ID

18319

Beschreibung

Valproic Acid in the Induction of EBV Lytic Cycle Antigen Expression in Nasopharyngeal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00181220

Link

https://clinicaltrials.gov/show/NCT00181220

Stichworte

Versionen (1)
  1. 31.10.16 31.10.16 -
Hochgeladen am

31. Oktober 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Nasopharyngeal Carcinoma NCT00181220

Englisch

Eligibility Nasopharyngeal Carcinoma NCT00181220

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
all subjects must fulfill the following criteria to be eligible for study admission:
Beschreibung

Clinical Trial Eligibility Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1550543
subjects are of age 18 years and above
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
biopsy proven nasopharyngeal carcinoma – who type 3
Beschreibung

Nasopharyngeal carcinoma | Biopsy | WHO performance status scale

Datentyp

boolean

Alias
UMLS CUI [1]
C2931822
UMLS CUI [2]
C0005558
UMLS CUI [3]
C1298650
must have tumor which is accessible to biopsy
Beschreibung

Neoplasm Amenable Biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0005558
for patients with disease localized to the pns, the lesion must be visualized by endoscopy
Beschreibung

Lesion Localized Nasal sinus | Endoscopy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0392752
UMLS CUI [1,3]
C0030471
UMLS CUI [2]
C0014245
subjects with metastatic disease with disease accessible to biopsy in the pns if they are deemed by their treating physicians not to require treatment for at least two weeks.
Beschreibung

Neoplasm Metastasis | Disease Amenable Paranasal biopsy | treatment need

Datentyp

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C3900053
UMLS CUI [2,3]
C0857438
UMLS CUI [3]
C0815189
an ecog performance status of 0–2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
for sexually active women of child-bearing potential, negative pregnancy test within 14 days of enrolling on trial
Beschreibung

Childbearing Potential Sex Behavior Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0036864
UMLS CUI [1,3]
C0427780
must be able to give informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
for patients with localized npc, pns lesions that cannot be visualized by endoscopy
Beschreibung

Nasopharyngeal carcinoma Localized | Nasal sinus Lesion | Endoscopy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2931822
UMLS CUI [1,2]
C0392752
UMLS CUI [2,1]
C0030471
UMLS CUI [2,2]
C0221198
UMLS CUI [3]
C0014245
patients with disease inaccessible to biopsy
Beschreibung

Disease Amenable Biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0005558
history of anaphylaxis after exposure to valproic acid
Beschreibung

anaphylaxis | Valproic Acid Exposure to

Datentyp

boolean

Alias
UMLS CUI [1]
C0002792
UMLS CUI [2,1]
C0042291
UMLS CUI [2,2]
C0332157
hepatic dysfunction as defined by total bilirubin 1.0x upper limit of normal. ast (sgot) and alt (sgpt)  3x upper limit of normal
Beschreibung

Liver Dysfunction | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
hemoglobin  8g/dl, absolute neutrophil count 1500 cells/mm, and platelet count 100,000 /mm
Beschreibung

Hemoglobin | Absolute neutrophil count | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0019046
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
creatinine 3x upper limit of normal
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
pt/ptt blood test result not within normal range
Beschreibung

Prothrombin time abnormal | Abnormal partial thromboplastin time (PTT)

Datentyp

boolean

Alias
UMLS CUI [1]
C0580412
UMLS CUI [2]
C4062448
patients who require treatment with an anticonvulsant besides valproic acid during the course of valproate prescribed by the protocol
Beschreibung

Anticonvulsant Patient need for | Valproic Acid | Valproate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003286
UMLS CUI [1,2]
C0686904
UMLS CUI [2]
C0042291
UMLS CUI [3]
C0080356
ecog performance status 3-4
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
patients who are pregnant or breast feeding (sexually active women of childbearing potential must use contraception during course of therapy and within 4 weeks of completion of trial)
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Sex Behavior Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0036864
UMLS CUI [3,3]
C0700589
participation in another clinical trial involving therapeutic intervention within 4 weeks of enrollment.
Beschreibung

Study Subject Participation Status | Operative Surgical Procedures

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0543467
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Ähnliche Modelle

Eligibility Nasopharyngeal Carcinoma NCT00181220

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Clinical Trial Eligibility Criteria Fulfill
Item
all subjects must fulfill the following criteria to be eligible for study admission:
boolean
C1516637 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Age
Item
subjects are of age 18 years and above
boolean
C0001779 (UMLS CUI [1])
Nasopharyngeal carcinoma | Biopsy | WHO performance status scale
Item
biopsy proven nasopharyngeal carcinoma – who type 3
boolean
C2931822 (UMLS CUI [1])
C0005558 (UMLS CUI [2])
C1298650 (UMLS CUI [3])
Neoplasm Amenable Biopsy
Item
must have tumor which is accessible to biopsy
boolean
C0027651 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
Lesion Localized Nasal sinus | Endoscopy
Item
for patients with disease localized to the pns, the lesion must be visualized by endoscopy
boolean
C0221198 (UMLS CUI [1,1])
C0392752 (UMLS CUI [1,2])
C0030471 (UMLS CUI [1,3])
C0014245 (UMLS CUI [2])
Neoplasm Metastasis | Disease Amenable Paranasal biopsy | treatment need
Item
subjects with metastatic disease with disease accessible to biopsy in the pns if they are deemed by their treating physicians not to require treatment for at least two weeks.
boolean
C0027627 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C0857438 (UMLS CUI [2,3])
C0815189 (UMLS CUI [3])
ECOG performance status
Item
an ecog performance status of 0–2
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Sex Behavior Pregnancy test negative
Item
for sexually active women of child-bearing potential, negative pregnancy test within 14 days of enrolling on trial
boolean
C3831118 (UMLS CUI [1,1])
C0036864 (UMLS CUI [1,2])
C0427780 (UMLS CUI [1,3])
Informed Consent
Item
must be able to give informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Nasopharyngeal carcinoma Localized | Nasal sinus Lesion | Endoscopy
Item
for patients with localized npc, pns lesions that cannot be visualized by endoscopy
boolean
C2931822 (UMLS CUI [1,1])
C0392752 (UMLS CUI [1,2])
C0030471 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C0014245 (UMLS CUI [3])
Disease Amenable Biopsy
Item
patients with disease inaccessible to biopsy
boolean
C0012634 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
anaphylaxis | Valproic Acid Exposure to
Item
history of anaphylaxis after exposure to valproic acid
boolean
C0002792 (UMLS CUI [1])
C0042291 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
Liver Dysfunction | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
hepatic dysfunction as defined by total bilirubin 1.0x upper limit of normal. ast (sgot) and alt (sgpt)  3x upper limit of normal
boolean
C0086565 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Hemoglobin | Absolute neutrophil count | Platelet Count measurement
Item
hemoglobin  8g/dl, absolute neutrophil count 1500 cells/mm, and platelet count 100,000 /mm
boolean
C0019046 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Creatinine measurement, serum
Item
creatinine 3x upper limit of normal
boolean
C0201976 (UMLS CUI [1])
Prothrombin time abnormal | Abnormal partial thromboplastin time (PTT)
Item
pt/ptt blood test result not within normal range
boolean
C0580412 (UMLS CUI [1])
C4062448 (UMLS CUI [2])
Anticonvulsant Patient need for | Valproic Acid | Valproate
Item
patients who require treatment with an anticonvulsant besides valproic acid during the course of valproate prescribed by the protocol
boolean
C0003286 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0042291 (UMLS CUI [2])
C0080356 (UMLS CUI [3])
ECOG performance status
Item
ecog performance status 3-4
boolean
C1520224 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Sex Behavior Contraceptive methods
Item
patients who are pregnant or breast feeding (sexually active women of childbearing potential must use contraception during course of therapy and within 4 weeks of completion of trial)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0036864 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
Study Subject Participation Status | Operative Surgical Procedures
Item
participation in another clinical trial involving therapeutic intervention within 4 weeks of enrollment.
boolean
C2348568 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
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