ANZCTR search results

An international collaboration of investigators has been established with the aim of assessing the benefits and risks of polypill-based care compared with usual care in populations at high risk of cardiovascular disease (CVD). Several trials are planned, as the effectiveness and economic impact of a polypill-based strategy may vary substantially between countries, given the varying influence of the health-care system within which the intervention is delivered. Primary outcomes for the individual patient data meta-analysis will include self-reported current use of antiplatelet, statin, and combination (>= 2) blood pressure lowering therapy at 12 months, and change in systolic blood pressure (SBP) and total cholesterol from baseline to 12 months. Non-inferiority margins of 3mmHg for SBP and 0.3 mmol/L for total cholesterol have been pre-specified. Secondary outcomes will include change in cholesterol fractions, diastolic blood pressure and creatinine from baseline to 12 months, quality of Life, new onset diabetes mellitus, mortality (cardiovascular, non-cardiovascular and all cause) and a composite outcome of cardiovascular events (including all coronary heart disease events, heart failure events leading to death or requiring hospital admission, cerebrovascular events and peripheral arterial events).

It is anticipated that the evidence gathered in this study will identify gaps in service delivery and inform policy directions such as investment into prevention strategies and/or better management of existing services.

The aim of this group randomised control trial is to evaluate a school-based physical activity and sedentary behaviour intervention for adolescent boys living in low-income communities who are ‘at-risk’ of obesity. The multi-component intervention will include a range of strategies to increase students’ participation and engagement in physical activity. The intervention will also include strategies to support parents to reduce their child’s time spent in screen-based recreation. Primary outcomes are body mass index, waist circumference and body fat (bio-electrical impedance analysis). Secondary outcomes include physical activity (accelerometers), screen time, fitness, resistance training skill competency, social and emotional well-being and sleepiness. Hypothesized mediators of physical activity and sedentary behaviour will also be explored. Assessments will be conducted at baseline, 9- and 18-months.

The aim of the ALIGN study is to better understand patient’s attitudes, beliefs and risks concerns towards their systemic medication.The ALIGN study deals with the collection of information only and is not designed for drug testing. You will also be asked to complete four types of questionnaires and one visual analog scale which will take approximately 30 to 45 minutes. You will have the opportunity to seal your answered questionnaires in an envelope so that they are not disclosed to your treating doctor.

Frequently toe walking gait is most commonly the result of disease processes, trauma or neurogenic influences like Cerebral Palsy, Muscular Dystrophy or Autism Spectrum Disorders. Idiopathic toe walking (ITW) is by definition, the diagnosis of a tip toe gait adapted in the absence of a medical condition. Toe walking can be normal in children up until the age of 3. Persistent toe walking after 3 years of age should present to medical and allied health staff for comprehensive assessment. ITW is reported to be present in up to 12% of the population and has a strong hereditary link. Long term ITW is associated with reduced ankle range of motion. Reported treatments often includes serial casting, Botox and in some cases tendoachilles surgical lengthening to improve this range of motion at the ankle. In the adolescent and adult, reduced ankle range of motion is associated with forefoot pain, heel pain and reduced quality of life. Investigating the immediate impact of simple and non-invasive treatment options for children with ITW is important for future research and treating clinicians. This pilot study investigates the acute impact of current footwear, footwear and orthotics and whole body vibration stimulation on ITW. The GAITRite ('Registered Trademark') system will be used to measure if any one intervention improves heel contact.

Hearing voices (auditory verbal hallucination) is a potentially distressing and disabling experience which often persists in spite of treatment with medication. This pilot study examines whether it is helpful for people who hear voices to receive assistance in coping with this experience from someone else who hears voices and has adapted to living with this experience.

The purpose of this study is to investigate the effects of family supervised therapist-devised physical rehabilitation programs for adults with acquired brain injury (ABI) in an inpatient rehabilitation setting. The specific aims are to compare therapist-devised physical rehabilitation programs conducted by the family members to usual care for the following outcomes: Physical function for clients with ABI; satisfaction with the health care provided for the family members; mood for family members.

This study evaluates the effectiveness of a nurse-led educational clinic offered to patients within 5-7 days after having a procedure on their heart. The main aim of the clinic is to reduce patient anxiety after discharge from hospital. This study also aims to reinforce education on post-operative cares, risk and lifestyle modification, and encouraging medication adherence whilst improving access to secondary prevention programs. Through the provision of nurse-led clinical follow-up, support and education in the early post-discharge period, it is hoped that patients can achieve confidence and independence in their health-management, resulting in improvements in psychosocial and physical well-being.

This is a 2-stage, Phase I/II (3 + 3 dose escalation with an expansion phase), open label, single centre study to determine the safety, tolerability and preliminary efficacy of escalating doses of the experimental drug VAL-1000. Enrolled patients will have a bone marrow aspirate to determine the baseline blast count and to collect samples for correlative laboratory studies by the Investigator. This study is open to Male and Female subjects aged 18 years of age or over with Acute Myeloid Leukaemia, Acute Lymphoblastic Leukemia (ALL) or high-risk Myelodysplastic Syndromes (MDS), who are unsuitable for treatment with standard chemotherapy regimens. Further details on the inclusion and exclusion criteria for this study can be found in the relevant section of this form. Trial details In this study, you will be assigned to receive an ascending dose of 100mg, 150mg, 200mg up to 250mg of VAL-1000 daily via oral administration for 12 months, with three patients enrolled in each of these cohorts (study groups). The maximum dose you will receive may vary depending on the safety, tolerability and efficacy of the earlier doses of oral VAL-1000. Patients experiencing a Dose Limiting Toxicity (DLT) or disease progression will be taken off the study; other patients will continue to be treated daily with 50mg oral twice a day (100mg/day) VAL-1000. Further details of this treatment can be found in the Description of intervention(s)/ exposure field in this form, and may be discussed further with your treating clinician.

Distal radius fractures are among the most common fractures seen in the hospital emergency department. In recent years with the advent of low profile plating, open reduction and internal fixation (ORIF) using volar plates has become the surgical treatment of choice in many hospitals. However, it is currently unknown which plating systems have better clinical and radiological outcomes following surgery, and also the lowest complication rates. Few studies have compared different types of plates, which may have different plate and screw designs, features or may be manufactured from different materials (for example, stainless steel or titanium). This study will specifically investigate and compare the clinical and radiological outcomes and complication rates of two commonly used volar plating systems for fixation of distal radius fractures: one made from stainless steel (Trimed Volar Plate) and the other made from titanium (Medartis Volar Plate). This study will use a two group (intervention) blinded (blinded outcome assessor, blinded data analysis, concealed randomisation, blinded participant) randomised trial in an adult population. A suite of outcome measures recommended for this patient group will be used. These measures include an assessment of range of movement, strength, function (quickDASH and Patient Rated Wrist Evaluation), pain(VAS) , complications (medical chart and self-report), quality of life (EQ5D), radiological outcome (XRay) and patient satisfaction (VAS). These outcomes will be administered by a blinded assessor at seven time points: baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years.