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.
  • Development of a group e-Parenting Intervention Targeting Behavioural Problems for Children with Leukaemia – A pilot study

    The current study aims to assess the feasibility of the Triple P Positive Parenting Program for parents who have a child diagnosed with cancer. Who is it for? You may be eligible to join this study if you are an English-speaking parent of a child aged 2-8 years who has been diagnosed with acute lymphoblastic leukaemia (ALL), and is on the maintenance phase of treatment. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will undergo the Triple P Positive Parenting Program straight away. Participants in the other group will be offered the same program approximately 5 months later. Triple P is an evidence-based program developed specifically to provide parents with practical strategies for dealing with problem behaviour in their children. This intervention will be delivered in an online group format, hence making it accessible to all families regardless of their personal or geographic circumstances. Both intervention and control group parents will complete online surveys measuring parenting strategies, child sleep, child diet, child behaviour and other feasibility questionnaires at three timepoints (2 weeks prior to the first intervention, and again at 2 and 12 weeks post intervention completion). The results from this pilot intervention will be used to inform the development of a cancer-specific Triple P Intervention (CancerCare Triple P) for implementation across multiple paediatric oncology sites nationally.

  • Does Evening Primrose Oil Improve Pruritis (Itching) in a Dialysis Population?

    Pruritis is a common symptom in patients on dialysis and has significant impact on their quality of life. The pathophysiology is not well understood and treatments are not very effective. Evening Primrose Oil has been used successfully in eczema and small studies suggest it may be of benefit in uraemic pruritis.This study is designed to investigate whether in fact Evening Primrose oil does has a beneficial effect on pruritis.

  • Positron Emission Tomography (PET) scan in predicting response and survival in patients undergoing chemoradiation followed by surgery for oesophageal cancer

    This phase II study aims to investigate whether PET scan performed after the completion of chemotherapy and radiation can predict response of oesophageal cancer. Who is it for ? You may be eligible to join this study if you are aged 18 years or more, have been diagnosed with a localised oesophageal cancer, and are suitable for chemotherapy combined with radiotherapy prior to surgery. Study details: Participants will undergo a single additional PET scan 4 weeks after the completion of chemo-radiotherapy. Approximately 2 weeks following this they will undergo surgery. Specimens obtained from surgery will be used to evaluate the predictive value of the PET scan. Participants will be scheduled to clinic visits for follow-up at 5 weeks after chemo-radiotherapy, 3 monthly for the first 12 months, and then 6 monthly thereafter until a minimum of 2 years. At each visit, apart from routine history and physical examination, participants will be asked to complete a series of short questionnaires which evaluate the health-related quality of life. This is a prospective, single arm, multi-centre study and a total of 200 participants will be recruited.

  • Effects of a high calcium pre-event meal on biomarkers of calcium homeostasis in female cyclists

    Background: An issue of high importance to the AIS is the prevention/treatment of low bone density in athletes: low bone mineral density (BMD) is common in both male and female cyclists. This may be because of a lack of weight-bearing activity, menstrual disturbances, and low energy availability due to weight loss practices or the high energy expenditure. An additional risk factor of interest is the acute effect of sweat calcium loss. These sweat calcium losses during prolonged exercise may cause a significant decline in blood calcium concentrations during training. The body protects blood calcium levels by stimulating the bones to release calcium into the blood to restore levels, and increasing bone re-absorption. Purpose: to determine whether a high calcium pre-event meal can reduce levels of hormones that are responsible for increasing bone resorption. Hypothesis: based on previous findings involving calcium-fortified water, it is hypothesised that a calcium-rich dairy based meal will reduce the exercise induced rise in biomarkers of bone resorption observed during cycling.

  • The effect of early mobility in patients after Total Knee Replacement on hospital length of stay,pain and function: A randomised control trial

    Trial aimed at determining whether mobilising patients after Total Knee Replacement within the first 4-6hrs after surgery compared to mobilising within the 24 hrs after surgery changes the outcome for these patients

  • A web-based randomised controlled trial exploring the impact of telephone-based practitioner support in an online parenting program.

    Preliminary trials have demonstrated Triple P Online to be an effective self-directed behavioural family intervention for reducing child social, emotional and behavioural problems, increasing parenting confidence and reducing ineffective and coercive parenting practices. However additional research is required to both replicate these results and further investigate factors that might impact program outcomes. The primary aim of this randomised controlled trial is to explore the value of brief, regular practitioner support when used in conjunction with Triple P Online. It is anticipated that parents participating in Triple P Online will demonstrate greater reductions in child disruptive behaviour and coercive parenting strategies than parents in the control group. We also anticipate that parents receiving practitioner support combined with the online program will experience greater improvements than parents completing Triple P Online as a self-directed intervention only.

  • 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.

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