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NCT ID: NCT05225909 Not yet recruiting - Infection Clinical Trials

aScope Single Use ERCP Study- ASSURE Study

ASSURE
Start date: April 1, 2022
Phase:
Study type: Observational

Patients undergo ERCP procedure (Endoscopic procedure with the help of x-rays) for a variety of reasons such as common bile duct (CBD)stones, bile duct obstruction secondary to bile duct narrowing (Strictures) and for bile leak. The incidence of infection post-ERCP is around one in 200. There are some group of patients where this risk is significantly increased. In this high risk group, the risk increases from 1 in 75 to in some diseases 1 in 15 (Described in PIS). There are some reports that some of the infection may be contributed by contamination of bacteria in the scope. This happens even after diligently sterilizing the scope. A multi-centre study reported that the risk of contamination is as high as 39% but what we do not know is how many resulted in bacterial infection. The investigators do not know what percentage of infection is secondary to the above. The new single use duodenoscope (aScope, Ambu Ltd) has been introduced in to the market to minimise the risk of post ERCP infection. It is CE marked but the evidence for performance of the aScope is limited. The investigators want to assess the performance of the scope simultaneously in multiple different hospitals. In addition, the investigators also want to assess the cost consequence to the NHS for using the above scope. Hence, the investigators want to assess the performance of the scope in the high risk groups for infection.

NCT ID: NCT05223140 Not yet recruiting - Perinatal Death Clinical Trials

Optimal Time Intervals for Vaginal Breech Births: A Multi-Site Case-Control Study

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

This study uses a case-control design to test the hypotheses that avoidable delay in late second stage and premature cord clamping are associated with admission to the neonatal unit and/or early perinatal death following vaginal breech births. We aim to determine the predictive value of: 1) adherence/non-adherence to the Physiological Breech Birth Algorithm; and 2) premature cord clamping (<1 minute following birth) for admission to the neonatal unit and/or perinatal death following vaginal breech births. The secondary objectives are to: 1) test all variables for a single-factor association with the primary outcome; and 2) test the predictive values of associated variables using linear regression; in order to 3) explore other factors contributing to adverse outcomes in vaginal breech births.

NCT ID: NCT05220436 Not yet recruiting - Mental Health Issue Clinical Trials

DISCOVER Workshop Programme for Care Experienced Young People

Start date: February 2022
Phase: N/A
Study type: Interventional

The NHS DISCOVER team has secured 2-year funding from the Maudsley Charity to tailor the workshop programme the investigators deliver in school Sixth Forms to meet the specific needs of Care Experienced young people. The investigators are planning to complete a pilot of this adapted workshop programme within Medway Children's Social Services to explore its feasibility, accessibility, acceptability and early-stage efficacy within this population of adolescents. Investigators from the DISCOVER team will recruit young people aged 16-19yrs who are currently known to the Medway Care Leavers 16+ teams. The study will be conducted at Medway Local Authority sites, with the option of some stages being completed remotely via Microsoft Teams if needed in the context of the ongoing COVID-19 pandemic.

NCT ID: NCT05217485 Not yet recruiting - Atrial Fibrillation Clinical Trials

Continuous Ambulatory Cardiac Monitoring for Recurrent Atrial Fibrillation After Sepsis

CAMS-AF
Start date: March 2022
Phase: N/A
Study type: Interventional

To detect atrial fibrillation after infection.

NCT ID: NCT05215756 Not yet recruiting - Healthy Volunteer Clinical Trials

The Accuracy and Efficacy of AI-driven tVNS Algorithm

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Pain, including somatic and visceral pain, is a common symptom. Persistent pain can lead to repetitive visits to hospitals and can limit patients' daily activities, which can result in tremendous medical cost and lower quality of life. For example, the prevalence rates of 25% are reported only for abdominal pain among adults (3), and it costs $10.2 billion each year in the US. Pain is usually treated according to the World Health Organisation (WHO) 3 steps analgesic ladder. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are mainly used in step 1, which can cause serious side effects such as GI bleeding, renal failure and cardiovascular disease. In step 2 & 3, opioids are used and are also associated with serious side effects (e.g., psychological addiction, dizziness, nausea, vomiting, constipation, physical dependence, tolerance, and respiratory depression). Therefore, a new effective non-pharmacological treatment is beneficial for patients. One such method is transcutaneous vagal nerve stimulation (tVNS). The auricular or cervical branch of the vagal nerve runs just under the skin and can be electrically stimulated through the skin by tVNS devices, which have shown the analgesic effects on various pain conditions. The autonomic activity, including parasympathetic tone, can be estimated from the beat to beat intervals in the electrocardiogram, which is called heart rate variability (HRV). To date, we have shown that visceral and somatic pain triggered the autonomic response with the change in HRV, and HRV could be a biomarker of pain. We hypothesised that the development of pain, including somatic pain and visceral pain, could be predicted by analysing heart rate pattern by artificial intelligence (AI). In this proof of concept study, we evaluate the detection rate of pain by the AI analysis of heart rate pattern. We also evaluate the effect of tVNS on the pain threshold.

NCT ID: NCT05178563 Not yet recruiting - Inflammation Clinical Trials

Mechanisms of Acute Inflammation Following Periodontal Treatment

MANTRA
Start date: September 1, 2024
Phase: N/A
Study type: Interventional

Periodontitis (gum disease) is a chronic inflammatory disease linked to a imbalance of oral microbiome. The most usual treatment involves removal of sub and supra-gingival plaque and calculus otherwise known as Non-surgical periodontal therapy (NSPT). Ample evidence now indicates that Periodontitis and NSPT are linked to both local and systemic inflammation. This in turn also explains the association between periodontitis and a number of systemic diseases including cardiovascular diseases. Vascular endothelium (the innermost lining of blood vessels) exerts protective, anti-inflammatory and anti-clotting functions. As the endothelium ages, and is exposed to the damaging effects of traditional cardiovascular risk factors such as elevated blood pressure, serum cholesterol, glucose and cigarette smoking; these protective properties appear diminished, leading to a state of endothelial dysfunction (ED). Understanding the mechanisms of ED in humans could lead to new therapeutic and/or preventive strategies of CV diseases. Sufficient evidence now suggests that periodontitis and its treatment (removal of sub and supra-gingival plaque and calculus-periodontal therapy) are linked to endothelial dysfunction. Studies have extensively characterized the time-course of a single session of non surgical periodontal treatment (IPT) associated with a one week acute inflammatory response. This substantial inflammatory response is also associated with ED assessed by flow-mediated dilation (FMD) of the brachial artery at 24 hrs. Photodynamic therapy (PDT) helps kill the local pathogens, thus preventing their systemic dissemination; which may ultimately reduce the systemic host inflammatory response generated.

NCT ID: NCT05161299 Not yet recruiting - Surgery Clinical Trials

CovidSurg-3: Outcomes of Surgery in COVID-19 Infection

CovidSurg-3
Start date: December 13, 2021
Phase:
Study type: Observational

COVID-19 has significant detrimental impacts on surgical systems and patient outcomes. CovidSurg has provided the best available evidence to guide delivery of safe surgery during the pandemic. However, CovidSurg data were collected in 2020 when the wildtype SARS-CoV-2 virus was dominant, and therefore there is a need to for renewed rapid data to guide global practice during Omicron COVID-19 waves. CovidSurg-3 is an extension to CovidSurg and was initiated in response to the emergence of the Omicron variant. CovidSurg-3 has two separate components: - Patient-level component: Collection of outcome data for patients with peri-operative SARS-CoV-2. - Hospital-level component: Collection of aggregated case-mix data. Hospitals in countries with low community SARS-CoV-2 infection rates can contribute towards this component.

NCT ID: NCT05140785 Not yet recruiting - Glioma Clinical Trials

Mapping Molecular Markers of Brain Tumour Activity Using MRI

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

Regions of tumour whose cells (the building blocks of the tumour) are actively multiplying generate a particular type of molecular footprint (consisting of various types of proteins) compared to tumours whose cells are relatively stable. In addition, tumour cells begin to develop a network of blood vessels that not only supply them with nutrients and oxygen, but also provide a pathway for tumour spread. There is a critical period between when these proteins and blood vessel network develops, and when tumour growth is visible using current MRI scanning. Therefore, making the process of tumour activity visible on clinical MRI scans is an important step in demonstrating and anticipating tumour growth. The study aims to do this by utilising various novel and non-invasive MRI techniques. This project is a collaboration between research groups at King's College London (UK) and the Erasmus University Rotterdam (The Netherlands). The novel MRI techniques will be incorporated into the pre-surgical imaging protocol of patients with primary brain tumours. The images will be compared with molecular measurements made from biopsies taken during surgery to show that they accurately map where activity is high and low within the tumour.

NCT ID: NCT05133206 Not yet recruiting - Clinical trials for Coronary Artery Disease

Fasting or Non-fasting Before Cardiac Catheterization

FORCE
Start date: March 2022
Phase: N/A
Study type: Interventional

The investigators hypothesise that there is no increased risk of peri-procedural complications, accompanied by improved patient satisfaction among patients allowed to eat up to the point of coronary angiography/angioplasty compared to patients, kept nil by mouth. Therefore, the investigators aim to change the practice of fasting for all patients before elective catheterization procedures. Consented patients will be randomised in a 1:1 ratio to either fasting (standard hospital fasting policy) or non-fasting (allowed to eat and drink freely up to the point of transfer to the Catheter Laboratory). Primary End Point will composite peri-procedural nausea, vomiting, pre-procedural hypotension, pre-procedural hypoglycemia, intra-procedural emergency endotracheal intubation and aspiration pneumonia. This will be calculated as the number of patients experiencing at least one event. Secondary end-points will include patient satisfaction questionnaire and the individual outcomes assessed in the primary end point.

NCT ID: NCT05128188 Not yet recruiting - Clinical trials for End Stage Renal Disease on Dialysis

SASH: Sodium Accumulation Study In Haemodialysis

SASH
Start date: January 15, 2022
Phase:
Study type: Observational

Haemodialysis (HD) sustains life in patients with end-stage kidney disease (ESKD) but is associated with a marked increase in incidence of cardiovascular disease (CVD) and high annual mortality rates. The pathogenesis of CVD in patients on HD is multifactorial and complex but hypertension is thought to be a major contributing factor. Sodium balance is normally regulated by the kidneys in health but has to be achieved by sodium removal during HD for those with ESKD. Recent evidence suggests that accumulation of sodium in the skin and / or muscle may be a critical factor impacting the development of hypertension and CVD in patients with ESKD and non-invasive methods are therefore required to study tissue sodium accumulation in this context. This study aims to determine the change in skin and muscle sodium content in patients undergoing haemodialysis. Participants will have a single haemodialysis session, and undergo two MRI scans (one prior to and one following dialysis).