Clamart

Researchers are studying acute pyelonephritis (AP), a common bacterial kidney infection in children, focusing on those aged 1 month to less than 3 years without prior urological malformations. The study compares a short 3-day intravenous (IV) antibiotic treatment alone to a 3-day IV treatment followed by 7 days of oral antibiotics. The goal is to see if the shorter IV-only treatment is as effective at preventing infection recurrence and long-term kidney scarring, while possibly reducing antibiotic resistance and preserving gut microbiota diversity. Participants receive either IV ceftriaxone and/or amikacin once daily for 3 days, or the same 3-day IV treatment followed by 7 days of oral cotrimoxazole or cefixime. The study includes procedures like procalcitonin testing and fecal or rectal swabs collected at several points during and after treatment (day 0, 3, 10 or 17, and 31 or 38) to monitor bacterial presence and gut microbiota changes. Treatment begins after initial confirmation of infection and favorable early response. During the study, children are closely monitored for infection recurrence 28 days after completing antibiotics. Assessments include clinical evaluations, urine cultures, and monitoring for any adverse effects. The total participation covers treatment and follow-up periods to ensure safety and measure outcomes such as infection recurrence and bacterial resistance. This is a Phase 4 open-label randomized trial conducted across multiple centers.

Researchers are evaluating whether an investigational drug called OHB-607 can prevent Bronchopulmonary Dysplasia (BPD), a common chronic lung disease, in extremely premature infants. The study compares infants receiving OHB-607 alongside standard neonatal care to those receiving standard care alone to reduce the burden of this lung condition. This is a Phase 2b, multicenter, randomized, open-label study focused on safety and clinical efficacy. Participants will receive an intravenous infusion of OHB-607 from birth until reaching a postmenstrual age (PMA) of 29 weeks and 6 days. The study includes two arms: one group receives the investigational drug plus standard care, while the other group receives only standard neonatal care. The treatment period ends at 29 weeks plus 6 days PMA, after which infants are monitored. Throughout the study, researchers will track the incidence of severe BPD or death up to 36 weeks PMA, whichever occurs first. Assessments will include clinical evaluations and monitoring for safety and any side effects. The study also involves long-term follow-up to observe the infants' health outcomes beyond the treatment period. Participation involves consent from parents and collection of birth and medical history information.

Researchers are investigating the effects of delaying radiotherapy in patients with low-grade oligodendrogliomas that have 1p/19q codeletion and IDH mutation. These patients often live a long time but risk cognitive decline when treated with immediate radiotherapy plus PCV chemotherapy. The study aims to see if postponing radiotherapy until tumor progression reduces neurocognitive deterioration without affecting overall survival, in a phase 3 randomized trial. Participants will be assigned to one of two treatment groups: one group will receive six cycles of PCV chemotherapy alone, while the other group will receive radiotherapy delivering 50.4 Gy in 28 fractions using IMRT followed by six cycles of PCV chemotherapy. Each cycle of PCV includes oral CCNU on day 1, intravenous vincristine on days 8 and 29, and oral procarbazine from days 8 to 21. Treatments will be carefully administered and monitored throughout the study. During the study, participants will undergo neurocognitive assessments and quality of life evaluations to monitor changes over time. Researchers will measure survival without neurocognitive deterioration over a nine-year period. Laboratory tests, imaging studies, and clinical examinations will be performed as needed to assess safety and disease progression. The study will also track adherence to treatment and follow participants long term to evaluate outcomes and side effects.

Researchers are studying the treatment LTP001 in two groups: healthy adults (Part A) and adults with pulmonary arterial hypertension (PAH) (Part B). The study aims to evaluate the safety, tolerability, and how the body processes LTP001 in healthy volunteers, and to assess the safety and effectiveness of LTP001 in participants with PAH. This trial includes a safety extension period for participants with PAH to monitor longer-term effects. In Part A, healthy adult participants will receive single and multiple ascending doses of LTP001 or placebo to assess safety and pharmacokinetics. Part B involves participants with confirmed PAH who will receive LTP001 or placebo alongside their standard PAH treatments. The study monitors participants from baseline through various treatment periods, including a treatment period of up to 106 weeks in Part B for long-term safety assessment. Participants will undergo evaluations including monitoring for adverse events and serious adverse events from baseline through Day 35 in Part A and through Week 106 in Part B. The study also measures changes in pulmonary vascular resistance (PVR) during Part B at Week 24. Assessments include physical exams, ECGs, and walking tests to evaluate heart and lung function. Researchers will track safety, efficacy, and tolerability throughout the study duration.

Researchers are investigating whether transferring a "blank" culture medium into the uterus a few days before a frozen embryo transfer can improve embryo implantation and pregnancy success in women undergoing in vitro fertilization (IVF). This study focuses on patients who have experienced pregnancy failure after a previous fresh or frozen embryo transfer. The goal is to enhance immune tolerance in the uterus to improve clinical pregnancy rates without increasing multiple pregnancies. The trial compares two procedures: one group receives a "blank" culture medium transfer, where a small amount of embryo culture medium is inserted into the uterine cavity two to three days before the frozen embryo transfer. The other group undergoes a sham transfer using an empty catheter at the same timing. The study is randomized, single-blind, and conducted across multiple centers. Participants' involvement includes undergoing these transfer procedures and subsequent frozen embryo transfers. Researchers will monitor pregnancy outcomes, specifically the clinically progressive pregnancy rate at 12 weeks of amenorrhea. Participants must provide informed consent and be covered by health insurance. The study also monitors for any pregnancy failures following the embryo transfers.

Pelvic organ prolapse is a common condition affecting 30 to 40% of women, with about 12% experiencing symptoms that impact their physical, psychological, and social well-being. Laparoscopic sacrocolpopexy, which uses a prosthesis to support the vaginal vault, is considered the surgical gold standard with a high patient satisfaction rate of 94% and a low complication rate of 11%. This research aims to evaluate the success of outpatient laparoscopic sacrocolpopexy with or without robotic assistance in treating symptomatic pelvic organ prolapse in women aged 40 to 80. The study includes two intervention groups: outpatient laparoscopic sacrocolpopexy performed with robotic assistance and without robotic assistance. The goal is to assess the feasibility and success rate of outpatient treatment, defined as not requiring hospital admission within 24 hours after surgery. Participants will undergo these procedures at specialized centers as part of a national multicenter prospective study involving 80 female patients. Participants will be followed for one month after surgery, with assessments at 30 days to evaluate the effectiveness of the surgical technique using standard measures like POP-Q and several quality-of-life questionnaires. Researchers will monitor outpatient treatment success, complications, and patient recovery, aiming to provide data to support outpatient care as a standard for this surgery. Safety and surgical success will be closely observed during this period.

Acute bronchiolitis is a common illness affecting children under two years old, mainly caused by the respiratory syncytial virus (RSV). It is often hard to predict how severe the infection will be when symptoms first appear. Some studies suggest that the body's microbiota, including the intestinal, oral, and nasal bacteria, as well as the immune response to RSV, play important roles in the disease course. This study involves 80 children under 12 months old who have bronchiolitis during the RSV epidemic season. Both hospitalized and non-hospitalized children will be included. Researchers will collect a single set of samples from the mouth, nose, and stool to study the microbiota and look for imbalances called dysbiosis. A small blood sample will also be taken to examine the immune response. Participants will be monitored through these samples to assess the presence of dysbiosis and immune factors related to bronchiolitis. The study focuses on understanding the relationship between microbiota changes and how the immune system reacts during bronchiolitis. This information may help improve future care and management for infants with this condition.

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 use of cannabidiol (CBD) as an add-on treatment during inpatient alcohol detoxification to help improve abstinence in patients with severe alcohol use disorder. This phase II, double-blind, randomized clinical trial aims to increase the rate of continuous abstinence at week 6 of the study, which is one month after discharge from the scheduled alcohol withdrawal inpatient stay. The study also assesses safety, reduction in alcohol use in case of relapse, withdrawal symptoms, anxiety symptoms, and cannabis use among patients who also use cannabis. Participants are randomized into three groups, each receiving oxazepam plus either a placebo, 450 mg of cannabidiol per day, or 900 mg of cannabidiol per day for 11 days during their inpatient stay. The inpatient stay typically lasts between 11 and 17 days. After discharge, all groups have weekly follow-up visits for up to six weeks to monitor if abstinence is maintained. In addition, a subgroup of patients will have blood tests to measure CBD levels and cannabinoid analysis if they are cannabis users. During the study, patients complete daily and weekly assessments including self-reported alcohol use using standardized timeline follow-back scales, withdrawal and craving scales, anxiety scales, sleep quality questionnaires, and side effect checklists. Urinary tests for alcohol metabolites and cannabinoids are performed multiple times during inpatient stay and follow-up. Researchers monitor clinical signs of intoxication and record any relapses or changes in substance use. The total duration of participation extends up to six weeks after discharge from inpatient care.

Congenital heart defects (CHD) are a major cause of birth defects affecting millions worldwide, including about 41,000 newborns each year in Europe. This study focuses on infants with critical CHD who often face neurodevelopmental disorders (NDD), which impact cognitive, emotional, and behavioral development. These disorders can affect language, learning, motor skills, social abilities, and more, significantly influencing quality of life beyond heart issues. Researchers aim to detect developmental delays as early as six months of age and understand factors contributing to these neurodevelopmental challenges. The study involves several assessments and sample collections. Infants will undergo neurodevelopmental evaluation using the Bayley-IV test administered by a neuropsychologist. Biological samples from the mother, father, infant, placenta, and meconium will be collected at various times around delivery and surgery to analyze genetic, metabolic, and other markers. Questionnaires about maternal diet, lifestyle, and stress will also be completed. Additionally, cardiovascular and developmental follow-up data, fetal ultrasounds, echocardiography, and postoperative brain MRIs will be gathered. Participants will be monitored up to six months of age to evaluate developmental outcomes, particularly the prevalence of delays. Researchers will collect detailed clinical and biological data to explore potential causes and risks for NDDs in infants with CHD. The study requires consent from both parents and includes support for families while tracking developmental progress and health through scheduled assessments and sample analyses.