Lulea

Researchers are evaluating the effectiveness of iberdomide maintenance therapy compared to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in adults with newly diagnosed multiple myeloma. This phase 3 study aims to determine which maintenance treatment better supports patients following their initial transplant and induction therapies. Participants must have responded to prior treatments and undergone ASCT within specified time frames. Participants will receive either iberdomide or lenalidomide at specified doses on scheduled days as maintenance therapy after their ASCT. The study is randomized, multi-center, and open-label, meaning both participants and researchers know which treatment is given. The treatments will be administered following a standard induction therapy including proteasome inhibitors, immunomodulatory drugs, and possibly monoclonal antibodies, with or without consolidation after transplant. Throughout the study, participants will be monitored for progression-free survival for up to 6 years to assess how well the maintenance therapies prevent disease progression. Researchers will also evaluate safety and treatment response according to established myeloma criteria. Regular assessments will include clinical evaluations and monitoring for any signs of disease relapse or adverse effects over the long term.

Researchers are evaluating treatments for patients with generalized Mantle Cell Lymphoma in this Phase 3 trial. The study aims to identify one of three treatment approaches as a future standard by comparing failure-free survival, which measures the time from treatment start until stable disease, disease progression, or death. Secondary goals include assessing overall survival, progression-free survival, response rates, safety, and tolerability of the treatments, as well as exploring factors like minimal residual disease and stem cell mobilization. Participants receive one of three treatment plans: the control arm with alternating R-CHOP and R-DHAP chemotherapy followed by autologous stem cell transplantation (ASCT); an experimental arm adding ibrutinib during induction and maintenance with ASCT; or an experimental arm with ibrutinib during induction and maintenance without ASCT. Chemotherapy includes drugs such as rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, dexamethasone, Ara-C, and cisplatin. Ibrutinib is given in certain induction cycles and as daily maintenance for two years. ASCT conditioning uses specific chemotherapy regimens or total body irradiation depending on the site. During the study, participants undergo regular assessments including imaging, laboratory tests, and evaluations of response and side effects. Researchers monitor failure-free survival up to 10 years, along with secondary outcomes like overall survival, progression-free survival, and safety events. Follow-up includes measuring molecular remission, relapse timing, and quality of life. The total duration includes treatment, maintenance, and long-term observation, with safety and efficacy carefully tracked throughout.

Researchers are evaluating the effects of betamethasone as a premedication to reduce postoperative nausea, vomiting (PONV), and pain after tonsillectomy in adolescents and adults. The study addresses uncertainties about the optimal dose and safety of betamethasone, especially concerning bleeding risks, which have been more studied with dexamethasone. This phase IV trial aims to clarify if 8 mg of oral betamethasone can provide benefits without increasing side effects. Participants will be randomly assigned to receive either 8 mg of betamethasone or a placebo (10% glucose solution) before elective bilateral tonsillectomy surgery. The study is double-blind and placebo-controlled, involving 100 patients aged 12 years and older. Treatment is given orally as premedication, and participants will be followed closely during the postoperative period. During the study, researchers will monitor postoperative nausea, vomiting, and pain for up to 5 days after surgery through phone calls and other assessments. They will also track any bleeding complications. Total participation lasts up to 95 days from screening to final follow-up, with active monitoring mainly in the first 5 days. The primary outcome is the occurrence of postoperative nausea and vomiting, with secondary outcomes focused on pain levels and bleeding risks.

This research aims to evaluate the clinical outcomes of Ponto-implantation procedures performed outside the main operating room. It is a combined retrospective and prospective observational study designed to follow routine clinical practice at multiple centers. The main goal is to investigate the rate of complications during these out-of-OR procedures for patients with hearing loss using bone-anchored hearing devices. The study involves Ponto implantation, a surgical procedure to place a bone-anchored hearing device that improves hearing by transmitting sound directly to the inner ear through bone conduction. The retrospective part reviews patient charts from 2019 onwards who had Ponto implants outside the operating room, while the prospective part enrolls patients planned for such surgeries. No experimental treatments are given, and the study only observes routine care. Participants will be followed through clinical records and asked to complete three questionnaires after surgery and during follow-up once the sound processor is loaded. The study measures intraoperative complications during the Ponto-implantation surgery. It includes adult patients undergoing these procedures from 2019 forward, with no exclusion criteria. The participation involves monitoring outcomes and collecting questionnaire data to assess safety and effectiveness in real-world practice.

This research aims to evaluate the feasibility of Health Web - Te@m 1.0, an interprofessional web-based group intervention designed to support healthy aging among older adults in selected primary healthcare settings in northern Sweden. The study focuses on understanding older adults' and healthcare professionals' experiences with the intervention, its acceptability, value, adherence, and the ability of assessments to detect potential outcomes. The intervention targets healthy older adults aged 65 and above who face life changes that may reduce social participation and health. The Health Web Te@m intervention is delivered by a team of professionals through a digital communication platform. It begins with an introduction session, followed by six theme sessions, each featuring an educational video, a reflection assignment, and a group discussion led by a professional. The program concludes with a closing session one month after the last theme session. The intervention aims to help older adults become more aware of, reflect on, and develop strategies for healthy aging. Participants will complete assessments before starting and after finishing the intervention, including the Swedish RAND-36 Health Survey. Researchers will collect both qualitative and quantitative data to evaluate the intervention's feasibility comprehensively. The study monitors adherence and gathers feedback from both participants and professionals. Total participation involves completing all sessions and assessments within the study timeline.

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 studying the prevalence of knee osteoarthritis visible on X-rays and the medium and long-term functional outcomes in patients who have had tibial plateau fractures. The study also aims to identify any risk factors related to these outcomes. This observational study focuses on patients from the Norrbotten region in northern Sweden who were treated for tibial plateau fractures between 2001 and 2015. All participants undergo radiographic evaluations and clinical examinations. Their condition-specific outcomes are measured using the Knee injury and Osteoarthritis Outcome Score (KOOS), while general health-related quality of life is assessed with the EuroQol 5-Dimension 5-level (EQ-5D-5L) tool. The study also examines potential factors such as gender, age, body mass index (BMI), fracture pattern, and treatment method to understand their relationship with the development of radiographic osteoarthritis. Data from the Swedish Fracture Register and the Swedish Arthroplasty Register are used to follow long-term results. The primary outcome measure is the number of participants showing radiographic osteoarthritis at least five years after injury. Participants are closely monitored through clinical assessments and standardized questionnaires to evaluate joint health, function, quality of life, and any complications related to treatment over time.

This research aims to explore complications following the closure of a temporary loop ileostomy in patients who have undergone rectal cancer surgery. The study focuses on two main questions: whether the choice of anastomotic method affects the postoperative recovery, and whether using a prophylactic mesh during stoma site closure reduces the occurrence of hernias. The study is a prospective randomized multicenter trial involving patients with rectal neoplasm. Participants will be randomly assigned to receive either a stapled or hand-sewn anastomosis after ileostomy closure. Additionally, they may be randomized to have the stoma site closed using either a lightweight mesh placed under the muscle (retromuscular) or a long-lasting suture. The anterior fascia and skin are closed with running monofilament sutures, with the skin closure performed using a pursestring technique. During the study, researchers will monitor participants for postoperative complications including small bowel obstruction within 30 days and stoma site hernia formation over two years. The assessments will gather data on healing and complications to evaluate the impact of the different surgical techniques. Participant involvement includes follow-up for safety and effectiveness outcomes over the specified periods.

Researchers are comparing the results of one-visit versus two-visit root canal treatments performed in general dental practices for infected (necrotic) teeth. The study focuses on how well the treatments work one and four years after completion, as well as differences in root filling quality and complication rates. This multi-center study involves several clinics across five counties in Sweden and plans to recruit 1,000 patients to ensure statistically meaningful results. Participants will be randomly assigned to receive either a single-visit or a two-visit root canal treatment. In the single-visit group, treatment including access, cleaning, shaping, and root filling may be completed in one appointment. In the two-visit group, the treatment is split into two appointments at least one week apart, with cleaning and medication placement done in the first visit and root filling in the second. Treatments follow usual clinical practices without a strict protocol. During the study, patients will be contacted by phone 5-7 days after treatment to check for complications and will have a follow-up visit one month post-treatment. Clinical examinations and X-rays will be done one and four years after treatment to assess healing. Two independent observers will review the radiographs to determine success based on clinical and radiographic normalcy. The study aims to detect differences in outcomes using statistical tests with significance set at p<0.05.

Researchers are conducting a multicenter, single-blinded, randomized controlled trial to study patients with ventral hernias that have an aperture width between four and eight centimeters. The study aims to compare the effects of a multimodal preoptimization program with surgery alone, focusing on the rate of complications three months after surgery. During the surgical procedure, biopsies of skin, muscle, and fascia will be collected, along with blood samples taken before and after surgery, to examine the molecular impact of preoptimization on collagen metabolism.