ANZCTR search results

This is a parallel, single-blinded, randomised clinical trial evaluating the effectiveness and cost-effectiveness of 8 weeks of treatment with a vaporised nicotine product (VNP) and liquid nicotine compared to traditional oral nicotine replacement therapy (NRT; gum or lozenge) for smoking cessation among low-socioeconomic smokers. We hypothesize a higher 6-month cessation rate among the VNP, compared with the NRT group.

Recurrent headache is a common, disabling condition affecting millions of Australians. TTH has a lifetime prevalence in the general population ranging between 30 and 78%. It affects approximately 1.4 billion people globally or 20.8% of the population. Headaches are a leading cause of lost work productivity, with reduced performance rather than absence from work being the main cause of lost productive time. Therefore, there would be considerable value in a simple, highly tolerable preventive therapy for the large number of people suffering from frequent TTH. This trial aims to assess a novel low-dose BP lowering combination in this regard.

This study will investigate the effectiveness of group-based Acceptance and Commitment Therapy (ACT) intervention in improving quality of life following treatment for early breast cancer. Who is it for? You may be eligible to join this study if you are a woman aged 18 years or above and have completed primary treatment for early breast cancer within the last two years. What does this study involve? In this study, all participants will receive the ACT intervention condition in random order. Participant will be randomly allocated to one of the following combination of study conditions: 1) Group A will first receive the ACT intervention program, then receive a breast cancer education (BCE) control program; 2) Group B will first receive the BCE control program, then cross-over to receive the ACT intervention program; or 3) Group W will first be on a 6-week wait-list during which participants receive neither programs, then they will receive the ACT intervention. As each study condition will be conducted weekly and will run for a 6-week period, with no allocated time interruption in between each condition, study duration is expected to be 12 weeks. In addition to attending group sessions, participation will also involve completing an ACT workbook. The workbook will guide participants through regular individual ACT practice outside group sessions. The ACT program will be delivered by an ACT-trained psychologist and will focus on providing participants with strategies based on the six core processes of ACT (Acceptance, Defusion, Self as Context, Values, Contact with the Present Moment, and Committed Action) aimed at enhancing participants' psychological flexibility and wellbeing. The BCE program will be facilitated by a trained breast care nurse and delivered by experts who will provide education relating to diet, physical activity, sexuality concerns, cancer biology, clinical physiology, relaxation techniques and sleep hygiene. At the beginning and end of each 6-week study condition period, questionnaires will be administered, blood and saliva samples will be collected, and blood pressure and resting heart rate will be measured. Participants will be followed-up at 6 and 12 months after the final session. Benefits of this study? Participating in this research has the potential to improve the quality of life of project participants and help them better manage anxieties related to fear of cancer recurrence. This study has been approved by the Human Research Ethics Committees of the Darling Downs Hospital and Health Services (DDHHS) and the University of Southern Queensland (USQ).

Many patients who require surgery on the shoulder experience significant post operative pain, particularly after their nerve block wears off. Despite the use of conventional analgesia many patients remain uncomfortable during this period. The aim of this project is to determine whether giving magnesium prior to surgery can improve this pain experience. The study proposes to give a single dose of magnesium to patients immediately prior to surgery and to assess their level of pain after surgery. This will involve the use of a subjective pain rating scale (1-10), and documentation of analgesic requirement. Patients will be randomly selected to receive either magnesium or placebo saline solution in order to assess the benefits of magnesium. Magnesium itself is a safe drug commonly used in clinical medicine for a number of different conditions.

A multicentre randomised controlled trial comparing outcomes for humeral shaft fractures (arm fractures) treated with and without an operation to 'fix' the bone (with a metal plate and screws or a rod versus treating with an arm brace). 200 patients will be randomised over 14 hospitals (100 to each treatment type) and followed up over one year to determine if there is any difference in outcome. The hypothesis is that those treated with surgery will have better outcomes. The primary outcomes is the difference between the groups for scores on the Disabilities of hand and shoulder survey at one year post injury. Other outcome measure will be fracture healing, pain and quality of life scores, complication rates and return to activity levels as well as a cost analysis of both treatment types.

The primary purpose of this trial is to evaluate the comparative accuracy of different scans and biopsy diagnostic techniques for low risk prostate cancer. Who is it for? You may be eligible to enroll in this trial if you are aged 40 to 75 years and have been diagnosed with low risk prostate cancer, and with a life expectancy of at least 10 years. Study details All participants enrolled in this trial will receive a 68Ga-HBED-CC PSMA PET/MRI of the prostate and pelvis, which involves injection of a radioactive substance (68Ga-HBED-CC PSMA) following by lying in the scanner for 1-2 hours. All participants will then receive a transperineal biopsy of the prostate. Participants who have lesions identified on the 68Ga-HBED-CC PSMA PET/MRI scan will receive a biopsy procedure targeting those lesions when they have transperineal biopsy of the prostate. Researchers will then complete genetic analysis on the previous biopsy sample. The results of the scanning techniques, the biopsy result and the genetic testing score will all be compared to determine the most accurate technique for reclassifying men previously diagnosed with low risk prostate cancer into higher risk categories.

Overview & Rationale: Borderline Personality Disorder (BPD) is a serious and highly prevalent (5.9%) psychiatric disorder. BPD sufferers experience severe emotional instability, social and occupational dysfunction, and engage in chronic self-mutilation and suicidal behaviours, with associated high levels of mortality, morbidity, and health service use. BPD patients are a complex group that are challenging to treat. Current psychological treatments are expensive and difficult for BPD patients to access, and there is currently no clearly designated pharmacotherapy. Underpinned by psychosocial causes, the pathogenesis of BPD is only now beginning to be understood. Childhood trauma is reported in most patients (>80%) and is linked to abnormalities in the development of the hypothalamus-pituitary-adrenal stress axis and, consequently, abnormalities in the hypothalamus-pituitary-gonadal axis. Both neuroendocrine axes have been reported as abnormal in BPD, indicating the neuroendocrine system as a potential therapeutic target for BPD symptoms. Significantly, cyclical fluctuations in ovarian hormones affect emotional and cognitive behaviours relevant to BPD. We propose to conduct a 12-week, double blind, placebo controlled two arm trial of i.) transdermal estradiol gel 2 pumps (1 pump =1.25mg gel = 0.75mg estradiol, total = 1.5mg daily estradiol) vs ii.) placebo inactive gel 2 pumps daily (in addition to treatment as usual), in a total of 72 women with BPD/CPTSD (48 for the estradiol arm and 24 for the placebo arm) over 12 weeks. Primary Aim: To determine whether estradiol is effective in treating symptoms of BPD/CPTSD. Secondary Aims: To determine if estradiol has effect on specific BPD/CPTSD symptom domains including: a) social - emotional regulation; b) cognition, including memory, decision making and executive functioning; c) concomitant mood and quality of life; and d) biological markers

For those with Multiple Sclerosis (MS), 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 MS, having already commenced a sister trial with participants with Acquired Brain Injury. 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 with this device. 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 MS. 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.

Infants are susceptible to a large number of illnesses and diseases. As a result, Australia has a strict protocol for immunising infants and young children at various ages. One of the few immunisations which is not mandatory for infants is the influenza vaccine. Influenza is often perceived as an 'adult' illness, however, as with many illnesses infants are even more susceptible than adults and it is recommended that both children and adults are immunised annually. The Aboriginal and Torres Strait Islander community in Victoria are considered a high-risk group for illnesses such as influenza and as a a result, the vaccine is offered for free for Indigenous infants and children and has been so since 2010. Unfortunately, the rate of immunisation is only around 2% which means many children are at risk of contracting this preventable disease. The aim of this project is to develop and test different messages for parents of Indigenous children to educate and encourage them to seek out the free flu vaccine for their infant/young child.

The harm that junk food marketing poses to children’s health has been acknowledged by leading health agencies, such as World Health Organization. Online marketing of foods to children is particularly pervasive yet relatively little is known about how this may affect children’s food preferences. The purpose of this experiment is to explore how children respond to online food marketing. It will investigate the marketing techniques used in branded online games, using a between subjects design, and will explore how this influences what they subsequently choose to eat. The key aims are to determine if food branded games can influence subsequent food choice and whether choice and consumption will vary across condition, indicating the ‘effectiveness’ of the employed marketing technique. To investigate this, children (N=150, age 7-12) are required for 25 minutes to complete some questionnaires, play a 4 minute online game, choose a snack from a selection of items and then have their height and weight measured. The results from the study will be used in a wider body of work (as part of an Australian Research Council project) which aims to inform future public policy decisions to further limit children’s exposure to unhealthy food marketing.