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NCT ID: NCT06398470 Recruiting - Prostate Cancer Clinical Trials

Study to Evaluate a New Method to Detect Residual Tumours During Surgery for Prostate Cancer Using Confocal Microscopy

Start date: May 15, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Prostate cancer is the most common solid cancer affecting male patients worldwide. When diagnosed early, it can usually be cured with surgery (radical prostatectomy), but this procedure is associated with side effects such as urinary incontinence and erectile dysfunction. If the nerves that surround the prostate are left intact (nerve-sparing), the risk of developing these side effects decreases. However, since these nerves are in intimate contact with the prostate there is a chance of leaving cancer cells behind, with the subsequent need for additional treatments. Sadly, the current methods surgeons use to select patients who can safely be offered nerve-sparing are not very accurate in predicting where the tumour is extending outside the prostate. NeuroSAFE is a technique that can inform the surgeon if there are tumour cells on the surface of the prostate and indicate the need for removing more tissue during the same operation. However, it requires a specialised team to process the sample in a reasonable amount of time that does not excessively prolong the surgery. Therefore, many centres are not able to perform it. A new technology called fluorescence confocal microscopy (LaserSAFE) can be used to examine the surface of the prostate and can identify when cancer is present. Critically, it requires minimal training and resources to produce results in a few minutes and the microscope can be placed in the operating room. The investigators aim to recruit a group of 20 patients who will undergo radical prostatectomy as a treatment for prostate cancer. The prostate specimen will be analysed using both techniques, but decisions on how much tissue to resect during surgery will depend on the results of NeuroSAFE. This feasibility study will allow us to understand the challenges associated with performing both techniques. This will allow us to plan a larger study to evaluate the accuracy of LaserSAFE.

NCT ID: NCT06398340 Not yet recruiting - Healthy Volunteers Clinical Trials

Identifying Wearable Biomarkers to Monitor Dietary Intake

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

Background: Measuring what people eat is a challenge in nutrition research. Traditional methods, like food diaries, rely on self-reporting of individuals, and suffer from poor accuracy and recall bias. Aims: This project aims to identify physiological biomarkers related to food and energy intake, which may be used to develop an objective tool to estimate individuals' food intake in future. Eating behaviours are accompanied by significant physiological changes such as skin temperature, blood oxygen saturation, pulse rate etc. The investigators intend to investigate whether monitoring these physiological changes can help us estimate eating behaviour, such as meal size, eating speed, and duration of meals. Study design: Ten healthy adults will be invited for two study visits at NIHR Imperial Clinical Research Facility. Each visit will last for approximately 2 hr. They will consume a high- and low-calorie meal designed by nutritional researchers in a randomised order. During eating events, the investigators will track their physiological changes via a bedside monitor and wearable sensors. Blood samples will be taken from participants to measure their glycaemic response. Associations between energy load, glycaemic response, and physiological changes will be investigated. Our findings may promote an accelerated development of a wearable tool for dietary assessment in future.

NCT ID: NCT06398132 Recruiting - Pain Clinical Trials

Understanding and Managing Pain for Thalidomide Survivors

TRIUMPH-TS
Start date: May 15, 2024
Phase:
Study type: Observational

Aim: To explore the pain experience of Thalidomide survivors and propose an effective pain management service, tailored to meet the unique needs of this population. Background: Approximately 400 thalidomide survivors live in the UK, who are also beneficiaries of the Thalidomide Trust. Such individuals have been mainly born with upper or lower limb problems, but some also experience sight, hearing, or speaking difficulties. Most tend to experience additional problems, acquired after birth, including persistent muscle or joint pain as well as mental health problems. Such conditions may reduce the quality of life of thalidomide survivors, who face significant difficulties in accessing healthcare services or receiving effective treatment. Specialist services such as pain management are not easily available to thalidomide survivors. Providers' lack of understanding or flexibility to treat populations with unique needs, and geographical or financial barriers have been considered as possible reasons. Methods: This is a cross-sectional observational study. Thalidomide survivors, who are also beneficiaries of the Thalidomide Trust, will be offered a questionnaire booklet to fill, featuring questionnaires aiming to explore their pain experience (0-10 Pain Numerical Rating Scale, Central Aspects of Pain, painDETECT, Widespread Pain Index), mental health (Hospital Anxiety and Depression Scale), beliefs (Pain Catastrophizing, Tampa Scale of Kinesiophobia), quality of life (EQ-5D-5L), disability (Health Assessment Questionnaire), sleep (Athens Insomnia Scale), and medicines use (Pain Medication Attitude Questionnaire). Linear regression modelling will explore the factors that best explain the overall pain experience of Thalidomide Survivors. Impact: The research will inform how thalidomide survivors might gain access to an evidence-based pain management service designed specifically for them, which will improve their quality of life.

NCT ID: NCT06397664 Recruiting - Sexual Dysfunction Clinical Trials

The Impact of Chronic Adolescent Skin Conditions on Sexual Health

Start date: April 29, 2024
Phase:
Study type: Observational

Background: Skin conditions are common in young people and are known to adversely affect emotional well-being and quality of life in a range of ways, including negative impact on intimate relationships. However, despite its importance, it has been shown that dermatology consultations rarely address issues like genital skin involvement or sexual dysfunction. Furthermore, there is currently very little data on the scale of the problem, risk factors, psychological impact of skin on sexual function or understanding of the most appropriate ways to manage it in this age group. Research aims: The Dermatology department at Oxford University Hospitals National Health Service Trust (Oxford, United Kingdom) have already set up an award-winning specialist dermatology service for young people with embedded psychological support. This study further explores how services can be improved by evaluating the impact of chronic skin conditions on quality of life and sexual dysfunction in adolescents. By identifying the associated risk factors, recommendations can be made to effectively meet the physical and mental health needs of adolescents. Design and methods: The study will gain perspectives from follow-up patients aged 17 - 25 years seen by the Dermatology departments in Oxford University Hospitals National Health Service Trust (Oxford, United Kingdom). They will complete an online anonymous survey to share how their skin condition affects their quality of life, including sex and intimacy, and how services can be improved to meet their needs. In-depth interviews will then be conducted in those who volunteer, to better understand the nuances of unmet needs. Participation is voluntary. Dissemination: Results of the research will be disseminated by national and international conferences, publications in academic dermatology journals and collaborations with other NHS departments. Improvements will be made to the local adolescent dermatology service as a result and shared via local meetings and posters.

NCT ID: NCT06396663 Recruiting - Opioid Dependence Clinical Trials

DE-eSCALation of Opioids Post-surgical dischargE

DESCALE
Start date: January 11, 2024
Phase: N/A
Study type: Interventional

The Descale Study aims to: 1. Look at the prescribing trends of opioids and the scale of long-term use following surgery within East Kent (United Kingdom) 2. Carry out a feasibility study to: - see if clinical pharmacists can support patients following surgery to manage their post-surgical pain safely and prevent long-term opioid use - calculate how much it costs the National Health Service (NHS) - see how the patients experienced the intervention For Aim 1, historic records of patients who have had surgery and were discharged on opioids will be reviewed. Data collected will include type and strength of pain-relieving medication prescribed; type of surgery; number of additional opioid prescriptions following discharge; use of medical services (e.g., General Practice appointments, physiotherapy); and patient demographics. For Aim 2, clinical pharmacists will carry out early high-risk medication safety reviews to ensure that patients have their pain managed safely. Investigators will collect key data from patients receiving the clinical pharmacist intervention to see how it affected opioid use, costs and healthcare use. Patients who took part in the study will be invited to participate in an interview and will be asked what they know about opioids and the health risks, and their experiences of the intervention.

NCT ID: NCT06396273 Active, not recruiting - Dementia Clinical Trials

Eye Scanning for Safety Driving

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

This is an experimental study protocol to investigate the use of vision-based assessments like eye-tracking and visual processing tests to evaluate driving ability in older adults with and without dementia. The study aims to address the research gap on the specific eye movement patterns and visual behaviors of individuals with Alzheimer's disease during high-risk driving scenarios. The study will recruit 15 participants aged 65+ with cognitive impairment and 15 without cognitive impairment. Their cognitive status will be assessed using the Mini-Mental State Exam (MMSE) and Hopkins Verbal Learning Test (HVLT). Participants will undergo visual screening tests like visual sensitivity, eye movement scanning, and the Corsi block span test. Their driving performance will be evaluated through a hazard perception test and driving experience survey. Statistical analyses like correlations, group comparisons, regression, and mediation analyses will be conducted to examine the relationships between cognitive status, visual screening scores, and driving performance scores. The goal is to determine if visual measures can predict driving ability and mediate the link between cognitive function and driving performance in those with dementia. In summary, it is a protocol for an observational study using vision-based techniques to assess driving capacity in older adults, especially those with Alzheimer's disease or dementia.

NCT ID: NCT06396065 Recruiting - Clinical trials for Non-Squamous Non-small Cell Lung Cancer

Phase III Study of AK112 for NSCLC Patients

Start date: May 4, 2023
Phase: Phase 3
Study type: Interventional

A Randomized, Double-blind, Multi-center, Phase III Clinical Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Progressed on or Following Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment (HARMONi)

NCT ID: NCT06394921 Recruiting - Long COVID Clinical Trials

Cardiopulmonary Exercise Tests in Patients With Long COVID

PREPP-19
Start date: March 1, 2023
Phase:
Study type: Observational

The value of clinical cardiopulmonary exercise testing (CPET) within healthcare settings has been established in the last decade. CPET methods remain highly relevant in the COVID-19 endemic phase and should be used to assess those recovering from COVID-19 (SARS-CoV-2) infection. This diagnostic tool could play an integral role in disease prognostication and evaluate the integrative response to incremental exercise. Date from such assessments can enable practitioners to characterise cardio-respiratory fitness and identify reasons for physical impairment or abnormal cardio-respiratory function. More than 50% of patients admitted to hospital will experience cardiorespiratory issues and significant morbidity during their recovery and will require significant rehabilitative support. In this context, measurements obtained from an assessment of cardio-respiratory responses to physiological stress could provide insight regarding the integrity of the pulmonary-vascular interface and characterisation of any impairment or abnormal cardio-respiratory function. Current approaches to rehabilitation are being developed on existing knowledge from Severe Acute Respiratory Syndrome (SARS) and Acute Respiratory Distress Syndrome (ARDS) related illness. These provide important insight but do not provide insight into the novel challenges provided by COVID-19.

NCT ID: NCT06393842 Recruiting - Heart Failure Clinical Trials

Correlation of Non-invasive CPM Wearable Device With Measures of Congestion in Heart Failure in Exercise

CONGEST-HFEX
Start date: March 22, 2024
Phase:
Study type: Observational

Fluid status and congestion can be determined by the CPM wearable device and correlates with non-invasive measures and biochemical markers of congestion and changes in congestion.

NCT ID: NCT06392659 Recruiting - Pain Clinical Trials

A Phase 1, Open-label Study Evaluating the Pharmacokinetics and Drug-drug Interaction of VX-993 in Healthy Adults

Start date: May 2, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics (PK), drug-drug interaction, and safety and tolerability of VX-993 in healthy participants.