Jonkoping

Researchers are studying head and neck squamous cell carcinoma (HNSCC) patients with factors that increase the risk of treatment failure. The goal is to personalize treatment and improve outcomes for those receiving curative radiotherapy. This phase III trial compares the standard radiation dose to a higher dose given more frequently (hyperfractionated radiotherapy) to see if intensifying treatment benefits patients with advanced disease. The study also explores advanced imaging and genetic tests to better predict treatment response and cancer behavior. Participants will be randomly assigned to receive either the standard radiotherapy dose of 68.0 Gy in 34 fractions once daily or a higher hyperfractionated dose of 83.0 Gy in 68 fractions given twice daily over five days a week. Different radiation doses are targeted to the primary tumor and affected lymph nodes based on risk areas. The trial includes translational research using MRI, CT, and PET scans, as well as gene and protein analyses, to understand tumor characteristics and treatment effects. Patients with lower-risk tumors not eligible for randomization can still join the research parts that do not involve altered radiation schedules. During the study, participants will undergo regular monitoring including imaging and clinical assessments every three months for two years, then every six months up to five years to check local tumor control. Researchers will collect data from these visits along with tissue and blood samples for genetic and immune profiling. Safety, treatment adherence, and long-term outcomes will be closely followed to evaluate the impact of the different radiotherapy approaches and the predictive value of the biological tests.

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.

This trial studies children aged 4 to 9.99 years who were recently diagnosed with Type 1 diabetes within the last 3 months. It aims to evaluate the safety and effectiveness of Verapamil in preserving the remaining function of insulin-producing beta cells. The study is a Phase I/II trial motivated by the importance of maintaining residual insulin secretion to improve treatment outcomes and quality of life in young children with this serious disease. The study has two parts: Part A involves 6 patients in an open-label safety evaluation receiving oral Verapamil at doses of 3-6 mg per kg of body weight per day, divided into two doses, for 12 months. After confirming safety and tolerability at 6 months, Part B enrolls 30 patients randomized 1:1 to receive either Verapamil at the same dosing schedule or placebo for 12 months in a double-blind manner. Efficacy is assessed using mixed meal tolerance testing (MMTT) and clinical measures including insulin dose, HbA1c, and continuous glucose monitoring data at baseline, 12 months, and 24 months. Participants undergo baseline screening including ECG, physical exams, and MMTT to assess beta cell function. Outcomes measured include changes in C-peptide levels during MMTT over 24 months and the number of treatment-related adverse events. Clinical monitoring includes HbA1c, insulin use, and glucose control data. Safety and tolerability are closely observed throughout both study parts. The total participation period extends to 24 months with evaluations at multiple time points to track treatment effects and safety.

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.

This research focuses on patients with Relapsed/Refractory Multiple Myeloma (RRMM) who have been treated with the T-cell redirectors teclistamab or talquetamab outside of clinical trials. The study aims to describe the clinical outcomes and safety management of these treatments in a real-world setting, analyzing how patients respond and survive after receiving these therapies. The study does not administer any new interventions but instead collects and analyzes retrospective data from medical records of patients who have received teclistamab or talquetamab. Participants are grouped based on when they received their first dose, covering different time periods up to the end of 2025. This allows the study to assess outcomes for patients treated with these drugs over several years. Throughout the study, researchers will monitor various outcomes, including overall response rates, time to response, duration of response, minimal residual disease status, overall survival, progression-free survival, and time to next treatment. Safety management during treatment is also described. Data will be collected from baseline (day 1) through up to 40 months following treatment initiation, using medical records to understand treatment effects and patient characteristics over time.

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.

Researchers are studying metastatic breast cancer by recruiting 1300 patients from many hospitals across Europe. This study focuses on patients aged 18 or older, both female and male, who have been diagnosed with metastatic breast cancer or a relapse and have not received more than one systemic treatment since the discovery of metastases. The main goal is to better understand the genetic changes in metastatic breast cancer and how patients respond or resist therapies, aiming to find the right treatment for each patient. Patients with genetic changes that match new drug trials may have the option to participate in those trials if available. Participants undergo a biopsy of the metastatic lesion to collect tissue samples, performed by a surgeon or radiologist. Biopsy samples, along with blood, serum, and plasma, are collected both at the start and during follow-up. Some samples are analyzed immediately, while others are stored in a bio-repository for future research. Biopsies can be from bone or brain tissue under specific conditions, and must be collected before starting or changing systemic treatment lines, following precise timing rules. Throughout the study, participants provide regular blood samples and allow collection of tissue samples from both primary and metastatic tumors. Researchers monitor participants' health status and treatment responses. The primary outcome is to improve understanding of metastatic breast cancer over the year following the end of patient recruitment. This research aims to enhance treatment outcomes for all patients diagnosed with metastatic breast cancer by using detailed molecular analyses and offering access to clinical trials when possible.

Researchers are evaluating optimized drug treatments for patients with Takotsubo Syndrome, also known as Broken Heart Syndrome. This large Phase 4 trial aims to include 1000 patients registered in SWEDEHEART to provide documented evidence for effective pharmacologic care, as current data is limited. The study is a multinational, multicenter, registry-based, open-label, randomized controlled trial focused on improving treatment outcomes for this heart condition. Participants may receive one of several treatments: an infusion of Adenosine at 70 g/kg/min for 3 hours, oral Dipyridamole 200 mg twice daily, oral Apixaban 5 mg twice daily, or care guided by recommendations from the Taskforce on Takotsubo Syndrome of the Heart Failure Association of the European Society of Cardiology, which may vary by local practice. The trial includes two randomizations with specific treatment options and criteria. During the study, researchers will assess heart function using wall motion scores and monitor for serious events such as death, cardiac arrest, heart failure hospitalization, or reduced heart ejection fraction up to 30 days after treatment. They will also track thromboembolic events and cardiac thrombus via echocardiography within the first few days and through day 30. Safety and treatment adherence will be monitored throughout, with detailed follow-up to understand treatment effects and patient outcomes.

Researchers are evaluating whether using the World Health Organization's Labour Care Guide (LCG) instead of standard care for monitoring labor progress can improve outcomes for newborns and mothers. This study compares these two guidelines to see if the LCG can reduce adverse neonatal outcomes, such as perinatal mortality, neonatal complications, and the need for cesarean sections during labor. The research also looks at other perinatal interventions, complications, and economic factors, using a multicenter, stepped-wedge cluster randomized trial design conducted from 2023 to 2025 in Sweden. Participants will receive care based on either the WHO's LCG or standard labor monitoring guidelines. The LCG is a next-generation partograph designed to follow the latest intrapartum care recommendations. The study involves multiple delivery units where women in active labor receive monitoring according to the assigned guideline. Researchers will compare outcomes such as neonatal morbidity, cesarean section rates, use of oxytocin, postpartum hemorrhage, labor duration, and experiences of women, their partners, and healthcare providers. Throughout the study, participants will be monitored for neonatal complications including low Apgar scores, hypoxic ischemic encephalopathy, intracranial hemorrhage, seizures, meconium aspiration syndrome, and neonatal unit admissions. The study will also assess maternal outcomes and collect feedback via questionnaires and interviews about childbirth experiences and guideline compliance. The primary outcomes are adverse neonatal events and intrapartum cesarean rates, with follow-up from 12 weeks up to 18 months after birth to gather comprehensive data on health and safety.

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.