ID

30922

Description

Efficacy of Gamma Camera Used Intraoperatively for ID of Sentinel Lymph Nodes w/ Lymphoscintigraphy; ODM derived from: https://clinicaltrials.gov/show/NCT01314963

Link

https://clinicaltrials.gov/show/NCT01314963

Keywords

Versions (1)
  1. 7/3/18 7/3/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 3, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT01314963

English

Eligibility Multiple Myeloma NCT01314963

1 forms  
Criteria
Description

Criteria

3.1.2 prior therapy has no impact on eligibility as long as sentinel lymph node biopsy is indicated
Description

Indication Sentinel Lymph Node Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0796693
3.1.4 adults age 18 or greater.
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
3.1.5 no life expectancy restrictions.
Description

Exclusion | Life Expectancy Restriction

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0023671
UMLS CUI [2,2]
C0443288
3.1.6 the patients must be healthy enough for surgery
Description

Fit Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0424576
UMLS CUI [1,2]
C0543467
3.1.8 patients must be able to understand and the willing to sign a written informed consent document.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
exclusion criteria:3.2.1 no therapy restrictions.
Description

Exclusion Criteria | Therapeutic procedure Restriction

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0443288
3.2.2 no restrictions on use of other investigational agents.
Description

Exclusion Criteria | Investigational New Drugs Restriction

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0443288
3.2.3 no exclusion requirements due to co-morbid disease or incurrent illness.
Description

Comorbidity | Illness

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0221423
3.2.4 patients will be excluded if they have a documented allergy to colloid.
Description

Exclusion Criteria | Hypersensitivity Colloid

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1527250
3.2.5 there are no known exclusion criteria relating to concomitant medications or substances that have the potential to affect the activity or pharmacokinetics of the study agent.
Description

Pharmaceutical Preparations Affecting Pharmacokinetics Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0031327
UMLS CUI [1,4]
C0013230
3.2.6 no other agent-specific exclusion criteria.
Description

Absence Exclusion Criteria Agent Specific

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0680251
UMLS CUI [1,3]
C1254351
UMLS CUI [1,4]
C0205369
3.2.7 pregnant and nursing patients will be excluded if lymphoscintigraphy is felt to be too high risk.
Description

Exclusion Criteria | Pregnancy | Breast Feeding | Lymphoscintigraphy High risk

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C0412375
UMLS CUI [4,2]
C0332167
3.2.8 cancer survivors and those who are hiv-positive will not be excluded from the study.
Description

Cancer Survivors | HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C1516231
UMLS CUI [2]
C0019699
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Similar models

Eligibility Multiple Myeloma NCT01314963

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Indication Sentinel Lymph Node Biopsy
Item
3.1.2 prior therapy has no impact on eligibility as long as sentinel lymph node biopsy is indicated
boolean
C3146298 (UMLS CUI [1,1])
C0796693 (UMLS CUI [1,2])
Adult | Age
Item
3.1.4 adults age 18 or greater.
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Exclusion | Life Expectancy Restriction
Item
3.1.5 no life expectancy restrictions.
boolean
C2828389 (UMLS CUI [1])
C0023671 (UMLS CUI [2,1])
C0443288 (UMLS CUI [2,2])
Fit Operative Surgical Procedures
Item
3.1.6 the patients must be healthy enough for surgery
boolean
C0424576 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Informed Consent
Item
3.1.8 patients must be able to understand and the willing to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria | Therapeutic procedure Restriction
Item
exclusion criteria:3.2.1 no therapy restrictions.
boolean
C0680251 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0443288 (UMLS CUI [2,2])
Exclusion Criteria | Investigational New Drugs Restriction
Item
3.2.2 no restrictions on use of other investigational agents.
boolean
C0680251 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C0443288 (UMLS CUI [2,2])
Comorbidity | Illness
Item
3.2.3 no exclusion requirements due to co-morbid disease or incurrent illness.
boolean
C0009488 (UMLS CUI [1])
C0221423 (UMLS CUI [2])
Exclusion Criteria | Hypersensitivity Colloid
Item
3.2.4 patients will be excluded if they have a documented allergy to colloid.
boolean
C0680251 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C1527250 (UMLS CUI [2,2])
Pharmaceutical Preparations Affecting Pharmacokinetics Investigational New Drugs
Item
3.2.5 there are no known exclusion criteria relating to concomitant medications or substances that have the potential to affect the activity or pharmacokinetics of the study agent.
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0031327 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
Absence Exclusion Criteria Agent Specific
Item
3.2.6 no other agent-specific exclusion criteria.
boolean
C0332197 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C1254351 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
Exclusion Criteria | Pregnancy | Breast Feeding | Lymphoscintigraphy High risk
Item
3.2.7 pregnant and nursing patients will be excluded if lymphoscintigraphy is felt to be too high risk.
boolean
C0680251 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0412375 (UMLS CUI [4,1])
C0332167 (UMLS CUI [4,2])
Cancer Survivors | HIV Seropositivity
Item
3.2.8 cancer survivors and those who are hiv-positive will not be excluded from the study.
boolean
C1516231 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
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