Clinical Trials Logo

Filter by:
NCT ID: NCT05259683 Completed - Sepsis Clinical Trials

Febrile Infant Diagnostic Assessment and Outcome Study

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

Febrile infants under 3 months of age represent a high risk group for invasive bacterial infection (IBI) and UTI with approximately 10-20% having bacteremia, meningitis or urinary tract infection. The assessment of febrile infants is challenging, and current National Institute for Health and Care Excellence (NICE) guidance advocates a cautious approach with the majority of infants requiring a septic screen, parenteral broad-spectrum antibiotics, and admission to hospital. Internationally there is significant variation in the approach to febrile infants with European and USA guidance advocating a tailored approach based on clinical features and biomarker testing. None of the available clinical decision aids (CDA) have been validated in a UK and Irish cohort. The main objectives of the FIDO study are to report performance accuracy of CDA in a UK (United Kingdom) and Irish population, and describe the aetiology of SBI in young infants. The FIDO study is a prospective observational cohort study of infants under 90 days of age with a measured fever greater than 38 Centrigrade within 24 hours of presentation. The study will run for approximately 12 months and recruit a minimum of 1000 participants.Symptoms, clinical features and laboratory results will be recorded on an electronic case report form (CRF) by the attending clinician.

NCT ID: NCT05258864 Completed - Alcohol Consumption Clinical Trials

Pilot Trial of an Online Personalised Normative Feedback Intervention to Reduce Drinking

Start date: February 27, 2022
Phase: N/A
Study type: Interventional

Unhealthy alcohol consumption is common in the UK and causes tremendous harm to the individual, as well as harm to others. A significant gap in providing alcohol support is that most people with unhealthy alcohol consumption will never receive advice to cut down on their drinking. However, many are interested in self-directed interventions to help them evaluate their drinking and to motivate reductions in alcohol use. One such promising intervention uses online personalised normative feedback (PNF) which compares a person's drinking with others in the general population of the same age and sex. PNF interventions are thought to work because many people with unhealthy alcohol consumption overestimate how much others drink. Multiple trials have demonstrated that providing PNF to people with unhealthy consumption reduces their alcohol use . While several UK websites do provide feedback on assessment of risk (e.g., Down Your Drink introductory section, Alcohol Change UK), there appears to be no online intervention that provides PNF for unhealthy alcohol consumption. The major objective of this pilot project is to conduct a two-arm, parallel group randomised controlled trial (RCT) in which 1,318 participants recruited from the Prolific website who have identified themselves as drinking 14 or more units per week are randomly assigned to one of two groups - a) those who are offered a PNF report, and b) those in a no intervention comparator group. Participants in the comparator group will not be provided any intervention materials but will instead be given a list of the different components of the PNF feedback and will be asked to think about how useful they would find each of them. Follow-up assessment will occur at 1 and 6 months post-randomisation. The project is described as a pilot because it is a preliminary evaluation of the PNF intervention in a UK context.

NCT ID: NCT05257460 Completed - Type 1 Diabetes Clinical Trials

Closing the Loop in Adults With Type 1 Diabetes Under Free Living Conditions (AP@Home04_Phase 4)

Start date: January 25, 2022
Phase: N/A
Study type: Interventional

The main objective of this study is to determine whether home use of day and night closed loop insulin delivery under free living conditions applying ultra-rapid insulin lispro (Lyumjev) is superior to home use of closed-loop applying standard insulin lispro (Humalog). This is a double-blind, single-centre, randomised, crossover design study, involving a run-in period followed by two study periods during which glucose levels will be controlled either by an automated closed-loop system using standard rapid acting Humalog or by an automated closed-loop system using ultra-rapid Lispro in random order. Subjects will receive appropriate training in the safe use of closed-loop insulin delivery system. Subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM during home stay. Secondary outcomes include time spent with glucose levels above and below target, as recorded by CGM, and other CGM based metrics.

NCT ID: NCT05256784 Completed - Immune Deficiency Clinical Trials

Mountain Food and Natural Probiotic in Nutrition

Start date: September 15, 2021
Phase:
Study type: Observational

Background/Objectives: The research discusses the importance of mountain foods/products and services in the context of healthier nutrition and behavior with the application to agribusiness. The purpose of the research is to highlight the necessity of human behavior in consuming mountain products as natural probiotics. Subjects/methods: As evidence, the research analyses mountain food and the associated entrepreneurship for Austria and other Central and Eastern European countries (foods/products and services), especially from the mountain area. The authors realized experimental research regarding representative mountain food from Central and Eastern European areas and used the Eurostat database. Data has been taken from Eurostat and processed in Excel and SPSS, using similar models of analysis from published research. Experimental analysis has been realized by the authors and collected from different recognized sources.

NCT ID: NCT05255822 Completed - Clinical trials for Influenza Prophylaxis

INNA-051 Influenza Challenge Study

Start date: February 28, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, placebo-controlled study of INNA-051 in healthy adults, administered prior to administration of an influenza challenge virus. This study will evaluate 2 active dose levels of INNA-051 and placebo.

NCT ID: NCT05253547 Completed - Dietary Habits Clinical Trials

Dietary Intervention Study on Food Based Dietary Guidelines for Sustainable and Healthy Lifestyles

SuHeGuide
Start date: March 21, 2022
Phase: N/A
Study type: Interventional

The aim of the study is to provide proof of the effectiveness, acceptability, healthfulness and nutritional adequacy of dietary guidelines to reduce greenhouse gas emissions. The study will compare the effect of dietary advice based on 1) healthy climate-friendly dietary guidelines (intervention group) or 2) standard healthy dietary guidelines (control) on greenhouse gas emissions associated with dietary intake over 12 weeks.

NCT ID: NCT05253248 Completed - Clinical trials for Micronutrients Reference Interval

Development of an Optimal Micronutrient Reference Range for Adults

OMIS
Start date: May 1, 2018
Phase: N/A
Study type: Interventional

This study aims to develop optimal micronutrient reference intervals from blood samples collected from "ideal" healthy adults and following micronutrient supplementation to minimise the chance of subclinical deficiencies.

NCT ID: NCT05253144 Completed - Clinical trials for Merkel Cell Carcinoma

Comparing Radical Surgery and Radical Radiotherapy as First Definitive Treatment for Primary MCC

Rational-MCC
Start date: March 19, 2016
Phase: N/A
Study type: Interventional

A randomised phase III multi-centre trial comparing radical surgery and radical radiotherapy as first definitive treatment for primary MCC

NCT ID: NCT05252819 Completed - Clinical trials for Ataxia Telangiectasia

Whole Body MRI for Cancer Surveillance in A-T

Start date: October 17, 2022
Phase:
Study type: Observational [Patient Registry]

Ataxia Telangiectasia (A-T) is an inherited disorder characterised by cerebellar neurodegeneration, immunodeficiency and respiratory disease. People with A-T have abnormal DNA repair and consequently have an increased risk of cancer. Despite this, current guidelines for management of children and young people with A-T do not include cancer surveillance. Improvements in MRI technology have allowed whole-body MRI (WB-MRI) scanning with relatively short acquisition times. Currently, WB-MRI protocols are used for diagnosing and monitoring some primary and secondary cancers, including cancer surveillance in people with the Li-Fraumeni syndrome, which is another genetic cancer predisposition syndrome. Therefore, the research team believe that whole-body MRI provides a safe method for cancer surveillance in children and young people with A-T. However, the investigators do not know whether cancer surveillance in children and young people with A-T using whole-body MRI is feasible and desirable. The research team proposes a feasibility study of MRI-based cancer surveillance with qualitative evaluation of participant experience with the primary aim to establish: - feasibility of whole-body MRI for cancer surveillance in children and young people with A-T - views of, and psychological impact on, participants and families / carers participating in whole-body MRI for cancer surveillance. - feasibility of conducting a formal screening trial in terms of statistical design, sample size, screening interval, comparator arms and international collaboration Completion of this study will provide us with evidence of technical feasibility, very strong evidence of child / family views, a viable formal screening trial design and an engaged international research community, allowing us to proceed to a formal trial establishing the efficacy of a cancer surveillance programme for children and young people with A-T.

NCT ID: NCT05252442 Completed - Covid-19 Clinical Trials

Association of the Risk for Thrombotic Thrombocytopenia Syndrome and Exposure To COVID-19 Vaccines

ATTEST
Start date: March 1, 2022
Phase:
Study type: Observational

Background/Rationale: A very rare syndrome of thrombosis associated with low platelets has been reported in a few cases of recent exposure to COVID-19 vaccine. This thrombotic thrombocytopenia syndrome seems to be affecting patients of all ages and both genders; at present there is no clear signal of risk factors. Objectives: To evaluate an association between COVID-19 vaccine exposure and thromboembolic events occurring with thrombocytopenia (thrombotic thrombocytopenia syndrome; TTS). Study design: Two primary study designs will be considered, a case control study and a self-controlled case series (SCCS). A cohort analysis will be considered, in addition or as an alternative to either of the primary study designs, pending feasibility assessment of the follow-up time. Data Source(s): Data for the study will be accessed through the NHS Digital Trusted Research Environment (TRE), providing national data coverage. Primary care data will be linked with vaccination, hospitalization, COVID-19 test results, mortality data. Initial exploratory analyses will be conducted using the Oxford-Royal College of General Practitioners sentinel network; ORCHID network database (N>15million). Subjects of interest are patients who have received a COVID-19 vaccine. However, investigators will require access to data from all subjects in the databases. Statistical Analysis: The study period will start on December 02, 2020, when the COVID-19 vaccine was first approved in the UK and will end at the end of data availability. For the case-control design, all cases of TTS will be matched with control using risk-set matching. A case or matched control will be considered exposed if a COVID-19 vaccination will be within risk interval prior to the diagnosis date of the matched case. For the SCCS, estimates of relative incidence (RI), in all risk intervals will be reported. For the retrospective cohort design, the incidence of TTS after receiving COVID-19 vaccine will be estimated and investigators will compare this incidence with that occurring in an unvaccinated comparator group about levels of infection across the whole population. Variables: Demographic, socioeconomic descriptors, clinical diagnosis, vaccines, potential confounders, thrombotic phenomena, COVID-19 infection, and other characteristics as applicable.