ANZCTR search results

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

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32707 results sorted by trial registration date.
  • Preventing Invasive Pneumococcal Disease in Children & Adolescents with Leukaemia

    Children receiving cancer therapy are at an increased risk of illness and death due to Invasive Pneumococcal Disease (IPD), caused by the bacteria Streptococcus pneumoniae. This study aims to determine the immune response in the blood (immunogenicity) of pneumococcal vaccination given as soon as possible after diagnosis in children and adolescents with leukaemia. A 10-valent conjugate pneumococcal vaccine (10vPCV), marketed as Synflorix(Registered Trademark), came onto the National Immunisation Program in 2009. The latest Australian Immunisation Guidelines (9th edition) recommend that those who develop haematological malignancies, such as leukaemia, have pneumococcal vaccine boosters according to their age. It is recommended that the pneumococcal vaccines be given as early as possible after diagnosis and ideally before chemotherapy and/or radiotherapy is started. This study aims to protect leukaemia patients from IPD as soon as possible after diagnosis. The study patients will be divided into two groups: Group 1: 1 dose of 10vPCV vaccine for those children & adolescents who have already completed their childhood primary pneumococcal conjugate vaccine course (3 doses) Group 2: 3 doses of 10vPCV vaccine 2 months apart for all other children & adolescents The endpoint is a blood test 1 month after each dose. That is Group 1 is assessed once and Group 2 is assessed 3 times. The blood test is to determine if the participants have responded as well as healthy subjects to at least 5 of the 10 serotypes in the Synflorix(Registered Trademark) 10vPCV vaccine.

  • Prospective clinical study using X-ray to evaluate fixation of cementless total knee replacement components

    This study assesses the clinical performance of implants used to treat osteoarthritis using total knee replacement. Highly-accurate X-rays will be used to measure any small motions of the implant components at regular intervals after the knee replacement operation. The health status of patients and ability for them to perform activities of daily living will also be measured. This information will be used to confirm that new methods of securing the knee replacement components to the bone are clinically effective.

  • A course of oxytocin nasal spray (OT) to treat social problems in youth with autism spectrum disorders

    This study tests whether a course of oxytocin over 8-weeks improves the social communication problems in young people with autistic spectrum disorders. It is predicted that individuals from the community diagnosed with autism or asperger's disorder and within ADOS assessment criteria for autism who receive a course of oxytocin nasal spray will show improved social functioning on self-report, diagnostic and experimental measures, in comparison to participants assigned to placebo admistration. Two single session assessment administered participants. All participants, therapists, assessors, and data entry staff are blind to condition.

  • Cone Beam Computed Tomography image guided radiation therapy for prostate cancer to improve treatment accuracy and outcomes.

    This research study will investigate using advanced prostate localisation x-ray imaging to make sure the radiation beams are on the target every day. This imaging is called Cone Beam Computed Tomography (or CBCT for short)

  • Does nicotine improve selective attention more than placebo in healthy volunteers and what does this tell us about mechanisms of attention?

    Selective attention is a cognitive skill that allows us to interpret and act in our environment. Although this skill is important, little is understoond about the neurochemical processes that are important to attention. This study will allow us to assess the importance of different brain chemicals in contributing to selective attention function.

  • A prospective, randomised, open label trial on the effect of metformin on in-vitro fertilisation outcome in women with polycystic ovary syndrome

    This trial aims to assess whether metformin during ivf treatment and in the first trimester of pregnancy increases livebirth rate and reduces miscarriage rate in women with polycystic ovary syndrome.

  • The effects of green tea and exercise on cardiovascular health

    Overweight individuals typically possess metabolic and vascular problems. Most overweight individuals have high levels of fat and sugar in their blood and also typically carry a lot of fat around their abdomen. Overweight individuals also possess problems in their arteries and veins which become stiff and are unable to stretch easily. Thus, the purpose of the study is to examine cardiovascular function following green tea supplement and its combination with exercise both acutely and chronically. It is hypothesised that (1) green tea supplement will reduce cardiovascular dysfunction in overweight males; (2) a combination of green tea supplement and exercise will normalize cardiovascular dysfunction possessed by the overweight males.

  • Melbourne Diabetes Prevention Study: A randomised control trial of the effectiveness and cost-effectiveness of a diabetes prevention program.

    The aims of this NH&MRC funded project are to evaluate the efficacy, effectiveness, and cost-effectiveness of a structured primary care based diabetes prevention program (Life!) being implemented in Victoria for people of the age over 50 years who are at high risk of type 2 diabetes. This will be achieved by monitoring clinical and behavioural outcomes of participants of the Life! program before and after completion (particularly any reduction in diabetes risk, weight and central body obesity, and changes in quality of life) and by comparing these with another group receiving usual care at the same time. Economic assessment will be performed by evaluating whether the program is ‘value-for-money’ using economic analysis, modelling of longer term impacts, and evaluating of any efficiency issues.

  • Midazolam Nasal Spray for the treatment of breathlessness in patients with life-limiting disease

    Dyspnoea, defined as an uncomfortable sensation of breathing (which is often reported by patients as breathlessness), is a common symptom affecting up to 80% of cancer patients and 95% of patients with chronic obstructive pulmonary disease (COPD). Nearly half of all patients requiring palliative care report breathlessness as a problem during the last year of life. Moreover, dyspnoea is consistently high-lighted as a poor prognostic factor and harbinger of impending death. Ventilatory drive is the net result of complex automatic and subconscious, peripheral and central, neural and chemical mechanisms. Dyspnoea is the conscious perception which has taken account of the net result of those mechanisms and integrated it with other cognitive and emotive factors that are also affecting the individual. Dyspnoea is thus a subjective symptom that is debilitating to patients, impacting greatly on quality of life of both patient and carer. It is a challenging symptom to manage and is often impossible to reverse despite maximal treatment of the underlying cause. Anxiety is often reported by patients as a major component of breathlessness with breathlessness leading to anxiety and anxiety exacerbating breathlessness leading to a progressive spiral of cause and effect. Hypothesis : Intranasal midazolam is superior to placebo for the palliation of dyspnoea in patients with optimally treated life limiting disease

  • A phase 1 study in healthy volunteers to determine the dermatopharmacokinetics of topically applied diclofenac in combination with the novel penetration enhancer Tocopheryl Phosphate Mixture (TPM), compared with Votaren(registered trademark) gel

    This study is being conducted to see if a TPM/Diclofenac gel mix will penetrate into the skin more, and more quickly, than Voltaren. It will also assess how safe the gel mix is.

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