ANZCTR search results

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

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32712 results sorted by trial registration date.
  • A pilot study on delivery suite mask ventilation in extremely preterm infants

    Neonatal mask ventilation (artificial breathing) is a technique that requires mastering, and previous simulation studies on manikin model suggest that mask leak is very common and significant in magnitude. Also airways obstruction occurs frequently when a resuscitator tries to minimise leak. A few studies in extremely preterm infants have suggested airways obstruction is common immediately after birth in infants requiring positive pressure ventilation. Studies in manikin models have described a simple 2-person four hand technique of mask ventilation that halves mask leak. Current UK neonatal guidelines (2010)suggest to consider using 2-person airway control on the basis of manikin studies. We propose to compare the current 1 person mask technique (Australian Resuscitation Council guideline, 2010) to 2 person mask technique. There are no studies available to inform which method is better. Aims : To measure respiratory function (lung function) parameters (mask leak, tidal volume, minute ventilation, end tidal CO2), and cerebral blood flow while using 1-person vs 2-person mask technique in delivery suite for extremely preterm infants.

  • Internet Mediated physiotherapy and Pain Coping skills Training for people with persistent knee pain - IMPACT trial

    Persistent knee pain, in people over 50 years, is usually attributable to knee osteoarthritis (OA), a common health problem that causes physical and psychological dysfunction. Exercise, delivered by physiotherapists, and pain coping skills training (PCST), normally delivered by psychologists, can help reduce the symptoms and impact of persistent knee pain. Access to specialised health professionals is not always available, however. Usual care, especially to those living in remote areas, often involves hand-out educational information alone. In a time of advancing technology and increasing access to the internet, remotely delivered internet-based treatment approaches, may provide novel alternatives for healthcare delivery of exercise and PCST. This study will evaluate whether a physiotherapy-guided home exercise program, delivered via the internet, combined with an online PCST program (PainCOACH) is more effective in improving pain and function than a control intervention (on-line provision of educational material alone).

  • Influenza Specific Immunity After Vaccination in Recipients of Haematopoietic Stem Cell Transplantation Compared to Healthy Controls

    This study is looking at whether children who have had a bone marrow transplant produce protective antibodies after the flu vaccine. We will compare this to healthy children, and also look at how many children get the flu despite being vaccinated. Who is it for? You or your child may be eligible to join this study if you/they are aged between 6 months to 18 years, and have undergone haematopoietic stem cell transplant 6 months to 2 years ago. Study details Bone marrow transplant (BMT) patients have significant problems with their immune system. The rate of problems caused by the flu (influenza) is particularly high in these patients. Vaccination is the main way to prevent the flu and the problems it causes. Vaccination of children and adolescents may not only protect the children themselves, but may also significantly decrease the rate of transmission and consequently, the knock-on effects in the general population. There are many studies in adults that have looked at the immune response of the flu vaccine in patients post transplant. Response rates are poor and whilst the response improves over time with recovery of their immune system, it rarely reaches that of healthy controls. The rates reported are between 9-40%. The studies that have been done are small. There are limitations to these studies and importantly, there is minimal amount of data for children. To our knowledge, there have been no studies conducted looking at the immune response to the flu vaccine in children alone. In this study all participants will receive the influenza vaccine as per immunisation guidelines. After each vaccine dose (1-2 doses may be administered), participants will undergo a blood test to evaluate influenza specific antibody levels. Participants will also be monitored from enrolment to the end of the influenza season (end of November of enrolment year) in order to identify frequency and severity of influenza infection.

  • Treatment of type 2 diabetes with antioxidant vitamin C therapy

    Reactive oxygen species are the by-products of energy generation and thought to cause problems with maintaining glucose levels in people with type 2 diabetes. Vitamin C (ascorbic acid) is an antioxidant and is the most common vitamin supplement taken by adult Australians (17% of the population). Its antioxidant effects might lower the levels of these reactive oxygen species and improve the health of people with type 2 diabetes. Aims: To examine if antioxidant vitamin C supplementation reduces the levels of reactive oxygen species and improves insulin sensitivity in skeletal muscle of people with type 2 diabetes. Significance: Studies that have examined the effectiveness of vitamin C supplementation in the treatment of type 2 diabetes and insulin resistance in humans have so far produced conflicting and disappointing results, due, at least in part, to inadequate study design and a failure to measure the antioxidant action of vitamin C and insulin sensitivity at the key site of insulin action, which is skeletal muscle. The outcomes will likely contribute to new Australian health guidelines regarding the use of antioxidant vitamin supplements for the treatment of insulin resistance in people with type 2 diabetes.

  • Quantifying the Physical, Cognitive and Social Activity Levels Early After Stroke: How Enriched is the Acute Stroke Environment?

    Acute stroke patients spend as little as 13% the day in physical activity (1), but how much of their day is spent participating in cognitive and social activities remains unknown. The proposed observational study seeks to determine the: (i) physical, cognitive and social activity levels of patients very early after stroke, (ii) relationship between stroke severity and activity levels, (iii) proportion of acute stroke patients capable of engaging in greater activity and, (iv) barriers and facilitators to activity in an acute neurology unit. This is important preliminary work required to inform the translation of the use of an enriched environment into the acute setting.

  • HFS ONE: Is high frequency spinal cord stimulation more effective than sham treatment during a 20 day trial period for lumbar spine pain and leg pain? A randomised double-blinded placebo-controlled cross over trial.

    HFS ONE is a trial designed to help establish whether 10KHz High Frequency Spinal Cord Stimulation devices are more effective than placebo in treating chronic lumbar spinal pain and leg pain. The treatment appears to be very promising and several observational studies report high rates of significant sustained reductions in lumbar spinal pain and leg pain with this device. The device is already being used widely in Australia and is TGA approved for use in spinal pain and leg pain. Our study design enables a comparison of active treatment with placebo with minimal increased risk over and above a routine trial of the device used in normal clinical practice.

  • Comparing cotrimoxazole and/or povidone-iodine ear wash with standard dry mopping and ciprofloxacin ear drops in Indigenous children with chronic suppurative otitis media (CSOM)

    This is a 2x2 factorial design randomised controlled trial of 4 months therapy with oral cotrimoxazole versus placebo and topical povidone iodine versus no wash, in addition to standard treatment to resolve chronic suppurative otitis media (runny ears) in children 2 months to less than 17 years of age. Standard treatment is twice daily dry mopping and topical ciprofloxacin drops.

  • Evaluate changes in physical activity levels in the weeks following left ventricular assist device implantation

    Left ventricular assist devices (LVAD) are pump that are implanted into the heart of patients with impaired heart function (heart failure) to assist in the pumping of blood around the body. An important objective of LVADs is to enable patients to achieve a more active lifestyle. Furthermore, physical activity and exercise are important components of the rehabilitation of patients with LVADs. The aim of this study is to compare the physical activity levels of stable patients with LVAD support (intervention group) compared with patients with advanced heart failure receiving optimal pharmaceutical management, but without LVAD support (control group).

  • Hip Osteoarthritis: effect of combining Pain coping skills training with Exercise and education - HOPE trial

    Persistent hip pain in individuals over 50 years of age is most often due to underlying hip osteoarthritis (OA). Hip osteoarthritis (OA) is a chronic musculoskeletal condition causing pain, physical dysfunction, psychological impairments and reduced quality-of-life. There is currently no cure, thus hip OA is a major public health problem contributing to substantial patient morbidity, health care costs and lengthy surgical waiting lists. Although exercise is recommended by all clinical guidelines for managing hip OA, clinical trials have shown that exercise is either not effective or has only modest benefits. Exercise, typically aimed at addressing muscle strength deficits and restricted joint range of motion, does not directly address psychological factors that are significantly increased in people with hip OA and are associated with higher pain levels and poorer function. Pain coping skills training (PCST), a form of cognitive behavioural therapy, is effective but its clinical application is limited because of poor access to appropriately-trained health professionals and high treatment costs. There is an urgent need to evaluate alternate delivery methods of PCST as an adjunctive treatment to exercise in OA. There are no studies in hip OA that have evaluated the efficacy of PCST (or any other behavioural intervention) either alone, or combined with biomedical treatments such as exercise. This study has two main aims comparing two interventions; Intervention A = Online general education and online PCST, followed by exercise, compared to Intervention B = online education, followed by exercise. In both interventions exercise commences in week 8, on completion of the online educational component. Both interventions are assessed at two separate time points, week 24 and week 8. The first aim is to assess and compare at 24 weeks the effect of the two interventions on pain and physical function. The second aim is to assess and compare the effect of Intervention A and B on pain and physical function prior to the commencement of exercise which is introduced in week 8 in both groups.

  • Evaluating the feasibility and utility of a Quality of Life instrument as a clinical aid in cancer and palliative care

    The study is evaluating the feasibility and utility of the Quality of Life at the End of Life (QUAL-E) instrument in helping staff care for and understand the concerns of people with advanced cancer. Who is it for? You may be eligible to join this study if you are aged over 18 years, have a diagnosis of advanced cancer and receiving inpatient palliative care or outpatient cancer care at the study hospital. Trial details All participants in this study will complete an interview with the QUAL-E used as an interview tool. The QUAL-E instrument explores four domains: symptom impact, relationship with healthcare providers, life completion and preparation for end of life, which have been found to influence patients’ quality of life. This study will use mixed methods to conduct a qualitative content analysis of patients’ responses to the QUAL-E when administered by a research nurse, and a quantitative assessment of feasibility and the possible association between QUAL-E and Distress Thermometer scores.

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