Vasteras

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.

Researchers are investigating a new immunotherapy called pTTL for adults with advanced stage IV colorectal cancer. This treatment uses a patients own T cells, taken from tumour-draining lymph nodes, which are stimulated in the lab with personalized tumour-specific neoantigens identified by sequencing the patients tumour. The goal is to evaluate the safety and tolerability of pTTL, which is designed to target multiple unique tumour mutations to help the immune system recognize and attack cancer cells more effectively. The study includes three parts Part I involves collecting tumour and lymph node samples, selecting neoantigens, and manufacturing the personalized pTTL product. This process takes about 8 to 12 weeks. Part II includes pre-conditioning chemotherapy with cyclophosphamide and fludarabine, followed by a single intravenous infusion of pTTL, with dose escalation across patient cohorts. Patients receive supportive care and are monitored for 26 weeks after treatment. Part III is a long-term follow-up lasting up to 4.5 years or until death. Participants will undergo biopsies or surgery to obtain tumour tissue and lymph nodes for creating pTTL. They will receive pre-conditioning chemotherapy before pTTL infusion. Researchers will assess safety by monitoring adverse events, focusing on immune-related effects. Additional evaluations include tumour response, progression, survival rates, and long-term outcomes. The entire study involves regular monitoring, clinical assessments, and follow-up visits over several years to understand the therapys impact and safety profile.

Researchers are investigating ways to personalize treatment for patients with head and neck squamous cell carcinoma HNSCC, especially those with advanced disease who face a higher risk of treatment failure. This phase III study compares two radiotherapy approaches for patients intended for curative treatment the standard radiotherapy and a hyperfractionated radiotherapy HFX-RT with a higher total radiation dose. The study also aims to improve prognostic and predictive methods by including exploratory analyses such as MRI to evaluate tumor hypoxia, gene profiling, immune profiling, and imaging texture analyses during treatment and follow-up. Participants will be randomly assigned to either standard radiotherapy, which delivers 68.0 Gy in daily fractions of 2.0 Gy, or to hyperfractionated radiotherapy, which delivers 83.0 Gy in smaller doses twice daily 1.22 Gy per fraction over five days per week. The doses vary depending on the tumor volume and lymph node involvement. Patients with lower-risk tumors not eligible for randomization may still participate in the translational research parts of the study. During the study, participants will be closely monitored with regular follow-up visits every three months for two years, then every six months up to five years, focusing on local tumor control. Researchers will collect imaging data, conduct gene and protein analyses, and assess tumor response. The study evaluates treatment effects and tumor behavior over time to better understand and improve outcomes for head and neck cancer patients.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

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 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.

This research investigates the use of superparamagnetic iron oxide SPIO nanoparticles as a tracer for delayed sentinel lymph node dissection d-SLND in women with breast conditions where immediate axillary surgery is not needed. This includes patients with a preoperative diagnosis of ductal carcinoma in situ DCIS, unclear suspicious breast lesions, or those planned for risk-reducing mastectomy. The study aims to assess the effectiveness and accuracy of the delayed SLND approach, allowing some patients to avoid upfront surgery in the axilla. Participants receive an injection of SPIO near the breast lesion during their primary breast surgery, either up to 24 hours before or during the operation. If the final pathology shows invasive breast cancer, a second operation is performed to remove the sentinel lymph nodes SLNs using either SPIO or a radioactive tracer, depending on random assignment. The procedure involves multiple steps including detection of magnetic and radioactive signals, incision, SLN identification, and removal. Blue dye may also be used to assist in locating the nodes. During the study, patients undergo initial breast surgery with SPIO injection and magnetic signal detection but no immediate SLN removal. If invasive cancer is found, the delayed SLND procedure is done later with additional tracers. Researchers measure detection rates of SLNs, concordance between methods, and malignancy rates. Safety and procedure success are closely monitored. The study includes a control group receiving standard upfront SLND, and participants are followed until the study ends in 2027.

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 tozorakimab as an additional treatment to standard care in adults hospitalized with viral lung infection who need supplemental oxygen. The study aims to determine if tozorakimab can help prevent death or the need for invasive mechanical ventilation or extracorporeal membrane oxygenation. This Phase III trial involves a large group of participants to assess the safety and effectiveness of this approach. Participants are randomly assigned to one of two groups one group receives a single intravenous dose of tozorakimab on the first day, while the other group receives a matching placebo. The study uses a double-blind design, meaning neither participants nor researchers know which treatment is given. This helps ensure unbiased results. The treatments are given once, and participants continue to receive standard care during the trial. During the study, participants are closely monitored and evaluated up to 60 days after treatment. Researchers track important outcomes such as death rates, progression to invasive ventilation, days alive outside intensive care, and oxygen use. They also assess clinical progression using a World Health Organization scale and monitor for any anti-drug antibodies. The trial lasts until November 2027, with multiple assessments throughout to understand the treatments impact and safety.