Thionville

This research investigates the use of ultrasound techniques to guide treatment in adults with heart failure who are seen in outpatient settings. The study aims to evaluate whether managing heart failure using pulmonary ultrasound and inferior vena cava assessments can improve a combined clinical and biological outcome within 30 days, including changes in natriuretic peptide levels. It also explores the impact of this guided approach on risks of cardiovascular death and hospitalization. Participants are randomly assigned to one of two groups one receiving heart failure treatment guided by lung and inferior vena cava ultrasound results, and the other receiving usual care without ultrasound guidance. The choice of treatment modifications is left to the investigators following European guidelines. The study is open-label and conducted across multiple centers. During the study, participants will have ultrasound assessments and blood tests to measure natriuretic peptides at the start and after 30 days. Researchers will also evaluate clinical signs of congestion and track events such as cardiovascular death or hospitalization within 30 days. Patients will be regularly monitored to assess changes in ultrasound congestion and corresponding biomarkers throughout the study period.

Researchers are studying patients with community-acquired pneumonia who need oxygen therapy due to acute respiratory distress and low blood oxygen levels. This research aims to see if placing patients in a prone position lying face down while they receive nasal high flow oxygen can reduce the need for intubation and improve outcomes. The study particularly excludes patients with COVID-19 and focuses on non-COVID pneumonia cases. Participants will be randomly assigned to one of two groups. One group will be encouraged and assisted to lie in the prone position for at least 8 hours per day in multiple sessions, aiming for up to 16 hours if tolerated. The other group will receive usual care with nasal high flow oxygen therapy but no prone positioning. Both groups will have oxygen levels monitored and care adjusted to maintain target oxygen saturation. During the study, patients will be observed for intubation rates within 28 days, comfort levels during prone positioning, oxygenation changes, time to escalation of breathing support, and overall outcomes including mortality up to 90 days. Safety measures like skin and infection monitoring will also be recorded. Quality of life will be assessed at 90 days and 5 years, with nursing workload tracked within the first day after randomization.

Researchers are studying children under 16 years old with spinal muscular atrophy SMA who are treated with therapies that restore SMN protein, such as nusinersen, risdiplam, or onasemnogene abeparvovec. The goal is to describe new types of SMA in these treated patients over two years, evaluate tools used to monitor the disease, and collect information on the overall costs associated with SMA in France. Participants receive SMN restoring therapies and are followed for two years with regular assessments every six months. These evaluations include muscle function tests, cognitive assessments, cardiac checks, MRI scans when possible, fatigue and activity monitoring, bulbar function tests, body composition and metabolism measurements, questionnaires on quality of life, and optional blood and cerebrospinal fluid sample collections. The study tracks disease progression at muscular, cognitive, orthopedic, respiratory, metabolic, cardiac, and bulbar levels. During the study, participants undergo various tests and questionnaires at multiple time points from the start up to 24 months. These include muscle strength measurements, developmental and behavioral assessments, heart exams, body scans, fatigue monitoring, swallowing evaluations, and quality of life surveys. Optional biological samples are collected periodically. The study carefully records disease markers and functional changes while monitoring participants wellbeing and impact on families throughout the two-year period.

Researchers are investigating the use of Trastuzumab deruxtecan T-DXd in adults with unresectable or metastatic HER2-low and HER2-ultralow breast cancer. This includes patients who have previously received chemotherapy for metastatic breast cancer or have hormone receptor-positive disease treated with endocrine therapy but are unsuitable for further endocrine treatment. The study aims to understand treatment effectiveness, patient characteristics, and experiences in a real-world setting through a non-interventional approach. Participants will be observed while receiving either T-DXd or conventional chemotherapy as part of their routine care, without any drug administration by the study itself. The study includes two groups one with patients having HER2-low breast cancer treated with T-DXd after prior chemotherapy, and another with hormone receptor-positive, HER2-low or HER2-ultralow breast cancer patients treated with either T-DXd or conventional chemotherapy but not prior chemotherapy for metastatic disease. Data will be collected on treatments, side effects, and management of adverse drug reactions. During the study, participants demographic and clinical data, treatment patterns, tolerability, and quality of life will be monitored over approximately 37 months. Assessments include the time to next treatment, treatment discontinuation, physician-reported safety events, patient-reported tolerability, quality of life questionnaires, and symptom diaries. This long-term observation will help evaluate real-world outcomes and patient experiences with T-DXd and conventional chemotherapy in this population.

The research focuses on childbirth, a significant event for women, aiming to assess maternal satisfaction during delivery and postpartum. The study explores how different epidural anesthesia approaches impact womens childbirth experiences, recognizing that negative birth experiences can lead to psychological and physical issues like postpartum depression and chronic pelvic pain. This observational study compares conventional epidural methods to newer ambulatory epidural techniques using modern pharmacological protocols. Participants will be observed during two periods before and after changes in epidural practice. In the before period, women receive conventional epidural anesthesia with local anesthetics and opioids. In the after period, an ambulatory epidural is used, involving lower doses that allow patients to walk while monitored. Both groups follow department protocols. Women complete the Childbirth Assessment Questionnaire QEVA 2 days after birth and again 4 weeks postpartum to provide feedback on their delivery and postpartum experience. During the study, participants childbirth experiences are captured by the QEVA questionnaire administered in hospital and via phone. Researchers assess maternal satisfaction, relationships with nursing staff, early mother-child bonding, and safety factors such as delivery room time, instrumental extraction needs, emergency cesarean rates, spontaneous urination ability, and ambulation safety. The study spans from delivery through 4 weeks postpartum, gathering detailed feedback and safety data to evaluate the impact of epidural techniques on maternal outcomes.

Researchers are investigating the use of fecal microbiota transplantation FMT capsules as a way to clear multi-drug resistant and extensively drug-resistant Gram-negative bacteria MDR-GNB from the gut. These bacteria are a serious global health threat because they increase the risk of infections and spread easily in healthcare and community settings. This phase III randomized controlled trial aims to see if FMT capsules can effectively decolonize patients carrying carbapenem-resistant or extended-spectrum beta-lactamase producing Enterobacteriaceae, which currently have limited treatment options. The study compares two groups one receiving FMT capsules made from healthy donor stool processed and frozen into capsules, and the other receiving placebo capsules containing only the solution used in FMT preparation. Participants will take 50 capsules in one day. This capsule form helps reduce side effects and supports outpatient treatment. The trial will assess the effect of FMT capsules versus placebo on bacterial decolonization and infection prevention over time. Participants will be monitored through stool cultures taken at the start, 30 days, and 90 days after treatment to check for bacterial clearance. Secondary assessments will track infection rates, safety, and tolerability for up to two years. The study includes detailed monitoring of microbiological and clinical outcomes, with the primary measure being clearance of MDR-GNB at 30 days post-randomization. The total follow-up may extend to two years to evaluate long-term effects and safety.

Researchers are evaluating two different locoregional anesthesia techniques to manage postoperative pain and aid recovery after a midline laparotomy, a type of abdominal surgery. This randomized controlled trial compares the commonly used epidural analgesia with a newer method called bilateral rectus sheath block. The study aims to understand how these pain relief methods influence patients quality of recovery after surgery, measured by the Quality of Recovery-15 score. Participants are randomly assigned to one of two groups one receiving thoracic epidural analgesia, where a catheter is placed in the epidural space to deliver local anesthetic, and the other receiving bilateral rectus sheath block under ultrasound guidance, with anesthetic delivered via catheters on both sides of the abdomen. Both groups undergo the same type of abdominal surgery, and the treatments are part of a multimodal pain management approach during and after surgery. During the study, patients will be monitored for changes in recovery quality on postoperative days 1, 2, and 3, as well as the day before surgery. Assessments include pain control effectiveness, blood pressure effects, nausea, complications related to the analgesic technique, length of hospital stay, bowel function, morphine use, and patient satisfaction up to 30 days after surgery. Catheter placement success, mobility, and other postoperative events are also tracked to understand the impact of each anesthesia method on rehabilitation.

Researchers are studying how gadolinium contrast agents Gd-CAs, used in MRI scans, are removed from the body through urine. Gadolinium is a rare earth element that is toxic in its isolated form but is safely used in complex molecules during MRI imaging. This study aims to describe the urinary excretion patterns of these agents to explore ways of recovering gadolinium and prevent environmental contamination. Participants with a prescription for MRI involving gadolinium contrast agents will have urine samples collected before the injection and multiple times up to two and a half hours after the injection. Blood samples are also collected before the injection. The focus is on measuring how much gadolinium is excreted in the urine shortly after MRI scans. During the study, participants will provide urine and blood samples around their MRI appointment. Researchers will assess kidney function, urine volume, and the timing of the first spontaneous urination after injection. They will also monitor study refusal rates and premature exits. The study continues until April 2028, with primary measurements taken within two and a half hours post-injection.

Researchers are exploring the use of transcutaneous auricular vagus nerve stimulation taVNS to help adolescents with non-suicidal self-injury NSSI disorder, a behavior involving intentional self-harm without suicidal intent. NSSI is common among adolescents and has increased during the COVID-19 pandemic. This study aims to understand if taVNS, which stimulates the vagus nerve and may influence stress hormone production, can improve the regulation of the stress response and reduce self-injury frequency in this population. Participants will use a device called TENS ECO PLUS with a vagus nerve ear electrode for taVNS treatment at home. The treatment involves daily stimulation sessions of 10 minutes twice a day or 20 minutes once a day for 8 consecutive weeks. The study includes an initial inclusion at week 0, treatment from week 2 to week 10, and follow-up until week 22. The main focus is to assess how well adolescents stick to this treatment schedule. Throughout the study, participants will be monitored for adherence to the treatment, frequency of self-injury episodes, anxiety and depression levels, and any adverse effects. Their experiences with taVNS will be collected at week 10. Follow-up assessments will continue up to 22 weeks after inclusion to evaluate long-term effects and safety. The study aims to provide insight into the feasibility of this home-based neurostimulation for adolescents with NSSI.

Researchers are investigating the complex relationships between trauma, substance use, migration experiences, and mental health perceptions among vulnerable young adults living in Transitional Housing in France. The study, called ATICC, uses a mixed-methods approach to understand risk factors, barriers to healthcare access, and the impact of group interventions on psychological well-being and attitudes toward mental health care. This research aims to develop culturally adapted prevention and support programs for this population. The study includes three parts a cross-sectional survey to identify risk factors using standardized questionnaires qualitative interviews with a subset of participants who use substances to explore their personal experiences and a longitudinal intervention involving focus groups called Well-Being Coffee Group. These groups meet in person or via videoconference, led by a psychologist, to discuss topics such as identity, substance use, migration, and mental health. Participants complete evaluations before and after the intervention to assess changes. During the study, participants will be assessed using questionnaires and interviews to measure attitudes toward mental health care, anxiety, depression, and substance use over six months. Data will be analyzed with advanced statistical methods to understand the interventions effects. The study includes quality assurance processes to ensure ethical compliance and data accuracy. Participant confidentiality is maintained through anonymized data and GDPR-compliant procedures. The total study duration includes repeated assessments and follow-up to track psychological and behavioral changes.