Dublin 12

The total study duration per patient will be 166 weeks that will consist of a 4- week screening, a 12-week core treatment phase, a 144-week extension phase, and a 6-week post-treatment follow-up.

Researchers are evaluating the safety and effectiveness of tralokinumab combined with topical corticosteroids (TCS) for treating moderate-to-severe atopic dermatitis (AD) in children and infants. The trial includes two age groups: children aged 2 to under 12 years and infants aged 6 months to under 2 years. The study will last up to 4 years with visits every 2 weeks during the first year and every 6 weeks afterward, some conducted by phone. The goal is to assess improvements in AD severity, symptom relief, general health, and quality of life. Children will be randomly assigned to receive either tralokinumab plus TCS or placebo plus TCS for the first 16 weeks in a double-blind setup, with a 2 in 3 chance of getting tralokinumab. After 16 weeks, all participants will receive tralokinumab plus TCS. Infants will receive open-label treatment with tralokinumab plus TCS throughout the treatment period. The medication is given as subcutaneous injections with dosing based on body weight and adjusted at specified weeks throughout the study. After treatment ends, all participants will have a 4-week safety follow-up. Participants will undergo screening lasting up to 4 weeks to confirm eligibility. During the trial, researchers will monitor skin condition using assessments like the Investigator's Global Assessment (IGA) and Eczema Area and Severity Index (EASI) at week 16. Other evaluations include symptom scores and body surface area affected by AD. Safety and health will be closely tracked throughout the study duration.

Researchers are evaluating the safety and performance of Abbott's Structural Heart (SH) devices used in routine hospital practices and standard-of-care procedures for patients with various heart diseases including septal defects and valvular heart disease. This Registry study collects real-world data to meet regulatory requirements such as the European Union Medical Device Regulations that mandate active post-market clinical follow-up for all commercially available devices. The study is designed to include patients who undergo procedures involving Abbott SH devices and to provide ongoing safety and performance data over time. The study includes devices like the Amplatzer Occlusion Devices, which are used to close multiple septal heart defects, and the Epic Surgical Tissue Heart Valve devices, which serve as replacements for diseased or damaged native or prosthetic aortic or mitral valves. Patients may be enrolled before or shortly after the implant procedure, with specific follow-up timeframes varying by device type. Follow-up visits align with routine care and may be conducted in person, by phone, or virtually. The follow-up period ranges from discharge or 7 days post-procedure to as long as 10 years, depending on the device, to ensure thorough monitoring of device safety and effectiveness. Participants will provide informed consent and be monitored through their standard care visits, with data collected at multiple points including discharge, short-term (1-3 months), mid-term (6 months), and long-term (12 months or up to 10 years) follow-ups. A special sub-study focuses on specific surgical valve sizes at European sites for regulatory approval purposes. The study aims to enroll about 500 subjects per year over at least five years at approximately 25 sites worldwide, with assessments including clinical outcomes and device-related safety measures.

Researchers are evaluating new treatments for children and adults with newly diagnosed and relapsed rhabdomyosarcoma (RMS) in this multi-arm, multi-stage Phase 1 and Phase 2 study called FaR-RMS. The study aims to assess the effects of new drug combinations, changes in maintenance therapy duration, dose adjustments, radiotherapy timing, and the use of genetic and imaging markers to improve outcomes and quality of life. It also explores risk classification using the PAX-FOXO1 fusion gene and FDG PET-CT scans as prognostic tools after initial chemotherapy. Participants may receive various chemotherapy drugs including Irinotecan, Actinomycin D, Doxorubicin, Ifosfamide, Vincristine, Vinorelbine, Cyclophosphamide, Temozolomide, and Regorafenib. Radiotherapy is also part of the treatment options. The study includes multiple randomizations and registrations depending on patient risk and disease status. Newly diagnosed patients are ideally enrolled before chemotherapy, but those at other treatment stages or with relapsed disease can also join. Some patients may enter more than one randomization based on their condition. During the study, participants undergo regular assessments to monitor tumor progression, treatment response, and side effects. Researchers track event-free survival and local failure-free survival over time, with follow-up ranging from 36 months to a minimum of 6 years for some groups. Safety, quality of life, and the impact of treatments are closely monitored through clinical exams, imaging, and laboratory tests. Participants provide informed consent and agree to contraception use if applicable. The total study involvement varies based on the treatment arm and disease status.