Malmo

Chronic kidney disease (CKD) affects over 800 million people worldwide and leads to high health burdens, multiple related diseases, frequent doctor visits, hospitalizations, and significant healthcare costs. New drug treatments like sodium-glucose co-transporter 2 inhibitors, finerenone, and semaglutide have shown promise in lowering albuminuria and protecting kidney function, but the best way to combine or sequence these treatments is unclear. This study aims to evaluate if using biomarkers to guide treatment choices can better slow kidney function decline compared to standard care in people with CKD and albuminuria. This is a Phase 4, prospective, randomized, open-label, parallel-group, multicenter study enrolling 125 adults with CKD who have an estimated glomerular filtration rate (eGFR) of at least 25 mL/min/1.73m2 and urinary albumin-to-creatinine ratio (UACR) between 100 and 5000 mg/g. Participants are randomly assigned to either a biomarker-targeted treatment approach or standard care. In the biomarker group, patients start treatment with one of three drugs (dapagliflozin, finerenone, or semaglutide) and after about four weeks on the maximum tolerated dose, urinary biomarkers are measured to decide whether to continue, switch, or add another drug. This process can repeat up to three drugs based on biomarker responses. Participants will be monitored for changes in kidney function primarily by measuring the chronic eGFR slope from week 26 to 104. Throughout the study, urine samples for biomarkers and clinical assessments will be conducted to track treatment effects. Safety and adherence will be evaluated, and the study duration includes regular follow-ups to assess long-term impacts of the biomarker-guided treatment compared to standard care.

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

Researchers are investigating new treatments for people with high-risk, early-stage breast cancer, specifically targeting triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2-negative breast cancer. These types have little or no HER2 protein and involve hormones like estrogen or progesterone. The study aims to evaluate if the addition of sacituzumab tirumotecan (sac-TMT), a targeted therapy, combined with pembrolizumab and chemotherapy can improve outcomes compared to pembrolizumab with chemotherapy alone. Participants receive treatments including sacituzumab tirumotecan, pembrolizumab, and chemotherapy drugs such as carboplatin and paclitaxel, all given by intravenous infusion. Rescue medications like antihistamines, acetaminophen, dexamethasone, or steroid mouthwash may be used as needed. The study is randomized and open-label, comparing sac-TMT followed by chemotherapy plus pembrolizumab to chemotherapy and pembrolizumab without sac-TMT. During the study, researchers will monitor participants up to about 30 weeks to assess the percentage of people with no remaining cancer cells at surgery. They will also follow participants for up to approximately 92 months to track event-free survival, meaning time without cancer growth, spread, or return. Participants will undergo imaging, clinical assessments, and laboratory tests to evaluate treatment effects and safety throughout the study.

Unhealthy lifestyle habits are major risk factors for cardiovascular disease (CVD), which is the leading cause of death worldwide and in Sweden. This research evaluates a digital lifestyle program developed within Swedish primary healthcare to see if it can improve important heart health outcomes and encourage healthier habits in adults aged 40 to 60. The study is a multi-center randomized trial comparing standard care alone to standard care plus the digital intervention. The main goal is to measure LDL-cholesterol levels six months after starting the study, along with other health and lifestyle factors. Participants receive standard care consisting of one structured health dialogue focused on lifestyle habits. Those in the intervention group also get access to the digital lifestyle program, which includes digital lectures, home assignments, and group meetings online. Healthcare providers can offer personalized digital support and feedback to help patients improve diet, physical activity, alcohol use, tobacco use, sleep, and stress management. The intervention is delivered entirely through digital means alongside regular primary care. During the study, participants will be monitored for changes in cholesterol levels, blood sugar, blood pressure, weight, body measurements, cardiovascular risk scores, diet, physical activity, sleep, stress, alcohol and tobacco use, and quality of life. These assessments happen six months after randomization to evaluate the effects of the intervention. The study uses these measures to understand how well the digital program supports healthier lifestyle changes and reduces cardiovascular risk.

Opioid overdose is a major global health problem causing significant death and disability. This research evaluates a new smartphone-based volunteer first responder system designed to alert trained volunteers equipped with naloxone, an opioid antidote, to suspected opioid overdoses before emergency services arrive. The study aims to assess the feasibility, safety, and acceptance of this model integrated with emergency dispatch services, building on successful volunteer systems for cardiac arrests. Volunteers complete detailed training in overdose recognition, naloxone use, and first aid according to European and Swedish guidelines before registering on a dedicated app connected to dispatch centers. When emergency calls suggest an opioid overdose, nearby volunteers receive alerts and can respond with naloxone kits to potentially reverse respiratory arrest. The study will run as a two-year pilot with each volunteer followed for one year. Multiple sub-studies will explore feasibility, mortality effects, and experiences from both responders and overdose survivors. Participants will be monitored through questionnaires, app data, emergency dispatch records, and hospital data. Key outcomes include the number of successful naloxone administrations, alert accuracy, safety perceptions, and clinical outcomes compared before and after the trial. Follow-up surveys will capture ongoing safety and acceptability over 12 months post-registration. The study’s comprehensive data collection intends to evaluate if this integrated volunteer responder approach can save lives by reducing time to naloxone treatment.

This research aims to improve the quality of life for older adults by addressing common issues like disturbed sleep, low physical activity, and limited daylight exposure that can affect their well-being. The study focuses on community-dwelling Swedish-speaking adults aged 70 and over who live alone in apartments. It evaluates a behavioral intervention designed to support healthier daily routines related to light exposure, outdoor walking, and sleep, hoping to promote active aging and independence. The intervention, called "Light, activity and sleep in my daily life" (LAS), is delivered as a web-based course with nine modules covering electric lighting, daylight, outdoor physical activity, and sleep habits. Participants receive a test kit containing light bulbs, a sleep mask, a room checklist, a cap, a notebook, and a sleep diary to help them engage with the material and try new routines. The course also includes four physical meetings held at a senior citizen meeting point, combining self-study with in-person support. Participants complete questionnaires, wear an accelerometer to track activity and rest, and take part in interviews about their daily routines and perceptions of outdoor walking. Measurements are taken before the course, immediately after, and at 3, 6, and 10 months afterward to assess usability, usefulness, and sustained changes. The study monitors quality of life, mood, sleep quality, and behavioral skills throughout, with the goal of refining the intervention for broader use in municipal health services.

Researchers are evaluating the Attempted Suicide Short Intervention Program (ASSIP) as a treatment for people who have recently attempted suicide. This randomized controlled trial involves six psychiatric clinics across four regions in Sweden and aims to determine if ASSIP, a brief clinical intervention, can better prevent future suicidal behavior compared to standard treatment alone. The study also explores factors influencing ASSIP's effectiveness and examines its cost-effectiveness. Participants are randomly assigned to receive either ASSIP plus treatment as usual or treatment as usual only. ASSIP includes a videotaped narrative interview, video playback sessions with the therapist, development of a personalized prevention plan, and optional mini-exposure, along with standardized letters sent to the patient over two years. Treatment as usual involves standard multidisciplinary psychiatric care, including psychotherapy and medication, monitored by the research team for consistency and safety. Participants will undergo assessments at baseline, 3 months, 12 months, and 24 months through interviews, self-rating scales, medical record reviews, and national registry data collection. Follow-up includes telephone interviews and questionnaires to track suicide attempts and other outcomes. The primary outcomes measured are the number of suicide attempts at 3, 12, and 24 months, as well as the cost-effectiveness of ASSIP. The total study duration for each participant is two years.

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 studying how different doses of a new medicine called Inno8 work in the bodies of people with haemophilia A, a genetic bleeding disorder. The main goal is to determine if Inno8 is safe for use in this group. This is a Phase 1 study, meaning it is an early-stage trial focused on safety and how the body processes the medicine. The study will last about 11 weeks. Participants will receive multiple increasing oral doses of Inno8 during the study. The study drug, known as NNC0442-0344 A, will be given by mouth. The trial will closely monitor the participants as they take the study medicine to observe how their bodies respond to different dose levels. During the study, researchers will track any side effects or adverse events that occur from the first dose until 46 days after dosing ends. Participants will undergo assessments to measure safety and how their bodies handle the medication. The study includes careful monitoring throughout the treatment and follow-up periods to ensure participant safety and collect important data on the medicine's effects.

Researchers are evaluating whether baricitinib can delay the onset of clinical stage 3 type 1 diabetes (T1D) in children and adults at high risk of developing the disease. This phase 3, double-blind, randomized, placebo-controlled study includes participants aged 1 to under 36 years who have early stages of T1D or multiple diabetes-related autoantibodies indicating increased risk. The study aims to measure the time from the start of the trial to diagnosis of stage 3 type 1 diabetes, with participation lasting up to approximately 5 years. Participants will be randomly assigned to receive either baricitinib or a placebo, both administered orally. The trial compares these two groups to assess the impact of baricitinib on delaying progression to stage 3 T1D. The study's design includes careful monitoring of participants over time to evaluate the effects of the medication or placebo on disease development. During the study, participants will undergo regular assessments to detect the progression of diabetes, including laboratory tests for autoantibodies and clinical evaluations. Researchers will track the time it takes for participants to develop stage 3 T1D, along with monitoring safety and any adverse effects. The total duration of participation can be up to 5 years, ensuring thorough observation of long-term outcomes related to the study interventions.