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Design and rationale for the non-interventional Global Investigation of Therapeutic DEcisions in Hepatocellular Carcinoma and Of its Treatment with Sorafenib (GIDEON) study.
Lencioni, R, Marrero, J, Venook, A, Ye, SL, Kudo, M
International journal of clinical practice. 2010;(8):1034-41
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Abstract
BACKGROUND Hepatocellular carcinoma (HCC) is a complicated condition influenced by multiple confounding factors, making optimum patient management extremely challenging. Ethnicity, stage at diagnosis, comorbidities and tumour morphology affect outcomes and vary from region to region, and there is no common language to assess patient prognosis and make treatment recommendations. Despite recent efforts to reduce the incidence of HCC, most patients present with unresectable disease. Non-surgical treatments include ablation, transarterial chemoembolisation and the multikinase inhibitor, sorafenib, but their effects in all patient subgroups are not known and further information is needed to optimise the use of these treatments. AIMS The Global Investigation of Therapeutic DEcisions in Hepatocellular Carcinoma and Of its Treatment with SorafeNib (GIDEON) study (ClinicalTrials.gov identifier NCT00812175; http://clinicaltrials.gov/) is an ongoing global, prospective, non-interventional study of patients with unresectable HCC who are eligible for systemic therapy and for whom the decision has been taken to treat with sorafenib under real-life practice conditions. The aim of this study is to evaluate the safety and efficacy of sorafenib in different subgroups, especially Child-Pugh B where data are limited. DISCUSSION This study will recruit 3000 patients from > 40 countries and follow them for approximately 5 years to compile a large and robust database of information that will be used to analyse local, regional and global differences in baseline characteristics, disease aetiology, treatment practice patterns and treatment outcomes, with a view to improve the knowledge base used to guide physician treatment decisions and to improve patient outcomes.
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Rationale and design of the AdRem study: evaluating the effects of blood pressure lowering and intensive glucose control on vascular retinal disorders in patients with type 2 diabetes mellitus.
Stolk, RP, Vingerling, JR, Cruickshank, JK, Hughes, AD, Stanton, A, Juming, L, Patel, A, Thom, SA, Grobbee, DE, ,
Contemporary clinical trials. 2007;(1):6-17
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Abstract
The ADVANCE Retinal Measurements (AdRem) Study is a large intervention study evaluating the effects of target driven intensive glucose control and placebo controlled blood pressure lowering on retinal vascular changes. AdRem is a sub-study of the ADVANCE Study (Action in Diabetes and Vascular disease), a 2x2 factorial randomized controlled trial with an ACE inhibitor-diuretic combination (perindopril-indapamide) and a gliclazide MR-based regimen in patients with type 2 diabetes mellitus. The AdRem study is based on seven-field stereoscopic retinal photographs of both eyes. These are taken within 3 months after randomization in ADVANCE (baseline), at the biennial and at the final visit. The primary outcome is progression of two or more steps in ETDRS classification. Secondary outcomes include progression of retinal vascular lesions and distortion of retinal vascular geometry. Retinal photographs are made on film and digitized at a central laboratory. The AdRem study uses fully digitized quality control and grading. Between August 2002 and January 2004 1978 patients were included in the AdRem study, from 39 centers in 14 countries. Approximately 85% comply with the strict AdRem quality requirements. Publication of the results is expected in early 2008. The AdRem study is designed to provide reliable evidence on the effects of intensive glucose control and blood pressure lowering on both diabetic retinopathy and abnormalities of retinal vasculature in patients with type 2 diabetes mellitus.
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Challenges in the conduct of Thai herbal scientific study: efficacy and safety of phytoestrogen, pueraria mirifica (Kwao Keur Kao), phase I, in the alleviation of climacteric symptoms in perimenopausal women.
Chandeying, V, Lamlertkittikul, S
Journal of the Medical Association of Thailand = Chotmaihet thangphaet. 2007;(7):1274-80
Abstract
OBJECTIVE To evaluate the preliminary efficacy and safety of Pueraria mirifica (Kwao Keur Kao), phytoestrogen, for the alleviation of climacteric symptoms. MATERIAL AND METHOD Perimenopausal women attending with climacteric symptoms, such as hot flushes and night sweats, were invited to join the present study, conducted at the Menopausal Clinic, Hat Yai Regional Hospital. The patients were voluntarily enrolled and randomly received the raw material of Pueraria mirifica, oral 50 and 100 mg capsule, once daily for six months, as an open-label study. RESULTS Of the 10 enrolled patients, 8 cases were completely evaluated. The modified Greene climacteric scale (MGCS) was satisfactorily decreased in both groups. The average scale declined from 44.1 at baseline, to be 26, 17, and 11.1 at 1-, 3-, and 6- month follow-up respectively. No other laboratory abnormalities, except one case had transiently increased the creatinine level, and one case of increased blood urea nitrogen. The mean serum estradiol was slightly increased, while the mean serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) were nearly stable. CONCLUSION Pueraria mirifica is relatively safe and preliminarily alleviates the climacteric symptoms in perimenopausal. women, but the data is insufficient to draw definite conclusions regarding the estrogenic effect.
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Strategies, time, and costs associated with the recruitment and enrollment of nursing home residents for a micronutrient supplementation clinical trial.
Gismondi, PM, Hamer, DH, Leka, LS, Dallal, G, Fiatarone Singh, MA, Meydani, SN
The journals of gerontology. Series A, Biological sciences and medical sciences. 2005;(11):1469-74
Abstract
BACKGROUND Concomitant with the substantial growth of the elderly population in the last decade, there has been a steady rise in the number of nursing home residents aged 65 years and older. Well designed, rigorously conducted clinical intervention trials provide an important source of data for evidence-based improvements in the medical care of nursing home residents. The information available on strategies for the recruitment and screening of participants for such studies in long-term care facilities, as well as the financial and time costs for carrying out these investigations, is limited. METHODS This report describes our experience in recruiting 617 nursing home residents for a multisite, double-blind, randomized, placebo-controlled trial designed to determine the efficacy of a 1-year period of vitamin E supplementation in preventing respiratory tract infections. Comparisons of the projected staffing costs and actual costs incurred are presented, using a retrospective method for the determination of unit costs. RESULTS Initially, 874 consents were obtained from 2815 potential participants, of which only 617 were enrolled. Each successful enrollment required an average of 15 hours of staff time at a combined personnel and supply cost of $515 per participant and a total study cost of $317,661. Several obstacles were encountered during the recruitment and enrollment process: resistance on the part of family or primary care provider; transfer out of facility; and changes in the medical condition of the patient, including death. DISCUSSION The results of this report should prove useful to investigators developing budgets for nursing home-based clinical trials by providing a more accurate determination of the personnel needed and the costs associated with recruitment and enrollment of participants.