ANZCTR search results

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

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32850 results sorted by trial registration date.
  • Testing a Peer Support Program for Intensive Care Unit Survivors to improve Psychological Recovery - Pilot Randomized Controlled Trial

    International and local research indicates that ICU survivors (patients and families) experience adverse outcomes. In Australia, ICU survivors return home with little or no follow-up. Peer support holds potential to improve post-ICU outcomes although this warrants explorations. Typically new models of care are designed only from the perspective of the health professionals without any patient or family input. We have recently conducted Phase 1 of the icuRESOLVE Project, where we engaged both ICU survivors and staff using a new and innovative method called experience-based co-design (EBCD). Through EBCD a Peer Support model for ICU survivors was developed. This study (phase 2 of the icuRESOLVE Project) aims to test the developed Peer Support Model to see if it is feasible to deliver (attendance rates, participant satisfaction, participant recruitment) as well as the impact of attending peer support on psychological and social outcomes. This is a small pilot study and the results of this study will inform a larger, multi-site randomized study. The time commitment required by participants in the intervention group (peer support) is estimated at 13 hours over approximately 14 weeks. For participants in the control group (no peer support), time commitment is estimated at 1 hour (to complete health related questionnaires). Anticipated ethical issues for the intervention group relate to a small risk of psychological distress by participating in the group sessions as they will be discussing their ICU experiences and recovery. For participants in both groups their may be a small degree that some of the questionnaires may be stressful or upsetting. Survivors are able to access any help needed. We do not anticipate any risk to staff.

  • Comparing the long-term clinical outcome of two designs of high strength ceramic (zirconia) crowns on dental implants

    The purpose of the study is to compare the clinical outcome of two different design concepts of full contour monolithic zirconia (FCZ) implant supported restorations. Metal-ceramic restorations are traditional restorations and have been used for many years with success. However, metal-ceramic restorations have multiple steps in the fabrication process, which makes the fabrication process time intensive and technically demanding. With increasing demands for aesthetic and metal-free dentistry, the use of ceramic restorations is increasing. Zirconia is a relatively new material with high strength, good aesthetics and contains no metal. Although zirconia may be a reasonable replacement for traditional metal-ceramic restorations, long-term clinical data is still lacking.

  • The Diet and Breast Milk Composition Study

    Breast milk is made up of nutrients including fat and sugar. It also contains hormones that help control how hungry or full we feel and how our body uses energy. When a mother breastfeeds, these hormones are transferred from the breast milk to the baby and may play a role in how baby grows and develops. We now know that what a mother eats while breastfeeding can affect how much breast milk she produces, but we still know very little about how this affects breast milk composition, including the levels of these hormones. The purpose of this study is to look at how consuming a breakfast meal containing different levels of fat and sugar affects the amounts of nutrients and other factors, including hormones in breast milk over the following 12 hours. This research will help us to understand the effect of different dietary choices during breastfeeding on the composition of the breast milk and, in the future, may help inform dietary guidelines for breastfeeding women.

  • Cannabinoids and Acute Post-operative Pain in Participants having Stoma Reversal.

    This is a research study examining whether medicinal cannabis can safely be given to people who are having a surgical procedure involving the bowel. When a person undergoes major surgery on the abdomen, care after the surgery involves the administration of medications that help relieve pain associated with the surgical procedure. Some of these drugs are called “opioids”. Most patients in this study will probably have had these drugs for the previous surgery in the form of morphine or “morphine-like” drugs given via the intravenous drip or a tablet taken by mouth. The side effects of these drugs include: • Slowing of bowel function • Sleepiness • Slowed breathing • Nausea and vomiting • Decreased appetite This study is not designed to test if medical cannabis is an effective pain management option, but rather seeks to assess if the drug can be safely administered and can be tolerated by patients having surgery such as your procedure and measure blood levels of cannabis chemicals.

  • A study of the effectiveness of Experiential Awareness Therapy for the treatment of Eating Disorders

    This study is evaluating a group therapy, Experiential Awareness Therapy, for people experiencing disordered eating. Experiential Awareness Therapy is an evidenced based therapy aimed at enhancing psychological functioning for eating disorder recovery. Benefits of participating This therapy will aim to: • Increase participants ability to regulate their emotions • Increase participants sense of self-worth and support a realistic and functional understanding of others • Enhance participants ability to identify and understand their emotions and feelings and also identify others intentions, emotions and feelings. • To facilitate an understanding of how these areas of psychological functioning impact eating disordered symptomology. Enhancing these abilities has been shown to be supportive of recovery from disorder eating and also enhance quality of life.

  • Fit4Two: Feasibility, acceptability and efficacy of a tailored eHealth lifestyle behaviours intervention for pregnant women integrated into clinical practice – a randomised controlled trial

    Inactivity and poor nutrition during pregnancy are associated with adverse health and pregnancy related outcomes for the mother and her unborn child. This innovative randomised controlled trial aims to increase physical activity and improve nutritional behavours in pregnant women by integrating an already examined eHealth intervention (Fit4Two) into clinical practice. This intervention will provide participants with highly personalised and automated physical activity and nutritional feedback, endorsed by their practitioner. As such, participants will receive high quality care in a convenient, credible and time efficient manner, whilst placing very little additional burden on practitioners.

  • Use of a novel synthetic for treatment of deep foot wounds in diabetic patients

    Complex diabetic foot wounds such as those with exposed tendon, muscle, fascia, joint or bone, present a great therapeutic challenge to health care professionals. This research aims to assess the use of a biodegradable temporising matrix (BTM) in reconstruction of complex diabetic foot wounds. BTM is entirely synthetic matrix made of polyurethane and works as a scaffold that results in creation of new dermis-like layer. It has the potential to improve wound healing complex wounds as it has been demonstrated in previous human studies. Participants will be diabetic patients with deep complex foot. Intervention will consist of of application of BTM in theatre followed by split skin grafting at a later date if necessary. Wound healing will be assessed using a WoundVue camera, which is a hand held portable device that takes 2D and 3D images and provides wound measurements.

  • A 32-week randomized, placebo-controlled, double-blinded pilot study to compare the efficacy and safety of low-dose oral minoxidil in male and female patients with patterned hair loss (androgenetic alopecia) followed by a 24-week open label extension period

    Female Pattern Hair Loss (FPHL) and Male Pattern Hair Loss (MPHL) are produced by Androgenetic Alopecia (AGA). AGA, the most common cause of hair loss in the community, is produced by androgen-mediated hair follicle miniaturization in genetically susceptible individuals. AGA can be treated medically or surgically. The most common treatment is the over-the-counter, TGA-approved topical treatment using Minoxidil lotion (2% and 5%) and 5% foam. Oral minoxidil, originally introduced in the 1970s, is TGA- and FDA-approved in doses up to 100 mg daily for treatment of refractory hypertension, malignant hypertension and for the treatment of hypertension in pregnancy. One of the commonly observed side-effects of taking Minoxidil is hypertrichosis or the condition where excessive hair growth is observed. The purpose of the study is to compare the efficacy and safety of a daily oral dose of 0.45mg minoxidil in patients diagnosed with either FPHL or MPHL. The primary aims are 1) to compare the change in hair count from first dose to end of study and 2)assess the subjective impact of hair growth and quality by completion of patient reported outcomes (PROs). This will be a single-centre, randomized, double-blind pilot study comprising 7 visits over 32 weeks followed by a 24 week open label extension period.

  • A randomised controlled trial to determine if use of a Bronchiectasis Action Management Plans (BAMP) compared to usual care improves clinical outcomes in children with bronchiectasis.

    Although once regarded as an ‘orphan disease’, BE remains a contributor to chronic respiratory morbidity and mortality in both children and adults in both low and high-income countries, in particular Indigenous people of high-income countries. Postnatally, lung growth is maximised in the first 7-yrs of life. While low birth weight impacts on future lung health, there is increasing evidence that early life events such as acute lung respiratory infections (ALRI) can reduce future lung function trajectories, and increase BE risk. In early childhood, severe (hospitalised) and repeated ALRI are independent risk factors for future chronic lung diseases, such as BE and non-smoking related COPD which are prevalent amongst Indigenous populations. Interventions to reduce ALRI during infancy and early childhood are important and needed for future lung health i.e. preserve lung function and improve quality of life (QoL). Our double blind RCT is designed to answer our primary question: To determine if the routine use of a personalised written BAMP (compared to standard care) improves clinical outcomes [improves cough-specific QoL (8 items) (PC-QoL -8) and reduces non-scheduled doctor visits]. We aim to enrol 198 (children less than 19 years old) from Royal Darwin Hospital and Lady Cilento Hospital. Participants will be seen clinically at enrolment and followed up monthly with phone calls for 12 months. To date, there are no such published studies in children or adults using BAMP with BE. It is not surprising that BAMP is not routinely used even in tertiary centres. If effective, this RCT will lead to a change in routine clinical practice in children with BE. This will be of great importance, particularly to those living in remote Indigenous communities, where specialist respiratory services are limited. The results will provide evidence for/against the use of BAMP when managing Indigenous and non-Indigenous children with BE.

  • Efficacy of PIEZO ICSI to improve fertilisation rates of oocytes

    The purpose of this study is to investigate the efficacy of piezo ICSI as an alternative to the traditional ICSI technique for human oocyte insemination and to assess if fertilisation rates can be improved. We will be able to assess if this alternative technique which uses a Piezo machine will decrease oocyte degeneration rates as well as improving embryo quality and pregnancy rates. A previous study demonstrated that a significantly higher survival rate post injection was seen for oocytes being injected with piezo rather than conventional ICSI (90% vs 95%) and were higher still using the ultra fine piezo pipette (99%). Fertilisation rates were also higher with piezo ICSI and higher still with ultra fine micropipette ICSI (68% vs 89%) and increased quality of D3 embryos was seen in the piezo groups compared to conventional ICSI. It is hypothesised that the lack of cytoplasmic aspiration coupled with a smaller injection site results in less oocyte damage and is the reason behind the improved outcomes seen. Patients will be recruited from Repromed Dulwich ICSI patient group that have booked on for treatment. To determine the efficacy of this technology initially patients recruited will need to meet the following inclusion criteria to ensure adequate oocytes retrieved so fertilisation data and embryos quality can be assessed in a statistically meaningful manner: Couple for whom the treating clinician recommends ICSI as insemination method of choice and those that have 6 or more mature oocytes for injection post egg retrieval. The hypothesis for this trial is that the use of piezo ICSI technology will increase fertilisation rates and decrease oocyte degeneration rates compared to conventional ICSI. Patient’s outcomes will be compared to a matched cohort of patients that are not participating in the Piezo trial undertaking treatment at a similar time in a 1:2 fashion. The proposed research protocol is as follows: 1. Patients interested in partaking in the trial will be provided with information sheet and consent form and will be contacted by the research team and provided the information sheet and consent form via email and opportunity to ask questions. Patients will be approached by recruitment staff from the list of patients booked on for ICSI treatment. 2. Consent to partake will need to be obtained on or before the day of egg retrieval 3. Patients will be flagged on paperwork at egg retrieval that they are participating in the PIEZO trial so lab can activate plan 4. If patient has less than 6 mature oocytes for injection they will be unable to partake in the trial as this is insufficient number of oocytes to draw adequate conclusions and will instead be inseminated via conventional ICSI 5. If patient has greater than or equal to 6 mature oocytes from injection they will be fully enrolled in the trial and oocytes will be piezo injected 6. Normal laboratory practice occurs from this point onwards

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