ANZCTR search results

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

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32707 results sorted by trial registration date.
  • The effects of acupuncture and instruction on post-exercise recovery in healthy adults

    The objective of the study is to determine if acupuncture is effective for improving recovery from maximal exercise, and whether instruction about the treatment influences the treatment effect. The current study employs a balanced placebo design consisting of a 2x2 factorial design with treatment allocation and expected allocation as factors. A total of 75 participants are expected to be recruited from the University of Western Sydney, Campbelltown and the general public. Participants are allocated to one of five groups; acupuncture with high expectancy, acupuncture with low expectancy, placebo with high expectancy, placebo with low expectancy, and a control no treatment group. All participants will attended a single testing session consisting of 15 minutes of supine rest (baseline), a maximal exercise test to volitional fatigue, and one hour of supine recovery with or without the treatment allocated. Oxygen consumption, heart rate, blood pressure, blood lactate, respiratory exchange ratio, and respiratory rate will be monitored throughout the session.

  • Prospective Assessment of the Clinical Outcome of High Tibial Osteotomy

    This prospective single centre outcome study will document in a longitudinal manner the clinical outcome of high tibial osteotomy. Patients who undergo a High Tibial Osteotomy by Dr Leo Pinczewski between 2000 and 2002 will be invited to participate. At 5 and 10 years after their surgery patients will be contacted by the researchers and invited to return for clinical assessment.

  • A 2-Part, Single-Dose Study to Evaluate the Interaction of Etoricoxib and Tizanidine Modified Release (MR) when Co-administered or Administered Alone in Healthy Subjects

    A 2-Part, Single-Dose Study to Evaluate the Interaction of Etoricoxib and Tizanidine MR when Co-administered or Administered Alone in Healthy Subjects MK0663B (combination treatment) is being developed for the treatment of acute pain in musculoskeletal conditions with swelling and muscle spasm. However, this study is in healthy volunteers only.

  • Ten Year Survivorship and Clinical Outcome of the Genesis II Prosthesis for Total Knee Replacement

    This study examines survivorship and the clinical outcome in a series of 340 consecutive patients 10 years after TKR with the Genesis II prosthesis. All arthroplasties were performed by a single surgeon over a 3 year period.

  • Effect of knee bracing in people with osteoarthritis after knee reconstruction

    Injury to the ACL is a well-recognized risk factor for post-traumatic knee osteoarthritis (OA). Degenerative radiographic changes are evident in 50-70% of people 10-15 years after the injury. In such cases, surgical reconstruction does not typically improve OA prognosis. Since knee OA has the potential to have a substantial negative impact on an individual, affecting their quality of life, physical function, and work status, it is important that this subgroup of individuals be investigated. It is well established that knee biomechanics, including joint motions and loads, are altered following ACL injury, and are not restored with surgical reconstruction. These biomechanical changes are frequently reported as a cause of cartilage damage and subsequent post-traumatic knee OA, due to changes in joint contact pressures and load distribution. Therefore, the focus of this program of research will be directed towards an intervention that may restore more normal knee joint biomechanics. The targeted brace (Donjoy unloader brace) has the potential to enhance knee joint function. It is primarily designed to control abnormal sagittal and transverse plane movements associated with ACL reconstruction, in addition to correcting frontal plane malalignment, which is a common feature of knee OA. The brace is targeted to an individual by compartmental distribution of OA (medial or lateral tibiofemoral, TFJ) and frontal plane knee alignment (varus or valgus). The brace can adjusted in the frontal plane to offload either medial or lateral TFJ compartment for use in medial and lateral TFJ OA, respectively. The degree of frontal plane adjustment is based on individual’s comfort during walking. However, no study to date has evaluated the capacity of knee bracing to restore knee joint function in individuals with knee OA following ACL reconstruction. The aims of this study are to evaluate, in individuals with knee OA after ACL reconstruction: i) the immediate effects of the targeted brace on lower limb biomechanics; ii) the short-term (4-week) effects of the targeted brace on pain, confidence and physical function; and iii) the medium-term (4-month) effects of the brace on pain, function and quality of life. Given that the knee brace has the potential to reduce knee pain and enhance physical function in arthritic patients, it is hypothesized that the immediate effects of the brace will be to improve knee joint kinematics, reduce external joint moments (associated with ACLR), reduce pain, as well as improve confidence, physical function and quality of life in these patients. The findings of this study will reveal whether knee biomechanics in people who have developed knee OA after ACL reconstruction can be altered by the targeted knee brace. It will also reveal whether the targeted brace can reduce pain, improve confidence, function and quality of life. If the brace can modulate the abnormal biomechanics in the reconstructed knee, it may slow OA progression and may be used to prevent the development of OA following ACLR, thus reducing the associated personal and societal costs of this common and debilitating condition.

  • Healthy Bowels Study - A randomised controlled trial of transcutaneous electrical stimulation to treat constipation caused by anorectal retention in children.

    This study will assess if a safe non-invasive transcutantous electrical stimulation can treat chronic constipation from the anorectal retention sub-group (the most common type of chronic constipation). Hypothesis TESIC can increase large bowel motility and defecation to overcome chronic constipation in children with AR, and is more effective than current best treatment (CBT, laxatives, diet, toilet timing and posture, education about brain-gut axis) alone.

  • Does the drug Galvus enhance the effects of a protein preload to reduce blood glucose concentrations after a meal?

    To determine whether: (i) A protein preload stimulates glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) secretion, and thereby reduces postprandial glycaemia following a carbohydrate-containing meal relative to a control condition. (ii) Galvus (vildagliptin) enhances the effect of a protein preload to stimulate GLP-1 and GIP secretion, and thereby further reduces postprandial glycaemia following a carbohydrate-containing meal.

  • Effects of common sleeping pills on arousal and muscle function during sleep

    The purpose of this physiology study is to examine the effects of common sleeping pills (sedatives) on the awakening (arousal) response to respiratory stimuli during sleep and their effects on upper airway muscles, airway function, and breathing responses during sleep.

  • Interval sprinting and cardiovascular function

    Obesity is becoming pandemic in the Australian population. Successful attempts to lose weight and maintain weight loss are dependent on regular physical activity. This training study will establish if high-intensity intermittent exercise will induce fat loss in overweight men. The current wisdom is that one should exercise at relatively low intensity because at this level fat is the dominant substrate used as a fuel. We are proposing that there is still significant fat utilization at higher exercise intensities and exercising at this higher intensity will lead to greater fat loss over time, as well as greater gains in health related fitness parameters. The opportunity to achieve greater benefits from a reduced time commitment may act as an inducement for reluctant exercisers to commence a fitness program. To our knowledge, the effects of training at higher intensities on regional and total fat deposits of overweight men has not been measured before. Pre- and posttraining testing will include body composition measures of anthropometry, bioimpedance, DEXA, CT, and vascular assessment. We hypothesize that 12 weeks of interval sprinting will result in significant fat loss and significant increase in aerobic fitness. Sixty subjects will be recruited and randomly assigned to one of two groups: Group 1 (n=30) interval training with work:rest ratio of 8 s: 12 s and Group 2 (n=30) a non-exercising control group. Testing protocols will also include a VO2max cycle ergometer test that will allow determination of maximum oxygen carrying capacity. Blood sampling will be used to determine blood lactate, fasting glucose, catecholamines, insulin, adiponectin, leptin and glycerol concentrations. Subjects will be given food diaries to complete to ensure that total energy intake, as well as macronutrient balance, is maintained over the study period. Subjects will also perform three tasks (see below) before and after the intervention so that vascular response can be assessed. Subjects will also be asked to complete a food intake diary in which they record the quantity and type of food they eat during each day. Random days will be selected for this purpose. Tasks The Stroop task involves verbally responding to coloured words displayed every second on a computer (5 minutes). An isometric handgrip task will involve subjects contracting a handgrip dynamomanometer at 30% of their maximal voluntary contraction for 5 min. Blood flow will be measured in the non-exercising arm. The leg cycle exercise task will involve subjects cycling at a low-moderate level of their maximal oxygen uptake (40%) on a stationary ergometer 8 minutes). Blood flow will also be assessed in the non-exercising arm. Each subject will be involved in a familiarity session involving exposure to the different tasks.

  • A Randomised Controlled Trial to Compare Administration of Prothrombin Complex Concentrate with Standard Haemostasis Management in Adult Patients Undergoing Peritoneal Cytoreductive Surgery Requiring Massive Transfusion.

    The purpose of this study is to investigate whether the early use of a blood clotting drug during peritonectomy surgery reduces the amount of bleeding that occurs and so reduces the amount of blood transfusion you may need. Who is it for? You may be eligible to join this study if you are aged 18 years or above and are scheduled to undergo a peritonectomy. Trial details: Peritonectomy surgery is associated with a high risk of bleeding and many patients will require what is known as massive blood transfusion. This typically involves a transfusion of at least 10 units of blood or roughly your whole blood volume. In this research we hope to compare two treatments. Half the participants will receive the standard treatment used in this hospital. This involves the use of blood clotting factors and blood transfusion. In addition patients who have persistently high blood loss are sometimes given a treatment called recombinant factor VIIa. The other half of the participants will receive a product known as Prothrombinex-VF early in the operation when the anaesthetist suspects that there will be high blood loss. Prothrombinex-VF is a commercial product that contains blood clotting factors – these help the blood clot. All other treatment will be the same as usual practice. With this research we hope to be able to show that early use of Prothrombinex-VF reduces the need for blood transfusion and the overall need for blood products such as blood clotting factor preparations.

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