ANZCTR search results

The aim of this research is to evaluate the functionality, efficacy, and utility of a new safety planning smartphone application. The trial will involve including the use of the smartphone application into existing Monash Health mental health services. Participants will include 60 patients who have experienced recent suicidal ideation or behaviours. Participants will be recruited by their treating mental health clinician. First, research staff will train the treating clinicians and participants in the use of the smartphone application, and conduct baseline measurement of suicide ideation and/or behaviour, as well as suicide resilience using self-report measures. Participants will then undergo 'treatment as usual' under the management of their treating clinician for a period of two months. Research staff will then conduct post trial measurement of suicide risk and resilience along with qualitative data on smartphone application functionality and utility. Data on smartphone application usage will be collected via Google analytics software. This information will not include personal information stored in the application.

Patients who present with an acute coronary syndrome remain at high risk of further events in subsequent years. Better identification of individuals at high risk can allow better targeting of novel therapies and resources. This study will create an imaging bio-bank that enables testing of multiple novel strategies involving new imaging, image analysis and biomarker approaches alone or in combination for improved risk stratification and targeting of prevention. Prospective follow-up in the cohort for outcomes enables the predictive value to be tested in a pilot data setting.

The project will use both a randomised control trial and prospective cohort design. Participants will be Western Australian travellers planning to depart for Bali. Half of participants will be randomly allocated into an intervention group and receive prepared online travel health information. After returning from Bali, both the intervention and non-intervention group will be invited to complete an online survey with questions concerning any communicable disease symptoms and health impacts.

The aim of the study is to obtain an understanding of mechanisms of action and the biological and psychosocial effects of an Endoluminal Bariatric Intervention (Endobarrier-DJBS) in an obese diabetic population. Hypothesis: Implantation of the Endobarrier device will reduce: 1. Body weight as compared to the baseline values and compared to control interventions, 2. Intraluminal digestion of triglycerides as measures by the 13C triglyceride breath test in patients with EB device as compared to baseline and controls; 3. Fasting insulin and fasting glucose during the intervention and improvement will be greater in actively treated subjects. In addition the implantation of the Endobarrier device will: 4. Alter the mucosal and stool microbiome, 5. Improve liver function and parameters of fibrosis (elastography, blood tests, liver biopsy ). 6. Improve cardiopulmonary reserve and exercise capacity, 7. Improve quality of life, self-image, anxiety and depression will improve in actively treated subjects as compared to baseline.

This trial is conducted to evaluate the Safety, Pharmacokinetics and Haemodynamic Effect of CRD-102 in a Fasted and Fed state in Healthy Adult Volunteers. 8 Healthy Adult volunteers will be administered a single dose of CRD-102 in a fasted state, followed by a single dose of CRD-102 in a fed state 7 days later. PK samples, blood pressures, ECGs will be taken to assess the PK and haemodynamic profile of the medication following administration in a fasted and fed state. Healthy volunteers will be screened up to 28 days prior to trial enrolment, Following enrolment, 8 healthy volunteers will be dosed with CRD-102 in a fasting state on day 1, followed by administration of CRD-102 in a fed state following a 7 day wash out. Subjects will return to clinic for a follow up 5 days after administration of the last dose of investigational product for a safety visit.

This study aims to determine - the effectiveness of using a CPP-ACP toothpaste in preventing dental caries in children - the microbial changes in plaque such as the reduction in decay causing bacteria Participants will attend routine dental examination appointments at public oral health services. In addition to standard examination a sample of plaque will be taken by swabbing selected teeth with a small brush. A questionnaire will be completed by the participant's parents regarding medical, social, toothbrushing and dietary histories. Dental radiographs will be taken at the recruitment appointment. All identified treatment will be undertaken. At the first appointment, a participant's toothbrushing group will be randomly allocated. The allocation is either the CPP-ACP toothpaste or the placebo toothpaste (blinded groups) or commercial fluoridated toothpaste (non blinded). For the blinded groups (CPP-ACP and placebo), the toothpaste packaging will be marked with a digital code, but the content will not be known to the participants, the clinicians or the investigator. The codes will be provided to the chief supervisor of the study. Only after the statistical evaluation is completed will the decoding occur. All the toothbrushes and toothpaste will be provided free of charge for the duration of the study. Participants are asked to brush twice daily will the allocated toothpaste. Compliance will be monitored by a phone call questionnaire at 3 and 9 months and in person at 6 and 12 month . The examination appointment will be repeated at 6 months and 12 months. Dental radiographs will be taken at 12 months.

Osteoarthritis (OA) is a leading cause of disability in developed nations. Total knee arthroplasty (TKA) is the mainstay of treatment for people with end-stage knee OA, and represents one of the highest volume medical interventions globally. Despite a high overall success rate with this operation, up to 1 in 3 patients remain dissatisfied following TKA. The reasons for this dissatisfaction include ongoing pain and functional limitation, which patients view as markers of poor outcome following surgery. Research indicates that the strongest predictor of patient dissatisfaction following TKA is unmet expectations. This is known to occur when patients and surgeons have different expectations of surgery. Decision making aids have been effective in aligning patient and surgeon expectations of surgery and improve health outcomes. This study will use a discrete choice experiment (DCE) as a type of decision making aid applied to patients prior to surgery to improve patient knowledge and realistic expectations of TKA. This study will test if this leads to greater health outcome and satisfaction amongst patients following TKA. 132 people with end stage OA on the waiting list for TKA will be recruited and randomly allocated to one of 2 groups using computer-generated block randomisation. A randomised controlled trial (RCT) adhering to CONSORT guidelines will evaluate the effect of applying a DCE prior to surgery on patient expectations, health outcomes and satisfaction following TKA. Patients in the intervention arm will complete a survey containing the DCE decision aiding tool, compared to the control group who will complete a modified survey that does not contain the DCE activity. Participants in both groups will be required to complete the survey prior to surgery during their routine pre-admission appointment at SVHM. Patients will also be required to complete a brief patient expectation survey 1-week prior to scheduled TKR. In addition, orthopaedic surgeons will complete a brief expectations survey for patients consented to TKA to compare matched surgeon and patient expectations for recovery following TKA. Primary outcomes will be evaluated by a blinded examiner at 12 months post-surgery using a validated self-reported pain and physical function scale. Secondary outcomes will include a range of validated measures of health and psychological wellbeing. All analyses will be conducted on an intention to treat basis using linear regression models. This study is the first of its kind to use this approach to elicit risk-benefit tolerance in surgery and to evaluate if guiding patients through a decision making process in the form of a DCE-based survey prior to surgery will improve patient expectations, health outcomes and satisfaction following TKA. Reducing the rate of patient dissatisfaction commonly seen in patients following TKA will help to reduce the burden associated with poor outcomes on the health system.

This is a parallel randomised controlled trial analysing the effect of adding a singular intra-operative platelet-rich plasma (PRP) injection into the gluteus medius tendon to current surgical standard of care consisting of endoscopic iliotibial band release and trochanteric bursectomy for recalcitrant greater trochanteric pain syndrome (GTPS). The singular PRP injection will be administered at the time of surgery while the patient is anaesthetised. The study aims to investigate whether adding PRP injection to surgery confers any additional reduction in pain and improvement in function compared to surgery alone. This study will be conducted as a randomised controlled trial with the control arm receiving the current surgical standard of care, consisting of endoscopic iliotibial band release and trochanteric bursectomy, without PRP. The experimental arm will receive the same surgical intervention but with an additional single PRP injection into the gluteus medius tendon. Our hypothesis is there will be an improvement in the experimental group with the addition of PRP. We are hoping this will result in a change in standard practice for this group of patients, whereby patients who undergo this operation receive PRP concurrently.

This neurobehavioural dysfunction, such as impaired driving ability, has a critical impact on health and society. Many individuals underestimate their impairment and there is wide inter-individual variability in how individuals are affected by sleepiness and its consequences. For example, some may report few symptoms while others with apparent mild disease exhibit severe sleepiness. Unravelling this problem of interindividual variability demands better assessment tools as conventional metrics such as sleep studies are uninformative. In this study, simulated driving and other performance tasks will be administered during a load of prolonged wakefulness extending throughout the night to unmask variation in neurobehavoural function. Performance under these conditions will be used to assess individual risk of vigilance failure such as impaired driving, and aid in the development of practically deployable biomarkers for predicting vulnerability to vigilance failure.

77% people demonstrate arm motor impairment following stroke, making everyday tasks like using a knife and fork, and doing up buttons, impossible for many. Around 67% of these people also experience impairment in their ability to sense touch and know where their limbs are in space. This project consists of training both movement and sensation with the aim of improving arm function for stroke survivors. This study will determine whether it is beneficial to deliberately do sensory and motor training together. If effective, the widespread implementation of COMPOSE training could potentially increase upper limb function of stroke participants worldwide, improving quality of life and capacity to to return to work, leisure and family roles. Participants will attend the Hunter Medical Research Institute in Newcastle for 4 sessions of measurements over 2 weeks, 10 sessions of treatment over 3 weeks, 1 measurement session immediately after the 3-weeks intervention and after 1-month.