Informações:
Falhas:
ID
30922
Descrição
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
Palavras-chave
Versões (1)
- 03/07/2018 03/07/2018 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
3 de julho de 2018
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT01314963
Eligibility Multiple Myeloma NCT01314963
- StudyEvent: Eligibility
Similar models
Eligibility Multiple Myeloma NCT01314963
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
C0019699 (UMLS CUI [2])