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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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Swedish Stroke Registry RIKSSTROKE - 2-years Follow-up

- 9/20/21 - 1 form, 1 itemgroup, 41 items, 2 languages
Itemgroup: RIKS-STRROKE - 2 YEARS FOLLOW-UP
Schwedisches Schlaganfallregister RIKSSTROKE Quelle: http://www.riksstroke.org/eng/ Riksstroke – a Swedish national quality register for stroke care primarily aimed at health professionals and decision makers in health care. We collect, analyze and follow-up data on morbidity and hospital stay. 2-years Follow-up

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

- 9/20/21 - 1 form, 5 itemgroups, 39 items, 1 language
Itemgroups: 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

- 9/20/21 - 1 form, 1 itemgroup, 7 items, 1 language
Itemgroup: 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

- 9/20/21 - 1 form, 5 itemgroups, 14 items, 1 language
Itemgroups: 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

- 9/20/21 - 1 form, 8 itemgroups, 33 items, 1 language
Itemgroups: 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

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

- 9/20/21 - 1 form, 5 itemgroups, 26 items, 1 language
Itemgroups: 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

- 9/20/21 - 1 form, 5 itemgroups, 42 items, 1 language
Itemgroups: 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

- 9/20/21 - 1 form, 1 itemgroup, 12 items, 1 language
Itemgroup: 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

- 9/20/21 - 1 form, 24 itemgroups, 397 items, 1 language
Itemgroups: 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

- 9/20/21 - 1 form, 14 itemgroups, 255 items, 1 language
Itemgroups: 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

- 9/20/21 - 1 form, 12 itemgroups, 81 items, 1 language
Itemgroups: 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

- 9/20/21 - 1 form, 9 itemgroups, 24 items, 1 language
Itemgroups: 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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