ANZCTR search results

This study aims to prospectively collect clinical data following sentinel node biopsy for vulval carcinoma in Australia and New Zealand. You may be eligible to join this study if you are a female aged 18 years or above with histologically confirmed, unifocal invasive squamous cell carcinoma of vulva less than 4cm in greatest dimension. Women in Australia and New Zealand women with early vulval cancer will be offered sentinel node procedures in place of groin node dissection. On the day before or the morning of your operation, you will have a small injection of a radioactive marker into the skin next to the cancer. A local anaesthetic cream will be used to reduce any discomfort from this injection. Pictures will then be taken over the next 2 1/2 hours to see which glands the marker has spread to. The marker will also help us find the ‘sentinel nodes’ during your operation. Either on the afternoon after the injection or the next day you will have your operation as planned by your doctor. Whilst you are asleep we will inject some blue dye around the cancer which will also help us to identify the sentinel glands. During the 60 minute operation we will remove the cancer. We will identify and remove the sentinel lymph gland(s) from one or both groins. When sentinel nodes in one or two groins can not be identified a full removal of the groin nodes (lymphadenectomy) on either one or both sides will be performed. The gland(s) will be sent to the laboratory for detailed assessment by the pathologist. Follow up clinical data will be collected from your clinical records at 3, 12, and 24 months after surgery (and at, 36, 48, and 60 months where possible), from information obtained when you attend outpatients clinic. The majority of women with early vulval carcinoma do not have groin node metastasis and these women are unlikely to benefit from groin node dissection. The use of sentinel node dissection is safe and should be part of the standard treatment for women with early stage vulvar cancer.

Antibiotic resistance is an international rapidly growing threat to health care. It is a direct result of antibiotic use and results in not just health resource waste, but significant and avoidable health burdens. Reducing antibiotic use is central to minimising resistance. Primary care is a priority target for reducing use as this is where antibiotics are used most (80% of all human consumption is in the community) AND with least effect, especially for acute respiratory infections (ARI). ARIs are the most common reason for an antibiotic prescription in primary care (>5 million per year in Australia) despite providing minimal benefits and some harms. We have identified that patients overestimate the benefits of antibiotics and underestimate their harms and patient expectations are a key driver of antibiotic prescriptions. Appropriately managing patient expectations in ARI consultations is crucial to reducing inappropriate prescribing. Shared decision making (SDM) provides a means of doing this, enabling the general practitioner (GP) and patient to discuss the benefits and harms of using and not using antibiotics and jointly decide on the most appropriate option. We have established that patients want more involvement in decision-making about ARI management and that SDM reduces antibiotic prescribing in primary care. However methods of implementing SDM are limited and it rarely occurs. We have systematically developed the first set of brief decision aids about antibiotic use for common ARIs and successfully piloted them. This project is a cluster randomised trial to determine whether these evidence-based decision aids (for acute otitis media, sore throat, bronchitis) and a brief training package reduces GPs’ antibiotic prescribing rate.

This study will test whether freezing all good or top quality day 5-6 embryos after IVF and subsequently thawing and transferring the best day 5-6 embryo into a natural or artificially prepared cycle leads to an increase in the probability of delivering a live baby from 35% to 50% as compared to the standard strategy of treatment which includes transferring the best quality day 5-6 embryo fresh and cryopreserving the remaining good or top quality embryos.

This pilot randomised controlled trial aims to develop and evaluate an innovative intervention to reduce sitting and improve activity in cancer survivors participating in clinical exercise rehabilitation. In addition to participating in the 4-week exercise clinic (1 1h session per week), half of the participants will be randomly allocated to also receive a text messaging intervention to support behaviour change outside of the face to face clinic. The 3-month intervention will consist of a suite of text messages tailored through coaching sessions conducted at baseline and 4-weeks. The primary outcome is overall sitting time (h/day) measured y the activPAL3 activity monitor. Secondary outcomes include standing time and stepping time, use of time and key clinical outcomes measured using the activPAL3, the Multimedia Activity Recall for Children and Adults (MARCA), and a clinical assessment battery, respectively. All outcomes will be measured at baseline, 4-weeks and 12-weeks. Feasibility and acceptability will also be assessed. It is hypothesised that the intervention will reduce sitting time in intervention participants compared to those that receive the exercise clinic only.

Malaria is one of the most common causes of fever in Australian travellers, with approximately 400 cases reported each year in Australia. In addition, some travellers develop malaria and seek treatment while overseas, and are not included in these reported numbers. Most travellers who develop malaria did not take anti-malarial medications, or did not take the medications properly (e.g. forgot to take tablets). Malaria is a serious illness, and could potentially be life-threatening if not treated promptly. Antimalarial medications reduce the risk of malaria by about 90%, and the most commonly used options in Australia are Malarone, Doxycycline, and Mefloquine (Lariam). This research project aims to reduce the risk of malaria in travellers by improving compliance with anti-malarial medications. We propose to test the acceptability and tolerability of a 3-day schedule of a malaria medication called Malarone. Currently, travellers are required to take Malarone daily, starting 2 days before travel to a malaria risk area and continuing until 7 days after leaving the area. With the 3-day schedule, travellers will only need to take medications for 3 days and be protected for 4 weeks. The schedule will likely improve compliance and therefore reduce the risk of malaria. For trips that are of 4 weeks duration or less, travellers will be able to complete their antimalarial medications before leaving home, and not worry about carrying or taking tablets during their trip.

Presently there is a large push in the non-scientific nutrition-diet community towards a high-fat diet for improving any disease state, with very little scientific evidence. In fact, research in animals (rats) has shown the negative effects of the high-fat, low carbohydrate diet to glucose regulation and weight management. In line with this research, much of the circadian rhythm and metabolomics literature published to date has been using animal models and no human data exists in this area. Establishing the circadian profile in a healthy middle aged population will act to inform future diet and exercise training studies. Currently, there are no dietary studies of circadian clock genes in humans and with increasing rates of type 2 diabetes and obesity, dietary alterations are common within today’s society that the consequences of such changes are not well understood.

All patients with upper gastrointestinal bleeding (UGIB) undergo a gastroscopy urgently. However, in a significant proportion of these patients a source is not identified. Small bowel bleeding is highly likely to be the source in a large number of these patients. This may be identified by capsule endoscopy. Proximal colonic bleeding is also likely in patients with melaena and is identifiable by colonoscopy. As per current standard practice, patients will undergo a colonoscopy frequently or a capsule endoscopy (CE) less often, in an attempt to find the cause of bleeding. Capsule endoscopy is noninvasive, better tolerated and preferred by patients as bowel prep and anaesthesia are not required. However,it is uncertain who will benefit most by having a capsule endoscopy as the second test. The focus of our study is to look at the subgroup of patients who will benefit most by having early Capsule Endoscopy in this context. The study aims to compare two groups of patients, one having capsule endoscopy VS the other having colonoscopy as the second test following a negative gastroscopy to determine differences in ability to detect bleeding source and therefore change patient outcome. All patients with UGIB with a negative gastroscopy will be considered for the study. This is a prospective randomised control trial. Primary endpoint measured will be identification of the source of bleeding. Secondary endpoints measured will be reduced blood transfusions, reduced length of stay, reduced number of investigations and reduced hospital admissions.

Benign Focal Epilepsy of Childhood (BFEC) is the most common type of partial motor epilepsy in the school aged child. BFEC is diagnosed based on clinical features and characteristic abnormalities on their Electroencephalogram (EEG). The frequency of seizures in BFEC is quite low and long term prognosis is generally good. Most children may not require anti-epileptic drugs (AEDs) to treat seizures. However the course may be complicated by language and cognitive impairment, by frequent or severe seizures, Todd's paresis and even status epilepticus. Inspite of being one of the most frequent epilepsies, the underlying brain abnormalities remain poorly understood. Transcranial magnetic stimulation (TMS) evaluates brain excitability in a safe, non-invasive manner. TMS may help predict the clinical severity, requirement and response to AEDs, and identify those likely to have language and cognitive impairment. BFEC is postulated to be a genetic epilepsy with possible multifactorial influence. Identical epileptiform features on EEG may be found in siblings and first degree relatives of affected children. It is not clear why some children in the family have seizures and others do not - study of brain excitability may help answer these questions. Epileptiform abnormalities similar to that in BFEC are also sometimes noted incidentally in EEGs of normal children. In this project we plan to use TMS to study children with BFEC, their unaffected siblings and parents using TMS and EEG. Abnormalities in brain excitability will be correlated with clinical features (including frequency and severity of seizures), requirement and response to AEDs, and abnormality in neurological development. This may allow us to use TMS to prognosticate whether asymptomatic children will develop seizures, which children will require treatment, which AEDs to use, and those likely to need monitoring of brain function (e.g. language).

Primary aim: - To determine whether the performance and satisfaction within meaningful occupations for adults with Chronic Pain improves in response to a Leaned Pacing intervention in comparison to Waitlist Control conditions. Hypotheses: - The Learned Pacing intervention group will have greater occupational performance and satisfaction in comparison to the Waitlist Control group Proposal research design: - Pilot Randomised Controlled Trial Two Group Pretest- Posttest Design. Methods: - Potential participants will be identified from a Community Based Rehabilitation Centre Multidisciplinary Pain Service waitlist and potential participants who consent to participating in the research project will be screened for eligibility based on inclusion/ exclusion criteria, - Eligible participants will be randomly assigned to either the Learned Pacing intervention or Waitlist Control - The experimental group intervention is a Learned Pacing intervention and will be provided over three separate sessions lasting between 60- 90 minutes, which will be provided over three consecutive weeks by a qualified Occupational Therapist. Participants allocated to this group will receive usual care subsequently with a current wait list time of approximately 3 months. - The Waitlist Control group will not receive the experimental intervention, however participants allocated to this group will receive usual care subsequently with a current wait list time of approximately 3 months. - The Canadian Occupational Performance Measure and the Brief Pain Inventory will be used as the outcome measures to record data, pre and post intervention, according to participant's occupational performance and satisfaction, as well as pain severity and interference.

Background: Familial hypercholesterolaemia (FH) is a generally unrecognised, inherited condition (prevalence 1:500-1:200) resulting in excessively high cholesterol levels in the bloodstream from birth, increasing the risk of heart attacks and angina by age 40 or earlier if left untreated. Affected individuals have a 50% chance of passing the condition onto their offspring. Only 15% of affected patients are diagnosed with 85% remaining at high risk of progressing to heart attacks and cardiovascular complications. Early diagnosis and treatment are very effective in preventing heart disease developing. Until recently FH has been managed mainly through hospital clinics. This WA-led national study trials an innovative primary care-based approach using clinical diagnostic criteria as per the Dutch Lipid Clinic Network Criteria (DLCNC) score rather than more expensive genetic testing. This new method of care will allow the condition to be managed predominantly by the patient’s General Practitioner (GP) and primary care team with support from the hospital specialist for more complex cases. Working with the GP, patient records are electronically screened to identify patients with possible FH before clinical examination to provide a definitive diagnosis. Once the first member of a family with the condition (index) is identified, the primary care team undertake family tracing/cascade testing of first-degree relatives to identify related FH patients. Primary Aims: 1) Increase in number of index cases clinically identified 2) Reduction in LDL-c of treated cases Secondary Aims: 1) Increase in the number of family cases detected/contacted (including children) 2) Evaluation of sustainability of method of care 3) Development of registry of FH patients Hypothesis: General practitioner (GP) - practice nurse (PN) led model of care improves the detection and management of FH in the community. Significance: Under a current model of care (MoC) for FH in Australia FH is diagnosed through a number of different routes and managed mainly through hospital-based lipid clinics undertaking genetic testing particularly if the clinical features (phenotype) are highly suggestive of FH. State and Federal Government policy is proposing to increase primary care management of most chronic conditions and the WA Health Department has initiated moves to re-locate the diagnosis and management of FH from the tertiary hospital sector to primary care. In Australia, over 81% of the population consult a GP annually. GP consultations therefore, offer a unique opportunity to help detect unknown index cases of FH in the community. Most of this work will be undertaken in the less expensive community setting of general practice using an electronic data extraction tool to retrospectively review patient records for FH.