ANZCTR search results

The primary purpose of this trial is to evaluate the safety and efficacy of durvalumab for the treatment of advanced endometrial cancer. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with advanced endometrial carcinoma which is suitable for chemotherapy. Study details All participants enrolled in this trial will receive an intravenous dose of durvalumab once every 28 days until the cancer is seen to have progressed, or until treatment side effects become intolerable. Participants will undergo continuous monitoring for side effects throughout treatment, as well as completing questionnaires and blood tests every four weeks, and CT scans every 8 to 12 weeks for the duration of treatment. It is hoped that this trial will provide information on whether durvalumab is safe and effective for the treatment of advanced endometrial cancer.

SUMMARY This study aims to compare the current standard-of-treatment Not-for-Resuscitation (NFR) form with the soon to be introduced Goals-of-Care (GOC) form. The purpose of these two forms is to help guide the clinical staff in defining the overarching treatment goals for hospitalised patients, especially potential limitations-in-therapy, but with some fundamental and important differences. The overall design is a quasi-experimental pre and post study over two 6-month periods that will be conducted on the predominately medical and oncological wards of 71, 72 and 35 at St John of God Subiaco Hospital. These wards where specifically chosen because they incorporate healthcare disciplines with a higher burden of advanced disease states (e.g. cancer) and frailty (e.g. old age) requiring a greater awareness of end-of-life issues. The first six-month period will be considered the control period and will investigate the current standard-of-practice NFR form. The second 6-month period will be considered the intervention and investigate the new GOC form. Within each research period the investigators will collect both qualitative (patient and clinical staff surveys and interviews) and quantitative (categorical and continuous variables) data. Before the introduction of the intervention GOC period an education programme about the new form will be undertaken with the relevant clinical staff. The hypothesis of this study is that the new GOC form will lead to an earlier, greater and more controlled delineation of appropriate patient treatment plans by primary care teams at the expense of an increased clinical staff workload. IMPORTANT PLANNED DIFFERENCES BETWEEN THE USE OF GOALS-OF-CARE & NOT-FOR-RESUSCITATION FORMS a) The GOC care form has four clinical pathways compared to the two clinical pathways on the NFR form. b) The GOC form has to be completed for all patients, where the NFR form is completed in an ad-hoc manner. Where patients are clearly for full resuscitation (GOC category A), then any doctor can complete the GOC form without prior patient discussion buy “ticking” Category A and signing and dating the form. All other categories require consultant input. c) The investigators are designating that the GOC form must be completed within 48 hours of admission. There is not designation of timing for the NFR form

Preterm birth is a leading cause of death and long-term neurological disability for infants, with PPROM accounting for over one-third of preterm births. Apart from perinatal morbidity, there is also maternal morbidity from PPROM related to infection, such as chorioamnionitis. This trial aims to provide evidence demonstrating that probiotic therapy in women with PPROM prolongs pregnancy duration, thereby delaying preterm birth and improving neonatal outcomes. Delaying preterm birth will have a major impact on clinical practice and benefit the health of infants locally, nationally and internationally. New molecular techniques using DNA sequencing methods are increasing knowledge and understanding of the organisms and microbiome of women with PPROM and preterm birth. Biospecimens collected in the pilot trial aim to demonstrate the change in the intrauterine and neonatal microbiome to provide more information on the beneficial effects of probiotics for women at risk of preterm birth. This will build on the emerging medical literature on the changes in the intrauterine and vaginal biomes of the pregnant woman and the gastrointestinal biome of the baby associated with preterm birth, antibiotics and probiotics. The changes in the maternal and neonatal biome for women with PPROM may assist in understanding the causation of PPROM and preterm birth.

In this study we aim to measure the effectiveness of a series of interactive stress-reduction modules developed into an online platform by the funder Medibio. The Medibio ‘Unwind’ Stress Reduction Tool version 1.0 is a newly developed program of seven (approximately) 20 - 30 minute modules which provides information and strategies to alleviate the mental, physical and emotional effects of stress using the latest resources and treatment strategies from the field of psychology.

Previous studies suggest that tafenoquine is an effective antimalarial, acting against both Plasmodium liver stages and subsequent asexual blood stages, although it is difficult to determine the contribution of each activity to the overall prophylatic effect of tafenoquine. Both activites would be important as any parasites that escape killing in the liver would need to be killed at the subsequent asexual blood stage. Furthermore, there was a paucity of observed P. falciparumin fections in non-immune participants during Study 033 (Nasveld 2010). Therefore, confirmation of blood parasite activity separate to any liver activity is warranted in a non-immune population to confirm the findings of the activity tafenoquine demonstrated in semi-immune participants in Africa (Dow 2015). This Phase Ib study will evaluate the prophylatic activity of a multiple dose regime of tafenoquine against challenge with P. falciparum asexual blood stage parasites in nonimmune participants. The Induced Blood Stage Malaria (IBSM) challenge model in which healthy non-immune participants are administered ~2,800 viable P. falciparum parasites within red blood cells is well suited to test this hypothesis. This study will help identify if a single dose of tafenoquine following three loading doses can prevent symptomatic blood stage infection following P. falciparum exposure. This study will also enable characterisation of the exposure-response relationship for tafenoquine and will also provide data regarding the safety and tolerability of tafenoquine in a controlled disease-like setting.

The aim of this study is to evaluate the effect of Surgicel use in parotid surgery on the incidence of post-operative sialocele formation. Who is it for? You may be eligible to join this study if you are aged 18-90 years and are scheduled to undergo a parotidectomy. Study details Patients will be randomized (allocated by chance) to use of Surgicel (a type of oxidised regenerated cellulose) or no use of Surgicel in the control arm. Surgicel is used after parotidectomy in the wound bed to aid in haemostasis and to protect the facial nerve. Surgicel Original Haemostat (Ethicon) 0.5x2inch will be placed in the wound bed after parotidectomy by the treating surgeon prior to closing. The primary outcome will be formation of a sialocele post-operatively, quantified on ultrasound if a sialocele is clinically detected at the one week follow up. Secondary outcomes examined will include drain output, length of hospital stay and other post-operative complications.

A comparison of the Tape Locking Screw (TLS) in Anterior Cruciate Ligament (ACL) reconstruction technique and conventional Anterior Cruciate Ligament reconstruction surgical technique. Hypothesis: The TLS ACL reconstruction technique has superior post-operative outcomes compared to conventional ACL reconstruction techniques. a) The single (semitendinosus) tendon harvest has less functional detriment compared with the double (semitendinosus/ gracillus) tendon harvest b) Retrograde tunnelling has superior post-operative outcomes compared to traditional anterograde tunnelling c) TLS fixation with 500N of pre-loading has better functional outcomes compared to a non-tensioned hamstring tendon graft

Stress urinary incontinence (SUI) is defined as urinary leakage with activities that increase intra-abdominal pressure (e.g. cough, sneeze, laugh and exercise). SUI is a prevalent condition with high burden of suffering. Management of stress urinary incontinence includes both conservative therapy and more invasive surgical intervention. The current main conservative approach to treatment of stress urinary incontinence is pelvic floor muscle therapy (PMFT). PFMT improves stress incontinence symptoms by 56 %. However, pelvic floor muscle therapy has poor long term compliance and women then choose more invasive surgical treatment. Fractionated CO2 laser has been established for use in dermatological and dental applications to stimulate collagen neogenesis and skin and tissue remodeling. Recently, use of fractionated CO2 laser has been introduced and has been successfully used for vulvovaginal atrophy. The rationale for the use of CO2 laser for treatment of SUI is to trigger tissue remodeling and regeneration to improve urethral support. Women may prefer to vaginal CO2 laser treatment as a conservative option to treat SUI over surgical intervention due to the morbidity of surgical intervention. The aim of this study is to evaluate the use of fractionated CO2 laser treatment in combination with physiotherapy as a potential treatment for women with stress urinary incontinence over physiotherapy alone.

For those with severe acquired brain injury, weight-bearing exercise can pose many challenges for both patients and their therapists. Due to physical demands and safety issues, those with severe mobility impairment are often denied the opportunity for weight bearing, task specific training. This type of training is essential if the recovery of functional abilities such as independent transfers and mobility are to be achieved. Advances in robotic technologies have led to the development of wearable lower body exoskeletons. These can be used to assist sit to stand, weight bearing activities and gait. This research team is in the fortunate position to be provided access to an exoskeleton (HELLEN) to research its applicability in people with acquired brain injuries. This device has the potential to assist therapists to increase patient opportunities for weight bearing training at higher intensity and dosage to maximise their potential for recovery. This is ground breaking research with no previously published literature on this topic. Our aim is to examine the potential health benefits and feasibility of using a lower limb exoskeleton as an adjunct tool for neurorehabilitation in those with severe mobility impairment due to acquired brain injury. This is a Phase I, wait-list controlled trial with 20 participants. Baseline measurements will be taken on enrolment into the study followed by a 12week waitlist period. They will then receive 12 weeks of intervention, provided by a physiotherapist (Nicola Postol). This will involve two 1 hour sessions of individualised upright weight-bearing exercise facilitated by HELLEN, per week. Participants will be provided with a home exercise program, updated throughout the trial as required. Reassessment will occur after 6 and 12 weeks of intervention and after 12 weeks follow-up and will comprise of a battery of impairment, function and quality of life measures.

This was the first study to investigate empirically the impact of the online melanoma awareness video, ‘Dear 16-year-old me’, on sun protection intentions and related cognitive processes in young adults aged 17-30. We examined changes in perceived threat, skin cancer fear, and intention to participate in a variety of sun protection behaviors after exposure to ‘Dear 16-year-old me’, the personal risk for melanoma questionnaire (PRMQ), or an informational control condition. It was anticipated that: (1) participants exposed to ‘Dear 16-year-old me’ or the PRMQ would demonstrate significant improvements in perceived threat, skin cancer fear, and sun protection intentions post-intervention, (2) participants in the control condition would not demonstrate any significant changes in perceived threat, skin cancer fear, or sun protection intentions post-intervention, (3) all significant effects would be maintained two weeks later at follow-up. A mixed within-between subjects design was used. Participants were randomly allocated to one of three experimental conditions: ‘Dear 16-year-old me’, PRMQ, control) and completed an online questionnaire at three time points (baseline, post-intervention, two-week follow-up).Data were obtained from 222 participants (158 female) at baseline and 187 at follow-up. There was a significant interaction between group and time for intended sun protection behaviors and perceived threat, with participants exposed to ‘Dear-16-year-old me’ reporting the greatest improvements. Heightened perceptions of threat among participants exposed to ‘Dear 16-year-old me’ were maintained at follow-up, although increased levels of skin cancer fear were not. Sun protection intentions increased across all groups over time, but this increase was significantly greater in the intervention groups than the control group. The results suggest that ‘Dear 16-year-old me’ is a promising intervention for reducing skin cancer risk among young adults. The study findings support the assertion that providing people with narrative evidence from other “real” people can be an effective strategy to increase perceptions of personal health risk and encourage health protective behavior.