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NCT ID: NCT06054009 Recruiting - Dissociation Clinical Trials

Dissociation CBT Studies

DisCS
Start date: September 20, 2023
Phase: N/A
Study type: Interventional

Dissociation involves distressing feelings of unreality and disconnection. Evidence suggests it is particularly common amongst people with existing mental health difficulties, where it has been linked with greater clinical severity, poorer treatment response, and increased self-harm and suicidality. However, there are currently no psychological treatments for dissociation that have been developed from a scientific understanding of its underpinning psychological factors. In this project, three studies, each with four participants, will test a different psychological factor. Participants will be: adults (16+ years); on a waiting list for NHS psychological therapy; high scorers on a dissociation questionnaire. Participants will complete assessments before and after treatment, and at a one-month follow-up. The studies follow a 'multiple baseline design', meaning that all four participants for that study will complete their baseline assessment in the same week, and then be randomly allocated to wait either one, two, three, or four weeks before starting the intervention. The intervention will consist of four therapy sessions taking place within a five-week 'window'. Taking part in the research is voluntary. Before deciding whether to participate, we will explain the study and answer any questions. Daily, participants will record a score for their dissociation and the psychological factor being targeted. At baseline, post-therapy, and follow-up, the researchers will also measure their levels of other factors related to dissociation (i.e. those not targeted by the therapy). Additionally, feedback will be requested from participants about the therapy at the end of their involvement, in order to improve it in future. Ultimately, if successful, these interventions could form a pilot therapy for further testing and development. This could mean fewer people struggle with the challenges of dissociation.

NCT ID: NCT06053840 Recruiting - Insomnia Clinical Trials

An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients With Severe Insomnia

RESTORE
Start date: September 21, 2023
Phase: Phase 4
Study type: Interventional

The primary aim of this Real-World Evidence trial is to establish whether short-term (2 weeks) treatment of Chloral Hydrate is effective in patients with severe insomnia which is interfering with normal daily life, and where other behavioural and pharmacologic therapies have failed in a real world setting.

NCT ID: NCT06053788 Completed - Hyperlipidemias Clinical Trials

PocDoc Lipids Usability Study for Self-test Use

Start date: April 26, 2023
Phase: N/A
Study type: Interventional

This study seeks to expand the approved indication of use for a UKCA approved IVD device. PocDoc lipids is approved for professional use to measure the levels of lipids in a fingerprick blood samples. This study will investigate the usability of the device by untrained lay people in order to expand the device's utility to the self-test setting.

NCT ID: NCT06053697 Recruiting - Preterm Birth Clinical Trials

Is the Vaginal Microbiome and Metabolome Associated With Spontaneous Preterm Birth (sPTB) in Multiple Pregnancies?

SPRUCE
Start date: July 5, 2022
Phase:
Study type: Observational

The aim of this study is to try and find links between the microscopic organisms (such as bacteria, yeasts and viruses) in the vagina, and twin pregnancies that deliver too early (preterm birth). Being born earlier than expected (preterm birth) happens in over half of twin pregnancies with 1 in 10 sets of twins delivering before 32 weeks gestation. Sometimes, when birth happens very early, babies can be at risk of serious harm including damage to the brain, lungs and bowel - all of which can result in life changing disabilities. How severe these problems are is related to how early they are born. Unfortunately, tests used to find women at risk of preterm birth have only been proven to work when the woman is carrying one baby, not twins, and at present no treatment has been shown to be effective in stopping a twin pregnancy from delivering early. Preventing twins from being born too early is therefore a target for research by the NHS and patient groups including the James Lind Alliance. It is normal for every woman to have microscopic organisms (such as bacteria, yeasts and viruses) in the vagina. New interest has been shown at looking closely at these organisms during pregnancy. These organisms can change and may be related to the number of weeks a woman will go into labour, however to date all research on this has been conducted in pregnancies with only one baby. We want to explore these organisms in twin pregnancies; taking swabs from the vagina at 16- and 28-weeks of your pregnancy, along with at the time of birth. Information will be gathered on the organisms present in the vagina (both of women that deliver too early and those that deliver on time), hoping this information will help us understand why preterm birth happens and help predict the chances of preterm labour in twin pregnancies. By identifying specific organisms linked with preterm birth, we also hope to be able to guide new targets for treatments to prevent preterm birth in twins in future. Due to the small number of twin pregnancies, measurements of how 'stiff' the neck of the womb (cervix) are along with blood samples will be taken. Research has shown that there may be links with how stiff the neck of the womb is and premature birth as well as markers within the blood that may help us predict preterm birth that are yet to be discovered. This will provide the foundations for a future research study.

NCT ID: NCT06053671 Recruiting - Epilepsy Clinical Trials

Mos-FED (Mosaicism in Focal Epilepsy Cortical Dysplasia Tissue)

MosFED
Start date: April 9, 2023
Phase: N/A
Study type: Interventional

Focal cortical dysplasia (FCD) is a malformation of brain development, the most common cause of drug-resistant epilepsy and often caused by mutations in mammalian target of rapamycin (mTOR) pathway genes. Patients with FCD develop drug-resistant seizures. This study will look at FCD tissue removed during epilepsy surgery and aims to detect mutations in mTOR pathway genes in brain cells. Secondly, the investigators will establish if evidence of mutations found in brain cells can also be detected as circulating free DNA (cfDNA) in blood. By looking at which genes are made into proteins in individual cells found in epilepsy surgical tissue (single cell expression profiling),the investigators will attempt to identify new genetic targets in FCD. The main outcome will be finding new causes of epilepsy with FCD and the development of new diagnostic and screening tools.

NCT ID: NCT06053177 Recruiting - Heart Failure Clinical Trials

Multi-morbidity Screening in People With Type 2 Diabetes and Pre Diabetes

Start date: January 25, 2023
Phase:
Study type: Observational

People with type 2 diabetes are at risk of complications linked with high blood sugars and these are monitored for in healthcare appointments. However, people with type 2 diabetes commonly suffer with additional health conditions that can affect the liver, heart and their breathing while sleeping. These conditions are thought to be caused by a similar underlying process that causes type 2 diabetes, as a result they are very common in people type 2 diabetes. Despite this they are not part of the routine health check for these people. Worryingly, current research suggests that the risk for developing these health problems, and direct complications of type 2 diabetes, can start at blood sugar levels below the threshold of type 2 diabetes. In a group of people said to have prediabetes. These people do not currently undergo annual healthcare appointments to monitor for these health complications or other linked health conditions. This study aims to pilot a new style of clinic to address these issues. The investigators will perform a multi-morbidity assessment, where they will look for several different health problems at the same time. The investigators will be looking at health problems linked with high blood sugars, this will include problems with the liver, heart, nerves, eyes, and participants breathing overnight. They have developed a clinic visit which uses questionnaires, simple examination techniques and modern devices to try and identify these health problems. An important part of healthcare is the burden it places on people with health problems, with this in mind the investigators will be giving the people involved in their study a voice to try and direct future research and healthcare, the investigators will ask them to provide feedback on their experience in taking part in the study and what their thoughts are in undergoing a longer but more comprehensive health appointment.

NCT ID: NCT06052475 Recruiting - Heart Failure Clinical Trials

Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades

PROTECT-UP
Start date: September 25, 2023
Phase: N/A
Study type: Interventional

Guidelines for patients having first-time implants advocate that even when heart function is only mildly impaired, modern pacing approaches should be utilised to avoid the potentially damaging effects of RV pacing to preventing symptoms from pacing induced or worsened cardiomyopathy. However, once a traditional (RV) pacemaker is implanted, development of impaired heart function does not prompt a device upgrade. Even at the end of battery life, physicians simply replace it like-for-like. This trial tests whether such patients have better symptoms and quality of life if changed to a modern physiological pacing strategy from the traditional RV pacing approach. In this crossover trial, participants will be upgraded to a physiological pacing strategy. After their procedure, they will have a one-month run-in period to recover from the procedure (their pacemaker will be programmed to continued RV pacing). They will be have 2 one-month blinded time periods, randomised to physiological pacing or right ventricular pacing alternately. They will subsequently undergo two six-month blinded randomised time periods. Patients will document symptoms monthly on a mobile phone application or computer. At the end of each time period, they will have measurements of heart function, a walking test and quality-of-life questionnaires including the SF-36 questionnaire. The investigators hypothesise that upgrading to physiological pacing strategies will improve patients' quality of life.

NCT ID: NCT06052371 Terminated - Diabetes Mellitus Clinical Trials

Project VerioVue Enhancements - Neonate Study

Start date: October 16, 2023
Phase:
Study type: Observational

The goal of this performance evaluation is to compare the blood glucose results obtained using the VerioVue Blood Glucose Monitoring system (BGMS) with those obtained from a validated comparator method (iSTAT 1 Analyser) using blood obtained from neonates. The main question it aims to answer is: •How accurate is the VerioVue BGMS when compared to a product that has already been confirmed as accurate (iSTAT 1 Analyser) when hospital staff test blood taken from neonates on these instruments? Participants (neonates) will have a small amount of blood taken from a heel prick (performed by a HCP for medical purposes) or from an existing arterial line.

NCT ID: NCT06052306 Recruiting - Clinical trials for Metastatic Castration-resistant Prostate Cancer

A Study to Learn How Safe the Study Treatment Actinium-225-macropa-pelgifatamab (BAY3546828) is, How it Affects the Body, How it Moves Into, Through and Out of the Body, and About Its Anticancer Activity in Men With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC)

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

Researchers are looking for a better way to treat people who have advanced metastatic castration-resistant prostate cancer (mCRPC). In men with metastatic castration-resistant prostate cancer (mCRPC), the cancer of the prostate has spread to other parts of the body (metastatic) and does not respond to the lowering of testosterone levels in the body (castration resistant). The cancer is 'advanced' and is unlikely to be cured or controlled with currently available treatments. Despite new treatment options for men with prostate cancer in recent years, the cancer often returns and worsens. The study treatment actinium-225-macropa-pelgifatamab (also called 225Ac-pelgi or BAY3546828) is a new type of treatment under development for men with mCRPC who have already received available treatments or have few treatment options available. It works by binding to a protein on the surface of the cancer cells called prostate specific membrane antigen (PSMA). As it gives off a type of radioactivity that travels a very short distance, it kills the nearby (cancer) cells that express PSMA. The main purpose of this first-in-human study in men with mCRPC is to learn: - How safe different doses of 225Ac-pelgi are. - To what degree medical problems caused by 225Ac-pelgi can be tolerated by the participants? - Which dose of 225Ac-pelgi is optimal for treatment (safe and working well)? - How good is 225Ac-pelgi's anticancer activity? To answer this, the researchers will look at: - The number and severity of medical problems that the participants have after treatment with 225Ac-pelgi (per dose level). - The ratio of medical problems and anticancer activity per dose. - Anticancer activity of the optimal 225Ac-pelgi dose as proportion of participants who have at least halved prostate-specific antigen (PSA) levels after 12 weeks of treatment or later and/or shrunken or no longer detectable tumors. - The lowest PSA level reached after treatment start. Doctors keep track of all medical problems (also called adverse events) that participants have during the study, even if they do not think that they might be related to the study treatment. Anticancer activity is measured using cancer imaging techniques and change in blood level of a protein called PSA. PSA is made by normal and by cancerous cells in the body. The PSA level is taken as a marker for prostate cancer development and is usually elevated in men with mCRPC. In addition, researchers want to find out how 225Ac-pelgi moves into, through and out of the body. The study will have two parts. The first part, called dose escalation, is done to find the most appropriate dose and schedule that can be given in the second part of the study. For this, each participant will receive one of the predefined increasing doses of 225Ac-pelgi as an infusion into the vein. All participants in part 2, called dose expansion, will receive the most appropriate dose and schedule identified from the first part of the study. More than one dose level or schedule from part 1 may be tested. Both the participants and the study team know what treatment the participants will take. Participants in this study will take the study treatment 225Ac-pelgi once in a period of 6 weeks called a cycle. Each participant will have 4 of these treatment cycles, if the participant benefits from the treatment. Each participant will be in the study for up to nearly six years, including a first test (screening) phase of a maximum of 28 days, up to 12 months of treatment depending on the participant's benefit, and a follow-up phase of 60 months after the end of treatment. The following visits to the study site are planned: 2 during the screening phase, 8 in the first treatment cycle, 7 in subsequent cycles, and a visit 6 to 12 weeks after the last dose. In the following 12 months, visits are planned every 6 weeks and during the next 48 months phone calls or clinic visits are planned approximately every 12 weeks. In addition, a sub study during the dose escalation part will gather information on the distribution of the study treatment in the body, the proportion that binds to the cancer cells, and the resulting radiation at the tumor site. During the study, the study team will: - Do physical examinations - Check vital signs such as blood pressure, heart rate, and body temperature - Take blood, and urine samples - Examine heart health using echocardiogram and electrocardiogram (ECG) - Take tumor samples - Track 225Ac-pelgi in the body using gamma imaging (generally available at all study sites) - Check the tumor status using PET (positron emission tomography), CT (computed tomography) or MRI (magnetic resonance imaging) and, if needed, bone scan - Ask questions about the impact of the disease on the participants' wellbeing and activities of daily life (Eastern Cooperative Oncology Group Performance status (ECOG PS)).

NCT ID: NCT06051877 Recruiting - Parkinson Disease Clinical Trials

Ocular Microtremor in Parkinson's Disease.

OMTinPD
Start date: September 1, 2023
Phase:
Study type: Observational [Patient Registry]

This is an exploratory, observational study that will use a novel handheld device - The iTremor ONE, which has been developed to rapidly, non-invasively assess and evaluate OMT frequency. This device uses incident laser technology directed at the sclera. PwPD who meet the inclusion criteria will participate in a home-based assessment involving cognitive, motor (using the UPDRS-III) and OMT measures. With OMT as the primary outcome, assessment with the iTremor is incredibly quick, taking just three seconds to obtain a reading. PwPD will be assessed both 'off' and on their anti-parkinsonian medication. 'Off' is defined as a 12Hr overnight washout period where participants are tested in the morning prior to their first dose. PwPD will also be invited into the laboratory to perform extensive cognitive assessments along with an assessment of balance, gait, and turning using wearable sensors. 40 PwPD, 20 with suspected PD, and 40 age-matched healthy control participants will be recruited for assessment of OMT. Ten PwPD will complete a test-retest reliability assessment at the same approx. time, exactly one week after their initial visit.