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Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039 - Visit 2: Laboratory Tests

- 27-09-21 - 1 Formulier, 4 Itemgroepen, 12 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Blood Sample for Antibodies to CS, Blood Sample for Antibodies to HBs, Blood Sample for Hematocrit
Study ID: 104297 Clinical Study ID: 104297 Study Title: An open study for a 2-year period to confirm the safety and immunogenicity of the candidate malaria vaccine RTS,S/AS02A in Mozambican children aged 1 to 4 years at the time of first vaccine dose. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00323622 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: SB257049 Study Indication: Malaria This study (Malaria-039 / NCT00323622 / GlaxoSmithKline Study ID 104297) is a two-year follow-up to Malaria-026 and consists of three clinic visits: Visit 1 / Informed Consent Visit at Visit 7 of Malaria-026 (i.e. 21 months post vaccine dose 1 in Malaria-026). Visit 2 / Interim Analysis 12 months +/- 1 month after Visit 1. Visit 3 / Final Analysis 24 months +/- 1 month after Visit 1. See https://clinicaltrials.gov/ct2/show/NCT00323622 This document is to be completed at Visit 2.

Hematology/ Oncology request form University Hospital Cologne

- 17-09-21 - 1 Formulier, 5 Itemgroepen, 73 Data-elementen, 1 Taal
Itemgroepen: patient information, laboratory procedure requested, radiology request, other examination, nursing medication request
Hospital Routine Documentation Subform at the University Hospital Cologne. Original Form name: HO-Anforderungsbogen

Hematology/ Oncology request elaboration form University Hospital Cologne

- 17-09-21 - 1 Formulier, 4 Itemgroepen, 74 Data-elementen, 1 Taal
Itemgroepen: patient information, laboratory procedure requested, radiology request, other examination
Hospital Routine Documentation Subform at the University Hospital Cologne. Original Form name: HO-Ausarbeitungsbogen

Hematology/ Oncology execution form University Hospital Cologne - Hematology/ Oncology execution elaboration form University Hospital Cologne

- 17-09-21 - 1 Formulier, 4 Itemgroepen, 75 Data-elementen, 1 Taal
Itemgroepen: patient information, laboratory procedure executed, radiologic examination execution, other examination
Hospital Routine Documentation Subform at the University Hospital Cologne. Original Form name: HO-Durchführungsbogen

clinic internal medicine A - gastroenterology SHIP-START-3 STU: DNA extraction

- 03-07-21 - 1 Formulier, 1 Itemgroep, 11 Data-elementen, 2 Talen
Itemgroep: STU: DNA extraction
STU: DNA extraction form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name SHIP.SHIP3.IMA.STU.STUDNA. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617

operational data SHIP-START-3 shipping laboratory findings

- 03-07-21 - 1 Formulier, 1 Itemgroep, 2 Data-elementen, 3 Talen
Itemgroep: shipping laboratory findings
shipping laboratory findings form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name SHIP.SHIP3.OPD.SHIPCore.BEF. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617

medical examination SHIP-START-3 blood sampling 1

- 03-07-21 - 1 Formulier, 1 Itemgroep, 28 Data-elementen, 3 Talen
Itemgroep: blood sampling 1
blood sampling 1 form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name SHIP.SHIP3.MEX.BIOMAT.BLOOD1. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617 The Portuguese version of this form is under development.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Local Lab Assessments

- 16-03-21 - 1 Formulier, 3 Itemgroepen, 13 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Laboratory Information, Local Lab Assessments
Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. This form has to be filled out at the screening visit, the first and last weekly visits during treatment cycles (week 1 and week 4), cycle observation visits, possible unscheduled and withdrawal visits.

Oral GW786034 treatment for ovarian cancer NCT00281632 - Screening

- 15-03-21 - 1 Formulier, 24 Itemgroepen, 129 Data-elementen, 2 Talen
Itemgroepen: Header, Eligibility Question, Demography, Physical examination, Disease Characteristics, Metastatic Disease Site, local laboratory, Residual toxicities related to previous therapy for cancer, Residual toxicities, Cancer related current medical conditions, Medical Conditions, non-cancer related medical conditions, Medical Conditions, Prior anti-cancer therapy, Prior anti-cancer therapy - medication, Prior anti-cancer therapy - radiotherapy, Vital signs, ECOG Performance Status Scale, 12 LEAD ECG, 12-lead ECG Abnormalities, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Urinalysis, Electronically transferred laboratory data
Study ID: 104450 Clinical Study ID: VEG104450 Study Title: This study is a non-randomized, open-label, multi-center Phase II study of GW786034 to evaluate the administration of oral GW786034 in subjects with ovarian cancer. Clinicaltrials.gov Identifier: NCT00281632 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib Trade Name: Votrient Study Indication: Neoplasms, Ovarian CRF Pages: 722-853

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Hepatitis - Local Lab

- 09-02-21 - 1 Formulier, 3 Itemgroepen, 8 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Hepatitis - Local Laboratory, Hepatitis - Local, Laboratory Procedures
Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. This form has to be filled out at the Screening Visit.

Collaborative Research Center | Transregio 240 (Sonderforschungsbereich Transregio 240) - Laboratory (Labor)

- 01-10-20 - 1 Formulier, 22 Itemgroepen, 95 Data-elementen, 1 Taal
Itemgroepen: Patient-ID, Biological markers: Inflammation parameters, Cardiac biomarkers: Troponin T, Cardiac biomarkers: NT-proBNP, Renal function marker: serum creatinine, Renal function marker: urine creatinine, Renal function marker: Urea, Lipids: Cholesterol, Lipids: High density Lipoprotein, Lipids: Low-density Lipoprotein, Lipids: triglycerides, Blood glucose (Spontaneous), Blood glucose (Fasting), Blood glucose: HbA1c, Blood glucose: fasting Insulin, Blood glucose (oral glucose tolerance test), Blood cell count: hematocrit, Blood cell count: hemoglobin, Blood cell count: leukocytes, Blood cell count: thrombocytes, Platelet Isolates, Multiplate Analysis
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. For all patients enrolled in a CRC/TR240 cohorts (routine) blood markers are collected from the first blood draw.

Collaborative Research Center | Transregio 240 (Sonderforschungsbereich Transregio 240) - Study specific blood sample and biobank (Studienspezifische Blutentnahme und Biobank)

- 01-10-20 - 1 Formulier, 8 Itemgroepen, 40 Data-elementen, 2 Talen
Itemgroepen: Administrative Data, Date, time and blood pressure at blood sample taking, Flow cytometry and aggregometry, Biobank, Biobank: EDTA wholeblood, Biobank: EDTA Plasma, Biobank: Citrat Plasma, Biobank: Serum
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. For all patients enrolled in a CRC/TR240 cohorts (routine) blood markers are collected from the first blood draw.

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