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Outcome event stroke Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521 - CABACS Case Report Form [Outcome event stroke]

- 07-03-16 - 1 Formulier, 3 Itemgroepen, 28 Data-elementen, 1 Taal
Itemgroepen: Endpoint event "stroke", Stroke follow-up, Modified Rankin Scale,structured interview
Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis. A randomized controlled clinical trial. Short title: "CABACS" DRKS Number:DRKS00000521 IRSCTN Number:ISRCTN13486906 Phase:Therapeutic confirmatory(Phase III) Head of clinical trial: Prof. Dr. med. Christian Weimar University Duisburg-Essen Phone: 0201/723-6503 Fax: 0201/723-6948 e-mail: christian.weimar@uk-essen.de University Hospital Essen Hospital for Neurology Hufelandstr. 55 45122 Essen Trial coordinator: Dr. med. Stephan Knipp Phone: 0201/723-4915 Fax: 0201/723-5451 e-mail: stephan.knipp@uk-essen.de University Duisburg-Essen University Hospital Essen Hospital for thoracic- and cardiovascular surgery Hufelandstr. 55 45122 Essen Data Management: Anja Marr Phone: 0201/92239-257 Fax: 0201/92239-333 o. 0201/723-5933 e-mail: anja.marr@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen Monitoring: Dipl.-Biol. Konstantinos Bilbilis Phone: 0201/92239-252 Fax: 0201/92239-310 e-mail: konstantinos.bilbilis@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen

Fifth year follow up Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521 - CABACS Case Report Form [fifth year follow up]

- 20-09-21 - 1 Formulier, 4 Itemgroepen, 37 Data-elementen, 1 Taal
Itemgroepen: Screening: Outcome events, Modified Rankin Scale,structured interview, Risk factors, Concomitant medication
Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis. A randomized controlled clinical trial. Short title: "CABACS" DRKS Number:DRKS00000521 IRSCTN Number:ISRCTN13486906 Phase:Therapeutic confirmatory(Phase III) Head of clinical trial: Prof. Dr. med. Christian Weimar University Duisburg-Essen Phone: 0201/723-6503 Fax: 0201/723-6948 e-mail: christian.weimar@uk-essen.de University Hospital Essen Hospital for Neurology Hufelandstr. 55 45122 Essen Trial coordinator: Dr. med. Stephan Knipp Phone: 0201/723-4915 Fax: 0201/723-5451 e-mail: stephan.knipp@uk-essen.de University Duisburg-Essen University Hospital Essen Hospital for thoracic- and cardiovascular surgery Hufelandstr. 55 45122 Essen Data Management: Anja Marr Phone: 0201/92239-257 Fax: 0201/92239-333 o. 0201/723-5933 e-mail: anja.marr@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen Monitoring: Dipl.-Biol. Konstantinos Bilbilis Phone: 0201/92239-252 Fax: 0201/92239-310 e-mail: konstantinos.bilbilis@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen

Third year follow up Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521 - CABACS Case Report Form [third year follow up]

- 20-09-21 - 1 Formulier, 4 Itemgroepen, 37 Data-elementen, 1 Taal
Itemgroepen: Screening: Outcome events, Modified Rankin Scale,structured interview, Risk factors, Concomitant medication
Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis. A randomized controlled clinical trial. Short title: "CABACS" DRKS Number:DRKS00000521 IRSCTN Number:ISRCTN13486906 Phase:Therapeutic confirmatory(Phase III) Head of clinical trial: Prof. Dr. med. Christian Weimar University Duisburg-Essen Phone: 0201/723-6503 Fax: 0201/723-6948 e-mail: christian.weimar@uk-essen.de University Hospital Essen Hospital for Neurology Hufelandstr. 55 45122 Essen Trial coordinator: Dr. med. Stephan Knipp Phone: 0201/723-4915 Fax: 0201/723-5451 e-mail: stephan.knipp@uk-essen.de University Duisburg-Essen University Hospital Essen Hospital for thoracic- and cardiovascular surgery Hufelandstr. 55 45122 Essen Data Management: Anja Marr Phone: 0201/92239-257 Fax: 0201/92239-333 o. 0201/723-5933 e-mail: anja.marr@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen Monitoring: Dipl.-Biol. Konstantinos Bilbilis Phone: 0201/92239-252 Fax: 0201/92239-310 e-mail: konstantinos.bilbilis@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen

Fourth year follow up Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521 - CABACS Case Report Form [fourth year follow up]

- 20-09-21 - 1 Formulier, 4 Itemgroepen, 37 Data-elementen, 1 Taal
Itemgroepen: Screening: Outcome events, Modified Rankin Scale,structured interview, Risk factors, Concomitant medication
Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis. A randomized controlled clinical trial. Short title: "CABACS" DRKS Number:DRKS00000521 IRSCTN Number:ISRCTN13486906 Phase:Therapeutic confirmatory(Phase III) Head of clinical trial: Prof. Dr. med. Christian Weimar University Duisburg-Essen Phone: 0201/723-6503 Fax: 0201/723-6948 e-mail: christian.weimar@uk-essen.de University Hospital Essen Hospital for Neurology Hufelandstr. 55 45122 Essen Trial coordinator: Dr. med. Stephan Knipp Phone: 0201/723-4915 Fax: 0201/723-5451 e-mail: stephan.knipp@uk-essen.de University Duisburg-Essen University Hospital Essen Hospital for thoracic- and cardiovascular surgery Hufelandstr. 55 45122 Essen Data Management: Anja Marr Phone: 0201/92239-257 Fax: 0201/92239-333 o. 0201/723-5933 e-mail: anja.marr@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen Monitoring: Dipl.-Biol. Konstantinos Bilbilis Phone: 0201/92239-252 Fax: 0201/92239-310 e-mail: konstantinos.bilbilis@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen

Second year follow up Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521 - CABACS Case Report Form [second year follow up]

- 20-09-21 - 1 Formulier, 4 Itemgroepen, 37 Data-elementen, 1 Taal
Itemgroepen: Screening: Outcome events, Modified Rankin Scale,structured interview, Risk factors, Concomitant medication
Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis. A randomized controlled clinical trial. Short title: "CABACS" DRKS Number:DRKS00000521 IRSCTN Number:ISRCTN13486906 Phase:Therapeutic confirmatory(Phase III) Head of clinical trial: Prof. Dr. med. Christian Weimar University Duisburg-Essen Phone: 0201/723-6503 Fax: 0201/723-6948 e-mail: christian.weimar@uk-essen.de University Hospital Essen Hospital for Neurology Hufelandstr. 55 45122 Essen Trial coordinator: Dr. med. Stephan Knipp Phone: 0201/723-4915 Fax: 0201/723-5451 e-mail: stephan.knipp@uk-essen.de University Duisburg-Essen University Hospital Essen Hospital for thoracic- and cardiovascular surgery Hufelandstr. 55 45122 Essen Data Management: Anja Marr Phone: 0201/92239-257 Fax: 0201/92239-333 o. 0201/723-5933 e-mail: anja.marr@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen Monitoring: Dipl.-Biol. Konstantinos Bilbilis Phone: 0201/92239-252 Fax: 0201/92239-310 e-mail: konstantinos.bilbilis@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen

Outcome event myocardial infarction Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521 - CABACS Case Report Form [Outcome event myocardial infarction]

- 07-03-16 - 1 Formulier, 1 Itemgroep, 17 Data-elementen, 1 Taal
Itemgroep: Endpoint event "myocardial infarction"
Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis. A randomized controlled clinical trial. Short title: "CABACS" DRKS Number:DRKS00000521 IRSCTN Number:ISRCTN13486906 Phase:Therapeutic confirmatory(Phase III) Head of clinical trial: Prof. Dr. med. Christian Weimar University Duisburg-Essen Phone: 0201/723-6503 Fax: 0201/723-6948 e-mail: christian.weimar@uk-essen.de University Hospital Essen Hospital for Neurology Hufelandstr. 55 45122 Essen Trial coordinator: Dr. med. Stephan Knipp Phone: 0201/723-4915 Fax: 0201/723-5451 e-mail: stephan.knipp@uk-essen.de University Duisburg-Essen University Hospital Essen Hospital for thoracic- and cardiovascular surgery Hufelandstr. 55 45122 Essen Data Management: Anja Marr Phone: 0201/92239-257 Fax: 0201/92239-333 o. 0201/723-5933 e-mail: anja.marr@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen Monitoring: Dipl.-Biol. Konstantinos Bilbilis Phone: 0201/92239-252 Fax: 0201/92239-310 e-mail: konstantinos.bilbilis@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen

Outcome event technical failure/restenosis Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521 - CABACS Case Report Form [Outcome event technical failure/restenosis]

- 07-03-16 - 1 Formulier, 1 Itemgroep, 18 Data-elementen, 1 Taal
Itemgroep: Endpoint event "technical failure/restenosis"
Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis. A randomized controlled clinical trial. Short title: "CABACS" DRKS Number:DRKS00000521 IRSCTN Number:ISRCTN13486906 Phase:Therapeutic confirmatory(Phase III) Head of clinical trial: Prof. Dr. med. Christian Weimar University Duisburg-Essen Phone: 0201/723-6503 Fax: 0201/723-6948 e-mail: christian.weimar@uk-essen.de University Hospital Essen Hospital for Neurology Hufelandstr. 55 45122 Essen Trial coordinator: Dr. med. Stephan Knipp Phone: 0201/723-4915 Fax: 0201/723-5451 e-mail: stephan.knipp@uk-essen.de University Duisburg-Essen University Hospital Essen Hospital for thoracic- and cardiovascular surgery Hufelandstr. 55 45122 Essen Data Management: Anja Marr Phone: 0201/92239-257 Fax: 0201/92239-333 o. 0201/723-5933 e-mail: anja.marr@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen Monitoring: Dipl.-Biol. Konstantinos Bilbilis Phone: 0201/92239-252 Fax: 0201/92239-310 e-mail: konstantinos.bilbilis@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen

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

- 20-09-21 - 1 Formulier, 12 Itemgroepen, 138 Data-elementen, 1 Taal
Itemgroepen: 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/

ICHOM Conditions and Treatment Approaches Covered for Stroke - Discharge +7 days - Clinical

- 30-04-20 - 1 Formulier, 5 Itemgroepen, 11 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Treatment/care related, Treatment variables, Acute Complications of treatment, Clinician reported health status
ICHOM Stroke data collection Version 2.0.1 Revised: June 21th, 2018 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. For stroke, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Patients who have been hospitalized for an index ischemic stroke (IS) or intracereberal hemorrhage (ICH). Patients with subarachnoid hemorrhage (SAH) are excluded. Inclusion of transient ischemic attack (TIA) or patients with IS or ICH who are evaluated but not hospitalized is not required. Treatment Approaches: IV Thrombolysis | Thrombectomy | Hemicraniectomy This form contains Discharge +7 days - Clinical form. If a second stroke occurs between discharge and the “90 day post index” collection, you should reset the measurement scale, treating them as a new patient. Questionnaires used in this standard set: PROMIS-10. It is free for all health care organizations, and a license is not needed. There are translations available for Spanish, French, German,and Dutch. As http://www.nihpromis.org is the official distribution site for PROMIS questionnaires and translations, only the total score will be included in this version of the standard set. Simplified Modified Rankin Scale Questionnaire (smRSq) – Clinician. There is no patent on thes smRSq or fee for using it in clinical practice; however Lippincott Williams & Wilkins (LWW) own the rights to the published article where the smRSq is introduced. Therefore here only the total score is included. The smRSq flow chart can be found at http://stroke.ahajournals.org/content/42/8/2276 “Simplified Modified Rankin Scale Questionnaire Reproducibility Over the Telephone and Validation With Quality of Life” Stroke 2011; 42: 2276-2279 © 2011 American Heart Association, Inc. Wolters Kluwer Health. Publication: Salinas J, Sprinkhuizen SM, Ackerson T, et al. An International Standard Set of Patient-Centered Outcome Measures After Stroke. Stroke. 2015;47(1):180–186. doi:10.1161/STROKEAHA.115.010898 For the Stroke Standard Set ICHOM was supported by the American Heart Association and the American Stroke Association. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Conditions and Treatment Approaches Covered for Stroke - Discharge +7 days - patient reported

- 30-04-20 - 1 Formulier, 2 Itemgroepen, 7 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Patient-reported health status
ICHOM Stroke data collection Version 2.0.1 Revised: June 21th, 2018 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. For stroke, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Patients who have been hospitalized for an index ischemic stroke (IS) or intracereberal hemorrhage (ICH). Patients with subarachnoid hemorrhage (SAH) are excluded. Inclusion of transient ischemic attack (TIA) or patients with IS or ICH who are evaluated but not hospitalized is not required. Treatment Approaches: IV Thrombolysis | Thrombectomy | Hemicraniectomy This form contains Discharge +7 days patient-reported form. If a second stroke occurs between discharge and the “90 day post index” collection, you should reset the measurement scale, treating them as a new patient. Questionnaires used in this standard set: PROMIS-10. It is free for all health care organizations, and a license is not needed. There are translations available for Spanish, French, German,and Dutch. As http://www.nihpromis.org is the official distribution site for PROMIS questionnaires and translations, only the total score will be included in this version of the standard set. Simplified Modified Rankin Scale Questionnaire (smRSq) – Clinician. There is no patent on thes smRSq or fee for using it in clinical practice; however Lippincott Williams & Wilkins (LWW) own the rights to the published article where the smRSq is introduced. Therefore here only the total score is included. The smRSq flow chart can be found at http://stroke.ahajournals.org/content/42/8/2276 “Simplified Modified Rankin Scale Questionnaire Reproducibility Over the Telephone and Validation With Quality of Life” Stroke 2011; 42: 2276-2279 © 2011 American Heart Association, Inc. Wolters Kluwer Health. Publication: Salinas J, Sprinkhuizen SM, Ackerson T, et al. An International Standard Set of Patient-Centered Outcome Measures After Stroke. Stroke. 2015;47(1):180–186. doi:10.1161/STROKEAHA.115.010898 For the Stroke Standard Set ICHOM was supported by the American Heart Association and the American Stroke Association. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Trauma-Patient assessment form University Hospital Muenster (UKM)

- 20-09-21 - 1 Formulier, 2 Itemgroepen, 18 Data-elementen, 1 Taal
Itemgroepen: Demographic Information, Outcome
Hospital Routine Documentation Form at the University Hospital Muenster. Original Form name: Schwerverletzten-Erhebungsbogen

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