ANZCTR search results

Mild Traumatic Brain Injury (mTBI) is a significant burden to Queensland emergency departments (EDs) in adults and children. Between 2019-2020, there were over 1800 presentations of isolated mTBI to Gold Coast Hospital Health Service (GCHHS) EDs, presenting outside of usual business hours with 26% re-presented within the first 6 weeks of their initial presentation, many of which were related to the initial injury. Management pathways to support this population and reduce the high rate of re-presentations must therefore be prioritized. With this in mind, the Occupational Therapy (OT) Outpatient Service are implementing an innovative practice model involving specialist OT follow up for these patients to facilitate recovery and linking into appropriate specialty referrals where indicated to prevent ED representations. The primary aim of this research is to evaluate the impact of this Occupational Therapy (OT) intervention pathway for patients presenting to ED with a mTBI outside of business hours compared to pre-implementation care. The study secondly aims to evaluate the process of implementing the pathway in relation to adherence, patient satisfaction, and staff experience. It is anticipated that the implementation of the OT pathway will lead to decreased ED readmission, enhanced clinical outcomes (including reduced functional burden and disability and days missed of work/school) and decreased ED length of stay for monitoring of symptoms.

Human amnion epithelial cells (hAECs) therapy attenuated infarct growth even when administered 3 days after the onset of stroke. The mechanisms of action involved modulation of the immune response to minimise further injury in the peri-infarct region. Our recent Phase 1 trial has now shown that amniotic stem cells can be given safely at up to 8 million cells/kg i.v.. We thus now propose a Phase 2 dose escalation trial providing a platform for a Phase 3 trial at a later stage. The design is based on the 1:1:1 randomisation (placebo versus 230 million cells or 460 million cells). Based on our published experimental findings and Phase I dose-escalation human safety trial, we hypothesise that hAECs therapy will reduce stroke disability.

The pilot study was to determine the safety and efficacy of a device which aimed to modify the repair of the extracellular matrix in skin. The hypothesis was that the structured magnetic field of the active device would enable a more efficient repair through enabling the alignment of molecules flowing into the wound thus decreasing the healing time and improving the strength of the repair. Although the intervention was intending to nanoengineer the repair, the outcomes were measured at a macroscopic level by taking photos of the wounds, removing sutures early to test wound strength and including the subject's experience of wearing the device. The control device was a weak active control, which permitted the discernment of a difference between each end to the wound corresponding to the active vs control devices yet enabled the clinical assessment of a weak dosage effect on the repair where the control end was found to have a significant clinical effect on wound strength.

While the ability to effectively prevent cardiovascular disease (CVD) in the elderly is imperative, there are few primary prevention therapies. The gout medicine colchicine inhibits the critical pathways of inflammation and platelet activation involved in atherothrombosis, but does not increase bleeding. Colchicine has a broad anti-inflammatory effect. Benefits of long-term low-dose colchicine have been confirmed in people with established coronary artery disease, with a substantial 31% (95%CI 22-40%) reduction in cardiovascular events. We have demonstrated that older people have a distinctive platelet phenotype of increased basal activation, hyperreactivity to adenosine diphosphate and thrombin resistance, correlating with elevated inflammation. Thrombin generation associated with systemic inflammation was identified as a possible novel target to prevent CVD in the elderly. A small pilot trial will be used to assess the effectiveness and safety of colchicine compared to usual care in inhibiting platelet activation and inflammation in elderly patients without cardiovascular disease.

The primary objective of this study is to assess the feasibility, acceptability, and effectiveness of a multimodal early supportive care program delivered during neoadjuvant chemotherapy treatment for women with breast cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed with breast cancer, and are planned to receive neoadjuvant (i.e. prior to surgery) chemotherapy. Study details All participants will receive the supportive care program for the duration of their chemotherapy treatment. The program will involve an holistic nursing assessment, tailored exercise (3x per week), three education modules and complementary therapies (acupuncture, massage etc) prescribed and provided when symptom burden is moderate to severe. Participants will complete a number of questionnaires, tests of physical function, and blood tests at the time of enrolment, mid-program, upon completion of the program, after completion of surgery, and at 6 months post-enrolment, in order to determine the safety, acceptability, and effectiveness of the program. It is hoped that this study may show that the multimodal early supportive care program is safe, acceptable to patients and their treating clinicians, and effective in modifying side effects of treatment, chemotherapy adherence, anthropometric measures, and selected cardiac, and disease recurrence risk factors, self-efficacy and satisfaction with surgery.

Functional defecation disorders are the underlying causes of one third of all constipation and half of all fecal incontinence. Anorectal biofeedback therapy is a safe and effective form of rehabilitation therapy that uses anorectal muscle exercises to restore normal bowel function. However, due to access and cost issues biofeedback therapy is not accessible to most patients. This randomized controlled trial involves an experimental internet-of-medical-things device that will aid in biofeedback therapy and allow for training to be conducted at a patient's home. We aim to compare therapy delivered using the experimental device against conventional clinic-based anorectal biofeedback therapy.

This is an investigational agent within the ALLG AMLM26 INTERCEPT trial platform, which is registered on ANZCTR with ID ACTRN12621000439842. This investigational agent (SNDX5613- a new treatment) will be evaluated for its activity alone in a population of participants with progressive acute myeloid leukemia (AML). Who is it for? You may be eligible for to receive this treatment if you are a part of the AMLM26 Intercept trial which is registered on ANZCTR with ID ACTRN12621000439842 (ie if you are aged 18 or older, you have been diagnosed with progressive acute myeloid leukemia, and are currently in your first or second morphologic remission with a known and trackable minimal residual disease (MRD) marker.). If you are on the AMLM26 Intercept trial you may be eligible for this treatment option if your disease is worsening. The trial management committee will review your disease characteristics and determine your best treatment option(s) available on the trial. Study details SNDX5613 is given orally by itself twice daily on an empty stomach at least 2hrs after a meal or 1 hour before the next meal. Administered days 1-28 of a 28 day cycle for 12 cycles. Patients with minimal residual disease will have a pilot safety run-in phase to confirm dose - investigating doses 276mg twice daily, 226mg twice daily and 163mg twice daily. Once a tolerable dose is determined that dose will be used in a proof of concept phase.. Patients with morphologic relapse will enter directly into a proof of concept phase using 276mg twice daily dose. Participants will undergo a disease assessment at screening after cycle 1, cycle 2, cycle 3, cycle 6 and then 2 monthly until progression. This will require blood tests and bone marrow biopsies. Safety and tolerability of treatment will be assessed throughout the trial whilst you are receiving treatment. Health related quality of life during treatment will be assessed on the first treatment day of 3 consecutive cycles. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that SNDX5613 will be well tolerated and may improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

Tobacco remains Australia’s single most preventable cause of death. While plain packaging with larger graphic health warnings and tobacco excise increases have recently reduced smoking prevalence, further progress is endangered by the tobacco industry’s rapid evolution of reassurance marketing. This marketing promotes particular product attributes, brand variants or sensory experiences that mislead smokers into believing these products offer reduced harm; in fact, they offer only the illusion of protection. Examples include an explosion of suggestive brand variant names and descriptors (e.g. ‘smooth’ taste, ‘quality’ descriptors) on packs, and vigorous promotion of mentholated products, filters that vary in appearance, filter-venting and ‘natural’ roll-your-own tobacco. Using principles of faulty belief correction, we aim to create a set of salient corrective warnings on packs that convey how specific product attributes (Product Attribute Health Warnings) do not reduce the likelihood of disease. This study aims to investigate the effectiveness of Product Attribute Health Warnings and an accompanying television advertisement on perceptions of enjoyment and concern when inhaling smoke with favourable sensory experiences as well as their impact on smoke limiting behaviours among Australian adults who smoke regularly. The four alternative warning label conditions to be tested via the online experiment include: two control groups (A) No Tobacco Health Warnings (consisting of warnings from over-the-counter medicine); and (B) New Standard Health Warnings (to represent the usual situation); and two groups exposed to systematically developed (C) Product Attribute Health Warnings; and (D) Product Attribute Health Warnings plus a TV advertisement. The findings from this study will contribute to the evidence base available for advocacy and forthcoming policy deliberations on tobacco health warning labels.

This study (called TELE-CONNECT) is a telehealth program to deliver pelvic floor muscle training to women with gynaecological cancer who suffer from urinary incontinence. Urinary incontinence affects around one-third of women causing signifcant physical, social, emotional and financial burden. The prevalence of incontinence is doubled in women with gynaecological cancer. Although evidence supports pelvic floor muscle training as first-line treatment for urinary incontinence, it is not known whether this treatment is as effective for women following gynaecological cancer treatment. This will be the first randomised trial to address this vital clinical question using the novel method of telehealth. Who is it for? You may be eligible for this study if you are an adult female following cancer treatment (with and without radiotherapy) for Stage I, II or III uterine, cervical, fallopian tube, primary peritoneal or ovarian cancer or borderline ovarian tumour. Study details: Participants who consent to be contacted by the research team will receive a phone call to determine their eligibility. Those who are suitable for the study and consent to participate will complete a baseline assessment and record any bladder leakage experienced over a 7-day period using an ‘Accident Diary’. They will then be asked to participate in one of two different treatment groups 1) usual care or 2) pelvic floor physiotherapy delivered via video-calls. Each participant is put into a group by chance (randomly) using a computer program. Participants in both groups will be sent high quality bladder and bowel advice handouts. Group 1 will receive one, 15-minute telephone call with a female member of the research team. Group 2 will receive an intensive, supervised, 16-week telehealth-delivered pelvic floor muscle training program (including 8 video-consultations) from a female, qualified and experienced physiotherapist. They will also receive their own pelvic floor muscle biofeedback device. All participants will complete questionnaires at the end of 17 and 52 weeks from the commencement of the study. It is hoped that this research trial will demonstrate that a 16-week, physiotherapist-supervised, telehealth-delivered pelvic floor muscle training program can reduce urinary incontinence compared with usual care, in women following gynaecological cancer treatment.

Comparison of the Slider prong Continuous positive airway pressure (CPAP) interface to the standard Fisher and Paykel CPAP interface in terms of effectiveness for the management of neonatal respiratory distress syndrome, incidence of nasal trauma and acceptability to nursing staff and parents of babies with respiratory distress syndrome in the Mercy Womens Neonatal intensive care unit.