ANZCTR search results

The aim of the study is to assess the safety and efficacy of chemotherapy treatment with a combination of erlotinib and vemurafenib in patients with BRAF V600E mutant colorectal and non-small lung cancer. Who is it for? You may be eligible to join this study if you aged 18 years or more and have a confirmed diagnosis of metastatic colorectal cancer or non-small cell lung cancer with a BRAF V600E mutation of your primary cancer or related metastases. Study details: There are two parts to this study. In the first part, participants with metastatic colorectal cancer will be treated with erlotinib and vemurafenib daily until disease progression or unacceptable toxicities. Both of these chemotherapy drugs are administered in tablet form and taken orally. The dose administered will be increased in subsequent patient groups in order to determine the maximum tolerated dose to be used in the second part of the study. Patients with metastatic colorectal cancer or non-small cell lung cancer are eligible for the second part of the study. They will also be treated with oral erlotinib and vemurafenib daily until disease progression or unacceptable toxicities. All participants will be regularly monitored and assessed for a period of up to 18 months in order to evaluate the safety and efficacy of treatment.

This study aims to investigate the feasibility and tolerability of stereotactic ablative body radiosurgery in patients with oligometastases from breast cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a confirmed primary diagnosis of breast cancer, with evidence of 1 to 3 bone metastases. Study details: Stereotactic ablative body radiotherapy (SABR) is a new form of cancer treatment involving high precision radiotherapy. Standard radiotherapy treatment is usually delivered in small doses over many treatments (usually 5 to 20 treatments). SABR treatment is different as it uses a dose of radiation delivered in 1 or 2 treatments that is much higher than standard radiotherapy dosages with the aim of destroying all cancer cells at the site of treatment. The total dose of radiation may be 5-10 times higher than standard radiotherapy doses. SABR treatment appears to be effective in controlling cancer in other sites elsewhere in the body, including the lung, kidney and the liver. All participants in this study will be treated with SABR delivered in 1-3 sessions of 45-90 minutes duration. Participants will be regularly monitored during treatment and for a period of up to 24 months post treatment in order to evaluate the feasibility and tolerability of treatment, as well as treatment response.

An investigator-initiated and conducted, international collaborative, regionally organised, multicentre, prospective, cluster randomised, crossover, blinded outcome assessment study to compare the effectiveness of the lying flat (0 degree) head position with the sitting up (greater than 30 degrees) head position, in the first 24 hours of admission to hospital for patients with acute stroke, on the poor outcome of death or disability over the subsequent 90 days.

This is a randomized cross over trial. Patients with type 1 diabetes will have their glucose levels controlled by either a closed loop (artificial pancreas) system, or sensor augmented pump therapy with low glucose suspend. During closed loop patients will still use the bolus function of their pump for meals. The study will start in hospital for 2 days and nights, and then the participants will continue in the home for a further 5 days. Then, after a washout for at least a week, they will cross over to the opposite intervention for a further 7 day period. Our primary outcomes are the ammount of time spent euglycaemic (3.9 - 10mmol/L), and hypoglycaemic events (<3.3mmol/L). We will recruit 14 participants.

The risk of developmental delay in the preterm population increases as gestational age decreases. As milder delays often go undetected, the challenge in premature infant follow up is early detection without over servicing. The primary aim of this study is to determine if early clinical assessment completed by 16 weeks post term will allow robust prediction of typical development and mild developmental delay at 2 years corrected age. Earlier prediction will enable clinicians to safely plan discharge for low risk infants from follow up services and facilitate the prioritisation of resources towards infants identified as likely to have mild to moderate or more severe outcomes. As developmental progress is dependent upon many variables, a combination of clinical tools including neurological assessment, motor assessment and parent questionnaires will be used to predict outcome at 2 years. Likewise a comprehensive selection of outcome measures will be used at 2 years to enable identification of subtle delays. Early findings will be compared to development at 2 years corrected age to determine any predictive relationship for typical outcomes and mild developmental delay. As families, clinicians and health services continue to want and need more immediate information regarding the short and long term outcomes of preterm infants, finding the best clinical biomarkers has the potential to streamline and effectively prioritise premature infant follow up programs.

This study will assess the safety and PK of single and multiple doses of the oral drug NP202 in healthy volunteers. Results from this study will help determine the development of NP202 as a treatment for preventing cardiac remodelling post acute myocardial infarction.

This study aims to investigate the efficacy of stereotactic ablative radiation therapy for treatment of Stage I non-small cell lung cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a diagnosis of Stage I non-small cell lung cancer. You must be able to lie flat and comply with the requirements of simulation and treatment. Participants in this study will be treated with stereotactic ablative radiation therapy with one of three dose and fractionation regimens. For peripheral lesions treatment dose will be 48 Gy in 4 fractions or 54 Gy in 3 fractions, depending on tumour size. For central lesions 50 Gy will be administered in 5 fractions. Overall treatment duration will vary from 11 – 14 days. Local control at 24 months is the primary endpoint of the study and is assessed by CT scans. Patients will be followed up until 5 years post treatment. A total of 100 patients will be recruited in this study.

Obstructive sleep apnea (OSA) is a condition consisting of intermittent upper airway obstruction during sleep, leading to periods of hypoxia (reduced oxygen levels) and acute hypertension (high blood pressure). It has been hypothesized that in OSA, physiological changes can result in retinal ischemia (restriction in blood supply to tissues) and associated retinal vascular changes and progression of glaucomatous damage to the optic nerve. In a previous study, we did not find an increased prevalence of optic disc edema or other optic neuropathies in the OSA population. However, retinal vascular changes were more common in patients with severe OSA, independent of blood pressure, suggesting that OSA patients should undergo ophthalmologic screening. Despite this, the risk for various ocular disorders among patients with OSA remains unclear, particularly because in prior studies only static (single) measures of retinal vessels were considered. Additionally, these studies did not adequately control for potential confounders of these associations, such as obesity and hypertension. The aim of the current study is to investigate dynamic (real time videos) retinal vasculature characteristics in OSA patients and determine any associated changes of the retina in this group of patients. This will provide a new-insight into specific OSA related changes in the eye.

We aim to develop a smartphone application (app) for supporting weight loss maintenance and evaluate the efficacy of the app in a 12 week clinical trial with 12 week follow up. The overall objective of this project is to develop and validate our app which aims to support people to maintain the weight losses they have achieved.

The purpose of this study is: 1. To determine whether Novel Transforming Powder, Altrazeal (TM) dressing will consistently reduce patient’s experience of pain compared with Calcium Sodium Alginate, Kaltostat (TM). 2. To determine if there is a difference in rate of healing of the donor site between Novel Transforming Powder, Altrazeal (TM) and Calcium Sodium Alginate, Kaltostat (TM). 3. To compare Novel Transforming Powder, Altrazeal (TM) and Calcium Sodium Alginate, Kaltostat (TM) dressings in terms of cost-effectiveness, wound infection rate and cosmetic outcome.