ANZCTR search results

This is a stage 1b placebo controlled clinical trial investigating the safety and tolerability of an attenuated live hookworm vaccine. The study will be performed in two parts. Stage 1. The degree to which attenuation will impede the larvae’s ability to penetrate the skin in vivo is unknown. This is a dose escalation stage performed to de ne the optimal dose to be used in stage 2. The dose in cohort 1 will be 50 attenuated larvae dermaly applied to the volar aspect of the forearm, approximately 4 inches proximal to the thumb. Dose escalation will occur after safety review following completion of cohort 1. Cohort 2 will consist of 100 attenuated hookworm larvae applied in the same way. The optimal dose is defined as the number of larvae required to produce a grade 2 -3 dermal reaction. Cohorts of two participants will be enrolled and inoculated sequentially with attenuated hookworm. Safety and tolerability data will be collected and used to guide the escalation of dose for use in the next cohort. STAGE 2 Pilot randomised control trial 15 participants will be randomly assigned 1:2 to receive either 2 doses of placebo or attenuated larvae via dermal application 6 weeks apart. Albendazole will be administered 4 weeks following each inoculation. 6 weeks following the second dose all participants will receive a challenge dose of 30 normal hookworm larvae (15 larvae dermaly applied to each forearm). Albendazole 400mg (200mg tablets, Zentel – Glaxo-Smith-Kline) will be administered at the termination of the studyat week 11. Outcomes measured will include adverse events, faecal hookworm egg content and immune response

Gangliosides are compounds of fat and carbohydrate (glycolipids) that are an important component in cell membranes of most animals and humans. They are found particularly abundant in the plasma membrane of the brain and central nervous system and are recognised as having an important role in their development. Gangliosides occur naturally in our diet and are high in foods from animal origin such as dairy products, meats and eggs. Gangliosides are particularly high in human breast milk. Enhanced cognitive development in infants is seen as an area of particular interest with previous research demonstrating that feeding infants from age 2-8 weeks until 24 weeks of age with an infant formula enriched in gangliosides was associated with improved cognitive development and increased blood levels of gangliosides at the 24 week time point, relative to normal formula fed controls. The ultimate long-term goal is to optimise infant formula to replicate breast milk as closely as possible in both composition and impact on development. However, key information gaps exist regarding the bioavailability and absorption of bovine milk derived gangliosides from the gut and their impact on circulating levels of gangliosides. Addressing these gaps is the primary aim of this study. Furthermore, the validation of a finger prick dried blood spot method may provide a long lived viable alternative to venepuncture-derived blood as a vehicle for quantifying total ganglioside levels in blood samples. In parallel with finger prick blood sampling, saliva samples will be collected from participants to identify if gangliosides are a measurable entity in this fluid, derived in a minimally invasive manner. This study aims to: 1. Understand normal diurnal and day-to-day variation in ganglioside levels in healthy women of child bearing age 2. Describe the kinetics of uptake of bovine gangliosides after consuming a ganglioside-rich meal 3. Validate a finger prick dried blood spot method for measuring blood gangliosides (minimally invasive technique compared to venepuncture derived blood). Collect saliva samples in parallel with finger prick blood samples as a further minimally invasive measure of gangliosides.

A small number of patients who are brought to the emergency department need a general anaesthetic. This lets us help them by keeping their airway open, improve their oxygen levels and breathe for them on a mechanical ventilator. Some of these patients have injured or severely diseased lungs. In these patients, a protective ventilator setting (small volumes of breath at lower pressures) reduces rates of death and time on a ventilator. Other patients have normal lungs initially, but are at risk of developing lung disease whilst on a ventilator. The use of the same protective ventilator settings on these patients can reduce the development of severe lung disease, including infections and lung collapse. Currently, the ventilator settings in our emergency department are set by the bedside, treating clinician. These may not always be with protective settings. We aim to improve the quality of our care of our ventilated patients by optimising ventilator settings and increasing the frequency by which protective settings are used. This will be done by implementing a guideline (called ELVIS) designed to prompt clinicians and bed-side nursing staff to set the ventilator to patient-specific, protective values whilst promoting frequent reassessment of these targets and adjusting settings on a regular basis to meet the patients needs. This guideline has been developed by both Intensive Care and Emergency Medicine specialists. The ELVIS guideline will be used on all ventilated patients in the emergency department, unless the clinician believes an alternate method is safer based on their underlying lung disease. For example, asthmatic patients do not need a protective strategy and will not have the guideline used. Most ventilated patients are transferred from the emergency department to the intensive care unit. These protective ventilator settings will be continued in intensive care. This study aims to compare clinical data, ventilation settings and outcomes of patients ventilated according to the ELVIS guideline to those who were ventilated during the subsequent two years (2015-2016).

The aim of this study is to determine the effectiveness of an online self-management program on cancer-related fatigue in cancer survivors. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with a haematological malignancy, completed cancer treatment, and experience cancer-related fatigue. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive a 12-week web-based interactive self-management program, whilst participants in the other group will receive usual care. The self-management program provides comprehensive information and multimodal fatigue management strategies based on best evidence reflecting the recommendations of the recent American Society of Clinical Oncology guidelines for the non-pharmacological management of cancer-related fatigue. Participants will be followed-up at the end of the 12 week period to assess the impact of the program on fatigue. After waiting for a period of 12 weeks, the group who received usual care will be invited to participate in the online program for a total of 12 weeks.

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of olaparib treatment in combination with durvalumab in patients with advanced cancers and tumours. Who is it for? All participants in this study must have completed screening as part of the Cancer Molecular Screening and Therapeutics (MoST) Program (ACTRN12616000908437), and been identified as having one of the following molecular targets: Germline or somatic deleterious mutations/deletions in BRCA1 or BRCA2; OR germline or somatic mutations/deletions in non-BRCA1/2 HR pathway genes (including ATM, PALB2, RAD51C, RAD51D, CHEK1, CHEK2, ATR, CDK12, BAP1, BARD1, BRIP1 and FANC genes). Study details: All participants in this study will take the oral drug olaparib for 28 days alone and then add the intravenous drug durvalumab once every 28 days. Treatment with durvalumab will be administered once every 28 days until 13 cycles are complete. Olaparib treatment will continue until progression, unacceptable toxicity or withdrawal. Retreatment with durvalumab after 13 cycles will be discussed with you by your doctor. All participants will undergo assessments at 8 weekly intervals or as clinically indicated in order to evaluate tumour response, safety and tolerability of treatment, health related quality of life during treatment, and overall survival. We cannot guarantee that patients will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that treatment will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

The common footwear advice provided to parents of young children involves seeking out shoes with particular fixtures and features. This advice is historic, and there is little evidence supporting this advice. It is unknown if there are particular features which change children gait. This also comes in the advent on softer and more flexible soles. This research aims to understand the impact of different features and sole hardness of common footwear on young children's gait compared to walking and running barefoot. That is, comparing sandals, boots and runners in identical styles with different sole hardnesses to barefoot to see if there are any differences. It is hoped through understanding any impact of footwear on gait, this research can be translated into parent footwear advice and shoe design.

Conflicting evidence and inconsistent criteria regarding Return to Sport (RTS) following Anterior Cruciate Ligament (ACL) highlights the necessity for further investigation into ACL Reconstruction (ACLR), and factors that influence RTS. The aim of this study is to investigate the correlation between an objective measure of quadriceps and hamstring isometric muscle strength and subjective assessment of knee joint function and perceived readiness to RTS at 6 months and 10 months after ACLR.

This study will investigate the effectiveness of a 24-week workplace exercise program MedicFit) to improve work-related physical fitness and reduce musculoskeletal injury rates of NSW paramedics and assess whether greater effects are achieved with the provision of regular health coach support. In comparison to a control group who do not participate in the exercise training, it is hypothesised that paramedics undertaking the MedicFit program will improve job-related physical fitness and achieve lower injury rates over the intervention period (vs. historical data), and that additional effects will be achieved by those receiving health coach support (i.e. greater increases in physical fitness and lower injury rates).

The aim of this study is to evaluate a new, auto-scoring, instant assessment feedback tool which can be utilized by clinicians during cannabis use assessment sessions. To achieve this aim, a randomized controlled trial will be conducted. Patients who present for an assessment of their cannabis use and consent to being involved in the trial will be randomized to the "instant assessment feedback tool" or "treatment as usual" condition. Patients in each condition will complete the same battery of validated, standardized questionnaires that are routinely administered during the assessment session. Patients in the "treatment as usual" condition will complete paper-based versions of the measures and will receive feedback on the measures in accordance with the clinician's usual approach. Patients in the "instant assessment feedback tool" condition will complete the same questionnaires using a tablet computer. The instant assessment feedback tool automatically scores the patient’s responses on the measures and presents their results on the clinician’s computer screen in tables and graphs, including comparisons with averages/norms from non-dependent cannabis users and cannabis users in treatment. The clinician will then discuss the patient’s results with them and show them visually how their scores compare to other groups of problematic and non-problematic cannabis users. These patients will be given a print-out summary of their results to take home with them. A brief pre- and post- session measure of motivation to change and a brief post-session measures of patient satisfaction will be also administered. It is hypothesized that patients who receive the instant assessment feedback tool will have significantly greater increases in their motivation to change their current cannabis use behaviour from pre- to post- assessment session compared to those in the treatment as usual condition. It is also predicted that patients in the instant assessment feedback tool condition will have significantly higher ratings of satisfaction with the assessment session compared to the assessment as usual condition.

Episiotomy is the most common obstetric operation, which consists of a surgically placed incision on the perineum and posterior vaginal wall. The operation is usually performed at the height of contraction when the birth is imminent or in attempt to shorten the second stage of labour for a foetal indication such as foetal distress, or a maternal indication, such as previous or underlying cardiac disease or potential obstetric anal sphincter inujuries. Midline episiotomy (where an incision is made from the posterior vagina in a vertical line toward the anus) is a known risk factor for obstetric anal sphincter injuries, leading obstetricians and midwives to prefer the use of mediolateral episiotomy (incision at 30-60 degrees). There has been found to be remarkable variation in the techniques and indications for episiotomy amongst midwives and obstetricians which may alter the consequences of a mediolateral episiotomy. While the technique of performing a mediolateral episiotomy is generally understood by accouchers, there are currently no standard guidelines or measurement tools to guide obstetricians and midwives in the length and angle of their incision. To standardised length and angle of episiotomy, Professor Rane developed a prototypal tool, called the 'Episiometer'. The Episiometer is made of transparent paper, the device is then sterilised, and is applied to the perineum to assist the clinician in measuring the angle of the episiotomy incision, given the clinical decision is made to proceed to episiotomy. This feasibility pilot study aims to find whether the Episiometer is a helpful tool for accouchers performing episiotomy and acceptable for women having an episiotomy performed. Primary objectives/outcomes: Assess feedback from clinicians (defined as ‘doctors and midwives’) about: 1.Perceived ease of use 2.Whether use of the device was burdensome (i.e. practicality, time etc.) 3. Opinions on feasibility of the tool (accuracy for performing mediolateral episiotomy) 4. Indication for performing episiotomy at the Townsville Hospital 5. Evaluate clinicians’ opinions about advantages/disadvantages of the device Secondary objectives/outcomes: 1. Assess patients’ attitudes surrounding episiotomy and use of the Episiometer 2. Patients reporting complications experienced following episiotomy at a 6-8 week follow-up (after use of the Episiometer) 3. Understanding current methods used at the Townsville Hospital (and in any clinical setting where the clinician has previously worked) to teach staff how to perform an episiotomy. 4. Comparing patient's opinions of the device with birth outcomes Research questions: -Is the Episiometer is easy to use OR does it interfere with standard of practice? -Do clinicians find the visual guidance that the Episiometer provides to be helpful and beneficial? -What are the advantages/disadvantages/limitations of having a visual device such as this one? -Can the Episiometer be used in everyday practice?