ID

27641

Description

Dark Chocolate and Platelet Function in Humans; ODM derived from: https://clinicaltrials.gov/show/NCT01099150

Link

https://clinicaltrials.gov/show/NCT01099150

Keywords

Versions (1)
  1. 11/23/17 11/23/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 23, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT01099150

English

Eligibility Cardiovascular Disease NCT01099150

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy male and/or female volunteers, aged between 18 and 70 years
Description

Healthy Volunteers | Age

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects are excluded if:
Description

Study Subject Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0332196
they are taking aspirin or aspirin-containing drugs, other anti-inflammatory drugs, or any drugs or herbal medicines known to alter platelet function or the haemostatic system in general (without a minimum washout period of one month)
Description

Aspirin | Pharmaceutical Preparations Containing Aspirin | Anti-Inflammatory Agents | Pharmaceutical Preparations Changing Platelet function | Herbal medicine Changing Platelet function | Pharmaceutical Preparations Changing Hemostatic function | Herbal medicine Changing Hemostatic function | Washout Period Minimum Absent

Data type

boolean

Alias
UMLS CUI [1]
C0004057
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C0004057
UMLS CUI [3]
C0003209
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0392747
UMLS CUI [4,3]
C1254881
UMLS CUI [5,1]
C2240391
UMLS CUI [5,2]
C0392747
UMLS CUI [5,3]
C1254881
UMLS CUI [6,1]
C0013227
UMLS CUI [6,2]
C0392747
UMLS CUI [6,3]
C0019116
UMLS CUI [7,1]
C2240391
UMLS CUI [7,2]
C0392747
UMLS CUI [7,3]
C0019116
UMLS CUI [8,1]
C1710661
UMLS CUI [8,2]
C1524031
UMLS CUI [8,3]
C0332197
they are taking fish oils or evening primrose oil, or fat soluble vitamin supplements within the last 4 weeks
Description

Fish Oils | Evening primrose oil | Fat soluble vitamin supplementation

Data type

boolean

Alias
UMLS CUI [1]
C0016157
UMLS CUI [2]
C0700602
UMLS CUI [3]
C0556111
they are taking any medicine known to affect lipid and/or glucose metabolism
Description

Pharmaceutical Preparations Affecting Lipid Metabolism | Pharmaceutical Preparations Affecting Glucose metabolism

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0598783
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0596620
they are taking hormone replacement therapy
Description

Hormone replacement therapy

Data type

boolean

Alias
UMLS CUI [1]
C0282402
they have any known clinical signs of diabetes, hypertension, renal, hepatic, hematological disease, gastrointestinal disorders, endocrine disorders, coronary heart disease, infection or cancer
Description

Clinical Signs Diabetes Mellitus | Clinical Signs Hypertensive disease | Clinical Signs Kidney Diseases | Clinical Signs Liver diseases | Clinical Signs Hematological Disease | Clinical Signs Gastrointestinal Diseases | Clinical Signs Endocrine System Diseases | Clinical Signs Coronary heart disease | Clinical Signs Communicable Disease | Clinical Signs Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0011849
UMLS CUI [2,1]
C3540840
UMLS CUI [2,2]
C0020538
UMLS CUI [3,1]
C3540840
UMLS CUI [3,2]
C0022658
UMLS CUI [4,1]
C3540840
UMLS CUI [4,2]
C0023895
UMLS CUI [5,1]
C3540840
UMLS CUI [5,2]
C0018939
UMLS CUI [6,1]
C3540840
UMLS CUI [6,2]
C0017178
UMLS CUI [7,1]
C3540840
UMLS CUI [7,2]
C0014130
UMLS CUI [8,1]
C3540840
UMLS CUI [8,2]
C0010068
UMLS CUI [9,1]
C3540840
UMLS CUI [9,2]
C0009450
UMLS CUI [10,1]
C3540840
UMLS CUI [10,2]
C0006826
they are suffering from alcohol or any other substance abuse or are having eating disorders
Description

Substance Use Disorders | Eating Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0013473
they are usually consuming a vegetarian diet
Description

Vegetarian diet Usually

Data type

boolean

Alias
UMLS CUI [1,1]
C0311164
UMLS CUI [1,2]
C3538928
they have a bmi below 18 or above 35 kg/ sqm
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
they are undertaking more than 6 hours of vigorous exercise per week
Description

Vigorous physical activity hours/week

Data type

boolean

Alias
UMLS CUI [1,1]
C4267713
UMLS CUI [1,2]
C0556976
they are having an abnormal menstrual cycle
Description

Abnormal menstrual cycle

Data type

boolean

Alias
UMLS CUI [1]
C0232933
they are pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
they suffer from an allergy to cocoa or any of the ingredients contained within either of the chocolate bars
Description

Hypersensitivity Cocoa | Hypersensitivity Chocolate Ingredient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0009209
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0008299
UMLS CUI [2,3]
C1550600
they have been giving a pint of blood for transfusion purposes within the last month
Description

Blood Donation pint Transfusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0560012
UMLS CUI [1,3]
C0005841
they have a low platelet count (< 170 x 10e09/ l)
Description

Decreased platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0392386
they have unsuitable veins for blood sampling and/ or cannulation
Description

Veins Inappropriate Blood sampling | Veins Inappropriate Cannulation

Data type

boolean

Alias
UMLS CUI [1,1]
C0042449
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0005834
UMLS CUI [2,1]
C0042449
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0917707
their hematocrit is below 40 % for males and 35 % for females
Description

Hematocrit measurement | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0018935
UMLS CUI [2]
C0079399
their haemoglobin is below 130 g/ l for males and 115 g/ l for females
Description

Hemoglobin measurement | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
they are not able to travel on their own to the rowett institute of nutrition and health, aberdeen for each of the interventions
Description

Travel Unable Intervention

Data type

boolean

Alias
UMLS CUI [1,1]
C0040802
UMLS CUI [1,2]
C1299582
UMLS CUI [1,3]
C0184661
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Similar models

Eligibility Cardiovascular Disease NCT01099150

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers | Age
Item
healthy male and/or female volunteers, aged between 18 and 70 years
boolean
C1708335 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Study Subject Excluded
Item
subjects are excluded if:
boolean
C0681850 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
Aspirin | Pharmaceutical Preparations Containing Aspirin | Anti-Inflammatory Agents | Pharmaceutical Preparations Changing Platelet function | Herbal medicine Changing Platelet function | Pharmaceutical Preparations Changing Hemostatic function | Herbal medicine Changing Hemostatic function | Washout Period Minimum Absent
Item
they are taking aspirin or aspirin-containing drugs, other anti-inflammatory drugs, or any drugs or herbal medicines known to alter platelet function or the haemostatic system in general (without a minimum washout period of one month)
boolean
C0004057 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0004057 (UMLS CUI [2,3])
C0003209 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0392747 (UMLS CUI [4,2])
C1254881 (UMLS CUI [4,3])
C2240391 (UMLS CUI [5,1])
C0392747 (UMLS CUI [5,2])
C1254881 (UMLS CUI [5,3])
C0013227 (UMLS CUI [6,1])
C0392747 (UMLS CUI [6,2])
C0019116 (UMLS CUI [6,3])
C2240391 (UMLS CUI [7,1])
C0392747 (UMLS CUI [7,2])
C0019116 (UMLS CUI [7,3])
C1710661 (UMLS CUI [8,1])
C1524031 (UMLS CUI [8,2])
C0332197 (UMLS CUI [8,3])
Fish Oils | Evening primrose oil | Fat soluble vitamin supplementation
Item
they are taking fish oils or evening primrose oil, or fat soluble vitamin supplements within the last 4 weeks
boolean
C0016157 (UMLS CUI [1])
C0700602 (UMLS CUI [2])
C0556111 (UMLS CUI [3])
Pharmaceutical Preparations Affecting Lipid Metabolism | Pharmaceutical Preparations Affecting Glucose metabolism
Item
they are taking any medicine known to affect lipid and/or glucose metabolism
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0598783 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0596620 (UMLS CUI [2,3])
Hormone replacement therapy
Item
they are taking hormone replacement therapy
boolean
C0282402 (UMLS CUI [1])
Clinical Signs Diabetes Mellitus | Clinical Signs Hypertensive disease | Clinical Signs Kidney Diseases | Clinical Signs Liver diseases | Clinical Signs Hematological Disease | Clinical Signs Gastrointestinal Diseases | Clinical Signs Endocrine System Diseases | Clinical Signs Coronary heart disease | Clinical Signs Communicable Disease | Clinical Signs Malignant Neoplasms
Item
they have any known clinical signs of diabetes, hypertension, renal, hepatic, hematological disease, gastrointestinal disorders, endocrine disorders, coronary heart disease, infection or cancer
boolean
C3540840 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C3540840 (UMLS CUI [2,1])
C0020538 (UMLS CUI [2,2])
C3540840 (UMLS CUI [3,1])
C0022658 (UMLS CUI [3,2])
C3540840 (UMLS CUI [4,1])
C0023895 (UMLS CUI [4,2])
C3540840 (UMLS CUI [5,1])
C0018939 (UMLS CUI [5,2])
C3540840 (UMLS CUI [6,1])
C0017178 (UMLS CUI [6,2])
C3540840 (UMLS CUI [7,1])
C0014130 (UMLS CUI [7,2])
C3540840 (UMLS CUI [8,1])
C0010068 (UMLS CUI [8,2])
C3540840 (UMLS CUI [9,1])
C0009450 (UMLS CUI [9,2])
C3540840 (UMLS CUI [10,1])
C0006826 (UMLS CUI [10,2])
Substance Use Disorders | Eating Disorders
Item
they are suffering from alcohol or any other substance abuse or are having eating disorders
boolean
C0038586 (UMLS CUI [1])
C0013473 (UMLS CUI [2])
Vegetarian diet Usually
Item
they are usually consuming a vegetarian diet
boolean
C0311164 (UMLS CUI [1,1])
C3538928 (UMLS CUI [1,2])
Body mass index
Item
they have a bmi below 18 or above 35 kg/ sqm
boolean
C1305855 (UMLS CUI [1])
Vigorous physical activity hours/week
Item
they are undertaking more than 6 hours of vigorous exercise per week
boolean
C4267713 (UMLS CUI [1,1])
C0556976 (UMLS CUI [1,2])
Abnormal menstrual cycle
Item
they are having an abnormal menstrual cycle
boolean
C0232933 (UMLS CUI [1])
Pregnancy
Item
they are pregnant
boolean
C0032961 (UMLS CUI [1])
Hypersensitivity Cocoa | Hypersensitivity Chocolate Ingredient
Item
they suffer from an allergy to cocoa or any of the ingredients contained within either of the chocolate bars
boolean
C0020517 (UMLS CUI [1,1])
C0009209 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0008299 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
Blood Donation pint Transfusion
Item
they have been giving a pint of blood for transfusion purposes within the last month
boolean
C0005794 (UMLS CUI [1,1])
C0560012 (UMLS CUI [1,2])
C0005841 (UMLS CUI [1,3])
Decreased platelet count
Item
they have a low platelet count (< 170 x 10e09/ l)
boolean
C0392386 (UMLS CUI [1])
Veins Inappropriate Blood sampling | Veins Inappropriate Cannulation
Item
they have unsuitable veins for blood sampling and/ or cannulation
boolean
C0042449 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
C0042449 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0917707 (UMLS CUI [2,3])
Hematocrit measurement | Gender
Item
their hematocrit is below 40 % for males and 35 % for females
boolean
C0018935 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Hemoglobin measurement | Gender
Item
their haemoglobin is below 130 g/ l for males and 115 g/ l for females
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Travel Unable Intervention
Item
they are not able to travel on their own to the rowett institute of nutrition and health, aberdeen for each of the interventions
boolean
C0040802 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
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