ANZCTR search results

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

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32885 results sorted by trial registration date.
  • Family intervention for adolescents with suicidal behaviour: A randomized controlled trial and mediation analysis.

    The purpose of the study was to evaluate the effectiveness of a family intervention, the Resourceful Adolescent Parent Program (RAP-P) in reducing adolescent suicidal behaviour and associated psychiatric symptoms. It was hypothesised that the RAP-P program would lead to significant improvements in suicidality, adolescent mental health, and family functioning.

  • Group Treatment versus Individual Treatment of Depression in Adults: A Comparison of Cogitive Behavioural Therapy and Emotional Freedom Techniques?

    Depression is one of the most common of all mental health problems and one in five people experience depression at some stage of their lives. A review by the National Institutes of Health found that some 20% of adolescents suffer from bouts of anxiety and depression before they reach adulthood. EFT (Emotional Freedom Techniques) has been shown to be efficacious for depression in a number of studies, including three randomized controlled trials. EFT contains elements of both exposure and cognitive therapy but to these established methods, adds the novel element of somatic stimulation. It has been found to have physiological mechanisms consistent with a lowering of the stress response, and a calming of the threat-assessment structures in the midbrain. These include a reduction in the body’s secretion of stress hormones such as cortisol, an increase in endogenous opioids, and a dampening of fear in the amygdala. This present study intends to compare the EFT treatment to a gold standard therapy for depression; Cognitive Behavioural Therapy (CBT), and a community control group. Understanding and improving the early intervention and treatment of depression and improving the health and quality of life for those with depression is critical to inform best practice. Hypotheses will include: 1. The EFT group treatment conditions will have significantly decreased scores on depression measures from pre- to post treatment, and will be significantly improved compared to the community control group 2. It is expected the CBT group will also have significantly decreased scores on depression measures from pre- to post treatment, and will be significantly improved compared to the community control group, but that the EFT condition may be superior

  • Effects of inhaled methoxyflurane (Penthrox) on psychomotor function in humans: a randomized placebo trial

    An unanswered issue relates to the use of Penthrox in clinical setting is its impact on psychomotor function and the ability to driving or operating complex tasks, as the lack of adverse psychomotor effects from Penthrox may allow patients to drive, and even return to work on the same day of the colonoscopy. Given colonoscopy is increasingly performed for screening and surveillance purposes, the ability to return home or work place without carers would carry significant cost benefit and minimize work disruption. Currently, there are no data on the impact of inhaled Penthrox, or methoxyflurane in general, on the psychomotor function in humans. The aim of this study is, therefore, to evaluate the effects of inhaled Penthrox on psychomotor functions of healthy volunteers as well as subjects who undergo colonoscopy with Penthrox. Hypothesis: Inhaled methoxyflurane has minimal sedative effect and thus, has minimal or no effect of psychomotor function in humans.

  • The effects of aerobic- versus resistance-based exercise on breast cancer-related lymphoedema

  • LIPPSMAck POP trial - Lung Infection Prevention Post Surgery (Major Abdominal) with Pre-Operative Physiotherapy education.

    Chest infections can occur in as many as 1 out of every 2 patients after they have had major bowel, stomach, liver or kidney surgery. This is serious and costly. Chest infections dramatically increase the risk of death following surgery, and the average length of time spent in hospital is doubled. Studies have shown that getting up, and out of bed, and walking as early as possible after surgery with a Physiotherapist reduces this chance of getting a chest infection down to as low as 1 in 20. Unfortunately, these studies have also included time spent with a Physiotherapist before the operation on learning how to do breathing exercises and how to get going again soon after the operation. So, it is really hard to say for certain if this significant reduction in chest infections is down, not just to the amount of walking a patient does after the operation, but also to the level of education they received before the operation. No clinical trial to this point has specifically looked at how effective this type of pre-operative education is, in its own right, in reducing the risk of a chest infection after an operation. The LIPPSMAck POP trial will provide education and training from a Physiotherapist to half of the patients about to undergo major abdominal surgery. The other half will get a pamphlet covering the same sort of information. All patients will get a follow up session with a physiotherapist on the first day after their surgery. The trial will compare these two groups and see if there is any difference in rates of chest infections and how long they stay in hospital. The result of this trial will assist in determining the wisest and most cost effective way to allocate Physiotherapy services to people having a major abdominal operation and assist them in recovering from their operation as quickly as possible.

  • Detectability of Anti-D and Compliance in Two Regimens

    Background, aims & objectives: In some pregnancies, the blood types of mother and baby are not the same – this may cause problems for the baby. The mother’s immune system may ‘see’ the baby’s blood type as a threat, a process called sensitisation. This is called Rhesus disease and can cause anaemia, jaundice, and possibly serious consequences. Ways of preventing Rhesus disease are both safe and well-established, and used as part of regular antenatal care at KEMH. This involves an injection of anti-D antibody to maintain a protective level of this antibody in the blood. This dampens the body’s immune response to the baby’s blood, and greatly reduces the risk of Rhesus disease. With current prevention methods, the risk of Rhesus disease is less than 1%. There are two main approved dosing regimes, 1) the single-dose regime and 2) the double-dose regime. Both have advantages and disadvantages. Currently, Australia uses a double-dose regime, but is considering moving to a single-dose regime. Although widely used in the UK, Europe and USA, the single dose has not been studied locally in Australia. At present, women at KEMH receive two doses of anti-D during their pregnancy. This study will investigate both regimes to identify any difference in protection that lasts up to the time of delivery. A smaller study will review all women with evidence of sensitisation in the last 3 years to identify the possible causes. The results of the studies will help doctors optimise the preventive treatment, and help reduce the impact of Rhesus disease. Study population: Anti-D Dosage Study: We will recruit 300 Rhesus-negative pregnant women who have a negative antibody screen, and have no history of adverse reactions to anti-D injections. Anti-D Sensitization Review: We will recruit women with evidence of sensitisation to the Rhesus-D antigen in the last 3 years. Based on population estimates, there will be up to 30 eligible women for this study in WA. Study design & methods: Anti-D Dosage Study: Three hundred women will be recruited from antenatal clinics in KEMH at <28 weeks of pregnancy. Women will be allocated to one of two groups. The control group will receive standard antenatal care, which includes two injections of anti-D antibody, six weeks apart (at 28 and 34 weeks of gestation). The single-dose group will receive one, larger dose injection of anti-D at 28 weeks. At delivery, all participants will have a blood test which checks for anti-D antibody. All participants will otherwise receive standard care for the prevention of sensitisation, including a) receiving additional anti-D injections after any potential sensitizing events during pregnancy and b) receiving an injection of anti-D antibody after delivery if their baby is Rhesus-positive. Relevant medical information will be extracted from medical records. Anti-D Sensitization Review: All women with evidence of sensitisation to the Rhesus-D antigen in the last 3 years will be interviewed and their medical records reviewed to identify, if possible, the timing and potential contributing factors for sensitisation. Outcomes: This study will provide unique data for the National Blood Authority and Australian clinicians. It will provide information about the proportion of women that still have circulating anti-D at the time of delivery using the Australian two-dose (625IU) regime. This will enable a direct comparison to that achieved by the one-dose (1500IU) regime that is currently being proposed for Australian pregnant women. The sensitization review will also provide information to further advance Rhesus disease prevention in Australia by identifying potential targets for education campaigns. Potential ethical issues: There is minimal risk to participants as the intervention (a single dose of anti-D antibody) is an approved regime used in routine clinical practice in Europe and the USA.

  • Upskilling physiotherapists in evidence-based assessment and management of patients with rheumatoid arthritis: a single-blind randomised controlled trial

    The aim of this research project is to evaluate the effectiveness of the resource, “Rheumatoid Arthritis for Physiotherapists – eLearning” (RAP-eL), in improving confidence and knowledge of best-practice physiotherapy management of rheumatoid arthritis. The evaluation of the RAP-eL resource aims to answer two research questions: 1. Is the RAP-eL resource effective in improving physiotherapists’ confidence and knowledge in the management of rheumatoid arthritis? 2. Are changes in confidence and knowledge retained over time?

  • ANZ 1301 (DOMINO): Exploring decision making about neoadjuvant chemotherapy for operable breast cancer.

    The study aims to identify relevant issues and information needs of women who have considered or have had neoadjuvant chemotherapy treatment within the last five years for initially operable cancer, and incorporate them into a prospective questionnaire and decision aid for women diagnosed with operable breast cancer considering neoadjuvant chemotherapy. Who is it for? You may be eligible to join this study if you are aged over 18 years, have had a diagnosis of invasive breast cancer in the last 5 years, have been offered or have discussed neoadjuvant chemotherapy as a treatment option and have completed a surgical intervention for breast cancer. Trial details Participants in this study will be interviewed once over the phone to identify the issues faced and their prevalence and impact on decision making, and the level of distress associated with treatment for women who have considered or have had neoadjuvant chemotherapy treatment within the last five years for initially operable breast cancer. The findings will be incorporated into a prospective questionnaire and subsequent decision aid for women considering neoadjuvant chemotherapy for operable breast cancer.

  • Evaluation of an online self-help cognitive behaviour therapy (CBT) based treatment for anxiety in children

    Over the last several years, our research team has been systematically developing an internet-based CBT program for the treatment of childhood anxiety disorders. The program has demonstrated effectiveness when offered with minimal therapist assistance. The current study examines the efficacy of this program when offered in a self-help only mode.

  • Can the use of low dose radioactive seeds to guide surgical removal of small areas of abnormal breast tissue reduce the rate of second operation compared with standard hook-wire technique? (ROLLIS RCT: Radio-guided Occult Lesion Localisation using Iodine-125 Seeds)

    This study is comparing the use of low dose radioactive seeds to standard treatment for surgical removal guidance in breast cancer patients. Who is it for? You may be eligible to join this study, if you are a female aged 18 years or above and have been diagnosed with breast cancer that is non-palpable (i.e. the surgeon cannot feel it), and thus require a procedure known as localisation. Trial details: When an abnormal area in the breast needs to be removed after a needle biopsy (and the surgeon cannot feel it), the abnormal area is localised. We are comparing two different localisation techniques in this study. Participants will be randomly (by chance) assigned to one of two techniques. Participants in one group will undergo a procedure known as ROLLILS (radioguided occult lesion localisation and removal of impalpable breast cancers). This involves inserting a low-dose sterilised radioactive iodine seed into the patient's cancer under local anaesthesia with imaging guiding. The patient will then undergo breast conserving surgery within 4 days, during which the surgeon uses the seed to guide removal of the impalpable cancer. Participants in the other group will undergo the standard treatment, known as hook-wire guided localisation (HWL). This is when a hook-wire is placed in the breast on the day of breast conserving surgery by a radiologist. Participants are followed for up to 5 years post-surgery in order to evaluate clinical and cosmetic outcomes, disease recurrence and patient satisfaction. A cost benefit analysis will also be undertaken.

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