ANZCTR search results

The primary purpose of this trial is to evaluate the efficacy of pharyngo-oesophageal dilatation for improving ease and comfort of swallowing in patients with head and neck cancer therapy-induced swallowing difficulty. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with head and neck cancer for which surgery and chemoradiation therapy finished at least 12 months previously, which has caused ongoing difficulty swallowing. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either the dilatation procedures, or to receive a single oeosophageal endoscopy during which no dilatation is provided. Participants in the dilatation group will receive a series of dilatation procedures. These involve passage of dilators to expand the calibre of the oesophagus under sedation and will occur at 2-3 weekly intervals. All participants will be followed up for 2 years following the final procedure to evaluate swallowing symptoms and satisfaction with the treatment. It is hoped that this trial will provide information on whether pharyngo-oesophageal dilatation may be an effective method for reducing symptoms of difficulties swallowing which have been caused by cancer therapies for head and neck cancer patients.

Genetic testing in the era of next generation sequencing technologies brings unique challenges to the genetic counselling of families. Families are confronted with large quantities of complex information for which they hold the responsibility of communicating with family members. In order to communicate genetic results or risk information the proband must have adequate understanding of the information received. Several studies indicate this may be problematic, and some individuals may not retain or understand the information presented to them. Few resources exist which aim to facilitate the process of cardiac genetic testing for patient understanding, recall and ability to communicate. Data from our research indicates cardiac genetic testing understanding, recall and ability to communicate risk to relatives may be insufficient in a subset of patients. Efforts to better communicate this information is therefore critical. We have developed a communication aid which aims to assist communication of genetic results and risk to family members. Feasibility and acceptability of the aid has been proven through a pilot study. We are seeking to determine whether a genetic counsellor- led intervention incorporating a communication aid improves knowledge, satisfaction and patient empowerment compared to current clinical practice. In addition, we aim to assess the dissemination of genetic risk information amongst family members. We are utilising a randomised controlled trial methodology. Eligible patients diagnosed with hypertrophic cardiomyopathy (with a genetic result available and ready for return) will be recruited to intervention or control. Those randomised to control will receive their result as per current clinical practice within the genetic heart disease clinic. This typically involves return of result by the genetic counsellor and cardiologist. Return of result is usually conducted after clinical cardiology review of the patient in their annual clinical review appointment.Those randomised to intervention will receive their result from a genetic counsellor with use of the communication aid. Primary and secondary outcomes will be compared between the two groups.

The primary purpose of this trial is to determine cancer patient’s physical and/or psychological changes and personal satisfaction following hydrotherapy rehabilitation. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have a cancer diagnosis and have been referred for rehabilitation. Study details All study participants will undergo a 6 week rehabilitation program where patients attend twice a week and have land based exercises, water based exercise and information sessions. Each exercise session is supervised and structured and tailored to suit the ability of the patient. The information sessions are face to face with the opportunity to engage with other patients and the presenter. It is hoped that this study shows that hydrotherapy is an effective and enjoyable form of rehabilitation for patients who have cancer.

This is a phase 1 safety study performed in male or female adult participants with an established diagnosis of severe to profound sensorineural hearing loss that meets the criteria for cochlear implantation and the participant has already chosen to undergo cochlear implant surgery. Approximately 13 participants will be enrolled in the study in one of three groups and will obtain either IP (investigational Product - FX-322) or placebo (in total 5 participants in group 1 - 3 active and 2 placebo - and 4 participants in group 2 and group 3 -3 active and 1 placebo). Assessed will be the diffusion of FX-322 from the middle ear, across the oval and round window membranes, and into the cochlear fluid (perilymph) as well as the tolerability of intratympanic injection of FX-322. In addition the pharmacokinetic (PK) profile of FX-322 will be assessed to determine the systemic exposure to FX-322. To assess safety by the evaluation of treatment-emergent adverse events (TEAEs); physical examination; Visual Analog Scale for pain, Tinnitus Visual Analog Scale (TVAS) and the Tinnitus Handicap Index (THI): to assess potential to cause, exacerbate or ameliorate tinnitus, and Vertigo Symptom Scale (VSS) Questionnaire and Dizziness Handicap Index (DHI): to assess effects on the vestibular system. Blood samples for determination of plasma FX-322 concentrations will be drawn pre-dose and post-dose at 1, 2, 4, and 6 hours on Day 1. Subjects will have the ~24 hour blood draw prior to discharge from the hospital. On post injection Day 3, the subjects will have their ~72 hour blood draw taken at their home. The duration of the study is 10 months.

This study aims to test the effectiveness of an innovative educational intervention ‘4D’. The intervention integrates all four methods of phosphate control, incorporating teach-back as a teaching strategy to improve adherence behaviours to phosphate control in adults receiving haemodialysis, with a target to maintain a serum phosphate level at near normal level between 0.7 – 1.6mmol/L. The anticipated study out comes will be reduced serum phosphate levels, increased knowledge on phosphate control methods, increased adherence to diet, phosphate binder medication and haemodialysis and increased self-efficacy for managing chronic disease

This project will explore the use of assistance dogs as the primary therapeutic tool in occupational therapy sessions for children and young persons with autism spectrum disorder (ASD). Five individual therapy sessions with an occupational therapist, an assistance dog and an assistance dog trainer will be conducted with 75 individuals with ASD. The content of the therapy sessions will be analysed to investigate the assistance dog as a tool to facilitate social engagement, communication and play in children and young persons with ASD. Interviews will be conducted with parents and caregivers of those involved in the sessions to understand their perceptions of their child’s experiences and outcomes of the sessions. This process will develop a shared understanding of the role of assistance dogs in supporting individuals to engage in the social and practical tasks that they want to, and are expected to, achieve. Enhanced insight into the unique role of assistance dogs will enable the development of occupational therapy sessions targeting the specific needs of children and young persons with ASD.

This research project is aiming to determine the effects of Ionix Supreme on stress, mood, energy and anxiety. Despite the widespread use of vitamins to compensate for the busy lifestyle and irregular eating patterns that often accompany busy modern lifestyles, there are few controlled trials directly investigating the relationship between dietary supplements on stress, mood, energy and anxiety. We will be measuring the effects Ionix Supreme compared to a placebo using assessments of mental performance, mood and stress measures, along with the collection of blood samples. A smaller group of participants will be invited to participate in a brain imaging component using Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS). These scans will allow us to assess the effects the supplement may have on the brain.

Background: Current data on the rates of macrosomia in women with gestational diabetes mellitus (GDM) are heterogenous. No study has specifically examined macrosomia rates in women with diet-controlled gestational diabetes. Aims: To compare the rates of macrosomia between mothers with diet-controlled GDM to mothers without diabetes mellitus. Methods: A retrospective case-control study in which all patients with diet-controlled GDM and singleton pregnancies in a single calendar year were considered for inclusion in the study. These cases were individually matched to controls without GDM and without type 1 or 2 diabetes. Cases were matched to parity, age and BMI. Controls were selected from the same year and as close as possible to the date of delivery of the case. Primary outcomes were macrosomia, defined by estimated fetal weight >90th centile and >95th centile (separately). Results: 217 cases were identified with diet-controlled gestational diabetes, out of a total of 7185 births. 15 cases were excluded, leaving 202 cases in total. A total of 16 babies were >90th% and 10 were >95th% in the diet-controlled GDM group. 21 babies were >90th% and 11 were 95th% in the control group. Conclusions: Our findings suggest that macrosomia is not increased in women with diet-controlled GDM, so women with diet-controlled GDM may not require extra surveillance for fetal growth beyond that of the normal obstetric population. Provided women attend appropriate initial consultations with a diabetes educator and a dietician, are linked in with an experienced maternity centre and care-givers are familiar with blood-glucose targets, serious consideration should be given to new guidelines allowing women with diet-controlled diabetes to have obstetric care within lower risk pathways.

Obesity, defined as a body mass index (BMI) > 30 kg/m2, has almost doubled since 1980, with more than 671 million people worldwide now classified as obese. Health problems associated with obesity impact on quality of life and impose a significant cost burden to the health service. The total financial cost of obesity is estimated to be $8.3 billion. Obesity is difficult to treat. Diet, exercise and medications being only modestly effective in aiding weight loss. In selected individual’s, bariatric surgery may offer a means of achieving long-term weight loss, improved health and cost reduction. The physiological and pathological changes that arise from obesity predispose to post-operative respiratory complications. Excess pressure exerted by an increased amount of fat tissue on the chest wall and in the abdomen, leads to collapse and closure of small airways within the lungs. This collapse of the small airways is worsened still by general anaesthesia and lying flat both of which are a requirement for surgery. This collapse persists longer into the postoperative period in the obese when compared to the non-obese population. High flow nasal oxygen therapy (HFN02) has been established as treatment for respiratory failure in infants and neonates. Its use has also become more prevalent in the adult population over the last decade, with an expanding list of clinical applications. High flow nasal cannula (HFNC) are designed to deliver a predetermined amount of heated and humidified oxygen to a patient. HFNC deliver oxygen at a much higher flow rate than a conventional face mask or nasal cannula, up to 70L/min vs 6L/min. The use of high flow nasal oxygen (HFN02) has been shown to improve the clearance of mucus from the airways, reduce the amount of energy used to breath, deliver a more accurate and reliable amount of oxygen to the lungs, and provide a degree of positive pressure into the lungs. The provision of positive pressure has been shown to increase the lung volume, this suggests that small airways that were previously closed are splinted open by the pressure provided. All of the positive effects of HFN02 outlined above are of potential benefit to obese patients in the postoperative period. Of particular interest is the provision of positive pressure which helps open up collapsed small airways. By carrying out our proposed study we hope to determine the impact that HFN02 has on postoperative lung volumes when compared to standard oxygen therapy. Lung volumes, specifically end expiratory lung volume (EELV) can be measured using electrical impedance tomography (EIT). EIT is a radiation free functional imaging modality invented over 30 years ago. It is non-invasive and can be used in real time at the patient’s bedside to assess lung volume changes. EIT has been successful validated against a number of other imagining and measurement modalities. It consists of 16 paired electrodes attached to a belt that is placed around the patient’s chest usually between the 4th/5th or 5th/6th rib. It then feeds back information about the patient’s volumes lungs as they breath to a computer for analysis. Both numerical measurements and images are produced. Hypotheses In obese, adult patients, undergoing laparoscopic surgery for weight reduction, prophylactic post-operative HFN02 therapy will increase EELV, improve respiratory function and reduce respiratory morbidity in the post-operative period

Research has repeatedly identified that stressful life events and childhood adversities are associated with increased risk of psychological disorders. For example, individuals who were maltreated as children are approximately twice as likely to develop recurrent or persistent depression than individuals who had not experienced maltreatment. Additional studies have also found a high association between childhood maltreatment and anxiety disorders. Eye Movement Desensitisation and Reprocessing (EMDR) is an evidence based psychological intervention utilised to treat symptoms of post traumatic stress disorder (PTSD). EMDR also has empirical support for treating comorbid symptoms of depression and anxiety in individuals with PTSD. By targeting early adverse experiences, therapists can work with clients, with a primary diagnosis other than post-traumatic stress disorder, to significantly improve treatment outcomes. Exploratory studies examining the impact of EMDR for clients experiencing depression and/or anxiety, indicate emerging evidence regarding the utility of these methods in improving treatment outcomes and decreasing relapse rates. However, studies in this area are scarce and the majority of studies identified have limitations including small sample sizes and lacking other key aspects of experimental design. The aim of this study is to build on the evidence to improve treatment outcomes for people with depression and anxiety. All participants will be partaking in a two week, outpatient group CBT based intervention for depression and anxiety. Participants will be randomly allocated to one of three treatment conditions, receiving either three 90 minute individual EMDR sessions; three 90 minute individual CBT sessions or treatment as usual (TAU)/delayed treatment. Psychological symptoms will be measured prior to treatment, at the completion of treatment, and at six and twelve week follow up sessions. The TAU group will be offered individual therapy following their six-week assessment. It is proposed that the addition of a EMDR targeting adverse childhood experiences will increase positive outcomes of treatment post treatment and at follow up.