Aci

Researchers are evaluating whether eptinezumab can reduce the number of days with episodic migraine in children and adolescents aged 6 to 17 years. This Phase 3 clinical trial focuses on the preventive treatment of episodic migraine in pediatric participants using intravenous infusion. The study is randomized, double-blind, and placebo-controlled to compare the effects of different doses of eptinezumab with a placebo. Participants will be assigned to one of three groups a single intravenous infusion of eptinezumab 300 mg adjusted for weight, a single intravenous infusion of eptinezumab 100 mg adjusted for weight, or a single intravenous infusion of a placebo matching eptinezumab. The dosing occurs once, and the study monitors results over subsequent weeks. This design allows for comparison of the medication against placebo to evaluate treatment effects in this population. During the study, participants and their caregivers will complete headache diaries to document migraine and headache days. Researchers will assess changes in the number of monthly migraine days over 12 weeks, response rates to treatment, headache duration and intensity, acute medication use, and disability related to migraine using questionnaires like the Pediatric Migraine Disability Assessment PedMIDAS. Blood samples will be collected to measure drug concentrations and antibodies. Safety and efficacy are monitored throughout the study period, which concludes approximately 12 weeks after dosing.

Researchers are evaluating the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate targeting EGFR and HER3 with a chemotherapy payload, compared to treatment chosen by physicians including paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine for patients with first-line metastatic triple-negative breast cancer TNBC or low estrogen receptor ER-low, HER2-negative breast cancer who cannot receive anti-PDL1 or endocrine therapies. This study includes adults with locally advanced, recurrent inoperable, or metastatic disease who meet specific eligibility criteria. Participants are randomly assigned to receive iza-bren or one of the physicians choice chemotherapy regimens. The treatments are given at specified doses on scheduled days. The study includes two phases Phase 2 to determine the recommended dose of iza-bren and Phase 3 to compare progression-free survival and other outcomes. The study will last several years, with follow-up extending up to approximately 47 months after randomization. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, laboratory tests, and monitoring for adverse events. Quality of life questionnaires will also be completed. Researchers will track progression-free survival, overall survival, treatment-related side effects, tumor size changes, and patient-reported outcomes to evaluate the treatments. The total participation duration may extend up to several years depending on treatment response and follow-up requirements.

Researchers are evaluating the efficacy and safety of a combination of KarXT and KarX-EC to treat cognitive impairment in individuals with mild to moderate Alzheimers Disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to understand how these treatments affect thinking and memory problems associated with Alzheimers. The study is sponsored by Bristol-Myers Squibb and focuses on participants aged 60 to 85 years diagnosed according to specific clinical criteria and biomarkers. Participants will be randomly assigned to receive either the combination of KarXT and KarX-EC or a placebo. The medications are given at specified doses on designated days, though exact dosing schedules are not detailed in the summary. The study follows a parallel-group design, comparing the effects of the active drugs against placebo over a treatment period lasting 24 weeks. During the study, participants and their caregivers will attend visits where cognitive function and daily living abilities are assessed using tools such as the Alzheimers Disease Assessment Scale-Cognitive Subscale ADAS-Cog11 and Clinicians Interview-Based Impression Plus Caregiver Input CIBIC. Safety is closely monitored through reports of adverse events, vital signs, laboratory tests, ECGs, and other clinical evaluations. The study lasts through the treatment period up to 24 weeks, with continuous monitoring of participant health and cognitive changes.

Researchers are studying adults aged 40 years or older who have at least one family member with pulmonary fibrosis, a condition that causes scarring in the lungs and makes breathing difficult. The trial aims to find out if a drug called nerandomilast can slow lung changes in people showing early lung abnormalities on scans. This study is a Phase 3 clinical trial involving participants who have early signs of lung scarring and a family history of pulmonary fibrosis. Participants are randomly assigned to one of two groups one group takes nerandomilast tablets, and the other takes placebo tablets that look the same but contain no medicine. They take a tablet twice daily for about 2 to 3 years. During the study, there is a 60% chance a participant will receive nerandomilast. The trial lasts approximately 2 to 3 years, with more frequent visits every three months during the first two years and then every six months, plus phone calls in the third year. Throughout the study, doctors regularly test lung function and perform chest scans to monitor lung changes and the effects of treatment. Health status and any unwanted effects are also checked. The main outcome measured is the time to worsening of lung abnormalities over the trial period. Participants will be followed closely with lung function tests, imaging, and health assessments to understand the impact of nerandomilast compared to placebo.

Researchers are evaluating whether compressive cryotherapy can reduce opioid use and improve recovery after primary total knee arthroplasty in patients with knee osteoarthritis. This randomized controlled trial compares compressive cryotherapy using the Game Readyae device with standard care using traditional ice packs to assess effects on postoperative pain and recovery. Participants will be randomly assigned to receive either compressive cryotherapy with the Game Readyae device or standard cryotherapy with ice packs. The Game Readyae device delivers circulating cold water combined with intermittent pneumatic compression applied to the knee for 20 minutes, four times daily during the first 7 days after surgery. Compression starts on day 3 at medium pressure. The standard care group will apply ice packs as needed and elevate the limb. Both groups follow the same postoperative pain relief and rehabilitation plan. During the 7-day postoperative period, participants will record daily pain levels using a visual analog scale and document opioid use in a pain diary. On day 7, researchers will evaluate knee swelling, hematoma size, and quality of recovery using the QoR-15 questionnaire. The main outcome measured is total opioid consumption during the first 7 days after surgery. This study lasts for the first week post-surgery, with follow-up assessments at day 7.

Researchers are creating a registry of patients with Pulmonary Hypertension who receive medical care at the Hospital Italiano of Buenos Aires. The study includes both new cases of pulmonary hypertension type I and existing patients diagnosed before the registry began, following updated diagnostic guidelines. This registry aims to gather important data on this condition to better understand its occurrence and outcomes. This is an observational study without treatment interventions. It enrolls patients diagnosed with Pulmonary Arterial Hypertension PAH WHO group 1 based on specific hemodynamic criteria from the 2022 ESCERS guidelines. Patients are included prospectively or as prevalent cases within the hospitals health maintenance organization. Participants will be monitored to collect data on the prevalence and incidence of pulmonary hypertension over one year. Researchers will also track mortality rates within that timeframe. The study involves reviewing medical records and clinical information. Participation continues as long as the patient remains in care, with the registry ongoing since 2017 and expected to continue through 2031.