ANZCTR search results

The purpose of this study is to assess if a structured exercise program will have an effect on physical fitness, strength and quality of life. We also aim to assess if exercise has any impact on treatment related side effects or chemotherapy dosage modifications. Who is it for? You may be eligible for this study if you are aged between 15-25 years old and have either commenced treatment for cancer in the past two weeks or are due to commence in the next two weeks. Study details Participants enrolled in this study will be randomly divided into two groups: - Group 1 will receive an exercise program shortly after enrolling in this study, which will involve both aerobic exercise (walking, cycling, etc.) and a strength component. Participants in this group will need to attend two face-to-face exercise sessions per week and are also expected to complete some exercise at home, for 10 weeks. - Group 2 will need to record the exercise they complete in their day-to-day activities for 10 weeks. After this, they will then also receive an exercise program similar to that completed by Group 1. As part of this study, all participants will need to complete questionnaires and functional assessments at baseline, week 10, and week 20. Participants will also be required to undergo weekly blood tests to ensure they are within safety parameters to complete the exercise program. These results will also be used to record any treatment toxicities. It is hoped that this research will help in determining if exercise is effective in decreasing decline in physical fitness, while also improving psychosocial outcomes during cancer treatment.

The aims of this study are to determine the effects of the medication reboxetine and combination therapy (AD128) on OSA severity (as measured by the apnoea/hypopnoea index during overnight polysomnography) versus placebo. We will also examine other key sleep parameters and the effects on next day sleepiness and alertness.

This is a study attempting to treat delirium in critically ill patients, by improving the quality and length of their sleep. The main hypothesis is that the bright and noisy environment within Intensive Care units difficult patients' sleep and those who sleep, have fragmented and shallow (non-restorative) sleep. The intervention is based on the administration of melatonin, a safe drug that has been shown to improve sleep in other groups of people.

This is a single site, prospective clinical trial aiming to determine if immediate tonsillectomy in patients presenting with acute tonsillitis is a safe and acceptable alternative to delayed elective tonsillectomy for patients with recurrent acute tonsillitis. Currently patients undergo elective tonsillectomy for recurrent tonsillitis but may wait for approximately 12 months on the public hospital waiting list for their procedure, during which time they may suffer further debilitating episodes of tonsillitis. Suitable patients who present to the hospital with acute tonsillitis will receive routine medical management but will proceed to coblation-assisted tonsillectomy under general anaesthesia, a newer surgical technique using a "tonsil wand" with a localised plasma field at the tip for tissue dissection. This approach represents a shift in current treatment paradigms much the same as in other infective surgical pathologies such as acute cholecystitis and appendicitis. We hypothesise that coblation tonsillectomy in the acute setting will be a safe alternative to delayed tonsillectomy, providing the impetus for further larger studies to corroborate these findings.

The purpose of this study is to compare the pharmacokinetics (what the body does to a drug), pharmacodynamics (effect of drugs on the body), immunogenicity (ability to provoke an immune response) and safety of BP14 with Neulasta in healthy males. Who is it for? You may be eligible to join this study if you are a healthy male aged 18 to 55 years. Study details All participants in this study will undergo two separate treatments in random order separated by a period of 42 days. One treatment involves administration of the ‘test product’, a drug called BP14 (pegfilgrastim). A single 6mg dose will be administered by injection under the skin (subcutaneous). The other treatment is a 6 mg injection of the European Union-approved drug, Neulasta. This drug is recommended for use in cancer patients undergoing chemotherapy, to reduce the incidence of infection. All participants will undergo regular blood tests and safety assessments throughout the study, in order to evaluate how the body responds to the drug. We hope that BP14 (pegfilgrastim) will be comparable to Neulasta, warranting further investigational trials to evaluate its efficacy in cancer patients.

This study aims to evaluate the effectiveness and safety of duloxetine and pregabalin for neuropathic cancer pain. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have a diagnosis of cancer and neuropathic pain. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will take an oral dose of the drug, Duloxetine, twice daily for 14 days. Participants in the other group will take twice daily oral pregabalin instead. Participants and the research team will be blinded to the treatment and will not know which treatment, Duloxetine or Pregabalin, has been allocated. The Duloxetine/Pregabalin dose will be gradually increased over 7 days. The maximal tolerated dose will be continued until Day 14. On Day 14, participants will have the option to be unblinded and find out the treatment they were allocated if they choose to continue on that same treatment. Those who do not wish to continue on the same treatment will not be unblinded at Day 14 and will gradually taper down the dose over the next 7 days and cease the study medication. These participants may then be unblinded once the tapering is complete and study medication has been ceased. All participants will be monitored for safety, and toxicity. They will also be asked to complete questionnaires to rate their cancer pain, quality of life, anxiety and depression for up to 21 days. It is hoped that this comparison of benefits and harms between duloxetine and pregabalin will help us to better treat people with neuropathic cancer pain.

We hypothesize that acutely hospitalized frail patients may have vitamin C deficiency and this could be associated with poorer outcomes during inpatient stay (longer LOS, higher mortality, complications etc). This study aims to look prospectively for an association between vitamin C deficiency and frailty, which hasn't been evaluated in the past and if this is demonstarted,this can pave the way to future research to determine new treatment options for frail patients.

In up to 5% of the population, a benign adrenal adenoma is identified when abdominal computer tomography (CT) scans are performed for an unrelated complaint. Many of these adenomas secrete low levels of excess cortisol (a steroid hormone). Although mild excess cortisol secretion has been linked to adverse cardio-metabolic effects and death, the mechanisms underlying this association have not been fully evaluated. This study aims to investigate and determine the mechanisms that underlie the association between low level cortisol excess and increased cardio-metabolic risk.

Anxiety disorders are the most common mental disorder in childhood affecting up to 10% of youth, and are associated with significant burden on individuals, families, schools, communities and the economy. Delivery of mental health services to treat adolescents is costly with many barriers to accessing evidence-based treatment. Primary Health Networks are encouraged to implement stepped care approaches to mental health treatment to increase service-efficiency. However, few scientific evaluations of stepped care models have been conducted. Our team are the first to demonstrate the efficiency of stepped care for anxious adolescents in a university clinic. This project partners with a New South Wales Local Health District (NSLHD) community mental health services (headspace and Child & Youth Mental Health Services [CYMHS]) to evaluate in a pilot randomised controlled trial, the service-efficiency and efficacy of implementing evidence based psychosocial treatments for adolescent anxiety using a stepped care approach. Adolescents will receive either treatment as usual or stepped care consisting of an internet intervention [step 1], and then if required, additional face-to-face evidence-based therapy [step 2]. The superiority of stepped care on service-efficiency and treatment effectiveness will be compared in two headspace and two CYMHS sites. The results will provide preliminary evidence for stepped care approaches in community mental health that can be used to further evaluate translation of stepped care on a larger scale.

International and Australian research has primarily focused on reducing the risk of syncope (fainting) and presyncopal symptoms ( e.g: lightheadedness, dizziness, weakness, nausea) in whole blood (WB) donors. One of the most effective strategies is to instruct donors to use lower body muscle tensing exercises at strategic time points during their donation to increase blood pressure and to distract donors from potential fainting triggers. To our knowledge, few studies have focused on reducing the risk of fainting in plasma donors. This is especially concerning as the number of faints and pre faints in plasma donors have increased in the last few years due to the increased number of plasma collections and the policy introduced in December 2017 in Australia allowing new donors to go direct to plasma. In 2018, over 8,500 donors experienced a a faint or prefaint while giving plasma in Australia, with the majority occurring in relatively inexperienced donors. In this trial, we will evaluate the effectiveness of using applied muscle tension (AMT) during a plasma donation in reducing faint and pre-faint symptoms. This study will use a pragmatic type II effectiveness-implementation hybrid (HEI) design. This allows for simultaneous testing of the effectiveness of AMT in reducing faint an pre-faints and to examine organisational perceptions that may increase adoption, implementation and sustainability of AMT in a blood donation setting. By combining the efficacy and effectiveness stages of intervention development, we can ensure more rapid translational gains (i.e. reduction in fainting/ pre-faints) while gathering information regarding the effectiveness of AMT. Aim 1 - Effectiveness: To determine whether the AMT intervention compared to a business as usual care condition reduces phlebotomist-registered pre-faint and fainting reactions among plasma donors. Aim 2 - Implementation: To develop strategies to facilitate the implementation and sustainability of AMT in plasma donations at 15 donor centres.