ANZCTR search results

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

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31350 results sorted by trial registration date.
  • How do tasks involving the upper limbs and trunk affect the sternum post-median sternotomy?

    - The median sternotomy remains the gold standard incision for cardiac surgery procedures and involves division of the sternum (otherwise known as the breastbone) to access the heart and surrounding structures. - After such procedures, patients are routinely asked to follow precautions that restrict upper limb and trunk movements in order to allow the sternum to heal. - However, little is known regarding the sternal healing process and how upper limb and trunk movements affect this process following cardiac surgery. - The primary aim of this research project is to investigate how tasks involving the upper limbs and trunk affect the healing sternum over time. - To achieve this, the research team will measure how much movement occurs at the sternal edges during upper limb and trunk movements with the use of a 2D ultrasound machine. - 75 participants will be recruited to take part in this study. All participants will receive standard pre and post-operative care. - Nested within the above main study is a reliability study which aims to investigate the inter and intra-rater reliability of ultrasound measures of sternal micromotion during upper limb and trunk movements, in acute patients following cardiac surgery (first time point- 3-7 days post-operation). - The first 20 participants recruited to the main study will form the sample for the reliability study.

  • Therapeutic Hypothermia in Acute Ischemic Stroke (THAIS)

    Hypothermia has great promise as a cytoprotective therapy after stroke given clinical benefit in other brain injury scenarios and animal models of stroke. THAIS is a pilot randomized trial of hypothermia (cooling) versus standard care that focuses on patients with major stroke who have undergone rapid, successful recanalization. This group often demonstrates initial improvement in brain imaging (diffusion MRI) followed by later re-appearance of the lesion which likely reflects a secondary injury. If hypothermia can reduce this secondary injury it has great potential to improve patient outcomes after severe stroke – a patient group that currently have very few treatment options.

  • Oral glucose tolerance testing in Cystic Fibrosis

    Assessment of the prevalence and incidence of glucose intolerance and diabetes in subjects with Cystic Fibrosis.

  • Visual performance assessment of prototype contact lenses in children and young adults

    Myopia (also known as near or short sightedness) is a condition of the eye where objects viewed in the distance appears blurred. Conventional methods of correcting this optical condition include spectacles and contact lenses. The rate of progression of myopia tends to be more rapid in the younger age and high degrees of myopia can lead to complications such as retinal degeneration and detachments, choroidal neovascular membranes and an increased risk of primary open angle glaucoma. Numerous studies have investigated different contact lens optical designs to correct and potentially treat myopia. One theory in the attempt to reduce myopia progression is to target the stimulus on the peripheral retina. Previous studies have shown that the peripheral retinal stimulus plays a role in myopia progression. It is now known that peripheral hyperopia, where the stimulus or focus falls behind the retina, can be a trigger for myopia progression. Myopic eyes tend to have peripheral hyperopia and unfortunately the design of conventional spectacles and contact lenses used to correct myopia, actually exacerbates this. Thus, in an attempt to minimise myopia progression, the optical design of contact lens should bring the focus from behind the retinal periphery to either on or in front of the retinal periphery. This concept has been tested in contact lenses previously and progression of myopia was found to be 34% less than when wearing spectacles only. Newer optical designs with this concept are required to be tested to enhance the myopic progression effect, however, as the lens designs are novel, myopic participants are required to test the lenses and ensure both vision and subjective acceptance of the lens prior to longer term assessments on the efficacy of these lenses. Previously conducted clinical studies assessed numerous prototype lenses after short-term (1.5 and 6 hours) lens wear compared to commercially available equivalent contact lenses in adults. The best performing prototype lenses from the short-term trial have been selected for further testing in the current study against the best performing commercial contact lenses for use in children and young adults.

  • Preventing asthma exacerbations in children aged 6 to 12 years with atopic asthma using a winter only treatment with OM-85

    Asthma imposes a huge social and economic burden on our community, accounting for approximately 1.4% of the total expenditure on health in Australia. Major risk factors for exacerbations include previous exacerbations, young age, poorly controlled asthma, and, in particular, viral respiratory infections. Viral induced exacerbations account for between 80 to 85% of all asthma exacerbations, with the most common viruses including rhinovirus, respiratory syncytial virus, human metapneumovirus and the influenza virus. The primary aim of this study is to prevent lower respiratory tract infections over the treatment period using a novel bacterial-derived immunostimulant OM85. OM85 has bacterial lysates of strains frequently encountered in respiratory infections. OM85 BV reduces the susceptibility to suffer from recurrent respiratory infections by priming the immune system. This will help in preventing and reducing the respiratory symptoms to better control asthma in children and reduce severe exacerbations of asthma in children. Lower respiratory events are defined as a wheezy lower respiratory infection lasting three or more days requiring additional asthma medication.

  • teen Mental Health First Aid: A Cluster Randomised Controlled Trial

    Mental health problems frequently have their first onset during adolescence, but adolescents often do not seek professional help or show long delays in getting professional help. They show a strong preference to seek help from informal sources such as family and friends. However, friends may lack the knowledge and skills to provide effective support. teen MHFA training is designed to give adolescents the basic skills they need to support peers and connect them with an adult helper. The aim of this trial is to compare the effects of teen MHFA training of Year 10 students with a physical first aid training control group on: recognition of mental disorders, help-seeking beliefs, mental health first aid intentions, stigmatising attitudes, confidence in supporting a peer, help provided to a peer, and mental health. In addition, the trial aims to provide initial evidence on whether teen MHFA training could have potential as a suicide prevention program by improving ability of students to assist a suicidal peer.

  • An open-label, multi-centre Phase I study of the safety and tolerability of intravenously (IV) infused PG545 in patients with advanced solid tumours

    This study aims to establish the maximum tolerated dose of PG545 and to evaluate its safety in subjects with advanced solid tumours. Who is it for? You may be eligible to join this study if you are a male or female aged 18 years or above who has been diagnosed with a non haematological malignant solid tumour, excluding primary brain or spinal tumours. To be eligible patients must have failed all standard therapies, no longer be a candidate for standard therapy, have no standard therapy available, or have chosen not to pursue standard therapy. Study details: All participants in this study will receive the drug PG545 once weekly via a 1 hour intravenous infusion (i.e. directly into the vein). Subjects will be treated until either disease progresses or they can't have further treatment due to tolerability. They will be regularly monitored throughout the treatment period in order to determine the safety and tolerability of treatment. The dose of PG545 will also be increased in new groups of patients in order to determine the maximum tolerated dose. In addition the study will explore whether PG545 exposure results in changes to chemicals produced by the body that are associated with cancer growth and spread. This is the first clinical study of PG545 administered by intravenous infusion.

  • Teriparatide for Pelvic Fracture Healing

    Teripartide is a medication that works on cells within the bone (called osteoblasts) to help form new bone which is approved in Australia to treat osteoporosis. A previous, but flawed study has shown some promising results with the use of parathyroid hormone (a medication very similar to teriparatide). There is also some inconsistent evidence of improved fracture healing after wrist fractures. Preclinical studies in rats have also shown some evidence of faster fracture healing. We will perform a small, pilot, randomised trial assessing the effect of 8 weeks of teriparatide on fracture healing. We will recruit up to 40 participants who have had a minimal trauma pelvic fracture, who would otherwise undergo conservative management, who can either selfadminister or have a carer able and willing to administer daily subcutaneous injections for 8 weeks. Each participant will be randomised to either the treatment (20 micrograms per day of teriparatide via subcutaneous injection) or standard care (pain relief, physiotherapy). Our primary aim is to demonstrate (assessed on computer tomography scan) that a larger proportion of participants will have demonstrable cortical bridging (fracture healing) at the fracture site after 8 weeks of treatment. Secondary aims will be to demonstrate improvements in pain, functional status and quality of life after 4, 8 and 16 weeks. This study will guide us in the design of a larger, multicentre trial, if the initial results show promise.

  • Efficacy of ultrasound-guided Platelet Rich Plasma injection to promote recovery in athletes with ankle syndesmosis injury. A pilot study

    As a low risk, readily available treatment, PRP injection is becoming an increasingly popular therapeutic adjunct offered by musculoskeletal clinicians. However, there is a clear need to scientifically assess the merits of this treatment option for athletes with ankle syndesmosis injury in order to establish recommendations for evidence-based practice. Since there are no trials that have investigated PRP for ankle syndesmosis injury, this pilot study aims to assess the feasibility of progression to such a higher quality, larger scale trial. If the treatment is shown to be beneficial, this would be of significant value to competitive and professional athletes who may otherwise require either a prolonged conservative treatment or a surgical treatment requiring at least six weeks of rest from competition.

  • Do discharge plans meet patients’ requirements and expectations? An observational study.

    The purpose of this observational study is to investigate whether discharge plans for patients undergoing rehabilitation that are put in place prior to patients’ discharge actually meet patients’ requirements and expectations following discharge.

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