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NCT ID: NCT05235399 Completed - Clinical trials for Bronchopulmonary Dysplasia

Right vEntricular Function Prediction mOdel to Identify pReterm infanTs With Early BronchoPulmonary Dysplasia.

REPORT-BPD
Start date: June 1, 2022
Phase:
Study type: Observational

Short title REPORT-BPD feasibility study Design A mixed methods observational cohort feasibility study Study Setting Neonatal Intensive Care Unit at University Hospitals Plymouth NHS Trust Aim To explore the feasibility of measuring the right ventricular function of the premature heart to develop a prediction model to identify early BronchoPulmonary Dysplasia in premature infants. Objectives 1. To assess the feasibility and acceptability of the study procedures e.g., recruitment, echo scans performance, data collection, storage, and analysis. 2. To identify the sensitive echo parameters in assessing the right ventricle function of the heart to be included in a prediction model to identify early BPD in premature infants. Study Participants Preterm infants born <32 weeks of gestational age, their parents and healthcare professionals involved in the care of the study's preterm infants. Sample size 40 preterm infants Follow-up Each preterm infant will be followed up till they are 36 weeks of post menstrual age (PMA) or until discharge home whichever comes first. Study Period 18 months Outcome Measures 1. Establishing sensitive and feasible echo parameters for detecting right ventricle dysfunction associated with early BPD pulmonary vascular changes. 2. Suitability of eligibility criteria and sample characteristics. 3. Fidelity to the study procedures such as recruitment, data collection including echo scans performance at the set time points. 4. Recruitment, accrual, and retention rates.

NCT ID: NCT05234645 Completed - Clinical trials for Endothelial Dysfunction

Short Term Effects of Probiotics in the Human Micro-vascular Physiology

PIMCO-KEFIR
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

While the beneficial properties of kefir consumption have been thoroughly studied for many years, very little research has been conducted to explore the potential protective properties of kefir consumption to the endothelium in humans. Therefore, the aim of the current study is to explore the short-term efficacy of kefir consumption in improving endothelial function in older and younger healthy, sedentary adults.

NCT ID: NCT05234515 Completed - Clinical trials for Surgical Site Infection

Bacteriology of sUrGical Site INfection Following Surgery for Intestinal Failure

BUGS-IN-IF
Start date: January 14, 2022
Phase:
Study type: Observational

This is a prospective observational study of patients undergoing planned surgery for intestinal failure. The aims of the study are: - To prospectively characterise preoperative bacterial populations amongst patients undergoing surgery for intestinal failure - To examine the relationship between preoperative bacteriology and surgical site infection (SSI) in this patient group - To investigate the effect of surgery and surgical site infection on generic and wound specific quality of life measures

NCT ID: NCT05233826 Completed - COVID-19 Clinical Trials

Safety and Immunogenicity of COVI-VAC as a Booster Dose in Adults Previously Vaccinated Against COVID-19

Start date: April 14, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to to evaluate the safety and immune response of COVI-VAC given as a single booster dose in healthy adults previously vaccinated against COVID-19 with an authorised mRNA or adenovirus-vectored vaccine. Approximately 30 participants who have been fully vaccinated ≥ 3 months ago will be enrolled and receive one dose of COVI-VAC. COVI-VAC is administered by drops into each nostril. To assess the safety of the vaccine, each participant will record symptoms and oral temperature in a diary daily for 7 days after receiving COVI-VAC or placebo. During the full study safety laboratory tests, physical exams, and vital signs (including oxygen saturation) will be conducted periodically for safety. Adverse events and medication use will be recorded. Blood samples and intranasal samples will be collected periodically to assess the immune response from the vaccine.

NCT ID: NCT05232708 Completed - Clinical trials for Healthy Volunteers (Diabetes Mellitus, Type 2)

A Clinical Trial Looking at the Comparability of 2 Different Forms of Semaglutide

Start date: January 19, 2022
Phase: Phase 1
Study type: Interventional

In this trial, two approved solutions of the medicine semaglutide will be compared in healthy volunteers. The purpose of this trial is to see if semaglutide B and semaglutide D solutions are comparable with regards to moving into, through and out of the body when given in two separate injections. Participants will receive semaglutide B and semaglutide D in different periods of the trial (Period 1 and Period 2). Participants will receive 1 subcutaneous injection of semaglutide B (0.5 mg) and 1 subcutaneous injection of semaglutide D (0.5 mg). The trial will last for 87 to 120 days (about 3 to 4 months), depending on how long the screening period (2 to 28 days) and washout period (14 to 21 days) are. Participants will have a screening visit, followed by an in house stay (5 nights/6 days) and 9 visits for each period. Participants will have to fast for at least 6 hours overnight with only water allowed before receiving the trial medicine on the second day of in house stay (Day 1) in Period 1 and Period 2.

NCT ID: NCT05231642 Completed - Type 1 Diabetes Clinical Trials

Individualised Postprandial Glucose Responses in Type 1 Diabetes

Start date: November 30, 2021
Phase: N/A
Study type: Interventional

Type 1 diabetes (T1D) is a lifelong disease which stops the body from producing insulin - an important hormone that controls blood sugar (glucose) levels. People with T1D use insulin replacement therapy, usually in the form of injections, to help control blood glucose levels, however keeping glucose levels within normal ranges is usually a challenge. Mealtime glucose control is fundamental to good diabetes management and are an important contributor to long-term diabetes complications. However, many individuals experience variability in glucose levels around mealtimes. The objective of this study is to establish whether and which parameters are important predictors of mealtime glucose levels in people with T1D. The investigators will monitor glucose levels using the latest glucose monitoring technology and collect blood samples to: 1. Characterise changes in glucose levels in individuals with T1D in response to different meals 2. Determine whether and what food characteristics and personal factors are linked to individual glucose responses to different meals. The investigators will recruit 150 individuals with type 1 diabetes. Firstly participants will attend a preliminary visit, where a blood sample will be donated to study laboratory blood markers of vascular and metabolic health accompanied by a full medical examination in which body composition will be established. During this visit participants will also complete questionnaires about their lifestyle, and be fitted with two wearable devices to monitor glucose levels and physical activity levels under free-living conditions. After 4-weeks of wearing the devices, participants will attend two experimental laboratory visits where breakfast and lunch will be served and blood samples taken. This will enable us to observe glucose and metabolic responses to feeding under controlled conditions.

NCT ID: NCT05231317 Completed - Nutrition, Healthy Clinical Trials

Effect of the Sustainable Diet on Gut Microbiota and the Metabolome: a Randomised Crossover Study

SUSUGUT
Start date: July 2, 2021
Phase: N/A
Study type: Interventional

Unhealthy diets are closely linked to non-communicable diseases and constitute higher risk of morbidity and mortality than unsafe sex, alcohol, tobacco and drugs use combined. According to the World Health Organization (WHO), a healthy diet follows a plant-based pattern with low quantities of red meat and a low simple sugar intake. It would also reduce anthropological ecologic impact. We hypothesize that a plant-based diet will beneficially modify the gut microbiota and metabolome, influencing also Trimethylamine N-oxide (TMAO), a metabolite associated to CVD. This study has a randomized single blind crossover design that compares a plant-based diet towards a control western diet. It is applied to volunteers aged 18-70 years, N=20. Each dietary intervention (plant-based and western) would last for 16 consecutive days separated by a minimum of 7 weeks washout period (intervention 1-washout-intervention 2). Samples of blood urine and faeces will be collected at day 1 and 14 of each intervention. On day 14 will be performed L-carnitine challenge with 1200mg of L-carnitine to test the levels of TMAO), in for the next 2 consecutive days (24h and 48h post treatment).

NCT ID: NCT05229172 Completed - Clinical trials for Respiratory Insufficiency in Children

Fabian Prospective Assessment of Volume Guarantee (Fabian PaVoG)

PaVoG
Start date: February 24, 2022
Phase:
Study type: Observational

This study is planned as a part of the post market clinical follow-up (PMCF) on a CE marked product and will provide performance data on the Volume Guarantee function of the fabian ventilator in daily clinical routine.

NCT ID: NCT05226650 Completed - Nitrogen Balance Clinical Trials

The Effect of Irregular Meal Pattern on Nitrogen Balance in Healthy Normal-weight Women

Start date: September 13, 2019
Phase: N/A
Study type: Interventional

Nitrogen balance (NB) is defined as the net difference between the intake of nitrogen (input) and its excretion (output). NB was considered as an indicator of the catabolic stress level. Thus, a negative NB can occur as a result of catabolism which leads to muscle mass loss. It was demonstrated that there is a relationship between meal frequency and N loss. Irregular meal patterns have been considered as a possible new risk factor for obesity and its consequences, specifically cardiovascular disease and metabolic syndromes. As the regular meal pattern is associated with higher BMI in many observational studies and has an impact on the metabolism of carbohydrates and lipids, it could also affect protein metabolism. Eating irregularly can cause chrono-disruption because the changes in the timing of food intake as a consequence may also alter the chrono-biological or circadian rhythm of many hormones such as insulin, glucagon, adiponectin, leptin and gastric acid secretion. From this, investigators hypothesized that following an irregular meal pattern can negatively influence the N balance and circadian rhythm.

NCT ID: NCT05226091 Completed - Clinical trials for General Practice (GP), Primary Care Settings

Trial to Assess Implementation of New Research in a Primary Care Setting (TRAINS)

(TRAINS)
Start date: August 1, 2019
Phase: N/A
Study type: Interventional

In England and Wales, unscheduled care for school-aged children with asthma significantly increases after their return to school in September, a trend linked with decreased asthma preventer prescriptions during the summer holidays. The PLEASANT study found that a reminder letter from GPs to parents of children with asthma led to a 30% increase in prescription uptake during August and reduced unscheduled medical visits from September to December. The TRAINS trial will now assess if informing GPs of PLEASANT findings would lead to its implementation. This pragmatic cluster randomised implementation trial will use routine data from Clinical Practice Research Datalink (CPRD).