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dbGaP phs001368 NHLBI TOPMed: Trans-Omics for Precision Medicine (TOPMed) Whole Genome Sequencing Project: Cardiovascular Health Study - Eligibility

- 2/21/23 - 4 forms, 1 itemgroup, 4 items, 1 language
Itemgroup: IG.elig
Principal Investigator: Bruce M. Psaty, MD, PhD, TOPMed Cardiovascular Health Study Project (TOPMed-CHS). University of Washington, Seattle, WA, USA MeSH: Cardiovascular Diseases,Myocardial Infarction,Stroke,Brain Ischemia,Intracranial Hemorrhage,Venous Thromboembolism,Venous Thrombosis,Pulmonary Embolism https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001368 Participants from the Cardiovascular Health Study (CHS), a large population-based longitudinal cohort study (phs000287), have been included in the TOPMed project. Whole genome sequencing will be performed to contribute to multiple analyses, including cardiovascular disease risk factors, subclinical disease measures, the occurrence of myocardial infarction (MI) and stroke, and analyses of venous thromboembolism (VTE).

pht007957.v3.p2

1 itemgroup 3 items

pht007958.v3.p2

1 itemgroup 2 items

pht007959.v3.p2

1 itemgroup 12 items

Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961 - Autopsy Form

- 10/25/19 - 1 form, 3 itemgroups, 32 items, 1 language
Itemgroups: Administrative documentation, Autopsy, Investigator's signature
Study ID: 103414 Clinical Study ID: 103414 Study Title: A Multicenter, Randomized, Double-blind, Parallel Group Trial to Demonstrate the Efficacy of Fondaparinux Sodium in Association With Intermittent Pneumatic Compression (IPC) Versus IPC Used Alone for the Prevention of Venous Thromboembolic Events in Subjects at Increased Risk Undergoing Major Abdominal surgery Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00038961 https://clinicaltrials.gov/ct2/show/NCT00038961 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Fondaparinux Sodium Trade Name: Fondaparinux Sodium Study Indication: Thrombosis This phase III placebo-controlled trial studies the efficacy and safety of Fondaparinux as an additional prevention measure of venous thromboembolic events (VTE) in patients above the age of 40 with intermediate or high VTE risk undergoing abdominal surgery. The study consists of a Screening Visit (Visit 0), the baseline visit on Day 1, the day of the surgery (Visit 1), the treatment period (denoted in its entirety as Visit 2) consisting of administration of Fondaparinux (2.5mg subcutaneously once daily) or placebo starting on Day 1 and continuing at least up to Day 5, possibly up to Day 9, in parallel to intermittent pneumatic compression and possibly elastic stockings, followed by a mandatory bilateral venography no longer than 24 hours after study drug cessation, and finally a Follow-up Visit (Visit 3) on Day 30 +/- 2. This form is to be filled in if an autopsy has been performed.

Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961 - Suspected Pulmonary Embolism Adjudication

- 10/17/19 - 1 form, 11 itemgroups, 32 items, 1 language
Itemgroups: Administrative documentation, Suspected PE Adjudication, V/Q Scan Adjudication Result, Spiral CT scan Adjudication Result, Pulmonary Angiogram Adjudication Result, Compression Ultrasonography Adjudication Result, Other test Adjudication Result, Venogram Adjudication Result, Venogram Adjudication Results, Classification Adjudication Result, Adjudicators
Study ID: 103414 Clinical Study ID: 103414 Study Title: A Multicenter, Randomized, Double-blind, Parallel Group Trial to Demonstrate the Efficacy of Fondaparinux Sodium in Association With Intermittent Pneumatic Compression (IPC) Versus IPC Used Alone for the Prevention of Venous Thromboembolic Events in Subjects at Increased Risk Undergoing Major Abdominal surgery Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00038961 https://clinicaltrials.gov/ct2/show/NCT00038961 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Fondaparinux Sodium Trade Name: Fondaparinux Sodium Study Indication: Thrombosis This phase III placebo-controlled trial studies the efficacy and safety of Fondaparinux as an additional prevention measure of venous thromboembolic events (VTE) in patients above the age of 40 with intermediate or high VTE risk undergoing abdominal surgery. The study consists of a Screening Visit (Visit 0), the baseline visit on Day 1, the day of the surgery (Visit 1), the treatment period (denoted in its entirety as Visit 2) consisting of administration of Fondaparinux (2.5mg subcutaneously once daily) or placebo starting on Day 1 and continuing at least up to Day 5, possibly up to Day 9, in parallel to intermittent pneumatic compression and possibly elastic stockings, followed by a mandatory bilateral venography no longer than 24 hours after study drug cessation, and finally a Follow-up Visit (Visit 3) on Day 30 +/- 2. This form contains information on the adjudication of any suspected Pulmonary Embolism (PE), information on which is recorded in a seperate form.

Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961 - Assessment of Suspected Pulmonary Embolism

- 10/16/19 - 1 form, 10 itemgroups, 28 items, 1 language
Itemgroups: Administrative documentation, General Pulmonary Embolism Information, Perfusion and/or Ventilation Lung Scan, Ultrasonography, Venography, Angiography, Spiral CT scan, Other tests, Treatment, Suspected PE fatal
Study ID: 103414 Clinical Study ID: 103414 Study Title: A Multicenter, Randomized, Double-blind, Parallel Group Trial to Demonstrate the Efficacy of Fondaparinux Sodium in Association With Intermittent Pneumatic Compression (IPC) Versus IPC Used Alone for the Prevention of Venous Thromboembolic Events in Subjects at Increased Risk Undergoing Major Abdominal surgery Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00038961 https://clinicaltrials.gov/ct2/show/NCT00038961 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Fondaparinux Sodium Trade Name: Fondaparinux Sodium Study Indication: Thrombosis This phase III placebo-controlled trial studies the efficacy and safety of Fondaparinux as an additional prevention measure of venous thromboembolic events (VTE) in patients above the age of 40 with intermediate or high VTE risk undergoing abdominal surgery. The study consists of a Screening Visit (Visit 0), the baseline visit on Day 1, the day of the surgery (Visit 1), the treatment period (denoted in its entirety as Visit 2) consisting of administration of Fondaparinux (2.5mg subcutaneously once daily) or placebo starting on Day 1 and continuing at least up to Day 5, possibly up to Day 9, in parallel to intermittent pneumatic compression and possibly elastic stockings, followed by a mandatory bilateral venography no longer than 24 hours after study drug cessation, and finally a Follow-up Visit (Visit 3) on Day 30 +/- 2. This form contains information on diagnostics (in particular imaging) used to assess a suspected pulmnoary embolism and is to be filled in as appropriate during the study.

Subcutaneous fondaparinux sodium for prevention of venous thromboembolic events; Study ID: 104619 - Assessment of Suspected Pulmonary Embolism

- 11/6/18 - 1 form, 9 itemgroups, 32 items, 1 language
Itemgroups: Pulmonary Embolism, Suspicion, Pulmonary Embolism; Lung Scan, Ultrasonography, Venography, Angiogram, Tomography, Spiral Computed, Other Tests, Therapeutic Procedure, Pulmonary Embolism, Seriousness
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

Simplified Pulmonary Embolism Severity Index (sPESI)

- 1/25/18 - 1 form, 1 itemgroup, 7 items, 1 language
Itemgroup: sPESI
The Pulmonary Embolism Severity Index (PESI) estimates the risk of 30-day mortality in patients with acute pulmonary embolism (PE). The simplified PESI has similar prognostic accuracy and clinical utility and greater ease of use compared with the original PESI. Reference: Jiménez, D., Aujesky, D., Moores, L., Gómez, V., Lobo, J. L., Uresandi, F., ... & Yusen, R. D. (2010). Simplification of the pulmonary embolism severity index for prognostication in patients with acute symptomatic pulmonary embolism. Archives of internal medicine, 170(15), 1383-1389.

Eligibility NCT00439725 Deep Vein Thrombosis - Eligibility

- 12/9/13 - 1 form, 3 itemgroups, 17 items, 2 languages
Itemgroups: Inclusion criteria, Exclusion criteria, Medical Concepts
This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT or PE who completed 6 or 12 months of treatment with rivaroxaban or VKA are eligible for this trial (Einstein-Extension study).

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