ID

23226

Beschreibung

Efficacy and Safety of Natto Extract; ODM derived from: https://clinicaltrials.gov/show/NCT00447434

Link

https://clinicaltrials.gov/show/NCT00447434

Stichworte

Versionen (1)
  1. 29.06.17 29.06.17 -
Hochgeladen am

29. Juni 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Thrombosis NCT00447434

Englisch

Eligibility Thrombosis NCT00447434

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Thrombosis NCT00447434
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
in order to be enrolled in the study, potential study subjects must meet the following inclusion criteria:
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. men and non-pregnant women who are at least 20 and younger than 70 years of age.
Beschreibung

Age | Pregnancy Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
2. subjects who are, in the opinion of the investigator, able to comply with the requirements of the study.
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
3. subjects who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving investigational product.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
group-specific inclusions criteria:
Beschreibung

Inclusion criteria Group Specific

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0441833
UMLS CUI [1,3]
C0205369
group a:
Beschreibung

Group A

Datentyp

boolean

Alias
UMLS CUI [1]
C0441835
1. subjects have no risk factors of cardiovascular diseases (see group c) or chronic renal diseases in the history.
Beschreibung

Cardiovascular Diseases Risk factors Absent | Chronic Kidney Diseases Risk factors Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C1561643
UMLS CUI [2,2]
C0035648
UMLS CUI [2,3]
C0332197
2. male subjects have creatinine≦1.4 mg/dl; female≦1.3 mg/dl.
Beschreibung

Creatinine measurement, serum | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
group b:
Beschreibung

Group B

Datentyp

boolean

Alias
UMLS CUI [1]
C0441836
1. patients have been receiving dialysis at the same institute for at least 3 months.
Beschreibung

Dialysis procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0011946
group c:
Beschreibung

Group C

Datentyp

boolean

Alias
UMLS CUI [1]
C0441837
1. patients have coronary artery disease (cad); or
Beschreibung

Coronary Artery Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1956346
2. patients have peripheral arterial occlusive disease (paod); or
Beschreibung

Peripheral arterial occlusive disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1306889
3. patients have history of stroke; or
Beschreibung

Cerebrovascular accident

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
4. patients have history of transient ischemic attack (tia); or
Beschreibung

Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1]
C0007787
5. patients have history of pulmonary embolism (pe); or
Beschreibung

Pulmonary Embolism

Datentyp

boolean

Alias
UMLS CUI [1]
C0034065
6. patients have history of deep vein thrombosis (dvp); or
Beschreibung

Deep Vein Thrombosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0149871
7. patients have more than 2 major risk factors of cardiovascular disease (cvd) listed by national health insurance guidelines such as hypertension, smoking, diabetes mellitus (dm), atrial fibrillation (af), lipid disorder, overweight, physical inactivity, etc.
Beschreibung

Cardiovascular Disease Risk factors Major Quantity | Hypertensive disease | Tobacco use | Diabetes Mellitus | Atrial Fibrillation | Lipid Metabolism Disorders | Overweight | Physical Inactivity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C0205164
UMLS CUI [1,4]
C1265611
UMLS CUI [2]
C0020538
UMLS CUI [3]
C0543414
UMLS CUI [4]
C0011849
UMLS CUI [5]
C0004238
UMLS CUI [6]
C0154251
UMLS CUI [7]
C0497406
UMLS CUI [8]
C3890554
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
in order to be enrolled in the study, potential study patients must not have any of the following exclusion criteria:
Beschreibung

Criteria Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0332197
1. known allergies to the component of study product.
Beschreibung

Hypersensitivity Investigational New Drugs Component

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1705248
2. current use of warfarin.
Beschreibung

Warfarin

Datentyp

boolean

Alias
UMLS CUI [1]
C0043031
3. patients have active disease status.
Beschreibung

Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0012634
4. patients have acute disease, and in the opinion of investigators, are not suitable to participate in this study.
Beschreibung

Disease | Study Subject Participation Status Inappropriate

Datentyp

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C1548788
group-specific exclusion criteria:
Beschreibung

Exclusion Criteria Group Specific

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0441833
UMLS CUI [1,3]
C0205369
group a:
Beschreibung

Group A

Datentyp

boolean

Alias
UMLS CUI [1]
C0441835
1. patients have coronary artery disease (cad).
Beschreibung

Coronary Artery Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1956346
2. patients have peripheral arterial occlusive disease (paod).
Beschreibung

Peripheral arterial occlusive disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1306889
3. patients have history of stroke.
Beschreibung

Cerebrovascular accident

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
4. patients have history of transient ischemic attack (tia).
Beschreibung

Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1]
C0007787
5. patients have history of pulmonary embolism (pe).
Beschreibung

Pulmonary Embolism

Datentyp

boolean

Alias
UMLS CUI [1]
C0034065
6. patients have history of deep vein thrombosis (dvp).
Beschreibung

Deep Vein Thrombosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0149871
7. patients have more than 2 major risk factors of cardiovascular disease (cvd) listed by national health insurance guidelines such as hypertension, smoking, diabetes mellitus (dm), atrial fibrillation (af), lipid disorder, overweight, physical inactivity, etc.
Beschreibung

Cardiovascular Disease Risk factors Major Quantity | Hypertensive disease | Tobacco use | Diabetes Mellitus | Atrial Fibrillation | Lipid Metabolism Disorders | Overweight | Physical Inactivity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C0205164
UMLS CUI [1,4]
C1265611
UMLS CUI [2]
C0020538
UMLS CUI [3]
C0543414
UMLS CUI [4]
C0011849
UMLS CUI [5]
C0004238
UMLS CUI [6]
C0154251
UMLS CUI [7]
C0497406
UMLS CUI [8]
C3890554
8. patients have history of chronic renal diseases.
Beschreibung

Chronic Kidney Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C1561643
9. male subjects have creatinine＞1.4 mg/dl; female＞1.3 mg/dl.
Beschreibung

Creatinine measurement, serum | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
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Ähnliche Modelle

Eligibility Thrombosis NCT00447434

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Thrombosis NCT00447434
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
in order to be enrolled in the study, potential study subjects must meet the following inclusion criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Age | Pregnancy Absent
Item
1. men and non-pregnant women who are at least 20 and younger than 70 years of age.
boolean
C0001779 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Protocol Compliance
Item
2. subjects who are, in the opinion of the investigator, able to comply with the requirements of the study.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
3. subjects who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving investigational product.
boolean
C0021430 (UMLS CUI [1])
Inclusion criteria Group Specific
Item
group-specific inclusions criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Group A
Item
group a:
boolean
C0441835 (UMLS CUI [1])
Cardiovascular Diseases Risk factors Absent | Chronic Kidney Diseases Risk factors Absent
Item
1. subjects have no risk factors of cardiovascular diseases (see group c) or chronic renal diseases in the history.
boolean
C0007222 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1561643 (UMLS CUI [2,1])
C0035648 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Creatinine measurement, serum | Gender
Item
2. male subjects have creatinine≦1.4 mg/dl; female≦1.3 mg/dl.
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Group B
Item
group b:
boolean
C0441836 (UMLS CUI [1])
Dialysis procedure
Item
1. patients have been receiving dialysis at the same institute for at least 3 months.
boolean
C0011946 (UMLS CUI [1])
Group C
Item
group c:
boolean
C0441837 (UMLS CUI [1])
Coronary Artery Disease
Item
1. patients have coronary artery disease (cad); or
boolean
C1956346 (UMLS CUI [1])
Peripheral arterial occlusive disease
Item
2. patients have peripheral arterial occlusive disease (paod); or
boolean
C1306889 (UMLS CUI [1])
Cerebrovascular accident
Item
3. patients have history of stroke; or
boolean
C0038454 (UMLS CUI [1])
Transient Ischemic Attack
Item
4. patients have history of transient ischemic attack (tia); or
boolean
C0007787 (UMLS CUI [1])
Pulmonary Embolism
Item
5. patients have history of pulmonary embolism (pe); or
boolean
C0034065 (UMLS CUI [1])
Deep Vein Thrombosis
Item
6. patients have history of deep vein thrombosis (dvp); or
boolean
C0149871 (UMLS CUI [1])
Cardiovascular Disease Risk factors Major Quantity | Hypertensive disease | Tobacco use | Diabetes Mellitus | Atrial Fibrillation | Lipid Metabolism Disorders | Overweight | Physical Inactivity
Item
7. patients have more than 2 major risk factors of cardiovascular disease (cvd) listed by national health insurance guidelines such as hypertension, smoking, diabetes mellitus (dm), atrial fibrillation (af), lipid disorder, overweight, physical inactivity, etc.
boolean
C0007222 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0020538 (UMLS CUI [2])
C0543414 (UMLS CUI [3])
C0011849 (UMLS CUI [4])
C0004238 (UMLS CUI [5])
C0154251 (UMLS CUI [6])
C0497406 (UMLS CUI [7])
C3890554 (UMLS CUI [8])
Item Group
C0680251 (UMLS CUI)
Criteria Absent
Item
in order to be enrolled in the study, potential study patients must not have any of the following exclusion criteria:
boolean
C0243161 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Hypersensitivity Investigational New Drugs Component
Item
1. known allergies to the component of study product.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Warfarin
Item
2. current use of warfarin.
boolean
C0043031 (UMLS CUI [1])
Disease
Item
3. patients have active disease status.
boolean
C0012634 (UMLS CUI [1])
Disease | Study Subject Participation Status Inappropriate
Item
4. patients have acute disease, and in the opinion of investigators, are not suitable to participate in this study.
boolean
C0012634 (UMLS CUI [1])
C2348568 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
Exclusion Criteria Group Specific
Item
group-specific exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Group A
Item
group a:
boolean
C0441835 (UMLS CUI [1])
Coronary Artery Disease
Item
1. patients have coronary artery disease (cad).
boolean
C1956346 (UMLS CUI [1])
Peripheral arterial occlusive disease
Item
2. patients have peripheral arterial occlusive disease (paod).
boolean
C1306889 (UMLS CUI [1])
Cerebrovascular accident
Item
3. patients have history of stroke.
boolean
C0038454 (UMLS CUI [1])
Transient Ischemic Attack
Item
4. patients have history of transient ischemic attack (tia).
boolean
C0007787 (UMLS CUI [1])
Pulmonary Embolism
Item
5. patients have history of pulmonary embolism (pe).
boolean
C0034065 (UMLS CUI [1])
Deep Vein Thrombosis
Item
6. patients have history of deep vein thrombosis (dvp).
boolean
C0149871 (UMLS CUI [1])
Cardiovascular Disease Risk factors Major Quantity | Hypertensive disease | Tobacco use | Diabetes Mellitus | Atrial Fibrillation | Lipid Metabolism Disorders | Overweight | Physical Inactivity
Item
7. patients have more than 2 major risk factors of cardiovascular disease (cvd) listed by national health insurance guidelines such as hypertension, smoking, diabetes mellitus (dm), atrial fibrillation (af), lipid disorder, overweight, physical inactivity, etc.
boolean
C0007222 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0020538 (UMLS CUI [2])
C0543414 (UMLS CUI [3])
C0011849 (UMLS CUI [4])
C0004238 (UMLS CUI [5])
C0154251 (UMLS CUI [6])
C0497406 (UMLS CUI [7])
C3890554 (UMLS CUI [8])
Chronic Kidney Diseases
Item
8. patients have history of chronic renal diseases.
boolean
C1561643 (UMLS CUI [1])
Creatinine measurement, serum | Gender
Item
9. male subjects have creatinine＞1.4 mg/dl; female＞1.3 mg/dl.
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
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