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Healthy Volunteers clinical trials

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NCT ID: NCT05088577 Completed - Healthy Volunteers Clinical Trials

Evaluation of Egg Consumption and Its Enrichment With Annatto on Cardiovascular Risk and Satiety in Healthy Adults

EGGANT
Start date: October 11, 2019
Phase: N/A
Study type: Interventional

Healthy adult volunteers (n= 105; 18-59 years) were randomly allocated to consume daily for 8 weeks, either two whole eggs (egg group), two whole eggs added with annatto (annatto-enriched egg group), or two egg whites (control). Volunteers were asked to continue with the habitual physical activity and diet, except for the consumption of additional eggs, egg whites or annatto. It is hypothesized that participants consuming eggs would have a less atherogenic lipid profile, feel more satisfied and increase antioxidant levels in blood, compared to the control group. Participants in the annatto-enriched egg group would have greater antioxidant capacity than the egg group and compared to control.

NCT ID: NCT05087069 Completed - Healthy Volunteers Clinical Trials

Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of BV100 in Healthy Male Subjects

Start date: October 8, 2021
Phase: Phase 1
Study type: Interventional

Safety and tolerability and Pharmacokinetics of multiple doses of BV100 in healthy volunteers

NCT ID: NCT05084807 Recruiting - Healthy Volunteers Clinical Trials

Evaluation of the Lymphocyte Subpopulations in the Normal Mucosa of the Upper Digestive Tract

GUTproject
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

The macro and microscopic findings of the upper gastrointestinal tract are useful in the differential diagnosis of digestive diseases such as Crohn's or celiac diseases. However, the histopathological findings (duodenal lymphocytosis, atrophy, chronic inflammatory infiltrate, etc.) are generally not pathognomonic, and there is a great overlap between different inflammatory diseases. The study of lymphocyte subpopulations of the intestine has shown its usefulness in cases of celiac disease that are difficult to diagnose. In patients with celiac disease, lymphocytes that infiltrate the duodenum present a specific pattern with increased percentage of TCRgẟ+ lymphocytes and reduced percentage of CD3- lymphocytes. However, it is currently unknown if other inflammatory diseases (e.g. Crohn's disease) have specific lymphocyte subpopulations that could be of great diagnostic aid. One of the main problems in establishing patterns associated with disease is the absence of immunological studies carried out in healthy individuals. Most of the studies include, as a control group, patients who undergo gastroscopy for the study of upper digestive symptoms and have microscopically normal duodenal biopsy. This is a heterogeneous population that includes, among others, patients with functional pathology in whom the existence of low-grade inflammatory phenomena has been suggested. Therefore, patients with digestive symptoms are not good controls to establish normal patterns of intestinal immunity.

NCT ID: NCT05083468 Completed - Healthy Volunteers Clinical Trials

The Safety, Tolerability, and Pharmacokinetics (PK) of SR750 in Healthy Volunteers

Start date: October 29, 2021
Phase: Phase 1
Study type: Interventional

This study is to evaluate the safety, tolerability, and PK of SR750 in healthy volunteers.

NCT ID: NCT05079945 Completed - Healthy Volunteer Clinical Trials

Tractography and Diffusion Tensor Imaging of the Human Spinal Cord in Healthy Subjects : Anatomical Atlas

TRACTOCORD
Start date: February 5, 2022
Phase: N/A
Study type: Interventional

Today, Spinal cord pathologies, whether are tumoral, vascular, traumatic, malformative, inflammatory, or degenerative still constitute a major medico-surgical challenge due to the particular anatomy of the spinal cord. Indeed, the spinal fibers (whether they have a sensory or motor function) are all condensed in an extremely small volume. To date, there is no reliable technique to know the precise position of the spinal tracts specifically involved in the sensory and motor functions of the upper and lower limbs. The purpose of this study is to evaluate the feasibility for differentiating spinal tracts by tractography from a cerebral Diffusion tensor imaging (DTI) Magnetic Resonance Imaging (MRI) sequence (associated with an anatomical sequence) by performing a stitching process with spinal cord DTI MRI sequence, in healthy subjects. The criterion of differentiation of the tracts will be assessed by highlighting already known cerebral tracts (cortico-spinal fibers, spinothalamic, posterior cord) and which will be monitored at the spinal level.

NCT ID: NCT05078905 Recruiting - COVID-19 Clinical Trials

Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases

Start date: October 13, 2021
Phase:
Study type: Observational

Background: Vaccines against SARS-CoV-2, the virus that causes COVID-19, have been highly effective against preventing severe disease. But the protective effects of these vaccines appear to wane over time. Researchers want to learn why. Objective: To learn more about how the immune system responds to vaccines against infections like SARS-CoV-2. Eligibility: Healthy adults ages 18 or older who are scheduled to receive either a new vaccine or a booster shot against SARS-COV-2 or another emerging infection. Design: Participants will be screened with a medical history and blood and urine tests. Participants will have up to 8 study visits in 1 year. Each visit should last less than 2 hours. At each visit, participants will give blood samples. Some blood samples will be used for genetic testing. They will also give updates on their health. After the first study visit, participants will receive either a first vaccination or a booster shot. They must get the vaccine in their community or workplace. They will not get the vaccine at NIH. This study currently focuses on SARS-CoV-2, but it will expand to other infectious diseases as they emerge and become the target of new vaccines. ...

NCT ID: NCT05075876 Completed - Healthy Volunteers Clinical Trials

Bioequivalence Study in Healthy Chinese Subjects Comparing SP-01 (Granisetron Patch) Manufactured at Two Different Sites

Start date: October 13, 2021
Phase: Phase 1
Study type: Interventional

This study is an open-label, single-center, two-period, two-sequence crossover study to assess the bioequivalence of SP-01 (Sancuso®: Granisetron Patch) manufactured at two different sites. Either the test product, namely SP-01-K, or reference product, namely SP-01-A, will be applied to the subject once in each period.

NCT ID: NCT05073627 Completed - Healthy Volunteers Clinical Trials

The Effect of Dicloxacillin on Oral Absorption of Drugs

Start date: February 7, 2022
Phase: Phase 1
Study type: Interventional

Worldwide there is an increase in antibiotic resistance which may have fatal long-term consequences. This is due to extensive use and sometimes misuse of antibiotics in the treatment of harmless infections. The primary aim of this study is to investigate if treatment with dicloxacillin can lead to drug-drug interactions through induction of the efflux transporter P-glycoprotein (P-gp). In this study it will also be investigated whether dicloxacillin induces its own metabolism. The hypothesis is based on a previous in vivo study showing that rifampicin induces the intestinal P-gp transporter, through activation of the pregnane X receptor (PXR). Dicloxacillin also activates the PXR receptor in vitro, which could result in an induction of P-gp in vivo. Trial subjects will ingest dicloxacillin for 30 days and at day 10 and 28 ingest dabigatran etexilate to determine if the P-gp transporter has been induced. Plasma and urine will be drawn over 32 hours to determine the concentration of dabigatran. Change in dicloxacillin concentration will also be measured at day 9 and 27 to establish if dicloxacillin induces its own metabolism.

NCT ID: NCT05070312 Completed - Healthy Volunteer Clinical Trials

Pharmacokinetics, Immunogenicity, Safety and Tolerability of MEDI3506 in Health Chinese Participants

Start date: August 23, 2021
Phase: Phase 1
Study type: Interventional

This study is to evaluate the pharmacokinetics, immunogenicity, safety and tolerability of investigational drug MEDI3506 with single dose in Healthy Chinese participants.

NCT ID: NCT05070273 Completed - Healthy Volunteers Clinical Trials

Safety and Feasibility of St. Mark's Electrode for the Hypoglossal Nerve and Cortico-lingual Pathway Study

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

The possibility of registering the M-response and the motor evoked potential (MEP) from the muscles of the tongue by using the St. Mark's electrode will be evaluated. The safety of method will be confirmed. Registered parameters will be compared with other known methods and comparative effectiveness of proposed method will be determined. The study will involve healthy volunteers without clinical symptoms of hypoglossal nerve and cortico-lingual pathway lesions and without surgical interventions in the tongue .The volunteers will be examined once for the parameters of the amplitude and latency of the M-response and MEP, as well as the difference between these indicators at different sides of the examination during nerve conduction study (NCS) and transcranial magnetic stimulation (TMS) of the hypoglossal nerve and the cortico-lingual pathway.