ID

42680

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00093236

Stichworte

Versionen (2)
  1. 25.07.16 25.07.16 -
  2. 17.09.21 17.09.21 -
Hochgeladen am

17. September 2021

DOI

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Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT00093236

Englisch

Eligibility Cardiovascular Disease NCT00093236

1 Formulare  
Inclusion Criteria
Beschreibung

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Cigarette smoker

Datentyp

boolean

Alias
UMLS CUI [1]
C0337667
Exclusion Criteria
Beschreibung

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Antibiotics

Datentyp

boolean

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

Contraceptive Agents | Hormone replacement therapy

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Substance Use Disorders Continuous

Datentyp

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.
Beschreibung

Viagra | Risk Hypotension Marked | Nitroglycerin Administration

Datentyp

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.
Beschreibung

Migraine Disorders | Disease Exacerbation Due to Nitroglycerin

Datentyp

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).
Beschreibung

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

Datentyp

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).
Beschreibung

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

Datentyp

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.
Beschreibung

Pregnancy | Serum Beta-HCG Test

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C1255526
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Ähnliche Modelle

Eligibility Cardiovascular Disease NCT00093236

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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