ANZCTR search results

The normal foods people eat release both acid and alkali into the human body. This is called the dietary acid-alkali load. Powdered vegetable (greens) supplements are currently marketed as alkalising to the body and are used by the public for this reason. The extent these supplements influence the dietary acid-alkali load has received little scientific attention. As such, this research will evaluate their capacity to modulate the dietary acid-alkali load. In addition, it may be possible to monitor the dietary acid-alkali load by urine pH (that is, by urine dipsticks). As such this research also aims to explore urine pH before and following greens supplementation

What the is aim of this study? The primary purpose of this trial is to evaluate the efficacy and cost-effectiveness of ginger supplementation for the treatment of chemotherapy-induced nausea and vomiting. Who is it for? You may be eligible to participate in this trial if you are aged 18 years or older, and are scheduled to begin your first regimen of chemotherapy using an agent classed as moderately or severely emetogenic, What does it involve? Participants enrolled in this trial will be randomly allocated (by chance) to receive either 1.2g ginger supplementation or a placebo per day in capsule form for five days of each of the first three chemotherapy cycles. Participants will complete a number of questionnaires relating to quality of life, control of nausea and vomiting and fatigue at baseline prior to commencing supplementation and five days after each of the first three chemotherapy cycles. It is hoped that the findings of this trial will provide information on the efficacy of supplemental ginger for chemotherapy-induced nausea and vomiting for cancer patients.

This study examines an intervention that provides additional sensory feedback during exercise. We are investigating the effectiveness of home-based whole-body vibration training to improve mobility outcomes and reduce prospective falls and or falls risk compared to standard exercises in people with MS. The hypotheses of this study are that risk of falling and the number of prospective falls will be reduced and dynamic balance, endurance, and functional mobility will be improved after whole body vibration intervention and exercise compared to standard exercises alone.

Following the recent decision made by the Australian Commonwealth government to enable the cultivation of cannabis crops for medicinal grade products, it is likely that medicinal cannabis products – plant matter or extracts – will become more available in Australia in the years to follow. Various states including NSW are also investing in clinical trials of cannabinoid medicines for a number of debilitating illnesses, including the use of vaporised leaf cannabis products containing THC (http://www.health.nsw.gov.au/cannabis/Pages/terminal-illness.aspx). In will therefore become increasingly relevant, from a road safety and medico-legal perspective, to better understand the effects of these medicines on driving. The psychoactive constituent of cannabis, THC, is only one of over 100 phytocannabinoids present in the Cannabis Sativa plant that may be promising therapeutic targets in medicine. CBD, for example, is a non-psychoactive cannabinoid with anti-inflammatory, neuroprotective antioxidant, anticonvulsive and antipsychotic properties. Preliminary studies suggest that in animal models CBD also modulates the pharmacological action of THC, dampening its psychotomimetic properties. The presence of phytocannabinoids other than THC (such as CBD) in some medicinal grade cannabinoid products distinguishes them from Australian street grade illicit cannabis, which contains very little to nil CBD. The presence of CBD could have important implications for the effects of cannabis-based medicines on driving. Although other medicines such as benzodiazepines, opioids, and some antidepressants have been shown to impair driving ability, NSW law permits a person who is taking these medicines to drive so long as the drivers’ mental or physical faculties are not affected [9]. The current legal framework for driving under the influence of cannabis (where it is a criminal offence to be driving if THC is detected in saliva – with no functional assessment) reflects the illegal status of cannabis and predates the emergence of medicinal cannabinoid preparations. The premise of the current proposal is to test the effects of a variety of medicinal cannabinoid preparations that differ in their concentrations of the cannabinoids THC and CBD. It is hypothesised that the impairing effects of THC will be modulated and possibly negated by the presence of CBD in medical grade cannabis. This study also seeks to test the efficacy of roadside testing equipment in discerning impaired from non-impaired driving. To establish if there are methods other than saliva testing that can predict driving impairment, this study will utilise an eye-tracking task, subjective measures and cognitive testing procedures.

Traditionally finger-prick blood measurements using a glucose meter have guided the dosing of insulin for people with diabetes. The investigational system in this study involves insertion of a fine sensing filament under the abdominal skin to measure glucose levels continuously. This glucose information is transmitted to a device which displays the glucose in real time to the wearer. This study aims to evaluate the impact of the investigational system on overall glucose levels in people with diabetes treated with multiple daily injections of insulin. Other study aims include evaluation of the performance of the technology and the wearer experience.

The primary purpose of this study is to develop and evaluate a decision aid tool for parents/carers of children with cancer, and adolescents with cancer to assist in the decision making process of clinical trial enrolment. Who is it for? You may be eligible to participate in this study if you are either a parent/carer of a child with cancer who has been invited to participate in the Study 9 clinical trial; or if you are aged 12-18 years of age, having had a cancer diagnosis and been invited to participate in the Study 9 clinical trial. Study details Parents/carers and adolescents enrolled with either receive the decision aid as a hard copy or as an online tool. They will then be asked to complete two short questionnaires (one before looking at the decision aid, and one after), including several open ended items, asking for their feedback regarding the decision aid, either by hard copy or online as chosen by each participant. It is hoped that this study will result in an acceptable and feasible online decision aid tool, which will assist parents/carers of children with cancer, and young people with cancer with the decision of whether or not to participate in a clinical trial.

UTIs are the commonest bacterial infections. They range from cystitis to life-threatening urosepsis. Recurrent UTIs are also common, particularly in women. Recurrent UTIs are debilitating, leading to high usage of medical resources including frequent prescription of antibiotics. There is an increasing frequency of antibiotic resistance among recurrent UTI causative organisms that are unresponsive not only to the routine antibiotics used for UTI, but increasingly, to more potent antibiotics reserved for severe infections. Suppressive antibiotics for recurrent UTI are not totally effective, are associated with substantial toxicity and select resistant bacteria. The bacteria that cause UTI are predominantly gram-negative, most commonly E. coli. Uropathogenic E. coli strains produce type I fimbriae; ‘arms’ of the bacteria, that allow it to attach to the lining of the urinary tract. These and other fimbriae are also involved in biofilm formation that is required for infections of urinary catheters as well as recurrent UTI. These bacterial factors; type I fimbriae production and biofilm formation in E. coli and other uropathogens, are both reduced by salicylic acid, the biometabolite of aspirin, and this drug may be useful in prevention of recurrent UTIs. The minimum salicylic acid concentration required for Type I fimbrial suppression is 0.1-0.5mM. This is exceeded by 300mg doses of aspirin as 30% of the total dose is excreted in alkaline urine. The safety of the 300mg dose has been precisely determined in large-scale studies. The rate of major haemorrhage (requiring transfusion or hospitalisation) in patients taking greater than 200mg aspirin/day is 2.29%. This Is significantly higher than those on doses <100mg, but even here the rate of major haemorrhage (1.56%) remains substantial. These risks must be balanced against the morbidity of recurrent UTIs and the toxicity of prophylactic antibiotics like nitrofurantoin. We will trial both doses of aspirin and hope to show that 100mg is as effective as 300mg. This randomised controlled trial aims to examine the efficacy of Aspirin, 100 mg and 300 mg, compared with matching placebo in reducing the frequency of UTIs in post menopausal women with recurrent UTIs. The time to first breakthrough UTI will be another primary endpoint measured. The secondary endpoints will be the safety of low dose Aspirin in these subject. Another secondary microbiological end point is the effect of Aspirin on biofilm formation.

It has been well established in the literature that snoring sounds can be used to detect the presence of obstructive sleep apnoea (OSA). Currently the gold standard in the diagnosis of obstructive sleep apnoea is Type I Polysomnography (PSG), which is both time and resource intensive. Streamlining the diagnostic process for patients with OSA is of great significance given the increasing prevalence and awareness of the condition. Retrospective pilot studies have been conducted previously through our unit to assess the utility of analysing snoring sounds as a predictor for obstructive sleep apnoea. Our proposed study aims to systematically explore the performance of our snore/breathing sound technology algorithm against Type I PSG by conducting a statistically powered study in a sleep laboratory as well as a home setting. We hypothesise that breathing sounds (including snoring), when analysed using appropriate mathematical methods and machine learning techniques, can provide sufficient information to detect OSA at a sensitivity and specificity >92% simultaneously, with respect to Type 1 PSG. It is planned to prospectively recruit up to 50 patients with suspected sleep disordered breathing who are already listed for diagnostic PSG study in our sleep lab. These patients will undergo the sleep study as planned, and will undergo a slightly modified protocol with additional sound measurements, along with oesophageal pressure monitoring. The patient will then proceed to have another 7 nights data collected with a portable sound recorded (stored as an "app" on a provided smart phone) to further validate data against PSG. Analysis of the recorded snoring sounds using the externally developed algorithim will then be correlated against Apnoea-Hypopnoea Index (AHI) as measured during the PSG, which is considered the current diagnostic gold standard. Ideally this information will aid in the validation of a streamlined technique to be used in the diagnosis of sleep disordered breathing.

Vitamin A is required for the development and growth of lungs in premature babies who are born with low vitamin A body stores. Supplementing premature babies with additional doses of vitamin A by intramuscular injections decreases bronchopulmonary dysplasia (BPD - a chronic lung disease related to premature birth). As intramuscular injections are painful, the supplementation has not been widely practiced. Oral vitamin A, especially fat soluble form, is poorly absorbed by premature babies and therefore may be less effective. This study aims to investigate if supplementation of water soluble form, which is better absorbed, to extremely premature babies decreases risk of BPD. As a part of the study we are also looking at if we can use saliva to assess vitamin A status instead of blood in the babies. .

Successful transition to home dialysis and maintenance of a home based therapy is influenced not only by medical and demographic factors but also by psychosocial stressors. There is evidence from other medical conditions that coping skills influence patients’ psychological well-being. Our previous research has suggested that people with adaptive coping skills, such as problem solving and active coping, are more likely to sustain home haemodialysis. Based on this research, we believe that by providing home haemodialysis patients with additional adaptive coping skills they are more likely to sustain the use of a home therapy. A coping skills intervention program has been modified for use by people learning home haemodialysis. The program has been developed by psychologists who work with patients of a nephrology department, and is designed to be delivered by any health practitioner. It includes basic skills in stress management, problem solving, mindfulness and healthy thinking. It is designed to be able to be incorporated into the existing education provided to learners during home haemodialysis training, delivered chair-side during dialysis over six one hour sessions. This coping skills intervention will be compared with treatment as usual with home haemodialysis learners. The outcomes to be tested are a) sustainability of home dialysis after training, b) change in levels of reported distress, and c) change in reported use of adaptive coping strategies. The intention of this intervention is to enhance the patient experience of this home based treatment and improve their quality of life.