ANZCTR search results

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

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32885 results sorted by trial registration date.
  • Control of breathing and measurement of disease severity in premature infants with chronic lung disease

    Apnoea of prematurity (AOP), where an infant stops breathing for more than 20seconds, is found in over half of babies born very prematurely. AOP may be accompanied by slowing of the heart rate as well as drop in the blood oxygen levels. Another form of breathing disorder called periodic breathing, is found primarily in premature infants where there is a repetitive pattern of breathing efforts alternating with pauses. Most preterm infants exhibit periodic breathing and it can continue until the infant reaches 4-6 months of age. Apart from breathing control disorderm preterm babies are also at risk of developing bronchopulmonary dysplasia (BPD) or chronic lung disease of prematurity, where there the injured premature lung develops in an abnormal way. There is still some debate about the best way of classifying this disease with the NICHD in the United States dividing this into three levels (mild, moderate and severe) based on the need for oxygen or respiratory support. Infants with BPD experience periods of low blood oxygen that may be severe, especially during sleep and these infants are thought to be at risk of sudden infant death syndrome (SIDS) or cot death. The major cause of oxygenation problems in BPD is due to the severity of the lung disease. The level of the lung disease will determine how much oxygen gets absorbed into the blood of the baby with every breath. A reliable way of determing the severity is by measuring how much the blood gets "oxygenated", i.e. the less severe the lung disease the better the oxygenation and vice versa. This measure is also called the right-to-left shunting and the ventilation: perfusion (V:Q )ratio. A nonivasive way of measuring the shunt will involve making stepwise reductions in oxygen that the baby breathes while ensuring that the oxygen level (that is constantly monitored) remains within intended range. The aim of this study is to investigate 1) firstly breathing patterns (or disorders) and develop tools for classifying breathing patterns and 2) secondly lung disease severity (right-left shunts) and develop quantitative measures of these in preterm infants with bronchopulmonary dysplasia or chronic lung disease.

  • A New Test for Detecting Endometrial Cancer

    The main aim of this study is to assess the ability of a new test to detect endometrial cancer in post-menopausal women. The diagnostic test being evaluated involves performing a wash of the uterus and collecting this wash fluid for analysis of markers that are shed from cancer cells. Two different laboratory testing methods will be used to obtain information that will enable us to develop a more cost-effective, sensitive and specific test for detecting early stages of endometrial cancer. Who is it for? This studyis open to peri- and post-menopausal women aged 45-80 years with endometrial cancer and who are currently undergoing a hystrectomy procedure. Trial details In this study you will undergo a uterine wash procedure while under general anesthetic prior to hysterectomy procedure. The wash sample is then tested for specific MMPs.

  • Can ginger ameliorate chemotherapy-induced nausea? A double blind, randomised placebo controlled feasibility study.

    This study aims to determine whether ginger can reduce chemotherapy-induced nausea and vomiting. Who is it for? You may be eligible to join this study if you are aged 18 years or more, and you are scheduled to undergo chemotherapy for the first time. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will take 4 ginger capsules per day, commencing 1 hour before chemotherapy and then every 3-5 hours for 4 days directly after. This will be repeated for 3 chemotherapy cycles. Participants in the other group will take an identical-looking sham tablet, i.e. one that has no active ingredients. Participants will not know whether they are taking the ginger or sham tablets until the end of the trial. All participants will be assessed over the 4 days post each chemotherapy session in order to determine: 1) the effect of ginger on chemotherapy-induced nausea; 2) the tolerability of ginger to chemotherapy patients when used alongside standard anti-nausea medication; and 3) the feasibility of introducing it in our clinical setting.

  • Neoadjuvant chemotherapy with nab-paclitaxel in women with HER2-negative high-risk breast cancer

    This study is comparing the treatment response to pre-operative chemotherapy with nab-paclitaxel versus paclitaxel in women with breast cancer. Who is it for? You may be eligible to join this study if you are aged over 18 years and have been diagnosed with HER-2 negative, invasive unilateral breast cancer with known hormone receptor status and tumour grade. Trial details Participants in this trial will be randomly (by chance) allocated to receive either 4 cycles of nab-paclitaxel (abraxane) or 4 cycles of paclitaxel, followed by 4 cycles of chemotherapy containing anthracyclines. Approximately 2-4 weeks following chemotherapy the patients will undergo breast surgery as part of local regional treatment. All patients will be followed for 10 years after the date of randomisation in order to evaluate treatment response and safety.

  • Phenylephrine Infusion in Caesarean section under spinal anaesthetic

    Comparing haemodynamic stability between commencing phenylephrine infusion five minutes prior to insertion of spinal anaesthetic compared with at time of insertion

  • Short-term effects of a high nitrate intake on blood pressure in treated hypertensive individuals

    There is now consistent and convincing evidence that dietary inorganic nitrate plays an important role in the physiological control of blood pressure. Clinical trials have established that an increase in nitrate intake, either from supplements or vegetables, results in a dose-related decrease in blood pressure in healthy normotensive individuals. This trial will address the question: "Can ingestion of a diet high in nitrate lower blood pressure in treated hypertensive individuals?"

  • The effectiveness of a home based 'Healthy Living' program in improving the dietary and exercise behaviours of people living with severe and enduring mental health conditions.

    The aim of the proposed study is to determine whether a home-based individually tailored education program has a positive effect on 1) dietary and exercise behaviours and 2) anthropometric measures (weight, Body Mass Index, body composition) of people with severe and enduring mental health issues who live in a CCU. If successful, the outcome of this project is the potential to improve the quality of life and long term physical health prognosis of not just the participants in this study and but also to improve usual care procedures for people with severe and enduring mental health conditions. It is hypothesised that the individuals with severe and enduring mental health issues that participate in a home-based exercise/nutrition education program will exhibit improved dietary and exercise behaviours at six months compared to their usual care.

  • Web-based Cognitive Behavioural Therapy for Women with Postnatal Depression

    Every year, Postnatal Depression (PND) affects at least 40,000 women in Australia. It has serious consequences for maternal mental health and infant development. Poor uptake of clinic-based treatments suggests a Web-based treatment can play a major role in tackling this public health problem, particularly as an increasing number of women will be identified as depressed through the National Perinatal Depression Initiative. Major barriers to treatment include stigma; poor access; treatment costs, and scheduling trips outside of the home with a new baby. We have developed an interactive, Web-based treatment targeted to women with PND and now aim to evaluate its efficacy comapred to Standard Care in a 2-group randomised controlled trial. The main aims are to: (a) pilot the efficacy of the program with respect to the primary outcomes of depressive episode remission, and amelioration of depression and anxiety symptoms; and (b) to pilot the efficacy of the MumMoodBooster program with respect to secondary outcomes including the putative CBT change mechanisms, perceived stress, and marital functioning. A total of 50 mothers will be recruited via our well-developed relationship with Maternal and Child Health Centres in Victoria. In addition, the study will be advertised widely, targeting rural women (i.e. Internet e.g. beyondblue, local newspapers, magazines), and appropriate health professionals/services (e.g., GPs, PaNDA, etc) will be contacted and encouraged to screen and/or refer women with suspected PND. Rural is defined as: women in regional, rural, and remote areas outside the CBD (more than 50kms). Women in these areas generally have poorer access to a variety of mental health services. Potential recruits will be screened with the Edinburgh Postnatal Depression Scale (EPDS) and those scoring 13-20, inclusive, on the EPDS will be considered for further involvement. Following referral, women will be contacted by a member of the research team to assess eligibility and explain the study. Inclusion criteria are: (a) EPDS score 13-20, (b) 18 years and older, (c) ability to understand English, (d) 6 weeks to 1 year postpartum, (e) home Internet access, (f) familiarity with the Internet and e-mail, (g) able/willing to give informed consent, (h) diagnosis of a major and minor depressive episode using the Structured Clinical Interview for DSM-IV (SCID). Exclusion criteria are: (a) risk of suicide, (b) current substance abuse, manic/hypomanic symptoms or depression with psychotic features meeting DSM-IV criteria; or c) current treatment for depression (medication or psychotherapy). Following contact with women via phone, a Participant Information and Consent Form will be sent in the mail and potential participants will be asked to sign it and return it to the researchers. A clinical assessment will be completed by phone and participants will be asked to complete the questionnaires by visiting the secure website. Women will be randomised in a 1:1 ratio to Web-based CBT with telephone support (n = 25), or to treatment as usual (n = 25), using a pre-generated permuted blocks allocation schedule. Post-test data will be collected at 9 weeks post-enrolment and follow-up data at three months post-enrolment.

  • Youth Depression Alleviation: Augmentation with Anti-inflammatory Agent (YoDA-A)

    This study is 12-week acute treatment trial for moderate to severe major depressive disorder (MDD). It is designed to establish whether the use of (i) rosuvastatin or (ii) aspirin, reduces symptom severity and prevents recurrence of depression in young people. In this 3-arm controlled design, add-on therapy to treatment as usual (TAU) with rosuvastatin or aspirin will be compared to placebo. Aims Using a randomised placebo controlled trial, we aim to assess in individuals presenting to specialised early intervention centres with moderate to severe major depression if: 1. 12 weeks treatment with either 10 mg rosuvastatin or 100 mg aspirin treatment reduces severity of depression compared to individuals taking treatment as usual: Primary aim. 2. 12 weeks with either 10 mg rosuvastatin or 100 mg aspirin treatment will improve self-reported symptom burden, quality of life, overall functioning and clinical impression and reduce symptoms of anxiety. 3. There are continued benefits following cessation of trial treatment assessed at 6 months following baseline. 4. whether 12-weeks treatment with 10 mg rosuvastatin or 100 mg aspirin reduces serum markers of inflammation, and 5. whether the reduction in inflammatory and oxidative markers correlates with change in depressive symptomatology Primary Hypothesis 1. 12-weeks of adjunctive rosuvastatin or aspirin treatment will be superior to placebo for reducing symptoms of depression using the Montgomery-Asberg Depression Rating Scale (MADRS). Analysis of rosuvastatin compared with placebo will be conducted separately to aspirin compared with placebo. Changes in MADRS scores in each medication individually are the primary outcomes. Predictors of outcome The study will also aim to explore predictors and moderators of treatment response. Predictors are variables present before treatment that influence a person's response to treatment, regardless of the type of treatment received; whereas moderators differentially predict response to the different treatments. We will explore questions such as whether young people with comorbid substance abuse and borderline personality disorder traits are less likely to respond to treatment overall and less likely to respond to one treatment compared to the other. We will also examine whether baseline cognitive factors predict response to the trial medication.

  • Colomid: Midkine as a predictive marker in colorectal cancer

    This study is recruiting participants with advanced or metastatic colorectal cancer, who are going to start on a new course of chemotherapy. It will investigate a new blood test, called Midkine, and determine if it is better than the standard tests (CEA and CT scans), at identifying whether or not the chemotherapy is effective. Who is it for? You may be eligible to join this study if you are 18 years or over, have been diagnosed with metastatic or locally advanced colorectal cancer and due to starting on a new course of chemotherapy. Full inclusion criteria for this study can be found in the appropriate section of this form. Trial details In this study, you will be observed for a total period of 6 months, or until your cancer progresses. You will have standard and midkine blood tests before starting chemotherapy, a midkine sample taken at 2 weeks and then standard and midkine blood tests every 3-4 weeks, whilst receiving chemotherapy for your colorectal cancer. The interval between blood tests depends on when blood tests are required for the chemotherapy regimen that is being used. The only extra blood test you will require is for midkine at 2 weeks after starting on the study.

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