Norrkoping

Researchers are evaluating an artificial intelligence (AI) decision support system called Dermalyser to help primary care physicians distinguish skin cancer from benign skin lesions. This study is a multicenter, cluster-randomized controlled trial conducted at about 30 primary care centers across Sweden, Germany, Scotland, the Netherlands, and Australia. The aim is to assess the accuracy, reliability, and clinical usefulness of Dermalyser in real-world primary care settings where most patients with skin concerns are managed. The study also explores whether using this AI tool can improve early detection of skin cancer and reduce unnecessary removal or referral of benign lesions. During the study, participating primary care centers are randomly assigned to either use the Dermalyser device as a complementary diagnostic aid (intervention phase) or follow their usual clinical assessment without AI support (control phase). After enrolling half of the planned 3000 participants (1500 patients), the centers switch phases, allowing all to experience both approaches. Physicians decide on the clinical management of lesions, with Dermalyser providing additional information only during the intervention phase. Participants are followed for up to 5 years to monitor tumor diagnoses, skin cancer rates, and related health outcomes. Participants are patients attending primary care to have suspicious skin lesions checked. Researchers will assess the proportion of skin cancers diagnosed within six months of enrollment using standard clinical procedures. Throughout the study, data on diagnoses, morbidity, and mortality related to skin cancer will be collected. This long-term follow-up aims to determine differences between those assessed with and without the AI decision support. The study results could help improve skin cancer diagnostics and patient care in primary care settings worldwide.

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.

In primary health care patients with chest symptoms are common. In many cases the cause is benign but chronic coronary artery disease (CAD) must often be considered. In the clinical work, evaluation of symptoms and risk factors are fundamental for a plausible working diagnosis and to judge if any further investigation is needed. The probability of CAD for a person of a certain age, sex and character of chest symptoms, scored from 0-3, i.e. pretest probability (PTP) for CAD, is substantially lower now than it was a decade ago in western countries. Consequently, recent European guidelines recommend that further investigation to rule out CAD may be omitted if the risk for CAD is judged to be low (PTP\<15 %) and there are no further cardiovascular risk factors. If further investigation is needed in the low-risk group, computed tomography angiography (CTA) is preferable. When the risk for CAD is judged to be intermediate (PTP\> 15 %) an imaging investigation is advocated instead of the well-established exercise stress bicycle test. A much-used imaging test is myocardial perfusion scan in which an exercise stress bicycle test is performed, with the addition of an intravenous injection of a small amount of radioactive tracer, whereafter the myocardial blood flow is demonstrated by imaging. Sensitivity for myocardial perfusion scan to detect significant CAD is 87 % (95 % CI 83-90) in comparison with exercise stress bicycle test where it is only 58 % (95 % CI 46-69). Specificity is 70 % (95 % CI 63-76) and 62 (95 % CI 54-69) respectively. However, the exercise stress bicycle test reveals indirect signs of myocardial ischemia and is reasonable in price, easy to perform and available in many clinics and hospitals. It is since long the first-line method for referral from the primary care setting. If the result from the exercise stress bicycle test is inconclusive, the work-up should be continued, e.g. with myocardial perfusion scan. An echocardiogram is often performed as well to evaluate the condition of the myocardium, heart valves and left ventricular ejection fraction. This stepwise or sequential clinical work-up strategy is well known and reasonable in general practice where patients in general have a low prevalence of serious diseases compared to organ specialist clinics. Since June 2021 in Region Östergötland (471 912 inhabitants 2022) CTA is recommended if further investigation is deemed necessary in patients with a low risk of CAD (PTP\< 15 %) in primary care. For patients with intermediate risk of CAD (PTP\> 15 %) exercise stress bicycle test is still the first-line choice. There may be advantages if myocardial perfusion scan and echocardiogram is performed on a single visit. In addition, a CT scan of the heart to determine coronary artery calcification (CAC) score is easy to perform on the same visit, gives only a small amount of radiation and adds useful information. The CAC-score has been shown to be an independent predictor of future cardiovascular events and is useful for reclassification of cardiovascular risk based on traditional risk factors like age, cholesterol levels and smoking habits. Furthermore, a clear and coherent answer on all three investigations, to the referring GP can provide a more secure basis for clinical decision making. For the individual patient it is probably an advantage to get a thorough investigation done at one single visit and possibly a faster and more valid statement from the investigations by the GP. On the other hand, if many advanced investigations are done unnecessarily, expenses and exposure to radiation will increase unjustifiably. Possibly there is also a risk of medicalization and to create worries for future cardiovascular events communicating the CAC-score to people that has not asked for the information. In order to get a faster and more complete basis for the evaluation of CAD in primary care patients with an intermediate (PTP\> 15 %) risk the investigators created a package investigation comprised of myocardial perfusion scan, echocardiogram and CT scan of the heart on a single visit. The results from myocardial perfusion scan will be written according to national guidelines and communicated to the referring GP together with results from echocardiogram and CAC-scoring as a coherent answer. Moreover, registration of heart sounds followed by risk calculation by a technical device Cadscore® will be performed but only for scientific analyzes and not be given as a clinical answer. In this study the investigators aim to compare the standard routine sequential investigation for detecting CAD with a single-visit package investigation.

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.

This research aims to compare the effects of three different fluid challenge strategies on plasma volume expansion during longer laparoscopic abdominal surgeries lasting over 90 minutes. The study will include 60 patients undergoing such surgeries, divided into three groups to receive different fluid treatments. The purpose is to understand how these fluids affect blood volume and circulation, using hemoglobin levels as an indicator. Participants will be randomly assigned to receive one of three treatments: acetated Ringers solution at 4 ml per kilogram of body weight, albumin 5% at 4 ml per kilogram, or albumin 20% at 1 ml per kilogram. The fluid bolus is given after the abdomen is inflated with carbon dioxide during surgery. If the patient's cardiac output increases after the first bolus, a second bolus is administered. Circulatory and volume effects are monitored throughout. Before surgery, blood samples and other measurements like bioimpedance and urine tests are taken. During surgery, a Cardio Q probe is placed via the nose into the esophagus to monitor circulation. Blood samples are collected at several time points before and after fluid infusions to measure hemoglobin, albumin, and colloid osmotic pressure. Arterial blood gases are also tested after infusions or as needed. The main outcome measured is the plasma volume expansion 60 minutes after the fluid bolus. The study spans the surgery period with detailed monitoring of blood volume and circulation changes.

Researchers are investigating the role of inflammatory markers and gene scores in predicting atrial fibrillation (AF) recurrence after electrical cardioversion (ECV). AF patients often experience high rates of AF returning after ECV, and this study aims to explore beyond common markers like high-sensitivity CRP and IL-6 to identify better predictors. This prospective cohort includes 182 patients with persistent AF, aged over 18, from two Swedish hospitals. Participants will have blood samples taken before ECV and during follow-up visits at 7, 30, 90, and 180 days. AF recurrence will be monitored using 12-lead ECG either during these scheduled visits or when patients report symptoms. The study includes an interim analysis after enrolling 80 patients to evaluate the significance of inflammatory and genetic markers in predicting AF recurrence. Throughout the study, researchers will track AF recurrence and assess inflammatory and genetic data from blood tests. The follow-up period extends to 180 days post-ECV, allowing close monitoring of patients' heart rhythm. The study will conclude early if significant predictors are identified during interim analysis, aiming to improve AF management by better understanding recurrence risks.

The International Collaborative Gaucher Group (ICGG) Gaucher Disease Registry is an ongoing global observational program tracking routine clinical outcomes in patients diagnosed with Gaucher disease. It includes patients regardless of their treatment status and aims to improve understanding of the variability, progression, and natural history of Gaucher disease. The Registry also seeks to support the medical community by developing monitoring recommendations, characterizing the patient population, and evaluating long-term treatment effectiveness of imiglucerase and eliglustat. The Registry involves no experimental treatments; patients receive clinical assessments and care as directed by their treating physicians. Additionally, there is a Gaucher Pregnancy Sub-registry that monitors pregnancy outcomes, complications, and infant growth up to 36 months postpartum for women with Gaucher disease. This Sub-registry collects medical and obstetric history and pregnancy data for participants who consent, without altering their standard care. Participants provide data through routine clinical visits, and researchers collect medical information to better understand patient outcomes and optimize care. The Registry tracks outcomes over long periods, including up to 42 years, to support ongoing care improvements. Women in the Pregnancy Sub-registry have additional data collected on pregnancy and infant growth, contributing to comprehensive monitoring of Gaucher disease impacts during and after pregnancy.

This research aims to find out if an internet-based cognitive behavioral therapy (CBT) combined with educational resources can improve mental health, disease understanding, and quality of life for adults living with chronic obstructive pulmonary disease (COPD). The study is a feasibility trial designed to determine if this online program is practical, acceptable, and effective enough to be tested in a larger future study. It focuses on reducing anxiety, depression, and stress while enhancing COPD symptom management and overall well-being. Participants will engage in an 8-10 week internet-based CBT program that includes Acceptance and Commitment Therapy (ACT) elements along with COPD-specific education. The program consists of several online modules covering coping strategies, mindfulness, disease knowledge, and symptom management. Participants complete these modules at home through a secure platform with ongoing support and feedback from trained healthcare professionals. During the study, participants will complete questionnaires about their mental health, stress, quality of life, COPD symptoms, and breathlessness before and after the program. They will visit the clinic twice for breathing tests (spirometry) and physical capacity assessments using a 6-minute walk test. Additionally, 10-15 participants will take part in interviews to share their experiences and satisfaction with the online program. The study will evaluate the program's feasibility and impact on mental health and COPD management over the intervention period.

Researchers are evaluating Interpersonal Psychotherapy (IPT) specifically adapted for adolescents and young adults aged 15 to 18 years with major depression. The project aims to study the effects, mechanisms of change, predictors, and implementation of IPT within child and adolescent psychiatric services in Norrköping. The study plans to include 60 patients with depression using a quasi-experimental multiple-baseline design, examining changes in depressive symptoms and related factors over time. Participants will receive Interpersonal Psychotherapy for Adolescents (IPT-A), a brief and structured treatment adapted from adult IPT to help improve depression by enhancing social support and addressing interpersonal challenges. The therapy includes scheduled meetings with parents and involves seven trained therapists. Treatment progress and change mechanisms such as mentalizing, emotion regulation, social support, and working alliance will be assessed session-by-session. The study includes a baseline waiting period of 4 to 25 weeks before treatment, followed by 12 weeks of therapy and a follow-up phase. During the study, participants will complete various assessments including depression rating scales before, during, and after treatment. These include the Patient Health Questionnaire-9, Montgomery Åsberg Depression Rating Scale, and process measures related to therapy mechanisms. Data collection also involves interviews with patients, parents, and therapists to explore experiences and implementation. Researchers will analyze symptom changes, treatment effects, and predictors of improvement, with safety monitoring to exclude those with acute suicidality or severe conditions. Total participation spans baseline, treatment, and follow-up phases over several months.