Arras

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 the management and follow-up of non-muscle-invasive bladder cancer (NMIBC), a type of bladder tumor that affects the inner lining and underlying tissue but not the muscle layer. This cancer type accounts for a significant portion of bladder cancer cases in France, with many patients experiencing tumor recurrence within five years. The study aims to evaluate the diagnostic accuracy of urine biomarker tests compared to bladder endoscopy, which is the current standard for detecting tumor recurrence. Additionally, it will describe tumor characteristics, patient history, treatments, and regional differences in care. Patients being monitored for NMIBC and undergoing routine care will have their medical details, including prior treatments and urine test results, recorded in a registry. Follow-up includes regular bladder endoscopy exams, with dates and findings noted by urologists. Urine test results taken before biopsies will also be tracked. This observational study will analyze the performance of urine tests by calculating sensitivity, specificity, and predictive values, and exploring differences based on tumor grade, stage, and previous treatments. The goal is to include 8000 patients across France over six years. Participants will provide data through medical records and routine exams during their personalized care plans. Urine samples and bladder fibroscopy results will be collected at each follow-up visit to assess test accuracy over a five-year period. Researchers will monitor recurrence-free survival and urine test performance, aiming to identify if urine tests can safely reduce the need for invasive cystoscopy. The study focuses on long-term monitoring to better understand and improve care for NMIBC patients.

Psoriatic arthritis (PsA) is a type of arthritis that causes joint swelling and stiffness and is often seen in people with the skin condition psoriasis. It results from an overactive immune system attacking healthy tissue. This research aims to describe the long-term use and effectiveness of risankizumab (RZB) compared to other advanced treatments for managing PsA in everyday clinical care. The study is not conducted in the United States but will take place in about 15 countries and include between 900 and 1200 adult participants. Participants will be assigned in a 2 to 1 ratio to receive either risankizumab or other advanced therapeutic agents. The treatments will be given following usual medical guidelines, including approved dosing and indications, as determined by local regulations and professional standards. All study visits will occur during routine clinical care with no extra burden on participants. Participants will be followed and monitored for 24 months to observe treatment persistence. During the study, participants will continue their regular clinical visits without additional procedures or tests required by the study. Researchers will measure how many participants continue their prescribed treatment over the 24-month period. The study focuses on real-world treatment patterns and outcomes in patients with active PsA who have previously shown an inadequate response or intolerance to certain medications. Safety monitoring will align with routine clinical practice throughout the study duration.

Radiotherapy after breast cancer surgery can cause arm lymphedema, which is swelling that may lead to long-term discomfort and impact quality of life. This research aims to evaluate whether using an artificial intelligence (AI) tool to predict each patient's risk of developing arm lymphedema can help patients and doctors make better treatment decisions. The study involves women aged 18 years or older with unilateral breast cancer who need regional lymph node irradiation after surgery, regardless of hormone receptor status or tumor grade. Participants will be randomly assigned to two groups. In the experimental group, patients and physicians will see the AI-predicted risk of developing arm lymphedema and use this information to guide treatment choices. In the control group, the risk prediction will not be shared. All participants will receive radiotherapy as they normally would, and the only difference is whether they are informed about their predicted risk using the XAINET AI tool presented via a web app. During the two-year follow-up, researchers will monitor how sharing risk information affects treatment decisions, the occurrence of side effects like arm lymphedema, the accuracy of the AI tool, patients' quality of life, and adherence to wearing compression sleeves. They will also track cancer recurrence and survival outcomes. Patients will have scheduled visits and assessments to collect this information throughout the study.

Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.

This research aims to better understand the long-term success of bariatric surgery in patients with severe obesity. Currently, there is limited information about how lasting the positive effects of bariatric surgery are on weight loss. The study also addresses the lack of consensus on which surgical weight loss procedure is best suited for individual patients. The goal is to improve patient selection and personalize treatment strategies for those undergoing bariatric surgery. The study involves patients who underwent bariatric surgery five years ago, evaluating their outcomes over this extended period. There are no specific interventions or treatment groups detailed, as it is a regional multicenter observational study focused on assessing real-world results of prior surgeries. Researchers will analyze long-term weight loss success and identify factors that may predict surgery outcomes. Participants will be monitored for their weight loss success five years after surgery. Researchers will collect data to determine the rate of sustained weight loss and understand the variability in outcomes among patients. This information will help improve patient counseling and tailor future surgical approaches. The study also ensures participants are informed and willing to take part, with ongoing assessments to track their progress and experiences.

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 evaluating the safety and performance of hyaluronic acid-based dermal fillers designed to enhance facial features such as the lips, perioral lines, nasolabial folds, cheeks, and infraorbital hollows. This post-market study aims to confirm how long the effects of these fillers last when used in real-life conditions on adults aged 18 years and older seeking aesthetic treatment. The fillers use COLD-X1932 technology by Symatese to modify skin anatomy and facial appearance. Participants will receive facial injections of these dermal fillers and attend follow-up visits every 6 months for up to 24 months. During these visits, the investigator will assess the treated areas using specific 5- or 6-point scales to determine if the area has returned to its pre-injection state. If desired, participants may receive retreatment at the 12- or 18-month follow-up if their treated areas have returned to baseline. Throughout the study, participants will undergo simple clinical examinations to monitor safety and performance. They will also evaluate their own aesthetic improvement compared to before treatment and report the pain level experienced during the initial injection. The main outcome measured is the number of patients whose treated areas return to their baseline state at each follow-up visit conducted at 6, 12, 18, and 24 months.