Poissy

Researchers are studying nulliparous pregnant women who have conceived through Assisted Reproductive Technology ART to evaluate if aspirin can help prevent preterm preeclampsia and related pregnancy complications. This group is considered at higher risk for preeclampsia and perinatal issues, with a current rate of preeclampsia up to 10%. The study aims to determine if aspirin given during pregnancy reduces these risks in this specific population. Participants are randomly assigned to receive either a daily oral dose of 150 mg low-dose aspirin or a matching placebo. Treatment starts between 9 and 14 weeks of pregnancy and continues until 35 weeks and 6 days of gestation or until labor begins. The study compares outcomes between these two groups to assess the effects of aspirin. During the trial, participants will be monitored for the development of preterm preeclampsia before 37 weeks of gestation and other pregnancy outcomes such as preterm birth, cesarean delivery, postpartum hemorrhage, placental abruption, and neonatal adverse events. The study will last up to 9 months, covering the pregnancy period, with data collected to evaluate the aspirins impact on these health measures.

Researchers are evaluating how the size of the bougie used during laparoscopic sleeve gastrectomy LSG affects the rate of postoperative stomach leaks, which is the most common and serious complication after this weight loss surgery. This prospective randomized trial compares the use of a larger 48-Fr bougie to standard smaller bougie sizes 34, 36, or 38 Fr to see if a bigger diameter lowers leak risk without reducing long-term weight loss. Participants will undergo laparoscopic sleeve gastrectomy using either the 48-Fr bougie or a standard care bougie. The bougie is inserted through the mouth by the anesthesiologist and positioned in the stomach before the gastrectomy is performed alongside it. Patients do not know which bougie size they receive. This study aims to assess differences in leak rates and weight loss outcomes between the two bougie sizes. During the study, researchers will monitor participants for stomach leaks within 30 days after surgery as the primary outcome. Secondary outcomes include complications within 90 days, weight loss at 3, 6, 12, and 24 months, and quality of life up to 2 years. Participants will have follow-up visits for these assessments to track recovery, safety, and weight changes over time.

Chronic hypertension affects 1 to 5% of women of childbearing age and can lead to serious complications during pregnancy, such as superimposed preeclampsia, placental abruption, intrauterine growth restriction, perinatal death, maternal death, or preterm delivery. This trial evaluates whether taking 150 mg of acetylsalicylic acid aspirin daily before 20 weeks of pregnancy can help prevent these complications in pregnant women with chronic hypertension. The study is a prospective randomized double-blind placebo-controlled trial conducted to provide clearer evidence on aspirins effectiveness in this specific population. Participants are randomly assigned to receive either aspirin 150 mg or a placebo once daily in the evening. The treatment starts immediately after randomization and continues until 35 weeks plus 6 days of gestation. Both the active drug and placebo are dispensed by the study centers pharmacy, and participants are given daily logs to record their treatment adherence. This design ensures careful monitoring and comparison of outcomes between the two groups. During the study, participants will undergo regular assessments of maternal and fetal health, including monitoring for preeclampsia, fetal growth, placental health, and timing of delivery. Researchers will measure a combined outcome of maternal and perinatal complications within 9 months, along with various secondary outcomes such as fetal development and child growth up to 4 years. Safety and treatment adherence are also tracked throughout. The total participation duration aligns with the pregnancy timeline, ensuring comprehensive observation of both mother and child.

Researchers are evaluating the effectiveness and safety of colchicine and non-enteric coated aspirin, used alone or together, to improve heart-related outcomes in high-risk adults aged 55 to 80 with type 2 diabetes. This study focuses on preventing major cardiovascular events such as heart attacks, strokes, and urgent hospitalizations in patients who have no prior history of coronary artery disease but possess other risk factors. Participants will be randomly assigned to one of four groups receiving either colchicine, aspirin, both drugs, or placebos. Aspirin is given as a 40 mg non-enteric-coated tablet twice daily, while colchicine is taken as a 0.5 mg tablet once daily. Those who cannot take aspirin will only be assigned to colchicine or its placebo groups. The study lasts up to 60 months, during which cardiovascular events and cognitive function using MoCA scores will be monitored. During the study, participants will undergo regular assessments to track cardiovascular events including heart attacks, stroke, cardiac arrest, atrial fibrillation, heart failure hospitalizations, and coronary procedures. Researchers will also evaluate cognitive function yearly. Safety checks and follow-up visits occur throughout the 5-year period to monitor the participants health and treatment adherence. The primary outcome is the time to the first major cardiovascular event after starting the study medications.

This research aims to improve genetic counseling by classifying gene variants found in families with a history of hereditary cancers, especially breast and ovarian cancer. Initially focused on BRCA1 and BRCA2 genes, the study now includes multiple genes from a large French oncogenetics database, covering thousands of families and variants. The goal is to better understand which gene variants are linked to cancer risk and to refine how these variants are classified for clinical use. Participants include index cases carrying specific gene variants and their family members. The study collects saliva samples from relatives to test for the presence of these variants, particularly those classified as uncertain significance class 3, likely pathogenic class 4, or hypomorphic pathogenic class 5. Genetic analyses are performed by specialized laboratories, and data from multiple families is combined to assess how these variants co-segregate with cancer occurrence. Throughout the study, researchers analyze genetic data using statistical models to estimate the likelihood that certain variants cause cancer. They use anonymous results for overall variant classification and share findings with families when variants are found to be pathogenic. This helps guide genetic counseling, possible preventive measures, and clinical management. The study spans up to 15 years and continuously updates classification methods and clinical recommendations based on new data.

Researchers are studying whether an investigational drug called Zelpultide Alfa can reduce the occurrence of Bronchopulmonary Dysplasia BPD in extremely premature babies. This randomized, double-blind, placebo-controlled phase 2b3 study has an adaptive design and includes two parts Part 1 for dose selection and exploratory safety and efficacy, and Part 2 for confirmatory evaluation of the selected dose. Participants will receive up to 7 doses of Zelpultide Alfa or a placebo air-sham administered intratracheally at 24-hour intervals while still intubated, alongside standard care. In Part 1, babies are randomized to either 4 mgkg Zelpultide Alfa, 6 mgkg Zelpultide Alfa, or placebo, and after evaluating safety and efficacy, the selected dose moves to Part 2. In Part 2, babies are randomized to receive the chosen dose plus standard care or placebo plus standard care. During the study, babies will be closely monitored for safety and efficacy outcomes, including the incidence of grade 2 or 3 BPD or death by 36 weeks post menstrual age. Researchers will assess ventilator-free days, oxygen use, extubation rate, hospitalizations, and adverse events. The study results will help determine if Zelpultide Alfa added to standard care helps prevent BPD in high-risk preterm neonates. Participation lasts until at least 36 weeks post menstrual age with follow-up assessments for up to 24 months corrected age.

Researchers are evaluating the effectiveness of cotrimoxazole compared to standard antibiotic therapy for treating ventilator-associated pneumonia VAP caused by Enterobacteriaceae in adult patients in intensive care units ICU. This multicenter randomized trial aims to determine if cotrimoxazole is not inferior to the best standard care in terms of survival 28 days after treatment begins. Patients with confirmed VAP and susceptibility to cotrimoxazole are included, with specific attention to those with or without septic shock and COVID-19 pneumonia. Participants are randomly assigned to receive either cotrimoxazole or standard antibiotic treatment, such as beta-lactams or fluoroquinolones, for a total of 7 days including initial empiric treatment. The antibiotic dosing and administration are adjusted based on current ICU recommendations. The treatment period can last up to 28 days or until death or ICU discharge if earlier. The study is not blinded due to variable therapies in the control group. During the study, patients are monitored daily until death, ICU discharge, or day 28 for vital signs, antibiotic use, new infections, and Clostridium difficile infection. Clinical and radiological evaluations occur at day 7, and weekly screening for multidrug-resistant bacteria is performed. Survival status is followed up to 90 days through phone or hospital interview. An independent committee reviews clinical and radiological outcomes without knowledge of treatment assignment to ensure unbiased assessment.

This research aims to evaluate the effect of virtual reality on reducing anxiety in women with suspected endometriosis during gynecological consultations. The study recognizes that patients often feel anxious in this situation and explores digital therapy as a method to help manage this anxiety. The trial is randomized and controlled, involving 46 patients divided into two groups, and is conducted over an 18-month inclusion period with individual participation lasting 6 months. Participants in the experimental group will receive Bliss DTX digital therapy, which uses a specialized video headset and audio headset to immerse patients in calming sound and visual programs for 13 minutes before their consultation. The control group will wait in the reception room without any intervention. Both groups will complete anxiety questionnaires before and after the consultation. Six months after the consultation, a follow-up call will collect information on compliance with endometriosis monitoring. Throughout the study, patients will be assessed using anxiety questionnaires and data collected during consultations. The primary outcome is the reduction in anxiety levels from before to after the consultation. Secondary assessments include pain experienced during the gynecological exam and satisfaction with the virtual reality device. Safety monitoring notes possible side effects such as nausea or dizziness related to the virtual reality headset. The total study duration for participants is 6 months, with data collection also at the 6-month follow-up.

This research aims to better understand how pregnancy affects women with multiple sclerosis MS and related neurological conditions, including neuromyelitis optica and myelin oligodendrocyte glycoprotein antibody-related disorders. The study focuses on important questions about the use of disease-modifying drugs during pregnancy, the effects on the mothers health and disability, the childs health, breastfeeding, and pain management during delivery. It is a national, prospective, observational study conducted within the French MS cohort called Observatoire Franais de la Sclrose en Plaque OFSEP. Women with MS or related disorders who are pregnant will be followed throughout their pregnancy and for one year after giving birth. Their children will also be monitored until they reach six years of age. There is no intervention or treatment given as part of this study instead, it collects detailed information on the course of MS during pregnancy and postpartum, including any use or discontinuation of disease-modifying drugs and other pregnancy-related factors. Participants will have regular follow-ups during pregnancy and postpartum to assess their health and any treatment-related side effects. Researchers will collect data on relapses, disability progression, breastfeeding, and use of pain relief during delivery. Children born to these women will be observed for up to six years to evaluate long-term outcomes. The main outcomes measured include the number of treatment-related adverse events during pregnancy and postpartum, helping to improve knowledge for neurologists and families regarding MS and pregnancy.

Multiple sclerosis MS is a long-lasting autoimmune disease affecting the central nervous system and is a leading cause of severe disability in young people, impacting many individuals in France. Researchers are studying the effects of ocrelizumab, an anti-CD20 monoclonal antibody, which has shown strong results in reducing disease activity in earlier trials. This study aims to compare the safety and effectiveness of giving ocrelizumab infusions once a year versus the usual every six months in adults with active MS who have already been treated for two years. Participants will receive ocrelizumab infusions either every 12 months or every 6 months. These two schedules will be compared to see if the less frequent dosing is not worse than the standard regimen in controlling the disease. The study is randomized and controlled, involving adults who have already had at least four cycles of semi-annual ocrelizumab. The goal is to see if extending the time between infusions can reduce infection risks and treatment costs without increasing disease activity. During the study, participants will have regular MRI scans to monitor for signs of MS activity, and disease symptoms will be tracked. Researchers will measure the absence of new radiological disease activity after two years as the main outcome. The study includes follow-up visits and assessments to ensure safety and effectiveness, with participants usual care continuing alongside the trial. The total study duration and detailed monitoring will help understand the impact of spacing out ocrelizumab infusions over time.