ANZCTR search results

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

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31593 results sorted by trial registration date.
  • The Effect of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP) on Overall Survival of Patients with Relapsed Diffuse Large B-Cell Lymphoma Post-Autologous Stem Cell Transplant

    Hypothesis: Relapsed diffuse large B-cell lymphoma (DLBCL) patients who received R-CHOP as their primary therapy have a poor outcome compared to patients who received CHOP as their primary therapy. The objective of this study is to assess the impact of R-CHOP on the overall survival of autologous stem cell transplant for patients with relapsed DLBCL. The information gained may benefit patients by altering standard therapy for this patient population.

  • Intensive Medical Treatment after Heart Attack

    Heart failure is a deadly condition with a 5 year survival rates of 35% following index admission, exceeding the rate of many cancers Population based study in elderly patients (>65 years of age) indicates that among Heart Attack survivors over 70% patients develop heart failure by 5 years, more than 60% of which occurs in the first year. Currently there are no sufficient data to support an intensive medical treatment in patients after heart attack with normal or only mildly abnormal heart function. We hypothesize that an optimised medical treatment in patients with initial normal or mild heart dysfunction but elevated Left Ventricle size (volumes) and serum cardiac hormone levels (BNP) as markers of heart remodelling (progressive weakening) may reduce the progression of the disease, delay the onset of heart failure and ultimately reduce the risk of death.

  • Health Status in Patients with Non-Obstructive Coronary Artery Disease

    The study aims to evaluate the natural history and health outcomes of patients with chest pain who have non-obstructive coronary artery disease. These patients traditionally have been though to have a benign prognosis and frequently have their symptoms trivialized. Despite this, persistence of chest pain symptoms is common and limited therapeutic strategies cause significant morbidity in these patients. This is in contrast patients who have obstructive coronary artery disease, who although are at increased risk of mortality, receive attention and experience symptom relief with medication and surgical interventions. There is limited longitudinal data available assessing and evaluating patients with non-obstructive coronary artery disease, especially utilizing valid and reproducible health status assessments and also comparing them to other patients who experience similar symptoms but have a clear etiology for their pain. This is important since the incidence of non-obstructive coronary artery disease may be as high as 30% of angiograms performed. Thus this study aims to evaluate the health status of patients who undergo coronary angiography for chest pain who show non-obstructive coronary artery disease and compare these to patients who undergo the procedure and show obstructive coronary artery disease, for a period of 12 months following index angiography.

  • Efficacy of coronary sinus ablation for treatment of atrial fibrillation.

    The coronary sinus shares similar morphological and electro-anatomical characteristics to pulmonary veins, which have already been established as arrhythmogenic triggers of AF, but the former structure has received relatively sparse attention. The coronary sinus has been indirectly implicated in atrial arrhythmias; however, no one has systematically assessed the clinical efficacy of ablating this structure in addition to the conventional AF ablation approach. The study aims to establish irrevocably, in a blinded randomised controlled comparison, whether or not the coronary sinus plays a role in maintaining AF in non-lone/long episode paroxysmal and persistent AF.

  • A Phase I, Randomised, Open-Label, Three-way Crossover Comparative Pharmacokinetic Study of EMA401 Sodium Salt When Administered Orally in Fed (high fat meal or orange juice only) and Fasted Healthy Adult Males.

    This study is planned to investigate the effect of food on the absorption of EMA401 when EMA401 Sodium Salt is administered orally in healthy adult males (18-55 years of age inclusive) at a dose level of 50mg.

  • A Pilot Study Examining the Efficacy of a Support Algorithm for Commencing Patients with Type 2 Diabetes on a Basal / Prandial Insulin Regimen in the Primary Care Setting With Professional Continuous Glucose Monitoring as an Adjunct.

    The purpose of this research project is to evaluate a plan of action designed for general practitioners and practice nurses to safely and efficiently start patients with Type 2 diabetes on insulin injections who have high sugar (glucose) levels despite taking tablets. To be eligible to take part in this study subjects must have Type 2 diabetes; be aged between 18-80 years old; are on at least two diabetes tablets at the highest doses that they are able to tolerate and that these doses have been unchanged over the last 3 months, or based on the opinion of the general practitioner who normally cares for the patient insulin, is required to ensure ensure their health health. The subject must have a HbA1c (a simple laboratory measurement on blood that reflects average glucose levels in a person's blood over the previous three months) between 7.5-10.5% which indicates less than satisfactory diabetic control; and must have never taken insulin before. Women of childbearing age must not get pregnant during the study. There will be up to 142 subjects recruited for this study across 16 sites in Victoria Australia only. Participating subjects will be commenced on insulin initially with a single injection of an insulin (Glargine) which lasts for 24 hours. The dose will then be adjusted to match the subject’s needs. If necessary, because sugar levels rise after meals despite providing an appropriate dose of the long acting insulin, a second injection of a short acting insulin (Glulisine) will be added in to coincide with the subject’s biggest meal for the day. A second purpose of this study is to determine if a new device that provides information regarding a patient’s glucose levels continuously is helpful in guiding treatment that results in better control of diabetes when compared to current methods for monitoring glucose levels by finger-prick readings. The study will be looking to see if the protocol used improves sugar levels as measured by a fall in HbA1c which will be measured at the start of a subject's involvement in the study, at 12 weeks and at 24 weeks.

  • Phase II study of aromatase inhibitors in women with potentially hormone responsive recurrent/metastatic gynaecological neoplasms

    There is compelling evidence to support a study of aromatase inhibitors in selected patients with potentially hormone sensitive recurrent or metastatic gynecological cancers. Hormonal therapy is an attractive option in patients with recurrent gynecological cancers where the objective of treatment is palliation and prolongation of survival rather than cure. Aromatase inhibitors are generally well tolerated and in contrast to chemotherapy can be administered for prolonged periods with relatively little cumulative toxicity. The degree of activity and response rates reported in previous studies has varied considerably. This variability almost certainly reflects the heterogeneous populations treated, which have included women with advanced chemotherapy and hormone resistant tumours and those with a poor performance status where response rates are generally low. There is a clear need to investigate the role of hormonal therapies, particularly AIs, in women with potentially hormone responsive recurrent gynaecological cancers. Studies are required to establish the response rates, clinical benefit and quality of life as well as to identify predictors of response.

  • Piloting of a Midwife Initiated Oral Health-Dental Service (MIOH-DS) to improve the oral health of pregnant women

    Oral diseases are among the most common health problems experienced by Australians, affecting almost 11 million people annually. Pregnant women are particularly at risk of poor oral health due to hormonal variations related to pregnancy. The government has commenced addressing these issues through the Australia’s National Oral Health Plan (2004-2013) which emphasises the need for health promotion, prevention and early identification of oral diseases as well improving access to appropriate and affordable services. However, research conducted by the investigators in this study has indicated that women are poorly informed about the implications of poor oral health during pregnancy and experience barriers to accessing dental services during pregnancy. Through a series of research activities, the study investigators have developed a unique oral health service (MIOH-DS), bringing together midwives and dentists, to improve maternal oral health. This innovative, high impact and internationally important intervention for pregnant women has the potential to offer an intervention relevant to all Australian child-bearing women and their antenatal care providers. This study will provide a pathway for national policy on oral health assessment and services for Australian women during the perinatal period. Aim The aim of this study is to determine the effectiveness of a Midwife Initiated Oral Health-Dental Service (MIOH-DS). The MIOH-DS will provide pregnant women with oral assessments by midwives, and referral to dental clinics, which we anticipate will improve women’s oral health status, uptake of dental services, oral health knowledge, and quality of oral health. We propose to pilot test the MIOH-DS service at a large metropolitan hospital in Sydney Southwest using a true randomised control trial. Intervention groups will receive either the MIOH-DS service which will include: a midwifery intervention involving oral health education, brief oral assessment and referrals and a dental intervention involving prompt treatment at dental clinics (through a voucher) or the MIOH service involving midwifery intervention and referral to current dental services. The control group will not receive any midwifery or dental intervention (current practice) but will be provided (if required), dental referrals after pregnancy. All participants will receive oral health promotional material at the time of recruitment

  • Child and Parents at Hospital: Improving Health and Well-being (The CAP@H project)

    The effect of cumulative stress and trauma on children and families has been demonstrated to lead to compromised outcomes in health and well-being for the child. Cumulative stress or trauma can arise from multiple co-existing or recurrent experiences such as poverty, inappropriate housing, unemployment, ill-health or injury, family breakdown, family violence, parental substance misuse, abuse or neglect. Acute paediatric health services play a unique role in contributing to the maintenance and improvement of child’s health and well-being and support of their families. They have been identified as playing a crucial role in the identifying children as risk of suffering deleterious effects of the cumulative stress and trauma. This study aims: 1) To describe the health and well-being of children admitted to The Royal Children’s Hospital (RCH) and identified by clinical staff as being vulnerable to the effects of cumulative stress or trauma 2) To compare the health and well-being of participants in this study to Australian reference data (using data from Growing Up in Australia: The Longitudinal Study of Australian Children) 3) To trial and evaluate an enhanced assessment and intervention program in an acute paediatric setting for children identified as being vulnerable to the effects of cumulative stress and trauma 4) To identify the interdisciplinary professional decision making processes of RCH health professionals working with clinical presentations of cumulative stress and trauma. This study will use a sequential comparison group design, collecting both quantitative and qualitative data, to address the above aims. Data will be collected by questionnaire, interview and hospital Unit Record audit at two time points: entry to study (T1); discharge from hospital (T2) and six months post-discharge (T3). Participating families will be recruited from children admitted to select Medical Units in The Royal Children’s Hospital Melbourne.

  • A pilot study to investigate the impact of Respiratory Gated Positron Emission Tomography (PET) scanning on classification and diagnostic accuracy in patients with Solitary Pulmonary nodules

    This is a pilot study to investigate a new scanning technique called respiratory gated (4D) PET scanning in patients with solitary pulmonary nodules. Who is it for? You can be part of this trial is you have a single round lesion in your lung that needs investigation with a PET scan. Trial details The participants will recieve their whole body PET scan as per normal but they will have an additional 4D PET scan that will take an extra 10 minutes. The 4D PET scan is a scan that will create a movie of the lung breathing. This movie can reduce blurring of lesions caused by movement due to normal breathing. The study aims to see the proportion of patients who have a change in the way the cancer is classified as a result of the additional 4D PET scan

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