ANZCTR search results

AIM: To evaluate the safety and efficacy of VATS fissure completion (closing of air passage between lobes of the lung) followed by insertion of Zephyr Valves on improving the clinical status of participants with severe Chronic Obstructive Pulmonary Disease who have collateral ventilation (air moving between lobes). PARTICIPANTS: 20 participants at SVHM and SVPH over 24 months. METHOD: Participants will undergo two surgical procedures. The first procedure will be VATS fissure completion followed by CT assessment to ensure successful fissure completion. If successful, participants will undergo a second procedure 4 weeks later for insertion of the Zephyr Valve. Participants will be followed up over a 6 month period. EXPECTED OUTCOMES: Assessment of absolute change from pre-operative baseline at 6 months for: a. Residual Volume (RV) b. Forced Vital Capacity (FVC) c. FEV1/FVC ratio d. Total Lung Capacity (TLC) e. Exercise capacity by Six-minute walk test f. Quality of life (SGRQ) g. Dyspnoea score Percent mean change from pre-operative baseline at 6 months h. Forced Expiratory Volume in 1 second (FEV1)

The COATI study aims to study the impact of the VDL1.1 algorithm for automated control of inspired oxygen in term newborns and young infants with respiratory insufficiency requiring mechanical respiratory support (ventilation) and oxygen therapy. Time spent within the oxygen saturation target range will be compared during 12h periods of standard manual control and automated oxygen control (using the VDL1.1 algorithm which has been built into the SLE6000 ventilator as the OxyGenie setting) in random sequence. Comparison will also be made of time spent in hypoxic (too little oxygen) and hyperoxic (too much oxygen) ranges, frequency of hypoxic and hyperoxic episodes, overall oxygen requirement and frequency of manual FiO2 adjustments. The expected outcomes/hypothesis for this study are; That, under standard clinical conditions, the VDL1.1 oxygen control algorithm will be more effective in SpO2 targeting than manual control in the two study groups, with specifically: a) a higher proportion of time within target and alarm ranges b) a reduction of time in hypoxic and hyperoxic SpO2 ranges c) fewer hypoxic and hyperoxic episodes d) need for fewer manual FiO2 adjustments

The aim of this study is to test whether a structured physical activity program influences exercise capacity and heart, metabolic and muscle function in allogeneic stem cell transplant patients. Metabolism or metabolic function refers to all chemical reactions that are involved in maintaining the living state of all cells within the body. Who is it for? You may be eligible to join this study if you are aged 18 years and above and if you have been scheduled to receive a allogeneic stem cell transplant. Study details: Participants in this study will be randomly allocated to one of two treatment groups as follows: Treatment group 1: Participants in this group will receive the usual care when receiving an allogeneic stem cell transplant and will receive the usual guidelines in regards to physical activity provided by their treating haematologists. Treatment group 2: Participants in this group will undertake a 16-week physical activity program that involves a sedentary reduction program and a structured exercise program. This 16 week program will begin from the time of admission to hospital for the stem cell transplant (approximately 4 weeks as an inpatient, 12 weeks as an outpatient). Participants in this group will also wear a wearable activity device for the duration of the physical activity program. It is hoped this research will contribute to research surrounding the exercise capacity, heart, metabolic and muscle function of patients receiving allogeneic stem cell transplants. It is also hoped that this study will determine if a physical activity intervention can improve quality of life, reduce symptoms of fatigue and improve functional independence in these patients, compared with the usual treatment programs that currently exist.

We will investigate whether delivery of positive inflation pressure (PIP) (singly or repeated), triggered by a 3 second pause in respiration, can re-establish breathing efforts in preterm infants on continuous positive airway pressure (CPAP), a form of non-invasive respiratory support. The study will involve infants born at <30 weeks gestation who require CPAP support, and are having episodes of respiratory pauses. We will conduct a 16 hours crossover study comparing the use of a device to generate PIP with standard CPAP support. The study will be in blocks of 4 hours (randomly assigned) in which PIP is delivered singly, repeatedly (up to 3), or not at all (standard CPAP). We hypothesise that PIP will improve the regularity of breathing, and shorten the duration of respiratory pauses.

Pain is an expected problem after haemorrhoidectomy surgery and there have been a number of studies that have examined metronidazole in helping to reduce post-operative pain. The results are conflicting and the purpose of this study is to further examine the role of oral metronidazole plus standardised analgesia in reducing post-heamorrhoidectomy pain and compare its efficacy to placebo plus standardised analgesia.

The purpose of this study is to determine if a nurse-led, distance-delivered, intervention called ‘Engage’ can be used to increase childhood cancer survivors' self-efficacy, and improve their long-term physical and mental health by promoting engagement in survivorship care. Who is it for? You may be eligible if you are over the age of 16 and were treated for cancer at least 5 years prior to participation in this study, or you may be eligible if you are a parent of a cancer survivor who is less than 18 years old. Study details All participants in this study will receive two online or telephone consultations with a clinical nurse consultant, and a medical case review with a multidisciplinary team. The purpose of these consultations is to provide a referral pathway, and survivorship care plan. Participants will also need to complete four questionnaires at 1, 6, 12 and 24 months. How will this research contribute to childhood cancer survivors? It is hoped that this intervention will be used to improve the quality of life of childhood cancer survivors and reduce pressure on healthcare services associated with managing treatment-related late effects.

Physical activity is impaired by chronic pain and there is evidence that the distribution of activities over the course of a day varies between persons with chronic low back pain and healthy individuals. Spinal Cord Stimulation can improve chronic pain which can lead to increased physical activity and improved quality of life in chronic pain patients. The objective measures of physical activity may be more useful than self-report to both patients and providers. The incorporation of accelerometry into Spinal Cord Stimulation, aside from allowing adjustment of stimulation in response to the patient’s position, provides the opportunity to objectively measure activity following Spinal Cord Stimulation implantation. Outcomes, including physical activity, should be evaluated using validated instruments to ensure accuracy and reliability. There is a need for the activity measured by the accelerometer imbedded in the Medtronic Intellis Spinal Cord Stimulator to be validated against credible measurements. Accelerometry is considered gold standard for physical activity measurement and the accelerometer imbedded in the disposable Vital Patch has demonstrated validity. The aim of this study is to test the validity of positional data (mobile, reclining, upright. lying – 4 positions) collected by the Intellis System. Patients who have completed a trial period of spinal cord stimulation and have opted to have a permanent Medtronic Intellis Spinal Cord Stimulator will be recruited into the study. Participants will be asked to wear the VitalPatch, a disposable adhesive device with an embedded accelerometer for five days to collect positional information for comparison with Intellis system. On the first day they will undergo an hour of in-clinic controlled testing of a range of positions (walking, sitting, standing, lying – 4 positions). A diary noting position changes will be kept by participants during the five days of VitalPatch wear. The primary endpoint will be comparison of Intellis positional data against Vital Patch and manual entry during the controlled testing phase. The secondary endpoint will be comparison of Intellis positional data against Vital Patch and ADL Diary during activity of daily living phase.

The aim of this project is to assess the effectiveness of a 10 day intervention of individualised vibrotactile neurofeedback training (iVNT) on balance performance and postural stability in an elderly population with moderate to severe hearing loss and self-reported dizziness. Two-hundred and seven participants will be recruited across Brisbane, Berlin and New York (69 per site) and they will be randomised to one of the three groups: intervention, placebo and control. The first 3 to 5 days of training will occur at the campus location and the following sessions will occur in-home with support provided as needed. The intervention involves the participant wearing a device that delivers vibrotactile neurofeedback during set training tasks. The primary outcome measure will be to determine the effect of training on balance immediately after the two-week intervention period. Secondary outcome measures are to determine the effect of training on balance at six months after the start of training; and on dizziness, gait speed under single and dual task conditions, balance confidence, and physical activity at 2 weeks and six months after the start of training.

The aim of the Omega Kid Study is to investigate the effect of omega-3 supplementation on behavioural outcomes such as self-regulation and executive function in preschool aged children. The study is parallel in design and placebo controlled with the intervention period lasting 12 weeks. Assessments will be conducted at baseline and at 12 weeks, after the intervention period. It is hypothesised that children who receive an active omega-3 supplement will show improvements in self-regulation and executive function, when compared to a matched placebo control group.

This is a randomised, double blinded, placebo controlled trial to assess antiarrhythmic properties of phenytoin and dantrolene, their efficacy and safety for treating arrhythmias and heart failure. The study will compare all the 3 arms together: phenytoin versus dantrolene, phenytoin versus placebo and dantrolene versus placebo. Randomisation will occur after consent is obtained and on enrolment into the study, 105 participants will be randomised in a 1:1:1 ratio to one of 3 arms: • 35 will receive phenytoin • 35 will receive dantrolene • 35 will receive placebo The participants then will be followed in a 2 month interval visits. The visit numbers can increase if there are any concerns regarding the procedure or medication adverse effects (AEs). Repeat blood tests (liver function test and biochemistry profile, medications serum level) and device data collection will be performed prior to office visits. At these office visits, blood test results, occurrence of ventricular arrhythmia, heart failure symptoms (assessed by New York Heart Association (NYHA) functional class and Minnesota Living with Heart Failure Questionnaire) and medications adverse effects will be reviewed. Participants will also have Six-Minute Walk Test (6MWT) at the screening visit, 6 months visit and the last visit of the study.