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NCT ID: NCT06112327 Not yet recruiting - Clinical trials for Hypercholesterolemia

Long-term Follow-up of Participants Dosed With an Investigational Gene Editing Therapy for Cardiovascular Disease

Start date: April 2024
Phase:
Study type: Observational

LTF-001 is a long-term follow-up study of participants who received an investigational gene-editing therapy developed by the sponsor to evaluate the long-term effects of the investigational therapy. Participants will be followed for a total of 15 years after the first administration of the gene-editing therapy, including time in both the interventional study and study LTF-001.

NCT ID: NCT06110845 Not yet recruiting - Breast Cancer Clinical Trials

CLinical Evaluation Of a comPuter Algorithm To Report BreAst cAncers (CLEOPATRAA)

CLEOPATRAA
Start date: December 1, 2023
Phase:
Study type: Observational

The goal of this non-interventionist observational study is to test the performance of a computer algorithm (QPORB) which examines breast cancer biopsy digital images to provide diagnostic support. The main question[s] it aims to answer are: 1. The principal research aim is to determine whether 4D Path's Technology Q-Plasia OncoReader Breast, that has been developed in the research setting, works robustly in the clinical environment (i.e. to define its real-life clinical utility) in terms of breast carcinoma grading and molecular subtyping 2. The secondary research aim is to perform an economic analysis alongside the trial in order to establish the time, resource and cost savings that the technology could afford the NHS, the ideal price point for engaging with the technology and the cost:benefit ratio for evaluation by the National Institute for Clinical Excellence 3. The tertiary research aim is to gather long-term follow-up data to better understand long-term response to therapy and prognosis and potential future uses of the algorithm Participants's specimens will be tested alongside routine clinical workflows without intervention or consent. Researchers will compare the algorithm's results to those of routine diagnostic standard of care workflows.

NCT ID: NCT06097195 Not yet recruiting - Epilepsy Clinical Trials

The Clinical Utility of BioEP in Diagnostic Decision Making in Epilepsy

CITADEL
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Neuronostics plan a prospective multisite trial to determine the clinical utility of BioEP in the context of diagnostic decision making. Neuronostics will use findings from the trial to improve user experience of the Neuronostics platform (the tool which clinicians use to obtain a BioEP score from EEG and the aligned report). The data coming from the trial will also enable Neuronostics to iterate the BioEP algorithms and so improve future performance.

NCT ID: NCT06095024 Not yet recruiting - Cancer Clinical Trials

INvestigating DIGital Outcomes in the Community

INDIGO-Com
Start date: December 1, 2023
Phase:
Study type: Observational

To explore the feasibility and best methodology for collecting patient-reported outcome measures in patients who have previously been treated for cancer and are living in the community. The investigators are working with primary care research teams, and using an online electronic questionnaire. Although the study is entirely observational, the study offers some of the questions in a random order, so the investigators can explore the effect of changing the way in which questions are asked.

NCT ID: NCT06089447 Not yet recruiting - Clinical trials for Wellness, Psychological

A Pilot Randomised Controlled Trial of Intervention for Children and Young People Experiencing Family Substance Use

Start date: October 2024
Phase: N/A
Study type: Interventional

The study is investigating the feasibility and acceptability of the story-based intervention, The Shadows of Tallystick Valley, aimed at improving the psychological wellbeing and resilience of children and young people who are affected by familial substance use. A secondary aim of the study is to identify whether there is a 'signal of efficacy'. The early intervention is a story and activity book designed and developed by Book of Beasties, in collaboration with the charity Change Grow Live (CGL), who work directly with children and young people experiencing familial substance use. The intervention is used by s at CGL with children and young people engaged with the service. In the present study, we aim to evaluate the story-based intervention within a pilot randomised controlled trial. Participants will be randomised to either receive the intervention or to join a waitlist for the same intervention. The effects of the story-based intervention will be assessed using pre and post psychological well-being and resilience measures, including KidCOPE, the Stirling Children's Wellbeing Scale and the Child and Youth Resilience Measure. The primary outcome measures are concerned with overall psychological wellbeing.

NCT ID: NCT06087471 Not yet recruiting - Depression Clinical Trials

Snack Foods and Their Impact on Mental Health and the Gut-brain Axis

NutriMood
Start date: October 16, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effects of snack foods on mental health and the gut-brain axis, in adults with mild to moderate symptoms of depression and anxiety.

NCT ID: NCT06085001 Not yet recruiting - Hypertension Clinical Trials

Use of Lumella-glycosylated Fibronectin for Diagnosis of Preeclampsia

Lumella
Start date: November 10, 2023
Phase:
Study type: Observational

women with symptoms of preeclampsia from antenatal clinic or triage will be offered Lumella test along with traditional blood tests. If Lumella test is positive which will be compared with the traditional blood test results. Once 50 positive cases have been analysed the study results will be submitted to NICE.

NCT ID: NCT06084546 Not yet recruiting - Leg Ulcer Clinical Trials

Geko™ KM40C Hydrogel Skin Adhesion Trial (XW-3)

Start date: December 2023
Phase: N/A
Study type: Interventional

Hydrogel KM40C is an electrically conductive skin adhesive incorporated in the self-adhesive, geko™ XW-3 neuromuscular electrical stimulation (NMES) device. KM40C has been formulated to adhere to the skin giving good electrical contact for the electrodes, be easy to remove without damaging the skin and be non-irritant. KM40C has been tested for safety in humans, however the skin adhesive performance of this improved hydrogel formulation has not been tested on patients receiving geko™ NMES treatment as an adjunct to standard care for wound management. The objective of this trial is to evaluate the skin adhesive performance of hydrogel KM40C during clinical use of the geko™ XW-3 NMES device to determine whether skin adhesion is at least equivalent if not superior to the adhesive hydrogel KM40A incorporated in the self-adhesive geko™ W3 device which is currently in use clinically. Both devices are indicated for use to promote wound healing, the geko™ W3 NMES device is UKCA and CE marked whereas the geko™ X-W3 is UK CA marked only.

NCT ID: NCT06067321 Not yet recruiting - Anesthesia Clinical Trials

Gastric Residual Volumes in Infants Fed at 4 and 6 Hours Prior to General Anaesthesia

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The safety implications of prolonged fasting in young children prior to general anaesthesia are well described. Current UK guidance recommends a fasting time of 6 hours for formula milk prior to general anaesthesia. European guidance published in 2022 recommended a reduced fast of 4 hours for infants taking formula milk, albeit with a downgraded level 2B of evidence given the paucity of high quality research in this area. Although pulmonary aspiration of gastric contents under anaesthesia in children is a rare event, animal studies suggest that aspiration of particulate matter at volumes greater than 0.8 ml/kg gastric volume are associated with demonstrable lung injury and mortality. Although rate of gastric emptying of formula preparations has been extensively studied in neonatal intensive care settings for preterm babies using ultrasound, few studies have measured gastric volume directly in healthy term infants undergoing anaesthesia.

NCT ID: NCT06064461 Not yet recruiting - Myasthenia Gravis Clinical Trials

Vitaccess Real MG Registry

VRMG
Start date: March 2024
Phase:
Study type: Observational

Vitaccess Real MG (VRMG) is a patient registry designed to capture longitudinal observational data on myasthenia gravis (MG), its treatment, and impact on symptoms, daily activities, and quality of life (QoL). The duration of the registry is 10 years from launch, and approximately 600 patients will be recruited in the US and Europe with no defined upper limit. The registry will link relevant patient- and healthcare professional (HCP)-reported data with clinical data from medical records. Patients will be recruited at clinical sites in all participating countries. In the US only, patients can additionally be recruited via community neurologists or direct-to-patient recruitment.