Vaxjo

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are evaluating whether a five-module online compassion course can help reduce stress of conscience and work-related stress while improving professional quality of life and self-compassion among healthcare professionals. The study addresses the high levels of stress and sick leave among healthcare workers in Sweden, especially during the COVID-19 pandemic, and aims to find effective ways to support staff well-being and patient care. The study compares an internet-based compassion course lasting five weeks, which includes traditional compassion-focused therapy methods and weekly feedback from a therapist, to a waiting list group that after ten weeks receives a general internet-based cognitive-behavioral therapy (CBT) stress management course. The CBT course is also five weeks long and involves structured self-help with weekly therapist feedback. This design allows evaluation of the compassion course against a general stress management approach. Participants are healthcare professionals working directly with patients who complete regular self-assessments including stress questionnaires. Researchers measure changes in stress of conscience over 15 weeks and six months from baseline. The study tracks work-related stress, professional quality of life, and self-compassion levels using questionnaires. Safety is monitored through participant-reported outcomes, with follow-up contacts as needed. The total participation includes the course periods and extended observation to assess lasting effects.

Researchers are evaluating an artificial intelligence (AI) decision support system called Dermalyser to help primary care physicians distinguish skin cancer from benign skin lesions. This study is a multicenter, cluster-randomized controlled trial conducted at about 30 primary care centers across Sweden, Germany, Scotland, the Netherlands, and Australia. The aim is to assess the accuracy, reliability, and clinical usefulness of Dermalyser in real-world primary care settings where most patients with skin concerns are managed. The study also explores whether using this AI tool can improve early detection of skin cancer and reduce unnecessary removal or referral of benign lesions. During the study, participating primary care centers are randomly assigned to either use the Dermalyser device as a complementary diagnostic aid (intervention phase) or follow their usual clinical assessment without AI support (control phase). After enrolling half of the planned 3000 participants (1500 patients), the centers switch phases, allowing all to experience both approaches. Physicians decide on the clinical management of lesions, with Dermalyser providing additional information only during the intervention phase. Participants are followed for up to 5 years to monitor tumor diagnoses, skin cancer rates, and related health outcomes. Participants are patients attending primary care to have suspicious skin lesions checked. Researchers will assess the proportion of skin cancers diagnosed within six months of enrollment using standard clinical procedures. Throughout the study, data on diagnoses, morbidity, and mortality related to skin cancer will be collected. This long-term follow-up aims to determine differences between those assessed with and without the AI decision support. The study results could help improve skin cancer diagnostics and patient care in primary care settings worldwide.

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.

This research investigates the effectiveness and safety of combining capivasertib with CDK4/6 inhibitors and fulvestrant in adults with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer that is locally advanced, inoperable, or metastatic. It includes a Phase Ib dose-finding portion to establish safe dosages for the triple combination, followed by a Phase III study comparing this combination to CDK4/6 inhibitors plus fulvestrant alone. The study focuses on patients who have not received prior endocrine therapy for advanced disease and aims to assess added benefit in a high-risk population. During Phase Ib, participants receive capivasertib orally twice daily for 4 days followed by 3 days off each week, combined with fulvestrant injections and one of the CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) at varying doses to find the recommended dose for Phase III. In Phase III, participants are randomized to receive capivasertib plus fulvestrant and a CDK4/6 inhibitor at the established dose or fulvestrant plus a CDK4/6 inhibitor alone, with dosing schedules maintained over 28-day cycles. Participants undergo regular monitoring including scans for tumor assessment, blood tests, and safety evaluations over extended periods—up to 47 months for progression-free survival assessment. Researchers track adverse events, serious side effects, and treatment tolerability throughout. Mandatory tumor and blood samples are collected for biomarker analysis. The study evaluates key outcomes such as dose-limiting toxicities, treatment-related adverse events, and progression-free survival, supporting long-term safety and effectiveness evaluation.

Researchers are investigating the use of superparamagnetic iron oxide (SPIO) nanoparticles as a tracer for delayed sentinel lymph node dissection (d-SLND) in women with ductal cancer in situ (DCIS), unclear breast lesions, or those planned for risk-reducing mastectomy where upfront axillary surgery is not needed. The study aims to evaluate the effectiveness and accuracy of delaying sentinel lymph node dissection until invasive cancer is confirmed by pathology, avoiding unnecessary upfront surgery. This is a phase 3 open-label randomized controlled trial designed to accommodate different surgical practices for mastectomy and breast-conserving surgery. Participants receive an injection of SPIO near the lesion either up to 24 hours before or during the primary breast surgery. The sentinel lymph node (SLN) is marked with SPIO but not removed during the initial operation. If final pathology shows invasive breast cancer, a second operation (d-SLND) is performed using either SPIO or radioactive isotope as the primary tracer, with randomization determining the order. The procedure involves measuring magnetic and isotope signals, incision, SLN identification, excision, and checking for residual signal. Blue dye use is optional but recommended, and all SLNs identified by any tracer are removed. A control group undergoing standard upfront SLND is also included. Participants undergo breast surgery with SPIO injection, potential second surgery for d-SLND if invasive cancer is found, and careful intraoperative monitoring of tracer signals. Researchers measure detection rates of delayed and late SLND and nodal concordance during operations. Data on technical success and procedure steps are collected. Patients are monitored for outcomes related to SLN detection and procedure success. The total participation duration depends on surgical findings and may include follow-up evaluations after both surgeries.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Symptoms of generalized anxiety is common in the general population and is often treated in primary health care. The core of the diagnostic criteria for generalized anxiety disorder (GAD) is excessive long-term worry that is difficult to control and concerns a number of events or activities. In this study we use the term "symptoms of generalized anxiety" by which we refer to these symptoms, regardless of whether the patient has a clinically established diagnosis of GAD or not. Anger is an emotion that can lead to interpersonal problems but can also be an agent for justice and change. Previous research has shown a link between generalized anxiety and anger but there is a lack of qualitative research on how individuals with symptoms of generalized anxiety experience anger. The aim of this research study is to increase knowledge about how anger is experienced in adult patients in primary health care with symptoms of generalized anxiety and about the experiences of health care professionals working with patients with symptoms of generalized anxiety. The study has the following research questions: 1. How do adult patients in primary health care with symptoms of generalized anxiety experience their own anger? 2. How do health care professionals experience anger in patients in primary health care with symptoms of generalized anxiety? 3. How do health care professionals experience attitudes towards and treatment of adult patients with symptoms of generalized anxiety in primary health care with special focus on the patients' anger? Patients with symptoms of generalized anxiety and health care professionals at primary health care centers are interviewed (se section on eligibility). The goal is to include 15-20 patients and 15-20 health care professionals. A questionnaire with background questions is completed and the interviews follow an interview guide. The background questionnaire and interview guide differ between patients and health care professionals. The interviews are audio recorded and transcribed into text. The data is analyzed using thematic analysis according to the guidelines given by Braun and Clarke (2006; 2013).

Spontaneous intracerebral hemorrhage (ICH) is a severe type of stroke accounting for 10-15% of all strokes but causing about half of stroke-related deaths and disabilities. Many patients with ICH have decreased consciousness when admitted, yet intensive care and neurosurgical treatments are not common. Prior studies in low- and middle-income countries showed that a treatment package including early intensive blood pressure lowering and managing fever and high blood sugar improved outcomes. The I-CATCHER study aims to test a similar structured Care Bundle approach in Sweden, Australia, and other high-income countries to improve treatment and prognosis for patients with spontaneous ICH. This study compares a Care Bundle involving early intensive blood pressure control, reversal of oral anticoagulation within 30 minutes, fever management, blood sugar control, and timely referrals to intensive care or neurosurgery against standard care. The Care Bundle targets specific blood pressure levels depending on initial readings and aims to avoid do-not-resuscitate orders or withdrawal of care for 48 hours. Repeat brain imaging is done as needed. Hospitals are randomized in batches over three phases lasting 18 months each: usual care, randomized evaluation, and post-implementation follow-up, with the entire study rolling out over 2.5 years. Participants are adults aged 18 or older with spontaneous ICH confirmed by imaging and admitted within 24 hours of symptom onset. Patient information, treatments, and outcomes are recorded, including functional status measured by the Utility Weighted modified Rankin Scale at 180 days. The study collects data on various treatments, monitoring, and complications to assess if the Care Bundle improves recovery. Safety and sustainability of the Care Bundle are evaluated through continued hospital participation and follow-up.

Researchers are comparing the results of one-visit versus two-visit root canal treatments performed in general dental practices for infected (necrotic) teeth. The study focuses on how well the treatments work one and four years after completion, as well as differences in root filling quality and complication rates. This multi-center study involves several clinics across five counties in Sweden and plans to recruit 1,000 patients to ensure statistically meaningful results. Participants will be randomly assigned to receive either a single-visit or a two-visit root canal treatment. In the single-visit group, treatment including access, cleaning, shaping, and root filling may be completed in one appointment. In the two-visit group, the treatment is split into two appointments at least one week apart, with cleaning and medication placement done in the first visit and root filling in the second. Treatments follow usual clinical practices without a strict protocol. During the study, patients will be contacted by phone 5-7 days after treatment to check for complications and will have a follow-up visit one month post-treatment. Clinical examinations and X-rays will be done one and four years after treatment to assess healing. Two independent observers will review the radiographs to determine success based on clinical and radiographic normalcy. The study aims to detect differences in outcomes using statistical tests with significance set at p<0.05.