ANZCTR search results

This is a double blinded prospective randomised trial to investigate the effect of methadone and bupivacaine on the development of chronic pelvic pain in women undergoing surgical management of endometriosis. Chronic pelvic pain is common in women with endometriosis, and can develop despite surgical treatment of the disease. Endometriosis causes pain in a variety of mechanisms including direct compression/infiltration of nerves by the lesions, inflammation, and damage to pelvic nerves during surgery and may lead to changes in the central nervous system which propagate chronic pain. The objective of this trial is to prove that active management of intra-operative analgesia with intravenous methadone and intraperitoneal bupivacaine, for women with long-standing pain from moderate to severe endometriosis leads to long-term benefit in terms of pain experience and quality of life. Patients will be recruited from the endoscopy clinic at King Edward Memorial Hospital. They will be eligible if they have an American Fertility Society Score of 2 or 3 on previous laparoscopy and are planned for laparoscopic treatment on endometriosis. At recruitment patients will undergo a visual analogue scale (VAS) assessment for pain and will complete a quality of life (QOL) assessment. Patients will be randomised to either the standard analgesia group (IV fentanyl 5mcg/kg + placebo (200ml saline) intraperitoneal) or the intervention group (IV methadone 0.2mg/kg and 200mL levobupivocaine 0.625% intraperitoneal). Repeat pain scores will be recorded on day 1, and repeat pain scores and QOL scores at 6 weeks, 6 months and 12 months post-operatively.

Rotator cuff tears are the most common condition affecting the shoulder. Conservative treatment can involve pain medication, corticosteroid injection, activity modification and physiotherapy. Surgical treatment is considered when conservative management has failed and quality of life is significantly impacted by shoulder dysfunction. In the rehabilitation phase following rotator cuff repair, patients follow a set protocol determined by the surgeon. There is currently no agreement on whether one rehabilitation approach is better than the other. One study found that patients that underwent a shoulder program for 4-6 weeks before surgery had better function and reduced pain in the rehabilitation phase compared to a delayed program group. Pre-operative programs for patients scheduled for spinal surgery and total knee replacements have demonstrated some encouraging results. This type of program has not been used for patients awaiting rotator cuff surgery. The effects of such a program on patient post-operative expectations, function and quality of life have not been investigated. The purpose of this research is to investigate whether the addition of a prehabilitation program to routine pre-operative care will result in better function, quality of life and post-operative expectations for patients awaiting shoulder surgery. The second aim of this research is to study the effect of prehabilitation on pain, shoulder range of movement, strength and exercise endurance. In addition, it may possibly reduce the need for surgery. It is hypothesised that addition of prehabilitation to optimise physical and mental preparation will improve post-operative outcome than usual care (waiting list).

The gene transfer product Cal-1 aims to protect CD4+ T lymphocytes and blood cells from CD34+ bone marrow stem cells from HIV-1 infection. The protective effect may suppress the HIV-1 RNA plasma viral load and maintain the CD4+ T lymphocyte count in a treated individual, thereby decreasing or delaying (either partially or completely) the need for ART. The purpose of this study is to help determine whether Cal-1, as well as the method used to deliver Cal-1, is safe in people. Cal-1 is an experimental treatment for HIV-1 infection. This means that Cal-1 is not an approved treatment for HIV-1 in Australia. Cal-1 has already been tested in the laboratory and in animals, this study is part of the first stage of testing Cal-1 in people. We aim to collect preliminary information on whether Cal-1 can protect the person’s immune system from the effects of HIV by reducing HIV-1 viral load and/or preventing further decline in T cell counts.

This study aims to measure the effectiveness of Acceptance and Commitment Therapy in reducing distress and increasing positive wellbeing in Adolescent and Young Adults (AYAs) who are offspring (children) of cancer patients. Who is it for? You may be eligible to join this study if you are aged between 14 and 22 years and have a parent or caregiver with a current (last 5 years) diagnosis of cancer, who is not currently in palliative care or terminal. Study details: Participants in this study will receive Acceptance and Commitment Therapy (ACT) in small group sessions administered by 2 psychologists/social workers trained in ACT. Sessions will be conducted weekly in 1.5-2 hour sessions across seven weeks. ACT is a psychological therapy designed to help people find new ways of managing their difficult thoughts and feelings by changing how they respond to them. ACT teaches skills in mindfulness and also ways to commit to values-based living despite difficult circumstances. Completion of 6 homework tasks, administered weekly is also required. Participants who are interested in the program but unable to attend the group or if it is not available in their area, will be provided with an informational booklet until eligible/available for group participation. All participants will be asked to complete some questionnaires at baseline, post-intervention and 2 months post intervention in order to evaluate their levels of distress, depression and their psychological wellbeing.

Acute exercise increases skeletal muscle insulin sensitivity for hours after exercise by mechanisms that are incompletely understood. The aim of this project is to examine whether increases in markers of bone remodelling including undercarboxylated osteocalcin (ucOC, a hormone secreted by the skeleton) following exercise is related to increases in insulin sensitivity (placebo), and whether attenuation of the increase in ucOC following exercise (by a single dose of prednisolone, a glucocorticoid) reduces insulin sensitivity and muscle insulin signalling activity post-exercise. This project will bring new insights into the connection between exercise, bone and glucose control. Understanding this connection may lead to new pharmacological and non-pharmacological interventions for the prevention and management of type 2 diabetes.

To determine if suprapubic cutaneous stimulation with cold fluid soaked gauze hastens CCU (within 5 minutes) in children aged 1 – 12 months in the paediatric emergency department, where a urine sample is required and the clinician has determined that CCU is an appropriate method of collection.

The aim of the Falls After Stroke Trial (FAST) is to test the effect of homebased, tailored intervention to reduce falls. A sample of communitydwelling stroke survivors who have finished formal rehabilitation, and therefore are at a high risk of falling again will assigned to an experimental group (habit-forming exercise and safety training) to test the feasibility of the intervention. The primary hypothesis is that the home-based, tailored intervention will be safe and reduce both the proportion of people falling and rate of falls over a one-year period in stroke survivors living in the community. The secondary hypotheses are: 2. That home-based, tailored intervention will also be associated with improvements in improving: balance, self-efficacy, mobility, physical activity, community participation, and health-related quality of life. This feasibility trial will test the experimental intervention over 6 months and evaluate feasibility of recruitment, intervention and assessment protocols as well as monitoring outcomes and adverse events.

Insomnia is a highly prevalent, complex and heterogeneous disorder. Diagnostically, insomnia is problematic due to a lack of objective markers and with the diagnosis based primarily on patient self-report. Patients with insomnia also have high rates of absenteeism, increased health risks and health-care utilisation, a higher risk of depression and neurocognitive impairments than good sleepers. The main nonpharmacological treatment for insomnia is Cognitive behavioral therapy for insomnia (CBT-I), which is an evidence-based psychological intervention, usually delivered by a psychologist individually, in small groups, or through automated web-based programs. CBT-I seeks to manage insomnia by targeting maladaptive thoughts, behaviors, and beliefs about sleep. CBT-I is a multicomponent approach and in the context of clinical trials improves sleep in 70% of insomnia patients and is considered the first-line treatment for insomnia by the American Academy of Sleep Medicine, National Institutes of Health, and British Association of Psychopharmacology. CBT-I is effective but it does not work for all patients with insomnia. As insomnia is a highly heterogeneous disorder it may be that certain phenotypes of insomnia respond differently to certain components of CBT-I. To date, insomnia phenotyping has focused on subjective clinical impressions by Sleep Physicians or Psychologists to label patients with a chief complaint of either: difficulty initiating sleep, difficulty maintaining sleep, early morning awakenings or mixed insomnia (a combination of at least two of the previously mentioned factors). Currently, there is a lack of objectivity in classifying insomnia phenotypes and evaluating phenotype treatment response to CBT-I. Our aim is to develop phenotyping toolkits to produce an objective diagnostic assessment of insomnia that will assist clinicians to determine the likelihood of an insomnia phenotype responding to treatment (CBT-I). We aim to phenotype all patients for the following three methods including: (A) Classic subjective insomnia phenotyping, diagnosed by a Sleep Physician / Sleep Psychologist interview (based on DSM-V criteria) will be used to identify four insomnia phenotypes characterised by a main complaint of either: (i) difficulty with sleep onset, (ii) difficulty with sleep maintenance, (iii) early morning awakenings, or (iv) mixed insomnia (a combination of at least two previously mentioned main sleep impairments). (B) One in-laboratory overnight polysomnographic assessment of sleep will also be used to quantify insomnia patients with either (i) short objective sleep with both sleep onset and maintenance impairments, (ii) short objective sleep with primarily sleep maintenance impairments, or (iii) long objective sleep. Based on previous results, participants will be assigned to either groups i, ii or iii through a pre-specified algorithm developed from insomnia clustering data (Miller et al., in preparation). (C) One in-laboratory dim light melatonin onset assessment (saliva) will be used to quantify insomnia patients with (i) late phase angle: the most severe 30% of the study sample with the greatest evening phase angle (i.e. melatonin rise after bedtime resulting in a mostly positive phase angle) and a melatonin rise time after 22:00 compared to (ii) normal phase angle: the remaining 70% of the sample. Phase angle onset is defined as the difference between 14 days (minimum of 5 days) of average actigraphy time for bed and the in-laboratory dim light melatonin onset rise time. We primarily aim to evaluate treatment response for these phenotypes of insomnia to standardised online CBT-I for measures of insomnia severity, sleep diary defined sleep onset latency and wake-time after sleep onset. Secondly, we aim to evaluate changes in neurocognition, mood, and actigraphy pre-to-post therapy for insomnia phenotypes. Third, we will compare phenotypes for differences in simulated driving (at 6pm and at one hour after habitual bedtime) and neurocognitive performance (at i. 6pm, ii. habitual bedtime, iii. in the morning after a full sleep opportunity with a patient preferred wake-time and iv. after a reduced sleep opportunity, by going to bed two hours later than average sleep-diary defined habitual bedtime). This study aims to provide evidence of tools to objectively phenotype insomnia by differentiating patients who may or may not respond well to CBT-I prior to the delivery of treatment. In turn, this will facilitate better treatment plans and lead to enhanced sleep, health and daytime performance.

Increased dietary calcium intake has been proposed as a population-based public health intervention to prevent osteoporotic fractures. We have examined whether calcium supplementation decreases clinical fracture risk in elderly women and its mechanism of action. This was a five-year, double-blind, placebo-controlled study of 1460 women recruited from the population and older than 70 years (mean age, 75 years) who were randomized to receive calcium carbonate, 600 mg twice per day, or identical placebo. The primary end points included clinical incident osteoporotic fractures, vertebral deformity, and adverse events ascertained in 5 years. Bone structure was also measured using dual x-ray absorptiometry of the hip and whole body, quantitative ultrasonography of the heel, and peripheral quantitative computed tomography of the distal radius.

This proposed investigation will build upon a previous feasibility study to explore acceptance, use, clinical utility (including effects of bidet use on asymptomatic bacteria in urine) and associated costs of the electronic toilet top wash-and-dry bidet by residents and staff of Australian residential aged care facilities, as a method of improving the toileting experience for older, frail and/or cognitively impaired residents of aged care facilities and staff.