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NCT ID: NCT06466473 Not yet recruiting - Healthy Clinical Trials

A Study to Learn How Different Forms of The Study Medicine Called Phenytoin Are Taken up Into the Blood in Healthy Adults

Start date: July 16, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to understand how the different formulation of phenytoin is taken up into the blood in Healthy Adults. This study is seeking healthy adult participants. All the study participants will receive Phenytoin 50 mg chewable tablets manufactured at Ascoli and Vega Baja manufacturing site. We will measure how the phenytoin will be taken up into the blood in Healthy Adults following oral dosing of Phenytoin. This will help us determine if the Phenytoin 50 mg chewable tablets manufactured at Ascoli and Vega Baja manufacturing site are similar or not.

NCT ID: NCT06464081 Not yet recruiting - Healthy Clinical Trials

Tongue Muscular Assessment in Children (TMAC) - Reproducibility Testing

Start date: July 1, 2024
Phase:
Study type: Observational

This study aims to assess intra-rater and inter-rater reliability in measuring tongue motor skills in children.

NCT ID: NCT06460246 Not yet recruiting - Healthy Clinical Trials

Pulse Oximeter Accuracy During Stable Hypoxia Plateaus

Start date: June 25, 2024
Phase: N/A
Study type: Interventional

This project aims to test the accuracy of pulse oximeters in the range of arterial HbO2 saturations from 100% down to 70%.

NCT ID: NCT06457204 Not yet recruiting - Healthy Clinical Trials

A Study in Healthy People to Compare Two Different Sifrol® Tablets

Start date: June 27, 2024
Phase: Phase 1
Study type: Interventional

The main objective of this trial is to establish the bioequivalence of Sifrol® tablets manufactured at two different sites.

NCT ID: NCT06453356 Not yet recruiting - Healthy Clinical Trials

A Study to Learn How the Study Medicine Called Zavegepant is Taken Up Into Blood and Breast Milk of Healthy Breast-Feeding Women

Start date: June 11, 2024
Phase: Phase 1
Study type: Interventional

The purpose of the study is to look at the amount of zavegepant that is present in breast milk after single dose of zavegepant is sprayed through the nose in healthy breast-feeding women. This would allow to see if there are any possible risk to infants from medicines during breast-feeding. The study is seeking for about 12 healthy breast-feeding females who are: - 18 to 55 years of age. - actively breast-feeding or producing breast milk. - at least 2 weeks post-partum and not pregnant at present. Participants will not be allowed to breast-feed their infant from the evening of the day before to the first dose till 48 hours (2 days) after the dose. Eligible participants will check into the clinical research unit (CRU) on Day -1. Participants will receive the zavegepant dose sprayed into the nose at the CRU on Day 1. The participants will stay at the CRU until the morning of Day 2. There will be collections of breast milk and plasma over 24 hours. Participants will be sent from the CRU on Day 2 and may begin to breastfeed their infant 48 hours (2 days) after the dose. A safety follow-up call will be done at about 28 to 35 days from the day the first dose of study medicine was given.

NCT ID: NCT06452199 Not yet recruiting - Healthy Clinical Trials

The BEGIN Study Bifidobacterium Infantis to Newborns: Effects of Modulating the Gut Microbial Composition on Growth, Immune Function and Inflammatory Conditions - a Randomized Placebo-controlled Double-blinded Intervention Trial

BEGIN
Start date: June 2024
Phase: N/A
Study type: Interventional

The goal of The BEGIN Study, a randomized controlled double-blinded intervention trial, is to learn if probiotics, with Bifidobacterium longum subspecies infantis Bifin02 (B. infantis), given to healthy newborns can affect various health outcomes and to explore impacts of the infant gastrointestinal microbiome. The main questions it aims to answer are: - Does B. infantis probiotics impact immune function and does it lower the number of bacterial infections and use of antibiotics? - Does B. infantis probiotics impact overall health, development, growth and wellbeing? - Does B. infantis probiotics impact inflammatory diseases, allergies and autoimmune diseases Researchers will compare B. infantis probiotics to a placebo (a look-alike substance that contains no probiotic) to see if B. infantis colonization impact the human immunesystem and various clinical and biochemical health markers. Participants (parents) will - Orally administrate the B. infantis probiotic to their newborn child daily in three weeks from 7 days of age. - Answer baseline and follow up questionnaires in a study app - Take five stool samples from the child and one stool sample from the mother - Collect a 4 week of passive dust sample at home (Electrostatic Dust fall Collector) - Donate one dried bloodspot and one blood sample from their child

NCT ID: NCT06443216 Not yet recruiting - Healthy Clinical Trials

Sleep Modulation to Treat Depression

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

Current first-line treatments for major depression (antidepressants and psychotherapy) show a long latency to response, and less than half of all patients experience full remission with optimized treatment, indicating the need for new developments. The aim of this study is to extend and further develop a longstanding line of research of using sleep neurophysiology as a 'window to the brain' and treatment development in major depression. Particularly, this project is designed to test the feasibility, efficacy and mechanisms of action of a new sleep-based treatment technology.

NCT ID: NCT06441188 Not yet recruiting - Healthy Clinical Trials

Sonography of the Nipple Areolar Complex

Start date: June 5, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to determine ultrasound scanning techniques of the nipple areolar complex (NAC) that provide optimal diagnostic imaging features.

NCT ID: NCT06440980 Not yet recruiting - Healthy Clinical Trials

A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight

Start date: June 24, 2024
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to see how much of orforglipron (study drug) gets into the bloodstream and how long it takes the body to get rid of it when given as capsules compared to tablets in healthy overweight and obese participants. The safety and tolerability (side effects) of orforglipron when given as capsules and tablets will also be evaluated. The study will be conducted in two parts, with part A and B lasting up to approximately 25 and 22 weeks each, including the screening period.

NCT ID: NCT06437314 Not yet recruiting - Healthy Clinical Trials

Effect of an Intervention Based on Back School in an Aquatic Environment on Non-specific Low Back Pain

Start date: July 10, 2024
Phase: N/A
Study type: Interventional

A controlled and randomized clinical trial will be conducted, in which scores on dependent variable measures will be compared before and after the intervention, both in the experimental group (EG) (individuals who will attend the in an aquatic program based on the back school) and in the control group (CG) (individuals who will not attend the in an aquatic program based on the back school). The experimental procedure will follow the recommendations of the CONSORT and TidIER guidelines. The study protocol will be approved by the Research Ethics Committee of the University of Vigo. This study will be conducted under the Declaration of Helsinki (2013 version). Participants will sign a written informed consent after being informed of the benefits and risks of the research. Participants in the EG will participate in an aquatic program based on the back school. This program will follow the recommendations of the biopsychosocial model of chronic pain and will be conducted in an aquatic environment. The intervention will be carried out by physiotherapists in a sports centre. The duration of the intervention will be six weeks, with a frequency of two sessions per week, totalling 12 sessions of 45 minutes each. Of all the sessions, 10 will have a practical focus and the other two will have a theoretical focus.