Myszkow

Psoriatic arthritis PsA is a chronic inflammatory condition that affects the joints and skin in people with psoriasis. This study aims to evaluate how well zasocitinib TAK-279 works in adults with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs. The trial is a Phase 3, randomized, double-blind study comparing zasocitinib with an active comparator and placebo. Participants will be assigned to one of four groups zasocitinib Dose A once daily, zasocitinib Dose B once daily, an active comparator capsule twice daily, or placebo once daily for 16 weeks followed by switching to zasocitinib Dose A or B up to 52 weeks. Treatments are taken orally as tablets or capsules over a period of up to 60 weeks. During the study, participants will undergo regular assessments including joint counts, skin evaluations, and various disease activity measurements such as ACR20 and PASI-75 responses. Researchers will monitor changes from baseline in functional and quality of life scores, as well as safety and tolerability. Participants will be involved in visits throughout the treatment period to evaluate the effects and collect data on the disease and treatment responses.

Atrial Septal Defect ASD is a type of congenital heart defect that may be closed without open-heart surgery. Traditionally, ASD closure was done surgically, but less invasive options like percutaneous transcatheter occluder devices have become available. This research aims to collect real-world clinical data and confirm the long-term safety and performance of the Lifetech Cera153 ASD Occluder, a device used to close ASD without surgery. The study also seeks to identify any previously unknown side effects of this device. Participants in this study will have received the Lifetech Cera153 ASD Occluder between January 2020 and December 2023, following instructions for use. The study is single-armed and observational, planned under the Regulation EU 2017745. Subjects will be followed up for two years after device implantation to track outcomes and safety. The enrollment period is expected to last about one year with a target of 139 participants. During the study, researchers will monitor procedural success six months after implantation and assess successful closure of the defect immediately after the procedure, at hospital discharge, and at 12 months. They will also track new onset arrhythmias requiring treatment, device or procedure-related adverse events and serious adverse events, as well as any deaths from the time of the procedure up to two years post-implantation. Participants must attend follow-up visits as part of the study, with all data collected and processed with their consent.

This research aims to evaluate the effects of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with a systolic blood pressure of at least 130 mmHg, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial focusing on preventing heart failure events and cardiovascular death. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those starting the baxdrostatdapagliflozin treatment may begin with a lower baxdrostat dose that can be increased if certain criteria are met. A run-in period with dapagliflozin alone for 4 to 6 weeks may occur for those not previously treated or treated less than 4 weeks with SGLT2 inhibitors. Treatment visits will occur at about 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months until study closure. Participants will undergo screening for eligibility within a 14-day period, with an optional pre-screening phase that does not require site visits or consent. During the study, regular assessments including monitoring for heart failure events and cardiovascular outcomes will be conducted. If participants stop the blinded treatment early, they may continue with open-label dapagliflozin unless specific discontinuation criteria apply. The study will continue until a predetermined number of cardiovascular events occur, with ongoing data collection and visits according to protocol.

Researchers are evaluating whether adding zilebesiran to standard antihypertensive treatment can reduce major cardiovascular events in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to determine if zilebesiran lowers the risk of cardiovascular death, heart attacks, strokes, or heart failure events compared to placebo. The study will continue until a targeted number of these events have occurred, which may take up to about 5 years. Participants will be randomly assigned to receive either 300 mg of zilebesiran or a placebo, both given as subcutaneous injections every 6 months, alongside their usual blood pressure medications. The study uses a parallel design and includes careful monitoring of blood pressure and cardiovascular events over time. Both groups will continue their standard antihypertensive therapies, including at least two medications where one must be a diuretic. During the study, participants will be regularly assessed for cardiovascular events such as heart attacks, strokes, heart failure hospitalizations, and cardiovascular death. Blood pressure measurements will be taken at baseline and at 6 months, among other times. The primary outcome is the time until the first occurrence of a major cardiovascular event, with secondary outcomes including changes in blood pressure and other cardiovascular events. Participants will be followed for up to approximately 5 years to monitor these outcomes and overall survival.