Search results - Portal of Medical Data Models (MDM-Portal)

Venous access Registry Oncology Thromboses UK Essen - Venous access

- 12/1/16 - 1 form, 1 itemgroup, 12 items, 1 language

Itemgroup: Venous access

Study part: Venous access Registry for oncologic patients with thromboses. The aim of the study was to determine the incidence of thrombosis in oncology patients. A register study of University Clinic Essen (UK Essen), permission granted by Claudia Ose from the Center for Clinical Studies Essen (Zentrums für Klinische Studien Essen, ZKSE).

Breast Cancer Swedish National Quality Registry - Secondary corrections/reconstruction

- 1/11/18 - 1 form, 3 itemgroups, 17 items, 2 languages

Itemgroups: National Quality Register for breast reconstruction, Secondary corrections/reconstruction, Form 4, Right side- surgery specification, Left side- surgery specification

Description of registry: The aim of the National Quality Registry for Breast Cancer is to: -in an objective and standardised manner, monitor the continuum of care from diagnosis to any recurrence and death -enable the identification of regional differences -collectively relate to current guidelines and quality targets set by specialist associations and the National Board of Health and Welfare -facilitate research and developments in breast cancer. Secondary corrections/reconstruction Source: http://www.cancercentrum.se/samverkan/cancerdiagnoser/brost/kvalitetsregister/dokument/ Facts Owner: Kerstin Sandelin surgeon, Karolinska University Hospital, Solna kerstin.sandelin@sll.se

Breast Cancer Swedish National Quality Registry - Late reconstruction surgery

- 1/9/18 - 1 form, 5 itemgroups, 37 items, 2 languages

Itemgroups: National Quality Register for breast reconstruction, Late reconstruction surgery, Form 2, Reconstruction after Mastectomy, Nipple Reconstruction, Areola reconstruction, Reconstruction after partial Mastectomy, Contralateral surgical Intervention

Description of registry: The aim of the National Quality Registry for Breast Cancer is to: -in an objective and standardised manner, monitor the continuum of care from diagnosis to any recurrence and death -enable the identification of regional differences -collectively relate to current guidelines and quality targets set by specialist associations and the National Board of Health and Welfare -facilitate research and developments in breast cancer. Source: http://www.cancercentrum.se/samverkan/cancerdiagnoser/brost/kvalitetsregister/dokument/ Facts Owner: Kerstin Sandelin surgeon, Karolinska University Hospital, Solna kerstin.sandelin@sll.se

Breast Cancer Swedish National Quality Registry - Reconstructive surgery within cancer surgery

- 1/9/18 - 1 form, 5 itemgroups, 39 items, 2 languages

Itemgroups: National Quality Register for breast reconstruction, Reconstructive surgery within cancer surgery, Form 1, Partial mastectomy + collective oncologic reconstruction surgery, Mastectomy + simultaneous reconstruction, Nipple Reconstruction, Areola reconstruction, Contralateral surgical Intervention

Description of registry: The aim of the National Quality Registry for Breast Cancer is to: -in an objective and standardised manner, monitor the continuum of care from diagnosis to any recurrence and death -enable the identification of regional differences -collectively relate to current guidelines and quality targets set by specialist associations and the National Board of Health and Welfare -facilitate research and developments in breast cancer. Reconstructive surgery within cancer surgery Source: http://www.cancercentrum.se/samverkan/cancerdiagnoser/brost/kvalitetsregister/dokument/ Facts Owner: Kerstin Sandelin surgeon, Karolinska University Hospital, Solna kerstin.sandelin@sll.se

Breast Cancer Swedish National Quality Registry - Bilateral prophylactic intervention, none cancer in history

- 1/9/18 - 1 form, 3 itemgroups, 30 items, 2 languages

Itemgroups: National Quality Register for breast reconstruction, Bilateral prophylactic intervention, none cancer in history, Surgery, Nipple Reconstruction, Areola reconstruction

Description of registry: The aim of the National Quality Registry for Breast Cancer is to: -in an objective and standardised manner, monitor the continuum of care from diagnosis to any recurrence and death -enable the identification of regional differences -collectively relate to current guidelines and quality targets set by specialist associations and the National Board of Health and Welfare -facilitate research and developments in breast cancer. Bilateral prophylactic intervention, none cancer in history Source: http://www.cancercentrum.se/samverkan/cancerdiagnoser/brost/kvalitetsregister/dokument/ Facts Owner: Kerstin Sandelin surgeon, Karolinska University Hospital, Solna kerstin.sandelin@sll.se

DZHK Data Catalogue - Spiroergometry

- 10/16/19 - 1 form, 2 itemgroups, 46 items, 2 languages

Itemgroups: 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.

DZHK Data Catalogue - Echocardiography

- 10/9/19 - 1 form, 9 itemgroups, 86 items, 2 languages

Itemgroups: Echocardiography details, Examination, Image quality, M-mode dimensions, 2-D measurements, Mitral valve PW Doppler, Tissue Doppler, Pulmonary venous flow, Heart valves

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 Echocardiography is used to document parameters of transthoracic echocardiography examinations. 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 "Transthoracic echocardiography" (version 1.0, effective as of 01/09/2014) and "Transthorakale Echokardiographie" (version 1.0, effective as of 01/09/2014) for the English and German language versions, respectively.

DZHK Data Catalogue - Laboratory

- 6/8/22 - 1 form, 4 itemgroups, 68 items, 2 languages

Itemgroups: EDTA blood for Haematology and HbA1c, Serum and heparin plasma for clinical chemistry, Citrate Plasma (Coagulation), Urinalysis

With permission from the DZHK Main Office and Transfer Office, we present the DZHK Data Catalogue: 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 and develop new therapies and diagnostic procedures that have an impact on the lives of people suffering from cardiovascular diseases. (https://dzhk.de/dzhk-heart-bank) They developed a data catalogue that contains a detailed description of the data and biospecimen collected in their clinical studies, including the associated metadata, shown on their DZHK Heart Bank website (https://dzhk.de/en/dzhk-heart-bank/data-and-biospecimens/resource-with-liquid-samples-and-image-data/data-catalogue/). The version shown here contains the metadata part only. The form Laboratory is used to document different measurement parameters of laboratory examinations. The documentation of clinical data has to be performed according to the DZHK's SOPs, which can be accessed at https://service4studies.dzhk.de/studienzentren/klinische-daten/. For more informations or to request data and/or biospecimens please visit the DZHK Heart Bank.

Swedish Stroke Registry RIKSSTROKE - Pain

- 11/29/17 - 1 form, 1 itemgroup, 7 items, 2 languages

Itemgroup: Pain

Swedish Stroke Registry source: http://www.riksstroke.org/eng/ Riksstroke – a Swedish national quality register for stroke care primarily aimed at health professionals and decision makers in health care. We collect, analyze and follow-up data on morbidity and hospital stay. Pain

German Rescuitation Registry (Reanimationsregister Version 2.0) - Secondary care max (Weiterversorgung Max)

- 3/18/20 - 1 form, 11 itemgroups, 135 items, 2 languages

Itemgroups: Basic Data, Admittance dates and status, Clinical measures, Temperature management, Temperature management Induction, Temperature management Maintenance, Temperature management Rewarming, Temperature management Fever prevention, Neuroprognostic tests, Result, Acquisition Status

Angaben für die Description: The German Resuscitation Registry (GRR) (Das Deutsche Reanimationsregister) is a supraregional database for the collection and evaluation of resuscitations in rescue services and clinics, as well as for intraclinical emergency care in Germany. https://www.reanimationsregister.de/downloads/formulare.html The translation is not an official translation. The TIMI risk score is part of this form. Morrow, D. A.; Antman, E. M.; Charlesworth, A.; Cairns, R.; Murphy, S. A.; Lemos, J. A. de et al. (2000): TIMI risk score for ST-elevation myocardial infarction: A convenient, bedside, clinical score for risk assessment at presentation: An intravenous nPA for treatment of infarcting myocardium early II trial substudy. In: Circulation 102 (17), S. 2031–2037. The modified Rankin-scale is part of this form. Rankin J. Cerebral vascular accidents in patients over the age of 60: II. Prognosis Scottish Med J. 1957; 2: 200–215. The Cerebral Performance Category is part of this form. Jennett B, Bond M. Assessment of outcome after severe brain damage. Lancet. 1975 Mar 1;1(7905):480-4. The EQ-5D is part of this form. The EuroQol Group. EuroQol—a new facility for the measure-mentofhealth-relatedqualityoflife.HealthPolicy.1990;36:199–208. The SF-12 is part of this form. Ware J, Kosinski M, Keller SD. A 12-item short-form health survey:construction of scales and preliminary tests of reliability and validity. MedCare. 1996;34:220–33.

DZHK Data Catalogue - MRI

- 10/16/19 - 1 form, 5 itemgroups, 29 items, 2 languages

Itemgroups: MRI details, Cine 4-chamber view, Cine 2-chamber view, Short-axis cine stack, Late Gadolinium Enhancement (LGE) details

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 MRI is used to document analyzing parameters of cardiac magnetic resonance imaging examinations. 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 "Cardiac magnetic resonance imaging" (version 1.0, effective as of 01/09/2014), and "Kardiale Magnetresonanztomographie" (version 1.0, effective as of 01/09/2014), for the English and German versions, respectively. The SOP is ased on the guidelines of the Society for Cardiovascular Magnetic Resonance (Kramer CM et al. Journal of Cardiovascular Magnetic Resonance 2008, 10:35 and Journal of Cardiovascular Magnetic Resonance 2013, 15:91). Contraindications to MRI are: - Pacemakers, defibrillators - Neurostimulators - Metal vascular clips - Cochlear implants - Ferromagnetic intravascular filters and shunts that were implanted less than 1 month ago - Starr-Edwards prosthetic heart valves (old type of heart valve made of metal, implanted prior to 1970) - Recently implanted ferromagnetic vascular clips - Implanted permanent magnets (magnetic dentures) - Implanted insulin or pain pumps - Recently implanted joint replacement, magnetic resonance imaging is safe with titanium prostheses or joint replacements that were implanted a while ago - Shrapnel

ISARIC/WHO Novel Coronavirus (nCoV) / COVID-19 Case Record Form - MODULE 3: OUTCOME CASE REPORT FORM

- 9/20/21 - 1 form, 12 itemgroups, 138 items, 1 language

Itemgroups: Participant Identification, Treatment, Complications, Diagnostics, Biospecimen Testing, Antiviral therapy, Antibiotic therapy, Corticosteroids, Heparin, Antifungal therapy, Other treatments administered for COVID-19, Outcome

This CRF is set up in modules to be used for recording data on the ISARIC COVID-19 Core Database or for independent studies. Module 1 and Module 2 complete on the first day of presentation/admission or on first day of COVID-19 assessment. Module 2 also complete on first day of admission to ICU or high dependency unit. In addition, complete daily for as many days as resources allow up to a maximum of 14 days. Continue to follow-up patients who transfer between wards. Module 3 (Outcome) complete at discharge or death General Guidance: - The CRF is designed to collect data obtained through examination, interview and review of hospital notes. Data may be collected retrospectively if the patient is enrolled after the admission date. - For more detailed guidance on how to complete these forms, please refer to the CRF Completion Guideline - Participant Identification Numbers consist of a 3 digit site code and a 4 digit participant number. You can obtain a site code and registering on the data management system by contacting ISARIC. Participant numbers should be assigned sequentially for each site beginning with 0001. In the case of a single site recruiting participants on different wards, or where it is otherwise difficult to assign sequential numbers, it is acceptable to assign numbers in blocks or incorporating alpha characters. E.g. Ward X will assign numbers from 0001 or A001 onwards and Ward Y will assign numbers from 5001 or B001 onwards. Enter the Participant Identification Number at the top of every page. - Printed paper CRFs may be used for later transfer of the data onto the electronic database. - For participants who return for re-admission to the same site, start a new form with a different Participant Identification Number. Please check “YES-admitted previously” in the ONSET & ADMISSION section. Enter as 2 separate entries in the electronic database. - For participants who transfer between two sites that are both collecting data on this form, it is preferred to have the data entered by a single site as a single admission, under the same Participant Identification Number. When this is not possible, the first site should record “Transfer to other facility” as an OUTCOME, and the second site should start a new form with a new patient number and indicate “YES-transferred” in ONSET & ADMISSION. - Complete every line of every section, except for where the instructions say to skip a section based on certain responses. - Mark ‘Not done’ for any results of laboratory values that are not available, not applicable or unknown. - Avoid recording data outside of the dedicated areas. Sections are available for recording additional information. - If using paper CRFs, we recommend writing clearly in ink, using BLOCK-CAPITAL LETTERS. - Place an (X) when you choose the corresponding answer. To make corrections, strike through (-------) the data you wish to delete and write the correct data above it. Please initial and date all corrections. - Please keep all of the sheets for a single participant together e.g. with a staple or participant-unique folder. - ISARIC would like the centers to enter data directly into their electronic data capture system. Please contact ISARIC about access. If your site would like to collect data independently, ISARIC can support you in the estabilishment of locally hosted databases. This version may serve as a basis for locally hosted databases. - Please contact ISARIC, if you need help with databases, have comments or to let ISARIC know that you are using the CRF. - Please let us know if you find any mistakes in the MDM Portal's version. FURTHER GUIDANCE AND DEFINITIONS (from the Completion guideline) Comorbidities: Comorbidities present before the onset of COVID-19 and are still present. Do not include those that developed following the onset of COVID-19 symptoms. More detailed guidance is provided. Hospital admission: For patients who were admitted to hospital with COVID-19 or symptoms consistent with possible COVID-19 infection, please enter details for the date of hospital admission. For patients with a clear alternative diagnosis leading to admission who subsequently acquired COVID-19, original admission date should be provided, but all subsequent references to admission should be taken as referring to day COVID-19 was first clinically suspected (or within the first 24 hours after first day of suspected or confirmed COVID-19 infection). Where a patient was admitted via multiple hospital departments, count admission from the time they came to the first department during the visit that led to their admission (e.g. arrival at the Emergency Department). Oxygen therapy: Include any form of supplemental oxygen received using any methods. Invasive ventilation: Please include any mechanical ventilation delivered following intubation or via a tracheostomy. Do not include patients who are breathing independently via a tracheostomy. Non-invasive ventilation: Please include any positive-pressure treatment given via a tight-fitted mask. This can be continuous positive pressure (CPAP) or bi-level positive pressure (BIPAP). Renal replacement therapy or dialysis: Please include any form of continuous renal replacement therapy or intermittent haemodialysis. Worst result: References to ‘worst result’ refer to those furthest from the normal physiological range or laboratory normal range. Results that were rejected by the clinical team (e.g. pulse oximetry on poorly perfused extremities, haemolysed blood samples, contaminated microbiology results) should not be reported. The following measures should be considered as a single observation and entered together: Blood gas results: Please report the measures from the blood gas with the lowest pH (most acidotic). Blood pressure: Please report the systolic and diastolic blood pressure from the observation with the lowest mean arterial pressure (if mean arterial pressure has not been calculated, report the measurement with lowest systolic blood pressure). Respiratory rate: If both abnormal low and high rate observed, record the abnormally high rate. General information about ISARIC ISARIC has developed a portfolio of resources to accelerate outbreak research and response. All resources are designed to address the most critical public health questions, have undergone extensive review by international clinical experts, and are free to use. ISARIC should be acknowledged and informed if you implement the protocol. Ethical apporval of the protocol and all necessary operational and financial arrangements are the responsibility of the investigators. This form refers to the CoV CASE RECORD FORM Version 1.3 25 Aug 2020. See https://isaric.tghn.org/COVID-19-CRF/

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Selected data models