Eligibility Degenerative Arthritis NCT02341391

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StudyEvent: Eligibility
1. Eligibility Degenerative Arthritis NCT02341391

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Gender

Item

1. male or female patients

boolean

C0079399 (UMLS CUI [1])

Age | Osteoarthritis of knee Kellgren-Lawrence score | Conventional Treatment Symptomatic Unsuccessful

Item

2. patients aged 45 years or more with grade iv [based on the international cartilage repair society(icrs) evaluation criteria from the mri scan results] degenerative arthritis of the knee, whose symptoms had not been relieved by the conventional symptomatic treatment

boolean

C0001779 (UMLS CUI [1])
C0409959 (UMLS CUI [2,1])
C3177117 (UMLS CUI [2,2])
C2945704 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C1272705 (UMLS CUI [3,3])

Healthy | Physical Examination Finding Major Absent | Hematology Finding Major Absent | Serum Chemistry Finding Major Absent | Urinalysis Finding Major Absent

Item

3. healthy, with no major physical examination, hematology, serum chemistry, and urine test findings and no significant medical history

boolean

C3898900 (UMLS CUI [1])
C0031809 (UMLS CUI [2,1])
C0243095 (UMLS CUI [2,2])
C0205164 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
C0200627 (UMLS CUI [3,1])
C0243095 (UMLS CUI [3,2])
C0205164 (UMLS CUI [3,3])
C0332197 (UMLS CUI [3,4])
C1883010 (UMLS CUI [4,1])
C0243095 (UMLS CUI [4,2])
C0205164 (UMLS CUI [4,3])
C0332197 (UMLS CUI [4,4])
C0042014 (UMLS CUI [5,1])
C0243095 (UMLS CUI [5,2])
C0205164 (UMLS CUI [5,3])
C0332197 (UMLS CUI [5,4])

Cartilage damage Size

Item

4. patients with cartilage damage sized 2-6 cm2 (based on the icrs evaluation criteria from the mri scan results)

boolean

C0549421 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])

Informed Consent

Item

5. voluntarily agreed to participate in this study and signed the informed consent form

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Hematology Clinical Significance | Serum Chemistry Measurement Clinical Significance | Urine test results Clinical Significance

Item

1. showed clinically significant hematology, serum chemistry, or urine test results at the screening visit

boolean

C0200627 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1883010 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0851020 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])

Anti-Inflammatory Agents prescribed | Anti-Inflammatory Agents Non-Prescription Drugs | Other Coding

Item

2. took an anti-inflammatory medication (prescribed or over-the-counter), including natural medicine, within 14 days from the administration of the investigational product

boolean

C0003209 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
C0003209 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
C3846158 (UMLS CUI [3])

Drug abuse | Urine drug screening Positive | Blood alcohol test positive

Item

3. has a history of drug abuse within one year from the enrollment, or the urine test or blood alcohol test result was positive at the screening visit

boolean

C0013146 (UMLS CUI [1])
C0202274 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0948726 (UMLS CUI [3])

Injection Target Knee

Item

4. received any injection in the target knee within two months before the initiation of the study

boolean

C1533685 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])

Pregnancy | Breast Feeding

Item

5. pregnant or breastfeeding female

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

Item

6. with another joint disease apart from degenerative arthritis (e.g., systemic rheumatic inflammatory disease associated with the knee or chondrocalcinosis, hemachromatosis, inflammatory arthritis, necrosis of the trochanter, paget's disease adjacent to a joint in the femur or the tibia, ochronosis, hemophilic arthropathy, infectious arthritis, charcot's disease in the knee joint, villonodular synovitis, and synovial chondromas)

boolean

C0022408 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0029408 (UMLS CUI [2,2])
C0442893 (UMLS CUI [3,1])
C0022742 (UMLS CUI [3,2])
C0564818 (UMLS CUI [4])
C1290884 (UMLS CUI [5,1])
C0022742 (UMLS CUI [5,2])
C0553730 (UMLS CUI [6])
C0018995 (UMLS CUI [7])
C0003864 (UMLS CUI [8])
C0027540 (UMLS CUI [9,1])
C0162370 (UMLS CUI [9,2])
C0029401 (UMLS CUI [10,1])
C0205117 (UMLS CUI [10,2])
C0022417 (UMLS CUI [10,3])
C0015811 (UMLS CUI [10,4])
C0029401 (UMLS CUI [11,1])
C0205117 (UMLS CUI [11,2])
C0022417 (UMLS CUI [11,3])
C1279118 (UMLS CUI [11,4])
C0028817 (UMLS CUI [12])
C0263725 (UMLS CUI [13])
C0003869 (UMLS CUI [14])
C0003892 (UMLS CUI [15,1])
C0022745 (UMLS CUI [15,2])
C0158168 (UMLS CUI [16])
C0948674 (UMLS CUI [17])

Communicable Disease | HIV Infection | Hepatitis B | Hepatitis C

Item

7. with an infectious disease, including hiv or hepatitis (hbv/hcv)

boolean

C0009450 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])

Disease Clinical Significance

Item

8. with a history any of the following clinically significant diseases:

boolean

C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])

Heart Diseases | Myocardial Infarction | Cardiac Arrhythmia | Heart Diseases Serious | Coronary Artery Bypass Surgery

Item

heart disease [e.g., myocardial infarction, arrhythmia, other serious heart disease, coronary artery bypass graft (cabg)]

boolean

C0018799 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
C0018799 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0010055 (UMLS CUI [5])

Kidney Diseases | Kidney Failure, Chronic | Glomerulonephritis

Item

kidney disease (e.g., chronic renal failure, glomerulonephritis)

boolean

C0022658 (UMLS CUI [1])
C0022661 (UMLS CUI [2])
C0017658 (UMLS CUI [3])

Liver diseases | Liver Cirrhosis | Fatty Liver | Chronic liver disease

Item

liver disease (e.g., liver cirrhosis, fatty liver, acute or chronic liver disease)

boolean

C0023895 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
C0015695 (UMLS CUI [3])
C0341439 (UMLS CUI [4])

Item

endocrine disease (e.g., hyperthyroidism, hypothyroidism, thyroiditis, diabetes insipidus, cushing's disease)

boolean

C0014130 (UMLS CUI [1])
C0020550 (UMLS CUI [2])
C0020676 (UMLS CUI [3])
C0040147 (UMLS CUI [4])
C0011848 (UMLS CUI [5])
C0221406 (UMLS CUI [6])

Diabetes Mellitus, Insulin-Dependent

Item

insulin-dependent diabetes mellitus

boolean

C0011854 (UMLS CUI [1])

Malignant Neoplasms | Other Coding

Item

medical history of or current malignant tumor in particular, the tumors that tissuegene-c may aggravate can be screened using the following tests

boolean

C0006826 (UMLS CUI [1])
C3846158 (UMLS CUI [2])

Leukemia | White Blood Cell Count procedure Hematology

Item

leukemia : white blood cell level in the hematology

boolean

C0023418 (UMLS CUI [1])
C0023508 (UMLS CUI [2,1])
C0200627 (UMLS CUI [2,2])

Item

osteochondroma, chondromas, chondroblastoma, chondromyxoid fibroma, chondrosarcoma : alkaline phosphatase level in the hematology

boolean

C0029423 (UMLS CUI [1])
C0936248 (UMLS CUI [2])
C0008441 (UMLS CUI [3])
C0221290 (UMLS CUI [4])
C0008479 (UMLS CUI [5])
C0201850 (UMLS CUI [6,1])
C0200627 (UMLS CUI [6,2])

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Item

9. participated in another clinical trial (using the investigational drug or a medical device) within 30 days before enrollment in this study

boolean

C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])

Drug screen Positive

Item

10. showed positive drug test results at the screening visit

boolean

C0373483 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])

Contraceptive methods Unwilling

Item

11. did not agree to use a contraceptive method (male and female)

boolean

C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])

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Eligibility Degenerative Arthritis NCT02341391