ANZCTR search results

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

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31163 results sorted by trial registration date.
  • Gait retraining interventions for people with knee osteoarthritis

    Knee osteoarthritis (OA) is one of the leading causes of physical disability in adults. It leads to symptoms of pain, reduced functional mobility, poor quality of life, and causes a substantial burden to the healthcare system. Mechanical loading patterns at the knee are believed to play a major role in the pathological cartilage and bone changes seen in people with knee OA. Therefore, there has been increasing interest in gait modification strategies that act to reduce loading in the knee. One such strategy is altering the foot progression angle (FPA) via a toe in or out method. FPA refers to the angle formed by the long-axis of the foot, constructed from the mid-heel through to the second toe, and the forward progression of the body. The typical FPA during normal gait tends to occur with the toes pointing slightly outward at approximately 5 degrees. Toe-out gait is thus achieved through increasing the FPA by externally rotating the foot, whilst decreasing the FPA through internal rotation of the foot is referred to as a toe-in gait. The primary objective of this study is to evaluate the effects of toe-in gait retraining intervention compared to toe-out gait retraining intervention on pain, physical function and proxy measures of medial knee load over 6 weeks in people with medial knee osteoarthritis. The design of the study will be a randomised clinical trial. Community dwelling individuals with medial knee OA will be recruited, screened and then randomly allocated to either a toe-in or toe-out gait retraining group for a 6 week intervention. To fulfil this knee OA diagnosis, participants must be over 45 years or older, with knee pain. To control for confounding variables, participants need to be free of neurological or systemic rheumatological conditions. Men and women will be invited to participate from the Sydney metropolitan region. The total sample size will be 60. Participants will be randomised with a 1:1 allocation to either receive toe-in intervention (30 participants) or toe-out intervention (30 participants).They will undergo a gait retraining intervention program for 6 weeks and are required to attend the laboratory a total of 7 times (including assessments). The first training session will run for 1 hour and will involve education of the participant, baseline assessments and commencement of the intervention program (week 0). The following five sessions (week 1 to 5) will be spaced one week apart, consisting of supervised gait retraining sessions of 30 minutes. The final session will be performed one week after the sixth session (week 6) at the completion of the gait retraining program and will involve re-assessment of outcome measures. The participants will also be prescribed a home-based program of 30 minutes per day during this 6-week period.

  • Automated artificial-intelligence based, preliminary cardiac diagnostics decision support tool to the medical practitioner.

    MedAl Cardiology is a software tool that will enable health care professionals to diagnose various heart conditions in real time using Artificial Intelligence (AI). It would provide a diagnosis of heart functioning by analysing heart sounds recordings. The MedAI Cardiology algorithm will classify the patient status as “Normal” or “Abnormal” and will provide in-depth insights about various heart conditions. An automated analysis capability will support medical practitioners in deciding whether or not to refer the patient for further investigation.

  • Simethicone in Prostate Radiotherapy

    This study will evaluate the effect of a drug called Simethicone versus no bowel preparation on rectal volume and side effects in men undergoing radiotherapy for their prostate. Who is it for? You may be eligible to join this study if you are male aged greater than 18 who is scheduled to receive external beam radiotherapy (ERBT) to the prostate. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group take an anti-flatulent medication, called Simethicone, 3 days prior to their planning CT scan, and then throughout radiotherapy treatment. Simethicone is administered as an oral capsule three times a day. Participants in the other group will receive treatment as usual without medical means of bowel preparation. All participants will undergo weekly Cone Beam CT scans throughout the 7 weeks of radiotherapy, in order to evaluate rectal volume and volume of gas in the rectum. They will also be asked to complete questionnaires to evaluate any radiotherapy side effects. It is hoped that this research will contribute to the further improvement of the accuracy of radiation treatment to prostate cancer patients.

  • A comparison of two techniques for pain relief following Knee Replacement Surgery

    To compare the outcomes (both analgesic and functional outcomes) between two methods of analgesia for knee replacement surgery, and determine if the addition of intrathecal morphine to a standardised regime including large dose local infiltration anaesthesia is equivalent, better, or worse than current best practice.

  • Reducing non-steroidal anti-inflammatory drug use in people with knee osteoarthritis

    This study aims to determine the feasibility and acceptability of a 12-week online and individually-tailored physiotherapy intervention, involving exercise and coaching program in people with knee osteoarthritis who regularly take non-steroidal anti-inflammatory drugs. The intervention will be focused on reducing medication use, increase physical activity and pain management. The study will involve participants with knee osteoarthritis who regularly take non-steroidal anti-inflammatory drugs to be monitored for 6 weeks as they take their medication and seek care, as they normally would do (usual care). After 6 weeks, participants will start a 12-week online physiotherapy intervention, which will include 6 physiotherapy consultations involving strength training exercise, coaching to reduce medication use and improve physical activity, and pain coping skills training using an online platform (pain trainer).

  • A prospective Phase II study of Isatuximab Rescue for Inadequate response to Lenalidomide and Dexamethasone in transplant ineligible patients with newly diagnosed multiple myeloma

    The purpose of this study is to determine whether Isatuximab (a new drug), when combined with chemotherapy, improves response to treatment. Who is it for? You may be eligible to participate in this trial if you are aged 18 years or over, have been newly diagnosed with multiple myeloma and are not a candidate for high dose chemotherapy and autologous stem cell transplant. Study Details Eligible participants will receive lenalidomide and dexamethasone (Ld). Participants who have inadequate response to upfront treatment with Ld, will have the addition of Isatuximab. Treatment (each cycle is 28 days) will be given until disease progression, unacceptable toxicity, or withdrawal of consent. Participants will be required to have blood samples taken at the beginning of each cycle along with a medical exam in order for researchers to monitor whether the treatment is safe and whether it is effectively treating the myeloma. It is hoped that the findings of this trial will establish the benefits of Isatuximab in combination with Ld for the treatment of multiple myeloma patients early in the course of their disease.

  • A study comparing the effect of two types of continuous nerve block on pain experienced by patients with multiple rib fractures.

    This study aims to determine if continuous thoracic erector spinae block is as effective as continuous thoracic paravertebral block in providing analgesia to patients with unilateral, multiple rib fractures. If similar analgesia is achieved with the continuous thoracic erector spinae block, it will become a viable, less invasive and simpler alternative to the continuous thoracic paravertebral block which may result in more patients receiving timely analgesia. Participants will be randomised to receive either the erector spinae or paravertebral intervention. The primary outcome is pain scores, at rest and with coughing, provided by patients at 24hrs and 72hrs after the intervention.

  • Analgesia for major laparoscopic abdominal surgery using Intrathecal Morphine. A Feasibility Study.

    Major abdominal surgery is a common procedure associated with significant postoperative pain and morbidity. The importance of high quality perioperative care is clear, and effective postoperative analgesia is fundamental to recovery. Intrathecal Morphine (ITM) is an increasingly popular analgesic option in major abdominal surgery and in laparascopic colorectal surgery, has been reported to reduce pain scores and total opioid consumption. In the context of a worldwide opioid epidemic, strategies to minimise opioid use whilst optimising patient comfort and functional recovery are priorities in the perioperative setting. We believe ITM will be superior to intravenous analgesia alone in terms of quality of recovery, cost saving and opioid-sparing in the context of similar or lower side effects. The results of this preliminary feasibility study will be used to design a large-scale phase III, multicentre trial with the objective of obtaining outcomes that will accurately inform clinical practice.

  • A comparison between the effectiveness of the body-worn alarm system and a bell-and-pad alarm system for the management of bed wetting in children.

    Bedwetting is a major issue for children in Australia. Currently the most widely used system for managing this issue is the bell-pad alarm system. This alarm is expensive and children often have to wait for long periods before they can get access. However, there is an alternative device that is cheaper and therefore more readily accessible for children and families. This project will consider how well this alternative device compares to the bell-pad for treating bedwetting in children. Enuresis is the most common chronic condition in children between 6-7 years of age, with approximately 1 in 5 children in Australia experiencing bed-wetting. Currently the most widely used system for managing enuresis in childhood is the traditional bell-pad alarm system. However, this system represents a significant expense that impacts upon the capacity of a health service to make these devices readily available to children and families, resulting in prolonged waiting periods for the afflicted (upwards of 6 months). It is widely appreciated by paediatric health professionals, that optimal clinical outcomes in overcoming nocturnal enuresis are achieved if therapy is commenced as soon as a child is psychologically ready to begin. This poses therefore an unfortunate conundrum for the stakeholders in paediatric healthcare and one that warrants research efforts. At a comparative cost ratio of 1:17, per/unit the body-worn alarm system offers a potential alternative. Therefore, this pilot-project will compare agreement between an alternative body-worn alarm system and the bell-pad system. The findings may have important implications for the practice of treating children with enuresis in Western Victoria and beyond. If good levels of agreement can be achieved, the body-worn alarm system would warrant further examination as a first line option for treatment that aligns with a child-focused ‘window of opportunity’ for optimal treatment.

  • A Trial of Suprascapular Nerve Block for shoulder Pain in Motor Neuron Disease.

    This study aimed to quantify the prevalence of shoulder pain in people with MND and assess the efficacy of suprascapular nerve block (SSNB) for its management.

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