ANZCTR search results

The purpose of this study is to compare dysplasia detection rates of conventional forward-viewing colonoscopy against Full Spectrum Endoscopy (FUSE) colonoscopy in an inflammatory bowel disease (IBD)-dysplasia surveillance population. Who is it for? You may be eligible to join this study if you are aged between 18 to 80 years and are eligible for inclusion into the IBD Surveillance Program according to the NHMRC guidelines - that is patients with colitis (at least 1/3 extent of the bowel) of at least 8 years duration. Those with concurrent primary sclerosing cholangitis or prior colonic dysplasia are eligible immediately (rather than at 8 years) Study details All participants in this study will undergo a conventional colonoscopy and a Full Spectrum Endoscopy (FUSE) back-to-back in a single day. The order of the procedures will be randomly allocated, i.e. by chance. Full Spectrum Endoscopy (FUSE) is a new imaging technology that adds two side camera lenses to the right and left sides of the colonoscope to the forward viewing lens. The combination of three lenses delivers a 330 degree panoramic mucosal view as opposed to the 170 degree view from conventional forward viewing colonoscopes. Dysplasia detection rates will be compared between procedures. The safety of both procedures will also be evaluated. The results of this study will help us to determine which method of early detection/screening is the most accurate.

Indigenous Australian children have the world’s highest published rates of hospitalised pneumonia and chronic lung disease including bronchiectasis (BE). Children from developing countries are also at a similar risk. Yet, optimal treatment of pneumonia and how to prevent its long-term effects remain unclear. Trials have focused upon short-term (1-2 wk) outcomes and reduced antibiotic (AB) courses in children with non-severe (viral) pneumonia. However, in high-risk populations from Australia and Malaysia, a longer course of ABs may enhance bacteria clearance and thus reduce the risk of chronic lung disease after severe bacterial pneumonia in young children whose lungs are still developing. Our international multicentre, double-blind RCT is designed to answer our primary question: Does a longer course of ABs (13-14 days) compared to a short course (5-6 days) improve short and long-term outcomes of young children hospitalised with chest xray-proven pneumonia? We will randomise 314 children (aged 3 months to 5 yrs) from 4 sites. Children will be seen at clinically important time points (4 wk, 12 and 24 months) and blood, nasopharyngeal swabs and chest x-rays collected, based on pilot data. Data from this first such study worldwide will substantially advance child pneumonia treatment with implications for future lung health, especially in high-risk Indigenous children. Results would lead to changes in national and international guidelines. As a longer AB treatment for all children may increase AB resistance and lead to ‘over-treatment’ in some, we will address these 2 issues by monitoring for AB resistance and embark on a discovery program to identify biomarkers that predict poor long-term respiratory health outcomes. Availability of novel biomarkers from host gene expression will help clinicians decide which children are at high risk, and therefore in need of more intensive follow up, and may enable targeting of longer AB treatment to those at highest risk of BE.

The primary aim of this study is to examine the association between the citrate concentration in haemofiltration fluid and the resulting Standard Base Excess (SBE) after several days of CVVHF. We expect to confirm that performing CVVHF using a relatively high citrate concentration HF (18.0mmol/l) results in an elevation of SBE. We expect to show that using a lower citrate concentration HF (15.0mmol/l) results in much less elevation of SBE. We also expect to show that use of the lower citrate concentration HF results in an acceptable filter life.

The primary purpose of this study is to evaluate the absorption of the oral form of drug OTS167 in healthy volunteers, and to establish its safety. Who is it for? You may be eligible to participate in this study if you are a healthy male or female volunteer aged 45 years or over. Study details: All participants will be randomly allocated (by chance) to receive either the active drug, given in cherry syrup, or cherry syrup alone. This study will recruit participants in three stages. Those recruited to the first two stages will receive one dose on the morning of day 1 of either the active or inactive cherry syrup mixture after fasting for 10 hours (liquid will be permitted). Those recruited to the third stage will receive two separate doses of either the active or inactive cherry syrup mixture at least 4 days apart; once after fasting for 10 hours, and once in a fed state following a high fat, high calorie breakfast. All participants across all stages will have a number of blood samples taken over the 24 hours following each dose, and will be monitored for 4 days for side effects of the drug. It is hoped that the findings of this trial will provide further information on the absorption and distribution within the body of this oral formulation of OTS167, which may provide a more tolerable and convenient method of dosing for cancer patients.

Project’s aim(s): We aim to assess the safety and efficacy of topical application of coconut oil in improving skin integrity in very preterm infants (<30 weeks) Justification: The skin of a premature baby is delicate. Loss of body water through the thin skin can cause dehydration, weight loss, dry skin and increased risk of infections. The skin care of premature babies includes minimal handling, humidification in the incubator, and topical application of creams and various natural oils. Studies have shown that topical application of creams increase the risk of infections. Studies from developing countries have shown that topical application of natural oils improves skin condition, causes weight gain, and reduces the risk of infection in preterm infants. Also, Coconut oil has large amount of fats with antibacterial properties. None of these studies reported any significant side effects of topical application of coconut oil. However these trials did not involve enough number of very premature babies. Considering that it is a simple and inexpensive option. We plan to conduct a study of topical application of coconut oil for improving skin condition of very premature babies born before 30 weeks. Participant group(s): Participants will be the preterm infants <30 weeks (Coconut oil+ standard treatment {minimal handling, high humidity}-36, Standard treatment-36) Project design and methods: This study will be a randomized controlled trial. The baby’s skin will be assessed by a trained nurse (using the routine protocol for skin assessment in hospital ) within 24 hours of admission and then on day 7, 14 and 21 after birth. Coconut oil will be applied (starting within 24 hours of admission in nursery) to the baby’s skin using gentle strokes without excessive pressure and avoiding massage. The application will not cover the face, head and drip site .Oil will be provided in separate tubes for each baby and the left over will be discarded after each application, to minimize the risk of infection. We will collect information about the progress of the baby (nutritional parameters and impact on various complications of prematurity). Skin surface swabs (from ear lobes, axilla and groin) would be taken weekly to monitor the change in bacterial flora on the skin. weekly weight gain per kg body weight during the study intervention and until discharge or death after first admission. Two blood samples of 500 microlitre each for assessment of plasma Lauric acid and Monolaurin levels will be taken from the infants veins prior to study intervention and after 10 days(within 72 hours of collection).Whenever possible, blood sampling will be combined with sampling for routine blood tests. No more than 2 attempts at blood collection will be performed. Expected outcomes: Based on our hypothesis we expect that coconut oil application in very preterm babies will be safe and would result in improvement in their skin condition and reduce the incidence of infections.

One of the most common types of anaesthetic used for caesarean section is a spinal anaesthetic. In order for women to be comfortable during the operation a large number of nerves are blocked. In addition to the pain nerves it is very common for other nerves to be affected, including those which are responsible for other types of sensation, movement in the legs and also those which normally help control blood pressure. Significantly low blood pressure in the mother may be associated with side-effects including nausea and vomiting, dizziness and possibly loss of consciousness and in extreme situations the baby may also receive a reduced blood supply from the placenta. For the anaesthetist to provide a safe anaesthetic it is very important to monitor these effects and especially any changes to blood pressure and how the woman’s body responds to it. This is particularly important during the first 5 to 10 minutes after the injection of the spinal anaesthetic. During this period it is usual to closely measure blood pressure, heart rate, the amount of oxygen in the blood and the electrical activity of the heart from an electrocardiogram. Recently, it has also become possible to directly observe the function of the heart relatively quickly and easily via a hand-held ultrasound probe placed on the chest – a transthoracic echocardiogram or TTE. These devices are very similar to those used for obtaining images of the baby during pregnancy. It is known from the use of these devices in other situations, including in pregnant women, that valuable information may be obtained about how the heart is performing. Until now this has not been done in healthy women having a spinal anaesthetic for an elective caesarean section. Hence, the purpose of our study is to document the effects of a standard spinal anaesthetic on the output of the heart by comparing measurements at approximately 10 minutes after the spinal injection with measurements taken immediately before the spinal using TTE. In keeping with usual practice, drugs will be given to help maintain normal blood pressure throughout. The drugs used will be ephedrine and metaraminol.. Information obtained from this study will be helpful in further understanding the impact of spinal anaesthetics on the cardiovascular system in pregnant women which is likely to help guide anaesthetists to reduce side effects and improve safety.

The purpose of this study is to determine if the CRAFT tool, a tool developed to promote deliberate teaching in the operating theatre, can improve the educational environment of junior doctors training in anaesthesia. The educational environment will be assessed using a specific survey tool developed for this purpose, the modified Anaesthesia Theatre Educational Environment Measure (mATEEM). In addition, qualitative aspects of the CRAFT tool application will measure assessed using focus groups. This pilot study aims to: 1.) Develop and validate the mATEEM survey items 2) Determine the feasibility of the quantitative and qualitative aspects of the study 3) Determine participation rates of specialists and trainees in each department, and subsequent compliance rates of utilising the CRAFT tool 4) Estimate the levels of outcome variability to determine samples sizes for a future definitive study

The project aims to examine whether supportive motivational text messages can serve as ongoing support to reduce relapse rates and extend the duration of continued abstinence among patients recently discharged from in-patient alcohol or other drug (AOD) withdrawal. To achieve this 100 patients who have completed detoxification at Wellington House will participate in a randomised controlled trial of the intervention (study design). Patients will be notified by nursing staff that the study is taking place during admission. Those deemed eligibility by the resident doctor will be approached and invited to participate towards the end of their stay. Eligibility criteria are: (i) owning a mobile phone with credit (ii) familiarity with sending and receiving text messages (iii) available for a telephone follow-up interview 1 month after discharge. If interested the doctor will provide information and oversee the consent taking process if they wish to participate. The consent process will include a request for permission for the researchers to access their screening and assessment data. The resident doctor will complete the client locator form so they can be contacted for a one-month follow-up interview. Once this documentation has been faxed to the research team, the study coordinator at Turning Point (Dr Manning) will take the next sealed envelope which will contains the condition to which the participant is allocated. Commencing the day after discharge and for the subsequent 4 weeks, the intervention group will receive twice daily motivational SMS and the control group will receive no motivational SMS and only one message a week providing them with the telephone number for Directline should they require support/assistance. Both groups of participants will continue to receive the usual care planned for them prior to discharge from Wellington House for the duration of the study. Baseline and outcome measures for this project are: (i) The AUDIT and DUDIT for substance use severity and (ii) the K10 to measure psychological distress (from the routinely completed screen and assessment). Additional measures at the one month telephone interview will be the Timeline Followback to establish alcohol and drug use in the past month. The follow-up interview will take approximately 30 mins to complete over the phone with a researcher. Participants will be sent a weekly SMS asking them to report (via reply SMS) the number of AOD using days for that week.

To investigate the residual effects of temazepam and zolpidem, and to investigate the analysis of speech for objectively measuring these changes.

A significant and well-established impact of Chronic Obstructive Pulmonary Disease (COPD) is poor balance and high rates of falling. People with COPD have well identified falls risk factors such as reduced balance, poor strength, and irregular walking patterns. However, further investigation into how balance changes during exertion is required in order to implement strategies for reducing the incidence of accidental falls in this population. The aim of the proposed study is to determine if adults with chronic obstructive pulmonary disease (COPD) have deterioration in their walking pattern (gait) regularity during walking with exertion, and have worse dynamic balance after exertional walking. This study examines changes in balance control (as measured by gait regularity and limits of stability) in adults with COPD during self-paced walking (6 Minute Walk Test) and externally paced walking with regular increases in pace (Shuttle Walking Test). Measures of exertion (Modified Borg Dyspnoea Scale, SPO2 and HR) will be recorded concurrent to each walking task. The study design is repeated measure crossover study in which twenty people with COPD will be recruited from the University Exercise Clinic. Participants with stable COPD will perform both a 6 Minute Walk Test and a Shuttle Walk Test one week apart in a randomised order with gait regularity and oxygen saturation recorded at one minute intervals. Both the walking tasks will be performed on a GAITRite sensor mat recording walking pattern and gait regularity. Before and after each walking task balance (Functional Reach) and perceived level of dyspnoea measures will be taken. Gait regularity will be analysed using linear regression modelling for within task and between task comparisons. If the residuals from linear modelling do not meet the requirements of linear regression then data will be analysed using logistic regression. A paired T test will be used to compare functional reach prior to and after each of the exertional tasks. Covariance accounting for baseline values will be undertaken.