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Found 4 Actively Recruiting clinical trials
Actively Recruiting
Food Protein Induced Enterocolitis Syndrome (FPIES) is a non-IgE mediated food allergy that mainly appears in infancy and can cause severe vomiting, diarrhea, and dehydration. This condition is often unfamiliar to many clinicians, and its diagnosis relies on specific clinical criteria established in 2017. This study aims to collect detailed clinical information and allergy test results for children diagnosed with acute FPIES and to describe its progression and atypical forms over three years in a French population. The study will include children aged 0 to 17 years with confirmed acute FPIES, diagnosed either by the 2017 JACI clinical criteria or by oral food challenge. Allergy tests such as oral food challenges, skin prick tests, and IgE blood tests will be used to monitor patients. Participants will be seen by allergologists at the start and annually for three years. If tolerance to the offending food is not acquired, an oral food challenge will be conducted in a hospital setting to evaluate resolution. This multicenter French prospective study will gather data on FPIES evolution, including the development of IgE sensitization and clinical symptoms of IgE-mediated allergy. Throughout the study, children will undergo clinical evaluations and allergy testing at inclusion and yearly follow-up visits. Researchers will assess tolerance acquisition over an average of six years, monitor multiple FPIES cases, and record personal atopic conditions. The study will last three years for inclusion and three years of follow-up per patient, aiming to improve management of FPIES in France by understanding its unique food triggers and long-term outcomes.
Actively Recruiting
Autism spectrum disorder (ASD) is a neurodevelopmental condition that begins early in childhood. It is marked by ongoing challenges in communication and social interaction, along with restricted and repetitive behaviors or interests. These symptoms affect areas like social life and schooling and are not caused by intellectual disability or global developmental delays. The study aims to better understand sensory experiences in children with ASD as they watch videos on screens and to explore a new therapeutic approach using videodrama sessions. Children in the experimental group will participate in 18 weekly videodrama sessions. Each session includes welcoming the child, watching a video excerpt (either in slow motion or normal speed), playtime, drawing activities, and a group closing session. The play and drawing materials are standardized and include small figurines, animals, shapes, plush toys, markers, colored pencils, and paper. This approach is designed to engage children with ASD in ways that may help improve their play and social interaction skills. During the study, researchers will assess participants using the Dunn Sensory Profile questionnaire at 9 months to evaluate sensory processing. The study involves children aged 3 to 15 years with a confirmed diagnosis of ASD who have a strong interest in screens or video content and can tolerate being around other children. Parents or legal guardians provide consent, and children are expected to complete all 18 videodrama sessions. The study also monitors adherence and collects data related to the children's sensory and social responses throughout the intervention period.
Actively Recruiting
Researchers are evaluating the effectiveness of arginine-vasopressin (AVP) combined with hydrocortisone compared to norepinephrine in improving survival and neurological recovery 30 days after cardiac arrest in patients with hemodynamic failure. This phase 3 trial focuses on patients who have experienced post-resuscitation syndrome, which includes multiple organ failures and brain damage following successful resuscitation and restoration of spontaneous circulation after cardiopulmonary resuscitation. Patients are randomly assigned to receive AVP, hydrocortisone, their placebos, or a combination, in a 1:1:1:1 ratio. AVP is given by infusion to maintain a target mean arterial pressure of 65 mmHg for up to 3 days. Hydrocortisone is administered intravenously, starting with a 100 mg dose followed by 50 mg every 6 hours for 7 consecutive days, without tapering. The study involves 17 intensive care units in France and plans to enroll 380 patients. Participants will be closely monitored with evaluations including neurological outcomes measured at day 30. Researchers will assess survival and brain function recovery. The study also monitors safety and treatment adherence during the intervention period and follows patients through the critical post-resuscitation phase to capture relevant clinical outcomes.
Actively Recruiting
Researchers are investigating the effects of preoperative immunomodulation using Oral Impact®, a nutrient-enriched dietary supplement, on reducing postoperative complications in patients undergoing major urological surgeries such as cystectomies and nephrectomies. While Oral Impact® has shown benefits in gastrointestinal, ENT, gynecological, and cardiac surgeries by modulating immune and inflammatory responses, evidence in major urological surgery is currently lacking. This study aims to evaluate whether Oral Impact® can decrease complications and shorten hospital stays in this specific patient group, addressing issues related to malnutrition and surgical stress. Participants will be divided into two groups: one group will receive a 7-day course of Oral Impact® before surgery, while the control group will not receive any intervention. The study focuses on the preoperative period to improve patients' nutritional and immune status to better handle surgical stress. The use of Oral Impact® includes immune-modulating nutrients such as arginine, omega-3 fatty acids, nucleic acids, vitamins, and antioxidants. Postoperative management may include nutritional rehabilitation and, if necessary, supplementation with 20% reduced albumin to correct hypoalbuminemia. During the study, patients will be monitored for major postoperative complications over a 3-month period. Assessments will include clinical evaluations, nutritional status, and length of hospital and ICU stays. Researchers will track complications related to immune deficiency, infections, and recovery progress. The goal is to measure the rate of major postoperative complications and understand the potential benefits of preoperative Oral Impact® immunomodulation in urological surgery patients.