ANZCTR search results

The end goal of this study is to provide Army with an evidence-based resilience training strategy that can be sustainably integrated into existing training frameworks. The objective of the evaluation is to determine whether RMC Cadets who undergo Mental Fitness Training report reductions in: (1) anxiety, (2) depression, (3) perceived stress, and (4) perceived stressor frequency in comparison to the BattleSMART group. Moreover, we will determine whether Cadets also report a related increase in: (1) adaptive stressor appraisal, (2) performance outcomes, and (3) subjective wellbeing compared to RMC Cadets receiving a revision of the BattleSMART program. It is hypothesised that: H1: Compared with Cadets receiving the BattleSMART comparison condition, Cadets who received Mental Fitness Training would show improvements between initial follow-up and longer-term follow-up in: (a) anxiety symptoms; (b) depression symptoms; (c) perceived stress and (d) perceived stressor frequency. In line with a resilience framework, we anticipate that these changes would be evident from initial follow-up and longer-term follow-up because this period is when training stressors temporarily subside after reaching a crescendo. H2: We anticipate that self-reflection quality (Mental Fitness Training group only) will determine the degree of change over time. Specifically, greater self-reflection quality would be related to a greater decline in: (a) anxiety symptoms; (b) depression symptoms; (c) perceived stress and (d) perceived stressor frequency between initial follow-up and longer-term follow-up reflecting greater return to normal functioning. H3: It is anticipated that compared to the BattleSMART group, the Mental Fitness Training group will report and demonstrate: (1) increases coping self-efficacy; (2) enhanced performance outcomes; (3) increased use of professional support services; and (4) increased perception of stressors as challenges rather than threats.

This research project is testing the safety, tolerability, immunology (how the study drug affects the immune system), pharmacokinetics (how the body effects the study drug) and pharmacodynamics (how the study drug effects the body) of single and multiple doses of a new drug called ACP-014 when given as a subcutaneous (into the skin) injection. Ascendis Pharma is developing the drug ACP-014 for the potential his study will run in 3 Parts: • Single Ascending Dose (SAD) Phase: will assess the effect of a single ascending dose of ACP-014 or placebo when administered as a subcutaneous (under the skin) injection abdomen. • Cross Over (Cohort X) Phase: will assess the effect of a single subcutaneous dose of ACP-014 in their abdomen and thigh. This phase of the study involves all participants receiving both study treatments in a particular sequence. • Multiple Ascending Dose (MAD) Phase: will assess the effect of multiple ascending daily doses of ACP-014 when administered as subcutaneous injections into the abdomen. Up to 80 participants will be enrolled in up to 8 cohorts (groups) with up to 10 participants in each cohort. In each cohort, 8 participants will receive the active drug (ACP-014) and 2 will receive the placebo. This study is a dose escalation study and total participation consists of 35 days.

Our goal is to produce automated continuous, real time ECG interpretation with artificial intelligence (AI), utilising our wristwatch-sized ECG machine. Our initial AI system will be focused on automated detection of atrial fibrillation. We have already developed a prototype ECG detection device and trained our initial AI system, which has undergone validation testing in a clinical environment. This study is intended to further develop our ECG system to be suitable for more widespread use.

Hyperglycaemia in hospitalised patients is independently associated with increased morbidity and mortality in a wide range of patient groups, including post-operative outcomes. The association between hyperglycaemia and poor post-operative outcomes is strong in patients without diabetes, but a weaker predictor in patients with diabetes. This discrepancy is in part driven by the difficulty in distinguishing genuine stress hyperglycaemia from chronic high levels seen in diabetic patients. A high plasma glucose concentration in a hospitalised patient can occur because of chronic poor diabetes control and be “normal” for that patient, represent a transient physiologic response to an inter¬current illness (stress hyperglycaemia), or be a combination of the above. A metric for stress hyperglycaemia has been developed at FMC - the Stress Hyperglycaemia Ratio is defined as glucose concentration divided by the Estimated Average Glucose concentration, which is calculated from HbA1c. This enables quantification of the relative change in hyperglycaemia eg a patient with a SHR of 1.4 has an glucose concentration 40% higher than their average glucose over the prior 3 months. Our previous work indicated that the relative change in glucose was a better indicator of stress hyperglycaemia and more strongly associated with adverse patient outcomes than glucose. Patients undergoing CABG surgery require mandatory post-op observation in the ICU setting, and commonly require intervention for glucose management. There is some conjecture that the commonly used glucose control range is no appropriate for all patients. We aim to determine the glucose control range that is associated with the best post-op outcomes.

Hyperglycaemia in hospitalised patients is independently associated with increased morbidity and mortality in a wide range of patient groups, including post-operative outcomes. The association between hyperglycaemia and poor post-operative outcomes is strong in patients without diabetes, but a weaker predictor in patients with diabetes. This discrepancy is in part driven by the difficulty in distinguishing genuine stress hyperglycaemia from chronic high levels seen in diabetic patients. A high plasma glucose concentration in a hospitalised patient can occur because of chronic poor diabetes control and be “normal” for that patient, represent a transient physiologic response to an inter¬current illness (stress hyperglycaemia), or be a combination of the above. A metric for stress hyperglycaemia has been developed at FMC - the Stress Hyperglycaemia Ratio is defined as glucose concentration divided by the Estimated Average Glucose concentration, which is calculated from HbA1c. This enables quantification of the relative change in hyperglycaemia eg a patient with a SHR of 1.4 has an glucose concentration 40% higher than their average glucose over the prior 3 months. Our previous work indicated that the relative change in glucose was a better indicator of stress hyperglycaemia and more strongly associated with adverse patient outcomes than glucose. This initial work was in a broad general hospital population. This study aims to determine the clinical applicability of the Stress Hyperglycaemia Ratio to post-op outcomes for patients undergoing CABG surgery. This group requires mandatory post-op observation in the ICU setting, and commonly require intervention for glucose management. We aim to determine if the Stress Hyperglycaemia Ratio is more strongly associated with adverse post-op outcomes in this group than glucose alone.

The research study will investigate the effect a common blood pressure tablet has on patients undergoing elective surgery. Participants will be randomly assigned to continue or cease their angiotensin converting enzyme inhibitors and angiotensin receptor blockers at least one day before their operation. Researchers will collate and analyze routinely collected patient information to detect if continuation or cessation results in better outcomes for the participants.

Patients with ulcerative colitis or Crohn's colitis have a slightly higher risk of bowel cancer after having the disease for a number of years. Colonoscopy is recommended to find polyps which can be flat and sometimes difficult to detect. This study aims to test the safety and efficacy of a new device named the Endocuff-vision, for surveillance for cancer and dysplasia in inflammatory bowel disease. Who is it for? You may be eligible to join this study if you aged 18 years or above and have ulcerative colitis or Crohn’s colitis involving more than one third of the colon in clinical remission, and are planned for routine colonoscopy for dysplasia surveillance. Study details All participants in this study will proceed with regular colonoscopy with the addition of the use of Endocuff-vision equipment during the procedure. This is a soft, rubber-like cap that fits to the end of the regular colonoscopy equipment, with a row of finger-like projections that extend when the colonoscope is pulled out. The aim of this device is to assist in anchoring the bowel wall and flattening mucosal folds to allow better vision of the bowel. The duration of the colonoscopy will be longer by about 10 - 15 minutes, as we will do the colonoscopy first without the Endocuff-vision device, then with the Endocuff-vision device, or vice versa. All test results will be analysed to determine whether the Endocuff-vision device is objectively better at detecting polyps. A member of the research team will also contact study participants at 21 days after the colonoscopy to ascertain if there have been any complications.

The increasing popularity of low carbohydrate diets in the community has meant that people with Type 1 Diabetes are adopting these diets, with the expectation of improved glucose control and weight loss. Where there is very limited research to guide this practice in people with Type 1 Diabetes, this project aims to assess whether lowering dietary carbohydrate improves glucose control and clinical outcomes for adults with Type 1 Diabetes Mellitus. This study is a randomized controlled study of adults with Type 1 Diabetes, that aims to compare the effect of a lower carbohydrate diet (average intake of less than 100g per day) with standard dietary recommendations (more than 150g per day) on glucose control, insulin doses, rates of hypoglycaemia, perceived quality of life and treatment satisfaction. We seek to explore potential mechanisms for changes in glucose control, focusing on the impact of dietary changes on the gut microbiome, intestinal epithelial permeability, body composition and inflammatory mediators. We hypothesise that intentional lowering of dietary carbohydrate will be associated with reduced dose requirement of insulin, reduced glucose variability and rates of hypoglycaemia, improved measures of perceived quality of life and alteration of gut microbiome. We expect to see a difference in the groups at 3 months, and will extend the intervention to 6 months to assess whether this dietary change is sustainable for people with Type 1 Diabetes. Participants will receive detailed education regarding carbohydrate counting, recommendations for meal plans that contain a reduced carbohydrate content and advice regarding insulin dose adjustments according to changing glucose levels. Close follow-up will be maintained by diabetes health care professionals. Data will be collected at baseline, 3 months and 6 months, to investigate traditional clinical outcomes - HbA1c, lipid profile, urinary protein and glucose variability as well as perceived quality of life. The effect of the dietary change will also be assessed on the intestinal microbiome, epithelial permeability and body composition.

Hospital readmissions are common and are risky for the patients and imposes additional financial burden on already constrained health care resources. Although numerous readmission predictor tools have been developed their ability to accurately identify patients at high risk of unplanned readmissions is only modest. Experts believe that this could be due to unknown variables, which needs to be identified. Majority of studies predicting hospital readmissions have so far been carried out in United States and only limited studies are available in Australia. Moreover, these studies are centred on 30-day readmission rate, as this is a commonly used benchmark to reimburse hospitals in US. The present study aims to study predictors, which can influence very early and late readmissions in medical inpatients and whether nutrition status as determined by Malnutrition universal screening tool (MUST) can be used as a predictor of hospital readmissions.

Obstructive sleep apnoea (OSA) is a condition in which the upper airway of patients closes off during sleep. This leads to low levels of oxygen and multiple awakenings during the night. There are many factors contributing to the abnormal blockage of the upper airway including the shape, length and strength of the airway itself. Upper airway surgery can help influence these factors. However, there are still patients with residual sleep apnoea despite upper airway surgery. The aim of this study is to test the impact of oxygen therapy in patients with residual sleep apnoea following upper airway surgery. Oxygen therapy will lower the sensitivity of participants ventilator control system and is expected to help further improve their OSA. The study is intended to discover if the combination of oxygen therapy and upper airway surgery can completely resolve OSA in patients where surgery is not able to resolve OSA on its own. The study will involve each identified participant to undergo two sleep studies over two nights. These visits will tell us if the administration of oxygen therapy after upper airway surgery can completely resolve OSA in patients who still snore. All participants will receive one night without oxygen, and one night with oxygen, to be used as a direct comparison. Measurements of breathing pattern, heart beat, blood pressure, muscle activity, eye movements, brain activity and the level of oxygen in the blood in the blood will be recorded and later interpreted by investigators specialized in OSA. We believe that the combination of oxygen and upper airway surgery could positively impact patients OSA and their quality of life. It can potentially provide additional treatment options for sufferers of residual OSA despite surgical management.