Colombes

This research aims to evaluate the use of digital tools in dentistry to improve the detection of dental conditions in adults. It compares the standard real-life examination by practitioners, which combines clinical and radiographic assessments, with examinations based on imaging results from digital devices. The study follows up on previous research that provided recent insights into adult patients oral health and care needs. The study involves digital imaging technologies such as intraoral scanners optical impression cameras, panoramic radiography orthopantomogram, and Cone Beam Computed Tomography CBCT. These tools provide 3D images and detailed views of dental structures, potentially offering more systematic and rapid clinical data collection. Radiographs are only performed when medically justified, and there are no deviations from standard care. Participants attend a single study visit where data is collected through clinical examination and imaging results. Researchers will assess various dental conditions, including the number of decayed, missing, or filled teeth, the extent and location of carious and wear lesions, dental restorations, periodontal involvement, and endodontic status. The study focuses on improving the quality and completeness of diagnostic information to support better treatment planning.

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.

This research aims to assess the effectiveness of using non absorbable mesh versus suture repair for ventral hernia VH during bariatric surgery BS in adults aged 18 to 60 years with morbid obesity. The main goal is to see if mesh repair lowers the chance of hernia returning within two years after surgery compared to suture repair. The study also evaluates other outcomes such as hernia recurrence at one year, need for reoperation, surgical complications, chronic pain, quality of life, weight loss, and cost-effectiveness. Participants will be randomly assigned to one of two groups one receiving VH repair with non absorbable mesh placed during BS either sleeve gastrectomy or bypass, and the other having suture repair of the hernia during BS. The mesh repair technique and mesh type depend on each surgical centers choice. The suture repair involves removing the hernia sac and closing the defect with slowly absorbable sutures through an open approach. Both groups undergo the bariatric procedure as decided before surgery. Throughout the study, patients will be monitored according to clinical guidelines with follow-up visits at 1, 3, 6, 9, 12, 18, and 24 months after surgery. Researchers will assess hernia recurrence rates, complications like infection or hernia strangulation, chronic pain levels, quality of life, weight loss progress, and costs. Safety and postoperative morbidity and mortality will be tracked up to 90 days after surgery. The study includes 29 surgical centers aiming to enroll 354 patients, with statistical analyses planned after follow-up completion and an interim analysis halfway through.

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.

Researchers are evaluating cannabidiol as an additional treatment during inpatient alcohol detoxification for patients with severe alcohol use disorder. This phase II randomized clinical trial aims to improve the rate of continuous abstinence at 6 weeks, which is one month after discharge from a scheduled hospital stay for alcohol withdrawal. The study also assesses safety, alcohol use reduction in case of relapse, withdrawal symptoms, anxiety, and cannabis use in patients who also use cannabis. Participants will be randomly assigned to one of three groups receiving oxazepam plus either placebo, 450 mg cannabidiol, or 900 mg cannabidiol daily for 11 days during their inpatient stay. After discharge, all groups will have follow-up visits once a week for 4 weeks to monitor abstinence and other outcomes. Blood and urine tests will be used to measure cannabidiol levels and confirm abstinence, alongside self-reported alcohol use and symptoms. During the study, participants will report daily alcohol use and symptoms from day 0 to day 10 and then weekly after discharge up to week 6. Clinical examinations and urine tests for alcohol metabolites will confirm abstinence. Researchers will also monitor side effects, withdrawal severity, anxiety, craving, sleep quality, and cannabis use. The total study duration for participants is about 6 weeks including inpatient treatment and outpatient follow-up visits.

Chronic hypertension affects 1 to 5% of women of childbearing age and can lead to serious complications during pregnancy, such as superimposed preeclampsia, placental abruption, intrauterine growth restriction, perinatal death, maternal death, or preterm delivery. This trial evaluates whether taking 150 mg of acetylsalicylic acid aspirin daily before 20 weeks of pregnancy can help prevent these complications in pregnant women with chronic hypertension. The study is a prospective randomized double-blind placebo-controlled trial conducted to provide clearer evidence on aspirins effectiveness in this specific population. Participants are randomly assigned to receive either aspirin 150 mg or a placebo once daily in the evening. The treatment starts immediately after randomization and continues until 35 weeks plus 6 days of gestation. Both the active drug and placebo are dispensed by the study centers pharmacy, and participants are given daily logs to record their treatment adherence. This design ensures careful monitoring and comparison of outcomes between the two groups. During the study, participants will undergo regular assessments of maternal and fetal health, including monitoring for preeclampsia, fetal growth, placental health, and timing of delivery. Researchers will measure a combined outcome of maternal and perinatal complications within 9 months, along with various secondary outcomes such as fetal development and child growth up to 4 years. Safety and treatment adherence are also tracked throughout. The total participation duration aligns with the pregnancy timeline, ensuring comprehensive observation of both mother and child.

This research investigates whether the Enterra Therapy System can reduce nausea and vomiting symptoms and improve quality of life in patients who experience chronic nausea with normal gastric emptying. The study focuses on patients whose symptoms have been persistent, drug-resistant, and active recently, aiming to assess the devices impact on these symptoms over time. Participants will have the Enterra Therapy System implanted, a gastric electrical stimulator consisting of an implantable pulse generator and leads, programmed and adjusted by clinicians. They will be randomly assigned to one of two groups an ON group receiving initial device stimulation, or an OFF group starting with the device turned off and later switched on. Adjustments to device programming will occur at follow-up visits, with individualized therapy settings introduced after initial study periods. Throughout about twelve months of participation, patients will regularly report their nausea and vomiting symptoms and quality of life impacts using a smart device and complete questionnaires during study visits. Researchers will monitor changes in nausea severity, vomiting frequency, total symptom scores, and quality of life scores at 4 and 12 months. This ongoing assessment helps evaluate the effects of the therapy system while ensuring patient safety and adherence to study protocols.

The registry focuses on patients with venous thromboembolism VTE, including those often excluded from typical clinical trials such as pregnant women, elderly patients, and those with serious health conditions. It aims to improve medical knowledge and patient care by collecting detailed data on these patients clinical status and treatment outcomes. The project also seeks to develop predictive scores to identify patients at higher risk of complications from thromboembolic disease. This observational registry collects extensive information on patients diagnosed with VTE, including details on coexisting conditions, antithrombotic treatment type, dose, and duration, as well as outcomes during the first three months of therapy. It captures data on VTE recurrences, bleeding complications, and deaths, providing insights into real-world treatment and patient management. Participants provide informed consent and are followed for at least three months to monitor clinical outcomes. The registry supports physicians by giving access to data on patients with similar profiles to help manage complex cases. The main outcomes measured include VTE events and complications over a three-year period, supporting ongoing improvements in patient care and risk assessment.

Preterm delivery, defined as birth before 37 weeks of gestation, is a leading cause of infant mortality and affects millions of births worldwide each year. This research aims to clinically validate the predictive accuracy of the PrediMAP in-vitro diagnostic medical device, which is designed to predict delivery within 7 days in women who visit obstetric emergency departments for suspected preterm labor. The study is conducted in three phases including device development, technical validation, and clinical performance evaluation. The study involves collecting vaginal secretions from all participating women during their emergency consultation. In the first phase, clinical and ultrasound data along with placenta and membrane samples from a subset of patients are gathered to develop and refine the predictive algorithm integrated into the device. In later phases, the devices reliability and clinical performance are assessed, including administering the Edinburgh Postnatal Depression Scale EPDS questionnaire to participants in the clinical performance phase. Participants will be involved in sample collections, clinical assessments, and questionnaire completions at the time of emergency consultations and after delivery. Researchers will monitor delivery occurrence within 7 days as the primary outcome, along with secondary outcomes such as delivery timing at 14 days and various gestational age thresholds, neonatal mortality, severe neonatal morbidity, and EPDS scores. Follow-up assessments will continue up to 5.5 months to evaluate these outcomes and the devices predictive value.

Gastro-esophageal reflux disease GERD causes symptoms like heartburn and regurgitation when stomach contents flow back into the esophagus. Many people take proton pump inhibitors PPI as a first treatment, but up to 60% still experience symptoms. This trial evaluates a new diagnostic method called post prandial esophageal High Resolution Impedance Manometry HRIM to better identify reflux episodes and understand their causes in patients not fully helped by PPI treatment. Participants with ongoing GERD symptoms despite PPI therapy will undergo several tests an upper gastrointestinal endoscopy with biopsies, wireless pH monitoring over 96 hours, and a post meal HRIM test lasting one hour after eating a standardized meal. Optionally, some may also have 24-hour pH-impedance monitoring while on PPI. These tests aim to measure reflux episodes, acid exposure, and esophageal pressures to clarify the diagnosis and guide treatment. During the study, patients will be monitored through these procedures, including a standardized meal intake and probe insertions. Researchers will measure the number of reflux episodes detected by HRIM, acid exposure times, esophageal pressures, and tissue samples. Patient preferences about the examinations will also be recorded. The trial will help determine how well post prandial HRIM identifies GERD in PPI-resistant patients and lasts until May 2027.