ID

29256

Beschreibung

Exploratory Study of Iocide Oral Rinse in a Diabetic Population; ODM derived from: https://clinicaltrials.gov/show/NCT00801164

Link

https://clinicaltrials.gov/show/NCT00801164

Stichworte

Versionen (1)
  1. 13.03.18 13.03.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

13. März 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes Type 2 NCT00801164

Englisch

Eligibility Diabetes Type 2 NCT00801164

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. have self-reported type 2 diabetes of more than three months duration.
Beschreibung

Non-Insulin-Dependent Diabetes Mellitus Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0449238
2. a current hba1c value between 7.0% and 12%.
Beschreibung

Glucohemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0202054
3. report no change in diabetes-related medications during the three months prior to enrollment.
Beschreibung

Antidiabetics unchanged

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0442739
4. be at least 35 years of age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
5. have at least 16 natural teeth.
Beschreibung

Natural teeth Quantity Minimum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0026644
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1524031
6. have moderate to severe chronic periodontitis, defined by loss of clinical attachment of >5 mm on two seperate teeth, and no treatment within six months.
Beschreibung

Chronic Periodontitis Moderate untreated | Chronic Periodontitis Severe untreated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0266929
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C0332155
UMLS CUI [2,1]
C0266929
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0332155
7. able and willing to comply with study requirements including following instructions on study treatment and returning for follow-up visits as required by the protocol
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
8. have full understanding of all elements of, and signature and dating of the written informed consent prior to the initiation of protocol specified procedures
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
9. females with childbearing potential must have a negative pregnancy test before and during the study period. sexually active females must be using an effective form of birth control. these methods include oral contraceptives ("the pill"), an intrauterine device (iud), levonogestrol implants (norplant®), medroxyprogesterone acetate injections (depo-provera®) or contraceptive foam with a condom.
Beschreibung

Childbearing Potential Pregnancy test negative | Gender Sexually active Contraceptive methods | Contraceptives, Oral | Intrauterine Devices | CONTRACEPTION NORPLANT | medroxyprogesterone acetate Injection | Depo-Provera | Vaginal Foam contraception | Female Condoms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0700589
UMLS CUI [3]
C0009905
UMLS CUI [4]
C0021900
UMLS CUI [5]
C0742782
UMLS CUI [6,1]
C0065864
UMLS CUI [6,2]
C1533685
UMLS CUI [7]
C0699700
UMLS CUI [8,1]
C0042254
UMLS CUI [8,2]
C0234007
UMLS CUI [9]
C0221829
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history, or current evidence, of any significant acute or chronic medical or psychiatric condition that, in the opinion of the investigator, would render examination difficult or invalid or prevent the subject from active study participation
Beschreibung

Medical condition Medical Examination Difficult | Chronic disease Medical Examination Difficult | Mental condition Medical Examination Difficult | Mental condition chronic Medical Examination Difficult | Medical condition Medical Examination Invalid | Chronic disease Medical Examination Invalid | Mental condition Medical Examination Invalid | Mental condition chronic Medical Examination Invalid | Medical condition Study Subject Participation Status Excluded | Chronic disease Study Subject Participation Status Excluded | Mental condition Study Subject Participation Status Excluded | Mental condition chronic Study Subject Participation Status Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0582103
UMLS CUI [1,3]
C0332218
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0582103
UMLS CUI [2,3]
C0332218
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C0582103
UMLS CUI [3,3]
C0332218
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C0205191
UMLS CUI [4,3]
C0582103
UMLS CUI [4,4]
C0332218
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0582103
UMLS CUI [5,3]
C1547465
UMLS CUI [6,1]
C0008679
UMLS CUI [6,2]
C0582103
UMLS CUI [6,3]
C1547465
UMLS CUI [7,1]
C3840291
UMLS CUI [7,2]
C0582103
UMLS CUI [7,3]
C1547465
UMLS CUI [8,1]
C3840291
UMLS CUI [8,2]
C0205191
UMLS CUI [8,3]
C0582103
UMLS CUI [8,4]
C1547465
UMLS CUI [9,1]
C3843040
UMLS CUI [9,2]
C2348568
UMLS CUI [9,3]
C2828389
UMLS CUI [10,1]
C0008679
UMLS CUI [10,2]
C2348568
UMLS CUI [10,3]
C2828389
UMLS CUI [11,1]
C3840291
UMLS CUI [11,2]
C2348568
UMLS CUI [11,3]
C2828389
UMLS CUI [12,1]
C3840291
UMLS CUI [12,2]
C0205191
UMLS CUI [12,3]
C2348568
UMLS CUI [12,4]
C2828389
2. tpoab positive
Beschreibung

Thyroid peroxidase antibody positive

Datentyp

boolean

Alias
UMLS CUI [1]
C2609311
3. baseline serum level of tsh <0.35 or >5.5
Beschreibung

Measurement of serum thyroid stimulating hormone

Datentyp

boolean

Alias
UMLS CUI [1]
C1277938
4. treatment with antibiotic within the three (3) month period prior to the screening examination
Beschreibung

Antibiotic therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0338237
5. presence of valvular disease, prosthetic implant, or any other systemic condition requiring antibiotic premedication
Beschreibung

Valvular disease | Artificial Implants | Condition Systemic Requirement Antibiotic Prophylaxis

Datentyp

boolean

Alias
UMLS CUI [1]
C3258293
UMLS CUI [2]
C0021113
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0205373
UMLS CUI [3,3]
C1514873
UMLS CUI [3,4]
C0282638
6. history of thyroid disease
Beschreibung

Thyroid Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0040128
7. purported sensitivity or allergy to iodine
Beschreibung

Iodine allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0571818
8. known sensitivity or allergy to shellfish
Beschreibung

Shellfish allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0577625
9. history of autoimmune disease, or chronic infections such as hiv or hepatitis
Beschreibung

Autoimmune Disease | Chronic infectious disease | HIV Infection | Hepatitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0151317
UMLS CUI [3]
C0019693
UMLS CUI [4]
C0019158
10. history of cardiovascular disease (heart attack or procedure within the past three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months), unstable angina pectoris or angina pectoris at rest,
Beschreibung

Cardiovascular Disease | Myocardial Infarction | Procedure on heart | Cerebrovascular accident | Transient Ischemic Attack | Pulmonary Embolism | Angina, Unstable | Angina at rest

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0027051
UMLS CUI [3]
C1279986
UMLS CUI [4]
C0038454
UMLS CUI [5]
C0007787
UMLS CUI [6]
C0034065
UMLS CUI [7]
C0002965
UMLS CUI [8]
C0152172
11. history of renal disease: serum creatinine exceeding 1.4 mg/dl (women) or 1.5 mg/dl (men), or currently receiving dialysis.
Beschreibung

Kidney Disease | Creatinine measurement, serum | Gender | Dialysis

Datentyp

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0079399
UMLS CUI [4]
C0011946
12. gross oral pathology (periodontal disease, rampant caries, tissue damage created by poor oral care or treatment, soft or hard tissue tumors) that, in the opinion of the investigator, could alter the treatment needs during the study
Beschreibung

Mouth Diseases Gross | Periodontal Diseases | Rampant caries | Tissue damage | Oral Care Poor | Therapeutic procedure Poor Oral cavity | Soft Tissue Neoplasms | Oral hard tissue Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0026636
UMLS CUI [1,2]
C0439806
UMLS CUI [2]
C0031090
UMLS CUI [3]
C0399397
UMLS CUI [4]
C0010957
UMLS CUI [5,1]
C2599893
UMLS CUI [5,2]
C0542537
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C0542537
UMLS CUI [6,3]
C0226896
UMLS CUI [7]
C0037579
UMLS CUI [8,1]
C0447208
UMLS CUI [8,2]
C0027651
13. current signs or symptoms of mucosal tissue ulcerations or inflammation, or canker sores
Beschreibung

Sign or Symptom Mucous Membrane Ulceration | Sign or Symptom Inflammatory disease of mucous membrane | Sign or Symptom Aphthous Stomatitis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0026724
UMLS CUI [1,3]
C3887532
UMLS CUI [2,1]
C3540840
UMLS CUI [2,2]
C0333355
UMLS CUI [3,1]
C3540840
UMLS CUI [3,2]
C0038363
14. presence of orthodontic appliances or any removable appliance that impinges on the oral tissues being assessed
Beschreibung

Orthodontic Appliances | Removable Orthodontic Appliances

Datentyp

boolean

Alias
UMLS CUI [1]
C0029331
UMLS CUI [2]
C0029333
15. history of or current alcohol abuse that, in the opinion of the investigator, could influence the outcome of the study
Beschreibung

Alcohol abuse Influence Research results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085762
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C0683954
16. history of, or current drug abuse
Beschreibung

Drug abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0013146
17. use of concomitant medication that, in the opinion of the investigator, might interfere with the outcome of the study (e.g. antibiotics, immuno-suppressants, steroids, or therapeutic doses of non-steroidal anti-inflammatory agents, phenytoin, calcium antagonists, cyclosporine or coumadin)
Beschreibung

Pharmaceutical Preparations Interferes with Research results | Antibiotics | Immunosuppressive Agents | Steroids | Anti-Inflammatory Agents, Non-Steroidal | Phenytoin | Calcium Channel Blockers | Cyclosporine | Coumadin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
UMLS CUI [2]
C0003232
UMLS CUI [3]
C0021081
UMLS CUI [4]
C0038317
UMLS CUI [5]
C0003211
UMLS CUI [6]
C0031507
UMLS CUI [7]
C0006684
UMLS CUI [8]
C0010592
UMLS CUI [9]
C0699129
18. concomitant therapy with another investigational drug or device without prior approval from the sponsor within four weeks prior to visit 2 (study day 1)
Beschreibung

Investigational New Drugs | Investigational Medical Device

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2346570
19. concomitant endodontic or periodontal therapy other than prophylaxis in the past six (6) months
Beschreibung

Endodontic procedure | Periodontal Treatment | Exception Prophylactic treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C0700632
UMLS CUI [2]
C1882340
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0199176
20. females with childbearing potential with a positive pregnancy test, pregnant or nursing mothers, suspected pregnancy, or intention to become pregnant during the study
Beschreibung

Childbearing Potential Pregnancy test positive | Pregnancy | Breast Feeding | Pregnancy Suspected | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0240802
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C0032961
UMLS CUI [4,2]
C0750491
UMLS CUI [5]
C0032992
21. residence in the same household as a subject already enrolled in the study (inclusion may create blinding and/or compliance issues)
Beschreibung

Study Subject Participation Status | Study Subject Household Same

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0020052
UMLS CUI [2,3]
C0445247
22. unable and unwilling to comply with the informed consent process, to meet study requirements including following instructions on study treatment, and to return for follow-up visits as required by the protocol.
Beschreibung

Informed Consent Unable | Informed Consent Unwilling | Protocol Compliance Unable | Protocol Compliance Unwilling

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]
C0525058
UMLS CUI [3,2]
C1299582
UMLS CUI [4,1]
C0525058
UMLS CUI [4,2]
C0558080
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Ähnliche Modelle

Eligibility Diabetes Type 2 NCT00801164

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Duration
Item
1. have self-reported type 2 diabetes of more than three months duration.
boolean
C0011860 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Glucohemoglobin measurement
Item
2. a current hba1c value between 7.0% and 12%.
boolean
C0202054 (UMLS CUI [1])
Antidiabetics unchanged
Item
3. report no change in diabetes-related medications during the three months prior to enrollment.
boolean
C0935929 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
Age
Item
4. be at least 35 years of age.
boolean
C0001779 (UMLS CUI [1])
Natural teeth Quantity Minimum
Item
5. have at least 16 natural teeth.
boolean
C0026644 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
Chronic Periodontitis Moderate untreated | Chronic Periodontitis Severe untreated
Item
6. have moderate to severe chronic periodontitis, defined by loss of clinical attachment of >5 mm on two seperate teeth, and no treatment within six months.
boolean
C0266929 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C0266929 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
Protocol Compliance
Item
7. able and willing to comply with study requirements including following instructions on study treatment and returning for follow-up visits as required by the protocol
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
8. have full understanding of all elements of, and signature and dating of the written informed consent prior to the initiation of protocol specified procedures
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Gender Sexually active Contraceptive methods | Contraceptives, Oral | Intrauterine Devices | CONTRACEPTION NORPLANT | medroxyprogesterone acetate Injection | Depo-Provera | Vaginal Foam contraception | Female Condoms
Item
9. females with childbearing potential must have a negative pregnancy test before and during the study period. sexually active females must be using an effective form of birth control. these methods include oral contraceptives ("the pill"), an intrauterine device (iud), levonogestrol implants (norplant®), medroxyprogesterone acetate injections (depo-provera®) or contraceptive foam with a condom.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0009905 (UMLS CUI [3])
C0021900 (UMLS CUI [4])
C0742782 (UMLS CUI [5])
C0065864 (UMLS CUI [6,1])
C1533685 (UMLS CUI [6,2])
C0699700 (UMLS CUI [7])
C0042254 (UMLS CUI [8,1])
C0234007 (UMLS CUI [8,2])
C0221829 (UMLS CUI [9])
Item Group
C0680251 (UMLS CUI)
Medical condition Medical Examination Difficult | Chronic disease Medical Examination Difficult | Mental condition Medical Examination Difficult | Mental condition chronic Medical Examination Difficult | Medical condition Medical Examination Invalid | Chronic disease Medical Examination Invalid | Mental condition Medical Examination Invalid | Mental condition chronic Medical Examination Invalid | Medical condition Study Subject Participation Status Excluded | Chronic disease Study Subject Participation Status Excluded | Mental condition Study Subject Participation Status Excluded | Mental condition chronic Study Subject Participation Status Excluded
Item
1. history, or current evidence, of any significant acute or chronic medical or psychiatric condition that, in the opinion of the investigator, would render examination difficult or invalid or prevent the subject from active study participation
boolean
C3843040 (UMLS CUI [1,1])
C0582103 (UMLS CUI [1,2])
C0332218 (UMLS CUI [1,3])
C0008679 (UMLS CUI [2,1])
C0582103 (UMLS CUI [2,2])
C0332218 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C0582103 (UMLS CUI [3,2])
C0332218 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0582103 (UMLS CUI [4,3])
C0332218 (UMLS CUI [4,4])
C3843040 (UMLS CUI [5,1])
C0582103 (UMLS CUI [5,2])
C1547465 (UMLS CUI [5,3])
C0008679 (UMLS CUI [6,1])
C0582103 (UMLS CUI [6,2])
C1547465 (UMLS CUI [6,3])
C3840291 (UMLS CUI [7,1])
C0582103 (UMLS CUI [7,2])
C1547465 (UMLS CUI [7,3])
C3840291 (UMLS CUI [8,1])
C0205191 (UMLS CUI [8,2])
C0582103 (UMLS CUI [8,3])
C1547465 (UMLS CUI [8,4])
C3843040 (UMLS CUI [9,1])
C2348568 (UMLS CUI [9,2])
C2828389 (UMLS CUI [9,3])
C0008679 (UMLS CUI [10,1])
C2348568 (UMLS CUI [10,2])
C2828389 (UMLS CUI [10,3])
C3840291 (UMLS CUI [11,1])
C2348568 (UMLS CUI [11,2])
C2828389 (UMLS CUI [11,3])
C3840291 (UMLS CUI [12,1])
C0205191 (UMLS CUI [12,2])
C2348568 (UMLS CUI [12,3])
C2828389 (UMLS CUI [12,4])
Thyroid peroxidase antibody positive
Item
2. tpoab positive
boolean
C2609311 (UMLS CUI [1])
Measurement of serum thyroid stimulating hormone
Item
3. baseline serum level of tsh <0.35 or >5.5
boolean
C1277938 (UMLS CUI [1])
Antibiotic therapy
Item
4. treatment with antibiotic within the three (3) month period prior to the screening examination
boolean
C0338237 (UMLS CUI [1])
Valvular disease | Artificial Implants | Condition Systemic Requirement Antibiotic Prophylaxis
Item
5. presence of valvular disease, prosthetic implant, or any other systemic condition requiring antibiotic premedication
boolean
C3258293 (UMLS CUI [1])
C0021113 (UMLS CUI [2])
C0348080 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C1514873 (UMLS CUI [3,3])
C0282638 (UMLS CUI [3,4])
Thyroid Disease
Item
6. history of thyroid disease
boolean
C0040128 (UMLS CUI [1])
Iodine allergy
Item
7. purported sensitivity or allergy to iodine
boolean
C0571818 (UMLS CUI [1])
Shellfish allergy
Item
8. known sensitivity or allergy to shellfish
boolean
C0577625 (UMLS CUI [1])
Autoimmune Disease | Chronic infectious disease | HIV Infection | Hepatitis
Item
9. history of autoimmune disease, or chronic infections such as hiv or hepatitis
boolean
C0004364 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
C0019158 (UMLS CUI [4])
Cardiovascular Disease | Myocardial Infarction | Procedure on heart | Cerebrovascular accident | Transient Ischemic Attack | Pulmonary Embolism | Angina, Unstable | Angina at rest
Item
10. history of cardiovascular disease (heart attack or procedure within the past three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months), unstable angina pectoris or angina pectoris at rest,
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C1279986 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0007787 (UMLS CUI [5])
C0034065 (UMLS CUI [6])
C0002965 (UMLS CUI [7])
C0152172 (UMLS CUI [8])
Kidney Disease | Creatinine measurement, serum | Gender | Dialysis
Item
11. history of renal disease: serum creatinine exceeding 1.4 mg/dl (women) or 1.5 mg/dl (men), or currently receiving dialysis.
boolean
C0022658 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0011946 (UMLS CUI [4])
Mouth Diseases Gross | Periodontal Diseases | Rampant caries | Tissue damage | Oral Care Poor | Therapeutic procedure Poor Oral cavity | Soft Tissue Neoplasms | Oral hard tissue Neoplasms
Item
12. gross oral pathology (periodontal disease, rampant caries, tissue damage created by poor oral care or treatment, soft or hard tissue tumors) that, in the opinion of the investigator, could alter the treatment needs during the study
boolean
C0026636 (UMLS CUI [1,1])
C0439806 (UMLS CUI [1,2])
C0031090 (UMLS CUI [2])
C0399397 (UMLS CUI [3])
C0010957 (UMLS CUI [4])
C2599893 (UMLS CUI [5,1])
C0542537 (UMLS CUI [5,2])
C0087111 (UMLS CUI [6,1])
C0542537 (UMLS CUI [6,2])
C0226896 (UMLS CUI [6,3])
C0037579 (UMLS CUI [7])
C0447208 (UMLS CUI [8,1])
C0027651 (UMLS CUI [8,2])
Sign or Symptom Mucous Membrane Ulceration | Sign or Symptom Inflammatory disease of mucous membrane | Sign or Symptom Aphthous Stomatitis
Item
13. current signs or symptoms of mucosal tissue ulcerations or inflammation, or canker sores
boolean
C3540840 (UMLS CUI [1,1])
C0026724 (UMLS CUI [1,2])
C3887532 (UMLS CUI [1,3])
C3540840 (UMLS CUI [2,1])
C0333355 (UMLS CUI [2,2])
C3540840 (UMLS CUI [3,1])
C0038363 (UMLS CUI [3,2])
Orthodontic Appliances | Removable Orthodontic Appliances
Item
14. presence of orthodontic appliances or any removable appliance that impinges on the oral tissues being assessed
boolean
C0029331 (UMLS CUI [1])
C0029333 (UMLS CUI [2])
Alcohol abuse Influence Research results
Item
15. history of or current alcohol abuse that, in the opinion of the investigator, could influence the outcome of the study
boolean
C0085762 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
Drug abuse
Item
16. history of, or current drug abuse
boolean
C0013146 (UMLS CUI [1])
Pharmaceutical Preparations Interferes with Research results | Antibiotics | Immunosuppressive Agents | Steroids | Anti-Inflammatory Agents, Non-Steroidal | Phenytoin | Calcium Channel Blockers | Cyclosporine | Coumadin
Item
17. use of concomitant medication that, in the opinion of the investigator, might interfere with the outcome of the study (e.g. antibiotics, immuno-suppressants, steroids, or therapeutic doses of non-steroidal anti-inflammatory agents, phenytoin, calcium antagonists, cyclosporine or coumadin)
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0003232 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
C0038317 (UMLS CUI [4])
C0003211 (UMLS CUI [5])
C0031507 (UMLS CUI [6])
C0006684 (UMLS CUI [7])
C0010592 (UMLS CUI [8])
C0699129 (UMLS CUI [9])
Investigational New Drugs | Investigational Medical Device
Item
18. concomitant therapy with another investigational drug or device without prior approval from the sponsor within four weeks prior to visit 2 (study day 1)
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
Endodontic procedure | Periodontal Treatment | Exception Prophylactic treatment
Item
19. concomitant endodontic or periodontal therapy other than prophylaxis in the past six (6) months
boolean
C0700632 (UMLS CUI [1])
C1882340 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0199176 (UMLS CUI [3,2])
Childbearing Potential Pregnancy test positive | Pregnancy | Breast Feeding | Pregnancy Suspected | Pregnancy, Planned
Item
20. females with childbearing potential with a positive pregnancy test, pregnant or nursing mothers, suspected pregnancy, or intention to become pregnant during the study
boolean
C3831118 (UMLS CUI [1,1])
C0240802 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0032961 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0032992 (UMLS CUI [5])
Study Subject Participation Status | Study Subject Household Same
Item
21. residence in the same household as a subject already enrolled in the study (inclusion may create blinding and/or compliance issues)
boolean
C2348568 (UMLS CUI [1])
C0681850 (UMLS CUI [2,1])
C0020052 (UMLS CUI [2,2])
C0445247 (UMLS CUI [2,3])
Informed Consent Unable | Informed Consent Unwilling | Protocol Compliance Unable | Protocol Compliance Unwilling
Item
22. unable and unwilling to comply with the informed consent process, to meet study requirements including following instructions on study treatment, and to return for follow-up visits as required by the protocol.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C0525058 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
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