ANZCTR search results

This randomised controlled trial will evaluate the effectiveness of a 12-week heart failure rehabilitation program that is delivered into the homes of patients via telerehabilitation (Telerehabilitation Group) compared to a 12-week program delivered in the face-to-face manner (Conventional Group).

Bronchiolitis is the leading cause of paediatric hospitalisation in Australia accounting for approximately 8000 admissions annually, of which approximately 500-600 are admitted to a paediatric intensive care unit (PICU) requiring respiratory support. There have been numerous attempts and studies over the last three decades investigating the roles of steroids, salbutamol, adrenalin and inhalation of hypertonic saline in infants with bronchiolitis. None have successfully changed the outcome of the disease or the burden on health care systems. High flow nasal cannula (HFNC) therapy has been used over the last 8 years in paediatrics with reports showing a reduction in the need for non-invasive and invasive ventilation. HFNC reduces the work of breathing, improves the gas exchange and can be applied very early in the disease process as there is little interference with the patients comfort. Despite the existing data, the uptake of HFNC therapy in paediatrics is sporadic. This is, in part, due to a lack of “best practice”. Similarly, many centres do not use the HFNC for bronchiolitis as there are opposing report about its benefit and a lack of consensus on how to use it. This study aims to develop a multi-centre trial and to assess which patients with bronchiolitis benefit using HFNC. For this purpose we will perform a randomised controlled trial comparing current best practice versus HFNC therapy. With the introduction of this simple to use respiratory system in regional hospitals we aim to reduce the need to transfer infants with bronchiolitis to tertiary centres.

This study is examining whether inserting gold markers (known as fiducial markers) into a tumour may aid surgical and chemotherapy response assessment in patients with oesophageal-gastric cancer. Who is it for? You may be eligible to join this study if you are aged over 18 years and have been diagnosed with biopsy proven primary (non-recurrent) squamous cell carcinoma (SCC) or adenocarcinoma of the stomach. Trial details: All participants in this trial will have 2-4 tiny gold markers (known as fiducial markers) inserted into the tissue beside their tumour during endoscopy. Endoscopy involves having a tube inserted into the back of the throat and takes about 30 minutes. Each gold marker is approximately the size of a grain of rice (1mm x 3mm). Having gold seed locators makes it easy for the surgeon or the radiotherapist to know exactly where to operate or irradiate because they show up clearly on the PET Scan, CAT Scan and Radiation Treatment machine. If the tumour shrinks very well with chemotherapy then the Pathologist may not know exactly where to find the tumour in the tissue removed. This can make it very difficult to provide a precise report and hence the need for any follow-up treatment after surgery. This study will not affect routine treatment in any other way. We wish to study approximately 20 patient’s scans and pathology reports to see exactly how much improvement we get in correlating these gold markers with scan results. At the moment there is no good information to show that they consistently improve accuracy of treatment for stomach and oesophageal tumours. We have good information over the last 40 years that gold marker seeds improve accuracy in Head and Neck Cancer and Cervical Cancer. Over the last 10 years they have become indispensable in Breast Cancer (titanium markers rather than gold) and particularly in prostate cancer radiotherapy, where gold seeds have reduced radiotherapy side effects massively in tens of thousands of men worldwide. Based on this information we expect that there will be benefits in the stomach and oesophagus as well.

This study will assess the safety and PK of the oral drug FT011 in healthy volunteers and in a small number of patients with diabetic nephropathy due to type 2 diabetes mellitus. Results from this study will help determine the development of FT011 as a treatment for diabetic nephropathy.

This study is examining the safety and biological effects of combining Ipilimumab and radiotherapy, or combining Ipilimmab, Nivolumab and radiotherapy in patients with metastatic melanoma. Who is it for? You may be eligible to join this study if you are aged over 18 years and have been diagnosed with advanced melanoma stage IIIc or IV. Trial details 6 participants in this trial will undergo 5 daily doses of radiotherapy during week 1. They will also receive Ipilimumab at a dose of either 3mg/kg or 10mg/kg at weeks 1, 4, 7, and 10. This drug will be administered intravenously (i.e. directly into the vein) over a period of 90 minutes. 24 patients in this trial will undergo 5 daily doses of radiotherapy during week 1. They will also receive Nivolumab at a dose of 1,g/kg together with Ipilimumab at a dose of 3mg/kg at weeks 1, 4, 7 and 10. This group will also receive Nivolumab 3mg/kg every 2 weeks after as maintenance. These drugs will be administered intravenously (i.e directly into the vein). Participants will be reviewed for up to 24 months in order to determine treatment toxicities, tumour response, and immune response.

The study is trying to find out which is the best way to deliver a medication for pain relief called a local anaesthetic (a drug that helps to numb areas of the body e.g. the skin) to the abdominal wall in patients undergoing major abdominal surgery in order to help reduce the post-operative pain.

The study aims to evaluate the effect of an LLD (Limb length discrepancy) using a modern measure of foot position; the Foot Posture Index (FPI).

This is first-in-Man study involving 32 healthy adult male subjects. Overall purpose of the study is to assess safety of pegylated human erythropoietin & tolerability in terms of plasma concentrations in normal male healthy volunteers.

Alcohol Dependence is a disorder with multiple adverse health and social impacts. Recent research has suggested that some of the ongoing tendency for relapse to heavy drinking is a consequence of pre frontal lobe dysfunction. An established marker of this dysfunction is high frequency beta electroencephalogram dysfunction. This pilot trial is designed to establish if the medication, baclofen, reduces this electroencephalographic marker. This medication has been used widely for this purpose in Australia and other countries based on empirical observations of its benefit for alcohol dependence. This study will hopefully further elucidate its mechanism of action in this condition.

Induction of labour is very common and may be associated with increased obstetric intervention. Information which helps guide the best approach to induction would potentially benefit many women and may help reduce healthcare costs. It is proposed to conduct a randomised controlled trial of women undergoing induction of labour who have commenced induction with a single dose of intravaginal Prostaglandin gel (PGE2). Women would be randomised to PGE2 arm (continue to administer further doses of PGE2 until the cervix is ripened and then perform an artificial rupture of membranes (ARM) and commence Syntocinon infusion to induce contractions) or the ARM group (perform ARM immediately or as soon as technically possible, followed by Syntocinon infusion to induce contractions).