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

32121 results sorted by trial registration date.
  • Midodrine for the prevention of perioperatIve hypotension

    Anaesthesia and surgery commonly contribute to low blood pressure during and after an operation through a variety of mechanisms. Adequate blood pressure is essential to allow for blood flow and oxygen delivery to organs throughout the body such as the heart, brain and kidneys. There is an accumulating body of evidence that low blood pressure after surgery is very common and is likely underrecognised. These episodes of low blood pressure have been linked to increased rates of organ injury, complications and death following surgery. Midodrine is a drug used to help increase blood pressure. The METEORITE trial has been designed to determine if the use of midodrine before and after surgery is able to reduce the occurrence of low blood pressure in the time following an operation. In this trial, one group of patients will receive midodrine before and for two days after surgery and another comparison group will receive standard care (no midodrine). Both groups will then be followed during and after their surgery to determine if there is a difference between the two groups with respect to important outcomes such as the number of times low blood pressure occurs and the requirement for medical emergency team review. Data on complications following surgery will also be collected. Finally, as this is a pilot study, a number of specific outcomes to assess the feasibility of performing a larger multi-centre study will also be collected and reported. If the study hypothesis is correct, patients who receive midodrine before and after their scheduled surgery will have fewer episodes of clinically significant low blood pressure following their operation and will be less likely to require unplanned medical emergency team review. This may result in improved outcomes after surgery.

  • Haemostatic Gel Prophylaxis for Post Colorectal Endoscopic Resection Bleeding: Observational Study

    The purpose of this study is to test a gel with blood-controlling properties called Purastat. This gel may be useful because bleeding a risk after endoscopy, especially if the patient uses anti-clotting medications Who is it for? You may be eligible for this study if you are aged over 18, are undergoing an endoscopic resection procedure for colorectal lesions and use an anti-clotting medication. Study details All participants in this study will undergo their procedure as scheduled. During the procedure the endoscopist will apply a few millilitres of the Purastat gel to the site of the resection. The procedure will otherwise be a per standard procedures. There will be no additional requirements from patients as part of this study – all patients will have routine care post-procedure. It is hypothesised this gel will reduce the rate of post-resection bleeding and improve outcomes for patients at risk of bleeding after endoscopic resections.

  • A first-in-human study of VG161 in participants with advanced malignant tumours that have not responded to conventional therapies.

    This study aims to evaluate the Safety, Tolerability of VG161 in the treatment of people with advanced malignant tumours that have not responded to conventional therapies. Who is it for? You may be eligible to join this study if you are aged 18 years or older and have late stage carcinoma which is refractory/relapsed and/or intolerant of standard therapies or for which no standard therapy exists. Eligible participants must have at least 1 injectable cutaneous or subcutaneous lesion greater than or equal to 20 mm in longest diameter. Study details: Part A of this study involves up to 3 increasing dose levels of VG161. The treatment will be given as a single dose, and the dose level will not be increased until the lower dose has been determined to be safe. Part B will test up to 3 increasing dose levels of VG161 given as multiple doses. Treatment will be given in cycles of 28 days, with VG161 given once daily on days 1-5, followed by a 23- day observation period each cycle. Participants from Part A will be able to take part in Part B only if eligibility criteria are still met. The study will also involve taking a variety of biological samples including, blood, urine, and tissue. The samples will be used to assess your eligibility to participate in the study, your safety profile during study participation, and to evaluate how the study drug is metabolised in the body. It is hoped that this study can provide greater insight to novel treatments that may stimulate anticancer immunity and help fight cancer. Furthermore it is hoped this treatment can improve control of disease.

  • Effect of home-based exercise training on muscle microvascular dysfunction in type 2 diabetes.

    Many patients with type 2 diabetes exhibit exercise intolerance (decreased capacity to exercise) and this is often associated with poorer insulin and glucose (glycaemic) control, accelerated disease progression, reduced quality of life, and decreased longevity and survival. However, the primary causes behind exercise intolerance and poor glycaemic control in these patients are not well understood. Using modern biochemical and ultrasound imaging techniques this project aims to determine whether skeletal muscle microvascular dysfunction (impaired blood flow through small blood vessels), is the main underlying cause behind exercise intolerance and poor glycaemic control. Furthermore, this study will investigate whether a 3-month home-based exercise program can improve muscle microvascular function, glycaemic control and exercise tolerance in patients with T2D.

  • Superior Hypogastric Nerve Block in Minimally-invasive Gynaecology: a Randomised Controlled Trial (Hypoplex Study)

    Minimally invasive gynaecology (MIG) requires a high level of pain medication both during the operation and after the operation. This is from the pain elicited during surgical skin incision, gas used in MIG and cutting of tissue and organs. Pain relief after surgery still has a high reliance on opioid medication. In opioid-naïve patients even small doses can lead to poor side effects including nausea and vomiting, slowing of gut transit and difficulty with breathing. A nerve block to the superior hypogastric nerves has been studied previously through observational trials. First in patients with pelvic cancers and more recently for patients after surgery. It is not a difficult nerve block to teach to laparoscopic surgeons. Ropivacaine which is used for the nerve block is a well-studied medication and approved for use by the TGA in Australia. It is also cheap. We plan to study the effect this nerve block as it could be useful adjunct to post-operative pain relief in the future. This is a single-centre, patient-blinded randomised controlled trial. Patients undergoing minimally invasive gynaecological surgery will be randomised to receive a superior hypogastric nerve block with Ropivacaine at the end of their surgery versus no nerve block. The primary outcome to be studied will be total opioid use in the first 24 hours after surgery. Our secondary outcome is pain scores at regular intervals in the first 24 hours. This will be performed using a visual analogue scale from 1 to 10. Our hypothesis is that patients receiving a nerve block will use 30% less opioid over the first 24 hours compared to patients not receiving one. We also predict patients receiving the nerve block will have lower pain scores.

  • Effect of Baricitinib on Insulin Production in Type 1 Diabetes

    Type 1 diabetes (T1D) results from the killing of insulin-producing pancreatic beta cells by cells of the immune system. We aim to slow the progressive, immune-mediated loss of insulin-producing beta cells that occurs after clinical presentation. We have identified a pathway that is important for immune cells to kill beta cells, and a drug that will block this pathway and prevent beta cell death. This drug, baricitinib, is already in clinical use for rheumatoid arthritis, and is currently in clinical trials for other diseases, including childhood autoimmune diseases. We hypothesize that baricitinib treatment for 48 weeks will preserve beta cell function in children and young adults with recently-diagnosed T1D. The trial aims to recruit 83 participants aged 12-30 years who have been recently diagnosed with T1D. Two thirds of the participants will be randomly assigned to receive baricitinib, one third will receive placebo. Our trial will test if baricitinib can slow the progressive loss of insulin-producing beta cells in these patients. The primary objective is to determine if baricitinib can reduce the loss of meal-stimulated plasma C-peptide, a measure of beta-cell function. Maintaining endogenous insulin in recent-onset T1D improves glucose control and may lead to long-term improvements in glucose and lower rates of serious diabetes complications and death.

  • Birth Environment Design Study for Pregnant Women

    The BED Study is a pilot randomised controlled trial to investigate whether physical changes to the Birth Unit room, increase mobility and upright positioning labour. Previous studies suggest that increased mobility decreases the use of pharmacological analgesia, decreases the length of labour, decreases the caesarean section rate, improves maternal satisfaction and therefore reduces length of hospital stay In Auburn Hospital Birth Unit, standard room set up encourages women to immediately place themselves on the bed and stay there throughout their labour. This study will examine if a simple change to the physical set up of the room (moving the bed to the side of room) and placing alternative birth equipment (e.g. yoga balls and birth mats) will encourage women to mobilise during labour. We will randomise 80 women to each arm of the study: standard birth room set up or alternate room set up without bed in central position. Data will be collected from a form that the primary midwife completes, the eMaternity database on length of labour, mobility during labour, pharmacological pain relief, caesarean section, length of hospital admissions and both the women and midwife caring for her in labour will also complete a short survey prior to discharge on the birth experience and satisfaction with the Birth Unit room.

  • Does exercise influence inflammation after a burn injury?

    The primary aim of the study will be to longitudinally analyse the effect a 6-week pulse of exercise has on the level of inflammatory biomarkers including TNF alpha and a multiplex of other cytokines at different times frames (>1year) after burn. A cross-over trial will be conducted with participants randomised to either an exercise or control condition in the first phase. In the second phase participants will cross over into the alternate condition e.g phase 1 exercise condition participants will change over to the control condition in phase 2. Outcome measurement and blood sampling time points will be pre-intervention, at 3 weeks after commencement of intervention/control and then at 6 weeks (completion of study period 1). These will then be repeated in study period 2 at the same time points. Evidence suggests that exercise directly influences inflammation and immune function therefore we hypothesize the chronic inflammatory load after burn injury will decrease after 6 weeks of exercise.

  • Investigating sodium selenate as a treatment for behavioural variant frontotemporal dementia

    This study will investigate a new drug, sodium selenate, for the treatment of behavioural variant frontotemporal dementia (bvFTD). Up to 120 patients with bvFTD will be recruited in to the study. Half of the patients will receive 52 weeks of treatment with sodium selenate (15 mg three times a day), and the other half a placebo (a sugar pill). The main outcome of the study will be the change in brain volume over 52 weeks, comparing the treatment group to the placebo group. Additional outcomes will look at the overall safety and tolerability of the treatment, the levels of tau (a protein involved in the development of bvFTD) in the cerebrospinal fluid, the rate of cognitive decline and changes in behavioural symptoms observed in patients over the 52 weeks of treatment.

  • Trial of new medication Ixekizumab to assess healing of venous leg ulcers.

    The purpose of this study is to see if the medication ixekizumab might be used to treat underlying inflammation associated with chronic venous ulcers. The study is for anyone with a chronic venous ulcer that has failed to respond to standard therapy (compression bandaging for four consecutive weeks). 28 patients are required for this trial. 14 patients will receive the treatment medication and 14 will receive the placebo medication. Neither the patients nor the staff will know who is receiving which medication. You will receive injections fortnightly for 12 weeks including continuing with the dressings and compression bandaging that you were being treated with prior to the trial. After the 12 weeks it is hoped that this medication Ixekizumab will have added in a significant reduction in the wound size.

Tags:
  • Finding clinical trials