ANZCTR search results

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

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32101 results sorted by trial registration date.
  • A randomised comparative effectiveness trial of YOGa and strengthening exercise for knee osteoArthritis (YOGA Trial)

    Osteoarthritis is a common joint disorder for which there is no cure. Knee osteoarthritis is the most common form of osteoarthritis. Exercise is a core treatment for knee osteoarthritis. Muscle strengthening exercise has been shown to improve pain and function and is recommended by clinical guidelines. Yoga is a mind-body exercise intervention that can provide increased flexibility, muscle strength, physical balancing, improved fitness, and has demonstrated pain-relieving properties. Yoga, with its potential for improving musculoskeletal function, nervous system, and sympathetic activity, may therefore have greater benefits than commonly used strengthening exercise. Previous studies of yoga in knee osteoarthritis patients have been of low-quality with a high risk of bias and did not perform subgroup analyses to identify patients who may specifically benefit from yoga. This randomised controlled trial aims to compare the effectiveness of the 24-week yoga program vs strengthening exercise (12 weeks (2x/week of group-based + 1x/week of home-based) + 12 weeks of (3x/week) home-based) on knee pain in knee osteoarthritis patients with a priori subgroup analysis of knee osteoarthritis patients with neuropathic pain compared to strengthening exercise. If successful, yoga can be easily implemented as a complementary treatment along with conventional treatment to improve the management of knee osteoarthritis.

  • An investigation of fit test rates of N95 respirators after two to four hours usage in a real-world intensive care unit setting

    Current guidelines in Victoria do not recommend fit testing of N95 respirators (tight fitting face masks). In addition they recommend use of N95 respirators for 4 hours before changing. Therefore we sought to test this as our hypothesis. The purpose of the study was to test the N95 fit test rates after 4 hours of use in a real-world intensive care unit setting to help assess if they adequately protected healthcare workers.

  • A randomised controlled trial of ice to reduce the pain of immunisation - the ICE trial

    Introduction: Pain is an adverse effect associated with vaccination. Ice may be used to reduce pain. This prospective randomised controlled trial aims to investigate the effect of applying an ice pack prior to immunisation on the outcome of pain in medical students receiving their flu vaccines. Methods and analysis: This double-blinded, multicentre, prospective randomised controlled trial is designed to investigate impact of ice packs in reducing injection-related pain in medical students receiving influenza vaccines. The study will include 90 patients who receive influenza vaccines. An ice pack (0°C) will be applied to the site of injection for 30 seconds in participants randomised to the intervention group (n = 45). A placebo cold pack (10°C) will be applied to those in the control group (n = 45) for the same duration immediately prior to vaccination. A standardised vaccination protocol will be used across both study arms. The primary objective is to test the hypothesis that applying an ice pack will significantly reduce pain in comparison to a cold pack. Secondary objectives aim to assess any potential adverse reactions. The study commenced in January 2019 and is due for completion by December 2020. The main analysis of data will follow the intention to treat principle. The measurement of pain, the primary dependent variable, in each of the two groups will be compared using an independent t-test or a Mann-Whitney U test. Multivariable logistic regression analysis will be used if necessary.

  • The QUEST initiative: QUality of life Evaluation STudy: Assessing Health Related Quality of Life in patients receiving medicinal cannabis.

  • Effectiveness and safety of large bolus intramuscular naloxone for opioid poisoning in the Emergency Department

    This study aims to find the best dose and route for naloxone to safely reverse the respiratory depression of opioid poisoning. This is a randomised controlled trial where adult patients with opioid poisoning and respiratory depression will receive a 100mcg intravenous bolus of naloxone and either a 1600mcg intramuscular bolus of naloxone or saline placebo. Patients will then be managed along the standard opioid poisoning pathway (where they are closely observed and receive titrated 100mcg IV boluses 5 minutely as required to reverse respiratory depression). We anticipate that the patients receiving the 1600mcg intramuscular bolus will have less recurrence of opioid toxicity and less requirement for a naloxone infusion without having an increased rate of opioid withdrawal symptoms.

  • Postprandial Glucose Excursions with Difficult Foods in Children with Type 1 Diabetes on Hybrid Closed Loop Therapy: A Pilot Study.

    Families of children with type 1 diabetes (T1D) have reported high fat and high protein (HF/HP) meals as ‘difficult’ foods, causing prolonged hyperglycaemia after eating. A newly developed Hybrid Closed Loop (HCL) system with an Auto-Mode function uses real-time glucose levels to deliver basal insulin in micro amounts. Yet, there is little evidence on whether Auto-Mode is more effective than standard insulin pump therapy (Manual Mode) at reducing glucose excursions caused by HF/HP foods. This pilot study examines the impact of Auto-Mode on glucose excursions following HF/HP meals compared to Manual Mode. Participants are asked to consume standardised frozen beef lasagne and margherita pizza two nights a week for four weeks, under controlled conditions (4 meals in Manual Mode, 4 meals in Auto-Mode). It is hypothesised that the use of the Auto Mode will reduce glucose excursions after eating HF/HP foods when compared to the participant’s preferred insulin bolus pattern delivery in Manual Mode.

  • A Prospective Randomised Control Trial Comparing the Effect of Functional Alignment with Mechanical Axis Alignment on Outcomes after Total Knee Arthroplasty.

    The objective of this study is to compare clinical and radiological outcomes in robotic-arm assisted TKA using mechanical alignment (MA TKA) versus robotic-arm assisted TKA with functional alignment (FA TKA). Both FA TKA and MA TKA are performed through similar skin incisions, robotic-guidance, and use identical implants. In MA TKA, bone is prepared and implants positioned to ensure that that the overall alignment of the leg is in neutral. In FA TKA, the bone is prepared and implants positioned to restore the natural alignment of the patient’s leg. Both of these surgical techniques provide excellent outcomes in TKA but it is not known which of the two techniques is better for patient recovery. Mako robotic-assisted TKA is an established treatment for arthritis of the knee joint. The positions of the implants and overall alignment of the leg are important as they influence how quickly the implants wear out and need replacing. The aim of this study is to determine if patient recovery is better with functionally aligned Mako robotic-assisted total knee arthroplasty (FA TKA) or mechanically aligned Mako robotic-assisted total knee arthroplasty (MA TKA)

  • The D-Frail Study 2: Does vitamin D deficiency cause frailty through its effects on early-stage vascular dysfunction (endothelial dysfunction)? – Interplay between vitamin D deficiency, chronic inflammation, and sarcopenia - A vitamin D intervention

    Physical frailty (functional decline including muscle weakness) is one of the significant public health problems in elderly and is strongly correlated with poor health outcomes including cardiovascular diseases, but we do not know why this occurs. Frailty is associated with the initial stages of vascular dysfunction, inflammation and vitamin D deficiency. Low vitamin D levels are common among old people due to low dietary intake, less sun exposure and low level of production in the body. Previous research show that vitamin D supplements can improve both vascular function and physical frailty (including muscle function). Therefore, this project will determine if the reduction of inflammation using vitamin D supplementation can prevent people becoming frail.

  • The D-Frail Study 1: Association between vascular endothelial dysfunction and physical frail in patients with cardiovascular comorbidities: A prospective crossectional cohort study

    The WSLHD HREC has approved project, certifying that the study proposal meets the requirements of the National Statement. The ethical approval for this research project is granted to be conducted at Blacktown Mount Druitt Hospital. The WSLHD HREC has been accredited by the NSW Department of Health as a lead HREC to provide the single ethical and scientific review of proposals to conduct research within the NSW public health system. This lead HREC is constituted and operates in accordance with the National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research and the CPMP/ICH Note for Guidance on Good Clinical Practice. The request to undertake the above protocol was reviewed by a subcommittee of members of the Scientific Advisory Committee (SAC) and the Human Research Ethics Committee (HREC) (Western Sydney Local Health District).

  • Drain Fluid Amylase as an early biomarker of anastomotic leak in low colorectal anastomoses

    Anastomotic leakage (AL) is a serious complication of intestinal surgery, resulting in increased morbidity and mortality. This study aims to explore the simple and non-invasive approach of measuring the enzymes amylase and lipase in the drain fluid following a low extra-peritoneal anastomosis to detect AL at an early stage in the post-operative recovery. The hypothesis is based on the premise that luminal content of the colon is high in amylase and lipase and that drain fluid levels will rise above the normal serum reference range when an AL occurs. Who is it for? You may be eligible for this study if you are aged 18 or older, you have undergone a low or ultra low colorectal operation without a diverting loop ileostomy, and have had placement of a rectal tube and a pelvic drain at surgery. Patients undergoing the above surgical operations for any indication will be eligible for this study. Study details All participants enrolled in this study will have a sample of drain fluid collected daily from their surgical drain whilst the pelvic drain is in place. Insertion of pelvic drains is an element of the standard of care following colorectal surgery. It is hoped this research will determine whether enzymes such as amylase and lipase in fluids drained from an intestinal surgical site can indicate whether a patient has experienced an AL from their intestinal join following surgery, at an earlier time point than when diagnosed based on clinical signs.

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