Resultados da pesquisa - Portal para modelos de dados médicos (portal MDM)

dbGaP phs000384 Genentech Whole Genome Sequencing of Four Hepatocellular Carcinoma Patients - Eligibility

- 12/10/2022 - 5 Formulários, 1 Grupo de itens, 1 Elemento de dados, 1 Idioma

Grupo de itens: IG.elig

Principal Investigator: Zemin Zhang, PhD, Genentech Inc., San Francisco, CA, USA MeSH: Hepatocellular Carcinomas,Hepatitis B https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000384 Hepatitis B virus (HBV) infection is a major risk factor for hepatocellular carcinoma (HCC). In this study we sequenced the whole genome (~80X) and transcriptome of tumor and non-tumor samples from four HCC patients and identified over two hundred HBV integration sites. We found significant clonal expansion of HBV-integrated hepatocytes specifically in the tumor samples. We observed a diverse collection of genomic perturbations near viral integration sites, including gene disruption, viral promoter-driven human transcription, viral-human transcript fusion and DNA copy number alteration. We also sequenced one patient at ultra-high coverage (~240X) to build the most comprehensive HBV-integration landscape yet attempted. Our data suggest that the viral integration significantly expands carcinogenic opportunities in HBV-infected individuals.

Eligibility Hepatitis B NCT00498212

- 27/09/2021 - 1 Formulário, 2 Grupos de itens, 16 Elementos de dados, 1 Idioma

Grupos de itens: Inclusion Criteria, Exclusion Criteria

A Safety and Efficacy Study of a Single or Double Dose of HEPLISAV™ Hepatitis B Vaccine in Adults With End-Stage Renal Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00498212

Eligibility Hepatitis B NCT00657657

- 27/09/2021 - 1 Formulário, 2 Grupos de itens, 18 Elementos de dados, 1 Idioma

Grupos de itens: Inclusion Criteria, Exclusion Criteria

Safety and Immunogenicity of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine; ODM derived from: https://clinicaltrials.gov/show/NCT00657657

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 12, Year 9) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

- 27/09/2021 - 1 Formulário, 7 Grupos de itens, 28 Elementos de dados, 1 Idioma

Grupos de itens: Administrative, Informed Consent, Demographics, Laboratory Tests, Follow-Up Studies, Tracking Document - Reason for non participation, Investigator signature

Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 11, Year 8) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

- 27/09/2021 - 1 Formulário, 7 Grupos de itens, 28 Elementos de dados, 1 Idioma

Grupos de itens: Administrative, Informed Consent, Demographics, Laboratory Tests, Follow-Up Studies, Tracking Document - Reason for non participation, Investigator signature

Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 10, Year 7) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

- 27/09/2021 - 1 Formulário, 7 Grupos de itens, 29 Elementos de dados, 1 Idioma

Grupos de itens: Administrative, Informed Consent, Demographics, Laboratory Tests, Follow-Up Studies, Tracking Document - Reason for non participation, Investigator signature

Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 9, Year 6) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

- 27/09/2021 - 1 Formulário, 7 Grupos de itens, 29 Elementos de dados, 1 Idioma

Grupos de itens: Administrative, Informed Consent, Demographics, Laboratory Tests, Follow-Up Studies, Tracking Document - Reason for non participation, Investigator signature

Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Immunogenicity and safety of hepatitis B vaccine when administered intramuscularly to healthy infants in their first two weeks of life (103860/277) - Annex 2: RAP version of cleaning report defining ELIM code criterion to use

- 20/09/2021 - 1 Formulário, 13 Grupos de itens, 95 Elementos de dados, 1 Idioma

Grupos de itens: RAP version of cleaning report defining ELIM code criterion to use, Summary, Serious adverse events, Pregnancies, Elimination from safety and immunology analysis, Elimination from immunology analysis, Extra Elimination from analysis, Other points to consider - Inform Consent procedure not respected, Other points to consider, Replacement Treatment Number, Pending Queries not to be resolved, Others, Signature

Study ID: 103860/277 Clinical Study ID: 103860/277 Study Title: Phase III study of immunogenicity and safety of 3 doses of GSK Biologicals' thimerosal-free hepatitis B vaccine compared to the US-licensed GSK Biologicals' preservative-free hepatitis B vaccine when administered intramuscularly on a 0, 1, 6-month schedule to healthy infants in their first two weeks of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B