ANZCTR search results

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

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31380 results sorted by trial registration date.
  • Outcomes following a Multimodal Pain Protocol in Total Knee Arthroplasty

    There are multiple modalities of analgesia utilised by anaesthetists during an arthroplasty procedure, ranging from general anaesthetic (GA), spinal/epidural catheters, femoral nerve blocks, fascia iliaca blocks and patient controlled analgesia (PCA), either on its own or in combination. Certain anaesthetists may decide to leave catheters in the patients so they may “top up” the local anaesthetic (LA) dose in the morning should pain increase, whether this may be through means of an epidural or FNB catheter. This is all based on expertise, experience and discretion of the anaesthetist. With such variability it is unknown which modality would be best for the patient in terms of outcomes post a total knee arthroplasty. A previous pilot study performed on patients undergoing total knee/hip arthroplasty at our centre revealed approximately 39% of patients were not mobilising day 1 post op due to ongoing complications following their surgery, either as an effect of their anaesthesia (hypotension, nausea, dizziness) or due to quadriceps weakness from the ongoing effects of either centrally/peripherally placed catheters. 50 out of our cohort of 201 patients did not mobilise till day 2 post op. This potentially has prolonged the stay in hospital and affected the rehabilitation period of these patients. As a result of this pilot study, the anaesthetists and orthopaedic surgeons from our centre sat down to formally create a multi-modal analgesic protocol that would hopefully decrease the complications inhibiting patients undergoing total knee arthroplasty from mobilising with the hope this would improve patient outcomes from a perspective of decreased quadriceps weakness, shorter length of stay with improved pain control. We know that there are various forms of multi-modal analgesic pathways out there that have been of proven benefit. Based on a literature review of the various forms of analgesia available, our multi-modal analgesic protocol will consist of either a GA/spinal for induction purposes, a single shot FNB performed after induction and injection of local anaesthetic (Bupivocaine 0.5% or Ropivocaine 0.75%) into the posterior capsule of the knee prior to cementing of the prosthesis. The aim of this research project will therefore be to determine the efficacy of applying this multi-modal analgesic protocol to patients undergoing elective total knee arthroplasty.

  • Can pre-operative Ivabradine and/or Atorvastatin prevent heart injury following surgery for neck of femur fracture in elderly patients?

    In patients undergoing urgent orthopaedic surgery , Heart muscle damage around the time of surgery(perioperative myocardial Injury-PMI) can occure in 52.9% of patients shown in a study conducted in the northern hospital. The majority of these patients were asymptomatic, with only 9.8% of patients meeting the universal definition criteria for myocardial infarction (heart attack). One year mortality was dramatically increased across the board in those with any troponin(a blood test showing heart muscle damage) elevation (37% versus 2.1%)after the surgery. The exact mechanisms of PMI are not well understood, however two broad theories are postulated; myocardial(heart muscle) stress and cholestrol plaque rupture. Prevention of myocardial stress and/or plaque rupture may reduce the incidence of PMI and have been the subject of multiple studies. This study is going to assess if Ivabradine(a medication lowers the heart rate without affecting the blood pressure) will reduce the rate and magnitude of PMI following emergent lower limb orthopaedic surgery by reducing heart rate and attenuating catecholamine(stress hormons) induced tachycardia(fast heart rate) after operation and to assess if it will correlate with a reduction in biomarkers of cardiovascular stress(blood tests) as measured by NT-proBNP, MR-proANP, MR-proADM and CT-proET-1 and if it will reduce the incidence and burden of atrial fibrillation after the surgery. Also this study is going to assess if Atorvastatin(a medication lowers the cholestrol and inflamatiom) will reduce the rate and magnitude of PMI following emergent lower limb orthopaedic surgery and if it will correlate with a reduction in sPLA2 and Lp-PLA2 mass and activity(markers of cholesterol plaque burden and inflammation ). Also we will assess if that patients with higher measures of platelet function(aggregation and reactivity) before and after surgery will have an increased incidence and magnitude of PMI and if patients with a higher burden of atherosclerotic(chorestrol plaque) disease as measured by CT coronary calcium scores( a ct scan messuring amount of calcium in arteries supplying blood to the heart) will have a higher incidence and magnitidue of PMI. And finally to assess if that the benefit from reduction in the incidence and magnitude of PMI by Ivabradine and Atorvastatin is derived primarily in patients with greater atherosclerotic (cholesterol Plaque) burden as measured by higher CT coronary calcium scores.

  • Non-invasive cerebellar stimulation for focal dystonia

    The purpose of the study is to assess whether noninvasive stimulation of the cerebellum (base of the brain) can improve the symptoms of primary focal dystonia. Dystonia is a movement disorder that may be expressed, in part, due to dysfunction of motor networks in the brain including the cerebellum. There are few treatments currently available. If stimulating this region improves dystonia then it has potential to be used as a therapeutic intervention in the future.

  • A prospective randomised Phase II study of single agent pomalidomide maintenance versus combination pomalidomide and low dose dexamethasone maintenance following induction with the combination of pomalidomide and low dose dexamethasone in patients with relapsed and refractory myeloma previously treated with lenalidomide

    The outcome in patients with Multiple myeloma (MM) who fail to respond to treatment or relapse after treatment is extremely poor. This study plans to treat approximately 80 patients in a number of sites throughout Australia and aims to investigate the effect of pomalidomide (a type of chemotherapy drug) on the immune system, and in turn, whether the outcomes of treatment with pomalidomide as single agent therapy for relapsed/refractory multiple myeloma (a blood cancer) are different to that achieved by patients treated with pomalidomide and dexamethasone (a steroid treatment commonly used in this disease) combination therapy. Who is it for? This study is open to male or female patients aged 18 or above with a diagnosis of MM and failing previous therapy, either refractory or relapsed after at least 2 previous lines of chemotherapy (including lenalidomide). The full details of the inclusion and exclusion criteria can be found in the relevant sections within this record. Trial details Initially, all patients will receive induction therapy consisting of four 28 day cycles of pomalidomide and dexamethasone. Patients then randomised to the pomalidomide arm for maintenance treatment will receive 4mg oral pomalidomide daily on a cyclic 21-day out of 28-day schedule for approximately 12 cycles. Patients randomised to the control arm for maintenance treatment will receive 4mg oral pomalidomide daily on a cyclic 21-day out of 28-day schedule along with 40mg oral dexamethasone on days 1, 8, 15, & 22 of 28 day cycle for approximately 12 cycles. For each arm of the study, the actual cycle number will be determined by the patient's treating clinician and based on response to and tolerability of treatment.

  • Australasian Leukaemia and Lymphoma Group National Blood Cancer Registry

    The Australasian Leukaemia and Lymphoma Group (ALLG) National Blood Cancer Registry (NBCR) is an ongoing collection of information and patient samples for patients with suspected, or known, or diagnosed blood cancer. Who is it for? You may be eligible to contribute to this registry if you are aged 15 years or above and have suspected, or known, or diagnosed blood cancer. Study details Patients will be enrolled when blood cancer is suspected, or known, or diagnosed. The following information will be collected: * clinical information prior to diagnosis * induction treatment summary and response to treatment * consolidation treatment summary and response to treatment * 6 months post diagnosis summary and response to treatment * annual treatment summary and response to treatment * clinical information at relapse Patients that are subsequently found not to have blood cancer will have no further follow up. Patients that are identified as potential candidates for ALLG clinical trials will be consented separately for these trials. Patients will also be offered the opportunity to donate blood and bone marrow samples to the Australasian Leukaemia and Lymphoma Group (ALLG) Bio Bank, which stores samples and approves formal research applications to use these samples in further research into haematological malignancies. The registry is expected to enhance recruitment to ALLG clinical trials by increasing cross referrals to sites which are running particular studies, to ensure appropriate screening procedures are conducted prior to the commencement of treatment, to facilitate the implementation of central review and central testing of factors critical to the successful treatment of blood cancer, to enhance consistency in clinical trial populations to ensure trial results are meaningful, to ensure that appropriate samples are collected to minimise repeat procedures to satisfy trial entry requirements (e.g repeat bone marrows), and to store tissue to enable future additional analyses as new biomarkers and molecular subtypes of blood cancers are identified, thus enhancing treatment and ensuring that clinical trial results remain relevant in the current landscape of blood cancer treatment.

  • Isofurans Production under Hyperbaric conditions: an observational study in patients with osteonecrosis secondary to radiotherapy

    ‘Isofurans’ are a group of compounds that are produced by the body when it is exposed to high levels of oxygen. It is a relatively new discovery (2002) and reflects the amount of stress to the body caused by exposure to oxygen. There is still a good deal we do not know about this subject, however it could be linked to a number of illnesses, including Parkinson’s and certain types of lung and eye injuries. We aim to study the production of Isofurans under high oxygen pressures (hyperbaric), which has not been done before. The study will involve taking blood samples from patients who require hyperbaric treatment to improve bone production after radiotherapy, and monitoring the effect this has on Isofurans levels.

  • Preterm infant massage by the mother

    Preterm birth can be associated with long-term neurodevelopment abnormalities. This is at least partly explained by the detrimental effects of a highly stressful environment and the lack of tactile stimulation normally experienced in the womb. Infant massage has been shown to accelerate brain development, resulting in a pattern more similar to that observed in term-born infants. We will teach mothers to directly perform massage as part of the intervention program, and the short term effects of infant massage on brain structure will be examined through advanced neuroimaging techniques. We will recruit 40 preterm infants, and we will randomly allocate them to one of two groups (intervention or control group). 10 healthy newborns will also be recruited to serve as a typically developing comparison group. Short term effects on mother's mood and anxiety and on mother-infant bonding will also be explored by structured scales and questionnaires. Long term outcome measures will assess child development, parent child interaction and parental pyshological, social and emotional problems.

  • The Swinburne Multivitamin Study: The Effects of Multivitamin Supplementation on mood, stress and brain function in older adults

    The use of complementary and alternative medicines is on the rise, with many people opting to supplement their diet in order to ‘top-up’ nutrients lacking from their diet. Recently, research has associated poor nutrition with cognitive decline, and it has also been suggested that aspects of nutrient intake may be associated with mood. Research has found associations between depressive symptoms and a number of key micronutrients, however little research has investigated the role of multivitamin supplementation on symptoms of anxiety and stress. This study will investigate the effect of supplementation with 50+ Ultivite on mood, stress and brain function in healthy, community-dwelling, older participants. Specifically, the study will aim to investigate the role of supplementation on measures of depression, anxiety and stress, as well as measures of brain function.

  • Safety and Efficacy of Eculizumab to prevent antibody mediated rejection in sensitized kidney transplant recipients from a deceased donor

    Antibody mediated rejection post kidney transplant has become a significant clinical problem given that over 25% of kidney transplant candidates have antibodies (are sensitized) to potential organ donors. Currently there are no approved treatments for AMR and options to treat are limited. It is hoped that eculizumab will reduce the incidence of AMR post kidney transplant from deceased donors to whom the recipient is sensitized.

  • Evaluation of the Guardian CPV(TM) Laryngeal Mask during Anaesthesia for General Surgery

    The main purpose of this study is to determine if claimed improvements in a new version of a common medical device are reasonable and if it is appropriate to use these devices instead of the current devices in use (at the Royal Adelaide Hospital)

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