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NCT ID: NCT04788511 Completed - Obesity Clinical Trials

Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity

STEP-HFpEF
Start date: March 16, 2021
Phase: Phase 3
Study type: Interventional

This study will look at how the participants daily life is affected by their heart failure. The study will also look at the change in participants body weight from the start to the end of the study. This is to compare the effect on heart failure symptoms and on body weight in people taking semaglutide (a new medicine) to people taking "dummy" medicine. Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach area, thigh or upper arm. During the study participants will have talks with the study staff about healthy lifestyle choices including healthy food and physical activity. The study will last for approximately 59 weeks. Participants will have 11 clinic visits and 1 phone call with the study doctor. Women: Women cannot take part if they are pregnant, breast-feeding or plan to become pregnant during the study period.

NCT ID: NCT04787887 Completed - Gaucher Disease Clinical Trials

A Phase I Study to Compare Abcertin and EU-sourced Cerezyme® in Healthy Volunteers

Start date: January 29, 2020
Phase: Phase 1
Study type: Interventional

Primary Objective: To compare the pharmacokinetics of Abcertin to the reference product, EU-sourced Cerezyme, after single intravenous administration of 60 IU/kg. Secondary Objective: To compare the safety, tolerability and immunogenicity of Abcertin to the reference formulation, EU-sourced Cerezyme, after single intravenous administration of 60 IU/kg.

NCT ID: NCT04786847 Completed - Clinical trials for Metastatic Prostate Cancer

177Lu-DOTA-TLX591 Safety, Biodistribution and Dosimetry Study

ProstACTSelect
Start date: January 30, 2022
Phase: Phase 1
Study type: Interventional

This is a Phase 1 trial of TLX591, a monoclonal antibody HuX591 conjugated with a DOTA chelator and radiolabelled with 177Lu (177Lu-DOTA-TLX591). TLX591 is being developed as a PSMA-targeting antibody to be radiolabelled with a therapeutic radiosotope for the treatment of PSMA-expressing tumours, therefore this study has been designed to assess the safety and tolerability, pharmacokinetics, whole body biodistribution and radiation dosimetry of 177Lu-DOTA-TLX591.

NCT ID: NCT04786405 Completed - Clinical trials for Mindfulness Meditation

Mindfulness Meditation Versus Clinical Hypnosis for Acute, Experimental Pain

Start date: March 15, 2021
Phase: Phase 2
Study type: Interventional

This trial aims to determine the effects and mechanisms (mediators and moderators) of brief training in mindfulness meditation versus clinical hypnosis on acute, experimental pain.

NCT ID: NCT04786392 Withdrawn - Clinical trials for Macula Lutea Opacity

Food or Supplemental Lutein Absorption

FSLA20
Start date: June 2021
Phase: Phase 1
Study type: Interventional

The aim of this study is to investigate in healthy adults, 18-40 years of age, how the absorption of 5 mg of L differs between consumption as a supplement, blended foods, and whole food equivalent of blended foods.

NCT ID: NCT04784390 Terminated - Amblyopia Clinical Trials

Proof of Concept Study of Binocular Videogames Versus Patching for Amblyopia

Start date: June 30, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this PoC study was to evaluate the potential therapeutic efficacy of binocular video games played on a tablet and to compare the efficacy of binocular video games versus patching in amblyopic patients 4 to 7 years old (Part A) as well as to gain experience with binocular video games in older children population of 8 to12 years old (Part B). Part A and Part B was designed to provide long term data on durability of binocular video games treatment. The study consisted of two parts, Part A: randomized, single masked PoC study in children 4 to 7 years old at Screening, and Part B: open-label substudy in children 8 to 12 year old at Screening.

NCT ID: NCT04783935 Completed - Multiple Sclerosis Clinical Trials

Extension to the MAGNIFY MS Trial on Mavenclad® (Magnify MS Extension)

Start date: March 10, 2021
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to evaluate the long-term effectiveness of Mavenclad® tablets, in terms of disease activity and safety, in participants with highly-active relapsing multiple sclerosis (RMS) previously participating in the MAGNIFY MS trial MS700568_0022 (NCT03364036).

NCT ID: NCT04783714 Completed - Clinical trials for Hypercholesterolemia

Investigating Effects of a Novel Nutraceutical on Hypercholesterolaemia in Australian Adults

CLoNE
Start date: April 30, 2021
Phase: N/A
Study type: Interventional

To evaluate the effects of daily consumption of 3 capsules of Swisse Nutra+ Cholesterol Balance on serum LDL-cholesterol in adults with hypercholesterolaemia compared to placebo over four months. This is a single-centre, randomised, double-blind, placebo controlled, parallel study. Applicants will be eligible to participate if they have hypercholesterolemia, defined by fasting LDL-cholesterol 2.5mmol/L and ≤5 mmol/L confirmed at screening visit. Participants who are otherwise healthy will be included in the study; individuals with a history of cardiovascular disease are excluded from this trial. Following pre-screening telephone assessment, applicants will attend an in-clinic screening visit and following informed consent, their general health and eligibility for inclusion into the study will be assessed. On Day 1 eligible participants will be randomly allocated to receive one of two study treatments (intervention or placebo). Participants will consume the assigned treatment daily for four months. Participants will return to the clinic at months 2 and 4 for assessment of primary and secondary outcomes. Compliance, adverse events and concomitant medication use will be assessed at these visits. In addition, participants will complete an online survey at months 1 and 3 to assess protocol compliance, adverse events and use of concomitant medications. Any queries that arise from the survey will be followed up by phone call. Dietary intakes will be assessed at the baseline and four-month visits. A final participant online survey and phone call (if needed) will be conducted one month after the 4-month visit for a final safety assessment.

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.