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Table of contents
  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
    1. 7.1. Anesthesiology
    1. 7.2. Dermatology
    1. 7.3. ENT
    1. 7.4. Geriatrics
    1. 7.5. Gynecology/Obstetrics
    1. 7.6. Internal Medicine
      1. Hematology
      1. Infectious Diseases
      1. Cardiology/Angiology
      1. Pneumology
      1. Gastroenterology
      1. Nephrology
      1. Endocrinology/Metabolic Diseases
      1. Rheumatology
    1. 7.7. Neurology
    1. 7.8. Ophthalmology
    1. 7.9. Palliative Care
    1. 7.10. Pathology/Forensics
    1. 7.11. Pediatrics
    1. 7.12. Psychiatry/Psychosomatics
    1. 7.13. Radiology
    1. 7.14. Surgery
      1. General/Visceral Surgery
      1. Neurosurgery
      1. Plastic Surgery
      1. Thoracic Surgery
      1. Trauma/Orthopedics
      1. Vascular Surgery
    1. 7.15. Urology
    1. 7.16. Dental Medicine/OMS
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medical examination SHIP-Trend-0 carotid plaques

- 11/21/17 - 1 form, 1 itemgroup, 48 items, 2 languages
Itemgroup: carotid plaques
carotid plaques form of SHIP Study (Study of Health in Pomerania), conducted by the University of Greifswald. SHIP unique domain name SHIP.SHIPTrend0.MEX.ULTRASOU.PLAQUE. 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

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.

Retinal Digital Photography Protocol PhenX Toolkit

- 9/27/17 - 1 form, 1 itemgroup, 15 items, 1 language
Itemgroup: PhenX - retinal digital photography protocol
Two 45¿ digital retinal images (Field 1 and 2) will be taken of each eye of the participant using the Canon Non-Mydriatic Retinal CR6-45NM camera with a digital Canon D60 camera back (6.3 megapixels per image). Field 1 is centered on the optic disc and Field 2 is centered on the macula, providing photographic documentation of the optic disc, macula, and substantial portions of the temporal arcades. These photographs may be graded for retinal microvascular characteristics, including focal arteriolar narrowing, arterio-venous nicking, retinopathy (e.g., microaneurysms, retinal hemorrhages) and other conditions. In addition, generalized arteriolar narrowing is quantified using a computer assisted measure of retinal vascular caliber. ODM derived from: https://cde.nlm.nih.gov Primary source: https://www.phenxtoolkit.org/ Recent publication: Hendershot, T., Pan, H., Haines, J., Harlan, W.R., Marazita, M.L., McCarty, C.A., Ramos, E.M., and Hamilton, C.M. (2015) Using the PhenX toolkit to add standard measures to a study. Curr. Protoc. Hum. Genet. 86:1.21.1-1.21.17. doi: 10.1002/0471142905.hg0121s86 Permission to publish granted by Carol M. Hamilton.

medical examination SHIP-Trend-0 sono carotid artery

- 12/6/17 - 1 form, 1 itemgroup, 24 items, 2 languages
Itemgroup: sono carotid artery
sono carotid artery form of SHIP Study (Study of Health in Pomerania), conducted by the University of Greifswald. SHIP unique domain name SHIP.SHIPTrend0.MEX.ULTRASOU.CAROTIDU. 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

reading of ultrasound examinations SHIP-Trend-0 carotis findings

- 12/6/17 - 1 form, 1 itemgroup, 19 items, 2 languages
Itemgroup: carotis findings
carotis findings form of SHIP Study (Study of Health in Pomerania), conducted by the University of Greifswald. SHIP unique domain name SHIP.SHIPTrend0.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

reading of ultrasound examinations SHIP-Trend-0 carotis findings data

- 11/29/17 - 1 form, 1 itemgroup, 10 items, 2 languages
Itemgroup: carotis findings data
carotis findings data form of SHIP Study (Study of Health in Pomerania), conducted by the University of Greifswald. SHIP unique domain name SHIP.SHIPTrend0.RUE.READCARO.CAROTIREADDATA. 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

Acute coronary syndrome (clinical) DSS 2013- Functional stress test cluster Metadata Online Registry (METeOR)

- 9/4/16 - 1 form, 2 itemgroups, 6 items, 1 language
Itemgroups: Functional stress test, Person
Health sector data set specifications from METeOR, Australia's repository for national metadata standards, developed by the Australian Institute of Health and Welfare (http://meteor.aihw.gov.au/content/index.phtml/itemId/345165) Acute coronary syndrome (clinical) DSS 2013-: The scope for the ACS data set specification is to collect data on the period between when a person with ACS symptoms was first referred to a hospital or directly presented at a hospital, and when a person leaves the hospital, either from the emergency department or is discharged from the hospital. Functional stress test cluster: A functional stress test evaluates arterial blood flow to the heart muscle during increased cardiac work through physical exercise or pharmacological methods. The functional stress test cluster collects information on the timing, characteristics and results of a functional stress test performed during the current hospital presentation. Metadata and Classifications Unit Australian Institute of Health and Welfare GPO Box 570 Canberra ACT 2601

Liver imaging GSK study Chronic Coronary Heart Disease NCT00799903

- 6/17/20 - 1 form, 11 itemgroups, 60 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: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Liver imaging - Repeating form (Unscheduled/Dynamic visit)

Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989 - Liver Imaging

- 10/5/19 - 1 form, 12 itemgroups, 62 items, 1 language
Itemgroups: Administrative data, Liver imaging, Method of imaging test, Image quality, Liver size, Liver texture, Diffuse and/or geographic fatty infiltrate of liver, Ascites, Focal Hepatic Lesions, Gallstones or gallbladder lesions, Biliary ductal lesions, Portal/Hepatic vein abnormalities
Study ID: 111539 Clinical Study ID: 111539 Study Title: A Single-Blind Study of the Safety, Pharmacokinetics and Pharmacodynamics of scalating Repeat Doses of GSK249320 in Patients With Stroke Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00833989 https://clinicaltrials.gov/ct2/show/NCT00833989 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Refanezumab, Placebo Trade Name: N/A Study Indication: Ischaemic Attack, Transient The study consists of 8 visits: Day 1, Week 1 (Day 5), Week 2 (Day 10), Week 4 (Day 30), Week 8 (Day 60), Week 12 (Day 90), Week 16 (Day 112), Follow-up (F/U). All subjects will receive two doses. The first dose within 24-72 hrs after stroke the second dose 9 +/- 1 days after the first one. Each dose will be given as an intravenous infusion over 60 minutes. This document contains the liver imaging form. It has to be filled in if a liver imaging was taken during study.

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Adjudication Events - Stroke / TIA

- 1/7/19 - 1 form, 10 itemgroups, 71 items, 1 language
Itemgroups: Administrative data, Stroke / TIA, Neurological Signs / Symptoms, Neurological Signs / Symptoms Tendencies, Diagnostic Investigations - CT Brain Scan, Diagnostic Investigations - MRI Brain Scan, Diagnostic Investigations - Cerebral Angiography, Diagnostic Investigations - Lumbar Puncture, Final Clinical Diagnosis, Narrative
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Echocardiography CARLA Follow-up

- 2/6/18 - 1 form, 13 itemgroups, 76 items, 2 languages
Itemgroups: General information, Heart failure / Myocardial insufficiency, Angina pectoris / Coronary heart disease, Cardiac arrhythmia, Further symptoms of cardiac insufficiency, Echocardiography, Data entry: Echocardiography, Echocardiography Online-/Offline-Reading, Data entry: Online-/Offline-Reading, Echocardiography Offline-Reading, Data entry: Offline-Reading, Final evaluation of medical investigations, Data entry: Final evaluation
Greiser KH, Kluttig A, Schumann B, Swenne CA, Kors JA, Kuss O, Haerting J, Schmidt H, Thiery J, Werdan K. Cardiovascular diseases, risk factors and short-term heart rate variability in an elderly general population: the CARLA study 2002-2006. Eur J Epidemiol. 2009;24(3):123-42 http://www.ncbi.nlm.nih.gov/pubmed/19199053 "Cross-sectional data of a population-based cohort including 1,779 women and men aged 45-83 years were used to analyse associations of time and frequency domain measures of HRV (derived from 5-min ECG segments) with age, behavioural and biomedical risk factors and disease in the whole sample and in a "healthy" subgroup." publication granted by Dr. rer. medic. Alexander Kluttig, MPH Leiter des Studienzentrums Halle der Nationalen Kohorte Institut für Medizinische Epidemiologie, Biometrie und Informatik Martin-Luther-Universität Halle-Wittenberg Magdeburger Str. 8 D-06097 Halle/Saale

ECG CARLA Follow-up

- 2/6/18 - 1 form, 8 itemgroups, 50 items, 2 languages
Itemgroups: General information, Interview / Short medical history, ECG: Thorax angle, ECG: Electrodes, ECG: Recording, ECG: Description of incidents, Final information, Data entry
Greiser KH, Kluttig A, Schumann B, Swenne CA, Kors JA, Kuss O, Haerting J, Schmidt H, Thiery J, Werdan K. Cardiovascular diseases, risk factors and short-term heart rate variability in an elderly general population: the CARLA study 2002-2006. Eur J Epidemiol. 2009;24(3):123-42 http://www.ncbi.nlm.nih.gov/pubmed/19199053 "Cross-sectional data of a population-based cohort including 1,779 women and men aged 45-83 years were used to analyse associations of time and frequency domain measures of HRV (derived from 5-min ECG segments) with age, behavioural and biomedical risk factors and disease in the whole sample and in a "healthy" subgroup." publication granted by Dr. rer. medic. Alexander Kluttig, MPH Leiter des Studienzentrums Halle der Nationalen Kohorte Institut für Medizinische Epidemiologie, Biometrie und Informatik Martin-Luther-Universität Halle-Wittenberg Magdeburger Str. 8 D-06097 Halle/Saale

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