ANZCTR search results

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).

Diabetic neuropathy is a common co-morbidity of diabetes that is a risk factor for foot ulceration and lower limb amputation. Exercise interventions may have the potential to reduce the burden of diabetic foot problems as a recent study demonstrated improvement in peripheral neuropathy symptoms after a structured exercise program in laboratory conditions. Exploration of these promising results in a pragmatic environment is required to understand the true effect of exercise in the management of peripheral neuropathy. Therefore, we will attempt to answer the following research question: Does structured exercise training improve neuropathic signs and symptoms in people with diabetes and peripheral neuropathy? To answer this question, a pilot randomised controlled trial will be conducted. People with diabetes and peripheral neuropathy will be recruited. Following preliminary testing and randomisation, participants will attend three supervised exercise sessions per week or a diabetes lifestyle coaching program for 8-weeks. Repeat testing will be completed after the completion of the exercise or education program. The primary outcome will be the validated Michigan Neuropathy Screening Instrument score and secondary outcomes will include three separate physical function tests that explore aerobic fitness, lower limb endurance and balance. Based on neuropathy-related effect found in the previous study, approximately 24 participants in each group are required to identify a medium effect (power = 80%, p = 0.05).

This study will assess the quality of life in women with breast cancer, from a surgical oncology practice in North Sydney, Australia, who undergo mastectomy and post-mastectomy radiotherapy (PMRT). Study details All participants in this study will be asked to complete a number of questionnaires over a period of 5 years post-mastectomy in order to assess quality of life, pain, aesthetic outcomes and clinical outcomes. If immediate breast reconstruction (IBR) is found to improve the quality of life of patients who are undergoing mastectomy and subsequent adjuvant treatments, then IBR could be offered as an option to breast cancer patients who are reasonable candidates for this procedure. This will be the first prospective cohort study in Australia to assess the quality of life of women undergoing mastectomy and PMRT, and allows for comparison of outcomes according to breast reconstruction choices - immediate, delayed or none.

The research design to be employed is a cluster randomized controlled trial of a multi-component intervention designed to improve the experience of Residential Respite Care (RRC) for people with dementia and their carers. Clustering will occur at the facility level with randomisation by necessity occurring at this level in order to prevent contamination of results due to changed processes during RRC admission required by the intervention. Thus, two facilities will be allocated as the intervention facilities and two as control facilities. Random allocation will occur via a random number generator. The program will provide support and communication before, during and after residential respite admission in order to facilitate the transition to respite care. Participants with dementia (PWD) and their carers will be interviewed face – to –face and also complete self –report instruments 2 weeks prior to moving into RRC. Allocation of residents will occur to either intervention or control group and all will be assessed during RRC admission. PWD and their carers will be interviewed face to face and asked to complete self report measures when transiting back to home care. PWD and their carers will be interviewed via telephone and asked to complete self report measures three months following return to home care.

The PROTECT-ICD study is a multi-centre randomised controlled trial targeting prevention of sudden cardiac death in patients who have reduced cardiac function following a myocardial infarct. The primary objective of the trial is to assess whether electrophysiologic study to guide prophylactic implantation of an implantable cardioverter-defibrillator early following MI (first 40 days) will lead to a significant reduction in sudden cardiac death. The secondary objective is to assess the utility of cardiac magnetic resonance imaging in assessing early myocardial viability, and its predictive value for both inducible and spontaneous ventricular tachyarrhythmias post-myocardial infarction.

Breast reduction surgery improves the quality of life of women with large breasts, with regard to both physical and psychosocial symptoms. At present two very different techniques predominate, with no consensus on whether the choice of operative technique affects patient satisfaction/quality of life (QOL). We aim to perform a prospective randomised cohort study to compare patient satisfaction/QOL following breast reduction using either the inferior pedicle Wise pattern or superomedial pedicle Hall-Findlay technique.

Many babies arrive naturally in a timely manner, however, sometimes we need to assist (or ‘induce’) a pregnancy if there are any complications, or if the pregnancy goes well beyond the due date. It is estimated that one in four women have an induced labour. The induction of labour is commonly commenced by placing some hormone gel (called Prostaglandin) in the vagina to make the cervix (the opening of the womb into the vagina) softer and allow it to open. Induction of labour can also be commenced using a small tube with a balloon on the end, inserted through the cervix and then inflated to mechanically stretch the cervix. In Australia, both methods are commonly used to prepare the cervix for labour. Following either method, when the cervix is more open, contractions are brought on by breaking the waters around the baby (called artificial rupture of membranes or ARM) and administering a hormone fluid (called Syntocinon) intravenously (IV; or into a vein). Sometimes, the induction process may be prolonged and it can take many hours, even days, before the cervix is more open. Prostaglandin hormone gel, in particular, can induce contractions. It is common practice that women undergoing induction remain an inpatient over this time. Balloon catheter induction is however very unlikely to induce contractions and there is even some published studies suggesting balloon catheter inductions may be associated with less chance of distress to babies. As such, for some women undergoing induction of labour with a low-risk, uncomplicated pregnancy, it would seem reasonable to go home after placement of the balloon catheter. The primary aim of the study is to demonstrate that going home after commencing an induction of labour using a balloon catheter is just as safe as having prostaglandin gel induction and remaining as an inpatient. We are additionally interested in the duration of labour, mode of birth, length of hospital stay, overall healthcare costs for women undergoing both induction policies, and which method is perceived by women to be more satisfactory.