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NCT ID: NCT04610983 Recruiting - Lifestyle Clinical Trials

Omega-3 Bioavailability From Vegetable-omega-3 Enriched Products

Start date: November 16, 2020
Phase: Phase 2
Study type: Interventional

CSIRO's Food Program has developed a novel vegetable-based Omega-3 long-chain polyunsaturated fatty acid (Omega 3)encapsulant to be used as ingredient in various food products, however, it is unknown whether the vegetable-based carrier matrix will affect omega-3 bioavailability. This project aims to compare the bioavailability of omega-3 from two test foods containing vegetable (cauliflower)-encapsulated algal oil (the "ingredient") against a control test product (algal oil gel capsules) across two ethnicities (Australian European vs. Chinese Singaporean).

NCT ID: NCT04609878 Recruiting - Asthma Clinical Trials

Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)

KALOS
Start date: December 15, 2020
Phase: Phase 3
Study type: Interventional

This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care

NCT ID: NCT04608630 Recruiting - Osteoporosis Clinical Trials

Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults

BoneZone
Start date: July 15, 2021
Phase: Phase 2
Study type: Interventional

The Bone Zone trial is a prospective, multi-centre, double-blind, phase II, randomised controlled trial evaluating the effect of denosumab or zoledronic acid compared to placebo on change in bone mineral density over one year in women aged 50 years or older and men aged 70 years or older requiring admission to intensive care for greater than 24 hours. 450 women aged 50 years or older and men aged 70 years or older, admitted to intensive care for greater than 24 hours will be recruited into the study from participating study centres.

NCT ID: NCT04607421 Recruiting - Neoplasms Clinical Trials

A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer

Start date: December 21, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that: - has spread to other parts of the body (metastatic); - has a certain type of abnormal gene called "BRAF"; and - has not received prior treatment. Participants in this study will receive one of the following study treatments: - Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection into the vein) at the study clinic. - Encorafenib plus cetuximab with chemotherapy: These participants will receive encorafenib and cetuximab in the way described in the bullet above. Additionally, they will receive standard chemotherapy by IV infusion and oral treatment at home. - Chemotherapy alone: These participants will receive chemotherapy, the standard treatment for this condition, by IV infusion at the study clinics and oral treatment at home. This study is currently enrolling participants who will receive either encorafenib plus cetuximab with chemotherapy or chemotherapy alone. The study team will monitor how each participant responds to the study treatment for up to about 3 years.

NCT ID: NCT04606446 Recruiting - Clinical trials for Locally Advanced or Metastatic Non-small Cell Lung Cancer

Study of PF-07248144 in Advanced or Metastatic Solid Tumors

KAT6
Start date: November 16, 2020
Phase: Phase 1
Study type: Interventional

This is an open-label, multi center study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-07248144 and early signs of clinical efficacy of PF-07248144 as a single agent and in combination with either fulvestrant or letrozole + palbociclib or with PF-07220060 + fulvestrant

NCT ID: NCT04604353 Recruiting - Clinical trials for Coronary Artery Disease

Early Detection of Coronary Artery Disease by Polygenic and Metabolic Risk Scoring

EDCAD-PMS
Start date: December 7, 2020
Phase: N/A
Study type: Interventional

The overall goal of this study is to develop a combined polygenic risk score (PRS) and metabolic risk score (MRS) and determine its impact on selecting community members for CCS. The trial component of this study will compare the use of these scores to motivate people to adhere to therapy, an ongoing challenge for clinicians, by providing feedback in a meaningful form to both the clinicians and the patients.

NCT ID: NCT04601467 Recruiting - Clinical trials for Acute Coronary Syndrome

PASSIvation of Vulnerable Plaque With AZD5718 in AcuTe Coronary syndromE

PASSIVATE
Start date: July 12, 2021
Phase: Phase 2
Study type: Interventional

This is a multi-center study conducted at 13 sites in 3 countries (Singapore, New Zealand, and the Australia). Approximately 260 patients with an acute myocardial infarction (AMI) will be randomized in a ratio of 1:1 ratio to receive AZD5718 125 mg or placebo for 12 months.

NCT ID: NCT04597411 Recruiting - Clinical trials for Prostatic Neoplasms, Castration-Resistant

Study of 225Ac-PSMA-617 in Men With PSMA-positive Prostate Cancer

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

This is a Phase 1, open-label, international, dose escalation study to evaluate the safety of [225Ac]Ac-PSMA-617 (225Ac-PSMA-617) in men with PSMA-positive prostate cancer who have and have not had prior exposure to [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) or [177Lu]Lu-PSMA I&T (177Lu-PSMA I&T).

NCT ID: NCT04596631 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes

PIONEER TEENS
Start date: November 2, 2020
Phase: Phase 3
Study type: Interventional

This study compares 2 medicines for type 2 diabetes: semaglutide (new medicine) and a dummy medicine (placebo). Semaglutide will be tested to see how well it works compared to the dummy medicine. The study will also test if semaglutide is safe in children and teenagers. Participants will either get semaglutide or the dummy medicine - which one is decided by chance. Participants will take 1 tablet of the study medicine every morning on an empty stomach. They have to wait 30 minutes before they eat, drink or take any other medication by mouth. The study will last for about 1 year and 3 months (66 weeks). Participants will have 12 clinic visits and 8 phone calls with the study doctor. At all 12 clinic visits, participants will have blood samples taken. Participants will also be asked some questions.

NCT ID: NCT04595734 Recruiting - Hepatitis Clinical Trials

Liver Toxicity in Lung Cancer Patients Treated With Immune-checkpoint Inhibitors.

Start date: January 7, 2020
Phase:
Study type: Observational

Immune-checkpoint inhibitors have recently become available as a new therapy for a variety of cancers. This drugs function by boosting the anti-cancer immune response, but unfortunately, may cause off-target, non-specific immune activation, resulting in liver and gut toxicity. In order to understand the development of liver immune-related adverse events we aim to collect full clinicopathological data from patients with advanced lung cancer treated with immune-checkpoint inhibitors at Blacktown, Westmead and Nepean Hospitals. Patients treated with standard chemotherapy will be used as a control group. This study aims to establish clinical risk factors that can predict the occurrence of liver immune-related adverse events in patients with advanced lung cancer treated with immune-checkpoint inhibitors. Such predictors may assist in the stratification of patients based on their risk for development liver toxicity as a result of immunotherapy, allowing early cessation/modification of treatment prior to the development of severe adverse reactions. In addition, this retrospective study will aim to determine the significance of pre-existing liver damage on the development of liver adverse events as well as establish a timeline defining the development of adverse events in the liver.