ID

19658

Beschrijving

Low Fat Versus Protein Sparing Diet for Weight Loss & Impact on Biomarkers Associated With Breast Cancer Risk; ODM derived from: https://clinicaltrials.gov/show/NCT01559194

Link

https://clinicaltrials.gov/show/NCT01559194

Trefwoorden

Versies (1)
  1. 19-01-17 19-01-17 -
Geüploaded op

19 januari 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01559194

Engels

Eligibility Breast Cancer NCT01559194

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged 30 and older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
premenopausal (may be confirmed by fsh)
Beschrijving

Premenopausal state Follicle stimulating hormone measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232969
UMLS CUI [1,2]
C0202022
no previous diagnosis of cancer (except non-melanomatous skin cancer)
Beschrijving

Malignant Neoplasms | Skin carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
body mass index between 25-34 kg/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
women must be expected to live in the columbus area for the next 18 months.
Beschrijving

Gender Reside Geographic area

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C2982691
UMLS CUI [1,3]
C0017446
all women must present a letter of medical clearance from their primary care physician.
Beschrijving

Gender Letter Medical Clearance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0746461
UMLS CUI [1,3]
C4042833
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant women or women who plan to become pregnant during the study period will not be enrolled. women who become pregnant during the intervention will be withdrawn from the study.
Beschrijving

Pregnancy | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
women who are already participating in a formal weight loss program (such as weight watchers)will not be eligible.
Beschrijving

Gender Participation Weight Reduction Program

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C3179079
women with a medical history that precludes adherence to either of the two dietary patterns will also be excluded. this includes a history of renal insufficiency, gluten enteropathy, crohn's disease or other medical conditions that significantly impact nutritional status or metabolism. women with either type i or controlled type ii diabetes will be eligible to participate in this trial.
Beschrijving

Gender | Medical History Excludes Dietary Patterns Quantity | Renal Insufficiency | Gluten enteropathy | Crohn Disease | Medical condition Impact Nutritional status | Medical condition Impact Metabolism | Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Controlled

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C1517289
UMLS CUI [2,4]
C1265611
UMLS CUI [3]
C1565489
UMLS CUI [4]
C0007570
UMLS CUI [5]
C0010346
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C4049986
UMLS CUI [6,3]
C0392209
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C4049986
UMLS CUI [7,3]
C0025519
UMLS CUI [8]
C0011854
UMLS CUI [9,1]
C0011860
UMLS CUI [9,2]
C2911690
all medical problems must be managed and controlled. lipid profile, blood glucose, hemoglobin a1c, and blood pressure will be assessed at the screening visit. these results will be reviewed by the study physician. women who have abnormal values that, at the discretion of the study physician, would benefit from medical management will be referred to a primary care physician prior to considering them for enrollment.
Beschrijving

Problem Medical Controlled | Lipids profile test | Blood Glucose Assessment | Glycosylated hemoglobin A Assessment | Blood Pressure Assessment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0033213
UMLS CUI [1,2]
C0205476
UMLS CUI [1,3]
C2587213
UMLS CUI [2]
C0850354
UMLS CUI [3,1]
C0005802
UMLS CUI [3,2]
C1516048
UMLS CUI [4,1]
C0019018
UMLS CUI [4,2]
C1516048
UMLS CUI [5,1]
C0005823
UMLS CUI [5,2]
C1516048
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Similar models

Eligibility Breast Cancer NCT01559194

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
aged 30 and older
boolean
C0001779 (UMLS CUI [1])
Premenopausal state Follicle stimulating hormone measurement
Item
premenopausal (may be confirmed by fsh)
boolean
C0232969 (UMLS CUI [1,1])
C0202022 (UMLS CUI [1,2])
Malignant Neoplasms | Skin carcinoma
Item
no previous diagnosis of cancer (except non-melanomatous skin cancer)
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
Body mass index
Item
body mass index between 25-34 kg/m2
boolean
C1305855 (UMLS CUI [1])
Gender Reside Geographic area
Item
women must be expected to live in the columbus area for the next 18 months.
boolean
C0079399 (UMLS CUI [1,1])
C2982691 (UMLS CUI [1,2])
C0017446 (UMLS CUI [1,3])
Gender Letter Medical Clearance
Item
all women must present a letter of medical clearance from their primary care physician.
boolean
C0079399 (UMLS CUI [1,1])
C0746461 (UMLS CUI [1,2])
C4042833 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Pregnancy, Planned
Item
pregnant women or women who plan to become pregnant during the study period will not be enrolled. women who become pregnant during the intervention will be withdrawn from the study.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Gender Participation Weight Reduction Program
Item
women who are already participating in a formal weight loss program (such as weight watchers)will not be eligible.
boolean
C0079399 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C3179079 (UMLS CUI [1,3])
Gender | Medical History Excludes Dietary Patterns Quantity | Renal Insufficiency | Gluten enteropathy | Crohn Disease | Medical condition Impact Nutritional status | Medical condition Impact Metabolism | Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Controlled
Item
women with a medical history that precludes adherence to either of the two dietary patterns will also be excluded. this includes a history of renal insufficiency, gluten enteropathy, crohn's disease or other medical conditions that significantly impact nutritional status or metabolism. women with either type i or controlled type ii diabetes will be eligible to participate in this trial.
boolean
C0079399 (UMLS CUI [1])
C0262926 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C1517289 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C1565489 (UMLS CUI [3])
C0007570 (UMLS CUI [4])
C0010346 (UMLS CUI [5])
C3843040 (UMLS CUI [6,1])
C4049986 (UMLS CUI [6,2])
C0392209 (UMLS CUI [6,3])
C3843040 (UMLS CUI [7,1])
C4049986 (UMLS CUI [7,2])
C0025519 (UMLS CUI [7,3])
C0011854 (UMLS CUI [8])
C0011860 (UMLS CUI [9,1])
C2911690 (UMLS CUI [9,2])
Problem Medical Controlled | Lipids profile test | Blood Glucose Assessment | Glycosylated hemoglobin A Assessment | Blood Pressure Assessment
Item
all medical problems must be managed and controlled. lipid profile, blood glucose, hemoglobin a1c, and blood pressure will be assessed at the screening visit. these results will be reviewed by the study physician. women who have abnormal values that, at the discretion of the study physician, would benefit from medical management will be referred to a primary care physician prior to considering them for enrollment.
boolean
C0033213 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C2587213 (UMLS CUI [1,3])
C0850354 (UMLS CUI [2])
C0005802 (UMLS CUI [3,1])
C1516048 (UMLS CUI [3,2])
C0019018 (UMLS CUI [4,1])
C1516048 (UMLS CUI [4,2])
C0005823 (UMLS CUI [5,1])
C1516048 (UMLS CUI [5,2])
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