ID

22875

Descripción

Safety and Effectiveness of PRX-08066 in Patients With Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00345774

Link

https://clinicaltrials.gov/show/NCT00345774

Palabras clave

Versiones (1)
  1. 13/6/17 13/6/17 -
Subido en

13 de junio de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Pulmonary Hypertension NCT00345774

Inglés

Eligibility Pulmonary Hypertension NCT00345774

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. 25 to 79 years old.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. provide voluntary written informed consent to participate.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
3. smoking history of at least 10 pack years (1 pack of cigarettes per day for 10 years).
Descripción

smoking cigarettes: ____ pack-years history

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2230126
4. diagnosis of chronic obstructive pulmonary disease.
Descripción

Chronic Obstructive Airway Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0024117
5. become short of breath with physical activity.
Descripción

Physical activity Resulting in Shortness of breath

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0026606
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0013404
6. elevated systolic pulmonary artery pressures.
Descripción

Pulmonary artery systolic pressure Elevated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0428643
UMLS CUI [1,2]
C3163633
7. not pregnant, nursing, or planning a pregnancy.
Descripción

Pregnancy Absent | Breast Feeding Absent | Planned Pregnancy Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0032992
UMLS CUI [3,2]
C0332197
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. left ventricular ejection fraction <30%.
Descripción

Left ventricular ejection fraction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428772
2. heart attack or stroke within the last 6 months.
Descripción

Myocardial Infarction | Cerebrovascular accident

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
3. history of lung resection surgery.
Descripción

Lung excision

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0396565
4. use of supplemental oxygen >20 hours/day.
Descripción

Use of supplemental oxygen hours/day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4067893
UMLS CUI [1,2]
C0556974
5. blood donation or significant blood loss within the last 56 days.
Descripción

Blood Donation | Blood Loss

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2]
C3163616
6. plasma donation within the last 14 days.
Descripción

Plasma Donation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032105
UMLS CUI [1,2]
C0680854
7. use of any drugs for another research study within the last 30 days.
Descripción

Study Subject Participation Status | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
8. use of vasodilators, long acting nitrates, prostacyclin analogs, endothelin antagonists, or phosphodiesterase inhibitor drugs within the last 14 days.
Descripción

Vasodilator Agents | Nitrates Active Long-term | Epoprostenol Analog | Endothelin receptor antagonist | Phosphodiesterase Inhibitors

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0042402
UMLS CUI [2,1]
C0028125
UMLS CUI [2,2]
C0205177
UMLS CUI [2,3]
C0443252
UMLS CUI [3,1]
C0033567
UMLS CUI [3,2]
C0243071
UMLS CUI [4]
C1134681
UMLS CUI [5]
C0031638
9. positive blood screen hepatitis b surface antigen (hbsag) or hepatitis c antibody.
Descripción

Hepatitis B surface antigen positive | Hepatitis C antibody positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
10. major surgery within the last 28 days.
Descripción

major surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679637
11. any other medical condition that may jeopardize the safety of the subject, the validity of the study results, or interfere with the completion of the study according to the protocol.
Descripción

Medical condition compromises patient safety | Medical condition compromises Validity Research results | Medical condition Interferes with Clinical Trial Completion

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C2349101
UMLS CUI [2,4]
C0683954
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0008976
UMLS CUI [3,4]
C0205197
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Similar models

Eligibility Pulmonary Hypertension NCT00345774

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. 25 to 79 years old.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
2. provide voluntary written informed consent to participate.
boolean
C0021430 (UMLS CUI [1])
smoking cigarettes: ____ pack-years history
Item
3. smoking history of at least 10 pack years (1 pack of cigarettes per day for 10 years).
boolean
C2230126 (UMLS CUI [1])
Chronic Obstructive Airway Disease
Item
4. diagnosis of chronic obstructive pulmonary disease.
boolean
C0024117 (UMLS CUI [1])
Physical activity Resulting in Shortness of breath
Item
5. become short of breath with physical activity.
boolean
C0026606 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0013404 (UMLS CUI [1,3])
Pulmonary artery systolic pressure Elevated
Item
6. elevated systolic pulmonary artery pressures.
boolean
C0428643 (UMLS CUI [1,1])
C3163633 (UMLS CUI [1,2])
Pregnancy Absent | Breast Feeding Absent | Planned Pregnancy Absent
Item
7. not pregnant, nursing, or planning a pregnancy.
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0032992 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Left ventricular ejection fraction
Item
1. left ventricular ejection fraction <30%.
boolean
C0428772 (UMLS CUI [1])
Myocardial Infarction | Cerebrovascular accident
Item
2. heart attack or stroke within the last 6 months.
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Lung excision
Item
3. history of lung resection surgery.
boolean
C0396565 (UMLS CUI [1])
Use of supplemental oxygen hours/day
Item
4. use of supplemental oxygen >20 hours/day.
boolean
C4067893 (UMLS CUI [1,1])
C0556974 (UMLS CUI [1,2])
Blood Donation | Blood Loss
Item
5. blood donation or significant blood loss within the last 56 days.
boolean
C0005794 (UMLS CUI [1])
C3163616 (UMLS CUI [2])
Plasma Donation
Item
6. plasma donation within the last 14 days.
boolean
C0032105 (UMLS CUI [1,1])
C0680854 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational New Drugs
Item
7. use of any drugs for another research study within the last 30 days.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Vasodilator Agents | Nitrates Active Long-term | Epoprostenol Analog | Endothelin receptor antagonist | Phosphodiesterase Inhibitors
Item
8. use of vasodilators, long acting nitrates, prostacyclin analogs, endothelin antagonists, or phosphodiesterase inhibitor drugs within the last 14 days.
boolean
C0042402 (UMLS CUI [1])
C0028125 (UMLS CUI [2,1])
C0205177 (UMLS CUI [2,2])
C0443252 (UMLS CUI [2,3])
C0033567 (UMLS CUI [3,1])
C0243071 (UMLS CUI [3,2])
C1134681 (UMLS CUI [4])
C0031638 (UMLS CUI [5])
Hepatitis B surface antigen positive | Hepatitis C antibody positive
Item
9. positive blood screen hepatitis b surface antigen (hbsag) or hepatitis c antibody.
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
major surgery
Item
10. major surgery within the last 28 days.
boolean
C0679637 (UMLS CUI [1])
Medical condition compromises patient safety | Medical condition compromises Validity Research results | Medical condition Interferes with Clinical Trial Completion
Item
11. any other medical condition that may jeopardize the safety of the subject, the validity of the study results, or interfere with the completion of the study according to the protocol.
boolean
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C2349101 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0008976 (UMLS CUI [3,3])
C0205197 (UMLS CUI [3,4])
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