ANZCTR search results

The objective of this Phase 1B, multicentre, longitudinal, prospective, PK, open label study is to assess any changes in LCM plasma concentrations that may result from physiological changes that occur during pregnancy in women with epilepsy. A change of PK during pregnancy will be assessed relative to postpartum LCM concentrations. In addition, if subjects give additional consent, this study will also measure LCM concentrations in mature breast-milk to estimate newborn LCM exposure. This collaborative study will be conducted as a sub-study of The Raoul Wallenberg Australian Pregnancy Register (RWAPR), which is an observational, prospective, longitudinal study of pregnancies in women taking ASMs, and also women with epilepsy not taking ASMs. The study is interventional due to the additional collection of blood samples and breast milk from women which are exceeding medical practice. However, all other study assessments are part of routine clinical practice, and any decision to continue/discontinue or change LCM therapy during pregnancy and breastfeeding will be made between the participant and her treating physician, taking into account potential risks and benefits, and according to the local label.

This study aims to assess whether the technique of snare tip soft coagulation (STSC) during polypectomy (removal of colon polyps) improves safety and reduces polyp recurrence. Who is it for? You may be eligible for this study if you are aged 18 years or above, and will undergo elective colonoscopy. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. One group will be treated with STSC therapy following removal of their colonic polyp. The other group will be treated with standard of care during their removal of colonic polyps removed, without any additional procedures. After treatment, there will be 30-day monitoring of adverse events via a questionnaire. Polyp recurrence will be assessed at 6 months with a follow up colonoscopy. It is hoped that this research will reveal if the STSC technique is safe and effective in reducing polyp rates, thus improving patient outcomes and reducing risk of colon cancer.

There is an acknowledged lack of available specialist vocational rehabilitation services for adults with stroke. This trial-within-a-cohort will investigate the effectiveness of two models shown to be effective outside of Australia: (1) a resource facilitation approach which will support existing clinical rehabilitation teams to address return-to-work goals, and (2) a more intensive specialist rehabilitation model where a central team of expert clinicians will provide the rehabilitation. The aim is to determine whether a model of vocational rehabilitation will support returning to work after stroke more than clinical rehabilitation.

Rates of cross-reactivity to rocuronium and vecuronium can be used to estimate population exposure and therefore correct individual rates to exposure to give a risk per dose.

Half of mental health condition present before the age of 14, making schools an important platform for supporting student mental health. However most of the research has focused on secondary schools with little attention on the effectiveness of mental health support in primary schools. Therefore, the current study will train a qualified teacher in a new role of Mental Health and Wellbeing Coordinator (MHWC) in primary schools across Victoria, Australia to build the capacity of schools to support student mental health. Our hypothesis is that the MHWC role and associated training (ie. the 'MHWC model') is effective in improving teacher and student outcomes using objective and self-reported measures, when compared to business as usual schools. The primary objective of this study is to assess whether the MHWC model leads to changes in classroom teachers’ self-reported confidence to support student mental health and wellbeing. This study will also assess changes to teachers’ mental health literacy, perceived levels of support to manage child mental health and wellbeing among staff, the prioritisation of child mental health and wellbeing within schools and student mental health and wellbeing. Our hypothesis is that teacher's self-reported confidence to support student mental health and wellbeing will increase following the implementation of the MHWC model.

The purpose of this research is to further the knowledge on the benefits of aerobic exercise to persons with advanced multiple sclerosis (MS). As MS worsens, the ability to perform aerobic exercise at moderate to high intensities becomes difficult due to leg and or arm paresis, access to equipment and the possible effects of MS related fatigue. Low physical fitness and inactivity is associated with a higher risk of cardiovascular and metabolic disease and poor body composition in persons with advanced MS. The main purpose of the study will be to assess exercise capacity, cardiorespiratory and power outcomes on two modes of exercise during three different exercise protocols. The results will allow us to understand how to elicit higher intensities of exercise in people with advanced MS.

This online mental health check aims to identify and detect symptoms of anxiety and depression in children, while triaging aims to increase children’s access to evidence-based care to support children’s mental health. The primary purpose of this study is to evaluate whether the mental health check alone significantly impacts stigma in children aged 6 to 12 years by conducting a school-based cluster randomised controlled trial. Specifically, this study aims to answer the following question: Does the mental health check significantly impact stigma for children aged 6 to 12 years and their parents, compared to children who do not complete regular mental health checks and their parents?

The purpose of this research study is to provide safety information for a new eye pain management option for patients that have been diagnosed with moderate to severe eye pain. Ocular (Eye) surface disease is a debilitating problem causing chronic pain for many patients and is often due to more than one cause. In many of these patients, even with treatment of the underlying cause, the patient is left with persistent, symptomatic eye surface pain. Recent research has identified a link between patients with chronic ocular surface discomfort, and the sensory receptors for painful stimulus, Topical cooling has a long, well-established association with temporarily reducing peripheral peripheral nerve sensitivity. Recently, in other clinical uses of applied topical cooling, it was noted that some patients had a reduced sensitivity. The ETX-4143 device delivers a cooling treatment that is applied to the surface of the eye via a handheld medical device that contains an internal frozen (-20° Centigrade) mixture of purified water and glycerol; ETX-4143 2.0 Device does not contain an active pharmaceutical ingredient. It is applied topically to the scleral surface and the temperature is transferred via a metal plate. Depending on when you are enrolled into the study, the cooling treatment will be applied for either 30 seconds, 2 minutes, 6 minutes, or 10 minutes. Approximately 16 subjects will be enrolled at three clinical sites in Australia. There will be a total of 8 subject visits occurring over 8 weeks. Each visit should take approximately 2 hours.

The study will be a randomised, placebo-controlled double-blind parallel-group trial; over a 12 week period. The primary objective in this study is to determine the impact of a 12 week treatment of CBD on the PANSS positive score in patients with clozapine refractory schizophrenia compared to placebo. Specifically, it is hypothesised those participants allocated to the active arm CBD treatment will have meaningful difference in PANSS positive score of at least 1.8 at week 12 compared to individuals taking placebo.

The purpose of the current study is to evaluate the feasibility and efficacy of adding a telephone coaching element to the Healthy living after Cancer Online program. Who is it for? You may be eligible for this study if you are aged 18 years or older, live in Australia, you have been diagnosed with a localised cancer and you have completed your cancer treatment, which may include surgery, chemotherapy, radiation. Patients on hormonal treatment or Herceptin will still be eligible. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to receive either the Healthy living after Cancer Online program plus telephone coaching, or to receive the Healthy living after Cancer Online program only. Participants in both groups will be asked to work through an online program for 12 weeks that addresses multiple areas of health, including physical activity, healthy eating, mental health, finding the new normal after cancer treatment, fatigue, and weight management. Questionnaires will be collected before and after the intervention. Participants who are allocated to the telephone coaching group will also receive 2x one-on-one 15 minute telephone sessions with a Provisional Psychologist during the first and fourth weeks of the program. The purpose of these sessions will be to help the participants to identify goals that are meaningful to them, to help plan activities that will assist them to meet their goals and to check their progress in meeting these goals over time. It is hoped this research will determine whether the combination of an online cancer program and telephone support sessions are feasible and acceptable to cancer patients. If this pilot program is successful, a larger study enrolling a greater number of patients may go ahead and could lead to future benefits for more cancer patients.