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NCT ID: NCT06271213 Recruiting - Healthy Clinical Trials

The Gut-Lung Axis and Respiratory Illness in Children

Start date: February 4, 2024
Phase:
Study type: Observational

The goal of this single-centre observational study conducted at the Royal Hospital for Children in Glasgow, Scotland, is to employ a multi-omics approach to investigate the "gut-lung axis" in health and disease. Part A is a cross-sectional study design investigating the postulated bidirectional link between the gut and lung microbiomes in children suffering from respiratory or gastrointestinal conditions. Children with no GI or respiratory issues attending for orthopaedic care will be used as a benchmark for a healthy gut-lung axis. The main questions we aim to answer are: - What does a healthy gut-lung axis look like? - Do children with respiratory issues show an altered gut microbiome? - Do children with GI issues show an altered lung microbiome? Part B is a longitudinal study design, that aims to assess the effects of biologics on the gut-lung axis by comparing the gut and lung microbiomes in children with asthma at two time-points who are indicated to start biologics therapy (Asthma treatment) or will not receive biologics therapy (asthma control). Participants will provide: - airway samples (to investigate the lung microbiome) - blood samples (to assess inflammatory and metabolic factors which may mediate communication between the two sites) whilst under general anaesthetic for a treatment related to their standard of care - stool samples (to assess gut microbiome) - dietary information (food diary and/or food frequency questionnaire) to assess relationships between diet and the gut-lung axis.

NCT ID: NCT06267976 Recruiting - Healthy Clinical Trials

Validation of the ProSomnus® RPMO2 Device

Start date: June 15, 2024
Phase:
Study type: Observational

The purpose of the study is to: 1. Evaluate the SpO2 accuracy of the oximeter component of the ProSomnus RPMO2 Device during non-motion conditions over the range of 70-100% SaO2 by comparison to SaO2 values determined by arterial blood sample specimen analyzed by a CO-oximeter. 2. Evaluate the pulse rate performance simultaneously collected over the SpO2 range.

NCT ID: NCT06261476 Recruiting - Healthy Clinical Trials

Safety of Ashwagandha (Withania Somnifera) Root Extract

Start date: February 2024
Phase: N/A
Study type: Interventional

The primary objective is to evaluate the laboratory safety of Ashwagandha standardized root extract 500 mg capsules in healthy adults over 12-week therapy based on Complete Blood Count, Renal Function Test, Liver Function Test, Lipid Profile and Thyroid Function Test, Fasting blood sugar and HbA1c Test. The secondary objectives are to evaluate the clinical safety of Ashwagandha standardized root extract 500 mg capsules in healthy adults over 12-week therapy and to evaluate the effect of the Ashwagandha standardized root extract 500 mg on Quality of Life (QoL) using the SF-36 tool.

NCT ID: NCT06256445 Recruiting - Healthy Clinical Trials

Evaluate the Efficacy and Safety of AYP-101 for the Reduction of Submental Fat in Chin Area

Start date: March 26, 2024
Phase: Phase 3
Study type: Interventional

To Evaluate Efficacy and Safety of AYP-101 S.C injection for the Reduction of Submental Fat in Adults

NCT ID: NCT06255340 Recruiting - Healthy Clinical Trials

A Study in Healthy Men to Test How Different Doses of BI 3031185 Are Tolerated and How Food Influences the Amount of BI 3031185 in the Blood

Start date: March 8, 2024
Phase: Phase 1
Study type: Interventional

This trial starts the clinical development of BI 3031185. The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of a range of single doses of BI 3031185 as basis for further development. The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3031185 tablet formulation.

NCT ID: NCT06254898 Recruiting - Healthy Clinical Trials

Use of Incentives for Stressful Medical Procedures

Start date: June 2, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about the use of incentives in pediatric patients requiring medical procedures. The main questions it aims to answer are: - Are incentives effective at reducing pediatric anxiety for medical procedures? - What is the best way to use incentives with pediatric populations requiring medical procedures? Participants will be provided support in preparation for their procedure and during the procedure by a child life specialist and might receive an incentive prize after their procedure. Participants distress levels during the procedure will be observed and they will be asked to rate their anxiety on a visual analog scale. Researchers will compare the anxiety of those who did or did not receive an incentive after their procedure to see if incentives reduced procedural anxiety.

NCT ID: NCT06245928 Recruiting - Healthy Clinical Trials

The Effects of Individualized Respiratory Exercise Device in Healthy Individuals

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Respiratory exercise devices can be grouped as respiratory muscle training (RMT) devices and incentive spirometers (IS). IS can improve pulmonary ventilation using visual feedback but cannot increase respiratory muscle strength. RMT devices strengthen the respiratory muscles by their resistance mechanisms but they cannot provide visual feedback. It has been stated that RMT increases exercise performance in healthy individuals. RMT devices usually allow only one of inspiratory muscle training or expiratory muscle training. The need to acquire 2 devices for combined training increases the cost. It is seen that the RMT devices available in Turkey do not allow combined training and a significant part of them do not offer sufficient loading range. The aims of the project are; to develop a multifunctional individualized respiratory exercise device originating in Turkey, and to analyze the clinical effects of an individualized respiratory exercise device on pulmonary function, respiratory muscle strength, and functional capacity in healthy individuals. The device to be developed in this project will be the first multifunctional respiratory exercise device originated in Turkey. The device will have the clinical features of IS and RMT devices and can be individualized according to the desired purpose. With the same device, the individual will be able to both improve the ventilation of the lungs like the IS and strengthen the respiratory muscles in the direction of inspiration and/or expiration with wide loading intervals. A total of 46 healthy individuals will be included in the study. The healthy individuals included in the study will be randomly divided into two groups experimental group (n=23) and control group (n=23). The individuals in the experimental group will be trained with an individualized respiratory exercise device for 5 days a week for 8 weeks. The individuals in the control group will be trained with Threshold® IMT + Threshold™ PEP training for 5 days a week for 8 weeks. In both groups, pulmonary function, respiratory muscle strength, and functional capacity will be assessed before and after the 8 weeks of training.

NCT ID: NCT06243198 Recruiting - Healthy Clinical Trials

A Study to Investigate the Safety and Pharmacokinetics of Lebrikizumab in Healthy Chinese Participants

Start date: March 28, 2024
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to determine the tolerability and side effects related to lebrikizumab comparing with placebo given as a single dose administered under the skin to healthy Chinese participants. The study will also assess how fast lebrikizumab gets into the blood stream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of either Lebrikizumab or placebo. For each participant, the total duration of the study will be approximately up to 21 weeks, including screening period.

NCT ID: NCT06232252 Recruiting - Healthy Clinical Trials

A Study to Test How Well Multiple Doses of BI 765423 Are Tolerated by Healthy Men

Start date: April 30, 2024
Phase: Phase 1
Study type: Interventional

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics of BI 765423 in healthy male subjects.

NCT ID: NCT06229002 Recruiting - Healthy Clinical Trials

Effect of Transcranial Alternative Current Stimulation at Alpha Frequency (α-tACS) on Stressed Healthy Subjects

CAF-TAS
Start date: January 24, 2024
Phase: N/A
Study type: Interventional

stress. Notably, several studies reported that stress could alter impulsivity, source monitoring, and time perception. Several mechanisms are involved in the response to a stress factor, among them the hypothalamic-pituitary-adrenal (HPA) axis. The cortisol reactivity (it means the cortisol secretion after the exposure to a standardized stress factor) is a reliable tool to assess the function of HPA. Cortisol secretion is bidirectionally influenced by the prefrontal cortex (PFC), which is involved in the expression and regulation of stress as well. The asymmetry of the alpha band (AFα) is a well known electrophysiological parameter to assess the function of PFC. More precisely, AFα is arising a growing interest, as it is believed to be correlated with the cortisol reactivity. Modifying this asymmetry could influence the stress response. Transcranial Alternating Current Stimulation (tACS) consists in delivering a sinusoidal alternating current between two electrodes placed on the scalp at a predefined frequency. Previous studious reported that tACS, if delivered at the alpha frequency, increased the alpha band in the stimulated areas