ANZCTR search results

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

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31330 results sorted by trial registration date.
  • Conservative management of first carpometacarpal (CMC) joint osteoarthritis: a single blinded randomised controlled trial

    Arthritis at the base of the thumb is common in ageing adults. It can result in pain and impact on function and quality of life. There are many treatments available to help relieve pain and improve hand function. Currently, it is common practice in Australia and overseas for health care providers (such as General Practitioners, Surgeons, Rheumatologists and Hand Therapists) to initially recommend non-surgical/conservative treatments for their patients. Treatments can include splinting the joint to relieve pain and enable hand function; injection of corticosteroid into the joint to reduce inflammation and provide pain relief; and hand therapy to provide exercises and patient education to inform on strategies for protecting the joints, managing pain and improving function. Preliminary research on these types of treatments has had mixed results, yet, health care professionals continue to offer these as treatments. This study will compare the effectiveness of the following non-surgical treatments: Push BraceTM splint; corticosteroid injection; and hand therapy treatment in relieving symptoms and improving function in adults with osteoarthritis at the base of the thumb. There has been no previous randomised controlled trial comparing the outcomes of these types of treatments.

  • Effect of beetroot juice and sodium bicarbonate supplementation on 4 km cycling time trial time to completion in well-trained male cyclists

    The primary purpose is to determine if there is an additive effect of beetroot juice and sodium bicarbonate on 4 km cycling time trial performance. Sodium bicarbonate and beetroot juice act via different mechanisms once ingested and therefore we hypothesise that combined supplementation will improve 4 km time trial performance (time to completion) more than beetroot juice or sodium bicarbonate alone or placebo.

  • PAEAN – Erythropoietin for hypoxic ischaemic encephalopathy in newborns

    A lack of oxygen (hypoxia) or low blood supply (ischaemia) before or during birth can destroy cells in a newborn baby's brain. The damage caused by the lack of oxygen continues for some time afterwards. One way to try to reduce this damage is to induce hypothermia cooling the baby or just the baby's head for hours to days. Erythropoietin (Epo) given in the first week after birth shows promise as a treatment that may also help. This study is to find out whether Epo plus induced hypothermia (cooling) of nearterm newborn babies who have suffered from low blood or oxygen supply to the brain at birth reduces death and disability in survivors at two years of age. The target population is 300 newborn term or near term infants(greater than or equal to 35+0 weeks gestation) with hypoxic ischaemic encephalopathy who are receiving, or planned to receive hypothermia and who are able to be recruited in time to allow study treatment to commence before 24 hours of age. This is a double blind, placebo controlled, parallel, 2 arm randomised, phase III multicentre trial, stratified by study site and by severity of encephalopathy at study entry. The treatment group of 150 infants will receive human recombinant Epo, 1000 IU/kg IV on days 1, 2, 3, 5 & 7 of life. The control group will receive 0.9% sodium chloride as a placebo on days 1, 2, 3, 5 & 7 of life. Families will be followed up every 6 months until the primary assessment of death and disability at 2 years of age.

  • A Phase III, multi-centre, multi-national randomised control trial investigating 1cm v 2cm wide excision margins for primary cutaneous melanoma.

    This study will determine whether there is a difference in local recurrence rates and melanoma survival rates for patients treated with either a 1cm excision margin or 2cm margin for both intermediate & high risk melanomas. Who is it for? You may be eligible to participate in this study if you are aged 18 years or above and have been diagnosed with a primary invasive cutaneous melanoma greater than 1mm in thickness. Study details: Whilst patients with a primary invasive melanoma are generally recommended to undergo excision of the primary lesion with a wide margin, there is evidence that less radical margins of excision may be just as safe. Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will undergo surgery with the 2cm excision margin, whilst participants in the other group will undergo surgery with a 1cm excision margin. Participants will be monitored for up to 120 months, in order to determine melanoma recurrence, survival rates and quality of life, and additionally, adverse events and health resource usage.

  • FLUid intervention and Renal Outcome TRIAL in patients undergoing major surgery: an observational single-centred study (The FLURO TRIAL)

    The administration of intravenous (IV) crystalloid fluids (also known as fluid therapy) is a ubiquitous intervention in patients undergoing surgery. Worldwide, the most commonly used crystalloid fluids available for patients undergoing major surgery include Saline (0.9%), Hartmann’s and Plasmalyte solutions. All three solutions are available for IV use at Austin Hospital and considered standard of care for all patients undergoing major surgery. Choice of these fluids amongst anaesthetists at Austin Hospital is similar to worldwide practices. In this study we will be collecting information about intravenous fluid intervention (type of fluid and amount) for adult patients undergoing major surgery (duration greater or equal to 2 hours and at least one overnight stay). Data will be collected over a 12-week period. Specifically, the effects of these fluids on kidney function will be investigated. Perioperative care and fluid intervention therefore will remain completely at the discretion of the treating clinicians.

  • High-Frequency Spinal Cord Stimulation at 10kHz (HF10 SCS) for the Treatment of Post-Surgery Back Pain Patients

    Patients with persistent back pain and suspected mechanical instability are referred to spine surgeons for spine stability assessment and, if need be, stabilization surgery. A significant proportion of these patients fail however to derive adequate benefits from the surgery and these chronic pain patients are often left with few options. Traditional spinal cord stimulation (SCS) is a widely accepted, cost-effective therapy for patients with chronic pain, especially in patients with post-surgery back and leg pain. High-Frequency Spinal Cord Stimulation at 10 kHz (HF10 SCS) has established itself as a key treatment in treating patients with chronic back pain: data from European pain centers has shown that HF10 SCS is safe and effective at reducing pain, improving function and sleep, and reducing opioid in patients with predominant back pain. HF10 SCS has been used in Australia to treat chronic pain ever since its TGA approval, especially back and leg pain patients. The purpose of this non-interventional data collection study is to collect data on the improvement in pain relief and quality of life associated with HF10 SCS, as used in the clinic routine practice in patients with chronic back pain following back surgery.

  • An evaluation of a single session behavioral activation intervention to improve wellbeing in non-depressed caregivers

    The project will assess the utility of a single session behavioral activation intervention to improve wellbeing in a non depressed sample. To assess the possible preventative benefits of the treatment, the study will employ a sample of carers, who are hypothesised to be at increased risk of developing depressive symptomatology due to lifestlye factors such as high stress. It is predicted that a single session of behavioral activation will significantly improve wellbeing outcomes, as indicated on self report measures, compared to a waitlist control and that this pre/post improvement will be significantly maintained at follow up.

  • Treatment of pelvic and acetabular fractures with variable dose heparin for the prevention of pulmonary embolus.

    This was a prospective study of 369 consecutive patients referred to a single surgeon for treatment of pelvic and acetabular fractures over a 20 year period. All patients were treated with chemoprophylaxis using unfractionated heparin, according to a sliding scale, at an ‘antithrombotic’ dose. Treatment was withheld for 48 hours post-injury and 48 hours post-operatively, due to the risk of bleeding. Patients were fully anticoagulated with warfarin 7 days post-operatively when the risk of secondary bleeding was over. Patients with clinical evidence of pulmonary embolus (PE) were investigated with ventilation-perfusion lung scans early in the study and CT angiography or MRI angiography when those investigations became available. Seven patients developed PE (1.9%). There was 1 fatal PE (0.3%) CONCLUSION: Variable dose unfractionated heparin followed by warfarin offers excellent protection against PE compared to published results of fixed dose regimens using fractionated heparin or unfractionated heparin in patients with pelvic and acetabular fractures.

  • Comparison of Contrast Enhanced UltraSound to Magnetic Resonance Imaging for the detection of synovitis in patients with haemophilic arthropathy. A pilot study

    The aim of this project is to demonstrate that contrast enhanced ultrasound is an equally effective method for detecting synovitis in patients with haemophilia in whom the diagnosis of synovitis (joint capsule inflammation) from physical examination is unclear. Currently, MRI is the screening tool for synovitis in this population; however it is time consuming, claustrophobic for some patients and has long waiting times. Contrast-enhanced ultrasound is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents may be used during an ultrasound examination to improve the clarity and accuracy of a conventional ultrasound image.

  • Taste and Smell to improve milk tolerance in preterm infants

    We believe that exposure to the taste and smell of milk before and during tube-feeding in very preterm infants may lead to better milk tolerance, and subsequent better growth.

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