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CEC - revascularisation GSK study Chronic Coronary Heart Disease NCT00799903

- 1/11/18 - 1 form, 3 itemgroups, 37 items, 1 language
Itemgroups: CEC - revascularisation, Urgent coronary revascularisation for myocardial ischemia, CEC Status
Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: CEC -revascularisation Repeating form (Scheduled visits)

Investigational product GSK study Chronic Coronary Heart Disease NCT00799903

- 12/22/17 - 1 form, 3 itemgroups, 16 items, 1 language
Itemgroups: Investigational product, Investigational product discontinuation, Post-IP Follow-up status
Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Investigational product

Investigational product (Liver) GSK study Chronic Coronary Heart Disease NCT00799903

- 1/4/18 - 1 form, 2 itemgroups, 8 items, 1 language
Itemgroups: Liver event during treatment period, Liver event after treatment period
Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Investigational product (Liver)

Standard of care medications GSK study Chronic Coronary Heart Disease NCT00799903

- 12/12/17 - 1 form, 1 itemgroup, 23 items, 1 language
Itemgroup: Standard of care medications
Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Standard of care medications

Investigational product Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

- 12/22/17 - 1 form, 2 itemgroups, 8 items, 1 language
Itemgroups: Investigational product, Investigational product compliance
Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Investigational product Repeating form (Scheduled visits)

Concomitant medications Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

- 12/22/17 - 1 form, 1 itemgroup, 13 items, 1 language
Itemgroup: Concomitant medications
Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Concomitant medications - Repeating form (Scheduled visits)

Eligibility Pulmonary Hypertension NCT01156636

- 6/10/17 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Phosphodiesterase-5 (PDE5) Inhibition and Pulmonary Hypertension in Diastolic Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01156636

Acute coronary syndrome (clinical) DSS 2013- Coronary artery cluster Metadata Online Registry (METeOR)

- 9/4/16 - 1 form, 1 itemgroup, 14 items, 1 language
Itemgroup: Person
Health sector data set specifications from METeOR, Australia's repository for national metadata standards, developed by the Australian Institute of Health and Welfare (http://meteor.aihw.gov.au/content/index.phtml/itemId/345165) Acute coronary syndrome (clinical) DSS 2013-: The scope for the ACS data set specification is to collect data on the period between when a person with ACS symptoms was first referred to a hospital or directly presented at a hospital, and when a person leaves the hospital, either from the emergency department or is discharged from the hospital. Coronary artery cluster: This cluster collects information on the characteristics of and interventions performed for the coronary arteries during the current hospitalisation. The coronary arteries included in this cluster are: · Left anterior descending coronary artery · Inferior surface artery · Left circumflex coronary artery · Diagonal coronary artery · Left main coronary artery · Posterior descending artery · Right coronary artery Metadata and Classifications Unit Australian Institute of Health and Welfare GPO Box 570 Canberra ACT 2601

Acute coronary syndrome (clinical) DSS 2013- Acute coronary syndrome pharmacotherapy data cluster Metadata Online Registry (METeOR)

- 9/2/16 - 1 form, 2 itemgroups, 14 items, 1 language
Itemgroups: Person with acute coronary syndrome, Person
Health sector data set specifications from METeOR, Australia's repository for national metadata standards, developed by the Australian Institute of Health and Welfare (http://meteor.aihw.gov.au/content/index.phtml/itemId/345165) Acute coronary syndrome (clinical) DSS 2013-: The scope for the ACS data set specification is to collect data on the period between when a person with ACS symptoms was first referred to a hospital or directly presented at a hospital, and when a person leaves the hospital, either from the emergency department or is discharged from the hospital. Acute coronary syndrome pharmacotherapy data cluster: The pharmacotherapies collected in this data cluster are recommended for the management of acute coronary syndromes (ACS) in the national guidelines. The following pharmacotherapies are collected as part of this data cluster: · Aspirin · Angiotensin converting enzyme (ACE) inhibitor · Angiotensin II receptor blocker · Antithrombin · Beta-blocker · Clopidogrel · Fibrinolytic · Glycoprotein IIb/IIIa receptor antagonist · Statin The pharmacotherapy cluster collects information on the type of pharmacotherapies prescribed and the timing of each prescription.

Acute coronary syndrome (clinical) DSS 2013- Metadata Online Registry (METeOR)

- 9/2/16 - 1 form, 10 itemgroups, 84 items, 1 language
Itemgroups: Acute coronary syndrome clinical event cluster, Emergency department stay, Episode of admitted patient care, Episode of care, Establishment, Health service event, Laboratory standard, Non-admitted patient emergency department service episode, Person with acute coronary syndrome, Person
Health sector data set specifications from METeOR, Australia's repository for national metadata standards, developed by the Australian Institute of Health and Welfare (http://meteor.aihw.gov.au/content/index.phtml/itemId/345165) Acute coronary syndrome (clinical) DSS 2013- The Acute coronary syndrome (ACS) data set specification is not mandated for collection but is recommended as best practice if ACS data are to be collected. This data set specification enables individual hospitals or health service areas to develop collection methods and policies appropriate for their service. The scope for the ACS data set specification is to collect data on the period between when a person with ACS symptoms was first referred to a hospital or directly presented at a hospital, and when a person leaves the hospital, either from the emergency department or is discharged from the hospital. Some of the data relevant to the management of patients attending hospital with ACS symptoms is specified for collection at follow-up visits with a specialist or as a non-admitted patient. Acute coronary syndromes reflect the spectrum of coronary artery disease resulting in acute myocardial ischaemia, and span unstable angina, non-ST segment elevation myocardial infarction (NSTEMI) and ST-segment elevation myocardial infarction (STEMI). Clinically these diagnoses encompass a wide variation in risk, require complex and time urgent risk stratification and represent a large social and economic burden. The definitions used in this data set specification are designed to underpin the data collected by health professionals in their day-to-day acute care practice. They relate to the realities of an acute clinical consultation for patients presenting with chest pain/discomfort and the need to correctly identify, evaluate and manage patients at increased risk of a coronary event. The data elements specified in this metadata set provide a framework for: • promoting the delivery of evidenced-based acute coronary syndrome management care to patients; • facilitating the ongoing improvement in the quality and safety of acute coronary syndrome management in acute care settings in Australia and New Zealand; • improving the epidemiological and public health understanding of this syndrome; and • supporting acute care services as they develop information systems to complement the above. This is particularly important, as the scientific evidence supporting the development of the data elements within the ACS data set specification indicate that accurate identification of the evolving myocardial infarction patient or the high/intermediate risk patient leading to the implementation of the appropriate management pathway impacts on the patient's outcome. Having a nationally recognised set of definitions in relation to defining a patient's diagnosis, risk status and outcomes is a prerequisite to achieving the above aims. The ACS data set specification is based on the American College of Cardiology (ACC) Data Set for Acute Coronary Syndrome as published in the Journal of the American College of Cardiology in December 2001 (38:2114-30) as well as more recent scientific evidence around the diagnosis of myocardial infarction presented in the National Heart Foundation of Australia/Cardiac Society of Australia and New Zealand Guidelines for the management of acute coronary syndromes (MJA 2006;184;S1-S32). The data elements are alphabetically listed and grouped in a similar manner to the American College of Cardiology's data set format. These features of the Australian ACS data set should ensure that the data is internationally comparable. Many of the data elements in this data set specification may also be used in the collection of other cardiovascular clinical information. Where appropriate, it may be useful if the data definitions in this data set specification were also used to address data definition needs in non-clinical environments such as public health surveys etc. This could allow for qualitative comparisons between data collected in, and aggregated from, clinical settings (i.e. using application of the ACS data set specification), with that collected through other means (e.g. public health surveys, reports). A set of ACS data elements and standardised definitions can inform the development and conduct of future registries at both the national and local level. The working group formed under the National Heart Foundation of Australia (Heart Foundation) and the Cardiac Society of Australia and New Zealand (CSANZ) initiative was diverse and included representation from the following organisations: the Heart Foundation, the CSANZ, the Australasian College of Emergency Medicine, the Australian Institute of Health and Welfare, the Australasian Society of Cardiac & Thoracic Surgeons, Royal Australian College of Physicians (RACP), RACP - Towards a Safer Culture, National Centre for Classification in Health (Brisbane), the NSW Aboriginal Health & Medical Research Council, the George Institute for International Health, the School of Population Health at the University of Western Australia and the National Cardiovascular Monitoring System Advisory Committee. To ensure the broad acceptance of the data set specification, the working group also sought consultation from the heads of cardiology departments, other specialist professional bodies and regional key opinion leaders in the field of acute coronary syndromes. Metadata and Classifications Unit Australian Institute of Health and Welfare GPO Box 570 Canberra ACT 2601

Therapy Registry Oncology Thromboses UK Essen - Therapy

- 12/1/16 - 1 form, 1 itemgroup, 28 items, 1 language
Itemgroup: Therapy
Study part: Therapy 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).

End form: Enoxaparin administration measures for the intervention group VTETumor02 Prophylactic Treatment of Thromboembolism with Enoxaparin EudraCT number: 2007-002036-28 - Enoxaparin administration measures for the intervention group

- 9/28/16 - 1 form, 3 itemgroups, 52 items, 1 language
Itemgroups: Drug administration Enoxaparin, Therapy interrupted, prescription Heparin
Study documentation part: Enoxaparin administration measures for the intervention group, VTETumor02. This is a prospective, randomized, controlled, unicentric, open study on prophylactic treatment of thromboembolism with Enoxaparin in non-surgical oncology patients under systemic antineoplastic therapy. Principal Investigator Prof. Dr. Max E. Scheulen, Clinic and Polyclinic for Internal medicine (Tumor research), University Hospital of Essen, Germany. EudraCT number: 2007-002036-28, Version 0.6 vom 06.08.09.

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