Malmo

Chronic kidney disease CKD affects over 800 million people worldwide and leads to significant health challenges, including multiple secondary diseases, frequent hospital visits, and high costs. Recent advances have identified promising drugs like sodium-glucose co-transporter 2 inhibitors, finerenone, and semaglutide that may slow CKD progression. This study aims to evaluate whether a biomarker-guided treatment approach can better reduce kidney function decline compared to standard care in CKD patients with albuminuria. This prospective, randomized, open-label study plans to enroll 125 participants with CKD and albuminuria who will be randomly assigned to either a biomarker-targeted treatment group or a standard care group. In the treatment group, medications such as dapagliflozin, finerenone, and semaglutide will be added stepwise based on urinary biomarkers UACR and UEGF and individual response. After about four weeks on each drugs maximum tolerated dose, biomarker levels will be reassessed to decide whether to continue, switch, or add treatments. Participants will undergo regular evaluations of kidney function through estimated glomerular filtration rate eGFR and urinary biomarkers throughout the study, which lasts over two years. The main outcome measured is the change in eGFR slope from week 26 to week 104. Additional assessments include changes in eGFR and UACR from baseline to week 104 or 112. Safety and effectiveness of the biomarker-guided approach will be monitored carefully during the trial.

Researchers are studying metastatic castration-resistant prostate cancer mCRPC to find new treatment options. This trial evaluates if the study medicine ifinatamab deruxtecan I-DXd or MK-2400 helps people live longer overall and experience slower cancer growth or spread compared to chemotherapy. The study is a Phase 3 trial comparing I-DXd with standard chemotherapy for mCRPC patients. Participants are randomly assigned to receive either I-DXd at 12 mgkg every 3 weeks through intravenous infusion or docetaxel chemotherapy at 75 mgm2 every 3 weeks combined with daily prednisone pills. Treatment continues until the disease progresses, unacceptable side effects occur, or treatment is stopped for other reasons. Premedication is given before each dose of I-DXd to help prevent nausea and vomiting. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess overall survival and radiographic progression-free survival for up to about 36 months. Additional measures include response rates, time to pain progression, PSA progression, and adverse events. The study tracks safety, treatment effects, and quality of life over a long follow-up period to better understand the potential benefits and risks of I-DXd compared to chemotherapy.

Researchers are investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

Cardiovascular disease CVD is a leading cause of death worldwide and unhealthy lifestyle behaviors are well-known risk factors. This study evaluates whether a digital lifestyle intervention developed within Swedish primary healthcare can improve important cardiovascular health outcomes and promote healthier lifestyle behaviors in patients aged 40 to 60 years. Participants are recruited from multiple centers in Sweden and randomized to either the intervention or control group with standard care. Participants in the intervention group receive support through a digital lifestyle program that includes lectures, home assignments, and group meetings, along with personalized digital feedback from healthcare providers. Both groups receive standard care, which is one structured health dialogue focused on lifestyle habits. The study measures outcomes at 6 months post-randomization, including LDL-cholesterol as the primary outcome, and several secondary outcomes related to cholesterol levels, blood glucose, blood pressure, weight, lifestyle behaviors, and quality of life. Throughout the study, participants undergo assessments of blood lipids, glucose, blood pressure, body measurements, and lifestyle factors such as diet, physical activity, sleep, stress, alcohol, and tobacco use. Researchers also evaluate cardiovascular risk scores and collect participant feedback on using the digital intervention. The total study duration is 6 months post-randomization with data collected to assess the impact of the digital program compared to standard care.

Opioid overdose causes significant global health problems, and while prevention and treatment programs exist, more efforts are needed to reduce deaths and complications. This research evaluates a novel smartphone-based volunteer first responder system integrated with national emergency call services to assist suspected opioid overdoses. The system aims to alert trained volunteers equipped with naloxone, an opioid antidote, to provide early treatment before emergency medical services arrive, potentially saving lives by reducing the time to naloxone administration. Volunteer responders, called naloxone-responders, will complete training in opioid overdose recognition, naloxone use, and first aid based on European and Swedish guidelines. They will also learn low-arousal communication techniques for interacting with overdose victims. Each responder receives a kit with two doses of nasal naloxone and will be registered on a dedicated responder smartphone app. The study includes a two-year pilot phase with one-year follow-up per participant, along with multiple sub-studies examining feasibility, safety, acceptability, mortality, and experiences of responders and overdose survivors. Participants will be monitored through questionnaires, app data, and medical records from dispatchers, paramedics, and hospitals. The primary outcomes include the number of successful naloxone responder alerts, responder acceptability, clinical outcomes of overdose victims, and safety experiences during alerts. Mortality rates before and after the trial will also be analyzed. The study runs from September 2025 to August 2027, assessing both short- and long-term effects of integrating volunteer responders with emergency medical dispatch.

Researchers are evaluating a behavioural intervention called Light, activity and sleep in my daily life LAS aimed at improving quality of life for community-dwelling older adults aged 70 and over. The study focuses on addressing challenges related to circadian rhythm sleep disorders, poor sleep, reduced physical activity, and time spent indoors, which affect wellbeing in this population. The intervention targets light-related behaviour, outdoor walking, and sleep routines to promote active ageing and independence. The LAS intervention is delivered as a 9-week web-based course with nine modules covering electric lighting, daylight, outdoor physical activity, and sleep. Participants also receive a test kit with items like light bulbs, a sleep mask, and a sleep diary to support engagement and experimentation. The course includes one introductory physical meeting and three additional meetings held at a senior citizen meeting point. All participants receive the same noninvasive behavioural education and support. Participants complete questionnaires, interviews, and wear accelerometers to track activity and rest patterns before and after the course, with follow-ups at 3, 6, and 10 months after baseline. Outcomes measured include usability of the intervention, mood, sleep quality, behavioural skills, quality of life, physical activity, sedentary behaviour, and step counts. The study also explores factors that help or hinder daytime outdoor walking. Results will guide improvements for future delivery within municipal health promotion services.

This research aims to compare two different weekly doses of Alpha1-Proteinase Inhibitor given by injection under the skin with the standard doses given through a vein in adults with Alpha-1 Antitrypsin Deficiency. The trial focuses on understanding how the body processes the medicine and evaluates how safe and tolerable the different weekly doses are. Both study doctors and participants know which treatment is being given during this open-label study. Participants will be randomly assigned to one of two treatment groups. One group receives 8 weeks of intravenous treatment with 60 mgkgweek Liquid Alpha1-PI followed by 8 weeks of subcutaneous treatment with 90 mgkgweek Alpha-1 15%. The other group receives 8 weeks of intravenous treatment with 120 mgkgweek Liquid Alpha1-PI followed by 8 weeks of subcutaneous treatment with 180 mgkgweek Alpha-1 15%. The study uses a parallel design to evaluate these dosing regimens. During the study, participants will undergo assessments to measure the steady-state exposure of the medicine over weekly dosing intervals and trough levels at specified weeks. Safety and tolerability will be monitored closely throughout. The study lasts about 16 weeks of active treatment, with visits scheduled to collect blood samples and monitor health status. The main outcome is the measurement of the medicines activity over time to understand how different doses are processed by the body.

Researchers are evaluating the Attempted Suicide Short Intervention Program ASSIP to prevent future suicidal behavior in people who have recently attempted suicide. This multicenter, randomized controlled trial in Sweden aims to compare ASSIP as a supplement to usual psychiatric care versus usual care alone. The study also explores factors that may influence ASSIPs effectiveness and assesses its cost-effectiveness. Participants receive either ASSIP plus standard treatment or standard treatment alone. ASSIP involves up to four therapy sessions, including a videotaped narrative interview, video playback with discussion, development of a personalized prevention plan, and an optional mini-exposure session. Therapists also send standardized letters to participants over two years to maintain contact. Standard treatment includes multidisciplinary care such as psychotherapy, medication, and referrals to specialist or primary care as needed. Participants undergo baseline interviews and self-assessments, followed by telephone interviews and self-assessment scales at 3, 12, and 24 months. Researchers collect data from medical records, national health and social insurance registers, and track suicide attempts and health outcomes over two years. The primary outcomes include the number of suicide attempts and cost-effectiveness over this period, with secondary measures covering suicidal thoughts, quality of life, healthcare use, and employment status.

Researchers are investigating whether regular radiological assessments during follow-up after surgery for high-risk malignant melanoma improve patient survival. The study addresses concerns about the resource demands, potential radiation exposure, and anxiety caused by such imaging, especially given the recent introduction of effective medical treatments for melanoma. There is currently no clear evidence supporting routine imaging in this context. Participants are randomly assigned to one of two groups. One group follows national guidelines with regular doctor appointments for 3 years, while the other group receives the same follow-up plus additional whole-body CT or PET scans and blood tests at baseline, 6, 12, 24, and 36 months. An interim analysis will be done after 1,000 patients enroll. During the study, researchers will monitor overall survival at 5 years as the primary outcome. They will also assess quality of life through questionnaires over the 3-year follow-up. Participants will attend scheduled visits for clinical evaluations, imaging, and blood tests, with the study aiming to provide clear evidence about the role of imaging in post-surgical melanoma care.

Researchers are evaluating a new oral medicine called Inno8 in people with haemophilia A, a condition characterized by low factor VIII activity. The study aims to understand how different doses of Inno8 are processed in the body and to assess its safety. This clinical trial is a Phase 1 study sponsored by Novo Nordisk AS and will last about 11 weeks. Participants will receive oral doses of the study drug NNC0442-0344 A in one of three experimental cohorts. The trial is non-randomized and open-label, meaning all participants receive the study drug without placebo or blinding. The dosing occurs over several days, and the study includes follow-up assessments to monitor drug levels and effects. During the study, participants will have regular assessments to monitor safety and how the drug behaves in the body. Measurements include tracking treatment-emergent adverse events, laboratory tests for blood clotting factors, antibody development, and drug concentration levels at specified times. The total participation duration is approximately 11 weeks, including dosing and follow-up to ensure safety and gather detailed pharmacokinetic and pharmacodynamic data.