ANZCTR search results

This study will determine the safety and tolerability of PG545 in combination with Nivolumab in patients with advanced solid tumours or metastatic pancreatic cancer. Who is it for? You may be eligible to join this study if you are aged 18 years old or above and have a non- haematological, malignant solid tumour (for Stage 1) or metastatic adenocarcinoma of the pancreas (for Stage 2). Study details This study has two stages: Stage 1 to establish the maximum tolerated weekly dose of PG545 intravenous (IV) infusion in combination with fortnightly Nivolumab IV infusion, and stage 2 to safety and tolerability of the recommended dose from stage 1 of PG545 IV infusion in combination with fortnightly Nivolumab IV infusion. Treatment in both stages will continue until disease progression, unacceptable toxicity or participant withdrawal. Participants will be regularly assessed throughout the study in order to monitor safety and tumour response. It is envisaged that the combination of PG545 and Nivolumab will improve on the limited treatment options currently available for patients with pancreas cancer. Once demonstrated to be safe, the combination can then be explored in larger clinical studies in pancreas cancer and other tumour types.

The goal of this study is to investigate whether commercially available UV indicating stickers are acceptable to users and encourages sun protection. Commercially available cosmetic products have been developed and marketed direct to consumers, which use a UV light activated (photochromic) ink to illustrate that sunscreen is no longer protecting their skin adequately. To assess this product and if it adds any benefit for future public health programs we are conducting a study at the Ashes Cricket Test at the Brisbane Cricket Ground, commonly known as the Gabba, which is a major sports stadium in Brisbane. The event is being held November 23rd – November 27th 2017. The researchers will be at the venue entry and will ask interested members of the public to consent to participate before they enter the stadium. Participants in the intervention group will be asked to complete a brief baseline survey and be provided with 1 sticker and sunscreen. After using the sticker at the cricket, participants will be emailed an evaluation survey to complete. Participants will have 7 days after using the sticker to complete the evaluation survey. A comparative control group will be provided with sunscreen only (no stickers).

This study will determine the effect of stereotactic ablative body radiotherapy (SBRT) with endoscopic ultrasound inserted fiducial markers for unresectable pancreatic cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have adenocarcinoma of the pancreas which has been deemed inoperable and are planning for treatment with combined chemotherapy. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive chemotherapy only In this trial, patients receive a FOLFIRINOX based regime given over a 4 month period (oxaliplatin, irinotecan, leucovorin, fluorouracil every 2 weeks, totalling 8 cycles). While participants in the other group will receive chemotherapy of Folfirinox based regime and they will also receive 2 weeks of Capecitabine as a radio-sensitizer (850 mg/m2 twice daily for 5 days of each week (Monday to Friday)), prior to fiducial guided SBRT (25Gy in 5 fractions delivered to gross tumour and simultaneous integrated boost of 35Gy in 5 fractions to region of vessel encasement). Participants will be followed-up for up to 12 months post-completion of treatment to determine survival rates, resectability rates, technical success of fiducial placement, pain and quality of life. The use of radiotherapy, either alone or in combined with chemotherapy, has been evaluated in the past but evidence is limited due the lack of ability to deliver the radiation to the pancreatic mass without causing adverse effects to surrounding organs. One of the approaches to overcome this problem is to use marker-guided stereotactic radiotherapy, which is increasingly applied in the field of radiation oncology. The majority of studies have looked at technical success and safety rather than patient survival and quality of life.

Managing pain and distress for hospitalised children undergoing medical procedures is very important as it reduces the occurrence of paediatric medical traumatic stress and other significant negative outcomes (Lindeke et al., 2006). Evidence has shown that non-pharmacological interventions such as distraction are a highly successful method in reducing distress and pain in adult and paediatric patients. At present, paediatric patients undergoing painful procedures do not routinely receive distraction therapy due to limitations such as time. With modern technology rapidly evolving, research designed to assess the effectiveness of child-led distraction using a tablet computer in reducing distress and pain in children undergoing painful medical procedures is essential. Through exploring this, a valuable contribution may promote the therapeutic practice and improve health care outcomes for children and their families. The results of this study will assist in determining whether child-led distraction through the use of a tablet computer (Apple iPad) reduces distress, pain and procedural time by incorporating a wide range of distraction methods in one convenient and cost-effective device.

Comparing the use of ultrasound for cannulation of arteriovenous fistula for haemodialysis compared to the standard practice of cannulating 'blind' (without assistance of ultrasound) and measuring the outcomes in relation to the amount of success with each condition and the needle tip position inside the vessel. All nurses in the study will cannulate all patients with both ultrasound guided cannulation and blind cannulation.

Using Community-Based Participatory Research (CBPR) methods, the completed first Phase of the Early Start to Self-Regulation project engaged key stakeholders in formative research (Phase 1; HE2017/029) to inform the design and piloting of a self-regulation intervention (Phase 2; HE2017/347). This next phase involves implementation and evaluation of our self-regulation program (Phase 3). Phase 3 will involve recruiting 50 pre-school centres, half of which will implement the PRSIST self-regulation program while the other half continues with normal practice. Data on children’s self-regulation, as well as related abilities, will be collected from participating children before and after implementation of the program to evaluate its impact. Data will also be collected from participating educators regarding their perceived self-regulatory knowledge, attitudes and self-efficacy related to self-regulation, both before and after the program, to evaluate change.

Non-immune people exposed to hepatitis A are recommended to receive either hepatitis A vaccine or normal immunoglobulin (which contains hepatitis A antibodies), with the latter recommended for those in the most vulnerable groups. We have previously completed a pharmacokinetic modeling study using published data to estimate the minimum dose of hepatitis A antibodies that would be protective against hepatitis A up to day 50 after injection. This modeling study supported the hypothesis that the current national guideline provides insufficient antibodies for people who weigh over 85kg. The current study seeks to validate these modelling results in order to recommend the optimal dose of normal immunoglobulin for the prevention of hepatitis A. This study will compare the level of antibodies present in blood as a result of passive immunisation with the recommended dose of normal immunoglobulin to the level of antibodies in blood as a result of dosing by weight with the same product in healthy adults. To do this, we will conduct a randomised controlled trial where the usual care group will receive 2mL normal immunoglobulin irrespective of weight, and the test dose group will received 0.025mL/kg to a maximum of 5mL of normal immunoglobulin. Blood samples will be taken from both groups at days 0, 1, 3, 7, 28 and 50 and the groups mean hepatitis A antibody titres compared.

The aim of this study is to compare treatment informed by ctDNA results to standard care in patients with stage III colon cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or more and have undergone curative surgery for stage III colon cancer. Study details All participants in this study will have a blood draw during week 5-6 post surgery for ctDNA analysis. They will then be randomly allocated to one of two treatment groups. One group will receive standard of care treatment as selected by their clinician: either no chemotherapy, single agent fluoropyrimidine chemotherapy or combination fluoropyrimidine plus oxaliplatin chemotherapy. Treatment selection in the other group will be informed by ctDNA blood test results. All patients will be followed up every 3 months for 2 years, then every 6 months for 3 years in order to evaluate treatment safety and efficacy. Follow-up involves additional blood tests and radiological assessments. It is hoped that the findings from this study will demonstrate that using ctDNA results to help make a decision regarding adjuvant chemotherapy is not inferior to standard of care in terms of recurrence-free survival.

The primary purpose of the study is to determine the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of PXS-5382A after oral administration SAD This is a randomised, double-blind, placebo controlled, dose escalating study with single ascending dose of PXS-5382A. There will be 6 cohorts consisting of 8 subjects each. Subjects within a cohort will be randomly assigned to one of the two groups (PXS-5382A or placebo) in a 3:1 ratio respectively. Sentinel dosing will be conducted for each cohort, such that; Sentinel dosing – Total N = 2, where N=1 = PXS-5382A N=1 = Placebo Main Cohort – Total N = 6, where N=5 = PXS-5382A N=1 = Placebo Doses will be escalated across the cohorts but not within each cohort. The starting dose and incremental dose increase through the cohorts has been determined based on the results of the pre-clinical studies. MAD Multiple ascending doses of PXS-5382A will be assessed during the MAD phase of the study. Within each cohort, each subject will be randomly assigned to one of the two groups (PXS-5382A or placebo) in a 3:1 ratio respectively wherein each subject will receive the active drug or placebo once daily. The doses and dosing duration chosen for MAD will be based on evaluation of the PK data and all safety information as well as any other relevant data that is available from the SAD phase

Obesity has reached epidemic proportions globally and is associated with serious co-morbidities, including type 2 diabetes. Once adipose tissue has been accumulated, and food intake is limited by low calorie diets, counter-regulatory mechanisms induce an increase in appetite and a decrease in energy expenditure, which makes weight loss very difficult to maintain. To combat the global burden of obesity and its co-morbidities, a major challenge lies in the development of effective therapies that increase fullness and satiety, and result in improvements in blood glucose control, while lacking adverse effects that are often associated with current therapies. There is increasing evidence that nutrient stimuli in the gastrointestinal tract play a central role in the control of energy intake and blood glucose. Proteins, and their building blocks, amino acids, are of interest, as high-protein diets are very effective for weight loss, particularly loss of fat, rather than muscle mass, and for improving postprandial glycaemic control, in obese individuals with and without type 2 diabetes. There is some evidence that a number of amino acids (including L-tryptophan) also have effects on energy intake, blood glucose and gut function in humans. We have previously investigated the effects of intraduodenal tryptophan and found that its effects to reduce subsequent energy intake were related to plasma cholecystokinin and tryptophan concentrations prior to the test meal. Thus, amino acids, here specifically tryptophan, may represent potential therapeutic approaches for obesity and type 2 diabetes. We have recently evaluated the effects of intragastric tryptophan at 3 g on gastric emptying, blood glucose, gut hormones, and appetite following a mixed-nutrient drink. Energy intake at a subsequent buffet style meal was also assessed. L-tryptophan slowed gastric emptying in both lean and obese groups. While overall energy intake was not affected, there was a decrease in energy intake in approximately half the subjects of each group, but less so in the obese. In the lean group, energy intake was found to be related to elevated concentrations of plasma tryptophan. A limitation of this study design may have been too long a duration between tryptophan administration and the meal at which energy intake was assessed (1 hr 15 min), thus mitigating the overall effect on energy intake. This new study has been designed with a shorter duration between tryptophan administration and buffet meal (30 min) and will investigate the effects of intragastric administration of L-tryptophan, vs saline control, on energy intake at a subsequent ad libitum buffet style meal, and the relationship with plasma gut hormone and tryptophan concentrations, appetite perceptions and intragastric volume in healthy, normal weight and obese, subjects.