ID

31743

Description

Mechanisms for the Effect of Acetylcysteine on Renal Function After Exposure to Radiographic Contrast Material; ODM derived from: https://clinicaltrials.gov/show/NCT00558142

Lien

https://clinicaltrials.gov/show/NCT00558142

Mots-clés

Versions (1)
  1. 24/09/2018 24/09/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

24 septembre 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Radiocontrast-induced Nephropathy NCT00558142

Anglais

Eligibility Radiocontrast-induced Nephropathy NCT00558142

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
study 1 and 3: healthy male volunteers over 45 years of age with bmi between 22 and 40.
Description

Study Number | Gender | Healthy Volunteers | Age | Body mass index

Type de données

boolean

Alias
UMLS CUI [1,1]
C2603343
UMLS CUI [1,2]
C0237753
UMLS CUI [2]
C0079399
UMLS CUI [3]
C1708335
UMLS CUI [4]
C0001779
UMLS CUI [5]
C1305855
study 2: male volunteers with ckd iii with bmi between 22 and 40.
Description

Study Number | Gender | Volunteer | Chronic Kidney Disease Stage | Body mass index

Type de données

boolean

Alias
UMLS CUI [1,1]
C2603343
UMLS CUI [1,2]
C0237753
UMLS CUI [2]
C0079399
UMLS CUI [3]
C1997894
UMLS CUI [4,1]
C1561643
UMLS CUI [4,2]
C1306673
UMLS CUI [5]
C1305855
study 4: male patients over 45 year of age with stable ckd iii and bmi between 22 and 40, undergoing elective coronary angiography.
Description

Study Number | Gender | Age | Chronic Kidney Disease Stable Stage | Body mass index | Coronary angiography elective

Type de données

boolean

Alias
UMLS CUI [1,1]
C2603343
UMLS CUI [1,2]
C0237753
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C1561643
UMLS CUI [4,2]
C0205360
UMLS CUI [4,3]
C1306673
UMLS CUI [5]
C1305855
UMLS CUI [6,1]
C0085532
UMLS CUI [6,2]
C0439608
exclusion criteria for studies 1 and 3:
Description

Exclusion Criteria Study Number

Type de données

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2603343
UMLS CUI [1,3]
C0237753
lack of informed consent
Description

Informed Consent Lacking

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332268
age <46 years
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
current involvement in a clinical trial
Description

Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
clinically significant co-morbidity: heart failure, hypertension, known hyperlipidaemia, diabetes mellitus, coagulopathy, peripheral vascular disease, or bleeding disorder
Description

Comorbidity Significant | Heart failure | Hypertensive disease | Hyperlipidemia | Diabetes Mellitus | Blood Coagulation Disorder | Peripheral Vascular Disease | Bleeding disorder

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0018801
UMLS CUI [3]
C0020538
UMLS CUI [4]
C0020473
UMLS CUI [5]
C0011849
UMLS CUI [6]
C0005779
UMLS CUI [7]
C0085096
UMLS CUI [8]
C1458140
thyroid disease, myasthenia gravis, asthma, atopy, or a history of allergy/sensitivity to acetylcysteine or contrast medium
Description

Thyroid Disease | Myasthenia Gravis | Asthma | Atopy | Acetylcysteine allergy | Contrast media allergy

Type de données

boolean

Alias
UMLS CUI [1]
C0040128
UMLS CUI [2]
C0026896
UMLS CUI [3]
C0004096
UMLS CUI [4]
C0392707
UMLS CUI [5]
C0571014
UMLS CUI [6]
C0570562
current intake of prescription medicines, in particular beta blockers
Description

Prescription Drugs | Adrenergic beta-1 Receptor Antagonists

Type de données

boolean

Alias
UMLS CUI [1]
C0304227
UMLS CUI [2]
C0304516
recent infective/inflammatory condition
Description

Communicable Disease | Inflammatory disorder

Type de données

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C1290884
blood donation during the preceding three months
Description

Blood Donation

Type de données

boolean

Alias
UMLS CUI [1]
C0005794
exclusion criteria for studies 2 and 4:
Description

Exclusion Criteria Study Number

Type de données

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2603343
UMLS CUI [1,3]
C0237753
lack of informed consent
Description

Informed Consent Lacking

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332268
age <46 years
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
current involvement in a clinical trial
Description

Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
thyroid disease, myasthenia gravis, asthma, atopy, or a history of allergy/sensitivity to acetylcysteine or contrast medium
Description

Thyroid Disease | Myasthenia Gravis | Asthma | Atopy | Acetylcysteine allergy | Contrast media allergy

Type de données

boolean

Alias
UMLS CUI [1]
C0040128
UMLS CUI [2]
C0026896
UMLS CUI [3]
C0004096
UMLS CUI [4]
C0392707
UMLS CUI [5]
C0571014
UMLS CUI [6]
C0570562
recent infective/inflammatory condition
Description

Communicable Disease | Inflammatory disorder

Type de données

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C1290884
blood donation during the preceding three months
Description

Blood Donation

Type de données

boolean

Alias
UMLS CUI [1]
C0005794
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Similar models

Eligibility Radiocontrast-induced Nephropathy NCT00558142

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Study Number | Gender | Healthy Volunteers | Age | Body mass index
Item
study 1 and 3: healthy male volunteers over 45 years of age with bmi between 22 and 40.
boolean
C2603343 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
C1708335 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
C1305855 (UMLS CUI [5])
Study Number | Gender | Volunteer | Chronic Kidney Disease Stage | Body mass index
Item
study 2: male volunteers with ckd iii with bmi between 22 and 40.
boolean
C2603343 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
C1997894 (UMLS CUI [3])
C1561643 (UMLS CUI [4,1])
C1306673 (UMLS CUI [4,2])
C1305855 (UMLS CUI [5])
Study Number | Gender | Age | Chronic Kidney Disease Stable Stage | Body mass index | Coronary angiography elective
Item
study 4: male patients over 45 year of age with stable ckd iii and bmi between 22 and 40, undergoing elective coronary angiography.
boolean
C2603343 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C1561643 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
C1306673 (UMLS CUI [4,3])
C1305855 (UMLS CUI [5])
C0085532 (UMLS CUI [6,1])
C0439608 (UMLS CUI [6,2])
Exclusion Criteria Study Number
Item
exclusion criteria for studies 1 and 3:
boolean
C0680251 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Informed Consent Lacking
Item
lack of informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Age
Item
age <46 years
boolean
C0001779 (UMLS CUI [1])
Study Subject Participation Status
Item
current involvement in a clinical trial
boolean
C2348568 (UMLS CUI [1])
Comorbidity Significant | Heart failure | Hypertensive disease | Hyperlipidemia | Diabetes Mellitus | Blood Coagulation Disorder | Peripheral Vascular Disease | Bleeding disorder
Item
clinically significant co-morbidity: heart failure, hypertension, known hyperlipidaemia, diabetes mellitus, coagulopathy, peripheral vascular disease, or bleeding disorder
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2])
C0020538 (UMLS CUI [3])
C0020473 (UMLS CUI [4])
C0011849 (UMLS CUI [5])
C0005779 (UMLS CUI [6])
C0085096 (UMLS CUI [7])
C1458140 (UMLS CUI [8])
Thyroid Disease | Myasthenia Gravis | Asthma | Atopy | Acetylcysteine allergy | Contrast media allergy
Item
thyroid disease, myasthenia gravis, asthma, atopy, or a history of allergy/sensitivity to acetylcysteine or contrast medium
boolean
C0040128 (UMLS CUI [1])
C0026896 (UMLS CUI [2])
C0004096 (UMLS CUI [3])
C0392707 (UMLS CUI [4])
C0571014 (UMLS CUI [5])
C0570562 (UMLS CUI [6])
Prescription Drugs | Adrenergic beta-1 Receptor Antagonists
Item
current intake of prescription medicines, in particular beta blockers
boolean
C0304227 (UMLS CUI [1])
C0304516 (UMLS CUI [2])
Communicable Disease | Inflammatory disorder
Item
recent infective/inflammatory condition
boolean
C0009450 (UMLS CUI [1])
C1290884 (UMLS CUI [2])
Blood Donation
Item
blood donation during the preceding three months
boolean
C0005794 (UMLS CUI [1])
Exclusion Criteria Study Number
Item
exclusion criteria for studies 2 and 4:
boolean
C0680251 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Informed Consent Lacking
Item
lack of informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Age
Item
age <46 years
boolean
C0001779 (UMLS CUI [1])
Study Subject Participation Status
Item
current involvement in a clinical trial
boolean
C2348568 (UMLS CUI [1])
Thyroid Disease | Myasthenia Gravis | Asthma | Atopy | Acetylcysteine allergy | Contrast media allergy
Item
thyroid disease, myasthenia gravis, asthma, atopy, or a history of allergy/sensitivity to acetylcysteine or contrast medium
boolean
C0040128 (UMLS CUI [1])
C0026896 (UMLS CUI [2])
C0004096 (UMLS CUI [3])
C0392707 (UMLS CUI [4])
C0571014 (UMLS CUI [5])
C0570562 (UMLS CUI [6])
Communicable Disease | Inflammatory disorder
Item
recent infective/inflammatory condition
boolean
C0009450 (UMLS CUI [1])
C1290884 (UMLS CUI [2])
Blood Donation
Item
blood donation during the preceding three months
boolean
C0005794 (UMLS CUI [1])
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