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NCT ID: NCT05764252 Recruiting - Epilepsy Clinical Trials

A Prospective Diagnostic Belief Updating Study to verIfy the Utility of BioEP in First Seizure Clinics.

PRISTINE
Start date: August 23, 2023
Phase: N/A
Study type: Interventional

The goal of this belief updating study is to assess the utility of BioEP as a complementary support tool in aiding clinical decision making in adults in first seizure clinics. The main outcomes we shall measure are: - Clinicians' perception of seizure probability. - Clinicians' decision to recommend commencing or deferring ASM (anti-seizure medications) - Clinicians' decision to refer for additional investigations/services. Participants will consent to have their EEG (that is taken at their routine care) to be used in the study. There is not extra burden to the participants taking part in the study.

NCT ID: NCT05763121 Recruiting - Asthma Clinical Trials

A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma.

EXHALE-2
Start date: January 30, 2023
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of dexpramipexole as an adjunctive oral therapy in participants with inadequately controlled asthma with an eosinophilic phenotype and a history of asthma exacerbations.

NCT ID: NCT05762848 Completed - Clinical trials for Hydrocephalus in Infants

Clinical Application and Functionality for an Application for Measurement of Head Circumference.

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

Title of clinical study:Clinical application, validation, and functionality evaluation of the Mobile Head Circumference Application in neonates and children Sponsor: University Hospitals NHS Foundation Trust Purpose of study:Evaluate and validate the utility of the mobile Head Circumference application for use in the clinical and outpatient setting for evaluation of head circumference of neonates and infants Primary objectives:Evaluate usefulness of and feasibility of the application in the clinical setting comparing it to normal practice. Secondary objectives:Evaluate parent/guardian reliability and satisfaction of the use of the mobile head circumference app. Study Design:Prospective Sample Size:Treating clinicians employed by Cambridge University Hospitals NHS Foundation Trust will identify patients eligible for this study (infants <18 months of age) and notify research team members with the patient's/guardian's consent. Once identified, research team members will approach patients' parents/guardians to seek informed consent before their clinic appointment or at the bedside on the ward. An information sheet will be used. If they choose to participate, we will measure the HC during the clinic appointment or on the ward. (Please refer to Flowchart 1). Sample size estimation was calculated with 90% statistical power to detect a change of means by 1 and a standard deviation of 1. This, along with 10% iteration, equals 33 participants. Summary of eligibility criteria:Neonatal patients and infants with need of continuous measurement of Head Circumference up to the age of 18months. Investigational techniques:Mobile application for Automatic measurement of head circumference.

NCT ID: NCT05762770 Recruiting - Infertility Clinical Trials

A Trial of Sperm Injection (PICSI) on Miscarriage Rates in Assisted Conception

PICSI
Start date: March 27, 2023
Phase: N/A
Study type: Interventional

Physiological intracytoplasmic sperm injection (PICSI) is a technique used to select healthy, mature sperm for use in infertility treatment based on their physiological ability to bind to hyaluronan (HA), a natural compound found in the body. The relationship between sperm and hyaluronan can be used a marker of sperm maturity and optimal fertilising potentialÍž this principle can be observed in vitro using a PICSI sperm selection device. The PICSI Dish contains microdots of hyaluronan, which only mature sperm bind to and these are selected by the embryologist prior to use in the intracytoplasmic sperm injection (ICSI) procedure. Recurrent miscarriages following infertility treatment are mainly idiopathic, but can be linked with increased chromosomal abnormalities. PICSI has been shown to result in better embryo development and reduced chromosomal abnormalities, due to selection of mature sperm with low DNA damage. Therefore, PICSI may be a useful tool for reducing the rate of miscarriage following infertility treatment. The recent HABSelect study investigated treatment outcomes following PICSI, and whilst they concluded no effect on livebirth rate, they found a significant association in their secondary analysis between PICSI and reduced miscarriage rate compared to ICSI. The implications of the HABSelect study deserve to be explored further with miscarriage rate assessed as a primary outcome measure. This proof-of-concept randomised-controlled-trial aims to investigate whether PICSI shows some promise that would merit evaluation in a fully-powered trial to assess its efficacy as an advanced sperm selection method for the reduction of miscarriage rate. Eligible study participants will be patients undergoing fertility treatment using ICSI, who have provided consent for PICSI. Patients will be randomly allocated to two groups: the control group will receive ICSI according to standard protocol, and the intervention group will have additional sperm selection by HA-binding in a PICSI dish.

NCT ID: NCT05761873 Active, not recruiting - Asthma Clinical Trials

Letters in Addition to Emailed Audit and Feedback in Refining Asthma Treatment in Primary Care

CLEARAIR
Start date: April 24, 2023
Phase: N/A
Study type: Interventional

Public Health England have estimated that 36,000 excess deaths occur each year due to UK air pollution. Respiratory inhalers produce 3% of NHS greenhouse gas production. The two main inhaler device categories are pressurised Metered Dose Inhalers (pMDIs) and Dry Powder Inhalers (DPIs). The chemical propellant in pMDIs is the majority cause of inhaler carbon footprint, with pMDIs having an 18 times higher carbon footprint than DPIs. The rates of asthma in the UK population are amongst the highest worldwide and its mortality rate remains amongst the worst in Europe. A pre-existing Audit and Feedback (A&F) quality improvement project (QIP) is being undertaken by NHS West Yorkshire Integrated Care Board (ICB) with the aim of improving asthma outcomes and reducing the environmental impact of inhalers in primary care. The A&F being utilised here has been validated locally in two peer reviewed studies and is now standard practice in the region. There is convincing evidence that A&F has a positive effect on enacting behaviour change, especially where behaviour change is related to prescribing with low baseline compliance with guidelines. However, the evidence base is poor on which design features of A&F produce enhanced results. There is supporting evidence from local studies suggesting that posted paper A&F may be more effective at producing behaviour change than emailed copies of A&F alone. This study seeks to randomise the primary care practices within the pre-arranged QIP, to receive either a paper and emailed A&F report bimonthly for the duration of the study period, or to receive an emailed A&F report alone. The primary outcome of the study would be a comparison of the number of 'low-global warming potential' inhalers prescribed as a percentage of the total prescribed inhalers from each intervention group.

NCT ID: NCT05761600 Completed - Mental Health Clinical Trials

Learning Disability Group Art Therapy: Looking and Asking

GATher-LD
Start date: February 14, 2023
Phase:
Study type: Observational

A qualitative study of group art therapy in England for adults with a learning disability accessing community services. Different stakeholder views and experiences will be gathered using ethnographically-informed group observation, semi-structured individual interviews and a focus group. People with a learning disability will support the data analysis and dissemination of findings in accessible means.

NCT ID: NCT05760313 Recruiting - Clinical trials for Functional Constipation

A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide

Start date: April 27, 2023
Phase: Phase 2
Study type: Interventional

Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility. Currently, there are no pharmacological therapies approved for the treatment of FC. This study will assess adverse events and change in disease activity with linaclotide therapy in participants with FC. Linaclotide is an approved drug being developed for the treatment of FC in pediatric patients who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 3 groups, which occur consecutively. Each group receives a different dosage of linaclotide. In Part 2 of the study, participants will be randomly assigned to receive either linaclotide or placebo. There is a 1 in 2 chance that participants will be assigned to placebo. Approximately 30 pediatric participants 6 months to less than 2 years of age with FC will be enrolled in the study at about 25 sites worldwide. Participants will receive oral solution of linaclotide prepared from capsule by parent/guardian once daily for 4 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05760261 Suspended - Clinical trials for Urinary Tract Infections

Drug Interaction Assessment of GSK3882347 in Healthy Participants Aged 18 to 65 Years

Start date: March 6, 2023
Phase: Phase 1
Study type: Interventional

The objective of this study is to determine the magnitude and clinical relevance of a potential drug-drug interaction of GSK3882347 with midazolam (MDZ) in healthy participants. This study assesses the effect of GSK3882347 as an inducer of Cytochrome P450 3A4 (CYP3A4) using MDZ, a sensitive substrate of hepatic and intestinal CYP3A4. The study will investigate MDZ pharmacokinetic (PK) effect in two dosing periods: Period 1: A single dose of MDZ Period 2: 14-days of once daily repeat dosing of GSK3882347 followed by single dose of MDZ co-administered with GSK3882347 on Day 15 (14-days has been selected as this duration is required in order to maximize any potential CYP3A4 enzyme induction).

NCT ID: NCT05759936 Completed - Menopausal Syndrome Clinical Trials

4-week Seaweed Supplementation on Menopause Symptoms and Psychological Wellbeing

Start date: March 20, 2023
Phase: N/A
Study type: Interventional

Menopausal symptoms have a substantial effect on quality of life as well as potentially serving as markers for future health. Previous research has suggested that diet can impact menopausal symptoms. Seaweed is marketed as a treatment to alleviate menopause symptoms, but no research has tested whether it is effective in reducing the symptoms and psychological effects associated with menopause. The aim of this study is to investigate the effects of consuming a seaweed supplement over a 4-week time period on menopausal symptoms and psychological well-being.

NCT ID: NCT05758727 Completed - Older Adults Clinical Trials

Homebased Strength and Tai-chi Exercise Snacking for Improving Physical Function in Older Adults

Start date: May 20, 2022
Phase: N/A
Study type: Interventional

Engaging in muscle strength and balance (S&B) exercises and has numerous health benefits for older adults, promoting greater mobility, reducing risk of falling, and overall improved health and wellbeing. Given the rising age of global populations, reducing the burden associated with lost physical function is essential to minimise health and social care costs. Unfortunately, very few older adults engage in sufficient S&B exercise to reap these benefits, with a lack of time, self-efficacy and access to leisure facilities cited as the key barriers. Finding innovative ways promote an acceptable and engaging format of S&B exercise is consequently a public health priority. One novel way that aims to address typical barriers to participation in older adults is through the promotion of exercise 'snacks', as opposed to a more traditional, lengthy structured exercise session at a leisure centre. Exercise snacking describes short bursts of exercise that are designed to be undertaken over a short period in the home environment and without the need for any specialised exercise clothing or equipment. In the initial laboratory and cross-sectional and pilot intervention research, the investigators have been testing two formats of 5-minute, twice-daily, strength exercise- and tai-chi-snacking, which has been shown to be acceptable and feasible to implement in older adults. This protocol presents initial efficacy for evoking improved physical function in people aged 65 years or more. The investigators' remote study demonstrated that remote assessment and delivery of 4-week exercise and tai-chi snacking interventions were acceptable and feasible. However, qualitative feedback indicated that exercise programmes may be more acceptable and interesting with simpler tai-chi movements and exercise snacking programme with upper body movements. Nevertheless, the investigators only recruited healthy older adults, doing short-term interventions in previous studies. This study aims to test the effectiveness of progressive S&B interventions over a sustained period in pre-frail older adults.