ID

15276

Descripción

Liver Cancer Immunotherapy: Placebo-controlled Clinical Trial of Hepcortespenlisimu (V5); ODM derived from: https://clinicaltrials.gov/show/NCT02232490

Link

https://clinicaltrials.gov/show/NCT02232490

Palabras clave

Versiones (1)
  1. 24/5/16 24/5/16 -
Subido en

24 de mayo de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT02232490

Inglés

Eligibility Hepatocellular Carcinoma NCT02232490

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects who are at least 18 years old and are willing and capable of providing informed consent. both men and non-pregnant women will be included.
Descripción

Age | Informed Consent | Not pregnant

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
UMLS CUI [3]
C0232973
hcc diagnosis documented prior to study entry by either cytology/histology, ct scan, and afp serum test higher or equal to 30 iu/ml.
Descripción

Liver carcinoma | Cytology | Histology | X-Ray Computed Tomography | Alpha one fetoprotein measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2]
C1305671
UMLS CUI [3]
C0344441
UMLS CUI [4]
C0040405
UMLS CUI [5]
C0201539
all subjects with reproductive potential are advised to utilize effective contraception throughout the course of this study.
Descripción

Females & males of reproductive potential Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
health score status at baseline. agreement to participate in the study and to give at least 3 samples of blood for lab tests.
Descripción

Health assessment questionnaire score | Informed Consent | Collection of blood specimen for laboratory procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2960025
UMLS CUI [2]
C0021430
UMLS CUI [3]
C0005834
readily available home or o other address where patient can be found. -
Descripción

Home Availability | Address Availability

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0442519
UMLS CUI [1,2]
C0470187
UMLS CUI [2,1]
C1442065
UMLS CUI [2,2]
C0470187
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who might have already taken v5 in prior trials and have no baseline data. those who met inclusion criteria can be retrospectively enrolled. pregnant or breast-feeding women are excluded.
Descripción

Investigational New Drug Intake Previous | Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1512806
UMLS CUI [1,3]
C0205156
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
subjects who have taken other immunomodulatory therapies within 2 months prior to entry: systemic corticosteroids, immune globulin (iv gamma globulin, ivig), interferons, interleukins, pentoxifylline (trental), thalidomide, filgrastim (g-csf), sargramostim (gm-csf); dinitrochlorobenzene (dncb), thymosin alpha 1 (thymosin alpha), thymopentin, inosiplex (isoprinosine), polyribonucleoside (ampligen), ditiocarb sodium (imuthiol), any locally available immune modulators, and any other therapeutic or preventive hcc vaccine. subjects requiring concurrent participation in another experimental research treatment study, or who received an experimental agent within four weeks prior to study entry.
Descripción

Immunomodulation Other | systemic steroids | Immunoglobulin Therapy | Gamma globulin Intravenous | Immunoglobulins, Intravenous | Interferons | Interleukins | Pentoxifylline | Trental | Thalidomide | Filgrastim | sargramostim | Dinitrochlorobenzene | alpha-Thymosin | thymalfasin | Thymopentin | Inosine Pranobex | Isoprinosin | Ampligen | Ditiocarb Sodium | Imuthiol | Biological Response Modifiers | Liver carcinoma Vaccines | Study Subject Participation Status | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1963758
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C2825233
UMLS CUI [3]
C0021022
UMLS CUI [4,1]
C0017007
UMLS CUI [4,2]
C0348016
UMLS CUI [5]
C0085297
UMLS CUI [6]
C0021747
UMLS CUI [7]
C0021764
UMLS CUI [8]
C0030899
UMLS CUI [9]
C0699487
UMLS CUI [10]
C0039736
UMLS CUI [11]
C0210630
UMLS CUI [12]
C0216231
UMLS CUI [13]
C0012460
UMLS CUI [14]
C0368651
UMLS CUI [15]
C0076612
UMLS CUI [16]
C0080225
UMLS CUI [17]
C0022230
UMLS CUI [18]
C0795760
UMLS CUI [19]
C0051764
UMLS CUI [20]
C0700086
UMLS CUI [21]
C0878291
UMLS CUI [22]
C0005525
UMLS CUI [23,1]
C2239176
UMLS CUI [23,2]
C0042210
UMLS CUI [24]
C2348568
UMLS CUI [25]
C0013230
evidence of active or acute cardiac disease, epilepsy, or life-threatening diseases unrelated to hcc.
Descripción

Heart Diseases | Epilepsy | Disease Life Threatening

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0014544
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C2826244
medical conditions such as active alcohol or substance abuse, or psychological issues that in the opinion of the local investigator would interfere with adherence to the requirements of this study.
Descripción

Medical condition Interferes with Study Protocol | Substance Use Disorders | Mental problem

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1699700
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348563
UMLS CUI [2]
C0038586
UMLS CUI [3]
C0848067
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Similar models

Eligibility Hepatocellular Carcinoma NCT02232490

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent | Not pregnant
Item
subjects who are at least 18 years old and are willing and capable of providing informed consent. both men and non-pregnant women will be included.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0232973 (UMLS CUI [3])
Liver carcinoma | Cytology | Histology | X-Ray Computed Tomography | Alpha one fetoprotein measurement
Item
hcc diagnosis documented prior to study entry by either cytology/histology, ct scan, and afp serum test higher or equal to 30 iu/ml.
boolean
C2239176 (UMLS CUI [1])
C1305671 (UMLS CUI [2])
C0344441 (UMLS CUI [3])
C0040405 (UMLS CUI [4])
C0201539 (UMLS CUI [5])
Females & males of reproductive potential Contraceptive methods
Item
all subjects with reproductive potential are advised to utilize effective contraception throughout the course of this study.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Health assessment questionnaire score | Informed Consent | Collection of blood specimen for laboratory procedure
Item
health score status at baseline. agreement to participate in the study and to give at least 3 samples of blood for lab tests.
boolean
C2960025 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0005834 (UMLS CUI [3])
Home Availability | Address Availability
Item
readily available home or o other address where patient can be found. -
boolean
C0442519 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C1442065 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Investigational New Drug Intake Previous | Pregnancy | Breast Feeding
Item
subjects who might have already taken v5 in prior trials and have no baseline data. those who met inclusion criteria can be retrospectively enrolled. pregnant or breast-feeding women are excluded.
boolean
C0013230 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Immunomodulation Other | systemic steroids | Immunoglobulin Therapy | Gamma globulin Intravenous | Immunoglobulins, Intravenous | Interferons | Interleukins | Pentoxifylline | Trental | Thalidomide | Filgrastim | sargramostim | Dinitrochlorobenzene | alpha-Thymosin | thymalfasin | Thymopentin | Inosine Pranobex | Isoprinosin | Ampligen | Ditiocarb Sodium | Imuthiol | Biological Response Modifiers | Liver carcinoma Vaccines | Study Subject Participation Status | Investigational New Drugs
Item
subjects who have taken other immunomodulatory therapies within 2 months prior to entry: systemic corticosteroids, immune globulin (iv gamma globulin, ivig), interferons, interleukins, pentoxifylline (trental), thalidomide, filgrastim (g-csf), sargramostim (gm-csf); dinitrochlorobenzene (dncb), thymosin alpha 1 (thymosin alpha), thymopentin, inosiplex (isoprinosine), polyribonucleoside (ampligen), ditiocarb sodium (imuthiol), any locally available immune modulators, and any other therapeutic or preventive hcc vaccine. subjects requiring concurrent participation in another experimental research treatment study, or who received an experimental agent within four weeks prior to study entry.
boolean
C1963758 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2825233 (UMLS CUI [2])
C0021022 (UMLS CUI [3])
C0017007 (UMLS CUI [4,1])
C0348016 (UMLS CUI [4,2])
C0085297 (UMLS CUI [5])
C0021747 (UMLS CUI [6])
C0021764 (UMLS CUI [7])
C0030899 (UMLS CUI [8])
C0699487 (UMLS CUI [9])
C0039736 (UMLS CUI [10])
C0210630 (UMLS CUI [11])
C0216231 (UMLS CUI [12])
C0012460 (UMLS CUI [13])
C0368651 (UMLS CUI [14])
C0076612 (UMLS CUI [15])
C0080225 (UMLS CUI [16])
C0022230 (UMLS CUI [17])
C0795760 (UMLS CUI [18])
C0051764 (UMLS CUI [19])
C0700086 (UMLS CUI [20])
C0878291 (UMLS CUI [21])
C0005525 (UMLS CUI [22])
C2239176 (UMLS CUI [23,1])
C0042210 (UMLS CUI [23,2])
C2348568 (UMLS CUI [24])
C0013230 (UMLS CUI [25])
Heart Diseases | Epilepsy | Disease Life Threatening
Item
evidence of active or acute cardiac disease, epilepsy, or life-threatening diseases unrelated to hcc.
boolean
C0018799 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C2826244 (UMLS CUI [3,2])
Medical condition Interferes with Study Protocol | Substance Use Disorders | Mental problem
Item
medical conditions such as active alcohol or substance abuse, or psychological issues that in the opinion of the local investigator would interfere with adherence to the requirements of this study.
boolean
C1699700 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0038586 (UMLS CUI [2])
C0848067 (UMLS CUI [3])
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