ID

28808

Beschrijving

Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Degenerative Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01300598

Link

https://clinicaltrials.gov/show/NCT01300598

Trefwoorden

Versies (1)
  1. 05-02-18 05-02-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

5 februari 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Degenerative Arthritis NCT01300598

Engels

Eligibility Degenerative Arthritis NCT01300598

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects who understand and sign the consent form for this study.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
age :18-75, males and females.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
clinical diagnosis of degenerative arthritis by radiographic criteria of kellgren and lawrence.
Beschrijving

Degenerative arthritis Kellgren-Lawrence score

Datatype

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C3177117
patients who can't treat with traditional medication and need a arthroplasty.
Beschrijving

Traditional therapy Pharmaceutical Preparations Unsuccessful | Patient need for Arthroplasty

Datatype

boolean

Alias
UMLS CUI [1,1]
C3650840
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1272705
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0003893
patients whose lesion is 2~6 cm2 in size.
Beschrijving

Lesion size

Datatype

boolean

Alias
UMLS CUI [1]
C0449453
duration of pain over grade 4(11-point numeric scale) : > 4 months
Beschrijving

Pain Duration Visual Analog Pain Scale

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0042815
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant or breast feeding or planning to become pregnant during the study.
Beschrijving

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
objects who administer with a anti-inflammatory drugs contain herbal medicine within 14 days prior to inclusion in the study.
Beschrijving

Anti-Inflammatory Agents | Herbal medicine

Datatype

boolean

Alias
UMLS CUI [1]
C0003209
UMLS CUI [2]
C2240391
history or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications.
Beschrijving

Substance Use Disorders | Illicit drug use Recreational | Pharmaceutical Preparations prescribed Recreational

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0281875
UMLS CUI [2,2]
C0242508
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0278329
UMLS CUI [3,3]
C0242508
treatment with intra-articular injection therapy within 2 months prior to screen.
Beschrijving

Intra-Articular Injections

Datatype

boolean

Alias
UMLS CUI [1]
C0021488
other joint diseases except degenerative arthritis : systemic or rheumatic or inflammatory chondropathy, chondrocalcinosis, hemachromatosis, inflammatory joint disease, avascular necrosis of the femoral head, paget's disease, hemophilic arthropathy, infectional arthritis, charcot's disease, villonodular synovitis, synovial chondromatosis.
Beschrijving

Arthropathy | Exception Degenerative arthritis | Cartilage Diseases Systemic | Cartilage Diseases Rheumatic | Cartilage Diseases inflammatory | Calcium pyrophosphate deposition disease | Hemochromatosis | Inflammatory joint disease | Avascular Necrosis of Femur Head | Osteitis Deformans | Hemophilic arthropathy | Arthritis, Infectious | Neurogenic arthropathy | Villonodular synovitis | Chondromatosis, Synovial

Datatype

boolean

Alias
UMLS CUI [1]
C0022408
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0029408
UMLS CUI [3,1]
C0007302
UMLS CUI [3,2]
C0205373
UMLS CUI [4,1]
C0007302
UMLS CUI [4,2]
C0035435
UMLS CUI [5,1]
C0007302
UMLS CUI [5,2]
C0333348
UMLS CUI [6]
C0553730
UMLS CUI [7]
C0018995
UMLS CUI [8]
C0683381
UMLS CUI [9]
C0410480
UMLS CUI [10]
C0029401
UMLS CUI [11]
C0263725
UMLS CUI [12]
C0003869
UMLS CUI [13]
C0003892
UMLS CUI [14]
C0158168
UMLS CUI [15]
C0008476
positive serology for hiv-1 orhiv-2, hepatitis b (hbsag, anti-hcv-ab), hepatitis c (anti-hcv-ab) and syphilis.
Beschrijving

Serology positive HIV-1 | Serology positive HIV-2 | Serology positive Hepatitis B | Serology positive Hepatitis B Surface Antigens | Serology positive Hepatitis B Antibodies | Serology positive Hepatitis C | Serology positive Hepatitis C Antibodies | Serology positive Syphilis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0242089
UMLS CUI [1,2]
C0019704
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0019707
UMLS CUI [3,1]
C0242089
UMLS CUI [3,2]
C0019163
UMLS CUI [4,1]
C0242089
UMLS CUI [4,2]
C0019168
UMLS CUI [5,1]
C0242089
UMLS CUI [5,2]
C0019164
UMLS CUI [6,1]
C0242089
UMLS CUI [6,2]
C0019196
UMLS CUI [7,1]
C0242089
UMLS CUI [7,2]
C0166049
UMLS CUI [8,1]
C0242089
UMLS CUI [8,2]
C0039128
serious pre-existing medical conditions like cardiovascular diseases, renal diseases, liver diseases, endocrine diseases, cancer and diabetes mellitus.
Beschrijving

Medical condition Serious Pre-existing | Cardiovascular Diseases | Kidney Diseases | Liver diseases | Endocrine System Diseases | Malignant Neoplasms | Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2347662
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0014130
UMLS CUI [6]
C0006826
UMLS CUI [7]
C0011849
overweight expressed as body mass index (bmi) greater than 30 (obesity grade ii). bmi estimated as mass (kg) / corporal surface (m2).
Beschrijving

Overweight | Body mass index | Obesity Grade

Datatype

boolean

Alias
UMLS CUI [1]
C0497406
UMLS CUI [2]
C1305855
UMLS CUI [3,1]
C0028754
UMLS CUI [3,2]
C0441800
participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study.
Beschrijving

Study Subject Participation Status | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
other pathologic conditions or circumstances that difficult participation in the study according to medical criteria.
Beschrijving

Other medical condition Study Subject Participation Status Difficult

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332218
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Similar models

Eligibility Degenerative Arthritis NCT01300598

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
subjects who understand and sign the consent form for this study.
boolean
C0021430 (UMLS CUI [1])
Age
Item
age :18-75, males and females.
boolean
C0001779 (UMLS CUI [1])
Degenerative arthritis Kellgren-Lawrence score
Item
clinical diagnosis of degenerative arthritis by radiographic criteria of kellgren and lawrence.
boolean
C0029408 (UMLS CUI [1,1])
C3177117 (UMLS CUI [1,2])
Traditional therapy Pharmaceutical Preparations Unsuccessful | Patient need for Arthroplasty
Item
patients who can't treat with traditional medication and need a arthroplasty.
boolean
C3650840 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
C0686904 (UMLS CUI [2,1])
C0003893 (UMLS CUI [2,2])
Lesion size
Item
patients whose lesion is 2~6 cm2 in size.
boolean
C0449453 (UMLS CUI [1])
Pain Duration Visual Analog Pain Scale
Item
duration of pain over grade 4(11-point numeric scale) : > 4 months
boolean
C0030193 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0042815 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
women who are pregnant or breast feeding or planning to become pregnant during the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Anti-Inflammatory Agents | Herbal medicine
Item
objects who administer with a anti-inflammatory drugs contain herbal medicine within 14 days prior to inclusion in the study.
boolean
C0003209 (UMLS CUI [1])
C2240391 (UMLS CUI [2])
Substance Use Disorders | Illicit drug use Recreational | Pharmaceutical Preparations prescribed Recreational
Item
history or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications.
boolean
C0038586 (UMLS CUI [1])
C0281875 (UMLS CUI [2,1])
C0242508 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C0278329 (UMLS CUI [3,2])
C0242508 (UMLS CUI [3,3])
Intra-Articular Injections
Item
treatment with intra-articular injection therapy within 2 months prior to screen.
boolean
C0021488 (UMLS CUI [1])
Arthropathy | Exception Degenerative arthritis | Cartilage Diseases Systemic | Cartilage Diseases Rheumatic | Cartilage Diseases inflammatory | Calcium pyrophosphate deposition disease | Hemochromatosis | Inflammatory joint disease | Avascular Necrosis of Femur Head | Osteitis Deformans | Hemophilic arthropathy | Arthritis, Infectious | Neurogenic arthropathy | Villonodular synovitis | Chondromatosis, Synovial
Item
other joint diseases except degenerative arthritis : systemic or rheumatic or inflammatory chondropathy, chondrocalcinosis, hemachromatosis, inflammatory joint disease, avascular necrosis of the femoral head, paget's disease, hemophilic arthropathy, infectional arthritis, charcot's disease, villonodular synovitis, synovial chondromatosis.
boolean
C0022408 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0029408 (UMLS CUI [2,2])
C0007302 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0007302 (UMLS CUI [4,1])
C0035435 (UMLS CUI [4,2])
C0007302 (UMLS CUI [5,1])
C0333348 (UMLS CUI [5,2])
C0553730 (UMLS CUI [6])
C0018995 (UMLS CUI [7])
C0683381 (UMLS CUI [8])
C0410480 (UMLS CUI [9])
C0029401 (UMLS CUI [10])
C0263725 (UMLS CUI [11])
C0003869 (UMLS CUI [12])
C0003892 (UMLS CUI [13])
C0158168 (UMLS CUI [14])
C0008476 (UMLS CUI [15])
Serology positive HIV-1 | Serology positive HIV-2 | Serology positive Hepatitis B | Serology positive Hepatitis B Surface Antigens | Serology positive Hepatitis B Antibodies | Serology positive Hepatitis C | Serology positive Hepatitis C Antibodies | Serology positive Syphilis
Item
positive serology for hiv-1 orhiv-2, hepatitis b (hbsag, anti-hcv-ab), hepatitis c (anti-hcv-ab) and syphilis.
boolean
C0242089 (UMLS CUI [1,1])
C0019704 (UMLS CUI [1,2])
C0242089 (UMLS CUI [2,1])
C0019707 (UMLS CUI [2,2])
C0242089 (UMLS CUI [3,1])
C0019163 (UMLS CUI [3,2])
C0242089 (UMLS CUI [4,1])
C0019168 (UMLS CUI [4,2])
C0242089 (UMLS CUI [5,1])
C0019164 (UMLS CUI [5,2])
C0242089 (UMLS CUI [6,1])
C0019196 (UMLS CUI [6,2])
C0242089 (UMLS CUI [7,1])
C0166049 (UMLS CUI [7,2])
C0242089 (UMLS CUI [8,1])
C0039128 (UMLS CUI [8,2])
Medical condition Serious Pre-existing | Cardiovascular Diseases | Kidney Diseases | Liver diseases | Endocrine System Diseases | Malignant Neoplasms | Diabetes Mellitus
Item
serious pre-existing medical conditions like cardiovascular diseases, renal diseases, liver diseases, endocrine diseases, cancer and diabetes mellitus.
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C0007222 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0014130 (UMLS CUI [5])
C0006826 (UMLS CUI [6])
C0011849 (UMLS CUI [7])
Overweight | Body mass index | Obesity Grade
Item
overweight expressed as body mass index (bmi) greater than 30 (obesity grade ii). bmi estimated as mass (kg) / corporal surface (m2).
boolean
C0497406 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
C0028754 (UMLS CUI [3,1])
C0441800 (UMLS CUI [3,2])
Study Subject Participation Status | Investigational New Drugs
Item
participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Other medical condition Study Subject Participation Status Difficult
Item
other pathologic conditions or circumstances that difficult participation in the study according to medical criteria.
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332218 (UMLS CUI [1,3])
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