Dunfermline

Researchers are evaluating whether skipping additional axillary treatment for patients with early-stage breast cancer who had cancer in their lymph nodes before chemotherapy but show no remaining cancer in those nodes after treatment is as effective as the standard approach. This study focuses on disease-free survival and reducing the risk of lymphoedema five years after treatment. It is a randomized, open, multicenter trial including patients with specific breast cancer stages and confirmed nodal metastases. Participants will all receive standard therapies including HER2-targeted treatment, endocrine therapy, and radiotherapy to the breast or chest wall if needed. They will be randomly assigned to one of two groups one group will not get further axillary treatment such as lymph node removal or radiotherapy, while the other group will receive these axillary treatments according to local guidelines. Follow-up visits will occur annually for at least five years. During the study, participants will undergo assessments to monitor disease-free survival and self-reported lymphoedema using specific questionnaires. Additional evaluations include arm function, quality of life, recurrence rates, survival, and cost-effectiveness analyses. The total study duration is planned for 120 months, including setup, recruitment, follow-up, analysis, and reporting.

Researchers are studying the use of Bladder EpiCheck, a urine test, to detect urothelial carcinoma in adults aged 45 years or older who have experienced blood in their urine haematuria. This observational study aims to confirm how accurately the Bladder EpiCheck test identifies urothelial carcinoma compared to standard methods like cystoscopy and pathology when performed. The study focuses on participants undergoing evaluation for haematuria to improve detection methods for bladder-related cancers. Participants will provide a urine sample that will be tested using Bladder EpiCheck. The results of this test will not be shared with the clinical care team or the participant, and their usual medical care will continue unchanged. The study collects data from the standard diagnostic work-up for haematuria, including cystoscopy scheduled within 60 days after enrollment. During the study, participants will provide at least 10 ml of voided urine and undergo standard cystoscopy as part of their routine evaluation. Researchers will assess the sensitivity and specificity of the Bladder EpiCheck test to detect urothelial carcinoma within six months following enrollment. The study includes monitoring for high-grade urothelial carcinoma and compares Bladder EpiChecks performance to urine cytology. Participation requires adherence to study procedures and will continue through the diagnostic process without altering treatment plans.

Alopecia areata AA is a chronic autoimmune condition causing nonscarring hair loss on the scalp and other body areas, affecting people of all ages, genders, and races. The main types include patchy alopecia, alopecia totalis, and alopecia universalis. Researchers aim to study the real-world effectiveness and patient outcomes of ritlecitinib, a drug approved for treating severe AA in patients 12 years and older, building on results from previous clinical trials. Participants in this observational study will receive ritlecitinib as prescribed by their doctors according to the approved label and standard care practices, independent of the study. The study will follow patients over time to observe treatment patterns, disease progression, and responses to ritlecitinib in routine clinical settings. Treatment dosing and schedules will be determined by physicians based on individual patient needs. Throughout the study, participants will attend regular clinic visits to assess disease severity, hair regrowth, and other clinical features using tools like the Severity of Alopecia Tool score. Patient-reported outcomes such as treatment satisfaction and quality of life will also be collected. Researchers will monitor changes over weeks 24, 48, 72, and 96 to evaluate effectiveness and safety. The study aims to capture comprehensive real-world data on ritlecitinib use in AA patients.

Researchers are evaluating the safety of two minimally invasive devices, iTind and UroLift, for treating lower urinary tract symptoms caused by benign prostatic hyperplasia BPH in men aged 50 and older. The study compares the temporary iTind device, which reshapes the prostatic urethra over 5 to 7 days, with the permanent UroLift implants that widen the urethral passage by retracting enlarged prostate lobes. This international, randomized study aims to assess the safety and effectiveness of these treatments for BPH symptoms. Participants will be randomly assigned to receive either the iTind temporary nitinol implant or the UroLift permanent implant procedure. The iTind device remains in place for 5 to 7 days before removal, while UroLift implants are placed permanently during the procedure. Both treatments are minimally invasive and designed to relieve urinary symptoms by improving urine flow through the prostate. During the study, participants will attend scheduled visits to monitor safety and symptom changes using questionnaires like the International Prostate Symptom Score IPSS and quality of life assessments at multiple time points up to 60 months. Researchers will also track any intraoperative or post-operative complications within the first 3 months and monitor rates of additional interventions needed. The study involves detailed evaluations including prostate imaging and urinary flow measurements to assess treatment outcomes and participant well-being over time.