ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32894 results sorted by trial registration date.
  • Meeting the education and support needs of women with breast cancer who are referred for radiotherapy: A multiple-baseline study

    This study aims to determine whether a tailored educational package can reduce psychological distress in women with breast cancer who are referred for radiotherapy. Who is it for? You may be eligible to join this study if you are a woman aged 18 years or more who has been diagnosed with breast cancer for which you are about to commence a course of radiation therapy that will be more than 4 weeks. Trial details Participants in this trial will be allocated to one of two groups. One group will receive the standard information provided in radiation oncology. The other group will undergo an innovative radiotherapy program, consisting of two one-on-one 20 minute educational sessions with their radiotherapist. During the consultations the radiation therapist will discuss the procedure that is about to occur, what will be expected of the patient, any immediate discomfort or pain they should anticipate, and any short or long term side effects that may result from the procedure. Participants will be assessed on four occasions before and after treatment to determine their psychological distress levels, specific concerns about radiotherapy, knowledge of radiotherapy, and preparedness for treatment.

  • A cluster-randomised controlled trial of family-mediated personalised activities for nursing home residents with dementia

    Background Following admission to a nursing home, the feelings of depression and burden that family carers may experience do not necessarily diminish. Additionally, they may experience feelings of guilt and grief for the loss of a previously close relationship. At the same time, individuals with dementia may develop symptoms of depression and agitation (BPSD) that may be related to changes in family relationships, social interaction and stimulation. Until now, interventions to alleviate carer stress and BPSD have treated carers and relatives separately rather than focusing on maintaining or enhancing their relationships. One-to-one structured activities have been shown to reduce BPSD and also improve the caring experience, but barriers exist to the implementation of activities in aged care facilities, for example lack of resources. The current study will investigate the effect of individualised activities based on the Montessori methodology administered by family carers in residential care. Methods/ Design We will conduct a cluster-randomised trial to train family carers in conducting personalised one-to-one activities based on the Montessori methodology with their relatives. Montessori activities derive from the principles espoused by Maria Montessori and subsequent educational theorists to promote engagement in learning, namely task breakdown, guided repetition, progression in difficulty from simple to complex, and the careful matching of demands to levels of competence. Persons with dementia living in aged care facilities and frequently visiting family carers will be included in the study. Consented, willing participants will on facility level be randomly assigned to a treatment condition using the Montessori approach or a control waiting list condition. We hypothesise that family carers conducting Montessori-based activities will experience improvements in quality of visits and overall relationship with the resident as well as higher self-rated mastery, fewer depressive symptoms, and a better quality of life than carers in the waiting list condition. Discussion Training family carers to deliver personalised activities to their relatives in a residential setting may make visits more satisfying and improve the quality of life for carers and their relatives. These beneficial effects might also reduce nursing staff burden and thus impact positively on residential facilities.

  • Early Childhood Oral Health Promotion

    The aim of the study is to examine if an early oral health promotion intervention using a brief motivational interviewing counseling session among parents of new-born children will affect the occurrence of early childhood dental decay. The hypothesis being tested is that the motivational interviewing intervention will reduce the occurrence of early childhood dental decay compared with standard "Lift the Lip" screening program.

  • Can fish oil supplementation improve endothelial function in asymptomatic offspring of patients with peripheral arterial disease?

    Peripheral Arterial Disease (PAD) is a major public health problem in Australia. The incidence increases with age and an estimated 10-25% of men and women over the age of 55 years are affected. The ageing Australian population will see an increase in the prevalence of PAD and consequently the national annual health expenditure on cardiovascular disease is likely to increase, greatly exceeding the 5.4 billion dollars spent in 2000-01. PAD is preceded by endothelial dysfunction, show an increase in inflammatory markers and failing of the circulation in affected limbs. EPA and DHA have been demonstrated to exert anti-inflammatory effects within the blood vessel wall thus reducing the amount of potent inflammatory markers produced. They also exert anti-thrombotic effects thus increasing the flow of blood within vessels. Dietary supplementation with fish oil rich in n-3 PUFA has been shown to positively impact on vascular function in the setting of atherosclerosis. It is known that there is a heritable basis to PAD, however, little is known whether improvements in endothelial function can be achieved in asymptomatic children of those with established PAD using n-3 PUFA. Early detection and intervention using a non-invasive, readily available, affordable and acceptable supplement such as fish oil has the potential to improve clinical management and prevent or delay the onset of those at high risk of developing symptomatic PAD. The aim of this study is to implement a 12 week, moderate dose fish oil intervention (10ml/day containing ~1.5g EPA and ~1g DHA), that will result in clinically and statistically significant improvements in terms of: a) Endothelial function; b) Inflammation; c) Lipid status (Total cholesterol, LDL, HDL, TG); and d) Omega 3 Fatty Acid levels.

  • Application of a prescribing indicators tool to assist in identifying and resolving drug-related problems in older Australians - a randomized controlled trial.

  • Effect of Mupirocin in patients with refractory chronic rhinosinusitis - A prospective, randomised double-blinded controlled trial

    We hypothesise that Mupirocin nasal rinses are more efficacious compared to placebo in patients that are bothered by persistent S.aureus infection despite complete sinus surgery.

  • Investigation of Giant Cell Tumour of bone

  • The effect of Galvus on post-meal artery function and triglyceride levels in Type 2 diabetic individuals with high triglyceride levels who are on a statin medication.

    Cardiovascular disease is a common major complication in patients with Type 2 diabetes. People with Type 2 diabetes have abnormal blood fat levels which contribute to this risk of heart disease, particularly high triglycerides, low HDL (good) cholesterol and high small dense LDL (bad) cholesterol. Cholesterol lowering medications called ‘statins’ are widely used to treat this abnormal blood fat metabolism found in Type 2 diabetes. Cholesterol guidelines advise that the LDL-cholesterol be treated to a level of less than 2.5mmol/L. However, more than 30% of patients with Type 2 diabetes continue to have high triglycerides at levels greater than 1.7mmol/L even when their LDL-cholesterol is treated to less than 2.5mmol/L. These patients with high triglyceride levels remain at higher risk of cardiovascular disease despite the statin therapy. Vildagliptin is used to lower blood sugar in patients with Type 2 diabetes. It belongs to a class of medicines known as DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) and is effective in lowering post-meal blood sugar levels. Current evidence suggests that vildagliptin lowers post-meal blood triglyceride levels in patients with Type 2 diabetes not taking statin therapy. It is not known whether vildagliptin improves artery function (a marker of risk of cardiovascular disease) in people with Type 2 diabetes. It is proposed that, for the group of patients with Type 2 diabetes and high blood triglyceride levels despite statin treatment, an improvement of artery function could occur concurrently with improvement of post-meal blood triglyceride levels with vildagliptin treatment. Thus, vildagliptin may help reduce the high risk of future cardiovascular disease in this group of patients. The aim of this study is to examine the effect of vildagliptin on post-meal blood fat levels and post-meal artery function in patients with type 2 diabetes and high blood triglyceride levels despite taking statins. Participating patients will already be receiving metformin to control blood sugar.

  • Upper limb - Baby Early Action-observation Training: Randomised trial of the effect of infant action observation training on the early development of hand reaching and grasping in healthy infants and in infants with early brain injury.

    This project aims to explore, in a randomised trial, whether a novel training program based on the observation of hand action can influence the early development of hand reaching and grasping in healthy infants and infants with asymmetric brain injury. This study will compare Action Observation Training with standard Observation Training in a population of healthy term infants, as well as in a population of infants with asymmetric brain injury. It is predicted that: (1) Action Observation Training will improve the symmetry of bimanual hand function as measured on the Infant Hand Assesment at 18 weeks, compared to standard Observation Training; and (2) Action Observation Training will have a greater impact on the quantity and quality of reaching and grasping of the impaired hand as measured on the Reach and Grasp Assessment at 18 weeks, compared to standard Observation Training.

  • A comparison of Internet-based Cognitive Behavioural Therapy for Posttraumatic Stress Disorder with and without exposure: A randomized controlled trial

    The purpose of this project is to explore the relative efficacy of three education programs in reducing PTSD symptoms in a population of adults (aged 18-75), when administered over the internet. A secondary purpose is to determine how acceptable people find each form of treatment. The study will inform how services can best improve future treatment programs for adults with PTSD.

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