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NCT ID: NCT05848765 Recruiting - Clinical trials for Refractory Follicular Lymphoma

Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy

REFRACT
Start date: September 4, 2023
Phase: Phase 2
Study type: Interventional

The aim of the REFRACT clinical trial is to find new therapies with improved outcomes compared to the current standard treatment available, in patients with relapsed or refractory follicular lymphoma. This will be done by comparing patients who have received a new treatment against patients who receive standard treatment based on their response to the treatment received.

NCT ID: NCT05848674 Recruiting - Clinical trials for ST Elevation Myocardial Infarction

CArdiac Brief INtervention: A Feasibility Study to Promote Engagement With Cardiac Rehabilitation

CABIN
Start date: November 15, 2023
Phase: N/A
Study type: Interventional

Background: An ST-elevation myocardial infarction (STEMI) is a specific type of heart attack. In a previous study, patients requested more mental and emotional support after a STEMI. To provide this support, the research team worked with hospital staff and patients to create a brief intervention called CABIN (CArdiac Brief INtervention), which involves a short discussion between a patient and a nurse, along with a leaflet that summarises the information discussed. Aim: To test if the plan for giving CABIN to patients after a STEMI is suitable, and to explore what impact the intervention may have on mental and emotional well-being, along with knowledge about their condition. Methods: Forty patients who had a STEMI will be recruited from two hospital centres in Northern Ireland (Royal Victoria Hospital and Ulster Hospital). Participants will be randomly put in a group who receive the full CABIN intervention or a group who receive a shortened version of CABIN. Both groups will receive their respective interventions before leaving the hospital, which will take about twenty minutes. Participants will be asked to complete brief questionnaires before the intervention, after the intervention, 3-4 weeks from diagnosis, and 14 weeks from diagnosis. At the end of the study, patients who took part and staff from the hospitals will be asked to complete an exit interview (patients) or a focus group (staff), which will provide information about their experience of the study / intervention and changes required. Outcome of Study: If the study is suitable for patients and appropriate for staff to deliver, the research team will examine the effectiveness of CABIN in a larger study, which may lead to the intervention being used in clinical practice to improve cardiac rehabilitation uptake and outcomes for patients after a STEMI.

NCT ID: NCT05848258 Recruiting - Clinical trials for Rheumatoid Arthritis

An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis

Start date: May 23, 2023
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the efficacy and safety of LY3871801 in adult participants with active moderately-to-severe rheumatoid arthritis (RA).

NCT ID: NCT05848011 Recruiting - Immunotherapy Clinical Trials

A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer

Start date: September 28, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether the amount of time before disease progression can be prolonged in participants with metastatic castration-resistant prostate cancer (MCRPC) who receive lorigerlimab in addition to the standard of care (SOC) of docetaxel and prednisone. About 150 participants with mCRPC will be enrolled. Participants will be randomized in a 2:1 ratio to receive lorigerlimab with docetaxel and prednisone (experimental arm) or docetaxel and prednisone alone (standard-of-care arm). Lorigerlimab+docetaxel or docetaxel will be administered intravenously (IV) in clinic on Day 1 of each 3-week cycle. Prednisone will be administered orally twice daily. Lorigerlimab will be administered for up to 35 cycles. Docetaxel and prednisone will be administered up to 10 cycles until treatment discontinuation criteria are met. Participants will undergo regular testing for signs of disease progression using computed tomography (CT) scans, magnetic resonance imaging (MRI) and prostate-specific antigen (PSA) blood tests. Participants will be asked to complete questionnaires about their health and well-being. Routine examinations and blood tests will be performed and evaluated by the study doctor. Participants who have disease progression standard-of-care arm have the option of continuing on the study to receive lorigerlimab monotherapy.

NCT ID: NCT05847556 Recruiting - Hearing Loss Clinical Trials

Video Game Hearing Tests for Remote Monitoring of Ototoxicity

VAROT
Start date: March 16, 2022
Phase: N/A
Study type: Interventional

The reason for this clinical trial is to test different ways of carrying out hearing tests to be able to detect for hearing loss within the hospital and at home. Pathway 1: The goal of this clinical trial is to learn whether video game hearing tests work well to detect hearing loss caused by antibiotics at home in patients with long-term lung infections. Pathway 2: The goal of this clinical trial is to compare tablet-based (iPad) hearing tests with formal sound booth hearing tests in patients attending hospital outpatient clinics. Pathway 3: The goal of this clinical trial is to learn whether audio-training improves listening to speech in the presence of background noise. Researchers will compare participants receiving audio-training with those who did not receive audio-training. This will test if audio-training can improve participant's everyday listening experiences.

NCT ID: NCT05847452 Recruiting - Asthma Clinical Trials

Beyond the Eosinophil: Understanding the Impact of Eosinophil Depletion on T2 Inflammation. (BEUTI)

BEUTI
Start date: May 22, 2023
Phase:
Study type: Observational

Benralizumab is a relatively new treatment that is approved by NICE (National Institute for Health and Care Excellence, https://www.nice.org.uk/) for patients with severe asthma who have ongoing eosinophilic inflammation that remains poorly controlled despite high dose inhaled glucocorticosteroid medication. Eosinophils are a type of white blood cell that are linked to allergy and inflammation and are raised in people with severe asthma. Severe asthma is associated with a type-2 (T2) inflammation phenotype characterised by increased T2 cytokines (IL-13, IL-4, IL-5). Increased levels of eosinophils can cause inflammation in the lungs, increasing the risk of asthma attacks. The standard treatment for asthma involves taking inhaled glucocorticosteroid medication which primarily work by suppressing eosinophilic inflammation in the lungs. Benralizumab is a monoclonal antibody that targets a receptor on the surface of eosinophils called interleukin-5 receptor-α (IL-5Rα) leading to the rapid death of these cells and consequently a reduction in airways inflammation. In clinical trials, benralizumab has been shown to reduce both symptoms and the number of asthma attacks suffered by those with severe eosinophilic asthma. However, it remains unclear whether this clinical efficacy relates purely to the removal of the eosinophil, or additionally to the impact of this on other parts of the immune system. The BEUTI study will examine the structure and function of airway cells in patients with severe eosinophilic asthma. Particularly how the immune function of these cells changes with treatment and whether benralizumab leads to a reduction in T2 mediators and/or activation in airway cells. The aim is to take samples of cells from the airways during a bronchoscopy (a camera test looking into the lungs) before starting benralizumab and after 12 weeks of treatment. These investigations will allow us to better understand how benralizumab affects the cells within the airways and the pathways involved.

NCT ID: NCT05847387 Recruiting - Clinical trials for Corneal Endothelial Cell Loss

The Viability Control of Human Endothelial Cells Before Keratoplasty (V-CHECK) Study

V-CHECK
Start date: December 1, 2023
Phase:
Study type: Observational

The purpose of this international cohort study is to validate a new method for preoperative assessment of endothelial viability in donor corneal tissues for transplantation, and to correlate endothelial health as assessed by the surgical team to functional and structural long-term outcomes in the cohort of patients receiving them.

NCT ID: NCT05847322 Recruiting - Clinical trials for Pertussis/Whooping Cough

Periscope Phase C Bordetella Pertussis Human Challenge Study With Delayed Antibiotic Therapy for 6 Weeks

Start date: December 6, 2022
Phase: N/A
Study type: Interventional

Primary objective- To assess the safety of nasal inoculation of healthy volunteers with B. pertussis with antibiotic therapy given to eradicate colonisation at 6 weeks after inoculation or at symptom onset, whichever occurs first Secondary objectives - To measure the rate of natural clearance of carriage of B. pertussis following nasal inoculation - To assess the kinetics of B. pertussis colonisation density following nasal inoculation - To describe the microevolution of B. pertussis and adaptation of the resident microbiome during B. pertussis carriage - To measure B. pertussis-specific antibody and cellular immunological responses in healthy volunteers during colonisation with B. pertussis - To identify biomarkers that correlate with natural clearance of B. pertussis carriage after induced B. pertussis colonisation - To detect transmission of B. pertussis to bedroom contacts of inoculated volunteers during prolonged asymptomatic colonisation

NCT ID: NCT05846581 Recruiting - Clinical trials for Chronic Kidney Diseases

Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access

AVG22-09
Start date: January 12, 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to evaluate safety and performance of GORE® ACUSEAL Vascular Graft for the treatment of CKD in patients with ESRD in hemodialysis. The main questions it aims to answer are: - Safety: Freedom from device-related infection adverse events at 24 months from device implant - Performance: Secondary patency at 24 months from device implant. Participants, after informed consent is obtained, will be implanted with GORE® ACUSEAL Vascular Graft and followed for 24 months in standard of care, to evaluate safety and performance of the device.

NCT ID: NCT05845229 Recruiting - Healthy Nutrition Clinical Trials

Bioavailability of N-acylethanolamines: an Ileostomy Study (NAE Study)

NAE
Start date: January 16, 2023
Phase: N/A
Study type: Interventional

The endocannabinoids (ECs) and N-acylethanolamines (NAEs) are a group of endogenous lipid mediators which have a pleiotropic activity in the body modulating several biological pathways such as: appetite cues, food intake, blood pressure, inflammation, glycaemia, cognition and immunity. The ECs consist of N-arachidonoylethanolamide (AEA) and 2-arachidonoylglycerol (2-AG). They may have agonist activity on cannabinoid receptors CB1 and CB2 which are located in the central nervous system (CNS) and in peripheral tissues such as in the enteric nervous system (ENS), in the liver and in the adipose tissue. NAEs are known as "endocannabinoid-like" molecules and include oleoylethanolamine (OEA), linoleylethanolamine (LEA), and palmitoyletahanolamine (PEA). Evidence indicates that diet composition may affect fasting and post-prandial plasma ECs, N-acylphosphatidylethanolamines (NAPEs) and NAEs profile due to the content of their precursors, fatty acids and amines. It is hypothesized that the concentration of NAPEs, NAEs and ECs in a meal could influence the intestinal concentrations of these lipid mediators that could bind the receptors located on the intestinal mucosa and in turn, differently modulate appetite and energy metabolism. The study is an acute randomized crossover feeding study in ileostmists (n=14), having a breakfast meal low or high in NAPEs, NAEs and ECs. The meals are designed on a database published by our collaborators (University of Naples) and detailed in the research proposal. Concentrations of NAEs and ECs in urine, plasma and ileal fluid, beside the blood glucose, hormonal response, appetite feelings and food intake will be monitored over the experimental days.