Eskilstuna

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 if adding LY3537982 olomorasib to standard anti-cancer drugs improves treatment for participants with untreated advanced non-small cell lung cancer NSCLC that has a specific KRAS G12C gene change. This Phase 3 treatment study includes participants with locally advanced or metastatic NSCLC and aims to compare this combination against standard care. The study is sponsored by Eli Lilly and Company and could last up to 3 years depending on individual response and disease progression. Participants receive LY3537982 orally combined with pembrolizumab given intravenously in 21-day cycles. Some groups also receive chemotherapy drugs pemetrexed and platinum cisplatin or carboplatin intravenously. There are different dose levels and combinations being tested, including placebo groups for comparison. Treatment continues until specific discontinuation criteria are met. Parts of the study are randomized and double-blinded, with some parts non-randomized for safety lead-in. During the study, participants have regular assessments including imaging scans to measure tumor response, blood tests, and questionnaires about symptoms and quality of life. Researchers monitor side effects and survival outcomes. The main measures include progression-free survival and treatment-emergent adverse events over about one year, with overall survival followed for up to three years. Participants are closely followed throughout treatment and after to evaluate the effects and safety of the study medications.

Researchers are evaluating the study medicine PF-08046054 compared to the standard treatment docetaxel in adults with non-small cell lung cancer NSCLC that has PD-L1 expression of 1% or higher. These participants have cancer that has spread or cannot be treated with surgery or definitive radiation and have shown disease progression during or after previous treatments including PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for known genomic alterations. The study is a randomized phase 3 trial assessing treatment options for advanced NSCLC. Participants are randomly assigned to one of two groups one receives PF-08046054 as an intravenous IV infusion twice during each 21-day cycle, and the other receives docetaxel as an IV infusion once every 21 days. The study treatment may continue for up to 5 years if the participants cancer responds to therapy. Both treatments are given in cycles, and participants receive the medicine through infusions during clinic visits. During the study, participants will have regular clinic visits to monitor their health and how well the treatment is working. Assessments include measuring overall survival, progression-free survival, tumor response rates, and quality of life through questionnaires. Safety is monitored for adverse events up to 90 days after treatment ends. Blood samples are also taken to study the medicines levels and immune response. The total study duration can be up to 5 years depending on individual responses and outcomes.

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 a brief psychological treatment called Behavioral Activation BA to prevent and treat depression in adults aged 65 and older within a municipal care setting in Sweden. Depression is common among older adults and affects quality of life and daily functioning. This trial aims to understand whether BA can improve depressive and anxiety symptoms, self-rated activation, functional ability, loneliness, self-efficacy, mental wellbeing, quality of life, and reduce the need for community care services. The study also explores experiences of both patients and therapists involved in the BA treatment. Participants will continue their usual care, and half will be randomly assigned to receive a five-session BA treatment over two months, delivered face-to-face in their homes by social workers. The BA sessions start weekly for four weeks, followed by a booster session four weeks later. The other half will receive care as usual without the BA intervention. This design allows comparison between BA plus usual care and usual care alone. Participants will complete questionnaires at the start, after two months, and at 3, 6, and 12 months to assess outcomes including depressive symptoms measured with the Montgomery-sberg Depression Rating Scale. Additional evaluations include anxiety, disability, loneliness, self-efficacy, mental wellbeing, quality of life, and community care needs. The total participation spans one year, with data collected to understand both short- and long-term effects of the BA treatment.

Researchers are investigating the use of Trastuzumab deruxtecan T-DXd in adults with unresectable or metastatic HER2-low and HER2-ultralow breast cancer. This includes patients who have previously received chemotherapy for metastatic breast cancer or have hormone receptor-positive disease treated with endocrine therapy but are unsuitable for further endocrine treatment. The study aims to understand treatment effectiveness, patient characteristics, and experiences in a real-world setting through a non-interventional approach. Participants will be observed while receiving either T-DXd or conventional chemotherapy as part of their routine care, without any drug administration by the study itself. The study includes two groups one with patients having HER2-low breast cancer treated with T-DXd after prior chemotherapy, and another with hormone receptor-positive, HER2-low or HER2-ultralow breast cancer patients treated with either T-DXd or conventional chemotherapy but not prior chemotherapy for metastatic disease. Data will be collected on treatments, side effects, and management of adverse drug reactions. During the study, participants demographic and clinical data, treatment patterns, tolerability, and quality of life will be monitored over approximately 37 months. Assessments include the time to next treatment, treatment discontinuation, physician-reported safety events, patient-reported tolerability, quality of life questionnaires, and symptom diaries. This long-term observation will help evaluate real-world outcomes and patient experiences with T-DXd and conventional chemotherapy in this population.

Researchers are evaluating the effectiveness of oral pivmecillinam as a step-down treatment for adult patients with febrile urinary tract infections fUTI caused by Escherichia coli. This phase 4, randomized controlled trial compares pivmecillinam to standard antibiotic treatments following initial intravenous therapy. The study aims to see if pivmecillinam, a narrow-spectrum antibiotic, is as effective as the usual care in resolving infection symptoms and preventing bacterial growth in urine. Participants who have received 2 to 4 days of intravenous antibiotics and shown improvement will be randomly assigned to either oral pivmecillinam or standard treatment, which may include various oral or intravenous antibiotics determined by their doctor. Pivmecillinam will be taken as 400 mg tablets four times daily for 7 or 10 days depending on patient factors. The control group will receive standard care antibiotics for 7 to 14 days. Some participants will provide additional samples to study the drugs effects on gut bacteria and how it is processed in the body. During the study, participants will keep a diary to record medication use, symptoms, and side effects, and will have phone interviews 7 and 28 days after treatment ends to assess recovery. Urine samples will be collected at these times to check for bacteria. Subgroups will provide fecal samples over three months to study microbiome changes, and blood and urine samples will be taken from some on pivmecillinam to understand drug levels. The study will monitor clinical and microbiological responses as well as adverse events throughout the follow-up period, which extends up to 28 days post-treatment with some assessments continuing for three months.

Researchers are evaluating the effects of a restrictive approach to giving non-resuscitation fluids compared to usual care in adult patients with septic shock. The goal is to understand both the beneficial and harmful impacts of limiting these fluids in this critical condition. This trial is led by Region Skane and involves adult patients diagnosed with septic shock under specific clinical criteria. Participants are assigned randomly to one of two groups. One group receives non-resuscitation fluids following a strict protocol that starts within two hours of randomization and continues during their ICU stay, up to 90 days. This protocol includes stopping maintenance fluids if fluid balance is positive and the patient is not dehydrated, adjusting intravenous and enteral fluids to correct electrolyte disturbances, and using concentrated intravenous medications. The other group receives fluids according to usual local care routines, which involve maintenance fluids at about 1 mlkgh unless otherwise specified and glucose at a maximum concentration of 10%, with medications concentrated per local protocol. Participants are monitored during their ICU stay and followed for up to 90 days to assess mortality, complications, and days free from mechanical ventilation. Cognitive function and health-related quality of life are evaluated six months after inclusion. The study uses a triple-blind randomized design to compare outcomes between the protocolized fluid reduction and usual care. Regular assessments and follow-up visits will track participant status and safety throughout the study period.

Researchers are evaluating the efficacy of perioperative dostarlimab compared with the standard of care in participants with untreated T4N0 or Stage III resectable colon cancer that shows defective mismatch repair or high microsatellite instability dMMRMSI-H. This phase 3, open-label, randomized study focuses on these specific colon cancer patients to assess if dostarlimab can improve outcomes compared to current treatments. Participants are randomly assigned to receive either dostarlimab before and after surgery or the standard of care treatments, which include FOLFOX or CAPEOX chemotherapy or post-surgery observation. Dostarlimab is given as monotherapy during the perioperative period. The study carefully monitors participants for up to approximately 5 years to evaluate long-term effects. During the trial, participants undergo regular assessments including event-free survival reviewed by blinded independent central review, overall survival, and pathological response evaluations. Safety is closely monitored by tracking adverse events, immune-related effects, and serum concentrations of dostarlimab across treatment cycles. The study involves frequent follow-ups to understand treatment impact and ensure participant well-being throughout the extended observation period.

Researchers are evaluating whether regional radiotherapy can be safely omitted in clinically node-negative breast cancer patients who have one or two sentinel node macrometastases and an estrogen receptor positive, HER2-negative tumor. This trial aims to improve quality of life and reduce side effects without worsening recurrence free survival at five years. The study is a randomized, multicenter, non-inferiority trial with a planned enrollment of 1350 patients. Participants will be randomly assigned to receive either standard locoregional radiotherapy, which includes treatment to the remaining breast or chest wall and regional lymph nodes, or a de-escalated radiotherapy approach. In the intervention group, no lymph node irradiation is given radiotherapy is only delivered to the remaining breast after breast conserving surgery, and not after mastectomy unless there is widespread multifocality. Gene expression analyses will be performed for all patients to relate gene signatures to recurrence risk and radiotherapy benefit. During the study, patients will be monitored through regular assessments to measure recurrence free survival at five years, which is the primary outcome. Secondary outcomes include locoregional and regional nodal recurrence, new contralateral breast cancer, distant recurrence free survival, overall survival, arm morbidity, and health-related quality of life. Follow-up will continue for at least five years to evaluate these outcomes and monitor safety and quality of life changes over time.