ANZCTR search results

Ambroxol is a simple cough medicine that is predicted to slow ALS disease progression. This study aims to investigate if ambroxol in high doses is effective in treating ALS. This study will be carried out across 5 research sites in Australia (2 NSW, 1 VIC, 1 SA and 1 TAS), where newly diagnosed ALS patients will be asked to participate. Participation will be over a 32-week period, where they will come in for a 4-week screening, 24-week treatment, and 4-week end of study safety follow-up period. The participants will receive either the placebo or drug solution that they will take three times a day, up dosing each week till they reach the maximum dose or highest dose they can tolerate. Throughout the study their disease progression will be assessed using tests, questionnaires, and blood biomarkers.

This pragmatic effectiveness-implementation hybrid type-1 cluster randomised controlled trial in general practice will determine effectiveness and cost-effectiveness of two multi-strategy interventions, RELEASE and RELEASE+, in supporting safe cessation of long-term antidepressants when there is no clinical indication for continued use. Implementation strategies will be evaluated and assessed for scale up to improve primary health care and outcomes for patients. All prescribing decisions are made as usual by patient and GP together.

The aim of this study is to determine the maximum safe and effective dose of a novel therapeutic ADVC001 complexed with the radio-isotope alpha-212 ([212Pb]Pb-ADVC001) for the treatment of metastatic prostate cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, have a diagnosis of metastatic adenocarcinoma of the prostate, and have received at least one cycle of androgen receptor therapy and exposure to a taxane-based chemotherapy. Study details All participants will receive treatment with four cycles of [212Pb]Pb-ADVC001. The intervention will be administered intravenously on day 1 during each 6-week cycle. Participants will be monitored for any adverse events for up to 36 weeks after commencing therapy, and will undergo imaging and blood tests for the duration of treatment to determine their response to therapy. Participants will also have blood samples collected to determine how the study drug is metabolised by the body. It is hoped that this study may help to determine the maximum dose at which [212Pb]Pb-ADVC001 is both safe and effective for the treatment of metastatic prostate cancer. This may help to direct how this novel treatment is used for individuals with metastatic prostate cancer in future.

The goal of our study is to assess the effects of increasing left ventricular assist device speed (an artificial heart pump) and intravenous GTN (a medications that dilates the vessels) on exercise capacity. We will also assess the effect of these interventions on the pressures inside the heart and the amount of blood pumped by the LVAD (cardiac output), using an intracardiac catheter and cardiac ultrasound (echocardiography). Blood tests will also be taken during the study for additional information. Patients will perform the exercise protocol on a stationary bike while lying down. Our main hypothesis is that both pump speed increase and intravenous GTN will lead to lower cardiac pressures and vessel dilatation, maximising cardiac output and exercise capacity.

Multifocal contact lenses (MFCLs) have shown promising results in slowing myopia progression in children. However, the underlying mechanism for treating myopia with MFCLs is still uncertain; it is assumed that MFCLs reduce hyperopic defocus in the periphery, inhibit accommodation lag, and improve the amplitude of accommodation in myopes. It has been demonstrated that myopic blur induced by the peripheral portions of these lenses can reduce myopia progression in children by 36.4% and axial elongation by 37.9%. However, the effect of MFCL on the ability of the eye to detect the stimulus properties such as contrast, colour, and motion remains unknown, and it is possible that MFCL impact these functions, which may contribute to its effect in slowing myopia progression. It is assumed that both optical and pharmaceutical treatments use two different mechanisms to reduce myopia progression and combining both interventions (known as combined therapy) may provide better myopia control than one treatment alone (monotherapy). The primary objective of this study is to examine the effects of MFCL alone (monotherapy) and its combination with 0.05 % atropine sulfate eye drops (combined therapy) on a range of basic visual functions (contrast sensitivity, colour, and motion detection), pupil size, and image quality. This research is expected to provide a greater understanding of the effect of MFCL on the blur detection mechanism of the eye and associated visual function changes and the potential mechanisms underlying myopia development and progression. To achieve this, the outcome measurements will be taken twice, first with MiSight contact lenses and then with 0.05 % atropine.

Topical atropine is a cycloplegic (reduces or temporarily eliminates focusing ability) and mydriatic (increases pupil size) agent that has shown promising results in slowing myopia (nearsightedness) progression in children in a dose-dependent manner. However, the exact mechanism of topical atropine slowing myopia is still unclear. Atropine is known to reduce the focusing ability and increase the pupil size of the eye; however, the effect of atropine on the ability of the eye to detect the stimulus properties such as contrast, colour, and motion remains unknown, and it is possible that atropine impact these functions, which may contribute to its effect in slowing myopia progression. The primary objective of this study is to examine the impact of 0.05 % atropine sulfate eye drops for approximately 2 hours on a range of basic visual functions (contrast sensitivity, colour, and motion detection), pupil size, and image quality. This research is expected to provide a greater understanding of the effect of 0.05 % atropine on the blur detection mechanism of the eye and associated visual function changes and the potential mechanisms underlying myopia development and progression. To achieve this, 0.05 % atropine will be applied to the participant's eye, and the outcome measurements will be taken.

This study will assess the feasibility of delivering a novel remotely monitored, dose measured cycling exercise rehabilitation program to patients following total knee arthroplasty (TKA). This new method uses a mobile cycling device with an in-built power meter remotely monitored by clinicians to prescribe and modify the post-operative exercise regimen, tailoring it specifically to the patient. The feasibility outcomes from this study will inform the acceptability and efficacy of a post-operative cycling exercise program and a larger randomised controlled trial on knee muscle strength, function and post-operative recovery outcomes of a cycling based protocol versus a standard exercise regimen post TKA.

The purpose of this study is to examine if a window of 7 to 21 days between radiotherapy and surgery is feasible for metastatic brain cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed with non-small cell lung cancer (NSCLC) or melanoma, and have confirmed metastatic brain cancer. Study details All participants in this study will undergo radiation therapy to individual brain tumours. This will be performed as per standard clinical practice, and involves 1-5 outpatient visits to the Peter MacCallum Cancer Centre for treatment. In general, each treatment will take approximately 30 minutes. Blood tests will be performed before radiation therapy, and at 1 week, 4 weeks, and 3 months after radiation therapy. These blood tests will coincide with follow-up appointments with a doctor. After radiation therapy is completed, 7-21 days later there will be surgery to remove the radiation-treated brain tumours. The surgery will be performed as per standard clinical practice at the Royal Melbourne Hospital. There will be a few days of hospital stay after the surgery. Brain cancer tissue from surgery will be collected for this study. It is hoped that this research will reveal if having a window of 7 to 21 days between radiation therapy and surgery for brain cancers is beneficial, and lead to better outcomes for cancer patients.

Diabetes related foot ulcers are a condition with significant financial and physical burden. New guidelines highlight a concerning lack of evidence related to the role of exercise in the management of this condition and that, given the well-known benefits of participation in exercise, it should be considered an important area of future research. However, there may be a number of physical and psychological barriers which prevent patients participating in physical activity and exercise, particularly when admitted to hospital. This project aims to explore and describe current barriers to activity and exercise in this patient group. We will also investigate the feasibility and safety of prescribing an exercise programme to patients who are admitted to hospital with diabetes related foot ulcers.

Dysphagia is common in adults living in Residential Aged Care Homes (RACHs). It can lead to malnutrition, dehydration, reduced quality of life, aspiration pneumonia, choking and death. Timely instrumental swallowing assessment, specifically Flexible Endoscopic Evaluation of Swallowing (FEES), can help to minimise these complications. Adults living in RACHs in Australia do not have equitable access to FEES compared to older adults living in other settings. This study explored a mobile service model to increase older adults access to FEES. The hypothesis was that portable FEES delivered onsite in RACHs is a safe, well-tolerated, and practical service model that can increase access to timely, person-centered, high quality swallowing care.