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NCT ID: NCT06234410 Recruiting - Clinical trials for Cardiovascular Diseases

Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation

CRAFT-CTCA
Start date: January 24, 2024
Phase:
Study type: Observational

Cardiovascular disease (for example, heart attack, stroke, heart failure) is the commonest complication of kidney failure. Kidney transplantation reduces cardiovascular risk but cardiovascular disease remains the commonest cause of death in patients following transplantation. Current strategies to assess patient's cardiovascular risk prior to kidney transplantation do not identify those at highest risk and do not improve outcomes. This study will use a heart scan known as computed tomography coronary angiography (CTCA) to see whether this scan can identify patients at highest risk of future cardiovascular disease prior to transplantation. Studies have shown it is able to do this in patients with normal kidney function. The aim of this study is to develop CTCA as an effective tool to risk stratify patients prior to kidney transplantation.

NCT ID: NCT06233734 Recruiting - Stroke Clinical Trials

Robot-Assisted Gait Training in Early-Subacute Stroke

Start date: April 30, 2024
Phase:
Study type: Observational

A stroke happens when blood flow to the brain is cut off. Many people struggle to walk after having a stroke. Regaining the ability to walk is a key aim for many stroke survivors and rehabilitation practitioners as it allows improved independence and better health. This study will assess a rehabilitation method called robot-assisted gait training (RAGT) with stroke patients. RAGT uses a robotic device to assist the patient in taking steps. The RAGT device being investigated in this study is called the Lokomat. This device uses a treadmill, a harness, and a robotic suit to help the user to take steps. In particular, the study will aim to determine whether this form of training can improve the health of the heart and blood vessels (cardiovascular health) of people with stroke. Also, the study will assess whether RAGT helps stroke patients to be more physically active in the initial stages after they have a stroke. Physical activity and cardiovascular health are linked. Physical inactivity, and increased sedentary behaviours, which are both common post-stroke, can lead to worsening cardiovascular health, and increase the risk of another stroke, hence why these are both principal research questions of the study. Patients at one of two NHS inpatient stroke units will be invited to participate in the research - one which uses the Lokomat as standard care and one which does not. The decision to participate (or not) will not result in a change in their care plan, but if they do decide to participate, the research team will collect some additional data to help answer the questions this study is attempting to answer. All the measurements taken will be safe, non-intrusive and pain free. The results of patients using the Lokomat at one stroke unit will be compared to patients in the other inpatient stroke unit not using the device. The investigators expect to see that participants who complete RAGT are more physically active both during and after the RAGT they receive.

NCT ID: NCT06233461 Recruiting - Crohn's Disease Clinical Trials

A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease

Start date: March 5, 2024
Phase: Phase 2
Study type: Interventional

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. The purpose of this study is to evaluate the efficacy and safety of TAK-279 versus placebo in participants with moderately to severely active Crohn's disease (CD). The main aim of this study is to learn if the 3 different doses of TAK-279 reduce bowel inflammation and ulcers in the bowel compared to the placebo after 12 weeks of treatment. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate any problems. An endoscopy will be used to check the bowel for inflammation. The participants will be treated with TAK-279 for 52 weeks (1 year). During the study, participants will visit their study clinic 15 times.t

NCT ID: NCT06231706 Recruiting - Gut Microbiome Clinical Trials

ZOE BIOME Study: Biotics Influence on Microbiome Ecosystem

Start date: January 26, 2024
Phase: N/A
Study type: Interventional

The differences observed in host gut microbiome communities between health and disease states, and between different dietary patterns, has led to an increase in the use of dietary modulations to influence microbiome composition, both in research and in commercial contexts. Two particular groups of gut-active compounds include prebiotics (providing a direct source of nutrition that can stimulate host-beneficial microbiota as they are indigestible to the host) and probiotics (providing a direct source of live microorganisms that may potentially colonise the gut after reaching the large intestine, thus altering gut microbiome dynamics). Using a randomised controlled parallel trial design, the ZOE BIOME Study aims to investigate the efficacy of prebiotic and probiotic compounds in improving health outcomes including gut microbiome composition, gastrointestinal symptoms, and cardiometabolic markers of lipaemic, glycaemic and inflammatory status in a remote setting. Further, consumption of high fibre supplements or food ingredients in combination with high carbohydrate meals has been shown to decrease the postprandial glycaemic response. To investigate the acute metabolic effects of prebiotic compounds , a randomised controlled crossover design postprandial study will be conducted. The ZOE BIOME Postprandial Study aims to investigate the efficacy of prebiotic compounds in improving acute postprandial glycaemic response, subjective feelings of hunger, satiety, mood, and subsequent eating behaviours.

NCT ID: NCT06226987 Recruiting - Clinical trials for Fabry Disease, Cardiac Variant

Molecular Imaging in Fabry Disease of the Heart

Start date: January 2, 2024
Phase:
Study type: Observational

Better methods for early detection of cardiac involvement in Fabry disease are needed to inform clinical management decisions that can help prevent or slow the progression of cardiac complications. In the Molecular Imaging of Inflammation in Fabry Disease of the Heart study, we will test the use of 68Ga-DOTATATE PET/MRI for identifying myocardial inflammation in patients with Fabry disease.

NCT ID: NCT06226545 Recruiting - Eye Diseases Clinical Trials

A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease

Start date: March 5, 2024
Phase: Phase 2
Study type: Interventional

LASN01 is a novel, fully human antibody directed against the human IL-11 receptor being developed for treatment of patients with thyroid eye disease (TED). The primary and secondary objectives of this study are to evaluate the safety, efficacy, and pharmacokinetics of LASN01 administered IV in patients with TED with no prior anti-IGF-1R treatment or in patients with TED who have previously received teprotumumab treatment.

NCT ID: NCT06226233 Recruiting - Anorexia Nervosa Clinical Trials

Efficacy of Juniver, a Digital Self-help Intervention, on Symptoms of Eating Disorders: A Randomised Controlled Trial

Start date: December 23, 2023
Phase: N/A
Study type: Interventional

This project aims to assess the efficacy of the Juniver program on symptoms of eating disorders via a randomised controlled trial. The Juniver program is a self-help intervention for eating disorders delivered digitally, through an iPhone app. It features three components: an evidence-based curriculum, interactive tools, and moderated peer support groups. These three components integrate the evidence for (a) Cognitive-Behavioural Therapy (CBT) and Dialectical Behaviour Therapy for eating disorders; (b) Just-in-Time Adaptive Intervention; and (c) peer mentorship as an adjunct intervention for the treatment of eating disorders. The program was developed by the Juniver team made up of people with lived experience with eating disorders and professional experience in digital health, a panel of neuroscientists and experts specialising in eating disorders, and direct research with 500 participants. This trial aims to investigate the impact of the Juniver program on self-reported eating disorder symptoms, as well as on symptoms of depression, anxiety, psychosocial impairment associated with eating disorders, and perceived stress. This will occur via a randomised controlled trial comparing Juniver to a wait-list control condition over a 12-week period, with further evaluation of the effects of Juniver up to 24-weeks.

NCT ID: NCT06225531 Recruiting - Suicidal Ideation Clinical Trials

An Autobiographical Memory-Based Intervention for Suicidality

Start date: February 7, 2024
Phase: N/A
Study type: Interventional

The study involves a short therapy intervention for people who are experiencing thoughts of suicide. The intervention will focus upon different memories from the person's life. These memories will vary in the emotions they evoke - some memories will be associated with neutral emotions, whereas others will bring up positive emotions. The intervention will have a particular focus upon memories of times when the participants have moved away from thinking about suicide, with the aim of reinforcing memories of what helped them to reconnect with life. The intervention will also introduce relaxation techniques, in addition to involving a safety planning component. The project aims to consider whether this intervention is acceptable and feasible for this population.

NCT ID: NCT06224751 Recruiting - Clinical trials for Macular Degeneration

Developing Better Computerised Vision Tests (CVTV)

CVTV
Start date: April 2024
Phase:
Study type: Observational

Clinical vision measurements usually involve printed charts with an eye care professional interpreting patient responses to generate a score. Those scores determine the need for or outcome of treatment. Detecting change can be improved with strict procedures/scoring, lending itself to computerisation. This in turn allows integration with electronic medical records. Many eye tests could be computerised in this way. At Guys and St Thomas' NHS Foundation Trust, the investigators have developed and validated a computerised test of distance visual acuity, called COMPlog which is now in widespread use. The investigators now want to increase the range of tests available. There is also a need to longitudinally monitor for adverse change. Such monitoring must be developed to keep false positive and false negative change detection to a minimum. The aims of this two year linked program are to: Part A) validate an extended range of computerised vision measurement tests against their gold standard hard copy printed equivalents. Some of these tests are designed for use in children and all are meant to quantify both normal and impaired vision. Patients of all ages and visual function will therefore be recruited from St Thomas' Hospital. The specific tests we aim to validate are logMAR Letter Near Acuity, Word Near Acuity, Letter Contrast Sensitivity, Auckland Optotypes Picture Acuity, Low Contrast Letter Acuity, Stereoacuity and Vanishing Optotypes. Patients will undergo test-retest measurements with up to two of these. Part B) Iteratively develop an application for use in home monitoring of subjects at risk of treatable vision loss due to age related macular degeneration. All computerised tests in parts A and B will be performed on prototype software. Eye patients will be recruited as subjects. Patients recruited to part A will undergo tests on one day for up to an hour, subjects in part B will participate for between 1 hour and two months.

NCT ID: NCT06224569 Recruiting - Clinical trials for The Focus of the Study is Healthy Volunteers

Understanding the Effects of Daily Tea Consumption on Attention, Sleep, and Mood, in Healthy Adults

Reactivi-Tea
Start date: September 2, 2023
Phase: N/A
Study type: Interventional

The goal of these series of N-of-1 trials is to compare the effects of three tea interventions on cognition, mood, and sleep, in healthy adult participants. The main questions they aim to answer are: - What are the short-term effects of, and differences between, three different black tea interventions on cognition, mood, and sleep, in individual participants? - What are the short-term effects of, and differences between, three different green tea interventions on cognition, mood, and sleep, in individual participants? - Are there any other lifestyle factors that influence the relationship between tea intake and cognition, mood, or sleep, and to what extent do they have an effect? Participants will be asked to drink three different tea interventions in four blocks of three weeks, where each week is assigned one tea intervention. At regular intervals three times per day, seven days per week, for the 12-week study duration, participants will be asked to complete a sleep questionnaire, mood questionnaire, personalised questionnaire (with questions pertaining to physical activity and work, for example), a tea consumption recall questionnaire, and two cognitive tasks based on attention (lasting one minute each). These questionnaires and tasks comprise one measurement point and take approximately five to six minutes to complete.