ANZCTR search results

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

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33673 results sorted by trial registration date.
  • Supporting expectant mothers to quit smoking

    The purpose of this pilot study is to determine whether providing quit incentives ('paying' [with vouchers'] for abstinence) to pregnant smokers will motivate them to quit during their pregnancy and stay quit once the baby is born. The study will determine if such an incentives intervention is more effective than the current 'usual care' smoking cessation protocols used in public hospital antenatal clinics in Tasmania. Furthermore, the proposed research will determine if incentivising partner support, that is, paying the partner of the pregnant smoker to be a more effective and active 'quit buddy', is more effective than providing cessation-contingent incentives to the expectant mother alone. All participants, during the initial study enrolment visit, will receive publicly available self-help quit materials developed especially for pregnant smokers, as well as a ‘partner pack’ containing materials especially designed for supporters of people trying to quit. At the completion of the initial enrolment visit, participants will be allocated to one of two groups: Control group (CG) or Treatment group (TG). For participants allocated to the Control group, only the participant (pregnant smoker) will be eligible to receive a monthly $50 voucher incentive if they verify (via exhaled breath carbon monoxide [CO] sample < 7ppm) as quit; for participants allocated to the Treatment group, both participant and nominated support person (where possible, spouse) will each be eligible to receive a monthly $50 voucher incentive if the participant verifies (CO sample < 7ppm) as being quit. After the initial enrolment visit (V1), where baseline measures, quit materials, and group allocation takes place, the researcher will telephone the participants on a monthly basis to determine smoking status. If during these calls the participant self-reports as quit, they will be invited to attend the study centre where, upon verification (via CO monitor) of their quit status, they will receive the $50 voucher incentive (plus partner incentive if in the TG). As well as participating in monthly telephone calls until 6 months postpartum (approximately 10 telephone calls), participants, regardless of smoking status, will be required to attend study visits at the end of pregnancy (V2; approximately 8 months gestation) and at 2 months postpartum (V3). During these study visits, participants will be asked to complete follow-up questionnaires (e.g., intention to quit, reasons for quitting, partner interaction questionnaire, smoking knowledge quiz) and have their smoking status verified (via CO monitor). If the participant quits smoking after the initial enrolment visit they may be eligible for a total incentive amount of $570 (plus a further $550 for TG partners). Participants will also participate in a final 12-month follow-up telephone call to determine long term quit status.

  • Care coordination through Emergency Department, Residential Aged Care and Primary Health Collaboration.

    CEDRiC (Care coordination through Emergency Department, Residential Aged Care and PrImary Health Collaboration) is an innovative model of service delivery which aims to reduce RACF resident trauma and distress by reducing inappropriate transfer to the hospital emergency department (ED) and to maximise the care and efficiency of care where transfer to ED is appropriate. CEDRiC has two interconnecting components: (i) the Health Intervention Program for Senior (HIPS) the provision of proactive care in the Residential Aged Care Facility (RACF) via a Nurse Practitioner Candidate (NPC) working closely with GPs and RACF staff; and (ii) Geriatric Emergency Department Intervention (GEDI) program advanced practice nurses in the ED who case manage older adults in the ED. The aim of this trial is to determine the effect of the intervention via the outcomes. The trial aims to: 1. Determine ED re-presentation rates up to 72 hours and 28 days for patient cohort seen by GEDI nurses compared with this not seen by GEDI nurses 2. Determine number of RACF transfers avoided via NPC model of care 3. Determine cost effectiveness and sustainability of the GEDI and NPC model of care 4. Measure the ED length of stay on patient cohort seen by GEDI nurses compared with this not seen by GEDI nurses 5. Measure the number of hospital admissions on patient cohort seen by GEDI nurses compared with this not seen by GEDI nurses Group matching will be undertaken from hospital data for the 12 months prior to implementation of interventions.

  • Open Label Study to Evaluate tanibirumab (TTAC-001) in Patients with Recurrent Glioblastoma

    The primary purpose of this study is to evaluate the safety and efficacy of tanibirumab in participants with recurrent glioblastoma multiforme (GBM). Who is it for? You may be eligible to join this study if you are aged 19 or over, and have been diagnosed with recurrent GBM following treatment with temozolomide chemotherapy with radiotherapy. Study details Tumour angiogenesis is the process that leads to the formation of blood vessels in a tumour, which in turn support cancer cell survival, local tumour growth, and the development of distant metastasis. The investigational drug tanibirumab (TTAC-0001) interferes with the angiogenesis process, inhibiting the formation of the blood vessels and thereby starving the tumour cells of the nutrients and oxygen required for growth. Participants in this study will be enrolled sequentially to arm 1, 2 or 3 with participants enrolled to arm 2 and 3 only after a safety evaluation of the previous arm. Each patient will only be allocated to one arm depending on the time of enrolment. All participants will receive tanibirumab in 3 or 4 doses, one per week, per cycle, for a total of up to 1 year, disease progression or study withdrawal. Throughout the study safety will be assessed by monitoring and assessment of adverse events, vital signs, laboratory tests including testing for immunogenicity (the ability of the study drug to provoke an immune response). Tumour response will be assessed by evaluating MRI scans performed every 8 weeks during treatment and at treatment termination. Blood sampling for drug interaction and distribution within the body will also be collected. It is hoped that the findings of this trial will develop our understanding of the safety of tanibirumab and of it's efficacy as a potential drug treatment for recurrent glioblastoma.

  • Muscling-up against disability in older adults with home care packages - Implementing an evidence-based progressive resistance training service model of care.

    Progressive resistance training (PRT) is a powerful but underutilised tool in the battle against later life disability. With regular and ongoing PRT older adults can reduce their decline into dependency and disability. This has important implication for an individual's quality and dignity of life and for the national healthcare budget. The primary objective of this project is to evaluate evidence-based PRT as a service delivery option for community-dwelling older adults receiving government subsidised home care assistance. A comparison will be made between PRT participation and wait list control participants. Given the strength of evidence we hypothesise that with regular PRT, participants will reduce their trajectory of health decline, improve and prolong their wellbeing, with benefits retained for up to 24 weeks after the training period. Three hundred adults 65 years and older residing in north Brisbane and receiving a government subsidised home care assistance will be randomised to twice weekly PRT or a wait list control group. Participants will be bussed to and from their training and assessment sessions. All assessments and training session will be supervised by accredited exercise physiologists with special population expertise in disability and gerontology prescription. Data will be collected prior to and following long-term participation (24 weeks), and following a long-term period of non-participation (24 weeks), so the residual impact of PRT can be evaluated.

  • Acupuncture to treat cancer related fatigue

  • Is ketamine a useful addition for the management of acute pain in patients where opiates alone have failed to provide adequate analgesia?

    Opioids have been successfully used as analgesics in the management of acute pain in the emergency department for many years. Unfortunately, in the setting of moderate to severe pain, the large doses required to relieve the pain are associated with adverse side effects. This can range from nausea and vomiting to respiratory depression. We believe that the addition of ketamine (a dissociative agent with analgesic properties) will help to alleviate moderate to severe pain that has not responded to traditional opioid dosing. The added benefit of the use of ketamine is that it has been shown to be a safe analgesic with a limited side effect profile at the doses required to provide adequate analgesia. The primary aim of the project will be to see if patients in the emergency department who have moderate to severe pain (defined as a pain score of >5/10) despite already receiving opiate analgesia can attain significantly better pain relief with the addition of ketamine rather than further doses of opiates.

  • Indications and physiological effects of fluid bolus therapy in emergency department patients

    A prospective study was performed in a tertiary referral centre ED, where the number, types, and volumes of fluid bolus (FB); Indications of fluid bolus.; and their perceived success rates were recorded. The physiological effect of these FBs on blood pressure (MAP, mmHg), heart rate (HR, per minute), respiratory rate (RR, per minute) and temperature (Temp, °C) were recorded before, and 10 minutes, 1 hour, 2 hour and 4 hour after the FB. We hypothesized that, in a tertiary level ED of an Australian teaching hospital, FB therapy will have varied indications and have limited physiological efficacy.

  • iStride: A locomotor training program for children with cerebral palsy

    Cerebral palsy is the most common cause of physical disability in childhood. Physiotherapy is an important patient focused healthcare delivery intervention that is necessary to improve functioning of muscles, walking and in the prevention of deformities. The life-long impact of cerebral palsy is higher than many conditions because of the early age onset. Hence physiotherapy needs to be provided from an early age to influence not only muscular structure (such as strength and flexibility) but also neurological structures such as the brain - which can learn and change when given the right stimulus to do so. There has been a recent paradigm shift in how to train and promote walking in people with neurological conditions. Activity and intensity of training are crucial and much of this has been drawn from neurological research and spinal cord injury research. It is increasingly recognized that teaching the pattern of walking is important to stimulate the central pattern generators – the intrinsic and reflexive pathways in our neurological system that guide movement. This approach is not well understood in the area of cerebral palsy but given the theoretical foundation combined with our clinical experience and observations that have demonstrated feasibility and potential efficacy, a controlled larger scale study is necessary. This is particularly relevant because technology is now increasingly available in the community but is supported by limited evidence. Evidence based approaches are necessary to ensure ethical use of limited funds. The significance of this research recognizes that one in three children with cerebral palsy cannot walk and rely on equipment aides and physical support from carers. Hence programs focusing on walking will address known issues due to sedentary behaviour in children with cerebral palsy and in the prevention of obesity and pain. Such interventions will improve independence and functioning hence reducing the burden of care, which is by far, accountable for the highest economic impact of this condition. Therefore training to walk at an early age even with the use of mobility aides such as walking frames actually translates to increasing and maintaining movement, strength, independence, function, participation and well-being to reduce the burden of care not just for short term gain but well into the future as children become adults. This approach combines the knowledge and principles needed to improve muscular structures, central pattern generators and an avenue to improve walking speed and endurance in young children with cerebral palsy even though children are classified as having lower gross motor function (GMFCS III, IV and V). The primary aim of this research is to determine if robotic assistive rehabilitation improves functional mobility in children with cerebral palsy who usually require assistance to walk and reduced burden of care for their parents and families.

  • An investigation of the effects of intranasal oxytocin spray on socio-emotional brain regions in ageing in healthy adults.

    The overall aim of the current study is to examine social and emotional brain regions involved in healthy ageing using a double-blind placebo controlled intranasal oxytocin design and MRI techniques involving fMRI.

  • An assessment of the flow rate of Baxter balloon pumps in a hyperbaric chamber

    Elastomeric pumps are balloons filled with antibiotics. As they deflate they deliver the medication to the patient at a constant rate. Patients that require long term antibiotics, such as as for infections in the bone, often use these pumps. These patients may also require treatment in the hyperbaric chamber for their infection. This study will compare the flow rate of the elastomeric pump in the hyperbaric chamber with its flow rate outside the hyperbaric chamber. If the pump flows at the same rate in the hyperbaric chamber there will be no need for disconnecting the pump before hyperbaric treatment. This will improve patient care by reducing the risk of infection and ensure appropriate antibiotic dose administration.

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