Poissy

Researchers are evaluating the use of aspirin to prevent preterm preeclampsia and improve pregnancy outcomes in nulliparous women who became pregnant through Assisted Reproductive Technology (ART). This study focuses on this subgroup because they have a higher risk of preeclampsia and related complications, with rates rising up to 10% in this population. The study aims to validate whether aspirin given during pregnancy can reduce the risk of preterm preeclampsia and other negative perinatal outcomes in these women. Participants will receive either aspirin at a daily dose of 150 mg or a placebo, starting between 9 and 14 weeks of pregnancy. Aspirin is taken orally, and the study compares this treatment against placebo to see its effect on preventing preterm preeclampsia before 37 weeks of gestation. The trial builds on current knowledge that aspirin can reduce preeclampsia in high-risk women, with the goal of better targeting those who might benefit, especially nulliparous women after ART. During the study, women will be monitored up to delivery, with assessments to track the occurrence of preterm preeclampsia and pregnancy outcomes. Researchers will gather data on maternal and perinatal health, and safety will be closely watched throughout. Participation includes informed consent and routine clinical follow-up as per study protocol, with the total duration covering the pregnancy period until birth.

This trial investigates the effect of bougie diameter size on the risk of staple-line leaks following laparoscopic sleeve gastrectomy (LSG), a common weight-loss surgery for people with morbid obesity. Staple-line leaks occur in about 3% of cases and can lead to serious complications and long recovery. The study compares the use of a standard bougie size (34, 36, or 38 French) versus a larger 48-Fr bougie to see if a bigger diameter reduces leak rates without affecting weight loss outcomes. Participants undergo LSG where a bougie is inserted through the mouth by the anesthesiologist to calibrate the size of the stomach remnant. The surgery is done alongside the bougie, with patients unaware of which bougie size is used. The study is randomized and prospective, focusing on comparing postoperative outcomes related to gastric leak and mid-term weight loss between the two bougie sizes. During the study, researchers monitor patients for 30 days after surgery to measure the rate of gastric leaks. Participants are followed to evaluate mid-term weight loss results. The study includes regular assessments and safety checks to track complications. This research aims to identify if using a larger bougie can lower leak risks while maintaining effective weight loss after LSG.

Researchers are evaluating the effectiveness of acetylsalicylic acid (aspirin) at a dose of 150 mg per day, started before 20 weeks of pregnancy, to prevent maternal and fetal complications in women with chronic hypertension. Chronic hypertension affects 1 to 5% of women of childbearing age and can lead to serious pregnancy complications such as superimposed preeclampsia, placental abruption, intrauterine growth restriction, preterm delivery, perinatal death, and maternal death. Despite current recommendations by some health organizations to use low-dose aspirin in these cases, there is insufficient conclusive evidence, especially for aspirin doses of 150 mg started before 20 weeks gestation, which this study aims to address in a phase 3 randomized, double-blind, placebo-controlled trial. Participants will be randomly assigned to receive either aspirin 150 mg or a placebo daily, taken in the evening, starting immediately after randomization and continuing until 35 weeks and 6 days of pregnancy. Both treatments will be dispensed by the study center's pharmacy. Participants will keep a daily log of their treatment intake. The study focuses on assessing the prevention of a composite outcome including maternal and perinatal complications such as preeclampsia, intrauterine growth restriction under the 10th percentile, placental abruption, preterm birth before 37 weeks, perinatal death, and maternal death. During the study, participants will be closely monitored for these complications over nine months. Researchers will evaluate maternal and fetal health outcomes, including the appearance of significant proteinuria or neurological signs indicating preeclampsia. Daily treatment adherence will be tracked through patient logs. Safety and effectiveness will be assessed through regular clinical evaluations and outcome measurements related to both maternal and perinatal morbidity and mortality.

Researchers are evaluating the effectiveness and safety of colchicine and non-enteric coated aspirin, alone or combined, to improve heart-related outcomes in high-risk patients with type 2 diabetes. This Phase 3 trial focuses on adults aged 55 to 80 years who have type 2 diabetes and no prior coronary artery disease events but have additional risk factors like long diabetes duration, high blood sugar levels, smoking, or other markers of cardiovascular risk. The study aims to reduce serious cardiovascular events such as heart attacks, strokes, or urgent hospitalizations. Participants are randomly assigned to receive either colchicine 0.5 mg once daily, aspirin 40 mg twice daily, both medications together, or matching placebos. The aspirin is given as a non-enteric-coated tablet twice daily. Those who cannot take aspirin or have certain conditions may still receive colchicine or its placebo. The treatment and follow-up period lasts up to 60 months, during which the occurrence of serious cardiovascular events is closely monitored. During the study, participants will undergo regular assessments including monitoring for cardiovascular events like heart attacks and strokes. Safety labs and clinical evaluations will be conducted to track any side effects or adverse events. The main outcome measured is the time until the first major cardiovascular event occurs. Researchers will also ensure participants adhere to the medication schedule and will follow all patients for up to five years to evaluate long-term safety and effectiveness.

This research aims to evaluate the safety and effectiveness of an investigational drug called Zelpultide Alfa in reducing the occurrence of Bronchopulmonary Dysplasia (BPD) in extremely premature babies. The study is a randomized, double-blind, placebo-controlled multicenter trial with an adaptive seamless design, combining Phase 2b and Phase 3. It focuses on high-risk preterm neonates born between 22 and 27.6 weeks gestational age who require invasive mechanical ventilation and surfactant treatment. The study is divided into two parts. In Part 1 (Phase 2b), participants are randomly assigned in equal groups to receive either standard care plus Zelpultide Alfa at doses of 4 mg/kg or 6 mg/kg, or standard care plus a placebo (air-sham). Treatment is given via intratracheal administration up to seven times at 24-hour intervals while the babies remain intubated. Based on safety and early efficacy results, one dose will be selected to advance to Part 2 (Phase 3), where participants will be randomized to receive either the selected dose of Zelpultide Alfa plus standard care or placebo plus standard care. During the study, participants will be closely monitored for the development of moderate to severe BPD or death by 36 weeks postmenstrual age. Researchers will assess safety, tolerability, and efficacy through clinical evaluations and standard care procedures. The study includes careful follow-up to evaluate the impact of the drug on lung health in these vulnerable neonates, with the total treatment period covering the time they remain intubated and under mechanical ventilation.

Researchers are evaluating the effectiveness of cotrimoxazole compared to the best standard antibiotic treatment for ventilator-associated pneumonia (VAP) caused by Enterobacteriaceae in adult patients admitted to intensive care units (ICU). This is a multicenter, randomized, non-inferiority Phase 3 trial aiming to show that cotrimoxazole is not worse than standard care in terms of patient survival 28 days after treatment begins. Participants must have a confirmed diagnosis of VAP with bacteria susceptible to cotrimoxazole. Patients are randomly assigned to receive either cotrimoxazole or the best standard antibiotic therapy, which may include beta-lactam or fluoroquinolone antibiotics. Treatment lasts for seven days, starting with an initial appropriate empiric antibiotic therapy. The dosing and administration of antibiotics are tailored according to current ICU guidelines. The trial is open-label due to variable antibiotic regimens in the control group. During the study, patients are closely monitored daily until death, ICU discharge, or 28 days after inclusion. Assessments include vital status, antibiotic use, new infections, and Clostridium difficile infections. Clinical signs and chest X-rays are reviewed on day 7 to evaluate cure. Weekly screenings for multidrug-resistant bacteria are performed until ICU discharge. The vital status is also checked at day 90, with follow-up contact for patients discharged before this time. An independent committee reviews the clinical and radiological outcomes without knowing the treatment assignments.

Researchers are evaluating the effectiveness of virtual reality therapy in reducing anxiety during gynecological consultations for women with suspected endometriosis. This study involves women aged 18 to 45 years who are consulting for the first time at the hospital and have imaging confirming endometriosis. The goal is to improve anxiety levels, treatment compliance, pain management, and quality of life through a non-drug digital therapy approach. Participants are randomly assigned to one of two groups. The experimental group uses the Bliss DTX digital therapy delivered via a video headset and audio headphones for 13 minutes while waiting for their consultation. The control group waits without any intervention. Both groups complete anxiety questionnaires before and after the consultation. The study lasts 18 months for inclusion, with each participant involved for 6 months in total. During the study, participants complete anxiety questionnaires before and after the consultation and provide feedback on their experience. A follow-up phone call is conducted 6 months later to collect information about ongoing monitoring and treatment adherence. Researchers measure the reduction in post-consultation anxiety as the primary outcome and also assess pain levels, satisfaction with the device, and compliance with endometriosis monitoring. Safety is monitored, noting possible side effects of virtual reality such as nausea or dizziness.

Researchers are investigating the interactions between pregnancy and multiple sclerosis (MS), including related disorders such as neuromyelitis optica (NMO) and myelin oligodendrocyte glycoprotein (MOG)-antibody related disorders. This national prospective study aims to better understand how pregnancy impacts MS and associated conditions, focusing on questions about disease-modifying drugs (DMDs), breastfeeding, locoregional analgesia, and the short- and long-term effects on both mother and child. The study is nested within the Observatoire Français de la Sclérose en Plaque (OFSEP) cohort and includes patients across various MS-related diagnoses without age limits. Participants will not receive any experimental treatment but will be observed throughout pregnancy and up to one year after delivery. Their children will be followed until six years of age. The study collects data on pregnancy-related factors, use or discontinuation of DMDs, breastfeeding practices, and analgesia methods during delivery. Neurologists and researchers will gather information on the course of MS and related disorders before, during, and after pregnancy. During the study, participants will be monitored for treatment-related adverse events during pregnancy and the postpartum period, with assessments continuing for up to two years. Data collected will include clinical evaluations and long-term follow-up of both mothers and children. This comprehensive observation aims to provide clearer answers about the safety and impact of therapies and pregnancy-related factors on MS and related neurological conditions over time.

Multiple sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system and is a leading cause of severe disability in young people. This trial studies patients with active MS who have already been treated with ocrelizumab for 2 years and aims to compare the effects of spacing ocrelizumab infusions every 12 months versus the standard 6-month schedule. The goal is to see if the annual infusion schedule can maintain control of the disease without increasing activity, potentially reducing infection risk and treatment costs. Participants receive ocrelizumab infusions either every 6 months or every 12 months after having completed at least four semi-annual cycles of treatment. The study evaluates the non-inferiority of the 12-month interval compared to the 6-month interval. The two treatment groups help assess whether extending the time between infusions affects disease control in patients with active MS. Throughout the study, participants undergo follow-up MRI scans to monitor disease activity, and clinical evaluations to check for relapses and disability status using EDSS scores. The main outcome measured is the absence of radiological disease activity after 2 years. Participants also provide informed consent and must have proficiency in French and social insurance coverage. Safety and efficacy are monitored over the course of the study to understand the impact of infusion spacing on disease control and infection risks.

Researchers are studying women with colorectal deep infiltrating endometriosis (DIE) and infertility to understand the effects of complete surgery on fertility. The trial compares two groups: one undergoing complete surgery of colorectal DIE before assisted reproductive technology (ART), and the other receiving ART alone without surgery. The study aims to evaluate the impact of these approaches on clinical pregnancy outcomes. Participants are randomly assigned to either have complete surgery for colorectal DIE followed by in vitro fertilization (IVF) or to have IVF without prior surgery. The surgery involves addressing the endometriosis lesions confirmed by MRI and other imaging techniques. Both groups proceed with IVF treatment cycles to assess fertility outcomes. Women in the study will be monitored through two IVF cycles, with pregnancy outcomes measured six weeks after each embryo transfer. Researchers will assess clinical pregnancy rates after the second IVF cycle. Participants undergo evaluations including imaging to confirm diagnosis and follow-up visits to monitor treatment effects and safety during the study period.