Lens

This research aims to evaluate the real-world effectiveness of deucravacitinib treatment in adults diagnosed with moderate-to-severe plaque psoriasis. The study is conducted in France and focuses on understanding how this treatment performs outside of controlled clinical trial settings. Participants in this observational study will be newly starting deucravacitinib as prescribed by their treating clinician. There are no additional study treatments or placebo groups, as the study observes the outcomes of the treatment during routine clinical care. During the study, researchers will assess clinical outcomes including the Physician's Global Assessment (PGA) and the Dermatology Life Quality Index (DLQI) at baseline and at months 4, 12, 18 (optional), and 24. They will also monitor how long participants remain on deucravacitinib treatment, up to 24 months. These evaluations help to measure both the effectiveness and impact on quality of life for participants with plaque psoriasis.

Researchers are studying adults with community-acquired pneumonia who need oxygen therapy due to acute respiratory failure meeting acute respiratory distress syndrome (ARDS) criteria. This condition often leads to tracheal intubation and poor outcomes. Previous studies showed that prone positioning reduces mortality in invasively ventilated ARDS patients and improves oxygenation in non-intubated patients with viral pneumonia, including COVID-19 cases. This trial focuses on patients with non-COVID community-acquired pneumonia using nasal high flow therapy, aiming to see if awake prone positioning can reduce the need for intubation and related treatments like sedation and muscle relaxation. Participants will be encouraged to spend as much time as possible in the prone position, ideally 4 to 8 hours per session, with a goal of up to 16 hours or more within each 24-hour period, depending on their tolerance. This intervention is compared to usual care without prone positioning. The study excludes patients with recent COVID-19 infection or those requiring immediate intubation. During the study, researchers will monitor patients for up to 28 days after randomization, focusing on whether they require intubation. Participants will be admitted to an intensive care or intermediate care unit, and their oxygen levels will be closely assessed using the PaO2/FiO2 ratio or equivalent SpO2/FiO2 measurements. Consent and social security affiliation are required. Safety and effectiveness of awake prone positioning in reducing intubation needs will be evaluated throughout the study period.

Chronic use of nitrous oxide can cause toxicity leading to neurological problems such as combined sclerosis of the spinal cord. This can result in difficulties walking or sensations like numbness and tingling, which may improve or worsen to the point of requiring a wheelchair. Recently, cases of blood clots have also been linked to nitrous oxide use. Blood or urine tests for nitrous oxide are not commonly done because the gas leaves the body quickly, so other markers like vitamin B12 and homocysteine levels are studied instead, though no official monitoring guidelines currently exist. The exact biological processes causing these health problems are still not well understood. The study involves collecting blood samples from participants for biological analysis to better understand markers related to nitrous oxide use. Participants include current or former recreational nitrous oxide users, both with and without clinical signs or biological effects from use. Blood samples are preserved for testing as part of routine care within the study framework. Participants will be monitored with blood tests to measure markers linked to nitrous oxide consumption over about one year. The main outcome measured is the change in blood markers related to nitrous oxide use during this period. The study requires participants to consent and be socially insured, and it excludes pregnant or breastfeeding women and those who have not used nitrous oxide recently or are unwilling to complete the study.

Researchers are evaluating the ongoing safety and performance of CORCYM devices and accessories used to treat aortic, mitral, and tricuspid valve diseases in a real-world setting. This global, multi-center, prospective post-market clinical follow-up study, called MANTRA, uses an overarching Master Protocol that allows multiple sub-studies to be conducted and combined for comprehensive data collection. The study aims to provide long-term information on the heart valve products offered by Corcym S.r.l., a manufacturer specializing in solutions for cardiac surgeons. The trial includes three sub-studies focusing on different valves: the Aortic Sub-Study, the Mitral/Tricuspid Sub-Study (excluding Memo 4D), and the Memo 4D Sub-Study. Approximately 2,150 subjects will be enrolled worldwide, with treatments given according to the device instructions for use and at the investigator's discretion. The study collects data during standard medical care without additional interventions. The Memo 4D sub-study involves specialized echocardiogram imaging assessed by a Core Laboratory to monitor device performance and heart valve dynamics. Participants will be followed up at hospital discharge, 30 days after device implantation, and then annually for up to 10 years. Data collected include informed consent, baseline demographics and medical history, procedural details, hospitalization and discharge information, and follow-up data. Quality of life questionnaires will be completed at baseline, 30 days, and one year. The primary outcomes measure the number and percentage of subjects achieving device success 30 days after implantation. Safety events and device deficiencies will also be monitored throughout the study period.

Researchers are evaluating a new ecological tool called the Memory Test With Self-Initiated Items (MAI) to assess episodic memory in older adults. The study focuses on individuals aged 70 and above and compares the performance of those with neurocognitive disorders to those without such disorders. Neuropsychological assessments are used to determine the presence or absence of neurodegenerative diseases, including Alzheimer's, vascular dementia, and other major neurocognitive disorders. Participants undergo the ecological MAI test as part of the study. They are divided into two groups based on neuropsychological evaluation: one with neurocognitive disorders and one without. The test lasts about 30 minutes for patients seen during routine care and up to 2 hours and 30 minutes for participants recruited from external institutions or accompanying patients. The study aims to detect cognitive anomalies early, especially in participants without neurodegenerative disorders. During the study, participants' memory performance is measured and compared between groups. The main outcome is the overall ecological MAI score. Assessments include neuropsychological testing and monitoring for potential fatigue, with no constraints placed on those seen during scheduled consultations. Participants receive a cognitive evaluation, and the study monitors safety and tolerability. Total participation time varies depending on recruitment source, from 30 minutes to 2.5 hours.

Researchers are evaluating whether using fungal biomarkers can help doctors stop antifungal treatment earlier in critically ill patients suspected of invasive Candida infections. The study aims to compare this biomarker-based approach to the usual care strategy, assessing if early discontinuation can safely reduce unnecessary antifungal use without increasing mortality by day 28. This is a randomized controlled open-label study involving patients who need empirical antifungal therapy for the first time in the ICU. Participants are divided into two groups. The intervention group will have their antifungal treatment duration guided by blood tests measuring (1,3)-Beta-D-glucan and mannan levels at the start of treatment and on day 3, with recommendations to stop treatment early if biomarker results allow. The control group will receive routine care based on international guidelines, typically involving 14 days of treatment if no proven infection occurs and the patient improves, or shorter durations in other cases. During the study, researchers will monitor when antifungal treatment is stopped, particularly noting if treatment ends before day 7 after it begins. They will also track patient outcomes up to day 28 to ensure safety. Participants must provide informed consent and are expected to stay in the ICU for at least 6 days after starting treatment. The main outcome measured is the percentage of patients who stop antifungal therapy early according to the study protocols.

Researchers are evaluating the effects of caffeine on cognitive decline in people with Alzheimer's disease at the beginning to moderate stages. This phase 3 trial aims to compare the impact of caffeine treatment versus placebo on cognition over 30 weeks. Alzheimer’s disease is a complex condition with no current cure, and caffeine's properties may offer symptomatic benefits, although high doses could cause anxiety and insomnia, especially in this vulnerable group. Participants will undergo a 6-week caffeine diet before starting treatment. Then, caffeine or placebo capsules will be given with a titration phase of 3 weeks increasing the dose by 100mg every stage until reaching a target of 400mg daily in two doses, maintained for 27 weeks. After treatment, doses will be gradually decreased following the same schedule. During the study, participants will be monitored for changes in cognitive function measured by neuropsychological tests at 30 weeks after randomization. Caregivers will be involved, and participants’ clinical status, safety, and adherence to a low caffeine diet will be assessed. The total participation duration includes the caffeine diet, titration, treatment, and dose reduction phases.

Researchers are evaluating the effects of early intravenous high-dose vitamin C combined with vitamin B1 in patients admitted to intensive care after an out-of-hospital cardiac arrest (OHCA) who develop post-cardiac arrest shock. This shock involves heart and blood circulation failure and can lead to multiple organ failure and early death in up to 35% of patients. The study is a phase II multicenter randomized controlled trial designed to assess if vitamin C and vitamin B1 can improve outcomes compared to standard care following OHCA. Participants are randomly assigned to one of two groups. The experimental group receives standard care plus intravenous high-dose vitamin C at 200 mg/kg per day, given as 50 mg/kg every 6 hours for 3 days, starting within one hour after randomization. They also receive intravenous thiamine (vitamin B1) 200 mg twice daily for 3 days. The control group receives standard care according to guidelines, with no high-dose vitamin C during the first 3 days. From day 4, standard vitamin C and thiamine supplementation at lower doses are allowed. During the 28-day participation, patients are monitored for recovery from the shock, including the need for blood pressure support medications (vasopressors). The primary outcome is the cumulative rate of weaning off vasopressors by day 3 after cardiac arrest. Researchers will also assess safety and recovery progress. The study plans to enroll 234 patients over 24 months, with follow-up lasting 28 days after enrollment.

Researchers are studying whether frailty, measured by the Clinical Frailty Scale (CFS), is an independent risk factor for death in adults aged 18 to 65 admitted to intensive care for septic shock. Frail patients are defined as those with a CFS score of 5 or higher, and severely frail patients have scores between 6 and 7. The study also explores if frailty affects the length of hospital stay, risk of readmission, and quality of life after intensive care. The study focuses on young critically ill patients admitted to intensive care units for suspected or confirmed septic shock, a condition known for high morbidity and mortality. Participants must have specific clinical signs such as the need for vasopressor amines to maintain blood pressure and elevated lactate levels. This study does not involve investigational treatments but evaluates clinical outcomes related to frailty scores at admission. Participants will be assessed for frailty upon admission and monitored for mortality 28 days after inclusion. Researchers will also examine hospital stay length, readmission rates, and quality of life. The results aim to improve understanding of how frailty impacts prognosis, support decision-making about care intensity, and provide better information to patients and families regarding survival and quality of life expectations.

Charcot foot, a complication of diabetes involving progressive damage to bones, soft tissues, and tendons with joint dislocation in the ankle and foot, is not well understood by patients and caregivers. This condition often goes undiagnosed or is diagnosed late due to non-specific clinical signs. The study focuses on a prospective multicenter cohort in France to evaluate how quality of life changes over two years in patients with chronic, wound-free Charcot foot and to identify factors that predict worse outcomes in this population. Participants with chronic Charcot foot will complete several questionnaires including the SF-36, FAAM-F, PHQ-9, PHQ-2, and a simplified EPICES score. These tools aim to assess various aspects of health and quality of life. The study will track patient responses over two years to understand how their condition evolves without wounds and how it impacts their daily functioning and well-being. Throughout the study, patients will fill out these questionnaires at inclusion and follow-up visits. Researchers will analyze the results at the start, 12 months, and 24 months to measure changes in quality of life and foot and ankle functionality. This approach will help capture the progression of symptoms, any deformities, and the effect of comorbidities or diabetic complications. Participants will be monitored for two years to gain insight into long-term outcomes.