ANZCTR search results

The primary purpose of this study is to provide long-term patient follow-up and review of clinical and correlative data outside of clinical trials. Who is it for? The registry will collect information on patients with a diagnosis of sickle cell disease, alpha-thalassemia, beta-thalassemia and other haemoglobinopathies. Study Details Treating clinicians at sites will identify patients and enrol them to the study. The following categories of data items will be collected to the Haemoglobinopathy database using a web portal: Demographic details Clinical presentation Laboratory results Therapy Complications (of therapy or condition) Outcomes It is hoped that the findings from this study will identify patterns of treatment and variation in outcomes, for survival and quality of life. Findings will be valuable in informing optimal treatment strategies.

The primary purpose of this study is to provide long-term patient follow-up, and review of clinical and correlative data outside of clinical trials. Who is it for? The registry will collect information on patients age 18 years or older, with a new diagnosis of non-Hodgkin lymphoma, Hodgkin lymphoma, chronic lymphocytic leukaemia and related diseases. Study details Treating clinicians at sites will identify patients at the time of referral and enrol them to the study. The following categories of data items will be collected to the LaRDR database using a web portal: Demographic details Health at diagnosis Laboratory and imaging results at diagnosis Therapy decisions, including pre-therapy benchmarking, chemotherapy, autologous and allogeneic stem cell transplantation, and maintenance and supportive therapies Outcomes including (survival and QoL measures. It is hoped that the findings from this study will identify patterns of treatment and variation in outcomes, for survival and quality of life. Findings will be valuable in informing optimal treatment strategies for lymphoid cancers and assist with evaluation of the translation of advances in therapies outside the setting of clinical trials.

The study aims to assess the effectiveness of structured, mindfulness-based practice on improving stress, empathy and workplace engagement in junior medical officers (“JMOs”) and final-year medical students who will imminently become JMOs. Based on current available evidence, we hypothesize that mindfulness-based program participation will: 1. Reduce levels of stress, anxiety, and burnout, and improve mood 2. Improve employee work-related outcomes including empathy and engagement We also aim to evaluate the acceptability, feasibility and implementation barriers to this approach in routine practice.

This pilot clinical trial will characterize the wild type Plasmodium malariae isolate HMPBS-Pm as an agent for use in CHMI for the future assessment of antimalarial treatments. The study has been designed based on previous experience with similar Plasmodium spp. master cell banks. Inoculum preparation, administration and clinical score criteria are unchanged. Participant follow up intervals have been adjusted to account for differences in Plasmodium spp. lifecycles. The study population will consist of healthy participants who meet the inclusion and exclusion criteria for similar trials, including appropriate ABO and Rh (female participants) blood group matching. It is hypothesized that the inoculum HMPBS-Pm will demonstrate infectivity in healthy participants. Parasite growth rates are expected to be slower compared to P. falciparum and P. vivax cell banks.

This study aims to build the evidence base for an effective public education campaign for young people. It involves the development and testing of content which will culminate in the production of four Community Service Announcements (CSAs) with different key messages, designed for television or cinema. 240 young people will be recruited from the general population and headspace, and randomly allocated to view one of the 3 suicide prevention intervention CSAs or a control CSA on accessing emergency contraception. Participants will answer questions pre-viewing, post-viewing and four weeks later to permit an examination of several positive and negative outcomes. In addition to understanding the impact of three suicide CSAs this project provides a unique opportunity to collect information about how well a CSA about emergency contraception may work at improving knowledge among young adults.

To replace the midday meal with Medlab’s W8Biotic(Trademark) product for a duration of 8 Weeks. W8Biotic(Trademark) is scientifically formulated to support lean body mass, weight management and maintain healthy blood glucose levels in healthy individuals when taken in conjunction with a calorie controlled eating plan. W8Biotic(Trademark) contains Hi-Maize Resistance Starch, which is a Type 2 Resistant Starch (RS2) with therapeutic properties that may help to increase satiety and assist with weight management. Hi-Maize is also a prebiotic and produces short-chain fatty acids that help to support healthy gastrointestinal function. Leucine is a branched-chain amino acid that assists in the metabolic regulation of healthy blood glucose levels and in supporting skeletal muscle protein synthesis in healthy individuals. W8Biotic(Trademark) also contains Lactobacillus plantarum and Lactobacillus paracasei that naturally synthesise alpha-hydroxy isocaproic acid (HICA) from leucine, which is indicated to support lean muscle mass in healthy individuals. Furthermore, L-carnitine assists with modulating energy expenditure in healthy individuals.

Recent research has shown that resistance-trained men who supplemented with 6 g.d-1 of d-aspartic acid (DAA) over 14 days significantly reduced total testosterone and free testosterone levels. The long-term training consequences of reduced testosterone from DAA supplementation are currently unknown. The primary objective of this study was to evaluate the effectiveness of DAA to increase basal testosterone levels over three months of resistance training. A secondary objective was to establish potential mechanisms for changes in strength and hypertrophy. Based on our previous findings, it was hypothesised that the DAA group would experience decreased total testosterone and free testosterone. In addition, it was hypothesised that the DAA group would experience increased strength, explained by improved neural plasticity.

Alcohol detoxification is associated with a myriad of withdrawal symptoms ranging from headaches and nausea to anxiety and potential seizures. Typically relief for these withdrawal symptoms involves treatment with benzodiazepines, which come with their own set of associated risks. Benzodiazepines have a high potential for dependence as well as cognitive and psychomotor impairment. Flumazenil, conventionally viewed as a benzodiazepine antagonist with agonist actions having been observed at low doses, has demonstrated potential as a management tool to assist both alcohol and benzodiazepine withdrawal. This study aims to assess the efficacy and safety of low-dose flumazenil infusion administered subcutaneously as an option for detoxification from alcohol. It will also explore the role of flumazenil-assisted alcohol withdrawal in maintaining abstinence post-withdrawal.

The aim of this study is to determine the feasibility of implementing a pedometer intervention to reduce the incidence of excessive gestational weight gain in pregnant obese women in a cost effective, reliable manner. The results from this feasibility trial will help guide a future large, multicentre randomised trial. In detail, we aim to: 1. Refine and test the trial protocol for a follow-on large multicentre trial; 2. Examine efficacy in increasing activity level to a target of 150 minutes of “fairly active” or “very active” time per week in pregnant obese women via feedback from the Fitbit Zip (registered trademark) pedometer in line with Australian National Physical Activity Guidelines for adults; 3. Examine efficacy in increasing step count at least 150% from baseline measurements (up to 10,000 steps) via feedback from the Fitbit Zip (registered trademark) pedometer; 4. Evaluate the impact of investigator feedback compared with participant self-monitoring alone, on the reduction in excessive gestational weight gain of pregnant obese participants; 5. Confirm earlier trial results, in healthy volunteers, in assessing acceptability of the trial protocol and pedometer use to our patients and antenatal staff, as a high recruitment and participation rate will be required for a viable definitive study; 6. Determine retention rates over the trial period (as dropouts over participants’ pregnancies will significantly limit a future RCT); 7. Assess the magnitude of any effect of the interventions (with particular respect to reducing the incidence of excessive gestational weight gain, and increasing activity and step count levels) to further inform sample size calculation for a definitive trial. Study Outline Thirty obese pregnant women (body mass index greater than or equal to 30 kg/m2 at first clinic booking ) aged 18 years or over, will be supplied with the Fitbit Zip (registered trademark) pedometer and wear it on a daily basis during waking hours until final antenatal visit. Women will be randomised into three groups of 10: 1. Control Group: will wear the pedometer, blinded to daily step counts. 2. Intervention Group A, Pedometer feedback only: will have pedometer “synched” to their personal smartphone, with ability to self-monitor daily step counts. 3. Intervention Group B, Pedometer feedback + behavior change: will have an added behavior change program in addition to pedometer feedback, with additional regular support from study investigators. Participants in groups 2 and 3 will be encouraged to increase their physical activity levels in line with the Australian Physical Activity guidelines for adults, aiming for at least 30 minutes of moderate physical activity most days of the week (or 150 minutes per week). The Fitbit pedometer registers this level of physical activity as “fairly” or “very” active and equates to approximately 10,000 steps per day.

The primary purpose of this trial is to evaluate the safety and efficacy of a combination treatment of EnGeneIC Dream Vectors (EDV's) packaged with the chemotherapy PNU-159682, given with adjuvant EDV-60mer. Who is it for? You may be eligible to enroll in this trial if you are aged 18 to 75 years old and have an advanced solid tumour that is metastatic or unresectable which cannot be treated with standard care or for which standard care treatment is no longer effective. Study details All participants enrolled in this trial will receive combination treatment with the following: 1. The EnGeneIC Dream Vector(TM) (EDV(TM)). The EDVs are very small particles known as nanocells, which are made from Salmonella bacteria. The type of Salmonella is one that does not cause disease. The EDV is the delivery vehicle used to transport the study drug directly to the site of the cancer. 2. The Cancer Treatment. The study drug is called PNU-159682. PNU-159682 is a type of chemotherapy. The study drug is packaged inside the EDVs (EGFR(V)-EDV-PNU) and is delivered directly to the site of the tumour, rather than the body’s healthy cells and tissues. The EDVs will also be packaged with another substance that is designed to boost the immune system, called EDV-60mer. 3. Bispecific antibody. The EDV delivery system works in 2 ways, as well as carrying the study drug, the EDV surface is also coated with a bispecific antibody. A bispecific antibody is two antibodies linked together, such that one can attach to the EDV and the other to cancer cells. Once attached, the EDVs are taken up inside the cancer cells, and the study drug is delivered directly inside the cell itself, causing the cancer cell to die. Treatment will be administered in 8-week cycles. The treatment is combined in a syringe and administered in to a vein (intravenous), over a period of 20 minutes using a special pump. One dose of the treatment is given each week for the first 7 weeks, followed by a treatment free week where a CT or MRI scanning is performed to evaluate the tumours response to treatment (Week 8). Treatment will continue for up to 12 months or until the patient or investigator deems it suitable to stop treatment, for example if serious side effects occur or if the patients disease continues to grow. Each participant will receive one of two possible dose levels, depending on when they are enrolled and on the drug effects in previous participants. It is hoped that the findings from this trial will provide information on whether EGFR(V)-EDV-PNU and EDV-60mer treatment may be safe and effective for the treatment of otherwise incurable advanced solid tumours.