ANZCTR search results

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

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32712 results sorted by trial registration date.
  • A blinded randomized controlled trial on the efficacy of post surgical debridement of sinus cavities on wound healing following endoscopic sinus surgery.

    Chronic sinusitis affects up to 20% of the population with a significant impact on quality of life for the sufferer. Endoscopic sinus surgery is currently the treatment of choice for chronic rhinosinusitis which fails to respond to medical therapy. This usually involves a combination of oral antibiotics, oral and topical steroids, and saline irrigation of the nose. The main complaint which patients have from this type of surgery is the discomfort and pain associated with debridement of the sino-nasal cavity following surgery. The main cause of failure of this surgery which may require revision surgery is poor wound healing with the formation of excess scar tissue in the form of bands between sides of the nose, called adhesions. Regular wound debridement to achieve the best outcomes following ESS has been strongly advocated, but the basis is largely empirical. Experts in the field have called for regular cavity debridement. There is no standardized regime for post operative care amongst ESS surgeons. In some cases debridement as frequently as daily during the early healing phase has been used. Weekly debridement for the first few weeks until healing occurs is still commonly employed. Sinus cavity debridement is uncomfortable and unpleasant for patients. It requires regular visits to the treating surgeon, with considerable cost implications on the patient and the health service. The literature as it stands is conflicting. There is only 1 pilot study investigating 17 pts in a non-blinded fashion. This pilot study demonstrated no significant difference in adhesions, however this was non-blinded and involved only 17 patients. There are studies that point to early debridement as key to limiting adhesion formation, whereas other studies show that minimal post-operative care is equally successful. The aim of this study is to ascertain whether early debridement, with its related costs and patient discomfort, limits adhesion formation as evaluated by a blinded observer, via video-endoscopy at 3 months post surgery.

  • Brief Cognitive-Behavioural Therapy (CBT) for Young People with Cannabis Problems

    The study aimed to evaluate a brief intervention for a young population of cannabis users with comorbid mental health disorders. It was intended that this would serve as an adjunct to treatment-as-usual for the mental health disorder, with the goal to reduce cannabis use behaviour and to reduce disability associated with cannabis use. The intervention involved a motivational interviewing (MI) enhanced CBT treatment. The brief MI-enhanced CBT intervention was evaluated by comparison to a delayed treatment control (DTC) condition. The DTC group was offered the treatment after the completion of the 3 month follow-up assessment. Approximately one week after baseline assessment, the treatment group commenced their first of three weekly sessions, which lasted approximately one hour. Session one involved a discussion of a personalised feedback report which was based on the data gathered from assessment. This feedback was delivered in a motivational interviewing style which aimed to explore ambivalence and promote problem recognition and enhanced motivation to change. Clinical sessions two and three focused predominantly on CBT skill building. Session two focused on understanding the concept of how situations, thoughts, feelings, physical sensations, emotions and behaviours interact and goal setting. Motivational interviewing was used, when applicable. Session three primarily aimed to review prior skills learnt, examine homework outcomes, maintain/build motivation to change cannabis use behaviours, and train in additional coping skills (e.g. managing cravings, dealing with rationalizations, and relapse prevention). Follow-up assessments were conducted at 1- and 3-months post-baseline. These follow-up interviews were conducted by an independent research officer. The DTC group was offered the treatment after they completed the 3-month follow-up.

  • The Effect of Oral Glucosamine Supplementation on Young Adults Experiencing Mild, Undiagnosed Knee Pain.

    Glucosamine sulphate is a supplement that is marketed as a joint builder. Potential benefits include: restoration in joint function, an increase in joint flexibility, and alleviation of joint pain. Previous investigations into glucosamine sulphate have found it to have a positive effect on cartilage regeneration within the knee joint, along with a lower incidence of adverse reactions when compared to other over the counter medications used to treat knee pain, such as non steroidal anti-inflammatory drugs. This study will aim to determine whether oral supplementation with a product containing GS is effective in reducing pain and improving physical function of the knee joint in young people suffering from “regular (once a week), mild, undiagnosed knee pain”. Male and female participants aged between 18-35 years of age will be recruited and randomly allocated into one of two groups: 1. Glucosamine sulphate containing product 2. Placebo (Maltodextrin, which is has no published effects on joint function) The trial will last for 8 weeks, and a number of measures will be employed during this time to assess the effects of the glucosamine sulphate supplementation e.g. a daily log of medication usage and physical activity.

  • Rehabilitation after elective total hip replacement.

    Rehabilitation after total hip replacement is important for recovery; at the Canberra hospital physiotherapy provides this rehabilitation. As physiotherapists we don’t know yet how long, what kind or when rehabilitation is most effective. Our own survey showed that only 50% of Australian hospitals offer rehabilitation for hip replacements at all. The project aims to see how effective rehabilitation is by measuring patient outcomes after their total hip replacement surgery. This is a randomised controlled trial with division into two groups after total hip replacement. Group one will receive rehabilitation in the form of the current supervised exercise class and group two will receive a home exercise program to be performed independently. We hypothesise that rehabilitation provided via a home based exercise program without formal supervision after hospital discharge, relying on patient compliance, will produce similar outcomes to those produced by the current method of rehabilitation for total hip replacement patients after hospital discharge, which is that of a centre based program with formal supervision.

  • Sedation Practice in Intensive Care in Australia and New Zealand- A Pilot Study

    The purpose of the SPICE Pilot RCT is to obtain preliminary data on the feasibility of conducting a large phase III RCT. The hypothesis of the proposed RCT is that a sedation regimen based on dexmedetomidine as the primary sedative agent, and in which benzodiazepine use is minimised, will lead to improved patient centred outcomes.

  • Microarray analysis following Anti-Inflammatory Interventions in Chronic Obstructive Pulmonary Disease (COPD)

    This study will use microarray analysis to investigate the effects of statins, antioxidant nutrients and omega-3 fatty acids (fish oil) in COPD. COPD is a condition that involves inflammation of the airways that can cause scarring and airflow limitation of the lung, with the primary cause being cigarette smoking. Statins are drugs which are usually used to lower cholesterol levels but are also known to have anti-inflammatory and possible antioxidant effects. Omega-3 fatty acids and antioxidants have also been found to be useful in reducing inflammation. Hypothesis: Statins, antioxidants and fish oil supplements may have different and potentially complementary effects, on genes involved in inflammatory pathways. The combined use of these interventions may provide a superior approach to reducing inflammation and slowing deterioration of lung function in ex-smokers with obstructive airway disease.

  • Tobacco, EXercise and dieT MEssages (TEXT ME): The effect of semi-personalised lifestyle reminder text message intervention on cardiovascular disease risk.

    To establish the feasibility, patient acceptability, effect on risk factors and thereby overall potential of repeated semi-personalized lifestyle reminders sent via mobile phone text messages in a population at high risk of cardiovascular events. The main hypothesis that will be tested is that a program of brief and repeated lifestyle messages will improve cardiovascular risk factor levels compared to usual care.

  • Quality of life, days in hospital, lung function and fitness before and after attending the outpatient cystic fibrosis (CF) physiotherapy service

    To determine the effect of participation in the new Ambulatory CF Physiotherapy Clinic on patients' quality of life, lung function, fitness and number of days in hospital.

  • Safety and Efficacy Study of CYT387 in Primary Myelofibrosis (PMF) or Post-polycythemia Vera (PV) or Post-essential Thrombocythemia (ET)

    This is an open-label, non-randomized, dose-escalation study, to be conducted in two phases: a single-centre dose-escalation phase with supernumerary patient addition (Part 1), to determine the safety and tolerability of CYT387, and to identify a therapeutic dose for the confirmation portion of the study; and a multiple-centre dose-confirmation phase (Part 2), which will be a cohort expansion at or below the maximum tolerated dose (MTD) of CYT387.

  • Group Schema Therapy for Borderline Personality Disorder.

    In the last five years, a treatment specifically developed for borderline personality disorder namely Schema Therapy has been found to be more effective than existing usual treatments and a specialized form of psychodynamic therapy. When compared to other specialized treatments, Schema Therapy has very low drop-out rate and is very effective, not only in reducing symptoms, but in improving quality of life. Schema Therapy can lead to full recovery from BPD and normal functioning. However, this schema therapy is yet to be tested outside of the centres that developed the programme. A large scale international study to investigate the efficacy of the treatment programme across six countries in several different languages is planned for 2011. The research will compare two different delivery modes of Schema Therapy with existing treatments to see if there is some benefit of this new therapy. The study will enable us to determine not only if the therapy is beneficial in other parts of the world, but by including an Australian site, we can make specific recommendations in an Australian context.

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