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NCT ID: NCT05913219 Recruiting - Stroke Clinical Trials

Smart Wearable Device (gaitQ): Walk Better Project

Start date: September 15, 2023
Phase:
Study type: Observational

This study will be underpinned by the new MRC guidelines for developing a complex intervention with a participatory design methodology that uses evidence-based research and behaviour change models alongside COSMIN methodology for validating a measure. Research question: To what extent does gaitQ's smart cueing system improve people with long-term conditions including people with Parkinson's (PwP's) gait? Is it effective in the everyday environment? What factors are associated with good mobility? What is the impact of cueing on healthy people? Aims and objectives: To finalise the product development and evaluation comprising (1) algorithm refinement and (2) monitoring system development. To evaluate the reliability, concurrent validity, and potential for efficacy, as determined by responsiveness in response to the gaitQ product using gait data collected in laboratory environments. To prepare for market entry and NHS adoption: early economic modelling, pricing, marketing strategies, and early adopter partnerships. Design: Participatory design with testing for validity, reliability and responsiveness Participants: This will involve healthy people and people with long-term conditions affecting their movement, including people with Parkinson's [PwP]. Additional patient groups will be investigated, including stroke, and people with hip/knee injuries. Methods The Researchers will collect movement data using the gaitQ system, which monitors and cues, to both collect data and cue in the lab environment and investigate the reliability of the measure, concurrent validity of the metric to gold standard gait capture, the responsiveness of measures to the cueing system and usability for participants and clinical teams. To determine reliability, 60 participants will be invited to repeat testing on a second visit. Researchers will describe participants' conditions using standard questionnaires and their mobility and functioning. This study will be underpinned by the new MRC guidelines for developing a complex intervention with a participatory design methodology that uses evidence-based research and behaviour change models to identify intrinsic and extrinsic factors that contribute to a given outcome in a specific population.

NCT ID: NCT05912517 Recruiting - Clinical trials for Hemolytic Disease of the Fetus and Newborn

A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

AZALEA
Start date: December 20, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effectiveness of nipocalimab when compared to placebo in decreasing the risk of fetal anemia (a condition in which a baby's red blood cell volume falls below normal levels while the baby is developing in the womb) with live neonates in pregnant participants at risk for severe hemolytic disease of the fetus and newborn.

NCT ID: NCT05912179 Recruiting - Liver Diseases Clinical Trials

Prospective Single Centre Observational Study to Compare the Diagnostic Yield of Different Modalities of Liver Biopsy

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

The goal of this study is to learn about endoscopic ultrasound(EUS) guided liver biopsy and how this compares to traditional methods of obtaining liver biopsy samples, in patients with liver disease. The main questions it aims to answer are: 1. is EUS liver biopsy equally as good as other types of techniques 2. are there any advantages to using the EUS technique to obtain liver biopsies Researchers will compare data from patients who have had a liver biopsy with a traditional technique with those who have undergone EUS-guided biopsy.

NCT ID: NCT05911347 Recruiting - Clinical trials for Irritable Bowel Syndrome

Effect of Modified Cellulose on Colonic Fermentation of Inulin

COCOA2
Start date: May 9, 2023
Phase: N/A
Study type: Interventional

A 3-way randomised cross-over study to test the hypothesis that combining either psyllium or methylcellulose to form a gel incorporating inulin will reduce gas production as compared to inulin given with a placebo, maltodextrin. Subjects will attend on 3 separate days separated by a minimum of one week an consume one of 3 test meals. Serial breath samples with be obtained to measure hydrogen and methane over the next 24 hours. Primary endpoint: Area under curve (AUC) from time 0-6 hours (AUC 0-6) of breath hydrogen (ppm.hour) after treatment intake. We will also assess whole gut transit time using the blue muffin and correlate breath hydrogen production with in vitro fermentation results.

NCT ID: NCT05910112 Recruiting - Pleural Effusion Clinical Trials

Prospective Data Collection on Clinical, Radiological and Patient Reported Outcomes After Pleural Intervention

PROSPECT
Start date: September 1, 2020
Phase:
Study type: Observational

The PROSPECT study aims to look at the number of problems or side effects which occur after patients have had a procedure completed to remove fluid or air from the space between the lung and the chest wall. Other information will also be collected to see whether anything else affects which patients have problems after the procedure such as bleeding or infection. This study will also investigate whether it is possible to find out which patients are likely to feel a lot better after the procedure. Not all patients feel significantly better but it is not clear why this is. There are a number of different reasons patients may not feel better, for example if the lung is not able to fully re-expand. The study aims to look at whether it is possible to predict these problems before the procedure using ultrasound. If it is possible to find the answers to some of these questions it might be possible to prevent patients undergoing treatments which are not likely to benefit them. The study will use information already collected as part of clinical care, as well as questionnaires from patients receiving care at a variety of centres. The different features of these centres will also be considered in analysis.

NCT ID: NCT05909904 Recruiting - Clinical trials for Head and Neck Cancer

Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma

Start date: July 21, 2023
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the efficacy and safety of tislelizumab and tislelizumab in combination with investigational agent(s) in first-line recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

NCT ID: NCT05909020 Recruiting - Clinical trials for Head and Neck Cancer

EVEREST-HN 1: EVolution of a patiEnt-REported Symptom-based Risk Stratification sySTem

Start date: March 17, 2023
Phase:
Study type: Observational

Can a patient-reported symptom-based risk stratification system improve the suspected head and neck cancer (HNC) pathway? Our methodology includes six interlinked work packages to deliver our aim, with EVEREST-HN 1 encompassing the first of these and seeking to optimise a patient-reported symptom inventory for HNC and outline requirement specification for the SYmptom iNput Clinical (SYNC) system.

NCT ID: NCT05908786 Recruiting - Clinical trials for Carcinoma, Hepatocellular

A Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients With Surgically Resectable Hepatocellular Carcinoma

Start date: December 5, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase Ib/II, open-label, multicenter, randomized platform study to evaluate neoadjuvant immunotherapy combinations in participants with resectable HCC. The study is designed with the flexibility to open new treatment arms as new agents become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population.

NCT ID: NCT05908474 Recruiting - Healthy Clinical Trials

The Effects of io Fibrewater Supplementation on Gut Health, Immunity and Metabolism in Overweight Adults

IOFW
Start date: April 25, 2023
Phase: N/A
Study type: Interventional

Despite availability of many alternative and conventional weight loss options, the prevalence of obesity increased from 15% in 1993 to 27 in 2015. In 2015, 68% of men and 58% of women in the UK were overweight or obese. Overweight and obesity increase the risk for comorbidities such as hypertension, dyslipidaemia, cardiovascular disease, type 2 diabetes and certain cancers. Hormonal regulation of appetite has been shown to influence body weight and body fat . Gut hormones secreted from the intestine are particularly important both in the regulation of appetite and blood glucose level, and recently the gut hormone Glucagon Like Peptide -1 (GLP-1) has been successfully targeted to treat both type 2 diabetes and obesity. Targeting the gut microbiota has been shown to influence gut hormones, in a way is likely to help treat or prevent obesity and type 2 diabetes. In past decades, considerable attention has been given to investigating the new applications of natural prebiotic polymers on gut microbiota composition. Moreover, recent trend in research indicates a bidirectional communication between the gut microbiota and the central nervous system through the microbiome-gut-brain axis (MGBA). Therefore an in vivo intervention feeding study is proposed performed with a variety of psychological and nutritional tests aiming to compare io fibrewater with an equivalent placebo control water and also highlight both cognitive function, emotional bias and response to appetite and also metabolic profiles of the gut microbiota.

NCT ID: NCT05907954 Recruiting - Uveal Melanoma Clinical Trials

(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma

Start date: July 3, 2023
Phase: Phase 2
Study type: Interventional

Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma