ANZCTR search results

The principal aim of the proposed study is to develop, implement and evaluate a minimally invasive model of care to deliver effective primary dental services, including treatment and preventive services, to Aboriginal pre-school children. This will be compared with standard care for cost and benefits in terms of improved dental health, quality of life and reduced childhood dental anxiety.

We are aiming to assess the effect of commencing empagliflozin (Jardiance), a medication used for blood glucose lowering on heart function and structure. This ultimately may lead to a better understanding of the effects of this class of medication on heart function.

This multi-centre randomised controlled trial will investigate the effectiveness and feasibility of a six-week behaviour change intervention to reduce sedentary time in people with COPD. Eligible participants with COPD on the waiting list for pulmonary rehabilitation at Royal Prince Alfred Hospital and Prince of Wales Hospital, Sydney, will be randomised to either a six-week behaviour-change intervention to reduce sedentary time or to a sham intervention. The intervention uses goal setting and motivational interviewing techniques to determine individualised ways of replacing sedentary behaviour with light intensity physical activity. Outcomes will include sedentary time according to self-report and objective device-based measures, feasibility of the intervention, functional exercise capacity, quality of life, patient activation, and anxiety and depression. Semi-structured interviews will also be conducted to obtain qualitative data on participant satisfaction and acceptance of the different components of the intervention.

Fasting may have benefits for weight loss, the acute effects of this on cognitive function and mental fatigue throughout fasting days are not well understood. Some studies have shown negative impacts of fasting including slower psychomotor speed, slower reaction times, reduced memory capacity, reduced working memory function, and poorer inhibition and reasoning skills. These deficits have the potential to impact negatively on activities including driving, and functioning within the workforce more generally. Ultimately these negative effects may impact on retention in these weight loss programs due to potentially unwanted side-effects, thus moderating their impact on health outcomes resulting from sustained weight loss. A current trend in weight loss programs is to avoid true fasting days and instead, incorporate extreme Caloric Restriction days. One current approach, known as the 5:2 intermittent fasting method, recommends a total caloric intake allowance of ~2100kj/day (500 kcal) for women, and ~2500kj/day (600kcal) for men on two days out of every seven (i.e., two days per week). Despite suggestions in the literature that intermittent fasting (including caloric restriction) improves metabolic markers in young women and in those with diabetes, to date, little is known about the impact of caloric restriction on cognitive function, fatigue and satiety. In particular, there has been limited exploration about how best to distribute the permissible restricted calories across the day. The timing of energy consumption is likely an important factor that could alter any potentially negative effects of caloric restriction on cognitive function and fatigue, particularly in the context of carbohydrates. This study will explore the impact of different nutrient intake timing during caloric restriction days on cognitive performance, fatigue, satiety and blood glucose. In light of literature showing negative effects of fasting on cognitive function, our hypotheses are as follows: 1) Fasting will result in poorer cognitive function and enhanced fatigue compared to both of the caloric restriction arms (Bulking and Extended Distribution) 2) Extended Distribution of calories will result in less fatigue throughout the afternoon assessments compared to Bulking 3) Fasting will lead to significantly higher subjective ratings of fatigue and satiety compared to both caloric restriction conditions 4) Fasting will result in significantly lower blood glucose readings compared to both caloric restriction conditions

Over 35 million smokers try to quit smoking each year, yet less than 5% reach their 1-year anniversary. Numerous passive transdermal nicotine systems (reservoir and matrix) have been marketed over the past 13 years [i.e., Nicotrol (registered trademark), NicoDerm (registered trademark), CQ (registered trademark), Habitrol (registered trademark), ProStep (registered trademark), etc.]. These systems have been well characterized with regard to skin flux rates for nicotine Transdermal patches deliver 5 to 30 mg of nicotine over 24 hours, with the used patch still containing a significant amount of residual, undelivered nicotine. Chrono Therapeutics has developed an innovative programmable transdermal drug delivery system. The CQSS2 provides “off” periods (periods in which little to no nicotine is delivered), which is an advantage over existing systems that currently provide continuous delivery. Programmable drug delivery fulfills unmet medical needs in the treatment of critical diseases, based on the novel finding that patient compliance and medicinal efficacy can be enhanced with sequential bursts, or pulses, and are potentially more effective than traditional treatment regimens.

This is a pilot trial of 8 weeks duration examining whether additional supplementation of leucine (3 grams/day) during calorie restriction is better than weight loss alone in reducing fat loss and muscle loss. The hypothesis is that leucine will improve muscle mass retention and increase fat loss, hence improving insulin action. We envisage an improved body composition that will favour those at risk of metabolic syndrome to reduce their risk of type 2 diabetes and cardiovascular disease.

The aim of this study is to evaluate the absorption characteristics of FOUR COENZYME Q10 PRODUCTS. As such this study proposes to evaluate the absorption characteristics of these products by measuring the plasma concentrations following an oral dose. There is significant interest from researchers, general practitioners and the public re: the administration of Coenzyme Q10 supplements for health maintenance or disease treatments such as those with mild to moderate cardiovascular disease, and what differences exist in the absorption characteristics of different formulations.

This study aims to find out how varying eye prescription impacts on vision and satisfaction of vision. To achieve this, we wish to monitor participants' eyes’ responses to the changes to their prescription we introduce. A minimum of 20 people will take part in this study. At each visit, a pre-determined number of changes to their prescription will be shown to the participant through a phoropter (standard optometric equipment used to determine spectacle prescriptions), they will then be asked to read a letter chart and rate their vision clarity and satisfaction.

Women are 2-3 times more likely to have an anxiety disorders compared to men. One proposed biological reason for this difference is that changes in sex hormones, particularly, estrogen impact treatment efficacy. The aim of this study is to assess whether sex hormones, particularly estrogen, impact a single-session cognitive intervention for women with spider phobia. Naturally cycling women with spider phobia will receive a one-session cognitive intervention for spider phobia. Outcome measures (scores on the BAT and SPQ, conviction ratings and diagnostic criteria) will be compared for women with high estradiol levels (the main estrogen derivative) versus low estradiol levels as determined by blood serum levels. It is hypothesised that women with high estradaiol levels will have better treatment outcomes compared to women with low estradiol levels.

What is this project about? EWING 2008 is a joint protocol of European and North American Ewing sarcoma study groups. The protocol is aimed at optimising treatment and treatment results of patients with Ewing sarcomas. Who is it for? The EWING 2008 protocol is open to all patients aged 4-49 years, diagnosed with Ewing sarcomas of bone or soft tissue, localised or metastatic, who are considered eligible for neoadjuvant chemotherapy. Study details All patients registered will receive induction chemotherapy consisting of six cycles of vincristine, ifosfamide, doxorubicin and etoposide (VIDE). The decision regarding local therapy must be made following the fifth cycle of induction treatment, with a preference for surgical intervention with or without additional radiotherapy. Standard Risk R1 Good responders (R1) (< 10% viable tumour cells) with localised disease are allocated to the standard risk arm and will receive a further eight cycles of chemotherapy composed of vincristine, actinomycin D, and cyclophosphamide (VAC) (females) or ifosfamide instead of cyclophosphamide (VAI) (males). They will be randomised to receive add-on treatment with zoledronic acid, or no add-on treatment. Very High Risk R3 Patients with disseminated disease, i.e. dissemination to bone and/or other sites and possibly additional pulmonary dissemination (R3), receive six cycles of VIDE induction chemotherapy. Patients are then randomised to either continue with eight cycles of vincristine, actinomycin D and cyclophosphamide (VAC) chemotherapy or high dose treosulfan-melphalan (TreoMel) chemotherapy followed by autologous stem cell reinfusion followed thereafter by eight cycles of VAC chemotherapy. Local therapy in R3 patients is following VIDE induction, whenever feasible prior to high dose therapy (HDT). It is hoped that the findings from this trial will provide information of the efficacy and toxicity of each of the chemotherapy treatment protocols for patients newly diagnosed with Ewing sarcoma.