Kirkcaldy

Researchers are evaluating whether less frequent dosing of pembrolizumab after six months of standard treatment is safe and effective for patients with advanced non-small cell lung cancer NSCLC. Pembrolizumab, an immunotherapy targeting the PD-1 receptor, has improved outcomes in NSCLC, but current dosing every six weeks for up to two years may result in overtreatment. This UK phase III trial aims to find if reducing dose frequency can maintain effectiveness while improving quality of life and lowering costs. Participants who have received six months of pembrolizumab, with or without chemotherapy, and plan to continue treatment will be randomized to receive pembrolizumab intravenously every six weeks control or every twelve weeks initially. If the 12-week dosing is found to be not less effective, additional groups receiving doses every nine, fifteen, and eighteen weeks will be included. Patients who experience disease progression while on reduced frequency dosing can return to the standard six-week schedule. Throughout the study, participants will be monitored for overall survival at 18 months from randomization, along with other outcomes such as progression-free survival, response rate, duration of response, and adverse events over two years. The study involves regular hospital visits for treatment and assessments, and the results may lead to safer, more convenient treatment options for NSCLC patients. The total participation time varies depending on individual treatment and follow-up schedules.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

This research aims to describe the characteristics, clinical outcomes, and event rates in participants with propionic acidemia PA, a rare metabolic disorder. It is a non-interventional, observational, global, multicenter study that collects data retrospectively from medical records to better understand PA over time. Data will be gathered by reviewing medical records from various study sites, including hospitals, clinics, and academic centers. Participants included will be those diagnosed with PA confirmed by genetic testing, with records documenting specific metabolic events. The study will cover up to 10 years of medical history and events. Participants involvement consists of allowing researchers to review their medical records to collect information about metabolic decompensation events, hospitalizations, and urgent healthcare visits related to PA. Researchers will analyze the number and severity of these events, along with hospitalization data, to understand PAs clinical impact. The study does not involve direct treatment or interventions and focuses on data collection and analysis.

Researchers are evaluating the MobileLink hip prosthesis system, a medical device approved for safety and performance, in patients undergoing hip joint replacement surgery due to osteoarthritis. The study aims to collect clinical data on the outcomes and patient satisfaction with this device over short, mid, and long-term follow-up periods. Participants who receive the MobileLink hip prosthesis system will be followed for up to 10 years. The study monitors the survival rate of the complete prosthesis system and tracks revisions for any reason at multiple time points, including 3 months, 1 year, and up to 10 years post-implantation. The study also observes revision rates for different components, hip functionality changes, complication rates, implant positioning, and other related outcomes. During the study, participants will undergo regular follow-up visits at 3 months, 1 year, and then at 3, 5, 7, and 10 years after surgery. These visits include assessments of hip function, imaging to check implant position, and monitoring for complications or need for revision surgery. Researchers will measure the devices survival, patient satisfaction, and any issues with the hip joint or prosthesis components throughout the study duration.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are conducting Enroll-HD, a large, ongoing observational study that combines and expands previous Huntingtons disease HD registries across multiple continents, including Europe, North America, Australasia, and Latin America. This study collects longitudinal clinical data and biological samples from individuals with manifest HD, those carrying or at risk of carrying the HD gene mutation, and control participants without the mutation. The goal is to build a rich database to support research into disease progression, prognosis, and developing clinical trial endpoints. Participants include those with diagnosed HD, pre-manifest carriers, relatives with unknown or negative genotype status, family controls, and community controls. The study involves annual assessments with no planned end date, allowing for long-term data collection. Researchers collect demographic, clinical, family history, genetic, and blood sample information systematically from over 150 sites worldwide. During the study, participants undergo motor, functional, behavioral, and cognitive assessments using standardized tools such as the Unified Huntingtons Disease Rating Scale and Problem Behaviors Assessment-Short. Data are updated at each visit, including clinical signs and genotyping results. The study database is periodically made available to researchers globally, and participants may contribute for many years, helping to advance understanding and support future interventional studies in HD.

Researchers are conducting a long-term observational study called HDClarity to collect cerebrospinal fluid CSF and plasma samples from at least 2,500 participants at various stages of Huntingtons disease HD. The main goal is to gather high-quality CSF samples to study biomarkers and disease pathways that may help develop new treatments for HD. Additionally, plasma samples will be collected to support biomarker research relevant to HD. Participants attend two annual visits a Screening Visit and a Sampling Visit. The Screening Visit involves collecting medical history and clinical data. Those eligible and willing continue to the Sampling Visit, where blood is drawn via venipuncture and CSF is collected through lumbar puncture after fasting for at least six hours or overnight. Some participants may also attend an optional Repeat Sampling Visit 4-8 weeks after the first Sampling Visit during their first year of enrollment. Annual visits continue regularly with a two-month window. Throughout the study, participants health and clinical status are monitored, with the option to skip visits without leaving the study. If a participant misses Sampling Visits for three consecutive years, they may be discontinued but can re-enroll later with consent. The study collects detailed clinical and phenotypic data alongside biological samples to evaluate biomarkers and pathways related to HD, supporting therapeutic development. The study is open-ended and ongoing.

Researchers are evaluating the long-term safety of Deucravacitinib compared to Ustekinumab in adults with moderate-to-severe plaque psoriasis. This Phase 3b4 study focuses on cardiovascular events and other health outcomes over an extended period, aiming to understand how these treatments impact patients with psoriasis who have cardiovascular risk factors. The study is led by Bristol-Myers Squibb and involves random assignment of participants to either treatment. Participants receive either Deucravacitinib or Ustekinumab at specified doses on scheduled days. The study is open-label, meaning both participants and researchers know which treatment is being given. This trial runs for up to 5 years, during which patients are monitored for cardiovascular safety and other health events related to their psoriasis treatment. Throughout the study, participants undergo regular assessments to track major cardiovascular events like heart attacks, strokes, and hospitalizations, as well as monitoring for infections, cancer, and treatment side effects. Researchers collect data on liver function and lipid levels up to 60 days after the last dose. The long-term follow-up helps evaluate safety and health outcomes over several years, with study activities continuing until early 2031.

Researchers are evaluating the real-world use of nemolizumab for treating moderate-to-severe atopic dermatitis AD in adolescents and adults. This observational study aims to assess the treatments effectiveness through physician evaluations and patient-reported outcomes over six months, providing insight into how the medication performs in everyday clinical practice. Participants receiving nemolizumab as part of their routine care will be observed for about 12 months. Treatment decisions are made by the participants physician before joining the study, with no extra visits or tests beyond usual medical care. A sub-study in Germany and the UK involves daily remote reporting of symptoms such as peak and average itch, sleep disturbance, and pain for the first two weeks. During the study, participants will have regular medical visits as determined by their doctors, with data collected from routine assessments and patient questionnaires. Researchers will measure outcomes like the Investigator Global Assessment and Peak Pruritus Numerical Rating Scale at six months, along with other severity and symptom scores up to 12 months. No additional procedures outside standard care are required, allowing for natural monitoring of treatment effects and safety.