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NCT ID: NCT04623450 Recruiting - Appetitive Behavior Clinical Trials

Macronutrients and Satiety in Older and Younger Adults

MACROSAT
Start date: May 5, 2019
Phase: N/A
Study type: Interventional

This study aims to compare the effect of meals high in protein, fat and carbohydrate but equal in energy and volume on energy intake, perceived appetite and gastric emptying in younger (<40 years) and older (> 65 years) people living in the United Kingdom (UK).

NCT ID: NCT04621474 Recruiting - Barrett Esophagus Clinical Trials

Non-magnified NBI in Barrett's Oesophagus Neoplasia Detection and Delineation

Start date: April 8, 2019
Phase:
Study type: Observational

Endoscopy plays a pivotal role in the management (diagnosis and treatment) of Barrett's related neoplasia. The standard endoscopy is generally done under white light, which is known to be imperfect in detecting early neoplastic lesion. Narrow band imaging (NBI) improves definition of the superficial morphology and vasculature of GI mucosa. Some studies have shown the potential to improve diagnostic accuracy and reduce the number of biopsies required for Barrett's related neoplasia. This can ultimately improve the cost-effectiveness of endoscopic surveillance. The ability to discriminate between healthy and diseased tissue also makes NBI a useful technique for the delineation of lesions to treat with endoscopic mucosal resection (EMR). However not all studies provide evidence of diagnostic utility. Also the majority of these studies have been conducted by expert endoscopists, which makes the results difficult to extend to general endoscopy practice. The limited number of Barrett's specialists in certain areas of the country validates the need for a study to investigate whether there is an objective improvement in detection and delineation of Barrett's neoplastic lesions by less experienced observers. The aim of this study was to determine the utility of non-magnified NBI in non-expert identification of lesions as compared to expert endoscopists as well as the inter-observer agreement among endoscopists on WLE and NBI.

NCT ID: NCT04620824 Recruiting - Spleen; Septic Clinical Trials

Tissue Models for Invasive Disease (TIMID)

TIMID
Start date: August 3, 2018
Phase:
Study type: Observational

The human immune response to bacterial blood stream infection (sepsis) and systemic viral infection are fairly well understood, but we lack details on the most early phases. Better knowledge of these events would be important for the prevention and treatment of severe bacterial or viral disease. From models of infection, we have data showing that bacteria replicate in a specific type of cells in the spleen from where the bacteria then seed to the blood to cause blood stream infection. In order to gain more relevant data for humans, we have developed a spleen perfusion model using pig organs. This model confirms our previous work and most importantly will now allow us to study these events in human organs. In order to move novel treatment strategies into human trials, we propose to test early events during infection using human spleens and the cells and tissues derived thereof. This research is expected to provide data on the relevance of the early events in bacterial and viral disease, in particular on the role of immune cells. The research includes work with human cells and tissue obtained from human spleens. In these settings, we will test pharmacological prevention and treatment of severe bacterial or viral infection (sepsis). The expected outcome of this work on human organs and tissue is expected to provide evidence that allows to move new treatment options into clinical trial. This study is a preclinical research project and does not involve any intervention on patients, but it involves human tissue. The source of the human splenic tissue for our research will be spleen tissue removed during radical surgery. The present application relates exclusively to the ethical approval for the use of spleen tissue removed during radical surgery and discarded. The utilisation of the spleen or splenic tissue for research purposes does not alter in any way the surgical procedures at any stage and importantly the research will involve only anonymity samples.

NCT ID: NCT04620538 Recruiting - Clinical trials for Hepatocellular Carcinoma

Volatile Organic Compounds for the Assessment of Liver Disease

VOCAL
Start date: April 1, 2021
Phase:
Study type: Observational

This study aims to determine whether a breath test could be used for early detection of hepatic fibrosis, cirrhosis or hepatocellular carcinoma. Patients who are attending for a planned liver outpatient services or investigations will be approached to provide a breath sample. Multi platform mass spectrometry analysis will be performed to establish volatile biomarkers that can discriminate between fibrosis, cirrhosis and hepatocellular carcinoma.

NCT ID: NCT04620356 Recruiting - Nocturnal Enuresis Clinical Trials

Effect of Use of DryNites Absorbent Pants on the Rate of Spontaneous Resolution of Paediatric Nocturnal Enuresis (NE)

Start date: February 21, 2020
Phase: N/A
Study type: Interventional

Children vary in the age at which they achieve night-time dryness; in almost all cases children will stop bed-wetting without any need for treatment. Use of absorbent pants for the management of nocturnal enuresis is controversial regarding the impact on the speed at which children become dry throughout the night. The aim of this study is to determine the effect of using DryNites absorbent pants in children with monosymptomatic nocturnal enuresis on the speed they become dry throughout the night compared with removing absorbent pants.

NCT ID: NCT04619732 Recruiting - Clinical trials for Transplant;Failure,Kidney

Real-time Monitoring of Kidney Grafts on Hypothermic Machine Perfusion

REMO-HYMAP
Start date: July 1, 2021
Phase: N/A
Study type: Interventional

A significant number of deceased donor kidneys donated for transplantation are not used and are thrown away due to lack of ways of checking their condition and function before the operation. This significantly reduces the number of potentially life saving transplants. The researchers wish to run a small pilot study to see if it is possible to improve the way transplant kidneys are assessed before transplantation by measuring how well they filter the blood, and how good their metabolism is. The researchers believe this new method will help transplant surgeons make better decisions about which kidneys to use. This pilot study will look at 10 kidneys obtained from older deceased donors. These kidneys are most at risk of being thrown away because of the condition of the donor they came from. At the hospital, these kidneys are usually put onto a machine which pumps cold preservation solution through them for a couple of hours. This time lets the transplant surgeons see how well or poorly the kidney responds to the flowing fluid. In this study the research team will do exactly the same, but also insert a small probe less than a millimetre in diameter into the kidney and the vein (draining blood pipe) and urine output to monitor a number of chemicals made by the kidney. The researchers believe that the changing levels of these chemicals will give the surgeons much more information than they have now. This probe is removed when the kidney is transplanted. Combining these levels with news of how well the patients recover after surgery will allow the research team to design a much larger study to get the right level of information to change the way surgeons choose kidneys and help more transplants happen in the future.

NCT ID: NCT04619030 Recruiting - Breast Cancer Clinical Trials

Augmented Reality (AR): The Future of "Patient Information Leaflets

Start date: November 30, 2020
Phase: N/A
Study type: Interventional

This project aims to assess a new type of Augmented Reality Patient Information leaflet, in order to demonstrate that it is a beneficial information resource to patients when facing the diagnosis of sarcoma, breast cancer or to explain difficult concepts such as cleft lip repair. There are no published studies on the use of AR in patient leaflets.

NCT ID: NCT04618835 Recruiting - Covid19 Clinical Trials

Physical Activity a Vital Sign? 40 Steps to Safety Test for Patients With COVID-19

Start date: January 11, 2021
Phase:
Study type: Observational

Exertional desaturation is a feature of COVID-19. The study will measure vital signs of patients discharge by practitioners in primary care, secondary care or by paramedic practitioners. Patients will then undertake a 40-steps on the spot walk followed by measurements of heart rate and oxygen saturations for up to two minutes. Association of desaturation with 30 days hospital admission and mortality will be reported.

NCT ID: NCT04617925 Recruiting - AL Amyloidosis Clinical Trials

A Study of Belantamab Mafodotin in Patients With Relapsed or Refractory AL Amyloidosis

EMN27
Start date: February 26, 2021
Phase: Phase 2
Study type: Interventional

This is an open-label, multicenter, Phase 2 study in subjects with previously treated patients with light chain (AL) amyloidosis in need for therapy. Approximately 35 subjects will receive therapy with belantamab mafodotin. Subject participation will include a Screening Phase, a Treatment Phase, a Post-Treatment Observation Phase, and a Long-term Follow-up Phase. A safety run-in will be conducted in 6 subjects treated with belantamab mafodotin for at least 1 cycle. According to the two-stage statistical design of the study, an interim analysis of efficacy will occur. If after 15 patients have been enrolled at least 3 complete or very good partial responses have been recorded, the accrual will continue until all planned patients have been enrolled

NCT ID: NCT04615871 Recruiting - Covid19 Clinical Trials

Semaglutide to Reduce Myocardial Injury in PATIents With COVID-19

SEMPATICO
Start date: September 10, 2021
Phase: Phase 2
Study type: Interventional

With the results of this study the investigators aim to identify an effective treatment that will reduce morbidity and mortality of patients with symptomatic COVID-19 infection, which would in turn reduce the burden on the healthcare system by decreasing the need for intensive care. Objectives: The main objective of this research is to determine if once weekly treatment with the GLP-1 agonist semaglutide for 4 doses will reduce cardiac as well as non-cardiac complications of COVID-19 infection. Study Plan: The study design is prospective randomized open-label blinded-evaluation (PROBE). Eligible patients with symptomatic COVID-19 infection and an enhanced risk profile as described above, who have been admitted to hospital due to symptoms of COVID-19 infection but do not as yet require critical care will be approached to participate in this study. Provided there are no exclusion criteria and the participants agree by means of documented written informed consent, The participants the participants will be randomized to receive s.c. semaglutide 0.25 mg s.c. or control immediately after randomization and then 0.5 mg s.c. at Day 7, Day 14 and Day 21. Blood will be drawn at Day 7±2 and Day 14±2 for the cardiac troponin biomarker and safety parameters. ECG will be obtained at Day 7±2 and Day 14±2. Primary outcome will be assessed on Day 28. Primary outcome measure: A composite of (1) death from any cause or (2) mechanical ventilation (invasive or non-invasive) at 28 days. Major secondary outcome measure: (1) an elevation to >99th percentile URL upper reference limit (URL) in those with a baseline cardiac troponin level ≤99th percentile URL; or 3x elevation from baseline in those with a baseline cardiac troponin >99th percentile URL; measured at 1 week (7-days) post randomization. Other major secondary outcome measure: A composite of 1. Death from any cause, mechanical ventilation or vasopressor or ECLS support at 28 days 2. an elevation to >99th percentile URL in those with a normal baseline troponin level; or 3x elevation from baseline in those with a baseline troponin; measured at 1 and 2 weeks (7±2 and 14±2 days) post randomization.