Vaxjo

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Healthcare professionals often face severe stress, which can lead to sick leave and affect their well-being. This research aims to evaluate whether a five-week internet-based compassion course can help reduce stress of conscience and work-related stress, while improving professional quality of life and self-compassion. The study compares this compassion course with a general internet-based cognitive behavioral therapy CBT stress management course and a waitlist group. Participants will be randomly assigned to one of three groups a therapist-guided internet compassion course, a therapist-guided general internet CBT stress management course, or a waitlist for 10 weeks followed by the general CBT course. Both courses are structured self-help programs lasting five weeks, including weekly reports and therapist feedback delivered online. The compassion course focuses on compassion-focused therapy methods, while the CBT course uses traditional CBT techniques. Throughout the study, participants will complete assessments at baseline, 5, 10, and 15 weeks, and again at 6 months. These assessments measure changes in stress of conscience, professional quality of life, work-related stress, and self-compassion. Data are collected through self-assessment forms, and the study tracks progress over time to understand the effects of the courses. The total participation time spans up to 6 months to monitor longer-term outcomes and maintenance of benefits.

Researchers are evaluating an artificial intelligence AI decision support system called Dermalyser to help primary care physicians distinguish between skin cancer and benign skin lesions. This multicenter randomized controlled trial is conducted at about 30 primary care centers across Sweden, Germany, Scotland, the Netherlands, and Australia. The study aims to assess the accuracy, reliability, and clinical usefulness of Dermalyser in real clinical settings where most patients with skin lesions are managed. Participants will be assessed at primary care centers randomized to either use Dermalyser as a complementary diagnostic tool or follow the standard clinical procedure without AI support. After reaching half of the planned enrollment, centers switch from one phase to the other. Physicians can choose to use Dermalyser when they find it indicated, but the final clinical decision about lesion management remains with the physician. Both groups will be followed for up to five years to track tumor diagnoses, proportions of skin cancer versus benign lesions, and related health outcomes. During the study, participants will have their skin lesions evaluated according to either the AI-supported or standard procedure. The primary outcome measure is the proportion of skin cancers detected within six months of enrollment. Researchers will monitor morbidity and mortality related to skin cancer and compare differences between the groups. Participation may last up to five years with follow-up to assess diagnostic outcomes and safety. The study is sponsored by Linkping University.

Researchers are evaluating whether a shorter period of immunotherapy after radical surgery is as effective as the standard longer treatment for patients with high-risk malignant skin melanoma. This study focuses on people aged 18 and older who have undergone surgery for stage IIb-c, III, or IV melanoma. The goal is to see if six months of immunotherapy can prevent cancer recurrence as well as the current 12-month treatment, potentially reducing side effects, hospital visits, and healthcare costs. The study is a randomized phase 3 trial conducted internationally with patients followed for up to five years. Participants will receive immunotherapy drugs, currently nivolumab or pembrolizumab, given intravenously. They are randomly assigned to either six months experimental group or 12 months standard group of treatment. Patients who had immunotherapy before surgery neoadjuvant treatment can also join, with their pre-surgery treatment time added to the post-surgery treatment. Medical exams and imaging scans CT or PET-CT are done at the start, six months, and 36 months, along with regular check-ups over three years. If cancer returns, additional tests and treatments are planned based on medical team decisions. During the study, participants will have scheduled visits for physical exams, blood tests, and scans to monitor their health and detect any recurrence. Researchers will measure relapse-free survival and distant metastatic-free survival at two years as primary outcomes, with overall survival and health economic effects also assessed over five years. Safety monitoring includes standard care practices and follow-up for up to five years. The study aims to confirm if shorter immunotherapy duration maintains the same outcomes while benefiting patients and healthcare systems.

Researchers are evaluating the combination of capivasertib with CDK46 inhibitors and fulvestrant in adults with hormone receptor-positive and HER2-negative locally advanced or metastatic breast cancer. This Phase IbIII study aims to determine the safe dose for the combination treatment in the initial Phase Ib part and then compare its effectiveness and safety to standard treatment in the Phase III part in participants who have not received prior endocrine therapy in the advanced setting. In the Phase Ib portion, participants receive capivasertib combined with one of the CDK46 inhibitorspalbociclib, ribociclib, or abemacicliband fulvestrant to establish recommended doses. In the Phase III part, participants are randomly assigned to receive either capivasertib plus fulvestrant with a chosen CDK46 inhibitor palbociclib or ribociclib or fulvestrant with a CDK46 inhibitor alone. Treatments are given in 28-day cycles with specific dosing schedules for each drug, including oral doses of capivasertib and CDK46 inhibitors and injections of fulvestrant. Participants undergo screening and regular monitoring throughout the study, including assessments of treatment side effects, tumor progression, and blood samples for pharmacokinetics and biomarker analysis. The primary outcomes include dose-limiting toxicities and adverse events in Phase Ib and progression-free survival in Phase III, with follow-up lasting up to several years to evaluate overall survival, response rates, physical functioning, and quality of life.

This research investigates the use of superparamagnetic iron oxide SPIO nanoparticles as a tracer for delayed sentinel lymph node dissection d-SLND in women with breast conditions where immediate axillary surgery is not needed. This includes patients with a preoperative diagnosis of ductal carcinoma in situ DCIS, unclear suspicious breast lesions, or those planned for risk-reducing mastectomy. The study aims to assess the effectiveness and accuracy of the delayed SLND approach, allowing some patients to avoid upfront surgery in the axilla. Participants receive an injection of SPIO near the breast lesion during their primary breast surgery, either up to 24 hours before or during the operation. If the final pathology shows invasive breast cancer, a second operation is performed to remove the sentinel lymph nodes SLNs using either SPIO or a radioactive tracer, depending on random assignment. The procedure involves multiple steps including detection of magnetic and radioactive signals, incision, SLN identification, and removal. Blue dye may also be used to assist in locating the nodes. During the study, patients undergo initial breast surgery with SPIO injection and magnetic signal detection but no immediate SLN removal. If invasive cancer is found, the delayed SLND procedure is done later with additional tracers. Researchers measure detection rates of SLNs, concordance between methods, and malignancy rates. Safety and procedure success are closely monitored. The study includes a control group receiving standard upfront SLND, and participants are followed until the study ends in 2027.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Generalized anxiety symptoms are common and often treated in primary health care. This research aims to better understand how adults with these symptoms experience anger and how healthcare professionals perceive and manage anger in these patients. The study focuses on adults with symptoms of generalized anxiety regardless of a formal diagnosis and explores the connection between anxiety and anger through qualitative interviews. The study involves interviewing two groups patients aged 18 or older with symptoms of generalized anxiety and healthcare professionals who work with these patients in primary care settings. There is no intervention or treatment applied, as it is an observational study. Interviews are guided by questionnaires and are audio recorded and transcribed for analysis. Participants will complete background questionnaires and take part in interviews about their experiences and attitudes towards anger in the context of generalized anxiety. The data will be analyzed thematically to identify patterns and insights. Researchers will evaluate the experiences of anger up to six months after enrollment. The total study duration varies per participant, focused on collecting qualitative data without active treatment or follow-up procedures.

Spontaneous intracerebral hemorrhage ICH is a serious type of stroke with high death and disability rates. Researchers are investigating whether a structured treatment package called a Care Bundle can improve the 3-month outcomes for patients with acute ICH compared to standard care. The study is an international, multicenter, parallel, cluster-randomized clinical trial focusing on implementing this Care Bundle in high-income countries, building on results from previous trials mostly done in low- and middle-income countries. The Care Bundle includes early intensive blood pressure lowering, treatment of fever and high blood sugar, rapid reversal of oral anticoagulation, and timely referrals to intensive care or neurosurgery when needed. Hospitals are randomized in batches through three phases usual care, randomized evaluation of the Care Bundle versus usual care, and a post-implementation follow-up where all hospitals apply the Care Bundle. Each batch lasts 18 months, with 6 months per phase, and the overall study rollout spans 2.5 years. Participants are adults aged 18 or older diagnosed with spontaneous ICH confirmed by imaging within 24 hours of symptom onset. During the study, patient management details and outcomes will be closely monitored, including brain imaging, blood pressure, glucose levels, and functional status. The primary outcome is functional recovery measured by a utility-weighted modified Rankin Scale score at 180 days. Secondary outcomes include disability, death, and health-related quality of life. The study also collects data on treatments and care decisions to evaluate the Care Bundles effectiveness and sustainability.

Researchers are comparing one-visit versus two-visit root canal treatments for infected necrotic teeth in general dental practice. The study aims to evaluate the outcomes one and four years after treatment, focusing on periapical health, root filling quality, and complication rates. A pilot study will first identify and address any protocol issues before the main multicenter trial across several clinics in Sweden begins. Patients will be randomly assigned to receive either a root canal treatment completed in one visit or in two visits spaced at least one week apart. Both treatment methods follow standard clinical practices without rigid protocols. After treatment, patients will have a phone call 5-7 days later, a control visit at one month, and clinical evaluations at one and four years including intra-oral radiographs reviewed by independent observers. During the study, participants will undergo regular assessments of post-operative pain, medication use, tooth survival, and any complications. Follow-up includes clinical exams and radiographic checks to determine treatment success based on clinical and radiographic normalcy. The study plans to recruit about 1000 patients to ensure statistically meaningful results, with monitoring continuing up to four years after treatment completion.