ANZCTR search results

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

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31435 results sorted by trial registration date.
  • Outcomes of patients aged over 90 years undergoing open heart surgery

    Given the rarity of nonagenarians (age > 90 years) undergoing open cardiac surgery requiring cardiopulmonary bypass, there is a dearth of research describing their characteristics, comorbidity burden, perioperative course. Consequently, there is little evidence to guide and inform patient selection, clinical practice and enhance recovery pathways in this vulnerable patient cohort. Accordingly, this case series study aims to provide a detailed description of nonagenarians undergoing open cardiac surgery at four teaching hospitals in our state. Specifically, we aim to describe the demographics of nonagenarians undergoing cardiac surgery, their perioperative paradigm, their postoperative outcomes. In turn, this may help facilitate the selection of nonagenarians for surgery, help guide perioperative management, and allow for focused allocation of hospital resources. Who is it for? You may be eligible for this study if you are an adult patients over 90 years of age who underwent open cardiac surgery for for any indication at Austin Health, Warringal Private Hospital, Epworth Eastern Hospital or Epworth Richmond Hospital in Victoria, Australia Study details This study will be conducted using a review of medical records, and no patient contact is required. The study will review the medical records of adult patients who underwent cardiac surgery at the above Hospital from 1 January 2012 to 31 December 2019. It is hoped that this research will help to provide a better understanding of outcomes associated with open cardiac surgery in this unique patient cohort.

  • Hospital costs of complications following cystectomy

    There has been recent interest in understanding the costs associated with post-operative complications of patients undergoing radical cystectomy (removal of the entire bladder). Accurately defining the costs of complications allows institutions to make more informed decisions as to what these costs are, and then implement strategies to reduce the incidence of complications, thereby mitigating hospital costs. The aim of this study is to provide a detailed costs analysis for patients who undergo radical cystectomy. Who is it for? You may be eligible for this study if you are an adult who underwent a radical cystectomy. Study details This study will be conducted using a review of medical records, and no patient contact is required. The study will review the medical records of adult patients who underwent a radical cystectomy at the Austin Hospital between 1 Jan 2012 and 31st July 2021. It is hoped that this research will help to provide a better understanding of the costs associated with major surgery.

  • Feasibility study for a novel approach to delivery of breakthrough analgesics in palliative care

    Pain is the most common symptom experienced by people at the end of life in an inpatient hospice setting. In nearly all cases, a person who is dying receives analgesics, usually opioid, including bolus injection of breakthrough analgesic to manage incidental pain. Our aim is to evaluate the safety, efficacy, usability and acceptance of a novel modality to administer breakthrough analgesics in palliative care patients. 1. Safety – evaluate the safety of a novel method for administering breakthrough analgesics by monitoring adverse events associated with equipment, adherence to regulatory practices, audit of prescribing and administration practices 2. Efficacy – assessment and comparison of opioid dose, total MED, time in motion and use of other medications for breakthrough dosing such as anti emetics and anxiolytics 3. Usability – survey of staff about use of equipment and the method of administration 4. Acceptability- survey of staff, family, carers about experience

  • Assessing the impact of the size of a maxillary sinus graft and its contact with surrounding sinus walls on bone regeneration

    Based on the graft healing after maxillary sinus augmentation, the fraction of new bone formation is hypothesized to be positively correlated to the area of resident bone walls in contact with the bone graft and negatively correlated to the volume of the graft. The inter-relation of these parameters on new bone formation has never been investigated. As such, the ratio of surface area in contact with the graft and the graft volume will be explored in this study.

  • Faecal microbiota transplant to improve motor function in patients with advanced Parkinson’s disease: A pilot study

    Parkinson’s disease is a neurological condition that results in degeneration of nerve cells in a particular part of the brain that produce the chemical dopamine. The exact cause of Parkinson’s disease is not yet known, however there is some evidence that the gut may be involved. Faecal Microbiota Transplant (FMT) involves delivering a stool sample from a healthy individual (“donor”), to the bowel of the person taking part in the study (“recipient”). The aim of this study is to determine whether FMT is tolerated in individuals with Parkinson's disease and to evaluate for side effects, if any. This treatment is already TGA approved and used in many other conditions. We also aim to evaluate if FMT can improve motor function in patients with Parkinson’s disease, for example tremor, walking, stiffness and slowness. We also aim to determine whether FMT improves constipation or quality of life in Parkinson’s disease. We will also examine the stool of participants over the course of the study to see how the stool make-up changes after receiving the transplant. Participants will receive infusions of placebo or FMT via a gastrointestinal tube and then swap over after the first two infusions. Participants will not know what infusion they are receiving. This is a pilot study, which means it is a small study to test whether FMT might work but it is not yet an established treatment for Parkinson’s disease.

  • The Light Knee Study: The effects of light therapy on post-operative pain and functional mobility in people undergoing knee replacement surgery.

    In this study (called a randomised, sham-controlled clinical trial) we want to find out if the application of an innovative new adhesive light patch can reduce pain and improve recovery of movement after knee replacement surgery. In this study, we will compare the effect of the active device with the inactive (sham) device. Half of the participants will receive the active treatment, and half will receive the sham treatment. Today, the usual approach to pain relief and movement recovery after knee replacement surgery is a combination of pain-relief drugs (analgesics) and exercise rehabilitation. They work well, but some people continue to have pain after knee replacement for up to 6 or even 12 months; and they may require continued need for pain medications. We have previously carried out a small feasibility study to work out the protocol details for this new research study. In the feasibility study, we found that patients accepted and tolerated the device, that it was easy for patients to apply at home, and the device provided good pain relief both before and after knee replacement surgery and good recovery of physical movement after the surgery. Based on our previous research, we expect that using a low dose of light therapy daily before knee replacement surgery, and daily after the surgery for one week after surgery, may help people to have less pain in the days following surgery. We also think that further treatment in the second week after surgery will aid recovery of movement and reduce pain in the weeks and months following the operation. The device we are testing is called CareWear. CareWear is a novel, 3-D printed self-adhesive patch with hundreds of micro-diodes (light emitting diodes are found in many home appliances) that emit specific light frequencies that have been found in other research to reduce inflammation and pain. The CareWear patch is registered in the USA and with the Australian Therapeutic Goods Administration (TGA) for applying light to areas of pain and inflammation.

  • The Effect of Exercise Prescription and Delivery in Congenital Heart Disease – The Congenital Heart Fitness Intervention Trial: CH-FIT

    Congenital heart disease (CHD) is the most common congenital disorder in newborns, with an estimated 2400 Australian babies born with CHD each year. Despite improved survival due to advances in surgical techniques and medical care, premature morbidity and mortality are common. In this multi-centre randomised controlled trial, eligible participants with CHD will be allocated to either a 4-month face-to-face or telehealth moderate-to-vigorous physical activity and exercise training program or a usual care (control) group. Participants allocated in the intervention groups will also engage in an 8-month maintenance phase. Detailed assessment of exercise capacity, body composition, vascular function, physical activity levels, liver stiffness, cardiac function, quality of life, cognitive function, lung function, dietary and nutritional status, peripheral venous pressure, and musculoskeletal fitness will be performed. Testing and assessments will be performed at baseline, 4-months, and 12-months.

  • Braun Enteroenterostomy for Reconstruction after Pylorus-resecting Pancreaticoduodenectomy (BERP) trial

    The purpose of this study is to examine the effect of the Braun Enteroenterostomy (BE) surgical method during surgery to remove cancer in the pancreas or small intestine. Who is it for? You may be eligible for this study if you are over 18 years of age and will be undergoing surgery to remove cancer in the pancreas or small intestines. Study details All patients will undergo pancreaticoduodenectomy surgery with antecolic Billroth II style reconstruction, as per usual treatment. Patients will be randomly allocated to either have the BE procedure added to their surgery or to not have BE. The BE procedure is by joining the small bowel to the large bowel (also known as Braun Enteroenterostomy). This takes which takes an additional 15 minutes. Hospital data will be collected to assess surgery recovery daily and questionnaires will be given days 30 and 90 after surgery. It is hoped that this research will reveal if adding the BE surgical technique during surgery will improve patient safety and recovery after surgery, and results in better surgical treatment for digestive system cancer.

  • Cardiac and vascular Evaluation using 4D-flow magnetic resonance (4DCARE).

    To perform a prospective non-inferiority study of a rapid cardiac MRI acquisition protocol using 4D-flow compared to the current gold standard cardiac MRI examination to measure cardiac function and detect pathology

  • METMED: Metformin for cognitive and brain recovery in children treated for Medulloblastoma

    The purpose of this study is to test whether metformin treatment is associated with greater improvement of cognitive function and brain growth compared to placebo group for children/adolescents with medulloblastoma. Who is it for? You may be eligible to participate in this study if you are between 7 years and 17 years and 11 months old and have been treated for medulloblastoma. Study Details Participants will be required to take oral medication in tablet form daily for 16 weeks. 'Participants will be randomly allocated to receive either metformin as an oral tablet taken daily or a placebo tablet. Participation in this trial will require an overall time commitment of 40 weeks as participants must undergo screening and pre-treatment assessments and as well as a 6 month post-treatment follow-up. Assessments will include MRI scans and cognitive testing to measure memory, attention and processing speed. It is hoped that this research will help to determine if metformin has a positive effect on cognitive and brain recovery from medulloblastoma in this population

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