Alingsas

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

This trial investigates the safety and effectiveness of risankizumab compared to vedolizumab in adults with moderate to severe ulcerative colitis (UC) who have not previously received targeted therapies. Ulcerative colitis is an inflammatory bowel disease causing inflammation and bleeding in the rectum and colon. The study is a Phase 3b, randomized, open-label trial enrolling about 530 participants across 285 sites worldwide. Participants will be randomly assigned to receive either risankizumab or vedolizumab. Those in the risankizumab group will receive the drug intravenously during the initial induction phase, followed by subcutaneous injections for maintenance. Participants in the vedolizumab group will receive the drug intravenously throughout the study. The treatment period lasts 44 weeks for risankizumab and 46 weeks for vedolizumab, following a screening period of up to 35 days. During the study, participants will attend regular outpatient visits for medical assessments, side effect evaluations, and to complete questionnaires. Researchers will monitor disease activity and drug safety, focusing on the percentage of participants achieving endoscopic improvement by week 48. The total study duration is approximately 69 weeks for risankizumab and 71 weeks for vedolizumab recipients.

Out-of-hospital cardiac arrest (OHCA) often involves dangerous heart rhythms like ventricular fibrillation (VF) or ventricular tachycardia (VT), which require defibrillation to restore a normal heartbeat. Survival chances decrease the more defibrillations are needed. Recent research suggested that using Double Sequential Defibrillation (DSD), which applies two defibrillators sequentially, may improve survival in patients with refractory VF. This trial aims to evaluate if applying DSD earlier, right after the first failed defibrillation in patients with shockable rhythms, improves 30-day survival compared to standard single defibrillation. Participants will receive either the early DSD strategy, where a second defibrillator is added with electrodes placed on the chest and back (anterior-posterior position) and shocks are delivered sequentially, or the usual care involving standard defibrillation with one defibrillator and pads placed in the anterior-lateral position. The study is an open-label, randomized controlled trial with equal allocation to each group, conducted by emergency medical services equipped with two defibrillators on site. During the trial, emergency teams will screen eligible adult OHCA patients with shockable rhythms who have had at least one unsuccessful defibrillation. The main outcome measured is survival 30 days after the cardiac arrest. The trial involves initial rhythm analysis, delivery of assigned defibrillation methods, and follow-up to assess outcomes. This study could influence future advanced cardiac life support guidelines if early DSD proves beneficial for a wider group of patients.

Aortic valve stenosis (AS) is the most common valve disease among older adults, often leading to high mortality when symptoms develop. Transcatheter aortic valve implantation (TAVI) is an important treatment option for older patients with symptomatic AS, especially those who are frail or have other health conditions. Despite TAVI improving survival, many patients face challenges in recovery, including reduced physical fitness and quality of life. This trial aims to evaluate whether physiotherapist-led exercise-based cardiac rehabilitation (PT-X) after TAVI can improve physical fitness, physical activity levels, and health-related quality of life in these patients. Participants will undergo a 12-week PT-X program involving individually tailored aerobic and muscle endurance exercises twice a week in a hospital setting, with additional home-based sessions tracked in an exercise diary. The control group will continue their usual lifestyle without this specific rehabilitation program. The study will compare exercise capacity, muscle function, physical activity, and quality of life between those who participate in PT-X and those who do not. Follow-up assessments will also be conducted 12 months after completing the intervention to examine long-term effects. During the study, researchers will measure exercise capacity using watt output and perceived exertion scales at the start, after 12 weeks, and at 12 months post-intervention. Muscle endurance tests focusing on shoulder flexion, shoulder abduction, and unilateral heel-lift will also be performed at these times. Additionally, lower extremity function, physical activity levels, and self-assessed physical activity and health-related quality of life will be evaluated. The study will also observe frailty prevalence and hospital admissions during the first year after TAVI to understand broader health outcomes and safety.

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.

Researchers are evaluating how well tofacitinib works and how patients stick to their treatment for ulcerative colitis in real-life clinical settings in Sweden. This observational study uses data from the ongoing National Swedish registry called SWIBREG and also looks at prescription records to understand treatment adherence. The focus is on measuring clinical disease activity and remission rates over time. Participants in the study receive tofacitinib as prescribed by their doctors according to standard clinical practice and official guidelines. The study does not assign treatments but observes patients who have already been prescribed tofacitinib. Data collection includes records from SWIBREG and the Swedish Prescribed Drug Register to monitor treatment use and clinical outcomes. During the study, researchers track participants' disease activity through clinical assessments and laboratory tests, including fecal calprotectin levels and endoscopic scores. The main outcome measured is the proportion of participants in remission after 52 weeks, as indicated by the Partial Mayo Score. Patients provide informed consent, and their data is collected at baseline and throughout the study to assess treatment effectiveness and adherence over time.

Children with functional constipation often need care at primary healthcare centers, pediatric clinics, and emergency departments due to symptoms related to constipation. This condition causes physical and psychological suffering that affects both the child and their family. While medical treatments and dietary advice are provided, current healthcare rarely includes physiotherapists in managing these children. Regular physical activity is recommended but lacks strong scientific support specifically for functional constipation, even though it has shown benefits in other gastrointestinal conditions like irritable bowel syndrome. The study aims to explore parents' perspectives on their children's physical activity to better understand its role in managing functional constipation. The study involves interviewing parents of children aged 6 to 12 years who have functional constipation and are being treated at two pediatric clinics in Sweden. These interviews will be semi-structured and in-depth, allowing parents to share their experiences and views on physical activity related to their child's condition. The conversations will be recorded, transcribed, and analyzed using qualitative content analysis to uncover both explicit and underlying messages. Participants will be involved by sharing their experiences through interviews conducted between November 2025 and April 2026. Researchers will analyze these interviews to generate new knowledge about physical activity in children with functional constipation. The findings may help improve care for these children and support the inclusion of physiotherapists in their treatment. The study's outcomes could also provide a foundation for future research on this topic.

This research aims to understand patient recovery after surgery for benign prostatic hyperplasia (BPH) by studying pain, urinary symptoms, and medication use over three months after different surgical methods. It focuses on three procedures: transurethral resection of the prostate (TUR-P), transurethral vaporization of the prostate (TUV-P), and GreenLight laser enucleation of the prostate (GreenLEP). The study also explores how these outcomes differ among the three surgical techniques and how urinary symptoms change over time using patient-reported data. Patients undergoing one of the three surgeries will complete daily self-assessment forms for three months, reporting pain levels, burning sensations, urine leakage, and presence of blood in urine. They will document their use of pain medications daily. After this period, patients will fill out symptom questionnaires (IPSS) at six months and then annually up to five years. The study includes up to 500 men over 50 years old undergoing surgery at several hospitals in Sweden. Participants will be closely monitored through daily reports during the first three months and longer-term symptom questionnaires to assess changes in urinary tract symptoms. Researchers will analyze pain changes day by day, urinary leakage, medication use, and hematuria duration. The study aims to identify typical recovery patterns and differences among the surgical methods to improve patient care and counseling. Safety and ethical standards will be maintained throughout the study.

Distal radius fracture is the most common fracture in Sweden, yet little is known about how patients experience pain and hand function in the first three months after the injury. This research aims to provide detailed daily information on pain levels, use of pain medication, splint usage, and hand function in patients with this fracture. The study includes patients treated conservatively with a cast as well as those who have undergone surgery, focusing on patient-reported outcomes without additional hospital visits. Participants are divided into two groups: 200 patients treated with a forearm cast and 100 patients who receive surgical treatment for their fracture. Each patient will complete questionnaires for three months. These questionnaires track daily pain on a scale from 0 to 10, daily use of specific analgesic drugs including dose and number taken, weekly wrist function using the Patient Reported Wrist Evaluation form, weekly use and effectiveness of prefabricated wrist splints, and details about sick leave and return to work at the end of the study period. During the study, patients will not have extra appointments, as all data is collected through questionnaires. Researchers will measure hand function weekly and gather daily pain and medication records. The study focuses on patient experiences to better understand recovery and satisfaction after distal radius fractures. The total participation time is three months with ongoing monitoring of symptoms and treatment effects.

Researchers are evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on cardiovascular death and heart failure events in patients with chronic heart failure and impaired kidney function who recently experienced a heart failure event. This is a Phase III, international, randomized, double-blind, parallel-group, active-controlled study involving approximately 700 sites in about 40 countries. Participants will be randomly assigned in a 1:1:1 ratio to receive one of three treatments once daily: a capsule of balcinrenone/dapagliflozin 15 mg/10 mg with a placebo tablet, a capsule of balcinrenone/dapagliflozin 40 mg/10 mg with a placebo tablet, or a dapagliflozin 10 mg tablet with a placebo capsule. The study is event-driven, with an estimated average duration of 22 months that includes a screening period, a 20-month blinded treatment phase, and a one-month follow-up on open-label dapagliflozin. During the study, participants will be monitored for the time to first occurrence of cardiovascular death, heart failure hospitalization, or heart failure events without hospitalization over approximately 38 months. Assessments include clinical evaluations, laboratory tests, and safety monitoring throughout the study and follow-up period to track treatment effects and patient outcomes.