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.
  • Quadruple UltrA-low-dose tReaTment for hypErTension - QUARTET

    The QUARTET Trial is a double-blind randomised controlled trial of low-dose quadruple combination therapy (LDQT) versus current guideline-based care. This study was funded by National Health and Medical Research Council. It aims to recruit 650 patients with high blood pressure (untreated or not controlled on one medication). Patients will be randomised to LDQT or irbesartan. The primary outcome is the difference between groups in office systolic blood pressure at 12 weeks.

  • An investigation of the relationships between pain, aerobic exercise, physical activity, sleep and mood in people with Parkinson's disease.

    The proposed project aims to investigate: 1) if aerobic exercise in the form of treadmill walking acutely relieves pain through exercise-induced analgesia (EIA); 2) if any EIA varies with the dose of exercise; and 3) the relationships between measures of pain and EIA with physical activity levels, sleep and mood in people with PD. We hypothesize that people with Parkinson's disease will have the usual exercise-induced analgesia response to exercise, and that this response will be stronger with a higher dose of exercise. We hypothesize that increased physical activity, better sleep and better mood will be associated with a better exercise-induced analgesia response and with less pain in people with Parkinson's disease.

  • Is telephone consultation a safe, satisfactory and cost-effective alternative to outpatient review for follow up post emergency laparoscopic appendicectomy and cholecystectomy?

    In this randomised control trial, we aim to assess the possibility of replacing current outpatient post-operative follow-up after laparoscopic appendicectomy and cholecystectomy with telephone consultation.

  • The influence of pain education on pain responses to exercise in people with chronic pain and healthy individuals

    Pain is multifactorial and involves both biological and psychological components. Multi-disciplinary treatment approaches incorporating drugs, cognitive-behavioural therapy and exercise interventions are the most efficacious for managing chronic pain. Single sessions of exercise and pain education are both demonstrated to have positive effects on pain in people with chronic pain such as fibromyalgia and osteoarthritis, however it is not known whether pain education delivered immediately prior to exercise can enhance the efficacy of exercise in relieving pain. Recent studies from our group have identified that the pain relieving effects of exercise involve a psychological component that influences the appraisal of pain; this would likely be augmented by a combination of exercise and education. The current project will examine the effect of explicit pain education about the pain relieving effect of exercise, compared to more general exercise and pain education, on pain responses to exercise in people with chronic pain (fibromyalgia and osteoarthritis) and healthy individuals. The results will provide insight into: 1) the impact of pain education on the pain response to exercise; and 2) whether this differs between healthy individuals and people with chronic pain. The outcomes may have implications for how exercise and pain education are combined in clinical practice in the management of chronic pain.

  • To investigate the correlation between surgical pleth index and early postoperative pain/comfort in children aged 2 to 16 years of age who are undergoing surgery under general anaesthesia.

    To date, validated depth of anaesthesia and depth of muscle relaxation monitors are available and routinely used in anaesthesia care. However, depth of analgesia has not been specifically monitored and anaesthetists tend to rely on clinical signs (i.e. blood pressure or heart rate) in order to estimate the need for intraoperative analgesics (i.e. opioids). However, the latter may be unreliable and hence a monitor for analgesia is highly desirable. Surgical Pleth Index (SPI) is a score (0-100), which is calculated from the beat-to-beat interval of the heart rate and also the peripheral pulse wave amplitude. Essentially, this data is utilized to reflect the cardiac and peripheral sympathetic tone of a patient – the latter is assumed to correlate with the depth of analgesia. The acquisition of this raw data is achieved via the standard peripheral oxygen saturation sensor and the latter is then computed into the normalized score. SPI requires no change of anaesthesia technique nor any extra monitors or consumables. It’s merely a software patch for GE monitoring systems. Though SPI has been demonstrated to reflect intraoperative stimuli (i.e. knife to skin incision), it cannot be used in awake patients as then the score is subjected to too many artefacts (e.g., arousal is a strong sympathetic stimulant). However, a recent study by Ledowski et al. at Royal Perth Hospital, Perth, Australia has shown a high positive predictive value for SPI more than 30 monitored just before patient arousal to indicate moderate-severe postoperative pain. Though this is promising, no study has yet investigated this matter in children. This observational trial proposes to prospectively investigate the association of SPI with postoperative pain in the recovery room in children from 2 to 16 years. Hypothesis: SPI during the last minutes of surgery may be predictive of moderate-severe acute postoperative pain on recovery room admission.

  • Cancer detection with a blood test.

    This study aims to determine whether a blood test can be used to detect prostate, breast, lung, pancreas, oesophageal, stomach and digestive tract cancers. Who is it for? You may be eligible to join this study if you are male or female aged 25 years or older and have a known diagnosis of primary adenocarcinoma of the prostate, breast, lung, pancreas, oesophagus, stomach or a digestive tract cancer (of any pathological stage). You must also be willing to undergo a venepuncture procedure. Study details All participants in this study will have blood collected through venepuncture (i.e. directly from the vein) by trained nurses prior to any type of cancer treatment. A blood sample will be collected before any cancer treatment to measure circulating tumour DNA (ctDNA) markers. In addition, for participants with oesophageal or stomach cancer, follow-up blood samples will then be taken at two monthly intervals up to six months during chemotherapy treatment, and at six monthly intervals up to three years after treatment, to monitor the effect of treatment on the different cancer types. For patients that undergo cancer resection prior to chemotherapy or radiotherapy, consent will be asked to obtain some tissue samples from any excess specimen from surgery. Blood and tissue samples will then be analysed for specific biomarkers of interest. Other information about the cancer (e.g. stage of disease), current medications, and other medical conditions will also be collected. Our research may lead to the development of improved non-invasive diagnostic tests for the detection of adenocarcinomas, including prostate, breast, lung, pancreas, oesophageal, stomach and digestive tract cancers. This would have beneficial health outcomes as early detection can contribute to early intervention and better prognosis. This test may also be beneficial in monitoring the effectiveness of cancer treatment in certain cancer types.

  • The impact of aged care resident’s written life-stories on aged care staff attitudes

    Thousands of older Australians live in aged care facilities (Australian Institute of Health and Welfare, 2015). This living arrangement can result in a significant loss of a person’s sense of identity. Professional care staff may not know a resident well, nor appreciate the resident’s individuality. Given the growing trend in Australian health care towards person-centred care in aged care settings, where care practices are tailored to individual needs, there is a need to develop effective methods for helping care staff better understand a resident, in order to promote the delivery of personalised care. Life-stories are narratives about an individual that can communicate to the care staff, the values, and self-image favoured by the resident. Such stories focus on individuals’ achievements, accomplishments, and interests. Although there are several programs worldwide that allow for older adults in residential care to tell their story, no research has been done to examine the impact of such written stories on the attitudes of residential professional care staff. The aims of this research is to examine the impact of life stories written by Swinburne Journalism students, on the attitudes of care staff about the residents. The project examines if care staff show a change in their attitudes, knowledge, and understanding about a resident after reading a 2-4 page story about the resident. In this study such stories are investigated for their impact on attitudes, knowledge and understanding of professional care staff and if positive, it could impact on care practices, and hence be used more widely in Australia for fostering a person-centred care culture in such settings.

  • Ventilation status of sedated patients in the cardiac catheterisation laboratory

    Respiratory depression is more likely to be detected during sedation when capnography is used. However, sedation-induced respiratory depression is commonly transient and does not always cause patient harm. Randomised controlled trials have produced conflicting results regarding whether capnography improves patient safety when used during sedation. Further research is required to determine whether applying capnography to the conscious sedation context is warranted. One considerable difficulty in designing a trial to determine whether a specific intervention improves the safety of conscious sedation is that adverse sedation events that pose potential risks to patient safety, such as hypoxaemia, should be so rare that it would not be feasible to recruit the required number of participants. In contrast, the number of participants required to detect a clinically significant difference in ventilation status during conscious sedation, as measured by transcutaneous carbon dioxide concentration (TcCO2), would be feasible to recruit in the context of a clinical trial. However, in order to calculate a sample size for such a trial, the expected control group TcCO2 needs to be identified. In this study, continuous TcCO2 measurements will be recorded from patients undergoing procedures with conscious sedation, starting before conscious sedation is induced (for measurement of baseline TcC02) and ceasing at the end of the procedure.

  • Liberal blood glucose control in critically ill patients with pre-existing type 2 diabetes.

    When patients with diabetes are very unwell (critically ill and admitted to ICU) their blood glucose levels are often higher than previously. This frequently requires the use of insulin which is administered directly into a vein. We are uncertain about how aggressively we should treat these blood glucose levels. Currently, patients with diabetes are treated exactly like all other patients, i.e. persons without diabetes, such that insulin is administered when blood glucose reaches 10 mmol/L and titrated to target a blood glucose less than 10 mmol/L. This approach - called conventional glucose control - may increase the risk of very low blood glucose levels (termed ‘hypoglycaemia’), which is known to be harmful to patients in ICU, and may cause blood glucose levels that are low relative to their normal blood glucose levels before they were sick (termed ‘relative hypoglycaemia’), which may also be harmful. Because intensive care clinicians are uncertain as to which of these approaches is better participants will be randomly assigned, like the flip of a coin, to receive either: Conventional glucose control participants will be treated the same way patients with diabetes usually are, which is exactly like all other patients without diabetes, and insulin will be administered when blood glucose reaches 10 mmol/L with insulin adjusted to target blood concentrations in the range 6-10 mmol/L. OR Liberal glucose control participants will only have insulin administered when their blood glucose is > 14 mmol/L and the insulin will be titrated to target a blood glucose 10-14 mmol/L. We are evaluating whether a more ‘liberal’ approach in patients with diabetes, i.e. insulin in administered when blood glucose is > 14 mmol/L and titrated to target a blood glucose 10-14 mmol/L leads to a reduction in complications that are associated with insulin use and result in better outcomes for patients with diabetes. This approach – called liberal glucose control - isn’t necessarily better, as higher blood glucose levels may increase the risk of developing infections in ICU and could lead to weakness after ICU. This study will include 450 patients who have diabetes and are admitted to ICU. Patients admitted to one of 12 hospitals in Australia or New Zealand will be asked to participate.

  • What is the difference in the safety of Ketamine versus Propofol when used to sedate Acute Psychiatric/ Psychotic Patients who require Aeromedical Retrieval?

    The inherent dangers of the aviation environment combined with the potential and unpredictable behaviour of acute psychiatric patients presents a challenge to even the most experienced aeromedical retrieval clinician. An efficacious sedation drug is vital in this environment to ensure crew and patient safety and to minimise patient distress. The incidence of psychiatric patients requiring retrieval from remote areas is increasing. Over a period of two years and nine months, CareFlight Northern Territory Operations has retrieved 660 psychiatric patients (01/02/2012 – 20/11/2014). There is no consensus on the optimal sedative to us in these patients. There has been no research undertaken that compares Ketamine and Propofol sedation in the aeromedical retrieval of acute psychiatric patients. Ketamine and Propofol are currently used within CareFlight Northern Territory Operations to sedate acute psychiatric patients who require aeromedical retrieval from their rural and remote areas. The primary purpose is to compare the safety and efficacy of sedating acute psychiatric patients with either Ketamine or Propofol whilst documenting and treating any potential complications that may arise. This study will also add to the paucity of literature on sedation methods for acute psychiatric patients requiring aeromedical retrieval. Study Hypothesis: Ketamine and Propofol are both as safe and efficacious as each other in sedating acute psychiatric patients who require aeromedical retrieval

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