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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
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Rezidiv / Tod EudraCT-Nr 2008-004583-40 Akute myeloische Leukämie(AML) AML alle außer FAB M3 - Rezidiv / Tod

- 9/17/21 - 1 form, 8 itemgroups, 60 items, 2 languages
Itemgroups: Patientendaten, Differentialblutbild, Knochenmarkuntersuchung, Zytologie, Molekulargenetik, Unterschrift, Patientendaten, Unterschrift
A randomized, multi-center phase II trial to assess the efficacy of 5-azacytidine added to standard primary therapy in elderly patients with newly diagnosed AML

Collaborative Research Center | Transregio 240 (Sonderforschungsbereich Transregio 240) - Follow-Up all centres

- 9/17/21 - 1 form, 6 itemgroups, 25 items, 1 language
Itemgroups: Patient-ID, Follow-Up, Demography: Living situation, Clinical endpoints, WHO (Five) Well-Being Index, Level 2 - Stroke
A central patient cohort within the interdisciplinary Collaborative Research Center / Transregio 240 aims to examine the role and function of platelets in different vascular diseases. This form contains the WHO-5-well being index: WORLD HEALTH ORGANIZATION, REGIONAL OFFICE FOR EUROPE, 1998. Use of well-being measures in primary health care - the DepCare project health for all. Target 12. E60246. Geneva: WHO. This form contains the modified Rankin Scale: Rankin J. Cerebral vascular accidents in patients over the age of 60: II. Prognosis Scottish Med J. 1957; 2: 200–215. This form contains the Barthel-Index: Mahoney F. Barthel D. Functional evaluation: the Barthel Index. Md Med J.1965; 14:61–65. This form contains the Fourth Universal Definition of Myocardial Infarction: Thygesen K et al. Fourth universal definition of myocardial infarction (2018). Eur Heart J 2019; 40(3):237-69.

Follow-Up - Lung Cancer - Localized Disease Follow-Up Form - 2019386v2.31 - Lung Cancer - Localized Disease Follow-Up Form

- 9/17/21 - 1 form, 8 itemgroups, 48 items, 1 language
Itemgroups: CRF Header, Lung: Vital Status, Lung: Disease Follow-Up Status, Lung: Notice of Progression/Site, Lung: Non-Protocol Therapy, Lung: Notice of New Primary, Lung: Long-Term Toxicity, Comments
Lung Cancer - Localized Disease Follow-Up Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=99CD59C5-A8FE-3FA4-E034-080020C9C0E0

Prostate Cancer NCT00499174 Follow-Up - NCIC-PR.11 Form 5S - Follow-Up after Distant Progression - 2457398v1.0 - NCIC-PR.11 Form 5S - Follow-Up after Distant Progression

- 9/17/21 - 1 form, 9 itemgroups, 48 items, 1 language
Itemgroups: Patient Information, Month of Report, Physical Exam, Adverse Event Status, Therapy for Lower Urinary Tract Symptoms/Prostate Cancer since the last report, Other Malignancies or Marrow Dysplasia, Comments, Supporting Documentation, Form Completion
NCIC-PR.11 Form 5S - Follow-Up after Distant Progression Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0EF819B0-5956-1C96-E044-0003BA3F9857

Breast Cancer NCT01101438 Follow-Up - NCIC MA.32 Short Follow-Up Report Form - 3026031v1.0 - NCIC MA.32 Short Follow-Up Report Form

- 9/17/21 - 1 form, 24 itemgroups, 118 items, 1 language
Itemgroups: TIMING OF REPORT - FOLLOW-UP, DISEASE STATUS, IN SITU DISEASE FOLLOW-UP, KIT RETURN - QUESTION, KIT RETURN, KIT DISPENSION - QUESTION, KIT DISPENSATION, METFORMIN/PLACEBO ADMINISTRATION - RAMP-UP, METFORMIN/PLACEBO ADMINISTRATION, RADIOLOGY INVESTIGATIONS - QUESTION, RADIOLOGY INVESTIGATIONS, HEMATOLOGY , BIOCHEMISTRY, SERIOUS ADVERSE EVENT - QUESTION, ADVERSE EVENTS ON TREATMENT - QUESTION, ADVERSE EVENTS, CARDIOVASCULAR MORBIDITY - QUESTION, CARDIOVASCULAR MOBIDITY, CANCER TREATMENT SINCE LAST REPORT ¿ QUESTION, CANCER TREATMENT SINCE LAST REPORT, MAJOR MEDICAL PROBLEMS, QUESTIONNAIRES, Comments, Contact Information
NCIC MA.32 Short Follow-Up Report Form A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=81DD7330-A8C4-A3E4-E040-BB89AD43612E

GSK TWINRIX™ Hepatitis A and B Vaccine: Persistence of Immune Response in 0,6 Month vs. 0,1,6 Month Schedule NCT00197119 - Longterm Follow-up Visit 12

- 9/17/21 - 1 form, 6 itemgroups, 23 items, 1 language
Itemgroups: Informed consent, Demographics, Laboratory Tests, Follow-up studies, Investigator signature, Tracking Document Reason for non participation
GSK TWINRIX™ Hepatitis A and B Vaccine: Persistence of Immune Response in 0,6 Month vs. 0,1,6 Month Schedule NCT00197119 - Longterm Follow-up VISIT 12 - YEAR 7 - 84 MONTHS + 2 MONTHS Study ID: 100566 Clinical Study ID: 100566 Study Title: Evaluate Persistence of Immune Response of GSK Biologicals’ TWINRIX™ Vaccine Administered According to 0,6 Month Schedule Versus TWINRIX™ JUNIOR Administered According to 0,1,6 Month Schedule, in Subjects Aged 12-15 years at Time of First Vaccine Dose Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197119 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: BIO HAB; Twinrix Study Indication: Hepatitis A; Hepatitis B

GSK TWINRIX™ Hepatitis A and B Vaccine: Persistence of Immune Response in 0,6 Month vs. 0,1,6 Month Schedule NCT00197119 - Longterm Follow-up Visit 11

- 9/17/21 - 1 form, 6 itemgroups, 23 items, 1 language
Itemgroups: Informed consent, Demographics, Laboratory Tests, Follow-up studies, Investigator signature, Tracking Document Reason for non participation
GSK TWINRIX™ Hepatitis A and B Vaccine: Persistence of Immune Response in 0,6 Month vs. 0,1,6 Month Schedule NCT00197119 - Longterm Follow-up Visit 11 - YEAR 6 - 72 MONTHS + 2 MONTHS Study ID: 100566 Clinical Study ID: 100566 Study Title: Evaluate Persistence of Immune Response of GSK Biologicals’ TWINRIX™ Vaccine Administered According to 0,6 Month Schedule Versus TWINRIX™ JUNIOR Administered According to 0,1,6 Month Schedule, in Subjects Aged 12-15 years at Time of First Vaccine Dose Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197119 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: BIO HAB; Twinrix Study Indication: Hepatitis A; Hepatitis B

GSK TWINRIX™ Hepatitis A and B Vaccine: Persistence of Immune Response in 0,6 Month vs. 0,1,6 Month Schedule NCT00197119 - Longterm Follow-up Visit 13

- 9/17/21 - 1 form, 6 itemgroups, 23 items, 1 language
Itemgroups: Informed consent, Demographics, Laboratory Tests, Follow-up studies, Investigator signature, Tracking Document Reason for non participation
GSK TWINRIX™ Hepatitis A and B Vaccine: Persistence of Immune Response in 0,6 Month vs. 0,1,6 Month Schedule NCT00197119 - Longterm Follow-up VISIT 13 - YEAR 8 - 96 MONTHS + 2 MONTHS Study ID: 100566 Clinical Study ID: 100566 Study Title: Evaluate Persistence of Immune Response of GSK Biologicals’ TWINRIX™ Vaccine Administered According to 0,6 Month Schedule Versus TWINRIX™ JUNIOR Administered According to 0,1,6 Month Schedule, in Subjects Aged 12-15 years at Time of First Vaccine Dose Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197119 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: BIO HAB; Twinrix Study Indication: Hepatitis A; Hepatitis B

GSK TWINRIX™ Hepatitis A and B Vaccine: Persistence of Immune Response in 0,6 Month vs. 0,1,6 Month Schedule NCT00197119 - Longterm Follow-up Visit 15

- 9/17/21 - 1 form, 7 itemgroups, 25 items, 1 language
Itemgroups: Informed consent, Demographics, Laboratory Tests, Follow-up studies, Occurrence of serious adverse event, Investigator signature, Tracking Document Reason for non participation
GSK TWINRIX™ Hepatitis A and B Vaccine: Persistence of Immune Response in 0,6 Month vs. 0,1,6 Month Schedule NCT00197119 - Longterm Follow-up VISIT 15 - YEAR 10 - 120 MONTHS + 2 MONTHS Study ID: 100566 Clinical Study ID: 100566 Study Title: Evaluate Persistence of Immune Response of GSK Biologicals’ TWINRIX™ Vaccine Administered According to 0,6 Month Schedule Versus TWINRIX™ JUNIOR Administered According to 0,1,6 Month Schedule, in Subjects Aged 12-15 years at Time of First Vaccine Dose Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197119 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: BIO HAB; Twinrix Study Indication: Hepatitis A; Hepatitis B

GSK TWINRIX™ Hepatitis A and B Vaccine: Persistence of Immune Response in 0,6 Month vs. 0,1,6 Month Schedule NCT00197119 - Longterm Follow-up Visit 14

- 9/17/21 - 1 form, 6 itemgroups, 24 items, 1 language
Itemgroups: Informed consent, Demographics, Laboratory Tests, Follow-up studies, Investigator signature, Tracking Document Reason for non participation
GSK TWINRIX™ Hepatitis A and B Vaccine: Persistence of Immune Response in 0,6 Month vs. 0,1,6 Month Schedule NCT00197119 - Longterm Follow-up VISIT 14 - YEAR 9 - 108 MONTHS + 2 MONTHS Study ID: 100566 Clinical Study ID: 100566 Study Title: Evaluate Persistence of Immune Response of GSK Biologicals’ TWINRIX™ Vaccine Administered According to 0,6 Month Schedule Versus TWINRIX™ JUNIOR Administered According to 0,1,6 Month Schedule, in Subjects Aged 12-15 years at Time of First Vaccine Dose Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197119 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: BIO HAB; Twinrix Study Indication: Hepatitis A; Hepatitis B

Quality assurance Follow-up Living Donor Renal Transplant (AQUA) - Quality assurance Follow-up Living Donor Renal Transplant (AQUA)

- 4/13/21 - 1 form, 1 itemgroup, 22 items, 2 languages
Itemgroup: Follow-up(auszufüllen nach 1, 2 und 3 Jahren)
Documentation form for quality assurance in German Health Care by the institute forapplied quality Improvement and Research in Health Care (Aqua), https://www.aqua-institut.de/en/home. Internal Aqua form version: NLSFU Specification 2015 V02

Maintenance AMLSG 21-13 DRKS00007189 NCT02013648 Akute myeloische Leukämie (AML) - Maintenance AMLSG 21-13 NCT02013648 Akute myeloische Leukämie (AML)

- 4/13/21 - 1 form, 6 itemgroups, 25 items, 1 language
Itemgroups: Maintenance, Dasatinib intake during last month (since last visit), Urinalysis, Adverse Event, Concomitant Medication, Signature
Randomized Phase III Study of Intensive Chemotherapy with or without Dasatinib (Sprycel(TM)) in Adult Patients with Newly Diagnosed Core-Binding Factor Acute Myeloid Leukemia (CBF-AML)

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