Sundsvall

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 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 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 effects of a medicine called BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. The study includes people with or without type 2 diabetes and those who may already be taking medicines like angiotensin converting enzyme inhibitors ACEi, angiotensin receptor blockers ARB, or sodium-glucose cotransporter-2 inhibitors SGLT2i. The goal is to understand if adding BI 690517 can help delay worsening kidney function, hospitalizations due to heart failure, or cardiovascular death. After a run-in period where all participants take empagliflozin and other standard medications, participants are randomly assigned to receive either BI 690517 tablets or placebo tablets once daily alongside empagliflozin. The run-in period confirms that participants are stabilized on empagliflozin before randomization. The treatment phase continues for about three to four years until enough kidney or heart-related events have occurred to compare outcomes between the two groups. During the study, participants visit the study site about five times in the first six months and then every six months thereafter. At these visits, health is regularly checked through blood and urine tests, blood pressure and weight measurements, kidney function monitoring, and collection of any side effect information. The main outcome measured is the time until the first occurrence of kidney disease progression, hospitalization for heart failure, or cardiovascular death.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are evaluating the effectiveness of adding gastropexy to conventional surgical repair for patients with primary paraesophageal hernias. This randomized, triple-blind clinical trial compares standard crural repair combined with a Nissen fundoplication against the same procedure with an additional three-point gastropexy. The study aims to determine if the gastropexy improves outcomes in hernia repair. Participants are divided into two groups the control group receives standard paraesophageal hernia repair, which includes crural suturing and a total Nissen fundoplication. The interventional group receives the same standard repair plus a gastropexy, which involves fixing parts of the stomach wrap to the diaphragm and abdominal wall using sutures. The study includes preoperative and postoperative imaging with CT scans at baseline, 1 year, and 3 years after surgery to assess anatomical results. Participants will complete several questionnaires before surgery and at 3 months, 1 year, and 3 years post-surgery to assess quality of life, gastrointestinal symptoms, reflux frequency, and swallowing difficulties. Outcomes include hernia recurrence at 1 and 3 years, surgical complications, hospital stay length, and patient-reported symptom changes. The total follow-up period extends to 3 years with regular assessments to monitor safety and efficacy.

Spontaneous intracerebral hemorrhage ICH is a serious type of stroke with high death and disability rates. Researchers are investigating whether a structured treatment package called a Care Bundle can improve the 3-month outcomes for patients with acute ICH compared to standard care. The study is an international, multicenter, parallel, cluster-randomized clinical trial focusing on implementing this Care Bundle in high-income countries, building on results from previous trials mostly done in low- and middle-income countries. The Care Bundle includes early intensive blood pressure lowering, treatment of fever and high blood sugar, rapid reversal of oral anticoagulation, and timely referrals to intensive care or neurosurgery when needed. Hospitals are randomized in batches through three phases usual care, randomized evaluation of the Care Bundle versus usual care, and a post-implementation follow-up where all hospitals apply the Care Bundle. Each batch lasts 18 months, with 6 months per phase, and the overall study rollout spans 2.5 years. Participants are adults aged 18 or older diagnosed with spontaneous ICH confirmed by imaging within 24 hours of symptom onset. During the study, patient management details and outcomes will be closely monitored, including brain imaging, blood pressure, glucose levels, and functional status. The primary outcome is functional recovery measured by a utility-weighted modified Rankin Scale score at 180 days. Secondary outcomes include disability, death, and health-related quality of life. The study also collects data on treatments and care decisions to evaluate the Care Bundles effectiveness and sustainability.

Researchers are evaluating a new e-health program designed to improve the neurodevelopment of very preterm infants, born before 32 weeks or with low birth weight, by supporting parents in responsive caregiving. The study aims to see if this program, called INSPIRE, can enhance cognitive, motor, feeding, language, and socio-emotional development up to 2 years of age. Additional goals include assessing parental stress, emotional availability, health inequalities, and gender differences. This trial is conducted by Ume University with a multi-professional team and builds on a pilot study involving nine families. The intervention group will receive the INSPIRE program, which consists of 18 sessions delivered digitally over two years, starting at hospital discharge. This program focuses on strengthening parent-child interactions and empowering parents with responsive parenting skills. Families in the control group will receive standard care without the INSPIRE intervention. The study randomly assigns families to either group and follows up with assessments over time. Participants will be involved from discharge through at least 2 years corrected age, with evaluations including neurodevelopmental tests such as the Bayley Scales of Infant Development at 24 months. Additional assessments cover motor skills, language, feeding, emotional availability, parental stress, and mental health using various standardized tools at multiple time points up to 5.5 years of age. Researchers will monitor child development, parent well-being, and other outcomes to understand the interventions impact and safety over the study period.

Researchers are evaluating a treatment approach for patients with newly diagnosed glioblastoma that have a methylated MGMT promoter, a specific genetic feature of the tumor. This phase 3 clinical trial compares the standard chemotherapy drug Temozolomide TMZ alone to a combination of Temozolomide plus Lomustine LOM. The study aims to determine if adding Lomustine improves survival rates, progression-free survival, safety, quality of life, and cognitive function. Participants are randomly assigned to one of two groups. The control group receives Temozolomide during and after radiation therapy. The experimental group receives both Temozolomide and Lomustine starting on the first day of radiation. Lomustine and Temozolomide are given as oral pills in cycles, with Lomustine cycles lasting 42 days for a total of six cycles over about nine months, while Temozolomide cycles last 28 days with six cycles over about 8.5 months. Radiation therapy is given concurrently with the start of chemotherapy in both groups. During the study, participants will have regular assessments including survival monitoring, tumor progression checks, and safety evaluations for side effects. Quality of life and detailed neurocognitive tests measuring memory, attention, motor skills, and reaction times are conducted at the start, end of radiotherapy, and every 24 weeks for up to 36 months. Adverse events are tracked from randomization until death or three years of follow-up. The study involves close monitoring to understand the long-term effects and benefits of adding Lomustine to standard treatment.

Researchers are evaluating data from Swedish national registries to study the occurrence of pain and postoperative nausea and vomiting PONV after gallbladder surgery. The study aims to understand factors linked to higher risks of PONV and pain, including patient characteristics and surgical details. It also explores whether different anesthesia types and regional blocks affect these outcomes and the risk of complications up to six months after surgery. This observational study uses linked data from the Gallriks registry for gallbladder surgeries and the Swedish Perioperative Register SPOR, which records detailed perioperative and postoperative information. Data include patient health, surgery details, anesthesia, pain scores, nausea, and complications. The study includes patients who had gallbladder surgery between 2016 and 2025, with data updated yearly. The study database will analyze thousands of cases, focusing on early postoperative pain and nausea during the average 3.5-hour stay in the post-anesthesia care unit PACU. Participants involvement is through the collection and analysis of registry data with no direct interventions. Researchers will assess pain scores, nausea occurrence, and complications up to six months post-surgery. The study uses descriptive and statistical analyses to identify associations between patient or surgical factors and outcomes. Personal data are pseudonymized to protect privacy. The study period covers surgeries over ten years, allowing comprehensive long-term evaluation.