ANZCTR search results

Current methods of retracting the liver during surgery (to allow sight of and access to target surgical organs) can be traumatic or painful, and can require additional surgical assistants. The LiVac Retractor System has been developed to retract and hold the liver by suction, therefore reducing trauma and the need for extra assistance. This proof of concept study will assss how well the devices work during surgery and whether there are any safety issues.

Substitution of an innovator to a generic drug product has been continuously rising. In the US, approximately $8 billion to $10 billion is the average cost saving per year of brand substitution and the generic drug prescription has increased from 19% in 1984 to 60-70% in 2009. The increase in drug brand substitution is a call for scientific attention of the appropriateness of available bioequivalence (BE) study guidelines at present. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same. The conclusion of BE studies is based on the assumption that if the test and reference drug products exhibit similar in vitro (i.e. acceptable drug content, similar dissolution/release profile) and in vivo performance (i.e. acceptable bioavailability), these drug products should possess therapeutic equivalence which includes efficacy and safety. However, because bioequivalence studies are conducted in healthy volunteers, these studies may or may not provide definitive evidence to guarantee the therapeutic equivalence in patients. This study aims to compare efficacy and safety of two warfarin products marketed in Australia, namely Coumadin registered trademark or Marevan registered trademark. The study is designed as an openlabel, prospective, observational trial. A total of 300 patients who are prescribed with either brand of warfarin will be recruited in accordance with the inclusion and exclusion criteria. The patients will be followed up opportunistically as their medical appointments for anticoagulant evaluation. The additional 5 mL of the participant blood samples and about 25 mL of urine samples will be collected at each visit. Total and free racemic, R- and S-warfarin enantiomer concentration in plasma, as well as 4',6,7,8, and 10hydroxywarfarin metabolites in urine will be quantified by LC MS/MS. The efficacy of the two warfarin brands will be compared by evaluating International Normalized Ratio (INR) values. The safety profile evaluation will be achieved by recording any adverse drug reactions or adverse events in a questionnaire. The frequency of adverse events reported from two groups of patients will be analyzed and compared.

Substitution of an innovator to a generic drug product has been continuously rising. In the US, approximately $8 billion to $10 billion is the average cost saving per year of brand substitution and the generic drug prescription has increased from 19% in 1984 to 60-70% in 2009. The increase in drug brand substitution is a call for scientific attention of the appropriateness of available bioequivalence (BE) study guidelines at present. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same. The conclusion of BE studies is based on the assumption that if the test and reference drug products exhibit similar in vitro (i.e. acceptable drug content, similar dissolution/release profile) and in vivo performance (i.e. acceptable bioavailability), these drug products should possess therapeutic equivalence which includes efficacy and safety. However, because bioequivalence studies are conducted in healthy volunteers, these studies may or may not provide definitive evidence to guarantee the therapeutic equivalence in patients. This study aims to compare efficacy and safety of two warfarin products marketed in Australia, namely Coumadin or Marevan. The study design is a randomized, open-label, two-way, two-period, crossover study. A total of 50 patients who are prescribed with either brand of warfarin and clinically stable will be recruited in accordance with the inclusion and exclusion criteria. The patients will be allocated as the assigned randomized treatment sequence into 2 groups. For the first 4 weeks, Group I will start with Coumadin and Group II will start with Marevan. Then the participants will be crossed over to the other brand for another 4 weeks. Participant blood samples will be collected at baseline and weekly until the end of the study. Total and free racemic, R- and S-warfarin enantiomer concentration in plasma, as well as 4',6,7,8, and 10hydroxywarfarin metabolites in urine will be quantified by LC MS/MS. The efficacy of the two warfarin brands will be compared by evaluating International Normalized Ratio (INR) values, warfarin dose variation, mean warfarin dose to achieve target INR, area under the plasma concentrationtime curve, and warfarin metabolites to drug ratio. The safety profile evaluation will be achieved by recording any adverse drug.

Obesity is a major health issue that is currently affecting millions of Australians, in addition to having a high economic cost both in this country and around the world. Some individuals are more susceptible to obesity that others; one factor may be variance in taste system due to genetic and environmental factors such as diet. The present study aims to identify and investigate the associations between individual differences in sweet and carbohydrate taste sensitivity with diet and BMI. Proposal research design and methods: The study will involve 100 subjects. These participants will be over 18 years of age and within a BMI range of 18-35kg/m2. Participation in this study involves attending at least 16 laboratory sessions. The first three sessions will involve taste function assessment of the five basic taste qualities (Sweet, sour, bitter, salty and umami). The remaining sessions will involve taste function assessment for different kinds of sugars, natural sweeteners and artificial sweeteners. Participants will be given a copy of the Cancer Council Food Frequency Questionnaire and a 7-day diet diary at baseline, and will be asked to complete them within one month of the sensory testing period. Subject's height, hip and waist circumference, and tongue swab for cell collection will be collected at baseline. Subject's weight will be measured twice, at baseline and at the final visit. The study will use a range of methods and will take place in Deakin University sensory laboratories. Sensory evaluations, including ascending detection and recognition thresholds (sample a series of eight solutions arranged in ascending order to determine taste thresholds) and ascending forced-choice test (correctly choosing a sample that has added sugars/sweeteners/starch at specific concentration) will be used to determine sweet and carbohydrate taste function.

Adolescents are at particular risk of vitamin D deficiency and are also a group who may not take medications regularly. The optimal dosage regimen for adolescents to help them take vitamin D regularly enough to correct deficiency is not known. Therefore the main aim of this study is to test two different vitamin D dosage regimens to see if they can both correct vitamin D deficiency in adolescents. The study will also show whether vitamin D deficient adolescents can be successfully identified through general practice and provide preliminary pilot data on whether correcting vitamin D deficiency results in significant improvements in bone density.

This is a single-center, randomized controlled, study using induced blood stage malaria (IBSM) infection to characterize the activity of griseofulvin as a potential treatment of early Plasmodium falciparum blood stage infection in healthy volunteers.

Patients having operations under general anaesthesia will be asleep for the duration of the procedure and their own breathing efforts will be reduced by the anaesthetic drugs. The anaesthetist will support the patients breathing and will place a breathing tube into his/her windpipe as soon as the patient have drifted off to sleep. Normally, the anaesthetist discontinues the administration of oxygen during this manoeuvre as it usually takes only a short time to insert the breathing tube. We believe that continuing the supply of oxygen through a small tube into the inside of the patients cheek at this stage will keep the body oxygen levels higher than they would be otherwise. This is especially important for patients who are overweight or pregnant and also in children as their oxygen reserves exhaust more quickly. Computer programs and our understanding of the biology of people have suggested this would be the case. However, we do not have proof of this at present.

Laparoscopy is increasingly replacing open surgery as the preferred treatment option in most patients across disciplines. Additionally as technological improvements have occurred, mini-laparoscopic instruments have been designed to further reduce surgical trauma and minimize invasiveness. There are several studies in the literature, which show that using mini-laparoscopic instruments does not increase complication rates and may reduce patient recovery. Typically a 10mm umbilical incision and endoscope is routine for a total laparoscopic hysterectomy. In 2011, St John of God Hospital began to use high definition 5mm endoscopes. At this stage Dr Salfinger began to complete his total laparoscopic hysterectomy with a 5mm umbilical incision and endoscope and anecdotally noted that patients were requesting discharge earlier. In 2012 Dr Salfinger and Acton audited 328 consecutive cases in a single-surgeon series of total laparoscopic hysterectomy, comparing use of 5mm and 10mm rigid laparoscopes examining for length of hospital stay (LOS), return to normal daily routine, complication rates and conversion to laparotomy in women aged between 29-92 years. Findings were a significant increase in the number of women being discharged from hospital on day 1 in the 5mm-scope group compared to the 10mm scope group. Both groups had similar blood loss and complication rates. Notably the 5mm-scope group also had a significantly shorter time to return to normal function (subjective, patient assessed outcome) with 8 days in comparison to 17 days for the 10mm scope group. Because of these findings we are encouraged to perform a randomized controlled trial examining the impact of umbilical incision, port size and endoscope size on total laparoscopic hysterectomy. This will be a randomized controlled trial with participants randomized to either the 10mm or 5mm incision and endoscope. Participants will be recruited from Dr Salfinger and Dr Tan’s patients. Data collected will include basic patient demographics, type of umbilical incision and endoscope used, operating time, complication rates, discharge time and post operative pain scores on day 1 and day 7. It is hoped that this data will be used by other surgeons and encourage them to trial 5mm umbilical incision and endoscope as well as other health centers, encouraging them to provide new technology for their surgeons and patients, aiming for shorter length of stay.

This is a Phase II study of cetuximab, carboplatin and radiotherapy (RT) in patients with Locally Advanced Head and Neck Carcinomas (LAHNC) who are unfit for cisplatin. The aim of this study is to show the feasibility and safety profile of the combination of cetuximab, carboplatin and RT in treatment of patients with LAHNC.

Background: Indigenous Australians suffer a disproportionate burden of preventable chronic disease compared to their non-Indigenous counterparts – much of it diet-related. Increasing fruit and vegetable intakes and reducing sugar-sweetened soft-drink consumption can reduce the risk of preventable chronic disease. There is evidence from some general population studies that subsidising healthier foods can modify dietary behaviour. There is little such evidence relating specifically to socio-economically disadvantaged populations, even though dietary behaviour in such populations is arguably more likely to be susceptible to such interventions. Aim: This study aims to assess the impact and cost-effectiveness of a price discount intervention with or without an in-store nutrition education intervention on purchases of fruit, vegetables, water and diet soft-drinks among remote Indigenous communities. Methods/ Design: We will utilise a randomised multiple baseline (stepped wedge) design involving 20 communities in remote Indigenous Australia. The study will be conducted in partnership with two store associations and twenty Indigenous store boards. Communities will be randomised to either i) a 20% price discount on fruit, vegetables, water and diet soft-drinks; or ii) a combined price discount and in-store nutrition education strategy. These interventions will be initiated, at one of five possible time-points, spaced two-months apart. Weekly point-of-sale data will be collected from each community store before, during, and for six months after the six-month intervention period to measure impact on purchasing of discounted food and drinks. Data on physical, social and economic factors influencing weekly store sales will be collected in order to identify important covariates. Intervention fidelity and mediators of behaviour change will also be assessed. Discussion: This study will provide original evidence on the effectiveness and cost-effectiveness of price discounts with or without an in-store nutrition education intervention on food and drink purchasing among a socio-economically disadvantaged population in a real-life setting.