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Healthy Volunteers clinical trials

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NCT ID: NCT04733144 Recruiting - Healthy Volunteers Clinical Trials

Bioequivalence Study of Prednisolone and Dexamethasone

CORE
Start date: March 4, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare two different glucocorticoids, prednisolone and dexamethasone at two different doses for their organ specific effects, utilizing modern day standards.

NCT ID: NCT04726618 Recruiting - Healthy Volunteers Clinical Trials

Development of Hardware and Software for Pulmonary Magnetic Resonance Imaging Using Inhaled Tracer Gases

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

This is a single centre study. The overarching hypothesis of this study is that MRI with inhaled tracer gases can provide high quality images of lung function to complement conventional 1H MRI. The study interventions do not affect the standard of care.

NCT ID: NCT04715529 Recruiting - Healthy Volunteers Clinical Trials

Phase 1 Study to Evaluate Safety and Pharmacokinetics of FZJ-003 in Healthy Volunteers

Start date: January 27, 2021
Phase: Phase 1
Study type: Interventional

A randomized, double-blinding, dose-escalated phase 1 trial to evaluate the tolerance and fasting/postprandial pharmacokinetics of FZJ-003, an oral Janus kinase1 (JAK1) inhibitor.

NCT ID: NCT04657042 Recruiting - Lung Cancer Clinical Trials

4D-MRI for Precision Medicine

Start date: November 5, 2020
Phase:
Study type: Observational

The purpose of this study is to develop new ways to make medical images of the lungs and liver of adults using a technique called four-dimensional magnetic resonance imaging (4D-MRI). This technique produces three-dimensional movies of the inside of the chest and abdomen while the patient is breathing. (The fourth dimension is time!) This new way of medical imaging is being developed to help cancer patients undergoing radiation therapy. Radiation therapy is used to treat cancerous tumors. For radiation therapy to be effective, the precise size, shape, and location of the tumor within the body must be known. A particular difficulty for radiation treatment of lung and liver cancer is that the tumor moves during treatment because the patient is breathing. Therefore, tumor motion must also be incorporated into the treatment plan. This study aims to improve radiation treatment planning through better targeting and dose estimation based on 4D-MRI. Before this new imaging method can be used for radiation treatment planning, it must be tested in living, breathing volunteers.

NCT ID: NCT04606095 Recruiting - Healthy Volunteers Clinical Trials

Explosive Synchronization of Brain Network Activity in Chronic Pain

Start date: November 13, 2020
Phase: N/A
Study type: Interventional

This project is being conducted to evaluate the impact of explosive synchronization (ES) and its treatment with non-invasive brain stimulation in fibromyalgia (FM). The study design has three components, however, only 2 aims are enrolling participants. The first part (Aim1) is a cross sectional assessment of brain network explosive synchronization activity, connectivity, and response to pain in healthy controls and age and sex-matched fibromyalgia patients; the third part (Aim 3) is a longitudinal assessment of fibromyalgia patients undergoing one week of sham followed by high-definition transcranial direct current stimulation (HD-tDCS) of the motor cortex (M1) or one week of ES HD-tDCS of a brain region identified from computer modelling (Aim 2).

NCT ID: NCT04532801 Recruiting - Healthy Volunteers Clinical Trials

Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance

Start date: September 1, 2019
Phase: Phase 1
Study type: Interventional

This study utilizes infusions of kisspeptin in healthy women to isolate the impact of kisspeptin on beta-cell responsivity assessed by the mixed meal tolerance test.

NCT ID: NCT04457622 Recruiting - Healthy Volunteers Clinical Trials

Language and Brain Rhythms

LaBRhythms
Start date: February 18, 2021
Phase: N/A
Study type: Interventional

For humans and other animals, predicting the timing of sensory events is essential for their daily behavior. Importantly, natural sensory stimulation (such as movements, music, or speech) can present temporal regularities allowing for temporal prediction of incoming sensory information. For instance, individuals can easily predict in time the next step of a walker, or the next beat of a song based on the rhythm. The phenomenon of temporal prediction has for now only been investigated experimentally in deterministic scenarios, i.e. when the duration between two sensory events is fixed, or when stimuli present a regular beat. The objective of this project is to understand how we process more natural, hence more complex forms of temporal regularities, and how individuals make inferences on the timing of sensory events based on past temporal statistics of sensory information. This is particularly important for speech processing, considering that speech is an acoustic signal that is known to possess some form of temporal regularity, and yet is not purely rhythmic nor does have a deterministic temporal structure. Temporal regularities are specific to each spoken language, and both native and non-native language listeners are known to use temporal acoustic cues during speech listening. This affects speech comprehension and has a strong impact during language learning. Hence, understanding the processing of temporal regularities in speech can help improve language abilities in first and second language learners. The project is composed of four experiments. The first behavioral experiment will investigate how auditory perception is affected by the temporal statistics of past sensory information using artificial stimuli. The second axis will investigate the neural mechanisms underlying auditory timing processing with electroencephalography (EEG). The last Magnetoencephalography (MEG, experiment 3) and EG (rxperiement 4) experiment will test the role of temporal statistics in an ecological setting, namely speech listening. The project will thus provide strong theoretical advances as it will give new insights on brain mechanisms for the processing of complex temporal information in audition and speech, and their role in language comprehension. It will also provide methodological advances. Specifically, the project will contribute to the development and validation of cutting-edge methods in MEG. Namely, it will aim at creating new tools to investigate the neural correlates of auditory and speech processing with an unprecedented temporal and spatial resolution.

NCT ID: NCT04438733 Recruiting - Healthy Volunteers Clinical Trials

Bioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Volunteers Under Fasted Condition

Start date: June 18, 2020
Phase: Phase 1
Study type: Interventional

An open-label, randomized, two-period, two-group, crossover study was conducted in 26 healthy Chinese volunteers under fasted conditions to assess the bioequivalence between two formulations of Anastrozole.

NCT ID: NCT04399447 Recruiting - Healthy Volunteers Clinical Trials

Multicenter Normal Reference Study of Tissue Motion Tracking of Mitral Annular Displacement(TMAD)

TMAD
Start date: June 2020
Phase:
Study type: Observational

To establish the range of TMADmid、TMADmidpt% by using tissue motion tracking of mitral annular displacement (TMAD), and to explore the influencing factors.

NCT ID: NCT04365907 Recruiting - Healthy Volunteers Clinical Trials

Omarigliptin in Four Healthy Egyptian Volunteers

Start date: March 11, 2020
Phase: N/A
Study type: Interventional

The proposed study will consider the LC-MS/MS quantitative determination of Omarigliptin after administration to four Egyptian volunteers. The main aim of the study is to confirm that the developed LC-MS/MS method is applicable for the bio-assay of the drug in the actual biological samples at the time of Cmax (nearly about 1.5 hours). The design of the study is open labeled, one treatment, one period, single dose study. The concentration of the drugs after 1.5 h will be determined in healthy human subjects according to the ethical regulations of World Medical Association Declaration of Helsinki (October 1996) and the International Conference of Harmonisation Tripartite Guideline for Good Clinical Practice. Written informed consent was provided (attached and signed by the four volunteers) in order to be approved by the ethics committee of the Faculty of Pharmacy, The British University in Egypt. The good health of the human subjects was confirmed by a complete medical history and physical examination. Samples from four, healthy, adult, male, smoking, Egyptian volunteers (age: 23-37 years, Average weight: 81.6 kg, Average BMI: 30.4) will be collected at 1.5 h, to be transferred to heparinized centrifuge tubes in order to be analyzed by LC-MS/MS study (developed & validated) after single oral dose administration of one Marizev® tablet nominally containing 12.5 mg of Omarigliptin (first arm as 4 volunteers). The blood samples (1 mL of each sample) will be centrifuged at 3000 rpm for 5 minutes, 100 µL of the plasma will be separated and spiked with the internal standard working solution and then the sample preparation and LC-MS/MS determination will be applied. Blood glucose level will be determined for all volunteers at different time intervals to monitor any hypoglycemic effect to ensure their safety all over the study. The study will be conducted as per FDA guidelines & the evaluation of safety of the study will be based on monitoring of blood glucose level, vital signs, pulse rate, monitoring of adverse events, and physical examination.