Eskilstuna

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 evaluating the effectiveness of adding LY3537982 (olomorasib) to standard anti-cancer drugs compared to standard treatment alone in participants with untreated advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C gene mutation. This pivotal Phase 3 trial includes participants with locally advanced or metastatic NSCLC and considers their programmed death-ligand 1 (PD-L1) expression levels. The study includes multiple parts: Dose Optimization, Part A, and Part B are randomized, while Safety Lead-In for Part B and Part C are non-randomized. Treatments being assessed include LY3537982 taken orally, pembrolizumab administered intravenously, and standard chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed given intravenously. Participants receive these treatments according to their assigned groups based on their PD-L1 expression and tumor histology. Participants will be monitored with regular assessments including measuring disease progression, safety evaluations, and treatment emergent adverse events for up to approximately one year, with overall study participation potentially lasting up to three years depending on individual response and health status. Outcome measures focus on progression-free survival and safety, capturing any adverse events from the start of treatment until disease progression or death.

Researchers are evaluating the study medicine PF-08046054 compared to the standard chemotherapy drug docetaxel in adults with non-small cell lung cancer (NSCLC) that has spread or cannot be removed with surgery or radiation. Participants must have PD-L1 expression on 1% or more of their tumor cells and have experienced cancer progression during or after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for those with known genetic mutations. The trial is a Phase 3 randomized study to better understand how well PF-08046054 works alone compared to docetaxel alone. Participants will be randomly assigned to receive either PF-08046054 or docetaxel. Those in the PF-08046054 group will get intravenous (IV) infusions twice every 21-day cycle, while those in the docetaxel group will receive one IV infusion every 21 days. The treatment period may last up to 5 years if their NSCLC responds to the therapy. No other treatments are combined during the study period. Throughout the study, participants will have regular clinic visits for evaluations and monitoring to see how they respond to the treatment. Researchers will collect information on overall survival over approximately 5 years. They will also monitor safety and disease progression during these visits to understand the long-term effects and benefits of the treatments.

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.

Depression affects a significant portion of older adults in Sweden, with many experiencing symptoms that reduce their quality of life and functional ability. This research aims to evaluate whether a brief psychological treatment called Behavioral Activation (BA) can help prevent and treat depression in older adults receiving municipal care in Sweden. The study will also explore how patients and therapists experience the BA treatment. The trial specifically focuses on older adults aged 65 and above who show depressive symptoms and are fluent in Swedish. Participants will all continue their usual care, with half randomly assigned to receive a five-session BA treatment in addition to their standard care. The BA treatment is delivered face-to-face in the participant's home over two months. The sessions include education about depression, setting life goals, planning and engaging in meaningful activities, troubleshooting challenges, and creating a maintenance plan to sustain progress. Throughout the study, participants will complete questionnaires at the start, after two months, and again at 3, 6, and 12 months to assess outcomes such as depressive and anxiety symptoms, activation levels, functional ability, loneliness, self-efficacy, mental wellbeing, quality of life, and the need for community care services. The main outcome measure is the Montgomery-Åsberg Depression Rating Scale (MADRS-S). Researchers will monitor participants’ progress and experiences during this period.

Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.

Researchers are evaluating if oral treatment with pivmecillinam is effective for adults hospitalized with febrile urinary tract infections (fUTI) caused by Escherichia coli. This Phase 4, open-label randomized clinical trial compares oral pivmecillinam to standard oral or intravenous antibiotic treatments following 2-4 days of intravenous therapy. The study aims to determine whether pivmecillinam is as effective as standard care by assessing clinical and microbiological responses after treatment. Participants will be randomly assigned to receive either pivmecillinam tablets (400 mg four times daily) for 7 or 10 days depending on patient factors, or standard care antibiotics chosen by their physician for 7 to 14 days. The control treatments include various intravenous and oral antibiotics guided by laboratory susceptibility testing. Some participants will provide additional samples to study changes in the gut microbiome and the pharmacokinetics of pivmecillinam. During the study, patients will keep a diary recording medication use, body temperature, urinary symptoms, and side effects until 7 days after treatment ends. Phone interviews will be conducted 7 and 28 days after treatment to assess clinical response. Urine samples will be collected at these times to evaluate bacterial growth. Subgroups will provide fecal samples over three months and blood and urine samples to study drug effects and metabolism. The main outcome is clinical response measured about one week after treatment ends.

This trial evaluates the effects of a restrictive approach to giving non-resuscitation fluids in adults with septic shock, a serious condition caused by infection leading to dangerously low blood pressure. The study aims to assess both the potential benefits and harms of limiting these fluids compared to usual care. The trial focuses on adult patients diagnosed within 12 hours of intensive care unit (ICU) admission who require medication to support blood pressure. Participants are randomly assigned to one of two groups. The first group follows a protocol to reduce non-resuscitation fluids, where maintenance fluids are stopped if the patient has a positive fluid balance and is not dehydrated. Fluids and nutrition are carefully managed according to specific guidelines, including concentrated intravenous medications and nutrition support if needed. The second group receives usual care with fluids and medications given according to local routines, including maintenance fluids at a set dose unless otherwise specified. During the study, researchers monitor participants closely, focusing on mortality within 90 days after enrollment as the primary outcome. Fluid balance, medication use, nutrition, and patient condition are assessed to compare the two approaches. The study includes adult patients admitted to the ICU with septic shock and requires monitoring during their stay and follow-up to understand the effects of fluid management strategies on survival and safety.

Researchers are evaluating whether remote video exercise-based cardiac rehabilitation (exCR) can increase participation in rehabilitation sessions after a myocardial infarction (heart attack), compared to traditional center-based exCR. The study is designed as a national multicenter registry-based cluster randomized crossover clinical trial, preceded by a feasibility and safety study conducted during the COVID-19 pandemic. Patients diagnosed with type 1 myocardial infarction and aged 18 to 79 years are included, with long-term follow-up planned at 1 and 3 years after the cardiac event. The study involves two phases: first, a feasibility study offering remote exCR at participating sites until the pandemic peak subsides, ending in August 2022; second, a randomized trial where cardiac rehabilitation centers are assigned to provide either remote exCR, usual center-based exCR, or a combination based on patient preference at intervention sites, while control sites offer only center-based exCR. The exercise program is standardized, requiring at least 24 supervised sessions over 3 to 4 months, each session including aerobic exercise and strength training at specified intensity levels. Success is defined as attending at least 75% of sessions within four months. Participants will be monitored through their attendance and adherence to the exercise sessions. Researchers will assess the average number of exCR sessions completed over 3 to 4 months. Additional evaluations include safety monitoring and long-term follow-up at 1 and 3 years to observe outcomes after the initial cardiac event. The study also considers patient access to internet for remote participation and evaluates exercise test results to ensure safety during rehabilitation.

Researchers are evaluating the effectiveness of perioperative dostarlimab compared to the standard of care in adults with untreated T4N0 or Stage III resectable colon cancer that shows defective mismatch repair or high microsatellite instability. This is a Phase 3, open-label, randomized study aiming to improve treatment outcomes for this specific type of colon cancer. Participants will receive either dostarlimab alone or standard chemotherapy regimens such as CAPEOX or FOLFOX. The treatments are given around the time of surgery (perioperative) to address the cancer before and after surgical removal. The study compares the new treatment approach with the current standard therapies to see which is more effective and safe. During the study, participants will be monitored for up to approximately 5 years to assess event-free survival, meaning the length of time they remain free from cancer recurrence or other related events. Researchers will perform regular evaluations, including imaging and clinical assessments, to track the participant’s progress and treatment response. Safety and side effects will also be closely observed throughout the study duration.