Corbeil Essonnes

This research aims to evaluate antibiotic treatments for acute pyelonephritis AP in children aged 1 month to 3 years. It compares a shorter intravenous IV antibiotic course of 3 days alone to a longer treatment consisting of 3 days IV followed by 7 days of oral antibiotics. The goal is to see if the shorter IV treatment is as effective in curing AP and preventing recurrence and renal scarring, while reducing the risk of antibiotic resistance and preserving gut microbiota diversity. Participants are randomly assigned to one of two groups. The experimental group receives only 3 days of IV antibiotics with ceftriaxone andor amikacin, after which treatment is stopped. The control group receives the usual care of 3 days IV antibiotics followed by 7 days of oral antibiotics, either cotrimoxazole or cefixime. The study includes collection of fecal or rectal swabs and blood tests to assess microbiota and resistance. Treatment effectiveness and safety are compared between groups. During the study, children are monitored for fever, symptoms, and urine cultures to confirm infection clearance. Researchers measure recurrence of febrile urinary tract infections within 28 days after treatment ends and follow clinical cure at 10 or 17 days depending on the group. Additional assessments include monitoring recurrence at 90 days, antimicrobial resistance in gut bacteria, and intestinal microbiota diversity over about a month. Participation lasts through treatment and follow-up visits up to several weeks.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating whether baricitinib can delay the development of clinical stage 3 type 1 diabetes T1D in children and adults at high risk. This phase 3, double-blind, randomized, placebo-controlled study includes participants aged 1 to under 36 years who have early stages of T1D or specific diabetes-related autoantibodies. The study aims to better understand preventing or delaying the onset of clinical diabetes in this at-risk population. Participants will be randomly assigned to receive either baricitinib or a placebo orally. The study lasts up to approximately 5 years, during which participants take the assigned treatment and are monitored regularly. The trial includes a control group receiving placebo to compare with the baricitinib group. The dosing schedule and exact treatment duration depend on the study protocol and participant response. Throughout the study, participants will undergo assessments including monitoring the time to diagnosis of stage 3 T1D, blood tests measuring glucose and C-peptide levels, body measurements, and health surveys. Researchers will track changes in these measures over time, including pharmacokinetics of baricitinib. Safety and response to treatment will be closely observed throughout the study duration to evaluate the effects of the medication.

Researchers are studying baricitinib to see if it can help preserve beta-cell function in children and adults aged 1 to 35 years who have been newly diagnosed with type 1 diabetes. This Phase 3 study aims to evaluate the treatments impact on preserving insulin production shortly after diagnosis. Participants will be followed for about 60 weeks to assess changes in key diabetes-related measures. Participants will be randomly assigned to receive either baricitinib or a placebo, both taken orally. The study compares these two groups to evaluate the effects of baricitinib on beta-cell function. The main measurement is the change in C-peptide area under the curve over 52 weeks, which indicates insulin production. Additional outcomes include changes in blood sugar control, insulin use, hypoglycemia events, and other health indicators. During the study, participants will attend visits for assessments and monitoring over approximately 60 weeks. Tests will include blood measurements like C-peptide and hemoglobin A1c, insulin dose tracking, and health surveys. Safety and drug levels will be monitored. Researchers will use these data to understand if baricitinib can help maintain beta-cell function in people newly diagnosed with type 1 diabetes.

Psoriatic arthritis PsA is a type of arthritis that causes joint swelling and stiffness, often occurring in people with the skin condition psoriasis. This study aims to understand how long patients continue treatment and how effective risankizumab RZB is compared to other advanced treatments for PsA in everyday clinical settings. The study will take place outside the United States across about 15 countries, involving between 900 and 1200 adult participants. Participants will receive either risankizumab or other biologic disease-modifying antirheumatic drugs bDMARDs as prescribed by their doctors following local guidelines. Treatments will be given as part of regular medical care without additional interventions from the study. Participants will be followed and observed for 24 months during their routine clinical visits. During the study, participants will attend their usual medical appointments where doctors will monitor their treatment persistence and response. The main outcome measured is how many participants continue their prescribed treatment up to 24 months. There is no expected extra burden or additional procedures for participants beyond their standard care.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

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.

This research aims to evaluate whether buddy taping can treat shaft fractures of the hands long fingers as effectively as a splint. The study focuses on adults with non-thumb metacarpal shaft fractures that have little or no displacement and no rotation disorder. Researchers want to determine if, two months after the fracture, hand activities and arm strength are similar between those treated with buddy taping and those treated with a splint. Participants will be randomly assigned to one of two groups one receiving buddy tape, which dynamically splints an injured finger to an adjacent uninjured finger, and the other receiving a short arm splint that immobilizes and stabilizes the injured finger and hand. Both devices will be removed around 30 days after treatment, with follow-up visits scheduled on days 15, 30, 60, and a final visit at day 90, including X-rays to monitor fracture healing. During the study, participants will attend four visits after receiving their assigned treatment to assess hand strength and fracture healing through orthopedic consultations and X-rays. Researchers will measure outcomes such as hand function using the Quick Dash score at day 60 and grip and clamp force at multiple time points. The total participation lasts around three months, with no additional procedures beyond routine care.

Researchers are evaluating the Medtronic Implantable Insulin Pump System MIIPS 2020 in adults with Type 1 diabetes who cannot manage their condition with subcutaneous insulin therapy, including those using external pumps. This study aims to assess the clinical performance of this implantable device in patients experiencing frequent, unexplained severe high or low blood sugar episodes. The investigation is a premarket, interventional, open-label study conducted at multiple centers. The study includes a run-in period to collect baseline continuous glucose monitoring CGM data while participants remain on their current therapy. Following this, during a 6-month study period, participants will be implanted with the MIIPS 2020 device and treated with insulin delivered directly into the peritoneal cavity intraperitoneal insulin infusion. After completing the study period, participants may continue using the investigational device under a continued access period until it receives commercial approval, after which they will keep wearing the implant. Participants will undergo assessments including insulin pump refill accuracy at 6 months and at each refill visit. Researchers will monitor device performance, including the percentage of pumps requiring a special rinse due to accuracy issues. Participants need to be able to operate the device and comply with data reporting requirements. The overall study duration includes the run-in, treatment, and continued access phases, with safety and effectiveness monitored throughout.

This observational study involves patients diagnosed with chronic myelomonocytic leukemia, a type of leukemia characterized by increased monocytes in the blood. The purpose is to better understand the diseases underlying mechanisms, with data collected over an average of 15 years. Biological samples and anonymized data will be gathered during routine care or clinical trials to support this research. The study is sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Participants will have biological samples collected, including blood and bone marrow, during scheduled medical assessments. Blood samples include standard tubes and may vary based on research needs, while bone marrow samples are taken during routine myelograms. In exceptional cases, tissue samples may be collected during surgical procedures if agreed upon with the surgeon. These collections occur alongside usual medical care without additional interventions. Throughout the study, participants will undergo sample collections aligned with their medical visits and tests. Researchers will analyze these samples and associated anonymized data to study the diseases pathophysiology. Participation involves no investigational treatments, and the study will monitor participants for up to 15 years to gather long-term data. Safety and routine care continue as usual during this period.