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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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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Liver imaging

- 11/26/21 - 1 form, 11 itemgroups, 61 items, 1 language
Itemgroups: Date of hepatic or liver imaging test,method used for imaging test,images technically adequate,liver size,liver texture,diffuse and/or geographic fatty infiltrate of the liver,Ascites present,Focal Hepatic Lesions characterisable,Gallstones or gallbladder lesions,Biliary ductal lesions,Portal/Hepatic vein abnormalities
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. Record the details of any Adverse Events or exacerbations of Adverse Events on the Non-Serious Adverse Event Form or the Serious Adverse Event form. Exacerbations of Adverse Events include increases in frequency and severity. It is particularly important to record any gallbladder or biliary disease, or pancreatitis, that occurred during the study. This form has to be filled out whenever / if liver imaging is performed (in case of a liver event).

Metronomic Treatment in Children and Adolescents With Recurrent or Progressive High Risk Neuroblastoma (METRO-NB2012) NCT02641314 - Therapeutic response

- 9/20/21 - 16 forms, 12 itemgroups, 78 items, 1 language
Itemgroups: Response to treatment,General assessment,Cardiology discipline examination,Lab results,Tumor Markers,Staging,local MRT/ CT examination,mIBG,Bone marrow examination,Ohter examination,Overall assessment,Footer module
NCT02641314 Phase 2 Trial of Metronomic Treatment in Children and Adolescents With Recurrent or Progressive Neuroblastoma (NB). The study investigates the tolerance and the efficacy of a new combination of five drugs consisting of propranolol (antiangiogenetic, anti-neuroblastic), Celecoxib (modulating immune response, ant-neuroblastic), cyclophosphamide (antiangiogenetic, anti-neuroblastic), etoposide (antiangiogenetic, anti-neuroblastic), and vinblastin (antiangiogenetic, anti-neuroblastic). Vinblastin is scheduled every 14 days intravenously, all other drugs are applied daily throughout 365 days (except etoposide for 4x3 weeks). The efficacies of each of the drugs have been demonstrated in vitro and in vivo in animal studies. All drugs have been used in children for other conditions. From those experiences low toxicities and a favorable Quality of life are expected. Prof. Dr. Frank Berthold Abt. für Kinderonkologie und –hämatologie Zentrum für Kinder- und Jugendmedizin Universität zu Köln

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12 itemgroups 78 items

Study relevant visits

12 itemgroups 78 items

Second malignancy

12 itemgroups 78 items

Birth sheet, ultrasound diagnostics Routine documentation in German hospitals DMI

- 9/20/21 - 1 form, 2 itemgroups, 30 items, 2 languages
Itemgroups: Ultrasound examination,Ultrasound examination
Routine documentation in German hospitals. Source file name: SD070109_Geburtenbogen. Examplary forms provided by DMI (http://www.dmi.de/)

DESCRIBE (DZNE – Clinical Register Study of neurodegenerative Disorders) CRF Baseline Basis Module - DESCRIBE CRF Baseline Basis Module

- 9/20/21 - 1 form, 23 itemgroups, 256 items, 1 language
Itemgroups: Date of visit,Demographics,National origin,Mother tongue,Clinical diagnosis,Living situation,Education and profession,Consumption of semiluxury food - nicotine,Consumption of semiluxury food - alcohol,Vital signs,Clinical phenotype - Anamnesis and inspection,Clinical phenotype - Further examination,Umsars I: Questions 9-12,Anamnesis motor skills,Montreal Cognitive Assessment (MoCA),Geriatric depression scale (GDS),Sampling - Blood collection,Sampling according to SOP,Registration of samples,Sampling - Urine sample,Sampling according to SOP (Urine),Results of urine strips,Registration of samples (Urine)
Background and Purpose: The purpose of the DESCRIBE study is to document the natural course of diseases in context of medical care of neurodegenerative disorders as well as cerebrovascular diseases and to perform phenotyping of the test persons. Disease-spanning analyses of the measured clincial data, the results of the imaging processes, results of the analysis of the biometerials including genetic analysis are planed. Principal Investigator: Prof. Klockgether, Dr. Spottke DZNE, Bonn. Source: DESCRIBE-Studie http://www.dzne.de/forschung/forschungsbereiche/klinische-forschung/studien/describe-bn006.html Participating Study Sites: Berlin, Bonn, Göttingen, Dresden, Köln, Magdeburg, München, Rostock/Greifswald, Tübingen

OPS Chapter 3 Diagnostic Imaging

- 9/20/21 - 1 form, 1 itemgroup, 1 item, 2 languages
Itemgroup: OPS 3
derived from: OPS - German Procedure Classification https://www.dimdi.de/static/en/klassi/ops/index.htm DIMDI publishes the OPS classification on behalf of the Federal Ministry of Health; it is in the public domain. Its use in inpatient care is laid down in 301 Volume V of the German Social Security Code (SGB V) and for surgical procedures in the outpatient sector in 295 SGB V.

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957 - Day -1 - 12-Lead ECG; Summary Holter; Summary Holter Abnormalities; Vital Signs; Electronically Transferred Lab Data; Urinalysis; PET; Functional MRI Scan; MRI Scan; Randomisation Number

- 9/17/21 - 1 form, 12 itemgroups, 107 items, 1 language
Itemgroups: Date of Visit,12-Lead ECG,Summary Holter,Summary Holter Abnormalities,Vital Signs - Pre-Baseline Scan,Electronically Transerred Lab Data ,Urinalysis - Dipstick Details ,Urinalysis - Microscopy Details ,PET - Scan Baseline,Functional MRI Scan,MRI Scan,Randomisation Number
Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

MRT SHIP-START-3 MRT ad hoc findings

- 7/3/21 - 1 form, 1 itemgroup, 14 items, 2 languages
Itemgroup: MRT ad hoc findings
MRT ad hoc findings form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name SHIP.SHIP3.MRT.MRTUNT.MRTADHOC. 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 English version of this form is under development.

MRT SHIP-START-3 measure values of heart measure

- 7/3/21 - 1 form, 1 itemgroup, 299 items, 2 languages
Itemgroup: measure values of heart measure
measure values of heart measure form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name SHIP.SHIP3.MRT.MRTASS.MRTCOR. 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 English version of this form is under development.

reading of ultrasound examinations SHIP-START-3 carotis findings

- 7/3/21 - 1 form, 1 itemgroup, 16 items, 2 languages
Itemgroup: carotis findings
carotis findings form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name SHIP.SHIP3.RUE.READCARO.CAROTIREAD. 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 English version of this form is under development.

reading of ultrasound examinations SHIP-START-3 echo findings

- 7/3/21 - 1 form, 1 itemgroup, 85 items, 2 languages
Itemgroup: echo findings
echo findings form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name SHIP.SHIP3.RUE.READECHO.ECHOREADING_S. 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 English version of this form is under development.

MRT SHIP-START-3 upload 4CV, SAX, TRA

- 7/3/21 - 1 form, 1 itemgroup, 19 items, 2 languages
Itemgroup: upload 4CV, SAX, TRA
upload 4CV, SAX, TRA form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name SHIP.SHIP3.MRT.MRTASS.MRTCORUP. 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 English version of this form is under development.

MRT SHIP-START-2 High Intensity Zones - High Intensity Zones

- 7/3/21 - 1 form, 1 itemgroup, 84 items, 2 languages
Itemgroup: High Intensity Zones
High Intensity Zones form of SHIP Study (Study of Health in Pomerania), conducted by the University of Greifswald. SHIP unique domain name SHIP.SHIP2.MRT.MRTASS.HIGHIZ. 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

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