ANZCTR search results

The aim of the EXHALE pilot project is to test whether the Personal Activity Intelligence (PAI) e-Health program improves adherence to exercise targets over a twelve month period in people withType 2 Diabetes. Sixty participants with Type 2 Diabetes will be randomised into the PAI e-Health Program or usual care. Those in the intervention group will receive a MIO Fuse wristband, which uses their heart rate to calculate PAI, the goal being to achieve 100PAI per week. Participants will attend group sessions to learn how to use the technology, and how exercise accumulates PAI. The control group will receive standard care from their GP and/or other healthcare providers. The primary outcome will be the ability to accumulate 100 PAI per week over twelve months. In addition, cardiorespiratory fitness, glycemic control and various physical measures will be assessed at baseline and follow-up. It is expected that the PAI e-Health program will be associated with superior adherence to physical activity compared to usual care.

This is an open label study in patients who have been previously treated with intravitreal anti-VEGF drug for macular oedema secondary to retinal vein occlusion despite regular injections. The study will describe the effectiveness, safety of intravitreal aflibercept and changes in health related quality of life (HRQoL) among these patients.

Fatigue causes a deterioration in cognitive performance that leads to workplace errors, injury and reduced safety. Shift work is a major source of fatigue because it disrupts the timing and duration of sleep opportunities; and therefore night workers are often chronically sleep deprived. Our work shows that 30min naps can be a powerful tool for maintaining performance during conditions of sleep deprivation. Naps can be particularly beneficial for night workers, who are on duty at times when their body rhythms naturally prime them to be asleep. However, napping can also be hazardous. Our studies show that it can have deleterious effects, in particular, `sleep inertia’, the groggy feeling and performance impairment experienced after waking where workers are extremely vulnerable to errors. This is problematic for oncall workers or health care professionals who take naps during extended hours or night shifts, but on waking need to process complex information, or engage in safety critical activities. Our recent systematic review found very few studies have investigated countermeasures that that can be implemented immediately on waking to reduce sleep inertia. Our work with caffeine gum, funded by USA and Australian Army has found it is fast acting (i.e. within 5min). It could therefore be the ideal countermeasure for the sleep inertia associated with night time naps. This study aims to answer two questions: 1. Will 200mg of caffeine (given in gum form) administered upon waking from a 30 min nap at 2:30am prevent sleep inertia when compared to placebo? 2. Will 200mg of caffeine (given in gum form) administered upon waking from a 30 min nap at 2:30am impact daytime recovery sleep between 12 and 6pm?

This project aims to observe the effects of an endoscopic sleeve gastroplasty utilising the overstitch procedure for the treatment of obesity and diabetes which is an increasing problem in our community. During the procedure, a small tube (the endoscope) is inserted through your mouth and passed down your oesophagus into the stomach and proximal small bowel for visual examination of the upper gut by the physician. The endoscope will be removed and provided the endoscopic examination of your upper gut was normal a stitching device (Overstitch, Apollo Endosurgery) will be attached to the endoscope tip. Then the endoscope will be reinserted and used to stitch the walls of the stomach together to create a smaller volume residual stomach in the form of a tube. This usually requires between 3 and 5 stitches to be placed. These stitches will remain in the stomach indefinitely but can potentially be removed if required. This study will also look to assess the following outcomes • Weight loss - assessed via weight on digital scales at each appointment • Health related quality of life as measured by the SF-36v2 • Psychological wellbeing measured by the Hospital Anxiety and Depression Scale • Pancreatic exocrine functional testing as measured by a 13C labeled mixed triglyceride breath test as measured by a 13C labeled mixed triglyceride breath test • Fasting insulin measured via blood assay • Composite secondary outcome measure of cardiopulmonary reserve and exercise capacity measured by a 6 minute walk test • Fasting Blood glucose measured by blood assay • Stool microbiome community profiling will enable characterisation of the bacterial diversity of the gastric and duodenal mucosa-associated microbiome. • Gastric emptying as measured by 13C Octanoid breath test • Liver function measured by non-invasive hepatic elastography. • Body composition assessment as measured by Dual-energy X-ray absorptiometry • Visceral sensitivity as measured by a Standard Nutrient challenge test. • Self reported diet quality as measured by diet history and 24 hour recall • Gastrointestinal This study will enroll 15 obese type 2 diabetic patients (males and females) recruited from the “Obesity clinic” run by the Department of Endocrinology, general practice referrals or on the waiting list for another study HREC/QPAH/15/246. Patients will be followed up for a period of 1 year from the time of procedure and assessed for changes in the above mentioned variables throughout the follow up period. The data will be compared to the study group baseline characteristics and to the results of a currently still ongoing trial conducted at our Department. In this ongoing trial a group of 15 patients underwent a temporary duodenaljejunal bypass sleeve insertion (HREC/QPAH/15/246).

About 20-30% of patients with angina have no obstructive coronary disease on coronary angiogram (NoCAD). Despite no significant obstructive CAD most of these patients continue to experience recurrent chest pain without any definitive diagnosis. Main aim of this study is to investigate patients with angina and NoCAD with a comprehensive invasive coronary and peripheral haemodynamic studies at the time of diagnostic coronary angiogram and to evaluate the prevalence of various vasomotor disorders in these patients. Further we aim to relate the results of testing to outcome by determining the clinical and coronary haemodynamic predictors of recurrent chest pain on one and 12 months follow up.

Current treatments to control damaging immune responses during autoimmunity use broad immunosuppressive drugs associated with undesirable side effects. Alternative strategies to control damaging immune responses are desirable. DEN-181 offers a novel liposomal therapy that does not broadly suppress the immune system, with the associated increased risk of infectious complications, but rather is designed to specifically address the underlying pathology of Rheumatoid Arthritis by re-programming the immune system towards tolerance for improved patient outcomes and minimal side effects. This study is designed to assess the safety and tolerability of a single dose of DEN-181 in Rheumatoid Arthritis patients.

This project intends to investigate the respiratory effects of a low dose ketamine infusion in patients suffering from obstructive sleep apnoea (OSA). Recent studies have shown that over 25% of patients undergoing surgery may be suffering from Obstructive sleep apnoea (OSA). An estimated 80% of patients with OSA would undergo surgery without a diagnosis. Due to the epidemic of obesity on the rise, the prevalence of OSA, which is common among overweight people, is expected to increase over time. Ketamine is a medication different from the morphine family of medications (opioids), that is used as an adjunct to opioids in pain management following surgery. Low-dose ketamine infusion results in reduced opioid requirements, less sedation, a lower rate of postoperative nausea and vomiting with no change in breathing patterns. Previous trials, both in volunteers and postoperative patients not suffering from OSA, has shown improved oxygen saturation and a lower carbon dioxide level in the blood when ketamine was used with opioid medications. Hypothesis: Based on results from previous trials involving ketamine, we anticipate this medication to have a beneficial effect on breathing during sleep in patients suffering from OSA. The results of this study will enable us to identify whether ketamine is a suitable medication for use in patients suffering from OSA. This will help create accurate guidelines on the management of patients with OSA undergoing surgery. Design: We will administer either low-dose ketamine or a placebo (normal saline) as an infusion to volunteers suffering from severe OSA and conduct a standard in-lab sleep study to assess the blood oxygen level, breathing pattern and sleep pattern. Each patient will receive both a ketamine infusion and the placebo infusion in a random order with a period of one week between the two sleep studies. This will be a single centre, double-blind, randomised, crossover study. Patients with severe OSA will be randomly assigned to receive either ketamine or a placebo in the sequence given below, during an in-lab, overnight polysomnogram (PSG). Sequence A – infusion of ketamine during PSG 1 and a placebo infusion during PSG 2. Sequence B – placebo infusion during PSG 1 and ketamine infusion during PSG 2. Sample size: 22 patients Study duration: 12 months Aim: To identify whether a ketamine infusion significantly affects the ventilation of OSA patients during sleep, when given in doses used for pain relief following surgery. Primary endpoint: ‘Oxygen desaturation index’ of the patients will be compared between the PSG with a ketamine infusion and the PSG with a placebo infusion.

Medlab Clinical is currently sponsoring an early phase clinical study evaluating the safety and efficacy of a new Cannabis formulation containing THC 8.33 mg/ml and CBD 8.33mg/ml in the form of an oro-buccal spray, for the management of severe pain in advanced cancer patients as an adjunct to opioid analgesia. The formulation is a 1:1 mixture of two distinct cannabis oil extracts produced from cultivated Cannabis sativa L. and Cannabis indica L. plants. Who is it for? Males and females aged 18+ diagnosed with advanced cancer who are experiencing intractable pain and are currently administering opioid analgesia. It is a requirement that participants continue to administer the prescribed opioid analgesia while on the study. Participants will not be allowed to drive while administering the study drug. Patients wishing to participate in the study will need a referral from their threating physician. Where? The study is taking place at a major Sydney metro hospital. Recruiting is now open. Study details This study will be conducted in two stages. During the first stage, participants will be enrolled and remain under clinical supervision in hospital for 48 hours. On day 1, a ‘standard dose’ of 2.6 mg delta-9-tetrahydrocannabinol (THC) and 2.4 mg cannabidiol (CBD) in 0.3 mL will be administered using a buccal spray delivery system. On day 2, three ‘standard doses’ will be administered. Participants will be monitored for any adverse events during hospital stay. Stage 2 of study will involve a dose escalation over 7 days commencing with one ‘standard dose’ every 4 hours and three ‘standard doses’ every 4 hours by day 7 which are then maintained until day 15. Several assessments are conducted over administration period and on day 30 post intervention commencement. Participants will be required to self-administer the drug for 15 consecutive days and visit the study site for a total of 8 visits within 30 days. Each visit is approximately 1 hr in duration. There are no overnight stays. In addition, participants will be required to provide a blood sample at each visit and complete daily questionnaires about their pain while on the study. This study may greatly contribute to the research into the pharmacokinetic and medicinal properties of the Cannabis plant, in particular C. sativa L. and C. indica L. strains. The treatment may be beneficial for the treatment of intractable pain in cancer patients in conjunction with the conventional opioid treatment. In the event that the medication is efficacious over the two-week period of the study, Medlab Clinical will make available the medication free of charge after the study to those trial participants that the Principal Investigator deems clinically appropriate to do so in consultation with their treating clinician.

The aim of this research trial is to investigate whether the Mindful Selfcare and Resiliency intervention is effective in reducing burnout, secondary traumatic stress, and symptoms of general psychological distress in General Practitioners working in a rural health service in Queensland, Australia. Secondary aims are to determine whether the intervention increases protective factors for occupational stress, including compassion satisfaction, self-compassion and resilience. Our primary hypothesis is that GPs completing the MSCR intervention will show significant reductions in symptoms of burnout, secondary traumatic stress and general psychological distress from pre to post intervention and from pre intervention to follow-up. A secondary hypothesis is that GPs completing the MSCR intervention would show significant improvements in compassion satisfaction, self-compassion and resilience from pre-post intervention and from pre-intervention to follow-up.

The aim of this project is to investigate the efficacy of N-acetylcysteine (NAC) (1.8g/day) for smoking cessation in a randomised, placebo-controlled trial of current smokers who wish to quit smoking. The primary outcome measure will be 6 months of continuous abstinence from end of treatment (EoT) in tobacco smoking, confirmed by biological measures. Secondary outcome measures include point prevalence abstinence, time to relapse and cigarette consumption. Safety, tolerability and subgroup analyses will also be conducted. Hypotheses: Primary: Treatment with NAC will be superior to placebo for smoking cessation at follow-up (week 42), confirmed by assaying exhaled carbon monoxide and salivary cotinine. Secondary: Treatment with NAC will be superior to placebo for smoking cessation at treatment endpoint (week 16), confirmed by assaying exhaled carbon monoxide and salivary cotinine. NAC is an agent that replenishes the antioxidant glutathione, and also has intrinsic antioxidant actions, as well as modulating glutamatergic, neurotropic and inflammatory pathways.There is evidence that glutamate and in particular the cystine-glutamate exchange system, mediate drug intake, craving and behavioural sensitisation in preclinical models of addiction. Glutamate, which is increased by NAC via cysteine-glutamate exchange, is core to relapse in addiction. NAC can also improve some of the physical harms caused by tobacco smoke exposure, improving mucociliary transport and preventing oxidative damage to lung and other tissues. NAC has several advantages over other pharmacotherapies: a different mechanism of action for smoking cessation, an excellent tolerability profile, low cost and is readily available.