ID

40746

Beschreibung

Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part II; ODM derived from: https://clinicaltrials.gov/show/NCT01598415

Link

https://clinicaltrials.gov/show/NCT01598415

Stichworte

Versionen (1)
  1. 07.05.20 07.05.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

7. Mai 2020

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Knee Osteoarthritis NCT01598415

Englisch

Eligibility Knee Osteoarthritis NCT01598415

1 Formulare  
Criteria
Beschreibung

Criteria

diagnosis of primary knee osteoarthritis, based upon the following:
Beschreibung

Primary osteoarthritis of knee

Datentyp

boolean

Alias
UMLS CUI [1]
C2893931
x-ray or magnetic resonance imaging (mri) evidence within the last 6 months for joint space narrowing and osteophyte formation
Beschreibung

Narrowed joint space X-Ray Computed Tomography | Narrowed joint space MRI | Osteophyte Formation X-Ray Computed Tomography | Osteophyte Formation MRI

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1859695
UMLS CUI [1,2]
C0040405
UMLS CUI [2,1]
C1859695
UMLS CUI [2,2]
C0024485
UMLS CUI [3,1]
C1956089
UMLS CUI [3,2]
C0439634
UMLS CUI [3,3]
C0040405
UMLS CUI [4,1]
C1956089
UMLS CUI [4,2]
C0439634
UMLS CUI [4,3]
C0024485
patients will be kellgren and lawrence classification ii/iii, and total western ontario mcmaster (womac) score 24 -72.
Beschreibung

Kellgren-Lawrence score | WOMAC scale

Datentyp

boolean

Alias
UMLS CUI [1]
C3177117
UMLS CUI [2]
C3472647
patients fulfilling the american college of rheumatology clinical and radiographic criteria for osteoarthritis.
Beschreibung

ACR Criteria Osteoarthritis Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3273747
UMLS CUI [1,2]
C0029408
UMLS CUI [1,3]
C1550543
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients younger than 40 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
women of child bearing potential.
Beschreibung

Childbearing Potential

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
women either sterilized for more than 3 months, or post-menopausal for more than 12 months. menopause is defined as over age of 60 years or being amenorrheic for at least 2 years with plasma fsh level >30 iu/l.
Beschreibung

Female Sterilization | Postmenopausal state | Age | Amenorrhea | Plasma FSH measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0015787
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0002453
UMLS CUI [5]
C1269629
secondary osteoarthritis: e.g., autoimmune disease, joint dysplasia, aseptic osteonecrosis, acromegaly, paget's disease, ehlers-danlos syndrome, gaucher's disease, stickler's syndrome, joint infection, haemophilia, haemochromatosis, calcium pyrophosphate deposition disease, or neuropathic arthropathy.
Beschreibung

Secondary osteoarthritis | Autoimmune Disease | Joint dysplasia | Osteonecrosis, aseptic | Acromegaly | Paget's disease | Ehlers-Danlos Syndrome | Gaucher Disease | Stickler syndrome | Joint infection | Hemophilia | Hemochromatosis | Calcium pyrophosphate deposition disease | Neurogenic arthropathy

Datentyp

boolean

Alias
UMLS CUI [1]
C2732281
UMLS CUI [2]
C0004364
UMLS CUI [3]
C1395954
UMLS CUI [4]
C0391980
UMLS CUI [5]
C0001206
UMLS CUI [6]
C0029401
UMLS CUI [7]
C0013720
UMLS CUI [8]
C0017205
UMLS CUI [9]
C0265253
UMLS CUI [10]
C0157749
UMLS CUI [11]
C0684275
UMLS CUI [12]
C0018995
UMLS CUI [13]
C0553730
UMLS CUI [14]
C0003892
presence of local skin abnormality at the affected knee joint.
Beschreibung

Skin Abnormality Local | Knee joint Affected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037268
UMLS CUI [1,2]
C0205276
UMLS CUI [2,1]
C0022745
UMLS CUI [2,2]
C0392760
intra-articular injection within 3 months.
Beschreibung

Intra-Articular Injection Recent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021488
UMLS CUI [1,2]
C0332185
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Beschreibung

Study Subject Participation Status | Considerations Additional

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0518609
UMLS CUI [2,2]
C1524062
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Knee Osteoarthritis NCT01598415

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Primary osteoarthritis of knee
Item
diagnosis of primary knee osteoarthritis, based upon the following:
boolean
C2893931 (UMLS CUI [1])
Narrowed joint space X-Ray Computed Tomography | Narrowed joint space MRI | Osteophyte Formation X-Ray Computed Tomography | Osteophyte Formation MRI
Item
x-ray or magnetic resonance imaging (mri) evidence within the last 6 months for joint space narrowing and osteophyte formation
boolean
C1859695 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C1859695 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C1956089 (UMLS CUI [3,1])
C0439634 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C1956089 (UMLS CUI [4,1])
C0439634 (UMLS CUI [4,2])
C0024485 (UMLS CUI [4,3])
Kellgren-Lawrence score | WOMAC scale
Item
patients will be kellgren and lawrence classification ii/iii, and total western ontario mcmaster (womac) score 24 -72.
boolean
C3177117 (UMLS CUI [1])
C3472647 (UMLS CUI [2])
ACR Criteria Osteoarthritis Fulfill
Item
patients fulfilling the american college of rheumatology clinical and radiographic criteria for osteoarthritis.
boolean
C3273747 (UMLS CUI [1,1])
C0029408 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Age
Item
patients younger than 40 years
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential
Item
women of child bearing potential.
boolean
C3831118 (UMLS CUI [1])
Female Sterilization | Postmenopausal state | Age | Amenorrhea | Plasma FSH measurement
Item
women either sterilized for more than 3 months, or post-menopausal for more than 12 months. menopause is defined as over age of 60 years or being amenorrheic for at least 2 years with plasma fsh level >30 iu/l.
boolean
C0015787 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0002453 (UMLS CUI [4])
C1269629 (UMLS CUI [5])
Secondary osteoarthritis | Autoimmune Disease | Joint dysplasia | Osteonecrosis, aseptic | Acromegaly | Paget's disease | Ehlers-Danlos Syndrome | Gaucher Disease | Stickler syndrome | Joint infection | Hemophilia | Hemochromatosis | Calcium pyrophosphate deposition disease | Neurogenic arthropathy
Item
secondary osteoarthritis: e.g., autoimmune disease, joint dysplasia, aseptic osteonecrosis, acromegaly, paget's disease, ehlers-danlos syndrome, gaucher's disease, stickler's syndrome, joint infection, haemophilia, haemochromatosis, calcium pyrophosphate deposition disease, or neuropathic arthropathy.
boolean
C2732281 (UMLS CUI [1])
C0004364 (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])
Skin Abnormality Local | Knee joint Affected
Item
presence of local skin abnormality at the affected knee joint.
boolean
C0037268 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0022745 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
Intra-Articular Injection Recent
Item
intra-articular injection within 3 months.
boolean
C0021488 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Study Subject Participation Status | Considerations Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
C0518609 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video