ANZCTR search results

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

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31420 results sorted by trial registration date.
  • Does Morosil (red orange) extract reduce the risk factors of metabolic syndrome?

    A 3-month intervention using encapsulated red orange (Citrus sinensis) juice extract in combination with nutritional intervention to investigate whether or not red orange juice extract decreases the risk factors of metabolic syndrome

  • Longitudinal outcomes of hearing-impaired children: early versus later identification

    This population-based study has two broad aims. The first is to derive speech, language, psycho-social and functional norms for children aided with hearing aids and/or cochlear implants. The second is to determine the effects of multiple factors, including age of intervention, on developmental outcomes of children with hearing loss. It is hypothesized that: 1. Compared to children who received later intervention, children who received early intervention will score better on measures of language, speech, functional performance and quality of life. 2. Compared to children who received later intervention, children who received early intervention will develop at a rate closer to that of normal hearing children over the first 10 years of life.

  • A study of risk factors for obesity in children with asthma

    Obesity and asthma are two of the most common conditions affecting Australian children and adolescents. Obesity is higher in children with asthma compared to children without asthma. We propose that children with asthma may have a higher prevalence of risk factors for obesity, namely increased sleep disturbance, poor dietary and physical activity patterns and altered resting energy expenditure.

  • Pre-consultation prevention summaries and reminders in general practice: cluster randomised controlled trial of effects on performance of preventive activities

    This trial seeks to discover whether giving patients arriving for consultations at general practices a summary of their preventive care status, that encourages them to discuss this with the GP or nurse that they are about to see, results in increased performance of preventive activities that are recommended and due to be performed for that patient. The study is aimed at improving the performance of a wide range of preventive activities, including all routine child and adult immunisations, screening for common chronic conditions including high blood pressure (hypertension), high cholesterol (hyperlipidaemia), diabetes and kidney disease, and prevention and early detection of a range of cancers. Who is it for? All patients attending a participating practice during the trial will be enrolled automatically in this study. Trial Details: The intervention will consist of a sheet of paper, generated and printed automatically, given to you when you arrive for a consultation at a general practice. You will receive no more than two information sheets, one every six months, over the one year trial period. The sheet will contain information about preventive activities that are recommended for you based on your age, gender and known medical history, why they are important, when each activity has last been performed, the result, finding or action at that time, and when the activity was or is due to be performed next. The sheet will encourage you to discuss the information on the sheet with your doctor or nurse in the imminent consultation. You will not be required to re-attend the practice for the purposes of this study, but can attend as and when you feel it is necessary or as agreed between you and your GP or nurse. If your general practice is randomly allocated to be in the ‘usual care’ control group, all care will occur as it normally would.

  • Exercise in Interstitial Lung Disease

    The interstitial lung diseases (ILDs) are characterised by shortness of breath, progressive deterioration in exercise tolerance, poor quality of life and reduced life expectancy. To date there are few treatments which have demonstrated improvements in this patient group. Exercise training (ET) is one of few treatments to improve symptoms and QoL in ILD. However the response to ET is variable and dependent on disease type and severity. The aim of this study is to establish the effect of ET in ILD and to identify whether there is optimal timing for maximal benefit to be obtained. improvements in this patient group.

  • Comparison of two different fibre supplements on body weight, body composition, metabolic and cardiovascular risk factors in overweight and obese individuals.

    The current dietary fibre recommendations are 25–30 g/day, given the benefits of higher fibre intakes on lower body weight, BMI, waist circumference, improved plasma lipid profiles, improved glycaemia/ insulinaemia and risk reduction for metabolic syndrome, CVD and type 2 diabetes. However, most Australians, Canadians and Americans do not meet the recommendations because most find it difficult to consume enough fruit, vegetables, legumes and whole grains through their daily diet. Therefore, using fibre supplements may be an alternative way to increase daily fibre intakes. A simple strategy of PGX fibre supplementation may offer an easier solution to long-term weight loss and then management as well as improvements in metabolic syndrome without the need for other nutrient modification. The effects of PGX supplementation may be better than that of psyllium due to its higher viscosity levels and its effects on postprandial glucose/insulin. Therefore, the results from this trial have the potential to provide the necessary scientific evidence required to endorse the use of PGX supplementation, over psyllium in the dietary management (prevention and treatment) of chronic diseases.

  • Bladder Care Following Laparoscopy for Benign Non-Hysterectomy Gynaecological Conditions – A Randomised Controlled Trial

    It is a standard part of performing keyhole surgery (laparoscopy) in gynaecology to insert a urinary catheter at the time of surgery. The optimal time to remove this urinary catheter is unknown. Some surgeons remove it immediately, whilst others keep the urinary catheter for some time (usually until the next day). The duration for which the urinary catheter is left in may have an effect on post-operative lower urinary tract symptoms and complications, such urinary tract infections and difficulty emptying the bladder. Up to 2 in 10 women may have difficulty passing urine or emptying the bladder properly after surgery. It is hypothesised that earlier removal of the urinary catheter after surgery may potentially increase the risk of this happening. Around 1 in 10 women may get a urinary tract infection after surgery. It is hypothesised that the risk of this occurring may be increased if the urinary catheter is left in for longer durations, or if a woman has difficulty emptying her bladder properly after surgery. Moreover, it is unknown as to what is the best means to assess whether a woman is emptying her bladder properly before being discharged from hospital after keyhole surgery. In the Department of Endo-Gynaecology at the Royal Hospital for Women and for patients of Dr Stephen Lyons at the Mater Hospital, there is a standard protocol where, after removal of the urinary catheter, women undergo serial bladder scans to measure the volume of urine left inside the bladder after voiding (post void residual urine volume, PVR). Women are not discharged from hospital until they are able to void at least 150 ml of urine on 2 consecutive occasions, and have a PVR of <100 ml after each of these voids. In contrast at many other institutions, no such protocol exists, and women are eligible for discharge from hospital without undergoing any bladder scans. It is hypothesised that women who are discharged from hospital with undiagnosed difficulty in emptying their bladder properly after their keyhole surgery may potentially have a higher risk of developing urinary tract infection and lower urinary tract symptoms. The objective of the study is to test these hypotheses, and thus allow more evidence-based practice in bladder care after gynaecological laparoscopy. This study is a prospective, randomised, multi-centre, clinical study, enrolling 690 women undergoing gynaecological laparoscopic surgery for benign indications, who would usually be expected to stay overnight due to their surgery. Women randomised to the study will have their scheduled surgery according to their treating team’s recommendations. Before surgery, subjects will complete a validated questionnaire regarding urinary symptoms and have a urine test to look for urinary tract infection. They will also be asked to void into a special device which will measure the rate and volume of urine flow (uroflowmetry), and a PVR will be measured. At the time of surgery, women will be randomised to one of two equally sized groups. One group of women will have the urinary catheter removed at 0600 hours on the morning after their surgery. This group of women will be managed according to the current standard protocol of the Department of Endo-Gynaecology at the Royal Hospital for Women. The other group of women will have the urinary catheter removed immediately at the end of surgery. This group of women will be eligible for discharge from hospital when they are able to void at least 150 ml on 2 consecutive occasions. These women will also undergo bladder scans after voiding, but the results of the bladder scan will be blinded from the staff and patient, and will not influence the decision for hospital discharge. After surgery, all women will be followed for 6 weeks post-operatively with health care visits and have their urinary function monitored. Permission will be sought from subjects for follow-up at 1 year after surgery.

  • Does the addition of a standing balance class to usual therapy improve balance, mobility and physical functioning among rehabilitation inpatients?

    The purpose of the study is to investigate whether the addition of six standing balance circuit classes to usual therapy over a 2 week period improves balance, mobility and physical functioning among rehabilitation inpatients. Participants will be allocated at random into one of two groups (Usual Care and Additional Training). People in the Usual Care group will receive standard care as offered by the Bankstown Lidcombe Hospital Physiotherapy service. People in the Additional Training group will receive usual care as well as participate in a 1 hour standing balance circuit class, involving exercises aimed at improving balance, three times a week for two weeks. All participants will be assessed at enrollment into the study, 2 weeks later, and again at 3 months. Assessments will include a questionnaire about mobility and activities of daily living, as well as physical tests including a 4 metre walking test, chair stand test, and balance tests.

  • Dignity Therapy: A Psychotherapeutic Intervention to Enhance the End of Life Experience for Persons with Motor Neurone Disease and their Family Carers

    Dignity Therapy, a brief psychotherapeutic intervention based on empirical research into the concept of dignity at the end of life, has proven successful at increasing hope, sense of meaning and will to live in a palliative care population where most patients had cancer diagnoses (Chochinov, Hack et al. 2005). This study will establish the feasibility and acceptability of offering Dignity Therapy to the MND patient population, and measure associations of the intervention with increased hope, meaning and dignity. It will lay the groundwork for a possible future experimental study. This study will also examine what impact Dignity Therapy has on the MND family carer during the caring experience, specifically looking at whether Dignity Therapy with the patient is associated with an increase in hope or decrease in anxiety, depression and caregiver burden in the family carer. Previous Dignity Therapy studies focused on the intervention’s positive influence on the bereavement experience of family members, but did not look at how the intervention may affect the carer during the caring experience.

  • Multimodal phenotyping for the prediction of oral appliance treatment outcome in obstructive sleep apnoea

    Obstructive sleep apnoea is a common sleep-related breathing disorder. Oral appliances worn during sleep to gently hold the lower jaw in a forward position are a novel treatment often appealing to patients. Currently use is limited as there is no means to determine if patients will be treated successfully. There is a need for simple, clinical methods to predict which patients are best suited to this new treatment approach and this project will address this by developing such a method. This study will use a combination of data measured from patients with obstructive sleep apnoea including sleep characteristics, lung function and facial dimension measured from photographs to produce a virtual model to predict whether or not a patient will respond to treatment with an oral appliance.

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