ANZCTR search results

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

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32834 results sorted by trial registration date.
  • Foot Exercise and Education in the Treatment of plantar heel pain (FEET trial): A feasibility study.

    Plantar heel pain is a common chronic condition that presents in a variety of populations. A characteristic feature is pain with weight bearing which limits an individual's occupational, recreational and activities of daily living. The high recurrence and persistence of plantar heel pain suggests that current management options may not address all modifiable factors, such as the intrinsic foot muscles, that are important contributors to optimal foot function. This study will determine the feasibility, credibility and acceptability of foot exercise and education for the management of plantar heel pain. Secondary outcomes will investigate whether foot exercise and education can improve pain, function and intrinsic foot muscle morphology and function in this population. The results of this study will inform the design of a full-scale randomised clinical trial for the treatment of plantar heel pain.

  • The Assessment of Fluoxetine in Stroke Recovery Imaging and Blood Biomarkers Sub - Study AFFINITY BM

    The main AFFINITY trial is investigating whether fluoxetine, 20mg once daily, started 2 -15 days after stroke onset and continued for 6 months, improves functional outcome at 6 months after randomisation. The aims of the sub study (AFFINITY BM) are to further investigate the underlying biological, structural and functional mechanisms by which treatment with fluoxetine may lead to improved functional outcomes following acute stroke.

  • Oxyfriend: A novel silicone device which aims to improve preoxgenation in healthy individuals.

    Preoxygenation is a process which occurs prior to anaesthetising patients prior to surgery. Preoxygenation is a difficult process as it requires placing a mask over a patient’s nose and mouth and creating an air tight seal forcing oxygen from the anaesthetic circuit into the patient’s lungs. The OxyFriend is a novel silicone device which was designed to be utilized with traditional anaesthetic mask. The OxyFriend was designed to improve preoxygenation and my reduce leaking during preoxygenation. The study aims to test whether the OxyFriend will make the process of preoxygenation more effective. A secondary aim to is test whether the OxyFriend will reduce the leakage around the anaesthetic mask.

  • Effects of exercise in controlling blood glucose in Type II Diabetes Mellitus patients.

    This study will involve a comparison of predominately eccentric (ET) versus concentric (CT) endurance exercise. Participants in one group will perform downhill walking, participants in second group will perform uphill walking and participants in the third group will perform level treadmill walking, twice a week for 12 weeks with 2-3 days between sessions. Exercise sessions will commence at 5 minutes duration at the same comfortable walking pace and progress to 30-minutes session by the last week. Outcome measures will be assessed at baseline and after the completion of the 12-week exercise program. Exercise will assess whether downhill walking is better than uphill or level walking in glucose handling among people with type 2 Diabetes Mellitus.

  • High-flow nasal oxygen vs standard care to prevent low oxygen levels during gastroscopy.

    Gastroscopy is a very common medical procedure undertaken to screen, diagnose and treat diseases of the upper gastrointestinal tract. Patients are sedated to allow them to tolerate the procedure but this carries a risk of low oxygen levels during the gastroscopy; this is more common in patients with higher body mass index. In order to protect against low oxygen levels, patients are normally given supplemental oxygen via the nose during gastroscopy. This project is comparing the normal way of giving oxygen versus a system that delivers high-flow, warmed, humidified oxygen (the Optiflow THRIVE device), for patients undergoing gastroscopy who have a body mass index greater than 30 or who weigh more than 100 kilograms. The hypothesis is that in these patients, high-flow, humidified nasal oxygen will reduce the incidence of desaturation (oxygen levels < 90%) versus the standard of care.

  • Weight loss outcomes in obese patients undergoing Laparoscopic Sleeve Gastrectomy

    Laparoscopic sleeve gastrectomy (LSG) has acquired considerable interest as preferred bariatric surgical procedure that leads to effective weight loss and control of type 2 diabetes and co-morbidities. However, there is marked individual differences in degree of weight loss achieved with little ability to detect individuals who will achieve less than expected weight loss outcomes before or early post-intervention. Additionally, no studies have assessed the relationship between weight loss outcomes, disease remission and biological and psychosocial factors influencing weight maintenance/ regain following LSG. The objective of the present cohort study is to better understand body triggers to optimise weight loss and health outcomes. This study involves comprehensive testing, metabolic characterisation (via biochemical analysis of blood and tissue), assessment of disease remission (diabetes, hypertension, hyperlipidemia, heart disease risk), general health and well-being and psycho-social factors influencing outcomes in patients undergoing LSG by same surgical team at Gold Coast Private Hospital.

  • The LiTE Study - A study of Light therapy for nipple Trauma in Exclusively breastfeeding women

    The purpose of this study is determine which wavelength (red or infrared) LLLT is more effective for the management of nipple trauma. We also aim to determine stakeholder’s acceptability of the use of LLLT as an adjunctive treatment modality for nipple trauma. Current guidelines recommend infants to be exclusively breastfed in the first 6 months of life to optimise their growth and development and minimise their risk of illnesses. Although most women are physiologically capable of breastfeeding, only 37% of infants worldwide are exclusively breastfeed for the first 6 months of life with nipple trauma being the second leading cause of early breastfeeding cessation. Current research supports that warm water compresses, menthol and breastfeeding correction are effective treatments modalities for nipple pain. However, future studies regarding other interventions, including LLLT, are currently limited and require more robust studies to draw firm conclusions. LLLT has been used to accelerate wound healing since its introduction in the 1960s. Although the exact mechanism of LLLT is not entirely understood, it is a phototherapy which has been shown to reduce pain and swelling and promote wound healing through cellular mechanisms. Typically, shorter wavelengths have more superficial penetration, where as longer wavelengths having more deeper penetration. Both red LLLT (660nm) and infrared LLLT (9040nm) have been studied, demonstrating promising effects on reducing nipple pain. However, no study has compared which wavelength is most effective in treating nipple trauma. The current Mater Mothers work guideline is centred around midwife’s and/or lactation consultants correcting latching and breastfeeding positioning. LLLT would be an adjunctive to current standard care provided at the Mater. The results of this study will be utilised to guide the Mater Mothers work place guidelines for nipple trauma and nationwide.

  • The role of a low emulsifier diet in treating Crohn’s disease - Study 1

    The only dietary therapy to treat Crohn's disease (CD) is exclusive enteral nutrition (EEN), which has shown to heal the gut in a proportion of patients. EEN is a treatment that involves removing all food and replacing it with a nutritionally-complete liquid formula, usually for a six-week period. This observation shows that there is something in diet that is involved in driving or alleviating inflammation in CD. The exact way in which EEN works is unknown, so we cannot design a diet that may be used in place of EEN. One hypothesis that fits the observation of EEN treating CD is that certain dietary emulsifiers, often not found in enteral formulas, contribute to gut inflammation. Emulsifiers are commonly found in natural and manufactured foods and help to keep food stable by preventing the separation of water and oil. Animal and laboratory-based studies have shown that certain emulsifiers cause a leaky gut (i.e., they break down the intestinal barrier) and cause inflammation. This has never been investigated in humans. This proposal aims to address the main research question: Are dietary emulsifiers associated with breakdown of the intestinal barrier and inflammation? Research is underway to design low and high emulsifier diets for application in trials, including compilation of a database of manufactured foods. Based on the designed diets, we plan to conduct the first human dietary trial to examine the effects of a low emulsifier diet compared with a high emulsifier diet on highly sensitive markers of intestinal barrier function and inflammation in healthy subjects. All food will be provided to subjects in a cross-over design (i.e., subjects have both diets). At the end of each diet period, subjects will give blood, urine and faecal samples, which will be analysed for subtle markers of barrier function and inflammation that have already been established to represent a leaky gut in healthy people. This includes analysis bacterial translocation (passage of bacteria from gut to other parts of the body). Based on the outcomes of this trial, to determine duration and level of emulsifiers, a second trial providing low emulsifier or a safe comparator diet in patients with CD will be conducted.

  • Work and spinal cord injury: developing a vocational service for job-seekers living in the community

    The current project builds on preliminary work conducted by our multidisciplinary team in conjunction with our community partner, the Paraplegic and Quadriplegic Association of South Australia (PQSA). This pilot work involved developing a written information resource, titled 'Work and SCI', for job-seekers with a traumatic spinal cord injury or spinal disorder (SCI/D). Co-created by a multi-disciplinary team including psychology, social work, occupational therapy, nursing and medicine, this purposely designed 6 module resource covers essential job-search and career planning skills (e.g. job interviewing, job maintenance, career development). Our preliminary findings indicated that 'Work and SCI' has significant potential benefits as an educational resource, but that more needs to be done in order to translate these benefits into behavioural changes (i.e. successful employment outcomes). One critical way to improve engagement is to supplement this self-directed learning with personalised vocational guidance and job coaching. In response to this need, PQSA, the peak community body for South Australians living with SCI/D, has developed an outreach allied health service. They are extending this service to include vocational counselling targeted to the needs of their members. PQSA has approached the School of Psychology at the University of Adelaide to assist with the setup and preliminary evaluation of this service.

  • Measuring coverage of low and high sun protection factor (SPF) cosmetics

    This study is aiming to assess the difference in coverage between moisturisers with SPF 15+ or SPF 50+ content. Who is it for? You may be eligible for this study if you are aged 18 years of age or older, and work mostly indoors. Participants are excluded if they are allergic to sunscreen. Study details Participants will be randomised to apply SPF 15+ moisturiser to either the left or right side of their face. Participants apply SPF 50+ to the other side of the face. Participants' face will be imaged with a UV camera. Participants will be asked about their satisfaction with products in an in-person interview. It is hoped this research will help to asses the difference in coverage between lotions with high and low SPF content.

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