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Preterm Infant Functional and Clinical Outcomes (PIFCO): Understanding Complex Factors That Influence Long Term Outcomes After Preterm Birth
Breathing problems persisting into infancy and later life is an important complication of premature birth with lifelong consequences. Breathing problems often occur together with lung disease, but prematurity can also affect heart and blood vessel development, and weakness of the main breathing muscle (the diaphragm). We will find out how much the heart, lung and muscles each contribute to breathing problems, as well as identify factors such as infection, nutrition and treatments that influence these and other long-term outcomes of very preterm birth. This knowledge will help us to better predict, diagnose, treat and prevent adverse outcomes after preterm birth.
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A Phase 1, Open-Label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Intravenously Administered CX-5461 in Patients with Advanced Haematologic Malignancies
The study is evaluating the maximum tolerated dose (MTD) by understanding the safety profile during incremental dosage escalation. Who is it for? You may be eligible to join this study if you are aged over 18 years with any histologically confirmed relapsed or refractory advanced haematologic malignancies for which no effective standard therapies are available, and have progressed following at least one prior treatment regimen. As every blood cancer patient has a unique disease and treatment history, it is highly suggested that you discuss the trial with your haematologist or oncologist who can also contact Peter Mac to determine whether this trial may be suitable for you. Trial details Participants in this study will receive CX-5461, an RNA polymerase I inhibitor. CX-5461 will be administered by intravenous infusion over 1 hour on day 1 and day 8 every 28 days. Four dose levels are planned: 70 mg/m2, 100 mg/m2, 150 mg/m2 and 220 mg/m2 per dose. Patients will be assigned to a dose level in the order of study entry. Participants will be required to undergo various assessment tests including blood, imaging, laboratory and physical assessment tests.
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A Phase 2 Multi-Centre Study to Characterise the Pharmacodynamics of Vessel Dilator Peptide (VSDL) in Patients with Acute Decompensated Congestive Heart Failure to be assessed by effects on renal function.
The CONTINUUM-HF study aims to evaluate whether vessel dilator peptide VSDL has effects on renal function in participants with acute decompensated congestive heart failure. It shall also evaluate the tolerability and safety of VSDL over 7 day dosing, and assess the pharmacodynamics of VSDL in these participants. The study is a multi-centre, blinded, randomised, placebo-controlled, multi-dose study to be conducted in 8 sites in Australia targeting two target peak concentrations following 1-hour intravenous bolus and daily 12-hour subcutaneous infusions for up to 7 days. The target plasma VSDL concentrations of 5ng/ml and 20ng/ml are chosen to reflect well tolerated and efficacious concentrations in previous trials using this drug. Study subjects shall be reviewed post-IV infusion, at 72 hours, pre-discharge, and at 30 days. A 6 month followup contact will be made via phone call or email. Participants will be given a diary to record any adverse events, changes in medication and visits to doctors.
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Combination treatment of child and adolescent anxiety disorders
Building emotional health in childhood sets the platform for a healthy and productive life. Optimising treatment outcome for common emotional disorders (e.g., anxiety disorders) in childhood is an important area of research. Research using anti-depressant medication in combination with CBT to treat anxiety has been conducted to investigate optimum treatment response. These studies indicate that combination therapy (CBT + anti-depressant medication) has greater efficacy than either treatment alone (March et al., 2004; POTS 2004). Such research provides the opportunity to use empirical data to inform treatment guidelines and enable child/adolescents and their families to receive the most efficacious interventions to reduce anxiety-related impairment and distress. However, research comparing the efficacy of interventions has typically employed a partially blinded approach, where participants are randomly allocated into Pill, Placebo, CBT only or Pill+CBT conditions. This research methodology is limited by the fact that participants receiving the combined CBT and pill treatment are aware that they are receiving two active interventions, so expectancy effects cannot be ruled out as a potential alternative explanation for the comparatively greater response rates found for participants in this condition (Hudson, 2009). Double-blinded research that compares the efficacy of CBT + placebo and CBT + pill conditions in the treatment of child/adolescent anxiety is necessary to clarify the additional benefits of combining medication with the currently recommended first line intervention, CBT. Additionally, existing research suggesting greater efficacy of combination treatment did not conduct long-term follow-ups. By adding long-term follow-ups the longer-term benefits of combination therapy for anxious children can be determined, and compared to the known long-term benefits of treating anxiety using CBT. It is expected that combined treatment (CBT + Sertraline) will produce better outcomes than CBT + Placebo condition for children and adolescents with anxiety disorders.
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Feasibility, safety and efficacy of an Argentine tango dance intervention for people living with Parkinson's disease: a pilot study
This pilot study will explore the feasibility and safety of an Argentine tango dance intervention. Will involve a single group pre-test/post-test design with 8 participant diagnosed with idiopathic Parkinson's disease. Participants will be invited to participate a 4 week dance intervention. Feasibility and safety outcomes will be monitored and assessed at throughout the intervention. Secondary outcomes (efficacy) of gait, balance, motor impairment, depression and HRQOL will be measured at baseline at 4 weeks. Results will inform a future RCT that will investigate the therapeutic benefits of a dance intervention for people with PD.
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Pharmacokinetics of IPX203
The objective of Study IPX203-B13-02 is to characterize the pharmacokinetics of IPX203 and levodopa formulations in healthy subjects.
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Vildagliptin in type 1 diabetes mellitus added to insulin
Type 1 diabetes is associated with significant fluctuations in blood glucose levels in patients on multiple daily insulin injections or insulin pump therapy. This glycaemic variability limits patients ability to adequately control blood glucose due to its association with hypoglycaemia and subsequent high readings or 'rebounds'. The medication vildagliptin is currently used in the treatment of type 2 diabetes and in this setting has the ability to lower glucose and reduce hypoglycaemia. Its action is both on insulin producing cells, beta cells, and glucagon producing cells, alpha cells. Patients with type 1 diabetes have traditionally been thought to have no insulin production, however recent studies using a more sensitive assay have shown residual beta cell function in many type 1 patients after 10 years. This study is designed to assess the effects of vildagliptin in patients with type 1 diabetes and aspects of blood glucose control including glycaemic variablity. The hypothesis is that vildagliptin may reduce variability due to its action on both alpha and beta cell activity in a glucose dependent manner.
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Effectiveness of Patient Feedback to Improve Medical Student Consultation Skills
This study is designed to test if feedback of patient satisfaction score after consultation sessions improves clinical consultation performance among medical students. We hypothesise that 1) additional feedback of patient satisfaction scores to students improves student performance over usual feedback; and 2) the teaching model increases patient satisfaction scores in student consultation over time.
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An innovative home-based internet health service project to improve outcomes for Haematopoietic Stem Cell Transplant survivors
Patients will be assessed for suitability for this study and then invited to participate. All participants will then undergo an initial face-to-face session by the investigators on matters related to methodology and technical requirements on conducting home-based internet programmes on exercise and stress management techniques. Following this initial session, supervised home based training sessions will be conducted over 4-6 weeks. This will be followed by assessment at end of the training period and then at 3, 6, and 12 months after the training sessions. .
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The Australia and New Zealand Emergency Department Airway Registry (ANZEDAR). A multi-centre observational study of the practice of intubation in the Emergency Department (ED)
Advanced airway management is an accepted core skill of Emergency Physicians in Australasia. Rapid Sequence INtubation (RSI) is, however, a high-risk procedure that has been shown to have an increased rate of severe complications – such as failed intubation, hypoxia, hypotension or surgical airway – when it takes place in the Emergency Department (ED) in comparison to the operating theatre. The recently published Fourth National Audit of Major Complications of Airway Management in the UK reviewed severe complications associated with airway management in the ED. The authors found that a large proportion of events occurred out of hours, without consultant supervision, or without the operators following standard airway management algorithms and “failing to plan for failure.” Several studies have been published that describe the performance of intubation in the EDs of North America, UK, Korea and Japan, but to date, only a single centre study has been published from an Australian ED. This study, carried out at the Royal North Shore Hospital, prompted significant changes in the practice of intubation in that ED, along with an increased educational focus on the subject, in order to improve clinical management. This current project is being led by Dr. Toby Fogg and Dr. John Vassiliadis from the Royal North Shore Hospital ED, as a collaborative research venture with other EDs across Australasia and the Emergency Care Institute in NSW. It is a surveillance study to acquire data on the practice of intubation in the ED in order to improve the quality of care associated with this procedure.