ANZCTR search results

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

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31380 results sorted by trial registration date.
  • The Influence of Anaesthetic Depth on Patient Outcome after Major Surgery

    Approximately 450,000 people undergo surgery for various reasons in New Zealand. Most of these people are given general anaesthesia for their procedure. We use a range of monitoring to assess vital signs and other safety factors. One of the monitoring systems we use is the Bi-spectral Index (BIS), which uses electroencephalogram (EEG) waves to determine the depth (how deeply anaesthetised) patients are during their procedure. These monitoring systems are widely available nationally and internationally, however, the optimal depth at which anaesthetics should be given is unknown. Recent observational studies have shown a 20% increase in mortality in patients undergoing major surgery who receive relatively deep anaesthesia. We plan to perform a large scale randomized trial investigating the difference between two clinically standard depth ranges, which are commonly referred to “light” and “deep” anaesthesia, to definitively answer the question of whether anaesthetic depth alters surgical outcome. In particular we will look at death rate at one year and also whether there are differences in other complications of surgery and anaesthesia, including wound infection, cardiovascular and neurological complications, pain and awareness

  • Outcome of Juvenile Anterior Cruciate Ligament (ACL) reconstruction with Live Donor Allograft

    This study will prospectively follow group of up to 100 patients who undergo ACL reconstruction under the age of 17 years with the use of a live donor allograft.

  • Interappointment pain experience with a new endodontic medicament: a randomised controlled trial

    A randomised controlled trial will be conducted on patients undergoing endodontic treatment in the Royal Dental Hospital of Melbourne. Two medicaments, placed inside the root canals of teeth, will be compared: Calcipulpe (calcium hydroxide paste) and Odontocide (calcium hydroxide and ibuprofen paste). Following treatment, patients will be required to record pain scores on a Visual Analogue Scale corresponding to specified times prior to and following treatment. If the amount of pain following treatment is severe enough, requiring the patient to take oral analgesics (rescue analgesia), then details regarding further drug administration will be recorded by the patient.

  • Effect of oral nicotinamide (vitamin B3) on nonmelanoma skin cancer incidence and actinic keratoses in renal transplant recipients: a randomised controlled trial

    This study aims to assess the effect of nicotinamide (vitamin B3) on nonmelanoma skin cancer incidence in renal transplant recipients. Who is it for? You may be eligible to join this study if you are aged 18 years or more and have had a renal transplant more than 12 months ago. You should be experiencing current immune suppression and have a past history of at least two confirmed nonmelanoma skin cancers within the past 12 months. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will take two 500mg nicotinamide (vitamin B3) tablets daily for 6 months, whilst those in the other group will take two placebo (inactive) tablets daily instead. Participants will not know which group they are in until the end of the trial. Participants will be regularly assessed over the treatment period to determine the efficacy of nicotinamide in preventing nonmelanoma skin cancers and the safety of this treatment in renal transplant recipients.

  • The effect of PARO (Therapeutic Robots) on quality of life (in people living with dementia in residential care

    To compare the effects of PARO and participation in a reading group on social engagement, communication and quality of life (QOL) in people living with moderate to severe dementia in a residential care setting. Furthermore, to examine the associations between changes in social engagement, communication and QOL resulting from PARO and changes in participants’ emotional state

  • Does inhaled salbutamol decrease the incidence of perioperative respiratory adverse events in children at high risk for respiratory complications?

    Despite the development of anaesthesia management guidelines, perioperative respiratory adverse events (PRAE) remain a major cause of morbidity and mortality during paediatric anaesthesia, causing more than three quarters of critical incidents and nearly one third of all perioperative cardiac arrests. In a previous large cohort study in over 9000 children, we identified several risk factors (current or recent upper respiratory tract infection, wheezing >3 times in the last 12 months, eczema, nocturnal dry cough, a family history of asthma, eczema, rhinitis or passive smoking) which can help in every day clinical practice to identify the children at a particularly high risk for PRAE. Additionally, we demonstrated in an audit of children with a recent URTI, that inhaled salbutamol reduced the incidence of perioperative bronchospasm (5% vs. 11%, p=0.027) and persistent coughing (5.5% vs. 11.5%, p=0.0314) in the perioperative period. The role of pre-treatment with reliever medications for other PRAE risk factors (such as asthma, present/past eczema) is unknown. We therefore propose a double blinded randomised controlled trial of the use of inhaled salbutamol in children with two or more known risk factors for PRAE on the incidence of PRAE. We will randomise 470 children (6-16 years) to receive either inhaled salbutamol or an inhaled placebo prior to the administration of anaesthesia. We will also assess lung function before and 15 minutes after the administration of salbutamol or placebo. Furthermore, we will monitor and record all respiratory complications (laryngospasm, bronchospasm, severe and persistent coughing, airway obstruction, oxygen desaturation (<95%) and postoperative stridor). We hypothesise that children receiving salbutamol will experience significantly less PRAE when compared with children who did not receive salbutamol preoperatively. This study may help to reduce the health costs associated with respiratory complications (e.g. unplanned hospital admissions, prolonged hospital stay, additional treatment) and may help us to avoid unexpected admissions to the intensive care unit. Additionally, our findings may lead to a reduction in waiting list times and aid us in deciding the best time for the child’s surgery. Finally, this study may increase the availability of preventative strategies that may reduce the numbers of children who have their surgery cancelled due to respiratory issues. Cancellation of surgery has an adverse economic impact for hospitals, causes enormous emotional and financial burdens on the child and his/her family who have made many arrangements to attend hospital. Reducing the number of cancellations will ease the distress experienced by children and their parents when surgery does not go ahead as planned, which will have add on effects for child/parent satisfaction regarding their hospital experience.

  • ONTRAC: Effect of oral nicotinamide (vitamin B3) on incidence of nonmelanoma skin cancer and actinic keratoses: a randomised controlled trial (Oral Nicotinamide To Reduce Actinic Cancer)

    This study aims to assess the effect of nicotinamide (vitamin B3) on incidence of nonmelanoma skin cancer and actinic keratoses. Who is it for? You may be eligible to join this study if you are aged 18 years or more and have had at least two confirmed nonmelanoma skin cancers within the previous 5 years. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will take two 500mg nicotinamide (vitamin B3) tablets daily for 12 months, whilst those in the other group will take two placebo (inactive) tablets daily instead. Participants will not know which group they are in until the end of the trial. Participants will be regularly assessed over the treatment period and for 6 months after the treatment period to determine the efficacy of nicotinamide in preventing nonmelanoma skin cancer.

  • The Neurocognitive Sub Study of Encore1:A Randomised, Double-Blind, Placebo-Controlled, Clinical Trial to Compare the Safety and Efficacy of Reduced Dose Efavirenz (EFV) With Standard Dose EFV Plus 2N(t)RTI in Antiretroviral-naive HIV-Infected Individuals Over 96 Weeks

    The purpose is to investigate whether HIV and HIV medication can affect certain areas of brain function. This study will look at possible changes in brain function including memory, concentration and thought processes to see if there are any differences between the two doses of efavirenz used in the Encore1 study and also the level of efavirenz in the blood http://clinicaltrials.gov/ct2/show/NCT01516060?term=Encore1&rank=4

  • DIAMIND: Diabetes SMS text reminders for women who have had gestational diabetes mellitus to test for type 2 diabetes or impaired glucose tolerance in the postpartum period

    Gestational diabetes is a form of diabetes, or glucose intolerance, that develops during pregnancy. Women who have had gestational diabetes are many times more likely to develop type 2 diabetes in the future compared with women who have normal blood glucose levels during pregnancy. Thus, it is important to screen these women after they have given birth to see whether they have type 2 diabetes, such that it can be treated, or to see whether they are on the way to developing type 2 diabetes (have impaired glucose tolerance), such that preventative changes can be made. The best way of detecting type 2 diabetes and impaired glucose tolerance is with an oral glucose tolerance test, and this test is recommended by many health organisations, such as the Australasian Diabetes in Pregnancy Society, to be undertaken in the early postpartum period. Despite this, evidence shows that many women who have had gestational diabetes do not receive this follow up testing. The DIAMIND study is aiming to test whether a text message based reminder system (using mobile phone technology) will increase the number of women who have had gestational diabetes who undertake oral glucose tolerance testing in the postpartum period.

  • Evaluation of an online support program for Type 2 diabetes self-management and dysphoria (depression, anxiety, and diabetes-specific distress).

    This study evaluates the efficacy of a novel, online support program that targets Type 2 diabetes self-management and dysphoria symptoms in aiming to improve glycaemic control and emotional well-being. Secondary aims of the program are to improve behavioural outcomes (physical activity, dietary intake, and medication adherence), self-efficacy for diabetes self-care, and quality of life. Program evaluations include cost-effectiveness and qualitative outcomes, for example implementation feasibility, user satisfaction, program usability and acceptability.

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