Karlskrona

Researchers are exploring how a digital life story application can support person-centred care for older adults with dementia. The study focuses on healthcare professionals perspectives and aims to see if the digital application can replace traditional written life story documents used in care. The life story tool is intended to help create security and improve communication between healthcare professionals and people with dementia by sharing important personal information and experiences. The study involves healthcare professionals who currently use a written life story in their daily care routines. They will participate in focus group interviews to share their experiences, then transfer information from the written life story to the digital application called Min Memoria. This digital tool will be tested in daily care settings, and researchers will observe how it is used during interactions and communication with older adults with dementia. Participants will be involved over several periods from October 2023 to August 2024, researchers will collect experiences of using the written life story from September 2024 to August 2025, usage data of the digital tool will be gathered and from September 2025 to December 2026, observations will be made on how the digital life story is used in care situations. The study will monitor these experiences and interactions to evaluate the potential benefits and application of the digital life story tool.

Researchers are evaluating the efficacy and safety of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease COPD who are receiving inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on adults aged 40 to 80 years who have experienced multiple COPD exacerbations in the year prior to enrollment. The trial aims to assess tezepelumabs impact compared to placebo on COPD exacerbations and lung function. Participants will receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. Treatment duration ranges from a minimum of 52 weeks to a maximum of 76 weeks. Following the treatment period, participants will undergo a 12-week off-treatment safety follow-up to monitor any lasting effects. Throughout the study, participants will be regularly assessed for COPD exacerbations, lung function changes measured by forced expiratory volume FEV1, and quality of life using questionnaires such as the St. Georges Respiratory Questionnaire and COPD Assessment Test. Blood samples will be collected to measure drug levels and immune responses. Safety and efficacy will be closely monitored, with total participation lasting up to approximately 88 weeks including follow-up.

Researchers are evaluating the effect of adding high-flow oxygen therapy using the Lumis HFT device to regular low-flow oxygen therapy in people with long-term oxygen therapy LTOT for chronic obstructive pulmonary disease COPD or interstitial lung disease ILD. This registry-based, randomized, controlled clinical trial aims to improve evidence-based treatment for patients with chronic respiratory failure, who face a high risk of adverse events and mortality. Participants will be randomly assigned to either receive added high-flow oxygen therapy during nighttime and at their discretion during the day alongside their usual low-flow oxygen therapy, or to continue with standard care using low-flow oxygen therapy alone. The study will last up to one year and is based on data from the Swedish National Registry for Respiratory Failure Swedevox in collaboration with the Swedish Respiratory Society. During the study, researchers will monitor time to first hospitalization or death from any cause over one year as the primary outcome. Secondary outcomes include hospitalization rates, intensive care admissions, mortality rates, exacerbations, quality of life, health status, breathlessness, sleep quality, physical activity, nasal symptoms, and adverse events at several time points. Participant assessments will include regular follow-ups over the year to gather these data and evaluate the impact of the added therapy.

Researchers are evaluating the effect of inhaled L-menthol on breathlessness and exercise capacity in patients with interstitial lung disease ILD, a condition marked by chronic shortness of breath triggered by daily physical activities. The study aims to assess how L-menthol may relieve this symptom, building on pilot data suggesting it may reduce lab-induced breathlessness by creating a cooling sensation in the airways through olfactory stimulation. This is a Phase 2 randomized trial focused on understanding L-menthols effectiveness and mechanisms for dyspnea relief in ILD patients. Participants will receive either an L-menthol patch or a placebo patch with a strawberry scent, attached inside a facemask connected to a breathing circuit before performing submaximal cardio-pulmonary exercise tests on two separate days. The trial uses a crossover design where participants experience both treatments in a randomized order, allowing comparison of breathlessness and exercise capacity under both conditions. During the study, participants undergo detailed assessments including breathlessness intensity, unpleasantness, exercise capacity, peak dyspnea, leg fatigue, ventilatory measures, oxygen saturation, heart rate, and adverse events. These are measured during the submaximal exercise tests on days two and three, with safety monitored through follow-up for about one week. The total participation duration covers these exercise tests and safety monitoring to evaluate how inhaled L-menthol influences breathing and physical ability in ILD.

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.

This research aims to determine if hip replacement surgery arthroplasty can reduce the need for additional operations compared to internal fixation in elderly patients with an undisplaced femoral neck fracture. Patients aged 75 years and older with this type of fracture will be included and randomly assigned to one of two treatments through the Swedish Fracture Register platform. The study focuses on combining reoperation rates and mortality into a single main outcome measure to evaluate which treatment offers better results. Participants will receive either arthroplasty, which may be hemi or total hip replacement depending on the patients condition and surgeons decision, or internal fixation using screws, pins, or a sliding hip screw device based on hospital routine. The study is a randomized controlled trial without blinding, comparing these two device-based treatments for hip fractures in elderly patients. During the study, researchers will monitor the combined rate of reoperations and mortality for 1 to 2 years after surgery. Additional outcomes include reoperation rates, short- and long-term mortality, and patient-reported physical function one year after surgery. Participants will be followed up to assess these outcomes, with care taken to track their progress and safety over the study period.

Spontaneous intracerebral hemorrhage ICH is a serious type of stroke with high death and disability rates. Researchers are investigating whether a structured treatment package called a Care Bundle can improve the 3-month outcomes for patients with acute ICH compared to standard care. The study is an international, multicenter, parallel, cluster-randomized clinical trial focusing on implementing this Care Bundle in high-income countries, building on results from previous trials mostly done in low- and middle-income countries. The Care Bundle includes early intensive blood pressure lowering, treatment of fever and high blood sugar, rapid reversal of oral anticoagulation, and timely referrals to intensive care or neurosurgery when needed. Hospitals are randomized in batches through three phases usual care, randomized evaluation of the Care Bundle versus usual care, and a post-implementation follow-up where all hospitals apply the Care Bundle. Each batch lasts 18 months, with 6 months per phase, and the overall study rollout spans 2.5 years. Participants are adults aged 18 or older diagnosed with spontaneous ICH confirmed by imaging within 24 hours of symptom onset. During the study, patient management details and outcomes will be closely monitored, including brain imaging, blood pressure, glucose levels, and functional status. The primary outcome is functional recovery measured by a utility-weighted modified Rankin Scale score at 180 days. Secondary outcomes include disability, death, and health-related quality of life. The study also collects data on treatments and care decisions to evaluate the Care Bundles effectiveness and sustainability.

Researchers are evaluating the long-term surgical treatment outcomes for patients with peri-implantitis lesions who have been treated since 2014 at the University of Malm, Blekinge hospital, and the Dental Clinic of the Sigmund Freud University Vienna. The study focuses on regularly assessing these patients up to once per year after their one-year postoperative control to monitor healing and treatment success. The research includes clinical and radiographic evaluations to better understand disease resolution over time. Patients included in the study receive standard surgical care for peri-implantitis lesions, which involves removing inflammatory lesions during surgery. For up to 200 future patients, these removed lesions will be collected and analyzed through histological, microbiological, and molecular methods. This collection happens during their routine surgical treatment, regardless of participation in the study. Participants will have annual clinical check-ups that include measuring peri-implant parameters like probing pocket depth and collecting peri-implant sulcus fluid. A peri-apical radiographic examination will also be performed to assess healing. The main outcome measured is disease resolution, recorded as a yes or no answer, at multiple time points up to ten years after surgery. This ongoing monitoring helps researchers understand the long-term effects of surgical treatment for peri-implantitis.

Researchers are evaluating the effectiveness of oral pivmecillinam as a step-down treatment for adult patients with febrile urinary tract infections fUTI caused by Escherichia coli. This phase 4, randomized controlled trial compares pivmecillinam to standard antibiotic treatments following initial intravenous therapy. The study aims to see if pivmecillinam, a narrow-spectrum antibiotic, is as effective as the usual care in resolving infection symptoms and preventing bacterial growth in urine. Participants who have received 2 to 4 days of intravenous antibiotics and shown improvement will be randomly assigned to either oral pivmecillinam or standard treatment, which may include various oral or intravenous antibiotics determined by their doctor. Pivmecillinam will be taken as 400 mg tablets four times daily for 7 or 10 days depending on patient factors. The control group will receive standard care antibiotics for 7 to 14 days. Some participants will provide additional samples to study the drugs effects on gut bacteria and how it is processed in the body. During the study, participants will keep a diary to record medication use, symptoms, and side effects, and will have phone interviews 7 and 28 days after treatment ends to assess recovery. Urine samples will be collected at these times to check for bacteria. Subgroups will provide fecal samples over three months to study microbiome changes, and blood and urine samples will be taken from some on pivmecillinam to understand drug levels. The study will monitor clinical and microbiological responses as well as adverse events throughout the follow-up period, which extends up to 28 days post-treatment with some assessments continuing for three months.

Researchers are investigating if early pain provocation tests on the pelvic joints in pregnant women without current pelvic pain can predict the development of pregnancy-related pelvic girdle pain PPGP. The study follows these women from early pregnancy until delivery, comparing those who develop PPGP with those who do not. This research aims to understand associations between test outcomes, risk factors, and sick leave due to pelvic pain. The study involves one group of pregnant women who undergo five validated manual pain provocation tests on their pelvic joints to check for any dysfunctions or ongoing symptoms. Participants also answer about 13 questions related to their medical history, previous pregnancies, physical activity, profession, gestational week, age, and BMI. After delivery, each participant receives a phone call to report any pelvic pain experienced and if sick leave was required. Participants are involved from early pregnancy until delivery, approximately six months per person. Researchers collect data through physical tests, questionnaires, and follow-up phone calls. They monitor and analyze the relationship between the pain provocation test results, risk factors, and the occurrence of sick leave due to pelvic girdle pain. No masking or randomization is used, and the study is observational within this interventional framework.