ANZCTR search results

The focus of this research is on anterior drooling (spillage of saliva from the mouth that is clearly visible). Many children with cerebral palsy (CP) experience difficulties controlling saliva. Potential reasons for this clinical feature of CP include: a reduction in swallowing ability; oral motor dysfunction, and hypersalivation; resulting in anterior loss of saliva from the mouth. Drooling can be a disabling condition for children with CP, adversely affecting physical health, emotional health, social interactions and self-esteem. These health impacts include skin maceration and skin breakdown; aspiration pneumonia and significant respiratory compromise; and social rejection from peers. Drooling has also been shown to increase the care needs of the child, putting families under increased stress. Thus, drooling has the potential reduce the quality of life of both children with CP and their families. A treatment approach that holds promise in improving swallowing and reducing swallowing in children with CP is the Lee Silverman Voice Treatment Approach (LSVT LOUD®), which is founded on neuroplasticity- and motor learning principles. This intensive voice treatment approach has level IV efficacy in improving speech, and has also resulted in significant improvement in swallowing in adults with Parkinson's Disease. Early phase I clinical outcome research has shown similar speech improvements in children with CP; and it is therefore reasonable to hypothesis that similar improvements in swallowing ability may occur, which in turn may facilitate a reduction in drooling.

Patients with non-obstructive coronary artery disease, who have had a comprehensive invasive coronary physiology assessment, will be asked to undergo a research cardiac MRI within two weeks of their invasive assessment. The results of the MRI will be compared to the invasive assessment. This will provide information on the utility of the new MRI method for diagnosis of coronary microvascular dysfunction.

This study is investigating the safety of administering heated (42 degrees Celsius) versus normal temperature (37 degrees Celsius) chemotherapy during surgery for ovarian cancer patients. Who is it for? You may be eligible for this trial if you are a female aged 18-75 years who has been diagnosed with primary stage III epithelial ovarian, fallopian tube or peritoneal cancer with disease that is limited to the abdominal cavity. You must have had 3-4 cycles of pre-operative platinum-based chemotherapy and be fit for surgery. Study details Participants will receive cisplatin chemotherapy administered intraperitoneally to the abdominal cavity during surgery. They will randomly be allocated to either a hyperthermic arm, who will receive the chemotherapy drug heated to 42 degrees Celsius, or a normothermic arm who will receive the drug at normal body temperature of 37 degrees Celsius. Follow-up information about adverse events, quality of life and disease outcomes will be collected following the surgery. Information from this study will be used to design future trials evaluating the efficacy of heated chemotherapy.

This pilot, feasibility randomised controlled trial (RCT) will recruit 42 people with knee osteoarthritis who have completed the GLA:D® Australia program. Consenting participants will be randomised to an additional intervention to promote physical activity (motivational interviewing and web-based support), or usual care (continuation of exercises and self-management learnt in GLA:D®). Objectives: The primary objective is to determine the feasibility (eligibility and recruitment rates; adherence to motivational interviewing sessions, drop-out rate, credibility of the intervention) of conducting a fully powered trial to evaluate the clinical effectiveness (i.e. increasing physical activity) of using SUpported Motivational InTerviewing (SUMIT) targeting physical activity following completion of a widespread exercise-therapy program (GLA:D®) in people with knee osteoarthritis. Secondary objectives include: • To determine if a worthwhile treatment effect could be observed for physical activity, physical endurance, joint-related quality of life (QoL), health-related QoL and pain. • To refine SUMIT through qualitative feedback from participants.

Alyra Biotech Pty Ltd is an Australian-owned biopharma company that wishes to develop an optimal intrauterine contraceptive device (IUCD) for young women with period or pelvic pain. We wish to determine the priorities of two end-user groups: women who may choose an IUCD for contraception or other health concerns, and Health Practitioners who advise women regarding the risks and benefits of IUCD use. Intrauterine devices are chosen as a form of contraception by 14% of women worldwide, with use of levonogestrel-releasing intrauterine devices increasing globally. However, some women experience increased pelvic pain in the 3-6 months after insertion. We wish to research the experiences, perspectives and preferences of both end-user groups to assist us in planning an optimal device for women with pain. The views and experiences of our end-user groups will guide our product development. Finally, to ensure that our product is commercially feasible, we wish to determine the cost premium that users, or prescribers, of the device would accept for such a device. The primary objectives of this study are: 1. To determine the market potential for an intrauterine device that reduced pain in the first 3 months post-insertion by 50%. 2. To determine whether these women whether these women would be prepared to pay a price premium for such a device sufficient to justify device commercialisation. 3. To determine whether Health Practitioners who offer intrauterine contraceptive devices would prefer a device that reduced pain by 50% in the first 3 months post-insertion. 4. To investigate whether Health Practitioners believe their patients with dysmenorrhea or Chronic Pelvic Pain would pay a price premium for an IUCD that reduced post insertion pain compared with their patients who are pain free.

Inadequacies in nursing assessment practices and clinical handover communication compromises early identification of risk of clinical deterioration, inpatient falls and pressure injury. The aim of this trial is to implement and evaluate the feasibility and effectiveness of a ward-level intervention (ACCELERATE) to improve bedside patient assessment and clinical handover. The ACCELERATE Intervention requires nurses to: i) undertake comprehensive assessments on every patient at the beginning of every shift; ii) communicate findings to the multidisciplinary team and iii) implement strategies to monitor and manage at an early stage clinical deterioration and risk of pressure injury and falls. Expected study outcomes are a reduction in the incidence of deteriorating patients, medical emergency team calls (rapid response and cardiac arrest); unplanned intensive care unit admissions; and hospital-acquired complications of falls, and pressure injuries. Evidence-based strategies will be used to implement the ACCELERATE intervention, including: formal education; barriers and facilitator analysis; multi-level multidisciplinary clinical leadership, external facilitation, audit and feedback, and reminders. Regular follow-up meetings will be conducted throughout implementation, as well as ongoing educational/facilitated outreach visits and audit and feedback progress sessions to assist in embedding change and addressing barriers.

The DADAE Program is an intervention which engages fathers in positive lifestyle role modelling and effective parenting strategies to improve the physical activity behaviours, physical confidence, sport skills and social-emotional wellbeing of their daughters. Importantly, DADAE also targets girls to improve the fitness and physical activity levels, and parenting skills of their fathers. The purpose of this nonrandomized, prospective trial is to expand the evidence-base for DADAE from intervention testing to intervention replication (i.e., the first phase of translation research) using a quasi-experimental research design. The present study will investigate whether: a) whether program fidelity, satisfaction, attendance and retention is maintained, b) the improvements (pre-post) in outcomes (physical activity, parenting practices, Father-daughter relationship and social-emotional well-being) for families established in the previous DADAE RCTs can be achieved and maintained over 12 months in multiple locations with multiple facilitators in a large sample (240 father-daughter dyads).

Chronic subdural haematoma (cSDH) is one of the most common neurosurgical conditions and its frequency continues to rise as a result of the aging population and the increasing use of anticoagulation and antiplatelet medications. While there are no established guidelines for its management, symptomatic cSDHs are usually treated with surgical evacuation. The reported recurrence rates following surgical evacuation in the literature vary widely from 2% to 37%, with most estimates ranging between 20% and 30%. Recent studies have suggested middle meningeal artery (MMA) embolisation to be a potential alternative treatment for cSDH. Numerous case reports and series have demonstrated MMA embolisation as a safe primary treatment for cSDHs or as an adjunct treatment following surgical evacuation. We aim to conduct the first randomised controlled trial to further confirm the efficacy of MMA embolisation. -Unstable cSDH patients who require urgent surgical evacuation on admission will be randomly allocated to receive post-operative MMA embolisation or observation (current standard treatment) during the same admission -We aim to demonstrate that post-operative MMA embolisation can reduce the rate of recurrent cSDH requiring repeat surgical evacuation

With novel surgical techniques and hardware design, plaster casts are not necessary to immobilise feet after 1st metatarsal surgery. Most surgeons support the use of a stiff sole post-operative shoe in either partial or full weight bearing to protect the surgical site and prevent complications over the course of 6 weeks post-surgery. We have previously demonstrated the use of rigid flat shoes improves satisfaction over the use of reverse camber shoe. The purpose of this study is to assess whether the use of comfortable shoes vs stiff sole shoes affects patient reported outcomes. Differences in long-term surgical outcomes of non-union and recurrence will also be investigated.

This study is investigating the perceived benefit of implementing a nurse led model of care for older myeloma patients undergoing oral cancer treatment. Who is it for? You may be eligible for this study if you are aged 65 years or older, you are newly diagnosed with Myeloma or first relapse and are being treated at one of the participating hospitals in South Australia. Study details All enrolled participants will be provided with additional education about the disease and treatment by a specialist nurse. The specialist nurse will also act as a first point of contact during chemotherapy to answer questions and provide additional support to participants as required. Participants will have their medical records reviewed by the specialist nurse and may be asked to complete questionnaires at various timepoints over a 12 month period. It is hoped this research will demonstrate that a nurse led model of care for older patients with myeloma has a positive impact on their treatment completion rates and quality of life during cancer treatment.