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D. B. PEARLSTONE ET AL. hormone and lipid levels, cardiac symptoms or events, episodes of dysfunctional uterine bleeding, psychosocial issues, bone mineral density, and Papanicolaou smears will be assessed at various times throughout the study. Additional clinical studies have also been initiated or are in the planning stages. In Scandinavia the HABITS trial Hormonal replacement therapy after breast cancer diagnosis-is it safe? ; , in which women with a history of breast cancer are randomized to either hormone replacement therapy or no hormone replacement therapy for 5 years, is currently underway. In the United Kingdom, the tibolone trial is currently randomizing women to receive tamoxifen plus tibolone a synthetic steroid hormone with progestational effects ; or tamoxifen plus placebo for 12 months. Endpoints include symptomatic relief and endometrial pathological changes. The Eastern Cooperative Oncology Group has approved and will soon be implementing a 6-month pilot study comparing tamoxifen and hormone replacement therapy with tamoxifen and placebo, with respect to their effects on menopausal symptomatic relief. The Southwest Oncology Group is also currently in the planning stages of a trial comparing 9-month treatment with megestrol acetate Megace ; with placebo treatment for relief of menopausal symptoms. Data from these studies are expected to permit scientifically valid conclusions regarding the role of hormone replacement for patients with breast cancer.
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Fixed working week AfC dictates that the working week for all Clinical Scientists is now 37.5 hours. Anything over and above that should be taken as time off in lieu at plain time although those at Band 7 can be paid overtime. For those previously contracted to work less than 37.5 hours protection may be in place. On call again terminology is important here and the definition of "on call" under AfC is different from what was understood under Whitley. AfC on call is essentially availability to provide an out-of-hours telephone consultancy. Anyone who is expected to be available for telephone advice out-of-hours on a regular basis is entitled to a percentage payment based on basic salary and frequency of provision. Moreover, it has been recently established that where this is a regular commitment then the payment is pensionable. It is important to emphasize that it is not the number of telephone calls that you receive which determines the frequency of provision but the frequency that you are expected to participate in the rota. For example, if there are three of you equally covering all out of hours on call then you should be each paid an extra 9.5% of your basic pay whether or not you receive any calls. In the event of actually being called out then a payment rated at time and a half or double time if on a bank holiday ; should be paid for the time spent on site together with travel time. Your trust may have a local agreement that sets a minimum call out period these are usually set up for Estates staff but should equally apply to you. Unlike overtime, this payment is not barred to staff in bands 8 or 9. Alternatively, time may be taken off in lieu at plain time. If you are on-call on a public holiday you get an additional day off in lieu. Unsocial hours at the moment this is still under review and current indications are that a final solution will be delayed until April next year. Interim conditions have been specified. For those groups, including ourselves, which didn't have unsocial hours provision prior to October 2004 then the previous Whitley terms and conditions for Nurses and Mid-wives apply. Unsocial hours payment is only due on those hours that are counted part of your normal 37.5 hour working week. For the many of us, this may include any weekend authorizing required of us provided it is not in addition to our normal hours. It also raises the possibility of payment for any remote from home ; authorizing that is performed after 8 p.m. There has been no national guidance on this and, as with so many issues with AfC, may require local negotiation and resolution. However work is work wherever you happen to be when you are doing it. If the trust wants the tasks done then it has to give you the consideration. Recruitment and Retention Premia RRP ; none of our members are eligible for pre-agreed national RRP though associate BMS staff are ; and thus the local criteria given in Appendix J regarding local recruitment difficulties ; of the handbook apply. Again, it is worth noting that RRP applies to posts and not individuals and the guidance in the handbook is quite explicit in describing the protocol that should be followed. RRP is a supplementary payment that should not exceed 30% of basic pay. For those fortunate enough to be in such a post you must beware any ad hoc agreements that deviate from the handbook, especially for long-term RRP, as it may jeopardize the principles of it being pensionable and counting towards over-time, unsocial hours and on-call payments. Finally, it is also worth re-visiting an earlier article published in the September 2005 issue of the News, "Agenda for Change .Now you know your banding" which is also reproduced on the re-vamped FCS website : federation.acb ; . s and tiotropium, for example, estrogen.
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We sought to determine the effect of tibolone on myocardial perfusion in postmenopausal women with ischemic heart disease. BACKGROUND T9bolone is a steroid that relieves climacteric symptoms and prevents osteoporosis. Recent studies have suggested a cardioprotective effect of this compound. However, its role on myocardial perfusion remains uncertain. METHODS Single-photon emission computed tomography myocardial perfusion imaging was performed in 26 postmenopausal women. Patients were randomly assigned to tibolone for six months treatment group ; or to usual care control group ; . All women underwent cardiac imaging at baseline and at six months. RESULTS Mean stress perfusion defect summed stress score ; was moderate and did not differ between the two groups 8 3 vs. 9 4; p NS ; Summed difference score also was similar for both groups 7 3 vs. 8 3; p NS ; The six-month study reveled that summed stress and summed difference scores significantly improved in the treatment group to 3 and to 2 p 0.001 ; whereas it remained unchanged for control patients to 10 4 and to 8 2; p CONCLUSIONS In postmenopausal women with ischemic heart disease, six months of therapy with tibolone significantly improved stress myocardial perfusion and the "amount of ischemia." J Coll Cardiol 2006; 47: 559 ; 2006 by the American College of Cardiology Foundation OBJECTIVES and tizanidine.
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Reference title Inclusion or exclusion Gong, H., Jr. 1992, "Air travel and oxygen therapy in GDG rec included intro cardiopulmonary patients", Chest, vol. 101, no. 4, pp. 1104-1113. In progress Holubarsch, C. J., Colucci, W. S., Meinertz, T., Gaus, W., & Tendera, M. 2000, "Survival and prognosis: investigation of Crataegus extract WS 1442 in congestive heart failure SPICE ; -rationale, study design and study protocol", European Journal of Heart Failure, vol. 2, no. 4, pp. 431-437. Kihara, T., Biro, S., Imamura, M., Yoshifuku, S., Takasaki, K., Ikeda, Y., Otuji, Y., Minagoe, S., Toyama, Y., & Tei, C. 1906, "Repeated sauna treatment improves vascular endothelial and cardiac function in patients with chronic heart failure", Journal of the American College of Cardiology., vol. 39, no. 5, pp. 754-759. 56 Kostis, J. B., Rosen, R. C., Cosgrove, N. M., Shindler, D. M., & Wilson, A. C. 1994, "Nonpharmacologic therapy improves functional and emotional status in congestive heart failure", Chest, vol. 106, no. 4, pp. 996-1001. Luskin, F., Newell, K., & Haskel, W. 1999, "Stress management training of elderly patients with congestive heart failure: Pilot study", Preventive Cardiology, vol. 2, no. 3, pp. 101-104. Maillefert, J. F., Eicher, J. C., Walker, P., Dulieu, V., RouhierMarcer, I., Branly, F., Cohen, M., Brunotte, F., Wolf, J. E., Casillas, J. M., & Didier, J. P. 1998, "Effects of low-frequency electrical stimulation of quadriceps and calf muscles in patients with chronic heart failure", Journal of Cardiopulmonary Rehabilitation, vol. 18, no. 4, pp. 277-282. McAlister, F. A., Lawson, F. M., Teo, K. K., & Armstrong, P. W. 2001, "A systematic review of randomized trials of disease management programs in heart failure. [see comments]", American Journal of Medicine, vol. 110, no. 5, pp. 378-384. Mills, F. J. & Harding, R. M. 1983, "Fitness to travel by air. I: Physiological considerations", Br Med J Clin Res Ed ; , vol. 286, no. 6373, pp. 1269-1271. Monpere, C. 1998, "Cardiac rehabilitation. Guidelines and recommendations", Disease Management & Health Outcomes, vol. 4, no. 3, pp. 143-156. Included, for instance, weight gain.
For example, in 1999, the national institutes of health launched a major research effort that will attempt to answer some of the many questions that remain and
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With E2 and tibolone on the extent of atherosclerosis. In that study oral tibolone at all three doses and sc administered E2 decanoate resulted in significantly less atherosclerosis than placebo treatment. However, unlike in women, the HDLC concentrations were not reduced in the tibolone groups, and total cholesterol was reduced by 50 70%. In previous studies performed by our group, we found that despite reductions in HDLC with oral contraceptive treatment, there was no exacerbation of coronary artery atherosclerosis CAA ; 13 ; . Thus, the primary purpose of this study was to determine whether tibolone-induced reductions in HDLC resulted in worsened atherosclerosis. In a preliminary study we determined that postmenopausal cynomolgus monkeys Macaca fascicularis ; shared with postmenopausal women decreases in HDLC after tibolone treatment 40 50% decreases were observed with monkeys ; . Reported herein are the results of a long-term study with surgically postmenopausal cynomolgus monkeys designed to evaluate the effects of tibolone on CAA and bone mineral density BMD ; and to compare those effects with the effects of conjugated equine estrogens CEE ; treatment, and treatment with CEE plus medroxyprogesterone MPA ; administered continuously.
And this Hi Tib effect was less than half the effect of CEE + MPA. In contrast to CEE and CEE + MPA, neither Lo Tib nor Hi Tib significantly increased endometrial Ki-67 or mammary lobular area. The lack of a proliferative response of the endometrium to tibolone, coupled with the lower incidence of endometrial bleeding, suggest that tibolone may have advantages over CEE and CEE + MPA regarding endometrial safety and efficacy.23 CONCLUSIONS Cynomolgus and rhesus macaques are uniquely suited to studies of multiple chronic diseases of relevance to postmenopausal women. In particular, the unique pathophysiologic features of the primate endometrium and breast require that periclinical studies of hormonallyactive compounds be done in monkeys. Studies of the multiple effects of HRTs, SERMs, and phytoestrogens are urgently needed. A cooperative multi-systemic approach to the use of nonhuman primates allows evaluation of novel agents and strategies in a controlled setting in a relatively short period of time while minimizing animal numbers used. With respect to the reproductive tract and breast, results from the monkey model have almost invariably predicted or mirrored human clinical outcomes. Further evaluations of HRTs and dietary phytoestrogens are in progress using these uniquely valuable animals to study issues critical to the health of women. REFERENCES and
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Among obese women, who are at higher risk of endometrial cancer than non-obese women, tibolone and estrogen-only hrt had little effect on risk, whereas combined hrt significantly reduced the incidence.
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Mean values were for e2 neta 5 1 years, 2 8 kg m sup 2 , and 2 years; for tibolone 5 2 and 9; and for placebo 5 2, and 6, respectively and
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36 comparison of the antiatherosclerotic effect of tibolone with that of estradiol and ethinyl estradiol in cholesterol-fed, ovariectomized rabbits.
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In this study we have examined the ability of tibolone and its metabolites to inhibit e1-sts activity in intact breast cancer cells, its effect on e1-sts activity in placental microsomes and also the expression of e1-sts mrna in more detail.
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The biomedical industry -- composed of pharmaceutical, biotech, medical device and diagnostics segments -- is shaped by a variety of distinctive forces. Among these are the need for specialized human capital, a formidable regulatory approval process, high sunk costs, a complex financing structure, science risks, and a range of ethical and political issues. The outlook for the industry in the next 10 years is very positive. It will experience explosive growth in markets for the treatment of both chronic and acute illnesses. These markets will be driven by a confluence of political and demographic trends -- most notably globalization and population growth and aging -- as well as by new products resulting from the genomic discoveries of the late 1990s and early 2000s and a generally favorable policy environment. This report makes the case for fundamental changes in the biomedical industry in the coming years. It anticipates the ascendance of personalized medicine and suggests ways in which industry players will have to adapt to profound demographic, political and technological shifts in order to compete successfully in a world transformed by forces of globalization. This executive summary highlights three principal aspects of the case presented fully in the larger paper, which will be made available in its entirety at the end of April: 1. Background: Basic Characteristics of the Biomedical Industry 2. Adapting to a "Flat" World: Implications of Globalization and Opportunities for the Industry 3. Business Models: How Successful Industry Players Can Adapt to Changing Conditions.
Friedman et al., 1994; Palomba et al., 1999 ; with a long-term follow-up of 2 years are available in the literature evaluating progestin or estro-progestin and tibolone addition to GnRH agonist as add-back therapy in women with uterine leiomyomas. The bone loss is the main and most studied side effect related to GnRH agonist use Surrey, 1995 ; . The continuous administration of GnRH agonist induces a signicant bone loss depending on the dose of the analogue, on the length of the.
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Delinquency, drug and alcohol issues, and music preference. The BARTS appears to be sensitive to delinquent and self-harming behaviors, and to the gradation of seriousness within the spectrum of suicide. The Early Detection of Emotional Disorders Program is another comprehensive bio-psycho-social predictive scale based on risk identified for suicidal behavior Martin et al., 1997 ; , which is also aimed at adolescents. Media Communications Overall, the evidence to date suggests that suicide contagion is a real effect, albeit of a smaller effect size than many other psychiatric and psychosocial risk factors for suicide Velting & Gould, 1997 ; . Hassan 1995 ; , for example, investigated the impact of media coverage on the incidence of suicide in Australia. Suicide stories appearing in two major metropolitan newspapers during 19811990 were examined for their position, size, and contents. Daily average male and female suicides were computed for the day of the high impact story and the following 2 days. The daily average male suicide rate increased significantly during the high impact period. Female suicide rates showed no such variance. Results showed that high impact stories may raise the suicide risk among vulnerable young men. Stack's 2000 ; recent review of the literature analyzed 293 findings from 42 studies on the possible impact of publicized suicide stories on suicide between 19741996. A logistic regression analysis found that characteristics of the stories were key predictors of finding a copycat effect. In particular, studies measuring the presence of either an entertainment or political celebrity suicide were 14.3 times more likely to find a copycat effect than studies that did not. Studies based on real stories as opposed to fictional stories were 4.03 times more apt to uncover an imitation effect. The medium of coverage was a significant predictor of copycat.
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AAPS PharmSciTech. Accepted: February 14, 2005. Author's final version. REFERENCES 1. Muller RH, Olbrich C. Solid lipid nanoparticles: Phagocytic uptake, in vitro cytotoxicity and in vitro biodegradation. Drugs made in Germany. 1999; 42: 49-53.
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