ANZCTR search results

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).

To determine whether contact lenses coated with melimine can be worn safely and prevent bacterial colonization of their surface. Both the dispensing optometrists and contact lens wearers will be masked.

This pilot study aims to develop a new approach to improve protection against pneumococcal disease, using a probiotic (Bifidobacterium Bi-07) to boost immune responses to and reduce invasion by the pneumococcal bacteria. We are particularly interested in whether Bifidobacterium lactis Bi-07 given early in life, together with vaccination, can improve protection against pneumococcal infection and therefore reduce disease. This study will involve 30 babies and the use of Bifidobacterium lactis Bi-07 is currently experimental.

This study will evaluate whether a simple eye test could detect Alzheimer’s disease earlier than current techniques. We have already found some changes to the blood vessels in the retina, at the back of the eye, in Alzheimer’s disease. This new study will investigate if amyloid plaques, the hallmark of Alzheimer’s disease in the brain, also occur in the retina. A specialised eye camera will be used to take photographs of the retina. In order to highlight amyloid plaques in these photographs, participants will be asked to take a pudding containing Curcumin once per day for 7 days. Curcumin, the main ingredient of the common food spice turmeric, has been reported to have many beneficial health effects, and is being tested in other trials for possible therapeutic benefit in Alzheimer’s disease. Curcumin also has molecular and optical properties that may enable us to image amyloid plaques and hence detect Alzheimer’s disease earlier. It is hoped that this technique could allow us to detect Alzheimer’s disease before the cognitive signs become apparent, hence participants with normal cognition as well as those with memory problems and diagnosed Alzheimer’s disease will be recruited for this study.