ID

40931

Descripción

A Clinical Trial Evaluating Platelet Rich Plasma Versus Hyaluronic-Acid in the Short-term Treatment of Symptomatic OA (Osteoarthritis) of the Hip; ODM derived from: https://clinicaltrials.gov/show/NCT01920152

Link

https://clinicaltrials.gov/show/NCT01920152

Palabras clave

Versiones (1)
  1. 7/6/20 7/6/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

7 de junio de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hip Osteoarthritis NCT01920152

Inglés

Eligibility Hip Osteoarthritis NCT01920152

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female age 40-72 inclusive.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
symptomatic early oa of the hip (kellgren-lawrence grade 1-2) documented by x-ray taken within the past 6 months.
Descripción

Hip osteoarthritis (early-onset) Symptomatic Kellgren-Lawrence score | X-Ray Computed Tomography

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1851543
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C3177117
UMLS CUI [2]
C0040405
women of childbearing potential will be allowed to enroll but must be willing to practice one highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception, placement of an intrauterine device (iud) or intrauterine system (ius) condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout the study.
Descripción

Childbearing Potential Contraceptive methods Quantity | Oral contraception | Injectable contraception | Contraceptive implant Hormonal | Intrauterine Devices | Intrauterine System | Female Condoms | CERVICAL CAP FOR CONTRACEPTIVE USE | Spermicidal foam/jelly/cream/film/suppository | Male sterilization | Sexual Abstinence

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0029151
UMLS CUI [3]
C1262153
UMLS CUI [4,1]
C1657106
UMLS CUI [4,2]
C0458083
UMLS CUI [5]
C0021900
UMLS CUI [6]
C4293370
UMLS CUI [7]
C0221829
UMLS CUI [8]
C0493327
UMLS CUI [9]
C3843415
UMLS CUI [10]
C0024559
UMLS CUI [11]
C0036899
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with polyarticular disease.
Descripción

POLYARTICULAR JOINT DISEASE

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0747730
patients with major conditions such as poorly control diabetes, cardiac heart failure (chf), chronic obstructive pulmonary disease (copd) or untreated depression
Descripción

Condition Major | Poorly controlled diabetes mellitus | Heart failure | Chronic Obstructive Airway Disease | Depressive disorder Untreated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0554876
UMLS CUI [3]
C0018801
UMLS CUI [4]
C0024117
UMLS CUI [5,1]
C0011581
UMLS CUI [5,2]
C0332155
patients with blood disorders (blood disorders (thrombopathy, thrombocytopenia, anemia with hemoglobin <9g/dl). only those patients with a positive history of blood disorders will have a cell blood count (cbc) performed a week prior to inclusion in the study.
Descripción

Hematological Disease | Thrombopathy | Thrombocytopenia | Anemia | Hemoglobin measurement | Blood Cell Count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018939
UMLS CUI [2]
C0865262
UMLS CUI [3]
C0040034
UMLS CUI [4]
C0002871
UMLS CUI [5]
C0518015
UMLS CUI [6]
C0005771
patients who had intra-articular treatment with steroids within 3 months of randomization in this study or received more than 3 previous intra-articular steroid injections to the effected hip.
Descripción

Intraarticular injection of corticosteroids Recent | Intraarticular injection of corticosteroids Quantity Hip Affected

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2064783
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C2064783
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0019552
UMLS CUI [2,4]
C0392760
patients who are pregnant or nursing at the time of consent.
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with inflammatory arthritic conditions (e.g. rheumatoid arthritis)
Descripción

Arthritis | Rheumatoid Arthritis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003864
UMLS CUI [2]
C0003873
non-english speaking patients. (scores used for evaluation have not been validated in spanish)
Descripción

Lacking Able to speak English Language

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564215
UMLS CUI [1,3]
C0376245
patients who had previous hip surgery
Descripción

Hip surgery Previous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0596706
UMLS CUI [1,2]
C0205156
additional disabilities in any of the lower limbs that would interfere with any of the clinical assessments.
Descripción

Disability of lower limb Additional | Disability of lower limb Interferes with Clinical assessment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1997550
UMLS CUI [1,2]
C1524062
UMLS CUI [2,1]
C1997550
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C4534461
chronic use of nsaid (defined as taking nsaid regularly every week for the last 6 months), steroids or chemotherapy drugs
Descripción

NSAID chronic | Steroids chronic | Antineoplastic Agents chronic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0003392
UMLS CUI [3,2]
C0205191
treatment with nsaids within 15 days prior to randomization in this study
Descripción

Non-steroidal anti-inflammatory agent therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4076159
patients with a bmi over 30. due to the fact that this study utilize an injection technique which may be inaccurate in obese subjects.
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
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Similar models

Eligibility Hip Osteoarthritis NCT01920152

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female age 40-72 inclusive.
boolean
C0001779 (UMLS CUI [1])
Hip osteoarthritis (early-onset) Symptomatic Kellgren-Lawrence score | X-Ray Computed Tomography
Item
symptomatic early oa of the hip (kellgren-lawrence grade 1-2) documented by x-ray taken within the past 6 months.
boolean
C1851543 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C3177117 (UMLS CUI [1,3])
C0040405 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Quantity | Oral contraception | Injectable contraception | Contraceptive implant Hormonal | Intrauterine Devices | Intrauterine System | Female Condoms | CERVICAL CAP FOR CONTRACEPTIVE USE | Spermicidal foam/jelly/cream/film/suppository | Male sterilization | Sexual Abstinence
Item
women of childbearing potential will be allowed to enroll but must be willing to practice one highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception, placement of an intrauterine device (iud) or intrauterine system (ius) condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout the study.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0029151 (UMLS CUI [2])
C1262153 (UMLS CUI [3])
C1657106 (UMLS CUI [4,1])
C0458083 (UMLS CUI [4,2])
C0021900 (UMLS CUI [5])
C4293370 (UMLS CUI [6])
C0221829 (UMLS CUI [7])
C0493327 (UMLS CUI [8])
C3843415 (UMLS CUI [9])
C0024559 (UMLS CUI [10])
C0036899 (UMLS CUI [11])
Item Group
C0680251 (UMLS CUI)
POLYARTICULAR JOINT DISEASE
Item
patients with polyarticular disease.
boolean
C0747730 (UMLS CUI [1])
Condition Major | Poorly controlled diabetes mellitus | Heart failure | Chronic Obstructive Airway Disease | Depressive disorder Untreated
Item
patients with major conditions such as poorly control diabetes, cardiac heart failure (chf), chronic obstructive pulmonary disease (copd) or untreated depression
boolean
C0348080 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0554876 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
C0024117 (UMLS CUI [4])
C0011581 (UMLS CUI [5,1])
C0332155 (UMLS CUI [5,2])
Hematological Disease | Thrombopathy | Thrombocytopenia | Anemia | Hemoglobin measurement | Blood Cell Count
Item
patients with blood disorders (blood disorders (thrombopathy, thrombocytopenia, anemia with hemoglobin <9g/dl). only those patients with a positive history of blood disorders will have a cell blood count (cbc) performed a week prior to inclusion in the study.
boolean
C0018939 (UMLS CUI [1])
C0865262 (UMLS CUI [2])
C0040034 (UMLS CUI [3])
C0002871 (UMLS CUI [4])
C0518015 (UMLS CUI [5])
C0005771 (UMLS CUI [6])
Intraarticular injection of corticosteroids Recent | Intraarticular injection of corticosteroids Quantity Hip Affected
Item
patients who had intra-articular treatment with steroids within 3 months of randomization in this study or received more than 3 previous intra-articular steroid injections to the effected hip.
boolean
C2064783 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C2064783 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0019552 (UMLS CUI [2,3])
C0392760 (UMLS CUI [2,4])
Pregnancy | Breast Feeding
Item
patients who are pregnant or nursing at the time of consent.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Arthritis | Rheumatoid Arthritis
Item
patients with inflammatory arthritic conditions (e.g. rheumatoid arthritis)
boolean
C0003864 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
Lacking Able to speak English Language
Item
non-english speaking patients. (scores used for evaluation have not been validated in spanish)
boolean
C0332268 (UMLS CUI [1,1])
C0564215 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
Hip surgery Previous
Item
patients who had previous hip surgery
boolean
C0596706 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Disability of lower limb Additional | Disability of lower limb Interferes with Clinical assessment
Item
additional disabilities in any of the lower limbs that would interfere with any of the clinical assessments.
boolean
C1997550 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C1997550 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C4534461 (UMLS CUI [2,3])
NSAID chronic | Steroids chronic | Antineoplastic Agents chronic
Item
chronic use of nsaid (defined as taking nsaid regularly every week for the last 6 months), steroids or chemotherapy drugs
boolean
C0003211 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0038317 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0003392 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
Non-steroidal anti-inflammatory agent therapy
Item
treatment with nsaids within 15 days prior to randomization in this study
boolean
C4076159 (UMLS CUI [1])
Body mass index
Item
patients with a bmi over 30. due to the fact that this study utilize an injection technique which may be inaccurate in obese subjects.
boolean
C1305855 (UMLS CUI [1])
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