ANZCTR search results

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

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33055 results sorted by trial registration date.
  • Extended Tube Feeding in Patients with Oesophageal Cancer - Pilot

    The aim of this project is to assess the impact of providing longer term tube feeding in patients with oesophageal cancer who are undergoing oesophagectomy. Who is it for? You may be eligible to join this study if you are aged 18 years or over and a have oesophageal cancer undergoing oesophagectomy at the John Hunter Hospital, NSW. Study details Study participants will be allocated by chance to either the intervention of the standard care control group. Participants in the intervention group will receive a tube feed supplying 20kCal/kg and 1g/kg protein per day (approx. 60-70% of requirements) for 12 weeks post operatively compared to a control group who will be tube fed at the same level (20kCal/kg and 1g/kg Protein) for the usual period of six weeks. On discharge all patients will be provided with standardised education regarding appropriate high energy and high protein foods and be guided through the process of reintroducing foods from puree to soft texture. It is hoped that this study will help us understand whether extending the period of tube feeding after oesophagectomy leads to better nutritional status outcomes compared to current tube feeding length.

  • Effects of yoga on combat-related Post-traumatic stress disorder (PTSD) symptoms and associated outcomes.

    The primary aim is to evaluate the effectiveness of a 6month programme of trauma-sensitive yoga (TSY), with mindfulness elements in a sample of ex-serving Defence members with a clinical diagnosis of combat-related PTSD. A secondary aim is to evaluate the effectiveness of the intervention for partners of participating ex-serving members. The study will be conducted at the Jamie Larcombe Centre by clinical staff trained in TSY. A sample of no less than 34 ex-serving Defence members will be recruited and provided with a 90minute session of TSY each week for 6 months. Data will be collected before the intervention and repeated at one, three and six months and after an additional three month follow-up. Analysis will determine change in PTSD and associated mental health symptoms in veterans. Outcomes will contribute to the emerging evidence base for yoga as an adjuvant treatment for PTSD. A convenience sample of partners will be recruited with qualitative analysis undertaken to understand their views on the effects of the programme on themselves, their partners and their relationships. The term 'partner' refers to the domestic/domiciliary partners of ex-serving Defence members. They have been included on the basis that they are in a position to offer support to the ex-serving Defence members that are the primary subjects of the study, and may also stand to benefit from participation.

  • Mouthwash as a treatment for oropharyngeal gonorrhoea

    The aim of this study is to determine whether an antiseptic mouthwash (twice a day over a 14-days period) can be used as an alternative treatment for oropharyngeal gonorrhoea without using antibiotics. If mouthwash can be used as an alternative treatment, then it would provide a possible treatment if gonorrhoea were to become multi-resistant, something that is clearly concerning the WHO and US CDC.

  • Reducing delays in aneurysmal subarachnoid haemorrhage

    Aneurysmal subarachnoid haemorrhage (aSAH) is a rare but devastating form of stroke caused by a ruptured brain aneurysm that kills at least 30% of sufferers within 1 month. Up to 50% of people with aSAH will experience delays greater than 24 hours between onset of aSAH and receiving treatment. This study aims to quantify the time delays in treatment of aSAH for patients across Tasmania and South-East Victoria.

  • Detection of taxane-induced neuropathy using patient-reported outcomes

    Many women receive chemotherapy to decrease the chance of breast cancer recurrence after surgery. These drugs include chemotherapy which is collectively termed taxane-based chemotherapy. Though this is effective in decreasing recurrence, it may cause adverse effects which include peripheral neuropathy, or damage to the nerves, particularly in the hands and feet. This nerve damage can be disabling, causing difficulty in work-related tasking such as typing on a keyboard, difficulty holding objects or fastening buttons. If severe, it can impair the ability to drive or cause falls. We hope to test a better way of detecting peripheral neuropathy than our current grading system, so that early symptoms can be identified and treatment changed to prevent this. Who is it for? You may be eligible for this study if you have a diagnosis of breast cancer and your oncologist plans to use weekly paclitaxel in your treatment plan. Study details If you participate, you will complete a form with details of pre-existing health problems and symptoms of neuropathy You will complete the neuropathy symptom tool (EORTC QLQ CIPN20) on cycle 1 day 1 of chemotherapy, then at 3, 6, 9, 12 weeks into your treatment There will be no additional visits. Your oncologist will not see the results of these questionnaires so if you have symptoms you should also discuss these with your oncologist in your clinic appointment. It is hoped this research will demonstrate that EORTC QLQ CIPN20 is more sensitive than standard practice, and could be used to identify neuropathy earlier that would allow modifications to treatment to be made before more severe symptoms develop.

  • A multi-centre, prospective randomised controlled trial to compare modified kinematically aligned total knee arthroplasty using iTKR™ Software with mechanically aligned total knee arthroplasty.

    This is a prospective, multi-centre, randomised, clinical trial to compare the outcomes following two different surgical implant alignment techniques used in total knee replacement surgery. The trial will enrol 102 participants over a 12-month recruitment period between 3 surgeons. The ideal alignment for a total knee replacement (TKR) provides the best outcomes, a stable knee with least pain, best range of motion and overall patient satisfaction and maintains this in the long term. Currently, mechanical alignment is a standard alignment method used to align TKRs. This is an alignment method that places the femoral component (end of the thigh bone) and the tibial component (top of the shin bone) at right angles to the floor when standing, so that the limb forms a straight line. Research has shown that mechanical alignment and the patient’s natural alignment are rarely the same and this is the likely cause for patient discomfort. This led to the development of modified kinematic alignment which looks at the alignment of the two bones that join to the knee, the femur and the tibia. The femur and tibia are aligned on the patient’s own natural axis, rather than the mechanical axis. This is determined by imaging scans such as an x-ray, software, and the surgeon. Most importantly, it places the focus on the patient’s own, natural knee alignment rather than a straight line between the hip and ankle. Study Hypothesis: Patient reported outcomes for robotic modified kinematic total knee replacement using a surgical plan developed using specialist software called iTKR, will be superior to mechanical alignment outcomes. Participants will complete patient reported outcome questionnaires pre-operatively and at 6 months and 2 years post-operatively. Range of motion of the knee will also be measured.

  • AUgmentation of the DIsc: Evaluating the safety and effectiveness of the Kunovus Disc Device (KDD) in maintaining disc height in subjects undergoing single level microdiscectomy for sciatica due to lumbar disc herniation.

    The overall objective of this study is to evaluate the KDD in maintaining disc height in subjects undergoing single level microdiscectomy as measured by DHI.

  • Cognitive Bias Modification for interpretation and Expectancy in Patients with Chronic Pain

    The purpose of this study is to evaluate how effective home-based Cognitive Bias Modification for interpretation (CBM-I) is at reducing pain outcomes for patients with chronic pain. We are also interested in whether education about pain mechanisms and the processes involved in CBM-I will make the intervention more effective. Participants will be randomised to receive internet-delivered CBM-I or a placebo, and will also be randomised to receive psychoeducation or no psychoeducation. We hypothesise that participants in the CBM-I condition will experience a reduction in pain and related measures relative to the placebo, and that CBM-I will be most effective for those who also received psychoeducation.

  • Comparison of Haemodynamic Assessment and Monitoring in Shock (CHAMS1)- a pilot study

    There is minimal evidence that the use of cardiac output monitor devices leads to an overall change in IV fluid use. We sought to investigate the feasibility of performing a randomised controlled study using calibrated cardiac output monitoring devices in shocked ICU patients and whether the use of these devices led to a difference in total volume of IV fluid administered.

  • The effects of nerve dysfunction upon blood vessels in diabetes.

    This randomised controlled trial aims to establish if there is a correlation between diabetic neuropathy (nerve pathways affected by diabetes) and markers of blood vessel health in response to remote ischaemic conditioning (RIC). Via activation of nerves and beneficial compounds within the blood, RIC is known to protect areas at a distance from damage caused by a more prolonged and serious lack of oxygen-rich arterial blood flow in some patients. Methodology 60 randomly recruited adult participants residing in the Armidale region with type 2 diabetes will have a baseline diabetic history taken, detailed physical examination and measurements collected. Non-invasive cardiovascular physiological measurements will be obtained prior to, during and up to 24 hours after the intervention. The RIC intervention consists of 5 mins upper arm ischaemia (brief cessation of oxygen-rich blood flow), with blood pressure cuff inflation to 200mmHg, followed by 5 mins of complete cuff deflation. This cycle will be repeated 3 times without delay between cycles. In the control group, the intervention will be the same, except cuff pressures inflated to a lower pressure. Venous blood samples will be collected immediately before intervention, then 15 and 60 minutes after RIC. Changes in markers of blood vessel health will be the primary outcome measure. Secondary outcome measures will include changes in blood levels of markers of inflammation and physiological changes of the heart and circulation Results will be correlated with variables. Blood samples will also be tested for blood sugar levels, full blood count, HbA1c (measure of diabetes control), and lipids. Aims of the study The study aims to provide a clearer insight into the mechanisms of RIC, assist in predicting which diabetic patients are most likely to benefit from RIC, and potentially guide the development of new therapeutic strategies for the vascular complications of diabetes.

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