Thionville

Researchers are evaluating the impact of using pulmonary ultrasound and inferior vena cava assessment to guide treatment in patients with heart failure who are seen in outpatient settings. This open-label, randomized clinical trial aims to understand how this ultrasound-guided management affects a combined clinical and biological outcome, including changes in natriuretic peptides (NtProBNP), death, and hospitalization within 30 days. Participants will be randomly assigned to either receive treatment guided by lung and inferior vena cava ultrasound results or to usual care without ultrasound guidance. The choice of treatments to address congestion is left to the investigators following European guidelines. The study includes evaluating ultrasound signs of congestion and comparing them with clinical signs and natriuretic peptide levels at baseline and 30 days. During the study, participants will be monitored for death, hospitalizations for heart failure, and changes in NtProBNP over 30 days. Researchers will also assess the presence of ultrasound-detected congestion, its association with natriuretic peptides, and differences between the intervention and control groups. This follow-up will include clinical examinations and ultrasound assessments to evaluate treatment effects and safety.

Researchers are studying adults with community-acquired pneumonia who need oxygen therapy due to acute respiratory failure meeting acute respiratory distress syndrome (ARDS) criteria. This condition often leads to tracheal intubation and poor outcomes. Previous studies showed that prone positioning reduces mortality in invasively ventilated ARDS patients and improves oxygenation in non-intubated patients with viral pneumonia, including COVID-19 cases. This trial focuses on patients with non-COVID community-acquired pneumonia using nasal high flow therapy, aiming to see if awake prone positioning can reduce the need for intubation and related treatments like sedation and muscle relaxation. Participants will be encouraged to spend as much time as possible in the prone position, ideally 4 to 8 hours per session, with a goal of up to 16 hours or more within each 24-hour period, depending on their tolerance. This intervention is compared to usual care without prone positioning. The study excludes patients with recent COVID-19 infection or those requiring immediate intubation. During the study, researchers will monitor patients for up to 28 days after randomization, focusing on whether they require intubation. Participants will be admitted to an intensive care or intermediate care unit, and their oxygen levels will be closely assessed using the PaO2/FiO2 ratio or equivalent SpO2/FiO2 measurements. Consent and social security affiliation are required. Safety and effectiveness of awake prone positioning in reducing intubation needs will be evaluated throughout the study period.

Researchers are studying children under 16 years old with infantile or juvenile spinal muscular atrophy (SMA) who are treated with therapies that restore SMN protein, such as nusinersen, risdiplam, or onasemnogene abeparvovec. They aim to describe new disease patterns emerging due to these treatments and to assess tools that could be useful for monitoring patients routinely or in future clinical trials. The study also plans to analyze the total costs related to SMA to support a prospective economic study in France. The study involves multiple evaluations over a two-year period, including muscle function tests like Myogrip and Myopinch, cognitive assessments (Vineland-II, Bayley-4, and others), cardiac examinations (ECG, ultrasound, Holter monitoring), MRI scans, and assessments of activity, muscle fatigue, bulbar function, body composition, and metabolism. Participants will wear activity trackers, complete questionnaires related to quality of life and disease impact, and may opt into blood and cerebrospinal fluid sample collection. Tests are scheduled at different points including baseline (Day 0), months 1, 6, 12, 18, and 24. Participants will undergo comprehensive monitoring including physical, cognitive, respiratory, orthopedic, metabolic, and quality of life assessments throughout the study. This includes repeated clinical tests, imaging, questionnaires, and bio-collections at specified intervals. Researchers will track markers of disease progression and new phenotype descriptions at these time points to better understand changes in SMA patients receiving SMN-restoring treatments. The total involvement lasts two years, with detailed follow-ups every six months and some additional assessments at one month and eighteen months.

This research focuses on patients with heart failure who have received remote monitoring after hospitalization at the CHR Metz-Thionville since 2020. Heart failure significantly affects quality of life and leads to many hospitalizations yearly, especially among those over 60. The study aims to describe patient adherence to remote monitoring and understand factors influencing it, highlighting the importance of timely monitoring given delays in consultations and hospital admissions. The study involves collecting retrospective data from patient records and telemonitoring software, along with prospective semi-structured telephone interviews for patients whose follow-up is ongoing or recently interrupted. Patients will be monitored for 12 months or until their follow-up ends. Those with interruptions shorter than a month will be contacted by a healthcare professional for an interview after giving oral consent. Participants will provide information through medical records and interviews. Researchers will assess socio-demographic and clinical characteristics, monitor adherence to remote monitoring, and examine reasons for interruptions. The main outcome measured is the time until a break in remote monitoring, tracked for up to four years after starting telemonitoring. This approach helps to better understand patient behavior and improve telemonitoring adaptation.

Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.

Childbirth is a significant event for women, and their satisfaction with this experience is very important. Negative childbirth experiences can lead to serious emotional and physical issues like postpartum depression, weakened mother-baby bonding, and chronic pelvic pain. Over time, childbirth has shifted toward being more natural while maintaining pain relief and safety. This research aims to study the effects of an ambulatory epidural approach, which has been less studied recently with current recommended drug protocols. This study is a multi-center prospective observational analysis comparing two periods: the "before" period where women receive a conventional epidural and the "after" period where women receive an ambulatory epidural. Women will complete a Childbirth Assessment Questionnaire (QEVA) 2 days after delivery while still in the hospital and again 4 weeks postpartum by phone to assess their satisfaction and postpartum feelings. Participants will be women with physiological pregnancies who have had either type of epidural depending on the period. Data collection includes the QEVA questionnaire and monitoring labor and delivery experiences up to 2 days postpartum. The study will measure maternal satisfaction and emotional well-being after childbirth while observing safety and care practices in these two epidural approaches.

Researchers are investigating whether fecal microbiota transplantation (FMT) using frozen capsules can help remove multi-drug resistant Gram-negative bacteria (MDR-GNB) from carriers. These bacteria pose a serious health threat by increasing infection risks and spreading resistance in healthcare and community settings. This phase III randomized controlled trial aims to compare the effectiveness of FMT capsules versus placebo capsules in decolonizing patients carrying carbapenem-resistant or extended-spectrum beta-lactamase-producing Enterobacteriaceae. Participants will receive either FMT capsules containing frozen fecal matter or placebo capsules made of the cryoprotectant solution. The fecal matter is processed and stored frozen to maintain bacterial viability and then encapsulated for oral intake. Capsules are designed to be taken orally, avoiding more invasive delivery methods, and stored at -80°C until use. The study uses a placebo-controlled design to evaluate the success of decolonization 30 days after randomization. During the study, participants will be monitored for bacterial colonization status through stool cultures and rectal swabs. Researchers will assess whether the treatment reduces MDR-GNB carriage, aiming to prevent infections and limit bacterial spread. The trial includes follow-up assessments to evaluate safety and efficacy. Participation involves oral capsule intake and clinical monitoring over the study period, with careful tracking of outcomes and adverse events.

Researchers are evaluating two types of locoregional anesthesia techniques as part of multimodal pain management in adults undergoing midline laparotomy. The study compares epidural analgesia with bilateral rectus sheath block to determine their impact on postoperative recovery, focusing on the Quality of Recovery-15 score two days after surgery. This prospective, randomized controlled trial is conducted at multiple centers with two parallel groups. Participants receive either epidural analgesia, where a catheter is placed in the epidural space during anesthesia induction and managed with patient-controlled dosing after surgery, or bilateral rectus sheath block performed under general anesthesia with ultrasound guidance, delivering ropivacaine via elastomeric pump. The surgical procedure involved is a midline sub or supra umbilical laparotomy or xypho-pubian laparotomy. During the study, patients are monitored for postoperative recovery quality using the QoR-15 score on the second day after surgery. Informed consent is required, and participants must be able to read and understand French. Safety and eligibility are assessed based on medical history and potential contraindications to anesthesia techniques. The trial aims to identify which analgesic method supports better recovery and fewer complications after laparotomy.

Non-suicidal self-injury (NSSI) involves intentional acts causing moderate injury and is increasing among adolescents, especially after the COVID-19 crisis. Adolescents with NSSI disorder often show low cortisol levels, which affects stress regulation. This study aims to evaluate if stimulating the vagus nerve can improve hormone function and reduce self-injury episodes, focusing on whether adolescents will stick to this home-based treatment. Participants will use transcutaneous auricular vagal nerve stimulation (taVNS) devices daily at home for 10 minutes twice a day, or 20 minutes once daily, over an 8-week period from week 2 to week 10. The study starts at week 0 with patient inclusion and continues with follow-up until week 22. The treatment involves using specific medical devices designed for nerve stimulation on the ear. During the study, researchers will monitor how well patients adhere to the treatment by measuring the percentage who complete at least 20 minutes of stimulation on 5 days per week for 6 weeks. They will also assess patient progress and safety up to week 22. The overall goal is to understand if this therapy is acceptable and manageable 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 for Young Adults in France. This mixed-methods study, called ATICC, aims to identify risk factors, barriers to healthcare access, and to evaluate group interventions designed to improve psychological well-being and attitudes toward mental health care. The study includes cross-sectional surveys, qualitative interviews, and longitudinal interventions using focus groups. The study is organized into three parts: a cross-sectional survey using standardized questionnaires to assess behaviors and mental health; qualitative interviews with participants who use substances to explore their personal experiences; and focus group interventions conducted in person or via videoconference, facilitated by a psychologist. These focus groups encourage open discussion on identity, substance use, migration, and mental health topics. Participants complete evaluation questionnaires at multiple time points throughout the study. Participants will be involved through surveys, interviews, and focus groups over a six-month period. Researchers will analyze data using statistical and thematic methods to assess psychological well-being and attitudes toward care. The study also includes quality assurance, ethical oversight, and data protection measures. The primary outcome measured is participants' attitudes toward mental health care at six months.