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Eligibility Coronary Artery Bypass NCT01715714 DRKS00000753

- 2017-07-07 - 1 Formulär, 2 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Responsible Party: PD Dr. Oliver J. Liakopoulos, Principal Investigator, University of Cologne ClinicalTrials.gov Identifier: NCT01715714 History of Changes Other Study ID Numbers: Uni-Koeln-1341 2011-001795-19 ( EudraCT Number ) DRKS00000753 ( Registry Identifier: German Clinical Trials Register (DRKS) ) Study First Received: October 18, 2012 Last Updated: May 11, 2016 Statin Recapture Therapy Before Coronary Artery Bypass Grafting (StaRT-CABG) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT01715714

ICHOM Coronary Artery Disease - Peri-Inverventional Clinical Form

- 2020-04-30 - 1 Formulär, 8 Item-grupper, 46 Dataelement, 1 Språk
Item-grupper: Administrative Data, Demographic factors, Baseline health status, Prior Treatments, TREATMENT VARIABLES, Acute complications of treatment, Major surgery complications, Major interventional cardiology complications
CORONARY ARTERY DISEASE DATA COLLECTION Version 2.0.3 Revised: April 5th, 2017 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. Conditions: Asymptomatic Coronary Artery Disease | Stable Angina | Acute Coronary Syndrome (Includes AMI) Treatment Approaches: Lifestyle Modification | Drug Therapy | Percutaneous Coronary Intervention (PCI) | Coronary Artery Bypass Grafting (CABG) This form contains peri-interventional clinical items. The items cover a timespan from prior to the intervention (e.g. PCI or CABG) until 30 days after it. They should be assessed at the entry event and at any new index event (e.g. new revascularization procedure or new diagnosis of ACS). Questionnaires used in this standard set: Rose Dyspnea Scale: The Rose Dyspnea Scale is free for all health care organizations, and a license is not needed. More information may be found at http://www.ahjonline.com/article/S0002-8703(09)00266-X/abstract Patient Health Questionnaire (PHQ-2): The PHQ-2 is free for all health care organizations, and a license is not needed. Copyright Pfizer, more Information on http://www.phqscreeners.com/ Seattle Angina Questionnaire (SAQ-7): Due to the need for a license for use of the SAQ-7 the actual questions of SAQ-7 will not be part of this version of the standard set. Publication: McNamara RL, Spatz ES, Kelley TA, et al. Standardized Outcome Measurement for Patients With Coronary Artery Disease: Consensus From the International Consortium for Health Outcomes Measurement (ICHOM). J Am Heart Assoc. 2015;4(5):e001767. Published 2015 May 19. doi:10.1161/JAHA.115.001767 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Venous access Registry Oncology Thromboses UK Essen - Venous access

- 2016-12-01 - 1 Formulär, 1 Item-grupp, 12 Dataelement, 1 Språk
Item-grupp: 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).

Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521 - CABACS Case Report Form [1 year follow up]

- 2021-09-20 - 1 Formulär, 7 Item-grupper, 79 Dataelement, 1 Språk
Item-grupper: Doppler Ultrasonography, Screening: Outcome events, Concomitant medication, NIH Stroke scale, Modified Rankin Scale,structured interview, DemTect A, Completion Form Hospital
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

Eligibility Coronary Artery Bypass Surgery NCT00653042

- 2016-08-11 - 1 Formulär, 2 Item-grupper, 18 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Clinical Study to Evaluate Nesiritide in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery A014 / NAPA; ODM derived from: https://clinicaltrials.gov/show/NCT00653042

Follow up completion form Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521 - CABACS Case Report Form [follow up completion form]

- 2016-03-07 - 1 Formulär, 1 Item-grupp, 8 Dataelement, 1 Språk
Item-grupp: Follow up completion
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

On-Study - Metastatic Brain Cancer - On-Study Form - 2287553v3.0 - Metastatic Brain Cancer - On-Study Form

- 2015-01-09 - 1 Formulär, 10 Item-grupper, 64 Dataelement, 1 Språk
Item-grupper: CRF Header, Brain: Form Administration, Non-CNS: Initial Disease Description, Brain: Current Disease Description, Brain: Concomitant Medications, Metastatic Brain: Prior Health History, Metastatic Brain: Prior Treatment, Brain: Prior Treatment - Systemic Regimens, Brain: Prior Treatment - CNS RT, Brain: Prior Treatment - CNS Surgery
Metastatic Brain Cancer - On-Study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EF3A8ACE-5457-4C56-E034-0003BA3F9857

Eligibility Brain Cancer NCT01065805

- 2019-08-20 - 1 Formulär, 2 Item-grupper, 13 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
A Study to Demonstrate the Safety and Preliminary Efficacy of 18F-FLT in Patients With Solid Tumours or Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01065805

On-Study - Primary Brain Cancer - On-Study Form Recurrent Treatment - 2293986v3.0 - Primary Brain Cancer - On-Study Form Recurrent Treatment

- 2015-01-09 - 1 Formulär, 9 Item-grupper, 62 Dataelement, 1 Språk
Item-grupper: CRF Header, Brain: Form Administration, Brain: Recurrent Disease Description, Brain: Neurologic Function, Brain: Concomitant Medications, Brain: Prior Health History, Brain: Prior Treatment, Brain: Prior Treatment - Systemic Regimens, Comments
Primary Brain Cancer - On-Study Form Recurrent Treatment Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E51DA7FB-264B-3B94-E034-0003BA3F9857

Subcutaneous fondaparinux sodium for prevention of venous thromboembolic events; Study ID: 104619 - Visit 03

- 2018-10-22 - 1 Formulär, 2 Item-grupper, 5 Dataelement, 1 Språk
Item-grupper: Follow-Up, Patient Discharge
Study ID: 104619 Clinical Study ID: 63129 Study Title:A multinational, randomized, double-blind comparison of once daily subcutaneous fondaparinux sodium with placebo for the prevention of venous thromboembolic events in acutely ill medical patients (ARTEMIS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fondaparinux sodium Trade Name: Arixtra Study Indication: Thrombosis, Venous

dbGaP phs000289 NHGRI Genome-Wide Association Study of Venous Thromboembolism (GWAS of VTE) - pht001883.v1.p1

- 2022-10-12 - 5 Formulär, 1 Item-grupp, 4 Dataelement, 1 Språk
Item-grupp: pht001883
Principal Investigator: John A. Heit, MD, Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN, USA MeSH: Venous Thrombosis,Pulmonary Embolism,Deep Vein Thrombosis,Thrombophlebitis https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000289 *Overview:* *Our overall long-term goal is to determine risk factors for the complex (multifactorial) disease, venous thromboembolism (*VTE*), that will allow physicians to stratify individual patient risk and target VTE prophylaxis to those who would benefit most.* In this genome-wide association case-control study (1300 cases and 1300 controls) we hope to identify susceptibility variants for VTE. Mutations within genes encoding for important components of the anticoagulant, procoagulant, fibrinolytic, and innate immunity pathways are risk factors for VTE. We hypothesize that other genes within these four pathways or within other pathways also are VTE disease-susceptibility genes. Therefore, we performed a genome wide association (GWA) screen and analysis using the Illumina 660W platform to identify SNPs within 1,300 clinic-based, non-cancer VTE cases primarily from Minnesota and the upper Midwest USA, and 1300 clinic-based, unrelated controls frequency-matched on patient age, gender, myocardial infarction/stroke status and state of residence. This is a subset of a slightly larger candidate gene study using 1500 case-control pairs to identify haplotype-tagging SNPs (*ht*-SNPs) in a large set of candidate genes (n~750) within the anticoagulant, procoagulant, fibrinolytic, and innate immunity pathways. *Study Populations.* **Cases*.* VTE cases were consecutive Mayo Clinic outpatients with objectively-diagnosed deep vein thrombosis (DVT) and/or pulmonary embolism (PE) residing in the upper Midwest and referred by Mayo Clinic physician to the Mayo Clinic Special Coagulation Laboratory for clinical diagnostic testing to evaluate for an acquired or inherited thrombophilia, or to the Mayo Clinic Thrombophilia Center. Any person contacted to be a control but discovered to have had a VTE was evaluated for inclusion as a case. Cases were primarily residents from Minnesota, Wisconsin, Iowa, Michigan, Illinois, North or South Dakota, Nebraska, Kansas, Missouri and Indiana. A DVT or PE was categorized as objectively diagnosed when (a) confirmed by venography or pulmonary angiography, or pathology examination of thrombus removed at surgery, or (b) if at least one non-invasive test (compression duplex ultrasonography, lung scan, computed tomography scan, magnetic resonance imaging) was positive. A VTE was defined as:- Proximal leg deep vein thrombosis (DVT), which includes the common iliac, internal iliac, external iliac, common femoral, superficial [now termed "femoral"] femoral, deep femoral [sometimes referred to as "profunda" femoral] and/or popliteal veins. (Note: greater and lesser saphenous veins, or other superficial or perforator veins, were not included as proximal or distal leg DVT). - Distal leg DVT (or "isolated calf DVT"), which includes the anterior tibial, posterior tibial and/or peroneal veins. (Note: gastrocnemius, soleal and/or sural [e.g., "deep muscular veins" of the calf] vein thrombosis was not included as distal leg DVT). - Arm DVT, which includes the axillary, subclavian and/or innominate (brachiocephalic) veins. (Note: jugular [internal or external], cephalic and brachial vein thrombosis was not included in "arm DVT"). - Hepatic, portal, splenic, superior or inferior mesenteric, and/or renal vein thrombosis. (Note: ovarian, testicular, peri-prostatic and/or pelvic vein thrombosis was not included). - Cerebral vein thrombosis (includes cerebral or dural sinus or vein, saggital sinus or vein, and/or transverse sinus or vein thrombosis). - Inferior vena cava (IVC) thrombosis - Superior vena cava (SVC) thrombosis - Pulmonary embolism Patients with VTE related to active cancer, antiphospholipid syndrome, inflammatory bowel disease, vasculitis, a rheumatoid or other autoimmune disorder, a vascular anomaly (e.g., Klippel-Trénaunay syndrome, etc.), heparin-induced thrombocytopenia, or a mechanical cause for DVT (e.g., arm DVT or SVC thrombosis related to a central venous catheter or transvenous pacemaker, portal and/or splenic vein thrombosis related to liver cirrhosis, IVC thrombosis related to retroperitoneal fibrosis, etc.), with hemodialysis arteriovenous fistula thrombosis, or with prior liver or bone marrow transplantation were excluded. **Controls*.* A Mayo Clinic outpatient control group was prospectively recruited for this study. Controls were frequency-matched on the age group (18-29, 30-39, 40-49, 50-59, 60-69, 70-79, and 80+ years), sex, myocardial infarction/stroke status, and state of residence distribution of the cases. We selected clinic-based controls using a controls' database of persons undergoing general medical examinations in the Mayo Clinic Departments of General Internal Medicine or Primary Care Internal Medicine. Additionally persons undergoing evaluation at the Mayo Clinic Sports Medicine Center, and the Department of Family Medicine were screened for inclusion as controls. This study is part of the Gene Environment Association Studies initiative (GENEVA, http://www.genevastudy.org) funded by the trans-NIH Genes, Environment, and Health Initiative (GEI). The overarching goal is to identify novel genetic factors that contribute to venous thrombosis through large-scale genome-wide association studies of 1,300 clinic-based, VTE cases and 1300 clinic-based, unrelated controls. Genotyping was performed at the Johns Hopkins University Center for Inherited Disease Research (CIDR). Data cleaning and harmonization were done at the GEI-funded GENEVA Coordinating Center at the University of Washington.

pht001884.v1.p1

1 Item-grupp 6 Dataelement

pht001885.v1.p1

1 Item-grupp 4 Dataelement

Eligibility

1 Item-grupp 12 Dataelement

pht001886.v2.p1

1 Item-grupp 39 Dataelement

Eligibility Pulmonary Arterial Hypertension NCT02032836

- 2021-09-17 - 1 Formulär, 2 Item-grupper, 17 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Comparative PK PD Study in PAH Patients (Fox vs. I-Neb); ODM derived from: https://clinicaltrials.gov/show/NCT02032836

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