Livingston

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are evaluating the safety and performance of the RTD Wound Dressing compared to the current standard care device used by the NHS for treating non-infected neuropathic, ischaemic, and neuro-ischaemic diabetic foot ulcers. This clinical evaluation is conducted in an open-label, randomized design within NHS Lanarkshires diabetic foot clinics. The primary goals are to assess complete wound healing and reduction in wound area after 12 weeks. Participants will be randomly assigned to either receive the RTD Wound Dressing, which is already CE marked and used for its intended purpose, or the NHS standard dressing normally used in podiatry clinics. Both groups will continue their regular NHS podiatry appointments. The study compares outcomes between these two groups over the 12-week period. During the study, participants will attend routine clinic visits where wound healing progress, wound area reduction, infection rates, and dressing changes will be monitored. Researchers will use medical photography and other evaluations to track healing and safety. Participants must be able to follow instructions and provide informed consent. The total follow-up period is 12 weeks with assessments focused on wound healing and related outcomes.

Researchers are studying the effectiveness of the IGEL laryngeal mask airway device in patients who have had radiation therapy to the neck. These patients face a higher risk of difficult mask ventilation and tracheal intubation during general anesthesia compared to most patients. The study aims to understand how well the IGEL device works as a rescue tool for maintaining oxygenation in this high-risk group, where failure to maintain oxygen can cause severe brain injury or death. The study involves inserting the IGEL device in anesthetized patients who have previously received radiotherapy to the neck. This device is being evaluated as a method to ensure adequate ventilation during surgery. The procedure is planned by physicians and is part of elective surgeries requiring general anesthesia. The study focuses on how successfully the device can be placed and used to ventilate the patient within a 10-minute timeframe. Participants will undergo the insertion of the IGEL device during their scheduled surgery. Researchers will assess the success of device placement and ventilation during this time. Data collected will focus on the effectiveness of airway control with this device in patients with previous neck radiation. The study does not involve blinding or comparison groups and will continue until September 2027. Participants are monitored closely to ensure safety during the procedure.

Researchers are conducting an observational study to understand the psychiatric and general medical conditions of adults admitted to NHS General Adult Psychiatry GAP inpatient wards. This study aims to provide detailed information on the health challenges faced by these patients, who often have complex conditions that may exclude them from typical clinical trials. The findings will help compare real-life GAP patients with those in clinical trials, potentially explaining differences in treatment outcomes. Participants include 100 adults aged 18 to 65 who are admitted to GAP wards and have mental health disorders that their general practitioners cannot treat. The study involves completing questionnaires, severity rating scales, and a review of medical case notes. Participants will be grouped based on their psychiatric diagnosis, such as schizophrenia, bipolar disorder, depression, or personality disorders. During the study, participants will spend about an hour completing questionnaires and discussing their health with a clinician. Researchers will collect data on psychiatric diagnoses, severity of symptoms psychosis, depression, mania, anxiety, substance use, physical illnesses, and treatment resistance. This data collection occurs at enrollment, with no treatment given, and participants can withdraw at any time. The study results will provide a baseline for better understanding the health of GAP patients.

Researchers are evaluating treatments for high-risk polycythemia vera PV, a blood condition. This phase III international trial compares the drug ruxolitinib against the best available therapy, which includes hydroxycarbamide or any form of interferon alpha, chosen by the doctor before randomization. The study aims to determine which treatment better prevents serious complications and improves patient outcomes over about three years. Participants will be randomly assigned to one of two groups one receiving oral ruxolitinib 10 mg twice daily, and the other receiving either hydroxycarbamide or interferon alpha via standard hospital care. There is no switching between treatments during the study. The trial is open-label, meaning both doctors and participants know which treatment is given. During the trial, participants will have regular assessments including blood tests, symptom and quality of life questionnaires, and monitoring for events like thrombosis, bleeding, or disease progression. Researchers will track treatment side effects, blood markers, spleen size, and time between blood removal procedures. The study duration is approximately three years per participant, with some outcomes followed up to eight years to assess long-term effects and health economics.

Researchers are investigating whether a wrist-worn activity monitor can provide helpful information about recovery after leaving the intensive care unit ICU. This study focuses on adults discharged from the ICU in three hospitals in Edinburgh who are at high risk of complex rehabilitation needs. The goal is to understand if movement data can reflect how patients feel and function, linking activity changes to symptoms like pain, anxiety, sleep, cognition, and daily functioning. Participants will wear a wrist accelerometer continuously for two months following hospital discharge. They will also complete several health-related questionnaires via structured telephone assessments at baseline, 2 weeks, 1 month, and 2 months after leaving the hospital. The study complements usual care provided by the Critical Care Recovery Service CCRS, which supports physical and psychological rehabilitation for ICU survivors. During the study, researchers will collect and analyze movement data alongside patient-reported outcomes on quality of life, physical and cognitive function, and sleep quality. They will monitor feasibility of wearable data collection, questionnaire completion rates, hospital readmissions, and mortality over two months. This approach aims to identify early signs of deterioration or unmet rehabilitation needs, improving support for recovery after critical illness.

Researchers are evaluating a new sixth-generation high-sensitivity cardiac troponin T test to diagnose heart attacks more quickly among patients with suspected acute coronary syndrome. This diagnostic study aims to determine if using this advanced test reduces the time patients spend in Emergency Departments while maintaining patient safety. The study compares data from one year before and one year after introducing the new test across a health board, using routinely collected hospital data and blood samples. The study involves two groups patients evaluated with the current fifth-generation troponin test before the new tests implementation, and those evaluated with the sixth-generation test afterward. The sixth-generation Elecsys Troponin T hs Gen 6 assay is designed to be more precise and less affected by interference than the previous version. Researchers will measure troponin levels from surplus blood samples collected during two six-month periods before and after the new tests introduction to directly compare the tests. Participants will not need to take any extra actions as the study uses data and samples collected during usual care. Researchers will examine Emergency Department length of stay as the primary outcome, along with hospital admission, cardiovascular events, and mortality up to one year. The study will also monitor serial troponin measurements and other clinical outcomes to assess the new tests impact on patient care and safety over time.