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.
  • Early phase II study of Azacitidine and Carboplatin priming for Avelumab in patients with advanced melanoma who are resistant to immunotherapy.

    This is a study of two medications that may increase the sensitivity of metastatic melanomas to a currently used immunotherapy. Who is it for? You may be eligible for this study if you are 18 years or older and have an unresectable or metastatic melanoma which has primary resistance to previous immunotherapy (anti-PD1 therapy). Study details All participants in the study will receive a course of the two study drugs (azacitidine and carboplatin) for 8 weeks, before a ongoing course of immunotherapy (avelumub). Over the course of the study, blood samples and tumour biopsies will be taken to assess the treatment’s effect on the melanoma. It is hoped this study will provide evidence of these study substances increasing the sensitivity of melanomas to the anti-PDL1 antibody class of immunotherapy agents.

  • The role of choice in weight loss.

    The aim of the research is to investigate if the option to choose a particular diet strategy as opposed to being prescribed a set strategy leads to greater weight loss. We hypothesise that freedom to choose the diet strategy will result in greater weight loss. This randomised parallel study and will include both men and women. Participants will be randomised to Choice or No Choice. The No Choice arm will be the 5 & 2 strategy (5 days of habitual eating with 2 very low energy intake days of 2000 - 3000kJ/day) compared with a Choice of 2 & 5 or continuous energy restriction (daily energy restriction between 4000-5000kJ/day). Participants will be asked to follow the diet for 8 weeks and attend the Sansom CTF at the start for randomisation and dietary instruction and every two weeks for 8 weeks. They will have height measured once and weight measured on each occasion. The first visit will take approximately 30 minutes and subsequent visits will take 15 minutes.

  • The effect of atropine sulfate 1% administered under the tongue on excessive saliva secretion and drooling caused by clozapine in patients with schizophrenia.

    Clozapine is one of the most effective medications used for the treatment of schizophrenia. Up to 80% of patients treated with clozapine may complain of an increased secretion of saliva in the mouth (known as hypersalivation) as a result of being treated with clozapine. Hypersalivation may result in an overspill of saliva outside the mouth (known as drooling). Excessive production of saliva may disrupt sleep and speech, and cause aspiration pneumonia. Drooling is not pleasant and may damage the skin around your mouth. Atropine sulfate is one of the medications used most often in inpatient units in New South Wales-Australia to treat hypersalivation or drooling that is caused by clozapine. However, studies testing the effect of atropine are lacking. The aim from this study is to test the effect of atropine sulfate when administered under the tongue for the treatment of hypersalivation and/or drooling that is caused by clozapine. One sub-study to this study involves testing the chemical content of saliva by researchers in the ANZAC Research Institute at Concord Hospital. This research is designed by the mental health pharmacist Omar Mubaslat and overseen and supervised by consultant psychiatrist Professor Tim Lambert.

  • Continuous Glucose Monitoring (CGM) for women with Gestational Diabetes Mellitus (GDM) study: pilot

    Updated criteria for the diagnosis of gestational diabetes (GDM) mean that larger numbers (approximately 18%) of women screened meet diagnostic criteria placing an increasing burden upon limited healthcare professional (HCP) resources. We hypothesise that while the 75g OGTT provides the standard for the diagnosis of GDM, continuous glucose monitoring (CGM) technology could provide a useful adjunct increasing efficiencies in patient care by more effectively triaging patients according to CGM profiles to identify those most likely to require intervention and expediting therapeutic decision-making by the health professional with the provision of more detailed data. All women with GDM diagnosed on OGTT between 24 to 28 weeks gestation will be offered retrospective CGM for a week, in addition to routine fingerprick glucose monitoring. They will also keep a record of HCP visits and time spent for the duration of the pregnancy. GDM management and maternal-fetal outcome data will be collected from medical records. Both OGTT (glucose levels) and CGM profiles (glucose levels and glycaemic variability) will be compared with subsequent therapeutic interventions, healthcare resource utilization and clinical outcomes to determine whether a set of criteria based on the glucose data obtained prior to 31 weeks can be employed to triage patients to either routine or more intensive follow up.

  • Nutritional supplements for prevention of type 2 diabetes - postprandial study

    Postprandial (post-meal consumption) blood sugar level has been implicated in the development of obesity, type 2 diabetes and cardiovascular disease. It has been indicated that a rapid rate of rise followed by slower decline in the blood glucose levels post meal consumption are linked with fat deposition and adversely affect metabolic health. Curcumin, a bio-active ingredient obtained from the spice turmeric, is a potent anti-inflammatory agent, which is being now evaluated for its effects for controlling post meal blood sugar levels. Long chain omega 3 fatty acids (eicosapentanoic acid and docosahexaenoic acid) are established triglyceride lowering agents which are primarily obtained from fish or fish oil. The current purpose of this study is to evaluate the efficacy of a single dose of dietary supplements (curcumin and/or fish oil) on the post meal blood glucose rise in healthy individuals.

  • Does exercise provided in group setting on top of usual physiotherapy be feasible and improve balance and functional outcome in Geriatric Evaluation and Management unit patients?

    Hospitalization of older adults appears to result in functional decline mostly likely due to reduced activity level. Bed rest and low level of mobility were common occurrences during hospitalization of older adults. On average, these hospitalized older adults only spend 43 min a day standing or walking and 80% of their hospital stay is spent in bed. While it is acknowledged that bed rest and inactivity are detrimental for mobility and function, it is often observed that patients in the Geriatric Evaluation and Management (GEM) Unit are inactive during day hours. Physiotherapists play a crucial role in maximising patient mobility and independence through the prescription and delivery of exercise programmes. The type and intensity of exercise are important factors in determining patient outcome. Systematic reviews have found that weight bearing and targeted task specific exercises can improve balance and decrease falls in older people. Usual care physiotherapy provided in GEM unit consists of one-to-one individualised session. Exercises provided in groups via circuit training have shown benefits in improving balance in frail older people in the inpatient setting. Very little is known about the delivery of circuit class (therapy provided to more than 2 participants, involving a tailored intervention program with a focus on practice of functional task received in group setting in older people admitted to GEM unit who have multiple co-morbidities and reduced physical capacity. This study sought to determine if additional exercise provided via circuit training improves balance and functional outcome more than usual physiotherapy alone in adults undergoing rehabilitation in GEM unit.

  • An evaluation of self-efficacy of patients with chronic pain attending a community based exercise program.

    This study aims to evaluate the pain self-efficacy, or confidence, of participants undertaking a ten week group exercise program for people with chronic pain. Specifically this study aims to answer the following questions: 1. Does the pain self-efficacy of participants attending the Physiocise Foundations program change between the initial assessment, the end of the ten week program and the 3 month follow-up? 2. Does participants level of confidence to perform set tasks at home change between weeks 1, 5 and 10 of the program? 3. Are there any associations between participants’ outcome scores for Goal Attainment Scale, and their pain self-efficacy, level of disability and fear avoidance scores?

  • Pelvic floor muscle training in radical prostatectomy

    This pilot study will assess the feasibility and effect of pelvic floor muscle training (PFMT) on post-operative UI in men undergoing RP at Western Health. WHO IS IT FOR? Men with a planned surgery date for radical prostatectomy who have been admitted to the Western Continence Service (WCS) at Western Health. Men who are English speaking background and have not experienced any bladder leakage in the 12 months prior to their operation can participate. 30 men will be recruited to this study. STUDY DETAILS Men will attend to participate in the study prior to having their surgery. This randomized controlled trial (RCT) allocates men to one of two groups: The functional training group where they are asked to do a series of functional exercises such as steps ups and lunges with a pelvic floor muscle pre-contraction; or the standard care group where they perform static pelvic floor contractions as part of their program. Men will complete questionnaires and pad weights at 4, 12 and 26 weeks after their surgery to help collect data. This study will assess the feasibility of this study and the potential for development of a larger scale study. It will also assess the effect that the above exercises have on post-operative UI.

  • Impact of Alveolar Ridge Preservation on Implant Supported Restorations

    The aim of this RCT is to determine if there are any benefits of placing dental implants into sites that have previously received alveolar ridge preservation (ARP) when compared to conventional implant placement protocol. This study will be carried out on patients recruited from a specialist clinical practice who are referred for single implant replacement in the aesthetic zone (teeth 13-to-23) and who meet the inclusion criteria.

  • A clinical trial where 120 participants will wear one of three contact lenses (SEED Pure, CooperVision Proclear or Johnson & Johnson Vita), for three months with monthly replacement to determine clinical performance.

    The purpose of this study is to compare the clinical performance (defined by visual acuity measurements, subjective response, lens surface characteristics and ocular physiological characteristics) of a commercially-available (Europe and Japan) contact lens (SEED Pure) against commercially-available (Australia) contact lenses (Proclear and Vita). To achieve this, participants will wear one of these for 3 months on a daily-wear basis with monthly replacement. All participants will use Alcon Puremoist multipurpose disinfection solution. Our hypotheses are there will be no difference between lens types for visual acuity, subjective response, lens surface characteristics and ocular physiological characteristics.

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