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Takahashi, Teikyo University School of Medicine, Tokyo, Japan, and T. Horie, Horie Dermatological Clinic, Tokyo, Japan, respectively. Preparation of inocula. Conidia were harvested from T. mentagrophytes KD-04 cultures grown on potato sucrose agar slants at 27C for 3 weeks. The culture was flooded with sterile saline containing 0.1% Tween 80 and scraped off with the aid of a loop. The conidial suspension was then pipetted into a test tube. After shaking, the suspension was filtered through gauze to remove hyphal fragments and agar blocks. The suspension was adjusted to make a conidial concentration of 2 x cells per ml by counting with a hemacytometer. Conidia and mycelia of M. canis KD-305 were harvested from cultures grown on Sabouraud glucose agar slants at 27C for 3 weeks. The experimental cell suspension was prepared as described above, except that the filtration step was not done. Determination of MIC and MFC. The in vitro fungistatic concentrations were determined by a serial dilution method by using Sabouraud glucose broth. Concentrations of the drugs ranged from 0.003 to 100 , ug ml. All tubes containing 3 ml of the assay medium were inoculated with approximately 3 x 104 cells and incubated at 30C for 7 days. The MIC was estimated as the lowest concentration that completely inhibited the growth of dermatophytes. The minimal fungicidal concentration MFC ; was estimated as the lowest concentration that prevented visible growth when subcultured onto Sabouraud glucose agar plates at 30C for 7 days. Infection. Infection was established by the procedure of Sakai et al. 10 ; . Briefly, hair was plucked by hand from an area 3 by 3 the backs of the guinea pigs to make a.
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Frequency of Types of Strokes, Prevalence, Incidence Rate, Mortality, and Disability after Stroke In most parts of the world, about 70 percent of strokes are due to ischemia, 27 percent are due to hemorrhage, and 3 percent are of unknown cause Gunatilake, Jayasekera, and Premawardene 2001 ; . Approximately 25 percent of all ischemic strokes are due to cardioembolic causes, with the proportion being higher among younger individuals. In some parts of the world--for instance, China and Japan--hemorrhagic strokes account for a greater proportion of all strokes, ranging from 17.1 to 39.4 percent in China Zhang and others 2003 ; to 38.7 percent in Japan Fukiyama and others 2000 ; . Comparable data do not exist for all parts of the world. Most morbidity data from Southeast Asian countries, for example, are hospital based and are, thus, likely to be underestimates, because many stroke patients die before they are brought to the hospital. Mortality data are also likely to be underestimates, because verifying the cause of death is usually difficult. In India, the prevalence of stroke has been estimated at 203 per 100, 000 population older than 20 Anand and others 2001 ; . The male-to-female ratio was one to seven. In Taiwan, China, the crude point prevalence was 592 per 100, 000 Huang, Chiang, and Lee 1997.
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5 In this report, FDA review staff refers to the staff in the Offices of Drug Evaluation III and V who reviewed the Plan B OTC switch application. The CDER structure described in this report is the one that existed at that time.
Hopper ordered blood work, which revealed high Hemoglobin A1C of 9.1% compared to a 4.3%-6.1% normal reference range, R. at 282 ; , low iron saturation of 8% compared to a 20-50% normal reference range, and a slightly low white blood cell count of 4.9 compared to a 5-10 reference range, R. at 283 ; . Huggins was taking Darvocet and imodium.
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Men are more likely to experience osteoporosis. CT stands for "computed tomography." It uses special X-ray equipment to capture images of the body from different angles. A computer processes the images to show a clear cross-section of body tissues and organs. If bone scans find problems in the bones, many doctors recommend MRI screening to evaluate them. Magnetic resonance imaging uses magnetism, radio waves, and a computer to produce detailed images of body structures. Many people believe that once cancer spreads, or metastasizes, to the bone, the outlook is poor. But people do live many years with cancer in their bones, most of them with no pain. These tumors--or lesions as your doctor may refer to them--can "scar" the bone. The lesions may continue to show up on bone scans, even after they have been treated and are no longer a problem. If that is the case, your doctor may order a more sensitive scan known as PET -- positron emission tomography. PET is an expensive test, not always covered by insurance. But if there is some uncertainty about whether the lesion is an active tumor, PET scans can help clarify that and chart a treatment course. In a PET scan, a radioactive substance is given to the patient either intravenously or as a gas that is inhaled. Tumors that are growing take up more of the substance than healthy tissue. The tumors "light up, " appearing brighter on the PET image. MEDICATIONS FOR BONE HEALTH When bones are weakened by cancer, they can break, sometimes spontaneously, without any apparent injury. But there are medications that help protect the bones: Zoledronic acid Zomeha ; is one of a class of drugs known as bisphosphonates. In men with prostate cancer, zoledronic acid prevents tumor cells from binding to the bone; they literally slip off, unable to get at the bone to make it weaker. Patients who are using leuprolide Lupron ; to treat advanced and meclizine.
IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF TENNESSEE NASHVILLE DIVISION IN AREDIA and ZOMETA PRODUCTS LIABILITY LITIGATION This document relates to: Case No. 3-05-0718 ; NO. 3: 06-MD-1760 ; JUDGE CAMPBELL MEMORANDUM Pending before the Court is Defendant's Motion for Summary Judgment on Carrie Lee's Claim Docket No. 628 ; . For the reasons stated herein, Defendant's Motion is GRANTED, and Plaintiff Carrie Lee's claims against Defendant in this action are DISMISSED. FACTS Plaintiff Carrie Lee has alleged in this action that she is at an increased risk of developing osteonecrosis of the jaw "ONJ" ; as a result of her use of the bisphosphonate drugs Zom4ta and or Aredia. Docket No. 690, 1. Defendant is the manufacturer of both Zlmeta and Aredia. Plaintiff has now conceded that she never took Zometa. Id., 2-4. Defendant has moved for summary judgment based upon their allegation that Plaintiff Lee also never took Aredia. Docket No. 628. It is undisputed that generic bioequivalents to Aredia have been manufactured and sold by manufacturers other than Defendant since April of 2001. Docket No. 690, 6. It is undisputed that Plaintiff Lee received a total of four infusions of intravenous pamidronate.1 Id., 8. It is also undisputed that Dr. James Stoever is the only physician who prescribed intravenous pamidronate for Plaintiff Lee and that Plaintiff Lee received those infusions of intravenous.
1. 2. Fleisch H. Bisphosphonates in Bone Disease: From the Laboratory to the Patient. Academic Press; 2000. Marx RE. Pamidronate Aredia ; and zoledronate Zomdta ; induced avascular necrosis of the jaws: a growing epidemic. J Oral Maxillofac Surg 2003; 61: 1115-1117 and antivert.
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We also know that, for medical reasons I obviously still don't understand, that by the time a man is diagnosed with prostate cancer, he likely also already has bone density issues. Since the majority of men are diagnosed with PC after 60 years of age, osteoporosis presence at that time can very well be the result of aging rather than the presence of PC. But now we add to the bone issue the medications used in treatment with androgen deprivation. And we do know that the reduction and near absence of testosterone caused by those medications has a direct effect on bone density. And since we know the cause of osteoporosis can come from both aging and medication, we are either medically prescribed bisphosphonates to counter the effects of the medication, or the physician or ourselves suggest self-prescribe the addition of supplements to similarly prevent and repair the loss of bone density. Important to note: If you are to be prescribed bisphosphonate injections Zoometa or Aredia, for example FIRST make an appointment with your dentist and get all necessary dental issues corrected before that first injection. Extractions, root canals, implants MUST NOT be performed while on bisphosphonates since these medications can weaken bone structure in the jaw. Jaw bone structure disturbed by dental procedures may not heal because of osteonecrosis of the jaw, though very rare, resulting from bisphosphonate medications. Also Important to note: If you are prescribed bisphosphonate injections - INSIST that the initially administered dose be at the lowest dosage possible and administered over a half-hour or so rather than the usual fifteen minutes. This can permit the system to tolerate the drug as well as prevent an effect known as Acute Phase Response APR ; which, if not prevented, can result in unnecessary discomfort and possible bone pain. Subsequent injection dosage level can be raised until reaching the normally administered level and colace.
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1. Baker S, et al. Constipation in infants and children: evaluation and treatment. A medical position statement of the North American Society for Pediatric Gastroenterology and Nutrition. J Pediatr Gastroenterol Nutr 1999; 29: 612-626. Clayden, G; Keshtgar, AS. Management of childhood constipation. Postgrad Med J 2003; 79: 616-621. Constipation Guideline Committee of the North American Society for Pediatric Gastroenterology. Evaluation and treatment of constipation in infants and children: recommendations of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr 2006 Sep; 43 3 ; : e1-13. Issenman, RM; Hewson, S; Pirhonen, D; et al. Are chronic digestive complaints the result of abnormal dietary patterns? J Dis Child 141: 679-682, 1975. Holten, Keith B. How should we evaluate and treat constipation in infants and children? The Journal of Family Practice Vol 54: No 8, 707, August 2005. Poenaru, Dan; et al. The pediatric bowel management clinic: Initial results of a multidisciplinary approach to functional constipation in children. Journal of Pediatric Surgery Volume 32: Issue 6, 843, June 1997. Young, Frank E.; Heckler, Margaret M. PA OTC Compilation, Part I. Federal Register Vol. 50: No.10, 106-113, January 15, 1985 and imuran.
To obtain application materials contact one of the Co-directors. The application deadline is February 1, 2001. Kevin G. Moores, Pharm. D. Director, Iowa Drug Information Network Assistant Professor Clinical ; The University of Iowa 100 Oakdale Campus, N344 OH Iowa City, IA 52242-5000 Phone: 319 335-4800 Fax: 319 335-4440 E-mail: kevin-moores uiowa.
THE erectile dysfunction drug vardenafil Levitra ; is effective in men who have been previously unresponsive to sildenafil Viagra ; , a study has shown. Researchers from the Vardenafil Study Group randomised 463 men with moderate to severe erectile dysfunction who had not responded to sildenafil to receive either placebo or vardenafil. Patients were initially given 10mg vardenafil for four weeks with the option to titrate up to 20mg ; or down to 5mg ; after each of two consecutive fourweek intervals. After 12 weeks, patients in the vardenafil group reported a 62 per cent general improvement in erectile function compared with 15 per cent in the placebo group P 0.001 ; . The efficacy of vardenafil was also assessed using sexual encounter profile scores. Vardenafil resulted in an improvement in penetration rates from 29 per cent at baseline to 62 per cent after 12 weeks compared with 32 per cent and 30 per cent, respectively, in the placebo group ; . Improvement was also seen in the length of time the erection lasted: in the vardenafil group, intercourse was completed in 10 per cent at baseline and 46 per cent at 12 weeks compared with 12 per cent and 16 per cent, respectively, in the placebo group ; . The study, funded by GSK Bayer, was presented at the Sexual Medicine Society of North America congress in Denver on 11 October. A spokeswoman for Pfizer commented: "A head-to-head comparative trial using a rigorous clinical design is the only way to secure comparative data that is scientifically sound. As this trial was not designed to compare one treatment with another, it is not possible to say that either treatment is more effective than the other and cytoxan and Buy cheap zometa.
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Avoid weed establishment; eliminate individual survivors. Identify and map weed infestations; keep records over years. Recognize and eliminate new weeds before they multiply and establish. Employ sanitary procedures; prevent weed spread. Diseases several examples of fungal and bacterial cultures for spraying to suppress or kill certain weeds; however, none in Pacific Northwest ; . or goat weed and levothroid.
The AERS findings, whereby Fosamax was found to be the causal factor for esophageal associated reactions, were in fact observed in clinical studies. A contradictory finding is that, although Zometa registered a higher number of cases in comparison to all 4 bisphosphonates, it recorded the least number of esophageal reactions. Boniva Reactions esophagitis esophagitis Ulcerative Erosive esophagitis Reflux esophagitis esophagitis Chemical Cases 24 2 1 Reactions esophagitis esophageal Stenosis Barrett's esophagus esophageal Disorder esophageal Pain Actonel Cases 15 7 8.
Product Abacavir Ziagen ; Abacavir lamivudine Kivexa ; Adefovir Hepsera ; Anagrelide Xagrid ; Caspofungin Cancidas ; Emtricitabine Emtriva ; Emtricitabine tenofovir Truvada ; Enfuvirtide Fuzeon ; Entecavir Ertapenem Invanz ; Fosamprenavir Telzir ; Ibandronic acid IV Bonviva ; Lopinavir ritonavir tablets Kaletra ; Moxifloxacin Avelox ; Paracetamol IV infusion Posaconazole Risperidone orodispersible tablets Risperdal ; Risperidone depot injection Risperdal Consta ; Tenofovir Viread ; Teriparatide Forsteo ; Tigecycline Tygacil ; Tipranavir Aptivus ; Trastuzumab Herceptin ; Triptorelin Decapeptyl SR ; Valganciclovir Valcyte ; Voriconazole VFEND ; Zoledronic acid Aclasta ; Zoledronic acid Zometa ; Indication HIV HIV Hepatitis B Thrombocythaemia Invasive candidiasis; empirical antifungal in febrile, neutropenic patients. HIV HIV HIV Hepatitis B Intra-abdominal infections HIV Postmenopausal osteoporosis HIV-1 Community acquired pneumonia Short term pain, fever Specific invasive fungal infections Schizophrenia Schizophrenia HIV Severe osteoporosis in post-menopausal women Complicated skin and soft-tissue infections, complicated intra-abdominal infection cIAI ; HIV HER2 positive early breast cancer Precocious puberty CMV retinitis in AIDS patients; prevention of CMV retinitis post organ transplant Invasive aspergillosis; serious fungal infections; candidaemia in non-neutropenic patients Paget's disease Metastatic bone disease associated with breast cancer.
Median time to progression of bone lesions and time to progression ofdisease were longer in the zometa groups than the placebo group.
The quarterly updates process for the DMEPOS fee schedule is located in the Medicare Claims Processing Manual, Pub. 100-04, Chapter 23 Fee Schedule Administration and Coding Requirements ; , Section 60 Durable Medical Equipment Prosthetics, Orthotics and Supplies DMEPOS ; Fee Schedule ; , which can be reviewed at: : cms.hhs.gov manuals 104 claims clm104c23.
1. Zometa Zoledronic acid for injection ; : Package insert. Basel, Switzerland, Novartis Pharma AG, 2002 2. Marx RE, Stern D: Oral and Maxillo-Facial Pathology: A Rationale for Diagnosis and Treatment ed 1 ; . Quintessence, Carol Stream, IL, 2003, pp 36-38 3. Laroche M: Intraosseous circulation from physiology to disease. Joint Bone Spine 69: 262-269, 2002 Wood J, Bonjean K, Ruetz S, et al: Novel antiangiogenic effects of the bisphosphonate compound zoledronic acid. J Pharmacol Exp Ther 302: 10551061, 2002 Fournier P, Boissier S, Filleur S, et al: Bisphophonates inhibit angiogenesis in vitro and testosterone-stimulated vascular regrowth in the ventral prostate in castrated rats. Cancer Res 15: 6538-6544, 2002 and buy lamictal.
Factors Defining High Risk 1. 2. 3. Presentation WBC 30, 000 at any age Presentation WBC 10, 000 B-cell phenotype over 30 years of age Presentation WBC 100, 000 T-cell phenotype at any age t 9; 22 ; , t 4; cytogenetics, FISH, or molecular methods Late or no achievement of CR Residual Leukemia on day 14 Bone Marrow T-cell phenotype Thymic CD5 + CD1a + ; good risk OS 50% ; Early T CD2 -, cytoplasmic CD3, without other T cell antigens ; Poor Risk Late T CD2 + , SCD3.
For your bone health and general well-being, plan on getting a minimum of 1200 to 1500 mg of calcium every day. The best food sources include: Milkwhole, reduced-fat or non-fat Yogurt Hard cheese or cottage cheese Salmon, mackerel or sardines canned with bones ; Broccoli Greenscollard, turnip, mustard, spinach and kale Calcium-fortified foodsread the labels Tips: Drinking too many soft drinks may keep your body from using the calcium found in foods. You can meet your day's requirement for calcium by consuming three 8-ounce glasses of milk, one ounce of reduced-fat cheese and one serving of leafy green vegetables.
ZOMETA is contraindicated in patients with clinically significant hypersensitivity to zoledronic acid or other bisphosphonates, or any of the excipients in the formulation of ZOMETA. Patients should be administered an oral calcium supplement of 500 mg and a multiple vitamin containing 400 IU of vitamin D daily. Due to the risk of clinically significant deterioration in renal function, which may progress to renal failure, single doses of ZOMETA should not exceed 4 mg and the duration of infusion should be no less than 15 minutes. IV bisphosphonates, including ZOMETA, have been associated with renal toxicity manifested as deterioration of renal function and potential renal failure. While this risk is reduced with the ZOMETA 4 mg dose administered over 15 minutes, deterioration in renal function can still occur. Risk factors for this deterioration include elevated baseline creatinine. Serum creatinine should be measured before each ZOMETA dose and treatment should be withheld for renal deterioration. In the clinical studies, renal deterioration was defined as an increase of 0.5 mg dL for patients with normal baseline creatinine and an increase of 1.0 mg dL for patients with abnormal baseline creatinine.
Parenteral Analgesics In patients for whom regional anesthetic techniques epidural, spinal ; are contraindicated or in centers where full-time anesthetic services are not available, intravenous or intramuscular injections of opioids, such as Demerol meperidine ; or Stadol butorphanol ; are commonly used. These agents are effective in earlier stages of labor, though less so as labor progresses. Due to the episodic nature of labor pain, systemically used medications often lead to inadequate analgesia during the peak of a contraction, followed by somnolence during the intervals between contractions. Furthermore, parenterally administered drugs may cross the placenta to the fetus, increasing the possibility of respiratory depression in the neonate. Neuraxial Techniques The two most commonly used neuraxial techniques for labor and delivery are epidural and spinal analgesia. Epidural analgesia involves placing a catheter to provide continuous analgesia into the epidural space, a potential space surrounding the dura that covers the spinal cord. Spinal analge.
In general, zometa was well tolerated across all studies for various tumortypes in patients with bone metastases.
FACULTY CANDIATE PRESENTATION AND STUDENT LUNCHEON Speaker: Carlos Zometa, PhD, MSPH Title: The process evaluation and refinement of REACH Detroit's "Journey to Health" curriculum. Date: Thursday, June 7 Time: 12: 00-1: 00pm Place: HPNP Building, Room G316 Faculty Candidate- Student Luncheon: for SBS Students and Dr. Zometa Date: Thursday, June 7 Time: 1: 00-1: 30pm Place: HPNP Building, Room 4170 RSVP Required: No later than Wednesday June 6 by 5: 00PM to amd phhp.ufl.
Ibandronate Boniva ; Roche ; is the first intravenous IV ; biphosphonate approved by the FDA for treatment of osteoporosis in postmenopausal women. Other oral biphosphonates approved for the prevention and treatment of osteoporois include Fosamex and Actonel which are taken weekly or daily. These drugs must be taken with 8 ounces of plain water after an overnight fast and remain NPO except for water ; for 30-60 minutes sitting upright. Zoledronic acid Zometa ; and pamidronae Aredia ; are parenteral biphosphonates used to treat hypercalcemia of malignancy and multiple myeloma. Zometa and Aredia have been used off-label to treat postmenopausal osteoporosis. Newly approved Boniva works by inhibiting osteoclast activity and reducing bone resorption and turnover. As a result, bone mass increases. Boniva is administered by a bolus injection once every 3 months. It is also available in oral form to be given as a once-a-month 150-mg tablet or as a 2.5mg tablet daily. IV Boniva may be useful for those women with esophageal abnormalities and for those who find it a challenge to remain upright 30-60 minutes after oral administration. Adverse effects of IV Boniva include acute reactions including fever, joint pain and or myalgia which are most frequently associated with the first dose. Dyspepsia and abdominal pain have been reported as well. Other reactions reported with other biphosphonates include jaw osteonecrosis especially with high doses of IV form in patients with bone cancer ; , severe musculoskeletal pain and ocular inflammation. Boniva is available in a 3 mg 3mL, single-use, prefilled syringe. Patients treated with biphosphonates for osteoporosis are recommended to take a calcium and vitamin D supplement. This drug is not recommended for those with severe renal impairment. Proper assessment of creatinine is necessary before each dose.
For 75 per cent of advanced prostate cancer patients the complications of bone metastases is a constant and painful reminder of their struggle with this disease. With the approval of Zometa zoledronic acid for injection ; , patients with bone metastases due to prostate cancer have access for the first time, to a treatment that can ease their pain and restore their quality of life. Granted priority review by Health Canada, Zometa has been approved for the treatment of complications from bone metastases due to prostate cancer in conjunction with standard antineoplastic therapy including chemotherapy and hormonal therapies. Priority review is granted to those drugs which are shown to fill significant unmet medical needs. Before the approval of Zometa, there was no effective treatment that specifically targeted the bone metastases resulting from prostate cancer. "Advanced prostate cancer commonly spreads to the bone and causes a variety of complications that can significantly impact a patient's day-to-day activities, " Dr. Fred Saad said. He is urologistoncologist at the Centre hospitalier de l'Universit de Montral, Notre-Dame site. "Zometa represents a significant advance in the overall treatment of advanced prostate cancer patients and is a welcome therapeutic addition.
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Many Courts of Appeals have noted the difficulties posed by class-treatment of mass products liability cases, although some have expressed a greater degree of skepticism than others. Compare Matter of Rhone-Poulenc Rorer, Inc., 51 F.3d 1293, 1304 7th Cir. 1995 ; noting criticism of the use of class actions in mass tort cases and decertifying class of hemophiliacs alleged to have contracted HIV following infusion of defendants' blood products ; , and Castano v. Am. Tobacco Co., 84 F.3d 734, 746 5th Cir.1996 ; decertifying class of smokers and noting that certification skews trial outcomes and increases pressure on defendants to settle ; , with Valentino v. CarterWallace, Inc., 97 F.3d 1227, 1233 9th Cir. 1996 ; decertifying pharmaceutical drug class but refusing to "close the door on class action litigation in products liability cases" ; , and Barnes v. Am. Tobacco Co., 161 F.3d 127, 142 3rd Cir. 1998 ; upholding decertification of class of smokers and noting that individualized issues tend to predominate in mass tort accidents that do not arise out of a single accident ; . Cf. In re Agent Orange Prod. Liab. Litigation, MDL No. 381, 818 F.2d 145, 151 2d Cir. 1987 ; expressing skepticism toward utility of class actions in the mass tort context but upholding certification of class of persons exposed to Agent Orange solely because the military contractor defense would apply in all cases ; . 8 See In re Aredia and Zometa Prods. Liab. Litig., 06-MD-1760, 2007 WL 3012972 M.D. Tenn. Oct. 10, 2007 ; users of intravenousbisphosphonate drugs seeking dental monitoring for ONJ In re Vioxx Prods. Liab. Litig., 239 F.R.D. 450 E.D. La. 2006 ; recalled prescription pain medication In re Prempro Prods. Liab. Litig., 230 F.R.D. 555 E.D. Ark. 2005 ; menopause drug Foster v. St. Jude Medical, Inc., 229 F.R.D. 599, 604-05 D.C. Minn. 2005 ; heart bypass device Zehel-Miller v. Astrazenaca Pharmaceuticals, LP, 223 F.R.D. 659, 663 M.D. Fla. 2004 ; depression drug In re Baycol Prods. Litig., 218 F.R.D. 197 D. Minn. 2003 ; recalled cholesterol drug Perez v. Metabolife Int'l, Inc., 218 F.R.D. 262 S.D. Fla. 2003 ; recalled over-the-counter dietary supplement In re Paxil, 212 F.R.D. 539 C.D. Cal. 2003 ; drug prescribed to treat depression.
How to Register The Leadership Academy Certificate Program Winter Quarter 2008 is open to all CSUSB students on a first-come, firstserved basis. Space is limited, plan to register early. To register, please submit this form to: Student Leadership and Development, SMSU 203, California State University, San Bernardino, 5500 University Parkway, San Bernardino, CA 92407 If you require special accommodations, please contact Rosemary Zometa at 909 ; 537-3241 at least 5 working days prior to the workshop.
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