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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.

Extracorporeal shockwave therapy (ESWT) is a new technology in the care of chronic non-healing wounds. The technology delivers high-energy pressure waves into the wound thereby enriching the ulcer with adequate blood through formation of new blood vessels. It also inhibits infection with its antibacterial property. Furthermore, it stimulates the body to produce natural growth factors which helps in repairing the damaged tissues of the wound. Recently, ESWT was reported to be effective in the initiation and acceleration of wound healing in various clinical settings including longstanding diabetic foot ulcers. The effectiveness of ESWT in wound healing, especially in treatment of diabetic foot ulcers has been demonstrated in numerous trials (1-2). It has been shown to be more effective value for money compared to hyperbaric oxygen therapy in management of chronic diabetic wounds (3). There are evidences demonstrating reduced length of stay for admitted patients when using this treatment model (3-4). Its safety profile has been proven in various studies (1-4). Numerous scientific investigations have been conducted on biological mechanism of action of ESWT in animals and humans and both proved to be safe and effective (5-6). Furthermore, it has been demonstrated that ESWT therapy achieves long-term healing results in diabetic wound care (7). Thus using this technology at The Townsville Hospital would likely improve the weighted activity unit per bed day figure for medical patients by increasing the total bed days saved, as that capacity will be filled by current access block / unmet demand of the chronic diabetic foot wounds at the hospital. In spite of these facts, ESWT technology has not been utilised in the care of diabetic foot ulcer patients in Australia in general and at The Townsville Hospital in particular. This is despite the fact that this technology is non-invasive, simple to use, well tolerated by patients, and only needs to be administered on fortnightly basis whereas even more invasive therapies need more frequent administration. Furthermore, ESWT is applied through an unfocused applicator which assures an almost painless treatment with no anaesthesia required and each therapy session only taking about 10 to 30 minutes. The main objective of this study was to evaluate wound healing rate and anti-inflammatory effect of shockwave therapy in subjects with diabetic foot ulcer at the Townsville Hospital, Australia. References 1. Wang C, Kuo Y, Wu R et al. J Surg Res. 2009; 152: 96-103. 2. Moretti B, Notarnicola A. et al. BMC Musculoskeletal Disorders 2009, 10:54, 1-8. 3. Wang CJ, Wu RW, Yang YJ. Diabetes Res Clin Pract. 2011 ;92(2):187-93. 4. Saggini R, Figus A, et al.. Ultrasound Med Biol. 2008 Aug;34(8):1261-71. 5. Mittermayr R, Antonic V, et al. Wound Repair Regen. 2012;20(4):456-65. 6. Kuo YR, Wang CT, et al. Wound Repair Regen. 2009;17(4):522-30. 7. Wang CJ et al. J Surg Res. 2014;189(2):366-72.

Recurrent or relapsing Clostridium difficile infection (CDI) is a significant and increasing health problem within Australia and a leading cause of gastrointestinal death within western countries. Standard antibiotic therapy has a high failure and relapse rate with further relapses becoming more likely. High quality studies published out of Europe have shown that faecal microbiota transplantation (FMT) for relapsing or recurrent CDI is highly efficacious and appears to be safe. However there is no data available for the use of FMT within an Australian population. We aim to recruit patients within Western Australia who have symptomatic recurrent or relapsing CDI having failed at least two courses of standard antibiotic therapy and offer them either a related fresh screen FMT or unrelated frozen screened FMT. FMT donors will be screen for a wide variety of infectious and non-infectious disease by a gastroenterologist and infectious diseases consultant. Their faecal microbiota will then be suspended, filtered and resuspended before delivery to the recipient's colon either via a colonoscope or via a nasogastric tube if the recipient has contraindications for a colonoscopy. Recipients will then be reassesed in the outpatient clinic at weeks 2, 12, 26 and 52 to assess their response to FMT and its safety.

Femoroacetabular (hip) impingement (FAI) is a painful condition that commonly affects healthy active younger adults. It can limit their ability to continue playing sport and perform normal daily activities. It can be related to extra bone formation at the hip joint known as a cam deformity. Physiotherapy is one treatment people may use to reduce their symptoms and improve their function. This study aims to investigate the feasibility of a randomised controlled trial (RCT) to reduce pain and improve function in people with FAI. The study will compare the effects of two different physiotherapy treatment interventions.

This is a parallel randomised controlled trial comparing operative versus nonoperative management for recalcitrant greater trochanteric pain syndrome (GTPS). While the majority of cases of GTPS improve significantly or resolve with nonoperative management, there is no evidence that compares operative to nonoperative management when the condition is deemed recalcitrant (after 6 months of symptoms). We are looking to investigate the natural history of the condition (what occurs when no treatment is given over a period of time). To do this, we are comparing nonoperative management consisting only of advice to continue your normal daily life with surgical treatment for the condition. Current surgical standard of care for recalcitrant GTPS consists of endoscopic iliotibial band release and trochanteric bursectomy. The study aims to investigate whether surgical intervention leads to reduced pain and improved function compared with continued nonoperative management in the treatment of recalcitrant greater trochanteric pain syndrome. This study will be conducted as a randomised controlled trial with the control arm receiving advice to continue along their daily life for the period of the trial. The intervention arm will receive the current surgical standard of care, consisting of endoscopic iliotibial band release and trochanteric bursectomy. Our hypothesis is there will be an improvement in the pain and function in the intervention group receiving the surgery compared to the control group. We are hoping this will result in a change in standard practice for this group of patients, whereby patients with severe recalcitrant GTPS symptoms undergo an appropriate intervention for their pain. At the end of the trial, any patients with ongoing pain despite the continued non-operative treatment will be offered the surgical treatment if they desire.