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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
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- 12/7/17 - 9 forms, 14 itemgroups, 50 items, 2 languages
Itemgroups: Angaben zum unerwünschtes Ereignis, Weitere Angaben zum unerwünschtes Ereignis, Einstufung des Ereignisses, Ausgang, Kausalität (UE & MS-Medikation), MS-Medikation, Kausalität (UE & Begleitmedikation), Begleitmedikation, Schwerwiegende unerwünschte Ereignisse, Patientenangaben, Behandlung, Relevante Vorerkrankung / Symptome, Ergebnisse der relevanten Diagnostischen Untersuchungen, Kontaktdaten des Berichterstatters
REGIMS is a registry of the administration, adverse events and benefit of immunotherapeutic agents in patients with Multiple Sclerosis. REGIMS is a project from the Institute of Epidemiology and Social Medicine of the University of Muenster, publication granted by Prof. Dr. Berger. For further information (in German), please view http://campus.uni-muenster.de/index.php?id=6075 or http://www.kompetenznetz-multiplesklerose.de/aktuelle-studien/regims. REGIMS ist ein Immuntherapieregister zur Verbesserung der Arzneimittelsicherheit in der Multiple Sklerose Therapie innerhalb des krankheitsbezogenen Kompetenznetzes MS. Das primäre Ziel von REGIMS ist die Erfassung der Häufigkeit, Charakteristika und Auswirkungen von Nebenwirkungen aktueller und neuer Immuntherapien in der klinischen Routinebehandlung der MS. Sekundäre Ziele sind die Auswertung von Faktoren, die a) mit Nebenwirkungen und b) mit guter Therapie-Adhärenz assoziiert sind. Optional können bei Zustimmung der Patienten Blutproben für die Biobank des KKNMS gesammelt werden. Patienten mit Multipler Sklerose (MS) weisen trotz des chronischen Verlaufs eine große Heterogenität klinischer Symptome, in Befunden der Bildgebung sowie pathophysiologischen Prozessen auf. Faktoren, die zur individuellen Krankheitsprognose beitragen sind kaum bekannt, jedoch hat die Einführung neuer Substanzen die Therapiemöglichkeiten der MS in den letzten Jahren deutlich erweitert. Die Anwendung sogenannter Immuntherapeutika (inklusive der neuen Substanzklasse der Biologika) bietet in der MS-Therapie eine Reihe von Chancen, birgt aber auch Risiken.
- 11/2/15 - 1 form, 5 itemgroups, 16 items, 19 languages
Itemgroups: Identity, Diagnosis, Therapy, Study, Follow-up
- 3/20/14 - 1 form, 6 itemgroups, 49 items, 2 languages
Itemgroups: CancerRegistry, Previous cancer, Current Neoplasm, Treatment, surgery, radiotherapy
- 8/5/16 - 1 form, 29 itemgroups, 267 items, 1 language
Itemgroups: Medical History (PGID 272) , Diseases, conditions , Treatment, Indication for treatment, Treatment target, Involved sites, Risk Factors, APACHE Score, Immunosuppressants, Types of isolation, Other Antifungals BEFORE initiation, Other Antifungals AFTER initiation, Temperature, Diagnostic procedures, Sites of Mycosis, CT finding, Sites of Mycosis, MRT finding, Sites of Mycosis, Sonography finding, Sites of Mycosis, Fundoscopy finding, Sites of Mycosis, microbiological culture finding, Sites of Mycosis, Tissue specimen finding, Method of biopsy, Micafungin Treatment (PGID 280), CYP450 inductors DURING treatment, Breakthrough Infections (PGID 281), Adverse Events, Laboratory Parameters (PGID 283) , Outcome Micafungin (PGID 284) , Other Antifungal, Outcome Final Antifungal Treatment (PGID 286), Follow Up (PGID 287)
- 5/7/13 - 1 form, 2 itemgroups, 12 items, 2 languages
Itemgroups: Unfallgeschehen, Straßenverkehr
- 4/4/14 - 1 form, 7 itemgroups, 38 items, 2 languages
Itemgroups: Patient data, Treating Clinic, General practitioner, Patient Characteristics, Professional career, Comments, Signature
- 12/9/14 - 1 form, 15 itemgroups, 119 items, 2 languages
Itemgroups: General information, First Symptoms, Diagnostic procedure within the past 12 months, Fatigability Multiple Sclerosis, Course, Aid, manufactured, Medical benefits, Medical benefits past 12 months, Treatment satisfaction, Family history, Symptoms within past 12 months, Medication within last 7 days, Demographics, Doctor visit, Quality of life
- 6/25/15 - 1 form, 10 itemgroups, 43 items, 2 languages
Itemgroups: SUE, Patientenangaben, SUE: Beschreibung, SUE: Behandlung, SUE: Ausgang, SUE: MS-Medikation, SUE: Begleitmedikation, SUE: Relevante Vorerkrankung / Sypmtome, Ergebnisse der relevanten Diagnostischen Untersuchungen, Kontaktdaten des Berichterstatters
- 1/19/15 - 1 form, 9 itemgroups, 38 items, 2 languages
Itemgroups: General information, Disease-specific information, Current Symptoms Multiple Sclerosis, Past treatment Multiple Sclerosis, Current Therapy Multiple Sclerosis, Cortisone, MRT, Disease history, Pregnancy, current
- 10/17/19 - 1 form, 7 itemgroups, 81 items, 2 languages
Itemgroups: Cardiac catheter details, Right heart catheterisation, Left heart catheterisation, Myocardial biopsy, Storage diseases, Histology/Immunohistochemistry/Immunology/Virology report, Procedural complications
With permission from the DZHK administrative office. http://dzhk.de The DZHK (Deutsches Zentrum für Herz-Kreislauf-Forschung e.V.; German Center for Cardiovascular Research) is a joint cooperation of twenty-eight institutions in seven locations throughout Germany to develop a common research strategy. They developed a data catalogue with metadata and data as well as information about available biological materials from all their studies. For more information on the data catalogue and access to actual data and biosamples please visit https://dzhk.de/en/resources/data-manual/ . This version contains the metadata part only. The form Cardiac Catheter is used to document a cardiac catheter examination. This examination enables a better phenotyping of cardiomyopathies, an assessment of the degree of severity and of the prognosis. An invasive cardiac assessment is indicated according to the current guidelines. In the context of the objective, this applies especially to patients in whom cardiomyopathy has already been verified by other imaging techniques, unexplained reduced left ventricular systolic function and/or corresponding symptoms. The documentation is to be performed according to the DZHK's SOPs, which can be accessed at https://dzhk.de/en/resources/sops/ (or https://dzhk.de/ressourcen/sops/ for the German language versions). The SOP for this form is "Cardiac Catheterization. Left and rightheart examination. Left ventriculography. Left and right ventricular myocardial biopsies." (version 1.0, valid as of 01/09/2014) for the English language version, and "Herzkatheter. Links- und Rechtsherzkatheteruntersuchung. Linksventrikuläre Ventrikulographie. Entnahme von links-/ rechtsventrikulären Myokardbiopsien." (version 1.0, valid as of 01/09/2014) for the German version.