ANZCTR search results

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

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31301 results sorted by trial registration date.
  • Testosterone treatment in men with liver disease

    Many cirrhotic men have reduced testosterone (T) levels. We recently found that testosterone deficiency is an independent predictor of death in this population. One possible explanation for this is that testosterone deficiency contributes to sarcopenia, a known risk factor for the development of both serious infections and mortality in cirrhotics. In a recent 12 month randomised study we showed that testosterone treatment has multiple short term beneficial effects in testosterone deficient cirrhotic men. These included improvement of sarcopenia, increased bone mass and increased haematocrit. However, this study was not powered to assess the effects of testosterone treatment on the major clinical endpoints linked to sarcopenia in cirrhosis of infection and death. We therefore propose to conduct a multi-centre randomised placebo-controlled trial (RCT) of 24 months T treatment in 250 cirrhotic men with a low T level (serum total T < 12nmol/L or free T < 230pmol/L) to investigate whether T treatment will reduce the composite outcome of mortality or hospitalisation for infection. Primary hypothesis: In cirrhotic men with low testosterone, T therapy will reduce the composite outcome of mortality or hospitalisation for infection, a major trigger for decompensation in chronic liver disease Secondary hypotheses: T treatment will improve the following measures: total numbers of days in hospital, muscle mass, muscle function, bone mass, fat mass, insulin resistance, haemoglobin and quality of life Aim: To conduct a 2-year, multi-centre, randomised, double-blinded, placebo-controlled trial to determine if T treatment together with dietary and exercise advice improves outcomes in men with cirrhosis.

  • Pilot study evaluating the efficacy of a very low energy diet (VLED) for treating obesity in obese older rehabilitation inpatients

    Obesity is common in older persons and predisposes to physical disability and loss of independence. After a hospitalisation for an illness or surgery, older people may have to go to a rehabilitation ward to get back to their previous abilities in their home and environment (ie their physical function), to be able to do everything they could do previously. Older people who carry a lot of extra weight may be at increased risk than others in the same age group of not being able to get back to their previous abilities after going to hospital, or it may take longer for them to get back to their previous state. Recent research has found that rapid, significant weight loss achieved with Very Low Energy Diets (VLEDs) were safe and effective in improving physical function. This treatment may be useful for improving the function of older, obese people who are on the rehabilitation ward, but we have not tested weight loss with a VLED in this situation. We would like to see whether it is possible to get people to start a weight loss program while a rehabilitation inpatient, and continue it for 12 weeks, even if they go home during that period. We would like to see which approach leads to better and/or faster improvements in physical function; usual rehabilitation care plus general healthy eating advice (ie the care people receive now) or usual rehabilitation care plus weight loss with a VLED. We will offer certain patients aged between 50 and 80 years of age who have a BMI between 40 and 60 the opportunity to join this study, the doctor on the ward will assess whether the study is suitable for the particular patient. Patients who meet the criteria (the “inclusion criteria”) and agree to be in the study will be randomly allocated to either the VLED group or the healthy eating group in addition to usual rehabilitation care – for every 2 patients allocated to the VLED group, one will be allocated to the healthy eating group.

  • The effect of Hybrid Closed Loop insulin delivery on glucose control in patients with type 1 diabetes aged 12 - 25 years.

    BACKGROUND: Hybrid closed-loop (HCL) insulin delivery, with automatic glucose sensing and insulin delivery reducing patient intervention, offers the potential to improve glycaemic control compared to conventional therapy in patients with type 1 diabetes. Superior glucose control has been demonstrated with lower rates of hypoglycaemia in many in-clinic studies, diabetes camp studies, hotel studies, and now in the first emerging short term outpatient studies using HCL systems. The primary rationale is to assess glycaemic control with the use of the HCL system versus standard therapy (either injections or standard pump therapy), including time in target range, as well as glycaemic excursions either hypoglycaemia or hyperglycaemia. We will explore the impact of this system on fear of hypoglycaemia and quality of life and other psychological measures. We seek to quantify the economic impact of HCL compared to standard therapy for translational purposes. AIM: To compare the proportion of time spent in target glycaemic range (sensor glucose level 3.9 - 10 mmol/l) while using HCL or using standard therapy (MDI and CSII). METHOD: Multi-centre randomized controlled trial in 160 patients aged 12 – 25 years with type 1 diabetes, comparing HCL with standard therapy (MDI or CSII) for 6 months. OUTCOMES: The primary outcome is the difference in the proportion of time the sensor glucose level is in target range (3.9–10 mmol/L) during HCL insulin delivery vs standard therapy (MDI and CSII), measured 23-26 weeks post-randomisation.

  • Jumper's knee: does exercise decrease pain and increase participation in basketball?

    The impact of patellar tendinopathy is underestimated as many athletes continue to participate with pain that affects performance in games and capacity to train. This study aims to determine if we can change the natural history of pain and impaired performance with exercise;

  • Does early post-operative physical activity predict recovery of function six months after lumbar spinal surgery?

    It is currently not known whether the amount of walking patients do following lumbar spinal surgery is associated with post-operative outcome, therefore there is considerable variation in the advice provided to patients regarding walking and physical activity in the period immediately following surgery. This research aims to establish whether the amount of physical activity patients do in the week following lumbar spinal surgery predicts recovery of function at six months. All patients admitted to St Vincent’s Private Hospital Fitzroy (SVPHF) for lumbar spinal surgery aged 18 years and over will be invited to take part in this study. Recruitment will take place over a six-month period, with an estimated 250-300 participants. Participation will involve completing a series of short questionnaires pre-operatively and at six months post-operatively. To measure physical activity in the week following surgery each participant will be required to wear a small device, called an accelerometer, fixed to the thigh with a waterproof dressing. During this first post-operative week participants will also be asked about pain, whether they require assistance while walking, and post-operative complications. Where patients are discharged prior to the seven-day monitoring period finishing they will be provided with daily questionnaires to complete and a reply paid envelope to return the accelerometer to the research team. There will be no changes to standard post-operative care currently provided by any of the staff at SVPHF, including advice regarding walking and physical activity immediately following surgery. The findings from this research will enable all health professionals involved in the post-operative rehabilitation process to provide consistent advice about activity levels following surgery, including information provided in educational resources. It will also build the foundation for further research into interventions designed to optimise post-operative activity.

  • Efficacy of oral, capsulised, frozen faecal matter transplant for the treatment of clostridium difficile diarrhoea.

    The majority of reported FMT procedures have been performed with fresh stool suspensions from related donors. This approach has practical barriers that hinder the development of scientifically sound treatment protocols. The use of fresh donations requires prior identification and screening of a suitable donor, thus precluding the use of FMT in acute situations. Furthermore, the limited viability of fresh samples, usually estimated at up to 6 hours, makes thorough screening of donors and donation aliquots impractical. To address these issues Yongster and colleagues have studied the use of a pre-prepared, frozen inoculum from unrelated donors delivered by both endoscopic and capsulized routes, however both of these studies have been pilot studies. The capsulized form of FMT when compared to FMT delivered by endoscopic means this method may have positive effects on: The timing of the procedure due to reduced logistical issues, the safety of the procedure (reduced risk of endoscopic/anaesthesia complications) and a reduction of overall cost to the health budget Strengthening the evidence base and clinical experience behind frozen, oral FMT will be of benefit to patients, staff and health services. Patients will be offered oral FMT using pre-made frozen capsules with the FM souced from unrelated donors

  • Electrical stimulation cycling exercise in persons with cerebral palsy

    Aim: The primary aim of this project is to evaluate the feasibility of functional electrical stimulation cycling exercise for persons moderately affected cerebral palsy. Electrical stimulation uses brief electrical pulses applied via gel-electrodes to the muscles to produce muscle contractions in weak or paralyzed muscles. Functional Electrical Stimulation cycling devices rhythmically apply electrical stimulation to the leg muscles to induce muscle contractions that can cause paralyzed legs to pedal a stationary exercycle and exercise the legs. Electrical stimulation exercises has many disadvantages, including the cost of equipment, the time invested in setting up the equipment each session and the low intensity of exercise it provides. However, persons with CP who have more severe mobility limitations often have less options for exercise, and even though it has many drawbacks electrical stimulation may be a good exercise mode for this population. Intervention: In this project twelve adolescents with moderate CP (i.e. gross motor function classification scale III) will perform 8 weeks of functional electrical cycling training at the Faculty of Health Sciences, University of Sydney. The method of functional electrical stimulation cycling which will be employed is one which we have shown to produce better enhancements in muscle mass than prior methods of electrical stimulation cycling. Participants will perform cycling two times per week and each session will involve 45min of exercise. Eight muscle groups will be electrically stimulated via self-adhesive gel electrodes. The quadriceps, gluteal muscles, hamstrings, and calf muscles of each leg will be electrically stimulated. We will measure the outcome variables before and after the 8 week intervention. Hypothesis: The primary hypothesis tested is that our method of electrical stimulation cycling is a feasible form of exercise for persons with moderate CP. We believe that appropriately designed ES-cycling exercise can enhance the exercise options that persons with moderate cerebral palsy can currently perform. We will measure feasibility through adherence to the program and test outcome measures related to health and function. Secondary hypotheses include that regular exercise with an appropriate ES cycling system results in leg muscle hypertrophy (assessed via ultrasound and leg circumference measures) in people with moderate CP and consequently produces improvements in lower limb function, and quality of life. Evaluation of our secondary hypotheses also include measures of perceived quality of life, cycling ability, leg extension strength, leg flexion strength, gait and leg function, and spasticity/tonus.

  • Does Physitrack 'Registered Trademark' improve participation in exercise programmes in children with cerebral palsy?

    Children with cerebral palsy (CP) and other physical disabilities are often prescribed individualised home exercise programmes by their therapists. These exercises may target flexibility, strength, endurance, gross motor development, balance, and sports skills. Home exercise programmes are used to complement the face-to-face physiotherapy sessions and help children to complete the number of exercise sessions, per week, required to achieve their goals. Physitrack 'Registered Trademark' is an online, app-based package for therapists to provide exercise programmes. It is designed to help people complete exercise programs with videos of exercises, audio and written instructions, a calendar, and capacity to communicate online with your therapist. We want to see if using Physitrack assists children with Cerebral Palsy to perform their exercises correctly, adhere to their exercise programme, and achieve their personal goals.

  • The Efficacy of Caralluma for Anxiety in Adults

    The aim of this study is to conduct a preliminary investigation of Caralluma supplement to examine its efficacy for reducing anxiety and stress in healthy adults over eight weeks. The study will assess 1 g/day compared to placebo. Satiety will also be measured to investigate any correlation between treatment effect for anxiety / stress and self-reported reduction in appetite. It is hypothesised that a reduction in anxiety and stress (i.e., a decrease in negative anxiety scores ) over eight weeks would be significantly greater in the active treatment group than in the placebo group. Regarding Caralluma’s effect on satiety, it is hypothesised that a decrease in the VAS score would be significantly greater in the active treatment group than in the placebo group. It is also hypothesised that a decrease in the VAS score for appetite would be positively correlated with a decrease in the anxiety and stress scales.

  • Oral appliance with built in airway for the treatment of obstructive sleep apnoea.

    Like other oral appliances to treat snoring and sleep apnoea, the O2Vent brings the jaw forward to reduce airway collapse. However, it also has a built in airway to allow breathing through the device. This may make it suitable for use by patients who find it difficult to breathe exclusively through the nose. A recent pilot study showed that original design, the Oventus Clearway, was safe, effective and well tolerated with a 62% reduction in the number of times patients stopped or reduced their breathing during sleep. No difference in response rate was observed in patients with or without subjective symptoms of nasal congestion. The new generation Oventus device, the O2Vent, has the built in airway of the original design, however it is 2 parts, an upper and lower part. This makes it much easier to adjust and find the optimal jaw position.. The aims of the present study are to: 1. To demonstrate safety and efficacy of O2Vent oral appliance 2. To demonstrate that the incorporation of an enclosed airway into the O2Vent improves comfort and compliance 3. To confirm the equivalent response rate in subjects with nasal congestion using rhinomanometry as an objective measure of nasal congestion The above aims will be addressed using a randomized crossover study design with patients in one arm using the O2Vent with the built in airway open and in the other arm using the device with the built in airway closed.

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