Month Trial (month + trial)

Distribution by Scientific Domains


Selected Abstracts


Tagatose, a new antidiabetic and obesity control drug

DIABETES OBESITY & METABOLISM, Issue 2 2008
Y. Lu
A potentially important new drug for treating type 2 diabetes, tagatose, is now in phase 3 clinical trial. The history, development, additional health benefits, mechanisms of action and the potential for the drug are presented in context with a review of the rapidly growing epidemic of type 2 diabetes and treatments for it. An epimer of fructose, the natural hexose tagatose was originally developed by Spherix Incorporated (formerly Biospherics Inc.) as a low-calorie sugar substitute. Only 20% of orally ingested tagatose is fully metabolized, principally in the liver, following a metabolic pathway identical to that of fructose. Following a decade of studies, tagatose became generally recognized as safe for use in foods and beverages under US FDA regulation. The simple sugar is commercially produced by isomerization of galactose, which is prepared from lactose. Early human studies suggested tagatose as a potential antidiabetic drug through its beneficial effects on postprandial hyperglycaemia and hyperinsulinaemia. A subsequent 14-month trial confirmed its potential for treating type 2 diabetes, and tagatose showed promise for inducing weight loss and raising high-density lipoprotein cholesterol, both important to the control of diabetes and constituting benefits independent of the disease. Furthermore, tagatose was shown to be an antioxidant and a prebiotic, both properties cited in the maintenance and promotion of health. No current therapies for type 2 diabetes provide these multiple health benefits. The predominant side effects of tagatose are gastrointestinal disturbances associated with excessive consumption, generally accommodated within 1- to 2-week period. The health and use potentials for tagatose (branded Naturlose® for this use) are given with respect to current type 2 diabetes drugs and markets. Under an FDA-affirmed protocol, Spherix is currently conducting a phase 3 trial to evaluate a placebo-subtracted treatment effect based on a decrease in HbA1c levels. Side effects, contraindications and possibly beneficial new findings will be carefully monitored. It is hoped that early results of the trial may become available by mid-2008. If a subsequent NDA is successful, tagatose may fill a major health need. [source]


Magistrates' Early Referral into Treatment (MERIT): preliminary findings of a 12-month court diversion trial for drug offenders

DRUG AND ALCOHOL REVIEW, Issue 4 2002
DAVID REILLY BSc(Psych Hons), MPsychol
Abstract The purpose of this paper is to present a description and preliminary findings of a 12-month trial of a Local Court diversion programme, called MERIT for Magistrates' Early Referral into Treatment. The aim of MERIT is to divert eligible drug offenders to treatment and rehabilitation services. A total of 172 offenders were assessed and 131 entered the programme. The sources of referral were court (58%), police (17%) and self (10%). Main problem drugs were heroin (57%), cannabis (21%) and amphetamines (11%). The majority (85%) had previous convictions and 50% had been in jail. At the end of the trial period one-third (33%) completed the programme and one-third (33%) remained in treatment. Main treatment interventions were case management and out-patient counselling, detoxification, residential rehabilitation and methadone maintenance. Police records showed that of the original 43 (33%) graduates only six had come to police notice, mainly for relatively minor offences. Early acceptance and preliminary results has led to an expansion of the MERIT programme across New South Wales. With the rapid expansion of drug courts and diversion programmes across Australia, descriptive studies are useful to provide beneficial data to assist policy makers and service providers to develop programmes. [source]


Nocturnal nutritional supplementation improves total body protein status of patients with liver cirrhosis: A randomized 12-month trial,

HEPATOLOGY, Issue 2 2008
Lindsay D. Plank
Patients with liver cirrhosis exhibit early onset of gluconeogenesis after short-term fasting. This accelerated metabolic reaction to starvation may underlie their increased protein requirements and muscle depletion. A randomized controlled trial was conducted to test the hypothesis that provision of a late-evening nutritional supplement over a 12-month period would improve body protein stores in patients with cirrhosis. A total of 103 patients (68 male, 35 female; median age 51, range 28,74; Child-Pugh grading: 52A, 31B, 20C) were randomized to receive either daytime (between 0900 and 1900 hours) or nighttime (between 2100 and 0700 hours) supplementary nutrition (710 kcal/day). Primary etiology of liver disease was chronic viral hepatitis (67), alcohol (15), cholestatic (6), and other (15). Total body protein (TBP) was measured by neutron activation analysis at baseline, 3, 6, and 12 months. Total daily energy and protein intakes were assessed at baseline and at 3 months by comprehensive dietary recall. As a percentage of values predicted when well, TBP at baseline was similar for the daytime (85 ± 2[standard error of the mean]%) and nighttime (84 ± 2%) groups. For the nighttime group, significant increases in TBP were measured at 3 (0.38 ± 0.10 kg, P = 0.0004), 6 (0.48 ± 0.13 kg, P = 0.0007), and 12 months (0.53 ± 0.17 kg, P = 0.003) compared to baseline. For the daytime group, no significant changes in TBP were seen. Daily energy and protein intakes at 3 months were higher than at baseline in both groups (P < 0.0001), and these changes did not differ between the groups. Conclusion: Provision of a nighttime feed to patients with cirrhosis results in body protein accretion equivalent to about 2 kg of lean tissue sustained over 12 months. This improved nutritional status may have important implications for the clinical course of these patients. (HEPATOLOGY 2008.) [source]


A placebo-controlled, double-blind trial of Ginkgo biloba for antidepressant-induced sexual dysfunction

HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 6 2002
Byung-Jo Kang
Abstract The aim of this study was to examine the effect of Ginkgo biloba on antidepressant-induced sexual dysfunction. The Ginkgo biloba (n=19) and the placebo groups (n=18) were divided; each to be administered with Ginkgo biloba and placebo respectively for 2 months by means of a randomized placebo-controlled, double-blind study. The results of this 2 month trial were: (1) there was no statistical significant difference from the placebo at weeks 2, 4 and 8 after medication; (2) in comparison with baseline, both the Ginkgo biloba group and the placebo group showed improvement in some part of the sexual function, which is suggestive of the importance of the placebo effect in assessing sexual function. This study did not replicate a prior positive finding supporting the use of Ginkgo biloba for antidepressant, especially SSRI, induced sexual dysfunction. Copyright © 2002 John Wiley & Sons, Ltd. [source]


Evaluation of a mobile learning organiser for university students

JOURNAL OF COMPUTER ASSISTED LEARNING, Issue 3 2005
Dan Corlett
Abstract This paper describes a 10-month trial of a mobile learning organiser, developed for use by university students. Implemented on a wireless-enabled Pocket PC hand-held computer, the organiser makes use of existing mobile applications as well as tools designed specifically for students to manage their learning. The trial set out to identify the most-used tools for such a learning device and their patterns and problems of usage. The primary uses of the organiser were communication, time-management and access to content. No single application took precedence. The results from an analysis of questionnaire surveys and focus groups indicate that there was a demand for institutional support of mobile learning, in particular to provide course content and timetabling information. Wireless connectivity was crucial to the usefulness of the organiser. Usability issues relating to the hardware and software had considerable impact on the students' usage and satisfaction with the system. [source]


Randomized, prospective, placebo-controlled trial of bosentan in interstitial lung disease secondary to systemic sclerosis,

ARTHRITIS & RHEUMATISM, Issue 7 2010
J. R. Seibold
Objective Endothelin is implicated as a participatory pathway in systemic sclerosis (SSc). We tested this hypothesis in a 12-month trial of bosentan, a nonselective endothelin receptor antagonist, as a therapy for SSc-related interstitial lung disease (ILD). Method Patients with SSc and significant ILD were recruited to this prospective, double-blind, randomized, placebo-controlled, parallel group study. The inclusion criteria were designed to select a cohort enriched for patients with active and progressive disease. Exclusion factors included significant pulmonary hypertension. Patients with a diffusing capacity for carbon monoxide of <80% predicted and a 6-minute walk distance of 150,500 meters or a 6-minute walk distance of ,500 meters with a decrease in oxygen saturation received bosentan or placebo. The primary efficacy end point was a change in the 6-minute walk distance from baseline up to month 12. Secondary end points included time to death or worsening results of pulmonary function tests (PFTs). The safety and tolerability of bosentan were also assessed. Results Among the 163 patients, 77 were randomized to receive bosentan, and 86 were randomized to receive placebo. No significant difference between treatment groups was observed for change in the 6-minute walk distance up to month 12. No deaths occurred in this study group. Forced vital capacity and diffusing capacity for carbon monoxide remained stable in the majority of patients in both groups. Significant worsening of PFT results occurred in 25.6% of patients receiving placebo and 22.5% of those receiving bosentan (P not significant). Conclusion No improvement in exercise capacity was observed in the bosentan-treated group compared with the placebo group, and no significant treatment effect was observed for the other end points. Although many outcome variables were stable, bosentan did not reduce the frequency of clinically important worsening. These data do not support the use of endothelin receptor antagonists as therapy for ILD secondary to SSc. [source]


Linking opioid-dependent hospital patients to drug treatment: health care use and costs 6 months after randomization

ADDICTION, Issue 12 2006
Paul G. Barnett
ABSTRACT Aims To conduct an economic evaluation of the first 6 months' trial of treatment vouchers and case management for opioid-dependent hospital patients. Design Randomized clinical trial and evaluation of administrative data. Setting Emergency department, wound clinic, in-patient units and methadone clinic in a large urban public hospital. Participants The study randomized 126 opioid-dependent drug users seeking medical care. Interventions Participants were randomized among four groups. These received vouchers for 6 months of methadone treatment, 6 months of case management, both these interventions, or usual care. Findings During the first 6 months of this study, 90% of those randomized to vouchers alone enrolled in methadone maintenance, significantly more than the 44% enrollment in those randomized to case management without vouchers (P < 0.001). The direct costs of substance abuse treatment, including case management, was $4040 for those who received vouchers, $4177 for those assigned to case management and $5277 for those who received the combination of both interventions. After 3 months, the vouchers alone group used less heroin than the case management alone group. The difference was not significant at 6 months. There were no significant differences in other health care costs in the 6 months following randomization. Conclusion Vouchers were slightly more effective but no more costly than case management during the initial 6 months of the study. Vouchers were as effective and less costly than the combination of case management and vouchers. The finding that vouchers dominate is tempered by the possibility that case management may lower medical care costs. [source]