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NCT ID: NCT05895786 Recruiting - Myositis Clinical Trials

A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]

Start date: May 20, 2023
Phase: Phase 3
Study type: Interventional

The purpose of the study is to understand how the study medicine PF-06823859 works in people with idiopathic inflammatory myopathies (DM and PM). These disorders cause inflammation that weakens the muscles that are important for movement and may also cause skin rash in people with DM. This study is seeking participants who: - Are 18 years of age or older or minimum legal adult age as defined per local regulation, whichever is greater - Have active DM or active PM. - Are receiving a stable dose of 1 corticosteroid taken by mouth and/or 1 traditional immunosuppressant. - Note: Corticosteroids and immunosuppressants are medicines that help reduce inflammation and may signal to the immune system not to attack the body. Dermatomyositis (DM) is a rare disease that causes muscle inflammation that results in muscle weakness and low muscle stamina. Patients with DM have a characteristic skin rash. Polymyositis (PM) is a rare disease that involves mainly muscle inflammation resulting in muscle weakness, that can sometimes be painful. Patients with DM and PM may have trouble going up the steps, walking or getting to a standing position. Some of the participants will receive the study medicine (PF-06823859) and some will receive placebo (which is similar to study medicine but contains no medicine in it). The study medicine or placebo will be given as an intravenous (IV) infusion (directly into the veins), which takes about1 hour; every 4 weeks from Day 1 to Week 48 of the study. Both PF-06823859 and placebo and will be given at the study site. The study will compare the experiences of people receiving study medication to those of the people who do not. This will help to see if PF-06823859 is safe and effective. Participants will take part in this study for about 13 months. During this time, participants will have 15 study visits. These visits will be performed at the study site.

NCT ID: NCT05894980 Recruiting - Suicidal Ideation Clinical Trials

How to Reduce Suicidal Thoughts and Impulsivity in Depression

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

The study aims at investigating if tDCS applied to left DLPFC or to right OFC to treatment as usual is effective in reducing severe suicidal ideas in major depressive episode.

NCT ID: NCT05894317 Recruiting - Clinical trials for Vascular Access Complication

Vascular Access Complications for Therapeutic Apheresis in Nephrology

VACTANE
Start date: June 1, 2020
Phase:
Study type: Observational

The aim of this study is to describe vascular access complications which are used for therapeutic apheresis in Nephrology.

NCT ID: NCT05894291 Recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Comparaison of Two Prone Position Techniques on Occurence of Pressure Sores in ICU

PROPOSE
Start date: November 24, 2023
Phase: N/A
Study type: Interventional

Acute respiratory distress syndrome (ARDS) is a diffuse inflammation of the lungs that occurs in a variety of diseases. According to the Berlin definition, ARDS is characterized by diffuse lung damage in patients with predisposing factors. Understanding the physiology of ARDS has led to improved ventilatory management, which must be protective to ensure adequate oxygenation and CO2 clearance. Prone position (PP) is a technique that can reduce mortality in patients with severe ARDS. PP results in a more homogeneous distribution of pulmonary stress and strain, helping to protect the lung against ventilator-induced lung injury (VILI). It also increases the PaO2/FiO2 (P/F) ratio, improves the pulmonary ventilation-perfusion ratio, decreases PaCO2 and promotes ventilation of the dorsal lung regions. This technique should be offered to all patients with severe ARDS for 16 consecutive hours, to improve survival and weaning success from mechanical ventilation. However, PP has adverse effects. A meta-analysis showed an increased risk of pressure sores, possibly linked to generalized acute inflammation associated with significant cytokine discharge and diffuse lesions of the vascular endothelium. PP also increased the risk of obstruction and displacement of the endotracheal tube. Final positioning in PP, (i.e., the position imposed on the patient for the duration of the PP session) varies from one ICU to another, and is rarely described in scientific articles. There are two main variants: 1. prone , with arms alongside the body 2. prone, swimmer's position The aim of our study is to show that the "swimmer" PP reduces the occurrence of stage 3 or higher pressure sores, compared with the "arms alongside the body" PP (standard care) at Day 28 post inclusion.

NCT ID: NCT05894239 Recruiting - Clinical trials for Metastatic Breast Cancer

A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

Start date: July 28, 2023
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).

NCT ID: NCT05894122 Recruiting - Metabolic Diseases Clinical Trials

Evaluation of Capillary Blood Collection Devices (Mitra® and HemaPEN®)

MitrAlanine
Start date: December 13, 2023
Phase:
Study type: Observational

The aim is to demonstrate a new application for a blood collection device. This device is already widely used in pharmacology. It is not currently used for metabolic diseases. Its ease of use enables repeated sampling at home. What's more, the device can be sent by post, making it ideally suited to the needs of this cohort of children, whose phenylalanine levels need to be monitored very regularly.

NCT ID: NCT05893797 Recruiting - Type 2 Diabetes Clinical Trials

A Study of LY8888AX in Participants Using a Connected Insulin Management Platform

Start date: October 5, 2023
Phase: N/A
Study type: Interventional

The main purpose of this study is to assess participant adherence and glucose control while using a connected insulin management platform. Approximately 50 participants will be enrolled in each country.

NCT ID: NCT05893719 Recruiting - Clinical trials for Acute Ischemic Stroke

Prospective, Multicentre Study to Evaluate the Thrombectomy System for Stroke: INEDIT, INDEEP and INTERCEPT

SEMTiC
Start date: July 1, 2022
Phase:
Study type: Observational

First prospective, single-arm, multicentre study to evaluate the safety and efficacy of the overall stroke thrombectomy system: INEDIT, INDEEP and INTERCEPT in patients with acute ischemic stroke.

NCT ID: NCT05893407 Recruiting - Ischemic Stroke Clinical Trials

Brain PERfusion Evaluation by Contrast-Enhanced UltraSound

PerCEUS
Start date: July 21, 2023
Phase:
Study type: Observational

The objective of the study is to assess brain tissue perfusion by contrast-enhanced ultrasound perfusion imaging (PerCEUS) in acute brain injuries. More precisely, it aims : - to evaluate the heterogeneity of brain perfusion and thus diagnose brain tissue hypoperfusion with contrast-enhanced ultrasound. - to correlate contrast-enhanced ultrasound with perfusion measurements by usual multimodal monitoring.

NCT ID: NCT05893121 Recruiting - Anxiety Clinical Trials

Evaluation of a Cardiac Coherence Session to Reducing Patients' Anxiety During a MRI Examination

RESP-IRM
Start date: December 8, 2023
Phase:
Study type: Observational

The present project aims at conducting a proof of concept study to explore the pertinence of a single session of cardiac coherence, carried out in patients prior to an MRI examination and presenting anxiety in relation to this examination, to reduce their level of anxiety and thus improve the course of the examination.