ID

22255

Descrição

Double-Blind,Randomized,Placebo-Controlled Efficacy & Safety Study of EUFLEXXA™ for Treatment of OA of the First CMC; ODM derived from: https://clinicaltrials.gov/show/NCT00423371

Link

https://clinicaltrials.gov/show/NCT00423371

Palavras-chave

Versões (1)
  1. 26/05/2017 26/05/2017 -
Transferido a

26 de maio de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00423371

Inglês

Eligibility Osteoarthritis NCT00423371

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. men or women ≥40 years of age
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
2. pain due to primary oa of the first cmc joint present for at least half the days of the previous month and a mean combined pain score ≥ 30 mm out of 100 mm of the 5 pain questions on the auscan index pain subscale (see appendix 1)
Descrição

Pain Frequency Pain score | Idiopathic osteoarthritis Carpometacarpal joint First

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0376249
UMLS CUI [1,3]
C0582148
UMLS CUI [2,1]
C0409952
UMLS CUI [2,2]
C1321524
UMLS CUI [2,3]
C0205435
3. a series of x-rays confirming oa of the first cmc joint of the target thumb obtained at screening with a stage of 2, 3, or 4 according to grading scale in appendix 3.
Descrição

Degenerative polyarthritis Carpometacarpal joint First Thumb Target | Degenerative polyarthritis Kellgren-Lawrence score Radiography

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C1321524
UMLS CUI [1,3]
C0205435
UMLS CUI [1,4]
C0040067
UMLS CUI [1,5]
C1521840
UMLS CUI [2,1]
C0029408
UMLS CUI [2,2]
C3177117
UMLS CUI [2,3]
C0034571
4. ability and willingness to use only acetaminophen as the analgesic (rescue) study medication
Descrição

Acetaminophen | Investigational New Drugs | Analgesics

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0000970
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0002771
the acetaminophen dose must not exceed 4 grams/day (4000 mg)
Descrição

Acetaminophen Dosage U/day

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0000970
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
if subject has known chronic liver disease, the maximum dose of acetaminophen must not exceed 2 grams/day (2000 mg)
Descrição

Chronic liver disease | Acetaminophen Dose Maximum U/day

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0341439
UMLS CUI [2,1]
C0000970
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0806909
UMLS CUI [2,4]
C0456683
the subject must be willing and able to discontinue acetaminophen at least 24 hours prior to all study-specific visits
Descrição

Acetaminophen Discontinue Willing | Acetaminophen Discontinue Able

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0000970
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C0000970
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0085732
the study specific acetaminophen provided will only be used for thumb/joint pain.
Descrição

Acetaminophen | Pain in thumb | Arthralgia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0000970
UMLS CUI [2]
C0241394
UMLS CUI [3]
C0003862
5. willingness and ability to complete efficacy and safety questionnaires and ability to read and understand study instructions
Descrição

Questionnaires Completion Able | Questionnaires Completion Willing | Comprehension Study Protocol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C0034394
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C0600109
UMLS CUI [3,1]
C0162340
UMLS CUI [3,2]
C2348563
6. signed study-specific subject informed consent form
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any major injury to the target thumb within the 6 months prior to the screening visit
Descrição

Thumb Target Major injury

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0040067
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0332677
2. anyone having carpal tunnel syndrome (cts), dequervain's tenosynovitis, trigger finger, or a ganglion cyst of the target hand only if there is evidence of extreme atrophy and two-point average discrimination is greater than 10-mm, or if the pain from these conditions renders the subject unable to objectively assess oa pain in the target hand
Descrição

Carpal Tunnel Syndrome | De Quervain Disease | Trigger Finger Disorder | Hand Target Synovial Cyst | Atrophy Extreme | Two point discrimination distance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007286
UMLS CUI [2]
C0149870
UMLS CUI [3]
C0158328
UMLS CUI [4,1]
C0018563
UMLS CUI [4,2]
C1521840
UMLS CUI [4,3]
C0085648
UMLS CUI [5,1]
C0333641
UMLS CUI [5,2]
C0205403
UMLS CUI [6]
C0576681
3. any surgery to the target joint within the 12 months prior to the screening visit
Descrição

Joint Target Operative Surgical Procedures

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0022417
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0543467
4. regular use of assistive devices such as a cane or crutch or a cts brace
Descrição

Self-Help Devices Use Regular | Cane user | Crutches

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036605
UMLS CUI [1,2]
C0457083
UMLS CUI [1,3]
C0205272
UMLS CUI [2]
C0920240
UMLS CUI [3]
C0010397
5. concomitant rheumatic disease (rheumatoid arthritis, lupus arthropathy, psoriatic arthritis)
Descrição

Rheumatism | Rheumatoid Arthritis | Arthropathy | Lupus Erythematosus, Systemic | Arthritis, Psoriatic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0035435
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0022408
UMLS CUI [4]
C0024141
UMLS CUI [5]
C0003872
6. history of chondrocalcinosis in the target joint
Descrição

Joint Target Chondrocalcinosis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0022417
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0221621
7. gout exacerbation in any joint in the past 6 months
Descrição

Joint Gout Exacerbated

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0022417
UMLS CUI [1,2]
C0018099
UMLS CUI [1,3]
C1444749
8. x-ray findings of acute fractures, severe loss of bone density, and/or severe bone or joint deformity in the target joint
Descrição

Radiography | Fracture | Bone Density Loss Severe | Joint Target Deformity of bone Severe | Target Joint Deformity Severe

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0034571
UMLS CUI [2]
C0016658
UMLS CUI [3,1]
C0005938
UMLS CUI [3,2]
C1517945
UMLS CUI [3,3]
C0205082
UMLS CUI [4,1]
C0022417
UMLS CUI [4,2]
C1521840
UMLS CUI [4,3]
C0410719
UMLS CUI [4,4]
C0205082
UMLS CUI [5,1]
C1521840
UMLS CUI [5,2]
C0022417
UMLS CUI [5,3]
C0302142
UMLS CUI [5,4]
C0205082
9. significant target joint infection or skin disorder/infection within the 3 months prior to study enrollment
Descrição

Joint Target Communicable Disease | Joint Target Dermatologic disorder | Joint Target Infectious Skin Disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0022417
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0009450
UMLS CUI [2,1]
C0022417
UMLS CUI [2,2]
C1521840
UMLS CUI [2,3]
C0037274
UMLS CUI [3,1]
C0022417
UMLS CUI [3,2]
C1521840
UMLS CUI [3,3]
C0037278
10. known hypersensitivity to acetaminophen, euflexxa™, or phosphate buffered saline solution
Descrição

Hypersensitivity Acetaminophen | Hypersensitivity Euflexxa | Hypersensitivity Saline Solution Buffered phosphate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0000970
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1637315
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0036082
UMLS CUI [3,3]
C0991865
11. women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period
Descrição

Childbearing Potential Contraceptive methods Unwilling | Pregnancy | Breast Feeding | Pregnancy, Planned

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4]
C0032992
12. recurrent medical history of severe allergic or immune-mediated reactions or other immune disorders
Descrição

Recurrent disease | Allergic Reaction Severe | Nonspecific immune reaction Severe | Immune System Diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0301874
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0021053
13. current treatment or treatment within the previous 2 years prior to the screening visit for any malignancy unless specific written permission is provided by the sponsor (excluding basal cell or squamous cell carcinoma of the skin)
Descrição

cancer treatment | Basal cell carcinoma | Squamous cell carcinoma of skin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0553723
14. active liver disease based on liver profile of ast, alt, and conjugated bilirubin >2 times the upper limit of normal
Descrição

Liver diseases | Aspartate aminotransferase increased | Alanine aminotransferase increased | Bilirubin conjugated increased

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0855625
15. renal insufficiency based on serum creatinine >2.0 mg/dl
Descrição

Renal Insufficiency | Creatinine measurement, serum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
16. any clinically significant laboratory value based on clinical history that the investigator feels may affect the study evaluation
Descrição

Laboratory Results Affecting Evaluation Clinical Trial

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1261322
UMLS CUI [1,4]
C0008976
17. any intercurrent chronic disease or condition that may interfere with the completion of the 6-month follow-up of the study, such as liver disease, severe coronary disease, drug abuse, disordered mental state, or other clinically significant condition
Descrição

Comorbidity chronic Interferes with Clinical Study Follow-up | Condition Interferes with Clinical Study Follow-up | Liver diseases | Coronary Artery Disease Severe | Drug abuse | Mental disorders | Condition Clinical Significance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C3274571
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C3274571
UMLS CUI [3]
C0023895
UMLS CUI [4,1]
C1956346
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C0013146
UMLS CUI [6]
C0004936
UMLS CUI [7,1]
C0348080
UMLS CUI [7,2]
C2826293
18. current alcoholism, and/or any known current addiction to pain medications
Descrição

Alcoholic Intoxication, Chronic | Analgesics Dependence

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2,1]
C0002771
UMLS CUI [2,2]
C0439857
19. any clinically significant finding that would place the subject at health risk, impact the study, or affect the completion of the study
Descrição

Finding At risk Study Subject Health | Finding Impact Clinical Trial | Finding Affecting Clinical Trial Completion

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0681850
UMLS CUI [1,4]
C0018684
UMLS CUI [2,1]
C0243095
UMLS CUI [2,2]
C4049986
UMLS CUI [2,3]
C0008976
UMLS CUI [3,1]
C0243095
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0008976
UMLS CUI [3,4]
C0205197
20. any psychiatric illness that would prevent comprehension of the details and nature of the study
Descrição

Mental disorder Preventing Comprehension Study Protocol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C2348563
21. participation in any experimental device study within 6 months prior to the screening visit, or an experimental drug study within 1 month prior to the screening visit
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C2346570
UMLS CUI [3]
C0013230
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Similar models

Eligibility Osteoarthritis NCT00423371

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. men or women ≥40 years of age
boolean
C0001779 (UMLS CUI [1])
Pain Frequency Pain score | Idiopathic osteoarthritis Carpometacarpal joint First
Item
2. pain due to primary oa of the first cmc joint present for at least half the days of the previous month and a mean combined pain score ≥ 30 mm out of 100 mm of the 5 pain questions on the auscan index pain subscale (see appendix 1)
boolean
C0030193 (UMLS CUI [1,1])
C0376249 (UMLS CUI [1,2])
C0582148 (UMLS CUI [1,3])
C0409952 (UMLS CUI [2,1])
C1321524 (UMLS CUI [2,2])
C0205435 (UMLS CUI [2,3])
Degenerative polyarthritis Carpometacarpal joint First Thumb Target | Degenerative polyarthritis Kellgren-Lawrence score Radiography
Item
3. a series of x-rays confirming oa of the first cmc joint of the target thumb obtained at screening with a stage of 2, 3, or 4 according to grading scale in appendix 3.
boolean
C0029408 (UMLS CUI [1,1])
C1321524 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C0040067 (UMLS CUI [1,4])
C1521840 (UMLS CUI [1,5])
C0029408 (UMLS CUI [2,1])
C3177117 (UMLS CUI [2,2])
C0034571 (UMLS CUI [2,3])
Acetaminophen | Investigational New Drugs | Analgesics
Item
4. ability and willingness to use only acetaminophen as the analgesic (rescue) study medication
boolean
C0000970 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0002771 (UMLS CUI [3])
Acetaminophen Dosage U/day
Item
the acetaminophen dose must not exceed 4 grams/day (4000 mg)
boolean
C0000970 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Chronic liver disease | Acetaminophen Dose Maximum U/day
Item
if subject has known chronic liver disease, the maximum dose of acetaminophen must not exceed 2 grams/day (2000 mg)
boolean
C0341439 (UMLS CUI [1])
C0000970 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
Acetaminophen Discontinue Willing | Acetaminophen Discontinue Able
Item
the subject must be willing and able to discontinue acetaminophen at least 24 hours prior to all study-specific visits
boolean
C0000970 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0000970 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Acetaminophen | Pain in thumb | Arthralgia
Item
the study specific acetaminophen provided will only be used for thumb/joint pain.
boolean
C0000970 (UMLS CUI [1])
C0241394 (UMLS CUI [2])
C0003862 (UMLS CUI [3])
Questionnaires Completion Able | Questionnaires Completion Willing | Comprehension Study Protocol
Item
5. willingness and ability to complete efficacy and safety questionnaires and ability to read and understand study instructions
boolean
C0034394 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0034394 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
C0162340 (UMLS CUI [3,1])
C2348563 (UMLS CUI [3,2])
Informed Consent
Item
6. signed study-specific subject informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Thumb Target Major injury
Item
1. any major injury to the target thumb within the 6 months prior to the screening visit
boolean
C0040067 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0332677 (UMLS CUI [1,3])
Carpal Tunnel Syndrome | De Quervain Disease | Trigger Finger Disorder | Hand Target Synovial Cyst | Atrophy Extreme | Two point discrimination distance
Item
2. anyone having carpal tunnel syndrome (cts), dequervain's tenosynovitis, trigger finger, or a ganglion cyst of the target hand only if there is evidence of extreme atrophy and two-point average discrimination is greater than 10-mm, or if the pain from these conditions renders the subject unable to objectively assess oa pain in the target hand
boolean
C0007286 (UMLS CUI [1])
C0149870 (UMLS CUI [2])
C0158328 (UMLS CUI [3])
C0018563 (UMLS CUI [4,1])
C1521840 (UMLS CUI [4,2])
C0085648 (UMLS CUI [4,3])
C0333641 (UMLS CUI [5,1])
C0205403 (UMLS CUI [5,2])
C0576681 (UMLS CUI [6])
Joint Target Operative Surgical Procedures
Item
3. any surgery to the target joint within the 12 months prior to the screening visit
boolean
C0022417 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Self-Help Devices Use Regular | Cane user | Crutches
Item
4. regular use of assistive devices such as a cane or crutch or a cts brace
boolean
C0036605 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
C0920240 (UMLS CUI [2])
C0010397 (UMLS CUI [3])
Rheumatism | Rheumatoid Arthritis | Arthropathy | Lupus Erythematosus, Systemic | Arthritis, Psoriatic
Item
5. concomitant rheumatic disease (rheumatoid arthritis, lupus arthropathy, psoriatic arthritis)
boolean
C0035435 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C0022408 (UMLS CUI [3])
C0024141 (UMLS CUI [4])
C0003872 (UMLS CUI [5])
Joint Target Chondrocalcinosis
Item
6. history of chondrocalcinosis in the target joint
boolean
C0022417 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0221621 (UMLS CUI [1,3])
Joint Gout Exacerbated
Item
7. gout exacerbation in any joint in the past 6 months
boolean
C0022417 (UMLS CUI [1,1])
C0018099 (UMLS CUI [1,2])
C1444749 (UMLS CUI [1,3])
Radiography | Fracture | Bone Density Loss Severe | Joint Target Deformity of bone Severe | Target Joint Deformity Severe
Item
8. x-ray findings of acute fractures, severe loss of bone density, and/or severe bone or joint deformity in the target joint
boolean
C0034571 (UMLS CUI [1])
C0016658 (UMLS CUI [2])
C0005938 (UMLS CUI [3,1])
C1517945 (UMLS CUI [3,2])
C0205082 (UMLS CUI [3,3])
C0022417 (UMLS CUI [4,1])
C1521840 (UMLS CUI [4,2])
C0410719 (UMLS CUI [4,3])
C0205082 (UMLS CUI [4,4])
C1521840 (UMLS CUI [5,1])
C0022417 (UMLS CUI [5,2])
C0302142 (UMLS CUI [5,3])
C0205082 (UMLS CUI [5,4])
Joint Target Communicable Disease | Joint Target Dermatologic disorder | Joint Target Infectious Skin Disease
Item
9. significant target joint infection or skin disorder/infection within the 3 months prior to study enrollment
boolean
C0022417 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
C0022417 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0037274 (UMLS CUI [2,3])
C0022417 (UMLS CUI [3,1])
C1521840 (UMLS CUI [3,2])
C0037278 (UMLS CUI [3,3])
Hypersensitivity Acetaminophen | Hypersensitivity Euflexxa | Hypersensitivity Saline Solution Buffered phosphate
Item
10. known hypersensitivity to acetaminophen, euflexxa™, or phosphate buffered saline solution
boolean
C0020517 (UMLS CUI [1,1])
C0000970 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1637315 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0036082 (UMLS CUI [3,2])
C0991865 (UMLS CUI [3,3])
Childbearing Potential Contraceptive methods Unwilling | Pregnancy | Breast Feeding | Pregnancy, Planned
Item
11. women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0032992 (UMLS CUI [4])
Recurrent disease | Allergic Reaction Severe | Nonspecific immune reaction Severe | Immune System Diseases
Item
12. recurrent medical history of severe allergic or immune-mediated reactions or other immune disorders
boolean
C0277556 (UMLS CUI [1])
C1527304 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0301874 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0021053 (UMLS CUI [4])
cancer treatment | Basal cell carcinoma | Squamous cell carcinoma of skin
Item
13. current treatment or treatment within the previous 2 years prior to the screening visit for any malignancy unless specific written permission is provided by the sponsor (excluding basal cell or squamous cell carcinoma of the skin)
boolean
C0920425 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
Liver diseases | Aspartate aminotransferase increased | Alanine aminotransferase increased | Bilirubin conjugated increased
Item
14. active liver disease based on liver profile of ast, alt, and conjugated bilirubin >2 times the upper limit of normal
boolean
C0023895 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0855625 (UMLS CUI [4])
Renal Insufficiency | Creatinine measurement, serum
Item
15. renal insufficiency based on serum creatinine >2.0 mg/dl
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Laboratory Results Affecting Evaluation Clinical Trial
Item
16. any clinically significant laboratory value based on clinical history that the investigator feels may affect the study evaluation
boolean
C1254595 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
Comorbidity chronic Interferes with Clinical Study Follow-up | Condition Interferes with Clinical Study Follow-up | Liver diseases | Coronary Artery Disease Severe | Drug abuse | Mental disorders | Condition Clinical Significance
Item
17. any intercurrent chronic disease or condition that may interfere with the completion of the 6-month follow-up of the study, such as liver disease, severe coronary disease, drug abuse, disordered mental state, or other clinically significant condition
boolean
C0009488 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C3274571 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
C0023895 (UMLS CUI [3])
C1956346 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0013146 (UMLS CUI [5])
C0004936 (UMLS CUI [6])
C0348080 (UMLS CUI [7,1])
C2826293 (UMLS CUI [7,2])
Alcoholic Intoxication, Chronic | Analgesics Dependence
Item
18. current alcoholism, and/or any known current addiction to pain medications
boolean
C0001973 (UMLS CUI [1])
C0002771 (UMLS CUI [2,1])
C0439857 (UMLS CUI [2,2])
Finding At risk Study Subject Health | Finding Impact Clinical Trial | Finding Affecting Clinical Trial Completion
Item
19. any clinically significant finding that would place the subject at health risk, impact the study, or affect the completion of the study
boolean
C0243095 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
C0018684 (UMLS CUI [1,4])
C0243095 (UMLS CUI [2,1])
C4049986 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0243095 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0008976 (UMLS CUI [3,3])
C0205197 (UMLS CUI [3,4])
Mental disorder Preventing Comprehension Study Protocol
Item
20. any psychiatric illness that would prevent comprehension of the details and nature of the study
boolean
C0004936 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs
Item
21. participation in any experimental device study within 6 months prior to the screening visit, or an experimental drug study within 1 month prior to the screening visit
boolean
C2348568 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
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