ANZCTR search results

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

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31615 results sorted by trial registration date.
  • Rifampicin test as a predictor of Irinotecan toxicity in metastatic colorectal cancer.

    Rifampicin increases bilirubin level in blood, in a small proportion of individual. This is because of deficiency of an enzyme called UGT (uridine diphosphate (UDP)-glucuronosyl-transferase ). The same enzyme metabolizes the chemotherapy drug called Irinotecan. If somebody has the deficiency of the UGT enzyme, they will be at increase risk of toxicity from irinotecan treatment. In this study we are trying to do the same. We will give rifampicin tablets and check whether bilirubin increases or not. Then the irinotecan treatment as scheduled will be given. The side effects from the treatment will be noted. We will try to find if by doing a simple blood test, one can predict if a particular patient is at risk of irinotecan toxicity.

  • High Protein Diets, Weight Loss and Diabetes Study 2007

    We propose to conduct a randomised controlled trial to compare the effect of eggs to a similar amount of protein and kilojoules from meat fish and chicken in the context of a high protein energy restricted dietary pattern. Primary outcome variables are LDL cholesterol and other cardiovascular risk factors. Our hypothesis is that daily consumption of 400mg dietary cholesterol as 2 eggs compared to an equivalent protein source low in saturated fat and low in cholesterol a kilojoule restricted diet will not adversely affect these outcomes We also propose to opportunistically compare the impact of these dietary patterns on post prandial glucose metabolism, cognitive function and satiety.

  • Skin exposure during conventional phototherapy in preterm infants: A Randomised Controlled Trial

    Phototherapy is effective in reducing total serum bilirubin (TSB) levels in preterm infants with physiologic hyperbilirubinemia. There is a clear relationship between the dose of phototherapy and the decline in the TSB level. To maximise the dose at a given irradiance, preterm infants are routinely nursed naked whilst receiving conventional overhead phototherapy. It is unclear if efforts to maximise the efficacy of phototherapy by increasing skin exposure achieve an optimal therapeutic response with a minimum of side effects. Conventional phototherapy lights are effective in reducing TSB but not without potential side-effects including increased insensible water loss, persistent patent ductus arteriosus, blunted post-prandial increase in mesenteric blood flow and the possibility of increased cerebral blood-flow velocity. Reports of poor infant regulation and disorganised behavior, early discontinuation of breastfeeding and parental anxiety may be more common side-effects with consequences extending beyond the neonatal period. Such concerns have led clinicians to consider a "kinder, gentler" approach to managing physiologic hyperbilirubinemia in the preterm infant, which includes supporting early positive parent-infant interactions. Providing a supportive environment may facilitate well-regulated infant behavior and positive interactions with parents without prolonging physiologic hyperbilirubinemia and phototherapy treatment. We undertook this study to assess the effect of different skin surface area exposed to conventional overhead phototherapy on TSB levels at 24-hours of treatment. An additional purpose of the study was to obtain information on the incidence of episodes of rebound jaundice, duration of phototherapy, parent-infant interaction and parental stress as well as mean TSB percentage change of infants who continued to require phototherapy treatment after the initial 24-hour period.

  • Anti-nausea Medication Survey

    The study aims to clarify whether patients on the first cycle of chemotherapy receiving anti-emetics recommended by international anti-emetic guidelines experience a change in mood (especially anxiety and depression) or sleep disturbance. We would also like to determine if there is a difference between anxiety and depression levels and level of sleep disturbance in patients with different cancer types; particularly breast cancer versus non-breast cancer patients. The final aim is to confirm prescribing compliance with international anti-emetic guidelines and assess the control of both acute (first 24 hours after chemotherapy) and delayed (2-5 days after chemotherapy) nausea and vomiting.

  • Optimising very preterm infant outcomes: an evidence based screening and surveillance method

    Studies in the United Kingdom have shown the feasibility of collecting a standardised core of data with specific criteria for defining disability in children born very preterm at two years of age from questionnaires completed by parents and health care clinicians. Evaluation of outcomes for children born very preterm by questionnaires are very important for the purpose of providing global and epidemiologic information on outcomes, and for planning of services. However, most of the available questionnaires are a subjective assessment of the child and liable to bias. We are proposing the use of questionnaires to collect late morbidity and disability data from the primary health sector in children born very preterm with the support of a structured preterm clinical pathway for screening and surveillance. The pathway has been designed to ensure standardised data collection providing a more objective and valid assessment of late morbidity and disability. It is not designed to replace specialist assessment of a child.

  • OVATURE (OVArian TUmor REsponse) study

    The OVATURE study will compare the investigational drug Phenoxodiol combined with the chemotherapy drug Carboplatin against a placebo combined with Carboplatin. It is hypothesised that Phenoxodiol will reverse chemo-resistance to platinum drugs in late stage ovarian, fallopian and primary peritoneal cancers. For more information on the study and sponsor go to http://www.marshalledwardsinc.com/ or www.phenoxodiol.com

  • Paediatric Exercise and Cardiac Performance Study

    The health benefits of proper hydration have long been recognized. A major component of the hydration process involves thirst which, depending on drinking availability, leads to voluntary fluid intake. Exercising to fatigue (which commonly occurs in adolescent athletes) creates conditions that are similar to acute dehydration. Acutely, fluid restoration is effective in restoring fluid balance in these situations and improving exercise performance. Adolescent athletes are particularly prone to the effects of acute dehydration during exercise. They frequently remain unaware or simply ignore thirst during exercise which may result in significant dehydration leading to poor exercise performance. The physiological effects of dehydration are well documented in athletes. In particular acute dehydration with exercise results in impaired of cardiac performance and inefficient oxygen delivery to the tissues, being a critical factor in severely limiting peak exercise performance very early on in exercise. The most important issue to remember here is that this impairment in exercise performance is preventable with an appropriate hydration strategy. Strategies utilizing oral fluid loading using sports drinks immediately prior to exercise have the potential to reduce the negative effects that early dehydration may have on cardiac performance. Current research supports a continued increase in Stroke Volume (SV) during exercise. This increase may well be augmented in adolescent athletes by a hydration strategy that preloads with oral fluid immediately prior to exercise. This is the underlying hypothesis of the study. If the hypothesis is proven to be correct, that preloading with oral fluid improves cardiac performance in adolescent athletes then the same can be said of older children during exercise. We would then have a scientifically proven hydration strategy for use in older children to prevent early dehydration with exercise and produce maximum exercise performance. This is a blinded randomise controlled trial involving 350 childhood athletes attending sports high schools in the Sydney West region. Participants are initially randomised to two groups. All participants are evaluated at baseline for hydration status, aerobic exercise and cardiac performance. The participants are then reevaluated 1 week later with hydration status controlled 24 hours prior to retesting. One group will be the intervention group (being preloaded immediately prior to exercise with oral fluid equivalent to half normal saline) and will receive GatoradeR 20mL/kg 15 minutes prior to exercise. All participants are then retested to determine differences in hydration status, aerobic exercise performance and cardiac performance between groups.

  • Effect of flaxseed lignans on biomarkers of breast cancer risk in postmenopausal women

    Data suggests that foods high in lignan precursors are plausibly associated with a lower risk of sex-hormone-related cancers, however the human evidence for this is not strong. Currently, no direct assessment of dietary consumption of lignans and breast cancer risk is available. The objectives of the proposed research are: 1. To directly assess the relationship between dietary consumption of flaxseed lignans and breast cancer risk. 2. To assess the relationship between dietary consumption of flaxseed lignans and concentrations of sex hormone binding globulin and free estradiol. 3. To examine the effects of flaxseed lignans as a dietary constituent on hormonal status in vivo. Research Questions This research will attempt to answer the following questions: 1. What effects does controlled dietary consumption of lignans have on hormonal status? 2. What effect does controlled lignan dietary consumption have on enterolactone from matairesinol and enterodiol from secoisolariciresinol in urine? 3. What effect does controlled lignan dietary consumption have on hormonal breast cancer risk markers?

  • Circumvenous ablation for atrial fibrillation

    Atrial fibrillation is the commonest heart rhythm disturbance in humans. It is associated with an increased risk of death and serious illnesses like stroke and heart failure. Drug therapy alone has limited effectiveness in some patients who remain in atrial fibrillation and they may be highly symptomatic despite maximal treatment. Recently, it has been possible to cure atrial fibrillation in many patients by creating ablation lesions in the heart using flexible plastic coated wire catheters to deliver electrical energy. This is done by passing these catheters via veins in the leg into the left upper chamber of the heart, the left atrium. This is a rapidly evolving technique and it is not clear what pattern of ablation lesions is most effective. Moreover, it is a time consuming procedure with significant serious complications and a small risk of death and this has limited its application. The aim of this project is to compare two different patterns of ablation in terms of safety and efficacy. The patients in this study will be randomly assigned to one of two groups. One group of patients will undergo circumvenous ablation consists of a single ring that encircles all the pulmonary veins which carry blood from the lungs back to the left atrium. The other group will have their veins isolated in pairs on each side. Patients in each group will also be randomised to receive ablation of the mitral isthmus. Both groups will then be followed up for a year to determine if either pattern is superior in terms of recurrence rates, complication rates, exercise capacity and quality of life. Both procedures will also be compared in terms of procedure time and radiation exposure. Atrial fibrillation is responsible for a considerable burden of illness and death on the community and any improvements in ablation techniques for its treatment can have a major impact on the quality of life for a significant number of people.

  • A study to investigate the effect of taking Nicotinic Acid Prolonged Release on abnormal artery blood vessel function in people with Type 2 diabetes who are on best-dose treatment with statin medications.

    People with diabetes and atherogenic dyslipidaemia who are treated with statin medication may still be at increased risk of cardiovascular disease and may require combination lipid regulating therapy to further reduce their risk. Endothelial dysfunction and increased arterial stiffness are present in early diabetic vascular disease and may be useful surrogate endpoints for cardiovascular risk. This 23 week, randomised single-blind, controlled, parallel group study in 50 participants with diabetes who have endothelial dysfunction despite optimal statin therapy, aims to investigate whether the addition of Nicotinic Acid Prolonged Release (titrated to a maximum dose of 1500mg orally daily) compared to a control group of no Nicotinic Acid Prolonged Release (Nicotinic Acid PR) improves endothelial dysfunction.

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