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NCT ID: NCT06159218 Recruiting - Clinical trials for Eosinophilic Esophagitis

Eosinophilic Oesophagitis Assessment With String Testing

EoEAST
Start date: November 9, 2022
Phase: N/A
Study type: Interventional

Eosinophilic oesophagitis (EoE) is an inflammatory condition of the oesophagus (food pipe) that can lead to difficulty swallowing and to food to getting stuck and has become increasingly common over the past 40 years. EoE is triggered by a protein in the diet but alterations to the types of bacteria (microbiome) in the oesophagus may also be involved. EoE is diagnosed with gastroscopy (a thin camera test via the mouth) where 6 tiny samples (biopsies) are taken. Treatment is either with removing food groups from the diet or medications including steroids (budesonide) or a proton pump inhibitor (PPI, omeprazole). The aim is to improve symptoms and to stop scar tissue forming that can cause food to get stuck. Patients with EoE will need to undergo many gastroscopies over their life, which even with sedation can be a daunting experience. There has been research into less invasive tests and two previous studies have shown that a thin swallowed string may be able to detect substances (biomarkers) that indicate how severe the EoE is. These studies were small and it is not known how the biomarkers change with different treatments or how well they relate to symptoms and findings with endoscopy. In this study the investigators will ask adults with EoE to swallow a thin string made of rayon for 30 minutes, with one end taped to the cheek, which the investigators will analyse for biomarkers and bacteria, on the same day as their routine gastroscopy and also perform a symptom survey. The investigators will also take an extra 2 biopsies to analyse the nerves which may explain why some patients have more symptoms than others. The investigators will repeat the string test on their next endoscopy, to assess what the changes have been in response to their treatments. These findings may improve understanding on how to monitor EoE in less invasive ways in future.

NCT ID: NCT06158555 Recruiting - Critically Ill Clinical Trials

Targeted Perfusion Based Haemodynamic Management in Critically Ill Patients Using Urethral Perfusion

TARGET UP
Start date: April 1, 2023
Phase: N/A
Study type: Interventional

To assess the safety and feasibility of the IKORUS device in critically ill patients and to gather exploratory data on haemodynamic coherence

NCT ID: NCT06157710 Recruiting - Procrastination Clinical Trials

Randomised Controlled Trial of a Digital Programme for Procrastination in UK University Students

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

The aim of this study is to evaluate the effect of an 8-week self-directed internet based CBT intervention on various psychological outcomes for young students struggling with procrastination in the UK. The psychological outcomes consist of motivation, depressive symptoms, impulsivity and anxiety. More specifically, the study aims to compare the effect of the intervention vs waitlist control at 8 weeks on primary and secondary outcomes. Additionally, the study aims to explore whether changes in primary and secondary outcomes as the result of the intervention are mediated or moderated by key intervention processes.

NCT ID: NCT06157255 Completed - Asthma Clinical Trials

An ADME Study of [14C]AZD4604 and the Absolute Bioavailability of AZD4604

Start date: February 16, 2024
Phase: Phase 1
Study type: Interventional

The Sponsor is developing the test medicine, AZD4604, as a potential treatment for asthma. Asthma is a common lung condition caused by inflammation (swelling) of the breathing tubes that carry air in and out of the lungs, causing occasional breathing difficulties such as wheezing, shortness of breath, chest tightness and cough. This study in healthy volunteers will explore the following questions. - Does the test medicine cause any important side effects? - What are the blood levels of the test medicine and how quickly does the body get rid of it? - How much of the test medicine gets into the bloodstream? - How does the body break down and get rid of the test medicine? This study will take place at one non-NHS site in Nottingham, and plans to enrol 8 healthy men and women aged 18-65 years who will be involved in both parts of the study.

NCT ID: NCT06156904 Recruiting - Clinical trials for Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic Injury

OSsIRIS Study - A Post-market Clinical Follow-up Investigation.

OSsIRIS
Start date: January 31, 2024
Phase:
Study type: Observational

This is a prospective, observational, non-randomized, multicenter, international post-market clinical follow-up investigation aiming to confirm the performance and safety of the bone substitute b.Bone after implantation in patients in isolation or as a graft expander requiring bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities. Patients enrolled in this clinical investigation will undergo orthopaedic surgery with b.Bone as recommended by the specialist and according to orthopaedic standard procedures. Patients will be evaluated preoperatively and at different time points after the surgery according to the standard practice of the sites. The expected schedule is at month 3, month 6 and month 12. Patients who require longer follow-up and could be subjected to metalwork removal will be evaluated up to 24 months. All safety data will be collected from patient inclusion to the end of the clinical investigation. All study visits will coincide with any of the patient's routine clinical visits, without interfering with the investigator's clinical duties. It is planned to enroll 135-193 patients from approximately 15 EU and UK sites.

NCT ID: NCT06156618 Enrolling by invitation - Dental Erosion Clinical Trials

The Effect of Nitrate Supplement on the Oral Microbiome and Saliva in Dental Erosion

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

Dental erosion happens when teeth lose some of their parts because of acid from the things people eat and/or drink or even from their stomach. It can make their teeth hurt and become sensitive. The mouth has a protective shield called salivary pellicle that helps, and there are some special bacteria called Nitrate-reducing bacteria (NRB) that can be good for the mouth and heart. Eating some fruits and vegetables or drinking beetroot can make these bacteria thrive, which might help the heart and blood pressure. This study wants to see how drinking beetroot juice affects these good bacteria in your mouth for people with healthy teeth and those with erosion. This study aims to find out if drinking beetroot juice can change the saliva and bacteria in the mouth for the better, in people with both healthy teeth and those with dental erosion. The proposed study is part of a PhD educational project and will be a double blind, randomised design, crossover trial for the effect of nitrate supplement on healthy control and people with dental erosion (PwDE). This study aims to explore the effect of nitrate supplement on oral microbiome in WMS and SP and its impact on blood pressure and arterial stiffness in healthy controls and PwDE.

NCT ID: NCT06156462 Completed - Pneumonia Clinical Trials

A Study Evaluating the Use of ResAppDx v2.0 as an Aid to Diagnose Respiratory Disease in Adolescent and Adult Patients in an Emergency Department

Start date: January 1, 2024
Phase:
Study type: Observational

Aim is to to demonstrate that the ResAppDx v2.0 algorithms provide an accurate diagnosis of respiratory disease in the study's clinical setting compared to a clinical adjudication committee's (CAC) diagnosis; and to establish a baseline for the resource use and cost of current care pathways for respiratory disease diagnosis in an emergency department. Eligible subjects will be consented/enrolled and their subject reported signs/symptoms of respiratory disease will be recorded in the study electronic case report form (eCRF). The enrolled subject's cough sounds will be captured (5 cough sounds are required) using the ResAppDx v2.0 Investigational Device (ID) software installed on a study smartphone; cough sounds may be voluntary and/or involuntary/spontaneous. As this is an observational study the treating team will be blinded to the ResAppDx v2.0 diagnoses. Additional medical information will be collected from the treating team, from the subject and from the subject's medical record. No follow-up/subsequent visits with the subject will be required by the study. As an efficacy comparator, a clinical adjudication committee (CAC) will determine the final clinical diagnosis using the disease case definitions, eCRF data and the subject's medical record. Information on time and scope of tests and consults ordered by the treating team will be recorded to set a baseline for resource use and cost of current standard of care treatment/assessment procedures. This data will allow future health economics analyses to be performed. The blinded ResAppDx v2.0 diagnoses will be unblinded after database lock and sensitivity and specificity will be calculated for the ResAppDx v2.0 diagnoses compared to agreement with the CAC's final clinical diagnoses.

NCT ID: NCT06156436 Completed - Pneumonia Clinical Trials

A Study Evaluating the Use of ResAppDx v2.0 as an Aid to Diagnose Respiratory Disease in Paediatric Patients in an Emergency Department

Start date: January 1, 2024
Phase:
Study type: Observational

Aim of study is to demonstrate that the ResAppDx v2.0 algorithms provide an accurate diagnosis of paediatric respiratory disease in the study's clinical setting compared to a Clinical Adjudication Committee's (CAC) diagnosis; and to establish a baseline for the resource use and cost of current care pathways for paediatric respiratory disease diagnosis in an emergency department. Eligible subjects/parents will be assented/consented, enrolled and their subject reported signs/symptoms of respiratory disease will be recorded in the study electronic case report form (eCRF).The enrolled subject's cough sounds will be captured (5 cough sounds are required) using the ResAppDx v2.0 Investigational Device (ID) software installed on a study smartphone; cough sounds may be voluntary and/or involuntary/spontaneous. As this is an observational study the treating team will be blinded to the ResAppDx v2.0diagnoses. Additional medical information will be collected from the treating team, from the subject/parent and from the subject's medical record. No follow-up/subsequent visits with the subject will be required by the study. As an efficacy comparator, a CAC will determine the final clinical diagnosis for each enrolled subject using the disease case definitions, eCRF data, the subject's medical record and cough sound recordings.Information on time and scope of tests and consults ordered by the treating team will be recorded to set a baseline for resource use and cost and time of current standard of care treatment/assessment procedures. This data will allow future health economics analyses to be performed.The blinded ResAppDx v2.0diagnoses will be unblinded after database lock and sensitivity and specificity will be calculated for the ResAppDx v2.0diagnoses compared to agreement with the CAC's final clinical diagnoses for this cohort.

NCT ID: NCT06156046 Recruiting - Bee Sting Clinical Trials

Tolerance in Beekeepers

Start date: January 22, 2024
Phase:
Study type: Observational

Beekeepers experience multiple bee stings each year. Many of these beekeepers (25-60%) become sensitized to bee venom through the production of specific antibodies that target the bee venom. Although these antibodies are important in the triggering of an allergic reaction only a small number of sensitised beekeepers go on to have an allergic reaction with symptoms away from the site of the sting. These reactions can be severe and are known as anaphylactic reactions. The study investigates why some beekeepers develop severe allergic symptoms after bee stings while others do not. This study will explore factors in the blood that protect sensitised individuals from having anaphylactic reactions - meaning that despite being sensitised they are tolerant and do not react to subsequent stings.

NCT ID: NCT06154837 Not yet recruiting - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease

Start date: November 27, 2023
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to investigate the safety and tolerability of ascending doses of GSK3862995B following single dose in healthy participants and repeat doses in participants with Chronic obstructive pulmonary disease (COPD).