ANZCTR search results

Varenicline remains the most effective pharmacological agent in supporting smokers to quit, though its effectiveness in promoting long term abstinence is inhibited by a number of issues 1. A recent meta-analysis reported that varenicline caused an increase in discontinuation compared to placebo as a result of adverse events, negatively impacting medication adherence and the likelihood of a quit attempt being successful 2. As adherence to varenicline is a major predictor of success during a quit attempt, ensuring completion of the prescribed regimen is needed to optimise the likelihood of a successful quit attempt 3. An additional issue during varenicline treatment is the resurgence of cravings and withdrawal symptoms at the end of the prescribed treatment period. Experiencing these symptoms increase the likelihood of lapse and relapse after achieving initial abstinence 4. The primary objective of this clinical study is to compare differences in safety and efficacy outcomes of three different varenicline regimens for smoking cessation over a treatment period of 16 weeks, followed by 12 weeks of follow-up. The regimens are designed to reduce the frequency and severity of adverse effects, cravings and withdrawal symptoms. The secondary objectives are a comparison of carbon monoxide (CO) confirmed continuous abstinence rates (CAR), 7-day point prevalence abstinence rates, and adherence to the study medication throughout treatment. The primary endpoints are the frequency, severity and duration of adverse events, cravings and withdrawal symptoms. The secondary endpoints are 7 day point prevalence and CO confirmed continuous abstinence rates from weeks 12-16, and weeks 16-28, and medication adherence. This study is a phase 4, randomized, double-blinded, placebo-controlled single-center study designed to evaluate the safety and efficacy of varenicline in motivated, smoking subjects allocated to a control group, step-up intervention group, or step-down intervention group. A total of up to 201 participants will be enrolled in to this study at a single site, with 67 participants randomly allocated in a 1:1:1 ratio to one of the three treatment groups. This will provide at least 80% power to detect a moderate effect in the primary endpoints. Participants meeting eligibility criteria will enter the 16-week double-blind treatment phase, followed by a 12-week follow-up phase, with the study completing at week 28. Follow-up will continue for participants who cease treatment early. Participant enrollment will run from December 2016 to December 2017, with data analysis occurring during and after this period.

This study will qualitatively and quantitatively assess MRI and PET-CT for the surveillance of patients with early stage Non-Small Cell Lung Cancer (NSCLC) or pulmonary oligometastatic disease treated with SABR. Similarly, it will also qualitatively and quantitatively assess the changes that occur in normal tissues after delivery of SABR. We intend to assess the validity of current recommendations that utilise CT and PET-CT, and to explore whether or not MRI adds anything to current recommendations. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with Stage I or II NSCLC or pulmonary oligometastatic disease. Study details: All patients who are enrolled in the study will receive the standard pre-treatment work-up, treatment and post treatment surveillance. In addition patients will be subjected to six additional MRIs and two additional PET-CTs and PFTs. In addition patients will be subjected to six additional MRIs and two additional PET-CTs and PFTs, conducted up to 24 months following radiotherapy treatment. This will best identify patients and/or circumstances where PET-CT and/or MRI are of additional value to the standard surveillance protocol currently recommended.

The purpose of this study is to determine whether there are any significant differences between amateur cricket pace bowlers and a healthy control population in side to side differences of lumbar multifidus resting thickness and recruitment between sides.

Major issues impacting survivors of stroke & their carers are reduced quality of life & depression. The period of transition from hospital to home is a critical time for recovery for survivors of mild stroke; bridging hospital discharge to community integration. It has been identified that stroke survivors feel ill-prepared mentally and physically to return to their lives after discharge from hospital (Cott et al., 2007; Turner et al., 2009; Rittman, Boylstein, Hinojosa et al., 2007). A discharge care plan developed by the stroke team focusing on the needs & goals of the person with stroke facilitates the transition home inclusive of medical management, ongoing rehabilitation, and education around lifestyle modification. However, a recent clinical audit of the Australian facilities revealed that less than 50% of survivors of stroke discharged from acute care received this (National Stroke Foundation, 2014). Survivors of mild stroke, typically present with minimal impairments & are often discharged home without inpatient rehabilitation. Recent research highlights that the impact of stroke only becomes obvious on returning home when re-engaging in previous life roles (e.g. work, leisure). The overarching aim of this research is to determine the efficacy of a new allied healthled model of care for individuals with mild stroke discharged from acute care. The primary aim is to assess the efficacy of MiStrEnGTH as compared to usual care on quality of life (QoL) and client mood. A secondary aim is to assess the efficacy of MiStrEnGTH as compared to usual care on daily activity, community participation, carer mood and strain. It is hypothesized that clients and carers receiving MiStrEnGTH will have improved QoL, mood and community participation, with lower levels of carer strain as compared to usual care. A study design of a randomized controlled trial with intention-to-treat analysis will be used. All participants with acute mild stroke will be randomized to one of two intervention arms at discharge: 1) control 'standard care'; 2) intervention 'MiStrEnGTH'. Data collection from participants will occur at baseline (recruitment), and 1-, 3- and 6-months post-discharge from hospital.

This study will be a randomised crossover trial in sedentary adult couples or individuals.The aim is to compare the acute effects of watching TV whilst sitting uninterrupted with sitting time interrupted by light-intensity simple resistance activities (during TV commercials) on post-meal metabolites (glucose,insulin, lipids), blood vessel function, and perceived hunger and fatigue. Overweight/obese adult couples or individuals aged between 25-40 years will be recruited for the study. Eligibility will be based on: having a BMI more than or equal to 25 kg/m ^2 but less than 40 kg/m ^2, currently watching more than 2 hours of TV per day and be English-speaking. The study will involve two experimental conditions (each of approx 4 hours duration), separated by a 1-day break period. Both conditions will occur in the evening (between 6 and 10pm) as a large amount of TV viewing often occurs following the evening meal. In condition 1 participants will sit for the entire duration of the movie (approximately 3 hours), after consumption of an evening meal, including during intermittent (every 20 minutes) advertisement breaks (of 3 minutes). Condition 2 will be identical to condition 1, except that participants will get up and perform light-intensity simple resistance exercises during the advertisement breaks. In both conditions participants will be provided with the same evening meal (based on 40% estimated energy requirements). Participants will be instructed to minimize excessive movement when sitting; only rising from the seated position to void. Participants will be fitted with a continuous glucose monitor (CGM) for a minimum duration as possible to limit discomfort (afternoon Monday to morning Friday; primary outcome). A number of other assessments performed will form the secondary outcomes and include; endothelial function via Flow Mediated Dilation (FMD); venous blood samples analysed for a range of markers of cardio-vascular health, like blood fats (lipids), sugar (glucose) and, insulin at regular intervals; 24 hour ambulatory blood pressure monitoring (24 ABPM) and hunger and fatigue perceptions.

The PEARL-CF study is a multi-center, double-blind, randomized, placebo-controlled trial comparing three cohorts: (1) Children with cystic fibrosis (CF) taking a probiotic daily for 1 year, (2) Children with CF taking a placebo daily for 1 year, and (3) Healthy non-CF controls (HC) not on probiotics or placebo (age and gender matched). The hypothesis is that: (i) Probiotics restore the abnormal gut microbiota in children with CF, which in turn reduces intestinal inflammation. We also hypothesize that when: (ii) Probiotics are administered daily for 1 year, they will have clinical benefits for patients with CF. (iii) Probiotics are administered in early life (0-3 years), the effects, even when ceased, are sustained compared to when probiotics are given after the gut microbiota has become established (~3 years old).

Obesity is a major health issue that is currently affecting millions of people worldwide. Differences in the taste system due to genetic and dietary factors might explain why some individuals are more prone to become obese than others. There is increasing evidence that humans, apart from being sensitive for the five primary taste qualities, can also taste fat in form of free fatty acids when additional sensory cues are masked. However, in the common diet, the concentration of free fatty acids is relatively low and fat is mainly consumed in the form of triglycerides. The present study aims to determine detection thresholds for canola oil as a triglyceride-rich source of fat and to investigate the associations between individual differences in fat taste sensitivity with detection thresholds of additional sensory stimuli, diet, body mass index, and saliva composition. In this study, detection thresholds of fat (canola oil, paraffin oil, canola oil + oleic acid) and fatty acids (oleic acid) will be determined in a repeated measure design in 30 subjects between 18-55 years. Each of the four stimuli will be tested on 3 separate days with 1 testing sessions per day. Hence, in total there will be 12 testing sessions of approximately 1 hour on 12 measuring days for each subject. All sessions will be held in the Deakin University Centre for Advanced Sensory Science laboratories. At the initial study appointment, body weight and height will be measured to calculate the subjects’ body mass index. Saliva samples will also be collected during the first session to determine the level of the saliva enzyme lingual lipase which is responsible for hydrolyzing triglycerides into free fatty acids. Additionally, eating behavior-related questionnaires and food diaries of each testing day will be collected. Each testing day, detection thresholds of one of the four stimuli will be determined using the ascending 3-alternative forced choice method. In this method, subjects receive a set of 3 samples (one test sample containg the stimulus at a specific concentration and two control samples) and the instruction to taste each sample and to identify the odd one out.

This study is designed to determine the safety and efficacy of non-operative antibiotic management of clinically diagnosed acute uncomplicated appendicitis in children. Enrolled patients will be randomised and an allocation ratio of 1:1 will be made via weighted minimisation, where half of the patients will receive non-operative management with intravenous Piperacillin with Tazobactam, while the other half will have an appendicectomy.

The primary purpose of this trial is to examine the safety and tolerability of a newly developed antibody, MIL-38/Gallium67 (MILGa) for imaging metastases in adults with prostate, bladder or pancreatic cancer. Who is it for? You may be eligible to participate in this trial if you are aged 18 years or older, have been diagnosed with prostate, pancreatic or urothelial (bladder, ureter, urethra, renal pelvis) metastatic cancer, with between 2 and 15 metastases, with the cancer determined to be stable or progressing slowly. Study details: Patients 4-12 will be given a single dose of unlabelled chMIL38-DOTA one hour prior to MILGa drug infusion. All participants in this study will be given a single dose of MILGa, followed by various scans and blood tests for the following 4 weeks. Scans will include a range of CT scans, and patients will also be monitored for adverse events. It is hoped that the findings from this trial will provide information on the safety and tolerability of MILGa administration, and on the efficacy of the antibody for imaging metastases. Cohort 2 (Patients 4, 5 and 6) Patients in this cohort will be infused with 3.5 mg of unlabelled chMIL-38-DOTA prior to receiving 1 mg chMIL-38-DOTA labelled with 250 MBq 67Ga. Each patient in this cohort will be dosed 2 weeks apart. Cohort 3 (Patients 7, 8 and 9) Patients in this cohort will be infused with an incrementally higher dose within the range of 3.5 mg and 24 mg of unlabelled chMIL-38-DOTA prior to receiving 1 mg chMIL-38-DOTA labelled with 250 MBq 67Ga and. Each patient in this cohort will be dosed 2 weeks apart. Cohort 4 (Patients 10, 11 and 12) Patients in this cohort will be infused with an incrementally higher dose within the range of 3.5 mg and 24 mg of unlabelled chMIL-38-DOTA prior to receiving 1 mg chMIL-38-DOTA labelled with 250 MBq 67Ga. Each patient in this cohort will be dosed 2 weeks apart. At end of each cohort: Safety assessment by DSMC and preliminary assessment of chMIL-38-DOTA-67Ga scan utility will be determined. Furthermore, the effect of the dose of un-labelled chMIL-38-DOTA used per cohort on tumour targeting will be reviewed at the end of each cohort to determine the cold antibody dose for the subsequent cohort.

This phase II study will determine whether the combination of Paclitaxel and Epirubicin can be used safely in the neoadjuvant setting in women with locally advanced breast cancer. The study will determine whether, in a multi-centre setting, the activity of this combination is maintained with acceptable toxicity. The study will also determine the disease free survival and overall survival in patients with locally advanced breast cancer, treated with neoadjuvant Paclitaxel and Epirubicin followed by definitive local surgery and radiotherapy and adjuvant Cyclophosphamide Methotrexate Fluorouracil.