ANZCTR search results

The primary purpose of this study was to examine if participants in the Collaborative and Proactive Solutions and Parent Management Training groups, treated in a community setting, would exhibit significant improvement in ODD symptoms at post-treatment and 6-month follow-up. We were also investigating if improvement in the CPS group would be similar to outcomes in the PMT condition. This study featured components of efficacy studies (studies set in universities with stringent criteria) and effectiveness studies (studies set in community settings with experienced settings). We further expected that there would be no differences in treatment outcomes related to elements of efficacy and effectiveness design (Michelson et al., 2013). In all, it was intended that this study would strengthen conclusions reached about the effectiveness of CPS by reproducing earlier RCT's in a community setting in Sydney, Australia.

This is a Phase 1, single-center, randomized, placebo controlled, single dose, double blind, parallel, pioneer-group, first-in-human (FIH) study to assess the safety, tolerability, and pharmacokinetics of RECCE®327 when administered as a single dose via a 1-hour IV infusion. All subjects will receive pretreatment with the antihistamine compound, cetirizine (Zyrtec®). Eight dose cohorts will be studied . An initial dose of 50 mg or placebo will comprise the 1st cohort of 10 subjects. The study will consist of a Screening period (up to 28 days), followed by Baseline assessments (Day -1), an in-patient Study Treatment Period (Day 1 and Day 2), and follow-up visit to the clinic at Day 7 (End of Study [EOS]). After fulfilling Screening requirements, all subjects will check into the clinic in the afternoon of Day –1 for Baseline assessments. Subjects will be randomized on Day -1 to the sequence of RECCE®327 or placebo. Subjects will remain under observation at the investigational site for the duration of the study, from admission on Day –1 until discharge from clinic on Day 2. All subjects will return on Day 7 for a follow-up visit, or sooner as the Investigator deems necessary.

This study aims to compare the effectiveness of a telehealth-delivered exercise program against a supervised clinic-based program at improving physical and mental health outcomes for prostate cancer patients. Who is it for? You may be eligible for this trial if you are an overweight/obese male aged 18 years or over, undergoing treatment or previously treated for prostate cancer involving androgen deprivation therapy. Study details Participants will be randomly assigned to a telehealth-delivered program or the supervised clinic-based program involving resistance and aerobic exercise for 6 months and then will be followed up for an additional 6 months. Additional consultations with a dietitian to address nutritional and dietary changes will also be involved. Information from this study will help develop a low cost and feasible program to improve the health outcomes of prostate cancer patients.

Hospitalised children regularly receive fluid that is infused through their veins (intravenous fluid therapy). The fluid is given to patients for resuscitation, as a routine daily requirement and to make up intravenous medicines. However, it can be harmful. When children are sick, they may hold on to fluid due to abnormal secretion of certain hormones. Additionally, their kidneys may not be working properly. These changes may lead to a child who inappropriately collects water in parts of the body, such as the lung. Unfortunately, this can cause difficulty with breathing and necessitate more support. Therefore, it may be beneficial to give less fluid and support their recovery. In this trial, we will directly compare a strategy of ‘less fluid’ to current standard care in critically ill children. With over 11,0000 children being admitted to intensive care units across Australia-New Zealand annually, knowledge from this project could potentially benefit many children.

This study investigates the role of endoscopy sedation information sheets in reducing the level of concern regarding possible awareness during the procedure. We hypothesised that concern of awareness would be reduced with the introduction of the information sheet in the intervention group compared with control group receiving only the standard procedure consent form.

Who is it for? You may be eligible to join this study if you are planning to but yet to receive COVID-19 vaccination; or if you have received 1 dose of vaccine only, or if you are within 3 months of your second dose of COVID-19 vaccination. You may have received the Pfizer, AstraZeneca or Moderna COVID-19 vaccines. You can either be a cancer patient receiving systematic treatment including chemotherapy, immunotherapy or targeted therapy; or participate as a healthy control (if you have no history of cancer). Study details Participants in this study will undergo blood tests at up to five time-points: baseline (prior vaccination), 1 week prior to second vaccine dose, and 1, 3, and 6 months after the second dose of Covid-19 vaccine. All participants will have the 3 and 6 months post second vaccine dose sample taken. Earlier blood sample time-points will be taken where applicable (depending on when the participant enrolled in the study). Administration of the vaccine itself will not be part of part of this study. Patients will receive vaccination at their usual GP clinic, pharmacy or at one of the government vaccination centres, and then report adverse events and continue cancer care as per standard practice. It is hoped this research will increase knowledge of how cancer treatment affects the efficacy of vaccination, and thus contribute to the cancer immunology field and improve health outcomes for patients with cancer.

This study aims to examine the effects of a brief mindfulness meditation induction and a mindfulness meditation training intervention on neural correlates of attention (as measured by event-related potential components and EEG spectral activity) and measures of anxiety in young adults with high levels of anxiety and minimal meditation experience. A secondary aim is to identify individual characteristics related to attention changes, engagement/adherence to the intervention, and psychological outcomes (i.e., anxiety, other measures of wellbeing). Improvements in attention processes and reductions in anxiety are expected.

Comprehension of prognostic information might be affected by how the information is presented to patients or their caregivers. Subsequently, this might affect what health management decisions they make and further affect their health wellbeing. This is a four-parallel arm online randomised controlled trial. Two separate groups of adult Australians will be recruited using an online provider (Dynata) to participate in one of two trials. Trial A: Acute middle ear infection (Acute medical condition) and trial B: Tennis elbow (chronic medical condition). Participants of each trial will be randomly assigned to one of four groups: text only, bar graph, pictograph, and line graph. The four interventions in each trial will convey the same prognostic information but will be presented in four different visual formats. Comprehension of the presented information will be measured and its association to health literacy, numeracy, and educational level. As secondary outcomes, we will measure participants’ intentions towards which treatment option they would choose in each condition. Additionally, we will measure participants’ satisfaction with the presentation they were allocated to as well as their preferred presentation to be used in future communication.

This project aims to understand how a parenting intervention influences emotional brain function in adolescent females at risk for depressive disorders. Participants will be randomly assigned to the intervention or the waitlist control group. Parents of adolescents in the intervention group will receive the TINT parenting program, which has shown to be effective in increasing parental emotional socialisation and decreasing adolescents' internalising symptoms. We hypothesise that adolescents whose parents are in the intervention group will show greater improvements in brain function and connectivity in the neural circuits underlying emotion regulation (i.e., greater reductions in amygdala activity and greater increases in prefrontal-amygdala connectivity) at 6-month follow-up compared to adolescents whose parents are in the waitlist control group.

The purpose of this study is to determine whether a nanoparticle cannabis-based medicine (NanaBis™) is effective in reducing metastatic bone pain in patients with cancer. Who is it for? You may be eligible for this study if you are aged between 18-75 years old, have been diagnosed with any cancer that has metastasised to bone, and are experiencing bone pain. Study details Participants will be randomised using a computer software program to receive either the NanaBis™ spray and placebo oxycodone tablets for breakthrough pain, a placebo spray and oxycodone tablets or a placebo spray and placebo tablets. Participants will self-administer the spray into their mouth up to 2-7 times every 4 hours unless asleep, and the tablet up to twice per day as needed. All participants will answer a number of questionnaires before the study starts and throughout the study. These questionnaires are answered weekly during the visits to the study site, except for the Numerical Pain Rating Scale which is completed twice daily as part of the participants medication diary. All questionnaires are also completed at the end of the 6-week period. Participants will also have the option to continue the treatment for a further 12 weeks after the study is complete. It is hoped that this study may demonstrate that NanaBis™ is safe, tolerable, and effective at reducing metastatic bone pain in patients with cancer.