ID

13058

Beschrijving

An Open Protocol for the Compassionate Use of Thalidomide; ODM derived from: https://clinicaltrials.gov/show/NCT00081757

Link

https://clinicaltrials.gov/show/NCT00081757

Trefwoorden

  1. 13-01-16 13-01-16 -
Houder van rechten

CC BY-NC 3.0

Geüploaded op

13 januari 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Multiple Myeloma NCT00081757

Eligibility Multiple Myeloma NCT00081757

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patients must have a confirmed malignancy which can be classified as locally advanced or distant metastatic disease and must have either 1) failed on standard therapy or 2) have disease for which in the opinion of the investigator, no adequate standard +therapy exists.
Beschrijving

multiple myeloma

Datatype

boolean

Alias
UMLS CUI [1]
C0026764
patients must be 18 years of age or older. women of childbearing potential must have a negative pregnancy test and fertile women and men must use a medically acceptable means of birth control while on study and for 6 months thereafter.
Beschrijving

age, pregnany, contraception

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0700589
patients must sign an informed consent to participate in this study.
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
swog performance status 0-3, unless related to cancer pain.
Beschrijving

swog performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1518965
before starting treatment, women of childbearing potential should have a negative pregnancy test performed within 24 hours prior to beginning therapy.
Beschrijving

pregnancy test

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
pregnancy testing is not required for 1) women who have been post-menopausal for at least 2 years with no menses, 2) women who have had a hysterectomy.
Beschrijving

post-menopausal or hysterectomy

Datatype

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0020699
patients must have adequate hematologic function as demonstrated by total white blood count > or = 2000/mm3, adequate renal function as demonstrated by serum creatinine < or = 3.0 mg/dl, and adequate hepatic function as demonstrated by bilirubin < or =1.5 mg/dl and transaminases < or =4 x uln.
Beschrijving

hematologic, renal and hepatic function

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0201976
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0002594
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must not be eligible for any uams participating clinical trial of higher priority.
Beschrijving

patients must not be eligible for any uams participating clinical trial of higher priority.

Datatype

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Multiple Myeloma NCT00081757

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
multiple myeloma
Item
all patients must have a confirmed malignancy which can be classified as locally advanced or distant metastatic disease and must have either 1) failed on standard therapy or 2) have disease for which in the opinion of the investigator, no adequate standard +therapy exists.
boolean
C0026764 (UMLS CUI [1])
age, pregnany, contraception
Item
patients must be 18 years of age or older. women of childbearing potential must have a negative pregnancy test and fertile women and men must use a medically acceptable means of birth control while on study and for 6 months thereafter.
boolean
C0001779 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
informed consent
Item
patients must sign an informed consent to participate in this study.
boolean
C0021430 (UMLS CUI [1])
swog performance status
Item
swog performance status 0-3, unless related to cancer pain.
boolean
C1518965 (UMLS CUI [1])
pregnancy test
Item
before starting treatment, women of childbearing potential should have a negative pregnancy test performed within 24 hours prior to beginning therapy.
boolean
C0032961 (UMLS CUI [1])
post-menopausal or hysterectomy
Item
pregnancy testing is not required for 1) women who have been post-menopausal for at least 2 years with no menses, 2) women who have had a hysterectomy.
boolean
C0232970 (UMLS CUI [1])
C0020699 (UMLS CUI [2])
hematologic, renal and hepatic function
Item
patients must have adequate hematologic function as demonstrated by total white blood count > or = 2000/mm3, adequate renal function as demonstrated by serum creatinine < or = 3.0 mg/dl, and adequate hepatic function as demonstrated by bilirubin < or =1.5 mg/dl and transaminases < or =4 x uln.
boolean
C0023508 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0002594 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
patients must not be eligible for any uams participating clinical trial of higher priority.
Item
patients must not be eligible for any uams participating clinical trial of higher priority.
boolean
C2348568 (UMLS CUI [1])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial