Henån, Sweden
Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children
Phase
N/ASpan
315 weeksSponsor
Centre Hospitalier Intercommunal CreteilCharenton-le-Pont
Recruiting
A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)
Phase
3Span
255 weeksSponsor
Dizal PharmaceuticalsParis
Recruiting
Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Staphylococcus
The RODEO 1 study is designed to determine the safety and efficacy of partial oral treatment of IE compared with traditional full-length parenteral treatment. Our primary objective is to demonstrate that in patients with left-sided multi-susceptible Staphylococcus who have received at least 10 days of IV antibiotic treatment with or without valvular surgery, a switch to an oral combination of rifampicin and fluoroquinolones between Day 10 and Day 28 after initiation of the IV antibiotic treatment, is not inferior to the continuation of the conventional IV antibiotic treatment regarding to treatment failure within 3 months after the end of antibiotic treatment. Nationwide, noninferiority, multicenter, randomized, controlled, open-label trials. Randomisation will only be offered to patients who have received at least 10 days of IV conventional antibiotic treatment of IE, and fulfil the inclusion criteria. Randomisation will take place between Day 10 and Day 28 after initiation of parenteral antibiotic therapy or valvular surgery, thus ensuring to have at least 14 days of oral therapy in the experimental group. Patients will be eligible whether they have undergone valvular surgery or not. This will imply that surgery procedure prior to randomisation will be heterogeneous, but randomisation will be stratified on the requirement of valvular surgery as part of the treatment of the current episode of IE or not.
Phase
3Span
448 weeksSponsor
University Hospital, ToursParis
Recruiting
Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Streptococcus
The RODEO 2 study is designed to determine the safety and efficacy of partial oral treatment of IE compared with traditional full-length parenteral treatment. Our primary objective is to demonstrate that in patients with left-sided multi-susceptible Streptococcus-Enterococcus IE who have received at least 10 days of IV antibiotic treatment with or without valvular surgery, a switch to an oral combination of amoxicillin between Day 10 and Day 28 after initiation of the IV antibiotic treatment, is not inferior to the continuation of the conventional IV antibiotic treatment regarding to treatment failure within 3 months after the end of antibiotic treatment. Nationwide, noninferiority, multicenter, randomized, controlled, open-label trials. Randomisation will only be offered to patients who have received at least 10 days of IV conventional antibiotic treatment of IE, and fulfil the inclusion criteria. Randomisation will take place between Day 10 and Day 28 after initiation of parenteral antibiotic therapy or valvular surgery, thus ensuring to have at least 14 days of oral therapy in the experimental group. Patients will be eligible whether they have undergone valvular surgery or not. This will imply that surgery procedure prior to randomisation will be heterogeneous, but randomisation will be stratified on the requirement of valvular surgery as part of the treatment of the current episode of IE or not.
Phase
3Span
448 weeksSponsor
University Hospital, ToursSaint-Mande
Recruiting
A Study to Learn About Abrocitinib in Adult Patients With Moderate to Severe Atopic Dermatitis.
Phase
N/ASpan
221 weeksSponsor
PfizerSaint-Mande
Recruiting
Research for Plasma Biomarkers Associated With Fatigue in Thrombocytopenic Patients
Thrombocytopenia is defined as a platelet count below 150×109/L. The mechanisms leading to thrombocytopenia are multiple, and may be linked to : - reduced platelet production in the bone marrow; - increased destruction of peripheral platelets; - increased splenic sequestration. In the event of a vascular breach, platelets contribute to hemostasis by sealing the lesion, thereby stopping bleeding. In thrombocytopenic patients, the best-known clinical signs are excessive mucocutaneous bleeding. Patients with severe thrombocytopenia (< 20×109 /L) may be at risk of life-threatening bleeding (cerebral bleeding). In the case of autoimmune thrombocytopenia, cognitive disorders have been reported, detected by appropriate questionnaires, the pathophysiological mechanism of which remains unclear. In a study of 1871 patients with thrombocytopenia, 39% of patients in the UK and 22% in the USA reported severe asthenia. Asthenia appears to be related to thrombocytopenia, but the mechanism has not been identified either. Asthenia is a recognized symptom in other autoimmune pathologies, such as primary biliary cirrhosis (autoimmune liver disease), in which asthenia has been shown to be mainly associated with autonomic nervous system dysfunction. While thrombocytopenia is primarily associated with bleeding risk, at least half of thrombocytopenic patients report fatigue and impaired mental and emotional health and social functioning, even though anemia is corrected and the association with autoimmune disease does not explain fatigue in all thrombocytopenic patients. The hypothesis is that thrombocytopenia is associated with a decrease in circulating neurotrophic factor levels through reduced platelet granule secretion, which may explain the fatigue.
Phase
N/ASpan
170 weeksSponsor
Assistance Publique - Hôpitaux de ParisParis
Recruiting
Healthy Volunteers
oCular Examination at Cell RESolution With Optical TransmissionTomography
For healthy subjects: an imaging examination using each system (OTT + OCT + specular microscopy) will be carried out twice, at an interval of two (2) years (inclusion visit + visit at 24 months). Several imaging images will be taken by two different operators during these sessions. For patients: an imaging examination using each system (OTT + OCT + specular microscopy) will be carried out by two different operators, and several imaging images will be taken. These examinations will be carried out at the inclusion visit and at the following visits according to the disease assessment schedule, lasting up to a maximum of 4 years.
Phase
N/ASpan
261 weeksSponsor
Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsParis
Recruiting
Healthy Volunteers
City For All Ages: Elderly-friendly City Services for Active and Healthy Ageing
Like many developed countries, Singapore faces the challenges of an ageing population. The number of Singaporeans aged 65 and above is increasing rapidly as population growth slows. The number of seniors has doubled from 220,000 in 2000 to 440,000 in 2015, and is expected to increase to 900,000 by 2030. Amongst the elderly people, close to 10% are living alone (from 35,000 in 2012 to 83,000 by 2030). The changing demographic not only increases healthcare costs but also the demand on healthcare services and care provision. Preventing frailty and MCI is key for the elderly to maintain their day-to-day activities and remain healthy and independent at home. Prior research has shown that frailty, like disability, is a dynamic process with older individuals moving back and forth between different frailty states. Transition to frailty is a gradual progression that occurs over the course of several months or years, and there are surprisingly high rates of recovery. However, it is important to intervene within the right time window before a person goes into full blown frailty. Hence it is important to detect the onset and progression of frailty and to identify the factors that may facilitate transitions to less frail states. This can inform the development of interventions to manage elderly at risk for fraility. City for All Ages project seeks to demonstrate that smart cities can play a pivotal role in "prevention" (i.e. the early detection and consequent intervention) of MCI and frailty-related risks. The core idea is that "smart cities", enabled by the deployment of sensor technologies and analytics can collect data about individuals: a) to identify segments of population potentially at risk, in order to start more stringent monitoring; b) to closely monitor selected individuals, in order to start a proactive intervention. In both cases adverse changes of behaviors that are identified through a set of indicators can prompt preventive actions. The aim is to advance the research on healthcare towards a proactive rather than reactive system. The research team will leverage the existing experimentations and pilot sites that have focused on detection of elderly risky behaviors both in France and Singapore. Lessons learnt from dealing with challenges either in terms of understanding the data (such as false positives, meaningful information, etc.) or providing the appropriate and timely intervention (such as difficulty in identifying and organizing the intervention effectively, large panel of stakeholders, excessive solicitation of caregivers, etc.) would be useful for this project. Our goal is to use sensing technologies installed in the elderly's home to monitor and detect their activities such as cooking, sleeping, going to the bathroom, going out of the apartment or potential wandering, bathroom falls. Sensor data will be collected unobtrusively and managed using a privacy-aware linked open data paradigm. Basic reasoning and learning algorithms will be applied to the data to identify relevant behaviours of individuals, and to detect behavioral changes that can be correlated with risks of MCI/frailty. The appropriate ICT based interventions (e.g. data visualization and alerts to caregivers) will then be applied to mitigate these risks.
Phase
N/ASpan
518 weeksSponsor
National University of SingaporeParis
Recruiting
Healthy Volunteers
Reliability of Minimally Trained Operator's Velocity-Time Integral Measurement Guided by Artificial Intelligence VTI
The main goal of Intensive Care Unit (ICU) physicians is to ensure cellular oxygenation by maintaining adequate organ perfusion in their patients. Stroke volume is a major determinant of tissue perfusion and therefore a key parameter to monitor in patients with hemodynamic instability. Left Ventricular Outflow Tract (LVOT) Velocity-Time Integral (VTI) measured using pulsed wave Doppler is widely used as an estimation of stroke volume to assess hemodynamic modifications. This value reflects the stroke distance, which varies proportionately to stroke volume in case of hemodynamic variations resulting from therapeutic interventions (fluid administration, vasoactive drugs...) or disease processes. An increase in stroke volume (or LVOT VTI) is expected in response to fluid administration and attests for its efficacy. A lack of increase indicates that the cardiovascular system is no longer fluid-responsive, and that fluid administration is not improving tissue perfusion and creates congestion. Therefore, measuring aortic VTI should be a competence required for every ICU physician. However, international ICU guidelines on echocardiography do not consider LVOT VTI measurement as a basic skill but rather as a competence of advanced operators. More recently, the European Society of Intensive Care Medicine published expert recommendations on echocardiography, setting the evaluation of LVOT VTI as basic skill but with a weak recommendation, lacking published evidence to support this statement. The main difficulty in measuring LVOT VTI is obtaining an adequate apical 5-chamber view. Recently, research in artificial intelligence (AI) applied to medical imaging constituted a breakthrough in the acquisition of images. UltraSight is a company specialized in AI applied to echocardiography. Their software is based on neural network using machine learning to analyse extremely precisely the image obtained by an operator. The software indicates to the operator in real time on-screen how to optimize the image by mobilizing the probe until the desired view is correctly obtained, with the best quality. The main objective of the present study is to characterize and to quantify the reliability and reproducibility of LVOT VTI measurements by comparing the measures obtained by minimally trained operators and experts, using an ultrasound platform equipped with real-time AI-based guidance (UltraSight). If interchangeability of minimally trained operators and expert measurements can be demonstrated, this will constitute a strong basis to upgrade the measurement of LVOT VTI as a basic competence in critical care ultrasound. The secondary objectives are to assess the concordance of therapeutic decisions made by the ICU clinician in charge of the patient (i.e.: continue or interrupt fluid administration) based on the VTI variation obtained by the minimally-trained operator, and that based on the VTI variation obtained by the expert, the agreement of the absolute value of the measure of LVOT VTI obtained by the minimally trained operators and the experts, the correlation between the measures of the VTI variation (% change following a fluid challenge of 250 mL or a passive leg-raising test) between the minimally-trained operators and those obtained by experts.
Phase
N/ASpan
42 weeksSponsor
Assistance Publique - Hôpitaux de ParisParis
Recruiting
Open-label Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
Phase
4Span
190 weeksSponsor
Amryt PharmaParis
Recruiting