ID

31469

Description

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

Link

https://clinicaltrials.gov/show/NCT01798225

Keywords

Versions (1)
  1. 8/26/18 8/26/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 26, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Periodontal Disease NCT01798225

English

Eligibility Periodontal Disease NCT01798225

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
gullah african americans;
Description

Other Coding | African American

Data type

boolean

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

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

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

Inclusion criteria Aim Specific

Data type

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.
Description

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

Data type

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.
Description

Chronic Periodontitis Severe | Tooth surface Quantity Probing depth

Data type

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
Description

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;
Description

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

Data type

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;
Description

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

Data type

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;
Description

Systolic Pressure | Diastolic blood pressure

Data type

boolean

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

C-peptide measurement Fasting

Data type

boolean

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

Creatinine measurement, serum

Data type

boolean

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

Liver Dysfunction

Data type

boolean

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

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

Data type

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;
Description

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

Data type

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;
Description

Informed Consent Unwilling | Study Subject Participation Status Unwilling

Data type

boolean

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

Pregnancy

Data type

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.
Description

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

Data type

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
Back to the top of the page

Similar models

Eligibility Periodontal Disease NCT01798225

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial