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NCT ID: NCT04783207 Completed - Healthy Clinical Trials

Effects of Mitopure (Urolithin A) on Skeletal Muscle Function, Iron Metabolism and Endurance Performance

ENDURO
Start date: April 21, 2021
Phase: N/A
Study type: Interventional

This is a randomized, double-blind, placebo-controlled study enrolling 36 (16 Elite and 20 Sub-Elite trained endurance runners (18 placebo and 18 Mitopure intervention) who are 18-40 years of age. Mitopure or Placebo supplement, will be given as a daily oral dose for 4-weeks.

NCT ID: NCT04782323 Completed - Influenza Clinical Trials

Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults

Start date: April 13, 2021
Phase: Phase 2
Study type: Interventional

This Phase 2, randomized, observer-blind, antigen and adjuvant dose-ranging Clinical study is evaluating different formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 800 subjects are to be randomized into 1 of 8 possible treatment groups. Immunogenicity and safety will be assessed in the overall study population (adults ≥50 years and above) and in the age subgroups ≥50-64 years and ≥65 years to determine the appropriate age population for this vaccine. Data from this study will be used to select the optimal dose to be tested in the pivotal Phase 3 immunogenicity and safety study in older adults. Disclosure Statement: This is a parallel-group dose-ranging study with 8 arms that is participant, investigator and observer-blinded.

NCT ID: NCT04781816 Completed - Clinical trials for Cutaneous Lupus Erythematosus

Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus

CLEan
Start date: April 1, 2021
Phase: Phase 2
Study type: Interventional

Primary Objective: - Assess the efficacy of SAR443122 in cutaneous lupus erythematosus (CLE) Secondary Objectives: - Assess the effect of SAR443122 on the physician's global assessment of disease activity (PhysGA - disease activity) - Assess the effect of SAR443122 on CLE induced itch and overall pain - Assess the effect of SAR443122 on the proportion of disease activity responders compared to placebo - Assess the effect of SAR443122 on the CLASI components score - Assess the effect of SAR443122 on the Investigator's global assessment for CLE (IGA-CLE) - Assess oral cavities for patients with oral lesions - Assess the disease specific quality of life (QoL) - Assess the safety and tolerability of SAR443122 in patients with CLE - Assess the pharmacokinetics (PK) exposure of SAR443122 in patients with CLE

NCT ID: NCT04779411 Completed - Clinical trials for Age Related Macular Degeneration

Online Validation of Dietary Intake Food Frequency Questionnaire Over Four Weeks, and Electronic Device Use Questionnaire Over Eight Weeks.

Start date: August 18, 2020
Phase:
Study type: Observational

Tools to investigate dietary lutein and zeaxanthin (L/Z) intake and electronic device (ED) use are important to progress research that investigates the role of ED blue light (BL) exposure, and dietary L/Z intake on macular health. This project aims to validate two questionnaires developed by our research group: The L/Z FFQ, and the Electronic Device Use Questionnaire (EDUQ). The L/Z FFQ aims to investigate dietary intake of L/Z over the prior week or month. The EDUQ aims to investigate usual hours and behaviours surrounding ED use over the prior three months. This aims of this project are to: 1. Validate a L/Z FFQ recalling over a weekly and monthly timeframe against multiple 24-hour diet recalls over four weeks. 2. Validate the EDUQ against multiple 24-hour ED use diaries over eight weeks. A cohort of 100 adults will be invited to participate to validate the FFQ and EDUQ. Participants will be offered to choose to participate in one or both the questionnaire validations (L/Z FFQ and EDUQ).

NCT ID: NCT04779398 Completed - Clinical trials for Age Related Macular Degeneration

Association of MPOD Values With Blue Light.

AMPBL19
Start date: September 25, 2020
Phase:
Study type: Observational

This study aims to investigate in healthy adults 18-65 years of age the association of electronic device blue light exposure and macular pigment optical density (MPOD) considering usual dietary intake of lutein and zeaxanthin (L/Z) as confirmed by serum lutein and zeaxanthin concentrations. It is hypothesised in healthy adults 18-65 years of age: 1. Higher usual daily electronic device blue light exposure will be negatively correlated with MPOD value. 2. Usual dietary intake of L/Z will be positively correlated with MPOD value. 3. L/Z concentration will be positively correlated with MPOD value. 4. Usual dietary intake of L/Z will be positively correlated with plasma L/Z concentrations. 5. Higher usual intake of L/Z will mitigate the effect of higher electronic device exposure on MPOD value.

NCT ID: NCT04778410 Completed - Clinical trials for Myeloid Malignancies

Study of Magrolimab Combinations in Participants With Myeloid Malignancies

Start date: June 28, 2021
Phase: Phase 2
Study type: Interventional

The goal of this clinical study is to learn more about the safety and dosing of the study drug, magrolimab (Mag), in combination with anti-leukemia therapies in participants with acute myeloid leukemia (AML).

NCT ID: NCT04776122 Completed - Breathing, Mouth Clinical Trials

Usability of a Breathing-CBT Platform (CBT = Cognitive Behavioural Therapy)

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

The study will examine the usability of a breathing platform in the home environment. It will be a randomized, open-label crossover study of 10 participants who will complete the CBT and breathing components in their home, prior to sleeping. Usability will be measured by scores assigned by participants. Qualitative feedback and compliance information will also be collected.

NCT ID: NCT04776031 Completed - Clinical trials for Early Age Related Macular Degeneration (Disorder)

Evaluation of R:GEN as Intervention in Subjects With Early Stages of AMD for Safety and Exploratory Efficacy Outcomes

Start date: February 15, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of the R:GEN Laser System in subjects with the early stages of age-related macular degeneration.

NCT ID: NCT04774185 Completed - Hearing Loss Clinical Trials

Hearing Aid Transmitter Performance Study - SRF-366

Start date: April 26, 2021
Phase: N/A
Study type: Interventional

Sonova Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Sonova Hearing Systems undergo a final quality control in terms of clinical trials. This is a confirmatory study, investigating benefits of a modified hearing aid loudspeaker. This will be a clinical investigation which will be conducted mono centric at National Acoustic Laboratories a well known institution with exceptional experience (Australia).

NCT ID: NCT04771273 Completed - Clinical trials for Non-alcoholic Steatohepatitis (NASH)

A Study to Test Safety and Efficacy of BI456906 in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)

Start date: April 27, 2021
Phase: Phase 2
Study type: Interventional

This study is open for men and women with a liver disease called nonalcoholic steatohepatitis (NASH) and liver fibrosis. The purpose of the study is to find out whether a medicine called BI 456906 helps patients with NASH and liver fibrosis. The study tests 3 different doses of BI 456906 to find the dose that helps best. Participants are put into 4 groups randomly, which means by chance. There are 3 groups that each receive a different dose of BI 456906 and there is 1 group that receives placebo. BI 456906 and placebo are given as an injection under the skin once per week. The placebo injection looks like the BI 456906 injection but does not contain any medicine. Participants are in the study for a little over 1 year (60 weeks). During this time, they visit the study site several times and have some video calls in addition. At the visits, the study doctors take different measurements. To see whether the treatment works, the doctors take a very small sample of liver tissue (biopsy) from each participant at the start and at the end of the study. They also examine the liver by ultrasound and MRI. The doctors also regularly check the general health of the participants.