ID

31663

Beskrivning

Combination Iodine 125 Seed Implants and LHRH Agonists for Locally Advanced (Stage T3) Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01813097

Länk

https://clinicaltrials.gov/show/NCT01813097

Nyckelord

Versioner (1)
  1. 2018-09-18 2018-09-18 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

18 september 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT01813097

Engelsk

Eligibility Prostate Cancer NCT01813097

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provision of written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
2. t2c-t3b n0 m0 (biopsy、 bone scan、 ct、 mri)
Beskrivning

TNM clinical staging Biopsy | TNM clinical staging Bone scan | TNM clinical staging CT | TNM clinical staging MRI

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3258246
UMLS CUI [1,2]
C0005558
UMLS CUI [2,1]
C3258246
UMLS CUI [2,2]
C0203668
UMLS CUI [3,1]
C3258246
UMLS CUI [3,2]
C0040405
UMLS CUI [4,1]
C3258246
UMLS CUI [4,2]
C0024485
3. no metastasis (bone scan、 ct、 mri)
Beskrivning

Neoplasm Metastasis Absent Bone scan | Neoplasm Metastasis Absent CT | Neoplasm Metastasis Absent MRI

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0203668
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0040405
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0024485
4. psa level>10ng/ml
Beskrivning

Prostate specific antigen measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201544
5. histological or cytological confirmation of prostate cancer
Beskrivning

Prostate carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0600139
6. able to understand and comply with the requirements of the study
Beskrivning

Comprehension Study Protocol | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. having been treated with external radiation therapy or chemistry therapy.
Beskrivning

External beam radiotherapy | Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0419095
UMLS CUI [2]
C0392920
2. clinical relevant disease and/or abnormalities (past or present), eg, significant cardiovascular, renal or liver disease, malignancy, gastro-intestinal disorders, or other conditions which could affect the absorption/elimination of drugs.
Beskrivning

Disease Clinical Relevant | Abnormality Clinical Relevant | Cardiovascular Diseases | Kidney Diseases | Liver diseases | Malignant Neoplasms | Gastrointestinal Diseases | Other medical condition Affecting Drug absorption | Other medical condition Affecting Drug elimination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C2347946
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0205210
UMLS CUI [2,3]
C2347946
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0023895
UMLS CUI [6]
C0006826
UMLS CUI [7]
C0017178
UMLS CUI [8,1]
C3843040
UMLS CUI [8,2]
C0392760
UMLS CUI [8,3]
C0678745
UMLS CUI [9,1]
C3843040
UMLS CUI [9,2]
C0392760
UMLS CUI [9,3]
C0683141
3. alanine amino transferase (alt) or aspartate amino transferase (ast) greater than 2 times the upper limit of normal (uln) at screening findings that make it undesirable for the patient to participate in the study in the opinion of the investigator(s)
Beskrivning

Alanine aminotransferase increased | Aspartate aminotransferase increased | Study Subject Participation Status Unfavorable

Datatyp

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
UMLS CUI [3,1]
C2348568
UMLS CUI [3,2]
C3640815
4. in the opinion of the investigator(s), any evidence of severe or uncontrolled systemic disease (eg, currently unstable or unresolved respiratory, cardiac, hepatic, or renal disease).
Beskrivning

Systemic disease Severe | Systemic disease Uncontrolled | Respiration Disorder Unstable | Heart Disease Unstable | Liver disease Unstable | Kidney Disease Unstable | Respiration Disorder Without Resolution | Heart Disease Without Resolution | Liver disease Without Resolution | Kidney Disease Without Resolution

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0035204
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C0023895
UMLS CUI [5,2]
C0443343
UMLS CUI [6,1]
C0022658
UMLS CUI [6,2]
C0443343
UMLS CUI [7,1]
C0035204
UMLS CUI [7,2]
C0332288
UMLS CUI [7,3]
C1514893
UMLS CUI [8,1]
C0018799
UMLS CUI [8,2]
C0332288
UMLS CUI [8,3]
C1514893
UMLS CUI [9,1]
C0023895
UMLS CUI [9,2]
C0332288
UMLS CUI [9,3]
C1514893
UMLS CUI [10,1]
C0022658
UMLS CUI [10,2]
C0332288
UMLS CUI [10,3]
C1514893
5. contra-indications (eg, known or suspected allergy) to gnrh antagonists or excipients(non-active ingredients of investigational product).
Beskrivning

Medical contraindication GnRH antagonist | Hypersensitivity GnRH antagonist | Hypersensitivity Suspected GnRH antagonist | Medical contraindication GnRH Excipient | Hypersensitivity GnRH Excipient | Hypersensitivity Suspected GnRH Excipient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1268855
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1268855
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0750491
UMLS CUI [3,3]
C1268855
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0023610
UMLS CUI [4,3]
C0015237
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0023610
UMLS CUI [5,3]
C0015237
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0750491
UMLS CUI [6,3]
C0023610
UMLS CUI [6,4]
C0015237
6. treatment with a non-approved or investigational drug within 30 days before study entry.
Beskrivning

Drugs, Non-Prescription | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2]
C0013230
7. bibulosity or drug abuse.
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
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Similar models

Eligibility Prostate Cancer NCT01813097

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. provision of written informed consent
boolean
C0021430 (UMLS CUI [1])
TNM clinical staging Biopsy | TNM clinical staging Bone scan | TNM clinical staging CT | TNM clinical staging MRI
Item
2. t2c-t3b n0 m0 (biopsy、 bone scan、 ct、 mri)
boolean
C3258246 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C3258246 (UMLS CUI [2,1])
C0203668 (UMLS CUI [2,2])
C3258246 (UMLS CUI [3,1])
C0040405 (UMLS CUI [3,2])
C3258246 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
Neoplasm Metastasis Absent Bone scan | Neoplasm Metastasis Absent CT | Neoplasm Metastasis Absent MRI
Item
3. no metastasis (bone scan、 ct、 mri)
boolean
C0027627 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0203668 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C0027627 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0024485 (UMLS CUI [3,3])
Prostate specific antigen measurement
Item
4. psa level>10ng/ml
boolean
C0201544 (UMLS CUI [1])
Prostate carcinoma
Item
5. histological or cytological confirmation of prostate cancer
boolean
C0600139 (UMLS CUI [1])
Comprehension Study Protocol | Protocol Compliance
Item
6. able to understand and comply with the requirements of the study
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
External beam radiotherapy | Chemotherapy
Item
1. having been treated with external radiation therapy or chemistry therapy.
boolean
C0419095 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Disease Clinical Relevant | Abnormality Clinical Relevant | Cardiovascular Diseases | Kidney Diseases | Liver diseases | Malignant Neoplasms | Gastrointestinal Diseases | Other medical condition Affecting Drug absorption | Other medical condition Affecting Drug elimination
Item
2. clinical relevant disease and/or abnormalities (past or present), eg, significant cardiovascular, renal or liver disease, malignancy, gastro-intestinal disorders, or other conditions which could affect the absorption/elimination of drugs.
boolean
C0012634 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C2347946 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C2347946 (UMLS CUI [2,3])
C0007222 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0006826 (UMLS CUI [6])
C0017178 (UMLS CUI [7])
C3843040 (UMLS CUI [8,1])
C0392760 (UMLS CUI [8,2])
C0678745 (UMLS CUI [8,3])
C3843040 (UMLS CUI [9,1])
C0392760 (UMLS CUI [9,2])
C0683141 (UMLS CUI [9,3])
Alanine aminotransferase increased | Aspartate aminotransferase increased | Study Subject Participation Status Unfavorable
Item
3. alanine amino transferase (alt) or aspartate amino transferase (ast) greater than 2 times the upper limit of normal (uln) at screening findings that make it undesirable for the patient to participate in the study in the opinion of the investigator(s)
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C2348568 (UMLS CUI [3,1])
C3640815 (UMLS CUI [3,2])
Systemic disease Severe | Systemic disease Uncontrolled | Respiration Disorder Unstable | Heart Disease Unstable | Liver disease Unstable | Kidney Disease Unstable | Respiration Disorder Without Resolution | Heart Disease Without Resolution | Liver disease Without Resolution | Kidney Disease Without Resolution
Item
4. in the opinion of the investigator(s), any evidence of severe or uncontrolled systemic disease (eg, currently unstable or unresolved respiratory, cardiac, hepatic, or renal disease).
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0035204 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0018799 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0023895 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0022658 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C0035204 (UMLS CUI [7,1])
C0332288 (UMLS CUI [7,2])
C1514893 (UMLS CUI [7,3])
C0018799 (UMLS CUI [8,1])
C0332288 (UMLS CUI [8,2])
C1514893 (UMLS CUI [8,3])
C0023895 (UMLS CUI [9,1])
C0332288 (UMLS CUI [9,2])
C1514893 (UMLS CUI [9,3])
C0022658 (UMLS CUI [10,1])
C0332288 (UMLS CUI [10,2])
C1514893 (UMLS CUI [10,3])
Medical contraindication GnRH antagonist | Hypersensitivity GnRH antagonist | Hypersensitivity Suspected GnRH antagonist | Medical contraindication GnRH Excipient | Hypersensitivity GnRH Excipient | Hypersensitivity Suspected GnRH Excipient
Item
5. contra-indications (eg, known or suspected allergy) to gnrh antagonists or excipients(non-active ingredients of investigational product).
boolean
C1301624 (UMLS CUI [1,1])
C1268855 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1268855 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C1268855 (UMLS CUI [3,3])
C1301624 (UMLS CUI [4,1])
C0023610 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C0023610 (UMLS CUI [5,2])
C0015237 (UMLS CUI [5,3])
C0020517 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
C0023610 (UMLS CUI [6,3])
C0015237 (UMLS CUI [6,4])
Drugs, Non-Prescription | Investigational New Drugs
Item
6. treatment with a non-approved or investigational drug within 30 days before study entry.
boolean
C0013231 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Substance Use Disorders
Item
7. bibulosity or drug abuse.
boolean
C0038586 (UMLS CUI [1])
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