ID

20756

Beschreibung

Safety and Tolerability of Liraglutide in Subjects With Impaired Kidney Function and in Subjects With Normal Kidney Function; ODM derived from: https://clinicaltrials.gov/show/NCT01508806

Link

https://clinicaltrials.gov/show/NCT01508806

Stichworte

Versionen (1)
  1. 15.03.17 15.03.17 -
Hochgeladen am

15. März 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes NCT01508806

Englisch

Eligibility Diabetes NCT01508806

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01508806
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects meeting the pre-defined gfr (glomerular filtration rate) criteria (estimated by the cockcroft and gault formula) for any of the renal function groups
Beschreibung

Glomerular Filtration Rate criteria Fulfill Cockcroft-Gault formula | Renal function Groups

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017654
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
UMLS CUI [1,4]
C2924627
UMLS CUI [2,1]
C0232804
UMLS CUI [2,2]
C0441833
body mass index (bmi) maximum 40 kg/m^2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected allergy to trial product(s) or related products
Beschreibung

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Suspected Pharmaceutical Preparations Related

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0439849
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0750491
UMLS CUI [3,3]
C0013230
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0013227
UMLS CUI [4,4]
C0439849
renal transplanted patients
Beschreibung

Kidney Transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C0022671
haemodialysis patients
Beschreibung

Hemodialysis

Datentyp

boolean

Alias
UMLS CUI [1]
C0019004
cardiac problems
Beschreibung

cardiac problem

Datentyp

boolean

Alias
UMLS CUI [1]
C0262402
uncontrolled treated/untreated hypertension
Beschreibung

Uncontrolled hypertension Treated | Uncontrolled hypertension untreated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0332155
history of alcoholism or drug abuse during the last 12 months
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
Beschreibung

Tobacco use Number of cigarettes per day | Tobacco Equivalent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
UMLS CUI [2,1]
C0040329
UMLS CUI [2,2]
C0205163
habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator
Beschreibung

Consumption Excessive Beverages methylxanthine | Consumption Excessive Food methylxanthine | Consumption Excessive Coffee | Consumption Excessive Tea | Consumption Excessive Soft Drinks | Consumption Excessive Cola drink | Consumption Excessive Hot chocolate drink

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009830
UMLS CUI [1,2]
C0442802
UMLS CUI [1,3]
C0005329
UMLS CUI [1,4]
C0066447
UMLS CUI [2,1]
C0009830
UMLS CUI [2,2]
C0442802
UMLS CUI [2,3]
C0016452
UMLS CUI [2,4]
C0066447
UMLS CUI [3,1]
C0009830
UMLS CUI [3,2]
C0442802
UMLS CUI [3,3]
C0009237
UMLS CUI [4,1]
C0009830
UMLS CUI [4,2]
C0442802
UMLS CUI [4,3]
C0039400
UMLS CUI [5,1]
C0009830
UMLS CUI [5,2]
C0442802
UMLS CUI [5,3]
C3489624
UMLS CUI [6,1]
C0009830
UMLS CUI [6,2]
C0442802
UMLS CUI [6,3]
C0452444
UMLS CUI [7,1]
C0009830
UMLS CUI [7,2]
C0442802
UMLS CUI [7,3]
C0452243
excessive consumption of food deviating from a normal diet as judged by the investigator
Beschreibung

Consumption Excessive Food | Normal diet Different

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009830
UMLS CUI [1,2]
C0442802
UMLS CUI [1,3]
C0016452
UMLS CUI [2,1]
C0184625
UMLS CUI [2,2]
C1705242
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Ähnliche Modelle

Eligibility Diabetes NCT01508806

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01508806
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Glomerular Filtration Rate criteria Fulfill Cockcroft-Gault formula | Renal function Groups
Item
subjects meeting the pre-defined gfr (glomerular filtration rate) criteria (estimated by the cockcroft and gault formula) for any of the renal function groups
boolean
C0017654 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C2924627 (UMLS CUI [1,4])
C0232804 (UMLS CUI [2,1])
C0441833 (UMLS CUI [2,2])
Body mass index
Item
body mass index (bmi) maximum 40 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected allergy to trial product(s) or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Kidney Transplantation
Item
renal transplanted patients
boolean
C0022671 (UMLS CUI [1])
Hemodialysis
Item
haemodialysis patients
boolean
C0019004 (UMLS CUI [1])
cardiac problem
Item
cardiac problems
boolean
C0262402 (UMLS CUI [1])
Uncontrolled hypertension Treated | Uncontrolled hypertension untreated
Item
uncontrolled treated/untreated hypertension
boolean
C1868885 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Substance Use Disorders
Item
history of alcoholism or drug abuse during the last 12 months
boolean
C0038586 (UMLS CUI [1])
Tobacco use Number of cigarettes per day | Tobacco Equivalent
Item
smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
C0040329 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
Consumption Excessive Beverages methylxanthine | Consumption Excessive Food methylxanthine | Consumption Excessive Coffee | Consumption Excessive Tea | Consumption Excessive Soft Drinks | Consumption Excessive Cola drink | Consumption Excessive Hot chocolate drink
Item
habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator
boolean
C0009830 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
C0005329 (UMLS CUI [1,3])
C0066447 (UMLS CUI [1,4])
C0009830 (UMLS CUI [2,1])
C0442802 (UMLS CUI [2,2])
C0016452 (UMLS CUI [2,3])
C0066447 (UMLS CUI [2,4])
C0009830 (UMLS CUI [3,1])
C0442802 (UMLS CUI [3,2])
C0009237 (UMLS CUI [3,3])
C0009830 (UMLS CUI [4,1])
C0442802 (UMLS CUI [4,2])
C0039400 (UMLS CUI [4,3])
C0009830 (UMLS CUI [5,1])
C0442802 (UMLS CUI [5,2])
C3489624 (UMLS CUI [5,3])
C0009830 (UMLS CUI [6,1])
C0442802 (UMLS CUI [6,2])
C0452444 (UMLS CUI [6,3])
C0009830 (UMLS CUI [7,1])
C0442802 (UMLS CUI [7,2])
C0452243 (UMLS CUI [7,3])
Consumption Excessive Food | Normal diet Different
Item
excessive consumption of food deviating from a normal diet as judged by the investigator
boolean
C0009830 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
C0016452 (UMLS CUI [1,3])
C0184625 (UMLS CUI [2,1])
C1705242 (UMLS CUI [2,2])
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