Colombes

Researchers are evaluating the use of digital tools in dentistry to improve the detection of dental conditions such as dental caries, plaque, and periodontitis in adults. The study compares the performance of traditional clinical and radiographic examinations performed by practitioners with examinations based on imaging results obtained from digital devices like intraoral scanners, panoramic radiography, and Cone Beam Computed Tomography (CBCT). This observational, descriptive, multicenter study builds on prior research to better understand the advantages of digital imaging in dental care. The study involves a single visit where participating patients undergo a standard oral examination that includes clinical assessment and imaging using digital tools like intraoral scanners and panoramic radiography. CBCT scans may be used when medically justified. These digital tools provide 3D images that may help improve the accuracy and efficiency of dental evaluations. No additional or experimental procedures are introduced, and all imaging methods are commonly used in dental practices. During the visit, dental surgeons will collect clinical and imaging data, including measurements of decayed, missing, or filled teeth using the DMFT index, both clinically and from intraoral scan images. Patients receive information about the study beforehand and may take up to seven days to decide on participation. The study assesses the quality and completeness of dental data collected through these methods to support better diagnosis and treatment planning in routine dental care.

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 evaluating if repairing ventral hernias (VH) with a non-absorbable mesh during bariatric surgery (BS) reduces the chance of hernia coming back within two years compared to traditional suture repair without mesh. This Phase 3 randomized controlled trial involves adults aged 18 to 60 who are candidates for BS and have specific types of ventral hernias. The study also assesses related outcomes such as reoperation rates, surgical infections, chronic pain, quality of life, postoperative complications, and weight loss up to two years after surgery. Participants are randomly assigned to one of two groups: one receiving hernia repair with mesh during BS, and the other receiving suture repair. The exact repair technique and mesh type may vary by center. The suture repair involves removing the hernia sac and closing the defect with absorbable stitches. Follow-up visits occur at 1, 3, 6, 9, 12, 18, and 24 months post-surgery, with multiple centers in France participating to enroll a total of 354 patients. During the study, participants undergo clinical assessments and imaging to monitor hernia recurrence and other health outcomes. Researchers track safety events like infections and surgical complications, chronic pain at several time points, and quality of life measures. The main outcome is hernia recurrence rate at two years. An interim analysis will be done halfway through to evaluate efficacy. Statistical comparisons will analyze differences in recurrence between the two repair methods.

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.

Researchers are evaluating the use of cannabidiol (CBD) as an add-on treatment during inpatient alcohol detoxification to help improve abstinence in patients with severe alcohol use disorder. This phase II, double-blind, randomized clinical trial aims to increase the rate of continuous abstinence at week 6 of the study, which is one month after discharge from the scheduled alcohol withdrawal inpatient stay. The study also assesses safety, reduction in alcohol use in case of relapse, withdrawal symptoms, anxiety symptoms, and cannabis use among patients who also use cannabis. Participants are randomized into three groups, each receiving oxazepam plus either a placebo, 450 mg of cannabidiol per day, or 900 mg of cannabidiol per day for 11 days during their inpatient stay. The inpatient stay typically lasts between 11 and 17 days. After discharge, all groups have weekly follow-up visits for up to six weeks to monitor if abstinence is maintained. In addition, a subgroup of patients will have blood tests to measure CBD levels and cannabinoid analysis if they are cannabis users. During the study, patients complete daily and weekly assessments including self-reported alcohol use using standardized timeline follow-back scales, withdrawal and craving scales, anxiety scales, sleep quality questionnaires, and side effect checklists. Urinary tests for alcohol metabolites and cannabinoids are performed multiple times during inpatient stay and follow-up. Researchers monitor clinical signs of intoxication and record any relapses or changes in substance use. The total duration of participation extends up to six weeks after discharge from inpatient care.

Researchers are evaluating the effectiveness of acetylsalicylic acid (aspirin) at a dose of 150 mg per day, started before 20 weeks of pregnancy, to prevent maternal and fetal complications in women with chronic hypertension. Chronic hypertension affects 1 to 5% of women of childbearing age and can lead to serious pregnancy complications such as superimposed preeclampsia, placental abruption, intrauterine growth restriction, preterm delivery, perinatal death, and maternal death. Despite current recommendations by some health organizations to use low-dose aspirin in these cases, there is insufficient conclusive evidence, especially for aspirin doses of 150 mg started before 20 weeks gestation, which this study aims to address in a phase 3 randomized, double-blind, placebo-controlled trial. Participants will be randomly assigned to receive either aspirin 150 mg or a placebo daily, taken in the evening, starting immediately after randomization and continuing until 35 weeks and 6 days of pregnancy. Both treatments will be dispensed by the study center's pharmacy. Participants will keep a daily log of their treatment intake. The study focuses on assessing the prevention of a composite outcome including maternal and perinatal complications such as preeclampsia, intrauterine growth restriction under the 10th percentile, placental abruption, preterm birth before 37 weeks, perinatal death, and maternal death. During the study, participants will be closely monitored for these complications over nine months. Researchers will evaluate maternal and fetal health outcomes, including the appearance of significant proteinuria or neurological signs indicating preeclampsia. Daily treatment adherence will be tracked through patient logs. Safety and effectiveness will be assessed through regular clinical evaluations and outcome measurements related to both maternal and perinatal morbidity and mortality.

This research aims to find out if the Enterra4 Therapy System can help reduce nausea and vomiting symptoms and improve the quality of life in patients who have chronic nausea with normal gastric emptying. It focuses on patients whose nausea has not improved with medication and who have had symptoms for more than six months. The study includes patients aged 18 years and older who have stable medical conditions and meet specific symptom severity and testing criteria. Participants will have the Enterra4 Therapy System implanted, which is a device that sends controlled electrical pulses to the stomach to help manage symptoms. After implantation, participants will be assigned to a study group and will use a smart device to report daily on their nausea, vomiting symptoms, and how these affect their quality of life. Quality of life questionnaires will also be completed at study visits. The device settings will be managed by clinicians using a programmer. Participants will be involved for about twelve months after group assignment. Throughout the study, they will answer daily symptom questions and complete periodic quality of life surveys. Researchers will monitor changes in nausea severity over four months as a primary outcome. Safety and effectiveness will be tracked through ongoing assessments, including symptom reports and questionnaires, to understand how the therapy impacts chronic nausea and vomiting over time.

Researchers are collecting detailed information about patients with venous thromboembolism (VTE), which includes blood clots in veins such as deep-vein thrombosis and pulmonary embolism. The project aims to improve doctors' understanding of VTE, especially in patients often excluded from clinical trials, like pregnant women, elderly individuals, cancer patients, and those with other complex health issues. The goal is to reduce deaths, clot recurrence, bleeding problems, and artery-related events by sharing this knowledge widely. The study involves gathering extensive data on each patient's health status, treatments, and outcomes during the first three months of therapy. This registry is available online to help doctors quickly find information on patients with similar medical profiles and make informed decisions about managing high-risk individuals. There are no specific interventions being tested; instead, the focus is on collecting real-world patient data. Participants provide informed consent and are followed for at least three years to monitor for new clot events and complications. Researchers track recurrences of VTE, bleeding episodes, and deaths, aiming to create tools that predict which patients are most at risk for problems. This ongoing data collection supports improving care and guiding treatment decisions for diverse patient groups over time.

Researchers are evaluating the PrediMAP in-vitro diagnostic medical device to predict delivery within 7 days in women who come to obstetric emergency departments with suspected preterm labor (PTL). Preterm delivery, which occurs before 37 weeks of pregnancy, is a leading cause of infant death and disability worldwide, including in France where many babies are born very early and face serious health risks. Despite efforts over the past decades, preventing early births remains challenging, and managing pregnancies at risk is critical to improving outcomes. The study involves three phases: Cohort 1 focuses on collecting vaginal samples, clinical and ultrasound data, and placenta and membrane samples to develop the device and its predictive algorithm. Cohort 2 will test the technical reliability and user-friendliness of the bedside PrediMAP device. Cohort 3 aims to validate the device's clinical performance in predicting preterm birth risk. Vaginal secretions will be collected during emergency consultations, placenta and membranes will be collected after delivery for some patients, and participants in Cohort 3 will complete the Edinburgh Postnatal Depression Scale (EPDS) questionnaire. Participants will be monitored for delivery occurrence within 7 days after inclusion, with assessments done 15-21 days after inclusion for Cohort 1 and at the end of follow-up (5.5 months) for Cohort 3. Data collection includes clinical exams, ultrasound, sample analysis, and questionnaire responses. The study measures how well the device predicts imminent delivery and monitors safety and other outcomes over several months following enrollment.

Gastro-esophageal reflux disease (GERD) occurs when stomach contents flow back into the esophagus causing symptoms like heartburn, regurgitation, chest pain, chronic cough, and sore throat. Many people experience these symptoms, and proton pump inhibitors (PPI) are often prescribed as first-line treatment. However, up to 60% of patients continue to have symptoms despite PPI therapy, possibly due to misdiagnosis, other conditions like rumination syndrome, or issues such as poor acid suppression or non-compliance. To better understand persistent symptoms, tests like upper gastrointestinal endoscopy and esophageal pH monitoring are used, but these have limitations. A newer method combining impedance and esophageal pressure monitoring, called high resolution impedance manometry (HRIM), may offer improved diagnosis with shorter recording times and insight into reflux mechanisms. This study evaluates the diagnostic value of a 1-hour post-meal esophageal HRIM test in patients with GERD symptoms resistant to PPI therapy. Participants undergo several procedures: an upper gastrointestinal endoscopy with biopsies and placement of a wireless pH capsule that records for 96 hours; a post-prandial HRIM test performed after a standardized meal with a 1-hour recording; and a 24-hour pH-impedance monitoring test using a catheter. These tests aim to identify reflux episodes and better understand the causes of persistent symptoms. During the study, participants will have their reflux episodes measured, especially focusing on the number detected during the 1-hour HRIM after eating. Researchers will collect data from endoscopy, pH monitoring, and HRIM to evaluate reflux and its mechanisms. Safety and tolerance of procedures will be monitored, and participants must meet specific criteria such as age and symptom frequency. The total study involves visits for testing and monitoring, with careful tracking of reflux episodes to assess the usefulness of the HRIM method in diagnosing GERD.