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NCT ID: NCT05824026 Completed - Clinical trials for Partial-thickness Burn

Investigation of the Clinical Performance of Biatain Fiber Ag on Burns

Start date: October 27, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to test a new gelling fiber wound dressing with silver on patients with a partial thickness burn wound, which is infected or at risk of infection. Participants will be asked to wear the test dressing in a two weeks period(+/- 2 days) consisting of 3-4 study visits, and will have the dressing changed once pr. week at the research facility. The wound will be cleaned, assessed and photos will be uploaded to a digital software system.

NCT ID: NCT05822908 Recruiting - Huntington Disease Clinical Trials

A Safety and Pharmacokinetics Trial of VO659 in SCA1, SCA3 and HD

Start date: February 14, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this first-in-human clinical trial is to assess the safety and tolerability of four doses of a new study drug called VO659 in people with genetic disorders called spinocerebellar ataxia type 1, type 3 or Huntington's disease. Another aim is to determine the concentrations of the study drug in the cerebral spinal fluid and blood after single and multiple doses. Study drug will be administered by lumbar intrathecal bolus injections.

NCT ID: NCT05822557 Completed - Stroke Clinical Trials

Bolus Pouch Feed Study

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

The primary aim of this study is to evaluate the impact of introducing a new enteral tube feed on health and feeding related quality of life. Secondary aims are to assess ease of use, liking, compliance, gastrointestinal tolerance, nutrient intake, anthropometric changes and safety.

NCT ID: NCT05821959 Recruiting - Clinical trials for Sensorineural Hearing Loss, Bilateral

Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss

Start date: September 15, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Part A of this trial will evaluate the safety and tolerability of a single unilateral administration of one of two dose levels of AAVAnc80-hOTOF and will evaluate the Akouos delivery device to safely achieve the intended product performance.

NCT ID: NCT05820984 Completed - Clinical trials for Adequate Reporting in Published Study Protocols of Randomized Controlled Trials

A Short SPIRIT Checklist for Peer Reviewers to Improve the Reporting Quality in Published Articles (SPIRIT-PR)

SPIRIT-PR
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

Transparent and accurate reporting is key, so that readers can adequately interpreting the results of a study. The aim of this project is to evaluate whether reminding peer reviewers of the most important SPIRIT reporting items (including a short explanation of those items) will result in higher adherence to SPIRIT guidelines in published protocols for RCTS. During the standard peer-review process, peer-reviewers will be randomly allocated to use either (i) a short version of the SPIRIT checklist including the ten most important and poorly reported SPIRIT items ; or (ii) no checklist. The aim is to find an intervention which improves the reporting, making it easier for readers to adequately interpret the presented articles.

NCT ID: NCT05820971 Completed - Clinical trials for Adequate Reporting in Randomized Controlled Trials

A Short CONSORT Checklist for Peer Reviewers to Improve the Reporting of Randomised Controlled Trials Published

CONSORT-PR
Start date: June 15, 2019
Phase: N/A
Study type: Interventional

Transparent and accurate reporting is key, so that readers can adequately interpreting the results of a study. Despite improvement with implementation of the CONSORT Statement (CONsolidated Standards for Reporting Trials), there remain major reporting deficiencies in published randomized controlled trials (RCT). The aim of this project is to evaluate whether reminding peer reviewers of the most important CONSORT items (including a short explanation of those items) will result in higher adherence to CONSORT guidelines in published RCTs. During the standard peer-review process, peer-reviewers will be randomly allocated to use either (i) a short version of the CONSORT checklist including the ten most important and poorly reported CONSORT items as defined by a group of experts of the CONSORT Statement (C-short); or (ii) no checklist. The aim is to find an intervention which improves the reporting, making it easier for readers to adequately interpret the presented results.

NCT ID: NCT05820698 Recruiting - Psoriasis Vulgaris Clinical Trials

The Mediterranean Diet and Time-Restricted Eating Dietary Interventions for Psoriasis Study

METRED-P
Start date: June 8, 2023
Phase: N/A
Study type: Interventional

The METRED-P study will test the feasibility of implementing a Mediterranean style diet and/or time-restricted eating as dietary patterns in individuals with psoriasis. This study will address the following research questions: 1. Are participants' able to adhere to the allocated dietary intervention? 2. What is the participants' acceptability of the allocated dietary intervention? 3. What is the practicality (from a clinician's stand point) of delivering the dietary interventions? 4. When adhering to the allocated intervention, are there changes in psoriasis severity? 5. When adhering to the allocated intervention, are there changes in measures of body composition? 6. When adhering to the allocated intervention, are there changes in fasting blood measures? Participants will attend an initial clinic visit for a fasting blood sample, psoriasis examination, body composition measurements, and will complete short multiple-choice questionnaires on the severity of their psoriasis. A Research Nutritionist will deliver the diet interventions as diet consultation sessions. These sessions are reoccurring throughout the study as virtual consultation booster sessions, which are supplemented with wellbeing check-in calls. Participants will complete short questionnaires on the severity of their psoriasis and will record their dietary intake for 4 days, before the start of the study, and on week 1, week 6, and week 12 of the study. The allocated diet should be adhered to for 12 weeks until the end of the study, where participants will return and attend a final clinic visit to repeat the measures obtained during the initial clinic visit. Researchers will compare the feasibility of implementing a Mediterranean style diet and a Mediterranean style diet with time-restricted eating, with a UK diet with time-restricted eating.

NCT ID: NCT05820594 Recruiting - Tuberculosis Clinical Trials

Using BCG Vaccine to Understand Tuberculosis Infection

Pilot BCG CHIM
Start date: June 30, 2023
Phase: N/A
Study type: Interventional

Tuberculosis (TB) is a disease that usually causes an infection in the lungs. The only vaccine to prevent TB is called BCG (Bacillus Calmette-Guérin). BCG contains a live germ similar to Mycobacterium tuberculosis, the germ that causes TB. BCG does not work very well, and TB remains the most common cause of death by infection worldwide. Human challenge models involve exposing healthy volunteers to an infectious disease in a safe and controlled way. This helps researchers understand more about an infectious disease and the body's response and can help develop new vaccines and treatments. The purpose of this study is to set up a human challenge model using BCG to understand how the body responds to this. If our human challenge model works well it may be used to help researchers develop new vaccines and tablets to treat TB in the future. This study will recruit healthy volunteers, of all genders, age 18-50 years. The first part of the study (phase A) will recruit 10 participants. Participants in phase A will receive intradermal injection with BCG into the upper arm at three times the usual dose. On day 14 after BCG the following skin samples will be taken from the BCG site with the use of local anaesthetic: skin swab, microbiopsy, skin scrape and punch biopsy. Participants in this phase of the study will also have blood tests to ensure they are safe to take part and to monitor the immune response to BCG. The overall aim of this part of the study will be to ensure BCG can be isolated (grown in culture and by molecular techniques) from participants' BCG site 14 days after the injection. The investigators aim to test whether BCG can be isolated by punch biopsy and minimally invasive techniques (microbiopsy, skin scrape and skin swab). If the investigators find that they can isolate BCG successfully using the minimally invasive methods of skin sampling and the participants have not experienced any serious adverse events, they can proceed to phase B of the study. In phase B 20 participants will be recruited. These participants will receive BCG as described for phase A. They will then have serial skin samples taken using either microbiopsy, skin scrape or skin swab on days 0, 2, 7, 14 and 28. The focus of this phase of the study is to assess immune responses to intradermal injection at the local (skin), systemic (blood) and respiratory mucosal (nose) compartments. This will involve longitudinal sampling from blood, nose and skin to measure BCG growth and the immune response over time.

NCT ID: NCT05820282 Recruiting - Health Behavior Clinical Trials

Using IF-THEN Plans to Increase Behaviour Change Intervention Delivery

Start date: February 24, 2022
Phase: N/A
Study type: Interventional

The aim of the present research is to test the effectiveness of an implementation intention-based intervention for increasing healthcare professional delivery of behaviour change interventions during routine healthcare. Each participant will be randomly allocated to one of two conditions. The two conditions are: (1) a control condition, and (2) intervention (form multiple implementation intentions from a drop-down menu). The main outcome measure will be use of face coverings.

NCT ID: NCT05819944 Recruiting - Asthma Clinical Trials

A Trial Evaluating Novel Technologies for the Diagnosis of Asthma The LUNG-TECH Trial

LUNG-Tech
Start date: January 9, 2023
Phase:
Study type: Observational

This trial aims to evaluate novel diagnostic technologies for asthma in 3 different pathways providing the necessary evidence-base to allow adoption into clinical practice: - Pathway 1 evaluates whether the technology can distinguish between people with asthma and healthy volunteers, and other respiratory conditions in a well characterised secondary-care population and whether the parameters they measure correlate with the current standard diagnostic tests; - Pathway 2 assesses whether the technology can accurately diagnose asthma (either independently or alongside current diagnostic tests) in a primary care population of patients where there is a clinical suspicion of asthma; - Pathway 3 explores the ability of the technology to identify clinically important phenotypic characteristics which are difficult to measure in primary care and/or significantly impact on patient management and treatment The novel technology and devices will be entered into the pathway most suited to their stage of development, with this study design also allowing information collected for participants with a confirmed diagnosis of asthma in pathways 1 or 2 to be included in pathway 3. Participants will undergo the investigations currently used to diagnose asthma as well as using the novel devices being investigated in the relevant pathway.