ANZCTR search results

This study aims to answer the following research question: Is metformin pharmacotherapy for 12 months as an adjunctive therapy to a 12-week lifestyle behavioural intervention program targeting physical activity, diet and sleep hygiene practices effective in improving clinical cardiometabolic health parameters and affective symptoms of young people with a clinically diagnosed mood or psychotic syndromes? The study will run for approximately 3 years. The total duration for each participant is 52 weeks involving 52 weeks of metformin/placebo, 12 weeks of lifestyle behavioural intervention, intermittent actigraphic assessments, and follow up at 12, 26, 38, and 52 weeks. Investigators expect to enrol 266 people in this trial.

We anticipate that participants recovering from stroke will be able to participate in inpatient and home-based ELEMENTS-T therapy effectively and will show enhanced motivation to engage in therapy as a result of their involvement. This will fulfil the principle that rehabilitation methods that encourage intense interaction are most beneficial. With the ELEMENTS-T system, intensity is ‘given for free’ because the therapy is fun and the benefits accrue incidentally as a function of active and playful interaction. We expect that the user interaction afforded by the system will enable inpatients to make significant gains in motor and cognitive function, compared to treatment as usual.

Acute ischemic stroke (AIS) is the most frequent pathological subtype of stroke affecting millions of people worldwide. Timely reperfusion treatment with the intravenous (IV) thrombolytic agent, recombinant tissue plasminogen activator ([rtPA] or alteplase) in carefully selected patients, offers them the potential benefit of surviving free of major disability. Clinical practice guidelines recommend that post-rtPA patients are closely observed and monitored over at least the subsequent 24 hours to allow early detection. However, it is unclear whether the standard intensive nursing monitoring protocol that forms the basis of guideline recommendations for the last 20 years should continue to be routinely applied to stable ‘low-risk’ post-rtPA patients with mild neurological deficits who do not require critical care intervention. OPTIMISTmain is an investigator-initiated and conducted, international, multicentre, stepped wedge cluster randomized controlled trial to determine whether compared to standard monitoring, less-intense monitoring is at least as effective ('non-inferior') on the functional recovery of acute ischaemic stroke patients post-rtPA infusion with mild-moderate neurological deficit. The study also aims to establish that less-intense monitoring can be safe, provides economic and resource benefits, relative to standard monitoring.

This research is being conducted to investigate the impact of a brief meditation on brain function using a functional MRI process. The benefits of this study will include determining the impact of Ecomeditation (a brief 22 minute meditation) on neural brain changes - participants will be asked to have a 10 minute brain scan then engage in listening to a meditation track for 4 weeks (daily) and then have another brain scan to see if there are any changes. Validating brief meditation as a physiological method of meditation that can be rapidly and reliably induced, may make brief meditation accessible to many who have found it difficult in the past. We will compare both experienced meditators and non-meditators (in order to ascertain whether non-meditators are able to achieve sustaining a meditative state over the 4 weeks and to see any changes it has on brain regions indicative of deep meditative states, such as the dorsolateral prefrontal cortex, the ventromedial prefrontal cortex, the thymus, and the hippocampus. It is hypothesized that changes in activity patterns and maybe connectivity will be observed).

The study is designed to assess cervical tissue penetration of Topical ABI-1968 Gel after multiple weekly dosing in participants with and without cervical cap. Participants who meet all inclusion and none of the exclusion criteria will be evaluated throughout the study. Up to 12 participants may be enrolled into one of the following four groups (3 participants per group). • Group 1: Four weekly dosing of up to 1% of Topical ABI-1968 Gel with cervical cap • Group 2: Four weekly dosing of up to 1% of Topical ABI-1968 Gel without cervical cap • Group 3: Up to 4 weekly dosing up to 1% of Topical ABI-1968 Gel (with or without cervical cap) • Optional Group 4: Repeat the same dosing regimen used in previous groups or test a different regimen (but not to exceed a dose up to 1% Topical ABI-1968 Gel and no more than four weekly dosing). • Group 5: Up to 4 weekly dosing just 1% gel of topical ABI-cream with a cervical cap.

Recommendations to increase intakes of foods rich in flavonoids have the potential to improve population health and reduce cardiovascular disease-related mortality. Flavan-3-ols are the most abundant subclass of flavonoids in the diet and are found in abundance in cocoa, apples, and tea. Currently, flavan-3-ol intake is estimated from food frequency questionaires. There is a crucial need for quality biomarkers of intake as a means of overcoming food questionnaire and food database limitations. Recently, a microbiome-derived flavan-3-ol catabolite, gamma-valerolactone (gVL), has emerged as a promising candidate. The primary aim of the proposed project is to establish the suitability of gVLs as biomarkers of flavan-3-ol intake.

This study is a randomised, crossover, double-blinded, single-dose experimental trial investigating the dose-dependent effects of purified, oral cannabidiol (CBD) on simulated car driving performance in healthy individuals. Participants will complete four experimental sessions involving different CBD treatments: (1) Placebo (0mg); (2) Low dose (15mg); (3) Moderate dose (300mg); and (4) High dose (1500mg). Trials will be conducted at the Woolcock Institute of Medical Research. We hypothesise that no dose of CBD will affect simulated car driving performance. Findings may assist to inform the development of guidelines and/or laws relating to the use of CBD drug therapies by drivers.

Brief description of the study purpose: This pilot study will examine the feasibility, safety and trends in effectiveness of providing a preoperative hospital and home-based rehabilitation program to individuals with stages I-IIIA Non-small cell lung cancer prior to surgery. The primary aim is to assess the feasibility of the prehabilitation program. Secondary aims are to assess postoperative outcomes (postoperative pulmonary complications and acute hospital Length of stay). Other secondary outcomes include changes in functional exercise capacity, physical activity levels, anxiety and depression and health-related quality of life. Who is it for? You may be eligible to participate in the study if you are over 18 years of age, have suspected stage I-IIIA lung cancer and are presenting for surgery and have no major comorbidities which would make exercise difficult. Study details: Participants will be randomly allocated to intervention or control groups. The intervention consists of preoperative exercise training (aerobic and resistance) for 1-4 weeks prior to lung cancer surgery. The control group will receive standard care (consisting of no preoperative exercise or physiotherapy intervention). It is hoped that this intervention will prove to be feasible and will improve postoperative outcomes, reduced hospital length of stay and improve the preoperative management of people with non-small cell lung cancer.

Paracetamol is one of the most common medications taken in overdose around the world. It is readily available and does not require a prescription to purchase. N-acetylcysteine (NAC) is the antidote used to treat patients at risk of developing liver toxicity secondary to the metabolites of paracetamol that accumulate following paracetamol overdose. The standard NAC treatment regimen lasts 20 to 21 hours and requires admission to hospital. Patients who present to hospital and receive NAC for paracetamol overdose and have normal liver function and subsequently have a less than therapeutic paracetamol concentration and normal liver function with at least 12 hours of treatment with NAC are unlikely to go on to develop liver toxicity. All study participants will be required to stay in hospital for the usual 20 hours (the time for a standard NAC infusion as per the current treatment guidelines) and will have liver function tests measured at this time. This trial aims to determine that a shorter treatment regimen (12 hrs) for paracetamol overdose is safe.

Paracetamol is one of the most common medications taken in overdose around the world. It is readily available and does not require a prescription to purchase. N-acetylcysteine (NAC) is the antidote used to treat patients at risk of developing liver toxicity secondary to the metabolites of paracetamol that accumulate following paracetamol overdose. The standard NAC treatment regimen lasts 20 to 21 hours and requires admission to hospital. Patients who present to hospital and receive NAC for paracetamol overdose and have normal liver function and subsequently have a less than therapeutic paracetamol concentration and normal liver function with at least 12 hours of treatment with NAC are unlikely to go on to develop liver toxicity. Conversely, patients who present late (greater than 8 hours post ingestion) to hospital, or with abnormal liver function, high paracetamol concentration and require NAC treatment, are likely to require a prolonged course of treatment and might develop liver failure. We aim to increase the dose of NAC in this high risk group and examine whether this decreases degree of liver injury and hospital length of stay.