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NCT ID: NCT06215248 Not yet recruiting - Heart Failure Clinical Trials

Myocardial Dysfunction Evaluation in Lower Extremity Arterial Disease Patients With Deformation Analysis

MEDAL
Start date: January 2024
Phase:
Study type: Observational

Single centre observational study to assess lower extremity arterial disease (LEAD) patients' cardiac dysfunction with strain analyses and to assess connections between cardiac dysfunction, metabolomic changes and target organ damage in LEAD.

NCT ID: NCT05947903 Not yet recruiting - Cancer Clinical Trials

Validation of the European Oncology Quality of Life Toolkit

Start date: April 1, 2024
Phase:
Study type: Observational

The improvement or preservation of quality of life (QoL) is one of the three pillars of the European Union (EU) Mission on Cancer, which underpins the needs of patients from cancer diagnosis throughout treatment, survivorship, and advanced terminal stages. Clinical studies and real-world data show that the use of Patient Reported Outcome Measures (PROMs) for QoL assessment in routine oncology practice has positive effects on patient wellbeing and healthcare resource utilization. However, full implementation of PROMs is not yet part of standard of care and is not adequately considered in cancer policies and programs. A comprehensive tool incorporating the perspective of patients at different stages of the disease trajectory and widely applicable across Europe is still lacking. The European Oncology Quality of Life Toolkit (EUonQoL-Kit) is a unified patient-centred tool for the assessment of QoL, developed from preferences and priorities of people with past or current cancer experience. The EUonQoL-Kit includes three electronic questionnaires, specifically designed for different disease phases (patients in active treatment, survivors, and patients in palliative care), available in both static and dynamic (Computer Adaptive Testing, CAT) versions and in several European languages. This is a multicentre observational study, with the following aims: - The primary aim is to perform the psychometric validation of the EUonQoL-Kit. - Secondary aims are to assess its acceptability, to validate the CAT version, and to provide estimates of QoL across different European countries. The EUonQoL-Kit will be administered to a sample of cancer patients and survivors from 46 European cancer centres. The sample will include patients in active treatment (group A), survivors (group B), and patients in Palliative Care (group C). Each centre will recruit 100 patients (40 from group A, 30 from group B, 30 from group C), for an overall sample size of 4,600 patients (at least 4,000 patients are assumed to be enrolled, due to an expected lower recruitment rate of 10-15%). Three sub-samples of patients (each corresponding to 10% of the total sample for each centre) will fill in an additional questionnaire: - EORTC QLQ-C30, to test concurrent validity. - Live-CAT version, to test the feasibility of such implementation. - EUonQoL-Kit, 2-7 days after the first completion, to assess test-retest reliability.

NCT ID: NCT05926349 Not yet recruiting - Urgent Surgery Clinical Trials

A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure

ANNEXA-RS
Start date: October 20, 2023
Phase: Phase 3
Study type: Interventional

The study will aim to find out if the drug andexanet alfa is safe and effective in preventing major bleeding during urgent surgery or invasive procedures. The study will compare the use of andexanet alfa to the usual care given at the study center.

NCT ID: NCT00893685 Not yet recruiting - Diabetes Mellitus Clinical Trials

Randomized Controlled Trial of Home Telemonitoring for Elderly People

Dreaming
Start date: May 2009
Phase: N/A
Study type: Interventional

The DREAMING clinical trial is part of the DREAMING project, which has the objective to demonstrate that the DREAMING platform consisting of integrated health monitoring, alarm handling and videoconferencing services produces clinical benefits to its users and economic benefits to the health authorities. The study evaluates the long-term (30 months) effect of continuous use of the DREAMING subsystems and is testing the hypothesis that such use is superior to usual care alone in reducing the deterioration of health related quality of life that is associated to age and chronic disease. It also tests the hypothesis that the DREAMING environment is superior to usual care in delaying the transfer to nursing or elderly homes and in reducing the incidence and duration of hospitalisation episodes. The trial will also evaluate the cost-effectiveness of the DREAMING platform. Outcomes are assessed in six different health care systems (Denmark, Estonia, Germany, Italy, Spain and Sweden) and will represent a basis for the adoption of DREAMING services by the respective health authorities.