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NCT ID: NCT06269549 Not yet recruiting - Clinical trials for Osteoarthritis, Knee

Kinesiological / Dietary Supplement Intervention in Knee Osteoarthritis

KDSKOA
Start date: March 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to assess the effectiveness of dietary supplement combined with exercise in managing knee osteoarthritis (KOA). The main questions it aims to answer are: - Is adding a dietary supplement to exercise additionally effective in managing KOA? - Is adding exercise to the dietary supplement additionally effective in managing KOA? Participants will be given in three groups: 1. Real dietary supplement alone 2. Real dietary supplement with exercise 3. Placebo dietary supplement with exercise Investigators will compare groups 1 and 2, or 2 and 3, to answer the research questions. The hypothesis is that participants who receive the dietary supplement along with exercise will experience greater reduction in pain level, improved physical function, and enhanced quality of life compared to those who receive a placebo combined with exercise or dietary supplement alone.

NCT ID: NCT06025123 Not yet recruiting - Hypothermia Clinical Trials

Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2

PRINCESS2
Start date: January 2024
Phase: N/A
Study type: Interventional

The aim of this clinical trial is to study the impact of ultra-early transnasal evaporative cooling after cardiac arrest and subsequent hypothermia at hospital, on survival with complete neurologic recovery, compared to currently recommended normothermia. The study population will consist of patients 18-79 years old, with out-of-hospital cardiac arrest with initial shockable rhythm. The main research question it aims to answer is whether there is a difference in survival with complete neurologic recovery at 90 days after cardiac arrest between the group of patients that received ultra-early cooling, compared to the group that was treated with normothermia. Participants will be randomized to two groups. One group (the intervention group) will receive ultra-early trans-nasal evaporative cooling initiated by EMS personnel at the scene of the cardiac arrest, and subsequent systemic hypothermia for 24 hours at hospital arrival. The other group (the control group), will receive standard of care (advanced cardiac life support and normal body temperature (normothermia)).

NCT ID: NCT06023550 Not yet recruiting - Sinusitis Clinical Trials

Complicated Infections in Otorhinolaryngology

ENT_infect
Start date: October 2023
Phase:
Study type: Observational [Patient Registry]

This observational study aims to learn more about complicated infections treated by otorhinolaryngologists. The main questions to answer are: - What is the management of complicated sinonasal infections in Ljubljana, Slovenia, - What is the management of complicated ear and temporal bone infections in Ljubljana, Slovenia, - What is the management of complicated neck soft tissue infections in Ljubljana, Slovenia, - What is the management of complicated laryngeal infections in Ljubljana, Slovenia Participants will receive standard treatment according to the established evidence-based clinical practice.

NCT ID: NCT06012604 Not yet recruiting - Clinical trials for Xerostomia Following Radiotherapy

Treatment of Post-radiation Xerostomia With Allogeneic Mesenchymal Stromal Stem Cells

Start date: September 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to learn about toxicity of allogeneic mesenchymal stromal stem cells (MSC, derived from umbilical cord tissue) treatment in head and neck cancer patients with for post-radiation xerostomia. The main question it aims to answer is the toxicity of intervention and the secondary objective is to assess preliminary efficacy. Participants will receive MSC in both parotid and submandibular glands: the toxicity of the intervention will be assessed using CTCAE v5.0 and its effect will be evaluated through measuring salivary flow and composition, radiologically (ultrasonography, magnetic resonance imaging), with scintigraphy and questionnaires. In the control group, salivary gland function (salivary flow and saliva composition) will be assessed for comparison with the intervention group.

NCT ID: NCT06007001 Not yet recruiting - Cancer Clinical Trials

Telerehabilitation and Tele-psychological Support in Cancer Patients eCAN JA

eCAN
Start date: September 15, 2023
Phase: N/A
Study type: Interventional

The integration of teleconsultation (TC) and telemonitoring (TM) in cancer patients care may allow to improve person-centered care and patients' empowerment. The eCAN JA explores the role of telemedicine tools (i.e. TC & TM) in clinical trials focusing on tele-rehabilitation and tele-psychological support in different populations of cancer patients in 10 European countries. The pilots will be conducted among 354 patients affected by breast (BC, pilot 1a), head & neck (H&N, pilot 1b) and advanced (pilot 2) cancers. The main aim is to assess the effect of TC and TM program focused on rehabilitation and psychological support for cancer patients on patient reported outcomes measures (PROMs) in three pilots compare to usual care. Patients will be randomly assigned either to the intervention or control groups using a 1:1 ratio. Patients in the intervention group will receive weekly TC of 30 minutes during 8 weeks through the secure Edumeet platform. In pilot 1, tele-rehabilitation training will be performed by a remote physiotherapist and will consist of a series of rehabilitation exercises. In pilot 2, tele-psychological support will be performed by a remote psychologist and will consist of techniques for managing emotions and stress. In the intervention group, patients will also have the possibility to wear a smartwatch to automatically collect physical parameters. Patients in the control group will receive usual care. PROMs (i.e. quality of life, distress and pain) and physical parameters (i.e. physical activity, sleep quality and heart rate) will be monitored by a dedicated telemonitoring systems. A secure web platform will provide dashboard to clinicians for decision support. Patients' experience and costs data will be also collected. The results of the eCAN project will improve our knowledge on benefits and risks for TC and TM in cancer patients care.

NCT ID: NCT05962463 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Pulsed Radiofrequency Therapy vs Canal Adductor Blockade in Knee Osteoarthritis

Start date: December 20, 2023
Phase:
Study type: Observational

This study is intended to prove the efficacy and safety of ultrasound-guided pulsed radiofrequency therapy on adductor canal nerves by patients with Knee osteoarthritis.

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: NCT05907577 Not yet recruiting - Clinical trials for Adenocarcinoma of Lung; Bronchial Neoplasms; Early Detection of Cancer; Machine Learning

Early Detection of Lung Cancer With Machine Learning Based on Routine Clinical Investigations

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

This observational, cross-sectional study in lung cancer patients and lung cancer-free controls aims to develop a machine learning model for early detection of LC based on routine, widely accessible and minimally invasive clinical investigations. The model with adequate predictive performance could later be used in clinical practice as an aid in defining the optimal population and timing for lung cancer screening program.

NCT ID: NCT05895097 Not yet recruiting - Heart Failure Clinical Trials

Conventional Versus Left Bundle Branch Pacing in TAVI

Start date: June 15, 2023
Phase: N/A
Study type: Interventional

This randomized study compares the effects of conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF < 40 %) versus left bundle branch pacing on left ventricular remodelling in patients with reduced left ventricular ejection fraction (< 50 %) that need permanent pacemaker implantation after transcatheter aortic valve implantation (TAVI).