Boulogne Sur Mer

Research shows that women who experience interpersonal violence are at a higher risk of developing post-traumatic stress disorder (PTSD). In France, female victims can request a medico-legal examination in clinical forensic medicine units, which also offer initial psychological evaluations. However, many women do not attend follow-up appointments. This trial aims to evaluate the effectiveness of a case management algorithm using early phone contact compared to usual care on clinical outcomes after such consultations for female victims of violence. Participants in the intervention group, called VIGITRAUMA, will receive a phone call three weeks after their initial consultation, with the possibility of a second call. If contact is not made after the second call, a postcard will be sent. The control group will receive the standard follow-up care without additional phone contact. The study is a prospective, multicenter, open-label, randomized controlled clinical trial involving women victims of violence. Women enrolled will be evaluated via phone at 3 months, 6 months, and 12 months following their consultation to assess clinical outcomes related to PTSD and violence-related symptoms. The study monitors the effectiveness of early phone contact in improving these outcomes and reducing the risk of PTSD development among participants.

Researchers are evaluating the effectiveness, safety, and behavior of a new treatment called sefaxersen (RO7434656), an Antisense Oligonucleotide (ASO) therapy, for people with primary IgA nephropathy (IgAN). The study focuses on participants who have a high risk of their kidney disease worsening despite receiving the best available supportive care. This is a Phase III, randomized, double-blind, placebo-controlled trial conducted at multiple centers. Participants will receive either sefaxersen or a matching placebo through subcutaneous injections according to a specified schedule. The study compares these two groups to see how the treatment affects kidney function over time. The intervention is designed to inhibit Complement Factor B, which is involved in the disease process. The study includes vaccination requirements and contraceptive use for women of childbearing potential to ensure safety. During the study, participants will be monitored for changes in their urine protein-to-creatinine ratio (UPCR) at baseline and at week 37, which is the primary measure of kidney function improvement. Other assessments include kidney biopsy results, kidney function tests estimating glomerular filtration rate (eGFR), and ongoing safety evaluations. The trial tracks participants' health closely to assess the treatment's effect and any side effects throughout the study period.

Researchers are evaluating the effectiveness of pioglitazone in improving kidney outcomes for patients with ANCA-associated vasculitis, a condition involving inflammation of small blood vessels that affects the kidneys. This Phase 3 multicenter randomized controlled trial includes patients with biopsy-proven kidney involvement of ANCA vasculitis, aiming to determine if pioglitazone can reduce kidney damage as measured by improvements in proteinuria and serum creatinine levels. Participants will be randomly assigned to receive either pioglitazone (30 mg/day orally) or a placebo for 26 weeks, alongside standard immunosuppressive care which includes rituximab infusions and corticosteroids following a tapered dosing schedule. Rituximab is given at 375 mg/m2 weekly for 4 weeks as induction, then 500 mg every 6 months as maintenance. Biological samples of plasma, serum, and urine will be collected at multiple visits throughout the 52-week follow-up period. Participants will be closely monitored with visits scheduled at weeks 1, 2, 3, 4, 8, 12, 26, 38, and 52, during which assessments will include kidney function tests, proteinuria measurement, and safety evaluations. The primary outcome is defined by a significant decrease in serum creatinine combined with a reduction in urine protein-to-creatinine ratio at 26 weeks. The study also evaluates secondary effects on blood pressure, metabolic changes due to glucocorticoids, vasculitis activity, and the overall safety of pioglitazone in this patient group.

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.

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.

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 the effects of the probiotic B. lactis B94 on infants diagnosed with infantile colic. This randomized, double-blind, placebo-controlled Phase 2 study aims to determine whether the probiotic can reduce the duration of daily crying compared to a placebo after 4 weeks of treatment. Infantile colic is characterized by prolonged periods of crying or fussiness, and this study seeks to explore a potential dietary intervention to ease these symptoms. Participants will be randomly assigned to one of two groups: one receiving a daily sachet of the probiotic B. lactis B94, and the other receiving a placebo. Both treatments are taken once daily, dissolved in 10 ml of lukewarm water, and administered at approximately the same time each day. The study spans 6 weeks, including a 1-week baseline period, a 4-week intervention period, and a 1-week follow-up. During this time, families will attend three in-person visits and participate in four phone calls to support adherence and monitoring. Throughout the study, parents will maintain questionnaires, records, and diaries related to their infant's symptoms. Researchers will track changes in daily crying duration as the primary outcome over 4 weeks. The study also involves clinical assessments during visits and telephone follow-ups to ensure safety and collect data. Participation requires exclusive breastfeeding and commitment to study procedures over the full 6-week period.

Researchers are investigating the use of elacestrant compared to standard endocrine therapy in patients with estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer who have a relapse detected by circulating tumor DNA (ctDNA). This international, multi-center, randomized, open-label phase III trial aims to determine if elacestrant offers a benefit over current endocrine treatments in this group of patients without distant metastases. The study includes a lengthy ctDNA screening phase to identify eligible participants and monitor their disease status over time. The study begins with a ctDNA screening phase, where patients receive standard adjuvant endocrine therapy such as tamoxifen, letrozole, anastrozole, or exemestane, and have blood collected every six months for ctDNA testing until about 5.7 years after enrollment ends. Those who test positive for ctDNA and show no distant metastasis on imaging will be randomized within four weeks to continue their current endocrine therapy or switch to elacestrant taken orally at 400 mg daily. Treatment duration varies based on prior endocrine therapy exposure, ranging from two to seven years. After treatment, further care is at the physician's discretion. Participants will have frequent follow-up visits with ctDNA testing at weeks 4 and 16 post-randomization and every 16 weeks thereafter for up to three years. Imaging studies including mammograms, bone scans, and CT scans will be conducted regularly to monitor for distant metastases or new cancers. The main outcome measured is distant metastasis-free survival, assessed up to 6.25 years following the first patient enrollment. The study ends when all patients complete their visits or discontinue for reasons such as withdrawal, loss to follow-up, or death, and data is fully analyzed and finalized.

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.