There are about 10460 clinical studies being (or have been) conducted in Australia. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.
With over one million operations a year, cardiac surgery with cardiopulmonary bypass is one of the most common major surgical procedures worldwide (1). Acute kidney injury is a common and serious postoperative complication of cardiopulmonary bypass and may affect 25% to 50% of patients (2-4). Acute kidney injury carries significant costs (4) and is independently associated with increased morbidity and mortality (2,3). Even minimal increments in plasma creatinine are associated with an increase in mortality (5,6). Multiple causes of cardiopulmonary bypass-associated acute kidney injury have been proposed, including ischemia-reperfusion, generation of reactive oxygen species, hemolysis and activation of inflammatory pathways (7-10). COMT LL genotype appears to increase the risk of vasodilatory shock and AKI after cardiac surgery. To date, no simple, safe and effective intervention to prevent cardiopulmonary bypass-associated acute kidney injury in a broad patient population has been found (11-14). Urinary acidity may enhance the generation and toxicity of reactive oxygen species induced by cardiopulmonary bypass (10,15). Activation of complement during cardiac surgery (16) may also participate in kidney injury. Urinary alkalinization may protect from kidney injury induced by oxidant substances, iron-mediated free radical pathways, complement activation and tubular hemoglobin cast formation (9,17,18). Of note, increasing urinary pH - in combination with N-acetylcysteine (19,20) or without (21) - has recently been reported to attenuate acute kidney injury in patients undergoing contrast-media infusion. In a pilot double-blind, randomized controlled trial the investigators found sodium bicarbonate to be efficacious, safe, inexpensive and easy to administer. These findings now need to be confirmed or refuted by further clinical investigations in other geographic and institutional settings. Accordingly, the investigators hypothesized that urinary alkalinization might protect kidney function in patients at increased risk of acute kidney injury undergoing cardiopulmonary bypass needs to be confirmed in an international multicenter, double-blind, randomized controlled trial of intravenous sodium bicarbonate.
This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. This study will last 3 months.
The disappearance of intestinal parasites from humans in developed countries may be responsible for the upsurge in many diseases including Celiac Disease, Crohn's, ulcerative colitis, asthma and hay fever. A parasite's survival relies on its ability to interfere with the host's immune response. The mechanisms employed to do this are similar to those required by a person to regulate against the so-called autoimmune disorders, diseases in which the system turns on itself. The investigators suspect that when parasites are excluded from the environment, some individuals become sufficiently self-reactive to develop an autoimmune disease. American researchers have successfully treated patients with Crohn's and ulcerative colitis using a pig whipworm (Trichuris suis). The investigators have undertaken a similar preliminary study using a human hookworm in Crohn's patients. Using a small group of healthy people with celiac disease, the investigators will test if a human hookworm, Necator americanus, inhibits immune responsiveness to gluten. Celiac disease is a very common autoimmune-like disease (1% of Americans are affected although only a minority are aware they have the condition). In this condition, an individual becomes reactive to gluten, a protein in foods derived from wheat, barley, oats and rye. What makes celiac disease such a good model for Crohn's disease is that similar immune changes are common to both, but in celiac disease the people are usually well, are not taking powerful immune suppressive drugs and the provocative antigens (the molecules that engage the immune system and provoke the disease) are known and can be excluded or introduced. As well as being of direct benefit to people with celiac disease, this study may give direction as to the potential of this parasite to manage inflammatory bowel disease. People with proven celiac disease who live in Brisbane, a modern Australian city, will be invited to participate. Enrollment will require that the candidate has been avoiding gluten for six months. The study is a blinded study (where the researchers and study subjects do not know who has gotten the parasites) aimed at comparing the disease activity and immunity after a controlled breach of the gluten-free diet in individuals with celiac disease, before and after hookworm infection. The disease severity and the immune system of celiac subjects before and after being inoculated with N. americanus will be examined using conventional and experimental investigations. This group's immunity will be compared to that of a group of matched, celiac control subjects (not infected with hookworm), before and after eating four pieces of standard white bread each day for three to five days. Twenty people, ten subjects per arm, will be recruited. Ten larvae initially, then five more after twelve weeks will be placed on the skin under a light dressing for thirty minutes. The investigators aim to test whether the hookworm infection will change the immune processes and suppress gluten sensitivity in people with celiac disease. Outcomes to be measured will be those that reflect the activity of celiac disease.
This study is to evaluate the highest tolerated dose, safety and activity of HCD122 in adults with non-Hodgkin's or Hodgkin's lymphoma who have received at least two prior therapies.
The primary objective of this study is to demonstrate a reduction in the proportion of new vertebral fractures in postmenopausal women with osteoporosis following 3-years of treatment with 20 and 40 mcg/day of teriparatide plus calcium and vitamin D compared with calcium and vitamin D alone.
To study the effect of long-term treatment with raloxifene, compared with placebo, on the rate of new vertebral fractures in osteoporotic postmenopausal women with and without existing vertebral fractures.
This study is a continuation of the placebo-controlled study CE1226_4001 (NCT00261833) to evaluate the efficacy and safety of Zemaira® i.v. administration in subjects with emphysema due to alpha1-proteinase inhibitor deficiency. The long-term verification of a disease-modifying benefit of Zemaira® on the progression of emphysema will be assessed by volume-adjusted lung density, measured yearly by computed tomography (CT).
No gold standard therapy exists for clearing mucus from the airways of patients with bronchiectasis. While rhDNase has a proven place in the treatment of CF, it failed to improve FEV1 in a short-term non-CF bronchiectasis study and has been shown to be detrimental after 6 months therapy in non CF bronchiectasis, moreover it has no proven effect on mucociliary clearance. Hypertonic saline has been shown to have a comparable mode of action to inhaled mannitol, but has yet to be examined as a long term treatment option in bronchiectasis. The purpose of this study is to examine the efficacy and safety of 52 weeks treatment with inhaled mannitol in subjects with non-cystic fibrosis bronchiectasis. Previous studies with inhaled mannitol have demonstrated improvement in mucociliary clearance; mucus rehydration; improvement in quality of life and respiratory symptoms in patients with bronchiectasis and pulmonary function in cystic fibrosis. The results of this current study in combination with a recently completed 3 month study seek to confirm these early findings and to extend the evidence to support its use as a mucoactive therapy in subjects with bronchiectasis. We hypothesize that mannitol will improve the overall health and hygiene of the lung through regular and effective clearing of the mucus load. As a consequence of the reduction in mucus load and inflammatory process, the frequency of bronchiectasis related pulmonary exacerbations and the need for exacerbation related antibiotic treatment should fall. Days in hospital and community health care costs are expected to change in line with improvements in respiratory health. Finally, we plan to demonstrate that inhaled mannitol is safe and well tolerated over a 52 week period. We will test these hypotheses using 400 mg mannitol twice daily against control.
This pilot study will examine one issue only in weight loss - food cravings in overweight (i.e. BMI between 25-29.9) or obese (BMI greater than 30) consumers. Food craving is hypothesized to be an important intervening causal variable and the development of obesity. This randomized clinical trial will explore whether a relatively under researched energy based therapeutic procedure, Emotional Freedom Techniques (EFT), can reduce food cravings in participants under laboratory-controlled conditions, and compare this to a waitlist group. The following foods will be tested: chocolate, salty foods (e.g. chips, crisps, salted nuts), sweet carbohydrate foods (eg. cakes, biscuits, soft/soda drinks), carbohydrate foods which are neither sweet nor salty such as white refined foods such as bread), and caffeinated items. Research examining energy based procedures (e.g. EFT) combines cognitive strategies with somatic procedures adapted from acupuncture and related systems for altering the cognitive, behavioural, and neurochemical foundations of psychological problems. It is often referred to as "psychological acupuncture". Few adequately controlled studies have been conducted on EFT however acupuncture has been quite extensively studied, with hundreds of research reports published (see attached references). Screening will occur over the telephone with one of the chosen self report questionnaires - the Food Craving Inventory (FCI; White et al., 2002). The FCI is a reliable and valid measure for the assessment of cravings for specific types of foods: High Fats, Sweets, Carbohydrates/Starches, and Fast Food Fats, all of which comprise the higher order construct of "food craving" or the FCI Total score (White et al., 2002). Higher numbers for each of the subscales reflect greater cravings for that food type with the highest score being 185. Scores of 93 or higher during the screen will be used to admit subjects to the next diagnostic interview phase of the trial. In addition, subjects will be asked their weight and height in order to ascertain their BMI and this will be confirmed in the diagnostic interview with a standardized weight machine. The Structured Clinical Interview (SCID-II; Spitzer, Williams, Gibbon, & First, 1990) has 12 groups of questions corresponding to12 personality disorders and will be used as a diagnostic tool in a face-to-face interview with subjects who are suitable from the telephone screen. The aim is to exclude any active diagnoses from the DSM-IV in order to obtain the purest non clinic sample possible. All subjects will be notified by letter of the outcome of their diagnostic interview and those unsuitable for the trial will be told they did not meet selection criteria. Suitable practitioners who would be able to provide individual support for the food cravings will be provided in written format. Subjects who meet a diagnostic category will be informed of this and appropriate referral will be offered. Participants will be randomly assigned (using the NHMRC Clinical Trials Centre service) to a free group EFT treatment condition or a non treatment waitlist control condition of the same duration (4 weeks). This design ensures that potential treatment gains are neither due to the mere passage of time nor regression to the mean. To limit attrition from waitlist conditions, several contacts will be made with the waiting clients. Prescheduled phone contacts, for example, may maintain adherence to the waitlist condition. Prior to treatment all subjects will be weighed and height measured for their BMI status and food craving outcome measures (pre, post and follow-up) will be measured using: 1. SUDS rating (subjective) in daily food diaries (food diaries were chosen as a method that best measures real-life eating behaviour) 2. Power of Food Scale (Didie, 2003) 3. Food Craving Inventory (White et al., 2002) Three aspects of eating behaviour will be measured using the Revised Restraint Scale (Herman & Polivy, 1980). The items are summed for a total score that ranges from 0 to 40. High scores indicate chronic dieting in which the individual is constantly cycling on and off the diet, typically without any substantial weight loss. Dietary restraint appears to play a causal role in the development of eating disorders and obesity and loss of control over intake. Food cravings may trigger these eating behaviours. The Symptom Assessment 45 (SA-45, Strategic Advantage, 1998) will be used to assess symptomatology across nine psychiatric domains and as measures of the outcome of the psychological intervention. Demographic information will be collected in questionnaire format at the beginning of the study. The EFT intervention will consist of 4 sessions (2 hours duration) with homework and will be based on standard delivery of EFT, as per founder Gary Craig's training for level 1 EFT certification ( see http://www.emofree.com/WorkShop/workshop-guidelines.htm#Level%201).