ANZCTR search results

The aim of this study is to determine the extent to which the Behaviour Skill Builder (BSB) is an acceptable, useable and effective tool for parents of young children with a developmental disability who are exhibiting difficult behaviour.

The prognosis for childhood onset type 1 diabetes (T1D) remains generally poor with the number of life years lost is 17 years for a child diagnosed aged 10 years. Whilst in the second decade from diagnosis diabetic nephropathy (DN)accounts for around 60% of deaths, by the third decade cardiovascular disease (CVD) accounts for two thirds of all deaths. Although complications are rarely seen during childhood, there is evidence that their pathogenesis begins soon after diagnosis and accelerates during puberty. Adolescence may be a critical period for lifetime risk of complications in childhood onset diabetes. During puberty, the first signs of complications become evident. Microalbuminuria, an early risk marker for DN and CVD may be found in 12 to 16% of adolescents and this has been associated with renal pathology indicative of early nephropathy. This study is investigating the changes in retinopathy, aortic intima media thickness (aIMT) and heart rate variability which are indicators of macrovascular disease and autonomic neuropathy respectively. Diabetic retinopathy is the most common cause of blindness in young adults less than 40 years in the developed world. Factors affecting the genesis of autonomic neuropathy include glycaemic control, lipids and blood pressure. Studies have shown that atherosclerosis develops first in the abdominal aorta and precedes that seen in the carotid arteries. A study has reported that both high blood pressure and lipids increase neuropathy risk and it is likely therefore that intervention with ACE inhibitors and / or statin impact on neuropathy progression. Specific aims: a. To assess retinopathy (by retinal photography), atherosclerosis ( by aortic intima media thickness and carotid intima media thickness) and neuropathy (by heart rate variability) in an identified sample of adolescents with T1DM at high risk of microalbuminuria as compared to adolescents with T1DM at low risk of microalbuminuria. b. To determine whether ACE inhibition/statin therapy during puberty will reduce retinopathy, atherosclerosis and autonomic neuropathy progression in adolescents with T1DM at high risk of Microalbuminuria compared to adolescents with T1DM at low risk of Microalbuminuria.

Studies have shown that adequate maternal docosahexanoic acid (DHA) intake during pregnancy is an important factor for optimal development of the foetus. Fish is a good source of DHA, however, its intake in Australian women is generally low and well below recommendation. This 8-week study aims to determine if a diet higher in fish (providing an average of at least 200mg of DHA/day) obtained from consuming Australian fish 4 times a week can improve health-related bio-makers and outcomes (e.g. erythrocytes membrane n-3 concentrations, lipids, inflammatory markers, depression score) without compromising iron nutriture when compared to a typical Australian diet that is generally low in fish and higher in meat. This study will also predict the blood level of mercury if the higher fish dietary pattern was to be maintained long term.

This study looks at the effectiveness of nimotuzumab (TheraCIM h-R3) in combination with external radiotherapy in treating non-small cell lung cancer (NSCLC) at stage IIB, III and IV. Who is it for? You can join this study if you have non-small cell lung cancer which is suitable for palliative radiation therapy, and is at stage IIB, III or IV. Trial details Participants will be divided into two groups. One group will receive 200 mg nimotuzumab in addition to 2 weeks' standard radiation. The second group will receive a non-active compound (placebo) plus standard radiation. Despite aggressive surgical and chemotherapeutic interventions, non-small cell lung cancer is the leading cause of cancer-related death in men and women, with overall cure rates of less than 15%. Nimotuzumab is a novel therapy which may offer new hope.

The current study aims to reduce the practical and cultural barriers to mental health treatment for Chinese Australians by developing an Internet-based cognitive behavior therapy (ICBT) program for depression, based on the Sadness Program developed by Perini, Titov & Andrews (2009; www.virtualclinic.org.au) that is culturally sensitive and appropriate. A randomized controlled trial will compare the enhanced Chinese ICBT program for depression (the Brighten Your Mood Program) with telephone support to a waitlist control group. The project will examine the efficacy of the Internet Program in reducing symptoms of depression and disability in Chinese Australians, as well as its acceptability.

This study has been designed to investigate how energy intake at a buffet meal will be affected when the meal is presented at different times following a nutrient preload, and and how it is related to antral area, gut hormones and appetite sensations. Volunteers are required to visit the department on 4 occasions approximately 1 week apart. They will be required to ingest either a water or liquid nutrient preload, and 2D Ultrasound scans, blood samples and VAS will be taken at various timepoints depending on the treatment. A buffet meal will be presented 30, 90 or 180 min after the preload, and will be consumed over 30 min until the volunteer is comfortable full.

This phase 4 clinical trial is to determine whether estradiol valerate (1 or 2 mg daily for 8 weeks prior to hysterectomy) will regenerate the endometrium from postmenopausal women sufficiently to enable endometrial mesenchymal stem cells to be isolated from a biopsy taken during surgery just prior to surgical removal of the uterus. It is a proof-of-principle study to determine if endometrial stem cells can be isolated from postmenopausal women for potential autologous use in tissue engineering as a construct for pelvic organ prolapse repair surgery.

The reponses of the human body to a high fat meal are largely unknown. This study aims to examine the responses of the immune system, fat cells and muscle cells to a breakfast meal containing saturated fats or polyunsaturated fats. This study will specifically investigate the saturated fat that comes fom dairy foods, including milk, butter, yoghurt and cheese. Our hypothesis is that although dairy is rich in saturated fat, many of these fats are beneficial for human health.

Asthmatic airways narrow too easily, a characteristic called airway hyperresponsiveness (AHR). To understand the cause of asthma we need to understand the cause of AHR. Thickened airway walls could amplify airway narrowing and increase AHR. However, thick airway walls are also stiff, and stiff walls could reduce narrowing and AHR. This projnect will examine the relationships between AHR and airway wall thickness and stiffness during and after treatment that reduces airway wall thickness. Airway wall thickness will be measured by high-resolution computed tomography (HRCT) scan of the chest. Airway stiffness will be measured using a simple breathing test. Measurements will be made at baseline and after six and twelve weeks of treatment. Treatment with inhaled corticosteroids over twelve weeks will be used to reduce airway inflammation and airway wall thickness. These drugs are recommended in all asthma management guidelines for the treatment of asthma, and will be used in standard, recommended doses.

This study looks at the effectiveness of the drug nimotuzumab in treating people with brain cancer which has spread (metatstases) from non-small cell lung cancer (NSCLC). Who is it for? You can join this study if you have NSCLC and it has spread to the brain where it is not suitable for surgical removal. Trial details Participants will be divided into two groups. One group will receive whole brain radiation therapy (WBRT) in combination with intravenous nimotuzumab administered weekly during radiotherapy and following radiotherapy. The other group will receiver WBRT in combination with a non-active compound (placebo). Treatment and monitoring continues until any progression of disease or unacceptable side effects. Participants will be assessed by laboratory tests, imaging studies, standardized neurologic examination, and neurologic symptoms. Brain metastases are found in 20% to 40% of adult patients with cancer and the current standard treatment is WBRT alone. New therapies are needed, and the current study aims to evaluate the effectiveness of nimotuzumab in treating the disease.