ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

You can narrow down the results using the filters

31331 results sorted by trial registration date.
  • Renal Replacement Therapy Intensity in Severe Acute Kidney Injury: An Individual Patient Data Meta-analysis of Randomized Trials

    Renal replacement (RRT) dose intensity may affect patient and kidney outcomes in severe acute kidney injury (AKI) but randomized controlled trial (RCTs) have been contradictory for mortality and inadequately powered for renal outcomes. The Investigation, Management, Prognosis, Recovery, Observation, Value and Evaluation of Acute Kidney Injury (IMPROVE-AKI) collaboration brings together investigators from current randomised clinical trials of RRT dose intensity in AKI to perform IPDMA of the effects of RRT dose intensity.

  • Pilot study on the influence of anaesthetic choice on prospective outcomes after the creation of an arteriovenous fistula.

    Kidney disease is a significant health issue, with around 2500 new patients requiring treatment every year (Australian data). Around half of these patients will need a surgical connection between their artery and vein (an “arteriovenous fistula” or “AVF”) to facilitate being connected to a machine that functions like a kidney (a haemodialysis machine). There are many methods of providing anaesthesia for the creation of an AVF including a local anaesthetic-based technique to numb the entire limb where the AVF will be created, or a general anaesthesia-based technique where consciousness is lost. It is currently not known whether any particular anaesthetic technique is superior. Theoretical advantages of a local anaesthetic-based technique (also known as a “regional anaesthetic”) include the avoidance of a low blood pressure and better surgical conditions by making the artery and vein larger which may prolong the life of the fistula. On the other hand, potential disadvantages of a regional anaesthetic include the risk of nerve injury. There have been no good quality studies evaluating both these issues, although smaller studies have suggested benefit of a regional anaesthetic technique. The aim of this study is to obtain prospective data from four hospitals regarding the six-week outcomes for patients having their first AVF created under a regional anaesthetic or a general anaesthetic. Patients will be recruited over two years. All four hospitals perform a significant number of regional anaesthetics for this procedure. The main purpose of this study is to determine the number of patients that would be eligible for a future comparative looking at the outcomes of AVF failure and peripheral neural injury; and to determine whether there are appropriate infrastructure mechanisms to collect relevant data for a future comparative trial. Another purpose of this study is to determine the direction of benefit (if any) of using a regional anaesthetic technique over a general anaesthetic technique for this surgery. This data will allow us to assess the feasibility of implementing a future trial where patients will be randomly allocated to receive either a regional anaesthetic or a general anaesthetic for this operation. Determining the impact of anaesthetic technique on six-week outcomes is important as it has the potential to change anaesthetic practice significantly. Reducing the overall complication rate is beneficial to patients with end stage kidney disease. This will facilitate a smooth transition into haemodialysis after initial AVF creation.

  • Clinical trial of a take-home rehabilitation device for vestibular patients.

    A randomized controlled trial will be conducted in 60 people with injury to their balance organ and/or balance nerve. We have developed a safe, non-invasive, ‘incremental’ rehabilitation technique that after a single 15 minute session increases the vestibular (balance) response many times more than current best practice, which takes 6-8 weeks to see any increase. We have shown that the technique can be successfully administered using a small portable device under a controlled setting. This project will determine the long–term (minimum of 24 months) changes in vestibulo-ocular reflex (VOR), balance and gait function in vestibular patients that train once daily (i.e., fixed dosage).

  • Dose-escalating, phase 2 study of oral lisdexamfetamine in adults with methamphetamine dependence

    There are currently no approved pharmacological treatments for methamphetamine dependence. There is a theoretical basis that drugs similar to methamphetamine, such lisdeamfetamine, may allow dependent users to stablise their use. Currently, there is no data on what dose of lisdexamfetamine is safe for people who are habituated to methamphertamine use. This study aims to ascertain the safety of giving a higher dose, while also looking for any change in methamphetine use or risk behaviours while taking the study drug.

  • The benefit of targeted pharmacist education in reducing prescribing errors by junior doctors – a controlled trial.

    Prescribing errors are a known cause of adverse patient outcomes. The objective of this study was to assess the effect of (1) targeted pharmacist feedback and education and (2) an e-learning prescribing module, on prescribing error rates by junior doctors in the inpatient general medical setting.

  • The use of intermittent compared to continuous energy restriction in type 2 diabetes

    The purpose of the study is to determine whether intermittent energy restriction is as effective as continuous energy restriction in achieving weight loss in people with type 2 diabetes

  • The FRIENDS anxiety prevention program: Does an additional parent resilience intervention affect child outcomes

    The etiology of mental ill-health is commonly complex and can often involve not one but a chain of genetic, environmental, social and psychological risk factors. Understanding these risk factors is essential to being able to identify children at risk of developing future mental health difficulties, planning appropriate timing of an intervention and ascertaining necessary treatment components for any intervention. Risk factors may be individual, familial and environmental characteristics that increase the likelihood of adverse developmental outcomes. Although no single risk factor is either necessary or sufficient in the development of a specific disorder, the commonly indicated risk factors in young children are parental psychopathology, temperament and prior symptomology. Parental psychopathology is commonly accepted as a risk factor for both genetic and environmental pathways towards childhood mental health problems. Family aggregation studies of both the offspring of clinically diagnosed parents and parents of children with mental health difficulties have demonstrated the heritability of mental disorders Connell and Goodman’s meta-analytic review investigated the associations between parental psychopathology and internalizing and externalizing disorders in their children. Based on the 230 articles identified on parental mental health concerns and childhood internalizing difficulties, the authors found that both maternal and paternal psychopathology significantly predicted childhood symptomology. It should be noted, however, that weighted mean effect sizes in this study were small. Additionally, it was found that effects were moderated by child factors, including age and gender, as well as type of parental diagnosis. These findings suggest that the relationship between parental psychopathology and child psychopathology is not a simple direct linear association. Rather, the interaction of parental influences and child influences is more likely to determine future symptomology. Despite an exponential increase in resilience research for children, there is currently a lack of evidence exploring how adult resilience affects the development of childhood resilience. As the link between vulnerability factors, protective factors and wellbeing in psychopathological pathways is unclear, it cannot be assumed that the heritability and modeling of psychopathology between parent and child directly indicates a similar link relationship for parent and child resilience. As such, this study will to explore both the relationship between parent-child resilience and symptomology and how resilience enhancement in parents affects children’s resilience and symptomology intervention outcomes.

  • Circulating tumour DNA (ctDNA) analysis informing adjuvant chemotherapy in Stage II Colon Cancer

    This study will determine the effect of the use of circulating tumour DNA (ctDNA) to guide adjuvant chemotherapy on recurrence-free survival in stage II colon or rectal cancer patients 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 II colon or rectal cancer and have had your cancer curatively resected. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will have blood samples taken and analysed for circulating tumour DNA (ctDNA) and be treated according to the ctDNA results. Those with positive ctDNA results will receive standard 5FU-based adjuvant chemotherapy (either single agent or combined with oxaliplatin), while those with negative ctDNA will not receive adjuvant chemotherapy. Participants in the other group will have a blood sample taken, but the ctDNA result will not be disclosed. Patients in this group will be treated according to standard clinical criteria at the discretion of the treating physician. Participants who had positive ctDNA results and are being treated with adjuvant chemotherapy will have monthly blood samples taken during treatment to track ctDNA levels. All participants will be followed up 3 monthly for 2 years, then 6 monthly for 3 years through their hospital for a total of five years for disease recurrence and survival.

  • Description of Lung Ultrasound From Initial Neonatal Transition, The DOLFIN Study

    Before birth, while a baby is in the mother’s womb, the baby’s lungs are filled with fluid and the baby gets oxygen from the placenta. Once the baby is born, the baby needs to transition to using the lungs to get oxygen. In the hours after birth, the baby’s body will reabsorb the lung fluid and the lungs will fill with air. The purpose of this study is to describe the normal filling of a newborn baby’s lungs with air over the first few hours of life using an ultrasound machine. We believe that with the knowledge gained in this study, we can improve our care for babies that need help breathing at birth. The lung ultrasound exams will be brief, limited to 2 minutes or less from the time of placing the ultrasound probe gently to your baby’s chest. The first two exams will be during the first 20 minutes after your baby is born and will be repeated when your baby is 1 hour old, 2 hours old, 4 to 6 hours old and 24 to 72 hours old. At 1 hour of life, the lung ultrasound exam will be slightly longer as we take images of the front, back and side of your baby’s chest to test if a specific location to place the probe is better than another.

  • Anterolateral ligament reconstruction in addition to Anterior Cruciate Ligament reconstruction ; Does it improve stability ?

    A functioning intact anterior cruciate ligament (ACL) is important as it stabilizes movement of the tibia in relation to the femur, providing the stability required to participate in sporting activities. It is often injured leading to rupture resulting in knee instability and primary repair of the ligament is usually unsuccessful. Surgeons have be reconstructing the ACL since 1930 and technique has been continuously refined. Even after surgical reconstruction, a small percentage of patients continue to experience knee instability, especially rotatory instability. Recently a scientific paper identified an additional ligament called the anterolateral ligament (ALL). The ALL has been bio-mechanically examined and plays an important role in stabilizing the knee in the rotational axis. Patients will be invited to participate in the study if they are undergoing ACL reconstruction surgery. Prior to the surgery commencing, after they have had a general anesthetic, they will have their pivot shift assessed on the operating table. If the pivot shift is grade 3 (as described by Macintosh - tibia persistently subluxing anteriorly on the femur even with external rotation) then they will be randomised to ACL only or ACL and ALL reconstruction. In this study patients will undergo standard arthroscopic ACL reconstruction using a hamstring graft and be randomized to have their ALL reconstructed using a hamstring graft. The group that the patients are allocated to will be concealed from them, the additional ALL reconstruction requires only one, very small additional incision. Those not undergoing ALL reconstruction will not undergo any form of sham ALL reconstruction. The patients knee function will be assessed pre-operatively and post-operatively, using subjective patient reported scores and objectively assessed using range of motion. They will be followed up at two weeks, six weeks, three months, six months and 12 months. A secondary objective of the study will be correlating the findings of the Antero-lateral ligament on MRI with the pivot shift findings under anesthetic.

Tags:
  • Finding clinical trials