ANZCTR search results

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

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31350 results sorted by trial registration date.
  • Identifying effective new interventions to prevent recurrence of leg ulcers in adults with chronic venous insufficiency.

    Venous leg ulcers are difficult and costly to heal, and unfortunately after healing, up to 70% of the ulcers recur. This study aims to obtain data on the effectiveness of a Venous Insufficiency Program of Leg exercise and/or elevation (VIP Legs) on prevention of venous or mixed venous/arterial leg ulcer recurrence. A randomised controlled trial will determine the effectiveness of VIP Legs interventions on health, quality of life and prevention of recurrence. Participants will be randomised to one of 3 groups: the VIP Legs elevation program, the VIP Legs exercise and elevation program, or routine post-healing recommendations as per RCN evidence-based guidelines. Participants in each group will be assessed upon healing, then at 3 months, 6 months, 9 months and 12 months after healing. Expected outcomes include early information on the interventions' effectiveness to provide urgently needed evidence on effective preventive strategies for this population.

  • The characterisation and correlation of cardiovascular haemodynamics and endothelial function in preeclampsia

    The incidence of preeclampsia is rising in Australia due to increasing numbers of pregnancies in women at high risk for this condition. Our understanding of the pathophysiology is still unclear and the clinical and pathalogical classifications are inconsistent. In particular, the inconsistency in classification makes the management and follow-up of patients with preeclampsia challenging. Various studies have measured haemodynamic, vascular physiology and biochemical markers individually , however studies correlating these measurements are few. This project will comprehensively characterise the cardiovascular haemodynamic and endothelial function changes that occur in preeclampsia. From this we will correlate these changs to the various clnical presentations of preeclampsia in an attempt to find a better way to classify and risk stratify this life threatening condition. The ultimate aim is to gain a better understanding of the pathophysiology of preeclampsia and translate this into better management strategies in the future.

  • Voice disorders in very preterm children: incidence, presentation and influencing factors.

    Greater numbers of children now survive preterm birth. Dysphonia is a newly-recognised long-term complication of extremely preterm birth, yet remains a relatively little-researched entity. Voice outcomes have been associated with gestational age, birthweight and cardiac surgery. However, the strongest association found has been with intubation in the neonatal period. Thus, there is a need to investigate voice quality of all who may be intubated. Laryngeal pathology of very preterm children has not been systematically documented in the literature. Yet knowledge of laryngeal pathology is essential for intervention planning. Laryngeal pathology is investigated jointly by the Ear, Nose and Throat medical speciality and the Speech Pathology Voice allied health speciality. Further, there has been no investigation of treatment effects in preterm voice disorders. Having identified that dysphonia is a long-term voice outcome for some preterm children, treatment options should be investigated. Finally, many preterm children participate in paediatrician follow-up programmes to maximise medical and developmental outcomes. As dysphonia can now be considered a possible long-term complication for some preterm children, a screening tool for voice difficulties could be incorporated into existing follow-up programmes. The ideal measure would have: i) diagnostic accuracy to correctly identify the presence of dysphonia; ii) sensitivity to change in voice quality due to therapy; and iii) be quick and simple to administer to minimise cost. This study consists of three phases: an observational study of voice quality and its impact on quality of life in 200 children born at less than 32 weeks gestation; assessment of the nature and extent of laryngeal pathology visualised in those children with moderate to severe dysphonia; and a quasi-randomised, non-blinded, controlled trial of behavioural voice therapy in the children with moderate to severe dysphonia. Additionally, the sensitivity to therapeutic change of an objective voice assessment, the Acoustic Voice Quality Index, validated by our laboratory as a measure of dysphonia severity in children, is being measured. This registration pertains to phases I and II of the study.

  • The Acute Effects of a Single Bout of Exercise on Asthmatic Airway Inflammation: A Pilot Study

    This project will determine the acute anti-inflammatory effects of a single bout of exercise in asthma. It is well known that exercise has numerous health benefits; however, research regarding the effect of exercise on airway inflammation in asthma is scarce. This project will examine the mechanisms by which exercise reduces airway eosinophilia in asthma. This research is highly significant to asthma management, as those with asthma have been shown to have very low exercise levels, possibly stemming from the belief that exercise will worsen asthma. We will begin with this study of short-term exercise and use the findings to inform the design of a later study which will examine the effects of exercise training on asthma.

  • Phase I open label trial of Abraxane (nab-paclitaxel) administered concurrently with radiotherapy in patients with locally advanced inoperable pancreatic adenocarcinoma.

    In this study we plan to evaluate the maximum tolerated dose (MTD) of the drug Abraxane, which can be safely given to patients concurrently with radiotherapy in locally advanced pancreatic cancer (LAPC). Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with locally advanced adenocarcinoma of the pancreas, which is not amenable to curative surgery. Study details Participants in this study will receive the chemotherapy drug Abraxane (nab-paclitaxel) by intravenous infusion (i.e. directly into the vein) over 30 minutes on a weekly schedule, concurrently with radiotherapy for 6 weeks. The first participants will receive Abraxane at a dose of 25 mg/m2 and if this is tolerated the dose will be increased for the subsequent groups until the maximum tolerated dose can be determined. Participants will be regularly monitored for safety and tolerability throughout treatment. On completion of treatment they will also be followed up for up to 5 years in order to evaluate efficacy of treatment in terms of disease response and survival.

  • Voice disorders in very preterm children: responsiveness to treatment.

    Greater numbers of children now survive preterm birth. Dysphonia is a newly-recognised long-term complication of extremely preterm birth, yet remains a relatively little-researched entity. Voice outcomes have been associated with gestational age, birthweight and cardiac surgery. However, the strongest association found has been with intubation in the neonatal period. Thus, there is a need to investigate voice quality of all who may be intubated. Laryngeal pathology of very preterm children has not been systematically documented in the literature. Yet knowledge of laryngeal pathology is essential for intervention planning. Laryngeal pathology is investigated jointly by the Ear, Nose and Throat medical speciality and the Speech Pathology Voice allied health speciality. Further, there has been no investigation of treatment effects in preterm voice disorders. Having identified that dysphonia is a long-term voice outcome for some preterm children, treatment options should be investigated. Finally, many preterm children participate in paediatrician follow-up programmes to maximise medical and developmental outcomes. As dysphonia can now be considered a possible long-term complication for some preterm children, a screening tool for voice difficulties could be incorporated into existing follow-up programmes. The ideal measure would have: i) diagnostic accuracy to correctly identify the presence of dysphonia; ii) sensitivity to change in voice quality due to therapy; and iii) be quick and simple to administer to minimise cost. This study consists of three phases: an observational study of voice quality and its impact on quality of life in 200 children born at less than 32 weeks gestation; assessment of the nature and extent of laryngeal pathology visualised in those children with moderate to severe dysphonia; and a quasi-randomised, non-blinded, controlled trial of behavioural voice therapy in the children with moderate to severe dysphonia. Additionally, the sensitivity to therapeutic change of an objective voice assessment, the Acoustic Voice Quality Index, validated by our laboratory as a measure of dysphonia severity in children, is being measured. This registration pertains to Phase III Intervention.

  • Comparing oral and intravenous patient controlled analgesia for post caesarean section pain relief: A randomised controlled trial.

    The CROPP trial evaluates the hypothesis that 2 drug regimens are equally effective to deliver pain relief after a caesarean section. The drug which we are testing is called Oxycodone. We deliver the Oxycodone to participants in the test group in controlled release form on a regular basis over 2 days. The participant is also able to request immediate release Oxycodone for the breakthrough pain. These tablets are swallowed with water. In the control group the participants will receive Morphine into a vein each time a computer called a Patient controlled analgesic device is activated by the participant. The primary aim of the research project is to see if the 2 types of drugs have the same ability to relieve pain. The secondary aims are to see if these 2 drugs have the same safety profile, nausea, vomiting and pruritis incidence and if patients in both groups are equally satisfied with their treatment.

  • Cochlear Implant Clinical Care - Evaluation of new methods for sound processor fitting, performance measurement and intra-operative testing in Nucleus Cochlear Implant recipients, compared to existing clinical software

    The study aims at evaluating new methods of sound processor fitting, performance assessments and intra-operative measurements for Nucleus Cochlear Implant recipients.

  • ANZ 1302A - Study to investigate the importance of aromatase inhibitor-induced musculoskeletal syndrome (AIMSS) in Australian women with breast cancer on aromatase inhibitors

    This study aims to use an online survey to gather information on the incidence and clinical impact of Aromatase Inhibitor-Induced Musculoskeletal Syndrome (AIMSS) in Australian women. Who is it for? You may be eligible to join this study if you are 18 years or older, female, have had a diagnosis of early breast cancer since 2007 and have been taking an aromatase inhibitor at any time since your diagnosis. Trial details. Many women with breast cancer are prescribed aromatase inhibitors as part of their breast cancer treatment. It is known that some women experience side effects from aromatase inhibitors which disrupt their quality of life. Some women may even choose to stop taking their medication before they have completed the recommended course (usually five years). This survey will ask a number of questions about women's experiences with side effects from aromatase inhibitors. The survey focuses specifically on joint, muscle and tendon pain, stiffness and discomfort. Women who have not had joint or muscle symptoms are also welcome to take part. The survey will assist the researchers to: * Better understand how the side effects of aromatase inhibitors affect Australian women. * Investigate possible ways of reducing these symptoms * Look at ways of improving the way doctors and other health professionals measure women’s symptoms and their impact on quality of life.

  • An experimental study to investigate the transmission of malaria from a person infected with a specific species of malaria to mosquito feeding on that infected person’s blood

    A renewed focus on malaria elimination has increased the priority of research towards development of interventions to block malaria transmission, including transmission blocking vaccines (TBVs). This Phase I clinical trial is designed test if our established malaria challenge system is suitable to study transmission to mosquitoes. A Plasmodium vivax malaria infection will be established in 6 human volunteers. Vector transmission studies will be undertaken with a laboratory strain of Anopheles stephensi mosquitoes to assess the transmission of parasites to the mosquitoes, both by direct feeding on volunteers and by artificial membrane feeding. Assessment of infection of the mosquitos will be done by mid gut dissection and microscopic visualisation, to evaluate the production of oocysts following the feeding experiments. Once feeding experiments have been completed, participants will then commence curative anti malarial treatment.

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