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.
  • Breakfast consumption: Temporal Self-Regulation Theory and Implementation Intentions

    The role of temporal self-regulation theory variables and implementation intentions in breakfast consumption will be investigated in a sample of healthy individuals from the community. Participants who join the study will be randomised to one of two groups (1) implementation intention group (2) no implementation intention group. All tasks will be completed online. All participants will complete a baseline assessment that measures perceptions of the environment as supportive or unsupportive (CAS), intention to consume breakfast, planning ability (Tower of London), response inhibition (Stroop), habit strength (Self-Report Habit Index), frequency of breakfast consumption in the past week, and relevant demographic variables (e.g. age and gender). Participants in the implementation intention group will also complete an implementation intention task that involves the generation of If-Then plans to overcome barriers to breakfast consumption (e.g. ‘If I wake up late on a weekday, then I will eat a tub of yoghurt for breakfast while waiting for the bus!’). At one week post-baseline all participants will be emailed an invitation to complete the follow-up assessment. This assessment will reassesses perceptions of the environment as supportive or unsupportive (CAS), intention to consume breakfast, planning ability (Tower of London), response inhibition (Stroop), habit strength (Self-Report Habit Index), and frequency of breakfast consumption in the past week.

  • A randomized clinical trial of a new binocular treatment for amblyopia (lazy eye)

    Amblyopia, also known as lazy eye, is a developmental disorder of vision whereby the brain ignores the information from one eye. This leads to a reduction in the vision of that eye. Also, the two eyes fail to work together resulting in a lack of binocular vision. This study is designed to test a new treatment for amblyopia implemented as a videogame on an iPod touch device that aims to strengthen binocular vision. The treatment is expected to establish stereopsis (3D vision) and to improve monocular acuity in participants with lazy eye. Participants will be given real or placebo treatment for 6 weeks and standard clinical tests of monocular and binocular vision will be used to assess treatment outcomes.

  • Sodium control in aneurysmal subarachnoid haemorrhage

    Hyponatremia, which describes low blood sodium levels, occurs frequently in patients who are in the hospital after aneurysmal subarachnoid haemorrhage, a condition where there has been bleeding in the brain. Hyponatremia can cause confusion and seizures, and possibly long term effects on a patient’s ability to function. A substantial amount of resources are used in treating this condition. This study looks at determining whether a medication called fludrocortisone can help in reducing the severity and duration of hyponatremia in this setting.

  • Pain Assessment and Management of the Cognitively Impaired Older Person Presenting to Emergency Departments with suspected long bone fracture

    We know very little about how ED clinicians adjust care practices to accommodate for the needs of cognitively impaired older Australian experiencing acute pain. Given the front line positioning of emergency services, emergency department nurses are well placed to become active leaders and innovatively responsive in reducing human suffering. Pain, is costly both in human suffering and lost productivity. Therefore, ensuring timely pain assessment and appropriate analgesic interventions for older people with cognitive impairment is critical. International studies have demonstrated the benefits of the Pain in Advanced Dementia Screening Tool (PAINAD), but no study has taken place in Australasian EDs. This research proposes to explore pain management in older (>64years) Australians with suspected long bone fractures and to randomise the use of the validated pain assessment tool (PAINAD tool) for patients with cognitive impairment. The aim of the study is to conduct a cluster randomised controlled trial of the PAINAD screening tool for cognitively impaired older people (>64years) presenting to emergency departments with suspected long bone fracture and compare results to standard treatment.

  • Modulation of experimental pain using non-invasive brain stimulation.

    Recent development of non-invasive brain stimulation techniques has provided further insight into human nervous system function. Transcranial direct current stimulation (tDCS) is one such technique, which involves delivering mild electrical current to the brain via surface electrodes. Further research, however, is required to evaluate the effects of consecutive daily application of tDCS on human sensory function. Consequently, the aim of this research project is to investigate whether five consecutive daily sessions (1 session / treatment day) of tDCS can improve sensory function in a healthy human population. The results of this study will lead to a better understanding of human sensory function modulation.

  • A phase I/II clinical study of deliverability and efficacy of high dose lenalidomide for the treatment of adult patients with acute lymphoblastic leukaemia

    The aim of this study is to assess the deliverability and efficacy of high dose lenalidomide for the treatment of adult patients with acute lymphoblastic leukaemia. 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 relapsed or refractory acute lymphoblastic leukaemia, which is unsuitable for further intensive chemotherapy. Study details All participants in this study will receive a drug called lenalidomide (Revlimid), which is administered as oral capsule. Treatment will be delivered in 28 days cycles until disease progression or unacceptable toxicity. The dose of lenalidomide administered will potentially be twice or thrice the dose that it is approved in Australia for the treatment of other blood cancers. Lenalidomide works against the cancer via multiple mechanisms. It damages the genetic code (DNA) of cancer cells (there is no evidence to suggest that normal cells are affected the same way), dampens the pro-survival genes in cancer cells and boosts the body’s natural immune response against the cancer cells. Lenalidomide has been found to be effective in cancers such as multiple myeloma, chronic lymphatic leukaemia, non Hodgkin’s lymphoma and acute myeloid leukaemia. However, it’s effectiveness is not examined exclusively in subjects with ALL. Participants will be regularly assessed throughout the duration of the trial in order to evaluate safety and efficacy of treatment.

  • Study of SUN-101 in Pancreatic Cancer

    The main goal of this study is to assess the safety and tolerability of the drug, SUN-101, in patients with pancreatic cancer. 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 metastatic or locally advanced ductal adenocarcinoma of the pancreas, which has been previously treated with first line chemotherapy. Study details: Participants in the first part of this study (Phase 1a) will be administered SUN-101 in a dose-escalation scheme with cohorts of three patients at each dose level (1.0, 1.5 and 2.0 mg/kg). All cohorts will receive injections of SUN-101 once daily Monday through Friday, for 2 weeks, repeated every 4 weeks for up to 5 full cycles (up to 50 injections) depending on response. Participants in the second part of this study (Phase 1b) will be administered SUN-101 at the maximum tolerated dose identified in Phase 1a for up to 5 cycles. SUN-101 is a small molecule which is similar to a compound found naturally in human cells. Laboratory and animal studies suggest that SUN-101 targets and destroys the ductal cells in the pancreas where the tumour grows. Participants will be regularly assessed during treatment in order to assess safety and tolerability. Other goals of this study are to measure the levels of SUN-101 in the blood and urine over time and test whether SUN-101 can slow the growth of, or shrink tumours.

  • Monitoring inhaled corticosteroid efficacy in persons with asthma in pulmonary function laboratories.

    This is a parallel group, prospective randomised trial comparing two methods of monitoring asthma control. Participants will be recruited from the Pulmonary Function Laboratory who have been referred for testing using inhaled mannitol to assess BHR in persons who are suspected of having asthma. Following the identification of a positive test, the provision of written consent and once there is confirmation the clinician has prescribed ICS, the subject will be contacted by phone and asked to return to the Laboratory at 6, 12 and 18 weeks to have either a mannitol challenge with spirometry performed or spirometry performed alone. The subject will be provided with feedback at each visit as to the benefit of ICS on the test outcomes and encouraged to seek the goal of achieving a reduction in their airway response to mannitol or improvement in lung function into the normal range. The referring clinician will also be provided with the results at each visit. Subjects will also perform an Asthma Control Questionnaire (ACQ) and Asthma Quality of Life Questionnaire (AQLQ) at each visit and both patient and clinician will be informed of these improvements. Prior to both spirometry and a mannitol challenge, participants will have two rapid non-invasive tests performed that measure the size of the small airways as well as the degree of inflammation by measuring a gas when expired known as nitric oxide.

  • A surveillance study investigating whole body magnetic resonance imaging and other diagnostic procedures in people at high risk of cancer

    The study is investigating whole body magnetic resonance imaging (MRI) and other diagnostic procedures in people at high risk of cancer. Who is it for? You may be eligible to join this study if you are aged between 18-70 years, and are a known NF1 patient, OR a known cancer risk gene mutation carrier, OR have a family member at 50% risk of carrying a mutation. You will not be eligible if you have an active cancer diagnosis. Study details - All participants in this study will have an initial clinical review followed by annual diagnostic procedures for a period of 3 years. This may include annual whole body MRI scans, breast MRI (females only), fecal occult blood test and full blood count. Additional investigations including colonoscopy and upper gastrointestinal endoscopy may also be conducted at varying time points, as indicated by family history and clinical appropriateness. Participants will also be asked to complete psychosocial questionnaires and invited to participate in in-depth interviews. This study will provide estimates of the prevalence and incidence of investigable lesions, and the acceptability, safety, psychosocial impact, and cost-effectiveness of the screening protocol. This information will be used to design a large scale screening project.

  • Prospective evaluation of pterygium excision and conjunctival autograft with autologous blood, fibrin glue, or vicryl sutures

    Our aim is to study the efficacy of pterygium excision and conjunctival autograft with autologous blood and compare with the gold standards of sutured autograft and autograft with fibrin glue. Conjunctival autografts with autologous blood have been reported to be effective in the literature. Only a small number of prospective studies with small numbers of patients have studied conjunctival autografts with autologous blood. Comparing this method to that with sutures and with fibrin glue will provide meaningful comparative data on efficacy of method, rates of recurrence, cost and patient comfort. We hypothesize that patients will experience less discomfort and will have similar rates of graft stability and recurrence.

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