Salouel

Septic shock is a life-threatening condition with a high risk of death. Researchers are studying how to better measure heart function using a method called transthoracic echocardiography. Specifically, this study focuses on measuring left and right atrial strain (LAS and RAS) with speckle tracking echocardiography, which has shown promise in predicting outcomes in heart diseases. The research aims to compare measurements obtained from two different echocardiographic software programs, ECHOPAC and UWS, to understand their differences and improve consistency in critically ill patients. This study is non-interventional and will use past echocardiographic data from adults treated for septic shock. It will evaluate the AutoStrain technology and check how reproducible the LAS and RAS measurements are when done by different observers. The focus is on comparing software outputs without adding new treatments or interventions. Participants are adult patients admitted to critical care with septic shock who had transthoracic echocardiography performed as part of their medical care. The study will analyze variations in LAS measurements between the two software over a one-year period. Researchers will assess measurement consistency and reproducibility. The study excludes patients with conditions that affect heart imaging quality or those with mechanical heart support. There is no maximum age limit, and all genders are eligible.

Clozapine is a second-generation antipsychotic drug commonly used to treat schizophrenia, affective disorders, and certain dementia symptoms. It is also frequently prescribed in neurology to manage psychosis related to Parkinson's disease (PD). While clozapine carries a known risk of neutropenia or agranulocytosis, requiring regular blood monitoring, some studies suggest it may cause immunodeficiency similar to conditions like common variable immunodeficiency. This study aims to evaluate the changes in immune system markers in Parkinson's patients treated with clozapine, focusing on serum immunoglobulin levels and lymphocyte subpopulations over time. Participants will undergo blood tests with additional immunological assays before starting clozapine treatment, then again at six months and one year after treatment begins. This allows the researchers to monitor immune changes potentially linked to clozapine use in this population. The study involves regular blood count monitoring weekly for the first 18 weeks and monthly thereafter, following standard clozapine safety protocols. During the study, participants will have their immune system markers measured through blood tests at specified intervals. Researchers will assess serum IgG levels as a primary outcome at six months and track lymphocyte subsets to understand immunodeficiency risk. Participants must continue regular blood count monitoring throughout treatment and for four weeks after stopping clozapine. The study is designed to closely observe immune changes over one year, helping to clarify clozapine's effects on the immune system in Parkinson's disease patients.

The high number of emergency visits in France, especially in adult emergency departments like the CHUAP where 60,000 visits occurred in 2022, threatens the organization and sustainability of the health system. Unlike well-structured care for medical emergencies such as heart or brain conditions, digestive surgical emergencies involving complex patients and urgent surgeries lack a personalized care and research pathway. This research evaluates a new care pathway called RAUC, aiming to reduce unplanned hospital readmissions after emergency digestive surgery by improving personalized care. The study assesses the RAUC pathway, which includes Enhanced Recovery After Surgery (ERAS) and several e-health tools for home monitoring. These tools include ROFIM, a teleexpertise solution connecting healthcare providers; DEEPSEN, a virtual reality headset to reduce anxiety; RDS, a patch for continuous physiological monitoring at home; Get ready, a digital management solution for patients at home; Lumiradx, a home CRP testing device; and Digital Surgery, which records different operating times. This integrated approach is designed to optimize patient care following emergency digestive surgery. Participants will be monitored for 30 days after surgery to track the rate of unscheduled hospital readmissions. Researchers will evaluate the effectiveness of the RAUC pathway in reducing these events while using various digital tools and home monitoring devices. The study focuses on adult patients treated in emergency settings for digestive conditions requiring surgery and involves assessments of postoperative outcomes, adherence to the care pathway, and safety during the follow-up period.

Polycystic ovary syndrome (PCOS) is a common condition linked to metabolic problems like insulin resistance and a higher risk of type 2 diabetes. PCOS is divided into four different types, and some types may have less risk of metabolic issues. This research aims to study glucose levels using continuous glucose monitoring and compare how glucose profiles differ among the various PCOS types. Participants will use a Free-style Libre Pro glucose sensor for 14 days to continuously monitor their glucose levels. Additionally, a device called the AGE reader will be used to analyze glycation end products. These technologies help gather detailed information about blood sugar patterns in women with PCOS. During the study, women with PCOS will carry the glucose sensor and undergo the AGE reader analysis. Researchers will measure the time spent in the target glucose range over 14 days. Participants will also be asked to provide consent and follow study procedures. The study focuses on understanding glucose behavior in PCOS to improve knowledge about metabolic risks.

This research evaluates whether guiding ultrafiltration (UF) during continuous renal replacement therapy (CRRT) using the extracellular to total body water ratio measured by bioelectrical impedance analysis (BIA) improves fluid and total body water reduction in critically ill patients. The study addresses the challenge of balancing fluid removal to avoid worsening edema or causing hemodynamic instability in patients with hemodynamic instability and fluid overload. It is a pilot, single-center, prospective, interventional, randomized, controlled, open-label trial with two parallel groups. Participants receive continuous renal replacement therapy once the physician prescribes renal replacement therapy according to hospital protocol. Patients are randomly assigned to either a standard group, where UF is prescribed by the physician based on clinical and hemodynamic status, or an experimental group, where UF is guided by the ECW/TBW ratio assessed by BIA. The treatment lasts for 72 hours during which fluid removal is monitored. Participants are monitored for changes in total body water over 72 hours. Assessments include clinical and hemodynamic evaluations, and BIA measurements to guide fluid removal in the experimental group. Safety and effectiveness are monitored through these measures to compare the two approaches to UF prescription. Participation includes consent provision, and patients must be hemodynamically stable with specific clinical parameters to enroll.

Researchers are studying women with endometriosis to better understand the condition by examining the role of genital and gut microbiota and exposure to pesticides. The project aims to measure circulating cell-free DNA (cfDNA) to assess oxidative stress caused by endometriosis and explore its epigenetic effects. The study also seeks to find connections between pesticide exposure, microbiota imbalances, and endometriosis, hoping to improve early diagnosis and open new treatment options. Participants will provide biological samples for various analyses, including blood for circulating DNA, vaginal samples from endocervical smears, endometrial samples obtained by uterine rinses, and optional fecal samples for gut microbiota analysis. Additionally, hair samples will be collected to evaluate exposure to endocrine-disrupting chemicals, alongside questionnaires about environmental and household factors. These procedures occur alongside usual infertility care, with some requiring specific medical procedures performed after consent. Throughout the two-year study, researchers will collect and analyze these samples and data to quantify cfDNA levels and establish microbiota signatures linked to endometriosis and pesticide exposure. Participants must be monitored for antibiotic use and medication status, and informed consent is obtained before inclusion. The study focuses on women aged 18 to 43, comparing those with confirmed endometriosis to controls without the condition but with male-factor infertility.

Medically intractable tremors, often seen in Parkinson's disease or essential tremor, can be challenging to treat, especially when patients are not candidates for deep brain stimulation due to medical, diagnostic, or social reasons. Alternative surgical methods like thalamotomy using radio-surgery or MRI-guided focused ultrasound have shown effectiveness in some cases. This trial investigates a newer technology called MRI-Guided Laser Interstitial Thermal Therapy (MRIg-LITT), which has been effective in treating epilepsies and brain tumors but has not yet been studied for treating medically intractable tremors. In this study, patients receive a minimally invasive surgical procedure where a laser electrode is implanted in the ventral and intermediary nucleus of the thalamus (VIM) using MRI guidance. This unilateral thalamotomy by MRIg-LITT is being evaluated for its effect and safety in managing tremors that do not respond to medical treatments. The procedure is specifically aimed at patients with Parkinson's disease or essential tremor who cannot undergo or refuse deep brain stimulation. Participants are monitored for changes in their total body weight from baseline at 72 hours after the procedure as a primary outcome. The study includes assessments to ensure safety and effectiveness of the treatment. The entire participation involves screening for eligibility, the surgical intervention, and follow-up evaluations to assess treatment impact and safety.

Researchers are investigating the effects of quizartinib compared to a placebo, both combined with chemotherapy, in adults newly diagnosed with FLT3-internal tandem duplication (ITD) negative acute myeloid leukemia (AML). This phase 3 clinical trial focuses on overall survival as the primary outcome and involves testing participants for FLT3-ITD mutation status at a central laboratory using a validated assay. Participants will receive either quizartinib or placebo at a dose of 60 mg taken orally once daily. Both groups will also receive standard induction and consolidation chemotherapy using cytarabine and an anthracycline (daunorubicin or idarubicin). After chemotherapy, quizartinib or placebo will be administered as maintenance therapy for up to 36 cycles. During the study, participants will be monitored for overall survival up to approximately 42 months from when the first patient is randomized to reach the target number of deaths. The study involves regular assessments including treatment monitoring and safety evaluations throughout the induction, consolidation, and maintenance phases to evaluate the effect of quizartinib in this patient population.

Researchers are evaluating the real-world use of HyQvia in adults with multiple myeloma (MM) who have secondary immunodeficiency (SID). This prospective, observational study aims to understand the infusion details of HyQvia treatment as part of routine clinical care. The study will include about 100 participants from several centers in Europe and South America and will focus on how HyQvia is administered in practice. Participants will receive HyQvia treatment according to their clinic's standard procedures without any additional intervention from the study. The study will observe infusion parameters such as dose per body weight, infusion volume and rate, number and location of infusion sites, needle size, and pump types used. Data on treatment interruptions, reasons for discontinuation or switching treatments, and caregiver support will also be recorded during the 12 months of follow-up after enrollment. During the 12-month follow-up, participants will attend multiple clinic visits where data will be collected through routine assessments and optional patient-reported outcomes. Researchers will monitor infusion characteristics, treatment intervals, and safety-related information. The overall study duration is 38 months, including enrollment and follow-up periods, to gather comprehensive information about HyQvia use in this patient group.

This research aims to observe patients in France who have HER2-negative early breast cancer and are treated with olaparib. The study focuses on understanding how many patients complete the full planned course of olaparib treatment, which is given as adjuvant therapy following initial cancer treatment. It is a national, multicenter, prospective cohort study conducted without altering the usual care provided by doctors. Patients enrolled will be those starting adjuvant olaparib treatment based on their doctor's decision. There are no experimental interventions or treatment changes imposed by the study. The study captures real-world use of olaparib across multiple centers in France. Participants will be followed for at least 18 months after joining the study to see if they complete the full duration of olaparib treatment. Researchers will collect data on treatment adherence and other relevant clinical information during this period. The main outcome measured is the proportion of patients who receive olaparib for the entire planned treatment period.