ANZCTR search results

This study aims to compare two treatments for the management of Dupuytren's disease of the hand. The two treatments can both be performed in the surgeons rooms without requiring a major surgical procedure. The two treatments are 1) the use of a needle to divide the tissue causing the contracture, and 2) the use of a chemical substance to break down the tissue causing the contracture. The hypothesis of this study is that the use of needle is as effective as the use of a chemical substance, and less expensive.

This research project is being conducted to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single 90 mg dose of FlecIH-101 when administered in healthy adult subjects via oral inhalation.

The purpose of this study is to determined how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplants in patients with germ cell tumours. Who is it for? You may be eligible for this study if you are 14 years and older and have a germ cell tumour that have either improved or not responded to treatment. Study details Participants will be randomised to one of two treatments: 1. Standard dose chemotherapy: included 4 cycles of chemotherapy every 21 days (including paclitaxel, ifosfamide, cisplatin and pegylated G-CSF). 2. High dose chemotherapy and stem cell transplants: including 2 cycles of chemotherapy (including paclitaxel, ifosfamide and pegylated G-CSF) and 3 cycles of chemotherapy (including carboplantin, etoposide and pegylated G-CSF) plus stem cell therapy. Drugs used in chemotherapy such as those used in this study work in different ways to stop the growth of tumour cells, either by killing the cells, by stopping them from dividing or by stopping them spreading. Those in the high dose group will also be receiving stem cell transplants which should replace the blood-forming cells destroyed in chemotherapy. Blood tests and other physical examinations will be conducted throughout the trial. It is hoped that this research will determine whether high dose combination chemotherapy and stem cell transplants are more effective than standard dose combination chemotherapy in patients with refractory or relapsed germ cell tumours.

The aim of this study is to investigate children's short-term responses to increases and decreases in physical activity above and below usual levels. Children will participate in three, one-off experimental sessions at school. These are: a) Indoor seated play: Children will participate in indoor play activities usually done during wet weather recess and lunchtime; b) Standing lesson: Children will participate in a standing lesson during class time; and c) Sports class: Children will participate in active sport and play activities during class time. The REACT Study will explore whether children ‘compensate’ for being more or less active than they would usually be by being more or less active later on in the day or the next day.

The purpose of this study is to determine the impact of a standardised weaning protocol for high flow O2. The primary outcome measure is the proportion of participants successfully weaned from high to low flow oxygen therapy. The secondary outcome is to determine whether weaning high flow oxygen leads to improved comfort and dyspnoea.

The purpose of the study is to investigate the effectiveness of compassion focused therapy as a treatment for body weight shame associated with obesity. Over the course of a 12 week compassion focused therapy program proposed by the Compassion Focused Therapy: Group Therapy manual by Gilbert, Kirby and Petrocchi (in press); participants will be assessed at pre, post and follow up times across primary and secondary outcome measures. Outcome measures are associated with mental health, compassion, relationship with food, physical health, and process variables.

The purpose of this study is to determine if Kinesiotape is an effective treatment option for hand lymphoedema secondary to cancer. Who is it for? You may be eligible for this study if you are an adult female or male who has unilateral secondary hand lymphoedema. Study details All participants will be asked to come in on two separate occasions two days apart. On the first visit participants will complete assessments involving medical history, physical measurements of the hand, hand assessment using Ultrasound and questionnaires. Next, Kinesiotape will be applied to the hand with lymphoedema. Participants will be asked to return two days later to have the tape removed and complete the same assessments again as completed in the first visit. These assessments will be physical measurements of the hand, hand assessment using Ultrasound, Bioimpedance spectroscopy and questionnaires. It is hoped that this research will provide an additional support to hand lymphoedema treatment to help with signs and symptoms of lymphoedema after cancer.

A priority area in the field of substance abuse treatment is reducing the rates of relapse. Studies in the United States have demonstrated that telephone delivered continuing care interventions are both clinically effective and cost effective when delivered as a component of outpatient treatment. The proposed trial will examine a well-established telephone delivered continuing care intervention for people exiting residential substance abuse treatment. The study will be conducted as a randomised controlled trial, where participants will be randomised to one of three arms: (i) continuing care plan only (, (ii) 4-session continuing care telephone delivered intervention, or (iii) 12-session continuing care telephone delivered intervention. Participants will be attending therapeutic communities provided by either The Salvation Army (Central Coast, Sydney) or We Help Ourselves (Sydney). Outcomes will be compared across the three arms. It is hypothesised that: (i) participants in the continuing care treatment arms will demonstrate significantly higher rates of percentage of days abstinent from alcohol and other drugs (excluding tobacco) at follow-up compared to the control (continuing care plan only) arm and (ii) that participants in the 12-session continuing care arm will demonstrate higher rates of percentage of days abstinent at follow-up compared to the 4-session arm. It is anticipated that the current study will demonstrate that a continuing care intervention is a relatively low cost clinical intervention that can help to support people following residential care. The study will also provide evidence on the number of telephone sessions required to improve abstinence and other outcomes as part of continuing care interventions.

Migraine is an episodic primary headache disorder, affecting 10% of adults with varying degree of disability that can interfere with daily living. The prevalence of migraine is 2 to 3 times greater in women than in men, particularly during reproductive years; peaking between 30 and 39 years of age and a second peak around 50 years old (onset of menopause). It is estimated that migraine attacks related to menstruation occur in 35-51% of women and are associated with the fall of estrogen levels (~2 days before menses) and may continue for a few more days until estrogen levels rise again. There is growing appreciation of the link between migraine and heightened risk of vascular diseases, particularly for stroke. In fact, studies have shown that women with migraine, especially with aura, are at twice the risk for ischemic stroke. We want to characterise any circulatory abnormalities in the brain in women who suffer from menstrual migraine. In this study, we will measure the flow of blood in the brain in premenopausal women and compare those who suffer from menstrual migraine with those who are not susceptible. We will also explore the role of blood pressure, differences in gene expression, stiffness of blood vessels, and the effects of menstrual migraine on quality of life and mental performance. We aim to see whether abnormalities of blood flow in the brain may predispose women to menstrual migraine and to see whether these abnormalities are associated with differences in gene expression between those who suffer from menstrual migraine and those who are not susceptible. This information will help us to design more effective interventions to counteract migraine.

Appendicitis has usually been treated with an operation (i.e. appendicectomy) for the last 125 years however recent studies have suggested antibiotics may be an effective treatment strategy in a subset of patients. While many recent studies have examined this, only one large rigorous clinical trial has been performed (the 2015 APPAC trial), itself with multiple caveats which limit generalizability to the Australian population. Another large trial, the CODA trial in the United States, also is underway however it too will be difficult to generalise this trial to the Australian setting. We aim to conduct a pilot trial to assess the feasibility and acceptability of a treatment protocol designed to compare antibiotics with laparoscopic appendicectomy for the treatment of mild acute uncomplicated appendicitis. The ultimate goal of this trial would be to perform a large, multi-centre trial in the future.