ID

41218

Beskrivning

Feasibility of Assessing Lymphoma Response to Precise Local Injection of Candidate Chemotherapy Agents; ODM derived from: https://clinicaltrials.gov/show/NCT01831505

Länk

https://clinicaltrials.gov/show/NCT01831505

Nyckelord

Versioner (1)
  1. 2020-07-18 2020-07-18 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

18 juli 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Lymphoma NCT01831505

Engelsk

Eligibility Lymphoma NCT01831505

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01831505
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age or over
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
has enlarged lymph node(s) highly suspicious of lymphoma; or has been diagnosed with lymphoma but is untreated; or has persistent recurrent, or progressive lymphoma
Beskrivning

Lymphadenopathy Suspicious Lymphoma | Lymphoma Untreated | Lymphoma Persistent | Recurrent Lymphoma | Lymphoma Progressive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0497156
UMLS CUI [1,2]
C0750493
UMLS CUI [1,3]
C0024299
UMLS CUI [2,1]
C0024299
UMLS CUI [2,2]
C0332155
UMLS CUI [3,1]
C0024299
UMLS CUI [3,2]
C0205322
UMLS CUI [4]
C4525062
UMLS CUI [5,1]
C0024299
UMLS CUI [5,2]
C0205329
at least one enlarged lymph node that is considered accessible for percutaneous injection by the investigator and that is at least 2 cm in longest dimension.
Beskrivning

Lymphadenopathy Quantity | Amenable Injection Percutaneous | Lymphadenopathy Longest Diameter

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0497156
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C3900053
UMLS CUI [2,2]
C1533685
UMLS CUI [2,3]
C1522243
UMLS CUI [3,1]
C0497156
UMLS CUI [3,2]
C0552406
ecog performance status of 0-2 (or a karnofsky performance status of >50%).
Beskrivning

ECOG performance status | Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
labs required for enrollment: absolute neutrophil count > 1000/mm3, platelet count > 50,000/mm3, hematocrit > 25%, creatinine <3.0 mg/dl, total bilirubin <4.0 mg/dl, sgot and sgpt less than five times the institutional upper limits of normal.
Beskrivning

Laboratory Results Required | Absolute neutrophil count | Platelet Count measurement | Hematocrit level | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate Aminotransferase Increased | Alanine Aminotransferase Increased

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1514873
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518014
UMLS CUI [5]
C0201976
UMLS CUI [6]
C1278039
UMLS CUI [7]
C0151904
UMLS CUI [8]
C0151905
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
lymphoma patients in which the delay of surgery until the lymph node resection date or other factors associated with the study are not feasible.
Beskrivning

Delay Operative Surgical Procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205421
UMLS CUI [1,2]
C0543467
patients with central nervous system disease.
Beskrivning

CNS disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0007682
any therapy that is potentially immunosuppressive or has anticancer activity in the 4 weeks prior to device microinjection.
Beskrivning

Therapeutic immunosuppression | Cancer treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0920425
patients with active fungal, viral, or bacterial infections
Beskrivning

Mycoses | Virus Diseases | Bacterial Infections

Datatyp

boolean

Alias
UMLS CUI [1]
C0026946
UMLS CUI [2]
C0042769
UMLS CUI [3]
C0004623
pregnant women.
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
inability to give informed consent.
Beskrivning

Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
Tillbaka till toppen

Similar models

Eligibility Lymphoma NCT01831505

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01831505
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 years of age or over
boolean
C0001779 (UMLS CUI [1])
Lymphadenopathy Suspicious Lymphoma | Lymphoma Untreated | Lymphoma Persistent | Recurrent Lymphoma | Lymphoma Progressive
Item
has enlarged lymph node(s) highly suspicious of lymphoma; or has been diagnosed with lymphoma but is untreated; or has persistent recurrent, or progressive lymphoma
boolean
C0497156 (UMLS CUI [1,1])
C0750493 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
C0024299 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0024299 (UMLS CUI [3,1])
C0205322 (UMLS CUI [3,2])
C4525062 (UMLS CUI [4])
C0024299 (UMLS CUI [5,1])
C0205329 (UMLS CUI [5,2])
Lymphadenopathy Quantity | Amenable Injection Percutaneous | Lymphadenopathy Longest Diameter
Item
at least one enlarged lymph node that is considered accessible for percutaneous injection by the investigator and that is at least 2 cm in longest dimension.
boolean
C0497156 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3900053 (UMLS CUI [2,1])
C1533685 (UMLS CUI [2,2])
C1522243 (UMLS CUI [2,3])
C0497156 (UMLS CUI [3,1])
C0552406 (UMLS CUI [3,2])
ECOG performance status | Karnofsky Performance Status
Item
ecog performance status of 0-2 (or a karnofsky performance status of >50%).
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Laboratory Results Required | Absolute neutrophil count | Platelet Count measurement | Hematocrit level | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate Aminotransferase Increased | Alanine Aminotransferase Increased
Item
labs required for enrollment: absolute neutrophil count > 1000/mm3, platelet count > 50,000/mm3, hematocrit > 25%, creatinine <3.0 mg/dl, total bilirubin <4.0 mg/dl, sgot and sgpt less than five times the institutional upper limits of normal.
boolean
C1254595 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518014 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
C0151904 (UMLS CUI [7])
C0151905 (UMLS CUI [8])
Item Group
C0680251 (UMLS CUI)
Delay Operative Surgical Procedure
Item
lymphoma patients in which the delay of surgery until the lymph node resection date or other factors associated with the study are not feasible.
boolean
C0205421 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
CNS disorder
Item
patients with central nervous system disease.
boolean
C0007682 (UMLS CUI [1])
Therapeutic immunosuppression | Cancer treatment
Item
any therapy that is potentially immunosuppressive or has anticancer activity in the 4 weeks prior to device microinjection.
boolean
C0021079 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
Mycoses | Virus Diseases | Bacterial Infections
Item
patients with active fungal, viral, or bacterial infections
boolean
C0026946 (UMLS CUI [1])
C0042769 (UMLS CUI [2])
C0004623 (UMLS CUI [3])
Pregnancy
Item
pregnant women.
boolean
C0032961 (UMLS CUI [1])
Informed Consent Unable
Item
inability to give informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Tillbaka till toppen 

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