ANZCTR search results

Giant cell arteritis is an inflammatory condition affecting the blood vessels of the head and neck, and it requires prompt diagnosis and treatment. The current gold standard for diagnosis involves an operation to biopsy the superficial temporal artery and examine this tissue specimen under the microscope by a pathologist. A new technology called confocal laser endomicroscopy (CLE) has recently been developed to aid intra-operative diagnosis of various conditions. It involves applying a laser microscope to the tissue of interest during a surgical procedure to create a digital histological image. CLE has been investigated in gastroenterology, and other fields of Neurosurgery involving brain tumours with promising results. However, it is yet to be investigated in the diagnosis of giant cell arteritis. This study aims to evaluate the clinical utility, sensitivity and specificity of intra-operative CLE in the diagnosis of giant cell arteritis. Patients who are undergoing a superficial temporal artery biopsy are eligible for this study. If CLE is found to be accurate, then this may obviate the need to perform a biopsy of the superficial temporal artery during the operation. This will expose patients to less harm, and therefore has the potential to change surgical practice moving forward.

This study is investigating the effectiveness of an individualised, preoperative exercise and education program on post-operative complications in patients undergoing major abdominal cancer surgery. Who is it for? You may be eligible for this study if you are aged 18-80 years and are undergoing elective major surgery for advanced or recurrent gastrointestinal cancer (i.e. pelvic exenteration, cytoreductive surgery, oesophagectomy, hepatectomy, gastrectomy or pancreatectomy). Study Details Participants will be randomly allocated (by chance) to either: (i) progressive preoperative exercise and education program, delivered over 4 to 8 weeks prior to surgery (ii) usual care (nutritional counselling, advice on smoking cessation and reduction of alcohol intake) Participants will then be followed up to 3 months post-surgery and will be asked to complete self-administered questionnaires at different time points to collect information on health complications and quality of life. This trial seeks to determine the effectiveness and cost-effectiveness of the preoperative exercise program, on reducing postoperative complications, length of intensive care and hospital stay, and improved quality of life, which will provide policy decision-makers with evidence to support reimbursement of preoperative exercise programs.

Neck pain is related to a reduction in tactile acuity that may reflect disrupted sensory processing. Tactile acuity training may normalise sensory processing and improve symptoms. This proof-of-concept trial aims to investigate the efficacy of a novel tactile acuity training device for improving tactile acuity in people with chronic neck pain and inform feasibility of a larger study. We hypothesise that training will improve tactile acuity. Moreover, we hypothesise that training will result in positive changes in pain and pain spread. This two-arm randomised clinical proof-of-concept trial will recruit participants with neck pain of at least six months duration, aged 18-75 years, receiving usual care physiotherapy in a secondary outpatient healthcare setting. Thirty-six consenting participants will be randomised 2:1 to receive four weeks of either tactile acuity training using the Imprint Tactile Acuity Device (iTAD), or a placebo intervention, in addition to usual care. Outcomes will be assessed at baseline, mid-treatment, and at 5-week and 2-month follow-up. The primary outcome tactile acuity will be evaluated using the two-point discrimination and locognosia tests. Feasibility will be informed by recruitment and attrition rates, adherence, treatment satisfaction and blinding. Pain intensity, anatomical spread of pain, and tactile acuity assessed using the iTAD, will be analysed as secondary outcomes. The effect of training on tactile acuity will be assessed using a 2 (Group: Intervention vs. Control) x 4 (Time: baseline, mid-treatment, 5-week and 2-month follow-up) mixed ANOVA. Secondary and exploratory outcomes will be analysed with a focus on informing outcomes and sample size in future trials.

Background: Glucocorticoids such as prednisolone are commonly prescribed for inflammatory and autoimmune conditions, with estimated long-term use in 1-3% of adults in the general population. Long-term glucocorticoid therapy is associated with significant adverse effects such as weight gain, osteoporosis, diabetes, hypertension and cardiovascular disease. Chronic high doses suppress the function of the pituitary-adrenal system and impair endogenous cortisol production, which may lead to adrenal insufficiency. An estimated 48-63% of patients receiving long-term glucocorticoids develop adrenal insufficiency. Recovery can occur approximately four weeks after stopping glucocorticoids, but may take up to one year or more. Few studies have described specific tapering regimens and associated outcomes and there is no standardised method to withdraw glucocorticoids. Whether continuing prednisolone in smaller doses or converting to hydrocortisone is superior in outcome is unknown. Hypothesis: That a glucocorticoid tapering regimen using the short-acting glucocorticoid hydrocortisone is superior to a standard gradual dose reduction in prednisolone.

This aim of this pilot trial is to assess the best management approach to rehabilitation of postnatal Diastasis of the Rectus Abdominis Muscle (DRAM), commonly referred to as abdominal muscle separation, 100 first-time mothers will be recruited for this study. Participants with DRAM at 6-8 weeks postnatal will be allocated to one of three intervention groups: advice only; abdominal binder; back and abdominal muscle exercise. Ultrasound imaging will be used to collect images of the abdominal muscles for the linea alba distortion index (primary outcome measure) and inter-rectii distance. Additional outcome measures include- low back pain, pelvic girdle pain, stress urinary incontinence and body image. It is hypothesised that: 1) the linea alba tension rather than the inter-rectii distance will have more of an impact on functional outcomes of low back and pelvic girdle pain, body image and pelvic floor function; and 2) the exercise group will demonstrate significantly less linea alba distortion than the control or abdominal binder groups.

A Phase 1, randomized, placebo controlled, single and multiple ascending dose escalation study to evaluate the pharmacokinetics, safety and tolerability of GS-1427 in healthy subjects

The study's purpose is to understand the appearance of your prostate-specific membrane antigen (PSMA) PET scan after you take 14 days of treatment with a drug called dasatinib alone or in combination with anti-testosterone drug call darolutamide. Who is it for? You may be eligible to join this study if you have metastatic prostate cancer and had a recent PSMA scan showing low PSMA uptake Study Details: Participants will receive dasatinib 100 mg daily or dasatinib 100 mg daily and darolutamide 600 mg twice daily for 14 days. They will undergo another PSMA PET scan after 14 days. Participants will be followed up on day 7 of treatment and 30 days after treatment. It is hoped that this research will provide insight into the mechanism of PSMA expression in advanced prostate cancer.

Mindfulness-based interventions are interventions that aim to address the causes of psychological stress and the pathways to relieving it (Crane et al., 2016). Furthermore, mindfulness-based intervention we will be evaluating is endorsed as a stress reduction program specifically for student populations (Monash University, 2020). For these reasons, the primary aim of the current study is to evaluate the effect of Mindfulness for Wellbeing and Peak Performance on psychological stress in a non-clinical (i.e., healthy) sample of tertiary education students. The chosen research design will be a pragmatic randomized pretest-posttest waitlist-controlled study, which will yield an unbiased estimate of the effect of this intervention on this dependent measure. A second exploratory aim of this study will be to evaluate the effect of this intervention on secondary outcomes, including mental health outcomes associated with stress (e.g., wellbeing, depressive symptoms, anxiety symptoms), physical health factors (e.g., sleep quality), interpersonal factors (e.g., loneliness), and factors that have been associated with improvements in mental health (e.g., mindfulness, emotion regulation strategies, self-compassion, and self-esteem). This study will be critical to determine whether participation in Mindfulness for Wellbeing and Peak Performance in a manner that is generalizable to typical usage in the target population is associated with the type of salutary mental health outcomes that are typically reported in more established mindfulness-based interventions, and which are claimed of this intervention in the course outline.

In this randomised, double-blind, placebo-controlled study, 100 adults experiencing high stress and sleep difficulties will be randomly assigned to receive capsules containing either an Ocimum tenuiflorum (Holy Basil) extract (125 mg twice daily) or a placebo for 8 weeks. We will assess change in stress levels, general mood, sleep quality, and quality of life via several validated self-report measures. We will also examine change in sleep quality and resting heart rate using a wrist-word device (Fitbit) that will be worn for 8 weeks. Group differences in hair cortisol concentrations collected at week 8 will also be examined. At week 8, participants will be exposed to an experimental stress procedure known as the Maastricht Acute Stress Test (MAST). We will assess group differences in salivary cortisol, a-amylase, blood pressure, pulse rate, and mood ratings during and after this procedure.

INNA051 is being developed as a prophylactic against SARS-CoV-2 (coronavirus). This is the first in human trial of INNA051 and will test increasing doses of study drug for safety and tolerability, and to measure how the immune system responds.