacemaker | Cardiac defibrillator | Biventricular pacemaker insertion
Item
patient with a history of pacemaker, cardiac defibrillator, or biventricular pacemaker insertion within 4 weeks of baseline.
boolean
C0030163 (UMLS CUI [1])
C1391956 (UMLS CUI [2])
C3805138 (UMLS CUI [3])
Nitrates therapy Withdrawal Unsuccessful
Item
patient who cannot be withdrawn from nitrate therapy.
boolean
C0028125 (UMLS CUI [1,1])
C0039798 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C1272705 (UMLS CUI [1,4])
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