ID

29771

Descrizione

A Phase-II Trial of ZIO 101 in Advanced Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00423306

collegamento

https://clinicaltrials.gov/show/NCT00423306

Keywords

versioni (2)
  1. 19/04/18 19/04/18 -
  2. 20/09/21 20/09/21 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

19 aprile 2018

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility HEPATOCELLULAR CARCINOMA NCT00423306

Inglese

Eligibility HEPATOCELLULAR CARCINOMA NCT00423306

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. hcc diagnosed by histology or clinical evidence supported by liver mass(es) at least 2cm in the longest diameter and afp equal to or more than 500 ng/ml in cirrhosis or chronic hbv or hcv infection27.
Descrizione

Liver carcinoma | Liver mass Diameter Size | Alpha one fetoprotein measurement | Liver Cirrhosis | Hepatitis B, Chronic | Hepatitis C, Chronic

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0240225
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0456389
UMLS CUI [3]
C0201539
UMLS CUI [4]
C0023890
UMLS CUI [5]
C0524909
UMLS CUI [6]
C0524910
2. male or female patients ≥ 18 years of age
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
3. patients who have a life expectancy of at least 12 weeks
Descrizione

Life Expectancy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023671
4. patients who have at least one uni-dimensional measurable lesion by ct-scan or mri according to response evaluation criteria in solid tumors (recist).
Descrizione

Measurable Lesion Linear Quantity CT scan | Measurable Lesion Linear Quantity MRI

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0040405
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0205132
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0024485
5. patients who have an eastern co-operative oncology group (ecog) performance status of 0 - 2 (see appendix 4).
Descrizione

ECOG performance status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1520224
6. patients who have received local therapy, such as surgery, radiation therapy, hepatic arterial embolization, chemo-embolization, radio-frequency ablation or cryo-ablation are eligible, provided that they either have a target lesion which has not been subjected to local therapy and/or the target lesion(s) within the field of the local therapy has shown an increase of ≥ 25% in the size. furthermore, the local therapy applied to target or non-target lesions needs to have been completed at least 8 weeks prior to study inclusion. lesions treated with external beam radiation therapy are not acceptable as target lesions, unless they fulfil the conditions described above.
Descrizione

Local Therapy | Operative Surgical Procedures | Therapeutic radiology procedure | Embolization of hepatic artery | Chemoembolization | Radiofrequency ablation | Cryosurgery | Local Therapy Absent Target Lesion | Target Lesion Increased size Percentage | Local Therapy Completed | External Beam Radiation Therapy Restricted

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1517925
UMLS CUI [2]
C0543467
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0397761
UMLS CUI [5]
C0796679
UMLS CUI [6]
C0850292
UMLS CUI [7]
C0010408
UMLS CUI [8,1]
C1517925
UMLS CUI [8,2]
C0332197
UMLS CUI [8,3]
C2986546
UMLS CUI [9,1]
C2986546
UMLS CUI [9,2]
C0332509
UMLS CUI [9,3]
C0439165
UMLS CUI [10,1]
C1517925
UMLS CUI [10,2]
C0205197
UMLS CUI [11,1]
C1517033
UMLS CUI [11,2]
C0443288
7. no more than one prior chemotherapy based regimen is allowed. patients can receive up to two regimes where target therapies have been used (washout)
Descrizione

Chemotherapy Quantity | Targeted Therapy Quantity

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C2985566
UMLS CUI [2,2]
C1265611
8. cirrhotic status of child-pugh class a or b only (appendix 5).
Descrizione

Child-Pugh Classification

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2347612
9. adequate hepatic function at screening as assessed by the following:
Descrizione

Liver function

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232741
platelet count ≥ 60 x 109/l
Descrizione

Platelet Count measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin ≥ 8.5 g/dl
Descrizione

Hemoglobin measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0518015
total bilirubin ≤ 3 mg/dl
Descrizione

Serum total bilirubin measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1278039
alt and ast ≤ 5 x upper limit of normal
Descrizione

Alanine aminotransferase increased | Aspartate aminotransferase increased

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
serum creatinine ≤ 2.0 x the upper limit of normal
Descrizione

Creatinine measurement, serum

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201976
pt-inr ≤ 2.3 or pt ≤ 6 seconds above control
Descrizione

Prothrombin time international normalized ratio (PT-INR) | Prothrombin time assay

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1821762
UMLS CUI [2]
C0033707
10. patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors [ta, tis and t1] or other malignancies curatively treated > 2 years prior to entry)
Descrizione

Malignant Neoplasms Previous | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Bladder Neoplasm Superficial TNM clinical staging | Exception Curative treatment Cancer Other

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0005695
UMLS CUI [4,3]
C0205124
UMLS CUI [4,4]
C3258246
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1273390
UMLS CUI [5,3]
C1707251
2. congestive heart failure > nyha class ii
Descrizione

Congestive heart failure New York Heart Association Classification

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
3. cardiac arrhythmias requiring anti-arrythmics (excluding beta blockers or digoxin for chronic stable atrial fibrillation) or qtc greater than 450 msec.
Descrizione

Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents | Exclusion Adrenergic beta-1 Receptor Antagonists Chronic atrial fibrillation Stable | Exclusion Digoxin Chronic atrial fibrillation Stable | Prolonged QTc

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003195
UMLS CUI [2,1]
C2828389
UMLS CUI [2,2]
C0304516
UMLS CUI [2,3]
C0694539
UMLS CUI [2,4]
C0205360
UMLS CUI [3,1]
C2828389
UMLS CUI [3,2]
C0012265
UMLS CUI [3,3]
C0694539
UMLS CUI [3,4]
C0205360
UMLS CUI [4]
C1969409
4. active coronary artery disease or cardiac ischemia
Descrizione

Coronary Artery Disease | Myocardial Ischemia

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2]
C0151744
5. active clinically serious bacterial, viral or fungal infections (> grade 2 nci-ctcae, version 3)
Descrizione

Bacterial Infections Serious CTCAE Grades | Virus Diseases Serious CTCAE Grades | Mycoses Serious CTCAE Grades

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1516728
UMLS CUI [2,1]
C0042769
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C1516728
UMLS CUI [3,1]
C0026946
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C1516728
6. known history of human immunodeficiency virus (hiv) infection for less than 2 years or uncontrolled disease on antiretroviral medication
Descrizione

HIV Infection Duration | Antiretrovirals Disease Uncontrolled

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C2222813
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0205318
7. metastatic brain or meningeal tumors
Descrizione

Metastatic malignant neoplasm to brain | Meningeal Neoplasms

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0025284
8. patients with seizure disorder requiring medication (such as anti-epileptics)
Descrizione

Epilepsy Requirement Pharmaceutical Preparations | Epilepsy Requirement Antiepileptic Agents

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0014544
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C0014544
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0003299
9. history of confusion or dementia or neurological condition that could mask a potential adverse response to the study drug (or something along these lines)
Descrizione

Confusion Interferes with Investigational New Drugs | Dementia Interferes with Investigational New Drugs | Nervous system problem Interferes with Investigational New Drugs

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009676
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0013230
UMLS CUI [2,1]
C0497327
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C0221571
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0013230
10. history of organ allograft
Descrizione

Organ Allograft

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0040739
11. substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Descrizione

Substance Use Disorders | Medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Social Conditions Interfere with Study Subject Participation Status | Medical condition Interferes with Evaluation Research results | Mental condition Interferes with Evaluation Research results | Social Conditions Interfere with Evaluation Research results

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C0037403
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2348568
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C1261322
UMLS CUI [5,4]
C0683954
UMLS CUI [6,1]
C3840291
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C1261322
UMLS CUI [6,4]
C0683954
UMLS CUI [7,1]
C0037403
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C1261322
UMLS CUI [7,4]
C0683954
12. known or suspected allergy to the investigational agent or any agent given in association with this trial
Descrizione

Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0013230
13. any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
Descrizione

Condition Unstable | Condition compromises Patient safety | Condition compromises Protocol Compliance

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C1113679
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C0525058
14. pregnant or breast-feeding patients. women of childbearing potential must have a negative pregnancy test performed within 14 days prior to the start of study drug. both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial
Descrizione

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Gender Barrier Contraception

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0004764
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Similar models

Eligibility HEPATOCELLULAR CARCINOMA NCT00423306

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma | Liver mass Diameter Size | Alpha one fetoprotein measurement | Liver Cirrhosis | Hepatitis B, Chronic | Hepatitis C, Chronic
Item
1. hcc diagnosed by histology or clinical evidence supported by liver mass(es) at least 2cm in the longest diameter and afp equal to or more than 500 ng/ml in cirrhosis or chronic hbv or hcv infection27.
boolean
C2239176 (UMLS CUI [1])
C0240225 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0456389 (UMLS CUI [2,3])
C0201539 (UMLS CUI [3])
C0023890 (UMLS CUI [4])
C0524909 (UMLS CUI [5])
C0524910 (UMLS CUI [6])
Age
Item
2. male or female patients ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
3. patients who have a life expectancy of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
Measurable Lesion Linear Quantity CT scan | Measurable Lesion Linear Quantity MRI
Item
4. patients who have at least one uni-dimensional measurable lesion by ct-scan or mri according to response evaluation criteria in solid tumors (recist).
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0040405 (UMLS CUI [1,4])
C1513041 (UMLS CUI [2,1])
C0205132 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0024485 (UMLS CUI [2,4])
ECOG performance status
Item
5. patients who have an eastern co-operative oncology group (ecog) performance status of 0 - 2 (see appendix 4).
boolean
C1520224 (UMLS CUI [1])
Local Therapy | Operative Surgical Procedures | Therapeutic radiology procedure | Embolization of hepatic artery | Chemoembolization | Radiofrequency ablation | Cryosurgery | Local Therapy Absent Target Lesion | Target Lesion Increased size Percentage | Local Therapy Completed | External Beam Radiation Therapy Restricted
Item
6. patients who have received local therapy, such as surgery, radiation therapy, hepatic arterial embolization, chemo-embolization, radio-frequency ablation or cryo-ablation are eligible, provided that they either have a target lesion which has not been subjected to local therapy and/or the target lesion(s) within the field of the local therapy has shown an increase of ≥ 25% in the size. furthermore, the local therapy applied to target or non-target lesions needs to have been completed at least 8 weeks prior to study inclusion. lesions treated with external beam radiation therapy are not acceptable as target lesions, unless they fulfil the conditions described above.
boolean
C1517925 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0397761 (UMLS CUI [4])
C0796679 (UMLS CUI [5])
C0850292 (UMLS CUI [6])
C0010408 (UMLS CUI [7])
C1517925 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
C2986546 (UMLS CUI [8,3])
C2986546 (UMLS CUI [9,1])
C0332509 (UMLS CUI [9,2])
C0439165 (UMLS CUI [9,3])
C1517925 (UMLS CUI [10,1])
C0205197 (UMLS CUI [10,2])
C1517033 (UMLS CUI [11,1])
C0443288 (UMLS CUI [11,2])
Chemotherapy Quantity | Targeted Therapy Quantity
Item
7. no more than one prior chemotherapy based regimen is allowed. patients can receive up to two regimes where target therapies have been used (washout)
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2985566 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Child-Pugh Classification
Item
8. cirrhotic status of child-pugh class a or b only (appendix 5).
boolean
C2347612 (UMLS CUI [1])
Liver function
Item
9. adequate hepatic function at screening as assessed by the following:
boolean
C0232741 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥ 60 x 109/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin ≥ 8.5 g/dl
boolean
C0518015 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin ≤ 3 mg/dl
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
alt and ast ≤ 5 x upper limit of normal
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Creatinine measurement, serum
Item
serum creatinine ≤ 2.0 x the upper limit of normal
boolean
C0201976 (UMLS CUI [1])
Prothrombin time international normalized ratio (PT-INR) | Prothrombin time assay
Item
pt-inr ≤ 2.3 or pt ≤ 6 seconds above control
boolean
C1821762 (UMLS CUI [1])
C0033707 (UMLS CUI [2])
Informed Consent
Item
10. patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms Previous | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Bladder Neoplasm Superficial TNM clinical staging | Exception Curative treatment Cancer Other
Item
1. previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors [ta, tis and t1] or other malignancies curatively treated > 2 years prior to entry)
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0005695 (UMLS CUI [4,2])
C0205124 (UMLS CUI [4,3])
C3258246 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C1707251 (UMLS CUI [5,3])
Congestive heart failure New York Heart Association Classification
Item
2. congestive heart failure > nyha class ii
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents | Exclusion Adrenergic beta-1 Receptor Antagonists Chronic atrial fibrillation Stable | Exclusion Digoxin Chronic atrial fibrillation Stable | Prolonged QTc
Item
3. cardiac arrhythmias requiring anti-arrythmics (excluding beta blockers or digoxin for chronic stable atrial fibrillation) or qtc greater than 450 msec.
boolean
C0003811 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003195 (UMLS CUI [1,3])
C2828389 (UMLS CUI [2,1])
C0304516 (UMLS CUI [2,2])
C0694539 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
C2828389 (UMLS CUI [3,1])
C0012265 (UMLS CUI [3,2])
C0694539 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
C1969409 (UMLS CUI [4])
Coronary Artery Disease | Myocardial Ischemia
Item
4. active coronary artery disease or cardiac ischemia
boolean
C1956346 (UMLS CUI [1])
C0151744 (UMLS CUI [2])
Bacterial Infections Serious CTCAE Grades | Virus Diseases Serious CTCAE Grades | Mycoses Serious CTCAE Grades
Item
5. active clinically serious bacterial, viral or fungal infections (> grade 2 nci-ctcae, version 3)
boolean
C0004623 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C0042769 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
C0026946 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C1516728 (UMLS CUI [3,3])
HIV Infection Duration | Antiretrovirals Disease Uncontrolled
Item
6. known history of human immunodeficiency virus (hiv) infection for less than 2 years or uncontrolled disease on antiretroviral medication
boolean
C0019693 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C2222813 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
Metastatic malignant neoplasm to brain | Meningeal Neoplasms
Item
7. metastatic brain or meningeal tumors
boolean
C0220650 (UMLS CUI [1])
C0025284 (UMLS CUI [2])
Epilepsy Requirement Pharmaceutical Preparations | Epilepsy Requirement Antiepileptic Agents
Item
8. patients with seizure disorder requiring medication (such as anti-epileptics)
boolean
C0014544 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0014544 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0003299 (UMLS CUI [2,3])
Confusion Interferes with Investigational New Drugs | Dementia Interferes with Investigational New Drugs | Nervous system problem Interferes with Investigational New Drugs
Item
9. history of confusion or dementia or neurological condition that could mask a potential adverse response to the study drug (or something along these lines)
boolean
C0009676 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0497327 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0221571 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
Organ Allograft
Item
10. history of organ allograft
boolean
C0178784 (UMLS CUI [1,1])
C0040739 (UMLS CUI [1,2])
Substance Use Disorders | Medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Social Conditions Interfere with Study Subject Participation Status | Medical condition Interferes with Evaluation Research results | Mental condition Interferes with Evaluation Research results | Social Conditions Interfere with Evaluation Research results
Item
11. substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
boolean
C0038586 (UMLS CUI [1])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0037403 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C1261322 (UMLS CUI [5,3])
C0683954 (UMLS CUI [5,4])
C3840291 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C1261322 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
C0037403 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C1261322 (UMLS CUI [7,3])
C0683954 (UMLS CUI [7,4])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs
Item
12. known or suspected allergy to the investigational agent or any agent given in association with this trial
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
Condition Unstable | Condition compromises Patient safety | Condition compromises Protocol Compliance
Item
13. any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
boolean
C0348080 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Gender Barrier Contraception
Item
14. pregnant or breast-feeding patients. women of childbearing potential must have a negative pregnancy test performed within 14 days prior to the start of study drug. both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0004764 (UMLS CUI [4,2])
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