Norrkoping

Researchers are evaluating an artificial intelligence AI decision support system called Dermalyser to help primary care physicians distinguish between skin cancer and benign skin lesions. This multicenter randomized controlled trial is conducted at about 30 primary care centers across Sweden, Germany, Scotland, the Netherlands, and Australia. The study aims to assess the accuracy, reliability, and clinical usefulness of Dermalyser in real clinical settings where most patients with skin lesions are managed. Participants will be assessed at primary care centers randomized to either use Dermalyser as a complementary diagnostic tool or follow the standard clinical procedure without AI support. After reaching half of the planned enrollment, centers switch from one phase to the other. Physicians can choose to use Dermalyser when they find it indicated, but the final clinical decision about lesion management remains with the physician. Both groups will be followed for up to five years to track tumor diagnoses, proportions of skin cancer versus benign lesions, and related health outcomes. During the study, participants will have their skin lesions evaluated according to either the AI-supported or standard procedure. The primary outcome measure is the proportion of skin cancers detected within six months of enrollment. Researchers will monitor morbidity and mortality related to skin cancer and compare differences between the groups. Participation may last up to five years with follow-up to assess diagnostic outcomes and safety. The study is sponsored by Linkping University.

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.

Researchers are evaluating a new combined procedure to investigate possible coronary heart disease, comparing it to the standard stepwise approach. The study aims to determine if this package investigation, which includes a myocardial perfusion scan, echocardiography, and heart CT scan all done in a single visit, is faster, less costly, or more costly. The trial also looks at how these approaches affect patients physical activity, mental well-being, adherence to heart-protective medications, and risk of cardiac events like heart attacks over several years. The study compares two groups one receiving the package investigation during one hospital visit, and the other undergoing the standard investigation involving sequential tests such as exercise stress bicycle test, echocardiography, and myocardial perfusion scan as needed. Both groups receive resting ECG and risk evaluation before further testing. Additional data from a heart sound recording device Cadscore4 is collected for scientific analysis but not used clinically. Participants are patients from primary care centers with chest symptoms and an intermediate risk for coronary artery disease. They give consent to answer questionnaires at enrollment and at one, three, and five years, and allow researchers access to medical records and registry data. The study measures include time to complete ischemia assessment, costs, health quality, physical fitness, anxiety, depression, medication adherence, and heart events, with follow-up lasting up to five years.

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 plasma expanding effects of three different fluid challenge strategies during longer laparoscopic abdominal surgeries lasting over 90 minutes. The study includes 60 patients randomized into three groups to compare acetated Ringers, albumin 5%, and albumin 20% solutions. The goal is to understand how these fluid treatments affect blood volume and circulation using hemoglobin as an indicator. The study groups receive specific fluid boluses acetated Ringers at 4 mlkg body weight, albumin 5% at 4 mlkg, and albumin 20% at 1 mlkg. After the first bolus infusion during surgery, if cardiac output increases by 10%, a second bolus is given and further studied. Circulatory effects are monitored using a Cardio Q probe inserted into the esophagus, and blood samples are taken at several intervals before and after fluid infusions. Participants undergo various assessments including blood tests for hemoglobin, albumin, and colloid osmotic pressure before surgery and at multiple time points during surgery. Additional measurements include bioimpedance, urine osmolality, and arterial blood gases. Researchers measure plasma volume expansion as the primary outcome at 60 minutes after fluid bolus, along with secondary measures like stroke volume, blood pressure, heart rate, and biochemical markers. The study is expected to conclude by October 2026.

Researchers are studying patients with persistent atrial fibrillation who are planned for electrical cardioversion to evaluate how inflammatory markers and gene scores may predict the recurrence of atrial fibrillation after this procedure. The study focuses on identifying better prediction models by examining a broader set of inflammatory indexes beyond those already studied, such as high-sensitivity CRP, CRP, and IL-6. This observational prospective cohort study is led by Vrinnevi Hospital and aims to improve understanding of factors related to atrial fibrillation recurrence. Participants will have blood samples drawn before electrical cardioversion and at several follow-up points 7, 30, 90, and 180 days after the procedure. This allows researchers to monitor changes in biomarkers and gene expression over time. The study involves collecting data through blood sampling only, with no experimental treatments administered. An interim analysis will be performed after including more than 80 patients to assess the significance of the findings. During the study, recurrence of atrial fibrillation will be tracked through 12-lead ECGs conducted at follow-up visits or when symptoms occur. Researchers will also observe fluctuations in inflammatory and genetic markers during the follow-up period. Participants can expect regular follow-up visits for blood sampling and heart rhythm monitoring over six months. The total duration of participation extends from the initial cardioversion through the 180-day follow-up, with ongoing assessment of heart rhythm and biomarker levels.

Researchers are tracking the natural history and clinical outcomes of patients with Gaucher disease through the ICGG Gaucher Registry, an international, multi-center observational program. This registry does not involve any experimental treatments, but collects information to better understand the variability, progression, and identification of Gaucher disease, aiming to improve patient care and therapeutic guidance. It also evaluates the long-term use of treatments like imiglucerase and eliglustat. The study includes two groups patients with Gaucher disease who receive routine clinical assessments and standard care as determined by their physicians, and a Pregnancy Sub-registry for women with Gaucher disease who are pregnant or have been pregnant. The Pregnancy Sub-registry collects information on pregnancy outcomes, complications, and infant growth up to 36 months postpartum, regardless of whether the women receive disease-specific therapy. Participants undergo clinical assessments and receive care according to their treating physicians decisions. Data collected includes medical history, pregnancy and birth details for the sub-registry, and patient outcomes over time. The primary goals are to provide recommendations for monitoring Gaucher disease patients, report outcomes to optimize care, and track pregnancy and infant growth outcomes. This ongoing registry allows long-term follow-up without experimental interventions.

This research aims to find out if an internet-based cognitive behavioral therapy CBT combined with an educational program can improve mental health, disease knowledge, and quality of life for adults living with chronic obstructive pulmonary disease COPD. The study is a feasibility trial designed to see if this online treatment is practical, acceptable, and potentially effective enough to be used in a larger study. It focuses on measuring changes in anxiety, depression, stress, COPD symptoms, and quality of life. Participants will take part in an 8-10 week online CBT and education program specifically developed for COPD. This program includes Acceptance and Commitment Therapy ACT techniques and covers topics such as coping strategies, mindfulness, disease knowledge, and symptom management. The program is completed from home through a secure internet platform with regular support from trained healthcare professionals. During the study, participants will complete questionnaires about mental health, stress, quality of life, and COPD symptoms before and after the program. They will also visit a clinic twice for breathing tests spirometry and a 6-minute walk test to assess physical capacity. A subgroup of participants will be interviewed about their experiences with the online program. Researchers will assess the programs feasibility and its effects on mental health, COPD symptoms, lung function, and quality of life.

Researchers are evaluating the effectiveness of Interpersonal Psychotherapy IPT for adolescents aged 15 to 18 years diagnosed with major depression. This study aims to analyze the effects, change mechanisms such as mentalizing and emotion regulation, predictors of treatment success, and how IPT is implemented within child and adolescent psychiatric services. The project plans to include 60 patients over four years and uses a quasi-experimental multiple-baseline design to measure outcomes. Participants will receive Interpersonal Psychotherapy for Adolescents IPT-A, a structured therapy adapted from adult IPT, designed to improve depressive symptoms by enhancing social support and processing interpersonal difficulties. Treatment includes some scheduled meetings with parents and is delivered by trained therapists within the psychiatric service. The study phases include a baseline period with no treatment followed by a treatment phase and a follow-up phase to observe changes. Throughout the study, participants will complete various assessments including the Montgomery sberg Depression Rating Scale and the Patient Health Questionnaire-9, administered at specific times before, during, and after treatment. Therapists and patients will also complete session-by-session measures evaluating mentalizing, emotion regulation, social support, and the working alliance. Qualitative interviews will explore patients experiences of change. The study monitors symptom improvement and predictors of treatment response over time.