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.
  • The Target-D Study: An individually randomised controlled trial of a clinical prediction tool to triage and target treatment for depressive symptoms in general practice.

    Up to 55% of patients who see a GP have problems with stress, worries or depression, however it’s not always clear which patients will naturally recover and which ones would benefit from treatment. Researchers from the University of Melbourne have developed the Target-D Toolkit which identifies patients that might benefit from treatment and helps GPs to more effectively manage their patients’ emotional well-being. This study will improve people’s health and well-being and make better use of GPs time at less cost to the healthcare budget. It is funded by the National Health and Medical Research Council (NHMRC No: 1059863).

  • Fostering Effective Early Learning (FEEL) study: Effect of a professional development program for early childhood educators on children's cognitive, social and self-regulatory development

    The aim of this study is to provide a model of sustainable and effective professional development for the early childhood education and care sector to improve staff understanding and competencies, as well as child outcomes. The overall design is a cluster randomized controlled trial with an intervention group (45 early childhood education centres) receiving a professional development intervention in 2016 and a control group (45 early childhood education centres) receiving this intervention on completion of the research evaluation in 2017. Pre- and post-intervention measures of centre quality (involving observation of typical centre operations) and child outcomes (involving direct and indirect assessment of participating children’s academic/cognitive, self-regulatory and social development) will permit estimation of effects of the intervention on both staff behaviour and child outcomes.

  • Long Term Intervention with Pravastatin in Ischaemic Disease

    This multicentre, double-blind, placebo-controlled clinical trial is designed to determine whether prolonged reduction in blood cholesterol with pravastatin, one of the class of 3-hydroxy-3-methylglutaryl-coenzyme-A reductase (HMG-CoA reductase) inhibitors, will reduce mortality from coronary heart disease in patients with a history of myocardial infarction or unstable angina pectoris. To qualify for entry, a patient must have a blood cholesterol level in the range 4.0 to 7.0 mmol/L, and must have suffered a myocardial infarction or have been admitted to hospital with unstable angina, within three months to three years prior to screening. The primary study outcome will be death due to coronary heart disease. Secondary analyses will be of death from all causes, combined incidence of non fatal myocardial infarction and fatal coronary heart disease, stroke (total and non-haemorrhagic), cardiovascular mortality, coronary revascularisation (CABG and coronary angioplasty), and number of days in hospital during the follow-up period. The goal of intervention is to reduce total blood cholesterol by an average of 25% in patients allocated pravastatin compared with those allocated placebo. To detect reliably the expected effect of such a cholesterol difference on the primary endpoint requires about 9,000 patients be randomised in equal numbers to pravastatin or placebo, and that follow-up of these patients continues for a minimum 5 years for each surviving patient.

  • An evaluation of the role of Magnetic resonance Imaging (MRI) in Mucosal Primary Head and Neck Cancer

    This study will evaluate the role of magnetic resonance imaging (MRI) in the treatment of Mucosal Primary Head and Neck Cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with histologically-proven invasive primary squamous cell carcinoma of mucosal primary head and neck region or suspect tumours for mucosal primary head and neck cancer. Study details: Imaging studies are not routinely performed during radiotherapy for head and neck cancer. In this study, all participants will receive multiple additional MRI sequences before, during and after radiotherapy treatment (with or without chemotherapy). MRI sequences used include DWI, R2*, and DCE. The results from all scans will be evaluated with respect to tumour response, local control, disease free survival and overall survival. The main purpose of this study is to see whether new MRI techniques during and after radiotherapy treatment provides the doctors with accurate information which predicts the later response of mucosal primary head and neck cancer to the treatment and also evaluates tumour recurrence following treatment.

  • Is contrast enhanced spectral mammography (CESM) useful in the investigation of possible abnormalities found on screening mammograms in women with dense breast tissue and does it add useful and important information over and above current standard imaging tests?

    The primary purpose of this trial is to investigate the feasibility and efficacy of performing contrast enhanced spectral mammography (CESM) in comparison with the standard of care tests (which are breast tomosynthesis and ultrasound) for the detection of breast cancer in women with dense breast tissue. Who is it for? You may be eligible to participate in this study if you are aged 18 to 65, have dense breast tissue and have been recalled for further investigation of least one non-calcified finding on a screening mammogram. Study details: As part of standard care investigations, all participants enrolled in this trial will undergo tomosynthesis of the breast in which a possible abnormality has been found and an ultrasound scan of both breasts. The tomosynthesis study is a type of mammogram that is able to show the breast tissue slices, As part of this trial, a contrast enhanced spectral mammogram is being tested. This involves the injection of a dye into a vein, followed by two mammogram pictures of each breast taken 2-4 minutes later. The specialised equipment used for the CESM study is able to take mammograms at two different energy levels as well as performing the normal tomosynthesis study. This CESM study is taken at the same time as the tomosynthesis scan and the combined tomosynthesis and CESM study will take about 12 minutes from the start of the injection to completion of the pictures. During this study, the injection will be given first with the participant seated. Two to four minutes later the participant is asked to stand and mammograms of both breasts will be taken with the breasts gently compressed. The tomosynthesis mammograms are taken first, immediately followed by the contrast enhanced mammogram. The tomosynthesis and CESM scans are both taken during the same episode of breast compression ie each breast is only compressed once for each of the views that is taken. Having the CESM scan will mean the breast is compressed for approximately one extra minute longer per view than for a tomosythesis only scan. Researchers will compare the results of the CESM scans to the results from the tomosynthesis and ultrasound scans. Based on all results available, the physician will then make a decision as to whether any further tests, such as a needle biopsy are needed. The treating doctor will be asked to rate their level of confidence in the diagnosis made, and researchers will follow-up to assess whether performing the CESM scan was able to reduce the need for further tests such as needle biopsy and ultrasound. It is hoped that the findings from this trial will provide information on whether CESM may be a useful and feasible tool to aid in the diagnosis of breast cancer in women with dense breasts and help prevent unnecessary extra tests.

  • Oxytocin in Chronic Neck and Shoulder Pain

    The overall aim of this study is to examine whether oxytocin has a mechanistic effects on pain perception, physical functioning, central sensitisation, and physiological and psychological arousal in individuals with musculoskeletal pain associated with chronic neck and shoulder pain. This study involves receiving a one-off administration of oxytocin, relative to placebo, to investigate the role of this peptide in pain experience. Oxytocin is a hormone that is produced naturally within the human body. Although it is traditionally known for its role in initiating childbirth and breastfeeding, oxytocin has also been shown to have pain- and anxiety-reducing effects. We expect that oxytocin will help you to modulate your responses to painful experiences.

  • High flow humidified nasal oxygenation in pregnant women

    One of the most serious complications of general anaesthesia in pregnant women is hypoxic brain injury and fetal and/or maternal death related to difficulty oxygenating a pregnant woman. This is due to inability of the anaesthetist to intubate the trachea and ventilate a pregnant woman because of the changed anatomy and physiology of pregnant women leading to the known problem of the difficult obstetric airway. The latest obstetric airway management guidelines by the Obstetric Anaesthetists’ Association (OAA) & Difficult Airway Society (DAS) discuss the importance of pre-oxygenation in managing pregnant women undergoing general anaesthesia as it increases oxygen reserve in the lungs during apnoea. The guidelines recommend that the end-tidal oxygen fraction (FetO2) of equal to or greater than 90%, indicating effective lung denitrogentation, should be achieved prior to induction of anaesthesia. The current way anaesthetists pre-oxygenate pregnant women undergoing general anaesthesia is to use a tight fitting face mask to deliver 100% inspired oxygen. The new guideline also states an alternative method. The guidelines states that nasal oxygenation, to facilitate bulk flow of oxygen to the alveoli could be considered as part of 1. Pre-oxygenation - A pre-oxygenation method and 2. Apnoeic oxygenation - A technique to increase apnoeic time. The guideline suggests that the anaesthetist should consider attaching nasal cannulae with 5 l.min-1 oxygen flow before starting pre-oxygenation, to maintain bulk flow of oxygen (O2) during intubation attempts, or attach nasal oxygenation after pre-oxygenation during the apnoeic period. There is also mention of humidified high flow nasal oxygenation however no data exists in pregnant women as to its safety or efficacy or acceptability by pregnant women. It is possible that a new pre-oxygenation technique, using high flow humidified nasal oxygen, may have an application in pregnant women however before this new pre-oxygenation technique is considered, it should be equivalent (at least) to the current available technique in terms of safety and efficacy i.e. be able to obtain FetO2 of at least 90% after three minutes of pre-oxygenation. Currently there are no studies reporting FetO2 values in pregnant women with high-flow humidified nasal oxygen delivery systems and no studies reporting the use of nasal high flow oxygen to increase apnoea times therefore it is unclear whether humidified high flow nasal oxygenation, is safe and beneficial in pregnant women. In this prospective study we aim to recruit two groups of women. The first group of women will be those who will electively undertake high flow humidified nasal oxygenation in order to examine this technique in the setting of pre-oxygenation (Pre-oxygenation group). The second group of women will be those who are undergoing general anaesthesia for caesarean section and will have high flow humidified nasal oxygenation after induction of anaesthesia.

  • A preliminary investigation on the effects of intermittent exposure to hypoxia on glucose homeostasis

    Obesity and diabetes have become global epidemics. It is known that adequate physical activity and a healthy diet are among the key factors in weight control and management of type 2 diabetes. However, participation in regular exercise could be a challenge to some individuals with various capacities. There have been reports in the literature that hypoxia interventions, alone or combined with exercise, may have beneficial effects on weight control and blood glucose homeostasis in individuals with obesity and hyperglycaemia. With advancement of technology, hypoxia chambers and breathing devices (hypoxicators) have become available to provide air with various levels of oxygen. Whether hypoxia can be validated as an alternative or complementary intervention for obesity and diabetes requires further research. The aim of this research is to conduct a preliminary investigation on the effect of four weeks intermittent exposure to mild hypoxia (with the target blood oxygen saturation level at approximately 90%) on blood glucose homeostasis and insulin sensitivity in individuals with impaired fasting blood glucose. The participants’ responses (including blood oxygen saturation level, heart rate, and blood pressure) during the intervention sessions will be closely monitored, and their blood glucose, insulin and HbA1c levels, and glucose tolerance will be assessed pre and post the intervention period to determine the effects.

  • The effect of pneumatic compression devices on intradialytic hypotension

    Intradialytic hypotension (low blood pressure during dialysis) is a common problem in hemodialysis patients and can lead to poor outcomes. Pneumatic compression devices (PCD) are well established in the prevention of deep venous thrombosis and pulmonary embolism. It is thought that the use of PCDs during hemodialysis will increase venous return and improve hemodynamic stability. However, there is paucity in evidence regarding the use of PCDs during dialysis. We aim to investigate the effect of PCDs on intradialytic hypotension, compared with standard of care. The study is a two-period, eighteen-treatment, randomized crossover trial. We aim to recruit between 16 and 25 patients from hemodialysis unit at Frankston Hospital. Participants will be randomised into 2 groups, either to start with PCD or without PCD. Group A participants will have 3 weeks of dialysis with PCD, then one-week washout period of no intervention, followed by 3 weeks of dialysis without PCD. Group B participants will have 3 weeks of dialysis without PCD, followed by 3 weeks of dialysis with PCD. Standard of care during dialysis will remain the same during non-treatment period and washout period. Primary outcome measured is intradialytic hypotension. Secondary outcomes are intradialytic hypotension with nursing intervention and patient symptoms, intradialytic hypotension with symptoms, lowest blood pressure less than 100 mmHg, ability to achieve dry weight, postural hypotension at the end of dialysis and maximum fluid removal. Postural hypotension is defined as a systolic blood pressure decrease of at least 20 mm Hg or a diastolic blood pressure decrease of at least 10 mm Hg within three minutes of standing.

  • A study looking at the reproducibility of Magnetic Resonance Imaging (MRI) Simulation Scans for Radiotherapy Planning

    This study will evaluate the reproducibility of magnetic resonance imaging (MRI) setup of patients in the radiotherapy treatment position and assess how this impacts the image quality for radiotherapy planning and treatment delivery. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with prostate, head and neck, central nervous system, rectal, cervix or lung cancer. Study details: Patients would otherwise be undergoing an MRI scan in the radiotherapy department for their cancer treatment or other research purposes. Patients will undergo a planning MRI scan in the treatment position then the patient would then get off the MRI couch and be set-up for a second MRI scan with limited MRI sequences. The main purpose of this study is to determine the consistency of positioning and the impact of MRI distortion, landmark positions and contours between scans.

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