ANZCTR search results

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.

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.

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.

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.

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.

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.

This study involves a prospective, single-group, observational design. No aspect of usual clinical care (i.e. medical, nursing, physiotherapy or other allied health) will be altered. Instead, the study involves documenting the feasibility and safety of our usual practice with respect to early progressive mobilisation of patients with non-traumatic acute subarachnoid haemorrhage or subdural haemorrhage.

This project will determine if exercise reduces or even prevents cognitive impairment in breast cancer patients receiving chemotherapy. Who is it for? You may be eligible to join if you are a female aged 18 years and over and are scheduled to receive adjuvant chemotherapy for the treatment of breast cancer with fluorouracil-epirubicin-cyclophosphamide- docetaxel (FEC-T) or docetaxel-cyclophosphamide (TC) regimens. Trial details. Participants in this study will be randomly (by chance) divided into one of two groups – exercise or usual care. Participants in the exercise group will attend a supervised exercise program for the duration of chemotherapy treatment. The exercise program involves resistance (i.e. lifting weights) and aerobic exercise (e.g. walking, jogging, cycling) undertaken 2 times per week in an exercise clinic. Exercise sessions will take approximately 60 minutes and will be conducted in small groups under the supervision of an accredited exercise physiologist. Participant in the usual care group will maintain usual care throughout their chemotherapy treatment. These participants will be offered participation in the supervised exercise program at 3 months after the completion of chemotherapy. Assessments will be conducted at baseline (7-10 days before chemotherapy), post-chemotherapy (7-10 days after final chemotherapy administration) and follow-up (3 months post-chemotherapy).

The left atrial appendage (LAA) is the most common source of thrombus in patients with atrial fibrillation (AF). Such thrombus has the potential to embolise to the brain, causing stroke. Ligation of the appendage is a commonly performed concomitant procedure in patients with AF undergoing heart surgery for other reasons . Current literature suggests that complete exclusion of the left atrial appendage occurs in only 40% of patients undergoing ligation and intra-atrial closure. A small amount of data suggests better long term exclusion of the LAA with the Atriclip device. In addition there is little risk of bleeding compare to excision and oversewing. We would like to collect data on patients undergoing left atrial appendage ligation using the Atriclip device

Studies have consistently shown that low trauma fractures are widely prevalent among patients with chronic kidney disease (CKD). However, the management of this condition remains controversial because the safety and efficacy of most currently available treatments for the prevention of fractures have not been adequately tested in patients with CKD. Further, many of these treatments are potentially toxic to kidneys and may also have deleterious effects in certain types renal bone disease. Therefore, there is a need for investigating new therapies for bone protection in CKD, using drugs that are safe and effective in patients with CKD. Recent evidence suggests that nitrates have all the attributes to be a potential candidate for bone protection in CKD. They have been shown to have bone protective properties in postmenopausal women, although not specifically in patients with CKD, and their safety in CKD, including in patients with advanced CKD, is well established. The current study is arandomised, placebo-controlled trail designed to assess the efficacy of isosorbide dinitrate, a commonly available oral nitrate preparation in Australia, versus placebo in the prevention of spinal bone loss in patients with moderately severe kidney disease (CKD stage 3 and 4).