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

33074 results sorted by trial registration date.
  • Aquatic versus land based exercise training : impact on functional outcomes in patients with stable heart failure

    The proposed project is a crossover prospective design study which aims to: 1.) compare hydrotherapy versus land based exercise for patients with CHF with respect to functional capacity and quality of life. 2.) measure cardiac function during immersion and exercise in water in this patient group. Patients will be recruited through the Heart Failure Services at Royal Brisbane and Women's Hosptal (RBWH) and Princess Alexandra Hospital (PAH). Patients will only be eligible if they have stable CHF and have successfully completed a hospital based, disease specific rehabilitation programme. Patients will be enrolled over a 6 month period and will be randomly selected into one of 2 intervention groups. All individuals will attend an exercise session once per week for 12 weeks which will include 6 weeks of land based exercise and 6 weeks of water based exercise. Whilst some will commence in the land based programme to be followed by the water based programme, the second intervention group will commence in the water based programme followed by the land based programme. Participants will undertake an assessment on 3 occasions: before starting, after the first 6 weeks and at completion of the 12 weeks. During each assessment a number of measures will be collected. These include exercise capacity using a submaximal walking test, grip strength using a hand held dynamometer and 4 balance tests. Participants will also be asked to complete a survey regarding their perception of water based exercise. In a small subgroup of 10 patients, cardiac function will be measured on 1 occasion. This will be done using a portable echo machine and measures will be completed in 3 positions which include: standing outside of the pool, and standing waist deep in the pool prior to and at the completion of the exercise session. To date, no studies have compared aquatic therapy versus land based maintenance exercise in patients with CHF. If shown to be at least equally effective as traditional maintenance exercise, this may provide patients with a valid alternative that is more accomodating for those with musculoskeletal or balance issues that normally hinder land based exercise. This study will inform clinical practice and will provide valuable pilot data that will enable our research team to participate in more comprehensive trials in the future.

  • Promoting activity for frail aged in post-acute hospital settings: a randomised controlled trial of accelerometry

    BACKGROUND A goal in rehabilitation for older people is promotion of mobility to reverse functional decline and deconditioning. Recent developments in accelerometry for quantifying ambulatory activity can assist clinical practice in rehabilitation settings. AIM The study tests the hypothesis that use of accelerometry to provide accurate activity data to patients and clinicians, in the context of explicit goal setting, substantially increases patient walking activity. The study will also explore the effects of increased activity on patient outcomes and undertake a cost utility analysis. RESEARCH PLAN A randomised controlled trial will be conducted in Geriatric Rehabilitation Units at 3 sites (QLD, NSW, SA). Eligible patients are aged greater than or equal to 60 and able to ambulate. Based on pilot data, a sample size of 270 patients (135 per group) is required to demonstrate a mean significant differencein daily walking time of 33% between intervention and control groups.Accelerometers will be fitted to eligible subjects to monitor daily activity. Intervention subjects will be offered a formal activity-related rehabilitation goal, and receive daily feedback, sourced from the accelerometer, of their activity levels. Neither staff nor subjects in the control arm of the trial will receive data on walking times. The primary outcome measure will be walking times measured by accelerometry. Secondary outcome measures will include lower extremity function, quality of life, length of stay, post discharge hospital readmissions and level of care at one month follow-up. The time frame for the study is two years six months. SIGNIFICANCE If patient activity can be increased through the use of accelerometer data, it will revolutionise the management of activity in hospital. There will be enormous impetus to further develop accelerometer technology for clinical application so that activity prescription will be a routine component of a rehabilitation care plan.

  • A phase II study of oxaliplatin/5-FU/Avastin and concurrent radiation in patients with simultaneous primary and metastatic rectal cancer

    This study looks at the tolerability and effectiveness of an 11 week program of integrated radiotherapy and chemotherapy with oxaliplatin, 5-flurouracil (5-FU), folinic acid and the agent bevacizumab in patients with simultaneous primary and metastatic adenocarcinoma of the rectum (back passage)

  • Surgical management and outcome of recurrent pelvic organ prolapse after mesh-surgery for the condition of a pelvic organ prolapse (mesh-failure)

    The purpose of the proposed project is to report the clinical presentation, the subsequent surgical management and the outcome of a series of 20 patients with recurrent pelvic organ prolapse (POP) following implantation of synthetic mesh in the vagina for the treatment of POP (mesh-failure). This study is conducted to obtain a better understanding of the surgical management after vaginal mesh-failure that should be proposed. The hypothesis of this study is to evaluate and to assess the surgical treatment in women who underwent surgical correction for recurrent POP after initial treatment with synthetic mesh in the vagina for POP. For gynaecologist clear surigcal strategies are required to propose the surgical intervention that is most effection in this situation.

  • Droperidol for rapid sedation of acute behavioural disturbance

    The recent randomised controlled trial of Droperidol versus Midazolam for acute behaviour disturbance (ACTRN 12607000527460) resulted in the drug type being droperidol as effective at sedation as Midazolam but with significantly less adverse effects. There was no significant QT abnormalities. With ethics approval an extension to this trial followed and we have introduced a protocol of sedation with inclusion criteria and guidelines with the recommendation to give droperidol in a set dose and route as an observational study in the emergency department. This extension of the original trial has resulted in positive outcome for both patients and staff. The patient cohort is over 250 patients to date with no serious adverse effects. We now wish to extend this observational study to include rural regional and metropolitan hospitals to increase the sample size of the safety study.

  • The Effects of Delta 9-tetrahydrocannabinol (THC) on Driving Performance, Cognition, Fatigue and Stress.

    This study aims to examine the effect of THC (active component in cannabis) on driving performance along with various measures of cognition and decision-making, fatigue, vigilance (attention) and stress during both the acute and residual phases of cannabis consumption. A double-blind, placebo-controlled, counterbalanced cross-over design means that 20 healthy participants will will attend 2 experimental conditions and smoke either 2* THC cigarettes or 2* Placebo cigarettes at each testing session.

  • A phase III study of active surveillance therapy against radical treatment in patients diagnosed with favourable risk prostate cancer (START)

    This study compares the safety and efficacy of two different treatment strategies (active surveillance with selective intervention versus radical treatment) in patients with favourable risk prostate cancer. Who is it for? You can join this study if you have been recently diagnosed with favourable risk prostate cancer and are a suitable candidate for radical prostatectomy or radiotherapy. Trial Details: Participants in this study will be randomly allocated to one of two treatment groups. Patients allocated to Group 1 will undergo either radical prostatectomy or radiotherapy based on you and your treating doctor’s preferences. Patients allocated to Group 2 will not undergo any immediate treatment. Rather, a ‘watchful waiting’ approach will be taken whereby your cancer is monitored closely and treatment (surgery or radiotherapy) is only undertaken if progression occurs. The results of this study will be useful to help guide patients and physicians in choosing the best treatment strategies to manage their cancer.

  • Comparison of the reliability of continuous with intermittent blood pressure monitoring during Caesarean section under spinal anaesthesia

    This project proposes to compare two methods of measuring women’s blood pressure during elective Caesarean sections. The safest and most common type of anaesthetic for a Caesarean section is a spinal anaesthetic. This abolishes painful sensation from the surgery and allows the woman to stay awake while her baby is delivered. However, a common side effect of a spinal anaesthetic is low blood pressure which can cause nausea and vomiting for the mother and may be harmful to the foetus. The pH (acidity) of blood from the umbilical cord taken immediately after delivery is lower (more acidic) if there has been low maternal blood pressure during the Caesarean. Blood pressure is closely monitored by the anaesthetist immediately after the spinal anaesthetic and a drug called metaraminol is given to increase the blood pressure if it is low. Metaraminol works by constricting blood vessels. The most common way of measuring blood pressure is with an automatic cuff on the arm called a noninvasive blood pressure (NIBP) device. This may be set to inflate every one, two or three minutes. However, the reliability of NIBP devices is poor and sometimes they fail to provide a blood pressure reading when required. This is a problem when the blood pressure is so variable in a short time period. An alternative device can provide continuous noninvasive arterial pressure (CNAP) measurement. It measures blood pressure using small cuffs on the finger. This study proposes to compare the reliability of the NIBP device with the CNAP device. Reliability is defined as the ability to provide a blood pressure reading every one minute during a Caesarean section. The main aim is not to compare the accuracy of these two devices. This is already well described in other research. The CNAP device often needs to recalibrate (at least every 15 minutes) and during this period, lasting between 40 and 180 seconds, no blood pressure readings are provided. It is therefore unknown which device is more reliable.

  • Neonatal core body temperature extended investigation

    Observational study of 5 body temperature sites on critically ill neonates. Hypothesis: that rectal temperature would be slower to respond to changes in environmental temperature than oesophageal temperature.

  • The use of Near-Infrared Spectroscopy to assist in the diagnosis of Compartment Syndrome in paediatrics

    Compartment syndrome occurs when swelling in a muscle interferes with the blood supply to that muscle. The syndrome happens most often in fractures, and after bone operations, and can lead to damage to the muscle and nerves of the limb affected. We are interested in using a new technology that is designed to look at the blood oxygen levels in tissue (in this case muscle). The technology uses probes attached to a machine. The probes are placed on the skin, and shine light into the muscle. The light is not damaging to the tissue. We would like to know more about the oxygen levels of muscles in compartment syndrome in children. All children 0 to 18 years of age can participate. They cannot participate if they have jaundice, or broken skin where the probes may be placed. For those presenting with suspected compartment syndrome, when the child comes to theatre, once they are asleep, we will place a probe on the skin over the muscle. We will do this on the affected and the unaffected side. We will also do a standard compartment pressure measurement simultaneously. The probe will be left on for 2 minutes in theatre, and then removed. For those presenting with a supracondylar fracture, the probes will be placed on the injured, and uninjured sides and left on for 48 hours or until hospital discharge. The monitor has not yet been shown to help in this problem, and we will not use the values to alter treatment in any way. We hope that the results of this study will help us to detect compartment syndrome early on, and allow quicker treatment, in those children who develop it.

Tags:
  • Finding clinical trials