ANZCTR search results

Breast milk is made up of nutrients including fat and sugar. It also contains hormones that help control how hungry or full we feel and how our body uses energy. When a mother breastfeeds, these hormones are transferred from the breast milk to the baby and may play a role in how baby grows and develops. We now know that what a mother eats while breastfeeding can affect how much breast milk she produces, but we still know very little about how this affects breast milk composition, including the levels of these hormones. The purpose of this study is to look at how consuming a breakfast meal containing different levels of fat and sugar affects the amounts of nutrients and other factors, including hormones in breast milk over the following 12 hours. This research will help us to understand the effect of different dietary choices during breastfeeding on the composition of the breast milk and, in the future, may help inform dietary guidelines for breastfeeding women.

This is a research study examining whether medicinal cannabis can safely be given to people who are having a surgical procedure involving the bowel. When a person undergoes major surgery on the abdomen, care after the surgery involves the administration of medications that help relieve pain associated with the surgical procedure. Some of these drugs are called “opioids”. Most patients in this study will probably have had these drugs for the previous surgery in the form of morphine or “morphine-like” drugs given via the intravenous drip or a tablet taken by mouth. The side effects of these drugs include: • Slowing of bowel function • Sleepiness • Slowed breathing • Nausea and vomiting • Decreased appetite This study is not designed to test if medical cannabis is an effective pain management option, but rather seeks to assess if the drug can be safely administered and can be tolerated by patients having surgery such as your procedure and measure blood levels of cannabis chemicals.

This study is evaluating a group therapy, Experiential Awareness Therapy, for people experiencing disordered eating. Experiential Awareness Therapy is an evidenced based therapy aimed at enhancing psychological functioning for eating disorder recovery. Benefits of participating This therapy will aim to: • Increase participants ability to regulate their emotions • Increase participants sense of self-worth and support a realistic and functional understanding of others • Enhance participants ability to identify and understand their emotions and feelings and also identify others intentions, emotions and feelings. • To facilitate an understanding of how these areas of psychological functioning impact eating disordered symptomology. Enhancing these abilities has been shown to be supportive of recovery from disorder eating and also enhance quality of life.

Inactivity and poor nutrition during pregnancy are associated with adverse health and pregnancy related outcomes for the mother and her unborn child. This innovative randomised controlled trial aims to increase physical activity and improve nutritional behavours in pregnant women by integrating an already examined eHealth intervention (Fit4Two) into clinical practice. This intervention will provide participants with highly personalised and automated physical activity and nutritional feedback, endorsed by their practitioner. As such, participants will receive high quality care in a convenient, credible and time efficient manner, whilst placing very little additional burden on practitioners.

Complex diabetic foot wounds such as those with exposed tendon, muscle, fascia, joint or bone, present a great therapeutic challenge to health care professionals. This research aims to assess the use of a biodegradable temporising matrix (BTM) in reconstruction of complex diabetic foot wounds. BTM is entirely synthetic matrix made of polyurethane and works as a scaffold that results in creation of new dermis-like layer. It has the potential to improve wound healing complex wounds as it has been demonstrated in previous human studies. Participants will be diabetic patients with deep complex foot. Intervention will consist of of application of BTM in theatre followed by split skin grafting at a later date if necessary. Wound healing will be assessed using a WoundVue camera, which is a hand held portable device that takes 2D and 3D images and provides wound measurements.

Female Pattern Hair Loss (FPHL) and Male Pattern Hair Loss (MPHL) are produced by Androgenetic Alopecia (AGA). AGA, the most common cause of hair loss in the community, is produced by androgen-mediated hair follicle miniaturization in genetically susceptible individuals. AGA can be treated medically or surgically. The most common treatment is the over-the-counter, TGA-approved topical treatment using Minoxidil lotion (2% and 5%) and 5% foam. Oral minoxidil, originally introduced in the 1970s, is TGA- and FDA-approved in doses up to 100 mg daily for treatment of refractory hypertension, malignant hypertension and for the treatment of hypertension in pregnancy. One of the commonly observed side-effects of taking Minoxidil is hypertrichosis or the condition where excessive hair growth is observed. The purpose of the study is to compare the efficacy and safety of a daily oral dose of 0.45mg minoxidil in patients diagnosed with either FPHL or MPHL. The primary aims are 1) to compare the change in hair count from first dose to end of study and 2)assess the subjective impact of hair growth and quality by completion of patient reported outcomes (PROs). This will be a single-centre, randomized, double-blind pilot study comprising 7 visits over 32 weeks followed by a 24 week open label extension period.

Although once regarded as an ‘orphan disease’, BE remains a contributor to chronic respiratory morbidity and mortality in both children and adults in both low and high-income countries, in particular Indigenous people of high-income countries. Postnatally, lung growth is maximised in the first 7-yrs of life. While low birth weight impacts on future lung health, there is increasing evidence that early life events such as acute lung respiratory infections (ALRI) can reduce future lung function trajectories, and increase BE risk. In early childhood, severe (hospitalised) and repeated ALRI are independent risk factors for future chronic lung diseases, such as BE and non-smoking related COPD which are prevalent amongst Indigenous populations. Interventions to reduce ALRI during infancy and early childhood are important and needed for future lung health i.e. preserve lung function and improve quality of life (QoL). Our double blind RCT is designed to answer our primary question: To determine if the routine use of a personalised written BAMP (compared to standard care) improves clinical outcomes [improves cough-specific QoL (8 items) (PC-QoL -8) and reduces non-scheduled doctor visits]. We aim to enrol 198 (children less than 19 years old) from Royal Darwin Hospital and Lady Cilento Hospital. Participants will be seen clinically at enrolment and followed up monthly with phone calls for 12 months. To date, there are no such published studies in children or adults using BAMP with BE. It is not surprising that BAMP is not routinely used even in tertiary centres. If effective, this RCT will lead to a change in routine clinical practice in children with BE. This will be of great importance, particularly to those living in remote Indigenous communities, where specialist respiratory services are limited. The results will provide evidence for/against the use of BAMP when managing Indigenous and non-Indigenous children with BE.

The purpose of this study is to investigate the efficacy of piezo ICSI as an alternative to the traditional ICSI technique for human oocyte insemination and to assess if fertilisation rates can be improved. We will be able to assess if this alternative technique which uses a Piezo machine will decrease oocyte degeneration rates as well as improving embryo quality and pregnancy rates. A previous study demonstrated that a significantly higher survival rate post injection was seen for oocytes being injected with piezo rather than conventional ICSI (90% vs 95%) and were higher still using the ultra fine piezo pipette (99%). Fertilisation rates were also higher with piezo ICSI and higher still with ultra fine micropipette ICSI (68% vs 89%) and increased quality of D3 embryos was seen in the piezo groups compared to conventional ICSI. It is hypothesised that the lack of cytoplasmic aspiration coupled with a smaller injection site results in less oocyte damage and is the reason behind the improved outcomes seen. Patients will be recruited from Repromed Dulwich ICSI patient group that have booked on for treatment. To determine the efficacy of this technology initially patients recruited will need to meet the following inclusion criteria to ensure adequate oocytes retrieved so fertilisation data and embryos quality can be assessed in a statistically meaningful manner: Couple for whom the treating clinician recommends ICSI as insemination method of choice and those that have 6 or more mature oocytes for injection post egg retrieval. The hypothesis for this trial is that the use of piezo ICSI technology will increase fertilisation rates and decrease oocyte degeneration rates compared to conventional ICSI. Patient’s outcomes will be compared to a matched cohort of patients that are not participating in the Piezo trial undertaking treatment at a similar time in a 1:2 fashion. The proposed research protocol is as follows: 1. Patients interested in partaking in the trial will be provided with information sheet and consent form and will be contacted by the research team and provided the information sheet and consent form via email and opportunity to ask questions. Patients will be approached by recruitment staff from the list of patients booked on for ICSI treatment. 2. Consent to partake will need to be obtained on or before the day of egg retrieval 3. Patients will be flagged on paperwork at egg retrieval that they are participating in the PIEZO trial so lab can activate plan 4. If patient has less than 6 mature oocytes for injection they will be unable to partake in the trial as this is insufficient number of oocytes to draw adequate conclusions and will instead be inseminated via conventional ICSI 5. If patient has greater than or equal to 6 mature oocytes from injection they will be fully enrolled in the trial and oocytes will be piezo injected 6. Normal laboratory practice occurs from this point onwards

This is a Multicentre, prospective, randomised, placebo-controlled, double-blind, parallel group phase III trial with an adaptive sample size re-estimation in stroke survivors enrolled 3 or more months after their event. The primary objective is to test the hypothesis that in stroke survivors, 200mg of modafinil taken once daily for at least 56 days significantly improves participant quality of life compared to placebo, due to the improvement of severe and persisting fatigue after stroke. The trial will screen potential participants with the Multidimensional Fatigue Inventory (MFI) score of above 60. Upon consent and if patient meets other specified inclusion and exclusion criteria they will be randomised to either modafinil (200mg) or placebo once daily for 56 days. The main study visits include screening, Day 0, Day 28 and Day 56 for trial assessments with the SF-36, TMTs, FSS, MoCA, DASS 42 and the EQ5D and mRS. Caregivers will also be compete CSI and OCBS at each study visit The study sample size has been calculated to be 300 recruited participants (150 in each arm). There are three optional sub-studies. 1. Open-Label modafinil for an additional 10 months and return to the study centre for trial assessments after the 10-month treatment phase. 2. Physical activity monitoring and 3. Cognitive assessments

A major gap exists in Australia, and internationally, for providing care to support and maintain functional and social independence of older people with dementia at home. The pilot study of the Interdisciplinary Home-bAsed Reablement Program (I-HARP) points to the benefit of an interdisciplinary team as having the maximum impact. The proposed project will implement and evaluate this novel bio-behavioural-environmental I-HARP model, into existing health and aged care services. I-HARP is a time limited bundle program, consisting of: 1) 12 x home visits, tailored to the individual client’s needs (carried out by occupational therapist, registered nurse, and other allied health staff); 2) minor home modifications and/or assistive devices to the value of up to $1000 per participant; and 3) three individual carer support sessions, at the beginning, middle and end of the series of home visits. The aim of the study is to determine the effectiveness of I-HARP on functional independence, mobility, quality of life and depression among people with dementia, their home environmental safety, carer burden and quality of life, and I-HARP cost-effectiveness. Participants will be older people with mild to moderate dementia, who receive care from participating aged home care services and hospital geriatric services, and their carers. Following informed consent and baseline assessment, eligible participants will be randomly allocated into either the intervention (I-HARP) or the control group (standard care). The study will test the following hypotheses: At 20 weeks, compared to the usual care group, the I-HARP group will have • improved functional independence (primary outcome); • enhanced quality of life; • improved mobility; • reduction in depressive symptoms; • improved carer quality of life; • decreased carer burden; and • improved home environment safety. At 52 weeks, compared to the usual care group, the I-HARP group will have • sustained the benefits of the intervention (1-7 above); and • had decreased total health care costs. I-HARP addresses one of the most costly, often overlooked and significantly undertreated aspects of old age, particularly among people with dementia: the ability to carry out everyday self-care activities and maintain independence. The proposed trial will confirm I-HARP’s scalability in community aged care services operating under Commonwealth supported home case service, and hospital based geriatric services, both of which are designed to support frail community dwelling older people to maximise their independence in their home environment.