ANZCTR search results

This is a prospective, open-labelled, single-centre phase IIa clinical study, which aims to evaluate the safety and tolerability, as well as the clinical efficacy of meropenem and piperacillin/tazobactam dosing regimens that are optimised to prevent the emergence of bacterial resistance in critically ill patients. Sepsis and septic shock are prominent causes of morbidity and mortality in critically ill patients. Antibiotic therapy that is not optimal is associated with substantially increased mortality. However, the process of optimising antibiotic therapy can be highly challenging in the intensive care unit. Increasingly clinical data are suggesting that higher antibiotic exposures are needed for critically ill patients with sepsis and achieving this target exposure may also prevent bacterial resistance. The general objective of this study is to evaluate the safety and tolerability, as well as the effectiveness of Pharmacokinetic and Pharmacodynamic (PK/PD)-based dosing that aims to prevent the emergence of bacterial resistance in critically ill patients in the ICU, in order to establish feasibility to proceed with a larger clinical trial. We plan to recruit at least 12 participants per antibiotic at the RBWH Intensive Care Unit. It is hoped that the knowledge gained from this study will enable the development of individualised optimised dosing regimens that ultimately reduce the prevalence of multi-drug resistant organisms in ICU patients. Whilst this study is classified as a Phase IIa clinical trial we are not testing the safety of a new drug we are only testing the tolerability of higher than standard dosing of two drugs which are currently used in standard practice for treatment of sepsis and septic shock in ICU.

The aim of this study to assess the Cancer Council Life Now exercise program contribution to physical functioning and quality of life in adolescent and young adult cancer survivors. Who is it for? You may be eligible for this study if you are aged between 15-27 years, have completed your cancer treatment within the previous 2 years and are enrolled in the Life Now exercise program. Study details Participants who have completed treatment for cancer in the last two years will be offered a 12 week exercise rehabilitation program in a group based setting (twice per week). The program will combine resistance and cardiovascular training. Findings from the initial assessments will inform the development and prescription of an appropriate exercise program for each individual by an accredited Exercise Physiologist. Effects of the exercise program upon physical functioning (strength, cardiovascular fitness and functional capacity) and quality of life (completion of questionnaires) will be measured following completion of the 12 week program. From this research it is hoped we will better understand the impact that exercise has on adolescents and young adults (AYAs) who have completed treatment for cancer. If this research demonstrates positive benefits in this cohort, it is expected that it will support the necessary integration of this program into AYA standard of care for cancer treatment.

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.