ANZCTR search results

A vaginal vault haematoma formation is a recognised complication of a hysterectomy and can be associated with post-operative infection, bleeding, pain, discharge, ileus, prolonged hospital stay or readmission, or even return to theatre. The aim of this randomised controlled trial is to evaluate the rate of sonographically proven vaginal vault haemotoma following a total laparoscopic hysterectomy with and without the use of TISSEEL. As secondary endpoints the rate of complications associated with a vaginal vault haemotoma post-TLH will be assessed including: re-admission, blood transfusion, vault infection requiring antibiotics, and return to theatre. Participants will include females aged 18 and over undergoing a total laparoscopic hysterectomy for benign pathology on theatre lists at the Gold Coast University Hospital under the supervision of the Gynaecology Director. After consenting, they will be randomly allocated with a 1:1 ratio. If the Director deems the use of TISSEEL is necessary due to the clinical situation then the participants will be excluded from the trial. Participants will be followed up with a phone call questionnaire regarding complications and undergo an ultrasound scan to evaluate for a vault haematoma.

This trial is evaluating the implementation of the Melanoma Care Program intervention addressing fear of cancer recurrence in routine clinical settings at both Melanoma Institute Australia and Royal Prince Alfred Hospital. Who is it for? You may be eligible for this trial if you are aged over 18 years and have a diagnosis of stage 0, I or II melanoma. Study details Based on initial screening of fear of cancer recurrence, participants will be allocated to an intervention arm based on their needs. They will receive a mix of standard care (usual patient education and support), access to the Melanoma: Questions and Answers booklet, and a variable number of psychotherapeutic telehealth sessions. They will then be asked to complete a number of questionnaires assessing their knowledge of melanoma, mental health-related outcomes and response to the program. Information from this study will be used to potentially implement the Melanoma Care Program into routine clinical practice in future.

AIM: The aim of this clinical trial is to investigate how different doses of aerobic exercise training affect cardiorespiratory fitness, brain blood flow, brain volume, and cognitive function in middle-aged (45-65 y) adults, and to translate this new knowledge into more individualised exercise prescriptions to better prevent the development of dementia. HYPOTHESIS: High-intensity interval training will improve cardiorespiratory fitness, brain blood flow, brain volume, and cognitive function to a greater extent than moderate-intensity continuous training. METHODS: In a single-blind, randomised-controlled trial, the study will follow a two-group parallel design. Groups will be matched on fitness, age, and sex, and participants will be assigned to one of two 12-week, work-matched, aerobic exercise interventions: 1) moderate-intensity continuous training (MICT; n =35), or 2) high-intensity interval training (HIIT; n = 35). These exercise modes were chosen as a means to investigate the most effective ‘dose’ of aerobic exercise training to improve fitness, brain blood flow, brain volume, and cognitive function. Briefly, the experimental protocol will consist of 1) screening, familiarisation, and baseline testing, 2) a 12-week aerobic exercise intervention with testing at the 6-week mark, 3) post-training testing, and 4) 12-week follow up testing.

Title: Feasibility of Instituting Graduated High intensity Training for Parkinson Disease (FIGHT-PD). Study one in a series of studies aimed at evaluating non-contact boxing exercise as an intervention for Parkinson Disease. Study objectives: The primary objective is to determine the feasibility of a non-contact boxing exercise program for PD patients. Feasibility will be measured by evaluating the recruitment and retention of subjects with PD, and then evaluating the safety and tolerability of increasingly intensive workouts, measuring perceived levels of physical and mental exertion, correlating this with heart rate and analyzing side effects or problems. A supervised exercise program of non-contact boxing utilizing a boxing machine, with instruction by a professional boxing coach and neurological physiotherapist, and oversight by exercise physiologists and a neurologist. The program includes a detailed warm up to sequentially prepare the upper body, trunk, then legs with movements, stretching and balance exercises, and then a series of aerobic exercise. This is followed by rounds of boxing using standardised sequences of punches and body movements utilising the machine. The 15 week program will include three, five weeks blocks. The first block will focus on development of boxing technique, the second on escalating workouts of increasing intensity, and the third will add additional cognitive challenges to the physical workout. Three workouts per week will be performed, ranging from 45-60 minutes duration. Each five week block will include a week with non-workout sessions allocated for assessments and review. Subjects will wear portable heart rate (Polar) monitors that will quantify heart rate during each workout. Subjects will rate their perceived level of physical and mental exertion at multiple points during the workout. Subjects will complete a questionnaire in a logbook at the end of each workout, assessing the tolerability of each workout and documenting the development of any musculoskeletal pain or change in PD symptoms.

We hypothesise that THC will influence anxiety, autism and psychosis proneness relative to both before drug and to CBD, and that these effects will correlate with THC levels in blood but not saliva or urine. This will be tested by administering THC or CBD to healthy volunteers once only.

This trial is investigating the impact of methadone rotation for management of cancer induced bone pain (CIBP), in comparison with other opioid rotation. Who is it for? You may be eligible for this study if you are aged at least 18 years old, have a diagnosis of solid tumour or haematological cancer with a predicted prognosis of greater than 8 weeks, have a diagnosis of CIBP and are currently taking a strong opioid (morphine, oxycodone or hydromorphone). Study details Participants will be randomly allocated (by chance) to one of two arms: Arm A: Methadone rotation for 14 days Arm B: Rotation to another strong opioid (morphine, oxycodone or hydromorphone) for 14 days All participants will be asked to complete questionnaires throughout the study assessing their pain levels. Information from this study will help investigators examine the efficacy and tolerability of methadone for providing pain relief to those with CIBP.

Acute pancreatitis can be complicated by local fluid collections in approximately 40% of cases. Sometimes these fluid collections contain necrotic debris (dead tissue), and are called walled off necrosis (WON). This can result in infection, pain, fevers or gastrointestinal upset. It can be life threatening without appropriate medical therapy. The primary treatment of pancreatic walled off necrosis is drainage of this collection into the stomach or duodenum (first part of the small bowel) using a stent inserted under endoscopic ultrasound (EUS) guidance. This study is being performed to assess the safety and effectiveness of a recently available TGA approved stent called the Hot SPAXUS stent. The Hot SPAXUS stent has been used for drainage of pancreatic fluid collections in the United States of America, Korea and parts of Europe. This research project is investigating its role in managing pancreatic WON collections in Australia, to provide further information on its use.

This study will test the efficacy of a novel therapeutic exercise machine at improving symptoms of Parkinson's disease and their neurological underpinnings in patients with Parkinson's Disease and Atypical Parkinsonism. The Reviver exercise machine simultaneously stimulates the vestibular system whilst inducing isometric exercise. We hypothesise that a 12 week intervention on the Reviver will improve balance, mobility, and other motor symptoms of Parkinson's Disease.

This study will develop methods for Australian education systems to help identify young people (aged 9-17) who are struggling with emotional disorders. We will develop an initial screening tool containing measures that will assess emotional disorders, as well as interpersonal relations with family and friends and lifestyle habits, which will be tested in a total of 100 schools. This initial screening tool will be delivered to an "immediate screening" group (n=50 schools) and tested in students in Year 4 through to Year 11 across different school sectors, socioeconomic levels, ages, cultural groups, as well as rural and urban schools. Students identified from their responses to the screener as being at-risk of emotional disorders will be flagged with the school and referred to appropriate pathways to care that we will have identified through input and feedback from students, parents, educators and policy-makers. To validate our screening tool, we will ask students and parents to complete clinical interviews and measures of prior help-seeking and quality of life, and also ask for access to school data on student attendance and academic performance. Using these validators, we will develop from the initial screener a shortened version that has as few items as possible, while being sensitive enough to accurately detect at-risk students. This final screener will be delivered to those in the "immediate screening" group 9 months after the initial screener. It will also be tested using a comparison "delayed screening" group (n=50 schools) to determine whether the screening and care process leads to a greater number of young people with emotional disorders getting the help that they need. Finally, we will measure costs and benefits and will conduct economic modelling to estimate how much these processes can save the Australian community. We will also assess the acceptability of school-based screening from the perspectives of students, parents and schools.

Paradigm Biopharmaceuticals Ltd (Paradigm) is evaluating Pentosan Polysulfate Sodium (PPS) for the treatment of symptoms (pain and diminished function) and mitigation of underlying tissue degeneration associated with osteoarthritis (OA) of the knee.. This study is designed to measure synovial fluid biomarkers indicative of the inflammation and cartilage degradation present in symptomatic knee OA, and to determine quantitative changes in individual biomarkers resulting from treatment with PPS. The results from this study will enhance understanding of the PPS mechanism of action and will provide information on the effect of PPS on joint inflammation and on the processes responsible for OA disease progression.