ANZCTR search results

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

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32856 results sorted by trial registration date.
  • Oxygen concentrations and responses of the immune system in surgery

    Surgery for many procedures involving the leg requires the surgeons to stop the blood flow for a variable period of time. During this period certain changes occur in the leg. When the blood supply is restored, these changes result in a very strong stimulus to the immune system. Some of these changes are beneficial, promoting healing of wounds and repair of damaged tissues. Some of these changes, however, can cause depression of the immune system and make infections more likely. During surgery, the anaesthetist administers anaesthetic drugs, and oxygen. The amount of oxygen that is given varies according to a number of factors. There is some evidence that the amount of oxygen in the body at the time of restoring blood supply to a limb may be of importance. This importance is in terms of the damage that may occur during surgery and the recovery from the surgery. We do not know how much oxygen is good or bad when the blood supply is restored, and we would like to perform a study looking at this question. At all times in this study, patients will receive at least more than the minimum amount of oxygen that is necessary for all of the bodies organs to function entirely normally, and make a complete recovery from anaesthesia and surgery. Study protocol After randomisation to one of the three groups, patients will receive a standardised general anaesthetic based upon the gas “Sevoflurane”. All patients will receive 30% oxygen during the surgery, up until the time of restoring blood supply to the leg. At that point patients in one of three groups will receive either a). 30% oxygen before the blood supply is restored and continued until the end of surgery -(Conventional Care) b). 30% oxygen before the blood supply is restored and then 50 % until the end of surgery c). 30% oxygen before the blood supply is restored and then 80 % until the end of surgery - all of the above are in addition to the usual standard anaesthetic care. A small ( 3 ml. ) sample of blood will be taken at ten separate times up until 2 hours after the blood supply is restored. The study period then ends for each patient at that point. In summary, our hypothesis is that different concentrations of oxygen will produce changes in biochemistry that we wish to measure. These changes will help us to identify which is the best oxygen concentration to give to patients who are having this type of surgery.

  • Effects of 4 weeks supplementation with a multi-vitamin/mineral preparation on neurocognitive function in healthy adults

    The aim of this study is to investigate the effects of 4 weeks of supplementation with a multivitamin and mineral preparation on brain activity and health as measured by cognitive function, mood, and nutritional status. The study will recruit healthy adults, aged 18-40 years, who will attend two testing sessions, one baseline and one after 4-weeks supplementation. During testing sessions participants will complete a series of common assessments including nutritional status, mood and cognitive assessment. A sub-sample will go on to complete an MRI assessment to explore changes in brain activity. The trial will test the predictions that 28-days treatment with the active multivitamin/mineral intervention will result in improved mood, increased functional brain activity, and improved cognitive performance under cognitive demand, when compared to those receiving placebo.

  • The impact of exercise timing (morning vs. evening) on the circadian metabolic systems disrupted in the face of a high fat diet in middle-aged overweight men.

    The purpose of the present study is to investigate if exercise can reduce the disruptions to circadian metabolomics observed with the intake of a high fat diet. Additionally, the effect of timing of exercise (i.e. morning vs. evening) will be examined by comparing exercise performed in the morning versus in the evening. We hypothesise that exercise will reduce the deleterious effects of high-fat diet on circadian metabolomics in overweight/obese individuals. Additionally, this study will give direct insight regarding the effects of timing of exercise on circadian metabolism.

  • Does cocaine routinely used in sinus surgery get absorbed into the body and have an effect on your sleep during anaesthetic?

    Endoscopic sinus surgery (ESS) requires pre-surgery medication applied into the nose to minimise bleeding. At Monash Health we either use a solution called modified Moffat’s solution which contains cocaine, adrenaline and saline, or just adrenaline with saline. Although acting inside the nose a small percentage of both adrenaline and cocaine may be absorbed into the blood. The absorption may depend on the concentration, method of application and time in contact with the lining of the nose. Overall there exists limited research looking at cocaine absorption in the context of sinus surgery. Specifically, no studies have looked at modified Moffat’s solution sprayed into the nose. It is important that we determine how much and for how long cocaine is absorbed so we can advise patients appropriately after the operation. Additionally, it is thought that cocaine may affect a brain chemical called dopamine, and this may in turn affect how much anaesthetic is required to keep you asleep. The study will aim to look at how deeply patients sleep after being administered either the Modified Moffat’s spray or the adrenaline spray. Overall we will aim to enroll a total of 30 patients. Half (15) will receive the modified Moffat’s solution prior to surgery and the other half (15) will receive the dilute adrenaline prior to surgery. Blood samples taken during and after surgery will measure cocaine blood levels.

  • Short-term effects of black tea on vascular function in healthy adults

    Population studies indicate that regular consumption of tea can reduce the risk of cardiovascular disease by between 5 and 15%. The pooled estimate of risk reduction for black tea is influenced by two studies which included populations from the United Kingdom where milk is traditionally added to tea. This has led to the suggestion that addition of milk may diminish or negate cardiovascular health benefits of tea. Results of population and intervention studies suggest that regular consumption of tea can reduce blood pressure by 1 to 10 mm Hg. At a population level, a 5 mm Hg lower blood pressure would be associated with a 10% lower risk of coronary artery disease, and a 20% lower risk of stroke. A meta-analysis of randomised controlled trials to have assessed the effects of tea on endothelial function was recently published. This analysis suggests that acute and chronic tea ingestion can improve endothelial function, assessed by measuring flow-mediated dilatation of the brachial artery, by 30 to 40% (~2% absolute improvement). If sustained, this would be associated with about a 25% reduction in risk of cardiovascular events, which would be consistent with estimates of risk reduction from population studies. The precise pathway linking flavonoids to vascular function is not clear. However, it is known that the majority of dietary flavonoids are not absorbed or bioactive without prior metabolism by specific groups of enzymes produced by the microbes residing in the gastrointestinal tract (the microbiome). Although increased flavonoid intake can improve measures of vascular function, there is substantial inter-individual variability in response. Current knowledge of flavonoid metabolism indicates that this is largely due to individual differences in the capacity of the microbiome to metabolise flavonoids. However, this hypothesis has yet to be explored. Initial research needs to describe changes to the microbiome that occur with tea consumption. Furthermore, despite studies showing that the effect of the addition of milk to tea on bioavailability of tea flavonoids is modest, questions remain regarding the effects of milk to black tea on its bioactivity. One study has suggested that addition of milk almost negates the acute improvement in endothelial function. However, it is possible that this may relate to the study design, where endothelial function was assessed at a single time point following a single dose of tea. It is possible that addition of milk may delay absorption of the active components of tea (the flavonoids), but the overall impact on endothelial function is similar. Thus, the primary aim of the proposed study will be to investigate the short-term effects of black tea on endothelial function. We will investigate the effect of the addition of milk to black tea on its bioactivity. We will also describe and compare the changes to the microbiome after short-term regular consumption of black tea with and without milk.

  • Melting freezing of gait with non-invasive cerebellar stimulation

    Freezing of Gait (FOG) is a devastating symptom of Parkinson’s disease (PD), causing regular falls and nursing home placement. Unfortunately, clinical management of FOG is very challenging with no current treatment completely alleviating FOG. As such, this study sets out to reduce FOG by using a safe and non-invasive magnetic stimulation technique called intermitted Theta Burst Stimulation (iTBS) of the cerebellum, which is a structure known to be involved with Parkinsonian gait disorders. This potential treatment has the advantage of non-invasively accessing a promising target for one of the most debilitating symptoms of PD, without the surgical risks associated with invasive brain stimulation techniques like deep brain stimulation.

  • Robotic and Open Surgery for Prostate Cancer: A Prospective, Multi-centre, Comparative Study of Functional and Oncological Outcomes

    This study will compare the effect of robotic and open surgery for prostate cancer on functional and oncological outcomes Who is this study for? You may be eligible to join this study if you are aged 18 years or above, are undergoing prostatectomy for prostate cancer at RPA or Concord Hospitals and are clinically suitable for robotic prostatectomy. Study details Participants will either have robotic assisted laparascopic surgery or conventional open surgery as determined by the treating surgeon. All participants will undergo tests to determine urinary and erectile function, biopsies to determine oncological outcomes and questionnaires to assess quality of life. These assessments will be conducted pre-operatively, post-operatively and at certain follow-up timepoints up to 10 years.

  • Antenatal Preparation for Childbirth. An Observational Study

    Overview / Synopsis: Antenatal classes are a pivotal point of contact between expectant parents and health care providers. Information is provided on topics such as: care of the newborn; labour and active birth; birth intervention (medical and pain relief); and practical skills for labour such as managing contractions or learning how to be a support person for the mother. Effective communication can optimise the birth experience and the parent’s ability to be flexible in their choices should medical intervention be required. Recently, there has been increasing interest in the choice of words used in the clinical setting, particularly in the form of suggestions. Hypnotic phrasing, commonly known as suggestions, are communications that can lead to subconscious, non-volitional changes in perceptions, mood and behaviour (Perry, Samuelsson, Cyna 2015). Our hypothesis is to identify the way information is described and presented by antenatal educators to see if hypnotic phrasing and metaphor are utilised, as this may have implications for birth expectations and experiences of women and their support people.

  • The effect of a high protein low carbohydrate meal compared with a control meal on morning and evening glucose responses in healthy adults.

    Considerable evidence suggests that insulin sensitivity decreases throughout the day, due to circadian variations in glucose homeostasis. Impaired glucose tolerance is a risk factor for metabolic syndrome, Type 2 diabetes, and obesity. This has implications for those whose behavioural phases are inverted to the normal diurnal cycle, such as shift workers. Certain foods (such as those with a low glycaemic value or high protein) may help modify this response as they do not raise blood glucose levels as much as other foods. It is of interest therefore to determine if manipulations of the macronutrient composition of meals could lead to reduced glycaemia at night. The purpose of this study is to explore whether consuming a high protein / low carbohydrate meal would lower the postprandial glucose excursions observed at night compared to an isocaloric control meal in healthy subjects,

  • A comparison of three different insulin dosing algorithms for meals of variable macronutrient composition on postprandial glucose levels in paediatric type 1 diabetes

    Mealtime insulin dosing for type 1 diabetes is a challenging area of practice. Current insulin dosing adjusts the insulin amount dependent on the carbohydrate content of the meal (carbohydrate counting [CC]). Meals high in protein, fat and protein and fat have all been shown to increase postprandial glycaemia. Novel insulin algorithms have been developed to account for the glycaemic effect of fat and protein: Food insulin index (FII) and Pankowska Equation (PE). Our study aimed to compare glycaemic outcomes for CC, FII and PE for a high protein and a high fat meal. Outcomes chosen included postprandial glucose excursions for 300 minutes following the test meal, postprandial blood glucose levels for 300 minutes following the test meal, percentage of time within target range (3.9-10mmol/L) and hypoglycaemic events.

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