ID

35719

Description

Placement of Hydrophilic TiZr Implants in Diabetic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02395315

Link

https://clinicaltrials.gov/show/NCT02395315

Keywords

Versions (1)
  1. 3/18/19 3/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 18, 2019

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 Diabetes Mellitus NCT02395315

English

Eligibility Diabetes Mellitus NCT02395315

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. adult patients with diagnosed type ii dm exhibiting at least one edentulous site in the posterior mandible.
Description

Adult | Diabetes Mellitus, Non-Insulin-Dependent | Partially edentulous mandible

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0011860
UMLS CUI [3]
C1299631
2. history of diabetes for at least two years prior to enrollment.
Description

History of diabetes mellitus Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0455488
UMLS CUI [1,2]
C0449238
3. hba1c >7.5% & <10% for enrollment in the pc group and hba1c ≤ 7.0% for enrollment in the wc group.
Description

Hemoglobin A1c measurement Group Poorly controlled | Hemoglobin A1c measurement Group Well controlled

Data type

boolean

Alias
UMLS CUI [1,1]
C0474680
UMLS CUI [1,2]
C0441833
UMLS CUI [1,3]
C3853134
UMLS CUI [2,1]
C0474680
UMLS CUI [2,2]
C0441833
UMLS CUI [2,3]
C3853142
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. females during pregnancy or lactation and females that plan to become pregnant in the following year (pregnancy test will be provided prior to enrollment).
Description

Pregnancy | Breast Feeding | Pregnancy, Planned | Gender Pregnancy Test

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0032976
2. mandibular incisor sites that will not allow bone core retrieval due to limited alveolar bone width.
Description

Other Coding | Alveolar Bone Loss

Data type

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2]
C0002382
3. smokers.
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
4. medications that affect bone healing (e.g. bisphosphonates or chronic steroids)
Description

Pharmaceutical Preparations Affecting Bone healing | Diphosphonates | Steroids chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1321023
UMLS CUI [2]
C0012544
UMLS CUI [3,1]
C0038317
UMLS CUI [3,2]
C0205191
5. active periodontal disease.
Description

Periodontal Disease

Data type

boolean

Alias
UMLS CUI [1]
C0031090
6. patients that will not agree to participate in this study or sign the consent form.
Description

Study Subject Participation Status Unwilling | Informed Consent Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
7. patients who are carriers of transmissible disease(s) that may unnecessarily expose laboratory personnel to risks.
Description

Carrier Communicable Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0560175
UMLS CUI [1,2]
C0009450
8. participants with a physician-diagnosed osteoporosis (z-score ≤ -2).
Description

Osteoporosis Z-score

Data type

boolean

Alias
UMLS CUI [1,1]
C0029456
UMLS CUI [1,2]
C0871421
Back to the top of the page

Similar models

Eligibility Diabetes Mellitus NCT02395315

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Diabetes Mellitus, Non-Insulin-Dependent | Partially edentulous mandible
Item
1. adult patients with diagnosed type ii dm exhibiting at least one edentulous site in the posterior mandible.
boolean
C0001675 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C1299631 (UMLS CUI [3])
History of diabetes mellitus Duration
Item
2. history of diabetes for at least two years prior to enrollment.
boolean
C0455488 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Hemoglobin A1c measurement Group Poorly controlled | Hemoglobin A1c measurement Group Well controlled
Item
3. hba1c >7.5% & <10% for enrollment in the pc group and hba1c ≤ 7.0% for enrollment in the wc group.
boolean
C0474680 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
C3853134 (UMLS CUI [1,3])
C0474680 (UMLS CUI [2,1])
C0441833 (UMLS CUI [2,2])
C3853142 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned | Gender Pregnancy Test
Item
1. females during pregnancy or lactation and females that plan to become pregnant in the following year (pregnancy test will be provided prior to enrollment).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0032976 (UMLS CUI [4,2])
Other Coding | Alveolar Bone Loss
Item
2. mandibular incisor sites that will not allow bone core retrieval due to limited alveolar bone width.
boolean
C3846158 (UMLS CUI [1])
C0002382 (UMLS CUI [2])
Tobacco use
Item
3. smokers.
boolean
C0543414 (UMLS CUI [1])
Pharmaceutical Preparations Affecting Bone healing | Diphosphonates | Steroids chronic
Item
4. medications that affect bone healing (e.g. bisphosphonates or chronic steroids)
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1321023 (UMLS CUI [1,3])
C0012544 (UMLS CUI [2])
C0038317 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
Periodontal Disease
Item
5. active periodontal disease.
boolean
C0031090 (UMLS CUI [1])
Study Subject Participation Status Unwilling | Informed Consent Unwilling
Item
6. patients that will not agree to participate in this study or sign the consent form.
boolean
C2348568 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Carrier Communicable Diseases
Item
7. patients who are carriers of transmissible disease(s) that may unnecessarily expose laboratory personnel to risks.
boolean
C0560175 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
Osteoporosis Z-score
Item
8. participants with a physician-diagnosed osteoporosis (z-score ≤ -2).
boolean
C0029456 (UMLS CUI [1,1])
C0871421 (UMLS CUI [1,2])
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