Falun

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are studying an intermittent dosing strategy of ibrutinib, a drug approved for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Ibrutinib is usually given daily at a continuous dose of 420 mg until the disease progresses. Due to increasing drug costs and some patients maintaining disease control even after stopping ibrutinib because of side effects, this pilot study explores whether cycling ibrutinib on and off could be effective and reduce costs and side effects. The study also looks at long-term effects on mutations related to the drug's target, Brutonb4s tyrosine kinase (BTK).

Researchers are investigating whether adding regular radiological scans during follow-up after surgery for high-risk malignant melanoma improves patient survival. This study focuses on patients who have undergone radical surgery for stage IIb-c and III cutaneous malignant melanoma. Since radiological exams can be costly, cause anxiety, and expose patients to radiation, the study aims to determine their value especially given the availability of effective medical treatments for melanoma. Participants are randomly assigned to one of two groups for a 3-year follow-up period. One group receives routine follow-up with regular doctor visits according to national guidelines. The other group receives the same follow-up plus whole body CT or PET scans and blood tests at baseline, 6, 12, 24, and 36 months. An interim analysis will be done after 1000 patients have enrolled. Throughout the study, researchers will monitor overall survival over a 5-year period. Participants will have scheduled assessments including scans and blood tests if assigned to the imaging group. The study also tracks adherence to follow-up visits and any health changes. This approach aims to provide clear evidence on the benefit and impact of imaging during follow-up after melanoma surgery.

Researchers are evaluating the safety and effectiveness of a new combination treatment using Surovatamig (AZD0486), a fully human bispecific monoclonal IgG4 antibody, together with rituximab. This Phase III, global, randomized, open-label study focuses on participants with untreated follicular lymphoma (FL) to see if this combination offers added benefits compared to three standard chemoimmunotherapy regimens chosen by the investigator. The study has two parts: a safety run-in and the main Phase III comparison. The first part, the Safety Run-in, compares different dose levels of Surovatamig plus rituximab to find the recommended Phase III dose (RP3D). The second part, Phase III, involves three groups: two groups receiving different schedules of Surovatamig plus rituximab, and one group receiving one of three standard regimens (R-CVP with rituximab maintenance, R-CHOP with rituximab maintenance, or Bendamustine plus rituximab maintenance) as chosen by the investigator. Treatment schedules and doses are monitored closely through the study. Participants will be followed for up to 10 years to monitor the occurrence and severity of side effects, treatment discontinuations, dose changes, and overall safety. The main goal is to assess whether the new combination is superior to standard treatments. Regular evaluations include safety assessments and monitoring treatment effects over time, with attention to both short-term and long-term outcomes.

Researchers are evaluating treatments for people with newly diagnosed multiple myeloma who are not candidates for or do not plan to have autologous stem cell transplant as initial therapy. The study compares the effectiveness of two new combination treatments: teclistamab with daratumumab and lenalidomide (Tec-DR), and talquetamab with daratumumab and lenalidomide (Tal-DR), against the standard treatment of daratumumab, lenalidomide, and dexamethasone (DRd). This is a Phase 3 randomized study designed to assess which treatment better controls the disease. Teclistamab, talquetamab, and daratumumab are given as subcutaneous injections, while lenalidomide is taken orally. Dexamethasone can be given either orally or by intravenous injection. Participants receive one of the three treatment combinations as assigned by the study. The treatments are administered regularly over the study period, with close monitoring and follow-up to evaluate outcomes. The study includes up to 9 years of follow-up to track disease progression and survival. Participants will undergo regular assessments including monitoring for disease progression and treatment response. Key measures include progression-free survival from the time of randomization and the presence of minimal residual disease-negative complete response at 12 months. Safety and tolerability are also tracked throughout the study. Total participation time includes treatment and extended observation to assess long-term outcomes and side effects.

Researchers are evaluating the study medicine elranatamab alone and in combination with daratumumab for people with relapsed or refractory multiple myeloma who have received prior treatments including lenalidomide and a proteasome inhibitor. The study aims to compare elranatamab to a combination therapy of daratumumab, pomalidomide, and dexamethasone, while also assessing the safety and activity of elranatamab with daratumumab. This is an open-label, phase 3 randomized trial involving multiple centers. The study includes three parts. Part 1 evaluates the safety and activity of different doses of elranatamab combined with daratumumab. In Part 2, participants are randomly assigned to receive either elranatamab alone, elranatamab with daratumumab, or the combination of daratumumab, pomalidomide, and dexamethasone. Part 3 investigates the effect of increased infection protection measures in participants treated with elranatamab alone or with daratumumab. All drugs are given by either subcutaneous injection or orally depending on the medication. Participants will receive study treatment until their disease worsens, unacceptable side effects occur, or they decide to stop. Researchers will monitor safety by tracking dose limiting toxicities during the first 42 days after starting elranatamab and treatment-emergent adverse events during the first 84 days. Progression-free survival will be assessed up to 51 months after randomization. Throughout the study, participants will undergo regular assessments to evaluate treatment safety and effectiveness.

Researchers are collecting prospective data on about 200 patients who undergo alloplastic total temporomandibular joint (TMJ) replacement, a treatment for TMJ disorders. The study aims to understand clinical indications, treatment patterns, outcomes, and quality of life changes after TMJ replacement. It also seeks to identify factors that predict better results and to document reasons why some patients refuse this surgery. The study follows patients for up to 5 years after their TMJ replacement surgery, with data collected at several time points: 10 days, 3 months, 6 months, 12 months, 24 months, and 60 months post-surgery. Information gathered includes the underlying disease, treatment details, functional outcomes, patient-reported outcomes, and any complications related to the procedure. Participating sites are also asked to register patients who decline the TMJ replacement. During the study, patients provide informed consent and are monitored over time with assessments focusing on pain, jaw movement, occlusion, and quality of life. Researchers track adverse events and collect data to understand long-term results and patient experiences. This registry design allows for comprehensive observation of patients from before surgery through 5 years of follow-up.

Researchers are investigating whether a shorter duration of immunotherapy is as effective as the current standard for patients with high-risk malignant skin melanoma who have undergone radical surgery. This phase 3 international study focuses on patients aged 18 and older with stage IIb-c, III, or IV melanoma. The goal is to compare six months versus twelve months of immunotherapy to determine if the shorter treatment can prevent cancer recurrence as well as the longer one, potentially reducing side effects, hospital visits, and healthcare costs. The study treatment involves immunotherapy using drugs nivolumab or pembrolizumab given intravenously according to routine clinical practice. Patients are randomized to receive either six months (experimental group) or twelve months (standard group) of treatment. For those who received neoadjuvant immunotherapy before surgery, treatment durations are adjusted accordingly to total six or twelve months. Follow-up includes imaging scans at baseline, six months, and thirty-six months, along with medical examinations at multiple time points up to three years. If relapse occurs, further evaluations and treatment decisions are made by a multidisciplinary team. Participants will have regular visits for physical exams, imaging tests, and blood work to monitor their health and treatment response. The main outcomes measured are relapse-free survival and distant metastatic-free survival at two years. Overall survival and health economic effects will also be assessed. Patients are followed for up to five years to track survival and any disease recurrence, ensuring close monitoring of safety and effectiveness throughout the study period.

Researchers are evaluating optimized drug treatments for patients with Takotsubo Syndrome, also known as Broken Heart Syndrome. This large Phase 4 trial aims to include 1000 patients registered in SWEDEHEART to provide documented evidence for effective pharmacologic care, as current data is limited. The study is a multinational, multicenter, registry-based, open-label, randomized controlled trial focused on improving treatment outcomes for this heart condition. Participants may receive one of several treatments: an infusion of Adenosine at 70 g/kg/min for 3 hours, oral Dipyridamole 200 mg twice daily, oral Apixaban 5 mg twice daily, or care guided by recommendations from the Taskforce on Takotsubo Syndrome of the Heart Failure Association of the European Society of Cardiology, which may vary by local practice. The trial includes two randomizations with specific treatment options and criteria. During the study, researchers will assess heart function using wall motion scores and monitor for serious events such as death, cardiac arrest, heart failure hospitalization, or reduced heart ejection fraction up to 30 days after treatment. They will also track thromboembolic events and cardiac thrombus via echocardiography within the first few days and through day 30. Safety and treatment adherence will be monitored throughout, with detailed follow-up to understand treatment effects and patient outcomes.

Researchers are evaluating whether using the World Health Organization's Labour Care Guide (LCG) instead of standard care for monitoring labor progress can improve outcomes for newborns and mothers. This study compares these two guidelines to see if the LCG can reduce adverse neonatal outcomes, such as perinatal mortality, neonatal complications, and the need for cesarean sections during labor. The research also looks at other perinatal interventions, complications, and economic factors, using a multicenter, stepped-wedge cluster randomized trial design conducted from 2023 to 2025 in Sweden. Participants will receive care based on either the WHO's LCG or standard labor monitoring guidelines. The LCG is a next-generation partograph designed to follow the latest intrapartum care recommendations. The study involves multiple delivery units where women in active labor receive monitoring according to the assigned guideline. Researchers will compare outcomes such as neonatal morbidity, cesarean section rates, use of oxytocin, postpartum hemorrhage, labor duration, and experiences of women, their partners, and healthcare providers. Throughout the study, participants will be monitored for neonatal complications including low Apgar scores, hypoxic ischemic encephalopathy, intracranial hemorrhage, seizures, meconium aspiration syndrome, and neonatal unit admissions. The study will also assess maternal outcomes and collect feedback via questionnaires and interviews about childbirth experiences and guideline compliance. The primary outcomes are adverse neonatal events and intrapartum cesarean rates, with follow-up from 12 weeks up to 18 months after birth to gather comprehensive data on health and safety.