Clamart

This research aims to evaluate antibiotic treatments for acute pyelonephritis AP in children aged 1 month to 3 years. It compares a shorter intravenous IV antibiotic course of 3 days alone to a longer treatment consisting of 3 days IV followed by 7 days of oral antibiotics. The goal is to see if the shorter IV treatment is as effective in curing AP and preventing recurrence and renal scarring, while reducing the risk of antibiotic resistance and preserving gut microbiota diversity. Participants are randomly assigned to one of two groups. The experimental group receives only 3 days of IV antibiotics with ceftriaxone andor amikacin, after which treatment is stopped. The control group receives the usual care of 3 days IV antibiotics followed by 7 days of oral antibiotics, either cotrimoxazole or cefixime. The study includes collection of fecal or rectal swabs and blood tests to assess microbiota and resistance. Treatment effectiveness and safety are compared between groups. During the study, children are monitored for fever, symptoms, and urine cultures to confirm infection clearance. Researchers measure recurrence of febrile urinary tract infections within 28 days after treatment ends and follow clinical cure at 10 or 17 days depending on the group. Additional assessments include monitoring recurrence at 90 days, antimicrobial resistance in gut bacteria, and intestinal microbiota diversity over about a month. Participation lasts through treatment and follow-up visits up to several weeks.

Researchers are studying patients with 1p19q-codeleted low-grade oligodendrogliomas who have been treated with radiotherapy plus PCV chemotherapy. The study aims to evaluate whether delaying radiotherapy until tumor progression can reduce the risk of neurocognitive decline without affecting overall survival. This is a phase 3 randomized trial sponsored by Hospices Civils de Lyon, focusing on preserving brain function while managing tumor growth. Participants are randomly assigned to one of two treatment groups one group receives six cycles of PCV chemotherapy alone, and the other group receives radiotherapy followed by six cycles of PCV chemotherapy. Radiotherapy delivers 50.4 Gy in 28 sessions using IMRT technique. PCV chemotherapy includes a cycle with CCNU orally on day 1, vincristine intravenously on days 8 and 29, and procarbazine orally from days 8 to 21. Treatment cycles are repeated six times. During the study, participants will undergo neurocognitive examinations and quality of life assessments. Researchers will monitor survival without neurocognitive deterioration over nine years, along with progression-free survival and overall survival. Laboratory tests and physical evaluations will be conducted before and during the study. The trial includes detailed follow-up to assess the long-term effects of the treatments on cognition and tumor control.

This research aims to evaluate LTP001 treatment in both healthy adults and participants with pulmonary arterial hypertension PAH. It explores safety, tolerability, and how the body processes LTP001 in healthy volunteers Part A, and assesses safety and efficacy in PAH patients Part B followed by an extended safety period. The study is designed as a randomized, double-blind, placebo-controlled trial sponsored by Novartis Pharmaceuticals. Participants in Part A receive single and multiple ascending doses of LTP001 or placebo to understand pharmacokinetics and safety over 35 days. Part B involves treatment with LTP001 or placebo alongside stable standard PAH therapies, with treatment periods up to 106 weeks including a 24-week initial evaluation and a longer safety extension. Both parts include placebo comparison and dose escalation in a parallel study model. Throughout the study, participants undergo monitoring for adverse events, changes in pulmonary vascular resistance, and functional assessments such as the Six-minute Walk Test and WHO functional class. Blood tests measure biomarkers like NT-proBNP. Safety and pharmacokinetic data are collected frequently in Part A, while Part B includes long-term efficacy and safety evaluations up to 106 weeks. Participant involvement includes regular visits for treatment administration, assessments, and follow-up until study completion in late 2028.

This research aims to improve pregnancy success rates in women undergoing frozen embryo transfers FET after in vitro fertilization IVF. It evaluates whether placing a blank culture medium into the uterus a few days before the embryo transfer can enhance immune tolerance and support embryo implantation. The study compares this approach to a sham transfer procedure without the culture medium, focusing on women who have experienced previous embryo transfer failures. Participants are randomly assigned to one of two groups the experimental group receives a small amount of warmed embryo culture medium injected into the uterine cavity two to three days before the frozen embryo transfer, while the control group undergoes a sham transfer with an empty catheter during the same timeframe. The study is single-blind and involves multiple centers. During the trial, researchers will monitor pregnancy outcomes, including early pregnancy occurrence, biochemical and clinical pregnancy rates at various time points, early miscarriage rates, and live birth rates. They will also assess cost-effectiveness between the two care strategies. Participant involvement includes consent, membership in a health insurance plan, and follow-up evaluations up to and beyond the pregnancy period, with the primary outcome measured at 12 weeks of amenorrhea.

Pelvic organ prolapse is a common condition affecting 30 to 40% of women, with about 12% experiencing symptoms that impact their psychological, physical, and social well-being. Laparoscopic sacrocolpopexy is considered the surgical gold standard treatment, aiming to support the vaginal vault using a prosthesis. The procedure shows a high patient satisfaction rate of 94% and a low overall complication rate of 11%. This study focuses on evaluating the success of outpatient laparoscopic sacrocolpopexy, with or without robotic assistance, in women with symptomatic pelvic organ prolapse. The study is a national multicenter prospective trial including 80 female patients aged 40 to 80 years with significant prolapse. Patients will undergo outpatient laparoscopic sacrocolpopexy, either with or without robotic assistance. Outpatient success is defined by no need for inpatient admission within 24 hours after surgery, based on specific clinical criteria such as CHUNG score, absence of perioperative complications, and no urinary retention requiring catheter reinsertion. The surgical procedure remains the same as in hospital, but patients will return home the same day if their condition allows. Participants will be followed for one month, with a postoperative visit at 30 days to assess the effectiveness of the surgery using standard measures like POP-Q and several quality-of-life questionnaires. Researchers will monitor the success rate of outpatient treatment and the percentage of failures within the 24-hour post-surgery period. This preliminary study aims to establish a reference for successful outpatient sacrocolpopexy, potentially guiding larger trials comparing outpatient and inpatient treatments for pelvic organ prolapse.

Researchers are studying acute bronchiolitis, a common lung infection in children under two years old caused mainly by the respiratory syncytial virus RSV. The study aims to understand why it is difficult to predict how severe the infection will become by looking at the role of the microbiota gut, oral, and nasal bacteria and the immune response to RSV in affected children. This observational study includes infants under 12 months old with bronchiolitis during the RSV season. The study involves collecting samples from 80 infants with different severities of bronchiolitis, including hospitalized, non-hospitalized, and those in intensive care. Researchers will take oral, nasal, and stool samples to study the microbiota and will collect capillary or venous blood samples to analyze immune responses. These samples help identify bacterial imbalances and immune markers during infection. Participants will provide these samples once during their illness. Researchers will measure dysbiosis, immune system markers like cytokines and chemokines, viral genetics, RSV antibodies, and bacterial load. The study team monitors these factors to better understand infection severity and immune response. The study runs from December 2024 through April 2026, and participation involves only sample collection with no treatment interventions.

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.

Researchers are evaluating cannabidiol as an additional treatment during inpatient alcohol detoxification for patients with severe alcohol use disorder. This phase II randomized clinical trial aims to improve the rate of continuous abstinence at 6 weeks, which is one month after discharge from a scheduled hospital stay for alcohol withdrawal. The study also assesses safety, alcohol use reduction in case of relapse, withdrawal symptoms, anxiety, and cannabis use in patients who also use cannabis. Participants will be randomly assigned to one of three groups receiving oxazepam plus either placebo, 450 mg cannabidiol, or 900 mg cannabidiol daily for 11 days during their inpatient stay. After discharge, all groups will have follow-up visits once a week for 4 weeks to monitor abstinence and other outcomes. Blood and urine tests will be used to measure cannabidiol levels and confirm abstinence, alongside self-reported alcohol use and symptoms. During the study, participants will report daily alcohol use and symptoms from day 0 to day 10 and then weekly after discharge up to week 6. Clinical examinations and urine tests for alcohol metabolites will confirm abstinence. Researchers will also monitor side effects, withdrawal severity, anxiety, craving, sleep quality, and cannabis use. The total study duration for participants is about 6 weeks including inpatient treatment and outpatient follow-up visits.

Congenital heart defects CHD are a major cause of birth defects affecting millions worldwide, including about 41,000 newborns annually in Europe. CHD is linked with high rates of illness and death throughout life, and over half of infants with critical CHD develop neurodevelopmental disorders NDDs. These NDDs involve early disruptions in brain development affecting cognitive, emotional, and behavioral functions, often leading to challenges in language, learning, motor skills, and social interactions. The CATAMARAN neonatal cohort project seeks to detect developmental delays as early as six months in infants with CHD and to identify factors that contribute to these delays. The study includes 150 fetuses diagnosed prenatally with critical CHD requiring cardiac surgery within the first three months of life, along with their two parents. Researchers will perform neurodevelopmental assessments using the Bayley-IV test and collect various biological samples at delivery and during hospitalization for surgery. These samples include maternal and infant blood, placenta tissue, and stool for genetic, metabolomic, microbiome, and other analyses. Additional data on pregnancy, obstetric events, fetal ultrasounds, echocardiography, and parental stress levels will also be gathered. Participants will be monitored at six months of age to evaluate the prevalence and specifics of developmental delays. The study will assess how genetic factors, placental anomalies, maternal behaviors, and surgical details relate to these delays. Parents will complete questionnaires about diet and post-traumatic stress. Researchers will collect cardiovascular and developmental follow-up data, postoperative brain MRI scans, and track neonatal microbiota to better understand the origins and impacts of neurodevelopmental disorders in infants with CHD.

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.