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NCT ID: NCT05536947 Recruiting - Healthy Clinical Trials

Micronutrient Bioavailability From Wheat

Start date: November 26, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if physical disruption of wheat aleurone cell walls (micro-milling) increases micronutrient availability.

NCT ID: NCT05536622 Recruiting - Fractures, Bone Clinical Trials

Hi-Res IR Thermography for the Diagnosis of Toddler's Fractures

Start date: February 11, 2021
Phase: N/A
Study type: Interventional

This is a pilot proof of feasibility study to explore the efficacy of high resolution thermal imaging (HRTI) to screen for toddler's fractures. In HRTI, a sensitive thermal camera is used to capture the temperature profile of the suspected fracture region and then analyse and interpret the information using image processing. Toddler's fractures are a common type of tibial fracture in children under 5 years old that can be particularly difficult to detect as the bone typically appears normal on x-ray for the first 10 days and becomes detectable thereafter only as new bone forms. The child's leg is put in plaster in the interim and the diagnosis cannot be confirmed until 10-14 days later. Around 60% of children with suspected toddler's fracture will not have a fracture, and would therefore have had plaster, repeat attendances and repeat x-ray unnecessarily. There is also the inconvenience and general risks of plaster immobilisation for the child. In an earlier study, the investigators demonstrated that HRTI has potential in diagnosing limp in children. This study included two children with toddler's fracture where HRTI detected the fracture's location on the patient's first Emergency Department(ED) visit. In this study, the investigators aim to build on earlier work to explore HRTI for screening for toddler's fracture. On its successful completion, the investigators aim to develop the technology in a follow on larger diagnostic study as a tool that could be used to quickly exclude cases where the injury has not resulted in a fracture. This would allow more objective decision making during the initial assessment of the child. In addition, a reduction in the number of unnecessary x-rays, revisits, treatment as well as cost is anticipated.

NCT ID: NCT05535946 Recruiting - Ulcerative Colitis Clinical Trials

ABTECT - Maintenance

Start date: January 16, 2023
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors]. This study is the maintenance phase of both previous induction studies ABX464-105 and ABX464-106. All eligible subjects who have completed either one of the induction studies above mentioned, will be given the opportunity to take part in the present ABX464-107 maintenance study and will be randomized to either a double blind, placebo-controlled part (Part #1) or allocated to ABX464 50mg or 25mg open label treatment arms (Part #2) depending on their clinical response at the end of induction. This study consists of a 44-week treatment phase and a 28-days follow-up period consisting in the End of Study (EOS) visit.

NCT ID: NCT05535868 Recruiting - Clinical trials for Streptococcus Pneumonia

Experimental Human Pneumococcal Challenge With SPN3

Challenge3
Start date: August 1, 2022
Phase: N/A
Study type: Interventional

The 'Experimental Human Pneumococcal challenge' (EHPC) model is a way of putting drops of bacteria into the nose. Investigators have studied this model of putting bacteria in the nose safely in over 1500 volunteers over the past decade with no serious side effects and now want to test the model using a different strain of the bacteria that is commonly found in the community, SPN3. The aim of this study is to determine how much pneumococcus is needed to achieve nasal colonisation and how long the bacteria live in the nose for before natural immune responses eradicate them. By doing this, Investigators will then be able to test how well future vaccines prevent colonisation with pneumococcus. Investigators want to learn more about how the immune system responds to nasal colonisation with pneumococcus, again to help with development of new vaccines.

NCT ID: NCT05535426 Recruiting - Adhesive Dental Clinical Trials

Feasibility Study to Assess Outcomes of Immediately Inserted and Restored Dental Implants Using pH-modified Tetranite

Start date: September 22, 2022
Phase: N/A
Study type: Interventional

The aim of this Pilot Study is to demonstrate the safety and efficacy of the use of Tetranite Implant Stabilization Material (TN-ISM) in delivering enhanced stability to immediately restored dental implants inserted into fresh extraction sockets, with both clinical and patient-related successful outcomes.

NCT ID: NCT05534958 Recruiting - Clinical trials for Mild Cognitive Impairment and Dementia

UK Validation of the Automated "AcceXible" Speech Analysis Software

Start date: August 1, 2022
Phase:
Study type: Observational

Dementia, especially dementia caused by Alzheimer's disease, is considered one of the most severe health problems of our time. It is currently known that the disease begins many years before clinical symptoms appear. The sooner the patient is diagnosed, the sooner the patient will be in a position to prevent further deterioration. A recent orientation is the analysis of language in relation to the description of images with a high and varied semantic and emotional content. It can be studied that changes in the description of an image check if these changes are associated with the evolution of a person with probable impairment both in memory and cognitive as well as emotional, psychiatric, behavioral and even in their interaction with environmental factors especially those associated with socialization and loneliness. The present study has the objective of validating a digital method for detection and follow-up of patients with mild cognitive impairment (MCI) or dementia in a memory clinic setting.

NCT ID: NCT05534906 Recruiting - Clinical trials for Hepatocellular Carcinoma

The Detection of Small Early Liver Cancer With Natural History Follow up

SELINA
Start date: May 23, 2022
Phase:
Study type: Observational

The SELINA study will recruit 200 patients with cirrhosis and small HCC and 50 patients with HCC but without cirrhosis (most of whom are expected to have FLD). Blood, urine and liver tissue samples (where available) will be collected for laboratory analysis. In a subgroup of patients (N=80, around 64 patients with HCC with liver cirrhosis and around 16 patients with HCC without liver cirrhosis), additional magnetic resonance liver imaging will be performed. The findings of the SELINA study aim to identify biomarkers that can be used to detect liver cancer at the earliest possible time, something we expect will increase the survival rate of HCC.

NCT ID: NCT05533697 Recruiting - Clinical trials for Advanced Solid Tumors

Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors

Start date: August 18, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The primary goal of this study is to assess the safety and tolerability of mRNA-4359 administered alone and in combination with pembrolizumab.

NCT ID: NCT05533541 Recruiting - Radiation Disease Clinical Trials

Pelvic Radiation Disease in Childhood Cancer Survivors

Start date: October 1, 2023
Phase:
Study type: Observational

This study aims to characterise the impact of radiotherapy on physical symptoms and quality of life in childhood and young adult cancer survivors. This is in line with current NHS strategic priorities and an unmet clinical need to optimise aftercare in this patient group. In order to provide effective treatment strategies, the scale and impact of symptom burden requires better characterisation. A significant proportion of adult patients suffer with gastrointestinal and urinary symptoms and sexual dysfunction following radiotherapy treatment. However there is a lack of data in the paediatric and young adult population. We will study patients who underwent abdomino-pelvic radiotherapy, who completed treatment between 2000 and 2021 and were under the age of 24 years at the time of treatment. Patients will be recruited from The Royal Marsden Hospital, Great Ormond St Hospital and University College Hospital. Once these patients are identified we propose to prospectively assess severity of their ongoing symptoms using an electronic questionnaire, including relevant extracts from existing validated questionnaires. Treatment and patient related factors will be extracted from patient hospital records. A further qualitative arm of the study will be completed on a sub-set of 10 patients. We will identify appropriate patients that are willing to participate in qualitative research at the time of consenting. One-to-one interviews will be conducted to gain a better insight into their symptom burden, quality of life, patient perceptions of current services and view of currently unmet needs. This study will provide novel data on the frequency and severity of gastrointestinal and bladder related radiotherapy toxicity in young adult cancer survivors and assess impact on sexual function and quality of life. We would then propose to use this data to focus on service improvements within the regional paediatric and TYA cancer aftercare service driven by patient experience and clinical need.

NCT ID: NCT05533515 Recruiting - Prostate Cancer Clinical Trials

Circulating Tumour Cells as Biomarkers to Predict Prostate Cancer Metastasis for Treatment Stratification of Cancer

C-ProMeta-1
Start date: February 8, 2022
Phase:
Study type: Observational

The goal of this study is to establish the value of Circulating Tumour Cell (CTC) positivity in predicting post-RP treatment failure, including BCR and new lesions detected by cancer imaging. We plan to recruit participants who will undergo Radical Prostatectomy (RP). Participants will have their blood samples taken just before surgery and 3 months after the surgery to test for CTCs. Then participants will be followed-up for cancer progression information at 3 month intervals for the first year then yearly intervals after that. Their PSA will be observed over time.