Bondy

Researchers are evaluating the impact of introducing the echOpen probe into the management of patients referred to the Jean Verdier Rapid Diagnostic Unit (UDR). This study aims to measure how the use of this device affects the time to diagnosis and related organizational aspects, such as diagnosis accuracy and the need for additional exams. The study is conducted in three phases, with each phase expanding the use of the echOpen probe to different healthcare settings including hospital departments, local medical practices, and a Health Bus outreach service. The study begins with training doctors to use the echOpen probe in the hospital UDR, followed by testing its added value in patient care and diagnosis efficiency. The second phase extends the use of the probe to referring structures like emergency departments and local health centers. The third phase introduces the probe in the Health Bus, aiming to differentiate urgent cases from those manageable in a mobile care setting. Each phase starts one month after the previous, with ongoing doctor training and patient inclusions. Participants will undergo a systematic 4-point echoscopy examination using the echOpen probe targeting organs such as the liver, spleen, lymph nodes, thyroid, and others depending on symptoms. Alongside standard care, patient and physician satisfaction surveys will be collected. Researchers will monitor time to diagnosis, accuracy, reduction in complementary exams, and the impact on patient pathways. The study period includes follow-up up to two months after inclusion, focusing on discharge timing and diagnostic outcomes.

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.

This research aims to characterize the autoimmune T and B lymphocytes involved in the development of type 1 diabetes (T1D) by comparing individuals with T1D, other forms of diabetes or autoimmune conditions, and those without disease. The study hypothesizes that understanding these immune cells will clarify disease mechanisms and help identify new biomarkers for diagnosis, prognosis, and treatment monitoring. Participants in this national multi-center non-interventional case-control cohort study will provide biological samples, including blood and stool specimens. For participants undergoing abdominal surgery with planned lymphadenectomy, lymph node samples will also be collected. This approach allows detailed analysis of immune cell characteristics across different groups. Participants will be followed for up to six years to measure the frequency and phenotype of autoimmune T lymphocytes reactive to islet antigens. Various assessments will include collection and analysis of biological samples and clinical information. Safety monitoring and informed consent will be strictly maintained throughout the study duration.

Immune thrombotic thrombocytopenic purpura (iTTP) is caused by a severe deficiency of ADAMTS13 due to autoantibodies, leading to harmful blood clots in small vessels. The current standard treatment combines daily plasma exchange (PEX), immunosuppressive drugs, and caplacizumab, which has helped reduce death and complications. However, PEX is invasive, time-consuming, and linked to complications, so researchers want to explore a treatment without PEX to reduce patient burden. This study evaluates a PEX-free regimen that uses daily plasma infusions (15 mL/kg/day) instead of plasma exchange, combined with corticosteroids or rituximab and caplacizumab. The plasma infusions involve quarantined or viral-inactivated plasma products. This approach aims to provide effective treatment with fewer risks and less complexity. The study is a multicenter, single-arm, non-inferiority trial assessing this combined therapy's safety and effectiveness. Participants will be closely monitored for 30 days after plasma therapy, tracking outcomes like death, treatment failure, disease worsening, or low ADAMTS13 activity. Researchers will assess how well the PEX-free regimen works compared to historical data. The study includes thorough clinical and laboratory evaluations to ensure patient safety and gather important treatment response information.

Hepatocellular carcinoma (HCC) is a common and serious form of liver cancer often developing in patients with cirrhosis caused by factors like alcohol use, metabolic syndrome, or hepatitis B or C infections. Current screening using liver ultrasound every six months detects early-stage HCC in only about 30% of cases, and about 20% are diagnosed at a later, less treatable stage. Liver MRI has shown better early detection rates but is costly and time-consuming, so abbreviated "Fast-MRI" protocols lasting less than 10 minutes are being studied as a faster and potentially cost-effective option for patients at high risk of HCC with an annual incidence above 3%. This study evaluates whether adding Fast-MRI to regular ultrasound screening improves early detection and is cost-effective compared to ultrasound alone. The study is a randomized controlled trial including patients with cirrhosis and a high risk of HCC. Participants are randomly assigned to one of two groups: one receives liver ultrasound every six months, and the other receives both liver ultrasound and Fast-MRI every six months. If either test detects a liver nodule, further diagnostic examinations including imaging or biopsy are conducted to confirm HCC. The trial will compare the rate of early-stage HCC detected and analyze the costs and quality-adjusted life years (QALYs) over a 3-year period to assess cost-effectiveness. During the study, participants will attend semi-annual visits for liver ultrasound with or without Fast-MRI depending on their group. If nodules are found, further tests will be done following international recommendations. Quality of life will be measured using standardized questionnaires, and healthcare costs will be tracked annually. The main outcome is the incremental cost per QALY gained at 36 months. This comprehensive follow-up aims to determine whether the addition of Fast-MRI improves early detection and represents a cost-effective screening strategy for high-risk patients.

Researchers are investigating whether the widespread use of GHB (gamma-hydroxybutyrate) in chemical submission cases is a myth or reality. Although national data shows GHB is involved in only a small number of drug-facilitated assaults, the substance's short detection window in blood and urine suggests it may be underreported. This study is a non-interventional, multi-center pilot research protocol focused on hair analysis to better detect GHB use in suspected victims in the Ile de France region. The study involves collecting hair samples from 200 volunteer victims who have suspected chemical submission experiences, regardless of whether they have filed complaints. Hair samples, taken between 2 and 6 months after the alleged events, undergo pre-analytical treatment and high-resolution mass spectrometry to detect GHB and other psychoactive substances. This approach aims to overcome the limitations of traditional testing methods by analyzing hair, which retains evidence of substance use longer. Participants provide information about their history and voluntary drug use during an interview before hair sampling. The study measures evidence of GHB intake through hair analysis and compares these findings with survey histories to evaluate the presence of chemical submission agents. The research also explores the usefulness of hair analysis for detecting drug-facilitated assaults. Participation is risk-free and does not affect medical care, with results contributing to improved prevention strategies.

Researchers are monitoring the long-term safety and effectiveness of Increlex4, a treatment for children and adolescents with Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD). This global registry study is observational and non-interventional, designed to collect safety data during treatment and for at least five years after treatment ends. The study includes participants who have already started Increlex4 therapy as well as those beginning treatment, across various countries including the USA and several European nations. Participants receive Increlex4, a mecasermin injection given twice daily at doses ranging from 40 to 120 mcg/kg or 0.04 to 0.12 mg/kg, as prescribed by their physician. The study does not assign treatments but records data from patients undergoing routine care. This registry captures real-world use of Increlex4 according to local approved guidelines for managing SPIGFD. Throughout the study, researchers collect information on serious adverse events, any adverse events, deaths, and withdrawals related to treatment. Data collection continues during the treatment period and up to 30 days after the last dose. Safety monitoring is the primary focus, with long-term follow-up planned for at least five years post-treatment to assess ongoing health outcomes in children and adolescents receiving Increlex4 therapy.

Researchers are conducting a multicenter genetic study to find new genes or variants linked to sudden infant death syndrome (SIDS) by analyzing whole-genome sequencing data from family trios. This study is part of a larger project called BIOMINRISK, which also looks at neurobiology and radio-anatomical aspects related to sudden unexpected infant death (SUDI). The study includes both past cases registered in the French SUDI registry and new cases identified at participating referral centers. The study involves whole genome sequencing of infants diagnosed with SIDS and their biological parents, forming trios for analysis. This sequencing examines all coding and non-coding regions of the genome to detect harmful genetic variants. Data analysis focuses on identifying new genetic changes present in the infant but absent in either parent. The research is open-label and non-randomized, involving 15 centers nationally. Participants and their families will provide biological samples and consent for inclusion in a biocollection. Researchers will monitor genetic variants over a period of up to 38 months. Data from post-mortem exams confirm SIDS diagnosis before sequencing. The study focuses on identifying genetic risk factors and involves careful oversight of genetic data and family participation within the BIOMINRISK project framework.

Researchers are studying women undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) to improve pregnancy success rates while reducing risks like ovarian hyperstimulation syndrome (OHSS) and implantation failure. The study compares a new approach using GnRH agonist triggering combined with GnRH agonist luteal phase support to the standard method of hCG triggering with vaginal progesterone support. The goal is to increase ongoing pregnancy rates per cycle by optimizing ovulation triggering and luteal phase support. Two treatment protocols are being evaluated. One group receives ovulation induction with hCG followed by vaginal progesterone for luteal support. The other group receives ovulation triggering with a GnRH agonist (Triptorelin) and nasal luteal phase support with Nafarelin. Ovulation triggering occurs 36 to 38 hours before oocyte retrieval, and luteal support starts from the evening of oocyte retrieval until the pregnancy test. This is a phase 3 randomized controlled trial comparing these two strategies. Participants will be carefully monitored through the IVF/ICSI cycle with ongoing assessments to track pregnancy success defined by live birth after 22 weeks of gestation. Researchers will evaluate hormone levels, ovarian response, and pregnancy outcomes. The study involves follow-ups until pregnancy tests and monitoring for safety and efficacy throughout the treatment cycle. The total participation duration corresponds to the IVF/ICSI cycle and early pregnancy assessment.

Researchers are investigating treatments for hepatocellular carcinoma (HCC), a common and deadly form of liver cancer. This phase II trial explores the combination of Atezolizumab and Bevacizumab with percutaneous thermal ablation to reduce the risk of cancer recurrence. The study builds on previous findings suggesting that combining vascular endothelial growth factor (VEGF) and programmed death-ligand 1 (PD-L1) blockade may benefit patients with HCC, particularly after ablation treatment for small tumors. Participants will be randomly assigned to receive either the standard percutaneous radiofrequency ablation (RFA) alone or a combination treatment involving neoadjuvant Atezolizumab, followed by RFA, then adjuvant Atezolizumab plus Bevacizumab. Atezolizumab is given intravenously every three weeks for two cycles before ablation and up to 15 cycles afterward, while Bevacizumab is administered intravenously every three weeks for up to 15 cycles. The ablation procedure uses approved radiofrequency devices but excludes microwave ablation or irreversible electroporation. Throughout the study, participants will undergo imaging assessments and laboratory tests, including MRI scans and blood work, to measure treatment effects and liver function. Researchers will monitor recurrence-free survival over two years following randomization. The study aims to enroll 202 patients across multiple centers, with a recruitment period of 36 months and a follow-up period lasting five years to gather long-term safety and effectiveness data.