ID

42680

Description

Impact of Gum Infection on Heart Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00093236

Link

https://clinicaltrials.gov/show/NCT00093236

Keywords

Versions (2)
  1. 7/25/16 7/25/16 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT00093236

English

Eligibility Cardiovascular Disease NCT00093236

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. the study seeks to enroll patients with periodontal disease and no other major co-morbidities including cardiovascular disease or other major medical problems.
Description

Periodontal Diseases | Comorbidity Major | Cardiovascular Diseases | Medical Problem Major

Data type

boolean

Alias
UMLS CUI [1]
C0031090
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205164
UMLS CUI [3]
C0007222
UMLS CUI [4,1]
C1254481
UMLS CUI [4,2]
C0205164
2. in this intervention study, cigarette smokers will be permitted as justified below and randomized in stratified fashion to ensure equal numbers in the two treatment groups.
Description

Cigarette smoker

Data type

boolean

Alias
UMLS CUI [1]
C0337667
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known cardiovascular disease including coronary heart disease, cerebral vascular disease, peripheral vascular disease, valvular heart disease, and congestive heart failure.
Description

Cardiovascular Diseases | Coronary heart disease | Cerebrovascular Disorders | Peripheral Vascular Diseases | Heart valve disease | Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0010068
UMLS CUI [3]
C0007820
UMLS CUI [4]
C0085096
UMLS CUI [5]
C0018824
UMLS CUI [6]
C0018802
2. major coronary risk factors including diabetes mellitus, hypertension, hypercholesterolemia requiring treatment according to the atp-iii guidelines.
Description

risk factors Coronary Major | Diabetes Mellitus Treatment required for | Hypertensive disease Treatment required for | Hypercholesterolemia Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1522318
UMLS CUI [1,3]
C0205164
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0332121
UMLS CUI [3,1]
C0020538
UMLS CUI [3,2]
C0332121
UMLS CUI [4,1]
C0020443
UMLS CUI [4,2]
C0332121
3. other major illness including cancer, liver disease, renal disease, pulmonary disease, chronic infectious disease (including hiv and hepatitis c infection), rheumatological disease, hematological disease, or any condition requiring hospitalization or chronic medical therapy.
Description

Illness Major | Malignant Neoplasms | Liver diseases | Kidney Diseases | Lung diseases | Chronic infectious disease | HIV Infections | Hepatitis C | rheumatologic disorder | Hematological Disease | Condition Requirement Hospitalization | Condition Requirement Therapeutic procedure chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0024115
UMLS CUI [6]
C0151317
UMLS CUI [7]
C0019693
UMLS CUI [8]
C0019196
UMLS CUI [9]
C0009326
UMLS CUI [10]
C0018939
UMLS CUI [11,1]
C0348080
UMLS CUI [11,2]
C1514873
UMLS CUI [11,3]
C0019993
UMLS CUI [12,1]
C0348080
UMLS CUI [12,2]
C1514873
UMLS CUI [12,3]
C0087111
UMLS CUI [12,4]
C0205191
4. use of antibiotics within three months.
Description

Antibiotics

Data type

boolean

Alias
UMLS CUI [1]
C0003232
5. use of oral contraceptives or hormone replacement therapy.
Description

Contraceptive Agents | Hormone replacement therapy

Data type

boolean

Alias
UMLS CUI [1]
C0009871
UMLS CUI [2]
C0282402
6. major psychiatric illness requiring treatment or that might interfere with the ability to understand and cooperate with the protocol.
Description

Mental disorders Major Requirement Therapeutic procedure | Mental disorders Major Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0087111
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205164
UMLS CUI [2,3]
C1321605
UMLS CUI [2,4]
C0439801
7. ongoing drug or alcohol abuse.
Description

Substance Use Disorders Continuous

Data type

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0549178
8. use of sildenafil (viagra) within 7 days because of the risk of marked hypotension with nitroglycerin administration.
Description

Viagra | Risk Hypotension Marked | Nitroglycerin Administration

Data type

boolean

Alias
UMLS CUI [1]
C0663448
UMLS CUI [2,1]
C0035647
UMLS CUI [2,2]
C0020649
UMLS CUI [2,3]
C1706089
UMLS CUI [3,1]
C0017887
UMLS CUI [3,2]
C1533734
9. history of migraine headaches that might be exacerbated by nitroglycerin.
Description

Migraine Disorders | Disease Exacerbation Due to Nitroglycerin

Data type

boolean

Alias
UMLS CUI [1]
C0149931
UMLS CUI [2,1]
C0235874
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0017887
10. use of cholesterol lowering therapy, angiotensin converting enzyme inhibitors (subjects should not be taking these drugs because they will have no history of cardiovascular disease risk factors).
Description

Therapeutic procedure Anticholesteremic Agents | Angiotensin-Converting Enzyme Inhibitors | Risk factor for cardiovascular disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0003277
UMLS CUI [2]
C0003015
UMLS CUI [3]
C0850624
11. antioxidant vitamins (vitamin c or vitamin e) in doses exceeding the recommended dietary allowances (rda), (60 mg/day and 30 iu/day, respectively).
Description

Antioxidant vitamin requirement Recommended Dietary Allowances | Ascorbic Acid | Vitamin E

Data type

boolean

Alias
UMLS CUI [1,1]
C0556073
UMLS CUI [1,2]
C0524787
UMLS CUI [2]
C0003968
UMLS CUI [3]
C0042874
12. pregnancy, as diagnosed by serum beta-hcg.
Description

Pregnancy | Serum Beta-HCG Test

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C1255526
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Similar models

Eligibility Cardiovascular Disease NCT00093236

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Periodontal Diseases | Comorbidity Major | Cardiovascular Diseases | Medical Problem Major
Item
1. the study seeks to enroll patients with periodontal disease and no other major co-morbidities including cardiovascular disease or other major medical problems.
boolean
C0031090 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0007222 (UMLS CUI [3])
C1254481 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
Cigarette smoker
Item
2. in this intervention study, cigarette smokers will be permitted as justified below and randomized in stratified fashion to ensure equal numbers in the two treatment groups.
boolean
C0337667 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cardiovascular Diseases | Coronary heart disease | Cerebrovascular Disorders | Peripheral Vascular Diseases | Heart valve disease | Congestive heart failure
Item
1. known cardiovascular disease including coronary heart disease, cerebral vascular disease, peripheral vascular disease, valvular heart disease, and congestive heart failure.
boolean
C0007222 (UMLS CUI [1])
C0010068 (UMLS CUI [2])
C0007820 (UMLS CUI [3])
C0085096 (UMLS CUI [4])
C0018824 (UMLS CUI [5])
C0018802 (UMLS CUI [6])
risk factors Coronary Major | Diabetes Mellitus Treatment required for | Hypertensive disease Treatment required for | Hypercholesterolemia Treatment required for
Item
2. major coronary risk factors including diabetes mellitus, hypertension, hypercholesterolemia requiring treatment according to the atp-iii guidelines.
boolean
C0035648 (UMLS CUI [1,1])
C1522318 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0011849 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C0020538 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
C0020443 (UMLS CUI [4,1])
C0332121 (UMLS CUI [4,2])
Illness Major | Malignant Neoplasms | Liver diseases | Kidney Diseases | Lung diseases | Chronic infectious disease | HIV Infections | Hepatitis C | rheumatologic disorder | Hematological Disease | Condition Requirement Hospitalization | Condition Requirement Therapeutic procedure chronic
Item
3. other major illness including cancer, liver disease, renal disease, pulmonary disease, chronic infectious disease (including hiv and hepatitis c infection), rheumatological disease, hematological disease, or any condition requiring hospitalization or chronic medical therapy.
boolean
C0221423 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0024115 (UMLS CUI [5])
C0151317 (UMLS CUI [6])
C0019693 (UMLS CUI [7])
C0019196 (UMLS CUI [8])
C0009326 (UMLS CUI [9])
C0018939 (UMLS CUI [10])
C0348080 (UMLS CUI [11,1])
C1514873 (UMLS CUI [11,2])
C0019993 (UMLS CUI [11,3])
C0348080 (UMLS CUI [12,1])
C1514873 (UMLS CUI [12,2])
C0087111 (UMLS CUI [12,3])
C0205191 (UMLS CUI [12,4])
Antibiotics
Item
4. use of antibiotics within three months.
boolean
C0003232 (UMLS CUI [1])
Contraceptive Agents | Hormone replacement therapy
Item
5. use of oral contraceptives or hormone replacement therapy.
boolean
C0009871 (UMLS CUI [1])
C0282402 (UMLS CUI [2])
Mental disorders Major Requirement Therapeutic procedure | Mental disorders Major Compliance behavior Limited
Item
6. major psychiatric illness requiring treatment or that might interfere with the ability to understand and cooperate with the protocol.
boolean
C0004936 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C0439801 (UMLS CUI [2,4])
Substance Use Disorders Continuous
Item
7. ongoing drug or alcohol abuse.
boolean
C0038586 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Viagra | Risk Hypotension Marked | Nitroglycerin Administration
Item
8. use of sildenafil (viagra) within 7 days because of the risk of marked hypotension with nitroglycerin administration.
boolean
C0663448 (UMLS CUI [1])
C0035647 (UMLS CUI [2,1])
C0020649 (UMLS CUI [2,2])
C1706089 (UMLS CUI [2,3])
C0017887 (UMLS CUI [3,1])
C1533734 (UMLS CUI [3,2])
Migraine Disorders | Disease Exacerbation Due to Nitroglycerin
Item
9. history of migraine headaches that might be exacerbated by nitroglycerin.
boolean
C0149931 (UMLS CUI [1])
C0235874 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0017887 (UMLS CUI [2,3])
Therapeutic procedure Anticholesteremic Agents | Angiotensin-Converting Enzyme Inhibitors | Risk factor for cardiovascular disease
Item
10. use of cholesterol lowering therapy, angiotensin converting enzyme inhibitors (subjects should not be taking these drugs because they will have no history of cardiovascular disease risk factors).
boolean
C0087111 (UMLS CUI [1,1])
C0003277 (UMLS CUI [1,2])
C0003015 (UMLS CUI [2])
C0850624 (UMLS CUI [3])
Antioxidant vitamin requirement Recommended Dietary Allowances | Ascorbic Acid | Vitamin E
Item
11. antioxidant vitamins (vitamin c or vitamin e) in doses exceeding the recommended dietary allowances (rda), (60 mg/day and 30 iu/day, respectively).
boolean
C0556073 (UMLS CUI [1,1])
C0524787 (UMLS CUI [1,2])
C0003968 (UMLS CUI [2])
C0042874 (UMLS CUI [3])
Pregnancy | Serum Beta-HCG Test
Item
12. pregnancy, as diagnosed by serum beta-hcg.
boolean
C0032961 (UMLS CUI [1])
C1255526 (UMLS CUI [2])
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