ANZCTR search results

To replace the midday meal with Medlab’s W8Biotic(Trademark) product for a duration of 8 Weeks. W8Biotic(Trademark) is scientifically formulated to support lean body mass, weight management and maintain healthy blood glucose levels in healthy individuals when taken in conjunction with a calorie controlled eating plan. W8Biotic(Trademark) contains Hi-Maize Resistance Starch, which is a Type 2 Resistant Starch (RS2) with therapeutic properties that may help to increase satiety and assist with weight management. Hi-Maize is also a prebiotic and produces short-chain fatty acids that help to support healthy gastrointestinal function. Leucine is a branched-chain amino acid that assists in the metabolic regulation of healthy blood glucose levels and in supporting skeletal muscle protein synthesis in healthy individuals. W8Biotic(Trademark) also contains Lactobacillus plantarum and Lactobacillus paracasei that naturally synthesise alpha-hydroxy isocaproic acid (HICA) from leucine, which is indicated to support lean muscle mass in healthy individuals. Furthermore, L-carnitine assists with modulating energy expenditure in healthy individuals.

Recent research has shown that resistance-trained men who supplemented with 6 g.d-1 of d-aspartic acid (DAA) over 14 days significantly reduced total testosterone and free testosterone levels. The long-term training consequences of reduced testosterone from DAA supplementation are currently unknown. The primary objective of this study was to evaluate the effectiveness of DAA to increase basal testosterone levels over three months of resistance training. A secondary objective was to establish potential mechanisms for changes in strength and hypertrophy. Based on our previous findings, it was hypothesised that the DAA group would experience decreased total testosterone and free testosterone. In addition, it was hypothesised that the DAA group would experience increased strength, explained by improved neural plasticity.

Alcohol detoxification is associated with a myriad of withdrawal symptoms ranging from headaches and nausea to anxiety and potential seizures. Typically relief for these withdrawal symptoms involves treatment with benzodiazepines, which come with their own set of associated risks. Benzodiazepines have a high potential for dependence as well as cognitive and psychomotor impairment. Flumazenil, conventionally viewed as a benzodiazepine antagonist with agonist actions having been observed at low doses, has demonstrated potential as a management tool to assist both alcohol and benzodiazepine withdrawal. This study aims to assess the efficacy and safety of low-dose flumazenil infusion administered subcutaneously as an option for detoxification from alcohol. It will also explore the role of flumazenil-assisted alcohol withdrawal in maintaining abstinence post-withdrawal.

The aim of this study is to determine the feasibility of implementing a pedometer intervention to reduce the incidence of excessive gestational weight gain in pregnant obese women in a cost effective, reliable manner. The results from this feasibility trial will help guide a future large, multicentre randomised trial. In detail, we aim to: 1. Refine and test the trial protocol for a follow-on large multicentre trial; 2. Examine efficacy in increasing activity level to a target of 150 minutes of “fairly active” or “very active” time per week in pregnant obese women via feedback from the Fitbit Zip (registered trademark) pedometer in line with Australian National Physical Activity Guidelines for adults; 3. Examine efficacy in increasing step count at least 150% from baseline measurements (up to 10,000 steps) via feedback from the Fitbit Zip (registered trademark) pedometer; 4. Evaluate the impact of investigator feedback compared with participant self-monitoring alone, on the reduction in excessive gestational weight gain of pregnant obese participants; 5. Confirm earlier trial results, in healthy volunteers, in assessing acceptability of the trial protocol and pedometer use to our patients and antenatal staff, as a high recruitment and participation rate will be required for a viable definitive study; 6. Determine retention rates over the trial period (as dropouts over participants’ pregnancies will significantly limit a future RCT); 7. Assess the magnitude of any effect of the interventions (with particular respect to reducing the incidence of excessive gestational weight gain, and increasing activity and step count levels) to further inform sample size calculation for a definitive trial. Study Outline Thirty obese pregnant women (body mass index greater than or equal to 30 kg/m2 at first clinic booking ) aged 18 years or over, will be supplied with the Fitbit Zip (registered trademark) pedometer and wear it on a daily basis during waking hours until final antenatal visit. Women will be randomised into three groups of 10: 1. Control Group: will wear the pedometer, blinded to daily step counts. 2. Intervention Group A, Pedometer feedback only: will have pedometer “synched” to their personal smartphone, with ability to self-monitor daily step counts. 3. Intervention Group B, Pedometer feedback + behavior change: will have an added behavior change program in addition to pedometer feedback, with additional regular support from study investigators. Participants in groups 2 and 3 will be encouraged to increase their physical activity levels in line with the Australian Physical Activity guidelines for adults, aiming for at least 30 minutes of moderate physical activity most days of the week (or 150 minutes per week). The Fitbit pedometer registers this level of physical activity as “fairly” or “very” active and equates to approximately 10,000 steps per day.

The primary purpose of this trial is to evaluate the safety and efficacy of a combination treatment of EnGeneIC Dream Vectors (EDV's) packaged with the chemotherapy PNU-159682, given with adjuvant EDV-60mer. Who is it for? You may be eligible to enroll in this trial if you are aged 18 to 75 years old and have an advanced solid tumour that is metastatic or unresectable which cannot be treated with standard care or for which standard care treatment is no longer effective. Study details All participants enrolled in this trial will receive combination treatment with the following: 1. The EnGeneIC Dream Vector(TM) (EDV(TM)). The EDVs are very small particles known as nanocells, which are made from Salmonella bacteria. The type of Salmonella is one that does not cause disease. The EDV is the delivery vehicle used to transport the study drug directly to the site of the cancer. 2. The Cancer Treatment. The study drug is called PNU-159682. PNU-159682 is a type of chemotherapy. The study drug is packaged inside the EDVs (EGFR(V)-EDV-PNU) and is delivered directly to the site of the tumour, rather than the body’s healthy cells and tissues. The EDVs will also be packaged with another substance that is designed to boost the immune system, called EDV-60mer. 3. Bispecific antibody. The EDV delivery system works in 2 ways, as well as carrying the study drug, the EDV surface is also coated with a bispecific antibody. A bispecific antibody is two antibodies linked together, such that one can attach to the EDV and the other to cancer cells. Once attached, the EDVs are taken up inside the cancer cells, and the study drug is delivered directly inside the cell itself, causing the cancer cell to die. Treatment will be administered in 8-week cycles. The treatment is combined in a syringe and administered in to a vein (intravenous), over a period of 20 minutes using a special pump. One dose of the treatment is given each week for the first 7 weeks, followed by a treatment free week where a CT or MRI scanning is performed to evaluate the tumours response to treatment (Week 8). Treatment will continue for up to 12 months or until the patient or investigator deems it suitable to stop treatment, for example if serious side effects occur or if the patients disease continues to grow. Each participant will receive one of two possible dose levels, depending on when they are enrolled and on the drug effects in previous participants. It is hoped that the findings from this trial will provide information on whether EGFR(V)-EDV-PNU and EDV-60mer treatment may be safe and effective for the treatment of otherwise incurable advanced solid tumours.

The TAME Cardiac Arrest trial will study the ability of higher carbon dioxide (CO2) levels to reduce brain damage, comparing giving patients ‘normal’ to ‘slightly higher than normal’ blood CO2 levels and assessing their ability to return to normal life-tasks. It will be the largest trial ever conducted in heart attack patients in the ICU. This therapy is cost free and, if shown to be effective, will improve thousands of Australian lives, transform clinical practice, and yield major savings.

The aim of the study is to examine the feasibility, safety and toxicity of focal stereotactic body radiation treatment (SBRT) for locally recurrent prostate cancer following definitive external beam radiotherapy. Who is it for? You may be eligible to join this study if you are a male aged 18 years or above who has been diagnosed with biopsy proven locally recurrent prostate cancer. Study details All participants in this study will first receive two different types of scans to locate the suspected regions of recurrence – these scans are called prostate-specific membrane antigen positron emission tomography (PSMA-PET) and magnetic resonance imaging (MRI). They will then proceed to receive six treatment sessions of Stereotactic Body Radiation Therapy (SBRT). The first 12 participants will receive a radiation dose of 36 grays (radiation dose unit). If this is tolerated, then the next 12 participants will receive a dose of 38 grays. Again if this is tolerated, then the final 12 participants will be treated at a dose of 40 grays. After treatment, all participants will have follow-up every 4 months for the first two years, After two years patients will have routine follow-up (6 monthly for one year, then yearly thereafter until 10 years). During the follow-up period, Patients will have PSA and toxicity assessments. PSMA-PET scans will be repeated at 12 and 24 months post treatment. Study related outcomes will be collected for 2 years. After 2 years outcomes will be collected as per departmental protocol. The study aims to combine the non-invasive advantages of SBRT re-irradiation using functional MRI plus PSMA-PET scans to define and treat the area of recurrence rather than the whole prostate gland.

The need for a period of fasting (not eating or drinking) before having a general anaesthetic is well known and accepted by the community. This measure is necessary to prevent patients from regurgitating and inhaling stomach contents, a phenomenon known as pulmonary aspiration. Many people find fasting an unpleasant experience with hunger, thirst and dry mouth common complaints. Some individuals find chewing gum while fasting helps with these symptoms, however, currently there is no significant medical evidence to either support or refute the safety of chewing gum in this period. Our group proposes to conduct a study in patients who are booked by their gastroenterologist for a gastroscopy (an inspection of the inside of their stomach with a telescope). We intend to randomly divide people into two groups, the first group will fast before their procedure as per the current normal instructions. The second group will also fast, but will be asked to chew gum during their period of fasting before the endoscopy. Both groups of patients will undergo their gastroscopy under a general anaesthetic. After insertion of the telescope the stomach will be inspected and then drained of any fluid by sucking it out through the suction channel of the telescope under direct vision by the gastroenterologist. It is normal for all people to a have a small volume (usually 20-30ml) of fluid in their stomach despite not eating or drinking due to swallowing saliva and the stomach producing its own secretions. The volume of the fluid sucked is then measured and recorded for each patient. The data collected during the course of the study will be collated and analysed statistically looking for any differences between the two study groups. Once completed, the results of the study will be published in the medical literature. The investigators postulate that chewing gum will make no significant difference in the amount of fluid in the stomach of a patient fasting before an operation. In fact, the action of chewing gum may actually be beneficial in stimulating the stomach to empty its normal residual volume of fluid. The information gained from this study will be valuable to all anaesthetists in streamlining pre-operative fasting guidelines for their patients to ensure safety as well as potentially improving comfort while they are fasting.

This will be a single-blind, randomized, single-dose, triple-cross over (a Latin square design), single-centre study. 24 Subjects will be enrolled. Each subject will receive all three treatments in random order. At each administration day approximately 1/3 of subjects will receive treatment A, 1/3 treatment B, and 1/3 treatment C and this will switch around on the second administration day and then again on third administration day until all participants have been administered all three treatments. Screening: Subjects will be screened for the study. Eligible subjects will return for the admission to the Unit within four (4) weeks following screening. All subjects will be instructed to maintain their lifestyle and background medications, if any. Baseline: Subjects will be admitted to the Unit in the evening of Day -1. Blood draw to establish the baseline for all measured endpoints will be drawn in the morning of Day 0. Randomisation: Following the completion of all baseline assessments and draws on Day 0, eligible subjects will be randomized so that approximately 1/3 of subjects will receive treatment A, 1/3 treatment B, and 1/3 treatment C. The first dose of study medication will be then promptly administered. Drug administration and assessment periods: Each subject will receive a drug three times in random pre-determined order, single dose, separated by at least 14 days of washout. Following each administration, blood for PK and safety will be drawn and safety and tolerability assessments will be conducted over the ensuing 36 hours. Final tolerability/safety assessment: Approximately seven (7) days following the administration of the last medication, the site will follow up over the phone with the subjects regarding any tolerability or safety issue; if clinically necessary, they could be invited back to the Unit for follow up tests or evaluation.

Negative rumination is a key maintaining factor in social anxiety disorder and the current study seeks to advance the limited literature on pre-event rumination in social anxiety. Given the lack of research investigating the effects of specific interventions on pre-event rumination, it is imperative to trial strategies that may reduce the frequency of pre-event rumination in individuals with social anxiety. This will have the positive benefit of assisting an individual with social anxiety to not enter a social situation in a negative self-focused processing mode and anticipating failure. One such strategy that has previously been suggested, but yet to be determined as efficacious, is instructing individuals with social anxiety to ban rumination as it serves no adaptive purpose for them. Additionally, the temporal pattern of pre-event rumination is unclear and determining this will assist in understanding this process for individuals with social anxiety and also make clearer when future interventions should be trialled. Specially this study aims are to investigate: 1. The effects of a brief intervention that instructs individuals to not engage in negative pre-event rumination. 2. The temporal pattern of pre-event rumination and determine optimal time points for future interventions to be delivered. The present study hypothesises that: 1. Individuals with social anxiety disorder whom receive the brief intervention will report reduced negative pre-event rumination before a planned speech task, compared to a control group, and thus will report reduce state anxiety in relation to a speech task. 2. While it is suggested that frequency, uncontrollability, severity, and distress of pre-event rumination will increase in linear fashion in the days before the planned speech task, the lack of research regarding the experience of pre-event rumination for individuals with social anxiety precludes a firm hypothesis.