ANZCTR search results

Caffeine is readily available and widely consumed by adults of all ages. We are interested in whether temporarily manipulating caffeine levels (from complete washout to a controlled dose of caffeine) has an effect on visual perception in healthy adults. Specifically, we are testing its effect on a contrast judgment task (is one stripey pattern higher in contrast than another?) that our laboratory frequently uses to indirectly measure changes in brain function that occur with normal ageing or in conditions such as migraine. If caffeine indeed influences our test results, then future studies may need to control caffeine consumption.

This is a novel study to determine if patients lying in the prone position for spinal surgery develop evidence of mild cardiac bruising as evidenced by a serial serum Troponin rise and ECG abnormalities We suspect that, after prolonged positioning in the prone position, some patients develop evidence of mild cardiac bruising. If so, we intend to study factors that may be predictive of such cases. If confirmed, our study would indicate that all patients undergoing prone position spinal surgery should be consented for the possibility of developing cardiac bruising. If certain risk factors could be identified and if supine position surgery was also simultaneously indicated, then the risk of cardiac bruising would have to be evaluated in conjunction with other pros and cons of each approach, so that the individual could decide upon the best approach for their spinal surgery: i.e. anterior or posterior approach.

The purpose of this Phase III study is to determine whether regorafenib is effective in prolonging survival in patients with Advanced Gastro-oesophageal Carcinoma Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with advanced (metastatic or locally recurrent) Gastro-oesophageal Carcinoma which has not responded to a minimum of 2 lines of prior anti-cancer therapy. Trial Details: Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants will either take regorafenib (Group 1) or a placebo (Group 2) tablet oncer per day on days 1-21 of each 28 day cycle. Treatment will continue until disease progression or prohibitive adverse events. Participants will not know whether they are taking regorafenib or the placebo until after the trial is completed. Participants will be followed up every 2-4 weeks in order to evaluate how they are responding to treatment.

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.