ANZCTR search results

OV4071 is an investigational product being tested for neurological disorders. Part B is a food effect cohort of eight participants being administered a single dose on Day 1, followed by a washout period of at least 7 days and a second single dose administered on Day 8 or later under fasted and fed conditions.

This Phase 1 study will evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of OV4071 in healthy participants. It is hypothesised that OV4071 will be safe and well tolerated within predefined exposure limits supporting further clinical development.

Intermittent has been shown to be beneficial in several medical conditions. Alzheimer's dementia has no definitive treatments yet. This study investigates the feasibility of intermittent fasting through time-restricted eating in people at risk for Alzheimer's dementia. The study hypothesis is that the feasibility of time-restricted eating in people at risk of Alzheimer's dementia will be comparable to normal diet.

This study is assessing the feasibility of an exercise prehabilitation program for adults with lymphoma planned to receive CAR-T therapy Who is it for? You may be eligible to join this study if you are aged 18 years or above and scheduled to receive CAR-T cell therapy for lymphoma cancer Study details All participants in this study will receive a personalized prehabilitation exercise program with an exercise physiologist involving 3 exercise sessions per week via telehealth for 4 weeks. Each supervised exercise session will go for 30-45 mins and will include aerobic and resistance exercises. Participants will commence exercise sessions up to 4 weeks prior to the planned start of CAR-T therapy and end just before CAR-T therapy commencement. All participants will complete questionnaires and physical assessments at baseline and 2 weeks post-intervention to determine feasibility and efficacy of the program and a questionnaire to assess the acceptability at 2 weeks post-intervention. We hope that the information learned from this study will help to inform larger prehabilitation exercise trials for people with haemotological cancers planned to receive CAR-T therapy.

This study will develop a pharmacokinetic model of isradipine, an oral treatment for acute hypertension in children, to facilitate accurate, age-specific dosing. We aim to clearly understand how isradipine is processed in children experiencing severe high blood pressure. With these data, we expect to prevent ‘under-doses’ that lead to delays, ineffective management, and disease progression requiring intensive care admissions. We also expect to avoid ‘over-doses’, leading to dangerously large blood pressure (BP) reduction and permanent damage to major organs. By identifying and quantifying critical factors that influence pharmacokinetic parameters in these children, we will develop a dosage regimen stratified by age and comorbidity. This approach will provide improved care to children over the current ‘trial-and-error’ approach with dosing regimens extrapolated from adult data in treating this at-risk population.

COBAT aims to help alleviate the chronic, severe disability experienced by people with treatment-resistant depression. Approximately 30% of people with depression don't respond to standard treatments. Ketamine has emerged as a novel treatment for this difficult-to-treat population, but approximately 50% don't respond and many relapse after ketamine treatment ends. This COBAT pilot is Phase 3 of broader COBAT study and aims to evaluate whether the co-adapted Behaviour Activation therapy manual can be feasibly delivered alongside ketamine treatment as a part of routine care, whether it is acceptable to patients, and whether it shows preliminary marginal effectiveness for future large-scale RCTs

We are conducting this online randomised trial to evaluate the effect of providing an additional explanatory imaging infographic alongside standard imaging reports to adults aged 18-50 years' understanding, treatment beliefs and intentions, information-seeking intentions, concern for symptom progression and confidence in managing hip pain conservatively. It is unclear how the way imaging findings are communicated influences patient understanding, worry, and willingness to engage with first-line physiotherapy treatment. Previous qualitative research suggests that focusing on structural patholoy alone may increase the perception that surgery is necessary course of treatment, potentially reducing engagement with conservative care, but this has not yet been tested experimentally. This study will compare two groups: both groups receive the same hypothetical hip pain scenario, then one group receives standard x-ray and MRI reports and the other receives the same reports plus an infographic explaining the imaging findings in clear, lay language that contextualises structural changes and emphasises the role of physiotherapy. Participants will then complete a nine-item purpose-built outcome survey assessing understanding, treatment beliefs and intentions, information-seeking intentions, concern about symptom progression and confidence in managing hip pain conservatively. The findings will provide insight into the effects of adding an infographic to standard imaging reports on patient understanding, treatment beliefs and intentions.

Open heart surgery is performed more than 2 million times each year worldwide. During and after surgery, doctors often use invasive devices to monitor the heart and blood vessels. One of these devices, the pulmonary artery catheter, provides detailed information about how the heart is functioning. Despite being widely used, it is still unclear whether this device actually helps patients recover better, because it has never been properly tested in a high-quality randomised trial. The PUMA study will address this question by randomly assigning adults undergoing open heart surgery to receive either a pulmonary artery catheter or standard care without one. We will compare outcomes that matter most to patients, including measures chosen with input from people with lived experience. This study will help determine whether routine use of this device improves recovery, safety, and overall outcomes after open heart surgery.

This randomised controlled trial will evaluate a 12-week intervention providing two eggs per day to older adults in retirement living (retirement villages, community living) , with outcomes assessed at baseline, week 6, week 12, and 6 months from the beginning of the intervention. The primary hypothesis is that participants in villages allocated to the increased egg intake intervention will have greater improvements in Mini Nutritional Assessment total scores at 12 weeks compared with control villages continuing usual intake (less than one egg per day). Key secondary hypotheses are that, at 12 weeks, intervention participants will have greater gains in physical function, assessed by the Short Physical Performance Battery and additional physical function tests (HGS, TUG, ADLs), than controls, and will report better health-related quality of life measured by the SF-36 Physical Component Summary. Additionally, it's hypothesised that all blood markers (total cholesterol, HDL, LDL, triglycerides and glucose) will have no significant difference between groups. The trial will also assess implementation outcomes, with the hypothesis that intervention participants will achieve high adherence, defined as consuming at least 80 percent of prescribed eggs over 12 weeks. A further hypothesis is that intervention participants will report high acceptability of incorporating eggs into their regular diet, including favourable ratings of taste, ease of preparation, frequency tolerance, and perceived health effects, and that trial data will identify practical strategies to support sustained egg consumption in this population.

The study aims to evaluate the adverse events and quality of life outcomes associated with prostate stereotactic ablative radiotherapy (SABR) for newly diagnosed metastatic prostate cancer, Who is it for? You may be eligible to join this study if you are aged 18 years or above and have newly diagnosed metastatic prostate cancer. Study details: Traditional radiotherapy for de novo metastatic prostate cancer typically involves four weeks (20 sessions) of daily treatment to the prostate, on top of standard care systemic therapy. In this study, all participants in this study will receive SABR to the prostate delivered in five fractions, one fraction per week over 5 weeks, for a total of 35 Gy, in addition to standard care systemic therapy. Participants will complete questionnaires, and blood tests during regular follow-up visits up to 5 years post-SABR completion to determine quality of life and efficacy outcomes, and adverse events. It is hoped this study may provide evidence for a safe and effective, and more convenient radiation therapy schedule in the form of prostate SABR, for patients with metastatic prostate cancer.