Kalmar

Childhood obesity is a growing global health concern linked to serious health problems such as type 2 diabetes, high blood pressure, certain cancers, and mental health challenges. Researchers are evaluating a digital support system called Evira to help improve treatment outcomes for children with obesity. This randomized controlled study aims to assess the effects of adding Evira to the usual lifestyle treatment for childhood obesity in children aged 4 to 17 years. The study compares two groups one receiving Evira Care combined with standard lifestyle treatment, and the other receiving standard lifestyle care alone. Evira Care involves daily weight monitoring at home using a special scale connected to a mobile app and website, allowing parents and clinicians to track weight changes and communicate easily. The intervention group will receive guidance on how to use the system and make feasible lifestyle changes, with weight targets set for the first three months. The control group continues with standard care without restrictions on visits or clinical support. Participants will be involved for 12 months, undergoing clinical exams including puberty assessment, cardio-respiratory, thyroid, skin, and abdominal checks, along with measurements of weight, height, and blood pressure. Blood tests may be done as needed. All participants will complete questionnaires about quality of life, eating disorders, and treatment satisfaction. Researchers will monitor weight change as the primary outcome, along with treatment compliance and psychosocial health measures, while collecting information on any side effects.

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.

This trial focuses on elderly patients aged 80 years or older, or those 75 years and older who are considered frail, with untreated diffuse large B-cell lymphoma DLBCL and related lymphoma subtypes. The study is a phase III, randomized, open-label, multicenter trial conducted in several countries including Sweden, Norway, Finland, Denmark, Italy, Australia, and New Zealand. It aims to compare the standard chemotherapy regimen R-miniCHOP with an experimental treatment R-pola-miniCHP, where vincristine is replaced by polatuzumab vedotin, to assess differences in outcomes for this patient population. Participants will be randomly assigned to one of two treatment groups. One group will receive R-mini-CHOP consisting of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone over six 21-day cycles. The other group will receive R-pola-mini-CHP, which includes rituximab, cyclophosphamide, doxorubicin, prednisone, and polatuzumab vedotin instead of vincristine, also given over six 21-day cycles. Both treatments last approximately 18 weeks. The study includes a screening period lasting up to 4 weeks before treatment begins. During the study, participants will be followed for up to 36 months after completing treatment to monitor progression-free survival over two years. Researchers will evaluate disease progression and safety outcomes through regular assessments during and after the treatment period. Participants will provide informed consent and undergo evaluations including health status and disease measurements to ensure eligibility and monitor treatment effects throughout the trial.

Researchers are investigating the use of adjuvant CDK46 inhibitors combined with endocrine therapy in older breast cancer patients aged 70 years and above. This study focuses on the specific challenges faced by this population, including comorbidities that may increase the risk of treatment-related toxicities and affect quality of life. Due to limited representation of older patients in previous trials, this study aims to better understand the benefits and risks of such treatment in this age group and the role of geriatric assessments to guide therapy. Participants will undergo geriatric screening using tools such as the Geriatric 8 G8 and Vulnerable Elders Survey-13 VES-13 to assess frailty before starting adjuvant CDK46 inhibitor therapy alongside endocrine treatment. The study will examine multiple outcomes including treatment side effects, dose intensity, treatment discontinuation, quality of life, hospitalization, cancer recurrence, and survival. These measures will be collected over several years with follow-ups at various intervals, up to 10 years for some outcomes. Throughout the study, participants will complete questionnaires assessing frailty and quality of life at baseline and at multiple points after starting treatment. Adverse events, hospitalizations, dose adjustments, and treatment discontinuation will be monitored regularly up to six months after ending CDK46 inhibitor therapy. Long-term outcomes such as breast cancer recurrence and survival will be tracked at 3, 5, and 10 years. This approach aims to provide a thorough evaluation of how geriatric screening relates to treatment effects and long-term health in this patient group.

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 evaluating the impact of two different guidelines for monitoring labor progress on neonatal and maternal outcomes. The study compares the World Health Organizations Labour Care Guide LCG with standard delivery care in Sweden. The goal is to see if using the LCG can reduce adverse neonatal outcomes and lower the rate of intrapartum Cesarean sections. This study uses a multicenter, stepped-wedge cluster randomized design to explore these effects along with economic considerations and experiences related to childbirth. Participants will receive labor monitoring either according to the WHOs LCG guidelines or standard care. The study will involve multiple delivery units in Sweden, and women in active labor will be randomly assigned to either group as the new guidelines are gradually introduced. Alongside the main study periods, researchers will examine perinatal interventions, labor complications, and collect qualitative data through questionnaires, focus groups, and interviews with women, their partners, and healthcare providers. During participation, women and their partners will be asked about their childbirth experiences, while providers compliance and views on using the LCG will also be assessed. The study will track outcomes such as perinatal mortality, neonatal morbidity, cesarean section rates, and obstetric events like postpartum hemorrhage and labor duration. Data collection and follow-up will occur from 12 weeks up to 18 months after delivery, including economic evaluations and provider experiences to fully understand the effects of the labor monitoring methods.

Many pregnant women experience mental health challenges such as depression and anxiety, which can have serious and lasting effects on the woman, her baby, and her partner. Researchers are studying a new digital tool called the HealthyMoms4MentalHealth app, designed specifically for pregnancy and postpartum, to see if it can improve mental health during the perinatal period. This trial compares this new app with a general HealthyMoms app that focuses on healthy lifestyle behaviors during pregnancy. The study is a randomized controlled trial with two groups one group uses the HealthyMoms4MentalHealth app aimed at promoting mental wellbeing, while the control group uses the HealthyMoms app focusing on healthy lifestyles. A total of 750 pregnant women will participate, starting between 8 and 15 weeks of pregnancy. Participants will be evaluated at three time points early pregnancy gestational weeks 10-12, late pregnancy weeks 35-38, and postpartum 8-10 weeks after birth. During the study, researchers will collect information through questionnaires measuring mental wellbeing, resilience, depression, attachment to the baby, fear of childbirth, and parental self-efficacy. They will also gather medical record data about birth outcomes like weight gain, delivery method, and infant size. Assessments will occur at baseline, late pregnancy, and postpartum to track changes. The total study participation covers pregnancy through early postpartum, with regular follow-up to monitor mental health and related factors.

This research aims to assess the impact of tailored exergaming on patients with symptomatic heart failure who are physically inactive. The study focuses on reducing sedentary time, enhancing daily physical activity, improving exercise capacity, decreasing frailty, and boosting health-related quality of life. It involves adult patients receiving standard guideline-directed medical therapy and is structured as a pilot study followed by a multicenter, open-label randomized clinical trial with a six-month follow-up. Participants will be randomly assigned to one of two groups for a three-month period a control group receiving tailored activity advice or an intervention group receiving the Heart-Exergame Heart-eXg. The Heart-eXg is a mobile exergame designed to promote physical activity through farming-themed challenges, adaptable to different mobility levels, and includes social play options. Patients in the intervention group receive feedback and personalized gaming advice from a coach, with weekly feedback in the first month and tailored contact thereafter. Control group participants receive protocol-based activity advice from healthcare professionals. During the study, participants will be introduced to the exergame and monitored using activity trackers. Researchers will assess sedentary time as the primary outcome, with secondary measures including exercise capacity, physical frailty, clinical frailty, and health-related quality of life at baseline, three months, and six months. The study includes assessments of physical activity levels and quality of life, with ongoing feedback and coaching to support adherence. The total participation duration covers active intervention and follow-up periods to evaluate sustained effects.

Researchers are evaluating the use of oral cortisone prednisolone treatment in children aged 1 to 17 years who have acute peripheral unilateral facial nerve palsy. This condition affects about 10 to 20 children per 100,000 annually in Sweden, with 20% experiencing lasting symptoms such as excessive tearing, drooling, and facial asymmetry. The study is a double-blind, randomized, placebo-controlled multicenter trial aimed at assessing whether prednisolone improves recovery compared to placebo over 12 months. Participants will be randomly assigned to receive either prednisolone tablets dosed at 1 mg per kg of body weight daily for 10 days up to a maximum of 50 mg per day or placebo tablets that look identical. The treatment will start upon admission, and clinical data will be collected during follow-up visits. The primary outcome is full recovery of facial nerve function measured by the House-Brackmann scale at 12 months, with additional facial function and disability assessments also conducted. During the study, children will undergo clinical evaluations at regular intervals up to 12 months to monitor nerve recovery and facial function using several scales and questionnaires. Researchers will track adherence to treatment and monitor for any side effects or complications. The total participation time for each child will be approximately one year, allowing detailed observation of long-term outcomes and treatment effects.

Researchers are evaluating the effects of different types of physical exercise on women experiencing menopausal symptoms. This study investigates how strength training and dance-based exercise may influence menopausal symptoms and sleep quality. It also examines adherence to digital, home-based exercise programs. The trial is designed as a randomized controlled study including a pilot phase and a planned larger main study.