ID

24497

Descripción

Study of AS902330 (rhFGF-18) Administered Intra-articularly in Patients With Knee Primary Osteoarthritis Who Are Candidates for Total Knee Replacement; ODM derived from: https://clinicaltrials.gov/show/NCT00911469

Link

https://clinicaltrials.gov/show/NCT00911469

Palabras clave

Versiones (1)
  1. 3/8/17 3/8/17 -
Subido en

3 de agosto de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT00911469

Inglés

Eligibility Knee Osteoarthritis NCT00911469

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. established diagnosis of knee primary femoro-tibial oa by standard american college of rheumatology criteria (acr) for at least six months (clinical and radiological criteria)
Descripción

Primary osteoarthritis of knee femorotibial Disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2893931
UMLS CUI [1,2]
C1269072
UMLS CUI [1,3]
C0872146
2. postmenopausal or surgically sterile female ≥ 40 years of age post-menopausal status will be confirmed by no menstrual periods for 12 consecutive months and no other biological or physiological cause for amenorrhea can be identified or male ≥ 40 years of age willing to use contraception (condom with spermicide) from the first day of treatment until 2 months after the end of the treatment (3rd injection in period 2) even though systemic exposure of the drug is not foreseen at the doses used in this study, due to the absence of data on teratogenic potential of the drug, a very conservative approach on contraception is taken based on the spermatogenesis duration in humans.
Descripción

Postmenopausal state | Female Sterilization | Age | Amenorrhea | Gender Contraceptive methods | Condoms, Male | Spermatocidal Agents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0002453
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0700589
UMLS CUI [6]
C0009653
UMLS CUI [7]
C0037862
3. candidate for total knee replacement in the target knee, according to nih consensus statement on total knee replacement (2003)
Descripción

Knee Replacement Arthroplasty Target Knee

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0086511
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0022742
4. date of planned total knee replacement in the target knee ≥ 2 weeks after the anticipated last injection of study drug
Descripción

Date Knee Replacement Arthroplasty Target Knee

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0086511
UMLS CUI [1,3]
C1521840
UMLS CUI [1,4]
C0022742
5. subjects may be on treatment for symptomatic relief of oa, including nsaids (including cox2 specific inhibitors); for nsaids, the dose should be stable for 4 weeks before baseline and during the study until day 4 after last injection. paracetamol/acetaminophen (according to local standards and up to 4 grams per day) is allowed as rescue medication
Descripción

Symptomatic relief Degenerative polyarthritis | Non-Steroidal Anti-Inflammatory Agents Dose Stable | Cyclooxygenase 2 Inhibitors | Acetaminophen

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3242309
UMLS CUI [1,2]
C0029408
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3]
C1257954
UMLS CUI [4]
C0000970
6. willingness to stay in hospital for 24h after injection for sad regimens and after first injection for mad regimens (and up to 4 hours after second and third injections for mad regimens) for safety and pk evaluation
Descripción

Hospital Stay Willing | Dose Ascending Single Regimen | Dose Ascending Multiple Regimen | Pharmacokinetic Evaluation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3489408
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0205385
UMLS CUI [2,3]
C0205171
UMLS CUI [2,4]
C0040808
UMLS CUI [3,1]
C0178602
UMLS CUI [3,2]
C0205385
UMLS CUI [3,3]
C0439064
UMLS CUI [3,4]
C0040808
UMLS CUI [4,1]
C0031328
UMLS CUI [4,2]
C1261322
7. willingness to complete a diary card to evaluate local tolerability and adverse events throughout the study
Descripción

Subject Diary Completion Willing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0600109
8. subjects must have read and understood the informed consent form and must have signed it prior to any study related procedure
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
9. subjects must fully understand the requirements of the study and be willing to comply with all study visits and assessments
Descripción

Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that in the opinion of the investigator constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation
Descripción

Laboratory finding Study Subject Participation Status At risk | Medical contraindication Study Subject Participation Status | Laboratory finding Interferes with Study Protocol | Medical History Study Subject Participation Status At risk | Medical History Interferes with Study Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C2348568
UMLS CUI [3,1]
C0587081
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348563
UMLS CUI [4,1]
C0262926
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C1444641
UMLS CUI [5,1]
C0262926
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C2348563
2. clinically significant abnormal hematology or biochemistry values (platelets, hemoglobin, leucocytes, alkaline phosphatase, ast, alt, blood creatinine, bilirubin)
Descripción

Hematology finding abnormal | Abnormal biochemistry finding | Platelet count abnormal | Abnormal hemoglobin finding | White blood cell abnormality | alkaline phosphatase abnormal | AST level abnormal | ALT level abnormal | Blood creatinine abnormal | Bilirubin abnormal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0475182
UMLS CUI [2]
C0586680
UMLS CUI [3]
C0580317
UMLS CUI [4]
C0349705
UMLS CUI [5]
C0152009
UMLS CUI [6]
C0740888
UMLS CUI [7]
C0580475
UMLS CUI [8]
C0580469
UMLS CUI [9]
C0853746
UMLS CUI [10]
C1142335
3. receipt of any investigational product or any experimental therapeutic procedure within the last 12 weeks preceding screening
Descripción

Investigational New Drugs | Therapies, Investigational

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0949266
4. intra-articular treatment with steroids or hyaluronic acid derivatives within the past 3 months (systemic symptomatic treatments with nsaids are allowed when stable for 4 weeks prior to first injection)
Descripción

Intraarticular Corticosteroid Therapy | Hyaluronic Acid Derivatives Intraarticular | Non-Steroidal Anti-Inflammatory Agents Stable | Therapeutic procedure Symptomatic Systemic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4054701
UMLS CUI [2,1]
C0020196
UMLS CUI [2,2]
C0243072
UMLS CUI [2,3]
C1522204
UMLS CUI [3,1]
C0003211
UMLS CUI [3,2]
C0205360
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0231220
UMLS CUI [4,3]
C0205373
5. planned major surgery (e.g. joint replacement) within 2 weeks after last injection
Descripción

Major surgery Planned | Joint replacement Planned

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1442800
UMLS CUI [2,2]
C1301732
6. history of previous surgery (tkr or partial knee replacement) on the target knee
Descripción

Operative Surgical Procedures Target Knee | Knee Replacement Arthroplasty | Arthroplasty, Replacement, Partial Knee

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0022742
UMLS CUI [2]
C0086511
UMLS CUI [3]
C0864243
7. lesions at the planned injection site that would present a contra-indication to local injection of the study drug (e.g., open wounds and infections of the skin)any drug or nutraceutical treatment with potential dmoad effect (glucosamine, diacerin, chondroitin sulfate) unless given at a stable dose over at least 4 weeks prior to first injection
Descripción

Lesion Injection site Planned | Medical contraindication Local injection Investigational New Drugs | Open wound | Skin Diseases, Infectious | Pharmaceutical Preparations Dose Stable | Nutraceuticals Dose Stable | Degenerative polyarthritis Pharmaceutical Preparations Disease Changing | Glucosamine | diacetylrhein | Chondroitin Sulfates

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C2700396
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C1657761
UMLS CUI [2,3]
C0013230
UMLS CUI [3]
C0332798
UMLS CUI [4]
C0037278
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C0205360
UMLS CUI [6,1]
C1518478
UMLS CUI [6,2]
C0178602
UMLS CUI [6,3]
C0205360
UMLS CUI [7,1]
C0029408
UMLS CUI [7,2]
C0013227
UMLS CUI [7,3]
C0012634
UMLS CUI [7,4]
C0392747
UMLS CUI [8]
C0017718
UMLS CUI [9]
C0057678
UMLS CUI [10]
C0008466
8. use of electrotherapy or acupuncture for oa
Descripción

Electric Stimulation Therapy Degenerative polyarthritis | Acupuncture Degenerative polyarthritis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013787
UMLS CUI [1,2]
C0029408
UMLS CUI [2,1]
C0394664
UMLS CUI [2,2]
C0029408
9. any known active infections, including suspicion of intra-articular infection and/or infections that may compromise the immune system such as hiv, hepatitis b or hepatitis c infection
Descripción

Communicable Diseases | Suspicion Infection Intra-articular | Communicable Diseases compromise Immune system | HIV Infections | Hepatitis B | Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0242114
UMLS CUI [2,2]
C3714514
UMLS CUI [2,3]
C0442108
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C0020962
UMLS CUI [4]
C0019693
UMLS CUI [5]
C0019163
UMLS CUI [6]
C0019196
10. history of sarcoma and/or history of other active malignancy within five years, except adequately treated basal cell and squamous cell carcinoma of the skin
Descripción

Sarcoma | Malignant Neoplasms | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1261473
UMLS CUI [2]
C0006826
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0553723
UMLS CUI [4,2]
C1522326
11. signs and symptoms suggestive of transmissible spongiform encephalopathy
Descripción

Signs and Symptoms Suggestive of Transmissible spongiform encephalopathy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0332299
UMLS CUI [1,3]
C0162534
12. secondary osteoarthritis: e.g. joint dysplasias, aseptic osteonecrosis, acromegaly, paget's disease, ehlers-danlos syndrome, gaucher's disease, stickler's syndrome, joint infection, hemophilia, hemochromatosis, calcium pyrophosphate deposition disease, or neuropathic arthropathy whatever the cause patients with risk factors for knee oa (e.g. obesity, meniscectomy) are not considered as having secondary oa and can be included in this study.
Descripción

Secondary osteoarthritis | joint; dysplasia | osteonecrosis; aseptic | Acromegaly | Osteitis Deformans | Ehlers-Danlos Syndrome | Gaucher Disease | Stickler syndrome | Arthropathy associated with infection | Hemophilia | Hemochromatosis | Calcium pyrophosphate deposition disease | Neurogenic arthropathy | Risk factors Knee Osteoarthritis | Obesity | Chondrectomy of semilunar cartilage of knee

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2732281
UMLS CUI [2]
C1395954
UMLS CUI [3]
C0391980
UMLS CUI [4]
C0001206
UMLS CUI [5]
C0029401
UMLS CUI [6]
C0013720
UMLS CUI [7]
C0017205
UMLS CUI [8]
C0265253
UMLS CUI [9]
C0157749
UMLS CUI [10]
C0684275
UMLS CUI [11]
C0018995
UMLS CUI [12]
C0553730
UMLS CUI [13]
C0003892
UMLS CUI [14,1]
C0035648
UMLS CUI [14,2]
C0409959
UMLS CUI [15]
C0028754
UMLS CUI [16]
C0187901
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Similar models

Eligibility Knee Osteoarthritis NCT00911469

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Primary osteoarthritis of knee femorotibial Disease length
Item
1. established diagnosis of knee primary femoro-tibial oa by standard american college of rheumatology criteria (acr) for at least six months (clinical and radiological criteria)
boolean
C2893931 (UMLS CUI [1,1])
C1269072 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,3])
Postmenopausal state | Female Sterilization | Age | Amenorrhea | Gender Contraceptive methods | Condoms, Male | Spermatocidal Agents
Item
2. postmenopausal or surgically sterile female ≥ 40 years of age post-menopausal status will be confirmed by no menstrual periods for 12 consecutive months and no other biological or physiological cause for amenorrhea can be identified or male ≥ 40 years of age willing to use contraception (condom with spermicide) from the first day of treatment until 2 months after the end of the treatment (3rd injection in period 2) even though systemic exposure of the drug is not foreseen at the doses used in this study, due to the absence of data on teratogenic potential of the drug, a very conservative approach on contraception is taken based on the spermatogenesis duration in humans.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0002453 (UMLS CUI [4])
C0079399 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C0009653 (UMLS CUI [6])
C0037862 (UMLS CUI [7])
Knee Replacement Arthroplasty Target Knee
Item
3. candidate for total knee replacement in the target knee, according to nih consensus statement on total knee replacement (2003)
boolean
C0086511 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
Date Knee Replacement Arthroplasty Target Knee
Item
4. date of planned total knee replacement in the target knee ≥ 2 weeks after the anticipated last injection of study drug
boolean
C0011008 (UMLS CUI [1,1])
C0086511 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C0022742 (UMLS CUI [1,4])
Symptomatic relief Degenerative polyarthritis | Non-Steroidal Anti-Inflammatory Agents Dose Stable | Cyclooxygenase 2 Inhibitors | Acetaminophen
Item
5. subjects may be on treatment for symptomatic relief of oa, including nsaids (including cox2 specific inhibitors); for nsaids, the dose should be stable for 4 weeks before baseline and during the study until day 4 after last injection. paracetamol/acetaminophen (according to local standards and up to 4 grams per day) is allowed as rescue medication
boolean
C3242309 (UMLS CUI [1,1])
C0029408 (UMLS CUI [1,2])
C0003211 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C1257954 (UMLS CUI [3])
C0000970 (UMLS CUI [4])
Hospital Stay Willing | Dose Ascending Single Regimen | Dose Ascending Multiple Regimen | Pharmacokinetic Evaluation
Item
6. willingness to stay in hospital for 24h after injection for sad regimens and after first injection for mad regimens (and up to 4 hours after second and third injections for mad regimens) for safety and pk evaluation
boolean
C3489408 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C0205385 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
C0040808 (UMLS CUI [2,4])
C0178602 (UMLS CUI [3,1])
C0205385 (UMLS CUI [3,2])
C0439064 (UMLS CUI [3,3])
C0040808 (UMLS CUI [3,4])
C0031328 (UMLS CUI [4,1])
C1261322 (UMLS CUI [4,2])
Subject Diary Completion Willing
Item
7. willingness to complete a diary card to evaluate local tolerability and adverse events throughout the study
boolean
C3890583 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Informed Consent
Item
8. subjects must have read and understood the informed consent form and must have signed it prior to any study related procedure
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
9. subjects must fully understand the requirements of the study and be willing to comply with all study visits and assessments
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Laboratory finding Study Subject Participation Status At risk | Medical contraindication Study Subject Participation Status | Laboratory finding Interferes with Study Protocol | Medical History Study Subject Participation Status At risk | Medical History Interferes with Study Protocol
Item
1. any condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that in the opinion of the investigator constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation
boolean
C0587081 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0587081 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348563 (UMLS CUI [3,3])
C0262926 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C0262926 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2348563 (UMLS CUI [5,3])
Hematology finding abnormal | Abnormal biochemistry finding | Platelet count abnormal | Abnormal hemoglobin finding | White blood cell abnormality | alkaline phosphatase abnormal | AST level abnormal | ALT level abnormal | Blood creatinine abnormal | Bilirubin abnormal
Item
2. clinically significant abnormal hematology or biochemistry values (platelets, hemoglobin, leucocytes, alkaline phosphatase, ast, alt, blood creatinine, bilirubin)
boolean
C0475182 (UMLS CUI [1])
C0586680 (UMLS CUI [2])
C0580317 (UMLS CUI [3])
C0349705 (UMLS CUI [4])
C0152009 (UMLS CUI [5])
C0740888 (UMLS CUI [6])
C0580475 (UMLS CUI [7])
C0580469 (UMLS CUI [8])
C0853746 (UMLS CUI [9])
C1142335 (UMLS CUI [10])
Investigational New Drugs | Therapies, Investigational
Item
3. receipt of any investigational product or any experimental therapeutic procedure within the last 12 weeks preceding screening
boolean
C0013230 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Intraarticular Corticosteroid Therapy | Hyaluronic Acid Derivatives Intraarticular | Non-Steroidal Anti-Inflammatory Agents Stable | Therapeutic procedure Symptomatic Systemic
Item
4. intra-articular treatment with steroids or hyaluronic acid derivatives within the past 3 months (systemic symptomatic treatments with nsaids are allowed when stable for 4 weeks prior to first injection)
boolean
C4054701 (UMLS CUI [1])
C0020196 (UMLS CUI [2,1])
C0243072 (UMLS CUI [2,2])
C1522204 (UMLS CUI [2,3])
C0003211 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0087111 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
C0205373 (UMLS CUI [4,3])
Major surgery Planned | Joint replacement Planned
Item
5. planned major surgery (e.g. joint replacement) within 2 weeks after last injection
boolean
C0679637 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1442800 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Operative Surgical Procedures Target Knee | Knee Replacement Arthroplasty | Arthroplasty, Replacement, Partial Knee
Item
6. history of previous surgery (tkr or partial knee replacement) on the target knee
boolean
C0543467 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C0086511 (UMLS CUI [2])
C0864243 (UMLS CUI [3])
Lesion Injection site Planned | Medical contraindication Local injection Investigational New Drugs | Open wound | Skin Diseases, Infectious | Pharmaceutical Preparations Dose Stable | Nutraceuticals Dose Stable | Degenerative polyarthritis Pharmaceutical Preparations Disease Changing | Glucosamine | diacetylrhein | Chondroitin Sulfates
Item
7. lesions at the planned injection site that would present a contra-indication to local injection of the study drug (e.g., open wounds and infections of the skin)any drug or nutraceutical treatment with potential dmoad effect (glucosamine, diacerin, chondroitin sulfate) unless given at a stable dose over at least 4 weeks prior to first injection
boolean
C0221198 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C1657761 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0332798 (UMLS CUI [3])
C0037278 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
C1518478 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
C0029408 (UMLS CUI [7,1])
C0013227 (UMLS CUI [7,2])
C0012634 (UMLS CUI [7,3])
C0392747 (UMLS CUI [7,4])
C0017718 (UMLS CUI [8])
C0057678 (UMLS CUI [9])
C0008466 (UMLS CUI [10])
Electric Stimulation Therapy Degenerative polyarthritis | Acupuncture Degenerative polyarthritis
Item
8. use of electrotherapy or acupuncture for oa
boolean
C0013787 (UMLS CUI [1,1])
C0029408 (UMLS CUI [1,2])
C0394664 (UMLS CUI [2,1])
C0029408 (UMLS CUI [2,2])
Communicable Diseases | Suspicion Infection Intra-articular | Communicable Diseases compromise Immune system | HIV Infections | Hepatitis B | Hepatitis C
Item
9. any known active infections, including suspicion of intra-articular infection and/or infections that may compromise the immune system such as hiv, hepatitis b or hepatitis c infection
boolean
C0009450 (UMLS CUI [1])
C0242114 (UMLS CUI [2,1])
C3714514 (UMLS CUI [2,2])
C0442108 (UMLS CUI [2,3])
C0009450 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0020962 (UMLS CUI [3,3])
C0019693 (UMLS CUI [4])
C0019163 (UMLS CUI [5])
C0019196 (UMLS CUI [6])
Sarcoma | Malignant Neoplasms | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated
Item
10. history of sarcoma and/or history of other active malignancy within five years, except adequately treated basal cell and squamous cell carcinoma of the skin
boolean
C1261473 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0007117 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0553723 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
Signs and Symptoms Suggestive of Transmissible spongiform encephalopathy
Item
11. signs and symptoms suggestive of transmissible spongiform encephalopathy
boolean
C0037088 (UMLS CUI [1,1])
C0332299 (UMLS CUI [1,2])
C0162534 (UMLS CUI [1,3])
Secondary osteoarthritis | joint; dysplasia | osteonecrosis; aseptic | Acromegaly | Osteitis Deformans | Ehlers-Danlos Syndrome | Gaucher Disease | Stickler syndrome | Arthropathy associated with infection | Hemophilia | Hemochromatosis | Calcium pyrophosphate deposition disease | Neurogenic arthropathy | Risk factors Knee Osteoarthritis | Obesity | Chondrectomy of semilunar cartilage of knee
Item
12. secondary osteoarthritis: e.g. joint dysplasias, aseptic osteonecrosis, acromegaly, paget's disease, ehlers-danlos syndrome, gaucher's disease, stickler's syndrome, joint infection, hemophilia, hemochromatosis, calcium pyrophosphate deposition disease, or neuropathic arthropathy whatever the cause patients with risk factors for knee oa (e.g. obesity, meniscectomy) are not considered as having secondary oa and can be included in this study.
boolean
C2732281 (UMLS CUI [1])
C1395954 (UMLS CUI [2])
C0391980 (UMLS CUI [3])
C0001206 (UMLS CUI [4])
C0029401 (UMLS CUI [5])
C0013720 (UMLS CUI [6])
C0017205 (UMLS CUI [7])
C0265253 (UMLS CUI [8])
C0157749 (UMLS CUI [9])
C0684275 (UMLS CUI [10])
C0018995 (UMLS CUI [11])
C0553730 (UMLS CUI [12])
C0003892 (UMLS CUI [13])
C0035648 (UMLS CUI [14,1])
C0409959 (UMLS CUI [14,2])
C0028754 (UMLS CUI [15])
C0187901 (UMLS CUI [16])
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