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

Fondaparinux sodium (Arixtra) versus unfractionated heparin with patients undergoing PCI; NCT - Hospital Discharge Visit

- 20/09/2021 - 1 Formulário, 5 Grupos de itens, 39 Elementos de dados, 1 Idioma

Grupos de itens: Administrative Data, Follow-Up Visit, Adverse Event, Interventional procedure, Since, Percutaneous Coronary Intervention, Concomitant Agent

Study ID: 104574 Clinical Study ID: AR1104574 Study Title: A randomized blinded pilot trial of fondaparinux sodium (Arixtra®) versus unfractionated heparin in addition to standard therapy in a broad range of patients undergoing percutaneous coronary intervention (ASPIRE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: fondaparinux sodium Trade Name: Arixtra Study Indication: Thromboembolism

Vital Signs- Follow- Up Pazopanib Macular Degeneration MD1103367 - Vital Signs- Follow- Up

- 20/09/2021 - 1 Formulário, 1 Grupo de itens, 7 Elementos de dados, 1 Idioma

Grupo de itens: Vital signs measurements

Study part: Vital Signs- Follow- Up. A phase 1 single-masked, randomized (with respect to placebo), placebo-controlled, parallel-group, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of repeat oral doses of GW786034 in elderly healthy volunteers. Trade Name: Votrient. Clinical Study ID: MD1103367.

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 13, Year 10) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion Before Booster

- 20/09/2021 - 1 Formulário, 5 Grupos de itens, 14 Elementos de dados, 1 Idioma

Grupos de itens: Administrative, Informed Consent, Demographics, Laboratory Tests, Serology Conclusion Before Booster

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

Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Long-Term Follow Up (Year 11) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Study Conclusion; Tracking Document

- 20/09/2021 - 1 Formulário, 8 Grupos de itens, 33 Elementos de dados, 1 Idioma

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

Study ID: 100556 (Y11) Clinical Study ID: 100556 Study Title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289718 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

Prostatic Surgical Intervention GSK study Prostatic neoplasms NCT00883909

- 20/09/2021 - 1 Formulário, 3 Grupos de itens, 11 Elementos de dados, 1 Idioma

Grupos de itens: Administrative data, prostate surgery, Prostate surgery

Study ID: 103094 Clinical Study ID: ARI103094 Study Title: ARI103094-Follow-Up Study for REDUCE Study Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00883909 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Neoplasms, Prostate

GSK Study ID 100386 & 100387 Persistence of immune response to TWINRIX™ ADULT Long Term Follow up Year 6 - Long Term Follow up Year 6

- 20/09/2021 - 1 Formulário, 5 Grupos de itens, 26 Elementos de dados, 1 Idioma

Grupos de itens: Long Term Follow up Visit 8, Demographics, Laboratory Tests, Blood sample conclusion, Investigator Signature

Phase III, open, randomized study, in two centres, to demonstrate the equivalence of the 0, 12 month schedule to the 0, 6 month schedule with respect to the immunogenicity and to evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals’ combined hepatitis A/ hepatitis B vaccine TWINRIX™ ADULT (720 EL. U. of hepatitis A antigen/ 20 μg of recombinant hepatitis B surface antigen) in healthy volunteers aged from 12 to 15 years inclusive. NCT00197171

Follow-up - GSK Milveterol COPD 100527

- 20/09/2021 - 1 Formulário, 5 Grupos de itens, 42 Elementos de dados, 1 Idioma

Grupos de itens: Vital Signs Follow-up, 12-Lead Electrocardiogram Follow-up, Hematology Follow-up, Clinical chemistry Follow-up, Urinalysis Follow-up

Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

CCR 2011 Template - Concomitant Measures/Medications

- 20/09/2021 - 1 Formulário, 1 Grupo de itens, 12 Elementos de dados, 1 Idioma

Grupo de itens: Concomitant Measures / Medications

Concomitant medications including therapies given to treat adverse events. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ACED3122-FE72-13E1-E040-BB89AD43020F

Hematopoietic Stem Cell Transplantation - Post-HSCT Data (100 Days) 2100 Revision 2

- 20/09/2021 - 1 Formulário, 24 Grupos de itens, 397 Elementos de dados, 1 Idioma

Grupos de itens: Registry Use Only, Identification Data, HSCT Type, Vital Status, Hematopoietic Reconstitution, Granulopoiesis / Neutrophil Recovery, Megakaryopoiesis / Platelet Recovery, Hematology findings, Immune Reconstitution, Chimerism analysis post transplantation, Chimerism Studies - Single Donor, Chimerism Studies - Multiple Donors, Engraftment Syndrome, Acute GVHD, Chronic GVHD, Infection, Pulmonary Function, Liver, Other Organ Impairment, New malignancy, Functional Status, Subsequent HSCT, Donor Cellular Infusion, Author Information

2100 Revision 2 - 100 Days Post-HSCT Data Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9FB3D5BF-EA64-EEEB-E040-BB89AD4331BD

Follow-Up for Greater Than Two Years Post-HSCT Data

- 20/09/2021 - 1 Formulário, 14 Grupos de itens, 255 Elementos de dados, 1 Idioma

Grupos de itens: Registry Use Only, Identification Data, HSCT Type, Product Type, Follow Up Visit, Vital Status, Functional Status, Acute GVHD, Chronic GVHD, New Malignancy, Other Organ Impairment, Subsequent HSCT, Donor Cellular Infusion, Author Information

2300 Revision 2 - Yearly Follow-Up for Greater Than Two Years Post-HSCT Data Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=849DFDB6-D6C2-FF34-E040-BB89AD431324

2005 Confirmation of HLA typing - NHLBI

- 20/09/2021 - 1 Formulário, 12 Grupos de itens, 81 Elementos de dados, 1 Idioma

Grupos de itens: Registry Use Only, Identification Data, HSCT, Product Type, HLA Typing Source, HLA Typing by DNA Technology, HLA Typing by DNA Technology: Class I , HLA Typing by DNA Technology: Class I , HLA Typing by DNA Technology: Class II (Optional) , Antigens Defined by Serologic Typing , Optional Antigen Reporting: Antigens Defined by Serologic Typing , Author Information

Confirmation of HLA Typing Uses The ISO Date Format Version 1 This form must be completed for all non-NMDP allogeneic or syngeneic donors or recipients, or non-NMDP cord blood units. If the donor, recipient, or cord blood unit was secured through the NMDP, then report HLA typing on the appropriate NMDP forms. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6AA94BD8-0ED4-61A3-E040-BB89AD434BE8

HSCT recipients - Cause of death

- 20/09/2021 - 1 Formulário, 9 Grupos de itens, 24 Elementos de dados, 1 Idioma

Grupos de itens: Registry Use Only, Identification Data, HSCT Type , Product Type, Death Date, Autopsy report, Primary Cause of Death, Secondary Cause of Death, Author Information

To define the primary and contributing causes of death for HSCT recipients reported as dead on follow up forms 2900 - RECIPIENT DEATH DATA Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6B9DD88E-9E08-08A7-E040-BB89AD430716

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