Corbeil Essonnes

Researchers are studying acute pyelonephritis (AP), a common bacterial kidney infection in children, focusing on those aged 1 month to less than 3 years without prior urological malformations. The study compares a short 3-day intravenous (IV) antibiotic treatment alone to a 3-day IV treatment followed by 7 days of oral antibiotics. The goal is to see if the shorter IV-only treatment is as effective at preventing infection recurrence and long-term kidney scarring, while possibly reducing antibiotic resistance and preserving gut microbiota diversity. Participants receive either IV ceftriaxone and/or amikacin once daily for 3 days, or the same 3-day IV treatment followed by 7 days of oral cotrimoxazole or cefixime. The study includes procedures like procalcitonin testing and fecal or rectal swabs collected at several points during and after treatment (day 0, 3, 10 or 17, and 31 or 38) to monitor bacterial presence and gut microbiota changes. Treatment begins after initial confirmation of infection and favorable early response. During the study, children are closely monitored for infection recurrence 28 days after completing antibiotics. Assessments include clinical evaluations, urine cultures, and monitoring for any adverse effects. The total participation covers treatment and follow-up periods to ensure safety and measure outcomes such as infection recurrence and bacterial resistance. This is a Phase 4 open-label randomized trial conducted across multiple centers.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating whether baricitinib can delay the onset of clinical stage 3 type 1 diabetes (T1D) in children and adults at high risk of developing the disease. This phase 3, double-blind, randomized, placebo-controlled study includes participants aged 1 to under 36 years who have early stages of T1D or multiple diabetes-related autoantibodies indicating increased risk. The study aims to measure the time from the start of the trial to diagnosis of stage 3 type 1 diabetes, with participation lasting up to approximately 5 years. Participants will be randomly assigned to receive either baricitinib or a placebo, both administered orally. The trial compares these two groups to assess the impact of baricitinib on delaying progression to stage 3 T1D. The study's design includes careful monitoring of participants over time to evaluate the effects of the medication or placebo on disease development. During the study, participants will undergo regular assessments to detect the progression of diabetes, including laboratory tests for autoantibodies and clinical evaluations. Researchers will track the time it takes for participants to develop stage 3 T1D, along with monitoring safety and any adverse effects. The total duration of participation can be up to 5 years, ensuring thorough observation of long-term outcomes related to the study interventions.

Researchers are studying whether baricitinib can help preserve beta-cell function in children and adults newly diagnosed with type 1 diabetes. This Phase 3 trial focuses on participants aged 1 to less than 36 years who have recently been diagnosed with this condition. The goal is to understand if baricitinib, compared to a placebo, can maintain insulin-producing cell activity. Participants will be randomly assigned to receive either baricitinib or a placebo, both given orally. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. Treatment and observation will continue for about 60 weeks. During the study, participants will undergo evaluations including measuring C-peptide levels to assess beta-cell function at the start and after 52 weeks. Researchers will monitor health status, collect laboratory tests, and track any side effects or changes in diabetes-related markers to determine the effects of baricitinib over the study period.

Psoriatic arthritis (PsA) is a type of arthritis that causes joint swelling and stiffness and is often seen in people with the skin condition psoriasis. It results from an overactive immune system attacking healthy tissue. This research aims to describe the long-term use and effectiveness of risankizumab (RZB) compared to other advanced treatments for managing PsA in everyday clinical care. The study is not conducted in the United States but will take place in about 15 countries and include between 900 and 1200 adult participants. Participants will be assigned in a 2 to 1 ratio to receive either risankizumab or other advanced therapeutic agents. The treatments will be given following usual medical guidelines, including approved dosing and indications, as determined by local regulations and professional standards. All study visits will occur during routine clinical care with no extra burden on participants. Participants will be followed and monitored for 24 months to observe treatment persistence. During the study, participants will continue their regular clinical visits without additional procedures or tests required by the study. Researchers will measure how many participants continue their prescribed treatment over the 24-month period. The study focuses on real-world treatment patterns and outcomes in patients with active PsA who have previously shown an inadequate response or intolerance to certain medications. Safety monitoring will align with routine clinical practice throughout the study duration.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

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 whether buddy tape can treat fractures of the long finger metacarpal shafts as effectively as a traditional splint. The study focuses on non-thumb metacarpal shaft fractures with little or no displacement, aiming to see if hand function two months after injury is as good with buddy taping as with splinting. This randomized study compares these two treatments to assess their effects on arm strength and recovery. Participants are randomly assigned to either receive buddy tape, which dynamically splints an injured finger to an adjacent one, or a short arm splint that immobilizes the injured finger and hand. Patients are monitored with follow-up visits at approximately days 15, 30, 60, and 90 after treatment begins. The buddy tape or splint is removed around day 30. During these visits, X-rays are taken to check healing and hand position. Participants will attend four visits after starting treatment to track healing and hand strength. Doctors will perform orthopedic consultations and X-rays at each visit to ensure proper recovery. The main outcome measured is hand function at 60 days, with a final visit at 90 days to assess overall recovery. No extra procedures beyond usual care are added by this study.

Researchers are studying chronic myelomonocytic leukemia, a type of leukemia, by collecting biological samples and associated anonymized data. This non-interventional, prospective study aims to better understand the disease's development and progression over time, with follow-up averaging 15 years. The study includes patients at any stage of the disease, whether or not they are receiving treatment. During the study, blood samples will be collected as part of routine medical assessments or clinical trials. Standard samples include two 10 mL EDTA tubes, with an additional 10 mL dry tube for initial assessments. Depending on the research needs, some tubes may be replaced with heparinized or citrated tubes. Bone marrow samples will also be taken during scheduled myelograms, and in rare cases, tissue samples may be collected during surgical procedures with surgeon consultation. Participants will be involved through their routine medical care, with samples collected during scheduled assessments. Researchers will monitor the disease by analyzing these samples and associated data to understand the disease's pathophysiology. The study requires signed consent and allows participation regardless of disease stage or treatment status. The average study duration is about 15 years, allowing long-term observation and understanding of chronic myelomonocytic leukemia.

This research investigates the impact of an early inhaled sedation strategy using Isoflurane delivered by an ANACONDA132; system compared to a conventional intravenous sedation method in intensive care patients who require invasive mechanical ventilation. The study focuses on preventing delirium, a common and serious complication in ventilated patients, by exploring sedation approaches in a Phase 3 clinical trial setting. Delirium is linked to worsened outcomes, including longer ventilation and hospital stays, and potential long-term cognitive effects. Participants receive either sedation through inhaled Isoflurane combined with analgesic drugs or conventional intravenous sedation with propofol and analgesics. Both groups use nurse-driven analgesia protocols including pain assessment scores and various pain management options such as opioids and non-opioid adjuncts. Sedation starts early, either at rapid sequence induction if intubated in intensive care or upon admission if pre-hospital intubation occurred. Throughout the study, patients are monitored for the occurrence of delirium within 28 days. Researchers assess comfort, safety, sedation effectiveness, and other clinical outcomes. Consent is obtained from patients or relatives, and sedation and analgesia are carefully managed using standardized protocols. The study excludes patients with certain neurological conditions, severe respiratory distress, and other specific criteria to ensure safety and reliable assessment of the sedation strategies.