ID

31231

Descripción

BMS-646256 in Obese and Overweight Type 2 Diabetics; ODM derived from: https://clinicaltrials.gov/show/NCT00541567

Link

https://clinicaltrials.gov/show/NCT00541567

Palabras clave

Versiones (1)
  1. 31/7/18 31/7/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

31 de julio de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Obesity and Type 2 Diabetes NCT00541567

Inglés

Eligibility Obesity and Type 2 Diabetes NCT00541567

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients aged 18-70 years and bmi ≥27 with type 2 diabetes who have been treated with diet and exercise only or with half maximal or greater metformin or sulfonylurea monotherapy (stable dose for at least three months), but who remained inadequately controlled (hba1c >7% and hba1c<10%).
Descripción

Age | Body mass index | Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Metformin Dose Stable | Sulfonylurea Dose Stable | Control Inadequate | Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1305855
UMLS CUI [3]
C0011860
UMLS CUI [4]
C0012159
UMLS CUI [5]
C0015259
UMLS CUI [6,1]
C0025598
UMLS CUI [6,2]
C0178602
UMLS CUI [6,3]
C0205360
UMLS CUI [7,1]
C0038766
UMLS CUI [7,2]
C0178602
UMLS CUI [7,3]
C0205360
UMLS CUI [8,1]
C0243148
UMLS CUI [8,2]
C0205412
UMLS CUI [9]
C0474680
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy
Descripción

Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
anti-diabetic medications other than baseline metformin or sulfonylurea monotherapy
Descripción

Antidiabetics | Exception Metformin | Exception Sulfonylurea

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0038766
history of myocardial infarction in the prior six months/ history of heart failure defined as new york heart association functional class i, ii, iii or iv/ history of symptomatic arrhythmia
Descripción

Myocardial Infarction | Heart failure New York Heart Association Classification | ARRHYTHMIA SYMPTOMATIC

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0741212
active hepatic disease/ any documented muscle disease
Descripción

Liver diseases | Myopathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0026848
history of multiple sclerosis/ baseline history of tremors, ataxia, anxiety or dizziness
Descripción

Multiple Sclerosis | Tremor | Ataxia | Anxiety | Dizziness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0040822
UMLS CUI [3]
C0004134
UMLS CUI [4]
C0003467
UMLS CUI [5]
C0012833
seizures within the last year, stroke, and transient ischemic attack/ known history of schizophrenia, dementia, or bipolar disorder as defined by dsm iv criteria.
Descripción

Seizures | Cerebrovascular accident | Transient Ischemic Attack | Schizophrenia | Dementia | Bipolar Disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
UMLS CUI [4]
C0036341
UMLS CUI [5]
C0497327
UMLS CUI [6]
C0005586
currently depressed subjects or a ces-d score greater or equal to 16 at the screening visit or at baseline (day 1)/ history of suicide attempt or ideation
Descripción

Depressed | CES-D Scale | Suicide attempt | Feeling suicidal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0344315
UMLS CUI [2]
C2699160
UMLS CUI [3]
C0038663
UMLS CUI [4]
C0424000
previous history of surgical procedures for weight loss (e.g. stomach stapling, bypass)/ weight loss greater than 5 kg in the prior 3 months
Descripción

Bariatric Surgery | Stomach Stapling | Bypass | Weight decreased Amount Timespan

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1456587
UMLS CUI [2]
C0149701
UMLS CUI [3]
C0741847
UMLS CUI [4,1]
C1262477
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0872291
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Similar models

Eligibility Obesity and Type 2 Diabetes NCT00541567

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age | Body mass index | Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Metformin Dose Stable | Sulfonylurea Dose Stable | Control Inadequate | Hemoglobin A1c measurement
Item
patients aged 18-70 years and bmi ≥27 with type 2 diabetes who have been treated with diet and exercise only or with half maximal or greater metformin or sulfonylurea monotherapy (stable dose for at least three months), but who remained inadequately controlled (hba1c >7% and hba1c<10%).
boolean
C0001779 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
C0012159 (UMLS CUI [4])
C0015259 (UMLS CUI [5])
C0025598 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
C0038766 (UMLS CUI [7,1])
C0178602 (UMLS CUI [7,2])
C0205360 (UMLS CUI [7,3])
C0243148 (UMLS CUI [8,1])
C0205412 (UMLS CUI [8,2])
C0474680 (UMLS CUI [9])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Antidiabetics | Exception Metformin | Exception Sulfonylurea
Item
anti-diabetic medications other than baseline metformin or sulfonylurea monotherapy
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0038766 (UMLS CUI [3,2])
Myocardial Infarction | Heart failure New York Heart Association Classification | ARRHYTHMIA SYMPTOMATIC
Item
history of myocardial infarction in the prior six months/ history of heart failure defined as new york heart association functional class i, ii, iii or iv/ history of symptomatic arrhythmia
boolean
C0027051 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0741212 (UMLS CUI [3])
Liver diseases | Myopathy
Item
active hepatic disease/ any documented muscle disease
boolean
C0023895 (UMLS CUI [1])
C0026848 (UMLS CUI [2])
Multiple Sclerosis | Tremor | Ataxia | Anxiety | Dizziness
Item
history of multiple sclerosis/ baseline history of tremors, ataxia, anxiety or dizziness
boolean
C0026769 (UMLS CUI [1])
C0040822 (UMLS CUI [2])
C0004134 (UMLS CUI [3])
C0003467 (UMLS CUI [4])
C0012833 (UMLS CUI [5])
Seizures | Cerebrovascular accident | Transient Ischemic Attack | Schizophrenia | Dementia | Bipolar Disorder
Item
seizures within the last year, stroke, and transient ischemic attack/ known history of schizophrenia, dementia, or bipolar disorder as defined by dsm iv criteria.
boolean
C0036572 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0036341 (UMLS CUI [4])
C0497327 (UMLS CUI [5])
C0005586 (UMLS CUI [6])
Depressed | CES-D Scale | Suicide attempt | Feeling suicidal
Item
currently depressed subjects or a ces-d score greater or equal to 16 at the screening visit or at baseline (day 1)/ history of suicide attempt or ideation
boolean
C0344315 (UMLS CUI [1])
C2699160 (UMLS CUI [2])
C0038663 (UMLS CUI [3])
C0424000 (UMLS CUI [4])
Bariatric Surgery | Stomach Stapling | Bypass | Weight decreased Amount Timespan
Item
previous history of surgical procedures for weight loss (e.g. stomach stapling, bypass)/ weight loss greater than 5 kg in the prior 3 months
boolean
C1456587 (UMLS CUI [1])
C0149701 (UMLS CUI [2])
C0741847 (UMLS CUI [3])
C1262477 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0872291 (UMLS CUI [4,3])
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