ANZCTR search results

This study will determine whether taking additional Vitamin D supplementation in pregnancy, above that contained in conventional pregnancy vitamin tablets, improves a woman's glucose metabolism and prevents the development of gestational diabetes, a common complication of pregnancy in Australia.

Patients with renal failure feel increasingly unwell as the disease progresses. The onset of taste changes, nausea, vomiting, fatigue, anorexia, and weight loss is thought to be due to an accumulation of toxins that the kidney can no longer get rid of as the patient becomes more and more uraemic. No single uraemic toxin has been identified that accounts for all the clinical symptoms. Taste influences food palatability and appetite and may cause an inadequate dietary intake contributing to malnutrition often seen in renal failure. Patients with kidney disease often suffer taste and upper gastro-intestinal problems and may need to start dialysis due to these symptoms. This implicates an accumulation of toxins but the responsible toxins have not been determined. The purpose of this project is to improve health outcomes and nutritional management of patients with chronic kidney disease. We would like to find out which strategies improve uraemic symptoms such as taste changes and nausea often experienced by chronic renal failure patients. If the reasons for these symptoms are found, the most suitable techniques to improve their symptoms can be determined. This would enhance renal patients’ wellbeing and potentially their nutritional status and may delay the need for dialysis. A total of 30 people will be asked to participate in this project recruited from the Renal outpatient clinics. Patients will be asked to provide saliva sample for analysis on two separate occasions. They will be asked to complete a questionnaire on symptoms concerned with taste and eating and record what they eat over 24hours at the start of the study and at the end of the study. Patients will be asked to taste and rate a variety of fluids using common foods or food ingredients thought to influence uraemic symptoms. Patients will then be asked to sip or rinse their mouth with the fluid they felt most beneficial to their symptoms for about 3 weeks. The toxins found in the saliva will be compared to symptoms and the solutions chosen and if their use improved any uraemic symptoms and nutritional intake.

The aim of this study is to assess the extent to which Deep Brain Stimulation (DBS) may help people suffering with treatment refractory Obsessive-Compulsive Disorder (OCD) and to evaluate how psychological functioning and activity within the brain is affected by DBS. There will be up to 12 participants with treatment refractory (not responding to multiple other treatments) obsessive-compulsive disorder (OCD) recruited into this study. Participants will be participating in a cross-over study, in which each participant has different phases of treatments (see below), in turn. The study will consist of 3 sequential treatment phases. i) After DBS implantation by surgery, participants will enter an open phase of 8 months during which they will be evaluated every 2 weeks (each visit will take approximately 60 minutes) for severity of symptoms and optimal adjustment of the settings of the DBS device. Once an initial and substantial decrease (6 points) in Y-BOCS score (a measure of OCD severity) has been obtained, a CBT (cognitive-behavioural therapy; a psychological treatment) program will be added. ii )After the above open phase (in which the participant knows that the DBS device is switched on), participants will enter an optional 1-month, blinded, sham-controlled phase, in which they do not know whether the DBS device is switched on or off. Participants will be randomly allocated to this phase of the study, with 2 periods of 2 weeks with the stimulators blindly turned on (active stimulation) in one period and turned off (sham stimulation) in the other period. A computer-generated random sequence, will be used to allocate active or sham treatment. Participants will be assessed 3 times (at baseline, after a 2-week period of active or sham stimulation, and after the second 2-week period of reversed active or sham stimulation), with each visit being approximately 60 minutes in duration. Treatment with CBT will be continued during this phase. iii)The ensuing maintenance phase will continue, during which participants will be evaluated at 3-month intervals. Each visit will last approximately 60 minutes. The stimulators will be turned on for all participants, and stimulation parameters will be adjusted if necessary. In terms of psychotropic medication, participants will continue with their prescribed medication for OCD without change for 2 months prior to implantation and with continuation during the first 2 phases of the study (that is for 9 months after implantation). Participants will have neuropsychological, MEG and PET scans of the brain, as described , if they consent to do so. If participants do not consent to any component of these, they will still be required to continue in the open, double-blind sham-controlled and maintenance phases of study to continue in the study, as well any of the neuropsychological, MEG and PET components of the study that they consent to, without coercion or prejudice to their care. The batteries in the DBS device will have to be changed possibly within 12 to 24 months, if a non-rechargeable neurostimulator (does not require regular recharging of the battery by participants) is used, and up to 9 years if a rechargeable neurostimulator (requires regular recharging of the battery by participants, approximately one to three times weekly) and also depending on settings,usage. The selection of a rechargeable or non-rechargeable neurostimulator is based on participant preference about monitoring and recharging the battery in the neurostimulator. Replacement of the neurostimulator requires additional surgery, under a general anaesthetic, to remove and change it in its position under the collar bone.

The aim of this study is to examine for differences in pulmonary function before and after the application of manual therapy to the thoracic spine and thorax (i.e., chest wall). We hypothesize that pulmonary function will improve following the application of manual therapy and that the improvement will be sustained throughout the post-intervention period.

This project follows a pilot project conducted in 2007 measuring the effect of the interventions of education and audit feedback on GP detection of dementia in their at risk practice population. The current trial tests the impact of an educational workshop on GP dementia guidelines and audit feedback of the number of documented dementia diagnoses in the patient population aged over 65 years seen in the two 6 month periods before and after commencement of the trial. The rationale is that documentation of this diagnosis in general practice is suboptimal but is necessary if dementia patients are to access appropriate support and treatments. GPs are recruited from practices in North Queensland and clustered according to practice location. Clusters are randomly assigned to one of four groups: interventions of educational workshop, audit feedback, educational workshop plus audit feedback, or control (usual practice). At the end of the trial all GPs are offered audit and educational workshops which enables them to receive 40 category 1 professional development points.

In our recent study we found that ~ 60% of people with MS experienced one or more fall during 6-month follow up and 31% fell 3+ times. This is consistent with previous reports. High rates of falls in MS are significantly associated with poor performance in clinical balance tests, especially stepping ability. There is limited information on balance training in MS. Here, we propose to use an interactive step training system as a home-based exercise program to improve balance and consequently prevent fall risk in MS. The interactive system has been developed by our group and has been shown to have beneficial to older adults. This will be a pilot study to prepare for a larger randomised controlled trial to formally evaluate potential fall-related health benefits of interactive step training system use by people with MS.

The study is evaluating a novel diagnostic technique for prostate cancer, known as multi-parametric magnetic resonance imaging (mpMRI). Who is it for? You may be eligible to join this study if you are a male who has been referred to a urologist with a high or concerning PSA (Prostate-specific antigen), or abnormal prostatic rectal examination. Trial details All participants in this study will undergo current treatment guidelines for diagnosis of prostate cancer, including PSA measurements and 12 core Transrectal ultrasound (TRUS) guided needle biopsies of the prostate. In addition, a highly specific imaging process, known as multi-parametric magnetic resonance imaging (multiparametric MRI or mpMRI), will be used to further assess the prostate gland and be used to take MRI guided biopsy of any MRI detected lesions. This examination takes 20-30 minutes and involves the administration of a gadolinium contrast agent. It is anticipated that the results of this study will lead to better informed treatment of prostate cancer and suspected prostate cancer, for example by decreasing the number of men who need biopsies, decreasing the number of biopsy cores in those men who need them from 12 to 2 or 3, and decreasing the overtreatment of non-significant prostate cancer

Depression is one of the most frequent psychiatric disorders in obstructive sleep apnoea (OSA) and is associated with more severe OSA, reduced engagement with ontinuous positive airway pressure (CPAP) therapy, reduced quality of life and social functioning. CPAP therapy may be an effective option for treating depression in OSA. Hypotheses: 1. OSA participants with depression who receive CPAP will show a significant reduction in depression scores at 3 months follow-up compared with participants treated with Sham CPAP; and 2. The persistence of depression in OSA, despite CPAP treatment, will have a negative impact upon OSA outcomes including symptoms and compliance with therapy.

The study aims to investigate the role of a bioactive food compound called resveratrol, found in grapes, peanuts, berries and derived food products and beverages, in the treatment of obesity related fatty liver disease. Studies in animal models of fatty liver disease have shown promising results with resveratrol treatment: improvement of insulin sensitivity, prevention of fat accumulation in the liver, reduction of inflammation and increased antioxidant activity.

The purpose of this study is to improve visual outcomes for patients who suffer with glaucoma. This outcome is known as contrast sensitivity. Glaucoma: is a disease in which the optic nerve is damaged, leading to progressive, irreversible loss of vision. It is often, but not always, associated with increased pressure of the fluid in the eye. The purpose of this study is to establish a proof of a principle known as neuroprotection. Neuroprotection: refers to the ability to directly promote survival of the optic nerve. The optic nerve is the nerve that transmits visual information from the retina to the brain. Contrast sensitivity: is the ability to differentiate between light and dark (contrast).