ID

27604

Beschreibung

The Effect of Processed Tomato Products on CVD Risks; ODM derived from: https://clinicaltrials.gov/show/NCT00937742

Link

https://clinicaltrials.gov/show/NCT00937742

Stichworte

Versionen (1)
  1. 21.11.17 21.11.17 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

21. November 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT00937742

Englisch

Eligibility Cardiovascular Disease NCT00937742

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women (>21 <70 years) nonsmokers, with a body mass index (bmi) ranging of 25 to 35 kg/m2, bp < or = 140/90 mmhg
Beschreibung

Age | Non-smoker | Body mass index | Blood Pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0337672
UMLS CUI [3]
C1305855
UMLS CUI [4]
C0005823
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. total cholesterol (tc) is greater than 300 mg/dl;
Beschreibung

Serum total cholesterol measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1445957
2. fasting triglyceride is greater than 300 mg/dl;
Beschreibung

Serum fasting triglyceride measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0582824
3. ldl cholesterol (ldl-c) is greater than 180 mg/dl;
Beschreibung

Low density lipoprotein cholesterol measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0202117
4. female subjects who are pregnant or lactating;
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
5. subjects who are actively losing weight or trying to lose weight;
Beschreibung

Weight decreased | Weight loss Attempted

Datentyp

boolean

Alias
UMLS CUI [1]
C1262477
UMLS CUI [2,1]
C1262477
UMLS CUI [2,2]
C1516084
6. subjects with known allergy or intolerance to tomato products;
Beschreibung

Hypersensitivity Tomato preparation | Intolerance to Tomato preparation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0885519
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0885519
7. taking any medications that would interfere with outcomes of the study, ie. lipid lowering medications, anti-inflammatory drugs, dietary supplements, such as fish oil or evening primrose;
Beschreibung

Pharmaceutical Preparations Interfere with Research results | Hypolipidemic Agents | Anti-Inflammatory Agents | Dietary Supplements | Fish oil | Evening primrose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
UMLS CUI [2]
C0086440
UMLS CUI [3]
C0003209
UMLS CUI [4]
C0242295
UMLS CUI [5]
C0556145
UMLS CUI [6]
C0874067
8. subjects' with documented atherosclerotic disease, inflammatory disease, diabetes mellitus, uncontrolled hypertension (>=140/90 mm hg - ok if controlled below this limit with medication), or other systemic diseases;
Beschreibung

Atherosclerosis | Inflammatory disorder | Diabetes Mellitus | Uncontrolled hypertension | Systemic disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0004153
UMLS CUI [2]
C1290884
UMLS CUI [3]
C0011849
UMLS CUI [4]
C1868885
UMLS CUI [5]
C0442893
9. subjects with low hematological counts as determined by >or <15% the upper or lower cut-off values of normal established for the lab;
Beschreibung

Complete Blood Count low

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009555
UMLS CUI [1,2]
C0205251
10. smokers. -
Beschreibung

Tobacco use

Datentyp

boolean

Alias
UMLS CUI [1]
C0543414
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Ähnliche Modelle

Eligibility Cardiovascular Disease NCT00937742

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Non-smoker | Body mass index | Blood Pressure
Item
men and women (>21 <70 years) nonsmokers, with a body mass index (bmi) ranging of 25 to 35 kg/m2, bp < or = 140/90 mmhg
boolean
C0001779 (UMLS CUI [1])
C0337672 (UMLS CUI [2])
C1305855 (UMLS CUI [3])
C0005823 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Serum total cholesterol measurement
Item
1. total cholesterol (tc) is greater than 300 mg/dl;
boolean
C1445957 (UMLS CUI [1])
Serum fasting triglyceride measurement
Item
2. fasting triglyceride is greater than 300 mg/dl;
boolean
C0582824 (UMLS CUI [1])
Low density lipoprotein cholesterol measurement
Item
3. ldl cholesterol (ldl-c) is greater than 180 mg/dl;
boolean
C0202117 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
4. female subjects who are pregnant or lactating;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Weight decreased | Weight loss Attempted
Item
5. subjects who are actively losing weight or trying to lose weight;
boolean
C1262477 (UMLS CUI [1])
C1262477 (UMLS CUI [2,1])
C1516084 (UMLS CUI [2,2])
Hypersensitivity Tomato preparation | Intolerance to Tomato preparation
Item
6. subjects with known allergy or intolerance to tomato products;
boolean
C0020517 (UMLS CUI [1,1])
C0885519 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0885519 (UMLS CUI [2,2])
Pharmaceutical Preparations Interfere with Research results | Hypolipidemic Agents | Anti-Inflammatory Agents | Dietary Supplements | Fish oil | Evening primrose
Item
7. taking any medications that would interfere with outcomes of the study, ie. lipid lowering medications, anti-inflammatory drugs, dietary supplements, such as fish oil or evening primrose;
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0086440 (UMLS CUI [2])
C0003209 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C0556145 (UMLS CUI [5])
C0874067 (UMLS CUI [6])
Atherosclerosis | Inflammatory disorder | Diabetes Mellitus | Uncontrolled hypertension | Systemic disease
Item
8. subjects' with documented atherosclerotic disease, inflammatory disease, diabetes mellitus, uncontrolled hypertension (>=140/90 mm hg - ok if controlled below this limit with medication), or other systemic diseases;
boolean
C0004153 (UMLS CUI [1])
C1290884 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
C1868885 (UMLS CUI [4])
C0442893 (UMLS CUI [5])
Complete Blood Count low
Item
9. subjects with low hematological counts as determined by >or <15% the upper or lower cut-off values of normal established for the lab;
boolean
C0009555 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
Tobacco use
Item
10. smokers. -
boolean
C0543414 (UMLS CUI [1])
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