ANZCTR search results

This study aims to examinie the acute administration effects of curcumin, on a cohort already taking long-term curcumin. In an earlier study within another investigator team a report of a significant effect was observed one hour after administration of curcumin within sustained attention and working memory tasks of the intervention group as compared to placebo group. Given that the KARVIAH study design provides an opportunity to re-test this hypothesis, using a different formulation of curcumin, we would like to undertake the following as a sub-study with those participants who have completed their final assessment time-point within the curcumin study.

The primary purpose of this trial is to evaluate the efficacy and safety of FOLFIRINOX chemotherapy for the treatment of gastric or gastroesophageal junction cancer prior to surgery. Who is it for? You may be eligible to participate in this trial if you are aged 18 to 80 years and have been diagnosed with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma for which you are scheduled to undergo radical gastrectomy. Study details The first ten participants enrolled in this trial will all receive FOLFIRINOX chemotherapy prior to surgery. If six of these participants are able to undergo surgery as planned, then all remaining participants enrolled in this trial will then be randomly allocated computer generated software to receive either FOLFIRINOX chemotherapy prior to surgery, or to receive standard care ECF chemotherapy prior to surgery. Participants in the FOLFIRINOX group will receive a 46 hours continuous infusion of chemotherapy once every 2 weeks for 12 weeks. Participants in the ECF group will receive a 46 hours continuous infusion of chemotherapy every 3 weeks for 12 weeks before surgery and 3 cycles after surgery which will be also be every 3 weeks for 12 weeks . It is anticipated that all participants will then undergo surgery within 3-6 weeks. Participants will be assessed for side effects and followed-up for up to five years to assess disease progression and survival. It is hoped that the findings of this trial will establish whether FOLFIRINOX chemotherapy may be a safe and effective alternative to ECF chemotherapy for the pre-surgical treatment of gastric or gastroesophageal junction cancer.

The ability to concentrate and stay focused on a task, to switch attention between tasks, to inhibit impulsive responding, and to mentally hold and use information are critical skills for learning and academic outcomes. The development of these skills is especially important in early childhood. In Australia around 10% of children (approx 400, 000) have attention difficulties. As of 2011 approximately 11% of children worldwide (6.4 million) have been diagnosed with clinical attention deficits. Attention difficulties are particularly prevalent in children with developmental disabilities such as autism spectrum disorder (ASD). Currently the primary treatment for attention deficits is stimulant medication such as Ritalin. There is an urgent need for effective non-pharmacological interventions for young children. We propose a randomised controlled trial to assess the efficacy of a computerized attention intervention in boosting core attentional skills, academic outcomes and behaviour in young typically developing children and children with ASD. The intervention is a computerized training program (TALI Train) developed at Monash University by Dr Kirk and Prof Cornish. TALI has been shown to improve attention and numeracy skills in a randomised controlled trial including young children with intellectual and developmental disabilities. The proposed trial will provide information on the potential of this program for broader populations and will also assess the feasibility of embedding this intervention into the classroom. Aim 1: To investigate if the TALI Train program is effective in promoting short term improvements in trained skills such as attention in young children with and without autism spectrum disorders (4 to 8years, IQ>75). Aim 2: To investigate if the TALI Train program is effective in promoting short term improvements in untrained skills such as executive functions (e.g. working memory), academic skills and behaviour in young children with and without autism spectrum disorders (4 to 8years, IQ>75). Aim 3: To evaluate whether any improvements in trained or untrained skills are maintained 6 months after the intervention. It is hypothesized that children will a) show improvements in trained skills such as attention immediately after training and b) show improvements in both trained and untrained skills, in particular academic skills, at the 6 month follow up.

Atrial fibrillation (AF) is a major public health burden with an estimated 33.5 million patients globally in 2010. Prevalence increases with age to 5-15% in people aged over 80 years, and evidence suggests that these figures continue to rise. AF contributes to a high burden on the Australian health care system mainly due to related hospitalisations, with an annual cost of $ 3.46 billion. Management of AF, including cardiovascular (CV) risk factors, is often not delivered according to evidence-based guidelines, leading to poor health outcomes in these patients. Integrated and comprehensive care management has been recognised as a way to reorganise medical treatment for people living with chronic diseases, and recent data demonstrate the importance of protocol-driven AF-Clinics. A randomised trial in Europe demonstrated that integrated care in a specialized, protocol-driven AF-Clinic was superior in terms of preventing cardiovascular hospitalisation and mortality, compared to usual care. An Australian trial comparing aggressive CV risk factor AF management with usual care a significant reduction of AF symptom burden and severity and improved arrhythmia free survival. Both trials were conducted in a single-centre setting. This model of care for people with AF integrates significant care components and focusses on the collaboration between important disciplines and involving patients in the care process, following a patient-centred and multidisciplinary approach. It is hypothesised that the model of care trialled in the iCARE-AF study will reduce all-cause hospitalisation and mortality in patients with AF (primary endpoint). To test this hypothesis, health outcomes of participants attending the iCARE-AF clinics will be compared with those receiving standard of care in this prospective, multi-centre, randomised controlled trial. Follow-up will be 24 months from the date of enrolment.

Patient outcomes can be significantly influenced by the characteristics of the system in which health care services are delivered, independently of patient and treatment characteristics. There has been no systematic examination of the relative impact of client, treatment and systems ­level variables on outcomes for alcohol dependence. This study aims to determine, using a prospective cohort study, the impact of: (a) individual client characteristics; (b) type of treatment; and (c) features of the system in which treatment is provided, on alcohol treatment outcomes. Eligible treatment centres will be those that provides a face­to­face specialist outpatient alcohol treatment service to adults and expect to treat at least 50 clients for alcohol as primary drug of concern in the next 12 months (or approximately 75 episodes). Fifty services across Australia will be recruited using stratified sampling. Eligible clients will be aged 18 years or older; presenting for a new episode of outpatient treatment at the service; have nominated alcohol as their primary drug of concern; have used alcohol in the last 30 days; have not previously been enrolled in the study in the last 6 months; and have a telephone contact number. Clients will be asked to complete an iPad survey at baseline while waiting for their appointment at the clinic. A telephone survey will be completed at 3 months follow up. The primary outcome measure will be the number of heavy drinking days (> 5 drinks per day) in past 14 days. Secondary outcome measures will include the number of drinking days; total alcohol consumption; and health related quality of life. Predictor variables will include client (e.g. demographics, substance use), intervention (e.g. treatment type), and system ­level variables (e.g. process of care). The relationship between predictor and outcome variables will be examined within a multilevel modelling framework. This is the first study internationally to examine the role of three levels of variables on treatment success. It will provide critical information for policy makers on which to base minimum service standards. Clinic Staff will be invited to participate in a web-based survey, from the Director (or delegate) of their clinic providing information about their own qualifications and skills, their role in relation to the delivery of client treatment, and their perceptions about staff attitudes, team culture and client relationship within the clinic, implementation of evidence-based practice and commitment to quality improvement. One key informant from the centre will be asked to participate in a telephone interview to obtain information number and type of staff, staff turnover, staff supervision, number and type of peripheral services, teaching status, continuity of care, participation in clinical trials, geographic location, funding type, number of clients treated per year, organisational accreditation.

Clinical histories of 83 patients who had laparoscopy to investigate pelvic pain were reviewed. Laparoscopies were performed at Mercy Hospital for Women, Epworth Freemasons by surgeons trained in advanced laparoscopy and currently work in a tertiary endometriosis surgical unit. Patients with deep infiltrative endometriosis or non- endometriosis pelvic pathology on either MRI or ultrasound were excluded from the study. Ultrasounds were performed by a single sonologist with expertise in endometriosis assessments between 2012 – 2015. The ultrasound findings were dividing into sub groups as follows – presence of a utero sacral ligament nodule of endometriosis, utero sacral ligament thickness, thickened peri colic fat, ovarian mobility and focal tenderness. This was compared with operative findings of those patients with superficial endometriosis. Other parameters collected were age, BMI and symptoms –dysmenorrhoea, dyschezia, dysuria and dyspareunia. Standard diagnostic and agreement statistics were calculated to assess the predictive effects of individual ultrasound markers and symptoms on operation findings. Endometriosis is a complex and heterogeneous condition. There is an increased incidence in women with pelvic pain and subfertility. Appropriate early triage for these patients has been shown to improve outcomes. There are no specific non-invasive methods of diagnosing superficial forms of endometriosis, whilst the ability to reliably detect deep infiltrative endometriosis on ultrasound is well established.

This study uses high definition, noninvasive, transcranial direct current stimulation in combination with exercises in balance and proprioception. We aim to improve performance on balance and proprioception tests in people with Parkinson's disease. As a result, we aim to see an increase in quality of life and a decrease in the risk of falls.

This study aims to investigate the effectiveness and safety of twice daily ZYN002, for 12 weeks in 320 (300 randomized) adults with knee pain due to osteoarthritis of the knee. This will be done by analysing a daily pain score and skin check, knee pain and rescue medication diary, and side effects. Safety will be monitored during the treatment visits using standard measures, including physical and neurological exams, vital signs (including oral temperature), 12-lead ECGs, clinical laboratory tests and side effect monitoring. Skin at the application sites will be checked to see if there is any irritation or reactions present after applications. Who is if for? You may be eligible to join this study if you are aged between 40 and 75 years, have knee pain due to osteoarthritis of the knee and are in otherwise general good health. Study details: This study will investigate two doses of ZYN002 compared to a placebo gel (a treatment with no active ingredients which looks like the real thing but it is not). This study is ‘double-blind’ which means you and your study doctor, together with the study staff will not know whether you are receiving ZYN002 or placebo gel. What does study participation involve? Your participation in the study includes a screening visit; a 1 week washout period, a 1 week baseline period; a 12 week study treatment period; and an end of study (EOS) visit at Week 12. During the washout period, participants will be asked to discontinue their anti-inflammatory agents (e.g., NSAIDs) and other analgesics prior to the Baseline Period. Only paracetemol (not more than 3 grams per day) will be allowed as rescue medication. During the Baseline Period, participants will use a 0 to 10 point numeric rating scale to capture their worst pain severity every day. Only paracetemol (not more than 3 grams per day) will be allowed as rescue medication. Participants will record rescue pain medication in a daily diary (Skin Check, Knee Pain, Rescue Medication Diary. During the treatment period four clinic visits are required for: blood sampling; review of daily diary, medications, AEs and skin irritation; measurement of blood pressure, heart rate, breathing rate and temperature ; suicide risk; and possibly, a brief physical and neurological exam, pregnancy tests (females only, if applicable) and an ECG. Participants will record rescue pain medication in a daily diary (Skin Check, Knee Pain, Rescue Medication Diary. Participants will apply all study drug to clean, dry, intact skin, thoroughly massaging it into both the right and left shoulders and/or upper arms until the area is dry.

Patients with liver cirrhosis are at risk of having varices (dilated vessels) in their oesophagus and stomach. These varices can bleed and bleeding is associated with serious complications. It is recommended that all patients have their oesophagus examined with an endoscopy (flexible telescope / camera) to detect these varices. Currently these endoscopies are performed in the Gastrointestinal Investigation Unit using sedation (medication to make you drowsy). The purpose of this study is to evaluate the accuracy of a new endoscope in detecting dilated vessel in the oesophagus and stomach compared to standard the endoscopy. The newer scope is very thin, disposable and can be performed in a consultation room. The thinness of the scope allows the examination to be performed without sedation, using only local sedation.

This study will be a randomised trial investigating whether changes in sensitivity to pressure pain are different when comparing spinal manipulation (a manual therapy technique) of the neck and the low back. It will measure any changes in pain sensitivity over 1 hour, and will measure pain sensitivity in 4 different areas of the body to study how widespread any changes are.