ID

31238

Descrição

Study of Macronutrients and Heart Disease Risk; ODM derived from: https://clinicaltrials.gov/show/NCT00609271

Link

https://clinicaltrials.gov/show/NCT00609271

Palavras-chave

Versões (1)
  1. 31/07/2018 31/07/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

31 de julho de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Obesity NCT00609271

Inglês

Eligibility Obesity NCT00609271

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00609271
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women aged 22 - 75 years, any race/ethnicity
Descrição

Age | Racial group Any | Ethnicity Any

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0034510
UMLS CUI [2,2]
C1552551
UMLS CUI [3,1]
C0015031
UMLS CUI [3,2]
C1552551
bmi of 30 - 45 k/m2
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
willing and able to provide informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of self-reported clinical cvd (angina/myocardial infarction, coronary revascularization, heart failure, stroke/transient ischemic attack, peripheral arterial disease)
Descrição

Cardiovascular Diseases | Angina Pectoris | Myocardial Infarction | Coronary revascularisation | Heart failure | Cerebrovascular accident | Transient Ischemic Attack | Peripheral Arterial Diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0877341
UMLS CUI [5]
C0018801
UMLS CUI [6]
C0038454
UMLS CUI [7]
C0007787
UMLS CUI [8]
C1704436
medical condition in which a low-carbohydrate diet may not be advised (diabetes, renal disease, cancer requiring treatment during the past year, osteoporosis, untreated thyroid disease, gout)
Descrição

Medical condition Low-carbohydrate diet Unfavorable | Diabetes Mellitus | Kidney Diseases | Malignant Neoplasms Treatment required for | Osteoporosis | Thyroid Disease untreated | Gout

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0259836
UMLS CUI [1,3]
C3640815
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0022658
UMLS CUI [4,1]
C0006826
UMLS CUI [4,2]
C0332121
UMLS CUI [5]
C0029456
UMLS CUI [6,1]
C0040128
UMLS CUI [6,2]
C0332155
UMLS CUI [7]
C0018099
current use of more than 2 antihypertensive or more than 2 cholesterol-lowering medications
Descrição

Antihypertensive Agents Quantity | Anticholesteremic Agents Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0003277
UMLS CUI [2,2]
C1265611
for women, current pregnancy or breastfeeding or plans to become pregnant during the study period
Descrição

Pregnancy | Breast Feeding | Pregnancy, Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
consumption of more than 21 alcoholic beverages per week
Descrição

Consumption Alcoholic Beverages Quantity Weekly

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0001967
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0332174
currently on a diet or using prescription weight loss medications, underwent weight loss surgery, and/or experienced weight loss >15 pounds within 6 months of study entry
Descrição

Diet therapy | Weight-Loss Agents | Bariatric Surgery | Weight decreased Pounds Quantity Timespan

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2]
C0376606
UMLS CUI [3]
C1456587
UMLS CUI [4,1]
C1262477
UMLS CUI [4,2]
C0439219
UMLS CUI [4,3]
C1265611
UMLS CUI [4,4]
C0872291
plans to move out of the study area (>1 hour from study site) or difficulty to come to the study site
Descrição

Relocation of home Planned | Distance Study Site Difficulty

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2699029
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0012751
UMLS CUI [2,2]
C2825164
UMLS CUI [2,3]
C0332218
participation of another household member in the study; employees or persons living with employees of the study
Descrição

Participation Household Member Clinical Trial

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C4330269
UMLS CUI [1,3]
C0008976
participation in other lifestyle intervention trials currently
Descrição

Study Subject Participation Status | Life Style Intervention

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0023676
UMLS CUI [2,2]
C0184661
at the discretion of the study coordinator
Descrição

Study Coordinator Decision

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1710220
UMLS CUI [1,2]
C0679006
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Similar models

Eligibility Obesity NCT00609271

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00609271
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age | Racial group Any | Ethnicity Any
Item
men or women aged 22 - 75 years, any race/ethnicity
boolean
C0001779 (UMLS CUI [1])
C0034510 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
C0015031 (UMLS CUI [3,1])
C1552551 (UMLS CUI [3,2])
Body mass index
Item
bmi of 30 - 45 k/m2
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
willing and able to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cardiovascular Diseases | Angina Pectoris | Myocardial Infarction | Coronary revascularisation | Heart failure | Cerebrovascular accident | Transient Ischemic Attack | Peripheral Arterial Diseases
Item
history of self-reported clinical cvd (angina/myocardial infarction, coronary revascularization, heart failure, stroke/transient ischemic attack, peripheral arterial disease)
boolean
C0007222 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0877341 (UMLS CUI [4])
C0018801 (UMLS CUI [5])
C0038454 (UMLS CUI [6])
C0007787 (UMLS CUI [7])
C1704436 (UMLS CUI [8])
Medical condition Low-carbohydrate diet Unfavorable | Diabetes Mellitus | Kidney Diseases | Malignant Neoplasms Treatment required for | Osteoporosis | Thyroid Disease untreated | Gout
Item
medical condition in which a low-carbohydrate diet may not be advised (diabetes, renal disease, cancer requiring treatment during the past year, osteoporosis, untreated thyroid disease, gout)
boolean
C3843040 (UMLS CUI [1,1])
C0259836 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C0011849 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0006826 (UMLS CUI [4,1])
C0332121 (UMLS CUI [4,2])
C0029456 (UMLS CUI [5])
C0040128 (UMLS CUI [6,1])
C0332155 (UMLS CUI [6,2])
C0018099 (UMLS CUI [7])
Antihypertensive Agents Quantity | Anticholesteremic Agents Quantity
Item
current use of more than 2 antihypertensive or more than 2 cholesterol-lowering medications
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0003277 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
for women, current pregnancy or breastfeeding or plans to become pregnant during the study period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Consumption Alcoholic Beverages Quantity Weekly
Item
consumption of more than 21 alcoholic beverages per week
boolean
C0001948 (UMLS CUI [1,1])
C0001967 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0332174 (UMLS CUI [1,4])
Diet therapy | Weight-Loss Agents | Bariatric Surgery | Weight decreased Pounds Quantity Timespan
Item
currently on a diet or using prescription weight loss medications, underwent weight loss surgery, and/or experienced weight loss >15 pounds within 6 months of study entry
boolean
C0012159 (UMLS CUI [1])
C0376606 (UMLS CUI [2])
C1456587 (UMLS CUI [3])
C1262477 (UMLS CUI [4,1])
C0439219 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0872291 (UMLS CUI [4,4])
Relocation of home Planned | Distance Study Site Difficulty
Item
plans to move out of the study area (>1 hour from study site) or difficulty to come to the study site
boolean
C2699029 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0012751 (UMLS CUI [2,1])
C2825164 (UMLS CUI [2,2])
C0332218 (UMLS CUI [2,3])
Participation Household Member Clinical Trial
Item
participation of another household member in the study; employees or persons living with employees of the study
boolean
C0679823 (UMLS CUI [1,1])
C4330269 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Study Subject Participation Status | Life Style Intervention
Item
participation in other lifestyle intervention trials currently
boolean
C2348568 (UMLS CUI [1])
C0023676 (UMLS CUI [2,1])
C0184661 (UMLS CUI [2,2])
Study Coordinator Decision
Item
at the discretion of the study coordinator
boolean
C1710220 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
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