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NCT ID: NCT05919693 Recruiting - Clinical trials for Diabetic Macular Edema (DME)

A 2-part Study Consisting of Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Masked Study to Assess the Safety and Efficacy of Intravitreal (IVT) EYE103 in Patients With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD)

AMARONE
Start date: June 12, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema (DME) given as monotherapy or neovascular macular degeneration (NVAMD) given in combination with anti-VEGF. In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE103 will be assessed at escalating doses. Approximately 12 participants will be entered in this part of the study. In the second part of the study, called the dose finding part two doses of EYE103 will be selected and their effectiveness will be compared. Approximately 80 participants will be entered in this part of the study.

NCT ID: NCT05919589 Recruiting - Healthy Clinical Trials

Evaluating Care Integration for Children With Special Health Care Needs v1.0

Start date: November 1, 2023
Phase:
Study type: Observational

The Evelina London Children's Hospital (ELCH) is planning to integrate care for children with special health care needs (CSHCN) using a package of support, including 1) family support workers to manage care coordination and support parents, and 2) 'navigation' packs outlining key services, for both the services users and providers. This study aims to explore the views and experiences of key stakeholders involved with these services, including the parents/caregivers of CSHCN, and professionals/staff team members. These will be explored using semi-structured qualitative interviews.

NCT ID: NCT05919342 Recruiting - Heart Failure Clinical Trials

Screening for earlY Heart Failure Diagnosis and Management in Primary Care or at HOme Using Natriuretic Peptides and echocardiographY "SYMPHONY-HF"

SYMPHONY-HF
Start date: December 22, 2022
Phase: N/A
Study type: Interventional

This is an international prospective, multicentre, unblinded, randomised-controlled trial. The primary aim is to assess a targeted screening strategy to detect undiagnosed heart failure in high-risk patients.

NCT ID: NCT05918926 Recruiting - Obesity Clinical Trials

Digitally Delivered Exercise in Helping People to Move More

Start date: May 18, 2022
Phase: N/A
Study type: Interventional

The main objective of this study is to examine the influence of the digital exercise prescription platform in increasing habitual physical activity in people on a weight management programme.

NCT ID: NCT05917574 Recruiting - Critical Illness Clinical Trials

A Study to Evaluate the Introduction of New Staffing Models in Intensive Care: a Realist Evaluation (SEISMIC-R)

SEISMIC-R
Start date: June 14, 2023
Phase:
Study type: Observational

Background: Staffing in intensive care units (ICU) has been in the spotlight since the pandemic. Having enough nurses to deliver safe, quality care in ICU is important. However, what the skill mix should be (how many should be qualified nurses or have an ICU qualification) is unclear. Very little research has been done to look at which nursing staff combinations and mix of skills works best in ICU to support patients (described as 'staffing models').Research shows that there is a link between the quality of nurse staffing and poor patient outcomes, including deaths. Aim: Our research plans to look at different staffing models across the UK. This study aims to examine new staffing models in ICU across six very different Trusts. This study will use a research technique called Realist Evaluation that examines what works best in different situations and help to understand why some things work for some people and not others. The design of this approach will help to better understand the use of different staff ratios across different ICU settings. This study will examine what combinations of staff numbers and skills result in better patient care and improved survival rates. The aim is to produce a template that every ICU unit can use. To do this, this study will compare staffing levels with how well patients recover, and seek to understand the decisions behind staffing combinations. Methods: This study will: 1. carry out a national survey to understand the different staff models being used, comparing this against the current national standard (n=294 ICUs in the UK including Scotland) 2. observe how people at work in 6 hospitals (called ethnography), watching how they make decisions around staffing and the effect on patients. The investigators will also conduct interviews (30 interviews plus 30 ethnographic observations) to understand staffing decisions. 3. look at ICU staffing patterns and models, and linked patient outcomes (such as whether people survive ICU) over 3 years (2019-2023) in those hospitals, including with a very different combination of staffing). The investigators will then carry out some mathematical calculations to understand the best possible staffing combinations, and how this varies.

NCT ID: NCT05917470 Recruiting - Clinical trials for Metastatic Castration-resistant Prostate Cancer

A Clinical Study of ONCT-534 in Subjects With Metastatic Castration-resistant Prostate Cancer.

Start date: September 20, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

A first-in-human clinical trial to test the investigational treatment ONCT-534 in participants with metastatic castration-resistant prostate cancer. The main questions it aims to answer are: - What are the most tolerable doses of ONCT-534? (Phase 1) - Does ONCT-534 have anti-tumor activity at tolerable doses? (Phase 2) This is a dose escalation and expansion study where participants will receive daily oral doses of ONCT-534.

NCT ID: NCT05916495 Recruiting - Clinical trials for Lung Transplant; Complications

An Evaluation of Remote Care (Questionnaire+Hybrid) in Patients Who Are Post-lung Transplant

Start date: September 29, 2023
Phase: N/A
Study type: Interventional

Lung transplantation is used to treat patients with lung damage when there is no other treatment option. Patients require close monitoring following their transplant, with hospital check-ups every 3-4 months usually lasting all day. Although check-ups often result in no change to patient management they are essential as patients have better outcomes if complications are detected quickly. The aim is to explore whether remote monitoring via an app (patientMpower) ± questionnaire (specifically designed to assess post-transplant patients' health), linked to a device to measure lung function, could replace some check-ups for lung transplant patients. Patients will be randomised to receive either normal care or remote monitoring (i.e. their symptoms will be evaluated using home spirometry combined with a questionnaire). 100 lung transplant recipients will be enrolled with 50 patients being assigned to either group. Health outcomes and costs of care between the two groups will be compared

NCT ID: NCT05915468 Recruiting - Clinical trials for Coronary Artery Disease

Large De-NOVo Coronary artEry Disease Treated With Sirolimus Drug Eluting Balloon (LOVE DEB)

Start date: July 12, 2023
Phase:
Study type: Observational [Patient Registry]

The objective of this post-market Registry is to evaluate the safety and efficacy of SELUTION SLR, a Sirolimus Drug Eluting Balloon (DEB), in treating de novo native coronary artery disease in larger vessels (≥ 2.75 mm). This is a post-market registry that collects the data of patients who have been treated with a SELUTION DEB. The primary objective is to evaluate the proportion of subjects who underwent Target Lesion Revascularization (TLR) within 1 year of the baseline PCI.

NCT ID: NCT05914597 Recruiting - Colorectal Cancer Clinical Trials

Trial Feasibility of Home Delivery of Colon Capsule Endoscopy Service With the Help of 5 G Technology

5GSUCCEEDS
Start date: December 12, 2022
Phase: N/A
Study type: Interventional

Patients without alarming symptoms are at low risk of bowel cancer . However, in majority of those patients colonoscopy (gold standard) is needed to diagnose colorectal cancer or other non-neoplastic conditions such as Inflammatory bowel disease . Evaluation of patients with lower gastrointestinal symptoms ( low-intermediate risk group) represent significant pressure for colonoscopy services . At the end of August 2019 there were a total 44,388 patients still waiting for colonoscopy. Covid 19 pandemic has placed significant pressure on healthcare systems since March 2020.The aerosol generating potential of endoscopy has led to multiple Gastroenterology and Endoscopy societies suggesting immediate cessation of all but emergency colonoscopy during the peak phase of the pandemic which put colonoscopy capacity even more under pressure Data from the National Endoscopy Database indicate that total endoscopic activity fell rapidly to 5% of normal levels during the peak phase of the COVID-19 epidemic in the UK (from approximately 35 000 reported procedures per week to 1700, for the week ending 13 April . In order to reduce potential diagnostic delays as a result of COVID pandemic , the role of colon capsule endoscopy (CCE) as a non invasive diagnostic test is being increasingly recognise, which allows for a pain-free colonic assessment by eliminating the need for instrument insertion, gas insufflation or sedation . The aim of the 5G SUCCEEDS study is to trial feasibility of home delivery of Colon Capsule Endoscopy service with the help of 5 G technology. Currently patients need to attend hospital to access this service.

NCT ID: NCT05914220 Recruiting - COPD Clinical Trials

DYNAMIC AI: Digital Innovation With Remote Management and Predictive Modelling to Integrate COPD Care With Artificial Intelligence-based Insights: An Acceptability, Feasibility and Safety Study

DYNAMIC AI
Start date: April 1, 2023
Phase:
Study type: Observational

DYNAMIC AI is an MHRA-regulated medical device trial that will examine the feasibility of using AI predictive models within COPD multi-disciplinary team meetings, to allow clinicians to prioritise and optimise COPD management.