ID

17856

Description

Gene Expression During Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Treated With Choline Magnesium Trisalicylate; ODM derived from: https://clinicaltrials.gov/show/NCT00156299

Lien

https://clinicaltrials.gov/show/NCT00156299

Mots-clés

  1. 05/10/2016 05/10/2016 -
  2. 05/10/2016 05/10/2016 -
Téléchargé le

5 octobre 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Leukemia NCT00156299

Eligibility Leukemia NCT00156299

  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00156299
Criteria
Description

Criteria

histologically confirmed acute myeloid leukemia
Description

Leukemia, Myelocytic, Acute

Type de données

boolean

Alias
UMLS CUI [1]
C0023467
newly diagnosed disease
Description

Newly Diagnosed Disease

Type de données

boolean

Alias
UMLS CUI [1]
C1334965
presence of cytogenetic abnormalities must be determined by standard cytogenetics with or without fish studies
Description

Chromosome Aberrations | Cytogenetic Analysis | Fluorescent in Situ Hybridization

Type de données

boolean

Alias
UMLS CUI [1]
C0008625
UMLS CUI [2]
C0752095
UMLS CUI [3]
C0162789
leukemic blast count > 5,000/mm³ of peripheral blood
Description

Leukemic Blast Count peripheral blood

Type de données

boolean

Alias
UMLS CUI [1,1]
C2697913
UMLS CUI [1,2]
C0229664
no acute promyelocytic leukemia (m3)
Description

Acute Promyelocytic Leukemia

Type de données

boolean

Alias
UMLS CUI [1]
C0023487
patient characteristics:
Description

Client Characteristics

Type de données

boolean

Alias
UMLS CUI [1]
C0815172
ecog performance status 0-3
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
bilirubin < 2.0 times upper limit of normal (uln)
Description

Serum total bilirubin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C1278039
ast < 3.0 times uln
Description

Aspartate aminotransferase measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0201899
creatinine < 1.5 times uln
Description

Creatinine measurement, serum

Type de données

boolean

Alias
UMLS CUI [1]
C0201976
not pregnant or nursing
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
negative pregnancy test
Description

Pregnancy test negative

Type de données

boolean

Alias
UMLS CUI [1]
C0427780
fertile patients must use effective contraception
Description

Fertility Contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
no uncontrolled psychiatric illness that, in the opinion of the principal investigator, would preclude study compliance
Description

Mental disorder Uncontrolled Excludes Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C0525058
no other concurrent medical condition that would preclude study compliance
Description

Comorbidity Excludes Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058
no allergies to any investigational drugs and/or chemotherapeutic agents
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Antineoplastic Agents

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0003392
no upper or lower gastrointestinal (gi) related hemorrhage within the past 6 months as determined by endoscopy
Description

Upper gastrointestinal hemorrhage | Lower gastrointestinal hemorrhage

Type de données

boolean

Alias
UMLS CUI [1]
C0041909
UMLS CUI [2]
C0024050
no clinical diagnosis of gi bleeding requiring blood transfusions
Description

Gastrointestinal Hemorrhage Requirement Blood Transfusion

Type de données

boolean

Alias
UMLS CUI [1,1]
C0017181
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0005841
prior concurrent therapy:
Description

Prior Therapy

Type de données

boolean

Alias
UMLS CUI [1]
C1514463
no prior induction therapy
Description

Neoadjuvant Therapy

Type de données

boolean

Alias
UMLS CUI [1]
C0600558
no prior chemotherapy for acute leukemia
Description

Prior Chemotherapy Acute leukemia

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0085669
no concurrent medications that would preclude study compliance
Description

Pharmaceutical Preparations Exclude Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058

Similar models

Eligibility Leukemia NCT00156299

  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00156299
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Leukemia, Myelocytic, Acute
Item
histologically confirmed acute myeloid leukemia
boolean
C0023467 (UMLS CUI [1])
Newly Diagnosed Disease
Item
newly diagnosed disease
boolean
C1334965 (UMLS CUI [1])
Chromosome Aberrations | Cytogenetic Analysis | Fluorescent in Situ Hybridization
Item
presence of cytogenetic abnormalities must be determined by standard cytogenetics with or without fish studies
boolean
C0008625 (UMLS CUI [1])
C0752095 (UMLS CUI [2])
C0162789 (UMLS CUI [3])
Leukemic Blast Count peripheral blood
Item
leukemic blast count > 5,000/mm³ of peripheral blood
boolean
C2697913 (UMLS CUI [1,1])
C0229664 (UMLS CUI [1,2])
Acute Promyelocytic Leukemia
Item
no acute promyelocytic leukemia (m3)
boolean
C0023487 (UMLS CUI [1])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-3
boolean
C1520224 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin < 2.0 times upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
ast < 3.0 times uln
boolean
C0201899 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine < 1.5 times uln
boolean
C0201976 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Mental disorder Uncontrolled Excludes Protocol Compliance
Item
no uncontrolled psychiatric illness that, in the opinion of the principal investigator, would preclude study compliance
boolean
C0004936 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
Comorbidity Excludes Protocol Compliance
Item
no other concurrent medical condition that would preclude study compliance
boolean
C0009488 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Antineoplastic Agents
Item
no allergies to any investigational drugs and/or chemotherapeutic agents
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0003392 (UMLS CUI [2,2])
Upper gastrointestinal hemorrhage | Lower gastrointestinal hemorrhage
Item
no upper or lower gastrointestinal (gi) related hemorrhage within the past 6 months as determined by endoscopy
boolean
C0041909 (UMLS CUI [1])
C0024050 (UMLS CUI [2])
Gastrointestinal Hemorrhage Requirement Blood Transfusion
Item
no clinical diagnosis of gi bleeding requiring blood transfusions
boolean
C0017181 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0005841 (UMLS CUI [1,3])
Prior Therapy
Item
prior concurrent therapy:
boolean
C1514463 (UMLS CUI [1])
Neoadjuvant Therapy
Item
no prior induction therapy
boolean
C0600558 (UMLS CUI [1])
Prior Chemotherapy Acute leukemia
Item
no prior chemotherapy for acute leukemia
boolean
C1514457 (UMLS CUI [1,1])
C0085669 (UMLS CUI [1,2])
Pharmaceutical Preparations Exclude Protocol Compliance
Item
no concurrent medications that would preclude study compliance
boolean
C0013227 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])

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