ANZCTR search results

Newly diagnosed individuals with T2D can be managed primarily by alterations to diet and physical activity (exercise) patterns, which are used to help control blood glucose. However, uptake and adherence to any behaviour change strategy is typically challenging and therefore low. Recently, time-restricted eating (TRE) has emerged as a promising therapeutic strategy that allows meals to be consumed alongside societal norms. Rather than stipulating the composition of meals, TRE aims to reduce the ‘eating window’ to facilitate a longer overnight fast (i.e. eating between 10 am-6 pm, rather than over periods longer than 12 h). Via TRE, meal timing can be aligned with the biological circadian rhythm. Specifically, an earlier dinner may contribute to better glucose control due to the known deterioration of the hormone insulin to regulate glucose declining over the day. In those with T2D, a later breakfast may also be beneficial to avoid eating at the same time as the morning spike in fasting glucose, which is known as the ‘dawn phenomenon’ in individuals with T2D and coincides with the increased circadian concentrations of cortisol, known to stimulate the liver to release glucose into the circulation. Acutely, to our knowledge, TRE has not been measured in individuals with type 2 diabetes. TRE performed over a period of weeks has been shown to effectively reduce post-meal insulin, blood pressure, and evening appetite; if continued for up to one year it has been demonstrated to result in sustained weight loss. However, there are a lack of studies investigating the acute, one-day effects of TRE, particularly in the context of other behaviours that might influence circadian rhythm. Exercise, for example, is a potent stimulus known to influence both circadian rhythm and glucose control. For individuals with T2D, just 10 minutes of walking in each of the 1 hour post-prandial period across a day is enough to improve blood glucose control. However, it is unknown whether strategically-timed exercise combined with TRE would result in an additive benefit to glucose control over the course of a day. In addition, it is unknown whether the benefits of exercise for glucose control would mitigate the detrimental effect of an extended feeding window on glucose control.

This study aimed to investigate the current vaccination coverage for influenza, pneumococcus, and herpes zoster amongst patients affected by immune-mediated inflammatory disease (IMID) and increase vaccination rates using targeted electronic and printed patient immunisation reminders, electronic health practitioner immunisation reminders, and educational activities in Australian general practice. Patients affected by IMID (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or inflammatory bowel disease) attending Australian general practice will be included in the study. Current vaccination coverage will be estimated based on de-identified data on influenza, pneumococcus and herpes zoster vaccinations for patients with IMID from all practices using the Doctors Control Panel (DCP) for 2013-2018, which accept to be part of the study. DCP is a well-established software package that retrieves medical information from electronic medical records and identifies preventive health care activities that are due. In the second part of the study, DCP will generate targeted electronic (SMS text message upon consultation booking and another on the day of the appointment) and printed (read in the waiting room) patient immunisation reminders to inform them about their higher risk of viral and bacterial infections and generate advice about recommended vaccines. All communication will be via the recruited practices, without intervention by the researchers. Patients who have agreed to receive SMS messages from the practice will receive a generic reminder SMS upon booking, and another generic reminder SMS on the day of their appointment. They will also receive a printed letter if they arrive for an in-person consultation. Patients who have refused to receive SMS messages from the practice or who don’t have a mobile telephone will not receive SMS text messages but will receive a printed reminder letter from the receptionist if their consultation with the GP is in the clinic. The DCP will also generate electronic GP immunisation reminders (GP computer) to inform them about patient's status regarding immunisation. The outcome measures at the end of the intervention (18 months including two influenza vaccination seasons) are 1) recorded administration of influenza, pneumococcus, and herpes zoster vaccines to patients with IMID, and 2) documented contraindications to, or refusal of, those vaccines. Compared to the baseline (Stage 1), we expect an improvement of at least 20% in vaccination coverage after the intervention (Stage 2).

Young people with borderline personality disorder (BPD) have difficulty engaging in and maintaining employment or education, despite having the desire to do so. Despite this, no randomised controlled trial (RCT) has investigated the effectiveness of targeted vocational services in this group. This is a single-centre, 52-week, parallel arm, ‘single blind’ RCT of Individual Placement and Support (IPS), compared with Usual Vocational Services (UVS). The primary endpoint is 52 weeks. The background treatment will be standardised across both groups in the Helping Young People Early (HYPE) early intervention program for BPD at Orygen Youth Health. Potential participants will be identified by liaising with HYPE clinicians with regard to clients’ vocational wishes and by using HYPE’s standardised assessment for DSM-5 BPD. Following screening and baseline assessment, participants will be assigned randomly and consecutively in a 1:1 ratio to one of two interventions – IPS or UVS. Research assessments will occur at 13, 26, 39 and 52 weeks. The primary outcome is number of days in mainstream education/competitive employment since baseline. Secondary outcomes are cost effectiveness of intervention, quality of life, and BPD severity.

When swallowed, the Atmo gas capsule consists of several gas and temperature sensors which provides information on oxygen concentrations, and therefore, passage of the capsule between aerobic (small intestine) and anaerobic regions (large intestine). That way, regional transit measurements can be accurately derived. To validate this device, simultaneous ingestion of this and an existing device measuring pH (SmartPill) to determine time comparison of gut transit will be conducted to show equivalence of the two devices in transit measurements.

Who is it for? You may be eligible for the study if you are 70 years or older and have a past history of two or more keratinocyte cancers (BCC or SCC) with at least one on lower limbs( histologically confirmed disease). Alternatively, a past history of one or more keratinocyte cancers and multiple keratotic lesions on the lower limbs. Study details All participants will be randomly assigned (50/50 chance) treatment on one of their legs. The treatment will involve VMAT radiation treatment targeted to the skin cancer. The treatment will occur in two separate segments. The first segment will deliver 10-12 radiation fractions over 2 - 2.5 weeks. This will be followed by a mandatory mid-treatment break of at least 2 weeks (extended up to 4 weeks if necessary). The second treatment segment will deliver the remainder of the 25 fractions (13 - 15 fractions, depending on the number of prior fractions delivered) over 2.5 - 3 weeks. The other leg will serve as the control leg and will not receive any treatment. The overall treatment period will last no longer than 10 weeks. Participants will then be required to attend follow up visits 28 days, 3 months, 6 months, 9 month, 12 months, 18 months and 24 months after the end of treatment. During the study participants will answer questions about their Skin Pain and Quality of life. Benefits of this study The findings from this study will help medical researchers understand how radiation treatment with VMAT may help prevent skin cancers on people who have a high likelihood of disease recurrence.

There is consistent evidence showing that very low energy diets (VLEDs) reduce weight amongst patients with obstructive sleep apnoea (OSA) and comorbid obesity. This method of obesity reduction although effective, may be accompanied by an associated change in body composition in patients with OSA, notably concurrent loss of muscle mass. Excessive loss of muscle mass may be undesirable because this tissue is responsible for the majority of resting metabolic rate, regulation of core body temperature, preservation of skeletal integrity, and maintenance of function and quality of life as the body ages. Our study has a pragmatic design and patients will attend a commercially available high intensity functional exercise training programme. To date, there have been no randomised trials of naturalistic exercise training that is practical and may promote exercise adherence in patients with OSA. We aim to show that this model of training can protect against the loss of muscle mass, as delivered through a programme that can be readily translated to real world settings. Furthermore, we will confirm whether there is an additive benefit of this model of training in addition to a VLED in reducing OSA severity as compared to dietary induced weight loss only.

This study represents a first-in-human clinical trial for ZY-19489 and aims to determine the safety, tolerability and pharmacokinetics activity of the drug when administered to healthy human subjects. The study will be conducted in three parts. This registration is for Part 3. Part 3 is an open label study using the P. falciparum induced blood stage malaria (IBSM) model to characterise the antimalarial activity of a single-dose oral administration of ZY-19489 to healthy, malaria naïve, male and female subjects aged between 18-55 years old. Part 3 will be conducted in up to 3 cohorts of 8 subjects each, enrolled sequentially. Each subject will be intravenously inoculated with approximately 2,800 viable P. falciparum 3D7 parasite infected human red blood cells (RBCs) on Day 0. Adverse events and concomitant medications will be followed throughout the study. The study will be overseen by Principal Investigator, Dr James McCarthy, an Infectious Diseases physician experienced in the conduct of malaria challenge studies.

What is this research about ? Lumbar disc herniation (LDH) also known as disc prolapse or bulge in the lower back that may cause severe pains down the leg. This research project aims to improve our understanding on the condition and choosing between surgery versus spinal injections. What is the hypothesis ? Is there any benefit when we use non surgical injections to treat sciatica from a disc herniation ? What does it mean to be part of this trial ? You will be randomly allocated a treatment option that either involves a spinal injection procedure under x-ray scanning control or spinal surgery. You will not able to choose a treatment option. Aside from this allocation, the medical care you receive is the same as that you would have received as part of standard care. At regular intervals you are required to complete forms that provide information on your symptoms and quality of life.

The present study is designed to explore a link between cognitive decline post-surgery as a cause of vitamin C decline following the surgery. The aim of the study is to to determine whether surgery has an effect on vitamin C levels and cognition with the use of a neuropsychological test battery. It is hypothesised that elective hip surgery will result in significantly depleted plasma vitamin C concentrations which will contribute to compromised cognitive function on the cognitive assessments. Cognitive tests will involve both paper and pen and computer tests, while blood tests will be undertaken to measure plasma vitamin C and serum vitamin B12 levels and levels of inflammation. Testing will be conducted roughly 1-2 weeks prior to the scheduled surgery and subsequent testing sessions will be performed within 1 week, 4-6 weeks, 3 months and 6 months after surgery.

Continuous positive airway pressure (CPAP) is the current gold standard treatment for OSA. While efficacious, CPAP is poorly tolerated. Nightly use may be inadequately brief and 50% of patients do not continue CPAP therapy beyond 3 months. Although alternative treatments such as mouth guard devices and surgery exist for CPAP-intolerant patients, individual responses to these treatments are difficult to predict and as such many clinicians and patients are stuck in a trial and error paradigm for these treatments. Traditionally OSA has been thought to be a disorder of aberrant upper airway anatomy. Recently, it has become clear though that OSA can be caused by both anatomical and non-anatomical pathophysiology. Much of this paradigm change can be attributed to recent developments to the ability to measure this physiology – work that has been carried out by our research team at Monash Health and Monash University. We have developed readily applicable clinical tool that can predict the patient’s response to upper airway surgery and mandibular advancement splint treatments. The tools we have developed are now ready for direct translation to the clinical setting. In this exciting research project we will run an observation study to assess the impact of making physiological information available to clinicians at the time of OSA diagnosis on the treatment referral patterns and treatment outcomes of OSA patients. We hope that this extra physiological data will be able to predict patient response to CPAP-alternative treatments and give clinicians and patients extra treatment options that are tailored to patients personal physiology.