ANZCTR search results

The objective of this study is to provide supporting clinical evidence in particular with regard to the efficacy and safety of the AlCath Force ablation catheter and the Qubic Force device. It might reveal indicators for hidden risks and trigger further dedicated investigations or tests.

Recruitment of parturients will occur at the Royal Brisbane and Women’s Hospital (RBWH). There is increasing use of ROTEM(TM) for point-of-care coagulation monitoring in patients with massive haemorrhage, but there still remains limited data on reference ranges in normal pregnancies and subsequently limited understanding of the effects of complicated pregnancies on ROTEM(TM) interpretation. With the recent implementation of ROTEM(TM) within the RBWH, reference ranges for the obstetric population need to be established to optimise interpretation of derived values.

Recruitment of parturients will occur at the Royal Brisbane and Women’s Hospital (RBWH). There is increasing use of ROTEM(TM) for point-of-care coagulation monitoring in patients with massive haemorrhage, but there still remains limited data on reference ranges in normal pregnancies and subsequently limited understanding of the effects of complicated pregnancies on ROTEM(TM) interpretation. With the recent implementation of ROTEM(TM) within the RBWH, reference ranges for the obstetric population need to be established to optimise interpretation of derived values.

The objective of this trial is to assess the effectiveness and safety of L-theanine (an amino acid constituent of green tea [Camellia sinensis]) as an adjunctive therapy to treat GAD by conducting a phase II double-blind randomised controlled trial. It is hypothesised that L-theanine will be superior to placebo in reducing anxiety in participants with GAD.

This is a prospective, international multi-centre clinical study. The study will enrol a minimum of 1000 patients over a 36 month recruitment period between approximately 25 surgeons at 30 centres in Australia and New Zealand. The objectives of the study are: * To evaluate the clinical outcomes of the Saiph Total Knee Replacement and ensure that it performs as intended. * To compare the results of this study to the optimal clinical results of the design surgeons to ensure their results can be reproduced. The Saiph Total Knee Replacement (TKR) is intended for use as a primary total knee replacement device consisting of a femoral, tibial, tibial bearing and optional patellar component. The Saiph TKR is CE marked, TGA approved and has a rebate code on the Prostheses List. Clinical evaluations: Standard, functional parameters such as range of motion will be assessed preoperatively, and postoperatively at 6 weeks and at 6/12 months. Further clinical evaluations at 2 years and 5 years will be collected only for those patients that return to clinic for this review. Patient outcome assessments: The KOOS (Full Version), Oxford Knee Score (OKS), EQ5D and UCLA Activity Scale will be assessed preoperatively, and postoperatively at 6/12 months, 2 years and 5 years. Radiographic evaluations: Anterior and lateral X-rays will be analysed preoperatively, immediately postoperatively and at standard of care time points thereafter.

Patients with atrioventricular block and/or sinus node disease are commonly characterised by impaired functional capacity. Exercise training improves cardiorespiratory fitness, quality of life and measures of heart function. However, there is little evidence regarding the benefits of exercise training in patients requiring a pacemaker. This study will assess the benefits of exercise in this cohort, when compared with usual medical care.

Many cirrhotic men have reduced testosterone (T) levels. We recently found that testosterone deficiency is an independent predictor of death in this population. One possible explanation for this is that testosterone deficiency contributes to sarcopenia, a known risk factor for the development of both serious infections and mortality in cirrhotics. In a recent 12 month randomised study we showed that testosterone treatment has multiple short term beneficial effects in testosterone deficient cirrhotic men. These included improvement of sarcopenia, increased bone mass and increased haematocrit. However, this study was not powered to assess the effects of testosterone treatment on the major clinical endpoints linked to sarcopenia in cirrhosis of infection and death. We therefore propose to conduct a multi-centre randomised placebo-controlled trial (RCT) of 24 months T treatment in 250 cirrhotic men with a low T level (serum total T < 12nmol/L or free T < 230pmol/L) to investigate whether T treatment will reduce the composite outcome of mortality or hospitalisation for infection. Primary hypothesis: In cirrhotic men with low testosterone, T therapy will reduce the composite outcome of mortality or hospitalisation for infection, a major trigger for decompensation in chronic liver disease Secondary hypotheses: T treatment will improve the following measures: total numbers of days in hospital, muscle mass, muscle function, bone mass, fat mass, insulin resistance, haemoglobin and quality of life Aim: To conduct a 2-year, multi-centre, randomised, double-blinded, placebo-controlled trial to determine if T treatment together with dietary and exercise advice improves outcomes in men with cirrhosis.

Obesity is common in older persons and predisposes to physical disability and loss of independence. After a hospitalisation for an illness or surgery, older people may have to go to a rehabilitation ward to get back to their previous abilities in their home and environment (ie their physical function), to be able to do everything they could do previously. Older people who carry a lot of extra weight may be at increased risk than others in the same age group of not being able to get back to their previous abilities after going to hospital, or it may take longer for them to get back to their previous state. Recent research has found that rapid, significant weight loss achieved with Very Low Energy Diets (VLEDs) were safe and effective in improving physical function. This treatment may be useful for improving the function of older, obese people who are on the rehabilitation ward, but we have not tested weight loss with a VLED in this situation. We would like to see whether it is possible to get people to start a weight loss program while a rehabilitation inpatient, and continue it for 12 weeks, even if they go home during that period. We would like to see which approach leads to better and/or faster improvements in physical function; usual rehabilitation care plus general healthy eating advice (ie the care people receive now) or usual rehabilitation care plus weight loss with a VLED. We will offer certain patients aged between 50 and 80 years of age who have a BMI between 40 and 60 the opportunity to join this study, the doctor on the ward will assess whether the study is suitable for the particular patient. Patients who meet the criteria (the “inclusion criteria”) and agree to be in the study will be randomly allocated to either the VLED group or the healthy eating group in addition to usual rehabilitation care – for every 2 patients allocated to the VLED group, one will be allocated to the healthy eating group.

BACKGROUND: Hybrid closed-loop (HCL) insulin delivery, with automatic glucose sensing and insulin delivery reducing patient intervention, offers the potential to improve glycaemic control compared to conventional therapy in patients with type 1 diabetes. Superior glucose control has been demonstrated with lower rates of hypoglycaemia in many in-clinic studies, diabetes camp studies, hotel studies, and now in the first emerging short term outpatient studies using HCL systems. The primary rationale is to assess glycaemic control with the use of the HCL system versus standard therapy (either injections or standard pump therapy), including time in target range, as well as glycaemic excursions either hypoglycaemia or hyperglycaemia. We will explore the impact of this system on fear of hypoglycaemia and quality of life and other psychological measures. We seek to quantify the economic impact of HCL compared to standard therapy for translational purposes. AIM: To compare the proportion of time spent in target glycaemic range (sensor glucose level 3.9 - 10 mmol/l) while using HCL or using standard therapy (MDI and CSII). METHOD: Multi-centre randomized controlled trial in 160 patients aged 12 – 25 years with type 1 diabetes, comparing HCL with standard therapy (MDI or CSII) for 6 months. OUTCOMES: The primary outcome is the difference in the proportion of time the sensor glucose level is in target range (3.9–10 mmol/L) during HCL insulin delivery vs standard therapy (MDI and CSII), measured 23-26 weeks post-randomisation.

The impact of patellar tendinopathy is underestimated as many athletes continue to participate with pain that affects performance in games and capacity to train. This study aims to determine if we can change the natural history of pain and impaired performance with exercise;