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NCT ID: NCT05947903 Not yet recruiting - Cancer Clinical Trials

Validation of the European Oncology Quality of Life Toolkit

Start date: June 15, 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 static and dynamic versions against each other, and to provide estimates of QoL across European countries. The EUonQoL-Kit will be administered to a sample of patients from 45 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 4,500 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: - FACT-G (Functional Assessment of Cancer Therapy - General) and EQ-5D-5L (5-level European Quality of Life Five Dimension), to test concurrent validity. - Live-CAT version, to validate the static and dynamic versions against each other. - EUonQoL-Kit, at least 1 hour after the first completion, to assess test-retest reliability.

NCT ID: NCT05946941 Recruiting - Sjögren's Syndrome Clinical Trials

A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome

POETYK SjS-1
Start date: September 11, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.

NCT ID: NCT05936827 Recruiting - Healthy Clinical Trials

Gyrocardiography- A New Non-invasive Cardiac Measurement Method to Measure Exercise Capacity and Cardiorespiratory Fitness

Start date: March 1, 2023
Phase:
Study type: Observational

The goal of this study is to produce a solution to measure the cardiorespiratory fitness (CRF), which can be used by commercially available smartphones without extra equipment, add-ons and special know-how. This observational study with follow-up is to test the feasibility of a new non-invasive cardiac measurement method (gyrocardiography, GCG) in detecting hemodynamic parameters to measure exercise capacity and cardiorespiratory fitness in healthy subjects. The objective is to produce a solution which can be used to measure the exercise capacity and cardiorespiratory fitness (CRF) of the exercisers, keep-fit athletes and professional athletes using hemodynamic parameters such as: - Heart rate and Heart rate variability - Cardiac Strength profile - Systolic and diastolic phase - Breathing frequency - VO2max Participants are either athletes or non-athletic persons. The athletes will perform spiroergometry and non-athletic persons ergometry to measure the CRF expressed as VO2max. Following parameters will be measured during the (spiro)ergometry: - Maximum workload (W) - VO2max (ml/kg/min) - HRmax - Blood lactate - Respiratory exchange ratio RER (VO2/VCO2) The GCG measurements for acquiring the hemodynamic parameters are performed before and after the (spiro)ergometry using smartphone. During a 1- minute GCG measurement, the smart phone is placed on the chest in the middle of the sternum.

NCT ID: NCT05936580 Not yet recruiting - Hemophilia A Clinical Trials

Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery

Start date: February 2024
Phase: Phase 4
Study type: Interventional

Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery

NCT ID: NCT05931081 Active, not recruiting - Clinical trials for Chronic Ulcer of Skin

Thermal Imaging in Diagnostics of Chronic Ulcers and in Monitoring Healing of Chronic Ulcers

R22108L
Start date: March 1, 2023
Phase:
Study type: Observational [Patient Registry]

Patients with chronic ulcer needing tertiary care referred to the Wound Center of Tampere University Hospital are invited to this study. Patients are treated according to standard treatment practices. The temperature of the lower limbs and ulcer area is measured during visits using the Thermidas Remote thermal imaging system, a CE-marked medical device for measuring and monitoring changes in skin surface temperature non-invasively. The measured temperatures and differences are compared in different ulcer aetiology groups and analyzed whether thermal imaging can be used to distinguish atypical ulcers from vascular ulcers. Thermal imaging measurements and clinical examinations are repeated to the patients with atypical ulcers during follow-up visits. Monitoring of ulcers will continue until the ulcer has epithelized completely or for up to a year.

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: NCT05923580 Recruiting - Clinical trials for Coronary Artery Disease

Group-based Cardiac Telerehabilitation and Its Effectiveness

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

Cardiovascular diseases (CVD) and coronary artery diseases (CAD) are the most common cause of death worldwide. After an acute cardiac event, prevention of new cardiac events is essential and reduces suffering. Group-based cardiac telerehabilitation (CTR) refers to the use of information and communication technologies for rehabilitation purposes in promoting CAD patients´ health.

NCT ID: NCT05919927 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

Diabetes and Cognitive Functions in Middle Age

DBC
Start date: June 7, 2018
Phase:
Study type: Observational

This study will examine the effects of type II diabetes on cognitive functions and mood in middle-aged patients. In addition, the association between cognitive functions and glycemic controls is studied in patients. Sixty patients and sixty healthy controls will be recruited and assessed by a multiprofessional team (neuropsychologist, physician).

NCT ID: NCT05917860 Recruiting - Prostate Cancer Clinical Trials

Neoadjuvant ADT With TULSA in the Treatment of Intermediate Risk Prostate Cancer

NeoADT-TULSA
Start date: October 1, 2023
Phase: Phase 1
Study type: Interventional

Clinical studies have shown that magnetic resonance imaging-guided transurethral ultrasound ablation (TULSA) of the prostate is safe and effective. In the TULSA procedure, prostate tissue is killed by heating with ultrasound. This clinical trial explores if adding drug therapy with Degarelix before TULSA has the potential to improve further the effectiveness of TULSA in the treatment of localized prostate cancer, especially for patients with more aggressive diseases.

NCT ID: NCT05915247 Completed - Parkinson Disease Clinical Trials

Single Ascending Doses of HER-096 in Healthy Subjects

Start date: March 29, 2023
Phase: Phase 1
Study type: Interventional

This study evaluates the safety and tolerability of HER-096 in healthy volunteer subjects by comparing the effects of active study treatment HER-096 to placebo (0.9% physiological saline). In addition, the pharmacokinetic profile of HER-096 in humans will be investigated. The investigational medicinal products will be administered as a single dose by subcutaneous injection.