Bondy

This research evaluates the use of the echOpen probe in managing patients referred to the Jean Verdier Rapid Diagnosis Unit UDR to see how it affects the time to diagnosis. The study focuses on improving diagnosis speed and accuracy and reducing the need for extra examinations. It is divided into three phases, each involving the introduction of the echOpen probe in different care settings, including hospital units, multi-professional health centers, and a Health Bus. The studys intervention involves using the echOpen probe for a systematic 4-point echoscopy examination that covers organs like the liver, spleen, lymph nodes, thyroid, and depending on symptoms, lung, kidney, bladder, and abdomen. The probe is CE marked and will be used alongside standard care. Each phase begins with training doctors to use the probe, followed by patient inclusions and testing the probes impact on care organization and diagnosis processes. Participants will undergo the echoscopy examination and complete satisfaction questionnaires alongside their physicians. Researchers will measure outcomes such as time to diagnosis, the number of patients with direct access to biopsy, and reduction in additional exams. Patient and physician satisfaction with the echOpen probe will also be assessed. The study includes follow-up visits up to two months after inclusion, with a total inclusion period lasting about 16 months.

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 conducting a national, multi-center observational study to understand the differences in autoimmune T and B lymphocytes among people with type 1 diabetes, other diabetes types or autoimmune conditions, and those without these diseases. The study aims to clarify how these immune cells contribute to type 1 diabetes development and to discover new biomarkers for diagnosis and treatment monitoring. This research is supported by the Institut National de la Sant Et de la Recherche Mdicale in France. Participants are grouped based on their diabetes status or autoimmune conditions, including those with type 1 diabetes, other types of diabetes, no diabetes, or those undergoing lymphadenectomy during abdominal surgery. Biological samples such as blood, stool, and lymph node tissues are collected to analyze immune cell characteristics. This study does not involve any treatment but focuses on detailed immune system profiling over six years. During the study, participants will provide biological samples and undergo evaluations to measure the frequency, phenotype, and activity of autoimmune lymphocytes. Researchers will compare immune cells in blood and pancreatic lymph nodes, identify novel autoimmune targets, and assess links between biomarkers and insulin secretion. The primary outcome is to define autoimmune T lymphocyte features related to islet antigens over six years, with secondary outcomes exploring B lymphocytes and pathogenicity. Participation involves ongoing monitoring and sample collection to better understand type 1 diabetes mechanisms.

Immune thrombotic thrombocytopenic purpura iTTP is a serious condition caused by a severe deficiency of ADAMTS13, leading to the buildup of large von Willebrand factor multimers and formation of blood vessel clots. The current standard treatment combines daily plasma exchange PEX, immunosuppressive drugs, and caplacizumab, which has shown to reduce death, complications, and the number of PEX sessions. However, PEX is invasive, time-consuming, and linked to complications, so researchers are exploring treatments without PEX to ease patient care. This study aims to evaluate the safety and effectiveness of a regimen without PEX using plasma infusion, corticosteroidsrituximab, and caplacizumab. The study replaces daily PEX with daily plasma infusions at a dose of 15 mL per kilogram of body weight, using different types of plasma such as quarantine fresh frozen plasma or inactivated plasma. This PEX-free regimen is combined with immunosuppression using corticosteroids and rituximab alongside the anti-adhesive drug caplacizumab. This approach is being tested as a single experimental treatment group for adults diagnosed with iTTP. Participants will be monitored for 30 days after starting plasma therapy to evaluate treatment outcomes. Researchers will assess the proportion of participants who experience death, treatment failure, disease worsening, or low ADAMTS13 activity below 20%. The study includes clinical and laboratory evaluations to track safety and effectiveness. The overall goal is to determine if this PEX-free regimen can provide a feasible alternative treatment for iTTP with fewer complications.

Researchers are investigating the use of Fast-MRI combined with liver ultrasound versus liver ultrasound alone for early detection of hepatocellular carcinoma HCC in patients at high risk due to cirrhosis. This study focuses on patients with an anticipated annual HCC incidence greater than 3%, aiming to evaluate cost-effectiveness and detection rates of early-stage HCC, which is crucial for curative treatments. The trial is a randomized controlled, multicenter study comparing these two surveillance methods in a high-risk population with either non-viral or controlled viral cirrhosis. Participants are randomized into two groups one receiving semi-annual liver ultrasound plus Fast-MRI, and the other receiving semi-annual liver ultrasound alone. Fast-MRI uses short imaging protocols lasting less than 10 minutes, focusing on sequences with high detection sensitivity. At each six-month visit, if either imaging detects a nodule, further characterization is performed through additional imaging or biopsy following international guidelines, with diagnosis confirmed by multidisciplinary consultation. During the study, participants undergo regular imaging tests every six months for up to three years. Researchers will measure the cost per quality-adjusted life year QALY, detection rates of very early-stage HCC, sensitivity, specificity, rates of curative treatments, survival, and compliance. Quality of life will be assessed using the EQ-5D5L scale. The study includes economic evaluations from the healthcare system perspective and considers long-term costs and benefits updated annually. Participants will be closely monitored to track outcomes and safety throughout the study period.

Researchers are conducting a global registry to monitor the long-term safety and effectiveness of Increlex therapy in children and adolescents with Severe Primary Insulin-like Growth Factor-1 Deficiency SPIGFD. This observational, non-interventional registry collects data from multiple countries including Austria, France, Germany, Italy, Poland, Spain, Sweden, the United Kingdom, and the USA. The main goal is to gather safety information during treatment and for at least five years after treatment ends. The registry includes participants who are starting, planning to start, or already receiving Increlex treatment as per local prescribing information. Increlex mecasermin is given as an injection with doses ranging from 40 to 120 mcgkg twice daily, prescribed by a physician. Data may be collected retrospectively for those already on treatment. The study tracks participants over long periods to observe treatment exposure, dose, and various health outcomes related to growth and development. Participants will be monitored for adverse events, including serious events and neoplasia, during treatment and up to five years afterward. Researchers will also assess changes in height, bone age, body mass index, pubertal stage, and quality of life. Biological markers like growth hormone and IGF-1 levels will be measured periodically. The registry collects comprehensive data on safety, effectiveness, and other health indicators to better understand outcomes in children and adolescents receiving Increlex therapy.

Researchers are conducting a multicenter genetic study to identify new genes or genetic variants linked to sudden infant death syndrome SIDS by using whole-genome sequencing of family trios. This study is part of a larger project called BIOMINRISK, which also explores neurobiology and radio-anatomical aspects. It includes both retrospective and prospective cases of sudden unexpected infant death SUDI registered in the French national registry. The study focuses on sudden unexpected infant death cases and their biological parents, forming trios for genetic analysis. Whole genome sequencing will be performed on the infant who died from SIDS and both parents to detect pathogenic variants, particularly those not inherited from the parents de novo variants. The sequencing data will be analyzed to better understand genetic factors contributing to SIDS. Participants will be involved through blood sample collection and inclusion in a biocollection. The research team will analyze genetic data to identify specific variants and potential correlations between genotypes and phenotypes over a period of up to 38 months. This observational study does not involve treatment, but closely monitors genetic markers associated with SIDS for research purposes.

The trial investigates luteal phase support strategies in women undergoing in vitro fertilization IVF or intracytoplasmic sperm injection ICSI cycles. Researchers aim to address the paradox where obtaining a large number of oocytes improves success but increases risks like ovarian hyperstimulation syndrome OHSS and implantation failure due to altered endometrial receptivity. The study evaluates a new protocol combining GnRH agonist triggering with GnRH agonist luteal phase support compared to the standard approach using hCG triggering and vaginal progesterone support. Two treatment groups are compared one receiving hCG injection before oocyte retrieval and vaginal progesterone afterward, and the other receiving a GnRH agonist Triptorelin injection before retrieval with nasal GnRH agonist Nafarelin support during the luteal phase. Both protocols begin treatment 36 to 38 hours before oocyte retrieval and continue luteal support until the first pregnancy test. The new protocol is designed to reduce OHSS risk and improve pregnancy rates by supporting the bodys own hormone production. Participants will be closely monitored through pregnancy testing and ultrasound assessments to measure outcomes such as live birth rates, embryo implantation, clinical pregnancy, miscarriage, and pregnancy complications. Hormone levels will be tracked at oocyte retrieval and during follow-up lasting up to 19 months. Safety events including OHSS and adverse outcomes will also be recorded. Women aged 18 to 39 undergoing their first or second IVFICSI attempt are involved, with the study lasting through pregnancy and delivery outcomes.

The trial investigates the impact of different antibiotic treatments on the digestive tract colonization by extended-spectrum beta-lactamase-producing Enterobacteriaceae E-ESBL in children with febrile urinary tract infections UTIs. E-ESBL bacteria are a significant public health concern due to their resistance to many antibiotics. This research compares the emergence of E-ESBL strains in stools following treatment with either intravenous amikacin or other recommended antibiotics like ceftriaxone or cefixime in young children. Participants receive treatment for febrile UTIs with either amikacin given intravenously or with usual antibiotics such as intravenous or intramuscular ceftriaxone or oral cefixime. Before starting antibiotics, an anorectal swab is taken to check for E-ESBL colonization. A follow-up swab is performed three to four days after starting treatment to assess changes in bacterial presence. Children are monitored for the presence and type of E-ESBL bacteria in their stools four days after treatment begins. Researchers also track antibiotic resistance patterns, fever resolution, side effects related to antibiotic use, and the rate of UTI relapse over one and a half months. Participation involves stool sampling and clinical evaluations during the treatment period, with the study expected to complete by mid-2026.

Researchers are investigating alcoholic hepatitis, a serious liver condition with a high short-term risk of death, especially in severe cases. This observational study aims to determine how common alcoholic hepatitis is among patients admitted with jaundice and to understand outcomes based on disease severity. The study also plans to assess survival rates, liver dysfunction markers, and to create a biobank with genetic samples to explore inflammatory and regenerative profiles. Additionally, it will evaluate non-invasive diagnostic methods for this condition. Participants will be grouped into those with alcoholic liver disease without hepatitis, those with severe alcoholic hepatitis Maddrey score 32 or higher, and those with non-severe alcoholic hepatitis Maddrey score below 32. The study involves collecting biological samples such as blood, serum, and plasma at different times, including baseline and various follow-up points up to 12 months, to analyze genetic and biochemical profiles and liver function changes. During the study, participants will undergo liver biopsy at baseline to confirm diagnosis. Follow-up assessments of liver function, including serum bilirubin, creatinine, and MELD score, will be conducted at 7 days, 30 days, 3 months, 6 months, and 12 months. Survival will be monitored for up to one year. The study will also measure diagnostic accuracy and collect data to better understand disease profiles and outcomes over time.