Arras

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.

Non-muscle-invasive bladder cancer NMIBC is a type of bladder tumor that affects the inner lining of the bladder without invading the muscle layer. This research aims to collect and analyze real-world data on how NMIBC is managed and followed up in clinical practice across France. The study seeks to assess the performance of urine tests used to detect tumor recurrence and to understand variations in treatment and patient outcomes. The study is observational and involves collecting medical data from patients being monitored for NMIBC, including results from urine biomarker tests done before biopsies or resections. Urologists participating in the French Urology Association will record findings from regular bladder endoscopic exams and urine test results during routine care visits. Data analysis will focus on the accuracy of urine tests in predicting tumor recurrence and how this varies by tumor characteristics and prior treatments. Participants will have their medical history, treatments, and urine test results entered into a registry at enrollment. During follow-up visits scheduled as part of their personalized care, data on bladder exams and urine tests will be collected. Researchers will evaluate outcomes such as recurrence-free survival and the diagnostic value of urine biomarkers over a five-year period. The study plans to include around 8,000 patients over six years to improve understanding of NMIBC management and follow-up.

Psoriatic arthritis PsA is a type of arthritis that causes joint swelling and stiffness, often occurring in people with the skin condition psoriasis. This study aims to understand how long patients continue treatment and how effective risankizumab RZB is compared to other advanced treatments for PsA in everyday clinical settings. The study will take place outside the United States across about 15 countries, involving between 900 and 1200 adult participants. Participants will receive either risankizumab or other biologic disease-modifying antirheumatic drugs bDMARDs as prescribed by their doctors following local guidelines. Treatments will be given as part of regular medical care without additional interventions from the study. Participants will be followed and observed for 24 months during their routine clinical visits. During the study, participants will attend their usual medical appointments where doctors will monitor their treatment persistence and response. The main outcome measured is how many participants continue their prescribed treatment up to 24 months. There is no expected extra burden or additional procedures for participants beyond their standard care.

Radiotherapy for breast cancer can cause arm lymphedema, which is swelling that may lead to long-term discomfort and affect quality of life. This clinical trial is designed to assess whether an artificial intelligence AI tool that predicts individual risk of arm lymphedema after radiotherapy can help patients and doctors make better treatment decisions. The trial includes women aged 18 or older with breast cancer needing regional lymph node radiotherapy after surgery, regardless of hormone receptor or tumor status. Participants will be randomly assigned to two groups. In the experimental group, patients and physicians will see the AI-predicted risk through a web app that explains risk factors and suggests measures like compression sleeves. In the control group, this risk information will not be shared. Both groups receive the same radiotherapy treatment they would normally have, with no changes to dose or technique. The AI tool is evaluated only for its impact on decision-making and outcomes. Throughout two years, participants will have regular check-ups to track treatment choices, side effects, shoulder movement, breast appearance, quality of life, and the accuracy of the AI tools predictions. Researchers will also monitor how well patients follow recommendations for using compression sleeves, as well as cancer recurrence and survival. Questionnaires and clinical exams will be conducted at baseline, during treatment, and at multiple follow-up points to gather detailed information.

Researchers are investigating the use of Trastuzumab deruxtecan T-DXd in adults with unresectable or metastatic HER2-low and HER2-ultralow breast cancer. This includes patients who have previously received chemotherapy for metastatic breast cancer or have hormone receptor-positive disease treated with endocrine therapy but are unsuitable for further endocrine treatment. The study aims to understand treatment effectiveness, patient characteristics, and experiences in a real-world setting through a non-interventional approach. Participants will be observed while receiving either T-DXd or conventional chemotherapy as part of their routine care, without any drug administration by the study itself. The study includes two groups one with patients having HER2-low breast cancer treated with T-DXd after prior chemotherapy, and another with hormone receptor-positive, HER2-low or HER2-ultralow breast cancer patients treated with either T-DXd or conventional chemotherapy but not prior chemotherapy for metastatic disease. Data will be collected on treatments, side effects, and management of adverse drug reactions. During the study, participants demographic and clinical data, treatment patterns, tolerability, and quality of life will be monitored over approximately 37 months. Assessments include the time to next treatment, treatment discontinuation, physician-reported safety events, patient-reported tolerability, quality of life questionnaires, and symptom diaries. This long-term observation will help evaluate real-world outcomes and patient experiences with T-DXd and conventional chemotherapy in this population.

This research aims to understand the long-term success of bariatric surgery in patients with severe obesity. Currently, there is limited information on how lasting the positive effects of weight loss surgery are, and no clear guidelines exist for choosing the best surgical procedure for each patient. The study seeks to personalize obesity treatment by identifying factors that predict success or failure after surgery. Participants in this observational study are individuals who underwent bariatric surgery five years ago. The study will collect data over time to compare different types of weight loss surgeries and their long-term outcomes. Researchers aim to improve patient selection and tailor surgical strategies based on these long-term results. During the study, participants weight loss success will be measured, focusing on the rate of weight loss five years after surgery. Secondary measures include success at one year, rates of additional surgeries related to bariatric procedures, and dropout rates over five years. The study involves reviewing medical records and follow-up assessments to gather this information, with the total duration extending up to five years after the initial surgery.

Researchers are investigating the timing of diagnosis and management of Gestational Diabetes Mellitus GDM in pregnant women, focusing on whether early intensive treatment starting before 20 weeks of pregnancy is better than the usual approach of waiting until 24 to 28 weeks. The study addresses concerns that early fasting plasma glucose testing may not accurately predict later GDM and examines if early intervention improves outcomes for mothers and babies. This is a randomized trial comparing two management strategies for early GDM, a condition characterized by high blood sugar during pregnancy. The trial compares two groups of pregnant women diagnosed with early GDM. One group receives intensive metabolic treatment immediately after diagnosis, including diet, physical activity, blood glucose monitoring, and possibly insulin therapy following French guidelines. The other group follows the standard approach with no intervention until GDM screening at 24 to 28 weeks, after which treatment begins if needed. The study continues treatment until delivery. Participants will be monitored throughout pregnancy with various metabolic tests, including fasting plasma glucose, HbA1c, and oral glucose tolerance tests. Researchers will track the frequency of maternal and fetal complications at delivery and assess insulin use, metabolic parameters, and neonatal outcomes up to six weeks postpartum. Additional analyses include studying microbiota and breast milk composition. The total participation period spans from early pregnancy until six weeks after delivery, with detailed data collected at multiple time points.

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.

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 interventional study aims to understand how long the effects of these products last under real-life conditions in adults aged 18 years or older. Participants may receive aesthetic treatments based on their preferences and the healthcare professionals agreement. The facial injections use hyaluronic acid-based dermal fillers with COLD-X17 technology by Symatese. Follow-up visits occur every 6 months after the initial injection, lasting up to 24 months. Retreatment is optional and may be performed at the 12-month or 18-month visits if the treated areas have returned to their pre-injection state. During each visit, investigators assess safety and performance through clinical examinations, while participants evaluate their aesthetic improvement compared to before treatment. The level of pain experienced during the initial injection is recorded. Researchers measure outcomes such as the number of patients returning to baseline appearance, injection site reactions, adverse device effects, and aesthetic improvements using validated scales. The study monitors participants over two years to gather comprehensive safety and effectiveness data.