ID

12845

Beschreibung

A Phase II Trial of Leuprolide + Flutamide + Suramin in Untreated Poor Prognosis Prostate Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00001266

Link

https://clinicaltrials.gov/show/NCT00001266

Stichworte

  1. 29.12.15 29.12.15 -
Hochgeladen am

29. Dezember 2015

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Prostatic Neoplasm NCT00001266

Eligibility Prostatic Neoplasm NCT00001266

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have a histologic diagnosis of carcinoma of the prostate and must not have had a trial of hormonal therapy or chemotherapy.
Beschreibung

patients must have a histologic diagnosis of carcinoma of the prostate and must not have had a trial of hormonal therapy or chemotherapy.

Datentyp

boolean

Alias
UMLS CUI [1]
C0600139
UMLS CUI [2]
C0279025
UMLS CUI [3]
C0392920
patients must be 18 years of age
Beschreibung

patients must be 18 years of age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
an sgot/sgpt within 2 times of normal.
Beschreibung

an sgot/sgpt within 2 times of normal.

Datentyp

boolean

Alias
UMLS CUI [1]
C0001899
UMLS CUI [2]
C0004002
patients must have stage d2 prostate carcinoma or state d1 disease with a gleason grade 7 or above (poorly differentiated).
Beschreibung

patients must have stage d2 prostate carcinoma or state d1 disease with a gleason grade 7 or above (poorly differentiated).

Datentyp

boolean

Alias
UMLS CUI [1]
C0027646
UMLS CUI [2]
C0332332
no other malignancy except curatively treated basal cell cancer of the skin.
Beschreibung

no other malignancy except curatively treated basal cell cancer of the skin.

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
performance status ecog of 0-3.
Beschreibung

performance status ecog of 0-3.

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
ability to give informed consent.
Beschreibung

ability to give informed consent.

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
no history of bleeding diathesis. patients with a history of peptic ulcer disease will be eligible if the ulcer is shown to be resolved by a barium study.
Beschreibung

no history of bleeding diathesis. patients with a history of peptic ulcer disease will be eligible if the ulcer is shown to be resolved by a barium study.

Datentyp

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0030920
no history of cerebrovascular event, either thrombotic or hemorrhagic.
Beschreibung

no history of cerebrovascular event, either thrombotic or hemorrhagic.

Datentyp

boolean

Alias
UMLS CUI [1]
C0852396
no current clinical signs of congestive heart failure, angina pectoris or myocardial infarction. patient cannot be on calcium channel blockers such as nifedipine, diltiazem, or verapamil.
Beschreibung

no current clinical signs of congestive heart failure, angina pectoris or myocardial infarction. patient cannot be on calcium channel blockers such as nifedipine, diltiazem, or verapamil.

Datentyp

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0006684
no clinical or radiographic evidence of brain metastases.
Beschreibung

no clinical or radiographic evidence of brain metastases.

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
patients with extensive liver replacement (greater than 50%) by tumor will be ineligible.
Beschreibung

patients with extensive liver replacement (greater than 50%) by tumor will be ineligible.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1883411
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0205231
patients must have a creatinine lest than or equal 2.5 mg/dl or creatinine clearance of greater than or equal to 40 ml/min.
Beschreibung

patients must have a creatinine lest than or equal 2.5 mg/dl or creatinine clearance of greater than or equal to 40 ml/min.

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0010294
patients must have adequate hepatic function (bilirubin less than 1.5mg%).
Beschreibung

patients must have adequate hepatic function (bilirubin less than 1.5mg%).

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
if the patient has white cells in his urinalysis or other evidence of a urinary tract infection, this must be evaluated and appropriate therapy initiation prior to the initiation of therapy.
Beschreibung

if the patient has white cells in his urinalysis or other evidence of a urinary tract infection, this must be evaluated and appropriate therapy initiation prior to the initiation of therapy.

Datentyp

boolean

Alias
UMLS CUI [1]
C0042029
patients must not have received chemotherapy.
Beschreibung

patients must not have received chemotherapy.

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
an absolute granulocyte count greater than 1,500; platelet count greater than 100,000; fibrinogen greater than 200 mg/dl; hgb greater than or equal to 9 gm/dl.
Beschreibung

an absolute granulocyte count greater than 1,500; platelet count greater than 100,000; fibrinogen greater than 200 mg/dl; hgb greater than or equal to 9 gm/dl.

Datentyp

boolean

Alias
UMLS CUI [1]
C0857490
UMLS CUI [2]
C0005821
UMLS CUI [3]
C0016006
UMLS CUI [4]
C0019046
reliability of the patient to take oral medication, go home and return for follow-up and treatment.
Beschreibung

reliability of the patient to take oral medication, go home and return for follow-up and treatment.

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605

Ähnliche Modelle

Eligibility Prostatic Neoplasm NCT00001266

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
carcinoma of the prostate
Item
patients must have a histologic diagnosis of carcinoma of the prostate and must not have had a trial of hormonal therapy or chemotherapy.
boolean
C0600139 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
age
Item
patients must be 18 years of age
boolean
C0001779 (UMLS CUI [1])
ALT and AST
Item
an sgot/sgpt within 2 times of normal.
boolean
C0001899 (UMLS CUI [1])
C0004002 (UMLS CUI [2])
tumor staging
Item
patients must have stage d2 prostate carcinoma or state d1 disease with a gleason grade 7 or above (poorly differentiated).
boolean
C0027646 (UMLS CUI [1])
C0332332 (UMLS CUI [2])
other malignancy
Item
no other malignancy except curatively treated basal cell cancer of the skin.
boolean
C0006826 (UMLS CUI [1])
performance status
Item
performance status ecog of 0-3.
boolean
C1520224 (UMLS CUI [1])
informed consent
Item
ability to give informed consent.
boolean
C0021430 (UMLS CUI [1])
bleeding diathesis
Item
no history of bleeding diathesis. patients with a history of peptic ulcer disease will be eligible if the ulcer is shown to be resolved by a barium study.
boolean
C0005779 (UMLS CUI [1])
C0030920 (UMLS CUI [2])
cerebrovascular event
Item
no history of cerebrovascular event, either thrombotic or hemorrhagic.
boolean
C0852396 (UMLS CUI [1])
congestive heart failure
Item
no current clinical signs of congestive heart failure, angina pectoris or myocardial infarction. patient cannot be on calcium channel blockers such as nifedipine, diltiazem, or verapamil.
boolean
C0018802 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0006684 (UMLS CUI [4])
brain metastases
Item
no clinical or radiographic evidence of brain metastases.
boolean
C0220650 (UMLS CUI [1])
extensive liver replacement
Item
patients with extensive liver replacement (greater than 50%) by tumor will be ineligible.
boolean
C1883411 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0205231 (UMLS CUI [1,3])
creatinine
Item
patients must have a creatinine lest than or equal 2.5 mg/dl or creatinine clearance of greater than or equal to 40 ml/min.
boolean
C0201976 (UMLS CUI [1])
C0010294 (UMLS CUI [2])
hepatic function
Item
patients must have adequate hepatic function (bilirubin less than 1.5mg%).
boolean
C1278039 (UMLS CUI [1])
urinalysis
Item
if the patient has white cells in his urinalysis or other evidence of a urinary tract infection, this must be evaluated and appropriate therapy initiation prior to the initiation of therapy.
boolean
C0042029 (UMLS CUI [1])
chemotherapy
Item
patients must not have received chemotherapy.
boolean
C0392920 (UMLS CUI [1])
blood results
Item
an absolute granulocyte count greater than 1,500; platelet count greater than 100,000; fibrinogen greater than 200 mg/dl; hgb greater than or equal to 9 gm/dl.
boolean
C0857490 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0016006 (UMLS CUI [3])
C0019046 (UMLS CUI [4])
patient compliance
Item
reliability of the patient to take oral medication, go home and return for follow-up and treatment.
boolean
C1321605 (UMLS CUI [1])

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