ANZCTR search results

This project aims to translate into the clinic a recently published study, demonstrating the protective role of vitamin B3 supplements (nicotinamide) in a mouse model of glaucoma. Glaucoma causes progressive loss of nerve tissue in the eye, and irreversible vision loss. This study investigates the short-term effect of taking nicotinamide supplements on the eye’s structure and function compared to placebo. Primary aims of this study include: 1) determining whether nicotinamide supplements in participants with glaucoma leads to short-term improvement in visual function measured using visual fields and the electroretinogram (ERG) and 2) determining whether nicotinamide leads to structural changes to the nerve tissue, imaged using hyperspectral imaging and optical coherence tomography. Participants diagnosed with glaucoma by an ophthalmologist will be invited to undertake the 24-week study with crossover design. They will be randomly assigned to take nicotinamide or placebo daily for 12 weeks. The ERG, visual fields and imaging are performed at baseline, 6 and 12-weeks post-intervention. Participants then crossover to take placebo or nicotinamide for another 12 weeks and the same measurements are repeated at 6 and 12-weeks post-intervention.

The COMBAT-MS study will determine the efficacy of a novel, world first management strategy for patients with MS involving combined cognitive remediation and cognitive behavioural therapy. The purpose of combining these techniques will be to create a novel holistic program that; (i) teaches individuals to engage in cognitively stimulating activities that aim to reduce the impact of and/or improve cognitive deficits, optimize day-to-day functioning, and have the capacity to build cognitive reserve and promote neuroplasticity, alongside techniques that; (ii) teach individuals to conceptualise problems as interactions between the person and environment. The COMBAT-MS study intervention will be delivered in a structured program over 3 months, with sustainability of effect tested to 12 months. Participants will be allocated to one of two groups: 1) a group that receives the study intervention, or 2) a group that does not receive the study intervention but receives standard clinical care as usual with their treating neurologist. All participants will be assessed at baseline, 3-month follow up and 12 month follow up. All participants will receive feedback on their results after each assessment. In the initial 12-18 months, we aim to determine whether this program has an impact on psychological factors (i.e. depression, anxiety, stress, coping, self-efficacy, health related quality of life and productivity) and aspects of cognitive functioning (i.e. memory, attention, speed of information processing, executive functions, visuospatial skills) contributing to adjustment. In a randomized controlled design, this will be achieved by administering standardised psychological and neuropsychological assessments pre and post intervention that have been shown to be sensitive in persons with MS. We also aim to determine whether the program is associated with secondary benefits to pharmacological treatment adherence and disease course (e.g. number of relapses; severity of physical symptoms).

This study aims to assess the safety profile and functional outcomes of salvage focal irreversible electroporation (IRE) in patients with prostate cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with local recurrent prostate cancer after radiotherapy (radio-recurrent prostate cancer) without metastatic disease. Study details All participants in this study will undergo a procedure known as salvage focal irreversible electroporation (IRE) as day surgery at St Vincent’s Private Hospital. The procedure is conducted under general anaesthesia and involves insertion of up to 6 needle-like electrode probes around the tumour. Microsecond electrical probes are then delivered to the tumour area to cause cell death and destroy the tumour. The procedure is conducted by a urologist and takes approximately 60 minutes. Participants will be monitored for safety throughout the procedure, and at 3, 6 and 12 months after the procedure. They will also be asked to complete questionnaires at these time points to assess quality of life and urinary and sexual functional outcomes. Cancer recurrence will also be assessed at 6 month and at one year post treatment. The results of this trial will build on a currently developing evidence base in order to guide the judicious use of IRE in patients with localised, radio-recurrent prostate cancer.

Reducing infant mortality and morbidity,and promoting breastfeeding, remain public health priorities. Sharing a sleep surface with a baby is a common, often culturally valued infant care practice that promotes breastfeeding but under certain circumstances increases risk of infant death. Limited published research has evaluated portable sleep spaces that allow close parent-baby proximity on the same or immediately adjacent sleep surface, especially within hospital environments. This pilot aims to determine acceptability, feasibility, safety and impact on breastfeeding outcomes and maternal-infant attachment of two safe sleep enablers within the SCHHS maternity unit. Families will be recruited at the 36-weeks antenatal visit. Eligible, consenting postpartum women admitted to postnatal ward (target sample n=180) during a 4-month period will be allocated either a First Days Pepi-Pod, MaBim Side-Car Crib or a Standard Hospital Cot. The priority of the pilot is to test the novel concept of safe sleep enablers for the first time in an Australian setting. Two primary hypotheses will focus on maternal acceptability of the safe sleep enablers as alternative infant sleep spaces and the feasibility of the proposed protocol in a busy maternity setting. This pilot study aims to determine 1. Acceptability and maternal satisfaction with a safe sleep enabler. 2. Acceptability of safe sleep enablers (intervention) by staff working within a busy postnatal maternity unit. 3. Feasibility of a large randomised controlled trial using the proposed protocol and 4. Describe clinical outcomes of the safe sleep enabler group and control (including maternal satisfaction with care options, breastfeeding initiation and duration, maternal-infant attachment, awareness of safe sleeping recommendations, incidence of shared sleeping, length of stay) to inform protocol revisions for the larger randomised controlled trial. The primary hypotheses are: 1. Acceptability with infant safe sleep enablers will be demonstrated by mothers in the maternity unit setting. 2. Feasibility of a pilot protocol to evaluate safe sleep enablers in the maternity unit setting will be demonstrated (as measured by staff support, appropriate application of the protocol: consent, randomisation, documentation processes). This will be a pilot feasibility study in the first instance, intended to support the design of a non-blinded, randomised controlled trial in the future. The study will use a concurrent mixed methods design conducted in three phases.

This study will focus on finding the right dose of aspirin for cancer prevention in people with a mismatch repair (MMR) gene defect, the underlying cause of Lynch syndrome, also known as HNPCC (Hereditary Non-Polyposis Colon Cancer). Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a confirmed hereditary gene defect in one of the mismatch repair genes; MSH2, MLH1, PMS2 or MSH6 manifesting a classic Lynch syndrome phenotype. Study details All study participants will take daily aspirin tablets for duration of two years but will be allocated by chance to one of three different doses (100mg, 300 mg or 600mg). Study investigators will not know which dose any participant is given and you will not be aware of the dose that you are taking. We will then measure number of participants that develop cancers over 5 years. Our previous study CaPP2 showed that 600mg of aspirin was effective at reducing the risk of cancer in people with Lynch Syndrome and in this study (CaPP3) we would like to determine if 100mg and 300mg of aspirin will be as effective as the higher dose. Taking lower doses of aspirin carries lower risk of side effects such as stomach bleeding occurring.

Peanut allergy affects up to 3% of infants in Australia and only 20% may outgrow their allergy. There is no approved treatment for peanut allergy although oral desensitisation shows promise. Research studies to date show high rates of adverse adverse events making existing protocols unsuitable for standard clinical practice. We have investigated and subsequently published the effect of heated water treatment on peanuts which reduces their allergenicity. We have produced for this trial two types of hypoallergenic peanuts: very low (12-hour treatment), and low allergenicity (2-hour treatment). We have also completed a pilot study which suggests that hypoallergenic peanuts have reduced capacity to cause adverse events and thus provide increased safety for desensitisation with roasted peanuts. Our hypothesis is that sequential treatment with very low allergenic peanut followed by low allergenic peanut will provide partial desensitisation for allergic subjects. This partial desensitisation will allow subsequent desensitisation with roasted peanut without significant adverse events. We will test this hypothesis by treating at least 66 peanut allergic children with HYPES (Hypoallergenic Peanuts Eaten Safely) protocol which utilises 3 phases of treatment, 12-hour heat treated peanut followed by 2-hour heat treated peanut and finally roasted peanuts over a combined total of 52 weeks. We will test the effectiveness of this treatment while monitoring adverse events, psIgE, IgG4 and skin prick test results.

Purpose of study to investigate the safety and efficacy of a novel attempt to achieve trans osseous repair of disrupted or torn rotator cuff using the knotless technique. This is essentially a safety and efficacy trial to confirm the biomechanical advantages in a clinical setting of the recently designed arthroscopic trans-osseous knotless technique using an ATOK implant.

Stress is very common in nursing and has a number of adverse consequences. The aim of this study is to pilot the feasibility of a brief workplace wellness intervention to emphasize the development of behaviours to strengthen the physical and mental health of emergency nurses. In this randomised controlled trial participants will be allocated to either control or intervention. The intervention group will receive a 5 week series of 1 hour classes guided by a Clinical Psychologist which teaches strategies to enhance resilience. Participants will be surveyed prior to starting the program, at the completion of the program and again 3 months later to assess the effect of the intervention on stress, professional quality of life, workplace engagement and resilience.

The prevalence of gestation diabetes mellitus (GDM) is increasing worldwide, with current Australian prevalence rates estimated to be between 13-16%. Little is known about how to prevent GDM in high risk individuals. Strategies to date have largely focused on structured exercise programs. However, the results from these trials have shown little success possibly due to low adherence rates. Recently, studies suggest that sedentary behaviour during pregnancy is associated with increased risk for abnormal glucose tolerance, gestational diabetes and preeclampsia. This suggests that strategies that target a reduction in sedentary time could be an additional, or alternative approach to GDM prevention. However, before such interventions are developed, it is important to investigate the associations of objectively measured sedentary time and sleep patterns on blood glucose and GDM risk. This study aims to examine various descriptors of sedentary behaviour (total sedentary time, prolonged sedentary bouts, number of breaks in sitting) which will help to inform the design of early targeted sedentary behaviour interventions to reduce GDM incidence. Hypothesis: We hypothesise that measurement of sedentary time in pregnant women at 18-28 weeks gestation will be associated with higher fasting and post-challenge glucose levels during the screening test for GDM

Adenomyosis is a condition characterised by the presence of endometrial lining/glands and stroma in the muscle wall of the uterus with surrounding swelling. Typically patients present clinically with a combination of abnormal uterine bleeding, secondary period pain and a tender enlarged uterus in the fourth and fifth decades of life. Infertility is a less common presentation, however as many women are delaying having children into their late thirties and fourties, adenomyosis is increasingly encountered during the clinical work up of infertile women. A definitive link between adenomyosis and infertility has not been established, however several studies have demonstrated a strong association between the two. A recent study looking at uterine wall thickness found that in vitro fertilisation and embryo transfer (IVF-ET) outcomes decreased with increasing uterine wall thickness and findings suggestive of adenomyosis, however two small trials of IVF-ET in patients with adenomyosis found no difference in pregnancy outcomes compared to matched cases. , There is therefore limited and conflicting evidence for the effectiveness of IVF-ET in patients with adenomyosis. The aim of this trial is to evaluate the outcomes of IVF-ET (InVitro Fertilisation - Embryo Transfer) in patients with an ultrasound diagnosis of adenomyosis. The primary hypotheses are that: 1. IVF-ET success rates (clinical pregnancy & live-births) will be different in women with adenomyosis compared to those without adenomyosis based on ultrasound. 2. That the above finding will be true regardless of whether adenomyosis is the only cause or one of multiple causes of infertility in the female. The secondary hypotheses are that: 1. The presence of adenomyosis will be associated with altered 1a. Implantation rates. 1b. Miscarriage rates per clinical pregnancy. 1c. Ectopic pregnancy rates per clinical pregnancy.