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.
  • Does hypohydration impact the beneficial effects of electric fan use during a simulated heatwave?

    It is as yet unknown whether fluctuations in hydration status, such as those which may occur in a realistic heatwave scenario, may impact the efficacy of electric fan usage during heatwaves, and hence should be accounted for in future publicly disseminated advice surrounding fan use during extreme heat events. Therefore, the proposed study aims to examine the combined effect of hypohydration (reduced body water) and fan use during heatwave conditions. To achieve this, participants (n=16) will undergo four separate passive heatwave simulations within a climatic chamber (39 degrees Celsius, 50% relative humidity, 3-h duration). Both hydration status and the presence of an electric fan will be varied resulting in four scenarios: 1. Well hydrated, no electric fan used (EUH-NF) 2. Well hydrated, electric fan used (EUH-F) 3. Hypohydrated, no electric fan used (HYP-NF) 4. Hypohydrated, electric fan used (HYP-F) Throughout these four heatwave simulations we will monitor markers of thermal and cardiovascular strain as well as indices of hydration status and different heat transfer pathways such as sweating output. Manipulation of hydration status prior to the each exposure will be achieved via either 24 h of adhering to a fluid consumption plan (EUH-NF and EUH-F) or 24 h of fluid restriction (HYP-NF and HYP-F). We hypothesise that, the use of an electric fan will be beneficial (i.e. lower thermal and cardiovascular strain) during the 'well hydrated condition'; EUH-F compared to EUH-NF. However, in the 'hypohydrated' conditions (HYP-F and HYP-NF) this relation will be reversed, as hypohydration will cause a reduction in sweating output and therefore the mechanism by which electric fans augment heat loss will be compromised.

  • An evaluation of spinal cord stimulation for the treatment of chronic pain, also its effect on mood , sleep, physical activity and analgesic medicine requirements.

    Clinical audit data suggests that electrical stimulation of the spinal cord is an effective treatment for chronic pain. but only a few high-quality experimentally-controlled studies of this treatment have been reported. We now wish to investigate effects of this stimulation on pain and associated symptoms (sleep and mood) in a double-blind randomised controlled trial. Specifically, we will compare pain and sensitivity to painful stimuli pressure and sharpness) while the stimulator is switched on and 3-4 days after the stimulator has been switched off. As BurstDR parasthesia free stimulation itself produces no detectable sensations, we will use a double blind strategy to investigate effects of stimulation (i.e , neither the participant nor investigator will know whether the stimulator is switched on or off). The therapeutic benefits of electrical stimulation will be evaluated in the patients own environment while they carry out their normal activities. The patient will monitor their pain, mood, analgesic consumption and sleep over 8 3-4 day blocks. The stimulator will be switched off during two of these blocks.

  • Remi-Fent1 Study: A Comparison of Remifentanil and Fentanyl in Mechanically Ventilated Patients

    The primary aim of this study is to determine the feasibility of conducting an RCT of remifentanil versus fentanyl for opioid analgesic infusion in invasively ventilated patients who are expected to require mechanical ventilation for longer than 24 hours.

  • Cannabinoid Medicine Observational Study (CMOS): Observation of cannabinoid prescribing and dosage patterns in Australian clinical practice

    This study is seeking to create a representative data set on the current cannabinoid prescribing and dosage patterns in Australian clinical practice for a range of health conditions including cancer. Who is it for? If you are an adult who is already receiving medicinal cannabis therapy for your health condition, or you are seeking to receive medicinal cannabis and your doctor is able to prescribe medicinal cannabis as a treatment for your health condition, you may be eligible to participate in this study. Study details Participants will be asked to complete two different online questionnaire types on alternating months for a total of 12 months while they are taking specific prescribed medicinal cannabis products under the care of a CMOS participating clinician. Each online questionnaire may take between 5 - 25 minutes to complete. It is hoped that this study will allow clinicians and researchers to better understand how medicinal cannabis products are being used in Australian clinical practice and their potential benefit/harms as measured by reporting of side effects and patient satisfaction.

  • A Open Label Study to Determine the Safety, Tolerability and Pharmacokinetics of STC3141 Administered as an Infusion for up to 72 hours in Subjects in an Intensive Care Unit

    Septic patients often present renal dysfunction,, while it is important to figure it out the safety coverage and dose adjustment for these patients. This is a dose-adjusted, open-label, multi-centre study to determine the safety, tolerability and PK of STC3141 administered as a continuous IV infusion of up to 72 hours in subjects with sepsis and normal or compromised renal function in an ICU, where the rate of infusion is adjusted to account for calculated creatinine clearance. Four target steady state plasma concentrations (Css) are planned: 5µg/ml, 10µg/ml, 20 µg/mL and 25 µg/mL. Up to a total of 26 subjects will be enrolled into four (4) cohorts in the study, but numbers will depend on dose escalation/expansion decisions.

  • Early versus Late Endermologie® Vacuum Therapy Evaluation (ELEVaTE)

    Hypothesis That the feasibility, acceptability, cost and effectiveness of early intervention using Vacuum Therapy in the management of burns scars will be supported, in addition to an improvement in scar parameter outcomes in the early intervention cohort when compared to the later intervention cohort.

  • To compare types of anaesthetics for patients having elective laparoscopic surgery

    Opioids are routinely used during surgery however opioids are associated with a range of side effects. As an alternative, opioid-free anaesthesia (OFA) is an emerging mode of anaesthesia intended to avoid these side effects. This study will utilise a randomised clinical trial to investigate the impact of OFA for patients having an elective laparoscopic cholecystectomy or tubal ligation. Patient outcomes to be measured include: • Quality of Recovery (QoR-15); • Oral Morphine Equivalent Daily Dose (OMEDD) at 24 hours post operatively; • Time to first opioid (TTFO) dose; • Post-operative nausea and vomiting (PONV); • Post Anaesthetic Care Unit (PACU) Length of stay (LOS); and • Hospital Length of stay (LOS).

  • Antenatal models of care and the effect on breastfeeding rates after discharge

    This project aims to examine the relationship between Midwifery Continuity models of care versus other models of antenatal care and breastfeeding continuation beyond hospital discharge, while accounting for potential confounding factors. The hypothesis is that women who were cared for under a Midwifery Continuity of Care model will have higher rates of breastfeeding duration and exclusivity during the postnatal period. The aim of this study is to compare postnatal breastfeeding outcomes at 1 week, 1 month and 4 months postpartum for women who received midwifery led, continuity of care and women who did not receive this model of care. Data will be collected via 5 questionnaires and interviews with pregnant and postpartum women.

  • A Phase 2 study of efficacy: The validation of Gastrografin measurement in postsurgical samples following low anterior resection when the rectal tube is flushed with Gastrografin

    The purpose of this study is to determine if a commonly used radiological solution (Gastrografin) is a suitable option to help with the detection of anastomotic leakage, a serious complication of intestinal surgery. Who is it for? You may be eligible for this study if you are an adult who is undergoing rectal resection and extra-peritoneal anastomosis without a diverting loop ileostomy. Study details All participants will undergo their rectal resection as per usual. In the 5 days following the resection, participants will undergo a rectal tube flushing 4 times a day with saline containing Gastrografin. Rectal tube is routinely flushed with saline 4 times per day as part of standard care. A drain fluid sample will be collected twice per day following the flushing of rectal tube with Gastrografin. Two rectal tube specimens will be also be collected, Routine blood tests, that are already performed for usual post operative care, will be recorded. The findings from this study are hoped to provide early evidence of anastomotic leakage and permit clinicians the opportunity to treat patients before they deteriorate. This will lead to better outcomes for patients and a cost saving to health systems.

  • Comparing user seal check and fit test between a new and a decontaminated N95 respirator.

    The study aim is to compare the user seal check and fit test between new and decontaminated N95 respirator. Institutions around the world have explored the options of decontamination and reuse of N95 respirators. Current literature has shown promising results with the use of aerosolised or vapour-phase H2O2 to decontaminate N95 masks. Although multiple studies have been done, there are only a few studies which evaluated fit testing of the decontaminated respirators. Most of these studies tested on a small sample size. We believe quantitative fit testing on a larger group of individuals is essential. This will ensure that tight seal can be maintained on healthcare workers with different facial features after H2O2 decontamination of the N95 masks.

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