ANZCTR search results

A double-blind, randomised, placebo-controlled study to evaluate the effect of orally-dosed LipiSperse curcumin and/or palmitoylethanolamide (PEA) on exercise recovery in healthy males.

The purpose of this study is to determine whether a brief electronic questionnaire is a feasible, useful and acceptable way to help guide treatment in older adults with cancer. Who is it for? You may be able to take part in this study if you have been referred to the Border Medical Oncology Unit in Albury, and are over the age of 70. Study details In this study, all participants will be required to fill in an electronic questionnaire and undergo two assessments completed by a clinician. The electronic questionnaire contains 21 questions about ability to perform activities of daily living, emotion and mood, supports at home, medications and other questions that may help the oncologist choose the most appropriate treatment. Two other assessments will be performed by a clinician after the questionnaire is completed. These are a test of the participant's ability to stand from a chair and walk 3 metres (Timed Up and Go) and a test of memory (Mini-COG) It is hoped that this research will help determine whether the electronic Rapid Fitness Assessment will help provide better treatment for patients with cancer in regional centres.

Cystic Fibrosis (CF) is associated with a significant increase in gut dysbiosis. Exposure to multiple courses of antibiotics as well as an inherently inflammatory gut contributes to this. We have shown that there are significant differences between the CF gut and healthy volunteers in these respects. High amylose maize starch (HAMS) is a pre-biotic food stuff produced in such a way as to encourage the production of beneficial, anti-inflammatory compounds. In laboratory culture, we have shown that HAMS increases the production of these compounds. What is not clear however is whether this laboratory data translates to a clinical benefit. This study will attempt to understand the impact of HAMS supplementation on the bacteria in the gut and the ability of the gut to make anti-inflammatory compounds, in adult patients with CF as well as in healthy control subjects.

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of vismodegib in patients with advanced cancers and tumours. Who is it for? You may be eligible to join the study if you are aged 18 years and older, with pathologically confirmed advanced and/or metastatic solid cancer of any cell type or an earlier diagnosis of a poor prognosis cancer and have received all standard anticancer therapy. Participants will have tumours with mutations in PTCH1 or SMO. Study details Participants will continue to consume one 150mg capsule of vismodegib for as long as they and their doctor agree there is a benefit from treatment. Participants will undergo imaging assessments at 8 weekly intervals or as clinically indicated in order to evaluate tumour response. Safety and tolerability of treatment and health related quality of life during treatment will be assessed at 4 weekly intervals. We cannot guarantee that patients will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that vismodegib will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

Aim? To determine whether exercise will result in favourable changes in gut microbial diversity, composition and metabolic profile of prostate cancer patients receiving androgen deprivation therapy (ADT). Who is it for? You may be eligible to join this study if you are a male aged 18 years or more and have histologically confirmed adenocarcinoma of the prostate, and currently receiving androgen deprivation therapy. Study details: Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group receive a 12 week exercise intervention. The exercise intervention group will receive a 3-month, supervised, progressive and individually tailored exercise program involving resistance and aerobic exercises undertaken 3 times per week in an exercise clinic setting, supervised by an accredited exercise physiologist. Participants in the other group will receive usual care for the duration of the trial. Following the trial, the control group will be offered the same exercise program if the intervention to thank them for participation. All participants will complete assessments at baseline and after 12 weeks in order to evaluate gut health and function, diet and nutrition practices, muscle-bone health, adiposity, physical fitness, functional capacity, and psychosocial health. What will this research contribute? This novel study will provide preliminary information among a group of prostate cancer patients who are at risk of gut dysbiosis, and subsequently test whether exercise (a low-cost, readily-accessible therapy) can reduce the risk of gut dysbiosis, and/or reverse the side-effects of this health complication in men with prostate cancer receiving androgen deprivation therapy.

The overall goal of the study is to evaluate whether Enbrel® and its biosimilar Brenzys® are interchangeable in the treatment of patients with rheumatoid arthritis. That is, different sequences of Enbrel® and Brenzys® use are not associated with increased immunogenicity as evident by treatment related loss of clinical efficacy and development of treatment related clinical toxicity. The specific aim of the study is to test whether multiple switching between the etanercept biosimilar Brenzys® and the etanercept reference product Enbrel® (the intervention group) is non-inferior with regard to disease control and clinical immunogenicity compared to no switching, that is, continuing on Enbrel® (the control group), in participants with stable rheumatoid arthritis on Enbrel® who are in clinical remission or a low disease activity state by the DAS28-CRP.

Orthokeratology contact lenses are specialised rigid contact lenses are worn overnight and are removed in the morning. During overnight wear, orthokeratology lenses temporarily change the shape of the front surface of the eye, or cornea, which acts to correct mild to moderate degrees of myopia, providing wearers clear unaided vision throughout the day. The renewal and regeneration of corneal cells are important for maintaining transparency of the cornea which is crucial for clear vision. Surrounding the clear cornea is the limbus or limbal region which contains the stem cells that are responsible for maintaining renewal and regeneration of corneal cells and thus it's clarity. Previous studies have demonstrated changes to the limbal stem cells associated with soft contact lens wear. A deficiency in limbal cells can lead to decreased vision. Although orthokeratology lenses have a smaller overall diameter than soft contact lenses, its proximity to the limbus and rigid nature of the lens raises the question of whether there are any mechanical impacts on the limbal region associated with lens movement which may lead to changes in limbal stem cells. This study aims to investigate if there are any associated limbal changes with orthokeratology lens wear.

This feasibility study is aiming to test the SunVisor app and messages to determine its effectiveness before it can be applied to a randomised controlled trial setting. The app aims to improve sun protection strategies and reduce sunburn incidence. We plan to recruit up to 115 participants to test the feasibility and satisfaction with the app. Participants will be asked to use the app for a two week period and receive a daily sun protection message. Participants will be asked to complete a evaluation survey after the 2 week intervention period to assess satisfaction with the app and messages.

A comparative randomised double blind study to evaluate the effect of Lutein supplementation on Macular Pigment Optical Density (MPOD) and blood Lutein levels in healthy adults over 16 weeks.

A double-blind, randomised, placebo-controlled interventional study to evaluate the effect of orally-dosed Almega PL on cardio-metabolic parameters and inflammatory markers in men and women.