ANZCTR search results

This Phase I study will evaluate the drug-drug interaction of the investigational medicinal and substrate product AK0529, when administered with either itraconazole, a strong cytochrome P450 3A4 and P-glycoprotein inhibitor (Cohort 1) or fluoxetine, a strong cytochrome P450 2D6 (Cohort 2) inhibitor in healthy adult subjects. The primary objective of this study is to evaluate the effect of multiple doses of itraconazole and fluoxetine on the pharmacokinetics of a single dose of AK0529. This is a two part, open-label, fixed sequence study to be conducted at a single clinical research centre.

The study aims to evaluate, via a randomised controlled trial (RCT), the effectiveness of Rebound, a moderated online social networking system in preventing relapse of Major Depressive Disorder (MDD) in young people (aged 14-27) with remitted MDD. Rebound includes therapeutic activities and information about mental health, mindfulness, personal strengths, and other topics relevant for young people recovering from MDD. Rebound also includes a social network where participants can communicate via posts and comments in a newsfeed and a problem-solving forum. The social network will be moderated by experienced mental health workers and trained peer workers with lived experience of mental ill-health. Enhanced TAU includes access to a private website with information about depression symptoms, causes and course, the relationship between behaviour and mood, information on diet, exercise, sleep, social support and getting support. Enhanced TAU does not include therapist support or online social networking. The primary hypothesis of the study is that, relative to enhanced TAU, TAU plus Rebound will reduce relapse rates among remitted young people with MDD.

The study aims to evaluate, via a randomised controlled trial (RCT), the effectiveness of Momentum, a moderated online social networking system in improving social functioning in young people (aged 14-27) at Ultra High Risk (UHR) for psychosis. Momentum includes therapeutic activities and information about mental health, mindfulness, personal strengths, and other topics relevant for UHR young people. Momentum also includes a social network where participants can communicate via posts and comments in a newsfeed and a problem-solving forum. The social network will be moderated by experienced mental health workers and trained peer workers with lived experience of mental ill-health. The primary hypothesis of the study is that, relative to Treatment as Usual (TAU), TAU plus Momentum will lead to improved social functioning at 12 months among young people at UHR for psychosis.

The purpose of the study is to compare the effectiveness of three different techniques for regional anaesthesia (nerve blocks) that are currently used by doctors in the Emergency Department at Lismore Base Hospital. The study is primarily interested in confirming the effectiveness of the pericapsular nerve group block (PENG block) which has recently entered clinical practice. It has a sound scientific basis and anecdotally it appears to be a very effective block, but there is not yet published evidence comparing it's effect to that of the other nerve blocks in use: the femoral nerve block and fascia iliaca compartment block.

We compared the effectiveness of high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) on a range of health and fitness measures in males with overweight or obesity. Participants completed 6 weeks x 3 sessions per week training, randomised to either group. We hypothesised that HIIT and MICT would increase aerobic fitness, reduce body fat, blood pressure and pressure pain sensitivity, and improve mood state after 6 weeks of training, with greater effectiveness following HIIT compared to MICT.

A randomized controlled trial will establish the extent of an increase in muscle mass and function during the novel liver-targeted testosterone therapy in older men and women with sarcopenia. We will combine this with progressive resistance training component in half of the patients to investigate independent and exercise-stimulated synergistic effects of resistance training and liver-targeted testosterone in improving muscle mass and function in sarcopenia.

This study aims to evaluate the safety, tolerability and signs of efficacy of a new investigational drug called tigilanol tiglate in participants with head and neck cancer. Who is it for? Patients may be eligible to join this study if aged 18 years or more and have been diagnosed with head and neck squamous cell carcinoma. Study details: All participants in this study will receive between one and three tigilanol tiglate injections directly into 1-4 tumours. Tigilanol tiglate may lead to breakdown of tumour blood vessels and recruitment and activation of white blood cells. This leads to rapid tumour cell death. This drug has previously been tested in humans (see QB46C-H01 - ACTRN12614000685617 and QB46C-H02 - ACTRN12614001207606). Participants will be monitored for at least 3 weeks following tigilanol tiglate injection in order to evaluate safety, tolerability, tumour response and pharmacokinetics (the action of the body on the drug). The results from this study will be analysed to see if it is worthwhile for this new drug to be tested in future studies involving larger numbers of cancer participants.

This pilot study aims to assess the feasibility and acceptability of conducting a pilot randomised control trial to evaluate using AllPlay Learn website and/or professional learning courses as a ‘professional learning intervention’ among educators in early childhood education and care settings (i.e. long day care centres and/or kindergartens) and teachers in primary school classrooms. We will use a feasibility and acceptability evaluation and will measure the effects of the intervention on educators’ and teachers’ self-reported competence and confidence, and children’s emotional regulation, conduct, attention, peer relations and pro-social skills (reported by educators, teachers and parents).

The purpose of this study was to ascertain whether adapting transdiagnostic-CBT to include intermittent MI outperforms transdiagnostic-CBT alone in anxiety disorder populations.

This is a Phase II RCT study that will explore the effects of orthotic intervention in addition to standard therapy on stiff post-traumatic elbows. The purpose of this 6-week trial is to establish the feasibility of proceeding to a larger definitive RCT. This study will also establish the reliability and validity of 2 clinical tools (Modified Weeks Test and Joint End Feel) that will evaluate elbow joint stiffness.