ID

16044

Beskrivning

Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02328599

Länk

https://clinicaltrials.gov/show/NCT02328599

Nyckelord

Versioner (1)
  1. 2016-06-27 2016-06-27 -
Uppladdad den

27 juni 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02328599

Engelsk

Eligibility Type 2 Diabetes Mellitus NCT02328599

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
original inclusion criteria for participation in the rcts at all sites included:
Beskrivning

Inclusion Clinical Trials, Randomized

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0206034
candidate for general anesthesia or unsupervised exercise.
Beskrivning

Indication General Anesthesia | Indication Exercise

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0002915
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0015259
age ≥20 and ≤65 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
body mass index >27 and ≤45 kg/m2.
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
diagnosis of type 2 diabetes confirmed by either requiring diabetes medication and/or having elevated glycemia based on hba1c, fasting plasma glucose, and/or oral glucose tolerance test (ogtt) results, according to american diabetes association criteria.
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent Requirement Antidiabetics | Blood glucose increased | Glycosylated hemoglobin A | Plasma fasting glucose measurement | Oral Glucose Tolerance Test

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0935929
UMLS CUI [2]
C0595877
UMLS CUI [3]
C0019018
UMLS CUI [4]
C0583513
UMLS CUI [5]
C0029161
ability and willingness to participate in the study and agree to any of the research arms.
Beskrivning

Study Subject Participation Status Ability Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0085732
UMLS CUI [1,3]
C0600109
able to understand the options and to comply with the requirements of each program.
Beskrivning

Compliance behavior Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C2348563
negative urine pregnancy test at screening and baseline visits (prior to surgery) for women of childbearing potential (i.e., biologically capable of becoming pregnant).
Beskrivning

Childbearing Potential Urine pregnancy test negative Before Operative Surgical Procedures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0543467
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who were randomized in one of the four rcts but never initiated intervention
Beskrivning

Subject is Randomized Clinical Trials, Randomized | Intervention Initiation Never

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3815594
UMLS CUI [1,2]
C0206034
UMLS CUI [2,1]
C1948041
UMLS CUI [2,2]
C1704686
UMLS CUI [2,3]
C2003901
/ did not receive randomized treatment
Beskrivning

Randomization Therapeutic procedure Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0332268
refusal to sign informed consent
Beskrivning

Informed Consent Refused

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02328599

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion Clinical Trials, Randomized
Item
original inclusion criteria for participation in the rcts at all sites included:
boolean
C1512693 (UMLS CUI [1,1])
C0206034 (UMLS CUI [1,2])
Indication General Anesthesia | Indication Exercise
Item
candidate for general anesthesia or unsupervised exercise.
boolean
C3146298 (UMLS CUI [1,1])
C0002915 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0015259 (UMLS CUI [2,2])
Age
Item
age ≥20 and ≤65 years.
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index >27 and ≤45 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent Requirement Antidiabetics | Blood glucose increased | Glycosylated hemoglobin A | Plasma fasting glucose measurement | Oral Glucose Tolerance Test
Item
diagnosis of type 2 diabetes confirmed by either requiring diabetes medication and/or having elevated glycemia based on hba1c, fasting plasma glucose, and/or oral glucose tolerance test (ogtt) results, according to american diabetes association criteria.
boolean
C0011860 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0935929 (UMLS CUI [1,3])
C0595877 (UMLS CUI [2])
C0019018 (UMLS CUI [3])
C0583513 (UMLS CUI [4])
C0029161 (UMLS CUI [5])
Study Subject Participation Status Ability Willing
Item
ability and willingness to participate in the study and agree to any of the research arms.
boolean
C2348568 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Compliance behavior Study Protocol
Item
able to understand the options and to comply with the requirements of each program.
boolean
C1321605 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Childbearing Potential Urine pregnancy test negative Before Operative Surgical Procedures
Item
negative urine pregnancy test at screening and baseline visits (prior to surgery) for women of childbearing potential (i.e., biologically capable of becoming pregnant).
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Subject is Randomized Clinical Trials, Randomized | Intervention Initiation Never
Item
subjects who were randomized in one of the four rcts but never initiated intervention
boolean
C3815594 (UMLS CUI [1,1])
C0206034 (UMLS CUI [1,2])
C1948041 (UMLS CUI [2,1])
C1704686 (UMLS CUI [2,2])
C2003901 (UMLS CUI [2,3])
Randomization Therapeutic procedure Lacking
Item
/ did not receive randomized treatment
boolean
C0034656 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Informed Consent Refused
Item
refusal to sign informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
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