ANZCTR search results

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

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31170 results sorted by trial registration date.
  • Comparing post-sinus surgery symptoms of chronic sinusitis patients using Flo Sinus Care or Flo Kappa sinus rinses

    To determine whether adding kappa carrageenan to over-the-counter sinus rinse Flo Sinus Care can hasten the recovery after surgery when compared to the product alone. 50 participants will be recruited from The Queen Elizabeth Hospital who require endoscopic sinus surgery to treat chronic rhinosinusitis. Their randomised blinded treatment will be either Flo Sinus Care or Flo Kappa sachets for reconstitution and delivered as a sinus rinse for 12 weeks following surgery. We will assess each patient at time of surgery, 2 weeks, 6-8 weeks, and 3 months post-surgery using endoscopic scores and symptom scores, as well as an. intranasal bacterial swab and mucus sample at each time-point to measure inflammatory cytokines. Following on from our in vitro work with the above-mentioned treatments, we expect Flo Kappa to have a positive effect on healing and patient symptoms by way of reduced infection and inflammation.

  • Look before you Leap: A randomized controlled trial of the impact on length of hospital stay of ECHOcardiography Goal-directed Ultrasound Informed Decision-making for Elderly patients undergoing emergency noncardiac surgery - The ECHOGUIDE III trial

    Emergency surgery is a growing health issue because it is becoming more common and the patients are becoming older and sicker. One month after surgery, one in twenty patients do not survive and one in five patients suffer a major medical issue. One of reasons for this poor outcome is that there is often not enough time for doctor’s to fully evaluate patient’s medical status before emergency surgery. Therefore, the surgery often proceeds without the doctors having a complete medical evaluation of the patient. This can result in errors in treatment and a delay in correct diagnosis, that can result in progression of the disease or harmful treatments. A brief ultrasound examination of the patient has been shown to improve doctor’s medical evaluation of patients before surgery. For example, an ultrasound of the heart may identify a weak heart or blocked valve. In this study we wish to find out whether an ultrasound of the heart, lungs and leg veins results in a better medical outcome and shorter length of hospital stay in patients over 65 years old requiring emergency surgery.

  • Evaluating the effects of high and low oxygen therapy compared to standard oxygen therapy in patients undergoing major surgery under general anaesthesia

    The World Health Organisation (WHO) and Centre for Disease Control (CDC) guidelines recommend liberal provision of oxygen intraoperatively and in the early post-operative period to reduce the risk of post-operative infection. However, evidence from related specialties indicates that overall, liberal oxygen therapy may be increase mortality and non-infection-related complications compared with restricted oxygen therapy raising the possibility that any decreased infection risk might come at the cost of an increased risk of other complications. For adults having major surgery, it is biologically plausible that more restricted use of oxygen therapy than occurs in standard practice might improve patient outcomes; however, it is also biologically plausible that more liberal oxygen therapy might improve patient outcomes compared with standard care. Overall, the optimal approach to oxygen therapy in the setting of major surgery is uncertain. HOT-ROX will be the first trial evaluating restricted oxygen therapy vs. standard care and liberal oxygen therapy vs. standard care in patients having major surgery that is powered to assess the effect of these treatments on days alive and at home at 30 days (DAAH30). DAAH30 is strongly associated with the occurrence of postoperative complications and encapsulates the patient-important effects of such complications because it effectively combines hospital length of stay, readmission episodes, discharge destination and early post-operative mortality into a single outcome measure. The first interim analysis is planned after recruitment of 210 participants and in addition to predefined early stopping criteria will assess the listed feasibility outcomes.

  • Impact of pain modulation on shoulder pain management.

    The primary aims of this study are to: 1) Evaluate pain modulation capacity in people with musculoskeletal shoulder pain; and 2) Investigate the effects of pain modulation on treatment outcomes in people with musculoskeletal shoulder pain. Study design: Prospective longitudinal cohort study with 6-month, 12-month, and 24-month follow up Outcome measures will be collected at baseline and at 6, 12, and 24 months follow up. These include: 1) Demographic, condition history information, physical screening (baseline) 2) Pain modulation tests (predictors, therefore only collected at baseline) and psychosocial questionnaires (baseline) 3) The outcomes to determine treatment effect are the Shoulder Pain & Disability Index and the Global Rating of Change (GROC) score, evaluated at baseline (Shoulder Pain & Disability Index only), and 6, 12, and 24 months follow up. Individuals aged 18-75 years who have a referral for treatment of musculoskeletal shoulder pain will be included in this study. Following baseline assessment, patients will undergo usual care for their shoulder pain, and clinical outcomes (global rating of change; pain and disability) will be collected at 6, 12, and 24 months follow up. The type of treatment received will be elicited from participants at follow up and extracted/confirmed from medical records.

  • Erector spinae plane block (ESPB) vs wound infiltration for colonic surgery

    The study will be conducted at the CALHN sites comprising The Queen Elizabeth Hospital and Royal Adelaide Hospital with patients who are scheduled for elective laparoscopic colonic surgery. The purpose of this study is to assess the efficacy of wound infiltration over the newer regional analgesic technique called erector spinae block (ESP) block for the postoperative analgesia.Efficiency is assessed by comparing pain scores, analgesics use and other outcomes measures analysed are, discharge time and clinical determinants of adverse effects. We hypothesize; that ultrasound-guided ESP block is superior to surgically guided wound infiltration in providing superior pain relief without major side effects.

  • Blackmores Memory (ARCLI II): Investigating the safety and efficacy of a Blackmores micronutrient formula on cognitive function in healthy adults aged 50-75 years.

    The current study will sample healthy older volunteers aged 50-75 years to examine the effects of the Blackmores micronutrient formulation on cognitive function, mood, cardiovascular function and brain function. Research has investigated the individual components of the combination formula but research is yet to examine the effects of this newly devised combination formula on cognitive, cardiovascular and biochemical outcomes. One hundred and twenty participants will be recruited to take part in this trial, to allow for a complete set of 100 participants after attrition. Participants will complete three visits at the site (screening, baseline and 90 days follow-up), as well as three testing sessions completed online in their own home (14 days, 30 days and 60 days post first dose). Forty participants (20 per treatment arm) will also undergo brain imaging procedures at the baseline and follow-up visits. We hypothesize that significant improvement in cognition will occur after 3 months administration of the combination formula relative to placebo. In addition, it is hypothesized that the largest cognitive improvements will be seen at the longest time points (3 months) of administration. Secondary or exploratory outcomes/hypotheses concern the effect of this supplement on the neuroimaging, biochemical and neuropsychological variables.

  • The Flake Study: a study trying to answer the question of whether children with fish allergy can eat flake safely.

    This is an interventional study investigating the rate of gummy shark (flake) allergy in children with previously diagnosed fish allergy. We aim to recruit 35 patients between the ages of 1 and 18 with fish allergy and challenge them flake in a medically supervised setting. Based on comparable studies with different allergens, we anticipate a rate of 30% tolerance in this group.

  • Prospective, double-blind, randomised study of the efficacy of ketamine for oropharyngeal mucositis pain

    This study looks at the effectiveness of a new treatment for cancer therapy-related oropharyngeal mucositis (throat or mouth ulceration) pain. Who is it for? You may be eligible for this study if you are aged 18 or over and have cancer treatment-related oropharyngeal mucositis (throat or mouth ulceration) pain. Study details This is a randomised controlled research project, meaning that patients will be assigned by chance to either the experimental arm to receive midazolam and ketamine, or to the control arm to receive midazolam alone. This is also a blinded study, meaning that study doctors and patients will not know which group a patient has been assigned to until the end of the study. Participants in both groups will receive medication through a needle in the arm for up to 5 days. All participants will provide blood samples and answer questionnaires. It is hoped this research will demonstrate ketamine is an effective drug in treating mucositis pain, and this treatment may then be offered to all suitable patients who are also experiencing mucositis pain.

  • Evaluation of a comprehensive online resource related to early menopause for consumers.

  • Evaluation of an enhanced feeding tube with integrated visualisation technology in the placement of small intestinal tubes in critically ill patients: A prospective multicenter international cohort study

    Nutritional therapy is a vital component of standard care in critically ill patients, with nasogastric tubes being the preferred route of administration. Despite this, approximately 50% of patients fail to meet their caloric targets, potentially leading to adverse effects on clinical outcomes. Unsuccessful nasogastric feeding in the critically ill has many possible causes, but primary reflects delayed gastric emptying. As small-bowel motility remains relatively preserved, direct nutrient delivery into the duodenum may increase caloric intake. Furthermore, post-pyloric feeding may decrease the frequency of ventilator-associated pneumonia. However, inserting a post-pyloric feeding tube can be technically challenging, expensive, and requires a gastroenterologist which is not routinely available in the ICU. The Kangaroo feeding tube with IRIS technology has been specially designed to facilitate the insertion of feeding tubes post-pylorically by allowing clinicians to visualise insertion and duodenal placement. This visualisation feature may diagnose certain occult gastointestinal pathologies and obviate the need for radiological confirmation (abdominal x-ray), as is current practice. This prospective multicenter international cohort study will evaluate the success of this device in post-pyloric feeding tube insertion in critically ill patients.

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