ID

30393

Beschreibung

Stem Cell Mobilization With Pegfilgrastim in Lymphoma and Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00794261

Link

https://clinicaltrials.gov/show/NCT00794261

Stichworte

Versionen (2)
  1. 01.06.18 01.06.18 -
  2. 01.06.18 01.06.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

1. Juni 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00794261

Englisch

Eligibility Lymphoma NCT00794261

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00794261
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients aged ≥ 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
patients with histologically confirmed lymphoma or myeloma
Beschreibung

Lymphoma | Multiple Myeloma

Datentyp

boolean

Alias
UMLS CUI [1]
C0024299
UMLS CUI [2]
C0026764
treatment with high-dose chemotherapy before inclusion
Beschreibung

High-dose chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1328050
intensification with high dose melphalan for patients with myeloma
Beschreibung

Melphalan High dose | Multiple Myeloma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025241
UMLS CUI [1,2]
C0444956
UMLS CUI [2]
C0026764
whatever the conditioning regimen, except tbi for patients with 1st relapse of hodgkin's lymphoma or with mnhl nb: patients having received two intensification courses are eligible if there has been more than 100 days between courses.
Beschreibung

Transplantation Conditioning | Exception Whole-Body Irradiation First Relapse Hodgkin Disease | Other Coding | Consolidation therapy Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C0376450
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0043162
UMLS CUI [2,3]
C4054953
UMLS CUI [2,4]
C0019829
UMLS CUI [3]
C3846158
UMLS CUI [4,1]
C1511484
UMLS CUI [4,2]
C1265611
autologous psc transplantation at the time of inclusion
Beschreibung

Primary sclerosing cholangitis Autologous Transplantation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0566602
UMLS CUI [1,2]
C0040736
reinjection of ≥ 2.106 cd34/kg
Beschreibung

Reinjection CD34 stem cell count

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0444600
UMLS CUI [1,2]
C1277788
patients hospitalized in the investigator center throughout the procedure until recovery from aplasia (pnn > 0.5 g/l)
Beschreibung

Hospitalization | Aplasia Recovery | Polymorphonuclear neutrophil Count

Datentyp

boolean

Alias
UMLS CUI [1]
C0019993
UMLS CUI [2,1]
C0243065
UMLS CUI [2,2]
C2004454
UMLS CUI [3,1]
C0027950
UMLS CUI [3,2]
C0750480
mandatory affiliation with a health insurance system
Beschreibung

Affiliation mandatory Health Insurance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1510825
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0021682
patients able to understand, read and write french
Beschreibung

Comprehension French language | Able to read French language | Able to write French language

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0233733
UMLS CUI [1,2]
C0376246
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376246
UMLS CUI [3,1]
C0584993
UMLS CUI [3,2]
C0376246
signed, written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
tbi during conditioning
Beschreibung

Whole-Body Irradiation During Conditioning

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0043162
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0376450
severe intolerance to the growth factor under study, or hypersensitivity to one of their components
Beschreibung

Intolerance Severe Growth Factor Study | Intolerance Severe Growth Factor Component

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231199
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0018284
UMLS CUI [1,4]
C2603343
UMLS CUI [2,1]
C0231199
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0018284
UMLS CUI [2,4]
C1705248
immunosuppressive syndrome
Beschreibung

Immunosuppression

Datentyp

boolean

Alias
UMLS CUI [1]
C4048329
pregnant or lactating women
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
difficult follow-up
Beschreibung

Follow-up Difficult

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0332218
documented history of cognitive or psychiatric disorders
Beschreibung

Cognition Disorders | Mental disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0009241
UMLS CUI [2]
C0004936
participation or consideration of participation in another biomedical study during the follow-up period of the present trial.
Beschreibung

Study Subject Participation Status | Biomedical Research | Consideration Participation Biomedical Research

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0005540
UMLS CUI [3,1]
C0518609
UMLS CUI [3,2]
C0679823
UMLS CUI [3,3]
C0005540
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Ähnliche Modelle

Eligibility Lymphoma NCT00794261

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00794261
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female patients aged ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Lymphoma | Multiple Myeloma
Item
patients with histologically confirmed lymphoma or myeloma
boolean
C0024299 (UMLS CUI [1])
C0026764 (UMLS CUI [2])
High-dose chemotherapy
Item
treatment with high-dose chemotherapy before inclusion
boolean
C1328050 (UMLS CUI [1])
Melphalan High dose | Multiple Myeloma
Item
intensification with high dose melphalan for patients with myeloma
boolean
C0025241 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
C0026764 (UMLS CUI [2])
Transplantation Conditioning | Exception Whole-Body Irradiation First Relapse Hodgkin Disease | Other Coding | Consolidation therapy Quantity
Item
whatever the conditioning regimen, except tbi for patients with 1st relapse of hodgkin's lymphoma or with mnhl nb: patients having received two intensification courses are eligible if there has been more than 100 days between courses.
boolean
C0376450 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0043162 (UMLS CUI [2,2])
C4054953 (UMLS CUI [2,3])
C0019829 (UMLS CUI [2,4])
C3846158 (UMLS CUI [3])
C1511484 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Primary sclerosing cholangitis Autologous Transplantation
Item
autologous psc transplantation at the time of inclusion
boolean
C0566602 (UMLS CUI [1,1])
C0040736 (UMLS CUI [1,2])
Reinjection CD34 stem cell count
Item
reinjection of ≥ 2.106 cd34/kg
boolean
C0444600 (UMLS CUI [1,1])
C1277788 (UMLS CUI [1,2])
Hospitalization | Aplasia Recovery | Polymorphonuclear neutrophil Count
Item
patients hospitalized in the investigator center throughout the procedure until recovery from aplasia (pnn > 0.5 g/l)
boolean
C0019993 (UMLS CUI [1])
C0243065 (UMLS CUI [2,1])
C2004454 (UMLS CUI [2,2])
C0027950 (UMLS CUI [3,1])
C0750480 (UMLS CUI [3,2])
Affiliation mandatory Health Insurance
Item
mandatory affiliation with a health insurance system
boolean
C1510825 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0021682 (UMLS CUI [1,3])
Comprehension French language | Able to read French language | Able to write French language
Item
patients able to understand, read and write french
boolean
C0233733 (UMLS CUI [1,1])
C0376246 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376246 (UMLS CUI [2,2])
C0584993 (UMLS CUI [3,1])
C0376246 (UMLS CUI [3,2])
Informed Consent
Item
signed, written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Whole-Body Irradiation During Conditioning
Item
tbi during conditioning
boolean
C0043162 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0376450 (UMLS CUI [1,3])
Intolerance Severe Growth Factor Study | Intolerance Severe Growth Factor Component
Item
severe intolerance to the growth factor under study, or hypersensitivity to one of their components
boolean
C0231199 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0018284 (UMLS CUI [1,3])
C2603343 (UMLS CUI [1,4])
C0231199 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0018284 (UMLS CUI [2,3])
C1705248 (UMLS CUI [2,4])
Immunosuppression
Item
immunosuppressive syndrome
boolean
C4048329 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Follow-up Difficult
Item
difficult follow-up
boolean
C3274571 (UMLS CUI [1,1])
C0332218 (UMLS CUI [1,2])
Cognition Disorders | Mental disorders
Item
documented history of cognitive or psychiatric disorders
boolean
C0009241 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
Study Subject Participation Status | Biomedical Research | Consideration Participation Biomedical Research
Item
participation or consideration of participation in another biomedical study during the follow-up period of the present trial.
boolean
C2348568 (UMLS CUI [1])
C0005540 (UMLS CUI [2])
C0518609 (UMLS CUI [3,1])
C0679823 (UMLS CUI [3,2])
C0005540 (UMLS CUI [3,3])
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