ANZCTR search results

Based on the results from our PiPIN trial (REC 1774/12/08, ACTRN12606000525583) - where increasing the protein content of human milk fortifier resulted in a borderline significant increase in length gain (P=0.08) but a significant reduction in SGA for length in preterm infants – we hypothesise a higher level of protein is required to meet the growth needs of preterm infants. In this study we wish to increase the protein fortification to 1.8g protein/100ml breast milk compared with standard fortification 1g/100ml. A novel aspect of this study is that we will deliver an ‘entrée’ of fortifier directly through the naso-gastric tube rather than mix the fortifier in expressed breast milk as is current practice. Our novel approach allows direct breast feeds to be fortified. Currently when babies feed directly from the breast their feeds are not fortified contributing to the growth deficits seen in breast fed preterm infants. This study will therefore test the effect of increasing the protein content of human milk fortifier on growth and the feasibility of delivering a fortifier solution directly to the infant.

Surgery on the hip joint is common but the provision of pain relief during and after the operation is challenging, especially since the patients are often frail and elderly. Injection of a local anaesthetic drug near to the nerves that supply the hip (a ‘nerve block’) can be very effective but a number of different nerves supply the skin over the hip joint and blocking the whole of the surgical wound is difficult. We plan a pilot study to map out the distribution of achievable pain relief when the lateral femoral cutaneous nerve (LFCN) is blocked under ultrasound guidance and relate this to the usual site of surgical incision for a variety of hip operations. This will indicate whether the block could provide reliable and effective pain relief to a predictable area of the hip.

The study will be recruiting patients with colorectal cancer with liver metastases (CRC-LM) or patients with hepatocellular carcinomas (HCC). The inclusion and exclusion criteria for both CRC-LM and HCC patients can be found in the relevant sections. This study involves the temporary surgical implantation of a large bore access port (a peripheral access system) in the common femoral artery or the subclavian artery. This procedure will take approximately 2 to 3 hours. You will undergo an operation to have the vascular access device implanted prior to receiving chemotherapy treatment sessions. The chemotherapy treatment sessions will subsequently be given as part of the treatment regime determined by the clinical investigator based on clinical observations. Depending on your response, you will be administered with the liver isolation chemotherapy treatment between 3 to 8 times during the month the device is implanted. After you the final chemotherapy treatment and on the same day, you will then undergo a second operation to remove the device.

The purpose of this study is to conduct a small, translational research trial in a group of men with prostate cancer, to determine the whole-genome effects of lycopene supplementation.

Asthma is a common condition and severe and difficult-to-treat in up to 5-20% of patients. Vocal cord dysfunction (VCD) is a disorder characterised by inappropriate closure of the vocal cords during respiration. Numerous asthmatics have VCD co-existing with asthma. Recent studies have detected VCD in as many as 50% of cases with Difficult-To-Treat-Asthma. Botulinium Toxin has been shown to effectively reverse the detrimental effects of VCD. This study looks at two hypotheses: 1. That in patients with VCD and DTTA, botulinium toxin treatment reduces VCD compared with saline control; 2. That in patients with VCD and DTTA, botulinium toxin treatment is associated with improvement in symptom-based, but not physiological, measures of asthma control, compared with saline control.

The incidence and severity of chemotherapy-induced nausea and vomiting (CINV) in patients receiving R-CHOP chemotherapy for in non-Hodgkin’s lymphoma is not well documented. The contribution of prednisolone to CINV control in the R-CHOP regimen is also unclear. This study aims to evaluate the overall effectiveness of antiemetic control using a standardised 5HT3 antagonist-containing regimen (e.g. ondansetron) in a heterogeneous group of patients receiving R-CHOP chemotherapy.

There is experimental human and animal data to support a role for bacteria and / or bacterial products in the cause of inflammatory bowel disease (IBD), especially Crohn’s disease. Furthermore antibiotics have been shown in some cases to provide beneficial effects in IBD. In the last few years there has been increasing interest in probiotic agents in the treatment of various gastrointestinal conditions. The aims of this trial are to 1) determine the efficacy of probiotic therapy upon clinical parameters in children with IBD 2) determine the efficacy of probiotic therapy upon quality of life parameters in children with IBD 3) define the effects of probiotic therapy in children with IBD upon markers of inflammation both standard and novel 4) define the effects of probiotic therapy in children with IBD upon gut bacteria and 5) to document the tolerance and acceptability of probiotic therapy in children with IBD

There is experimental human and animal data to support a role for bacteria and / or bacterial products in the cause of inflammatory bowel disease (IBD), especially Crohn’s disease. Furthermore antibiotics have been shown in some cases to provide beneficial effects in IBD. In the last few years there has been increasing interest in probiotic agents in the treatment of various gastrointestinal conditions. The aims of this trial are to 1) determine the efficacy of probiotic therapy upon clinical parameters in children with IBD 2) determine the efficacy of probiotic therapy upon quality of life parameters in children with IBD 3) define the effects of probiotic therapy in children with IBD upon markers of inflammation both standard and novel 4) define the effects of probiotic therapy in children with IBD upon gut bacteria and 5) to document the tolerance and acceptability of probiotic therapy in children with IBD

This study aims to determine the impact of a home based exercise program on cancer related fatigue in patients receiving radical radiotherapy for the treatment of breast cancer. Who is it for? You may be eligible to join this study if you are a woman with breast cancer who has been prescribed radical radiotherapy treatment for 3-6 weeks. Trial details. Participants in this trial will be randomly (by chance) allocated to one of two groups. One group will receive a home based exercise program which involves resistance (e.g. movements performed against resistance), aerobic (e.g. walking, jogging, cycling) and flexibility (e.g. stretching) exercises performed for a 9-12 week period during and after radiotherapy. The other group will be assigned to usual care (e.g. no treatment) for a 9-12 week period during and after radiotherapy. Participants will complete questionnaires assessing fatigue, quality of life, physical activity levels and physical activity motivation on 4 occasions (before starting radiotherapy, after finishing radiotherapy, 6 weeks after finishing radiotherapy and 6 months after finishing radiotherapy).

This study uses a newly­ developed spinal cord stimulator and measurement system. The aims of the study are: 1. To determine if the nerve response to stimulation recorded from the spinal cord can be used to maintain the stimulation at a constant and comfortable level for the patient. 2. To make measurements from the spinal cord to optimise the stimulator settings automatically. 3. To determine different stimulation patterns to provide pain relief without the patient feeling the stimulation. 4. To determine if a patient’s pain can be detected from the nerve signals measured in the spinal cord.