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NCT ID: NCT06087640 Active, not recruiting - Influenza, Human Clinical Trials

A Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an Adjuvanted Quadrivalent Influenza Vaccine Compared to a Non-adjuvanted Quadrivalent Influenza Vaccine in Adults ≥65 Years of Age

Start date: October 23, 2023
Phase: Phase 3
Study type: Interventional

This Phase 3 study is a randomized, observer-blind study of aQIV (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a non-adjuvanted quadrivalent influenza vaccine (QIV) in adults ≥65 years of age. The aim of the study is to evaluate aQIV compared with QIV in the prevention of reverse transcription-polymerase chain reaction (RT-PCR)-confirmed influenza A and/or B in subjects ≥65 years of age.

NCT ID: NCT06072690 Recruiting - Clinical trials for Cardiovascular Diseases

Respiratory and Cardiovascular Alterations in Patients With Chronic Obstructive Pulmonary Disease

Start date: April 15, 2021
Phase:
Study type: Observational

Chronic obstructive pulmonary disease (COPD) is a major cause of disability and death worldwide. People with COPD often have cardiovascular diseases (CVDs) that are associated with increased risk for hospitalization and prolonged stay as well as all-cause and CVD-related mortality. Nevertheless, CVDs in patients with COPD are tend to be underestimated in clinical practice. Mechanisms that define the relation between COPD and cardiovascular morbidity include lung hyperinflation, hypoxia, pulmonary hypertension, systemic inflammation and oxidative stress, exacerbation, shared risk factors and COPD phenotypes. Recently, some authors have announced that COPD treatment with dual bronchodilation may not only improve pulmonary function and quality of life, but also have a positive effect on cardiac function in cardiac magnetic resonance imaging (MRI) or two-dimensional cardiac ultrasound for the assessments. The aim of this study is to specify the state of respiratory and cardiovascular systems as well as exercise capacity and quality of life in patients with newly diagnosed moderate-to-severe COPD and to evaluate their changes after short-term treatment with dual bronchodilation. We hypothesize that patients with newly diagnosed COPD and no previous records of cardiac diseases and no apparent signs of heart failure have significantly impaired cardiac autonomic integrity that precedes to increased risk of cardiovascular events. It is believed that cardiac autonomic integrity might significantly improve with dual bronchodilation therapy.

NCT ID: NCT06054555 Recruiting - Melanoma Clinical Trials

A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma

Start date: November 2, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.

NCT ID: NCT06053632 Completed - Healthy Clinical Trials

Young Age Soccer Player's Lower Limb Muscle Imbalance and Functional Status

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

A randomized controlled trial is designed to examine the effects of low-load and high-velocity eccentric exercises on lower limb muscular properties, imbalances and functional status of 13-15 years old female football players.

NCT ID: NCT06029595 Recruiting - Uncontrolled Asthma Clinical Trials

Efficacy and Safety of Tanimilast in Asthmatics uNcontrolled on ICS-containinG backgrOund Maintenance Therapy

TANGO
Start date: November 26, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of CHF6001 (Tanimilast) as add-on to maintenance of inhaled corticosteroids in combination with Long-acting ß2-agonists in the target patient population. (TANGO)

NCT ID: NCT06028906 Recruiting - Trauma, Brain Clinical Trials

Research of Optimal Cerebral Perfusion Pressure Diagnosis

optCPP
Start date: June 21, 2021
Phase:
Study type: Observational

The research will investigate the hypothesis that timely identification of the optimal value of the cerebral perfusion pressure (optCPP) or optimal arterial blood pressure (optABP) is possible after detecting informative episodes of arterial blood pressure (ABP) that reflects the physiological autoregulatory reactions of the cerebral blood flow, This biomedical study will be conducted to test this hypothesis and to develop an algorithm for identification of optimal brain perfusion pressure within limited time (several tens of minutes). The goal of this observational study is to test the method of timely optimal cerebral perfusion pressure value or optimal arterial pressure value in intensive care patients after brain surgery. The main question it aims to answer are: how long it takes to identify optimal cerebral perfusion value when arterial blood pressure is changing within safe physiological limits. Objectives of the study 1. To perform a prospective observational study by collecting multimodal physiological brain monitoring data: intracranial pressure (ICP), arterial blood pressure (ABP), End-tidal carbon dioxide (ETCO2), cerebral blood flow velocity (CBFV), ECG. 2. To perform a retrospective analysis of the accumulated clinical monitoring data, in order to create an algorithm for the identification of informative monitoring data fragments, according to which it would be possible to identify the optimal cerebral perfusion pressure (optCPP) value in a limited time interval (within a few or a dozen minutes). 3. To perform a retrospective analysis of accumulated clinical monitoring data, determining correlations of cerebral blood flow autoregulation and optCPP-related parameters with the clinical outcome of patients and with the risk of cerebral vasospasm or cerebral ischemia.

NCT ID: NCT06019845 Recruiting - Clinical trials for Arrhythmias, Cardiac

The MAGiC™ Cardiac Ablation European Study

MAGiC-FEST
Start date: January 2, 2024
Phase: N/A
Study type: Interventional

The purpose of the first phase of this feasibility study is to gather safety and performance data on MAGiC to support European marketing approval.

NCT ID: NCT06018649 Active, not recruiting - COVID-19 Clinical Trials

The Effectiveness of Natural Resources for Reducing Stress

LUGISES
Start date: January 2, 2023
Phase: N/A
Study type: Interventional

High levels of stress cause serious health problems and reduce the quality of life. There is a lack of research proving the use of natural resources for the treatment or prevention of the stress and recovery from post Covid-19 condition. The goal of research: to assess the impact of natural resources (geothermal/mineral water, mud, salt, climate) on reducing stress and improving stress-related mental and physical health, as well as the safety of the procedures. The study will be randomized, controlled, parallel group, single- blinded (to researchers). The complex of procedures of water pool, mineral water bath, mud wrapping, salt therapy, nature therapy procedure will be provided with the different duration and mode (inpatient, outpatient). Primary outcomes- the effect on stress level; secondary outcomes: the effects on stress-related mental and physical health, work and social adaptation, tolerance and safety of balneotherapy procedures. The observation: before, after treatment, after 3 and 6 month of follow-up will be reveled.

NCT ID: NCT06007001 Recruiting - Cancer Clinical Trials

Telerehabilitation and Tele-psychological Support in Cancer Patients eCAN JA

eCAN
Start date: September 25, 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: NCT06006975 Recruiting - Ischemia Clinical Trials

Early Warning of Delayed Cerebral Ischemia

EWoDCI
Start date: September 21, 2021
Phase:
Study type: Observational

The goal of this observational study is to learn about the possibility to predict clinical course of subarachnoid hemorrhage (SAH) patients by performing the retrospective analysis of clinical data available in early pre-vasospasm phase. The main questions it aims to answer are: - What biomarkers retrieved from Computed Tomography (CT) and Computed Tomography Angiography (SAH location, leaked blood volume, cerebrospinal fluid volume, etc.) can be used to predict development of cerebral vasospasms, delayed cerebral ischemia and patients' outcome. - What biomarkers retrieved from transcranial Doppler examinations in early pre vasospasm can be used to predict development of cerebral vasospasms, delayed cerebral ischemia and patients' outcome. - What biomarkers retrieved from multimodal physiological monitoring in early pre vasospasm can be used to predict development of cerebral vasospasms, delayed cerebral ischemia and patients' outcome. - What is impact of other clinical data (blood test results, age, gender, etc.) on development of cerebral vasospasms and delayed cerebral ischemia.