ANZCTR search results

The primary purpose of this trial is to evaluate the efficacy of an internet program, iAdapt for depression and anxiety in men who are living with HIV. Who is it for? You may be eligible to participate in this study if you are aged 18 or over, suffer from anxiety or depression and have a diagnosis of HIV. Study details All participants enrolled in this study will be randomly allocated (by chance) to receive the iAdapt program soon after enrolment or 12 weeks later. The iAdapt program is a 12 week online program which involves learning about tackling depression with a form of therapy called Cognitive Behavioural Therapy (CBT). CBT looks at improving how we manage our thoughts, actions and feelings. There are 6 lessons, each one taking up to an hour to complete, with the recommendation to do a new lesson every 1 – 2 weeks. There will also then be additional activities to do for around 3 hours per week. Participants will complete a number of important questionnaires to assess their depression and anxiety levels among other psychological factors, at the beginning of the program, mid-way through, then again at the end of the program and the last time is 3 months after finishing the program. Participants will also be asked to complete a short questionnaire before every lesson. It is hoped that the findings of this trial will provide information regarding the efficacy of the iAdapt program in reducing depression and anxiety for men who are living with HIV

The study will be a randomised, placebo-controlled, double-blind parallelgroup trial over a 24 week period. The primary objective is to examine the clinical efficacy of the add-on treatment of Metformin XR for people newly commenced on clozapine. Specifically, it is hypothesised, that participants allocated to the active arm (2000mg once daily) Metformin XR will have lower mean body weight at week 24 compared to individuals taking placebo, adjusted for baseline body weight (ANCOVA).

This study aims to compare the efficacy of three methods of regional anaesthesia in shoulder arthroscopy, as well as to compare patient satisfaction with the three methods. People undergoing shoulder arthroscopy will be invited to take part in the trial and will be randomised to one of three groups if they accept. The three groups comprise an Interscalene block, inserted by an anaesthetist; a combined suprascapular & axillary nerve block inserted by an anaesthetist;and the combined block inserted by the treating surgeon during the procedure. Outcomes examined by this study include pain levels after the operation (in the recovery room, the next day & out to a week later), how much pain relieving medication was used and how satisfied the participants were with their experience of regional anaesthesia (through use of a survey form). The findings of this study will be utilised to guide clinical practice in the use of regional anaesthesia in arthroscopic shoulder procedures.

Exercise Physiology (EP) based physical activity interventions for older adults have been shown to be effective; however, no studies have investigated whether EP in residential aged care facilities leads to maintenance or improvement in physical or cognitive function. The organisation concerned is currently running a funded exercise program with the intention of improving the cognitive and physical functionality of Residents. Exercise Physiologists (EPs) specialise in clinical exercise interventions for persons at high risk of developing, or with existing, chronic and complex medical conditions and injuries. As a relatively new profession, EPs are developing ways to work effectively with the specific needs of older people, including those living in residential aged care. The organisation has been running an EP-led student clinic for residents in one facility, including delivering services to people with high-level needs in a secure dementia unit. This work has provided initial evidence around the positive impact exercise has on a range of chronic conditions (including dementia). Observed improvements include increased functional capacity and improved cognitive function. The positive impact on residents' wellbeing, as a result of improved function, is perceived to have had a ripple effect on family members: e.g. better quality of life for their loved ones. Staff also responded positively to the changes they saw in residents. This project aims to conduct an evidence-based evaluation of the project 'EP in Aged Care', exploring the effects of exercise primarily for residents with cognitive decline. The evaluation will take a person-centred approach.

A) Aims and Objectives This project aims to investigate the role of the neurotransmitter dopamine in complex decision making, and how three prescription stimulant medications that modulate dopamine levels in the brain in slightly different ways can affect the quality of complex decision making. These medications (dextroamphetamine, methylphenidate and modafinil) are increasingly used by healthy people for non-medical, cognitive enhancement purposes, however their effects on basic cognition are often found to be inconsistent, and their effects on more naturalistic, complex optimisation behaviours are not known. B) Key Question(s) Do stimulant medications, that increase dopamine in the brain, enhance, or have a deleterious effect, on the completion of a complex decision making task. More specifically do they; * Affect the amount of time taken to solve a problem? * Increase or decrease the likelihood that a participant will find the correct solution to the problem (the computational performance)? * Increase or decrease the computational distance between the participant’s solution and the correct solution (the economic performance)? * Affect the variety of search paths that participants take through the space of possible solutions? C) Research Design This study will utilize a double-blinded placebo-controlled crossover design. We will recruit 32 healthy participants with no history of neurological, psychiatric or heart conditions. Each one will participate in an initial assessment session and four testing sessions, each at least one week apart to allow for pharmaceutical washout. At each session, the participant will receive either a single dose of the three pharmaceuticals or the placebo. After a 90-minute waiting period, during which the participant fills out number of demographic and personality surveys, the participant will complete a series of computerised complex optimisation tasks and basic cognition tasks. Data collected includes the sequence and timing of the selection of items for each task solution, key variables from the more basic cognitive tasks and the answers to the survey questions.

Q-122 is being developed by QUE Oncology as a treatment for vasomotor symptoms (hot flashes) in female breast cancer patients/survivors. Q-122 has been studied in three Phase 1 clinical trials in cancer patients, healthy volunteers, and breast cancer survivors taking anti-estrogen therapy who were experiencing VMS. This study is designed to determine the effect of food on Q-122 pharmacokinetic (PK) parameters (Part 1) and PK parameters following a once daily or twice daily dosing regimen.

The main purpose of this study is to determine whether or not patients that are treated by spinal cord stimulation have the same or different treatment outcomes as patients that undergo spinal fusion in a group of patients that have received no treatment in the past for chronic low back pain. The outcomes are measured by pain scores, depression, anxiety and stress scores, patient impression of change, patient functionality, health outcomes assessments and disability scores. The patients' belief in the efficacy of the treatment will also be collected. There is also an aspect of the study that will look at whether spinal cord stimulation in conjunction with spinal fusion leads to better patient outcomes. Eligible subjects will be randomised to either the spinal cord stimulation arm or the fusion arm. Subjects randomised to the spinal cord stimulation arm will undergo an initial spinal cord stimulation trial. If this trial is positive (relieves pain by at least 50%), the subject will then be offered a spinal cord implant. If the trial is not positive, the subject will be withdrawn from the study and offered spinal fusion. If the implant is positive (pain relief of at least 50% is maintained) 6 months post implant, a subject will be followed for a further 12 months. If the implant is negative, the subject will be offered spinal fusion. Outcomes of the fusion will be assessed 6 months after surgery. If the fusion is positive (pain relief of at least 50% is maintained), the subject will be followed for a further 12 months. If the fusion is negative, the subject will be offered reactivation of the spinal cord stimulator. The subject will then be followed for 18 months post reactivation. Subjects randomised to the spinal fusion arm will be assessed 6 months post procedure. If the spinal fusion is positive (pain relief of at least 50% is maintained) , subjects will be followed for a further 12 months. If the spinal fusion is negative, subjects will then be offered a spinal cord stimulation trial. If this trial is positive (at least 50% of pain relief is obtained), subjects will be offered a spinal cord stimulation implant. Subjects will be followed for 18 months post implant (whether positive or negative). If the spinal cord stimulation trial is negative, subjects will be followed for 18 months post the spinal fusion procedure.

The purpose of this study is to determine whether baseline cognitive screening tests, Montreal Cognitive Assessment (MoCA), Addenbrooke’s Cognitive Assessment-III (ACE-III), Oral Trail Making Test-B (oTMT-B), reliable Digit Span predict functional outcomes in patients following a traumatic brain injury and whether they correlate with neuropsychological testing. In addition, the study aimed to determine the accuracy and validity of baseline cognitive screening tests in the detection of those patients with cognitive impairment on neuropsychological testing.

This randomised controlled trial seeks to compare the adherence rates and efficacy of internet-delivered cognitive behavioural therapy and internet-delivered mindfulness skills training for the treatment of adult depression and anxiety disorders immediately following treatment and at 6-month follow-up.

Delirium is an acute confusional state that is a medical emergency and is associated with significant morbidity and mortality. Delirium can often disrupt the times when someone is sleeping or awake. Although the main management of delirium is based on treatment of the underlying causes, specific medications are sometimes necessary to manage delirium-related behaviours. These interventions include the use of sedating medications that are associated with an increased risk of substantial harm. Melatonin is a natural-occurring substance made in the brain that helps regulate the timing of sleep and wakefulness. It is a well-established treatment for insomnia, has a good safety profile and has a potential theoretical benefit in the management of delirium by correcting the sleep-wake cycle disruption commonly seen in delirium. Although it has been used to manage delirium in hospitals around the world for some years, there have been no scientific trials to examine its effectiveness. Melatonin is approved in Australia to treat insomnia. However it is not approved to manage delirium. Therefore, it is an experimental treatment for delirium. This means that it must be tested to see if it is an effective treatment for delirium. This study aims to examine the effect of melatonin on delirium.