ANZCTR search results

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

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32712 results sorted by trial registration date.
  • Deprescribing in frail older people: a randomised controlled trial

    Older people are at high risk of adverse drug reactions and many medications cause confusion and falls in older patients. In addition, evidence for the benefit of preventative and symptomatic therapies in frail older people is limited, as most clinical trials specifically exclude these patients. Although polypharmacy is widely recognised as a serious problem in frail older people, data on the effects of active medication withdrawal ("deprescribing") are scarce. Our primary aim is to determine whether we can safely reduce the total number of medications prescribed to older people living in residential aged care facilities (RACF). Secondary aims are to estimate the effect of deprescribing on mortality, falls and fractures, sleep quality, cognitive function, and independence.

  • Physical Activity Levels During and After an Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD).

    Obtain current physical activity levels during hospital admission and post hospital discharge in COPD patients admitted to an Australian hospital with an acute exacerbation of COPD. If activity levels are shown to be reduced, this provides evidence for the need to investigate options to improve physical activity levels in hospital and once home in this group. The hypothesis is that in people admitted to hospital with an acute exacerbation of COPD, physical activity will be lower during hospitalisation and will improve in the first week after discharge and improve further six weeks after hospitalisation admission.

  • To predict a breakdown in the joint of the two ends of the bowel after bowel resection surgery.

    Colorectal anastomosis /joins in the colon following surgery leak around 2%. From previous studies we are aware that the most important reason being decreased blood supply. To this date there are lots of studies looking at how to detect anastomotic leaks, But very few studies in predicting anastomotic leak. We believe a prospective study which involves measuring blood flow with the help of rectal laser doppler probe used preoperatively and then post operatively will help us in predicting which anastomosis are more prone to leak. The proposed study is a non-randomised study.All participants who are considered for bowel anastomosis at the participating hospital will comprise the study sample. After obtaining an informed consent from the participants the study will be conducted. The laser doppler flowmetry is a well established method for providing non-invasive real time measurements of blood flow within local tissue

  • Placement of LMA Supreme versus GuardianCPV – a randomized controlled trial assessing leak pressure, cuff pressure and fibreoptic grading of airway placement.

    The research project aims to compare 2 different Laryngeal Mask Airways, and to establish which is superior of the two. The main interest of our trial is to determine which LMA is easier to insert properly, and how well they both maintain a good seal. To date we have seen that there is occasionally some difficulty in placing the LMA, with consequent suboptimal airway control. Device manufacturers are always presenting us with new and improved versions of these devices, and we feel that it is the place of research projects such as this to help us decide if the new devices are worth employing. This sort of research may also aid in the development of future airway devices, leading to safer delivery of anaesthesia to the community. 80 patients will be enrolled in this project which will only be run at the Princess Alexandra Hospital. All patients enrolled in this project will have either one of these “LMAs” inserted after the anaesthetic has started. We will only be trialing 2 types of “LMA”, namely the LMA Supreme and the GuardianCPV, as previously mentioned. All the researchers involved will be from the Princess Alexandra Hospital. This research will be used by the principal researcher Dr Colin Brodie (currently in training in the specialty of anaesthesia) as part of a requirement of his training to become a specialist anaesthetist. This project is not funded by any sponsorship or grant, and all funding for this project will come from the Anaesthetic Department at the Princess Alexandra Hospital.

  • Pharmacokinetics and Safety of Solid Oral Posaconazole(SCH 56592) in Subjects at High Risk for Invasive Fungal Infections

    Posaconazole (POS) is a systemic antifungal oral suspension approved for use as a treatment of refractory invasive fungal infection (rIFI), treatment of oro-pharyngeal thrush (candidiasis) and prevention (prophylaxis) of invasive fungal infection (IFI) in high-risk patients as a result of severe immuno-suppression. This includes those with neutropenia (low white blood cell count) after chemotherapy or patients who have had a bone marrow or stem cell transplant (HSCT) and are having treatment for graft-versus-host (GVHD) condition. It is recommended that Posaconazole (POS) oral liquid suspension is taken several times a day and/or with a high fat meal or nutritional supplement to ensure that the medication is absorbed into the body. Such food intake is difficult to achieve in immuno-compromised, acutely ill patients, particularly patients with active Graft-Versus-Host Disease or patients with leukaemia undergoing acute chemotherapy. A new solid oral formulation of Posaconazole (POS), SCH 056592, has been developed to optimize absorption in patients with limited food intake. It has been designed to release Posaconazole (POS) in the small intestine. This maximises its systemic absorption and overcomes the food-effect limitations of the oral suspension formulation. The purpose of this study is to evaluate the amount of drug absorption and safety of SCH 056592 in a broad population of subjects who would benefit from antifungal prophylaxis and 2) compare these findings with results from other studies to support the selection of a dose for registration of the solid oral formulation.

  • Use of Ajunctive Allopurinol in Azathioprine/6-Mercaptopurine Non-responders to Optimize 6-Thioguanine Nucleotide Production and Improve Clinical Outcomes in Patients with Inflammatory Bowel Disease (IBD).

    It is understood that the body metabolizes azathioprine (AZA) to produce two chemical end-products: 6-thioguanine (6-TGN) and 6-methylmercaptopurine (6-MMP). 6-TGN is the chemical that makes these drugs work, while 6-MMP causes side-effects. Our research group has previously shown that by adding another drug, allopurinol, patients who otherwise made 6-MMP switched to instead produce 6-TGN, thereby increasing their response to these drugs. Our proposal is for a clinical trial that aims to confirm the safety and efficacy of this clinical maneuver.

  • Does the anaesthetic drug propofol affect the blood levels of the endogenous cannabis-like substance anandamide?

    Anandamide is a body-own (endogenous) cannabis-like substance that is significantly involved in our response to stress, but also affects mood and has anti-nausea effects. In the proposed project we will investigate the effect of the drugs propofol and sevoflurane (two of the most commonly used anaesthetic agents) on the blood concentration of the cannabis-like substance anandamide in 30 patients having an operation at Royal Perth Hospital. In this trial, patients (15 each) will either receive an anaesthetic with propofol or with sevoflurane and we will measure the blood levels of anandamide by drawing blood (2x5ml) from a venous cannula anyway used to give the anaesthetic at 5 time points. Results of this project will help us to understand significant positive side effects of propofol, such as its anti-nausea properties.

  • 4D Positron Emission Tomography/Computerised Tomography (PET/CT) in Liver Surgical Planning

    The hypothesis of this study is that an enhanced PET/CT scanning protocol using new technology to monitor patient's breathing will detect disease that was not seen by any other scanning technique. The intervention being tested is the new respiratory scanning technology. This technology is able to create a video of a patient breathing rather that a snap shot to correct any blurring caused by normal breathing.

  • Tyrosine supplementation in preventing the cognitive effects of psychosocial stress

    This study aims to evaluate the effects of the administration of the natural amino acid, tyrosine, compared with that of a placebo on the cognitive functioning of healthy adult volunteers subjected to an acute psychosocial stress event. This is based on the hypothesis that pre-test administration with tyrosine will prevent or reduce the negative impact of psychosocial stress on a broad range of cognitive tasks through its effect on neurotransmitter functioning

  • Validating a Scored Salt Questionnaire against Urinary Sodium Excretion in Patients with Chronic Kidney Disease

    The purpose of this research is to validate a Scored Sodium Questionnaire (SSQ) as a quick and easy clinical and research tool for assessing salt intake in renal patients. Evidence Based Practice Guidelines internationally recommend a low sodium diet for renal patients to assist in the management of and retard progression in chronic kidney disease (CKD) 1-9. While dietary counselling is effective in lowering dietary sodium, the prevalence of this disease is increasing rapidly, making it impossible to provide individualised dietary education to all patients. It is essential that finite dietetic resources are directed at those with the greatest need for dietary intervention. Therefore, it is important that clinicians and researchers have a reliable and convenient method of screening and assessing dietary sodium intake to assist in identifying patients who would benefit most from individualised dietetic education and counselling support. Current methods for assessing dietary sodium intake are time consuming, subject to inter-rater variability and are therefore rarely used in the clinical setting. In addition, the gold standard (24-hour urinary sodium) is time consuming, costly and intrusive. A self-administered SSQ was recently developed by dietitians and researchers at the Royal Brisbane and Women’s Hospital (RBWH) but has not yet been validated in the target population. Research design: Cross-sectional validation study involving 90 consecutive patients with CKD visiting the Nundah or North Lakes Kidney Health Clinics. Consented participants will be asked to complete the SSQ and a 24-hour food record as well as provide 24-hour urine collections for estimating urinary sodium excretion (urine samples are collected as part of routine care). To validate the SSQ in this population, dietary sodium intake (grams) will be calculated using the tool, confirmed by comparing to 24-hour urinary sodium excretion (grams/day) (gold standard), and cross checked against sodium intake assessed by the 24-hour food record. Steps will also be taken to investigate which parts/questions in the SSQ are more strongly correlated to predict a higher sodium intake, so that clinical referral for dietetic resources can be directed accordingly (screening section of the tool). A valid tool will provide clinicians and researchers with a quick and efficient method of assessing patients’ sodium intakes without the need for intensive dietary interviewing and analysis. In addition, the screening section could be used by non-dietetic staff to identify patients with higher sodium intakes for dietetic referral.

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