ID

19111

Beschreibung

Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00080457

Link

https://clinicaltrials.gov/show/NCT00080457

Stichworte

Versionen (1)
  1. 05.12.16 05.12.16 -
Hochgeladen am

5. Dezember 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Pulmonary Hypertension NCT00080457

Englisch

Eligibility Pulmonary Hypertension NCT00080457

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
have a current diagnosis of symptomatic pah classified by one of the following:
Beschreibung

Pulmonary arterial hypertension Symptomatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0231220
1. primary pulmonary hypertension (pph) - also known as idiopathic pulmonary arterial hypertension (ipah);
Beschreibung

Idiopathic pulmonary hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C0152171
2. pah associated with connective tissue diseases;
Beschreibung

Pulmonary arterial hypertension Associated with Connective Tissue Diseases

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0009782
3. pah associated with one of the following congenital heart defects:
Beschreibung

Pulmonary arterial hypertension Associated with Congenital Heart Defects

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0018798
1. repaired asd, vsd or pda greater than one year post-operative
Beschreibung

Atrioseptoplasty Postoperative | Correction of ventricular septal defect Postoperative | Patent ductus arteriosus repair Postoperative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0189965
UMLS CUI [1,2]
C0032790
UMLS CUI [2,1]
C0189969
UMLS CUI [2,2]
C0032790
UMLS CUI [3,1]
C0013274
UMLS CUI [3,2]
C0374711
UMLS CUI [3,3]
C0032790
2. un-repaired secundum asd (with resting oxygen saturation greater than 88 percent in room air measured by oximeter)
Beschreibung

Ostium secundum atrial septal defect repair | Oxygen saturation measurement At rest on room air | Measurement Pulse oximeter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0344724
UMLS CUI [1,2]
C0374711
UMLS CUI [2,1]
C0523807
UMLS CUI [2,2]
C0443144
UMLS CUI [2,3]
C2709070
UMLS CUI [3,1]
C0242485
UMLS CUI [3,2]
C0182109
world health organization (who) functional class ii, iii, iv
Beschreibung

World Health Organization Class Functional

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0043237
UMLS CUI [1,2]
C0456387
UMLS CUI [1,3]
C0205245
greater than 12 and less than 75 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
women of childbearing potential must be using two forms of medically acceptable contraception (at least one barrier method)
Beschreibung

Childbearing Potential Contraceptive methods Quantity | Barrier Contraception Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0004764
UMLS CUI [2,2]
C1265611
have a cardiac catheterization within 6 months before study entry that shows the following values:
Beschreibung

Cardiac Catheterization Procedures

Datentyp

boolean

Alias
UMLS CUI [1]
C0018795
1. mean pulmonary artery pressure (papm) greater than 25 mmhg (at rest),
Beschreibung

Mean pulmonary arterial pressure At rest

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3854605
UMLS CUI [1,2]
C0443144
2. pulmonary capillary wedge pressure (pcwp) or left ventricular-end diastolic pressure less than 15 mmhg, and
Beschreibung

Pulmonary Capillary Wedge Pressure | Left ventricular end-diastolic pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0086879
UMLS CUI [2]
C0456190
3. pulmonary vascular resistance (pvr) greater than 3 mmhg/l/min.
Beschreibung

Pulmonary Vascular Resistance

Datentyp

boolean

Alias
UMLS CUI [1]
C0456261
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
portal hypertension or chronic liver disease
Beschreibung

Hypertension, Portal | Chronic liver disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0020541
UMLS CUI [2]
C0341439
alt or ast levels greater than 1.5 times the upper limit of normal at the screening visit
Beschreibung

Alanine aminotransferase increased | Aspartate aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
contraindication to treatment with an endothelin receptor antagonist
Beschreibung

Medical contraindication Endothelin receptor antagonist

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1134681
recent history of abusing alcohol or illicit drugs
Beschreibung

Alcohol abuse | Illicit Drugs abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2,1]
C0086190
UMLS CUI [2,2]
C0013146
chronic renal insufficiency
Beschreibung

Chronic Kidney Insufficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C0403447
pregnant or breastfeeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
atrial septostomy within 30 days before study entry
Beschreibung

Atrial septostomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0700586
previous failure on bosentan because of safety concerns of the lack of clinical response
Beschreibung

bosentan failed | Clinical Response Lack | Safety Concern

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0252643
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C4055223
UMLS CUI [2,2]
C0332268
UMLS CUI [3,1]
C0036043
UMLS CUI [3,2]
C2699424
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Pulmonary Hypertension NCT00080457

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Pulmonary arterial hypertension Symptomatic
Item
have a current diagnosis of symptomatic pah classified by one of the following:
boolean
C2973725 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Idiopathic pulmonary hypertension
Item
1. primary pulmonary hypertension (pph) - also known as idiopathic pulmonary arterial hypertension (ipah);
boolean
C0152171 (UMLS CUI [1])
Pulmonary arterial hypertension Associated with Connective Tissue Diseases
Item
2. pah associated with connective tissue diseases;
boolean
C2973725 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0009782 (UMLS CUI [1,3])
Pulmonary arterial hypertension Associated with Congenital Heart Defects
Item
3. pah associated with one of the following congenital heart defects:
boolean
C2973725 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0018798 (UMLS CUI [1,3])
Atrioseptoplasty Postoperative | Correction of ventricular septal defect Postoperative | Patent ductus arteriosus repair Postoperative
Item
1. repaired asd, vsd or pda greater than one year post-operative
boolean
C0189965 (UMLS CUI [1,1])
C0032790 (UMLS CUI [1,2])
C0189969 (UMLS CUI [2,1])
C0032790 (UMLS CUI [2,2])
C0013274 (UMLS CUI [3,1])
C0374711 (UMLS CUI [3,2])
C0032790 (UMLS CUI [3,3])
Ostium secundum atrial septal defect repair | Oxygen saturation measurement At rest on room air | Measurement Pulse oximeter
Item
2. un-repaired secundum asd (with resting oxygen saturation greater than 88 percent in room air measured by oximeter)
boolean
C0344724 (UMLS CUI [1,1])
C0374711 (UMLS CUI [1,2])
C0523807 (UMLS CUI [2,1])
C0443144 (UMLS CUI [2,2])
C2709070 (UMLS CUI [2,3])
C0242485 (UMLS CUI [3,1])
C0182109 (UMLS CUI [3,2])
World Health Organization Class Functional
Item
world health organization (who) functional class ii, iii, iv
boolean
C0043237 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C0205245 (UMLS CUI [1,3])
Age
Item
greater than 12 and less than 75 years of age
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Quantity | Barrier Contraception Quantity
Item
women of childbearing potential must be using two forms of medically acceptable contraception (at least one barrier method)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0004764 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Cardiac Catheterization Procedures
Item
have a cardiac catheterization within 6 months before study entry that shows the following values:
boolean
C0018795 (UMLS CUI [1])
Mean pulmonary arterial pressure At rest
Item
1. mean pulmonary artery pressure (papm) greater than 25 mmhg (at rest),
boolean
C3854605 (UMLS CUI [1,1])
C0443144 (UMLS CUI [1,2])
Pulmonary Capillary Wedge Pressure | Left ventricular end-diastolic pressure
Item
2. pulmonary capillary wedge pressure (pcwp) or left ventricular-end diastolic pressure less than 15 mmhg, and
boolean
C0086879 (UMLS CUI [1])
C0456190 (UMLS CUI [2])
Pulmonary Vascular Resistance
Item
3. pulmonary vascular resistance (pvr) greater than 3 mmhg/l/min.
boolean
C0456261 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypertension, Portal | Chronic liver disease
Item
portal hypertension or chronic liver disease
boolean
C0020541 (UMLS CUI [1])
C0341439 (UMLS CUI [2])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
alt or ast levels greater than 1.5 times the upper limit of normal at the screening visit
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Medical contraindication Endothelin receptor antagonist
Item
contraindication to treatment with an endothelin receptor antagonist
boolean
C1301624 (UMLS CUI [1,1])
C1134681 (UMLS CUI [1,2])
Alcohol abuse | Illicit Drugs abuse
Item
recent history of abusing alcohol or illicit drugs
boolean
C0085762 (UMLS CUI [1])
C0086190 (UMLS CUI [2,1])
C0013146 (UMLS CUI [2,2])
Chronic Kidney Insufficiency
Item
chronic renal insufficiency
boolean
C0403447 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Atrial septostomy
Item
atrial septostomy within 30 days before study entry
boolean
C0700586 (UMLS CUI [1])
bosentan failed | Clinical Response Lack | Safety Concern
Item
previous failure on bosentan because of safety concerns of the lack of clinical response
boolean
C0252643 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C4055223 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0036043 (UMLS CUI [3,1])
C2699424 (UMLS CUI [3,2])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video