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NCT ID: NCT04784845 Completed - Clinical trials for Microbial Colonization

Lactamica 9: Neisseria Lactamica Inoculation in Late Pregnancy

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Bacteria living in the nose and throat are generally harmless, but in some circumstances cause infections of the lungs (pneumonia) and brain (meningitis), which are among the commonest causes of death worldwide in young children (especially newborns). Babies with certain 'good' bacteria in the nose and throat are less likely to have infections by such 'bad' bacteria. Scientists have tried giving probiotics ('good' bacteria swallowed or sprayed into the nose) to pregnant women, new mothers and babies. These studies show that many probiotics are safe, but the amount of bacteria given is often unknown, and it is unclear if they work. A more precise option is to use controlled inoculation, by inserting a specific amount of particular 'good' bacteria into the nose under carefully controlled conditions. Our team have previously shown that inoculation with Neisseria lactamica ('good' bacteria) safely and reliably decreases Neisseria meningitidis ('bad' bacteria) in healthy adults' noses. N. lactamica is a type of harmless bacteria found in over 40% of children aged 1-2 years, but is uncommon in newborns and adults. We plan to inoculate 20 healthy pregnant women with N. lactamica nose drops, to find out if it is transferred to their babies after birth. Newborns become rapidly covered (colonised) with bacteria from their mothers, other people, and the environment, so this method mimics a natural way that babies receive bacteria. We will take saliva and nose swabs one day, one week, one month and four months after birth, and will use microbiological and genetic methods to study how the bacteria changes in babies compared with their mothers.

NCT ID: NCT04783935 Completed - Multiple Sclerosis Clinical Trials

Extension to the MAGNIFY MS Trial on Mavenclad® (Magnify MS Extension)

Start date: March 10, 2021
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to evaluate the long-term effectiveness of Mavenclad® tablets, in terms of disease activity and safety, in participants with highly-active relapsing multiple sclerosis (RMS) previously participating in the MAGNIFY MS trial MS700568_0022 (NCT03364036).

NCT ID: NCT04783883 Completed - Safety Issues Clinical Trials

Electrical Vestibular Nerve Stimulation (VeNS): A Follow-up Assessment of Long-term Usage

Start date: March 4, 2021
Phase:
Study type: Observational

A follow-up assessment study of the long-term safety of vestibular electrical stimulation as delivered by the Vestal DM Device.

NCT ID: NCT04781816 Completed - Clinical trials for Cutaneous Lupus Erythematosus

Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus

CLEan
Start date: April 1, 2021
Phase: Phase 2
Study type: Interventional

Primary Objective: - Assess the efficacy of SAR443122 in cutaneous lupus erythematosus (CLE) Secondary Objectives: - Assess the effect of SAR443122 on the physician's global assessment of disease activity (PhysGA - disease activity) - Assess the effect of SAR443122 on CLE induced itch and overall pain - Assess the effect of SAR443122 on the proportion of disease activity responders compared to placebo - Assess the effect of SAR443122 on the CLASI components score - Assess the effect of SAR443122 on the Investigator's global assessment for CLE (IGA-CLE) - Assess oral cavities for patients with oral lesions - Assess the disease specific quality of life (QoL) - Assess the safety and tolerability of SAR443122 in patients with CLE - Assess the pharmacokinetics (PK) exposure of SAR443122 in patients with CLE

NCT ID: NCT04780867 Completed - Stress Clinical Trials

Psychological and Lifestyle Factors on Health Outcomes

Start date: October 19, 2020
Phase: N/A
Study type: Interventional

Psychosocial and lifestyle factors in Army recruits likely contribute to increased susceptibility to infection and injury during basic Army training. The primary aim of this study is to assess the influence of psychosocial and lifestyle factors at the start of basic Army training on immune health (e.g. respiratory infection and antibody response to influenza vaccination) and injury during training, in an observational design. A secondary aim is to establish whether changes in psychosocial and lifestyle factors during training impact immune health (e.g. response to hepatitis B vaccination). Using an interventional design, participants will be randomly allocated into two experimental groups: (i) Routine vaccination group: to receive first hepatitis B vaccination at initial medical assessment upon entry to basic training and second hepatitis B vaccination 1 month later; (ii) Delayed vaccination group: to receive first hepatitis B vaccination during week 5 of training and second hepatitis B vaccination 1 month later.

NCT ID: NCT04779710 Completed - Pneumonia Clinical Trials

How Does Dysphagia Assessment in Acute Stroke Affect Pneumonia?

Start date: September 2, 2020
Phase:
Study type: Observational

Stroke-associated pneumonia (SAP) is common in acute stroke. A significant risk factor is dysphagia. To identify dysphagia, patients are screened using a bedside tool and those suspected of dysphagia then have a specialist Speech and Language Therapy (SLT) assessment. Currently there is a wide range of screening protocols used. The aim of this research is to investigate the variation in dysphagia assessment and management to identify what factors affect the risk of SAP. The type of screen and other variations in management and practice (such as time from hospital admission to when the screen is done) will be investigated to identify any associations with higher risk of SAP. A mixed methods study will include a systematic review of the literature, interviews with patients, carers and staff and a review of medical records to investigate the patient journey during the first 72 hours from admission. Findings will be triangulated to inform a national survey of dysphagia screening and management in hospitals registered with the Sentinel Stroke National Audit Programme (SSNAP). Data from the survey will be cross-referenced with the SSNAP register and analysed to identify relationships. Results will inform development of an intervention to reduce SAP for subsequent feasibility testing.

NCT ID: NCT04778423 Completed - Eating Disorders Clinical Trials

Feasibility and Acceptability of AVATAR Therapy in Eating Disorders.

Start date: August 5, 2021
Phase: N/A
Study type: Interventional

This project will answer the overarching research question "What is the feasibility of developing and implementing AVATAR therapy to reduce the power of the eating disorder voice in patients with eating disorders?". AVATAR therapy for eating disorders has been developed based on AVATAR therapy for psychosis. The feasibility of using AVATAR therapy in eating disorders will be tested using non-concurrent multiple baselines single case experimental design. The first stage (A1) will involve participants being randomly allocated to either a two, three or four week-baseline. The second will be the intervention phase (B) where participants will receive the AVATAR treatment which will last approximately 6 weeks. The third stage (A2) will be a 4-week follow-up period after the intervention phase, where participants will also complete a qualitative interview.

NCT ID: NCT04778410 Completed - Clinical trials for Myeloid Malignancies

Study of Magrolimab Combinations in Participants With Myeloid Malignancies

Start date: June 28, 2021
Phase: Phase 2
Study type: Interventional

The goal of this clinical study is to learn more about the safety and dosing of the study drug, magrolimab (Mag), in combination with anti-leukemia therapies in participants with acute myeloid leukemia (AML).

NCT ID: NCT04777630 Completed - Clinical trials for Charles Bonnet Syndrome

Neuroscience of Charles Bonnet Syndrome

Start date: September 1, 2021
Phase:
Study type: Observational

Charles Bonnet Syndrome (CBS) is a condition in which people experience complex visual hallucinations, such as 'Acrobats balancing on bicycles' or 'Spiders crossing meals'. The condition usually occurs in people who have significant vision loss due to eye disease. The aim of this project is to help understand how these hallucinations come about. In the healthy visual system, the eye provides input to a large area of the brain that performs the computations required to allow us to see the world. There are specialised brain regions responsible for processing of faces, objects, motion and colour. When the eye is no longer working, these parts of the brain lose their input and this may lead to abnormal activity. Not all people with eye disease and vision loss develop CBS, so the investigators will use magnetic resonance imaging (MRI) to compare the brains of people with and without the condition. In particular the investigators are interested in measuring the levels of chemicals in the visual areas of the brain to see whether they are disrupted in CBS, leading to the hallucinations. It is possible to measure how the different areas of the visual brain are connected together and see whether this is altered in CBS, perhaps with increases in the strength of connection between specialised areas. These measures will be related to questionnaires about hallucinations and vision. This will be done by comparing low vision who experience Charles Bonnet visual hallucinations compared to low vision patients who do not have hallucinations. Assessments will take place at the Wellcome Centre for Integrative Imaging (WIN) based at the John Radcliffe Hospital. The study will provide insight into the role of the brain in generating CBS hallucinations, helping us to design a larger study and eventually to test whether there are interventions to help improve the condition.

NCT ID: NCT04777461 Completed - Clinical trials for Polycystic Ovary Syndrome

Living With Polycystic Ovary Syndrome

LW-PCOS
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

This project aims to develop and pilot an evidence-based structured education program that can be run in groups to enable women with PCOS to make lifestyle changes, which will help them improve their PCOS and reduce the risk of future PCOS-related complications.