European Study

The lead sampling procedures described in Section 3.2 were evaluated in a European broad study (EUR19087,1999). The results of this study are described in this section. 

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Up until 1986 the major use for 2-j -butylphenol was in the production of the herbicide, 2-j -butyl-4,6-dinitrophenol [88-85-7] which was used as a pre- and postemergent herbicide and as a defoHant for potatoes (30). The EPA banned its use in October 1986 based on a European study which showed that workers who came in contact with 2-j -butyl-4,6-dinitrophenol experienced an abnormally high rate of reproduction problems. Erance and the Netherlands followed with a ban in 1991. A significant volume of 2-j -butyl-4,6-dinitrophenol is used worldwide as a polymerization inhibitor in the production of styrene where it is added to the reboiler of the styrene distillation tower to prevent the formation of polystyrene (31). OSBP is used in the Par East as the carbamate derivative, 2-j -butylphenyl-Ai-methylcarbamate [3766-81-2] (BPMC) (32). BPMC is an insecticide used against leaf hoppers which affect the rice fields. 

In summary, studies involving more than 4,000 patients provided consistent evidence of a beneficial effect of acamprosate in relapse prevention. On the basis of the drug s efficacy (as demonstrated by at least a doubling of the total abstinence rate in three European studies, two of which were of 12 months duration) and a good safety profile, the FDA approved the medica-... 

In contrast, three European studies have found slight but statistically significant increases in cancer in workers exposed to trichloroethylene. A survey of Finnish workers exposed to primarily trichloroethylene found an association of limited statistical significance between exposure and incidence of stomach, liver, prostate, and lymphohematopoietic cancers (Antilla et al. 1995). However, the study did not reliably separate the effects of individual solvents, so attributing these cancers to trichloroethylene exposure alone was not possible. A significant association between workplace exposure to trichloroethylene and kidney cancer was found in a retrospective cohort study of German cardboard factory workers (Henschler et al. 1995). The... 

Kardinaal, A.E. et al.. Association between beta-carotene and acute myocardial infarction depends on polyunsaturated fatty acid status the EURAMIC study (European Study on Antioxidants, Myocardial Infarction, and Cancer of the Breast), Arterioscler. Thromb. Vase. Biol, 15, 726, 1995. 

Dukes G. The effects of drug regulation a survey based on the European studies of drug regulation. Lancaster, MTP Press Ltd., 1985. 

Celecoxib, however, was effective. In the subgroup of patients with moderate to severe OA pain, the combination of glucosamine and chondroitin appeared to have a moderate effect, although this subgroup analysis must be interpreted with caution. On the other hand, a European study (the GUIDE trial) that compared a prescription glucosamine product with acetaminophen and placebo in patients with knee OA reported that glucosamine performed better versus placebo than did acetaminophen.27... 

Unfortunately, not all products that are used in clinical trials are available in the United States. In a randomized, double-blind, multicenter European study, 1069 men with moderate benign prostatic hyperplasia were randomized to receive saw palmetto (Permixon" )1 160 mg twice daily (90% free and 7% esterified fatty acids) or finasteride 5 mg once daily for 6 months [32]. As determined by patients and physicians, Permixon offered similar improvement in symptoms related to benign prostatic hyperplasia compared to finasteride. Since Permixon is not available in the United States, it should be recommended to patients to use a product that is similar to Permixon that contains a standardized extract of saw palmetto containing 85-95% sterols and fatty acids [18]. 

Ahrens M et al (2009) Nucleus replacement with the DASCOR disc arthroplasty device interim two-year efficacy and safety results from two prospective, non-randomized multicenter European studies. Spine (Phila Pa 1976) 34(13) 1376—1384... 

Three other studies were conducted to investigate the preventive potential of tamoxifen. One in Italy (Veronesi et al. 1998), one at the Royal Marsden Hospital, United Kingdom (Powles et al. 1998), and a multicentric international study (IBIS 2002). The British study was the smallest in size (2471 participants) but concentrated on women with a high incidence of family history and consequently presented a higher number of breast cancers. The Italian trial included only women with previous hysterectomy and, accordingly, around 50% had also undergone bilateral oophorectomy. The family risk was low only 15% had a first-degree relative affected by breast cancer. Both European studies permitted concurrent HRT, and 26% of the participants in the British trial received HRT while on study and 42% had ever received HT for menopausal symptoms. Neither of the studies showed any positive effect of the treatment with tamoxifen on the incidence of breast cancer. Reasons for this lack of effect can be different for each trial. 

Lechin et al. 1996, Gray et al. 1999), but also increases the risk of falls and hip fractures (Passaro et al. 2000, Ray et al. 2000, Wang et al. 2001). Daily dose and longer duration of benzodiazepine use is associated with higher risk of fracture (van der Hooft et al. 2008). These fractures lead to great hospitalisation costs. In a European study it was estimated that costs of accidental injuries related to benzodiazepine use in the EU are between Euro 1.5 and Euro 2.2 billion each year. More than 90% of these costs were in the elderly with fractures as the major contributor (Panneman et al. 2003). 

Among elderly women as much as 80% suffer from involuntary voiding of the bladder, urinary incontinence (UI). In the United States approximately 12.5 million people are affected by incontinence and a European study showed a prevalence of between 12% and 22% in all ages and an increase to 30-40% in ages over 75 years (Hampel et al. 1997). Women experience UI twice as often as men. Incontinence becomes more common in old age, with existing co-morbidity of all kinds and life styles (Box 5.5). There are different forms of urinary incontinence and they differ in cause and treatment. This problem causes not only personal distress but also a considerable cost for society as a whole (Jackson 1997). Lower quality of life is often reported in people with UI and the risk increases by the withdrawal from social interaction and participation in sports and other activities. An estimated cost for the care of patients with UI in the United States was approximately 26 billion dollars in year 1995 (Wagner and Hu 1998). Other studies have come up with a calculated cost that represents two percent of the total national health budget. 

Nicholl, D.J., Bennett, P., Hiller, L., et al. (1999) A study of five candidate genes in Parkinson s disease and related neurodegenerative disorders. European Study Group on Atypical Parkinsonism. Neurology, 53, 1415-1421. 

There were major differences in the protocol designs for rodent studies between Japanese and European studies. These were resolved by the ICH, which in 1993 published a guideline entitled Detection of Toxicity to Reproduction for Medicinal Products. ... 

The CARE-HF study was a European study of medical therapy alone versus medical therapy with the addition of a CRT pacemaker [119]. A total of 813 patients were enrolled and randomized in a 1 1 ratio prior to device implant, again a true intent-to-treat design. Patients were followed longer than in the COMPANION trial, for a mean of 29.4 months. The primary end point was the time to... 

Alonso J, Angermeyer MC, Bernert S, et al (2004) Prevalence of mental disorders in Europe results from the European Study of the Epidemiology of Mental Disorders (ESEMeD) project. Acta Psychiatr Scand Suppl 420 21-27 Andrade L, Caraveo-Anduaga JJ, Berglund P, Bijl R, Kessler RC, Dernier O, Walters E, Kylyc C, Offord D, Ustun TB, Wittchen H-U (2000) Cross-national comparisons of the prevalences and correlates of mental disorders. Bull World Health Organ 78 413-426... 

Lepine JP, Gastpar M, Mendlewicz J, Tylee A (1997) Depression in the community the first pan-European study DEPRES (Depression Research in European Society). Int Clin Psychopharmacol 12 19-29... 

Sydow et al Multicentre European study of thalamic stimulation in essential tremor A six year follow up. J Neurol Neurosurg Psychiatry 2003 74 1387. [PMID 14570831]... 

We focus in this chapter on particles from ambient origin. We first illustrate differences in outdoor and personal exposure using data on real-time particle number concentrations (PNC) from a recent study in Augsburg, Germany. We then present a model of indoor PM concentrations, illustrating the factors that affect indoor air quality. We summarize empirical studies that have assessed indoor-outdoor relationships for particle mass, particle number, and specific components of particulate matter. The focus is on European studies, but we included key studies from outside Europe as well. We conclude by comparing the strength of indoor-outdoor relationships of various particle fractions and components. 

Direcks A, Figueroa S, Mintzes B, Banta D. DES European Study DES Action the Netherlands for the European Commission Programme Europe Against Cancer . Utrecht DES Action the Netherlands 1991 13 25. 

Fosfestrol is an unusual agent used in Japan for the treatment of prostatic carcinoma but not accepted by experts in Europe. Described as an estrogen, in European studies it had a high incidence of complications, including fluid retention (16%), myocardial infarction (10%), and thromboembolism (6.3%). A case of adrenocortical insufficiency has now been documented in Japan, involving a 59-year-old man who had taken the drug for 10 years (3). 

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