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LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Liver cirrhosis sub-cohort

- 2021-05-06 - 1 Formulär, 10 Item-grupper, 48 Dataelement, 1 Språk
Item-grupper: Etiology of liver cirrhosis, Hepatic decompensation (Ascites, Variceal bleeding, Hepatic encephalopathy), Reasons of consultation / hospitalisation, Liver transplantation waiting list, Recent bacterial infection, Child-Pugh Score at Baseline, MELD Score, Acute-on-chronic liver failure during the SARS-CoV-2 infection, Recent medication, 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/. This document is for the liver cirrhosis sub-cohort. If a text field can't be filled out, note 'ND' (for not determined).

LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Liver cirrhosis sub-cohort

- 2021-07-16 - 23 Formulär, 10 Item-grupper, 48 Dataelement, 1 Språk
Item-grupper: Etiology of liver cirrhosis, Hepatic decompensation (Ascites, Variceal bleeding, Hepatic encephalopathy), Reasons of consultation / hospitalisation, Liver transplantation waiting list, Recent bacterial infection, Child-Pugh Score at Baseline, MELD Score, Acute-on-chronic liver failure during the SARS-CoV-2 infection, Recent medication, 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).

Baseline I

39 Item-grupper 280 Dataelement

Diagnostics (General virological and laboratory findings for all phases)

46 Item-grupper 320 Dataelement

Immunosuppressive premedication

31 Item-grupper 90 Dataelement

HIV sub-cohort

13 Item-grupper 55 Dataelement

Diabetes mellitus sub-cohort

11 Item-grupper 26 Dataelement

Cardiovascular sub-cohort

3 Item-grupper 9 Dataelement

REGIMS Multiple Sclerosis Immunotherapy Registry Version 2016 - Baseline Main Sheet

- 2021-09-20 - 9 Formulär, 25 Item-grupper, 116 Dataelement, 2 Språk
Item-grupper: Ein-Ausschlusskriterien, Patientendaten, Krankheitsspezifische Angaben, EDSS-Score vor 12 Monaten, Heutige Scores der Funktionssysteme, Frühere verlaufsmodifizierende MS-Therapien, Aktuelle MS-Therapie, WeitereErkrankungen, Herz- / Kreislauferkrankungen, Stoffwechselerkrankungen, Infektionserkrankungen, Gastrointestinale Erkrankungen, Neurologische / Psychiatrische Erkrankungen, Allergien, Urogenitale Erkrankungen, Autoimmunerkrankungen, Blutbild / Labor, Allgemeine Symptome, Operation, Krebserkrankungen, Welche Therapien wurden aufgrund der Krebserkrankung durchgeführt?, Andere Erkrankung, Keine Vorerkrankungen aus diesen obigen Krankheitsgruppen/Erkrankungen bekannt, Schwangerschaft, Biologisches Material (z.B. Blut)
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.

LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Critical Phase

- 2021-06-23 - 1 Formulär, 32 Item-grupper, 188 Dataelement, 1 Språk
Item-grupper: CR: Cardiovascular findings, CR: Respiratory findings, CR: Other severe organ damage, CR: Fever, CR: Vitals, CR: Lung ultrasound, CR: worst chest CT result, CR: Antivirals, CR: Antibiotics, CR: Antifungals, CR: Immunomodulators, CR: Cardiovascular medication, CR: Non-oral anticoagulants, CR: Oral anticoagulants, CR: Platelet aggregation inhibition, CR: Further anticoagulation / platelet aggregation inhibition, CR: Other COVID-19 related therapy, CR: ICU treatment, CR: Mechanical ventilation, CR: Other extracorporeal support, CR: Co/Superinfections, CR: Antibacterial treatment: Betalactams, CR: Antibacterial treatment: Macrolides, CR: Other antibacterial treatment, CR: Complications, Thrombotic and thromboembolic manifestations, CR: Complications, Neurological, Ischemic stroke: TOAST classification, Ischemic stroke: NIHSS score in acute phase, CR: Complications, Other, Acute kidney injury (KDIGO criteria), CR: SOFA score, CR: 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/. This document is for data aggregated in the critical phase. If a text field can't be filled out, note 'ND'. 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, i.e. those recorded after turning off life-support or heart rate "0" after death of the patient.

EBMT Haemoglobinopathy General Information

- 2021-09-20 - 1 Formulär, 11 Item-grupper, 79 Dataelement, 1 Språk
Item-grupper: GENERAL INFORMATION, Patient, DISEASE, CLINICAL FEATURES AND COMPLICATIONS, STATUS OF DISEASE AT HSCT, Enzymes, LIVER FUNCTION, RESULTS OF LIVER BIOPSY, CARDIAC FUNCTION, ADDITIONAL TREATMENT POST-HSCT, FORMS TO BE FILLED IN
ODM form derived from 113pp EBMT Haemoglobinopathy 12Hgbpthy.pdf refer to: http://www.ebmt.org/Contents/Data-Management/Registrystructure/MED-ABdatacollectionforms/Pages/MED-AB-data-collection-forms.aspx

REGIMS Registry Baseline - Baseline Main Sheet

- 2021-09-20 - 3 Formulär, 25 Item-grupper, 116 Dataelement, 2 Språk
Item-grupper: Ein-Ausschlusskriterien, Patientendaten, Krankheitsspezifische Angaben, EDSS-Score vor 12 Monaten, Heutige Scores der Funktionssysteme, Frühere verlaufsmodifizierende MS-Therapien, Aktuelle MS-Therapie, WeitereErkrankungen, Herz- / Kreislauferkrankungen, Stoffwechselerkrankungen, Infektionserkrankungen, Gastrointestinale Erkrankungen, Neurologische / Psychiatrische Erkrankungen, Allergien, Urogenitale Erkrankungen, Autoimmunerkrankungen, Blutbild / Labor, Allgemeine Symptome, Operation, Krebserkrankungen, Welche Therapien wurden aufgrund der Krebserkrankung durchgeführt?, Andere Erkrankung, Keine Vorerkrankungen aus diesen obigen Krankheitsgruppen/Erkrankungen bekannt, Schwangerschaft, Biologisches Material (z.B. Blut)
Baseline items for semantic analysis of the Multiple sclerosis immunotherapy registry REGIMS of the Institute of Epidemiology and Social Medicine of the University Hospital Münster provided by Prof. Dr. Klaus Berger and Dr. Maximov Stanislav.

Hematopoietic Stem Cell Transplantation - Post-HSCT Data (100 Days) 2100 Revision 2

- 2021-09-20 - 1 Formulär, 24 Item-grupper, 397 Dataelement, 1 Språk
Item-grupper: Registry Use Only, Identification Data, HSCT Type, Vital Status, Hematopoietic Reconstitution, Granulopoiesis / Neutrophil Recovery, Megakaryopoiesis / Platelet Recovery, Hematology findings, Immune Reconstitution, Chimerism analysis post transplantation, Chimerism Studies - Single Donor, Chimerism Studies - Multiple Donors, Engraftment Syndrome, Acute GVHD, Chronic GVHD, Infection, Pulmonary Function, Liver, Other Organ Impairment, New malignancy, Functional Status, Subsequent HSCT, Donor Cellular Infusion, Author Information
2100 Revision 2 - 100 Days Post-HSCT Data Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9FB3D5BF-EA64-EEEB-E040-BB89AD4331BD

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