ANZCTR search results

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

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32712 results sorted by trial registration date.
  • Evaluation of needle visibility during insertion of ultrasound guided transversus abdominis plane (TAP) blocks for women undergoing lower abdominal surgery.

    This trial is investigating whether echogenic needle technology improves needle visibility and ease of insertion when transversus abdominus plane (TAP) blocks are used for gynaecological and obstetric operations.

  • Pharmacokinetics, pharmacodynamics and pharmacogenomics of busulphan and other agents used in blood or marrow transplantation

    The primary purpose of this trial is to evaluate the relationship between drugs which are administered for blood or bone marrow transplants and the outcomes of the transplant. Who is it for? You may be eligible to enroll in this study if you are receiving intravenous busulphan and/or other conditioning agents prior to a blood or bone marrow transplant. Study details All participants enrolled in this study will have blood samples taken at different timepoints depending on the institution at which they are receiving treatment, but may be as frequent as weekly until three months following the transplant. Some of the samples will have been taken for clinical reasons and some additional samples are for research. Participants can choose how many additional samples they will contribute to the study. Researchers will review medical records to evaluate the clinical outcomes of the transplant, and participants will be followed-up for 5 years. It is hoped that by evaluating the concentration of these drugs in the body, and their longterm effects, it may be possible to individualise the dose given to patients to enhance efficacy, reduce toxicity and maximise the chance of disease control.

  • Evaluation of a program to enable older, at-risk drivers to stop or limit driving, but maintain mobility

    We are using a randomised controlled trial to evaluate a program designed to promote safe mobility for drivers aged 75 years and older. Half of our study participants will be randomly selected to receive an integrated program which includes individual advice about safe driving and promotion of alternative transport delivered over two sessions in the participants own home. All study participants’ cars will be fitted with a monitoring device which transmits GPS location, speed and acceleration patterns during the 12 month study. We will compare driving exposure and incident involvement (crashes and rapid deceleration events) through this objective measurement. Community participation and independent mobility will be assessed with surveys. The trial will determine if an individual program can improve safety in a group of older drivers. The trial will assess the impact on mobility and evaluate uptake of alternative transport. The study approach is robust using a randomised controlled design and safety outcomes will be measured objectively. Safety of older drivers, is of concern due to increased crash involvement per km travelled and their vulnerability to injury. While there are a number of programs designed to improve safe driving, there is very little evidence about their effectiveness. The results of this trial will contribute high level evidence for policy makers in this area.

  • The effect of neuromuscular training post-arthroscopic partial meniscectomy on medial knee joint loading: a randomised, controlled trial.

    Knee osteoarthritis is a common musculoskeletal condition that is increasingly prevalent as the population ages. Knee osteoarthritis research has largely focused on treating pain and disability. However, to reduce the incidence of this burdensome disease, prevention is also vital. Individuals who have undergone an arthroscopic partial meniscectomy (APM), a common surgical procedure to repair, remove or trim the inner knee meniscus are at increased risk to develop knee osteoarthritis. Post-APM patients, have increased knee joint loading as compared to matched healthy individuals. It is widely accepted that increased knee joint loads may be one factor related to the initiation and progression of knee osteoarthritis. In young healthy individuals neuromuscular exercises can reduce knee joint loading during athletic tasks however, the effects of neuromuscular exercises on knee joint loads are unclear in those considered at high risk of developing early knee osteoarthritis. This research will primarily investigate the effects of a neuromuscular exercise program on knee load in those who have undergone an arthroscopy to repair, remove or trim the inner knee meniscus. The neuromuscular intervention includes exercises designed to improve co-ordination, knee alignment and balance. This study will help us to develop better rehabilitation programs that could help delay the onset of knee osteoarthritis following knee arthroscopy.

  • A randomised prospective study of analgesic protocols for the management of orthodontic pain in relation to fitting of fixed appliances

    Investigation into the efficacy of the analgesic medications ibuprofen and acetaminophen (paracetamol) for the prevention of pain and discomfort in relation to the first 48 hours of fixed orthodontics treatment (braces). The study is a double blinded investigation with a placebo control group.

  • Effect of low dose steroids on blood glucose and risk of heart disease

    Glucocorticoids are potent anti inflammatory agents that are used to treat a wide range of inflammatory and rheumatologic conditions. Most patients require a relatively low dose of glucocorticoid for disease control, with one study reporting a mean prednisolone dose of 8mg/day which is approximately 2 to 3 times the physiological glucocorticoid production. The purpose of this study is to investigate : whether typical therapeutic steroid doses increase the risk of a heart attack. whether high blood sugars after a meal are related to risk of heart attack. a novel mechanism by which steroids might increase fat mass through reducing brown fat activity.

  • Cerebral Oximetry to Reduce Peri-operative Morbidity: A Pilot Study

    Cerebral oximetry is a clinical monitor which is used routinely for heart surgery patients at Austin Health. When the device is used, a sensor is applied to the forehead and safe near-infrared light is shone through the skull. The reflected light gives information about the level of oxygen in the brain. Previous research has shown that using this monitor can reduce the risk of complications after heart surgery. Other clinical research has shown that complications after surgery are more common as people get older. In one large study it was shown that complications occur in one fifth of patients over the age of 70. The complications studied included heart attack, major breathing complications, stroke, infections, kidney failure, being admitted to the intensive care unit, or death. The aim of this study is to find out whether using a cerebral oximeter during other types of surgery can reduce the rate of complications for patients over the age of 70. There is currently no research evidence to show whether this is the case. 40 patients over the age of 70 will be asked to participate in this study. These patients will all be having joint replacement or bowel surgery. All the participants will have a cerebral oximeter monitor applied at the start of the anaesthetic. For half the participants the anaesthetist will no be able to see the numbers on the monitor. In the other half, the anaesthetist will be asked to monitor the levels of oxygen in the brain, and to try to keep them close to (within 25% of) the participant’s starting level. This is done by methods which are part of normal anaesthetic care. For example, the anaesthetist makes small changes to the amount of anaesthetic, or to the blood pressure. There is no other change to the operation, anaesthetic, or hospital care. The number and types of complications which occur in each of these two groups will be compared. This study will determine if using the cerebral oximeter results in fewer complications. The results of this small study may help to design larger research studies in the future.

  • One injection in the palm versus two injections on the back of the hand to numb the finger for minor surgery

    Patients with finger injuries often require their finger to be numb to allow their injury to be assessed properly and treated. There are several methods available to numb the finger. Our study aims to compare two methods for numbing the patient’s finger to see which one of these methods is least painful for the patient. The first method is a single injection in the palm of the hand and the second method is two injections in the back of the hand or finger. The second method is the most commonly used method in our emergency department. Our hypothesis is that the single injection into the palm is less painful than the double injection in the back of the hand or finger. Patients who present to the emergency department with finger injuries that require their finger to be numb for treatment or assessment of their injury will be given a study information sheet and consent will be obtained for participation in the study. Participants will then be randomly assigned to receive either the single injection in the palm or the double injection in the back of the hand or finger. A medical officer will perform the injection to numb the finger and a separate medical officer will then ask the patients to rate the pain of the injection to numb their finger. Participants will also be asked to rate their pain level before and five and ten minutes after the injection. The patient’s finger injuries will be treated as per standard care for their injury. Patients will be contacted at one week following the injection to ask them if they have any pain or signs of infection such as redness or swelling.

  • The effect of non-steroidal anti-inflammatory drugs on hormones and metabolism in overweight men with low testosterone and obstructive sleep apnea (optional partner participation)

    This is a parrallel randomised controlled pilot study designed to investigate the effect of non-steroidal therapy on inflammation in obstructive sleep apnea (OSA) with regard to sleep apnea severity, reproductive function, androgen profile, cardio-metabolic health and quality of life. This study will use the drug celecoxib (Celebrex) which is a marketed drug in Australia that is commonly prescribed for arthritic conditions to relieve joint pain. Participants will be asked to attend the clinic for a 3 month period involving 5 short visits and 2 overnight stays with PSG and blood sampling.

  • MGMT Gene Therapy and Chemotherapy for the treatment of Childhood Brain Tumours

    This trial aims to test the safety and feasibility of infusing gene-modified bone marrow stem cells into paediatric patients with high risk brain tumours. Who is it for? Patients between the ages of 1 and 21 who have a brain tumour which has recurred, or a newly diagnosed brainstem tumour are eligible for this trial. Trial details. Bone marrow stem cells will be harvested from patients, and then modified with a form of a drug resistance gene called MGMT. These cells will be given back to patients after they have received chemotherapy to aid in the engraftment of the cells in the bone marrow and treat the tumour. Further cycles of chemotherapy will then be given at 4 weekly intervals and the survival and/or expansion of the gene-modified cells will be measured. If possible, the dose of chemotherapy given will be increased if the gene-modified cells successfully engraft in the patient and prove to be drug resistant to the chemotherapy.

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