ID

39370

Beschreibung

The Influence of Daily Intake of Whole Grain Barley or Oats on Biomarkers of Cardiovascular Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01293604

Link

https://clinicaltrials.gov/show/NCT01293604

Stichworte

Versionen (1)
  1. 03.01.20 03.01.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

3. Januar 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Healthy NCT01293604

Englisch

Eligibility Healthy NCT01293604

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Healthy NCT01293604
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women between the ages of 25-70 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
body mass index (bmi) ≥ 19 and ≤ 38
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
willingness and ability to make scheduled appointments at clinical site as required by study protocol
Beschreibung

Protocol Compliance | Patient Appointments

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0030675
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
do not regularly consume breakfast or dislike cereal for breakfast
Beschreibung

Breakfast routine Lacking | Breakfast cereal dislike

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0566556
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C0452557
UMLS CUI [2,2]
C0870431
known (self-reported) allergy or adverse reaction to grains (e.g., wheat, gluten, barley)
Beschreibung

Allergy to grains | Adverse reactions Grains | Wheat Hypersensitivity | Hypersensitivity Gluten | Allergy to barley

Datentyp

boolean

Alias
UMLS CUI [1]
C1096643
UMLS CUI [2,1]
C0559546
UMLS CUI [2,2]
C0086369
UMLS CUI [3]
C0949570
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C2362561
UMLS CUI [5]
C2321305
presence of kidney disease, liver disease, gout, untreated or unstable hypothyroidism, untreated or unstable hyperthyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
Beschreibung

Kidney Diseases | Liver diseases | Gout | Hypothyroidism Untreated | Hypothyroidism Unstable | Malignant Neoplasms | Gastrointestinal Diseases | Pancreatic Diseases | Metabolic Diseases | Malabsorption Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0018099
UMLS CUI [4,1]
C0020676
UMLS CUI [4,2]
C0332155
UMLS CUI [5,1]
C0020676
UMLS CUI [5,2]
C0443343
UMLS CUI [6]
C0006826
UMLS CUI [7]
C0017178
UMLS CUI [8]
C0030286
UMLS CUI [9]
C0025517
UMLS CUI [10]
C0024523
type 2 diabetes requiring the use of oral antidiabetic agents or insulin
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent | Requirement Antidiabetics Oral | Requirement Insulin

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0935929
UMLS CUI [2,3]
C1527415
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0021641
fasting triglycerides > 300 mg/dl
Beschreibung

Serum fasting triglyceride measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0582824
fasting glucose > 126 mg/dl
Beschreibung

Glucose measurement, fasting

Datentyp

boolean

Alias
UMLS CUI [1]
C0202045
use of cholesterol lowering medication
Beschreibung

Anticholesteremic Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0003277
blood pressure > 180/100 or hypertension treated with calcium channel blockers, direct acting vasodilators, or beta blockers
Beschreibung

Blood pressure determination | On treatment for hypertension | Calcium Channel Blockers | Vasodilators, Direct-acting | Adrenergic beta-Antagonists

Datentyp

boolean

Alias
UMLS CUI [1]
C0005824
UMLS CUI [2]
C0578998
UMLS CUI [3]
C0006684
UMLS CUI [4]
C4020592
UMLS CUI [5]
C0001645
history of bariatric or certain other surgeries related to weight control
Beschreibung

Bariatric Surgery | Operative Surgical Procedures Relationship Weight control

Datentyp

boolean

Alias
UMLS CUI [1]
C1456587
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0920298
history of major surgery within 3 months of enrollment
Beschreibung

Major surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
smokers or other tobacco users (during 6 months prior to the start of the study)
Beschreibung

Tobacco use

Datentyp

boolean

Alias
UMLS CUI [1]
C0543414
antibiotic use during the intervention or for 3 months prior to the intervention period
Beschreibung

Antibiotics

Datentyp

boolean

Alias
UMLS CUI [1]
C0003232
history of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
Beschreibung

Eating Disorders | Vegetarian | Very low fat diet | Diet, High-Protein

Datentyp

boolean

Alias
UMLS CUI [1]
C0013473
UMLS CUI [2]
C0042441
UMLS CUI [3]
C0452296
UMLS CUI [4]
C0425403
volunteers who have lost 10% of body weight within the last 6 months
Beschreibung

Weight loss Percentage Timespan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0872291
unable or unwilling to give informed consent or communicate with study staff
Beschreibung

Informed Consent Unable | Informed Consent Unwilling | Lacking Able to communicate Research Personnel

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C2364293
UMLS CUI [3,3]
C0035173
self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in alcoholics anonymous is not an exclusion)
Beschreibung

Substance Use Disorders | Substance Abuse Treatment | Alcohol-substance abuse rehabilitation treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C2551443
UMLS CUI [3]
C0947090
other medical, psychiatric, or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol
Beschreibung

Medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Factor Behavioral Interferes with Study Subject Participation Status | Medical condition Interferes with Protocol Compliance | Mental condition Interferes with Protocol Compliance | Factor Behavioral Interferes with Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C1521761
UMLS CUI [3,2]
C0004927
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C2348568
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C3840291
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0525058
UMLS CUI [6,1]
C1521761
UMLS CUI [6,2]
C0004927
UMLS CUI [6,3]
C0521102
UMLS CUI [6,4]
C0525058
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Ähnliche Modelle

Eligibility Healthy NCT01293604

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Healthy NCT01293604
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men and women between the ages of 25-70 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) ≥ 19 and ≤ 38
boolean
C1305855 (UMLS CUI [1])
Protocol Compliance | Patient Appointments
Item
willingness and ability to make scheduled appointments at clinical site as required by study protocol
boolean
C0525058 (UMLS CUI [1])
C0030675 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Breakfast routine Lacking | Breakfast cereal dislike
Item
do not regularly consume breakfast or dislike cereal for breakfast
boolean
C0566556 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0452557 (UMLS CUI [2,1])
C0870431 (UMLS CUI [2,2])
Allergy to grains | Adverse reactions Grains | Wheat Hypersensitivity | Hypersensitivity Gluten | Allergy to barley
Item
known (self-reported) allergy or adverse reaction to grains (e.g., wheat, gluten, barley)
boolean
C1096643 (UMLS CUI [1])
C0559546 (UMLS CUI [2,1])
C0086369 (UMLS CUI [2,2])
C0949570 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C2362561 (UMLS CUI [4,2])
C2321305 (UMLS CUI [5])
Kidney Diseases | Liver diseases | Gout | Hypothyroidism Untreated | Hypothyroidism Unstable | Malignant Neoplasms | Gastrointestinal Diseases | Pancreatic Diseases | Metabolic Diseases | Malabsorption Syndrome
Item
presence of kidney disease, liver disease, gout, untreated or unstable hypothyroidism, untreated or unstable hyperthyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0018099 (UMLS CUI [3])
C0020676 (UMLS CUI [4,1])
C0332155 (UMLS CUI [4,2])
C0020676 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0006826 (UMLS CUI [6])
C0017178 (UMLS CUI [7])
C0030286 (UMLS CUI [8])
C0025517 (UMLS CUI [9])
C0024523 (UMLS CUI [10])
Diabetes Mellitus, Non-Insulin-Dependent | Requirement Antidiabetics Oral | Requirement Insulin
Item
type 2 diabetes requiring the use of oral antidiabetic agents or insulin
boolean
C0011860 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0935929 (UMLS CUI [2,2])
C1527415 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C0021641 (UMLS CUI [3,2])
Serum fasting triglyceride measurement
Item
fasting triglycerides > 300 mg/dl
boolean
C0582824 (UMLS CUI [1])
Glucose measurement, fasting
Item
fasting glucose > 126 mg/dl
boolean
C0202045 (UMLS CUI [1])
Anticholesteremic Agents
Item
use of cholesterol lowering medication
boolean
C0003277 (UMLS CUI [1])
Blood pressure determination | On treatment for hypertension | Calcium Channel Blockers | Vasodilators, Direct-acting | Adrenergic beta-Antagonists
Item
blood pressure > 180/100 or hypertension treated with calcium channel blockers, direct acting vasodilators, or beta blockers
boolean
C0005824 (UMLS CUI [1])
C0578998 (UMLS CUI [2])
C0006684 (UMLS CUI [3])
C4020592 (UMLS CUI [4])
C0001645 (UMLS CUI [5])
Bariatric Surgery | Operative Surgical Procedures Relationship Weight control
Item
history of bariatric or certain other surgeries related to weight control
boolean
C1456587 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0920298 (UMLS CUI [2,3])
Major surgery
Item
history of major surgery within 3 months of enrollment
boolean
C0679637 (UMLS CUI [1])
Tobacco use
Item
smokers or other tobacco users (during 6 months prior to the start of the study)
boolean
C0543414 (UMLS CUI [1])
Antibiotics
Item
antibiotic use during the intervention or for 3 months prior to the intervention period
boolean
C0003232 (UMLS CUI [1])
Eating Disorders | Vegetarian | Very low fat diet | Diet, High-Protein
Item
history of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
boolean
C0013473 (UMLS CUI [1])
C0042441 (UMLS CUI [2])
C0452296 (UMLS CUI [3])
C0425403 (UMLS CUI [4])
Weight loss Percentage Timespan
Item
volunteers who have lost 10% of body weight within the last 6 months
boolean
C1262477 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
Informed Consent Unable | Informed Consent Unwilling | Lacking Able to communicate Research Personnel
Item
unable or unwilling to give informed consent or communicate with study staff
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0332268 (UMLS CUI [3,1])
C2364293 (UMLS CUI [3,2])
C0035173 (UMLS CUI [3,3])
Substance Use Disorders | Substance Abuse Treatment | Alcohol-substance abuse rehabilitation treatment
Item
self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in alcoholics anonymous is not an exclusion)
boolean
C0038586 (UMLS CUI [1])
C2551443 (UMLS CUI [2])
C0947090 (UMLS CUI [3])
Medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Factor Behavioral Interferes with Study Subject Participation Status | Medical condition Interferes with Protocol Compliance | Mental condition Interferes with Protocol Compliance | Factor Behavioral Interferes with Protocol Compliance
Item
other medical, psychiatric, or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C1521761 (UMLS CUI [3,1])
C0004927 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C2348568 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C3840291 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C1521761 (UMLS CUI [6,1])
C0004927 (UMLS CUI [6,2])
C0521102 (UMLS CUI [6,3])
C0525058 (UMLS CUI [6,4])
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