ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31234 results sorted by trial registration date.
  • Cancer Molecular Screening and Therapeutics (MoST) Program Substudy Addendum 3 substudies 6 - 8: olaparib plus durvalumab

    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.

  • Understanding the impact of footwear on young children's gait

    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.

  • Objective and subjective assessment of readiness to Return to Sport post Anterior Cruciate Ligament (ACL) reconstruction.

    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.

  • MedicFit: An investigation into the effectiveness of a workplace exercise program to increase physical fitness and reduce injury rates of Australian paramedics

    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).

  • Evaluating an instant assessment feedback tool among cannabis users referred to treatment.

    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.

  • Evaluating the usability of a new U-shaped measuring tool for episiotomy: a mixed methods study

    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?

  • Clinical Outcome of Epidermal Growth Factor Receptor mutated (EGFR+) Non-small cell lung cancer (NSCLC) patients with first-line tyrosine kinase inhibitors (TKI) resistance on Osimertinib (CONTROL)

    This study aims to evaluate clinical outcomes of patients with non-small cell lung cancer (NSCLC) with specific clinical and tumour mutation characteristics treated with osimertinib in NSW, Australia. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have metastatic EGFR mutated NSCLC with plasma/tumour positivity for T790M, currently taking osimertinib, and were previously treated with first generation EGFR inhibitor (gefitinib/erlotinib). Study details We will perform a retrospective analysis of the clinical outcomes in NSCLC patients. We will follow up on your clinical data (first CT scan results and long term outcome from your treatment) and correlate this with the level of T790M mutation shown in your plasma ctDNA. Participants will not be required to undergo any additional tests beside routine clinical tests requested by their oncologists. It is hoped that this study will add to the currently limited knowledge on the correlation between T790M mutation load (relative allelic frequency) and clinical outcomes.

  • A secondary analysis examining the changes in dietary glycaemic index and glycaemic load in Australian children between 1995 - 2012

    This secondary analysis aimed at examining the changes and temporal trends in the dietary glycaemic index and glycaemic load of Australian children and adolescents, as well as changes (if any) in the major sources of dietary glycaemic load. It will be performed using data from 3 Australian national nutrition surveys (i.e. 1995 National Nutrition Survey, 2007 Australian National Children's Nutrition and Physical Activity Survey, and 2011-2012 Australian Health Survey).

  • The Impact of Varying Exercise Training Intensity on Clinical Asthma Outcomes and Inflammation in Adults with Asthma

    Purpose of Study It is well known that exercise has numerous health benefits; however, research regarding the effect of exercise on airway inflammation in asthma is scarce. This project will examine the clinical and inflammatory impact of three months of exercise training in adults with asthma. This study will also determine whether this effect varies with exercise intensity. This research is highly significant for asthma management, as those with asthma have been shown to have low exercise levels, possibly stemming from the belief that exercise will worsen asthma. Increasing exercise may reduce the reliance on inhaled corticosteroid medication and offer better asthma control, by reducing inflammation. Hypothesis Exercise training will improve clinical asthma outcomes by reducing eosinophilic airway inflammation in adults with asthma. The beneficial effects of exercise in this setting are only evident with moderate-intensity exercise training. Aims 1. To examine the effects of three months of exercise training on asthma outcomes (quality of life, asthma control, asthma exacerbations, airway hyperresponsiveness, and airway and systemic inflammation); 2. To determine whether, and how, these effects vary by exercise intensity.

  • Pain assessment and management for older people with dementia in hospitals

    Undermanaged pain among older patient with dementia continues to impact on patient centre care provided among acute care settings. As the dementia population continues to grow, there is a need to address this issue by finding the solution for a better outcome. The challenges in assessing pain in dementia play a major barrier for nurses in conducting effective pain management (Bruneau & Benjamin, 2014; Coker et al., 2008; De Witt Jansen et al., 2017; Laflamme et al., 2012; Rantala, Kankkunen, Kvist, & Hartikainen, 2014b). This intervention study aims to investigate if nurses’ daily pain assessment and management for older patients with dementia can be improved by a simple and routinised intervention program. The project will introduce an innovative intervention program, which prompts nurse participants to undertake pain assessment during their routine vital sign round, that is, pain become embedded as a fifth vital sign. The study aims: 1). To explore if older people with dementia provide self-report of pain while hospitalised; 2). To examine whether routinisation of pain assessment and subsequent management by nurses has an effect on pain management in older people with dementia in hospital settings. Study hypothesis: H0: 1. There are no differences before and after the intervention program in the level of self-reported pain by older patients with dementia between two groups; intervention groups and control groups. 2. There are no effect on nurses’ practice in the routinisation of pain assessment and management for older patients with dementia before and after the intervention program between two groups; intervention groups and control groups. Ha: 1. There are differences before and after the intervention program in the level of self-reported pain by older patients with dementia between two groups; intervention groups and control groups. 2. There are effect on nurses’ practice in routinisation of pain assessment and management for older patients with dementia before and after the intervention program between two groups; intervention groups and control groups.

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