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NCT ID: NCT04807595 Completed - Breast Cancer Clinical Trials

Estimation of the Prevalence of HER2 Low and Describe the SoC, Treatment Patterns, and Outcome in Real-world Practice Among Unresectable and/or Metastatic Breast Cancer Patients With HER2 Low Status

Start date: May 28, 2021
Phase:
Study type: Observational

This is a worldwide, multicenter, non-interventional, retrospective study of patient medical records from metastatic breast cancer (mBC) patients previously identified as human epidermal growth factor receptor 2 negative (HER2-neg), regardless of hormone status.

NCT ID: NCT04800263 Completed - Asthma Clinical Trials

A Trial of SHR-1905 in Healthy Subjects

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

This is a randomized, double-blind, placebo-controlled, single dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of subcutaneous administered SHR-1905 in healthy subjects.

NCT ID: NCT04793659 Completed - Dementia Clinical Trials

Fasudil fOr redUcing elopemeNt and Spatial Disorientation

FOUND
Start date: December 15, 2020
Phase: Phase 2
Study type: Interventional

Fasudil, a Rho kinase inhibitor, is believed to reduce wandering behaviors of elopement and getting lost by improving spatial memory and navigation through improvements in hippocampal blood flow. Fasudil is non-sedating. The aim of the study is to assess the effectiveness of oral fasudil in reducing wandering behaviors of elopement and/or getting lost in subjects with dementia. In addition, effects on wandering behaviors of excess movement and pacing, cognition, memory, neuropsychiatric symptomatology, caregiver/nursing staff burden, and the safety and tolerability of fasudil treatment will be assessed.

NCT ID: NCT04788745 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Targeting Metabolic Flexibility in Amyotrophic Lateral Sclerosis (ALS)

MetFlex
Start date: June 29, 2021
Phase: Phase 2
Study type: Interventional

MetFlex is an investigator led, open-label, single-arm, Phase 2a trial to determine the safety and tolerability of trimetazidine for the treatment of amyotrophic lateral sclerosis/motor neuron disease (ALS/MND).

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: 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.