ANZCTR search results

The primary aim of this study is to determine the prevalence of PPGP in women attending Westmead Hospital for ante-natal care. The secondary aim is to identify factors associated with PPGP. The third aim is to determine the accuracy of a simplified assessment procedure for classification of PPGP compared to standard assessment procedure.

In both scientific and public domain, dietary saturated fatty acids (SFAs) are linked with adverse health effects. However, epidemiological and interventional studies have produced contradictory results. Although negative views about SFAs have prevailed, there is increasing evidence to suggest that SFAs are not as harmful as they appear to be and may not be the prime cause of elevated blood lipid levels. Some studies have shown that SFAs induce beneficial effects on blood lipid profiles and that not all SFAs have the same effect on cardiovascular health. SFAs are classified as short (SCFA), medium (MCFA) and long (LCFA) chain fatty acids. SCFA range between 2 to 4 carbons atoms and are found in milk and dairy products. MCFA contain 6 to 12 carbons atoms and are found in coconut oil, palm kernel oil and citrus seeds. LCFA are 14 or more carbons long and are found in animal products like lard, tallow and suet. The digestion, absorbtion and metabolism of fatty acid depends on their chain length. SCFA and MCFA are easily broken down and undergo rapid beta-oxidation for energy production. However LCFA are not easily digested and are deposited in the peripheral tissues. Thus it is convincing to suggest that consumption of SCFA and MCFA, because of their unique structural, absorption and metabolic characteristics can lower blood fat levels and result in less accumulation of fat in the adipose tissues. Evidence from pre-clinical studies have demonstrated that short and medium chain fatty acids do not contribute to obesity, improves blood lipid profiles and other cardiovascular risk factors. If the same is true for humans, naturally occurring SCFA and MCFA intake might help prevent cardiovascular and other chronic diseases. Thus, we hypothesize that short chain saturated fats (butter), medium chain saturated fats (coconut oil) may not be hyperlipidemic as long chain saturated fats (lard).

The prevalence of scabies is significant in Aboriginal and Torres Strait Islander children in Australia, affecting about 7 in 10 at any given time, more than six times the rate seen in the rest of the developed world. Existing scabies treatments have been associated with serious side effects and there is evidence of increasing resistance of scabies mites leading to treatment failures. These public health concerns clearly demonstrate the need for further clinical studies into alternative treatments. Tea tree oil (TTO) has shown promising results in preliminary studies and has been successfully used as an antimicrobial agent for several decades. Pre-clinical investigations have demonstrated that TTO out-performs widely used scabicidal agents (such as permethrin 5% cream and ivermectin) when tested against scabies mites in a laboratory setting. However, current data are insufficient to warrant a broad recommendation for its use for the management of scabies in a wider population because previous studies were small (interventional case studies focused on a small group of hospitalised patients) and limited to in vitro observations. The aim of this research is to examine the effectiveness and safety of a simple and low-cost TTO gel treatment as compared to permethrin cream in treating paediatric scabies infestation and preventing associated secondary bacterial infection in Aboriginal and Torres Strait Islander children living in remote Australia. The 200 participants will be aged 5-16 and randomised (1:1) into control treatment [permethrin 5% cream] and test treatment [5% TTO-gel] groups. The primary outcome investigated in this study will be the cure (i.e. complete resolution) or improvement of scabies skin lesion within 4 weeks after treatment. Other outcome measures determined will include relief of symptoms, scabies recurrence rate, patient compliance with treatment regimen, adverse effects and patient acceptability.

Hypothesis: Adult consumers with a mental health diagnosis will have increased skills in self-management and reduce likelihood of crisis presentations through utilising a Personal Safety Tool. The Personal Safety Tool aims to support adult consumers within a community mental health setting who are distressed and agitated to regain a sense of calm through identifying their triggers, early warning signs and using a range of individualised sensory strategies and tools to self-soothe and self-regulate. The Personal Safety Tool will adopt a strengths based approach and promote greater self-management in managing their symptoms and health care. The Personal Safety Tool will work to reduce emergency department presentations, inpatient admissions and length of care in hospital. The Personal Safety Tool adopts recovery and trauma informed care principles. It additionally aligns with the Mental Health act and supports least restrictive approach e.g. reducing need for restraint and seclusion. The pilot study will work to strengthen partnerships between Occupational Therapists within northern public mental health services and establish greater flow through of information across services. This will in turn, support continuity of communication and consumer care.

This RCT will evaluate the acceptability and efficacy of an online iCBM program targeting health anxiety symptoms by comparing positive iCBM with neutral iCBM. This study will also explore individual difference factors that predict better response to CBM, as well as the effect of the intervention on symptoms comorbid with health anxiety (such as depression).

The primary purpose of this study is to evaluate the clinical efficacy of a treatment designed to improve psychosocial function in depressed individuals. The proposed study assumes that cognitive, emotional and social cognitive impairments underlie (i.e., cause) psychosocial dysfunction. Accordingly, the proposed study will target functioning in these domains by administering repeated cognitive, emotional and social cognitive treatment tasks. Overall, the study consists of an 8 week RCT and an observational 6 months post-RCT follow-up phase. As primary outcome, we expect that psychosocial function (as measured by the FAST) will be improved at 8 weeks (end of RCT) relative to baseline, and that this improvement will be retained over a 6 month observational period. In addition, the effect of treatment on resilience, occupational functioning, functional disability, cognitive failures and depression symptom severity will also be measured. Also of interest is whether serum biomarkers related to cognition and psychosocial function are sensitive to treatment, as there is little research in this area. It is possible that personalising treatment by individuals’ baseline impairments will lead to more effective treatment outcomes. To this end, half of the participants will complete a personalised treatment while the other half complete a standard (i.e., non-personalised treatment). Although we expect that the personalised treatment arm will result in greater improvement than the standard treatment arm, we expect clinical improvements of patients in both treatment arms during the RCT phase.

Breastfeeding is distinctive to all newborn mammals and provides babies with optimal nutrition, protection from disease and enhanced development. Coordination of sucking swallowing and breathing (SSB) is critical for efficient feeding. The tongue plays major role in infant sucking, facilitating milk removal from the breast and safe swallowing of the milk bolus. Current evidence suggests that SSB coordination in breastfeeding babies with ankyloglossia differs to those without oral anomalies and they are likely to experience breastfeeding difficulties including maintaining attachment at the breast and reduced milk transfer. Further, their mothers may experience nipple pain and trauma that can result in early weaning. Although frenotomy is associated with decreased maternal nipple pain and improved breast attachment, the impact of ankyloglossia and frenotomy on SSB coordination and associated breastfeeding difficulties is not well understood. We aim to compare the following measures in age-matched healthy infants between those without and those with ankyloglossia and breastfeeding difficulties (pre and post frenotomy) 1. Intra-oral vacuum strength, 2. SSB coordination, 3. Tongue movement 4. Milk transfer (total mL) 5. Maternal nipple pain, and breastfeeding confidence 6. Breastfeeding duration We hypothesize that for infants with ankyloglossia more than one component of the SSB coordination will change post frenotomy to be comparable with those of the control group

Adults with congenital heart disease have excellent survival rate. However, late complications such as early-onset of cardiovascular events can affect quality of life later in life. We have recently demonstrated that adults with previous aortic coarctation repair (a procedure to correct narrowing of the heart’s main artery) have increased stiffening of the blood vessel in the brain, which may explain the heightened risk for stroke in this group of patients. The hardening of the blood vessel in the brain decreases the ability of the vessels to dilate effectively, thus decreasing blood flow in the brain. Over time, this can lead to poor mental performance and increases one’s risk for early-onset dementia. In this study, we are looking to examine whether patients with complex congenital heart disease may have disturbances in the blood flow in their brain and how this affects mental performance. We will use transcranial Doppler ultrasound (TCD) to measure blood flow in the brain during a series of mental tests and compare patients with complex congenital heart disease with healthy control participants. We are seeking a total of 30 participants - 15 adults with complex congenital heart disease and 15 adults without heart disease. Participants will be recruited via public advertisement, word of mouth and referral from the cardiologists at the John Hunter Hospital.

Background: This project is a cluster randomised clinical trial investigating the implementation of a computerised clinical decision support system into the Home Medicines Review (HMR) service to deprescribe inappropriate medications in older adults. Older Australians aged 65 years or over are commonly prescribed multiple medications and the doctor may arrange for a HMR. This service is a way for the pharmacist and doctor to help manage medications in the home. This project is investigating to see whether adding a computerised system into HMR will help to use medicines effectively and to avoid any unwanted side effects. Hypothesis: We hypothesise that the combination of pharmacist-led medication review (HMR) and a computerised clinical decision support system intervention that incorporates validated deprescribing tools and guides (e.g. drug burden index (DBI), patients attitudes towards deprescribing (PATD) and Goals of Care, i.e. G-MEDSS) may reduce the proportion of older adults using anticholinergic and sedative medications, and improve clinical outcomes in community-dwelling older adults. Purpose: This study aims to test the efficacy of the addition of GMEDSS in HMR to: • Reduce anticholinergic and sedative medication use (as measured by the DBI) in patients who are exposed to these medications • Measure the effect of these medication changes on clinical and functional outcomes (adherence, cognitive and physical function, falls, institutionalisation, mortality)

High-intensity interval training (HIIT) is becoming more widely recognized as a time-efficient alternative to traditional endurance exercise for improving markers of cardiopulmonary and metabolic health. A major benefit of HIIT is the time-efficiency of a single exercise session which can be completed in under 30 minutes. HIIT involves short, repeated periods of work at or above maximal aerobic capacity interspersed with rest intervals (e.g. 1 min work, 1 min rest repeated 10 times). Given that HIIT requires rapid contraction of type 2 skeletal muscle fibres, as seen with resistance exercise, it is possible that HIIT may also be able to precipitate muscle mass gains. Whether HIIT with protein supplementation can facilitate similar skeletal muscle adaptations reported following resistance exercise, such as hypertrophy, remains understudied in the literature. When an individual stops training (i.e. detraining), loss of adaptation from exercise can occur. However, no study to date has investigated the effects of a short-term (i.e. 2½ weeks) detraining period on measures of strength and aerobic fitness between resistance, endurance and HIIT training. The purpose of this study is to investigate the metabolic and anabolic effects of 6 weeks of HIIT with protein supplementation on measures of muscle cross sectional area, body composition, resting metabolic rate, blood glucose control, muscle architecture, maximal strength and aerobic capacity in overweight and obese adults. Study aims: 1. Compare the anabolic/muscle growth effects of six weeks of HIIT with protein supplementation vs resistance exercise with protein supplementation 2. Compare the metabolic effects of six weeks of HIIT with protein supplementation vs endurance exercise with protein supplementation 3. Investigate the metabolic and anabolic effects of a 2½-week detraining period following each of the exercise interventions Study hypotheses: 1. HIIT with protein supplementation will induce comparable increases in muscle fibre cross-sectional area, lean body mass, whole muscle transcriptome responses, muscle architecture, compared to resistance exercise with protein supplementation 2. HIIT with protein supplementation will induce comparable increases in insulin sensitivity, resting metabolic rate and mitochondrial protein content compared to endurance exercise with protein supplementation 3. Following a 2½-week detraining period, HIIT with protein supplementation will result in comparable losses in muscle cross sectional area, lean body mass, muscle thickness and muscle transcriptome responses compared to resistance exercise with protein supplementation 4. Following a 2½-week detraining period, greater losses in muscle cross sectional area, lean body mass, muscle thickness and muscle transcriptome responses will occur with endurance compared to HIIT exercise