Karlskrona

Researchers are evaluating a digital life story application called Min Memoria to support person-centred care for older adults with dementia. The study aims to see if this digital tool can replace traditional written life stories, which help healthcare professionals understand the individual's identity and life experiences to provide better care. The research is motivated by national and regional guidelines emphasizing person-centred approaches in dementia care and the growing use of digital devices among older adults and healthcare workers. The study involves several steps: first, focus group interviews with healthcare professionals to gather experiences using written life stories; next, transferring that information into the Min Memoria application; then, healthcare professionals will test this digital life story tool in daily care. Finally, observations will be made to see how the digital life story is used in communication and interaction within care settings. Participants will be healthcare professionals who use life stories in their daily care routines. The study will collect data on their experiences from October 2023 to August 2024, followed by data on the digital tool's use from September 2024 to August 2025, and observations from September 2025 to December 2026. Researchers will assess how the application supports person-centred care and its impact on communication and interaction with individuals living with dementia.

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). Participants must have experienced at least two moderate or one severe COPD exacerbations in the year before joining and be receiving inhaled maintenance therapy. The study focuses on adults who continue to experience symptoms despite current treatments and aims to assess the impact of tezepelumab on COPD exacerbations. Participants will be randomly assigned to receive monthly subcutaneous injections of either one of two doses of tezepelumab or a placebo. Treatment will last for a minimum of 52 weeks and may extend up to 76 weeks. After the treatment period, there will be a 12-week safety follow-up phase to monitor participants after stopping the study drug. The study compares tezepelumab to placebo to determine its efficacy and safety over this extended period. During the study, participants will undergo regular assessments to monitor their COPD status and any exacerbations. The main outcome measured is the annual rate of moderate or severe COPD exacerbations from the start of treatment through up to 76 weeks. Safety and tolerability will also be closely monitored throughout the treatment and follow-up periods. This long-term involvement ensures comprehensive data on how tezepelumab affects COPD progression and exacerbation frequency.

Researchers are evaluating the effect of adding high-flow oxygen therapy using the Lumis HFT device to standard long-term low-flow oxygen therapy in people with chronic respiratory failure due to chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD). This registry-based, randomized, controlled clinical trial involves patients who already receive long-term oxygen therapy (LTOT) and aims to improve evidence-based treatment for this high-risk population over a one-year period. Participants are randomly assigned to either receive added high-flow oxygen therapy during nighttime and optionally during daytime with usual low-flow oxygen care, or to continue with standard low-flow oxygen therapy alone. The intervention with high-flow therapy uses the Lumis HFT device, while the control group maintains regular care according to clinical routine. The study duration for treatment and follow-up lasts up to one year. During the study, participants are monitored for time to first hospitalization or death from any cause within one year. Researchers use the Swedish National Registry for Respiratory Failure (Swedevox) to identify and track patients. Assessments include adherence to therapy, clinical evaluations, and safety monitoring as part of routine care. The trial seeks to better understand outcomes related to long-term oxygen therapy in people with COPD or ILD and chronic respiratory failure.

Researchers are evaluating the effect of inhaled L-menthol on breathlessness and exercise capacity in patients with Interstitial Lung Disease (ILD). Dyspnea, or difficulty breathing, is a common symptom in ILD patients and is often triggered by everyday physical activities. Currently, there is no effective drug treatment for chronic dyspnea in ILD. This study aims to assess how inhaled menthol may help relieve chronic breathlessness by stimulating airflow sensation through a cooling effect in the airways. The study compares inhaled L-menthol, a drug sourced from Sigma-Aldrich, with a placebo that has a strawberry scent. Participants will be exposed to these treatments in a randomized crossover design to evaluate their effects. The intervention involves inhalation, and the study is conducted as a Phase 2 trial. It focuses on understanding both the effectiveness and mechanisms by which inhaled menthol might reduce breathlessness. Participants will undergo submaximal exercise tests during which breathlessness intensity is measured at specific times on days 2 and 3. The study includes assessments of exercise capacity and breathlessness. Researchers will monitor safety and collect data on how the treatments influence symptoms. The total study duration and additional follow-up details are not specified, but participants must be able to perform cycling and communicate in Swedish to take part.

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 treatments for elderly patients aged 75 and older who have an undisplaced femoral neck fracture (uFNF), classified as Garden I-II. The study compares whether replacing the hip (arthroplasty) reduces the need for further surgeries compared to preserving the hip with internal fixation. The goal is to lower the combined risk of needing reoperation or death within 1 to 2 years after surgery. Participants are randomly assigned to one of two treatment groups using the Swedish Fracture Register. One group receives arthroplasty, which may be either a hemi or total hip replacement depending on hospital routine based on patient age and mobility. The other group undergoes internal fixation, where the fracture is repaired using 2-3 screws, pins, or a sliding hip screw device, again according to hospital routine. Both treatments are devices applied to stabilize or replace the hip after fracture. During the study, participants are monitored for outcomes including the rate of additional surgeries and mortality up to 2 years after their initial operation. The main measure combines these two outcomes into a single variable to evaluate overall treatment success. The entire process is registered and randomized within the Swedish Fracture Register system, ensuring consistent follow-up and data collection.

Spontaneous intracerebral hemorrhage (ICH) is a severe type of stroke accounting for 10-15% of all strokes but causing about half of stroke-related deaths and disabilities. Many patients with ICH have decreased consciousness when admitted, yet intensive care and neurosurgical treatments are not common. Prior studies in low- and middle-income countries showed that a treatment package including early intensive blood pressure lowering and managing fever and high blood sugar improved outcomes. The I-CATCHER study aims to test a similar structured Care Bundle approach in Sweden, Australia, and other high-income countries to improve treatment and prognosis for patients with spontaneous ICH. This study compares a Care Bundle involving early intensive blood pressure control, reversal of oral anticoagulation within 30 minutes, fever management, blood sugar control, and timely referrals to intensive care or neurosurgery against standard care. The Care Bundle targets specific blood pressure levels depending on initial readings and aims to avoid do-not-resuscitate orders or withdrawal of care for 48 hours. Repeat brain imaging is done as needed. Hospitals are randomized in batches over three phases lasting 18 months each: usual care, randomized evaluation, and post-implementation follow-up, with the entire study rolling out over 2.5 years. Participants are adults aged 18 or older with spontaneous ICH confirmed by imaging and admitted within 24 hours of symptom onset. Patient information, treatments, and outcomes are recorded, including functional status measured by the Utility Weighted modified Rankin Scale at 180 days. The study collects data on various treatments, monitoring, and complications to assess if the Care Bundle improves recovery. Safety and sustainability of the Care Bundle are evaluated through continued hospital participation and follow-up.

Researchers are evaluating the long-term outcomes of surgical treatment for peri-implantitis lesions in patients treated at the University of Malmö, Blekinge hospital, and the Dental Clinic of the Sigmund Freud University Vienna. This study includes patients treated since 2014 and those receiving future treatment, with regular assessments to monitor healing and disease resolution over many years. The study aims to understand the effectiveness of surgical interventions for peri-implantitis by tracking clinical and radiographic healing progress. Patients who have undergone or will undergo surgical treatment are regularly monitored, with clinical peri-implant parameters such as probing pocket depth and peri-implant sulcus fluid collected. Peri-apical radiographic examinations are also performed. For 200 patients treated in the future, inflammatory peri-implant lesions removed during surgery will be collected for detailed histological, microbiological, and molecular analyses. These lesion removals are standard during surgery and occur regardless of study participation. Participants will be called in for annual check-ups after their surgical intervention to assess healing and disease resolution, with follow-up visits continuing for up to 10 years postoperatively. Clinical and radiographic assessments are done once a year after the first year following surgery. Researchers measure disease resolution at multiple time points ranging from 12 to 120 months after surgery to evaluate the long-term success of the treatment. This ongoing monitoring helps track implant health and identify any complications over time.

Researchers are evaluating if oral treatment with pivmecillinam is effective for adults hospitalized with febrile urinary tract infections (fUTI) caused by Escherichia coli. This Phase 4, open-label randomized clinical trial compares oral pivmecillinam to standard oral or intravenous antibiotic treatments following 2-4 days of intravenous therapy. The study aims to determine whether pivmecillinam is as effective as standard care by assessing clinical and microbiological responses after treatment. Participants will be randomly assigned to receive either pivmecillinam tablets (400 mg four times daily) for 7 or 10 days depending on patient factors, or standard care antibiotics chosen by their physician for 7 to 14 days. The control treatments include various intravenous and oral antibiotics guided by laboratory susceptibility testing. Some participants will provide additional samples to study changes in the gut microbiome and the pharmacokinetics of pivmecillinam. During the study, patients will keep a diary recording medication use, body temperature, urinary symptoms, and side effects until 7 days after treatment ends. Phone interviews will be conducted 7 and 28 days after treatment to assess clinical response. Urine samples will be collected at these times to evaluate bacterial growth. Subgroups will provide fecal samples over three months and blood and urine samples to study drug effects and metabolism. The main outcome is clinical response measured about one week after treatment ends.

Researchers are studying pregnant women early in pregnancy to understand if clinical manual pain provocation tests of the pelvic joints can help predict who will develop pregnancy-related pelvic girdle pain (PPGP). The study aims to compare women who develop PPGP with those who do not, focusing on how early test results relate to pain development and sick leave during pregnancy. Pregnant women without current pelvic joint pain before 20 weeks of gestation are invited to participate. During a visit with a manual therapist, five validated pain provocation tests of the pelvic joints are performed. Participants also answer about 13 questions covering previous low back pain, pelvic trauma, past pregnancy pelvic pain, number of previous pregnancies, contraception history, lactosis intolerance, profession, physical exercise level, gestational week, age, and BMI. After delivery, participants receive a phone call to report if they experienced pelvic pain and whether they required sick leave. Throughout the study, researchers track the correlation between early pain test results, risk factors, and full-time sick leave over approximately six months per participant. The study involves no treatment but diagnostic assessments and questionnaires. This follow-up allows understanding of how early pelvic joint tests relate to pregnancy-related pelvic pain and its impact on daily life and work.