ANZCTR search results

Prostate cancer is the most common cancer in men, and the second leading cause of cancer deaths (25%) in Australia. There is a need for better treatment combined with reliable assessments of treatment effectiveness. The purpose of this study is to determine whether Photodynamic Therapy (PDT) is an effective and safe treatment option for patients with prostate cancer. Who is it for? You may be eligible for this study if you are an adult male with prostate cancer. Study details Participants in this study will receive one of two treatments, with the treatment decided by chance. The two treatments participants may receive are: 1. Photodynamic Therapy, which involves participants being given a chlorophyll-derived liquid food product which will help absorb light along with 25 min light therapy using a red-light laser that is delivered through a rectal probe. 2. The Photodynamic Therapy described above plus additional whole body red-light therapy, which involves lying in a red-light-bed for 25 min 4 hours after the PDT rectal laser therapy. These treatments will be provided to participants 6 times over a 9 week period. Participants will complete an assessment at baseline and at 12 weeks where they will provide a blood and urine sample, and have their prostate measured. It is hoped that this research will help determine whether Photodynamic Therapy is an effective and safe option for the treatment of prostate cancer.

The purpose of this trial is to assess the efficacy of cannabidiol (98% CBD) for sleep disturbances in healthy adults. This study will compare the botanical CBD with a placebo and evaluate its efficacy via the PROMIS sleep disturbance instrument. The study will take place in 4 sites; Brisbane, Sydney, Lismore and Melbourne. In total, the study will successfully enrol 438 participants. Eligible participants will be between 18 to 65 years old, considered to be generally healthy and self-reports sleep difficulty and quality. The trial will be 10 weeks, with an initial two-week titration period and a phone call one month after stopping medication. The study will involve a 15mg CBD per soft gelatin capsule or placebo capsule that is similar in appearance, smell and taste. The active product will contain hemp seed oil as the carrier and 0.5 mL of liquid encapsulted into a gelatin/ glycerin soft capsule. CBD will make up >98% of the total cannabinoids in the capsule. Participants will take 1 capsule after breakfast and 1 capsule 30 minutes before bed and build up to a tolerance/ maximum dose during the titration period with the maximum morning dose being 2 capsules and the maximum night dose being 8 capsules. After the titration period, the participants will stay on their maximum dose for 8 weeks or until they withdraw from the study. In total, the study should be 10 weeks in total with a one month follow up phone call after the ceasing the medication. The expected outcome is that a botanical CBD (98%) will significantly improve people's sleep who suffer from sleep disturbance more than the placebo.

Improving perinatal bereavement care after the loss of a baby is an urgent priority in Australia, and accessible perinatal bereavement care approaches that include early psychological support are required, Internet-based programs offer one solution to address this gap, particularly for primary care settings and those parents in rural Australian communities. The primary purpose of this trial is to evaluate the acceptability and efficacy of a new internet-delivered cognitive behaviour therapy (iCBT) support program in reducing emotional distress for parents who have experienced a stillbirth or neonatal death, compared with usual care. We hypothesise that participants who complete the online program “Living with Loss” will experience greater improvements in psychological distress and psychosocial health and wellbeing outcomes (e.g. anxiety, depression, decisional regret etc) than those in the usual care control group. It is also hypothesised that the Living with Loss” will be acceptable to participants with high rates of program satisfaction reported, and will be more cost-effective in improving psychosocial health and wellbeing outcomes than usual care alone.

The X-ACTA Cemented Short Stem is a highly polished, double tapered cemented stem that has been manufactured in wrought iron stainless steel, with a Polymethyl methacrylate (PMMA) distal centraliser. This unique design is suggested to correct stem positioning and provide uniform cement distribution. The aim of this investigation is to evaluate the radiological performance of the X-ACTA Short Cemented Stem device in patients following Total Hip Arthroplasty. The hypothesis for this study is that the X-ACTA cemented short stem is non-inferior to other commercially available cemented stems in terms of stability and degree of migration.

The problem: The high burden of asthma and chronic obstructive pulmonary disease (COPD) on individuals, the health care system and the community. The solution: The identification of high risk asthma/COPD and reduction in subsequent avoidable hospitalisations, through a focused approach on the prevention of frequent disease flare ups (exacerbations) and improved management of chronic and complex health conditions, associated with preventable factors. The strategy: 1.To improve the quality of primary health care delivered, reduce frequent flare ups (exacerbations) and avoidable hospitalisations. 2.To implement an electronic clinical audit process utilising electronic medical record data and patient reported outcomes, which is multidisciplinary, structured, evidence-based and embedded in practice. 3. To apply new technologies to enhance current technological capabilities, increase efficiency, maximise capacity and optimise current infrastructure. 4. To harness strategic, stakeholder partnerships to support long-term change

Up to 80% of people discharged from the ICU experience various physical, cognitive, and/or psychological complications and enduring impairment, termed ‘post intensive care syndrome’ (PICS). The prevalence and burden of PICS remains uncertain, and current interventions are not effective longer-term; further research into prevention, early diagnosis and intervention of this syndrome is considered internationally is a priority. The interlinked aims of this study are 1. To describe the predictors, correlates and prevalence of PICS, and 2. To use this information to develop screening, diagnostic and outcome measures for use in research and clinical practice.

This study aims to determine if there is any association between endometrial cystic spaces identified on ultrasound and the incidence of endometrial hyperplasia (abnormal uterine cell growth that may or may not become cancerous), and the incidence endometrial cancer in women with abnormal uterine bleeding. Who is it for? You may be eligible for this study if you are aged 30 or older, have been diagnosed with abnormal uterine bleeding and you have been referred to the Royal Women's Hospital (Melbourne) for a hysteroscopy dilatation and curettage (HDC) procedure, or an endometrial biopsy. Study details All participants who choose to enrol in this study will be asked to complete a 15 minute online health questionnaire, and undergo a transvaginal pelvic ultrasound to determine the presence or absence of endometrial cysts. The ultrasound scan will be performed or directly supervised by a senior ultrasound specialist. Where possible this visit will be timed to occur on the same day as the hysteroscopy to avoid a further trip to hospital. It is hoped this research may improve health outcomes by allowing for early identification of endometrial hyperplasia or cancer, which could have additional positive impacts on the future management of women with endometrial cysts.

The purpose of this study is to determine if the gas-sensing capsule can be used to identify increased numbers and a change of the composition of microbiota or microorganisms in the gut (which can be a problem), and to identify people who are likely to respond to therapy. This study aims to compare the data collected from the Atmo gas capsule with conventional breath testing for bacterial imbalance/overgrowth. The results from the study may help show that the capsule is better than either a breath test, or taking samples through endoscopy for determining if someone has Irritable Bowel Syndrome (IBS) or Small Intestinal Bacterial Overgrowth (SIBO), and how likely they are to respond to therapy.

This project is a retrospective case-series of patients who have undergone periacetabular osteotomy with a single orthopaedic surgeon. All surgical patients performed at one institution received i-Factor during their surgery, surgical patients performed at other institution received standard care. The use of i-Factor was standard clinical practice for Mr Balakumar at the time of its use. The primary aim of this project is to compare bone healing timeframes between this two groups of patients. The secondary aim of this project is to compare surgical complications (for example infection rates) between these two groups. Medical notes and standard post-operative X-Rays will be reviewed.

This is an open label study in patients: previously treated with intravitreal ranibizumab or aflibercept for at least six months; on a 4 to 8 weekly injection regimen with at least one failed attempt to extend their treatment interval; who have persistent retinal fluid at their current treatment interval or have recurrent retinal fluid if the treatment interval is extended. Eligible participants will switch their study eye treatment to bevacizumab and have three, monthly, loading doses before commencing a treat and extend regimen where the treatment interval will be extended based on the investigators assessment of disease activity and predetermined criteria normally used in clinical practice. The study will run for 18 months: Six months recruitment with a 12 month treatment period) Following enrolment participants will be evaluated monthly. At each follow up they will have a clinical ophthalmic examination including intra-ocular pressure measurement, assessment of best corrected visual acuity, macular OCT and fundus photography. A quality of life questionnaire (NEI VQF-25) will be completed at baseline and at study. completion. Fluorescein angiography will be performed when clinically indicated.