ANZCTR search results

Purpose The purpose of this study is to describe the safety of treatment with the study drug (BTX 1503 5% Solution) with twice daily dosing in subjects with acne vulgaris. The study drug’s effect on acne vulgaris will be evaluated. Study participants Patients with acne vulgaris aged between 18 and 65 years, inclusive, will participate. Experimental Treatment The study will investigate 3mL of BTX 1503 5% Solution applied twice daily to the face for 28 days. The study consists of a screening visit (up to 14 days before receiving study treatment) and an enrolment visit initially. On Day 7, a call will be made to each participant to ensure that they continue with dosing per instructions. There is a visit on Day 14 during the 28 day dosing period. Participants will return to the clinic on Day 28 for safety assessments. There is a follow up visit on Day 35. The maximum study duration for any participant will be a total of up to 49 days; screening period (up to 14 days), 28 days of treatment, and 1 week of follow-up.

The purpose of this physiology study is to determine the mechanisms through which Abdominal Functional Electrical Stimulation (Abdominal FES) improves respiratory function. This will be achieved by measuring a range of respiratory outcome measures with 15 tetraplegic participants, both with and without Abdominal FES, and before and after four weeks of Abdominal FES training.

Aim The aim of this non-inferiority randomised controlled trial is to investigate a regional technique that is as efficacious in analgesia as paravertebral block (PVB) and thoracic epidural analgesia (TEA) for open thoracic surgery using postero-lateral thoracotomy incision, but less invasive and easier to perform. Hypothesis We hypothesise that Serratus Anterior Plane Block (SAPB) catheter provides non-inferior analgesia compared to surgically placed Paravertebral Block (sPVB) catheter in open postero-lateral thoracotomy, with the largest clinically acceptable difference of 150mcg fentanyl in first 24h post operatively. Specific objectives 1. To demonstrate that analgesic effects of SAPB catheter is not inferior to surgically placed PVB catheter in open postero-lateral thoracotomy 2. To demonstrate that SAPB is a minimally invasive, safe and easy to perform alternative to PVB Method This trial will be a single centre non-inferiority, pragmatic, randomised controlled trial (RCT) with 2 parallel groups and 1:1 allocation comparing efficacy of analgesia of SAPB catheters to sPVB catheters for elective open postero-lateral thoracotomy. Significance Open thoracotomy is one of the most painful surgical incisions. Effective analgesia is imperative to good postoperative outcomes but it is difficult to achieve. A multitude of regional techniques have been developed however no one technique is safe and efficacious for all patients. The two current gold standard of post thoracotomy analgesia, PVB and TEA, are associated with significant barriers including side effects, complications, contra-indications and technical challenges. SAPB is a relatively new but promising technique that in healthy volunteers and cadaveric models was able to achieve paraesthesia of the ipsilateral hemithorax with few side effects. However the clinical efficacy of SAPB is not well established. SAPB can potentially provide similar analgesia to PVB and TEA for thoracic surgery but with improved safety profile and easier learning curve; this would represent a significant advancement in post thoracotomy analgesia. Likely benefits An effective yet minimally invasive regional technique with few side effects will be a safer alternative to thoracic epidurals and paravertebrals for thoracic surgery. Furthermore it may be particularly useful in ambulatory surgery and as a rescue technique.

The primary purpose of this study is to evaluate whether the presence of circulating tumour DNA (ctDNA) in a patient's blood following surgery or chemotherapy for ovarian cancer, is associated with cancer recurrence. Who is it for? You may be eligible to enroll in this study if you are aged 18 or over and have stage I-IV curatively resected high grade serous, endometrioid and clear cell ovarian, fallopian tube or primary peritoneal cancer or ovarian carcinosarcoma for which you are scheduled to commence neoadjuvant or adjuvant chemotherapy. All patients enrolled in this study will have up to five blood samples collected over 6-8 months, followed by a clinical follow up every 3 months for 2 years following completion of chemotherapy. Your treating clinician may also decide to continue with further follow-up. It is hoped that the findings from this trial will demonstrate an association between ctDNA detection in the patients blood following surgery and chemotherapy, with ovarian cancer recurrence. This would allow real-time testing of the benefit of adjuvant chemotherapy by assessing ctDNA.

Adolescents diagnosed with ASD experience persisting deficits in social communication and social interaction across multiple contexts. Contrary to popular belief many children with ASD have insight into their impairments and accurately perceive their social and communication abilities. They experience high levels of social anxiety, loneliness and isolation, despite a strong desire for friends. It is likely that many of these adolescents have much to gain from social skills training. KONTAKT is a manualized Social Skills Training Group (SSTG) program designed for children and adolescents with ASD which aims to improve communication, social interaction skills, reduce the severity of ASD symptoms, improve the ability to empathise and adapt in a group setting. A large randomized controlled trial in Sweden found that adolescents who participated in KONTAKT demonstrated improvements in social skills, behaviour, reduced stress and improved overall functioning as reported by parents immediately following and at three months after the program. However, social skills are at least in part influenced by social cultural contexts and there is a need to understand the feasibility, acceptability and effectiveness of KONTAKT in an Australian context. The aim of the current project is to develop and evaluate the effectiveness of a social skills group training intervention, KONTAKT, for Australian adolescents with ASD. In meeting this overall aim this research will be conducted in four phases, commencing with a needs assessment. Phase two will involve the translation and modification of the original KONTAKT manual, and child and parent workbooks from Swedish to Australian English and to the Australian context, inclusive of appropriate homework. Following pilot testing, evaluating the clinical feasibility and acceptability of KONTAKT Australia, phase four will examine the efficacy of the KONTAKT Australia in a two armed randomized controlled trial in a sample of adolescents with ASD.

This study will investigate the use of Gallium 68 Prostate Specific Membrane Antigen (PSMA) positron emission tomography (PET) scans in the treatment of metastatic prostate cancer. Who is it for? You may be eligible to join this study if you are Male, aged 18 years or above, have a pathologically confirmed adenocarcinoma of the prostate that has metastasised. Study details There are two cohorts under investigation: one group who have castrate sensitive metastatic prostate cancer commencing androgen deprivation therapy for clinical reasons while the other has castrate resistant metastatic prostate cancer, who are commencing androgen blockage therapy (Abiraterone or Enzalutamide) for clinical reasons. Participants will receive a GaPSMA PET scan, free of charge. If the GaPSMA PET scan detects any cancer, the participant will continue with study. If the GaPSMA PET scan does not detect any cancer, then the participant is withdrawn from the study. Irrespective of whether or not the GaPSMA PET scan detects any cancer, the participant will receive clinical treatment as indicated. The eligible participant will return for follow-up PSMA PET scans at days 9, 18 and 28. The participant will continue with ADT as clinically required. Clinical information and imaging results will be collected at these times points (baseline, Days 9, 18 and 28). The findings of the study will enable clinicians to better plan for the treatment of metastatic prostate cancer, particularly with the use of treatment that target PSMA cancer sites.

This study aims to evaluate the effectiveness of a 6- week comprehensive supervised pre-surgical exercise program in prostate cancer patients scheduled for prostatectomy. Who is it for? You may be eligible to join this study if you are a male aged between 45 and 80 years of age and have been diagnosed with localised prostate cancer with at least seven weeks to until scheduled surgery date. Study details Study participants will be allocated by chance to one of the two groups. First group will receive a 6- week comprehensive supervised pre-surgical exercise program consisting of progressive resistance and aerobic exercise. Second group will receive usual care during the pre-surgery period along with information on performing exercises on the trunk stabilising muscles similar to the exercise intervention. This group will be provided an option to partake in the exercise intervention at completion of 6 weeks post-surgery assessments. Testing will be conducted at baseline, pre-surgery, 6 weeks post- surgery (6PS), and 12 weeks post-surgery (12PS). In addition, a 24-hr pad test will be undertaken after discharge from hospital. This research is a critical step in a series of studies required to determine the most effective and efficient ways to maximize prostate cancer patient health and therefore lay the foundation for future research.

Exercise is well known to induce multiple physical and psychological benefits, although the nature of these benefits is dependent on the type of exercise performed. For instance, resistance training can increase muscle strength and mass, while endurance exercise can enhance the ability and efficiency to use energy so that exercise can be performed at higher intensities or longer durations. During and immediately after exercise, a multitude of factors are released from skeletal muscle into the circulating blood. These exercise released biochemical components are termed ‘exerkines’. The presence of exerkines after exercise has been shown to be determined by the mode of exercise (i.e., resistance versus endurance). Whether exercise training can modulate the resting and post-exercise profile of exerkines has yet to be determined. Furthermore, no studies to date have investigated the effect of the acute post-exercise exerkine response on the ability of muscle to recovery and repair following itself. Thus, the aims of this study are to: 1. Characterize the exerkine expression profile present in serum of well-trained endurance athletes, strength athletes, and untrained individuals at rest and post-exercise. 2. Investigate the effect of resting serum from healthy untrained and trained individuals on muscle cell recovery and repair processes in vitro.

Glycogenic hepatopathy is an uncommon condition causing painful liver enlargement, impaired liver function and in the long term, may cause irreversible liver fibrosis in young individuals with type 1 diabetes. We wish to study whether there may be an underlying genetic cause which increases the risk for people to develop this condition. Glycogenic hepatopathy is thought to occur when there are concomitant high blood glucose levels and elevated insulin levels, and may be associated with elevated serum lactate levels. This triad contributes to increased liver glycogen storage ultimately culminating in liver damage. Excess hepatic glycogen storage is also characterstic of glycogen storage diseases, which are a group of heritable conditions where storage of glucose or release of glucose from storage does not occur normally, and can cause enlargement of the liver similar to glycogenic hepatopathy. People who have glycogen storage diseases typically have a mutation (change) in both copies of the causative gene. However, we are addressing the question of whether having type 1 diabetes with only one copy of the mutation for glycogen storage diseases (heterozygosity) is sufficient to precipitate abnormal glucose storage or release, resulting in the development of glycogenic hepatopathy. In support of our hypothesis, strict blood glucose control reverses glycogenic hepatopathy. This pilot study will help clarify whether genetic sequencing for mutations which cause glycogen storage disorders can identify young people with type 1 diabetes at risk of glycogenic hepatopathy. This will enable us to alter clinical practice by facilitating genetic counselling of these patients on the particular importance of tight blood glucose control in their case and make diagnosis of this disorder less invasive. Indeed, currently, a definitive diagnosis of glycogenic hepatopathy can only be made by liver biopsy. This may be hazardous particularly in young children, a common time when the disorder first presents. Determining whether there is a genetic mutation associated with glycogenic hepatopathy may enable diagnosis to be made without having to perform a liver biopsy.

Wearable activity trackers are increasingly being utilised by consumers in daily life. It is unknown if use of these more sophisticated devices leads to improved physical activity outcomes. The aim of the current study is to evaluate physical activity outcomes in healthy adults undertaking a health and lifestyle challenge called the Stepathlon, which is a 100-day event undertaken by adult employees in workplaces around the world. In the current study, a propensity score weighted analysis approach will be used to compare physical activity outcomes in users of wearable trackers compared to participants in Stepathlon who do not use one of these trackers, and instead choose to use a pedometer, which is an older technology.