Informations: Ceci n’est pas la version la plus récente du modèle de données. Vous trouverez un aperçu de la version à gauche, sous Versions. Vous trouverez la version la plus actuelle ici.
Informations:
Erreur:
ID
31468
Description
Influence of Periodontal Treatment on Systemic Inflammatory Mediators; ODM derived from: https://clinicaltrials.gov/show/NCT01201746
Lien
https://clinicaltrials.gov/show/NCT01201746
Mots-clés
Versions (2)
- 26/08/2018 26/08/2018 -
- 20/09/2021 20/09/2021 -
Détendeur de droits
See clinicaltrials.gov
Téléchargé le
26 août 2018
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY 4.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
Eligibility Periodontal Disease NCT01201746
Eligibility Periodontal Disease NCT01201746
- StudyEvent: Eligibility
Similar models
Eligibility Periodontal Disease NCT01201746
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
General | Medical
Item
a. general/medical
boolean
C0205246 (UMLS CUI [1])
C0205476 (UMLS CUI [2])
C0205476 (UMLS CUI [2])
Racial group Any | Ethnic group Any
Item
1. any race/ethnic group
boolean
C0034510 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C0015031 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
C1552551 (UMLS CUI [1,2])
C0015031 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
Age
Item
2. aged > 30 years
boolean
C0001779 (UMLS CUI [1])
Gender
Item
3. male or female
boolean
C0079399 (UMLS CUI [1])
Coronary heart disease Angiography
Item
4. chd case (chd angiographically confirmed)
boolean
C0010068 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
C0002978 (UMLS CUI [1,2])
Coronary heart disease Disease length
Item
5. chd diagnosed > 3 months prior to entry into study.
boolean
C0010068 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,2])
Systemic disease Absent | Systemic disease chronic Absent
Item
6. no acute or chronic systemic conditions (see exclusion criteria below)
boolean
C0442893 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0332197 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Absence Pharmaceutical Preparations Interfere with Study
Item
7. no medications/medication history that can interfere with the study (see exclusion criteria below)
boolean
C0332197 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2603343 (UMLS CUI [1,4])
C0013227 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2603343 (UMLS CUI [1,4])
Non-smoker | Former smoker
Item
8. non-smoker (=never smoker) or former smoker (=does not smoke now and has not smoked at all for a minimum of the last 12 consecutive months)
boolean
C0337672 (UMLS CUI [1])
C0337671 (UMLS CUI [2])
C0337671 (UMLS CUI [2])
Protocol Compliance
Item
9. able and willing to comply with study procedures
boolean
C0525058 (UMLS CUI [1])
Patient Available Study duration
Item
10. able and willing to be available for the duration of the study
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0489652 (UMLS CUI [1,3])
C0470187 (UMLS CUI [1,2])
C0489652 (UMLS CUI [1,3])
Informed Consent
Item
11. able and willing to provide signed informed consent
boolean
C0021430 (UMLS CUI [1])
Oral | Periodontium
Item
b. oral/periodontal
boolean
C0442027 (UMLS CUI [1])
C0031104 (UMLS CUI [2])
C0031104 (UMLS CUI [2])
Teeth Natural Quantity | Exception Third molars | Periodontal evaluation
Item
1. dentate with at least 14 natural teeth, excluding third molars, that can be evaluated periodontally.
boolean
C0040426 (UMLS CUI [1,1])
C0205296 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0026369 (UMLS CUI [2,2])
C1317609 (UMLS CUI [3])
C0205296 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0026369 (UMLS CUI [2,2])
C1317609 (UMLS CUI [3])
Bleeding on Probing Percentage Mouth Whole
Item
2. baseline whole mouth bop > 20% of sites.
boolean
C2698524 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0230028 (UMLS CUI [1,3])
C0444667 (UMLS CUI [1,4])
C0439165 (UMLS CUI [1,2])
C0230028 (UMLS CUI [1,3])
C0444667 (UMLS CUI [1,4])
Periodontitis | Teeth Quantity Depth of periodontal pocket | Teeth Quantity Attachment level
Item
3. periodontitis case; periodontitis case defined as subject having ≥ 4 teeth with ≥ 1 site with ppd ≥ 4 mm & cal ≥ 3 mm at same site
boolean
C0031099 (UMLS CUI [1])
C0040426 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0564382 (UMLS CUI [2,3])
C0040426 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1317110 (UMLS CUI [3,3])
C0040426 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0564382 (UMLS CUI [2,3])
C0040426 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1317110 (UMLS CUI [3,3])
Periodontal Treatment Mechanical Absent
Item
4. no mechanical periodontal therapy in the last 6 months.
boolean
C1882340 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0443254 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Mouth Diseases Absent | Lesion mucosal Absent | Oral infection Absent | Absence Requirement Dental Procedures | Absence Requirement Periodontal Treatment | Necrotizing Ulcerative Gingivitis Absent
Item
5. no acute oral diseases (mucosal lesions), oral infections, need for immediate dental/periodontal care (e.g., nug).
boolean
C0026636 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C0026724 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0555971 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0332197 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0011331 (UMLS CUI [4,3])
C0332197 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C1882340 (UMLS CUI [5,3])
C0017575 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0332197 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C0026724 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0555971 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0332197 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0011331 (UMLS CUI [4,3])
C0332197 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C1882340 (UMLS CUI [5,3])
C0017575 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
General | Medical
Item
a. general/medical
boolean
C0205246 (UMLS CUI [1])
C0205476 (UMLS CUI [2])
C0205476 (UMLS CUI [2])
Age
Item
1. age ≤ 30 years
boolean
C0001779 (UMLS CUI [1])
Coronary heart disease Criteria failed
Item
2. not fulfilling criteria of defined chd case
boolean
C0010068 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Coronary heart disease Criteria Fulfill | Coronary heart disease Newly Diagnosed
Item
3. fulfilling criteria of defined chd case, but diagnosed ≤ 3 months prior to start of study
boolean
C0010068 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C0010068 (UMLS CUI [2,1])
C1518321 (UMLS CUI [2,2])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C0010068 (UMLS CUI [2,1])
C1518321 (UMLS CUI [2,2])
Tobacco use
Item
4. current smoker
boolean
C0543414 (UMLS CUI [1])
Former smoker | Tobacco use Number of cigarettes per day
Item
5. former smoker who does not smoke but who has smoked ≥ 1 cigarette (or equivalent, in form of water pipe, pipe, cigar) in the last 12 months.
boolean
C0337671 (UMLS CUI [1])
C0543414 (UMLS CUI [2,1])
C3694146 (UMLS CUI [2,2])
C0543414 (UMLS CUI [2,1])
C3694146 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
6. females pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Chronic condition Systemic Associated with Periodontitis | Chronic condition Systemic | Relationship Change Inflammation Systemic | Diabetes Mellitus | Rheumatoid Arthritis | Rheumatic Fever | Lupus Erythematosus, Systemic | Malignant Neoplasms | Respiration Disorders | Kidney Diseases | Autoimmune Diseases | Mycoses | Immunodeficiency
Item
7. systemic chronic conditions known to be associated with periodontitis or with changes in systemic inflammation: diabetes,rheumatoid arthritis, rheumatic fever, sle, malignancy, respiratory diseases, renal diseases, other (e.g., autoimmune diseases, fungal infections, immunological deficiencies, etc.)
boolean
C4315615 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0332281 (UMLS CUI [1,3])
C0031099 (UMLS CUI [1,4])
C4315615 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0439849 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0021368 (UMLS CUI [3,3])
C0205373 (UMLS CUI [3,4])
C0011849 (UMLS CUI [4])
C0003873 (UMLS CUI [5])
C0035436 (UMLS CUI [6])
C0024141 (UMLS CUI [7])
C0006826 (UMLS CUI [8])
C0035204 (UMLS CUI [9])
C0022658 (UMLS CUI [10])
C0004364 (UMLS CUI [11])
C0026946 (UMLS CUI [12])
C0021051 (UMLS CUI [13])
C0205373 (UMLS CUI [1,2])
C0332281 (UMLS CUI [1,3])
C0031099 (UMLS CUI [1,4])
C4315615 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0439849 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0021368 (UMLS CUI [3,3])
C0205373 (UMLS CUI [3,4])
C0011849 (UMLS CUI [4])
C0003873 (UMLS CUI [5])
C0035436 (UMLS CUI [6])
C0024141 (UMLS CUI [7])
C0006826 (UMLS CUI [8])
C0035204 (UMLS CUI [9])
C0022658 (UMLS CUI [10])
C0004364 (UMLS CUI [11])
C0026946 (UMLS CUI [12])
C0021051 (UMLS CUI [13])
Systemic disease Affecting Biological Markers Inflammation | Bacterial Infections | Virus Diseases | Common Cold | Influenza | Sinusitis | Trauma Musculoskeletal | Operative Surgical Procedures
Item
8. systemic acute conditions known to affect systemic markers of inflammation: acute bacterial infection, acute viral infection (common cold, influenza, sinusitis), orthopedic trauma, surgery
boolean
C0442893 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005516 (UMLS CUI [1,3])
C0021368 (UMLS CUI [1,4])
C0004623 (UMLS CUI [2])
C0042769 (UMLS CUI [3])
C0009443 (UMLS CUI [4])
C0021400 (UMLS CUI [5])
C0037199 (UMLS CUI [6])
C3714660 (UMLS CUI [7,1])
C0497254 (UMLS CUI [7,2])
C0543467 (UMLS CUI [8])
C0392760 (UMLS CUI [1,2])
C0005516 (UMLS CUI [1,3])
C0021368 (UMLS CUI [1,4])
C0004623 (UMLS CUI [2])
C0042769 (UMLS CUI [3])
C0009443 (UMLS CUI [4])
C0021400 (UMLS CUI [5])
C0037199 (UMLS CUI [6])
C3714660 (UMLS CUI [7,1])
C0497254 (UMLS CUI [7,2])
C0543467 (UMLS CUI [8])
Pharmaceutical Preparations Affecting Biological Markers inflammatory | Statins | Systemic steroids | Anti-Inflammatory Agents, Non-Steroidal | Immunosuppressive Agents
Item
9. medications known to affect systemic inflammatory biomarkers: statins, systemic steroids, non-steroidal anti-inflammatory drugs, immunosuppressants,
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005516 (UMLS CUI [1,3])
C0333348 (UMLS CUI [1,4])
C0360714 (UMLS CUI [2])
C2825233 (UMLS CUI [3])
C0003211 (UMLS CUI [4])
C0021081 (UMLS CUI [5])
C0392760 (UMLS CUI [1,2])
C0005516 (UMLS CUI [1,3])
C0333348 (UMLS CUI [1,4])
C0360714 (UMLS CUI [2])
C2825233 (UMLS CUI [3])
C0003211 (UMLS CUI [4])
C0021081 (UMLS CUI [5])
Pharmaceutical Preparations Affecting Biological Markers inflammatory | Therapeutic procedure Start Recently | Hormone replacement therapy | Contraceptive Agents
Item
10. medications potentially affecting systemic inflammatory markers, if therapy started less than 3 months prior to study such as hormone replacement therapy, contraceptives
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005516 (UMLS CUI [1,3])
C0333348 (UMLS CUI [1,4])
C0087111 (UMLS CUI [2,1])
C0439659 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C0282402 (UMLS CUI [3])
C0009871 (UMLS CUI [4])
C0392760 (UMLS CUI [1,2])
C0005516 (UMLS CUI [1,3])
C0333348 (UMLS CUI [1,4])
C0087111 (UMLS CUI [2,1])
C0439659 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C0282402 (UMLS CUI [3])
C0009871 (UMLS CUI [4])
Antibiotic therapy Systemic
Item
11. systemic antibiotic therapy in the last 3 months
boolean
C0338237 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,2])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
12. unable or unwilling to comply with study procedures
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Patient Available Study duration Unable | Patient Available Study duration Unwilling
Item
13. unable or unwilling to be available for the duration of the study
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0489652 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C0030705 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C0489652 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
C0470187 (UMLS CUI [1,2])
C0489652 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C0030705 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C0489652 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
Informed Consent Unable | Informed Consent Unwilling
Item
14. unable or unwilling to provide signed informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Oral | Periodontium
Item
b. oral/periodontal
boolean
C0442027 (UMLS CUI [1])
C0031104 (UMLS CUI [2])
C0031104 (UMLS CUI [2])
Teeth Quantity | Exception Third molars | Periodontal evaluation
Item
1. <14 teeth that can be periodontally evaluated (excluding 3rd molars)
boolean
C0040426 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0026369 (UMLS CUI [2,2])
C1317609 (UMLS CUI [3])
C1265611 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0026369 (UMLS CUI [2,2])
C1317609 (UMLS CUI [3])
Bleeding on Probing Percentage
Item
2. bop ≤ 20% of sites
boolean
C2698524 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,2])
Periodontitis Criteria failed
Item
3. not fulfilling criteria of defined periodontitis case
boolean
C0031099 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Periodontal Treatment
Item
4. having received any periodontal therapy within last 6 months
boolean
C1882340 (UMLS CUI [1])
Antibiotic therapy Topical | Antibiotic therapy Local | Antiinflammatory therapy
Item
5. topical/local antibiotic or anti-inflammatory therapy in last 6 months
boolean
C0338237 (UMLS CUI [1,1])
C0332237 (UMLS CUI [1,2])
C0338237 (UMLS CUI [2,1])
C0205276 (UMLS CUI [2,2])
C1096024 (UMLS CUI [3])
C0332237 (UMLS CUI [1,2])
C0338237 (UMLS CUI [2,1])
C0205276 (UMLS CUI [2,2])
C1096024 (UMLS CUI [3])
Oral infection
Item
6. acute oral infections
boolean
C0555971 (UMLS CUI [1])
Wounds Oral | Tooth Extraction Recent
Item
7. oral wounds, including recent (< 2 months) extractions
boolean
C0043250 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])
C0040440 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0442027 (UMLS CUI [1,2])
C0040440 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])