ANZCTR search results

People having issues swallowing their medications may crush it and mix with food or drinks. In aged care homes and for dysphagic patients it is common to thicken water with commercial thickening agents to provide the correct viscosity to enable swallowing. In an in vitro study, we have found that drug dissolution was consistently reduced when the tablets were crushed and mixed with a commercially available thickened fluid consisting of xanthan gum and maltodextrin. It was observed that mixing crushed tablets with thickened fluid caused prolonged dissolution time compared to other mixers (water, jam, yogurt, honey and juice) and compared to dissolution of the whole tablet. Based on our in vitro data, we hypothesise that the rate of drug absorption will be significantly slowed, and the maximum drug concentration reached will be reduced when a drug is crushed and mixed with the thickened fluid in comparison to the whole tablet, crushed tablet delivered in water, and crushed tablet mixed with jam.

Patients will be recruited in the outpatient setting after they have been found to require cardiac surgery. They will have their body mass index (BMI) and waist circumference measured and will have blood tests. They will be reviewed by the Dietician, who will explain the very low calorie diet (VLCD) program. They will undergo the VLCD program, comprising liquid meal replacements for two weeks. They will then return for review by the Dietician and will be commenced on a Healthy Eating Plan, allowing for reintroduction of whole foods over the following four weeks. Diabetic patients will be monitored by the Endocrinology team throughout the period. On completing the program, they will be admitted for elective cardiac surgery and undergo routine preoperative assessment including repeat blood tests and calculation of their weight loss. They will be reviewed as an outpatient six weeks postoperatively. They will be contacted via phone or mail at 6 and 12 months postoperatively to assess mid-term outcomes.

The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males and females with intermediate and poor-risk metastatic germ cell tumours. Who is it for? Male and female participants aged 11 years to 45 years old and you have been diagnosed with metastatic germ cell tumour/s in the testes, ovary, retro-peritoneum or mediastineum and considering first-line chemotherapy. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive the current gold standard treatment for germ cell tumours, which is a chemotherapy combination called BEP (bleomycin, etoposide and cisplatin) administered on a 3 weekly cycle. BEP is given with a drug called pegfilgrastim which encourages white blood cell production and prevents blood cell complications of chemotherapy. Participants in the other group will receive the same dose of BEP but on a 2 weekly schedule. This is called 'accelerated BEP'. Participants will be regularly assessed for treatment response, side effects and quality of life for a period of up to 2 years. This will enable us to determine whether giving the dose of BEP on a 2 weekly schedule is more effective than a 3 weekly schedule. We will also be able to track whether the shorter schedule causes more, the same, or less side effects.

The sole objective of this study is to explore perceptions towards minimalist shoe running style by podiatrists practicing in Western Australia and runners.

The main objective of this study is to assess the effect of synbiotics (co-administration of both pre- and probiotics) as a potential treatment targeting damaging kidney toxins related to heart disease and kidney disease progression in advanced chronic kidney disease patients.

The aim of the current study was to evaluate the efficacy fo the Climate Schools: Psychostimulant and Cannabis module in Australian secondary schools. It was expected that students who recieved the intervention would have increased psychostimulant and cannabis related knowledge, decreased pro-drug attitudes, decreased psychostimulant and cannabis use, and decreased intentions to use psychostimulants and cannabis, compared to students in the control group.

This study will test the efficacy of Coping-Together – a couple-based self-directed, coping skills training intervention. It is anticipated that using the proposed Coping-Together skills will be associated with couples experiencing less anxiety. Who is it for? You may be eligible for the study if you have recently been diagnosed with Stage I, II or III breast, prostate or colorectal (bowel) cancer, or melanoma and are currently receiving or planning to receive treatment. Your partner must also be willing to participate and you must both be able to understand and complete surveys. Trial details: You will be randomised to one of two treatment conditions, either the Coping-Together intervention or to the Minimal Ethical Care condition. The purpose of the study is to test the suitability of the information resources and assess which condition enhances illness adjustment and coping with cancer. All groups will be supplied with cancer and coping information, which participants work through at their own pace. What are you being asked to do? To participate in this study you will need to complete 4 surveys and receive an orientation call from research staff over a 6 month period. You are also asked to use the information resources provided as much as possible.

The project aims to test the effectiveness of an interactive, web-based decision aid for parents of children diagnosed with autism via a randomised controlled trial (RCT). METHOD Following interview and baseline administration of outcome measures, participants who are randomly allocated (using a pre-prepared random numbers table) to the Intervention Group will receive the web-based/electronic educational intervention/ decision-aid. Participants in the Control Group will receive usual care (that is, standard information from autism advisors and other professionals as currently occurs. Three (3) months following baseline assessment, outcome measures will be readministered to all study participants, and interviews once again conducted to obtain information about decision-making processes and choices made regarding interventions. On completion of data collection for the trial, parents in the Control Group will be offered the opportunity to receive the educational intervention. PARTICIPANTS 150 parents/ carers of children newly diagnosed with autism will be invited to participate in the trial (N=75 per group). Participants will be sourced from all Australian states and territories, and will be parents (most likely mothers) of a child (or children) who is/are less than 7 years old and who has been diagnosed with an Autism Spectrum Disorder (ASD) within the past 12 months. To account for anticipated attrition, 10 additional participants will be recruited to each group. Participants will be recruited via newsletters and websites of ASD organisations in each state and territory, in addition to early childhood/ special education facilities, and other support agencies for children with autism spectrum disorders. INSTRUMENTS To ensure that the children of participants meet the diagnostic criteria for ASD, parents will be asked to complete a parent report diagnostic tool called the Gilliam Autism Rating Scale (GARS). Demographic data (e.g. age, gender, educational level, household income bracket, length of time since child’s diagnosis)) will be collected for each participant, and a telephone interview conducted before and after the trial to obtain information about which autism interventions had been considered/ trialled and reasons for the selection of various interventions. Health literacy levels will also be measured using the REALM. The primary outcome measure will be the Decisional Conflict Scale (DCS) (O'Connor, 1993 (updated 2010)). It will measure participant’s self-efficacy with decision-making, factors affecting decision-making, and satisfaction levels in relation to decisions made (O'Connor, 1993 (updated 2010)). Because this scale will be used to measure decision-making before and three months following receipt of the intervention, responsiveness to change is relevant. The DCS requires participants to read and respond to 16 items across five (5) subscales (Informed, Values Clarity, Support, Uncertainty, and Effective Decision), by ticking boxes marked Strongly Agree, Agree, Neither Agree Or Disagree, Disagree and Strongly Agree. Secondary outcome measures will be a Likert scale measuring self-efficacy specifically for accessing educational information, and the Parenting Sense of Competence Scale (PSOC) (Johnston & Mash, 1989). This tool contains 16 items across two scales, which address parents' perceived competence, problem-solving ability, capable parenting, value/comforting, and parental frustration, anxiety and motivation. This self-report tool will be used to evaluate parent efficacy and satisfaction before and three months post trial. DATA ANALYSIS Statistical software will be used to calculate between-group differences post-intervention (using either paired t-tests or ANCOVA) and regression coefficients will be used to determine which predictor variables (such as intervention, parental level of education etc) influence decisional conflict (decision-making) as the outcome variable. ADDITIONAL INFORMATION Upon completion of the study, it is anticipated that information regarding this resource, if proven effective in improving parents' ability to make informed decisions, will be distributed by the health professional or health care team involved in supporting parents during and after autism diagnosis. The resource will also be made available freely online. The website hosting the decision-aid will be optimised to ensure that parents seeking information on the internet using frequently used keywords, will find the relevant webpage within the top search results.

One of the main symptoms of Major Depression is Anhedonia, or a reduced ability to experience pleasure. Anhedonia can reduce one’s motivation to engage in pleasurable activities as well reducing the sense of enjoyment they experience from activities that would typically give them pleasure. As such, it is likely that anhedonia can influence our day-to-day decision-making choices as well. Prior research has shown that transcranial direct current stimulation (tDCS; a research tool that involves applying low-voltage electrical stimulation to electrodes placed on the scalp) can alter cognitive processing and decision-making in humans. The goal of the present study is to investigate how tDCS to part of the brain known as the dorsolateral prefrontal cortex (DLPFC) can influence economic and social decision-making behaviour in individuals with anhedonia. By comparing the effects of tDCS on healthy people with varying levels of anhedonia, we hope to better understand the role of the DLPFC in decision-making, and how this is modulate by anhedonic symptoms. The use of electroencephalography (EEG; a research tool that involves recording brain waves from electrodes placed on the scalp), in this study may help us gain a better understanding of the neurological basis of decision-making, and how this is affected by anhedonia. The hypotheses of the study are that participants receiving tDCS treatment designed to simultaneously increase activity on the right side of their brain and decrease activity on the left side of their brain will (compared to participants receiving tDCS treatment designed to simultaneously decrease activity on the right side of their brain and increase acitivitry on the left side of their brain), be more willing to accept unfair offers to distribute a sum of money and less willing to place a risky bet when playing a gambling game. We also hypothesize that variations in participants' anhedonia levels will affect their behaviour in these tasks; individuals with higher anhedonia levels are hypothesised to show increased acceptance of unfair offers and a decreased willingness to play a risky bet.

The aim of this study is to evaluate whether a test dose of melphalan can be used successfully to target a desired exposure in patients with multiple myeloma scheduled to undergo autologous stem cell transplantation. Higher drug exposure is associated with improved disease control and survival post transplant. Who is it for? You may be eligible to join this study if you are a male or female of any age who is scheduled to receive single agent high dose melphalan and autologous stem cell rescue for multiple myeloma. Trial details All participants in this trial will receive a test dose of 20 mg/m2 melphalan 4 days prior to scheduled autologous stem cell transplantation. This drug will be administered intravenously (i.e. into the vein). A series of six blood samples will be collected after the test dose to allow pharmacokinetic assessment and predictions of exposure for the full dose. The treating clinician will decide the actual full dose to be administered. Whatever dose is given, blood sampling and pharmacokinetic assessment of the full dose will allow determination of whether the test dose exposure accurately predicts the full dose exposure. The test dose amount was increased from 10 mg/m2 in an amendment which was approved in December 2013 to improve the quality of the predictions.