ANZCTR search results

This study aims to assess the accuracy and reliability of the Oscar 2 non-invasive blood pressure measuring device during; 1. fixed wing; and 2. helicopter transportation of critically ill patients.

The aim of this clinical trial is to establish whether stuttering and speech sound disorder can be treated simultaneously. It is estimated that between 30-40% of children who stutter also have a speech sound disorder. Both disorders are known to have effects that may continue into the child's school years and beyond if not treated early. Currently there are a number of effective interventions that aim to treat fluency and speech sound disorders when they present in isolation. A small number of participants will be recruited to carry out a combined stuttering/speech sound disorder treatment program to establish safety and correct clinical protocols.

Excessive dryness of mouth and throat, occurs in patients with Sjogrens Syndrome. This could result in sleep disturbance and predispose to obstructive sleep apnea. A previous study has reported that nocturnal humidification (moistening the mouth and throat at night) improved mouth dryness and decreased sleep disturbance. It might be possible therefore to improve sleep apnea and sleep quality in patients with Sjogrens Syndrome by using special mask and device which will deliver humidified air and keep mouth and throat moistened, during night.Our aim is to find out the usefulness of nocturnal humidification (giving humidified air through a mask during sleep at night) in improving sleep apnea and sleep quality in patients with Sjogrens Syndrome.

Breast cancer is the most commonly diagnosed invasive cancer in women. Breast cancer patients often suffer from suppressed immune functioning as a result of the cancer and its therapies. The aim of this project is to examine whether resistance exercise can enhance immune functioning in breast cancer survivors. Participants will undergo a testing protocol consisting of measurements of immune function (blood sample), strength and quality of life (questionnaires). Participants will then be randomly assigned to undertake a 16 week resistance training intervention or to continue on as normal in a control group. At the completion of the 16 weeks the participants will undergo the same tests as at baseline. These tests (strength and quality of life) will also be completed at a 6 month follow up. Who is it for? The study is open to postmenopausal women aged 40-70 years who are recovering from stage I to IIIA breast cancer and its associated treatment. Full details of the inclusion and exclusion criteria for this trial can be found in the relevant sections of this form. Trial details This study involves participating in a 16 week resistance exercise intervention, conducted 3 times per week in groups for approximately 1 hour per session encompassing full body weight training and progressive resistance training consisting of the use of free weights and machines, under the supervision of a qualified trainer who is assisted by 3rd year students.

The purpose of this study is to measure cancer specific gene changes in the blood as a biomarker in monitoring disease status in colorectal cancer. Biomarkers are substances that can be found in blood and/or tumour tissue and may be used to measure the effects or progress of a disease or condition. Genes are substances in the body which contain information about characteristics us as individuals. Previous studies have found that the majority of colorectal cancers contain mutations in several genes (the gene is changed or different from the common form) and that these cancerrelated mutations can be detected in the blood. Identifying biomarkers are important because they may be linked with disease progression, they may help to identify people who are most likely to benefit from a certain treatment such as chemotherapy, or they may be used to track the status of cancer without the need for invasive procedures, such as biopsies.

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.

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.

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.

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.

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.