ANZCTR search results

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

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32842 results sorted by trial registration date.
  • Reducing the risk of post-operative delirium in elderly hip fracture surgical patients by implementing a multidisciplinary approach to analgesia, education, and medications

    Delirium is a common complication of patients admitted for hip fracture surgery, and is associated with increased risk of mortality, morbidity, and loss of functional independence, as well as high social, nursing and health care costs. National guidelines describe care plans and delirium reduction strategies, but inadequate education and lack of coordinated clinical management results in large variations in quality of care in Australian and New Zealand hospitals. This study will investigate if a multidisciplinary care bundle, which includes evidence based clinical interventions and regular educational initiatives reduces the risk of delirium in hip fracture patients classified as intermediate or high risk by 40%.

  • Pharmacokinetics of Intravaginal Lactoferrin Preparations

    This research study in BV patients is testing the safety, tolerability, pharmacokinetics (the levels of drug in the blood and in vaginal fluid) of a formulation of a drug called Metrodora Therapeutics bovine Lactoferrin (MTbLF) when it is given Intravaginally (into the vagina). Lactoferrin is a naturally occurring protein present in milk, saliva, tears, and other bodily fluids that has antimicrobial activity and may have an important therapeutic effect for the treatment of Bacterial Vaginosis (BV). The overall goal of this study is to optimize the formulation to test in future studies as a treatment for BV. BV patients will receive 10 daily doses of study medication; 3 doses of a single formulation in the clinical unit separated by 24 hours in consecutive days of their preference and the remaining days, they will self-administer the same formulation daily. A series of vaginal swabs and blood samples will be collected over a 24-hour period following each of the two first doses in clinic, once approximately 12 hours after the third in-clinic dose and after each home dosing and at the Follow Up visit 21 to 35 days after first dose of study medication .

  • Time to Oxygenation during ‘CICO’ Simulation: Rapid-O2 insufflation Device versus Manujet Ventilator

    We aim to investigate the time taken for medical and nursing anaesthesia staff to set up the Rapid-O2 oxygen insufflation device and compare this with the Manujet ventilator in a simulated ‘CICO’ (Can’t Intubate, Can’t Oxygenate) scenario. A Can’t Intubate/Can’t Oxygenate (CICO) scenario arises when attempts at oxygenation of the patient via the anatomical conduits of the upper airway have failed. In such a scenario, the creation of a patent airway via the front-of-neck either by cricothyroidotomy or tracheotomy remains the only option for rescue oxygenation. A variety of rescue techniques are advocated currently, including cannula-, or scalpel-based techniques as well as wire-guided techniques . Regardless of technique chosen the CICO scenario in anaesthetic practice is often poorly managed with potentially catastrophic outcomes. Important contributory factors include institutional ill-preparedness and equipment not fit-for-purpose. Delays in providing rescue oxygenation, even when appropriate equipment is available, is an additional factor implicated in poor outcome. Our hypothesis is that the Rapid-O2’s simplicity and intuitiveness allow for its setup by naive operators in a clinically acceptable timeframe versus the manujet during a simulated CICO scenario.

  • Enabling mobility in labour for women with complex pregnancies with beltless TransAbdominal Monitoring (TAM) technology: feasibility of use in Australian clinical setting

    Women identified as having complex pregnancies are often advised to have continuous intrapartum fetal monitoring – commonly referred to as CTG monitoring. Conventional forms of CTG monitoring require the labouring woman to wear two tight elastic belts around her abdomen and to be tethered to a machine by wiring, thus restricting her mobility during labour and her choice of position whilst giving birth. In the Australian context, this affects over half of the 310,000 women giving birth each year. However, enabling women to have mobility during labour and birth results in a shorter labour, lower likelihood of caesarean section, fewer epidurals as well as providing psychological benefits by strengthening women’s sense of choice and control. A new wireless and beltless monitoring device, the transabdominal fetal electrocardiogram (referred to herein as TAM) will be released in Australia by Philips Healthcare in early 2019. Although there is a body of international evidence supporting the safety and efficacy of the device, and it has been registered by the Therapeutic Goods Administration (TGA) for clinical use in Australia, little is known about the implementation of TAM in authentic clinical settings. To investigate this, use of the device will initially be trialled in an Australian tertiary maternity care facility. This is the first stage of a broader investigation of the impacts of TAM in clinical practice.

  • High-flow nasal oxygenation in sedated lung transplant patients during transbronchial biopsy

    Post-lung transplant bronchoscopy is a commonly performed diagnostic procedure, typically performed under sedation with Low Flow Nasal Cannula (LFNC) oxygenation. Procedural desaturations are not infrequent. Recently High Flow Nasal Cannula (HFNC) oxygenation has been demonstrated to be a safe alternative to LFNC oxygenation in a number of clinical scenarios. This trial will assess the use of HFNC oxygenation as an effective alternative to LFNC oxygenation in sedated lung transplant patients undergoing diagnostic transbronchial biopsy. We hypothesise there will be fewer, and shorter, desaturations in the HFNC group as well as fewer airway interventions.

  • Medicine adherence in chronic heart failure patients

    This research proposal will explore the effectiveness of using the NPS MedicineWise mobile phone application in increasing the medication adherence in chronic heart failure. In increasing the medication adherence, it is expected that patients will be able to decrease the substantial burden on healthcare services.

  • Neoadjuvant Immune-Chemo-Radiotherapy in operable oEsophageal and gastro-oesophageal junction cancers with Carboplatin Paclitaxel Radiotherapy and Avelumab - a Trial assessing feasibility and preliminary Efficacy

    This study aims to evaluate the safety and preliminary efficacy of a drug called Avelumab in combination with chemotherapy plus radiotherapy (CRT) in patients with resectable oesophageal/ gastro-oesophageal junction (GOJ) adenocarcinoma. Who is it for? You may be eligible to join this study if you are aged 18 years or more, and have a confirmed diagnosis of early or local gastro-oesophageal junction or oesophageal adenocarcinoma. Study details All participants in this study will receive the drug Avelumab in addition to chemoradiotherapy (CRT). Patients will receive 5 weeks of carboplatin-paclitaxel-Radiotherapy. Avelumab will be given as intravenous infusion at the dose of 10mg/kg over 60 minutes in 250mL Sodium Chloride 0.9% every 2 weeks concurrently with CRT and then for 2 more cycles (total 5 cycles of Avelumab; 3 concurrently and 2 cycles as single agent) pre surgery. Surgery will be carried out 6-8 weeks post completion of the CRT component. After surgery patients will then be followed up every 3 months for 2 years then 6 monthly for one year. Standard of care imaging results will be collected as well as blood tests. It is hoped that this research will show support for improved patient outcomes by using an immunotherapy.

  • Teleaudiology hearing aid fitting follow-up consultations for adults

    Participants were ordinary patients of real world clinics. Participants in both groups received two follow-up hearing aid fitting consultations (face-to-face and remote respectively delivered at the clinic and at participant's home/office), and a third consultation at their homes for outcome assessment where interventions were applied to address their individual needs. A combination of measures were used to assess changes in participants' communication, fitting, aspects of quality of life, service and hearing aid aspects, outcomes that are already part of routine clinical procedures. Objective: To compare outcomes of the follow-up consultations for hearing aid fittings conducted remotely by telehealth to those conducted face-to-face by conventional consultations, utilizing subjective measures. The overall hypothesis of this study is that participants’ outcomes with remote consultation will not significantly differ from those with face-to-face consultation.

  • Use of the antipsychotic olanzapine to treat agitation in traumatic brain injury

    Following traumatic brain injury, patients frequently enter a state of post-traumatic amnesia and may become agitated. Agitation is threatening to staff and families, impacts access to treatment and is associated with longer hospital stays. Atypical antipsychotics are prevalent in the management of agitation despite a complete lack of well-designed studies underpinning their use in treating agitation in traumatic brain injury. We hypothesise that patients in post-traumatic amnesia, exhibiting agitation who are administered the atypical antipsychotic olanzapine will show lower levels of agitation than those administered placebo.

  • The IRONWOMAN pilot feasibility study: oral versus intravenous iron therapy for iron deficiency anaemia in late pregnancy

    Iron-deficiency anaemia (IDA) affects approximately 1 in 7 Australian pregnant women, and optimal treatment for improving maternal wellbeing and decreasing blood transfusion remains uncertain. An issue with prior randomised trials of IV versus oral iron is lack of patient and clinician blinding to treatment received, so the primary aim of this study is therefore to determine the feasibility and effectiveness of blinding treatment allocation to IV iron or saline placebo infusion. Participants will be pregnant women with iron deficiency anaemia between 26 weeks and 33 weeks gestation, and will either be given IV iron and placebo capsules or iron capsules and placebo IV. It is expected that using an opaque sleeve covering the syringe and giving set when administering IV iron or saline placebo, followed by matching placebo or active iron oral tablets, respectively, is feasible and effective.

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