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NCT ID: NCT04763421 Completed - Clinical trials for Upper GI; Lower GI; Gynecological

A Prospective, Single-Arm Multi-Center Study of the ENSEAL X1 Curved Jaw Tissue Sealer in Select Procedures

Start date: April 22, 2021
Phase: N/A
Study type: Interventional

This prospective, single-arm, multi-center study will collect clinical data in a post-market setting by procedure group (upper gastrointestinal [GI], lower GI, and gynecological). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ENSEAL X1 Curved Jaw and Generator G11 instructions for use.

NCT ID: NCT04762914 Completed - Colon Cancer Clinical Trials

Observing the Perioperative Effects of Prehabilitation in Colorectal Cancer Patients

Start date: September 1, 2018
Phase:
Study type: Observational

Quality Improvement Project to evaluate how prehabilitation can be incorporated into our colorectal cancer pathway and assess its clinical benefits.

NCT ID: NCT04762680 Completed - COVID-19 Clinical Trials

Study of Recombinant Protein Vaccines With Adjuvant as a Primary Series and as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older

Start date: February 24, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objectives of the study are: To assess the safety profile of the study vaccines in each study intervention group. To assess the neutralizing antibody profile after primary series vaccination in SARS-CoV-2-naïve adults. To demonstrate that a booster dose of monovalent or bivalent SARS-CoV-2 vaccine given to adults previously vaccinated with an authorized/approved COVID-19 vaccine induces an immune response that is non-inferior to the response induced by a twodose priming series with the monovalent vaccine, and superior to that observed immediately before booster. The secondary objectives of the study are: To assess the neutralizing and binding antibody profiles after primary series vaccination at pre-defined time points during the study. To assess the neutralizing and binding antibody responses of booster vaccination. To describe the occurrences of laboratory-confirmed symptomatic COVID19 after primary series and booster vaccination. To describe the occurrences of serologically-confirmed SARS-CoV-2 infection after primary series vaccination.

NCT ID: NCT04762446 Completed - Cardiac Surgery Clinical Trials

Pre-operative Risk Assessment of Surgical Site Infection After Cardiac Surgery

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

Surgical site infections (SSI) are serious complications accounting for 20% of all the healthcare-associated infections and are considered the second most frequent type of hospital-acquired infection in Europe and the United States. SSI after cardiac surgery is associated with delays to patient's discharge, readmissions and re-operations; and can result in increased hospital costs for staffing, diagnostics and treatment. Risk assessment has been identified as potentially useful intervention in SSI prevention and in identifying at risk populations who may benefit from specific interventions to reduce this possible complication of cardiac surgery. However, there is currently a lack of evidence as to which risk tools are the most valid and reliable to be used in clinical practice. The investigators developed and locally validated the Barts Heart Centre Surgical Infection Risk (B-SIR) tool to include patients with various types of cardiac surgeries and found that the B-SIR tool is a better tool in predicting SSI risk compared with the existing cardiac risk tools in the study population. However, various literatures recognised that the predictive performance of a risk model tends to vary across settings, populations and periods. Hence, the investigators aim to do a multi-centre validation of the newly developed B-SIR tool and apply all the other tools (Australian Cardiac Risk Index and Brompton and Harefield Infection Score) to identify what tool performs best that can potentially be use for the UK population. Further, the outcome of the study will be beneficial to future cardiac surgery patients to assess their risk of developing SSI and help identify those patients who may benefit from specific interventions. Existing patients' data, which will be anonymised, from the participating cardiac centres will be utilised to analyse and compare the performance of each risk tools.

NCT ID: NCT04761913 Completed - Clinical trials for Paediatric Inflammatory Multisystem Syndrome Temporally Associated With SARS-Cov-2

Paediatric Inflammatory Multisystem Syndrome During COVID-19 Pandemic

Start date: June 22, 2021
Phase:
Study type: Observational

During the COVID-19 pandemic, a small minority of children have been presenting to acute paediatric services with a new syndrome, Paediatric Inflammatory Multisystem Syndrome temporally associated with SARS-Cov-2 (PIMS-TS). Children with PIMS-TS present with symptoms of inflammation caused by the immune system going into overdrive - this is likely to be in response to the virus. More severe cases involve inflammation and damage to the heart. The focus of this project is to identify children with milder forms of PIMS-TS who are at risk of progression to more severe disease. Being able to predict the disease course of PIMS-TS at an early stage is important as it will allow clinicians to decide which patients should be treated with immunosuppressants, which have been shown to reduce the severity of the illness but have side effects. Early data suggests that children with PIMS-TS have elevated biomarkers associated with an over-reaction of the body's immune system (also known as a 'cytokine storm') reaction. This study will explore whether children presenting with milder PIMS-TS have elevated 'cytokine storm' blood profiles and whether these profiles differ between children who continue to have a mild disease course compared to those who develop severe disease.

NCT ID: NCT04761575 Completed - Diet Habit Clinical Trials

Validation of the eNutri Food Frequency Questionnaire for Adults Aged 65 y and Older

eNutriFFQ65+
Start date: April 21, 2021
Phase:
Study type: Observational

The aim is to determine whether the eNutri web application can effectively estimate the dietary intake of a UK older population. The eNutri FFQ65+ study will validate the eNutri online food frequency questionnaire (FFQ) using 100 adults aged 65+ years. The FFQ will be validated against an online 24-hour dietary recall system (Intake24) and its reproducibility will be evaluated by the completion of two FFQs within a 14-day interval. In addition, all participants will also be asked to provide dried blood spot (DBS) samples which will be analysed for key biomarkers of nutritional intake and health. Biomarker results will be compared to FFQ results to further validate the eNutri FFQ.

NCT ID: NCT04761198 Completed - Clinical trials for Advanced Solid Tumor

A Study of Etigilimab and Nivolumab in Subjects With Locally Advanced or Metastatic Tumors.

Start date: March 23, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, phase 1b/2, multicenter study designed to evaluate the efficacy, safety, tolerability, PK, and pharmacodynamics of etigilimab in combination with nivolumab in subjects with locally advanced or metastatic solid tumors. Subjects will be assigned to receive etigilimab (every 2 weeks) in combination with nivolumab (240 mg every 2 weeks).

NCT ID: NCT04761081 Completed - Inflammation Clinical Trials

Is Physical Activity, Obesity, and Ethnicity Associated With the Tethering and Migration of Pro-inflammatory Monocytes?

Start date: March 1, 2021
Phase:
Study type: Observational

Being south Asian or centrally obese may be associated with an increased risk of inflammation. The investigators are seeking to investigate whether this is the case by recruiting white European and south Asian men who are lean or have central obesity. Further, the investigators wish to investigate whether physical activity influences the associations.

NCT ID: NCT04760886 Completed - Paediatric Trauma Clinical Trials

Paediatric Rural vs Urban Trauma

Start date: April 1, 2019
Phase:
Study type: Observational

Retrospective cohort study examining paediatric trauma admission over 1 year in a rural hospital vs urban centre

NCT ID: NCT04759807 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

A Phase 1b Study of PUR1800 in Patients With COPD

Start date: January 4, 2021
Phase: Phase 1
Study type: Interventional

This is a randomised, placebo-controlled, double-blind 3-way crossover study in which PUR1800, or placebo is dosed daily for 14 consecutive days in adult subjects with stable COPD over three discrete TPs. Subjects will be randomised to one of the following 3 treatment sequences: Sequence Period 1 Period 2 Period 3 1. Placebo PUR1800 250 μg PUR1800 500 μg 2. PUR1800 250 μg Placebo PUR1800 500 μg 3. PUR1800 250 μg PUR1800 500 μg Placebo Since this is the first study in humans in which the iSPERSE formulation is being administered, the 3 treatment sequences are designed in order to ensure that the lower dose of PUR1800 (250 μg) is administered prior to the administration of the higher dose of PUR1800 (500 μg).