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NCT ID: NCT05965921 Recruiting - Barrett's Esophagus Clinical Trials

Real-life Prospective Evaluation of Computer-aided Detection (CAD) of Barrett's Neoplasia

MetaVision
Start date: July 26, 2023
Phase:
Study type: Observational [Patient Registry]

Barrett's oesophagus is a pre-cancerous condition in which normal cells in the lining of gullet undergo cell changes and this increases the risk of developing adenocarcinoma (a type of cancer) of the gullet. This type of cancer is the 5th most common type of cancer in the UK. To minimise this risk of developing cancer, patients with Barret's oesophagus have regular gastroscopy (a small camera at the tip of the slim tube) every 2-5 years to detect early cancer cell changes. During the procedure, the whole of oesophagus is carefully inspected, and small tissue samples (biopsies) are taken from visible abnormal area within Barrett's oesophagus and sent to the lab to check for cell changes. This is called targeted biopsies. As the endoscopist cannot always tell during gastroscopy where cells are changing, biopsies from each quarter of the gullet (called quadrantic biopsies) are also taken to reduce the risk of pre-cancerous cells being missed. However, this process is time consuming and expensive as numerous biopsies are required. Recently, there has been a huge development in artificial intelligence (AI). One of these developments is the aid of computer to detect (called computer-aided detection - CAD) the abnormal cell changes within Barrett's during gastroscopy. This system has recently been trained and tested on videos and photos to prove that its performance is as good as expert endoscopists. This system has been already approved to use in the UK. However, this system needs to be tested further and incorporated into real life use to prove that the CAD is useful in detecting cell changes during gastroscopy for targeted biopsies and therefore, the random biopsies can be avoided. A sample of patients with Barrett's oesophagus will be invited to participate in this study. Participants will have a gastroscopy as part of their usual care for Barrett's oesophagus. Endoscopist will inspect Barrett's oesophagus using AI and will take both targeted biopsies if clinically deemed appropriate along with quadrantic biopsies. Participants will continue to receive usual care and no additional follow up or procedures will be required as part of the study.

NCT ID: NCT05965479 Recruiting - Clinical trials for Gastrooesophageal Cancer

Developing ctDNA Guided Adjuvant Therapy for Gastrooesophageal Cancer

DECIPHER
Start date: April 10, 2024
Phase: Phase 2
Study type: Interventional

Multicentre, single arm, open label UK phase II trial to assess the efficacy of trastuzumab deruxtecan in reducing micrometastatic disease burden in HER2 positive GOA patients who are ctDNA positive after chemotherapy and surgery. 25 patients will be recruited from approximately 15 NHS secondary care sites.

NCT ID: NCT05965427 Recruiting - Monkeypox Clinical Trials

Morbidity, Mortality And Risk Factors of Mpox in HIV Negative High Risk Sexual Health Clinic Attenders and People Living With HIV

MASH 1
Start date: December 1, 2023
Phase:
Study type: Observational

This data collection study aims to describe and compare the outcomes of Mpox on people living with HIV (PLHIV) and HIV-negative individuals who are on pre-exposure prophylaxis (PrEP). The study also aims to identify risk factors for specific Mpox outcomes.

NCT ID: NCT05965089 Recruiting - Healthy Volunteers Clinical Trials

A First in Human Study of AX-202 in Healthy Subjects and Patients With Psoriasis.

Start date: April 25, 2023
Phase: Phase 1
Study type: Interventional

The first-in-human study will be performed in healthy volunteers and patients with a chronic inflammatory skin disease. The primary objective is to evaluate the safety, tolerability and pharmacokinetics of increasing doses of AX-202 infusion.

NCT ID: NCT05964491 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Video Resources for People With Chronic Obstructive Pulmonary Disease: An Exploratory Qualitative Study

Start date: October 20, 2022
Phase:
Study type: Observational

The IPCRG & Teesside University have searched the internet for video self management content for people living with COPD. Resources were reviewed by healthcare professionals and developed into a digital magazine to support people living with chronic obstructive Pulmonary Disease (COPD). The aims of this study are to 1. evaluate the use of the digital magazine format with video self-management content from an end user perspective, including 1. what characteristics a good video resource should have 2. what information is important to people with COPD to include in videos and digital magazines, 3. the useability of a digital magazine format 2. Explore the opinions, experiences and preferences of people living with COPD for accessing online self-management content including barriers and facilitators for accessing online self-management video content

NCT ID: NCT05964335 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

Cough Reduction in IPF With Nalbuphine ER

CORAL
Start date: February 6, 2024
Phase: Phase 2
Study type: Interventional

This is a multi-center randomized, double-blind, placebo-controlled, parallel, 4-arm study of nalbuphine ER (NAL ER). After meeting eligibility during the Screening Period, subjects will be randomized (1:1:1:1) to one of four treatment arms. - Arm 1: Placebo - Arm 2: 27 mg nalbuphine ER - Arm 3: 54 mg nalbuphine ER - Arm 4: 108 mg nalbuphine ER Each arm will be titrated to their fixed dose during the blinded 2-week Titration period followed by the 4-week Fixed Dose Period for a total of 6 weeks on drug.

NCT ID: NCT05964140 Not yet recruiting - Mandible Fracture Clinical Trials

The MANTRA Trial (MANdibular TRauma and Antibiotic Use)

MANTRA
Start date: August 1, 2024
Phase: Phase 3
Study type: Interventional

1. FULL TITLE OF THE PROJECT Should we use post-operative antibiotics following surgery for patients with mandible fractures? The MANTRA trial (MANdibular TRauma and Antibiotic use) 2. SUMMARY OF RESEARCH (ABSTRACT) Research Question: Are post-operative antibiotics required following surgery for patients with mandible fractures? Background: Mandible fractures are the commonest facial fractures needing surgery and account for a significant percentage of the acute workload in Oral & Maxillofacial Surgery (OMFS) units. The UK records over 6000 new cases per year. Patients having surgery for mandible fractures have a theoretical risk of developing surgical site infection, due to the proximity of the fracture lines to the oral cavity microbes and the presence of foreign body (titanium fixation miniplates). For this reason, clinicians often prescribe antibiotics after surgery, to reduce the risk of infection. Previous systematic reviews and a multicentre cohort study performed by this team, revealed significant clinical variation in post-operative antibiotic prescription amongst UK OMFS clinicians and the presence of clinical equipoise. Antibiotic overuse can lead to antibiotic resistance and other antibiotic-related side effects; judicious antibiotic use and stewardship is of paramount importance. Aim: To determine whether post-operative antibiotics are required at all, following surgery for mandible fractures, and, if so, what is the most clinically- and cost-effective regimen Objectives: Primary Objective To conduct a Randomized Controlled Trial (MANTRA) in order to establish the non-inferiority (or not) of not giving post-operative antibiotics versus 2 other post-operative antibiotic regimens. An internal pilot phase will optimise recruitment and retention. Secondary Objectives - Measure the cost-effectiveness of the proposed antibiotic pathways - Assess patient and clinician acceptability to change clinical practice - Process evaluation to inform dissemination and implementation Methods: The investigators designed and propose the MANTRA RCT to compare 3 post-operative antibiotic approaches to prevent Surgical Site Infections (SSIs) following surgery for mandible fractures. The MANTRA trial is a large open label, multicentre study in NHS OMFS units. The 3 study arms represent the most common clinical pathways in the UK based on previous work; the control group is the approach prescribed by most UK OMFS clinicians. All patients will receive 1 dose of IV antibiotics (co-amoxiclav 1.2g, if no penicillin allergy, which is the most commonly used prophylactic antibiotic currently) on induction of anaesthesia, prior to their surgery. The participants will be randomised to the following (1:1:1): Group A: No further antibiotics Group B: 2 further postoperative IV doses of co-amoxiclav 1.2g Group C: 2 further postoperative IV doses (as above), followed by a 5-day course of oral co-amoxiclav 625mg every 8 hours if no penicillin allergy (Control). Trial processes will be optimised by an internal pilot phase ensuring we recruit, randomise, and retain participants with clear progression criteria. We will also conduct cost-effectiveness analyses and process evaluation for dissemination and implementation Timeline: Start of grant: 1st July 2023 Start of RCT / pilot: 1st January 2024 End of pilot: 30th June 2024 End of recruitment: 31st December 2026 End of follow-up: 30th June 2027 Completion: 31st December 2027 Impact and dissemination: - Practice changing outputs that standardise the use of antibiotics in mandible fractures in the NHS and provide a framework for other surgical prophylaxis research - A bespoke clinical dissemination plan via an engagement and training legacy - Cost-effectiveness data to inform policy making - A research legacy and change of culture in the specialty of OMFS

NCT ID: NCT05964127 Recruiting - Clinical trials for Peri-Implantitis and Systemic Inflammation

Peri-implantitis and Systemic Inflammation

LASSO
Start date: July 19, 2023
Phase: N/A
Study type: Interventional

To investigate the effects of peri-implantitis (a disease around dental implants) and its treatment at both local and systemic levels using clinical and biological parameters. One study with two parts which will run simultaneously. An initial observational study comparing cases and controls and a subsequent interventional study in which the cases will proceed to treatments and all participants will be followed up for 6 months.

NCT ID: NCT05964075 Recruiting - Respiratory Failure Clinical Trials

RASECAL-Bronchoscopic Ambusampler

Rasecal
Start date: January 14, 2022
Phase:
Study type: Observational

Prospective, multi-centre, open labelled, 1:1randomized controlled study.

NCT ID: NCT05963997 Recruiting - Breast Cancer Clinical Trials

A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer

SUMIT-ELA
Start date: October 9, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and efficacy of samuraciclib in combination with elacestrant in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer.