ANZCTR search results

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

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31350 results sorted by trial registration date.
  • Evaluation of weekend allied health services on acute medical / surgical wards

    Provision of allied health services over 7 days per week as opposed to 5 days per week for medical and surgical hospital inpatients is a practice inconsistently applied across health services in Australia. Presently, no evidence from randomised trials is available to guide service delivery for this population. These services have developed incrementally and in an ad hoc process at Monash, Western and Melbourne Health, in a similar experience to other health services around the state. It is possible that this is wasting resources that could be used for other purposes within these organisations. This study aims to examine whether removal and provision of weekend allied health services on general medical and surgical wards has an impact on length of stay on those wards, other indicators of quality and safety of service provision, and staff satisfaction. A novel research methodology will be applied using a stepped wedge cluster randomised controlled trial design to both incrementally remove existing services, then reintroduce services in a structured, stakeholder driven process (the 2nd phase is registered as a separate trial on ANZCTR). At Monash and Western Health, existing weekend allied health services will be incrementally removed across 6 wards over a 7 month period (5 wards over 6 months at Melbourne Health). Outcomes will be collected predominantly through existing data collection processes, although additional data will be collected through staff group and key informant interviews, and random sampling of patients.

  • Investigation of a portable, non-invasive vibrator (the Respiratory Assist Device-RAD) to reduce breathlessness in people with Chronic Obstructive Pulmonary Disease (COPD).

    Breathlessness can stop people from being able to perform activities of daily living or exercise, and as such may have a negative impact on their quality of life. Past research has shown that applying mechanical vibration of 100 Hz to the chest wall decreases the sensation of breathlessness (dyspnoea) in both healthy subjects and in people with spinal cord injury, chronic obstructive airway disease and asthma. The devices used in previous research studies have not been portable nor have they been able to be used by people during activities of daily living. The Respiratory Aid Device (RAD) is a portable, battery operated, user friendly device which applies mechanical vibration (˜ 100 Hz) to the chest wall. Participants with stable COPD will be recruited from the pulmonary rehabilitation programme at Royal Prince Alfred Hospital via a flyer. All participants will be seen twice during their regular visits to the pulmonary rehabilitation programme. On the first occasion the level of exercise that causes moderate breathlessness will be established. On the second occasion, participants will perform two (2) 10 minute exercise bouts on a stationary cycle at an intensity based on 60% of the calculated peak work capacity (Hill et al 2008). The RAD will be attached to the chest wall during both exercise bouts, with the order of the placement randomised to either the active position or sham position. . The severity of the sensation of breathlessness will be recorded at one minute intervals throughout the exercise sessions using the Borg breathlessness scale. The RAD is a non-invasive, portable device consisting of two main components, a sensor and a vibrator. The respiration sensor is a 100K NTC thermister mounted on a plastic face mask such that the air flow through the face mask can effectively heat and cool the thermister in phase with respiration. The two vibrators consist of an off-the-shelf vibrator (normally used in mobile phones). When 3volts DC is applied to the vibrator it vibrates at 100Hz. The vibrators are taped to the chest wall. The system is powered by two 1.5V “AA” alkaline batteries.

  • Anti-inflammatory treatment for dermatological disorders.

    A Phase I, randomised, double blind, placebo-controlled, study of the safety, tolerability, pharmacokinetics and clinical activity of AKP-11 administration to healthy volunteers and patients with mild to moderate psoriasis.

  • The effect of a bout of resistance exercise on pressure pain sensitivity in knee osteoarthritis

    This study investigates the analgesic effects of a bout resistance exercise on pressure pain thresholds and pressure pain tolerance in healthy participants and participants with knee osteoarthritis. The pain measures will be assessed at baseline and will be repeated following a bout of resistance exercise. Questionnaires concerning physical activity, pain, disability and injury will be completed by the participants.

  • Implementing care coordination plus early rehabilitation in high-risk chronic obstructive pulmonary disease (COPD) patients in transition from hospital to primary care

    The aim of this project is to pilot the implementation of care coordination plus early rehabilitation in a high-risk COPD population in transition from hospital to primary care. This intervention will dovetail with the existing Sub-Acute Respiratory Services (SRS) of the Central Adelaide Local Health Network (CALHN) and the Central Adelaide and Hills Medicare Local (CAHML) COPD Project. Stronger partnerships will be created to improve the clinical handover of patients and address gaps identified by both services. This study will determine whether this model of care coordination plus early rehabilitation is feasible, acceptable, carried out with fidelity and effectiveness (compared with a no-intervention control group). If so, this model could be implemented in a larger Australian cluster randomised trial and outcomes examined over a longer duration. If effective, the role of specialist Nurse Practitioners as community care coordinators could be implemented as effective links between primary and acute hospital care of people with chronic lung conditions. Study Hypotheses (a) Implementation of the pilot intervention (care coordination plus early rehabilitation) is feasible, satisfactory to patients and carers and can be delivered with fidelity. (b) Care coordination plus early rehabilitation will result in (i) documentation of agreed patient goals and (ii) demonstrated progress toward them assessed by the four major Flinders Program Care Planning Tools: Partners in Health / Cue and Response / Problems and Goals assessment and Self-Management Plan in at least 85% of cases. (c) Care coordination plus early rehabilitation will involve collaboration with the patient's GP/practice nurse with generation of a Team Care Arrangement in at least 85% of cases. (d) People with COPD who participate in care coordination plus early rehabilitation will have lower hospital readmission rates at 28 days and greater physical activity levels at 28 days after discharge than a control group of similar patients.

  • A Randomised, Double-blinded, Placebo-controlled Study of Kivia (Trademark) 575mg Zyactinase (Registered Trademark) Capsule for the Improvement of Digestive Health Parameters in Subjects with Irritable Bowel Syndrome with Constipation Symptoms

    Irritable bowel syndrome (IBS) is the most common gastrointestinal disorder without any physical or physiological abnormality affecting approximately 10% of the population of Western countries. IBS is largely diagnosed in early adulthood and though the degree to which people are affected differs, IBS can cause significant impact of lifestyle, relationships and productivity. Kivia (Trademark) Zyactinase (Registered Trademark) is a 100% natural freeze-dried kiwifruit product which has been tested in both animals and humans and shown to be safe Kivia (Trademark) is manufactured in New Zealand and is commercially available in Australia. The purpose of this Phase III study is to see whether the product Kivia (Trademark) containing the active ingredient Zyactinase (Registered Trademark) can provide relief of IBS associated constipation and other symptoms of IBS. Subjects diagnosed with constipation dominant IBS will be randomised in a 1:1 ratio to receive either Kivia (Trademark) or matched placebo capsules for eight weeks Daily information about IBS-C symptoms will be captured by subjects using an electronic diary, and they will attend six clinic visits for efficacy and safety assessments.

  • The Effect of Afatinib on the Anti-Tumour Immune Response in Patients with Advanced Non-Small Cell Lung Cancer

    This study is evaluating the effect of Afatinib on the anti-tumour immune response in patients with advanced non-small cell lung cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with advanced non-small cell lung cancer (IIIb/IV). You also need to be willing to undergo study blood tests at Sir Charles Gairdner Hospital in Nedlands, Western Australia. Study details All participants in this study will undergo treatment with Afatinib. Afatinib is an oral drug which is known to be effective in treating some types of lung cancer, particularly those with a mutation in EGFR. The purpose of this research study is to determine how Afatinib affects the cells of the immune system during treatment for lung cancer. There is now evidence to suggest that some cancer treatment drugs may help the immune system to attack cancer cells. If this is the case, it might be possible to develop better cancer treatments by combining them with drugs that stimulate the immune system further. However, it is important to understand exactly how different drugs affect the immune system before deciding which combinations might work well together. Treatment with Afatinib is a once daily tablet, divided into 6 week courses. Treatment will continue while it is of benefit to the patient, and will be stopped for safety reasons or if consent is withdrawn. Research blood samples will be taken at baseline, after 3 weeks and 6 weeks on treatment, and a final one 28 days after last dose of Afatinib. The research bloods will be used to characterise and measure the numbers of different immune cells in the blood, and how well they are reacting against the cancer. Routine blood tests will be required every 6 weeks while on Afatinib to monitor the safety of treatment as is standard for all patients having cancer treatment. Research bloods can be taken with routine bloods at the appropriate time points. A CT scan will be performed at baseline, at 6 weeks and 12 weeks after starting treatment and thereafter at 12-week intervals. A clinic visit is required at baseline, 3 weeks after starting treatment, and then on the first day of each course. Approximately 20 people at Sir Charles Gairdner Hospital only will participate in this study.

  • Usability and initial efficacy testing of a website-delivered behaviour change intervention designed to promote physical activity among post-treatment breast cancer survivors.

    This study aims to examine the usability and initial feasibility of a low cost distance-based intervention delivered via the internet for promoting physical activity among post-treatment breast cancer survivors. Who is it for? You may be eligible to join this study if you are a woman aged 18 years or above who has been previously diagnosed with breast cancer (at any time point). To be eligible, you must have completed active cancer treatment and be proficient in the English language. Study details All participants in this study will receive a website-delivered tailored behaviour change intervention designed to promote physical activity. Participants will be randomly (by chance) allocated to one of three groups. Those in group 1 will receive a single module intervention only, whereas groups 2 and 3 will receive a three module intervention delivered over 3 weeks in group 2 and 3 months in group 3. All participants will be assessed at 1, 3, and 6 months post baseline in order to determine any changes in physical activity and quality of life.

  • Head Injury and Testosterone

    This project aims to investigate whether testosterone injections with initial administration within three months of traumatic brain injury (TBI) can assist in recovery from brain injury and reduce the risk for the development of Alzheimer’s Disease (AD) related biomarkers.

  • The effect of a formalised trauma tertiary survey procedure on missed injury rates in multi-trauma patients, protocol for a cluster-randomised controlled trial.

    Missed injury is commonly used as a quality indicator in trauma care. The trauma tertiary survey (TTS) has been proposed to reduce missed injuries. However a systematic review assessing the effect of the TTS on missed injury rates in trauma patients found only observational studies, only suggesting a possible increase in early detection and reduction in missed injuries, with significant potential biases. Therefore more robust methods are necessary to test whether implementation of a formal TTS will increase early in-hospital injury detection, decrease delayed diagnosis and decrease missed injuries after hospital discharge.

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