ANZCTR search results

The aim of the pilot study is to establish whether low dose Atomoxetine can be clinically effective in reducing stress/anxiety, have a favourable effects on cardiovascular risk, by not increasing and possibly reducing weight, along with blood pressure, blood cholesterol and glucose. The plan is to recruit 20 clinically stable patients for a 4 week "run-in" to establish a clear baseline, then prescribe Atomoxetine for 8 weeks. In consenting patients a further 6 weeks of double blind placebo v active will follow. All participants will be evaluated with a full history and physical examination.

This is a study designed to determine intra-participant repeatability and diurnal variation of various eye reflexes using a Neuro-Ophthalmic Device (NODe). The NODe is a pre-release, prototype table top imaging device that consists of visual stimulus presentations through a standard tablet (iPAD like) and imaging hardware mounted inside of an enclosure which includes a nose-bridge and a chin-rest for patient alignment. The device intends to test neuro -pathology such as mild traumatic brain injury (mTBI or concussion) by assessing eye movements and pupil reactions in response to different visual stimuli presented on the tablet screen. The aim of this investigation is to determine the repeatability of this device in healthy participants with no previous history of concussion and diurnal variation of eye movements and pupil reaction. The study will be conducted in two phases with each phase including 10 participants. The initial visit will include the participant performing the NODe tests repeatedly for 10 times, while the remaining 6 visits (2 visits per day) will test diurnal variation and will run NODe set of tests once in each visit. The initial visit may take up to 2 hours, while the remaining 6 visits will take up to 15 minutes each to complete. The instrument has not yet been released commercially, but does not contain any components that could potentially cause eye or other injury.

The purpose of this project is to investigate whether a soluble fibre supplement alone or in combination with a probiotic is able to reduce inflammation in adults with asthma. Once ingested orally, soluble fibre- a normal component of the diet- acts as a prebiotic and is digested by healthy gut bacteria to produce short chain fatty acids (SCFAs). These SCFAs may be beneficial in reducing airway inflammation in asthma. Supplementing with healthy bacteria using a probiotic may also increase the production of SCFAs. The project involves a nine week intervention where 20 subjects with stable asthma will be allocated to take the prebiotic alone, prebiotic with probiotic and placebo supplements for 7 days each, in random order, with a two week washout period between each supplement phase. Subjects will not know which supplement they are receiving throughout the study.

This is a pilot, single blinded randomised controlled trial assessing whether a treat-to-target TRAb approach with anti-thyroid drugs (carbimazole) results in lower risk of relapse of hyperthyroidism after treatment cessation in Graves' disease patients, compared with standard fixed length care. In addition, this trial will provide estimates of changes in quality of life, health care utilisation, and assess feasibility of recruitment. It will provide data for a sample size calculation for a properly powered randomised controlled trial.

This project aims to determine if a major flavonoid component found in apple skin can improve blood vessel function and blood pressure in human volunteers. The apple variety Cripps Pink, marketed as ‘Pink Lady’ is particularly rich in the flavonoid quercetin. Our previous short term studies with pure quercetin and apples show improved blood vessel function. We now wish to determine if long term consumption (4 weeks) of apples will improve vessel function and lower blood pressure and try to understand the biochemical mechanism of this beneficial effect.

The aim of this study is to evaluate the revised versions of the ATLAS and NEAT school-based health-related fitness (HRF) programs for adolescents using a cluster randomised controlled trial in 16 secondary schools located in the Hunter, Central Coast and Sydney regions of New South Wales (NSW), Australia. The revised ATLAS and NEAT programs will be delivered over 10-weeks to male and female students in grade 9 at the study schools. The ATLAS and NEAT programs include a range of strategies aimed at improving HRF and social and emotional well-being among adolescents. Assessments will occur at baseline, 6-months, and 12-months. The primary outcome is muscular fitness (push-ups and standing long jump). Secondary outcomes for students include perceived and actual HRF, physical activity, resistance training skill competency, social and emotional well-being, self-esteem, screen-time, consumption of discretionary foods, motivation for resistance training and physical activity, sleep time and sleep quality. Hypothesised mediators of physical activity and HRF will also be explored. Secondary outcomes for teachers include confidence to teach HRF activities, perceived barriers to teaching HRF activities, and perceived fitness.

A double blind single-dose study to evaluate pharmacokinetics, safety and tolerability of Stelis Teriparatide [rh-PTH (1-34)] with innovator product Forsteo Registered Trademark (European Innovator) in healthy volunteers via subcutaneous administration of a single dose of 20 mcg .

This pilot study aims to determine whether knowledge of personal genetic risk of melanoma, compared to standard prevention advice, can motivate behaviour change among the general population. Who is it for? People aged 18-69 years from the general population, who have never had melanoma and have registered with 'Join a Research Study' database. Study details All participants in this study will be required to provide a saliva sample and have their DNA tested to determine their risk of melanoma. Participants are then randomly allocated (by chance) to one of two groups. Participants in one group will receive personal information about their melanoma genetic risk, with access to telephone-based genetic counselling as well as written educational materials on melanoma preventive behaviours including sun exposure, sun protection and skin examinations. Participants in the other group will receive only written educational materials on melanoma preventive behaviours during the intervention period. This group will then be offered genetic risk information at the end of the study (about 8 months after the saliva sample). The aim of this study is to pilot methods for an intervention that provides information on personal genetic risk of melanoma to participants from the general population, and to gather pilot and feasibility data regarding its short-term effectiveness on sun protection, sun exposure and skin examination behaviours, as well as the broader impact on ethical, social, psychological and economic outcomes.

The rationale of the study is to evaluate the roles of memory reactivation and cognitive therapy as a means of preventing PTSD shortly after trauma exposure. This study compares the relative effectiveness of (a) Cognitive Therapy Combined with Memory Reactivation, (b) Cognitive Therapy Alone, and (c) Wait-list in reducing posttraumatic stress disorder symptoms. It is hypothesised that Cognitive Therapy combined with Memory Reactivation will lead to greater symptom reduction than Cognitive Therapy, which will lead to greater symptom reduction than Wait-List.

This project involves evaluating the effectiveness of a new parenting resource, Confident Body, Confident Child (CBCC). Parents who receive CBCC will be compared with parents who do not receive CBCC on attitudes, behaviours, and knowledge about body image and healthy eating patterns at pre-intervention, and at three post-intervention time points.