ID

20999

Beschreibung

Immunosuppression in Patients Undergoing Liver Transplantation for Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00355862

Link

https://clinicaltrials.gov/show/NCT00355862

Stichworte

Versionen (1)
  1. 03.04.17 03.04.17 -
Hochgeladen am

3. April 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT00355862

Englisch

Eligibility Hepatocellular Carcinoma NCT00355862

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 18 years and older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. histologically proven hcc before randomisation
Beschreibung

Liver carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C2239176
3. signed, written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. multiple-organ recipients.
Beschreibung

Recipient Organ multiple

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C0439064
2. known hypersensitivity to sirolimus or its derivatives.
Beschreibung

Hypersensitivity Sirolimus | Hypersensitivity Sirolimus derivatives

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0072980
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0072980
UMLS CUI [2,3]
C0243072
3. hyperlipidemia refractory to optimal medical management. (cholesterol >300 mg/dl; triglycerides >350 mg/dl).*
Beschreibung

Hyperlipidemia Unresponsive to Treatment | Serum total cholesterol measurement | Triglycerides measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020473
UMLS CUI [1,2]
C0205269
UMLS CUI [2]
C1445957
UMLS CUI [3]
C0202236
4. evidence of significant local or systemic infection.
Beschreibung

local infection Evidence of | Sepsis Evidence of

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1400591
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0243026
UMLS CUI [2,2]
C0332120
5. known hiv-positive patients.*
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
6. platelets <75,000/cubic mm.*
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
7. women of child-bearing potential not willing to take contraception.
Beschreibung

Childbearing Potential Contraceptive methods Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
8. patients with non-hcc malignancies within the past 5 years,excluding successfully treated squamous cell carcinoma and basal cell carcinoma of the skin.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0553723
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C1272703
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C1522326
UMLS CUI [3,3]
C1272703
9. extrahepatic hcc tumor manifestation
Beschreibung

Liver carcinoma Extrahepatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C1517058
10. patients with a psychologic, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule.
Beschreibung

Mental condition Protocol Compliance Limited | Condition Familial Protocol Compliance Limited | Sociological Factors Protocol Compliance Limited | Geographic Factors Protocol Compliance Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0241888
UMLS CUI [2,3]
C0525058
UMLS CUI [2,4]
C0439801
UMLS CUI [3,1]
C3850138
UMLS CUI [3,2]
C0525058
UMLS CUI [3,3]
C0439801
UMLS CUI [4,1]
C0017444
UMLS CUI [4,2]
C0525058
UMLS CUI [4,3]
C0439801
11. patients under guardianship (e.g. individuals who are not able to freely give their informed consent).
Beschreibung

Patients guardianship | Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0870627
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
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Ähnliche Modelle

Eligibility Hepatocellular Carcinoma NCT00355862

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age 18 years and older
boolean
C0001779 (UMLS CUI [1])
Liver carcinoma
Item
2. histologically proven hcc before randomisation
boolean
C2239176 (UMLS CUI [1])
Informed Consent
Item
3. signed, written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Recipient Organ multiple
Item
1. multiple-organ recipients.
boolean
C1709854 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C0439064 (UMLS CUI [1,3])
Hypersensitivity Sirolimus | Hypersensitivity Sirolimus derivatives
Item
2. known hypersensitivity to sirolimus or its derivatives.
boolean
C0020517 (UMLS CUI [1,1])
C0072980 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0072980 (UMLS CUI [2,2])
C0243072 (UMLS CUI [2,3])
Hyperlipidemia Unresponsive to Treatment | Serum total cholesterol measurement | Triglycerides measurement
Item
3. hyperlipidemia refractory to optimal medical management. (cholesterol >300 mg/dl; triglycerides >350 mg/dl).*
boolean
C0020473 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C1445957 (UMLS CUI [2])
C0202236 (UMLS CUI [3])
local infection Evidence of | Sepsis Evidence of
Item
4. evidence of significant local or systemic infection.
boolean
C1400591 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0243026 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
HIV Seropositivity
Item
5. known hiv-positive patients.*
boolean
C0019699 (UMLS CUI [1])
Platelet Count measurement
Item
6. platelets <75,000/cubic mm.*
boolean
C0032181 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Unwilling
Item
7. women of child-bearing potential not willing to take contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Malignant Neoplasms | Squamous cell carcinoma of skin Treated Successful | Basal cell carcinoma Treated Successful
Item
8. patients with non-hcc malignancies within the past 5 years,excluding successfully treated squamous cell carcinoma and basal cell carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1])
C0553723 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C1272703 (UMLS CUI [2,3])
C0007117 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C1272703 (UMLS CUI [3,3])
Liver carcinoma Extrahepatic
Item
9. extrahepatic hcc tumor manifestation
boolean
C2239176 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
Mental condition Protocol Compliance Limited | Condition Familial Protocol Compliance Limited | Sociological Factors Protocol Compliance Limited | Geographic Factors Protocol Compliance Limited
Item
10. patients with a psychologic, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule.
boolean
C3840291 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0241888 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0439801 (UMLS CUI [2,4])
C3850138 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C0017444 (UMLS CUI [4,1])
C0525058 (UMLS CUI [4,2])
C0439801 (UMLS CUI [4,3])
Patients guardianship | Informed Consent Unable
Item
11. patients under guardianship (e.g. individuals who are not able to freely give their informed consent).
boolean
C0030705 (UMLS CUI [1,1])
C0870627 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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