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NCT ID: NCT06320535 Recruiting - Malaria,Falciparum Clinical Trials

A Phase 1 Study to Assess an Escalating Dose, Multi-prime Vaccination Schedule of R21/Matrix-M™

Start date: March 25, 2024
Phase: Phase 1
Study type: Interventional

This is a phase I clinical study that aims to assess the safety and immunogenicity of a novel, escalating dose regimen of R21/Matrix-M™ in healthy, malaria-naïve adults.

NCT ID: NCT06320522 Recruiting - Ketosis Clinical Trials

Exogenous Ketosis in a Fed and a Fasted State

Start date: February 15, 2023
Phase: N/A
Study type: Interventional

The kinetics of circulating βHB following ingestion of the ketone monoester are dependent on several variables that determine the balance between appearance into, and disappearance from, the bloodstream. These dynamics have been well characterised in fasted humans but in the real world the ketone monoester is likely to be ingested in a fed state, pertinently within athletic spheres consumption would proceed a substantial high-carbohydrate meal. Within this, it is unclear how metabolism under exogenous ketosis might be affected in a fed versus fasted state. This four-arm crossover study looks to characterise the relationship between feeding status, βHB pharmacokinetics, and resting metabolism. As exogenous ketosis is known to reduce circulating glucose levels, this study will also explored if hepatic metabolism - for example, de novo lipogenesis - might consequently be altered, with implications for metabolic disease states such as Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and type II diabetes. Participants will be asked to consume either the ketone monoester drink or a placebo drink when fasted and when having previously consumed a meal.

NCT ID: NCT06319820 Recruiting - Clinical trials for Non-Muscle Invasive Bladder Cancer

A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

MoonRISe-1
Start date: April 18, 2024
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.

NCT ID: NCT06318442 Not yet recruiting - Clinical trials for Steroid-Induced Diabetes

The GAPSID Study - How GLP-1 Analogues Prevent Steroid-Induced Diabetes

Start date: April 6, 2024
Phase: N/A
Study type: Interventional

TITLE: How GLP-1 Analogues prevent steroid-induced diabetes (The GAPSID Study) DESIGN: A double-blind study evaluating how GLP-1 analogues, compared with metformin, prevent hyperglycaemia in response to a 7-day course of dexamethasone (DEX) 6 mg once daily. This is a mechanistic experimental medicine study. AIMS: To evaluate the mechanisms by which GLP-1 analogues reduce steroid-induced hyperglycaemia compared to metformin. OUTCOME MEASURES: - Primary: Glucose tolerance in response to standardised mixed meal test (MMT) lasting for 240 minutes, measured in all participants at baseline and on day 7 DEX. - Secondary: Indices of insulin resistance (M-value), beta-cell function (acute insulin response to glucose) and disposition, as measured by a combined IV glucose tolerance test and hyperinsulinaemic-euglycaemic clamp, performed at baseline and on day 7 DEX. - Exploratory: Tissue specific changes in adipose AMPK determined from adipose and muscle biopsies, taken from a subset of approximately 8 individuals in each group. ELIGIBILITY: People living with pre-diabetes or lifestyle controlled diabetes STUDY DURATION: This study will take place over 3 weeks for each partcipant. Study procedures include 10 days of baseline continuous glucose monitoring (CGM) followed by 7 days of dexamethasone with GLP-1, metformin or placebo. Participants will attend a follow-up visit 3-5 days after completing the 7-day course of study drug. The study will run over a period of 3 years. ANTICIPATED IMPACT: Mechanistic evidence for the use of GLP-1 analogues, compared with metformin, in the treatment of steroid-induced diabetes.

NCT ID: NCT06315556 Recruiting - Clinical trials for Retinopathy of Prematurity

An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)

Start date: March 5, 2024
Phase:
Study type: Observational

This is an observational study in which only data from babies with retinopathy of prematurity (ROP) who are being treated with aflibercept (Eylea) in prefilled syringe (PFS) using a paediatric dosing device (PDD) are collected and studied. ROP is a condition that affects the eyes of preterm babies. It occurs when the baby's retina, the part of the eye that senses light, does not develop normally. This may result in vision problems, including blindness, if left untreated. Preterm babies are born before 37 weeks of pregnancy. ROP is more likely to develop in babies who are born before 32 weeks of pregnancy or weigh less than 1.5 kilograms at birth. Aflibercept is a drug that is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth of blood vessels in the retina. Aflibercept in PFS given using a PDD is approved for the treatment of babies with ROP. The prefilled syringe will be fitted with an injection needle to give aflibercept. And a PDD is a tool used to give the right amount of aflibercept to children in a safe manner. Since there are other treatments which are commonly used for babies with ROP, the extent of use of aflibercept given using a PDD is unknown. The main purpose of this study is to: - find the number of preterm babies who are treated with aflibercept using a PDD in the UK - inform whether this number is enough to perform a study to learn about the long-term safety of aflibercept given using a PDD in babies with ROP An additional purpose of this study is to describe characteristics including age, sex, and race, and signs and symptoms of ROP observed in babies being treated with aflibercept using a PDD. The data will come from a database called the National Neonatal Research Database. The study will cover the period from March 2024 to March 2025, if the number of babies found is enough to perform the safety study. If not, data will be collected till April 2027. In this study only available data from preterm babies born during the study period are collected. No visits or tests are required as part of this study.

NCT ID: NCT06314451 Recruiting - Respiratory Disease Clinical Trials

Cross-condition Validation of the Steroid PRO

Start date: June 1, 2022
Phase:
Study type: Observational

Testing a questionnaire about treatment with steroids for skin, lung or gastric conditions

NCT ID: NCT06312163 Completed - Keratoconus Clinical Trials

Validation of Innovative Scheimpflug Topography Derived RGP Contact Lens Designs In Optometry Network

VISION
Start date: June 6, 2022
Phase:
Study type: Observational

The goal of this Prospective, single-site, cohort study is to validate rigid gas permeable corneal contact lens (RGP) designs for keratoconus derived from combining the data from corneal topography scans and contact lenses ordered in patients with keratoconus (KC) attending a UK tertiary NHS Hospital contact lens clinic. The main questions it aims to answer are: - Does a Scheimpflug topography derived RGP contact lens design for keratoconus have the equivalent overall contact lens fit as the patients' own lens? - Is the number of trial lenses required to fit a patient is reduced compared to standard practice? - Is the time taken to fit a contact lens is reduced compared to standard practice? - Is there user acceptance of the new lens? - Are the Axial ege lift (AEL) changes clinically significant? There will be 3 work packages WP1: For each participant data collection will take place over two visits. • Visit 1: Pentacam topography scans and optimal 'virtual' lens selection will take place. • • Visit 2: Participants are fitted with 4 contact lenses (i) the optimal lens design as specified by the virtual fitting module, (ii) a contact lens with a clinically significant step flatter AEL (iii) a contact lens steeper in axial edge lift (AEL) (iv) the participant's own contact lens. Each CL fit will be assessed with slit lamp photography according to the standardised method proposed by Wolffsohn et al. (2013), Anterior segment OCT MS39) (CSO Hansom Instruments, UK) and best-corrected visual acuity with each lens design using high-contrast logMAR . WP2. Participants will attend one appointment where a traditional lens fit, and a lens fitted using the topography guided 'virtual' module will be undertaken (with the fitting method selected for each eye randomised). For each fitting method the total fitting time will be measured and the total number of trial contact lenses used. Patients will be invited to complete a questionnaire that probes their satisfaction of this process. WP3. Clinicians not involved in the study will be invited to examine a demo version of the virtual fitting module and complete the validated system usability scale tool.

NCT ID: NCT06311708 Recruiting - Clinical trials for Arrhythmogenic Right Ventricular Cardiomyopathy

Non-interventional Study of Seroprevalence of Pre-existing Antibodies Against Adenovirus-associated Virus Vector (AAV9) and the Progression of Disease in Patients With Plakophilin 2 (PKP2)-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)

RIDGE
Start date: January 31, 2023
Phase:
Study type: Observational

This is a multicenter, non-interventional study to observe the natural progression of the disease and to study the prevalence of pre-existing antibodies to AAV9 used for gene therapy in a population of patients with PKP2 gene-associated ARVC. Participation from all patients is encouraged regardless of interest in or eligibility for gene therapy.

NCT ID: NCT06311552 Completed - Clinical trials for Heart Failure With Preserved Ejection Fraction

Optimising CMR Scan Acquisitions for Novel Equipment/Sequences in Clinical Cardiovascular Populations.

OPTMISE-HFpEF
Start date: January 31, 2022
Phase:
Study type: Observational

The purpose of this study is to develop robust protocols for the optimisation of novel hardware, software and exercise equipment in the magnetic resonance imaging (MRI) environment in various cohorts with cardiovascular disease (CVD) with the first study focusing on those with established heart failure with preserved ejection fraction (HFpEF) or those at risk of or with pre-HFpEF.

NCT ID: NCT06311084 Completed - Clinical trials for Mental Health Disorder

IMAGINATOR 2.0: Co-design and Early Evaluation of a Novel Blended Digital Intervention Targeting Self-harm in Young People

IMAG2
Start date: November 25, 2022
Phase: N/A
Study type: Interventional

This study aims to investigate acceptability and feasibility of a new version of the Imaginator intervention, Imaginator 2.0, targeting self-harm behaviour in young people aged 12-25 under mental health services in the UK. Following an initial proof-of-concept study of Imaginator (Di Simplicio et al., 2020), we co-designed a new version of the app that supports consolidation and practice of the techniques learnt in therapy, and adapted the protocol to be extended to younger adolescents. Imaginator 2.0 uses 'functional imagery training', training in individuals to develop and use functional (that is, helpful) mental images to support an alternative behaviour instead of self-harm. Mental imagery is the process of picturing something in the mind, and mental images have strong emotional and motivational characteristics. Functional Imagery Training (FIT) within Imaginator helps young people imagine adaptive behaviours as an alternative to self-harm when dealing with distressing emotions.