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NCT ID: NCT05748301 Not yet recruiting - Sepsis Clinical Trials

AI Clinician XP2 - A Study of the AI Clinician Running in Real Time in the ICU

Start date: February 28, 2023
Phase:
Study type: Observational

The cornerstone of sepsis resuscitation is the administration of intravenous fluids (IVF) and/or vasopressors (drugs that squeeze the blood vessels to increase blood pressure) to maintain blood flow to prevent organ failure. However, there is huge uncertainty around the individual dosing of these drugs in an individual patient, partially due to high sepsis heterogeneity. The current guidelines provide recommendations at a population-level but fail to individualise the decisions. Wrong decisions lead to poorer outcomes and increased ICU-resource use. A tool to personalise these medications could improve patient survival. The investigators have developed a new method to automatically and continuously review and recommend the correct dose of these medications to doctors, which was created using artificial intelligence (AI) techniques applied to large medical databases. The method used is called reinforcement learning, and we call the technology the "AI Clinician". In the AI Clinician XP1, the investigators tested the safety of the AI Clinician when running in "shadow mode", i.e. in pseudonymised batches of patient data presented to off-duty ICU clinicians. This enabled the investigators to 1) develop methods and software to connect to real-time electronic health records (EHR); 2) check the safety of the algorithm when used in a contemporary UK ICU patient cohort. In XP2, the AI Clinician will be running in real-time on dedicated computers at the bedside of actual patients in 4 ICUs across 2 NHS Trusts (Three ICUs at ICHT and one ICU at UCLH).

NCT ID: NCT05747924 Recruiting - Clinical trials for Muscular Dystrophies

Phase 1/2 Study of AOC 1020 in Adults With Facioscapulohumeral Muscular Dystrophy (FSHD)

FORTITUDE
Start date: April 4, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

A Randomized, Double-blind, Placebo-controlled, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of AOC 1020 Administered Intravenously to Adult Participants with Facioscapulohumeral Muscular Dystrophy (FSHD)

NCT ID: NCT05747001 Completed - Epilepsy Clinical Trials

This is a Retrospective Study on the Use of CENOBAMATE as Adjunctive Treatment in Patients Suffering From Epilepsy in Early Access Program in Germany, France and UK

CENOR
Start date: January 27, 2023
Phase:
Study type: Observational

Cenobamate is a newly-FDA and EMA approved drug used to treat -focal-onset seizures in adult patients. The aim of the current study is to analyse retrospectively the overall effectiveness and tolerability of cenobamate from real-world data collected in patients who partecipated in the Early Access Program (EAP) and were treated with cenobamate as adjunctive ASM.

NCT ID: NCT05746559 Recruiting - Clinical trials for Chronic Kidney Disease

ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE

ARTEMIS
Start date: April 6, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the efficacy of a single dose of ravulizumab IV compared with placebo in reducing the risk of the clinical consequences of AKI (MAKE) at 90 days in adult participants with CKD who undergo non-emergent cardiac surgery with CPB.

NCT ID: NCT05746364 Recruiting - Eating Disorders Clinical Trials

Case-Series Examination of a Brief CAT-Informed Intervention for Young People Experiencing Difficulties With Eating (RIDE)

RIDE
Start date: May 1, 2023
Phase: N/A
Study type: Interventional

Eating Disorders (ED) are mental health conditions where people alter food intake in some way to help with weight gain, managing emotions or other situations. EDs are increasingly common in young people. They can cause both the young person and those around them significant distress. Talking therapies can help. Cognitive Analytic Therapy (CAT) is a talking therapy that is becoming increasingly widely used within the NHS to help with a wide range of problems. CAT focuses on the relationships clients have with themselves and others around them. From CAT, we have developed Relational Intervention for Difficulties with Eating (RIDE), This is a brief talking therapy. The aim is to help the young person and those around them build an understanding of their difficulties. This will hopefully mean others can support them with their disordered eating. The aim of the study is to examine the feasibility (is it possible to conduct a study about this intervention?) and acceptability (do participants find the therapy is helpful and makes sense to them?) of RIDE. As a secondary aim, the study will look at whether RIDE shows preliminary evidence for positive change on relevant measures of psychological difficulties (e.g. distress, how young people feel about themselves and others). The study will aim to recruit nine young people (aged between 14-25) with ED. Participants must be under the care of an ED service. They will attend 8 appointments (3 assessment, 5 therapy) either at their home, University of Manchester campus or a health service clinic. A video conferencing platform (e.g. Zoom, Teams) can be used if required. Participants will complete questionnaires before, during and after therapy. The findings will help to develop the therapy and improve further testing in larger studies. If successful, RIDE could be available as a treatment for young people.

NCT ID: NCT05746260 Recruiting - Stroke Clinical Trials

Sleep and Motor Learning in Stroke

SMiLES
Start date: March 1, 2023
Phase:
Study type: Observational

This study will explore whether sleep disruption in the sub-acute phase of stroke explains variation in clinical motor outcomes, and whether this relationship is mediated by variation in behavioural measures of overnight consolidation.

NCT ID: NCT05746221 Recruiting - Stroke Clinical Trials

INflammation and Small Vessel Disease Study

INSVD
Start date: August 10, 2022
Phase:
Study type: Observational

A prospective observational cohort study in patients with cerebral small vessel disease deterring whether changes in systemic inflammation predict brain white matter damage measured using MRI and cognitive decline. This is a study funded by a joint BHF-Dutch Heart Foundation research grant and will be conducted in both Cambridge UK and Nijmegen Netherlands with 100 of the 200 total participants recruited at each site, and data from both sites analysed together.

NCT ID: NCT05745961 Recruiting - Healthy Clinical Trials

Quantifying 18kDa TSPO Expression in the Lung in Pulmonary Artery Hypertension (PAH)

Start date: February 1, 2023
Phase:
Study type: Observational

The aim of this study is to determine whether there is an increase in the TSPO PET signal (measured with the radioligand [11C]PBR28) in the lungs of patients living with PAH relative to age matched controls. If so, TSPO PET may be a useful technique to non-invasively monitor response to therapy. To do this, we will perform 2 [11C]PBR28 PET scans. The first will quantify the total [11C]PBR28 PET signal. This signal is a combination of the specific signal (VS) and the nonspecific signal (VND). The second scan will be performed following dosing with an unlabelled TSPO ligand. By directly measuring the total [11C]PBR28 signal (scan 1) and the nonspecific [11C]PBR28 signal (scan 2) we can therefore calculate the specific [11C]PBR28 signal, and hence the amount of TSPO in the lung.

NCT ID: NCT05745155 Not yet recruiting - COPD Clinical Trials

REMAP-WEST-FLARE - FLAg for Review Efficacy Investigation

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

The goal of this clinical investigation is to explore the efficacy and economics of a novel medical device system which, through the remote monitoring and evaluation of acoustic pathophysiological parameters in long-term respiratory conditions, flags patients who are beginning to deteriorate for clinical review, in order to reduce time-to-intervention in respiratory disease flareups. The main question it aims to answer are: Would the use of the Senti-AI and Senti-Wear Device System reduce time-to-intervention in respiratory disease flareups? Participants will wear the Senti-Wear device up to twice per day as tolerated for 12 weeks. The Senti-AI subsystem will generate FLAREs (flags for review) and these will retrospectively be compared to the standard of care to evaluate whether acting on the FLARES would have reduced time-to-intervention.

NCT ID: NCT05744843 Recruiting - Clinical trials for Post Thrombotic Syndrome

Structured Exercise Versus Endovascular Reconstruction in Post Thrombotic Syndrome

SEvERe-PTS
Start date: September 5, 2023
Phase: N/A
Study type: Interventional

The goal of this pilot study and randomised control trial is to compare a smartphone-based exercise programme to deep venous stenting in patients with Post Thrombotic Syndrome. The main questions it aims to answer are: - Is exercise as effective as stenting in these patients? - What type of exercise is useful in these patients? - Can exercise be used to improve the results from surgery? Participants will be split into two groups at random. They will complete a smartphone-based exercise programme or have a deep venous stent. They will do the following tests before and after. - Exercise testing - Calf muscle strength and function tests - Ultrasound of the deep veins - Quality of life questionnaires - Clinical assessment of their disease They will be compared to healthy volunteers in the pilot study. Investigators will compare exercise to stenting to see if it improves symptoms in these patients. The pilot study will help decide how many patients are needed and what exercise tests will be used for the Randomised control trial.