Uddevalla

Researchers are investigating whether regular radiological assessments during follow-up after surgery for high-risk malignant melanoma improve patient survival. The study addresses concerns about the resource demands, potential radiation exposure, and anxiety caused by such imaging, especially given the recent introduction of effective medical treatments for melanoma. There is currently no clear evidence supporting routine imaging in this context. Participants are randomly assigned to one of two groups. One group follows national guidelines with regular doctor appointments for 3 years, while the other group receives the same follow-up plus additional whole-body CT or PET scans and blood tests at baseline, 6, 12, 24, and 36 months. An interim analysis will be done after 1,000 patients enroll. During the study, researchers will monitor overall survival at 5 years as the primary outcome. They will also assess quality of life through questionnaires over the 3-year follow-up. Participants will attend scheduled visits for clinical evaluations, imaging, and blood tests, with the study aiming to provide clear evidence about the role of imaging in post-surgical melanoma care.

This trial focuses on elderly patients aged 80 years or older, or those 75 years and older who are considered frail, with untreated diffuse large B-cell lymphoma DLBCL and related lymphoma subtypes. The study is a phase III, randomized, open-label, multicenter trial conducted in several countries including Sweden, Norway, Finland, Denmark, Italy, Australia, and New Zealand. It aims to compare the standard chemotherapy regimen R-miniCHOP with an experimental treatment R-pola-miniCHP, where vincristine is replaced by polatuzumab vedotin, to assess differences in outcomes for this patient population. Participants will be randomly assigned to one of two treatment groups. One group will receive R-mini-CHOP consisting of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone over six 21-day cycles. The other group will receive R-pola-mini-CHP, which includes rituximab, cyclophosphamide, doxorubicin, prednisone, and polatuzumab vedotin instead of vincristine, also given over six 21-day cycles. Both treatments last approximately 18 weeks. The study includes a screening period lasting up to 4 weeks before treatment begins. During the study, participants will be followed for up to 36 months after completing treatment to monitor progression-free survival over two years. Researchers will evaluate disease progression and safety outcomes through regular assessments during and after the treatment period. Participants will provide informed consent and undergo evaluations including health status and disease measurements to ensure eligibility and monitor treatment effects throughout the trial.

Researchers are studying baricitinib to see if it can help preserve beta-cell function in children and adults aged 1 to 35 years who have been newly diagnosed with type 1 diabetes. This Phase 3 study aims to evaluate the treatments impact on preserving insulin production shortly after diagnosis. Participants will be followed for about 60 weeks to assess changes in key diabetes-related measures. Participants will be randomly assigned to receive either baricitinib or a placebo, both taken orally. The study compares these two groups to evaluate the effects of baricitinib on beta-cell function. The main measurement is the change in C-peptide area under the curve over 52 weeks, which indicates insulin production. Additional outcomes include changes in blood sugar control, insulin use, hypoglycemia events, and other health indicators. During the study, participants will attend visits for assessments and monitoring over approximately 60 weeks. Tests will include blood measurements like C-peptide and hemoglobin A1c, insulin dose tracking, and health surveys. Safety and drug levels will be monitored. Researchers will use these data to understand if baricitinib can help maintain beta-cell function in people newly diagnosed with type 1 diabetes.

This observational study aims to describe the use of teclistamab and talquetamab in treating patients with relapsed or refractory multiple myeloma RRMM outside of clinical trial settings. It collects real-world data to better understand how these treatments are used and their outcomes in typical healthcare environments. The study enrolls participants who have received at least one dose of teclistamab or talquetamab outside clinical trials during specified time periods from before December 2022 through December 2025. No study interventions are administered instead, researchers analyze existing medical records to document treatment details and patient experiences with these therapies. Participants medical records are reviewed to capture baseline characteristics, response rates, time to response, duration of response, survival outcomes, safety management, and treatment use up to 40 months. The study focuses on collecting comprehensive retrospective data without requiring active treatment or additional procedures, providing insight into real-world treatment patterns and outcomes for RRMM patients.

Researchers are evaluating a new treatment approach for patients with recurrent non-muscle invasive bladder cancer, specifically those with Ta low-grade tumors that have returned after previous treatment. This randomized, multinational Phase 4 study aims to compare the long-term effectiveness of dose-dense chemoablation using Mitomycin C MMC combined with adjuvant BCG against the current standard treatment involving transurethral resection of bladder tumors TURBT and intravesical instillation therapy. The study follows previous promising findings from the NICSA trial and seeks to improve clinical outcomes by tailoring treatment to patient response. Participants in the experimental group will receive MMC chemoablation three times a week for two weeks six total instillations, followed by a cystoscopy eight weeks later. Those who show complete tumor response will continue with monthly MMC maintenance instillations for six months before joining regular follow-up care. Patients without complete response will undergo TURBT or biopsy with tumor fulguration, followed by adjuvant BCG induction and maintenance therapy. The control group will receive TURBT or biopsy followed by standard intravesical therapy MMC weekly for six weeks plus monthly maintenance for low-grade tumors or BCG weekly for six weeks plus one-year maintenance for high-grade tumors. During the study, participants will be monitored for tumor recurrence through cystoscopies and other assessments over two and five years. Researchers will measure outcomes such as two-year and five-year recurrence-free survival, progression-free survival, overall survival, the number of surgeries required, and serious adverse events related to MMC treatment. The trial will last several years, with long-term follow-up to understand how well the treatments prevent tumor return and improve patient outcomes.

This research aims to study the recovery process in men undergoing surgery for benign prostatic hyperplasia BPH. It specifically looks at patient-reported outcomes such as pain, burning sensation, urine leakage, hematuria, and the use of pain-relieving medications during the first three months after surgery. The study will compare these outcomes across three different surgical techniques transurethral resection, transurethral vaporization, and GreenLight laser enucleation of the prostate Green-LEP. Patients undergoing any of the three surgical methods for BPH will be included in this prospective observational study. They will complete a daily self-assessment form for three months to record pain levels, burning sensation, urine leakage, use of painkillers, and hematuria. After this period, patients will be sent questionnaires to assess their urinary symptoms using the IPSS form at six months and then annually for up to five years, allowing for long-term follow-up of their recovery and symptom changes. Participants will be closely monitored through daily reports for three months and periodic questionnaires afterward. The study will use numeric rating scales for pain and burning, daily yesno questions for urine leakage and hematuria, and detailed medication logs. Researchers aim to understand the timeline and intensity of recovery symptoms, evaluate differences between surgical methods, and provide insights to improve patient care and counseling. The total observation period can be up to five years including annual follow-ups.

Multiple myeloma is a cancer affecting plasma cells in the bones and bone marrow, causing bone pain, fractures, infections, weak bones, and kidney failure. This study is evaluating the investigational drug etentamig compared to standard available therapies in adults with relapsed or refractory multiple myeloma. The study aims to understand changes in disease symptoms and treatment effects over time in this population. Participants are randomly assigned to one of two groups Arm A receives etentamig as an intravenous infusion given in 28-day cycles, and Arm B receives standard available therapies chosen by the investigator based on local guidelines. The study will last about 3.5 years, with treatments and monitoring continuing throughout this period. Participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will measure outcomes such as progression-free survival, response rates, overall survival, symptom changes, and quality of life using questionnaires and clinical tests. The study includes careful safety monitoring and may involve more treatment visits than standard care.

Researchers are studying ODX OsteoDex in people with relapsed or refractory multiple myeloma to evaluate its safety and biological effects. This phase IIIa, multi-center, open-label trial tests up to three increasing dose levels of ODX to find the best tolerated dose and gather early evidence of how it affects the disease and related biomarkers. The trial also explores the time to disease progression by tracking specific blood proteins. Participants receive ODX treatment every two weeks for up to seven doses, unless they experience unacceptable side effects or disease progression. There are three dose groups 3.0 mgkg, 6.0 mgkg, and 9.0 mgkg. The study includes a screening period, a treatment period with visits including telephone contacts, and a follow-up visit two weeks after the last dose. Dose escalation decisions are based on safety data reviewed after initial patient dosing. During the study, participants will undergo safety and tolerability monitoring over 14 weeks, including assessments of treatment-related side effects and disease response using established criteria. Researchers will also measure changes in blood markers related to the disease and bone metabolism. Follow-up visits will track any progression of the disease. The trial aims to provide detailed safety and early efficacy information to guide future treatment development.

Researchers are studying diabetic foot ulcers DFU in people with diabetes to compare the effectiveness of two topical antimicrobial agents in helping ulcers heal. The goal is to find out if cleaning DFU with Hypochlorous Acid HClO leads to faster complete healing than cleaning with Polyhexamethylene biguanide PHMB. This randomized, double-blind, controlled trial involves 202 participants and aims to measure time to healing as the primary outcome over 24 weeks. Participants will be randomly assigned to have their diabetic foot ulcers cleaned twice a week with either Dakins Solution containing Hypochlorous Acid or Prontosan containing PHMB. Both treatments will be applied following specific instructions until the ulcer is fully healed or for up to 24 weeks. The study also explores differences in healing patterns, ulcer size, depth, antibiotic use, quality of life, and cost effectiveness between the two treatments. During the study, participants will undergo regular wound cleaning sessions twice weekly with either HClO or PHMB. Researchers will assess healing progress by measuring the time until the ulcer is completely covered with intact skin. Additional evaluations include changes in ulcer size and depth, antibiotic use, and quality of life questionnaires EQ-5D and SF-12. Safety and treatment effects will be monitored throughout the 24-week treatment period.

Researchers are investigating whether women aged 50 years and older who have isolated acute hemorrhagic cystitis AHC with visible blood in the urine need a full cancer workup. This observational study focuses on those with acute lower urinary symptoms lasting less than a week. The goal is to find out if some women at low risk can avoid invasive tests, while all participants are followed for one year to monitor cancer detection. All participants undergo a thorough initial assessment including cystoscopy, CT urography, urine cytology when needed, and a full clinical history covering smoking, family history, and other health factors. Participants are grouped based on symptoms and lab findings into AHC and non-AHC categories. Data collected includes demographics, symptom details, cancer diagnoses if any, treatments, and outcomes. The study monitors participants for at least 12 months to capture any delayed cancer diagnoses. During the study, medical records are reviewed for a year to track the occurrence of urological cancers. Researchers evaluate the rate of cancer, how quickly it is diagnosed, and the number of unnecessary invasive procedures that might be avoided. Data is securely stored with privacy protections. The study aims to improve personalized care for women with hematuria by identifying those who may safely skip extensive testing.