Montauban

Researchers are evaluating a port delivery system PDS with ranibizumab for adults aged 50 and older who have neovascular age-related macular degeneration nAMD. This Phase IIIb study aims to assess the effectiveness, safety, and patient-reported outcomes of refilling the PDS implant every 36 weeks. The study focuses on maintaining vision and reducing the treatment burden for people with nAMD who have already received prior anti-VEGF injections. Participants will have a PDS implant surgically inserted in their study eye on Day 1, pre-filled with ranibizumab at a concentration of 100 mgmL. Those who show disease activity or receive supplemental ranibizumab injections before Week 24 will have refill exchanges every 24 weeks, while others will receive refill exchanges every 36 weeks. Supplemental intravitreal ranibizumab injections may be given as needed during the study. Throughout the trial, participants will undergo assessments including vision tests using the Early Treatment Diabetic Retinopathy Study chart, eye imaging, and monitoring of eye thickness. Researchers will track changes in vision, need for supplemental treatments, implant safety, and patient preferences. The study lasts until Week 72, with safety and adverse event monitoring continuing for approximately 19 months after implantation.

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.

This research aims to evaluate the safety and performance of bilateral implantation of LuxBoost intraocular lenses compared with the LuxGood Monofocal lens in patients with aphakia. The study focuses on assessing how well these lenses function in replacing the cataractous human crystalline lens and their impact on visual acuity. The trial is sponsored by Cutting Edge SAS and involves adult participants aged 50 years and older who are planned for posterior chamber intraocular lens implantation due to bilateral cataracts. Participants are randomly assigned to receive either the LuxBoost intraocular lens or the LuxGood parent intraocular lens. Both lenses are hydrophobic acrylic monofocal intraocular devices implanted bilaterally in the capsular bag to replace the natural lens. The study does not use masking or blinding. The main evaluation period occurs 4 to 6 months after surgery to compare the outcomes between the two groups. During the study, participants will undergo various eye examinations including measurements of best corrected distance visual acuity, uncorrected distance and near visual acuity, and defocus curve assessments at 4 and 6 months post-surgery. Researchers will monitor lens performance and safety throughout follow-up visits. Participants must be willing and able to comply with all study procedures and attend all follow-up visits. The total participation timeline includes pre-surgical assessments, implantation, and several months of monitoring after surgery.

Researchers are evaluating the effects of the probiotic B. lactis B94 on infants with infantile colic. The study aims to see if this probiotic can reduce the duration of crying in infants compared to a placebo. This is a randomized, double-blind, placebo-controlled trial designed to provide clear evidence on the potential benefits of B. lactis B94 for infantile colic symptoms. Participants will be randomly assigned to one of two groups one receiving the probiotic B. lactis B94 and the other receiving a placebo. Both groups will take one sachet daily, dissolved in 10 ml of lukewarm water, for 4 weeks. The study includes a 1-week baseline period before treatment and a 1-week follow-up after the intervention. The trial involves three in-person visits and four phone calls. During the 6-week participation, caregivers will complete questionnaires, keep diaries, and attend scheduled visits and calls to monitor the infants crying, sleep, bowel habits, and quality of life. Researchers will measure changes in daily crying duration, crying patterns, sleep time, gut bacteria composition, and probiotic recovery. Safety and adherence will be tracked throughout the study, ensuring detailed observation of all participants.

This observational study evaluates the Polymer Free Sirolimus Eluting Coronary Stent System, known as the Vivo ISAR, in everyday clinical practice for patients with coronary artery stenosis. The purpose is to collect real-world data on clinical outcomes over a 12-month follow-up period, focusing on patients who receive this stent system as part of their routine care. The study is sponsored by Translumina GmbH and involves standard procedures and medications with known safety profiles. Participants will be treated with the Vivo ISAR stent during percutaneous coronary intervention to improve coronary artery diameter in those experiencing symptoms of ischemic heart disease. The study monitors patients who receive the stent in one or multiple vessels, observing their progress without altering standard care practices. The follow-up extends to 12 months after the procedure to assess various success rates and treatment effects. During the study, participants undergo routine clinical evaluations including assessments of device and procedural success shortly after treatment, and measures of target lesion failure and reperfusion at 12 months. Researchers also evaluate antiplatelet therapy adherence and effectiveness. The total participation involves regular check-ups and data collection to understand long-term outcomes and safety of the Vivo ISAR stent system in typical healthcare settings.

Researchers are analyzing the real-world experience of patients treated with Glofitamab for relapsed or refractory large B-cell lymphoma DLBCL. This observational study focuses on patients who participated in the French Expanded Access Programme EAP, with more than 300 treated patients and a median follow-up expected to exceed nine months. The study particularly aims to confirm the response rates of Glofitamab in patients who have previously received CAR-T therapy and to determine the best timing to start the treatment. The study includes patients who received at least one infusion of Glofitamab following pretreatment with Obinutuzumab as part of the Early Phase Access program. The treatment details are collected retrospectively from patients enrolled before November 1, 2024. The primary outcome being assessed is the best complete response rate during treatment, based on investigator evaluation using Lugano 2014 criteria at six months. Participants data will be reviewed to measure treatment effectiveness and safety, including complete metabolic response rates, progression-free survival, event-free survival, overall survival, rates of immune-related side effects like neurotoxicity and cytokine release syndrome, ICU admissions, and hospitalization events over six months. This analysis helps to better understand Glofitamabs performance in a large real-world patient group, with continued monitoring of outcomes and adverse events during the follow-up period.

The trial focuses on nurses working day shifts who often experience anxiety linked to their demanding healthcare roles. Researchers are evaluating whether immersive virtual reality VR hypnosis can reduce anxiety levels during coffee breaks. This pilot, open-label randomized controlled trial aims to provide scientific evidence on the effectiveness of VR hypnosis as a complementary anxiety management tool for nurses. Participants are randomly assigned to one of two groups the active group receives a hypnotic immersive VR session during their coffee break, while the control group takes their coffee break normally without VR. The VR intervention is delivered using immersive VR headsets in a calm environment. Both groups complete anxiety assessments using the Spielberger questionnaire before and after the coffee break, and satisfaction is measured with a Likert scale. Nurses participate for one day, including a pre-inclusion visit for study information and consent. On the study day, anxiety levels are assessed before and after the coffee break, alongside satisfaction and any adverse effects like nausea. The main outcome measured is the change in anxiety scores, with secondary focus on satisfaction. The study includes close monitoring and aims to complete recruitment within 24 months, with a total duration of 27 months.

Researchers are evaluating the safety and performance of the LuxHighAdd intraocular lens compared with the LuxGood Monofocal lens in people with cataracts. This study involves bilateral implantation of these lenses to replace the cataractous natural lens. The trial aims to assess how well these lenses work and their safety after surgery. Participants will be assigned to one of two groups one group will receive the LuxHighAdd multifocal intraocular lens, while the other group will receive the LuxGood monofocal intraocular lens. Both lenses are implanted in the capsular bag of the eye to replace the cloudy lens. The study does not use random assignment, and both eyes are treated during the procedure. During the study, participants will be followed for 4 to 6 months after surgery. Researchers will measure outcomes such as distance corrected near visual acuity, best corrected distance visual acuity, uncorrected distance, intermediate and near visual acuity, refraction, and contrast sensitivity. They will also assess side effects, including halo and glare, and gather patient feedback through quality of vision and spectacle independence questionnaires. Participants will need to attend all follow-up visits and comply with examination procedures throughout the study.

Researchers are evaluating the effects of balcinrenone combined with dapagliflozin compared to dapagliflozin alone in patients who have chronic heart failure, impaired kidney function, and have recently experienced a heart failure event. This Phase III study is conducted internationally across about 700 sites and aims to assess how these treatments impact cardiovascular death and heart failure events. Participants will be randomly assigned to one of three groups balcinrenonedapagliflozin 15 mg10 mg plus placebo, balcinrenonedapagliflozin 40 mg10 mg plus placebo, or dapagliflozin 10 mg plus placebo. Each participant will take one capsule and one tablet daily. The study duration averages 22 months, including screening, about 20 months of blinded treatment, and a one-month follow-up with open-label dapagliflozin. During the study, participants will undergo assessments for heart failure events, hospitalizations, and cardiovascular death. Researchers will monitor these outcomes over about 38 months, including symptom scores and other health measures. Safety and treatment effects will be followed during the treatment and the one-month post-treatment period.

Researchers are investigating kidney cancer through the UroCCR network, a national registry and research platform in France that collects detailed real-world data on patient care and disease progression. Established in 2011, this extensive database includes over 21,000 cases from 58 centers and links clinical information with annotated biological samples and national health data. The platform supports multiple types of research, including translational studies, clinical evaluations, and social science investigations, aiming to improve understanding and management of renal cell carcinoma. The study involves adult patients diagnosed with kidney cancer and documents their treatments, including procedures such as radical or partial nephrectomy as determined by the surgeon. Data collected encompasses clinical parameters, imaging, patient-reported outcomes, and socioeconomic factors. The registry supports prospective research projects and ancillary studies, with a focus on real-world practice following national guidelines. It also integrates digital tools for monitoring and prediction, enhancing personalized treatment strategies. Participants contribute data continuously from enrollment through long-term follow-up, which may last until death or withdrawal. The study collects comprehensive clinical, biological, imaging, and patient-reported information, along with biological samples like plasma, urine, and tumor tissue. Researchers measure outcomes related to research project promotion, biological sample collection, epidemiology, treatment monitoring, quality of life, biomarker research, and clinical practice evaluation. This ongoing data collection supports knowledge advancement and improved kidney cancer care over many years.