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NCT ID: NCT06118281 Not yet recruiting - Cardiovascular Risk Clinical Trials

ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack

ARTEMIS
Start date: June 25, 2024
Phase: Phase 3
Study type: Interventional

The research study is being done to see if ziltivekimab can be used to treat people who were admitted to hospital because of a heart attack. Ziltivekimab might reduce development of heart disease, thereby preventing new heart attacks or strokes. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study will last for about 2 years.

NCT ID: NCT06118255 Recruiting - Dravet Syndrome Clinical Trials

A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less Than 2 Years of Age With Dravet Syndrome

ORCHID
Start date: May 21, 2024
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is evaluate the safety and tolerability of fenfluramine hydrochloride (HCl) 0.2 to 0.8 mg/kg/day in infants 1 year to less than 2 years of age with Dravet syndrome.

NCT ID: NCT06118203 Completed - Pulmonary Embolism Clinical Trials

Semaglutide Use in Acute Pulmonary Embolism

Start date: January 2, 2022
Phase:
Study type: Observational

Evaluation of circulating endothelial inflammatory biomarkers in response to GLP-1 agonist Semaglutide in acute pulmonary embolism

NCT ID: NCT06117007 Recruiting - Quality of Life Clinical Trials

Effects of Betalains on Cardiovascular Health and Quality of Life

Start date: October 30, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized, double-blind, placebo-controlled, cross-over trial is to investigate the effects of beetroot-derived betalains on cardiovascular health, sleep and quality of life in healthy middle-aged individuals. The main question[s] it aims to answer are: - Do betalains improve vascular function? - Do betalains improve sleep? - Do betalains improve quality of life? Participants will be involved with the following: - Consuming a daily betalain-rich or placebo capsule for a month - Non-invasive cardiovascular measurements - Wearing a fitness tracker for tracking physical activity and sleep - Answering questionnaires regarding quality of life Researchers will compare results between the intervention versus the placebo group to see if any of the study outcomes are significantly different.

NCT ID: NCT06116604 Recruiting - Crohn Disease Clinical Trials

Early Bowel Resection for Terminal Ileal Crohn's Disease

E-BRIC
Start date: September 7, 2023
Phase:
Study type: Observational

The goal of this multicentre mixed -methods study is to understand the patient and clinician perspective on the ideal timing of an operation for Crohn's disease of the terminal ileum (last part of the small bowel). The main questions it aims to answer are: - What factors influence patients' and clinicians' preferences with regards to the timing of the first bowel resection for isolated Crohn's disease of the terminal ileum? - What are patients' and clinicians' views on 'early' bowel resection (as an alternative to medical therapy) in this context? - What are the facilitators and barriers to implementation of early surgery in practice? Participants will be patients with Crohn's disease of the terminal ileum and healthcare professionals involved in treating inflammatory bowel disease. Healthcare professionals have previously been asked to participate in an interview to understand their views on the role of surgery for Crohn's disease of the terminal ileum. They will now be invited to participate in a choice exercise to understand how much weight they attribute to various factors and outcomes when choosing between surgery and medication for Crohn's disease of the terminal ileum. Patients will be asked to participate in: 1. an interview about their treatment choices 2. a choice exercise to understand how much weight they attribute to various factors and outcomes when choosing between surgery and medication for Crohn's disease of the terminal ileum 3. a survey, for patients with a previous ileocaecal resection, assessing their experience of the operation

NCT ID: NCT06116331 Recruiting - Ulcerative Colitis Clinical Trials

The Mind-Body IBD Study: Understanding the Mind-body Connection in IBD

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

An aspect of IBD care that is often overlooked is mental health treatment. Common mental health problems, such as anxiety and depression are very common in IBD, with a meta-analysis estimating prevalence as high as 25.2% for depression and 32.1% for anxiety. The prevalence of anxiety and depression increases when individuals with active disease are considered, with rates as high as 57.6% for anxiety and 38.9% for depression. Comorbid depression and anxiety in IBD is associated with greater symptom severity, even when statistically controlling for disease activity; more frequent and expensive emergency department visits and inpatient stays, higher costs relating to IBD-related surgery, medication and personal expenditure; noncompliance with medical treatment and finally, increased likelihood of experiencing flares. However, very few studies attempt to unpick the precise mechanism of these bidirectional relationships. Indeed, depression and anxiety may have direct effects on physical health through inflammatory or psychoneuroimmunological pathways. Very few studies investigate the longitudinal brain-gut relationship with regards to objective measures of inflammation. Additionally, the indirect effects of mental health are often overlooked. Depression and anxiety are routinely associated with health behaviours, such as diet, physical activity, sleep, and tobacco/alcohol use.These health behaviours are important factors, given their impact on physical health outcomes. Therefore, a thorough investigation is required to ascertain the precise mechanisms that underpin the bidirectional relationship between depression/anxiety and inflammation/physical health, as this will enable practitioners and researchers to establish non-invasive, behavioural treatment targets for this patient group. AIM The broad aim of this project is to explore whether anxiety/depression has a direct or indirect (via health behaviours) on i) inflammation levels ii) clinical activity and iii) healthcare usage at follow-up, in a population of IBD patients. A secondary aim of the project will be to explore whether changes in disease activity, as measured by self-report measures and faecal calprotectin, explains changes in anxiety and depression symptoms at follow up.

NCT ID: NCT06116279 Not yet recruiting - Epilepsy Clinical Trials

First-in-human Experience Using Novel Ultraflexible Low-impedance Electrode Arrays: an IDEAL Stage 1 Study

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

The goal of this first-in-human study is to evaluate a novel ultraflexible microelectrode in children undergoing neurosurgery to remove tissue that causes epilepsy (seizures) in focal cortical dysplasia (FCD) or long-term epilepsy-associated tumours (LEAT). The main questions it aims to answer are: 1. The safety and feasibility of the novel microelectrode into current operative workflow 2. The unique electrophysiological tissue signatures in FCD or LEAT

NCT ID: NCT06115967 Recruiting - Clinical trials for Rheumatoid Arthritis

A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of Subcutaneous AZD6912 in Healthy Participants

Start date: November 15, 2023
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of AZD6912 administered subcutaneously (SC) in healthy participants.

NCT ID: NCT06115317 Enrolling by invitation - Clinical trials for Homonymous Hemianopia

Homonymous Hemianopia in Childhood

HHIC
Start date: May 4, 2023
Phase: N/A
Study type: Interventional

The study will consist of two connected components at a single centre. Phase 1 is observational, phenotyping children with Homonymous hemianopia (HH). Phase 2 is a pilot double blind cross over RCT in which segmental prisms are compared with sham prisms in glasses.

NCT ID: NCT06115044 Active, not recruiting - Critical Illness Clinical Trials

The DINE-Normal Proof-of-concept Study

Start date: December 27, 2023
Phase: N/A
Study type: Interventional

Overarching hypothesis In critically ill adults enteral feeding in a diurnal intermittent pattern improves patient centred outcomes. Research questions for this study Are the same derangements in metabolic and hormonal function observed in healthy volunteers when fed continuously via a nasogastric tube observed in critically ill patients and can those derangements be mitigated by intermittent diurnal feeding? Aim of this study Assess the effect of an enteral nutrition regimen mimicking the usual diurnal meal pattern on hormonal profile and metabolism in critically ill adults. This will generate novel and important proof of concept data and support progression to a clinical trial integrating investigation of physiological responses and patient centred outcomes. Objectives of this study Laboratory: Characterise patterns of hormone, lipid and metabolite response to intermittent diurnal feeding in critically ill adults. Clinical: assess feasibility, tolerability (vomiting and gastric residual volume) and efficacy (calorie delivery) of intermittent diurnal feeding in critically ill adults.