ID

41152

Beschreibung

Phase III Study of CG100649 in Osteoarthritis Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01765296

Link

https://clinicaltrials.gov/show/NCT01765296

Stichworte

Versionen (1)
  1. 02.07.20 02.07.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

2. Juli 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Localized Primary Osteoarthritis of Hip NCT01765296

Englisch

Eligibility Localized Primary Osteoarthritis of Hip NCT01765296

1 Formulare  
Criteria
Beschreibung

Criteria

1. males or females, age 20 years or above, able and willing to provide written informed consent
Beschreibung

Age | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
2. knee or hip oa diagnosed according to american college of rheumatology guidelines
Beschreibung

Osteoarthritis, Knee | Osteoarthritis of hip

Datentyp

boolean

Alias
UMLS CUI [1]
C0409959
UMLS CUI [2]
C0029410
3. chronic pain for ≥3 months from oa
Beschreibung

Chronic pain Duration | Etiology Osteoarthritis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0150055
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0029408
4. bp [systolic 90-140 mmhg, diastolic 50-90 mmhg] and pulse rate [resting 40-100 bpm].
Beschreibung

Blood pressure determination | Systolic Pressure | Diastolic blood pressure | Pulse Rate At rest

Datentyp

boolean

Alias
UMLS CUI [1]
C0005824
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4,1]
C0232117
UMLS CUI [4,2]
C0443144
5. womac-pain score in the index joint must be between 4-8 on a 0-10 numerical rating scale
Beschreibung

WOMAC - pain subscale Joint Affected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C5190460
UMLS CUI [1,2]
C0022417
UMLS CUI [1,3]
C0392760
6. blood chemistry must be within 2x normal range
Beschreibung

Blood Chemical Analysis

Datentyp

boolean

Alias
UMLS CUI [1]
C0005774
7. urinalysis must be within normal limits; minor deviations are acceptable
Beschreibung

Normal urinalysis

Datentyp

boolean

Alias
UMLS CUI [1]
C0749920
8. subjects and their sexual partners must agree to use double barrier contraception during the study period and for 3 months afterward, or be at least one year post-
Beschreibung

Study Subject Barrier Contraception Double | Partner Barrier Contraception Double

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0004764
UMLS CUI [1,3]
C0205173
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C0004764
UMLS CUI [2,3]
C0205173
menopause, or provide proof of surgical sterility
Beschreibung

Postmenopausal state Duration | Sexual sterilization

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232970
UMLS CUI [1,2]
C0449238
UMLS CUI [2]
C0038288
9. for prior non-steroidal inflammatory drug (nsaid) users only, the subject has a history of positive therapeutic benefit
Beschreibung

Anti-Inflammatory Agents, Non-Steroidal | Benefit Therapeutic

Datentyp

boolean

Alias
UMLS CUI [1]
C0003211
UMLS CUI [2,1]
C0814225
UMLS CUI [2,2]
C0302350
10. subject is willing to limit alcohol intake to 2 or less drinks per day during study and the follow-up period
Beschreibung

Alcohol consumption Limiting Willing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0600109
11. subjects must be able to read, understand and follow study related documents.
Beschreibung

Able to read Study Protocol | Comprehension Study Protocol | Adherence Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C2348563
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C2348563
UMLS CUI [3,1]
C1510802
UMLS CUI [3,2]
C2348563
exclusion criteria (abbreviated)
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
1. use of any analgesics except the study medication or acetaminophen at any time
Beschreibung

Analgesics | Exception Investigational New Drugs | Exception Acetaminophen

Datentyp

boolean

Alias
UMLS CUI [1]
C0002771
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0000970
2. use of any medications for ongoing chronic symptoms, or psychiatric disorders that could significantly diminish the cognitive ability or cause behavioral changes that would prevent the subject from complying with study procedures.
Beschreibung

Pharmaceutical Preparations Symptoms chronic | Mental disorders Causing Impaired cognition | Mental disorders Causing Behavioral change | Mental disorders Preventing Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0338656
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0678227
UMLS CUI [3,3]
C0542299
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C0525058
3. subject is legally incompetent, or has active psychosis, or significant emotional problems which are sufficient to interfere with the conduct of the study
Beschreibung

Legal competency Lacking | Psychotic Disorders | Emotional problems Interfere with Completion of clinical trial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680554
UMLS CUI [1,2]
C0332268
UMLS CUI [2]
C0033975
UMLS CUI [3,1]
C0677660
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2732579
4. use of anticoagulants (aspirin, warfarin, heparin, etc.) within 2 weeks of v1
Beschreibung

Anticoagulants | aspirin | warfarin | heparin

Datentyp

boolean

Alias
UMLS CUI [1]
C0003280
UMLS CUI [2]
C0004057
UMLS CUI [3]
C0043031
UMLS CUI [4]
C0019134
5. previous history of hypersensitivity or allergy to nsaids, cox-2 inhibitors, carbonic anhydrase inhibitors, sulfa drugs, aspirin, or acetaminophen/paracetamol
Beschreibung

Allergy to nonsteroidal anti-inflammatory agents | Allergy to COX-2 inhibitors | Carbonic anhydrase inhibitor allergy | Allergy to sulfonamide | Allergy to aspirin | Allergy to paracetamol

Datentyp

boolean

Alias
UMLS CUI [1]
C0746949
UMLS CUI [2]
C2136452
UMLS CUI [3]
C0571931
UMLS CUI [4]
C0038757
UMLS CUI [5]
C0004058
UMLS CUI [6]
C0570513
6. subjects requiring knee or hip arthroplasty within 2 months of screening or anticipating any need for a surgical procedure on the index joint during the study
Beschreibung

Knee Replacement Arthroplasty Required | Repair of hip Required | Patient need for Operative Surgical Procedure Joint Affected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0086511
UMLS CUI [1,2]
C1514873
UMLS CUI [2,1]
C0186193
UMLS CUI [2,2]
C1514873
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0543467
UMLS CUI [3,3]
C0022417
UMLS CUI [3,4]
C0392760
7. diagnosed or treated for active gi ulcer, gi bleeding, ulcerative colitis, or severe renal, hepatic, or coagulant disorder within 6 months prior to randomization
Beschreibung

Gastrointestinal ulcer | Gastrointestinal ulcer Treated | Gastrointestinal Hemorrhage | Ulcerative Colitis | Kidney Disease Severe | Liver disease Severe | Blood Coagulation Disorder Severe

Datentyp

boolean

Alias
UMLS CUI [1]
C0237938
UMLS CUI [2,1]
C0237938
UMLS CUI [2,2]
C1522326
UMLS CUI [3]
C0017181
UMLS CUI [4]
C0009324
UMLS CUI [5,1]
C0022658
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C0023895
UMLS CUI [6,2]
C0205082
UMLS CUI [7,1]
C0005779
UMLS CUI [7,2]
C0205082
8. history of nasal polyps, bronchospasm, urticaria, or anaphylactic shock
Beschreibung

Nasal Polyps | Bronchospasm | Urticaria | Anaphylactic shock

Datentyp

boolean

Alias
UMLS CUI [1]
C0027430
UMLS CUI [2]
C0006266
UMLS CUI [3]
C0042109
UMLS CUI [4]
C4316895
9. subjects who have had surgery on the affected joint within 6 months prior to the study and subjects with a prosthesis at the index joint
Beschreibung

Operative Surgical Procedure Joint Affected | Prosthesis Joint Affected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0022417
UMLS CUI [1,3]
C0392760
UMLS CUI [2,1]
C0175649
UMLS CUI [2,2]
C0022417
UMLS CUI [2,3]
C0392760
10. pregnant or breast-feeding, or expecting to conceive within the projected duration of the study
Beschreibung

Pregnancy | Breast Feeding | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
11. subjects who are currently participating or have participated in other clinical studies within 4 weeks of screening or in any other clinical trial evaluating nsaids or cox-2 inhibitors within 6 months of screening
Beschreibung

Study Subject Participation Status | Clinical Trials | Anti-Inflammatory Agents, Non-Steroidal | Cox-2 Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3]
C0003211
UMLS CUI [4]
C1257954
12. subjects who have received even one dose of rofecoxib or etoricoxib at any time in their life
Beschreibung

Rofecoxib Dose Quantity | Etoricoxib Dose Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0762662
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0972314
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C1265611
13. history of congestive heart failure with a status of new york heart association ii-iv, ischemic heart disease, uncontrolled hypertension, peripheral arterial disease, cerebrovascular disease or subjects who have one of these diseases
Beschreibung

Congestive heart failure New York Heart Association Classification | Myocardial Ischemia | Uncontrolled hypertension | Peripheral Arterial Diseases | Cerebrovascular Disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0151744
UMLS CUI [3]
C1868885
UMLS CUI [4]
C1704436
UMLS CUI [5]
C0007820
14. current user of recreational or illicit drugs or has had a recent history (1 year) of drug or alcohol abuse or dependence
Beschreibung

Drug abuse | Illicit medication use | Substance Use Disorders | Substance Dependence

Datentyp

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2]
C0281875
UMLS CUI [3]
C0038586
UMLS CUI [4]
C0038580
15. history of neoplastic disease or chemotherapy within 5 years of v1, with the exception of non-metastatic skin cancer that has been completely cured
Beschreibung

Neoplastic disease | Chemotherapy | Exception Skin carcinoma Cured

Datentyp

boolean

Alias
UMLS CUI [1]
C1882062
UMLS CUI [2]
C0392920
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [3,3]
C1880198
16. subjects with gout, pseudogout, inflammatory arthritis, paget's disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease
Beschreibung

Gout | Pseudogout | Arthritis | Osteitis Deformans | Chronic pain syndrome | Fibromyalgia | Arthropathy Major

Datentyp

boolean

Alias
UMLS CUI [1]
C0018099
UMLS CUI [2]
C0033802
UMLS CUI [3]
C0003864
UMLS CUI [4]
C0029401
UMLS CUI [5]
C1298685
UMLS CUI [6]
C0016053
UMLS CUI [7,1]
C0022408
UMLS CUI [7,2]
C0205164
17. subjects using i.v, i.m., or oral corticosteroids, i.a. steroids or hyaluronic acid injections within 1 month of v1
Beschreibung

Adrenal Cortex Hormones Intravenous | Adrenal Cortex Hormones Intramuscular | Adrenal Cortex Hormones Oral | Injection of steroid Intraarterial | Hyaluronic acid Injection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1522726
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1556154
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C1527415
UMLS CUI [4,1]
C1261311
UMLS CUI [4,2]
C1561451
UMLS CUI [5,1]
C0020196
UMLS CUI [5,2]
C1828121
18. subjects receiving a chinese traditional arthritis treatment within 1 week of v1
Beschreibung

Therapy Traditional Chinese Medicine Arthritis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0025124
UMLS CUI [1,3]
C0003864
19. subjects who are not suitable to participate in the study by the investigator's clinical decision
Beschreibung

Study Subject Participation Status Inappropriate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Ähnliche Modelle

Eligibility Localized Primary Osteoarthritis of Hip NCT01765296

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Age | Informed Consent
Item
1. males or females, age 20 years or above, able and willing to provide written informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Osteoarthritis, Knee | Osteoarthritis of hip
Item
2. knee or hip oa diagnosed according to american college of rheumatology guidelines
boolean
C0409959 (UMLS CUI [1])
C0029410 (UMLS CUI [2])
Chronic pain Duration | Etiology Osteoarthritis
Item
3. chronic pain for ≥3 months from oa
boolean
C0150055 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0029408 (UMLS CUI [2,2])
Blood pressure determination | Systolic Pressure | Diastolic blood pressure | Pulse Rate At rest
Item
4. bp [systolic 90-140 mmhg, diastolic 50-90 mmhg] and pulse rate [resting 40-100 bpm].
boolean
C0005824 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0232117 (UMLS CUI [4,1])
C0443144 (UMLS CUI [4,2])
WOMAC - pain subscale Joint Affected
Item
5. womac-pain score in the index joint must be between 4-8 on a 0-10 numerical rating scale
boolean
C5190460 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
Blood Chemical Analysis
Item
6. blood chemistry must be within 2x normal range
boolean
C0005774 (UMLS CUI [1])
Normal urinalysis
Item
7. urinalysis must be within normal limits; minor deviations are acceptable
boolean
C0749920 (UMLS CUI [1])
Study Subject Barrier Contraception Double | Partner Barrier Contraception Double
Item
8. subjects and their sexual partners must agree to use double barrier contraception during the study period and for 3 months afterward, or be at least one year post-
boolean
C0681850 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0205173 (UMLS CUI [1,3])
C0682323 (UMLS CUI [2,1])
C0004764 (UMLS CUI [2,2])
C0205173 (UMLS CUI [2,3])
Postmenopausal state Duration | Sexual sterilization
Item
menopause, or provide proof of surgical sterility
boolean
C0232970 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0038288 (UMLS CUI [2])
Anti-Inflammatory Agents, Non-Steroidal | Benefit Therapeutic
Item
9. for prior non-steroidal inflammatory drug (nsaid) users only, the subject has a history of positive therapeutic benefit
boolean
C0003211 (UMLS CUI [1])
C0814225 (UMLS CUI [2,1])
C0302350 (UMLS CUI [2,2])
Alcohol consumption Limiting Willing
Item
10. subject is willing to limit alcohol intake to 2 or less drinks per day during study and the follow-up period
boolean
C0001948 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Able to read Study Protocol | Comprehension Study Protocol | Adherence Study Protocol
Item
11. subjects must be able to read, understand and follow study related documents.
boolean
C0586740 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0162340 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C1510802 (UMLS CUI [3,1])
C2348563 (UMLS CUI [3,2])
Exclusion Criteria
Item
exclusion criteria (abbreviated)
boolean
C0680251 (UMLS CUI [1])
Analgesics | Exception Investigational New Drugs | Exception Acetaminophen
Item
1. use of any analgesics except the study medication or acetaminophen at any time
boolean
C0002771 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0000970 (UMLS CUI [3,2])
Pharmaceutical Preparations Symptoms chronic | Mental disorders Causing Impaired cognition | Mental disorders Causing Behavioral change | Mental disorders Preventing Protocol Compliance
Item
2. use of any medications for ongoing chronic symptoms, or psychiatric disorders that could significantly diminish the cognitive ability or cause behavioral changes that would prevent the subject from complying with study procedures.
boolean
C0013227 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0338656 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0678227 (UMLS CUI [3,2])
C0542299 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Legal competency Lacking | Psychotic Disorders | Emotional problems Interfere with Completion of clinical trial
Item
3. subject is legally incompetent, or has active psychosis, or significant emotional problems which are sufficient to interfere with the conduct of the study
boolean
C0680554 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0033975 (UMLS CUI [2])
C0677660 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
Anticoagulants | aspirin | warfarin | heparin
Item
4. use of anticoagulants (aspirin, warfarin, heparin, etc.) within 2 weeks of v1
boolean
C0003280 (UMLS CUI [1])
C0004057 (UMLS CUI [2])
C0043031 (UMLS CUI [3])
C0019134 (UMLS CUI [4])
Allergy to nonsteroidal anti-inflammatory agents | Allergy to COX-2 inhibitors | Carbonic anhydrase inhibitor allergy | Allergy to sulfonamide | Allergy to aspirin | Allergy to paracetamol
Item
5. previous history of hypersensitivity or allergy to nsaids, cox-2 inhibitors, carbonic anhydrase inhibitors, sulfa drugs, aspirin, or acetaminophen/paracetamol
boolean
C0746949 (UMLS CUI [1])
C2136452 (UMLS CUI [2])
C0571931 (UMLS CUI [3])
C0038757 (UMLS CUI [4])
C0004058 (UMLS CUI [5])
C0570513 (UMLS CUI [6])
Knee Replacement Arthroplasty Required | Repair of hip Required | Patient need for Operative Surgical Procedure Joint Affected
Item
6. subjects requiring knee or hip arthroplasty within 2 months of screening or anticipating any need for a surgical procedure on the index joint during the study
boolean
C0086511 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0186193 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0022417 (UMLS CUI [3,3])
C0392760 (UMLS CUI [3,4])
Gastrointestinal ulcer | Gastrointestinal ulcer Treated | Gastrointestinal Hemorrhage | Ulcerative Colitis | Kidney Disease Severe | Liver disease Severe | Blood Coagulation Disorder Severe
Item
7. diagnosed or treated for active gi ulcer, gi bleeding, ulcerative colitis, or severe renal, hepatic, or coagulant disorder within 6 months prior to randomization
boolean
C0237938 (UMLS CUI [1])
C0237938 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0017181 (UMLS CUI [3])
C0009324 (UMLS CUI [4])
C0022658 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0023895 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0005779 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
Nasal Polyps | Bronchospasm | Urticaria | Anaphylactic shock
Item
8. history of nasal polyps, bronchospasm, urticaria, or anaphylactic shock
boolean
C0027430 (UMLS CUI [1])
C0006266 (UMLS CUI [2])
C0042109 (UMLS CUI [3])
C4316895 (UMLS CUI [4])
Operative Surgical Procedure Joint Affected | Prosthesis Joint Affected
Item
9. subjects who have had surgery on the affected joint within 6 months prior to the study and subjects with a prosthesis at the index joint
boolean
C0543467 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0175649 (UMLS CUI [2,1])
C0022417 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
10. pregnant or breast-feeding, or expecting to conceive within the projected duration of the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Study Subject Participation Status | Clinical Trials | Anti-Inflammatory Agents, Non-Steroidal | Cox-2 Inhibitors
Item
11. subjects who are currently participating or have participated in other clinical studies within 4 weeks of screening or in any other clinical trial evaluating nsaids or cox-2 inhibitors within 6 months of screening
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0003211 (UMLS CUI [3])
C1257954 (UMLS CUI [4])
Rofecoxib Dose Quantity | Etoricoxib Dose Quantity
Item
12. subjects who have received even one dose of rofecoxib or etoricoxib at any time in their life
boolean
C0762662 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0972314 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Congestive heart failure New York Heart Association Classification | Myocardial Ischemia | Uncontrolled hypertension | Peripheral Arterial Diseases | Cerebrovascular Disorders
Item
13. history of congestive heart failure with a status of new york heart association ii-iv, ischemic heart disease, uncontrolled hypertension, peripheral arterial disease, cerebrovascular disease or subjects who have one of these diseases
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0151744 (UMLS CUI [2])
C1868885 (UMLS CUI [3])
C1704436 (UMLS CUI [4])
C0007820 (UMLS CUI [5])
Drug abuse | Illicit medication use | Substance Use Disorders | Substance Dependence
Item
14. current user of recreational or illicit drugs or has had a recent history (1 year) of drug or alcohol abuse or dependence
boolean
C0013146 (UMLS CUI [1])
C0281875 (UMLS CUI [2])
C0038586 (UMLS CUI [3])
C0038580 (UMLS CUI [4])
Neoplastic disease | Chemotherapy | Exception Skin carcinoma Cured
Item
15. history of neoplastic disease or chemotherapy within 5 years of v1, with the exception of non-metastatic skin cancer that has been completely cured
boolean
C1882062 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1880198 (UMLS CUI [3,3])
Gout | Pseudogout | Arthritis | Osteitis Deformans | Chronic pain syndrome | Fibromyalgia | Arthropathy Major
Item
16. subjects with gout, pseudogout, inflammatory arthritis, paget's disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease
boolean
C0018099 (UMLS CUI [1])
C0033802 (UMLS CUI [2])
C0003864 (UMLS CUI [3])
C0029401 (UMLS CUI [4])
C1298685 (UMLS CUI [5])
C0016053 (UMLS CUI [6])
C0022408 (UMLS CUI [7,1])
C0205164 (UMLS CUI [7,2])
Adrenal Cortex Hormones Intravenous | Adrenal Cortex Hormones Intramuscular | Adrenal Cortex Hormones Oral | Injection of steroid Intraarterial | Hyaluronic acid Injection
Item
17. subjects using i.v, i.m., or oral corticosteroids, i.a. steroids or hyaluronic acid injections within 1 month of v1
boolean
C0001617 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C1556154 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C1261311 (UMLS CUI [4,1])
C1561451 (UMLS CUI [4,2])
C0020196 (UMLS CUI [5,1])
C1828121 (UMLS CUI [5,2])
Therapy Traditional Chinese Medicine Arthritis
Item
18. subjects receiving a chinese traditional arthritis treatment within 1 week of v1
boolean
C0087111 (UMLS CUI [1,1])
C0025124 (UMLS CUI [1,2])
C0003864 (UMLS CUI [1,3])
Study Subject Participation Status Inappropriate
Item
19. subjects who are not suitable to participate in the study by the investigator's clinical decision
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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