- 2021-07-16 - 23 Formulär, 11 Item-grupper, 26 Dataelement, 1 Språk
Item-grupper: Diabetes Mellitus details, Hemoglobin A1c (HbA1c ) in blood, C-peptide in blood, Glucose in blood, C-peptide-to-Glucose Ratio (CGR) in blood, Insulin level in blood, Cortisol level in blood, Insulin treatment before SARS-CoV-2 detection (Baseline), Change of insulin scheme at the time of SARS-CoV-2 detection (Baseline), Oral antidiabetic treatment before SARS-CoV-2 detection (Baseline), Is data entry for this section finished?
Study Title: LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients https://leoss.net Study Indication: COVID-19 Date: 19.03.2021 Published with permission by Prof. Dr. med. J.-J. Vehreschild. LEOSS, a multi-center cohort study, has been created to get more in-depth knowledge about the epidemiology and clinical course of patients infected with SARS-CoV-2. Initiated by the ESCMID Emerging Infections Task Force (EITaF) and the German Infectious Disease Society, and supported by all German Centers for Health Research (DZG), LEOSS has developed into an international network of contributors. Via an integrative research approach with anonymous recruitment and collection of routine data in an open science context, LEOSS is building a uniform clinical dataset and providing real-time analyses. For more information feel free to explore https://leoss.net/. Please note that only cases with known outcome are collected! Baseline / diagnosis is defined as the day the sample of the first positive SARS-CoV-2 result was taken. Criteria of the Uncomplicated Phase: Asymptomatic OR Symptoms of upper respiratory tract infection and/or Nausea, emesis, diarrhea and/or Fever Remember: The Uncomplicated Phase ends, if a previously febrile patient has no fever anymore and has completed 14 days of follow-up without entering Complicated or Critical Phase; then move to Recovery Phase. Also, as soon as one of the criteria of the Complicated or Critical Phase are fulfilled, Uncomplicated Phase ends; move over to there. If the patient has died, the phase ends with the death of the patient. If the patient has died, do not report terminal values, e.g. those recorded after switching off life-support or heart rate "0" after death of the patient. Criteria of the Complicated Phase: * Need for oxygen supplementation (In patients with prior oxygen home therapy, clinically meaningful increase in need for oxygenation.) * paO2 at room air < 70 mmHg * SO2 at room air < 90 % * GOT or GPT > 5x ULN * New cardiac arrhythmia * New pericardial effusion >1cm * New heart failure with pulmonary edema, congestive hepatopathy or peripheral edema Remember: The Complicated Phase ends, if none of the criteria for the Complicated Phase is fulfilled anymore AND the patient is free of fever; then move to Recovery Phase. Also, as soon as one of the criteria of the Critical Phase are fulfilled, Complicated Phase ends; move over to Critical Phase. If the patient has died, the phase ends with the death of the patient. If the patient has died, do not report terminal values, e.g. those recorded after switching off life-support or heart rate "0" after death of the patient. Criteria of the Critical Phase: * Need for catecholamines * Life-threatening cardiac arrhythmia * Mechanical ventilation (invasive or non-invasive) * Liver failure with Quick< 50% * qSOFA >= 2 * Renal failure in need of dialysis Remember: The Critical Phase ends as soon as none of the criteria for the Critical Phase is fulfilled anymore AND the patient is free of fever. If the patient has died, it ends with the death of the patient. If the patient has died, do not report terminal values, i.e. those recorded after turning off life-support or heart rate "0" after death of the patient. Criteria of the Recovery Phase: *Improvement by at least one phase, i.e. Critical to Complicated or Complicated to Uncomplicated * Defervescence Remember: Uncomplicated asymptomatic patients enter recovery phase after 14 days of observation without disease progression No further progression or re-hospitalization If a text field can't be filled out, note 'ND' (for not determined).
- 2021-06-28 - 1 Formulär, 11 Item-grupper, 26 Dataelement, 1 Språk
Item-grupper: Diabetes Mellitus details, Hemoglobin A1c (HbA1c ) in blood, C-peptide in blood, Glucose in blood, C-peptide-to-Glucose Ratio (CGR) in blood, Insulin level in blood, Cortisol level in blood, Insulin treatment before SARS-CoV-2 detection (Baseline), Change of insulin scheme at the time of SARS-CoV-2 detection (Baseline), Oral antidiabetic treatment before SARS-CoV-2 detection (Baseline), Is data entry for this section finished?
- 2023-01-05 - 13 Formulär, 16 Item-grupper, 101 Dataelement, 1 Språk
Item-grupper: Chronische Lungenerkrankungen, Herz-Kreislauf-Erkrankungen, Chronische Lebererkrankungen, Rheumatologische / immunologische Erkrankungen, HIV-Infektion, Organtransplantiert, Diabetes, Aktive Tumor-/Krebserkrankungen, Raucherstatus, Chronische neurologische oder psychiatrische Erkrankungen, Bestehende Sauerstoff- oder Beatmungstherapie, Chronische Nierenerkrankungen, Reiseaktivität, Magengeschwüre, Impfungen, DNR-Anordnung
Disclaimer: Der „GECCO - German Corona Consensus - Covid-19 Research-Dataset“ Inhalt, der auf dem Portal für medizinische Datenmodelle (MDM Portal) zu finden ist, ersetzt nicht den GECCO Datensatz auf simplifier.net. Für die Nutzung von GECCO-FHIR-Profilen verwenden Sie bitte die auf https://simplifier.net/ForschungsnetzCovid-19/ verfügbaren Profile. Der FHIR-Download auf MDM erzeugt lediglich eine FHIR-Fragebogenresource. Ziel Überarbeitung August 2021: höhere Kompatibilität mit der NUM-COMPASS-App bzw. der Schnittstelle zur zentralen Datenbank; Zwischenstand, gewisse Module sind noch nicht kompatibel mit der Schnittstelle (u.a. Medikation und Laborwerte; Beatmungstherapie ist aktuell doppelt hinterlegt) This version of the GECCO logical model is based on https://art-decor.org/art-decor/decor-datasets--covid19f-, and the implementation for REDCap by the University of Tübingen (3.3.2021), partially updated with https://simplifier.net/guide/GermanCoronaConsensusDataSet-ImplementationGuide/Home information. For actual use of FHIR profiles, please use the actual profiles available on https://simplifier.net/ForschungsnetzCovid-19/ResearchDatasetGECCO/~overview (FHIR download on MDM is only a FHIR questionnaire resource). This version is not compatible with the REDCap to FHIR GECCO converter of the University of Tübingen. It aims at a higher compatibility with the app generated for the NUM-COMPASS project (conversion to COMPASS-compatible FHIR questionnaire necessary) and from there with the central platform of the NUM-CODEX project. A few modules are not yet compatible (e.g. Medication and lab values; ventilation is currently double). Official German text from http://cocos.team/datasets.html: Zur Bewältigung der aktuellen Pandemie und der damit einhergehenden Behandlung von Patienten fördert das Bundesministerium für Bildung und Forschung (BMBF) ein nationales Netzwerk der Universitätsmedizin im Kampf gegen COVID-19. Unter anderem soll das Netzwerk die Daten der behandelten COVID-19 Patienten systematisch erfassen und bündeln. Die Forschenden sollen die Behandlung der COVID-19-Patienten standardisiert erheben, verfolgen und analysieren. Die hohe Bedrohungslage hat zu intensiver wissenschaftlicher Aktivität zu COVID-19 geführt, wozu zahlreiche regionale, nationale und internationale epidemiologische Erhebungen und Registerstudien zählen. Der Konsensusdatensatz gibt der Wissenschaft um COVID-19 eine gemeinsame Sprache und Arbeitsgrundlage. Inofficial translation: In order to cope with the current pandemic and the associated treatment of patients, the Federal Ministry of Education and Research (BMBF) is funding a national network of university medicine in the fight against COVID-19. Among other things, the network will systematically collect and bundle the data of the treated COVID-19 patients. The researchers are to collect, track and analyze the treatment of COVID-19 patients in a standardized way. The high threat level has led to intensive scientific activity on COVID-19, including numerous regional, national and international epidemiological surveys and register studies. The consensus data set provides a common language and working basis for the science around COVID-19.
- 2019-10-16 - 1 Formulär, 2 Item-grupper, 46 Dataelement, 2 Språk
Item-grupper: Cardiopulmonary exercise testing details, Cardiopulmonary Exercise Test
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 module Spiroergometry is used to document spiroergometry examinations. The cardiopulmonary exercise test analyses the reactions and the interplay of the heart, circulation, breathing and metabolism during gradually increasing exercise, both in terms of qualitative and quantitative measures. The cardiopulmonary exercise test should be the last test performed on the examination day. This form uses the Borg scales of dyspnoea (Borg, G.A., Psychophysical bases of perceived exertion. Medicine and science in sports and exercise, 1982. 14(5): p. 377-81) and exertion (Borg, G., Anstrengungsempfinden und körperliche Aktivität. Dtsch Arztebl International, 2004. 101(15): p. 1016-). 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 SOPs for this form are "Cardiopulmonary exercise test (spiroergometry)" (version 1.1, effective as of 01/07/2017), and "Spiroergometrie " (version 1.1, effective as of 01/07/2015), for the English and German versions, respectively. Inclusion Criteria: All subjects who are capable of cycling on an ergometer or of doing exercise on a treadmill and to whom no exclusion criteria apply can take part. Special inclusion criteria are stipulated in the study protocol of the respective study/register. Exclusion criteria: Absolute contraindications: • Acute relevant disease, e.g. recent myocardial infarction, systemic infections, thromboses or embolisms, acute exacerbation of a respiratory disease. • Severe cardiac arrhythmia or blocks (second- or third-degree AV block). • Insufficiently controlled arterial hypertension (RRsyst >170 mmHg, and/or RRdiast >110 mmHg). • Known symptomatic or severe aortic stenosis. Relative contraindications: • Tachycardia at rest (>120 bpm). • Poorly managed epilepsy with the risk of provoking a seizure through exercise. • Symptomatic electrolyte imbalance or metabolic imbalance. • Symptomatic impaired cerebral circulation. If necessary, specific criteria of the respective studies or registers have to be observed.
- 2016-07-04 - 1 Formulär, 6 Item-grupper, 39 Dataelement, 2 Språk
Item-grupper: MANIFESTATIONS (Manifestiations defined only by metabolic activity (PET) without morhological correlate in CT scan should NOT be indicated as positive!, Peripheral lymph nodes (LN), Head and neck, Thorax, Abdomen, Other Localisations

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