ID

31469

Beskrivning

Relationship of Periodontal Disease Treatment and Type 2 Diabetes Mellitus in the Gullah Population; ODM derived from: https://clinicaltrials.gov/show/NCT01798225

Länk

https://clinicaltrials.gov/show/NCT01798225

Nyckelord

Versioner (1)
  1. 2018-08-26 2018-08-26 -
Rättsinnehavare

See clinicaltrials.gov

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26 augusti 2018

DOI

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Creative Commons BY 4.0
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Eligibility Periodontal Disease NCT01798225

Engelsk

Eligibility Periodontal Disease NCT01798225

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
gullah african americans;
Beskrivning

Other Coding | African American

Datatyp

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2]
C0085756
with type 2 diabetes mellitus defined according to the american diabetes association criteria;
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
other inclusion criteria are presented under each specific aim:
Beskrivning

Inclusion criteria Aim Specific

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1947946
UMLS CUI [1,3]
C0205369
aim 1: participants who have received oral, dental, periodontal, diabetes and genotype assessment through enrollment in dr. j. fernandes' cobre project.
Beskrivning

Patient assessment Oral | Patient assessment Dental | Patient assessment Periodontium | Patient assessment Diabetes Mellitus | Genotype determination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679830
UMLS CUI [1,2]
C0442027
UMLS CUI [2,1]
C0679830
UMLS CUI [2,2]
C0226984
UMLS CUI [3,1]
C0679830
UMLS CUI [3,2]
C0031104
UMLS CUI [4,1]
C0679830
UMLS CUI [4,2]
C0011849
UMLS CUI [5]
C1285573
aim 2 and 3: participants with severe chronic periodontitis, as defined by at least one tooth surface with probing depth (pd)≥5mm.
Beskrivning

Chronic Periodontitis Severe | Tooth surface Quantity Probing depth

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0266929
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0447301
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1317646
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe concurrent illnesses / conditions that would limit their daily life or require extensive systemic treatment, such as malignancy, severe cardiovascular disease, organ transplant, or inadequate understanding due to mental disorders;
Beskrivning

Comorbidity Severe Limiting Activities of Daily Living | Comorbidity Severe Requirement Systemic therapy | Condition Severe Limiting Activities of Daily Living | Condition Severe Requirement Systemic therapy | Malignant Neoplasms | Cardiovascular Disease Severe | Organ Transplantation | Inadequate comprehension Due to Mental disorders

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C0001288
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C1515119
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0439801
UMLS CUI [3,4]
C0001288
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C1514873
UMLS CUI [4,4]
C1515119
UMLS CUI [5]
C0006826
UMLS CUI [6,1]
C0007222
UMLS CUI [6,2]
C0205082
UMLS CUI [7]
C0029216
UMLS CUI [8,1]
C4063025
UMLS CUI [8,2]
C0678226
UMLS CUI [8,3]
C0004936
finger stick blood glucose measurement of more than 350mg/dl or less than 70mg/dl after second measurement;
Beskrivning

Finger-prick Blood glucose measurement | Finger-prick Blood glucose measurement second

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0457575
UMLS CUI [1,2]
C0392201
UMLS CUI [2,1]
C0457575
UMLS CUI [2,2]
C0392201
UMLS CUI [2,3]
C0205436
systolic blood pressure of more than 180mm hg or diastolic pressure of more than 100mm hg;
Beskrivning

Systolic Pressure | Diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
fasting serum c-peptide < 1ng/ml (documentation or test);
Beskrivning

C-peptide measurement Fasting

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0202100
UMLS CUI [1,2]
C1976106
serum creatinine ≥ 1.6mg/dl;
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
abnormal hepatic function;
Beskrivning

Liver Dysfunction

Datatyp

boolean

Alias
UMLS CUI [1]
C0086565
hemoglobinopathy (sickle cell trait/hemolytic anemia) interfering with hba1c monitoring;
Beskrivning

Hemoglobinopathy Interferes with Glycosylated hemoglobin A Monitoring | Sickle Cell Trait | Anemia, Hemolytic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019045
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0019018
UMLS CUI [1,4]
C1283169
UMLS CUI [2]
C0037054
UMLS CUI [3]
C0002878
other underlying illness/conditions which, in the doctor's judgment, may prevent patient from adherence to the study protocol;
Beskrivning

Primary disorder Preventing Protocol Compliance | Primary health condition Preventing Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0277554
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C4019131
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0525058
unwillingness to sign the informed consent form or enter the study;
Beskrivning

Informed Consent Unwilling | Study Subject Participation Status Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0558080
pregnant women;
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
patients in need of antibiotic prophylaxis prior to dental procedures or patients that have been treated with any kind of antibiotics in the past 3 months.
Beskrivning

Patient need for Antibiotic Prophylaxis prior to Dental Procedures | Antibiotic therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0282638
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0011331
UMLS CUI [2]
C0338237
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Similar models

Eligibility Periodontal Disease NCT01798225

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Other Coding | African American
Item
gullah african americans;
boolean
C3846158 (UMLS CUI [1])
C0085756 (UMLS CUI [2])
Diabetes Mellitus, Non-Insulin-Dependent
Item
with type 2 diabetes mellitus defined according to the american diabetes association criteria;
boolean
C0011860 (UMLS CUI [1])
Inclusion criteria Aim Specific
Item
other inclusion criteria are presented under each specific aim:
boolean
C1512693 (UMLS CUI [1,1])
C1947946 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Patient assessment Oral | Patient assessment Dental | Patient assessment Periodontium | Patient assessment Diabetes Mellitus | Genotype determination
Item
aim 1: participants who have received oral, dental, periodontal, diabetes and genotype assessment through enrollment in dr. j. fernandes' cobre project.
boolean
C0679830 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])
C0679830 (UMLS CUI [2,1])
C0226984 (UMLS CUI [2,2])
C0679830 (UMLS CUI [3,1])
C0031104 (UMLS CUI [3,2])
C0679830 (UMLS CUI [4,1])
C0011849 (UMLS CUI [4,2])
C1285573 (UMLS CUI [5])
Chronic Periodontitis Severe | Tooth surface Quantity Probing depth
Item
aim 2 and 3: participants with severe chronic periodontitis, as defined by at least one tooth surface with probing depth (pd)≥5mm.
boolean
C0266929 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0447301 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1317646 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Comorbidity Severe Limiting Activities of Daily Living | Comorbidity Severe Requirement Systemic therapy | Condition Severe Limiting Activities of Daily Living | Condition Severe Requirement Systemic therapy | Malignant Neoplasms | Cardiovascular Disease Severe | Organ Transplantation | Inadequate comprehension Due to Mental disorders
Item
severe concurrent illnesses / conditions that would limit their daily life or require extensive systemic treatment, such as malignancy, severe cardiovascular disease, organ transplant, or inadequate understanding due to mental disorders;
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0001288 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C1515119 (UMLS CUI [2,4])
C0348080 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C0001288 (UMLS CUI [3,4])
C0348080 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C1514873 (UMLS CUI [4,3])
C1515119 (UMLS CUI [4,4])
C0006826 (UMLS CUI [5])
C0007222 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0029216 (UMLS CUI [7])
C4063025 (UMLS CUI [8,1])
C0678226 (UMLS CUI [8,2])
C0004936 (UMLS CUI [8,3])
Finger-prick Blood glucose measurement | Finger-prick Blood glucose measurement second
Item
finger stick blood glucose measurement of more than 350mg/dl or less than 70mg/dl after second measurement;
boolean
C0457575 (UMLS CUI [1,1])
C0392201 (UMLS CUI [1,2])
C0457575 (UMLS CUI [2,1])
C0392201 (UMLS CUI [2,2])
C0205436 (UMLS CUI [2,3])
Systolic Pressure | Diastolic blood pressure
Item
systolic blood pressure of more than 180mm hg or diastolic pressure of more than 100mm hg;
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C-peptide measurement Fasting
Item
fasting serum c-peptide < 1ng/ml (documentation or test);
boolean
C0202100 (UMLS CUI [1,1])
C1976106 (UMLS CUI [1,2])
Creatinine measurement, serum
Item
serum creatinine ≥ 1.6mg/dl;
boolean
C0201976 (UMLS CUI [1])
Liver Dysfunction
Item
abnormal hepatic function;
boolean
C0086565 (UMLS CUI [1])
Hemoglobinopathy Interferes with Glycosylated hemoglobin A Monitoring | Sickle Cell Trait | Anemia, Hemolytic
Item
hemoglobinopathy (sickle cell trait/hemolytic anemia) interfering with hba1c monitoring;
boolean
C0019045 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0019018 (UMLS CUI [1,3])
C1283169 (UMLS CUI [1,4])
C0037054 (UMLS CUI [2])
C0002878 (UMLS CUI [3])
Primary disorder Preventing Protocol Compliance | Primary health condition Preventing Protocol Compliance
Item
other underlying illness/conditions which, in the doctor's judgment, may prevent patient from adherence to the study protocol;
boolean
C0277554 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C4019131 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Informed Consent Unwilling | Study Subject Participation Status Unwilling
Item
unwillingness to sign the informed consent form or enter the study;
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Pregnancy
Item
pregnant women;
boolean
C0032961 (UMLS CUI [1])
Patient need for Antibiotic Prophylaxis prior to Dental Procedures | Antibiotic therapy
Item
patients in need of antibiotic prophylaxis prior to dental procedures or patients that have been treated with any kind of antibiotics in the past 3 months.
boolean
C0686904 (UMLS CUI [1,1])
C0282638 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0011331 (UMLS CUI [1,4])
C0338237 (UMLS CUI [2])
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