Boulogne Sur Mer

Women who have experienced interpersonal violence often face a higher risk of developing post-traumatic stress disorder PTSD. In France, female victims can request a medico-legal examination at a clinical forensic medicine unit, which also offers initial psychological assessment. However, many women do not attend follow-up appointments. This research is a prospective, multicenter, open-label, randomized controlled trial aiming to evaluate the effectiveness of a case management algorithm that uses early phone contact to improve clinical outcomes after such consultations for female victims of violence. Participants are divided into two groups. The experimental group, called VIGITRAUMA, will receive a phone call three weeks after their consultation, with a second call if needed. If contact is not made after the second call, a postcard will be sent. The control group will receive the usual follow-up care without this additional phone contact. The study is conducted by the University Hospital, Lille. Participants will be assessed through phone calls at 3, 6, and 12 months after their consultation to monitor clinical outcomes. Researchers will measure PTSD symptom severity, general psychopathology, somatic symptoms, medical costs, judicial outcomes, suicidal thoughts, and suicide attempts. The study aims to track these outcomes over a full year to understand the impact of the case management algorithm compared to standard care.

Researchers are evaluating the efficacy, safety, and pharmacokinetics of sefaxersen RO7434656, a new Antisense Oligonucleotide ASO therapy, in adults with primary IgA nephropathy IgAN who are at high risk of worsening kidney disease despite receiving optimized supportive care. This phase III study focuses on participants who continue to face disease progression despite standard treatments. Participants will receive subcutaneous injections of either sefaxersen or a matching placebo. The dosing schedule includes injections on Days 1, 15, and 29, followed by doses once every four weeks until Week 105. After Week 105 or the primary data cut-off, eligible participants may switch to open-label sefaxersen treatment at the investigators discretion. Throughout the study, participants will undergo assessments to measure changes in urine protein-to-creatinine ratio at Week 37, kidney function eGFR slope at Week 105, and monitor for hematuria resolution, kidney failure events, fatigue, and treatment-emergent adverse events. Blood samples will be collected to measure plasma sefaxersen levels. The total study duration extends up to approximately 36 months, with ongoing safety and efficacy monitoring.

Researchers are evaluating the use of pioglitazone to improve kidney outcomes in people with ANCA-associated vasculitis, a condition that affects blood vessels and involves kidney inflammation. This multicenter, randomized controlled trial includes patients with biopsy-confirmed kidney involvement of ANCA vasculitis at diagnosis. The study aims mainly to see if pioglitazone can reduce kidney damage by improving protein levels in urine and serum creatinine. It also examines effects on blood pressure, metabolic changes from steroids, vasculitis activity, and safety in this group of patients. All participants receive standard immunosuppressive treatment combining corticosteroids and rituximab. They are randomly assigned to take either pioglitazone 30 mg daily or a placebo for 26 weeks alongside the standard care. Rituximab is given weekly for four weeks as induction, then re-administered every six months. Participants follow a predefined steroid tapering schedule. Biological samples are collected at multiple points throughout the study for analysis. Participants are followed for a total of 52 weeks with visits scheduled at weeks 1, 2, 3, 4, 8, 12, 26, 38, and 52. During these visits, kidney function, proteinuria, vasculitis activity, quality of life, and safety are assessed through clinical exams, blood and urine tests, and questionnaires. The primary outcome is measured at week 26, and secondary outcomes continue through week 52 to monitor effects and safety of pioglitazone over time.

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.

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.

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 evaluating the effect of digital monitoring of self-reported symptoms on how treatment is managed in patients with advanced clear cell renal cell carcinoma RCC receiving cabozantinib plus nivolumab. This Phase 4 study focuses on the first three months of combined treatment in a real-life setting, aiming to improve patient care by adjusting treatments based on weekly symptom reports. The study is sponsored by Centre Francois Baclesse. Participants receive cabozantinib orally once daily and nivolumab intravenously every two weeks as prescribed in the labeling. During this treatment, a digital monitoring system collects weekly patient reports on treatment tolerance. The system uses an algorithm to classify patients risk levels and generate alerts that may lead to treatment adjustments. This digital telemonitoring platform supports early detection of adverse events related to the combination therapy. Participants will be involved in regular weekly self-reporting of symptoms through a mobile digital device for up to six months. Researchers will assess treatment management adjustments within the first three months and track symptom evolution, fatigue, quality of life, anxiety, depression, pain, and adverse reactions over six months. The study evaluates the feasibility of this digital approach to follow-up and the impact of alerts generated by the monitoring platform on patient management and outcomes.

Researchers are evaluating the effects of the probiotic B. lactis B94 on infants with infantile colic. The study aims to see if this probiotic can reduce the duration of crying in infants compared to a placebo. This is a randomized, double-blind, placebo-controlled trial designed to provide clear evidence on the potential benefits of B. lactis B94 for infantile colic symptoms. Participants will be randomly assigned to one of two groups one receiving the probiotic B. lactis B94 and the other receiving a placebo. Both groups will take one sachet daily, dissolved in 10 ml of lukewarm water, for 4 weeks. The study includes a 1-week baseline period before treatment and a 1-week follow-up after the intervention. The trial involves three in-person visits and four phone calls. During the 6-week participation, caregivers will complete questionnaires, keep diaries, and attend scheduled visits and calls to monitor the infants crying, sleep, bowel habits, and quality of life. Researchers will measure changes in daily crying duration, crying patterns, sleep time, gut bacteria composition, and probiotic recovery. Safety and adherence will be tracked throughout the study, ensuring detailed observation of all participants.

Researchers are evaluating 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 focuses on patients without distant metastasis who show ctDNA positivity during screening. The study aims to assess whether elacestrant can improve outcomes over the current standard endocrine treatments. The study consists of two phases. First, during the ctDNA screening phase, patients on standard adjuvant endocrine therapy will have plasma samples collected every six months for about 5.7 years to detect ctDNA. Patients who test positive will undergo imaging to confirm no distant metastasis and then be randomized 11 to either continue their current endocrine therapy or receive elacestrant 400 mg orally once daily. Treatment duration depends on prior endocrine therapy length, lasting between 2 to 6 years. Intensive follow-up with ctDNA testing and imaging occurs for up to 3 years after randomization. Participants will be monitored closely with blood tests for ctDNA at weeks 4, 16, and every 16 weeks thereafter, along with yearly mammograms, bone scans, and CT scans every 16 weeks to detect metastases or recurrences. Safety, quality of life, and overall survival are assessed throughout, with follow-up continuing until three years after the last patient enrolls. The primary outcome measured is distant metastasis-free survival at 6.25 years after the first randomization.

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.