Lens

Researchers are evaluating the real-world effectiveness of deucravacitinib in adults diagnosed with moderate-to-severe plaque psoriasis. This observational study aims to understand how this treatment works outside of controlled clinical trials, focusing on health outcomes important to patients and doctors. It is sponsored by Bristol-Myers Squibb and conducted in France. Participants in this study have started treatment with deucravacitinib as prescribed by their doctors. The study observes these patients over time without altering their treatment plans. There are no placebo or comparison groups since this is an observational study that follows patients initiating deucravacitinib treatment. During the study, doctors will assess skin condition using the Physicians Global Assessment and measure quality of life with the Dermatology Life Quality Index at baseline and several points up to 24 months. Patients will also report symptoms like itch, skin pain, and fatigue using visual scales. Researchers will track how long patients remain on treatment and reasons for stopping. The study involves regular follow-ups at months 1, 4, 12, 18 optional, and 24 to gather this information.

Researchers are studying patients with community-acquired pneumonia who need oxygen therapy due to acute respiratory distress and low blood oxygen levels. This research aims to see if placing patients in a prone position lying face down while they receive nasal high flow oxygen can reduce the need for intubation and improve outcomes. The study particularly excludes patients with COVID-19 and focuses on non-COVID pneumonia cases. Participants will be randomly assigned to one of two groups. One group will be encouraged and assisted to lie in the prone position for at least 8 hours per day in multiple sessions, aiming for up to 16 hours if tolerated. The other group will receive usual care with nasal high flow oxygen therapy but no prone positioning. Both groups will have oxygen levels monitored and care adjusted to maintain target oxygen saturation. During the study, patients will be observed for intubation rates within 28 days, comfort levels during prone positioning, oxygenation changes, time to escalation of breathing support, and overall outcomes including mortality up to 90 days. Safety measures like skin and infection monitoring will also be recorded. Quality of life will be assessed at 90 days and 5 years, with nursing workload tracked within the first day after randomization.

Researchers are studying the biological effects and monitoring methods of chronic nitrous oxide abuse, which can cause neurological problems such as combined sclerosis of the spinal cord. Patients may experience walking difficulties, abnormal sensations, and in severe cases may require a wheelchair. There have also been reports of thrombosis linked to nitrous oxide use. Traditional tests measuring nitrous oxide levels in blood or urine are not reliable due to the gass short half-life, so other markers like vitamin B12 and homocysteine are being evaluated. The underlying causes of these clinical effects are not yet fully understood. The study observes two groups of nitrous oxide users those hospitalized with clinical symptoms assessed by neurological evaluation using the Peripheral Neuropathy Disability score or thrombotic events, and those without clinical symptoms seen during routine medical consultations. Participants undergo blood collections for biological analysis, with samples preserved for further study. This is an observational study without experimental treatment. Participants will have blood tests at the start and at intervals up to six months to measure markers related to nitrous oxide use and clinical outcomes. Researchers will also assess nitrous oxide consumption through self-reporting and estimation, alongside the severity of related clinical signs. The main outcome is the change in blood markers over about one year. The study includes people aged 14 to 65 who currently or formerly use nitrous oxide and have social insurance coverage.

Researchers are conducting a global, prospective, multi-center post-market clinical follow-up study called MANTRA to monitor the safety and performance of CORCYM devices and accessories used for aortic, mitral, and tricuspid valve diseases in real-world settings. This umbrella protocol allows multiple sub-studies to be added, covering the sponsors entire cardiac surgery heart valve portfolio and including core lab assessments for some products. The study plans to enroll about 2150 subjects across up to 130 sites worldwide. The study includes three sub-studies the Aortic Sub-Study, the MitralTricuspid Sub-Study excluding Memo 4D, and the Memo 4D Sub-Study. Subjects diagnosed with valve diseases and considered suitable for treatment with specific CORCYM devices can participate in the corresponding sub-study. Follow-up visits are planned at discharge, 30 days post-implantation, and annually for up to 10 years. The Memo 4D sub-study involves additional echocardiogram imaging assessed by a core lab. Participants will provide informed consent and share baseline, procedural, hospitalization, discharge, and follow-up data during standard medical care. They will complete quality of life questionnaires at baseline, 30 days, and one year. Researchers will monitor device success at 30 days as the primary outcome and track mortality, adverse cardiovascular events, rehospitalizations, valve function, and patient outcomes up to 10 years. Safety and performance data will be collected continuously throughout the study.

This research aims to develop and assess an ecological tool called the Memory Test With Self-Initiated Items MAI to evaluate episodic memory in older adults aged 70 and above. Participants include those with and without neurocognitive disorders, such as Alzheimers disease, mixed dementia, and other neurodegenerative conditions. The study seeks to compare memory performance between these two groups to better understand memory impairments in geriatrics. Participants undergo a neuropsychological assessment using the ecological MAI test to identify the presence or absence of neurodegenerative disease. They are divided into two groups those with neurocognitive disorders and those without. The assessment lasts about 30 minutes for patients seen during routine care and up to 2 hours 30 minutes for accompanying persons or those recruited from external institutions like senior clubs. During the study, participants will be evaluated on overall memory performance and specific aspects of episodic memory, including temporal, spatial, and association components. Researchers will monitor participants for any fatigue during testing. No significant constraints are expected for those attending scheduled consultations. The studys duration and follow-up details are aligned with routine care and study visits. The main outcome is to compare ecological MAI scores between the two groups on the day of assessment.

Researchers are evaluating the effects of caffeine on cognitive decline in people with Alzheimers disease at early to moderate stages, characterized by a Mini-Mental State Examination MMSE score between 16 and 24. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to study the 30-week impact of caffeine treatment on cognition. The study addresses the potential benefits and risks of caffeine, considering its complex effects on the central nervous system, including possible anxiety and insomnia at high doses, which may be more pronounced in Alzheimers patients. Participants begin with a 3-week dose escalation period, followed by a 27-week treatment phase. The caffeine group receives capsules starting at 100 mg, titrated up by 100 mg increments to a target dose of 400 mg per day divided into two doses, while the placebo group undergoes a similar regimen with placebo capsules. After the treatment period, caffeine is tapered off using the same negative titration. Both groups follow a low caffeine diet before and during the study. During the study, participants undergo regular assessments of cognitive function using the Neuropsychological Test Battery NTB scores at 30 weeks and six weeks after treatment ends to observe any lasting effects. Additional evaluations include MMSE scores, attention tests, sleepiness scales, daily living activities, quality of life, caregiver burden, clinical global impression, and safety monitoring of heart rate and blood pressure. Blood samples will measure caffeine and its derivatives. The study involves caregivers living with the patient and lasts for at least 36 weeks from randomization.

Researchers are investigating the use of high-dose intravenous vitamin C combined with thiamine vitamin B1 to manage post-cardiac arrest shock in patients admitted to intensive care units after out-of-hospital cardiac arrest. This condition often leads to cardiac and circulatory failure, causing multi-organ failure and early death in a significant portion of patients. The study is a phase II, multicenter, randomized controlled trial comparing standard care with the addition of high-dose vitamin C and thiamine to assess potential benefits on shock recovery and neurological outcomes. Participants are randomly assigned to one of two groups the control group receiving standard post-cardiac arrest care according to international guidelines, and the experimental group receiving standard care plus high-dose intravenous vitamin C at 50 mgkg every 6 hours for 3 days, starting within an hour after randomization, along with intravenous thiamine 200 mg twice daily for 3 days. From day 4 onwards, standard vitamin C supplementation up to 1000 mg daily and thiamine are allowed in both groups. During the 28-day participation period, patients will be closely monitored for recovery from shock, neurological function, and organ failure. Assessments include measuring the time to stop vasopressors by day 3, survival rates related to shock by day 7, neurological status at day 28, maximum vasopressor doses within 3 days, changes in organ failure scores, and arterial lactate levels. Safety and effectiveness data will be collected throughout to evaluate the impact of the vitamin C and thiamine treatment alongside standard care.

This research aims to understand how clinical frailty affects adults aged 18 to 65 admitted to intensive care for septic shock. It focuses on whether patients classified as frail or severely frail using the Clinical Frailty Scale CFS face higher risks of death, longer hospital stays, increased readmission rates, and poorer quality of life. The study seeks to improve predictions and care decisions for critically ill younger patients with sepsis. The study observes patients admitted for suspected or confirmed type 3 sepsis who require vasopressor support to maintain blood pressure and have elevated lactate levels. There are no experimental treatments or interventions instead, this observational study collects data on patients frailty scores and their health outcomes over time. Participants will be closely monitored for 28 and 90 days after admission to evaluate mortality risk, length of hospital stay, use of invasive therapies, and readmission rates. Researchers will also assess changes in frailty and quality of life at 90 days. This detailed follow-up helps clarify the impact of frailty on recovery and survival, aiding better care planning and communication with patients and families.

Charcot foot is a complication of diabetes that causes progressive damage to bones, soft tissues, and tendons in the ankle and foot, often leading to joint dislocation. This condition is not well understood by patients and caregivers, and its non-specific symptoms often result in delayed or missed diagnosis. Researchers are studying a group of patients with chronic Charcot foot in France to assess how quality of life changes over two years and to identify factors that predict worse outcomes among these patients. Participants in this observational study will complete questionnaires including the SF-36, FAAM-F, PHQ-9, PHQ-2, and a simplified EPICES score to evaluate quality of life, foot and ankle function, depression, and social precarity. These assessments will be conducted at the start, after 12 months, and after 24 months. In addition, X-rays will be used to track changes in foot bone and joint deformities. The study will also monitor diabetes complications, medical treatments for Charcot foot, presence of wounds or infections, amputations, hospitalizations, and depression symptoms over the two-year period. Participants will be asked to fill out questionnaires at these three time points and undergo foot X-rays and clinical evaluations to track their condition. Researchers will evaluate results from these questionnaires and imaging studies to understand how quality of life evolves and what factors contribute to outcomes. The study includes a comprehensive assessment of diabetic complications, foot deformities, and mental health. Participants will be followed for two years to gather this detailed information and help improve understanding of chronic Charcot foot.

Researchers are investigating the best way to manage fever in patients with septic shock, a severe condition caused by infection leading to organ failure and requiring mechanical ventilation. This study compares two fever management strategies allowing fever to run its course or controlling fever to maintain normal body temperature using external cooling. The trial aims to determine which approach better improves survival by looking at death rates 60 days after treatment starts. Participants will be randomly assigned to one of two groups one group will receive external cooling to keep their body temperature normal for 48 hours, while the other group will have their fever left untreated without antipyretic therapy. The study uses a special randomization method to ensure groups are comparable and includes a subgroup of patients with lung injury. Safety is closely monitored by an independent committee that can stop the study if needed. During the trial, patients will be monitored for various health outcomes including organ function, need for ventilator support, kidney therapy, and blood pressure support over specific time points. Researchers will also track side effects such as shivering, seizures, low body temperature, heart rhythm problems, infections, and development of lung or kidney complications. The total study duration includes follow-up to assess these outcomes and safety events up to 60 days after randomization.