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NCT ID: NCT05817357 Active, not recruiting - Asthma in Children Clinical Trials

Use of Air Purifiers to Improve Respiratory Health in Children

Start date: May 2, 2023
Phase: N/A
Study type: Interventional

The goal of this pilot study is to investigate if installing an air purifier in the homes of children and young people with asthma improves their asthma outcomes. The main questions it aims to answer are: - Does installing an air purifier in the homes of children and young people with asthma improve their asthma outcomes - Is the use of an air purifier in the home acceptable to children and young people and their families? Children and young people with asthma attending our clinic will be selected at random to be invited to take part. For those that take part, an air purifier (Rensair Ltd. - Rensair Compact) will be installed in their home for a one-year period. Data will be collected on numbers of asthma attacks, rescue oral steroids, quality of life, symptoms, lung function at the beginning and at three-monthly intervals throughout the study period. The acceptability to children and young people and their families taking part in this study of using an air purifier in their home will also be assessed.

NCT ID: NCT05817266 Withdrawn - Clinical trials for Inflammatory Bowel Diseases

Role of FCI in the Detection of Proctosigmoiditis Caused by IBD

ROOFTOPS-IBD
Start date: March 2024
Phase: N/A
Study type: Interventional

The goal of this pilot study is to explore the ability of field-cycling imaging, a new scanning technology being developed at the University of Aberdeen, to detect active disease in patients with proctosigmoiditis caused by inflammatory bowel disease.

NCT ID: NCT05817175 Recruiting - Breast Cancer Clinical Trials

International Prospective REgistry on Pre-pectorAl Breast REconstruction

I-PREPARE
Start date: October 16, 2023
Phase:
Study type: Observational

This is an international multicenter prospective cohort study aimed at collecting data on breast reconstruction techniques with pre-pectoral implants after mastectomy for breast cancer. The aim of the study is to collect data on the surgical, aesthetic and oncological results, as well as on the quality of life of the patients who will undergo breast reconstruction with a pre-pectoral approach.

NCT ID: NCT05817136 Recruiting - Heart Failure Clinical Trials

Prospective Longitudinal Evaluation of AI-ECG in a NEwly Diagnosed Heart Failure

(PLANE-HF)
Start date: January 11, 2023
Phase:
Study type: Observational

Background: Heart Failure (HF) is a condition in which the heart can no longer adequately pump blood around the body. The number of patients diagnosed with HF is increasing, consuming 4% of the NHS budget, and deadlier than most cancers. Most patients suffer from HF with reduced Ejection Fraction (HFrEF), where adequate treatment can improve quality of life and survival. Less than 50% of patients receive gold standard NHS guided medication and less than 20% receive appropriate monitoring (via echocardiography surveillance). This study looks at the use of a 'smart stethoscope' (Eko DUO), a stethoscope that uses information collected from the heart in the form of electrical (ECG) and sounds (phonocardiogram, PCG) waveforms, to predict the pumping function of the heart via artificial intelligence (AI-ECG). Aims: By using the smart stethoscope, this study evaluates whether the use of an easy-to-use home self-monitoring programme can: - Provide a solution for the current poor compliance of NHS echocardiogram surveillance programmes for people with newly diagnosed HF - Provide real-time assessment of heart function in response to medication changes - Improve the health economic and health outcomes of HF in the NHS Methods: 80 participants with newly diagnosed HFrEF, due to pre-existing heart disease and non-heart related causes, will be identified by the clinical team at Imperial College NHS Trust and obtain consent for the research team to approach them. All consented participants will receive a smart stethoscope and instructions for twice-weekly, 15-second self-examination for 3-months. Participants will also be invited for an additional echocardiogram at 6 weeks post-diagnosis, in addition to the routine, standard of care NHS echocardiogram surveillance for HF.

NCT ID: NCT05815745 Recruiting - Bradycardia Clinical Trials

"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)

PROTECT-HF
Start date: June 5, 2023
Phase: N/A
Study type: Interventional

The PROTECT-HF multi-centre randomised controlled trial will compare two different pacing approaches for treating patients with slow heart rates. In it the investigators will compare a long-standing standard approach for pacing; right ventricular pacing, with a new form of pacing, physiological pacing (His and Left bundle area pacing) in 2600 patients. Patients will be allocated at random to receive either right ventricular pacing or physiological pacing. Endpoint measurements will be undertaken at baseline, and at six-monthly intervals post-randomisation. Treatment allocation will be blinded to the endpoint assessor and the patient. Recruitment and pacemaker implantation will be carried out at each participating centre. The primary analysis will be intention to treat. The investigators will also perform an on-treatment analysis. 2048 patients are needed to detect the expected effect size with 85% power. A total of 2600 patients will be recruited to allow for patient drop-out and crossover. 500-patient sub-study will assess within patient, and between groups, echocardiographic changes over a 24-month period to try and improve mechanistic understanding of PICM (Pacing Induced Cardiomyopathy).

NCT ID: NCT05815498 Active, not recruiting - COVID-19 Clinical Trials

A Study of mRNA-1283.222 Injection Compared With mRNA-1273.222 Injection in Participants ≥12 Years of Age to Prevent COVID-19

NextCOVE
Start date: March 28, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety, reactogenicity, and relative vaccine efficacy (rVE) of the mRNA-1283.222 vaccine as well as its immunogenicity in comparison to the mRNA-1273.222 vaccine.

NCT ID: NCT05815459 Completed - Clinical trials for Major Depressive Disorder

Mobile Observation Of Depression

MOOD
Start date: July 15, 2022
Phase:
Study type: Observational

The primary aim of this project is to test if OCOsense glasses can function as a digital phenotyping tool derived from behavioural and physiological signals related to facial expression and motion recorded using the glasses.

NCT ID: NCT05814627 Recruiting - Clinical trials for Rheumatoid Arthritis

Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis

SELECT- SWITCH
Start date: June 15, 2023
Phase: Phase 3
Study type: Interventional

Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will assess how safe and effective upadacitinib is in treating RA when compared to adalimumab in adult participants with inadequate response or intolerance to one TNF-inhibitor who are on a stable dose of methotrexate (MTX). Adverse events and change in disease activity will be assessed. Upadacitinib is an approved drug for the treatment of RA. This study is double-blinded means that neither the participants nor the study doctors will know who will be given upadacitinib and who will be given adalimumab. Study doctors put the participants in 1 of the 2 groups, called treatment arms randomly, to receive either upadacitinib or adalimumab. There is 1 in 2 chance that participants will receive adalimumab. Each group consists of 2 periods. Approximately 480 participants diagnosed with RA will be enrolled in approximately 250 sites across the world. Participants will receive the oral upadacitinib once daily and matching adalimumab placebo every other week, or the subcutaneous adalimumab every other week and matching upadacitinib placebo once daily during Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1 and will be followed for 30 days and 70 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

NCT ID: NCT05814523 Withdrawn - Clinical trials for Refractory Status Epilepticus

To Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus (RSE)

Start date: March 2024
Phase: Phase 3
Study type: Interventional

This is a multicenter, double-blind, randomized, placebo-controlled study that will evaluate the efficacy, safety, and tolerability of intravenous (IV) ganaxolone versus placebo co-administered with IV antiepileptic drug (AED) according to standard of care for the treatment of RSE. Approximately 70 participants will be randomized in a 1:1 ratio to receive ganaxolone IV solution or placebo IV solution along with standard of care (SOC) IV AED.

NCT ID: NCT05814484 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Role of Inhaler Adherence and Blood Eosinophil Count in Exacerbations of COPD

INCLINE
Start date: August 10, 2023
Phase:
Study type: Observational

This is an observational study examining inhaler adherence and subsequent changes in blood eosinophil count in exacerbations of Chronic obstructive pulmonary disease (COPD) population. The study will run for 6 months as an observation period. Passive inhaler adherence monitoring will be done electronically via inhaler sensors connected to mobile Apps, and collecting symptoms questionnaires, diary of exacerbation events and trial visits predominantly in remote fashion. It will explore the feasibility of digital platform in clinical practice to collect the adherence data along with exacerbation events.