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NCT ID: NCT06145880 Recruiting - Clinical trials for Pulmonary Hypertension

ADOPT: Improving Diagnosis of Pulmonary Hypertension With AI and Echo

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

Pulmonary Hypertension (PH) is a condition caused by high blood pressure in the blood vessels that carry blood to the lungs. It can cause severe breathlessness and failure of the right side of the heart. Sadly it is often fatal, and life expectancy ranges from months to years. For some subtypes of PH, effective treatments exist which can improve life expectancy and quality-of-life. Accurate tools for the assessment of PH are therefore essential so that life-saving medications can be started earlier. In existing diagnostic pathways, evidence for the suspicion of PH is frequently overlooked, significantly delaying the time to diagnosis. Echocardiography (echo) is a quick, safe and well-tolerated test requested to investigate breathless patients, and which can provide useful information about the suspicion of PH. However, outside of specialist PH centres, doctors may not routinely look for and comment on the presence of clues to possible PH. The investigators think that using Artificial Intelligence (AI) techniques to read echo's could make their interpretation faster and more reliable. There may also be subtle clues to the presence or severity of PH on echo, less recognisable to the human eye, which AI can identify. In this study the investigators will gather echo images from 5 specialist PH hospitals across the UK which have all been anonymised (patient's name and personal details removed). These will all be historic scans (i.e. have already taken place) and will be grouped into those with PH present (including PH sub-type) or absent. These anonymised echo images will be used to develop and train an AI tool to identify scans where PH is present, including which specific type of PH may be present. The developed AI tool will then be tested on a separate group of scans (not used in the training stage) to validate its performance.

NCT ID: NCT06145178 Recruiting - Clinical trials for Cytomegalovirus Infections

A Study of Human Cytomegalovirus (HCMV) Vaccine SPYVLP01 With and Without Adjuvants

SPYVAC01
Start date: November 22, 2023
Phase: Phase 1
Study type: Interventional

The main purpose of the study is to evaluate the safety and immunogenicity of SPYVLP01 in two different doses with and without adjuvants in healthy adults aged 18-50 years old.

NCT ID: NCT06145087 Recruiting - Healthy Aging Clinical Trials

Effects of a Supplement to Target Ageing Mechanisms on Vascular Function (STAMINA)

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

In the ageing society, extending the healthy lifespan is a major challenge and a healthy diet may play an import role in maintaining health throughout life. With increasing age cardiovascular function declines and large and small blood vessels change in various and complex ways and these changes may lead to many age-related diseases. On a molecular level, there are many mechanisms that are associated with ageing including cellular senescence, loss of proteostasis, altered cellular communication, genomic instability, epigenetic alterations, telomere shortening, deregulated nutrient sensing, stem cell exhaustion and protein crosslinking. Animal and human studies suggest that dietary supplements may be able to affect these mechanisms. What the effect of the NOVOS Core supplement is on cardiovascular functions is not known. The aim of the present study is to investigate the short and intermediate term effects of a supplement mix designed to target ageing mechanism on vascular function in healthy middle-aged subjects. (STAMINA Study) The hypothesis is that the supplement will lead to acute and sustained changes in biomarkers of vascular function and health. 60 healthy middle-aged people will be recruited and randomly assigned to either daily intake of the NOVOS Core supplement (n=30) or placebo (n=30) for up to 6 months (3-6). The supplement (NOVOS Core) is a commercially available product and has 12 ingredients. It was developed and is provided together with the placebo by AgeLess Sciences LLC, a Public Benefit Corporation. The study will require 2 visits by participants during which non-invasive vascular exams will be performed, venous blood taken and spot urine sample collected. The primary endpoint is change in flow-mediated dilation, secondary endpoints are change in blood pressure, cholesterol, arterial stiffness, microvascular function cardiovascular risk SCORE and daily walking distance. Tertiary endpoints are changes in biomarkers of ageing as assessed in blood samples including DNA damage. In addition, we will assess anxiety, depressive feelings, happiness, well-being and the diet with several questionnaires. Measurements will be taken on the first day before and 2 hours after ingestion of the first supplement or placebo. Participants will consume the supplement or placebo for 6 months and vascular exams and one blood draw will be repeated during the final visit. During the time, participants will receive 2 phone calls to improve compliance.

NCT ID: NCT06144840 Recruiting - Clinical trials for Erythropoietic Protoporphyria (EPP)

INcreased Sun Exposure Without Pain In Research Participants With EPP or XLP

INSPIRE
Start date: December 11, 2023
Phase: Phase 3
Study type: Interventional

To investigate the efficacy of MT-7117 on time to onset and severity of first prodromal symptoms (burning, tingling, itching, or stinging) associated with sunlight exposure in adults and adolescents with EPP or XLP.

NCT ID: NCT06144684 Recruiting - Healthy Volunteers Clinical Trials

A First-In-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GUB014295

Start date: November 29, 2023
Phase: Phase 1
Study type: Interventional

This is a single center, double-blind, randomized, placebo-controlled, single ascending subcutaneous dose study in lean to overweight or obese but otherwise healthy men. It is planned to enroll 4 cohorts of 8 subjects (Regimens A, B, C and D), with 2 additional optional cohorts of 8 subjects (Regimens E and F). Within each cohort, subjects will be randomized in a ratio of 6 active to 2 placebo. The primary objective is to assess the safety. Secondary objectives are to characterize the pharmacokinetics (PK) and to investigate pharmacodynamic effects.

NCT ID: NCT06144476 Recruiting - Asthma Clinical Trials

Study of Inflammatory and Physiological Profiles of Healthy and Diseased Lung

RETAIN
Start date: February 8, 2024
Phase:
Study type: Observational

There are over 700,000 UK hospital admissions every year with lung disease symptoms. Two of the most common lung diseases contributing to these numbers are asthma and chronic obstructive pulmonary disease (COPD). The immunopathology of these diseases is not fully understood. Matched samples from the respiratory tract and circulation will be used to identify immune patterns throughout the respiratory system to elucidate the immunopathology of airway disease.

NCT ID: NCT06144047 Recruiting - Epilepsy Clinical Trials

Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG

REAL-ASE
Start date: July 18, 2023
Phase: N/A
Study type: Interventional

The study will investigate whether a novel method to accurately count epileptic seizures, using a CE-marked minimally-invasive ultra long-term subcutaneous electroencephalography (EEG) solution (UNEEG™ SubQ , including 24/7 EEG SubQ), (i) is more accurate than a participant-reported seizure diary; (ii) is feasible and acceptable to participants and clinicians; (iii) reduces impacts of epilepsy and improves quality-of-life; and (iv) provides gains to the healthcare system when rolled-out into the National Health Service (NHS). 33 participants with drug-resistant epilepsy will be implanted with the UNEEG™ SubQ device and will collect data for six months. Annotated seizures from the EEG data will be sent weekly to the treating clinicians, who will communicate with the participants on a monthly basis, and will be free to make any management changes.

NCT ID: NCT06143891 Recruiting - Clinical trials for Chronic Graft Versus Host Disease

A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease.

ROCKnrol-1
Start date: January 23, 2024
Phase: Phase 3
Study type: Interventional

This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD. The study duration for a participant includes up to 4 weeks for screening; a treatment period until clinically meaningful cGVHD progression (defined as progression requiring addition of new systemic treatment for cGVHD), relapse/recurrence of the underlying disease, participant starts new systemic treatment for cGVHD or experiences an unacceptable toxicity, at the request of the participants or the investigators, or until the end of study is reached, whichever comes first; at least 30 days follow-up of adverse events (AEs) after the last dose until resolution or stabilization, if applicable; and long-term follow-up until death or study close-out, whichever comes first.

NCT ID: NCT06143878 Recruiting - Plaque Psoriasis Clinical Trials

A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Start date: January 17, 2024
Phase: Phase 3
Study type: Interventional

The purpose of the study is to see how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.

NCT ID: NCT06143072 Recruiting - Faecal Incontinence Clinical Trials

CArE for OAsI Study: Care Pathways and Anorectal Evaluation for OASI Associated Incontinence

CArE for OAsI
Start date: January 1, 2024
Phase:
Study type: Observational

The aim of this study is to ascertain which pathways currently exist in relation to the follow up of patients with obstetric anal sphincter injury related incontinence. This is particularly important as afflicted individuals may not readily volunteer information about their symptoms and struggles and need to be safeguarded by the presence of robust care pathways that ensure adequate follow up and care provision. As obstetric anal sphincter injuries have been associated with increased litigation rates over the years, positive interventions towards patient care will help ameliorate the financial burden that litigation carries on the National Health Service. It is noteworthy of mention that perineal injury, in itself, may not be suggestive of negligent care and is a recognized complication of vaginal delivery. However, a failure to adequately manage the injury may carry medicolegal implications.