ID

44497

Beschreibung

Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy in Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01798134

Link

https://clinicaltrials.gov/show/NCT01798134

Stichworte

Versionen (2)
  1. 16.05.20 16.05.20 -
  2. 27.09.21 27.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

27. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01798134

Englisch

Eligibility Hepatocellular Carcinoma NCT01798134

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with a confirmed diagnosis of hcc according to the easl criteria for diagnosis, and staged according to the bclc criteria
Beschreibung

Liver carcinoma | Hepatocellular Carcinoma by BCLC Stage

Datentyp

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2]
C3898888
2. subject is competent and willing to provide written informed consent in order to participate in the study
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
3. adults (male or female) patients ≥ 18 years of age
Beschreibung

Adult | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
4. ecog performance status 0-2 or child pugh classification is 0-11
Beschreibung

ECOG performance status | Child-Pugh Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C4050412
5. multidonar or single nodular tumor ≥3-10cm, patients with bilobar disease who can be treated superselectively in a single session or both lobes able to be treated within 3-5 weeks. patient must have at least one tumor lesion that meets the following criteria: lesion can be accurately measured in at least one dimension according to mrecist criteria
Beschreibung

Tumor Multinodular | Tumor Single nodule | Tumor size | Disease Bilobar | Measurable lesion Dimension Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0205416
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C2221193
UMLS CUI [3]
C0475440
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0444465
UMLS CUI [5,1]
C1513041
UMLS CUI [5,2]
C0439534
UMLS CUI [5,3]
C1265611
6. no invasion in the major blood vessel (hepatic portal, hepatic vein) or bile duct by the mri or ct
Beschreibung

Invasion Absent Blood Vessel Major | Invasion Absent Hepatic portal | Invasion Absent Hepatic vein | Invasion Absent Bile duct | MRI | CT

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1269955
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0005847
UMLS CUI [1,4]
C0205164
UMLS CUI [2,1]
C1269955
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0227498
UMLS CUI [3,1]
C1269955
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0019155
UMLS CUI [4,1]
C1269955
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0005400
UMLS CUI [5]
C0024485
UMLS CUI [6]
C0040405
7. proper blood, liver, renal, heart function: testing result within 2 weeks from registry of this study
Beschreibung

Hematologic function | Liver function | Renal function | Cardiac function

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
UMLS CUI [4]
C0232164
8. no current infections requiring antibiotic therapy
Beschreibung

Exclusion | Communicable Diseases Requirement Antibiotic therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0338237
9. not actively on cumarin based anticoagulation or suffering from a known bleeding disorder
Beschreibung

Exclusion Criteria | Coumarin Anticoagulation Therapy | Blood Coagulation Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0010206
UMLS CUI [2,2]
C0003281
UMLS CUI [3]
C0005779
10. measurable disease per the response evaluation criteria in solid tumors (mrecist)
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
11. expected survival more than 6 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. ecog performance status >2; or child-pugh class c11 or more, or asa class 5
Beschreibung

ECOG performance status | Child-Pugh Classification | ASA physical status class

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C4050412
UMLS CUI [3]
C0578808
2. bilirubin levels >3 mg/dl
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
3. hcc with large vessel or biliary duct invasion, diffuse hcc or extrahepatic spread
Beschreibung

Liver carcinoma | Invasion Large vessel | Invasion Bile duct | Liver carcinoma Diffuse | Spread Extrahepatic

Datentyp

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C1269955
UMLS CUI [2,2]
C0225990
UMLS CUI [3,1]
C1269955
UMLS CUI [3,2]
C0005400
UMLS CUI [4,1]
C2239176
UMLS CUI [4,2]
C0205219
UMLS CUI [5,1]
C0332261
UMLS CUI [5,2]
C1517058
4. patients in which any of the following are contraindicated or present:
Beschreibung

Medical contraindication Specified Any

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C1552551
the use of doxorubicin
Beschreibung

Doxorubicin

Datentyp

boolean

Alias
UMLS CUI [1]
C0013089
mri
Beschreibung

MRI

Datentyp

boolean

Alias
UMLS CUI [1]
C0024485
hepatic embolization procedures
Beschreibung

Hepatic embolisation

Datentyp

boolean

Alias
UMLS CUI [1]
C0744813
wbc < 3000 cells/mm3
Beschreibung

White Blood Cell Count procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
neutrophil < 1500 cells/mm3
Beschreibung

Neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0200633
cardiac ejection fraction < 50 percent assessed by isotopic ventriculography, echocardiography or mr
Beschreibung

Cardiac ejection fraction Radionuclide Ventriculography | Cardiac ejection fraction Echocardiography | Cardiac ejection fraction MRI

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0034610
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0013516
UMLS CUI [3,1]
C0232174
UMLS CUI [3,2]
C0024485
elevated creatinine greater than or equal to 2.5 mg/dl
Beschreibung

Serum creatinine raised

Datentyp

boolean

Alias
UMLS CUI [1]
C0700225
impaired clotting test (platelet count < 5 x 104/mm3, pt-inr > 2.0)
Beschreibung

Clotting test Impaired | Platelet Count measurement | PT-INR

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1277719
UMLS CUI [1,2]
C0221099
UMLS CUI [2]
C0032181
UMLS CUI [3]
C1821762
ast and/or alt >5x uln or, when greater >250 u/l
Beschreibung

Aspartate aminotransferase increased | Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
known hepatofugal blood flow
Beschreibung

Hepatofugal flow

Datentyp

boolean

Alias
UMLS CUI [1]
C4086746
arterio-venous shunt
Beschreibung

Arteriovenous fistula

Datentyp

boolean

Alias
UMLS CUI [1]
C0003855
arterio-portal shunt
Beschreibung

Portasystemic shunt Arterial | Other Coding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0948900
UMLS CUI [1,2]
C0221464
UMLS CUI [2]
C3846158
main stem portal vein occlusion(point 6 in inclusion criteria)
Beschreibung

Main portal venous trunk Occlusion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1183135
UMLS CUI [1,2]
C0028778
5. women who are pregnant or breast feeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
6. allergy to iodinated contrast used for angiography
Beschreibung

Allergic reaction to iodinated contrast material

Datentyp

boolean

Alias
UMLS CUI [1]
C2215738
7. tumour burden of more than 50% of liver
Beschreibung

Tumor Burden Liver Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1449699
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0439165
8. patients with objective signs of active bacterial, viral (hiv), or fungal infection
Beschreibung

Signs Bacterial Infections | Signs Virus Diseases | Signs HIV Infections | Signs Mycoses

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C0004623
UMLS CUI [2,1]
C0311392
UMLS CUI [2,2]
C0042769
UMLS CUI [3,1]
C0311392
UMLS CUI [3,2]
C0019693
UMLS CUI [4,1]
C0311392
UMLS CUI [4,2]
C0026946
9. other primary malignancies or evidence of metastatic disease
Beschreibung

Cancer Other | Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2]
C0027627
10. patients previously treated with anthracyclines (other than doxorubicin).
Beschreibung

Anthracyclines | Exception Doxorubicin

Datentyp

boolean

Alias
UMLS CUI [1]
C0282564
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0013089
11. any co-morbid disease or condition or event that, in the investigator's judgment, would place the patient at undue risk that would preclude the safe use of deb-tace.
Beschreibung

Comorbidity At risk Patient | Condition At risk Patient | Event At risk Patient | Comorbidity Excludes DEB-TACE | Condition Excludes DEB-TACE | Event Excludes DEB-TACE

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0030705
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0030705
UMLS CUI [3,1]
C0441471
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0030705
UMLS CUI [4,1]
C0009488
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C3273294
UMLS CUI [4,4]
C3539919
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C0332196
UMLS CUI [5,3]
C3273294
UMLS CUI [5,4]
C3539919
UMLS CUI [6,1]
C0441471
UMLS CUI [6,2]
C0332196
UMLS CUI [6,3]
C3273294
UMLS CUI [6,4]
C3539919
12. under no circumstances should patients be enrolled in this study who is already participating in another study for treatment of primary liver cancer.
Beschreibung

Study Subject Participation Status | Clinical Trial Therapy Primary Malignant Liver Neoplasm

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0024620
13. under no circumstances should patients be enrolled in this study who has received any other embolotherapy (including sirt) for the treatment of primary liver cancer.
Beschreibung

Embolotherapy Primary Malignant Liver Neoplasm | SIRT

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013931
UMLS CUI [1,2]
C0024620
UMLS CUI [2]
C1831994
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Ähnliche Modelle

Eligibility Hepatocellular Carcinoma NCT01798134

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma | Hepatocellular Carcinoma by BCLC Stage
Item
1. patients with a confirmed diagnosis of hcc according to the easl criteria for diagnosis, and staged according to the bclc criteria
boolean
C2239176 (UMLS CUI [1])
C3898888 (UMLS CUI [2])
Informed Consent
Item
2. subject is competent and willing to provide written informed consent in order to participate in the study
boolean
C0021430 (UMLS CUI [1])
Adult | Age
Item
3. adults (male or female) patients ≥ 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
ECOG performance status | Child-Pugh Classification
Item
4. ecog performance status 0-2 or child pugh classification is 0-11
boolean
C1520224 (UMLS CUI [1])
C4050412 (UMLS CUI [2])
Tumor Multinodular | Tumor Single nodule | Tumor size | Disease Bilobar | Measurable lesion Dimension Quantity
Item
5. multidonar or single nodular tumor ≥3-10cm, patients with bilobar disease who can be treated superselectively in a single session or both lobes able to be treated within 3-5 weeks. patient must have at least one tumor lesion that meets the following criteria: lesion can be accurately measured in at least one dimension according to mrecist criteria
boolean
C0027651 (UMLS CUI [1,1])
C0205416 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C2221193 (UMLS CUI [2,2])
C0475440 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C0444465 (UMLS CUI [4,2])
C1513041 (UMLS CUI [5,1])
C0439534 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
Invasion Absent Blood Vessel Major | Invasion Absent Hepatic portal | Invasion Absent Hepatic vein | Invasion Absent Bile duct | MRI | CT
Item
6. no invasion in the major blood vessel (hepatic portal, hepatic vein) or bile duct by the mri or ct
boolean
C1269955 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0005847 (UMLS CUI [1,3])
C0205164 (UMLS CUI [1,4])
C1269955 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0227498 (UMLS CUI [2,3])
C1269955 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0019155 (UMLS CUI [3,3])
C1269955 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0005400 (UMLS CUI [4,3])
C0024485 (UMLS CUI [5])
C0040405 (UMLS CUI [6])
Hematologic function | Liver function | Renal function | Cardiac function
Item
7. proper blood, liver, renal, heart function: testing result within 2 weeks from registry of this study
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0232164 (UMLS CUI [4])
Exclusion | Communicable Diseases Requirement Antibiotic therapy
Item
8. no current infections requiring antibiotic therapy
boolean
C0680251 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0338237 (UMLS CUI [2,3])
Exclusion Criteria | Coumarin Anticoagulation Therapy | Blood Coagulation Disorders
Item
9. not actively on cumarin based anticoagulation or suffering from a known bleeding disorder
boolean
C0680251 (UMLS CUI [1])
C0010206 (UMLS CUI [2,1])
C0003281 (UMLS CUI [2,2])
C0005779 (UMLS CUI [3])
Measurable Disease
Item
10. measurable disease per the response evaluation criteria in solid tumors (mrecist)
boolean
C1513041 (UMLS CUI [1])
Life Expectancy
Item
11. expected survival more than 6 months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ECOG performance status | Child-Pugh Classification | ASA physical status class
Item
1. ecog performance status >2; or child-pugh class c11 or more, or asa class 5
boolean
C1520224 (UMLS CUI [1])
C4050412 (UMLS CUI [2])
C0578808 (UMLS CUI [3])
Serum total bilirubin measurement
Item
2. bilirubin levels >3 mg/dl
boolean
C1278039 (UMLS CUI [1])
Liver carcinoma | Invasion Large vessel | Invasion Bile duct | Liver carcinoma Diffuse | Spread Extrahepatic
Item
3. hcc with large vessel or biliary duct invasion, diffuse hcc or extrahepatic spread
boolean
C2239176 (UMLS CUI [1])
C1269955 (UMLS CUI [2,1])
C0225990 (UMLS CUI [2,2])
C1269955 (UMLS CUI [3,1])
C0005400 (UMLS CUI [3,2])
C2239176 (UMLS CUI [4,1])
C0205219 (UMLS CUI [4,2])
C0332261 (UMLS CUI [5,1])
C1517058 (UMLS CUI [5,2])
Medical contraindication Specified Any
Item
4. patients in which any of the following are contraindicated or present:
boolean
C1301624 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Doxorubicin
Item
the use of doxorubicin
boolean
C0013089 (UMLS CUI [1])
MRI
Item
mri
boolean
C0024485 (UMLS CUI [1])
Hepatic embolisation
Item
hepatic embolization procedures
boolean
C0744813 (UMLS CUI [1])
White Blood Cell Count procedure
Item
wbc < 3000 cells/mm3
boolean
C0023508 (UMLS CUI [1])
Neutrophil count
Item
neutrophil < 1500 cells/mm3
boolean
C0200633 (UMLS CUI [1])
Cardiac ejection fraction Radionuclide Ventriculography | Cardiac ejection fraction Echocardiography | Cardiac ejection fraction MRI
Item
cardiac ejection fraction < 50 percent assessed by isotopic ventriculography, echocardiography or mr
boolean
C0232174 (UMLS CUI [1,1])
C0034610 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
C0232174 (UMLS CUI [3,1])
C0024485 (UMLS CUI [3,2])
Serum creatinine raised
Item
elevated creatinine greater than or equal to 2.5 mg/dl
boolean
C0700225 (UMLS CUI [1])
Clotting test Impaired | Platelet Count measurement | PT-INR
Item
impaired clotting test (platelet count < 5 x 104/mm3, pt-inr > 2.0)
boolean
C1277719 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0032181 (UMLS CUI [2])
C1821762 (UMLS CUI [3])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
ast and/or alt >5x uln or, when greater >250 u/l
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Hepatofugal flow
Item
known hepatofugal blood flow
boolean
C4086746 (UMLS CUI [1])
Arteriovenous fistula
Item
arterio-venous shunt
boolean
C0003855 (UMLS CUI [1])
Portasystemic shunt Arterial | Other Coding
Item
arterio-portal shunt
boolean
C0948900 (UMLS CUI [1,1])
C0221464 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
Main portal venous trunk Occlusion
Item
main stem portal vein occlusion(point 6 in inclusion criteria)
boolean
C1183135 (UMLS CUI [1,1])
C0028778 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
5. women who are pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Allergic reaction to iodinated contrast material
Item
6. allergy to iodinated contrast used for angiography
boolean
C2215738 (UMLS CUI [1])
Tumor Burden Liver Percentage
Item
7. tumour burden of more than 50% of liver
boolean
C1449699 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Signs Bacterial Infections | Signs Virus Diseases | Signs HIV Infections | Signs Mycoses
Item
8. patients with objective signs of active bacterial, viral (hiv), or fungal infection
boolean
C0311392 (UMLS CUI [1,1])
C0004623 (UMLS CUI [1,2])
C0311392 (UMLS CUI [2,1])
C0042769 (UMLS CUI [2,2])
C0311392 (UMLS CUI [3,1])
C0019693 (UMLS CUI [3,2])
C0311392 (UMLS CUI [4,1])
C0026946 (UMLS CUI [4,2])
Cancer Other | Neoplasm Metastasis
Item
9. other primary malignancies or evidence of metastatic disease
boolean
C1707251 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
Anthracyclines | Exception Doxorubicin
Item
10. patients previously treated with anthracyclines (other than doxorubicin).
boolean
C0282564 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0013089 (UMLS CUI [2,2])
Comorbidity At risk Patient | Condition At risk Patient | Event At risk Patient | Comorbidity Excludes DEB-TACE | Condition Excludes DEB-TACE | Event Excludes DEB-TACE
Item
11. any co-morbid disease or condition or event that, in the investigator's judgment, would place the patient at undue risk that would preclude the safe use of deb-tace.
boolean
C0009488 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
C0441471 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0030705 (UMLS CUI [3,3])
C0009488 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C3273294 (UMLS CUI [4,3])
C3539919 (UMLS CUI [4,4])
C0348080 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
C3273294 (UMLS CUI [5,3])
C3539919 (UMLS CUI [5,4])
C0441471 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
C3273294 (UMLS CUI [6,3])
C3539919 (UMLS CUI [6,4])
Study Subject Participation Status | Clinical Trial Therapy Primary Malignant Liver Neoplasm
Item
12. under no circumstances should patients be enrolled in this study who is already participating in another study for treatment of primary liver cancer.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0024620 (UMLS CUI [2,3])
Embolotherapy Primary Malignant Liver Neoplasm | SIRT
Item
13. under no circumstances should patients be enrolled in this study who has received any other embolotherapy (including sirt) for the treatment of primary liver cancer.
boolean
C0013931 (UMLS CUI [1,1])
C0024620 (UMLS CUI [1,2])
C1831994 (UMLS CUI [2])
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