Montauban

This research aims to assess the effectiveness, safety, and patient-reported outcomes of a port delivery system (PDS) with ranibizumab 100 mg/mL refilled every 36 weeks in people with neovascular age-related macular degeneration (nAMD). The study is a Phase IIIb, multicenter, single-arm trial involving participants who have been diagnosed with nAMD within the past 24 months and previously treated with anti-vascular endothelial growth factor (VEGF) injections. The goal is to understand how well this refill regimen works and how safe it is for patients living with this eye condition. Participants will receive ranibizumab through a PDS implant that is refilled every 36 weeks. The treatment includes the implant delivering ranibizumab continuously, plus supplemental ranibizumab injections of 0.5 mg into the eye as needed. The study follows a schedule where the implant is exchanged or refilled at 36-week intervals to maintain treatment. The device is designed to provide a steady release of medication directly to the eye over time. During the study, participants will have their vision tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters, focusing on changes in their best corrected visual acuity (BCVA) at baseline and weeks 68 and 72. Researchers will monitor safety, effectiveness, and patient experiences throughout the trial. The total observation period includes assessments at these time points to evaluate how vision changes with the PDS treatment and to track any side effects or safety concerns.

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.

This research aims to demonstrate the safety and performance of the LuxBoost intraocular lenses when implanted in both eyes. It focuses on people aged 50 and over who have cataracts in both eyes and are scheduled for lens replacement surgery. The study compares the LuxBoost lens, a hydrophobic acrylic enhanced monofocal intraocular lens, with the LuxGood Monofocal lens. Participants will receive bilateral implantation of either the LuxBoost IOL or the LuxGood IOL to replace the cataract-affected natural lenses in their eyes. Both lenses are implanted in the capsular bag during cataract surgery. The study evaluates how well these lenses perform after surgery, focusing on safety and visual outcomes. During the study, participants will attend follow-up visits where their corrected distance visual acuity (CDVA) will be measured at 4 and 6 months after surgery. The study requires participants to comply with examination procedures and attend all follow-ups. Researchers will carefully monitor visual performance and safety throughout the study period.

Researchers are evaluating the effects of the probiotic B. lactis B94 on infants diagnosed with infantile colic. This randomized, double-blind, placebo-controlled Phase 2 study aims to determine whether the probiotic can reduce the duration of daily crying compared to a placebo after 4 weeks of treatment. Infantile colic is characterized by prolonged periods of crying or fussiness, and this study seeks to explore a potential dietary intervention to ease these symptoms. Participants will be randomly assigned to one of two groups: one receiving a daily sachet of the probiotic B. lactis B94, and the other receiving a placebo. Both treatments are taken once daily, dissolved in 10 ml of lukewarm water, and administered at approximately the same time each day. The study spans 6 weeks, including a 1-week baseline period, a 4-week intervention period, and a 1-week follow-up. During this time, families will attend three in-person visits and participate in four phone calls to support adherence and monitoring. Throughout the study, parents will maintain questionnaires, records, and diaries related to their infant's symptoms. Researchers will track changes in daily crying duration as the primary outcome over 4 weeks. The study also involves clinical assessments during visits and telephone follow-ups to ensure safety and collect data. Participation requires exclusive breastfeeding and commitment to study procedures over the full 6-week period.

Researchers are evaluating the Polymer-Free Sirolimus Eluting Coronary Stent System called Vivo ISAR in patients with coronary artery stenosis. The study aims to collect clinical outcome data in real-world patients with coronary artery disease, following standard care procedures. The goal is to assess results and safety with a 12-month follow-up after treatment. Participants receive treatment using the Vivo ISAR stent device, which is designed to improve blood flow by widening narrowed coronary arteries in patients with symptomatic ischemic heart disease. The study involves patients undergoing percutaneous coronary intervention, with the Vivo ISAR stent used exclusively when stenting one or more vessels. During the study, participants will be monitored for clinical outcomes including the rate of target lesion failure within 12 months after the procedure. Researchers will collect relevant data on health status and treatment effects as part of routine clinical practice. The study is observational and follows patients over a year to evaluate the device's performance and safety in everyday medical care.

This research aims to analyze the use of Glofitamab in patients with relapsed or refractory Large B-cell Lymphoma (DLBCL) treated under the Expanded Access Programme (EAP) in France. The study focuses on evaluating the effectiveness and safety of Glofitamab in a real-world setting, including a subgroup of patients previously treated with chimeric antigen receptor T-cell therapy (CAR-T). The goal is to confirm reported response rates and to determine the best timing for starting Glofitamab treatment. Participants in this study received Glofitamab as a treatment for DLBCL, with prior pretreatment using Obinutuzumab. The study involves retrospective analysis of patients who enrolled in the French Glofitamab EAP before November 1, 2024, and who have received at least one infusion of Glofitamab. No additional interventions or treatment arms are described, as the study reviews data from real-world use. During the study, researchers will assess the best complete response rate (CRR) to Glofitamab treatment over a six-month period using the Lugano 2014 criteria. The analysis includes a median follow-up of more than nine months to monitor treatment outcomes and safety. Participants' data will be collected only if they have consented or did not oppose their data use for this study.

The trial investigates the use of hypnotic immersive virtual reality (VR) to reduce anxiety among nurses, a group that often experiences significant stress and anxiety due to their demanding work environment. Anxiety not only affects nurses' mental and physical health but also impacts the quality of care they provide and contributes to absenteeism and turnover. This research aims to scientifically evaluate whether immersive VR hypnosis can help manage anxiety better than other complementary therapies, as previous studies showed promising but methodologically limited results. Participants in the study are day-shift nurses who will be randomized to receive hypnotic immersive VR sessions during their coffee breaks. The VR intervention involves immersive hypnosis delivered through VR headsets, designed to help reduce anxiety without medication. The study is a pilot, open-label, randomized controlled trial conducted at a single center, with the intervention given during a scheduled coffee break from 9:00 to 9:15 AM. The study will last one day per nurse, with recruitment planned over 24 months. Nurses will attend a pre-inclusion visit 2 weeks to 1 month before data collection to receive study information and consent, followed by an inclusion visit on the day of data collection to provide written consent. Researchers will measure anxiety levels using the Spielberger questionnaire before and after the coffee break to assess changes. They will also evaluate nurses' satisfaction with the intervention using a Likert scale. The total participation time is one day, with safety monitoring for potential side effects such as nausea or vomiting.

Obesity increases the risk of difficult intubation and mask ventilation, with serious complications more common during anesthesia induction in obese patients. This research evaluates and compares two oxygenation methods to improve safety during induction of general anesthesia with orotracheal intubation in obese individuals. The study focuses on how these strategies affect oxygen reserve after intubation in the operating room. The study compares two oxygenation approaches: one using a combination of Non Invasive Ventilation (NIV) and High Flow Nasal Oxygen (HFNO), and the other using NIV alone. Both methods involve preoxygenation before intubation. During the intubation process, NIV is stopped in the combined group while apneic oxygenation continues with HFNO. The goal is to assess how each method supports oxygenation during anesthesia induction. Participants undergo general anesthesia with orotracheal intubation in the operating room. Researchers monitor oxygen reserve two minutes after intubation to evaluate the effectiveness of the oxygenation strategies. The study records patient information including body mass index and consent status. Safety is assessed by excluding patients with contraindications or unstable conditions. The entire process focuses on improving oxygen management in obese patients during anesthesia induction.

Researchers are evaluating ABBV-RGX-314, a novel one-time gene therapy, for treating neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD causes vision loss due to abnormal blood vessel growth in the retina and affects millions in the United States, Europe, and Japan. Current treatments require frequent eye injections, which can be burdensome and may lead to reduced vision over time. This Phase 3 study aims to compare the effectiveness and safety of two doses of ABBV-RGX-314 against the standard anti-VEGF drug, aflibercept, in people with wet AMD. Participants will be randomly assigned to receive one of two doses of ABBV-RGX-314 gene therapy or aflibercept injections. The gene therapy involves a one-time subretinal injection delivering a gene that produces an anti-VEGF protein to help control abnormal blood vessels. In addition, a bilateral treatment substudy will examine safety and effectiveness when both eyes are treated in participants with wet AMD in both eyes. This substudy will enroll up to 15 participants for at least 50 weeks of follow-up. During the study, participants will have their vision measured regularly to assess changes in best-corrected visual acuity (BCVA). Safety will be monitored by recording any eye-related adverse events and serious side effects. Participants will be followed for up to 54 weeks or more to evaluate how well the gene therapy maintains or improves vision compared to aflibercept and to assess overall treatment safety and tolerability.

Researchers are evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on cardiovascular death and heart failure events in patients with chronic heart failure and impaired kidney function who recently experienced a heart failure event. This is a Phase III, international, randomized, double-blind, parallel-group, active-controlled study involving approximately 700 sites in about 40 countries. Participants will be randomly assigned in a 1:1:1 ratio to receive one of three treatments once daily: a capsule of balcinrenone/dapagliflozin 15 mg/10 mg with a placebo tablet, a capsule of balcinrenone/dapagliflozin 40 mg/10 mg with a placebo tablet, or a dapagliflozin 10 mg tablet with a placebo capsule. The study is event-driven, with an estimated average duration of 22 months that includes a screening period, a 20-month blinded treatment phase, and a one-month follow-up on open-label dapagliflozin. During the study, participants will be monitored for the time to first occurrence of cardiovascular death, heart failure hospitalization, or heart failure events without hospitalization over approximately 38 months. Assessments include clinical evaluations, laboratory tests, and safety monitoring throughout the study and follow-up period to track treatment effects and patient outcomes.