Granollers

Researchers are evaluating the long-term safety and effectiveness of abrocitinib, given as a liquid oral suspension, in children aged 2 years and older with moderate-to-severe atopic dermatitis. This Phase 3, open-label study includes children who have previously participated in abrocitinib studies as well as those who have not. The goal is to study up to 500 children globally over a period of up to 2 years or until the medicine becomes commercially available. Participants will receive abrocitinib oral suspension, with or without topical medications, throughout the study. The study consists of two groups: an extension group of children aged 2 to under 12 years who completed prior abrocitinib studies, and a de novo group of children aged 6 to under 12 years new to abrocitinib treatment. Both groups will be monitored for up to 24 months. During the study, children will be regularly assessed through evaluations, including monitoring for any adverse events, laboratory tests, and clinical examinations. Researchers will track treatment-emergent adverse events, serious adverse events, and any events leading to study discontinuation. Safety and efficacy will be closely followed throughout the entire study period to understand the long-term effects of abrocitinib in this population.

Researchers are evaluating the effectiveness, safety, and tolerability of two different doses of remibrutinib compared to a placebo in adults and adolescents with moderate to severe hidradenitis suppurativa (HS). This phase 3 study aims to determine how well remibrutinib works in treating this chronic skin condition characterized by painful abscesses and inflammatory nodules. The study lasts a total of 76 weeks and includes several phases: up to 4 weeks for screening, followed by a 16-week double-blind treatment period where participants receive either remibrutinib Dose A, Dose B, or a matching placebo. After this, there is a 52-week treatment period where all participants receive remibrutinib (Dose A or Dose B). Finally, a 4-week safety follow-up period occurs without treatment. Participants who stop treatment early are encouraged to stay in the study and complete the safety follow-up. During the study, participants will be regularly assessed for clinical response to treatment, focusing on the proportion achieving a 50% improvement in HS symptoms by week 16. Researchers will monitor safety and tolerability throughout the study, including during the follow-up period. Various evaluations such as physical exams and clinical assessments will be conducted to measure treatment effects and ensure participant safety over the entire 76-week duration.

Researchers are evaluating the medicine called abrocitinib in children aged 6 to less than 12 years old with moderate-to-severe eczema. This phase 3 study aims to find out if abrocitinib improves eczema symptoms and is safe for this age group. Participants will be randomly assigned to receive either abrocitinib or a placebo for 16 weeks, with the total study lasting about 24 weeks. Participants will receive abrocitinib or placebo as a liquid oral suspension. During the study, children will use an electronic diary on a device resembling a cell phone to record questionnaire responses and receive daily reminders to take their medicine. They will also wear a wrist device to monitor scratching due to eczema. The study includes regular clinic visits and calls from study staff to monitor progress and adherence. Throughout the study, laboratory tests, physical exams, and vital signs (height, weight, temperature, blood pressure, and heart rate) will be conducted to monitor health. Questionnaires will assess eczema severity and improvement using standardized scales. The main outcomes measured at week 12 include skin clearance or near clearance and at least 75% improvement in eczema severity. Safety and overall health will be followed for the entire study duration.

This trial investigates the safety and effectiveness of risankizumab compared to vedolizumab in adults with moderate to severe ulcerative colitis (UC) who have not previously received targeted therapies. Ulcerative colitis is an inflammatory bowel disease causing inflammation and bleeding in the rectum and colon. The study is a Phase 3b, randomized, open-label trial enrolling about 530 participants across 285 sites worldwide. Participants will be randomly assigned to receive either risankizumab or vedolizumab. Those in the risankizumab group will receive the drug intravenously during the initial induction phase, followed by subcutaneous injections for maintenance. Participants in the vedolizumab group will receive the drug intravenously throughout the study. The treatment period lasts 44 weeks for risankizumab and 46 weeks for vedolizumab, following a screening period of up to 35 days. During the study, participants will attend regular outpatient visits for medical assessments, side effect evaluations, and to complete questionnaires. Researchers will monitor disease activity and drug safety, focusing on the percentage of participants achieving endoscopic improvement by week 48. The total study duration is approximately 69 weeks for risankizumab and 71 weeks for vedolizumab recipients.

Researchers are evaluating the effects and safety of AZD6793 tablets in adults aged 40 years and older who have moderate to very severe chronic obstructive pulmonary disease (COPD). This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study involving approximately 1160 participants at around 400 sites worldwide. The study aims to compare three different doses of AZD6793 against placebo tablets over 24 weeks to assess how well the treatment works and its safety profile in this population. Participants will be randomly assigned to one of four groups receiving either one of three doses of AZD6793 or a placebo in equal proportions. The treatment involves oral administration of AZD6793 tablets or placebo tablets daily for 24 weeks. The study is designed with parallel groups and includes careful dose-ranging to evaluate different levels of the investigational drug. During the study, participants will be monitored for the annualized rate of moderate or severe COPD exacerbations from baseline up to 24 weeks. Assessments include lung function tests such as pre- and post-bronchodilator FEV1/FVC ratios, symptom questionnaires like the COPD Assessment Test (CAT), and documentation of COPD exacerbation history. Safety will be continually evaluated through clinical assessments and laboratory tests throughout the treatment period.

Researchers are evaluating the use of Methinks Stroke Suite, an artificial intelligence (AI) imaging software, to speed up decisions about transferring acute stroke patients who need thrombectomy. This study focuses on patients at local stroke centers in Catalonia, Spain, that cannot perform endovascular therapy (EVT). The main goals are to find out if the AI software reduces the time to decide on patient transfers and to assess how accurately it identifies patients who need EVT. The study compares this AI-based workflow with historical patient data. Patients arriving at local stroke centers will receive a CT scan analyzed in real time by Methinks Stroke Suite. If the AI and clinical judgment suggest the patient is a candidate for thrombectomy, they will be transferred to a specialized center capable of EVT. When the AI does not detect a large vessel occlusion, further CT angiography may be used to reassess. The study includes a historical control group of similar patients who were treated without the AI software. Participants will be followed for 90 days after their stroke to evaluate recovery and functional outcomes. Researchers will measure the reduction in time from patient arrival to transfer decision, the accuracy of AI in detecting large vessel occlusions, workflow improvements, thrombectomy rates, safety during transfer, and clinician satisfaction with the software. The entire study period includes 18 months of patient enrollment, 3 months of follow-up, and 2 months for data analysis.

This research focuses on surgical site infections (SSI) that occur after elective colorectal surgery, a significant type of healthcare-associated infection (HAI) that negatively impacts patient health and burdens healthcare systems. Surveillance of these infections is a core part of the World Health Organization's Infection Prevention and Control Programmes and is essential to reduce serious adverse events in hospitalized patients. The study aims to assess a new artificial intelligence (AI) algorithm designed to detect SSIs at different anatomical levels in patients previously monitored in a nationwide surveillance system. The study evaluates the performance of this novel AI algorithm by comparing it against the current manual diagnostic system used by infection control teams for colorectal surgery patients enrolled in an SSI surveillance program. Traditional surveillance methods are manual, time-consuming, and prospective, covering up to 30 to 90 days post-surgery to capture infections that appear after hospital discharge. The AI algorithm leverages modern information technology to automate the detection of suspected SSI events using clinical text, microbiology reports, and coded data related to diagnoses and readmissions. Participants who have undergone elective colorectal surgery are monitored for up to 30 days post-operation to determine the rate of surgical site infections. The study involves detailed surveillance including clinical data review and infection diagnosis comparisons between the AI system and manual methods. Researchers measure the accuracy of the AI tool in detecting infections and consider how automated surveillance could improve infection control practices and reduce the workload for healthcare teams.

Researchers are evaluating two treatments for breast cancer patients who have a positive sentinel lymph node after receiving neoadjuvant systemic therapy. The study focuses on comparing axillary radiotherapy (ART) without lymphadenectomy to axillary lymph node dissection (ALND) to see which approach lowers the risk of lymphedema while monitoring cancer recurrence and overall survival. The trial includes patients treated with either neoadjuvant chemotherapy or hormone therapy and aims to assess quality of life alongside clinical outcomes. This is a prospective, randomized, open-label, multicenter study involving about 820 patients divided evenly between chemotherapy and hormone therapy groups. Participants will receive either ART targeting axillary levels I and II plus level III, supraclavicular, and possibly the internal mammary chain, or undergo ALND followed by radiotherapy to level III, supraclavicular, and possibly the internal mammary chain. A pilot phase with the first 200 patients has been completed, and an interim analysis will be conducted on this group. During the study, researchers will track disease-free survival over up to five years from diagnosis, noting any recurrence or death. Patients will undergo imaging assessments such as ultrasound or MRI to evaluate axillary response after treatment. Quality of life and side effects like lymphedema will also be measured. Follow-up will include monitoring overall survival and recurrence, ensuring comprehensive evaluation of both treatment safety and effectiveness.

Healthcare-associated infections, such as surgical site infections (SSI), can negatively affect patient health and impose a significant burden on healthcare systems. Surveillance programs are essential for preventing these infections and require active, ongoing monitoring for up to 30 to 90 days after surgery. This research investigates the use of ChatGPT-4, an artificial intelligence tool, to detect SSIs at three anatomical levels in patients who have undergone elective colorectal surgery, comparing its results to a national infection surveillance system as the standard. The study evaluates ChatGPT-4's ability to identify SSI cases by analyzing electronic health records, including clinical notes and microbiology reports. The current manual surveillance method, which is time-consuming, will be compared with the AI-assisted approach to determine if automated detection can improve efficiency and accuracy. The research focuses on elective colorectal surgery patients and uses the CDC's SSI definitions for diagnosis. Participants will be involved retrospectively, with their surgical and infection data analyzed using both manual and AI methods. The primary outcome measured is the rate of surgical site infections within 30 days post-surgery. This diagnostic accuracy study aims to assess how well the AI chatbot can support infection control teams by automating parts of the surveillance process, potentially leading to better infection prevention and patient care.

This research aims to gather real-world information on using intravascular lithotripsy (IVL) with the Shockwave IVL system to treat calcified lesions in the femoropopliteal and crural arteries of patients with chronic limb-threatening ischemia (CLTI). The main goal is to understand how effective IVL is in helping wounds heal and avoiding amputations. The study also looks at how well the treatment restores blood flow immediately, its safety, and its effect on patients' quality of life. Participants receive treatment with the Shockwave Medical IVL System, a comprehensive device that includes a generator, connector cable, and a single-use catheter with an integrated balloon designed to break up artery calcification. The study is observational and collects data on patients who undergo this treatment for their calcified arterial lesions. During the study, researchers will monitor wound healing and whether participants avoid amputation over 12 months. They will also assess how well the blood vessels open after treatment and track safety and quality of life outcomes. Participants will be followed to collect this information over the course of a year to understand the impacts of IVL treatment for CLTI.