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1. Nagore E, Insa A, Sanmartin O. Antineoplastic therapy-induced palmar plantar erythrodysesthesia `hand-foot' ; syndrome: incidence, recognition and management. J Clin Dermatol 2000; 1: 225234. Lokich JJ, Moore C. Chemotherapy-associated palmar-plantar erythrodysesthesia syndrome. Ann Intern Med 1984; 101: 798799. Comandone A., Bretti S, La Grotta G et al. Palmar-plantar erythrodysestasia syndrome associated with 5-fluorouracil treatment. Anticancer Res 1993; 13: 17811783. Ellis GK, Livingstone RB, Gralow JR et al. Dose-dense anthracycline-based chemotherapy for node-positive breast cancer. J Clin Oncol 2002; 20: 36373643. Marini A, Hengge UR. Hand-foot syndrome with capecitabine therapy. Hautarzt 2006; 3. 6. Rifkin RM, Gregory SA, Mohrbacher A et al. Pegylated liposomal doxorubicin, vincristine, and dexamethasone provide significant reduction in toxicity compared with doxorubicin, vincristine, and dexamethasone in patients with newly diagnosed multiple myeloma: a phase III multicenter randomized trial. Cancer 2006; 106: 848858. O'Brien ME, Wigler N, Inbar M et al. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl CAELYX Doxil ; versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol 2004; 15: 440449. Gordon AN, Fleagle JT, Guthrie D et al. Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan. J Clin Oncol 2001; 19: 33123322.
262 Johnston DW, Gold A, Kentish J, Smith D, Vallance P, Shah D et al. Effect of stress management on blood pressure in mild primary hypertension. Br Med J 1993; 306: 963-966. Linden W, Lenz JW, Con AH. Individualized stress management for primary hypertension: a randomized trial. Arch Intern Med 2001; 161: 1071-1080. McGrady A. Effects of group relaxation training and thermal biofeedback on blood pressure and related physiological and psychological variables in essential hypertension. Biofeedback Self Regul 1994; 19: 51-66. Patel C, Marmot MG, Terry DJ. Controlled trial of biofeedback-aided behavioural methods in reducing mild hypertension. Br Med J 1981; 282: 2005-2008. Patel C, Marmot MG, Terry DJ, Carruthers M, Hunt B, Patel M. Trial of relaxation in reducing coronary risk: four year follow up. Br Med J 1985; 290: 1103-1106. Patel C, .Marmot M. Can general practitioners use training in relaxation and management of stress to reduce mild hypertension? Br Med J 1988; 296: 21-24. Schein MH, Gavish B, Herz M, Rosner-Kahana D, Naveh P, Knishkowy B et al. Treating hypertension with a device that slows and regularises breathing: a randomised, double-blind controlled study. J Hum Hypertens 2001; 15: 271-278. Seer P, .Raeburn JM. Meditation training and essential hypertension: a methodological study. J Behav Med 1980; 3: 59-71. van Montfrans, Karemaker JM, Wieling W, Dunning AJ. Relaxation therapy and continuous ambulatory blood pressure in mild hypertension: a controlled study. Br Med J 1990; 300: 1368-1372. Cottier C, Shapiro K, Julius S. Treatment of mild hypertension with progressive muscle relaxation. Predictive value of indexes of sympathetic tone. Arch Intern Med 1984; 144: 1954-1958. Hoelscher TJ, et al. Relaxation treatment of hypertension: do home relaxation tapes enhance treatment outcome? Behavior Therapy 1987; 18: 33-37. Zurawski RM, Smith TW, Houston BK. Stress management for essential hypertension: comparison with a minimally effective treatment, predictors of response to treatment and effects on reactivity. J .Psychosom Res 1987; 31: 453-462. Taylor BC, Farquhar JW, Nelson E, Agras S. Relaxation therapy and high blood pressure. Arch Gen Psychiatry 1977; 34: 339-342. Chesney MA, Black GW, Swan GE, Ward MM. Relaxation training for essential hypertension at the worksite: I The untreated mild hypertensive. Psychosom Med 1987; 49: 250-263. Hafner RJ. Psychological treatment of essential hypertension: a controlled comparison of meditation and meditation plus biofeedback. Biofeedback Self Regul 1982; 7: 305-316. LaGrone R, Jeffrey TB, Ferguson CL. Effects of education and relaxation training with essential hypertension patients. J Clin Psychol 1988; 44: 271-27. McGrady AV, et al. The effect of biofeedback-assisted relaxation training on blood pressure and selected biochemical parameters in patients with essential hypertension. Biofeedback and Self-Regulation 1981; 6: 343-353. Goldstein IB, Shapiro D. Comparison of drug and behavioral treatments of essential hypertension. Health Psychol 1982; 1: 7- Blanchard EB, et al. Evaluation of biofeedback in the treatment of borderline essential hypertension. J Appl Behav Anal 1979; 12: 99109. Aivazyan TA, et al. Efficacy of relaxation techniques in hypertensive patients. Health Psychol 1988; 193-200. 282 Irvine MJ, et al. Relaxation and stress management in the treatment of essential hypertension. J Psychosom Res 1986; 30: 437-450. Bosley F. Stress management training for hypertensives: cognitive and physiological effects. J Behav Med 1989; 12: 77-89. Murugesan R, Govindarajulu N, Bera TK. Effect of selected yogic practices on the management of hypertension. Indian Journal of Physiology & Pharmacology 2000; 44: 207-210. Bosley F. Stress management training for hypertensives: cognitive and physiological effects. J Behav Med 1989; 12: 77-89. Spence JD. Barnett PA, Linden W, Ramsden V, Taenzer P. 7. Recommendations on stress management CMAJ 1999; 160: S46S50. 287 Applegate WB, Miller ST, Elam JT, Cushman WC, El Derwi D, Brewer A et al. Nonpharmacologic intervention to reduce blood pressure in older patients with mild hypertension. Arch Intern Med 1992; 152: 1162-1166. Blumenthal JA, Sherwood A, Gullette EC, Babyak M, Waugh R, Georgiades A et al. Exercise and weight loss reduce blood pressure in men and women with mild hypertension: effects on cardiovascular metabolic and hemodynamic functioning. Arch Intern Med 2000; 160: 1947-1958. Kostis JB, Rosen RC, Brondolo E, Taska L, Smith DE, Wilson AC. Superiority of nonpharmacologic therapy compared to propranolol and placebo in men with mild hypertension: a randomized, prospective trial. Heart J 1992; 123: 466-474. Anderssen S, Holme I, Urdal P, Hjermann I. Diet and exercise intervention have favourable effects on blood pressure in mild hypertensives: the Oslo Diet and Exercise Study ODES ; . Blood Press 1995; 4: 343-349. Torjesen PA, Birkeland KI, Anderssen SA, Hjermann I, Holme I, Urdal P. Lifestyle changes may reverse development of the insulin resistance syndrome. The Oslo Diet and Exercise Study: a randomized trial. Diabetes Care 1997; 20: 26-31.
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JAP-00240-2001.R2 A Peripheral Cholinergic Pathway Modulates Stress-Induced Hyperthermia in the Rat Exposed to an Open-Field Stress.
Neurohormonal systems in the pathogenesis of congestive heart failure CHF ; has been increasingly recognized 12, 14, 27 ; . Numerous studies in patients and in experimental models of CHF have established the important role of the renin-angiotensin-aldosterone system.
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A total of 16 patients including 14 with recurrent ovarian cancer and two with fallopian tube carcinomas were identified as receiving 1-year caelyx doxil at the cut-off date of june 2004.
AC DOXIL doxorubicin HCI ; liposome injection and cyclophosphamide Brand names: Cytoxan, Neosar ; . Taxol generic name paclitaxel ; Injections is a registered trademark of Bristol-Myers Squibb Company. Data presented by Romond EH et al. at ASCO May 2005 and dronabinol.
According to Brockway et al. 28 ; . Transmitters TL 10-M2-C50-PE, TL11-M2-C50-PXT ; were implanted in the abdominal aorta, and two electrodes were implanted subcutaneously 28 ; . Receivers RLA 1000, RA 1000 ; were placed underneath the cage. The maximum transmitter range was 40 cm. Tissue Preparation. At the end of the experiment, retrograde perfusion fixation was performed as described above. Instead of ice cold NaCl, 3% glutaraldehyde was used 29 ; . After the perfusion, the heart of each animal was taken out for determination of weight and volume, and tissue sampling and section staining were performed according to the orientator method 29, 30 ; . Uniformly random sampling was achieved by preparing a set of equidistant slices of the left ventricle and the interventricular septum with a random start. Two slices were selected by area weighted sampling and processed using the orientator method. Semithin sections 1 m ; were prepared and stained with methylene blue and basic fuchsin. Quantitative Stereology. All investigations were performed in a blinded manner i.e., the observer was unaware of the protocol ; . Length density LV ; of capillaries i.e., the length of capillaries per unit tissue volume ; was measured on eight differentially oriented semithin sections per animal as described in detail elsewhere 29, 30 ; . Total capillary length per left ventricle was derived from LV times left ventricular volume LVvolume ; i.e., left ventricular weight [LVW] divided by specific weight ; . Intercapillary distance i.e., the distance between the centers of two adjacent intramyocardial capillaries ; was calculated according to a modification of the formula of Henquell and Honig 29, 31 ; . Morphologic techniques such as counting of capillary transects per area myocardial tissue and point counting are highly reproducible methods for tissue analysis. Intraobserver error of means of stereologic parameters i.e., capillary LV ; is 1%, whereas interobserver error is approximately 3.
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Errors involving the interchange of these drugs."6 JCAHO expects facilities to develop a list of lookalike sound-alike drugs that contains a minimum of 10 drug combinations from a JCAHO-provided list.7 Following is a list of JCAHO-identified name pairs that have been reported to PA-PSRS: Hydromorphone and morphine Insulin products Lipid-based doxorubicin DOXIL ; and conventional doxorubicin ADRIAMYCIN ; TAXOL paclitaxel ; and TAXOTERE docetaxel ; AMARYL glimepiride ; and REMINYL galantamine ; AVANDIA rosiglitazone ; and COUMADIN warfarin ; KLONOPIN clonazepam ; and clonidine CATAPRES ; LAMISIL terbinafine ; and LAMICTAL lamotrigine ; HESPAN hetastarch ; and heparin Whenever possible, having prescribers indicate the purpose of the medication on the order form or electronic transmission. Pharmacy and nursing could determine the indication or purpose of the medication if not noted by the prescriber prior to dispensing or drug administration. Most products with look-alike sound-alike names do not have similar indications for use. Considering the possibility of name confusion and instituting safeguards to avoid confusion when adding a new product to your organization's formulary. Encouraging the reporting of errors and potentially hazardous conditions within your organization to help focus your error prevention activities on those drug names that are commonly involved in errors and dss.
Protiviti, a leading risk consulting organization, identifies three imperatives for CIOs in optimizing their IT environment for SOX.7 One imperative is to "increase effectiveness of and reliance on automated controls." Gartner Research's advice to IT executives includes the use of automation among their 10 best practices for SOX.8 And it pays. According to Aberdeen's "The Insider Threat Benchmark Report, " among organizations using technology to address the insider threat, a 17.5% decrease in IT labor costs was realized. Further, they noted that the use of technology is associated with those organizations cited as best-in-class for data protection.9!
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MEDICO LABS, INC. NEW JERSEY CORPORATION ; 1000 NOTTINGHAM WAY HAMILTON, NJ 08609 FOR: PHARMACEUTICAL PRODUCT RESEARCH AND DEVELOPMENT; DESIGN SERVICES FOR OTHER IN THE FIELD OF PHARMACEUTICALS, IN CLASS 42 U.S. CLS. 100 AND 101.
SOURCES The U.S. Army Center for Health Promotion and Preventive Medicine : chppm- apgea.army l ; has produced this technical guide TG ; by integrating instructional material contributed by numerous military physicians and scientists. The TG is comprised of updated excerpts from existing U.S. Army publications, as well as new information that is directly relevant for current military operations. Original text for a large portion of this TG was contributed by the U.S. Army Medical Research and Materiel Command s: mrmc- army l ; through four of its laboratories and duragesic.
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PART I ITEM 1. BUSINESS GENERAL Johnson & Johnson, employing approximately 109, 900 people worldwide, is engaged in the manufacture and sale of a broad range of products in the health care field. Johnson & Johnson has over 200 subsidiaries that conduct business in virtually all countries of the world. Johnson & Johnson's primary interest, both historically and currently, has been in products related to human health and well-being. Johnson & Johnson was organized in the State of New Jersey in 1887. Johnson & Johnson is organized on the principle of decentralized management. The Executive Committee of Johnson & Johnson is the principal management group responsible for the operations and allocation of the resources of the Company. This Committee oversees and coordinates the activities of the Consumer, Pharmaceutical and Medical Devices and Diagnostics business segments. Each subsidiary within the business segments is, with some exceptions, managed by citizens of the country in which it is located. SEGMENTS OF BUSINESS Johnson & Johnson's worldwide business is divided into three segments: Consumer, Pharmaceutical and Medical Devices and Diagnostics. Additional information required by this item is incorporated herein by reference to the narrative and tabular but not the graphic ; descriptions of segments and operating results under "Management's Discussion and Analysis of Results of Operations and Financial Condition" on pages 28 through 38 and 64 of Johnson & Johnson's Annual Report to Shareholders for fiscal year 2004 which is filed as Exhibit 13 to this Report on Form 10-K. CONSUMER The Consumer segment manufactures and markets a broad range of products used in the baby and child care, skin care, oral and wound care and women's health care fields, as well as over-the-counter pharmaceutical and nutritional products. Major brands include AVEENO skin care products; BAND-AID Brand Adhesive Bandages; CAREFREE Pantiliners; CLEAN & CLEAR teen skin care products; JOHNSON'S Baby line of products; MOTRIN IB ibuprofen products; PEPCID AC Acid Controller from Johnson & Johnson - Merck Consumer Pharmaceuticals Co.; NEUTROGENA skin and hair care products; RoC skin care products; SPLENDA, a no calorie sweetener; STAYFREE sanitary protection products; and the broad family of TYLENOL acetaminophen products. These products are marketed principally to the general public and sold both to wholesalers and directly to independent and chain retail outlets throughout the world. PHARMACEUTICAL The Pharmaceutical segment's principal worldwide franchises are in the antifungal, anti-infective, cardiovascular, contraceptive, dermatology, gastrointestinal, hematology, immunology, neurology, oncology, pain management, psychotropic central nervous system ; and urology fields. These products are distributed both directly and through wholesalers and health care professionals for use by prescription by the general public. Key products in the Pharmaceutical segment include: PROCRIT Epoetin alfa, sold outside the U.S. as EPREX ; , a biotechnology derived product that stimulates red blood cell production; DURAGESIC fentanyl transdermal system, sold abroad as DUROGESIC ; , a treatment for chronic pain that offers a novel delivery system; RISPERDAL risperidone ; and RISPERDAL CONSTA risperidone long-acting injection ; , for treatment of the symptoms of schizophrenia; REMICADE infliximab ; , a novel monoclonal antibody therapy indicated to treat the symptoms of Crohn's disease, rheumatoid arthritis and ankylosing spondylitis; LEVAQUIN levofloxacin ; and FLOXIN ofloxacin ; , both in the anti-infective field; TOPAMAX topiramate ; , an anti-epileptic and migraine prevention treatment; ORTHO EVRA norelgestromin ethinyl estradiol transdermal system ; , the first contraceptive patch approved by the Food and Drug Administration FDA ; and ORTHO TRI-CYCLEN LO norgestimate ethinyl estradiol ; , a low dose oral contraceptive; DOXIL doxorubicin ; , a cancer treatment; DITROPAN XL oxybutynin chloride ; , for and echinacea.
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Serum phosphate levels decreased upon androgen treatment, which may be explained by the concomitant decrease in TmPO, GFR. This may be due to either testosterone administration itself or the subsequent decrease in endogenous estrogens. The latter is unlikely because comparable events with respect to the loss of endogenous estrogens, such as menopause 30 ; and ovariectomy 31 ; , are associated with an increase in serum phosphate levels and a concomitant increase in TmPO, GFR. The effect of testosterone administration on the renal handling of phosphate and serum phosphate levels in men or women has, as far as we know, not been studied. Regarding our finding of a decreased TmPO, GFR, it is important to consider that testosterone treatment had increased the levels of Cr and urinary Cr excretion in the transsexuals. These changes may have influenced the tubular reabsorption of phosphate and, thus, the determination of TmPO, GFR by the formula and nomogram used. Therefore, we cannot be conclusive whether the decrease in serum phosphate is indeed associated with a decrease in TmPO, GFR; consequently, elucidation of the observed decline in serum phosphate remains uncertain. Administration of ethinyl estradiol in combination with cyproterone acetate to males induced a dramatic decline in serum IGF-I levels without changes in its major binding protein, IGFBP-3. This is in agreement with earlier studies on the effect of oral estrogen administration in postmenopausal women 21 ; , men with prostate cancer 32 ; , and M-F transsexuals 33, 34 ; . Meyer et al. 34 ; showed that medroxyprogesterone acetate administration to M- + F transsexuals increased IGF-I levels. Consequently, the findings of our report suggest that the progestagen-like compound cyproterone acetate administered to M- + F transsexuals may have been unable to reverse the sharp decline in serum IGF-I levels caused by oral ethinyl estradiol treatment. The present study shows that testosterone administration to eugonadal females increases IGF-I levels. In agreement herewith, testosterone administration to hypogonadal men 351, eugonadal men 20 ; and oophorectomized women 36 ; has been shown to increase IGF-I levels. Alhough Meyer et al. 34 ; found no significant changes in serum IGF-I levels during parenteral testosterone administration in F- + M transsexuals, this might be explained by the different assays to measure IGF-I used in their and our studies and doxil.
First position call shall mean a call in which at least percent % ; of the presentation is dedicated solely to the product or the product in combination with doxil, each in accordance with the co-promotion plan and in which the product or the product in combination with doxil is the first product presented to the first position target and efalizumab.
Fore, urinary measurements of thromboxane metabolites have been used by many investigators to estimate thromboxane biosynthesis in vivo.27 We were unable to demonstrate an effect on the generation of thromboxane metabolites with ketoconazole. Interleukin 6 was selected as a generic marker of a systemic inflammatory response.28, 29 None of the prophylaxis trials measured this cytokine. We reasoned that if the arachidonic acid cascade was altered, there might be less secondary stimulation of other inflammatory pathways. We were unable to demonstrate such an effect. It is possible that the lack of effect of ketoconazole on clinical outcomes relates to the lack of a clinically significant effect on pulmonary and systemic inflammation. While the dosage chosen for this study was reasonable given previous clinical data, the dose-response curve of ketoconazole in ALI is unknown. It is conceivable that lower blood levels of ketoconazole, such as those seen in Yu and Tomasa's study, 14 have more of an anti-inflammatory effect than the higher levels achieved in this study. Biphasic dose-response effects have been observed when manipulating arachidonic acid metabolism as well as in the treatment of severe sepsis.30, 31 Although 21% of patients receiving ketoconazole developed abnormalities in liver enzymes with a hepatocellular or cholestatic liver injury pattern sufficient to suggest drug-induced hepatitis, this number was not significantly different from the placebo group 17% ; , and no serious adverse effects related to liver failure were reported. Thus, we believe most of these abnormalities were due to coexistent illness rather than to ketoconazole. This large, multicenter trial did not confirm promising initial reports from 3 smaller studies. Given the heterogeneous population studied, we believe our findings are generalizable to the majority of patients with ALI. The dosage and timing of the ketoconazole administration and patient selection do not appear to explain these disappointing results. Higher blood levels of ketoconazole were achieved than in previJAMA, April 19, 2000--Vol 283, No. 15 2001.
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1 Zhang JH, Geng ZH, Duan JY, Chen JT, He H, Huang JY. Calmodulin antagonist-effect of berbamine and its derivatives on the cytotoxicity of normal cells. Xibao Shengwuxue Zazhi 1997; 19: 76-79 Liu J, Qi S, Zhu H, Zhang J, Li Z, Wang T. The effect of calmodulin antagonist berbamine detivative-EBB on hepatoma in vitro and vivo. Chin Med J 2002; 115: 759-762 Zhang JH, Mao QL, Xu NH, Du XM, Shan T, Chen JT. Effect of calmodulin antagonist on calmodulin content in organs of mice bearing tumor. Nankai Daxue Xuebao 1998; 31: 72-77 Zhang JH, Mao QL, Xu NH, Chen JT. Effect of berbamine derivative EBB ; on anticancer and immune function of tumor-bearing mice. Zhongcaoyao 1998; 29: 243-246 Koh E, Ueda Y, Nakamura T, Kobayashi A, Katsuta S, Takahashi H. Apoptosis in young rats with adriamycin-induced cardiomyopathy--comparison with pirarubicin, a new anthracycline derivative. Pediatr Res 2002; 51: 256-259 Forrest GL, Gonzalez B, Tseng W, Li X, Mann J. Human carbonyl reductase overexpression in the heart advances the development of doxorubicin-induced cardiotoxicity in transgenic mice. Cancer Res 2000; 60: 5158-5164 Working PK, Newman MS, Sullivan T, Yarrington J. Reduction of the cardiotoxicity of doxorubicin in rabbits and dogs by encapsulation in long-circulating, pegylated liposomes. J Pharmacol Exp Ther 1999; 289: 1128-1133 Pacher P, Liaudet L, Bai P, Virag L, Mabley JG, Hasko G, Szabo C. Activation of poly ADP-ribose ; polymerase contributes to development of doxorubicin-induced heart failure. J Pharmacol Exp Ther 2002; 300: 862-867 Lim HJ, Masin D, McIntosh NL, Madden TD, Bally MB. Role of drug release and liposome-mediated drug delivery in governing the therapeutic activity of liposomal mitoxantrone used to treat human A431 and LS180 solid tumors. J Pharmacol Exp Ther 2000; 292: 337-345 Weinstein DM, Mihm MJ, Bauer JA. Cardiac peroxynitrite formation and left ventricular dysfunction following doxorubicin treatment in mice. J Pharmacol Exp Ther 2000; 294: 396-401 Cabanes A, Even-Chen S, Zimberoff J, Barenholz Y, Kedar E, Gabizon A. Enhancement of antitumor activity of polyethylene glycol-coated liposomal doxorubicin with soluble and liposomal interleukin 2. Clin Cancer Res 1999; 5: 687-693 Lyass O, Hubert A, Gabizon AA. Phase I study of doxil-cisplatin combination chemotherapy in patients with advanced malignancies. Clin Cancer Res 2001; 7: 3040-3046 Gabizon AA. Stealth Liposomes and tumor targeting: one step further in the quest for the magic bullet. Clin Cancer Res 2001; 7: 223-225 Marina NM, Cochrane D, Harney E, Zomorodi K, Blaney S, Winick N, Bernstein M, Link MP. Dose escalation and pharmacokinetics of pegylated liposomal doxorubicin Doxil ; in children with solid tumors: a pediatric oncology group study. Clin Cancer Res 2002; 8: 413-418 Wang GW, Kang YJ. Inhibition of doxorubicin toxicity in cultured neonatal mouse cardiomyocytes with elevated metallothionein levels. J Pharmacol Exp Ther 1999; 288: 938-944 and eletriptan.
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