Sundsvall

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 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 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 investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are evaluating the effectiveness of adding gastropexy to the conventional surgical repair of primary paraesophageal hernias. This randomized, double-blind, multicenter clinical trial compares the outcomes of patients undergoing standard crural repair and Nissen fundoplication with those receiving the same repair plus an additional gastropexy procedure. The study aims to determine if gastropexy improves the success of hernia repair by reducing recurrence rates. Participants are randomly assigned to either the control group, which receives crural repair combined with a short and floppy Nissen fundoplication, or the interventional group, which receives these repairs along with a three-point gastropexy. The gastropexy involves fixing parts of the stomach wrap to the diaphragm and abdominal wall using running non-absorbable sutures. Surgical procedures include careful dissection, mobilization of the esophagus, preservation of vagal nerves, and creation of the fundoplication without routine use of calibration bougies. Participants undergo imaging with computed tomography scans before surgery and at 1 and 3 years after surgery to assess anatomical results. Patient-reported outcomes are collected through various questionnaires measuring quality of life, gastrointestinal symptoms, reflux frequency, and swallowing difficulties before surgery and at 3 months, 1 year, and 3 years post-surgery. The primary outcome is the recurrence of hernia one year after surgery. Safety and follow-up extend for up to three years to monitor long-term effects and treatment success.

Spontaneous intracerebral hemorrhage (ICH) is a severe type of stroke accounting for 10-15% of all strokes but causing about half of stroke-related deaths and disabilities. Many patients with ICH have decreased consciousness when admitted, yet intensive care and neurosurgical treatments are not common. Prior studies in low- and middle-income countries showed that a treatment package including early intensive blood pressure lowering and managing fever and high blood sugar improved outcomes. The I-CATCHER study aims to test a similar structured Care Bundle approach in Sweden, Australia, and other high-income countries to improve treatment and prognosis for patients with spontaneous ICH. This study compares a Care Bundle involving early intensive blood pressure control, reversal of oral anticoagulation within 30 minutes, fever management, blood sugar control, and timely referrals to intensive care or neurosurgery against standard care. The Care Bundle targets specific blood pressure levels depending on initial readings and aims to avoid do-not-resuscitate orders or withdrawal of care for 48 hours. Repeat brain imaging is done as needed. Hospitals are randomized in batches over three phases lasting 18 months each: usual care, randomized evaluation, and post-implementation follow-up, with the entire study rolling out over 2.5 years. Participants are adults aged 18 or older with spontaneous ICH confirmed by imaging and admitted within 24 hours of symptom onset. Patient information, treatments, and outcomes are recorded, including functional status measured by the Utility Weighted modified Rankin Scale at 180 days. The study collects data on various treatments, monitoring, and complications to assess if the Care Bundle improves recovery. Safety and sustainability of the Care Bundle are evaluated through continued hospital participation and follow-up.

Researchers are evaluating a new e-health program called INSPIRE designed to support the brain development of very preterm infants born before 32 weeks or with low birth weight. The program focuses on helping parents develop responsive caregiving behaviors to improve multiple areas of the child's development such as cognitive, motor, feeding, language, and social-emotional skills. The study aims to see if this intervention improves child development up to 2 years of age, as well as examining parental stress, parent-child emotional connection, health inequalities, and gender effects. The INSPIRE intervention involves digital e-health sessions delivered to parents after hospital discharge, with a total of 18 sessions over two years. It uses video interaction to guide parents in strengthening their interactions with their infants and empowering them to respond to their child's needs in positive ways. Families will be randomly assigned to receive either the INSPIRE program or standard care, with the goal of assessing the program's impact compared to usual support. Participants and their families will be followed and assessed regularly up to the child's corrected age of 24 months. Researchers will measure the child's development using the Bayley Scales of Infant Development and evaluate parental experiences and stress. The study includes ongoing monitoring of child and parent outcomes to understand the intervention's effects and aims to establish a sustainable nationwide program to support preterm infants and their families, especially benefiting those far from specialized healthcare.

Glioblastoma (GBM), particularly with methylated MGMT promoter, is a challenging brain cancer to treat effectively. Current standard care includes surgery, radiation, and chemotherapy with Temozolomide (TMZ), which works better when the MGMT gene is methylated. Researchers are investigating whether adding Lomustine (LOM) to TMZ improves survival for patients newly diagnosed with this type of glioblastoma. This is a phase 3, open-label, multicenter randomized controlled trial comparing these treatments. Participants will be randomly assigned to one of two groups: one will receive the standard treatment of TMZ during and after radiation; the other will get a combination of TMZ and LOM starting on the first day of radiation therapy. Both drugs are taken as separate pills in the experimental group. The study also accounts for the use of Tumor Treating Fields (TTF) as standard care may evolve during the trial. During the trial, participants will be followed for at least 36 months from randomization to assess overall survival. Researchers will also monitor tumor progression, treatment safety, quality of life, and cognitive function. Patients will be evaluated through clinical assessments and data collection throughout the treatment and follow-up periods to understand the effects of the combined therapy compared to standard care.

Researchers are studying data from two Swedish national registries to understand pain and postoperative nausea and vomiting (PONV) after gallbladder surgery. The study uses quality registry data from patients who had gallstone surgery or ERCP between 2016 and 2025. The aim is to explore factors related to patients or surgical procedures that might increase the risk of PONV or pain following surgery. This research links data from the Swedish Gallriks registry and the Swedish Perioperative Register (SPOR). These registries collect detailed information on patient characteristics, surgical details, anesthesia type, and postoperative outcomes. The study focuses on nausea, vomiting, and pain recorded during the average 3.5-hour stay in the postoperative anesthesia care unit (PACU), as well as complications up to 6 months after surgery. Data linkage will produce a pseudonymized database for analysis. Participants' records will be analyzed for early PONV and pain risk, severity of pain, and postoperative complications. Factors like anesthesia type, surgery details, and patient demographics will be studied for associations with these outcomes. The study will measure nausea, vomiting, pain scores, severe pain occurrence, and complications including unplanned hospitalizations or reoperations. Results will be reported from surgeries over a 10-year span, with ongoing data updates and analysis.

Researchers are examining the effect of physical exercise during neoadjuvant chemotherapy (NACT) on breast cancer outcomes, focusing on pathological complete response (pCR), which means no invasive tumor remains after treatment. The Neo-ACT trial is designed to evaluate if supervised high-intensity interval and resistance training can increase pCR rates in patients with primary invasive breast cancer. Secondary goals include assessing residual cancer burden, tumor response via imaging, quality of life, physical activity, muscle strength, fitness, treatment-related toxicities, cognitive function, chemotherapy completion, and long-term sick leave. Participants are randomly assigned to either an exercise group or usual care. Those in the exercise group complete 120 minutes of supervised exercise weekly during NACT until surgery, about five months, supported by a personalized mobile app and local physiotherapists. Exercise sessions include warm-ups and are tailored based on individual fitness and perceived exertion. Physical activity is carefully monitored throughout the trial. During the study, participants undergo various assessments including tumor response scans, questionnaires about quality of life and physical activity, muscle strength and fitness tests, and cognitive evaluations. Physical activity levels are tracked using a Fitbit device, and safety is monitored through hospital admission records and toxicity assessments. Patients will be followed for up to two years to evaluate long-term outcomes and treatment effects.