ANZCTR search results

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

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33645 results sorted by trial registration date.
  • Endurance training characteristics and Cardiac Arrhythmias in Cycling

    The aim of the proposed research is to identify the influence of endurance exercise training on rates of cardiac arrhythmia, and how the manipulation of training variables can modify this relationship. Competitive and recreational cyclists will undergo monitoring of exercise and periodic screening for cardiac arrhythmia burden. This study will be run as a randomised, counterbalanced crossover trial with four intervention periods, those being: habitual training levels, high intensity, high frequency and high duration of exercise. Participants will attend laboratorial testing sessions at the beginning and end of each intervention period, where they will be tested for cardiac arrhythmia burden, aerobic fitness and for biochemical markers. During each observation/intervention period their daily exercise training and physical activity will be monitored.

  • Trialing a fruit and vegetable intervention to promote a healthy weight and reduce disease risk

    Only 5% of Australian adults meet the recommended intake of fruit & vegetables. Energy from discretionary foods contributes to one third of total energy intake. Together these dietary patterns contribute to the prevalence of overweight and obesity in Australia. This 6 month study will trial two dietary patterns aimed to increase fruit and vegetable consumption and subsequently decrease consumption of discretionary foods. Participants will be randomised to one of two fruit and vegetable eating patterns. All participants will receive 2 weeks worth of fruit and vegetables. The type of fruit and vegetables they receive will depend on the group they have been radomised into. Participants will also be supported via personalised dietary consultations which will be delivered intensively in the first three months and then less intensively (maintenance phase) in the second three months. Aim: Evaluate the effect of two dietary patterns on diet quality, body composition, skin & urinary carotenoids, blood lipids and glucose. 2. To validate the Australian Eating Survey (AES).

  • Evaluation of new exercise guidelines for young people with Type 1 Diabetes

    Exercise has numerous physical and psychological health benefits for people with type 1 diabetes (T1D) however, the varying effects exercise has on blood glucose levels makes it challenging for young people with T1D. The current T1D guidelines available for exercise vary, are challenging to follow and not very accessible. Our research team have developed an app collating the guidelines with data from our previous studies to assist people with T1D to safely participate in a more physically active lifestyle. This project aims to evaluate the acceptability and usability of the app in individuals with T1D aged between 12 to 25 years during physical activity. At the end of the pilot test, these participants will complete an interview and survey. Analysis of pilot results will contribute to amending the features of the App to improve its usability and acceptability before conducting a trial.

  • A DDI Study to Evaluate the Effects of Itraconazole and Fluoxetine on AK0529 in Healthy Volunteers

    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.

  • Preventing relapse of major depressive disorder in youth: Randomised Controlled Trial of a novel mindfulness-based cognitive online social therapy

    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.

  • Enhancing Social Functioning in Young People at Ultra High Risk for Psychosis: Randomised Controlled Trial of a Novel Strengths-based Online Social Therapy

    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.

  • Sub-Psoas Infiltration in the Emergency Department (SPIED). Comparing the pain relief provided by the three different nerve blocks currently in use for treating hip fractures in the emergency department.

    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.

  • High-intensity interval training for health and fitness in males with overweight or obesity.

    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 novel development of liver-targeted androgen therapy for sarcopenia and synergistic benefit of resistance training in elderly

    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.

  • Exploratory Phase Ib/IIa Study of Intratumourally Administered Tigilanol Tiglate to Assess Safety, Tolerability and Tumour Response in Patients with Head and Neck Squamous Cell Carcinoma

    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.

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