Kalmar

Researchers are evaluating a digital support system called Evira designed to help treat childhood obesity, a growing global health concern linked to serious health problems like type 2 diabetes and high blood pressure. The study aims to see if adding Evira to the usual lifestyle treatment can improve outcomes for children and adolescents aged 4 to 17 years with obesity. Evira offers daily weight monitoring at home using a special scale connected to a mobile app, allowing parents and clinicians to closely track weight changes and communicate easily. Participants will be randomly assigned to one of two groups: the intervention group receives Evira support alongside standard lifestyle treatment, while the control group receives only the standard lifestyle care without restrictions on visits or clinical support. The 12-month study begins with information and training on using Evira, including installing scales and apps for parents and possibly the child. The intervention includes personalized weight loss targets for the first three months, with continuous monitoring and communication through the app and website. Throughout the study, all children will undergo clinical exams assessing puberty, heart and lung health, thyroid function, skin, and abdomen, as well as measurements of weight, height, and blood pressure. Blood tests may be done as needed. Participants and parents will complete questionnaires on quality of life, eating behaviors, and treatment satisfaction. Researchers will track weight changes over 12 months and collect safety and background information via electronic forms to evaluate the effectiveness of adding Evira to standard obesity care.

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 conducting a phase III randomized, open-label, multicenter trial across several countries including Sweden, Norway, Finland, Denmark, Italy, Australia, and New Zealand. The study focuses on elderly patients with untreated diffuse large B-cell lymphoma (DLBCL), defined as patients aged 80 years or older, or those aged 75 years or older who are considered frail based on a simplified Comprehensive Geriatric Assessment. The trial aims to compare the effectiveness of two treatment regimens in this population. Participants are randomly assigned to receive either the standard R-miniCHOP treatment or an experimental R-pola-miniCHP regimen where vincristine is replaced with an immunoconjugate, polatuzumab vedotin. Both treatments involve cycles of drugs including rituximab, cyclophosphamide, doxorubicin, and prednisone, administered over 18 weeks. The trial includes a screening period lasting up to 4 weeks, followed by the active treatment phase, and then a follow-up period lasting up to 36 months after treatment completion. Throughout the study, participants will be monitored to measure progression-free survival over 2 years as the primary outcome. The study involves regular assessments including clinical evaluations and safety monitoring. Enrollment began in the first quarter of 2020, with the last patient visit expected by the first quarter of 2027, allowing for long-term observation of treatment effects and patient outcomes.

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 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.

Many pregnant women, up to 25%, experience mental health issues like depression and anxiety, which can have serious and lasting effects on the mother, baby, and partner. This research aims to study how effective a new digital tool called the HealthyMoms4MentalHealth-app is in supporting mental health during pregnancy and after birth. Unlike many other apps designed for the general population, this app is specifically tailored for the perinatal period. The trial is a randomized controlled study involving 750 pregnant women, divided into two groups. One group will use the HealthyMoms4MentalHealth-app, which focuses on promoting mental wellbeing, while the other will use the HealthyMoms-app, which targets lifestyle behaviors during pregnancy and postpartum. The study measures mental wellbeing and related factors at three key times: early pregnancy (weeks 10-12), late pregnancy (weeks 35-38), and about 8-10 weeks after childbirth. Participants will provide demographic information and complete questionnaires about mental health, resilience, depression, attachment, fear of childbirth, self-compassion, and physical activity. Researchers will also collect data on stressful life events and obstetric and neonatal outcomes like birth weight and delivery method from medical records. The study carefully monitors these factors over time to assess how the digital interventions may influence psychological wellbeing during and after pregnancy.

Heart failure (HF) affects over 20 million people worldwide and is a growing health concern. This research aims to evaluate how tailored exergaming can help inactive adults with symptomatic HF reduce their sedentary time, increase daily physical activity, improve exercise capacity, reduce frailty, and enhance health-related quality of life. The study includes both a pilot phase with 20 participants and a larger multicenter randomized clinical trial with 600 participants, followed for 6 months. Participants will continue their standard guideline-directed medical therapy and be randomly assigned to either receive tailored activity advice (control group) or use the Heart-Exergame (Heart-eXg) intervention for 3 months. Those in the Heart-eXg group will play a mobile exergame called Heart Farming, which encourages physical activity indoors and outdoors by collecting virtual products through movement. The game adapts to players' abilities, provides feedback, and allows playing with someone from their network. Throughout the study, researchers will monitor sedentary time using actigraphy, as well as daily physical activity, submaximal exercise capacity, physical frailty, and quality of life. Participants will wear activity monitors and be assessed at multiple points during the 6-month follow-up. The study aims to provide valuable insights into using an easy-to-apply and affordable exergame to benefit the large and growing population of heart failure patients worldwide.

Acute facial nerve palsy affects 10 to 20 children per 100,000 each year in Sweden, with about 20% experiencing lasting symptoms like excessive tearing, drooling, and facial asymmetry that can impact social interactions. This research aims to evaluate the benefit of cortisone treatment (prednisolone) in children aged 1 to 17 with acute facial nerve palsy by conducting a randomized, double-blind, placebo-controlled multicenter trial. Although cortisone has shown benefits in adults with this condition, strong evidence in children is lacking, prompting this study to assess if prednisolone improves recovery rates. Participants will receive either oral prednisolone at a dose of 1 mg per kilogram of body weight once daily for 10 days (up to a maximum of 50 mg per day) or matching placebo tablets. Treatment will begin shortly after admission at one of 9-12 study centers across Sweden during 2019-2020. The study will follow participants closely to monitor their progress and response to treatment over time. Children will be assessed regularly with clinical evaluations and recovery measurements, with the main outcome being total recovery of facial nerve function measured by the House-Brackmann scale at 12 months after inclusion. Researchers will track clinical data and recovery during the study period to determine the effectiveness of prednisolone compared to placebo. This long-term follow-up aims to provide clear evidence to guide future treatment for children with acute facial nerve palsy.

Researchers are evaluating how different types of physical exercise affect menopausal symptoms and sleep quality in women aged 45 to 55 who are experiencing menopause-related symptoms. This study compares two exercise programs: strength training and dance-based exercise, delivered as digital, home-based interventions. The project also investigates how well participants stick to these structured exercise routines and which type of exercise has the greatest impact on menopausal health. Participants will be randomly assigned to one of three groups: a strength training group, a dance-based exercise group, or a control group with no prescribed exercise. The strength training program lasts 8 weeks, with sessions three times weekly, each about 30 minutes, focusing on major muscle groups using body weight and household items. The dance program also consists of 30-minute sessions at moderate intensity, performed three times weekly through pre-recorded videos. After the pilot phase, a larger 15-week intervention may be conducted with adjustments to exercise selection and intensity. During the study, participants complete validated questionnaires assessing menopausal symptoms and sleep quality before and after the intervention, including the Menopause Rating Scale and Pittsburgh Sleep Quality Index. They maintain training diaries to track exercise adherence and intensity. The control group continues usual activities without new exercise during the 8-week period but will have access to the exercise programs after the study. Participant progress, symptom changes, and adherence will be carefully monitored to evaluate the effects of the exercise programs on menopausal health.

Researchers are studying the connection between knee joint range of motion and pain in people with patellofemoral pain syndrome (PFPS). This study uses a cross-sectional observational design where patients with PFPS perform three types of closed-chain exercises: squat, single-leg squat, and split squat. The goal is to understand how increasing the range of motion during these exercises relates to reported pain levels. Participants will do exercises with gradually increased knee joint range of motion. During each exercise trial, they will report their pain on a scale from 0 to 10 using the Visual Analog Scale (VAS). The trial continues until the participant either reaches full depth in the exercise or experiences a pain level greater than 5 on the VAS. Each participant is involved in a single session where pain levels and knee range of motion are measured. The main outcomes are the pain reported on the VAS and the range of motion during the exercises. These measurements help researchers understand the relationship between pain and knee movement in PFPS patients aged 15 to 35 years.