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Comorbidity of reading and mathematics disabilities: Genetics and environmental etiologies. Using a repeated reading program to improve generalization of oral reading fluency. A summary of the reading comprehension research undertaken with students who are deaf or hard of hearing. Language disorders from infancy through adolescence: Listening, speaking, reading, writing, and communicating. Multicultural students with special language needs: Practical strategies for assessment and intervention. Prerequisite skills, early instruction and success in first grade: Selected results form a longitudinal study. General language performance measures in spoken and written narrative and expository discourse of school-age children with language learning disabilities. Cross-disciplinary dialogue about the nature of oral and written language problems in the context of developmental, academic, and phenotypic profiles. Matthew effects in reading: Some consequences of individual differences in the acquisition of literacy. Language disorders are learning disabilities: Challenges on the divergent and diverse paths to language learning disability. Avoiding the devastating downward spiral: the evidence that early intervention prevents reading failure. Language-related differences between discrepancy- defined and non-discrepancy-defined poor readers: A longitudinal study of dyslexia in New Zealand. Effectiveness of a Spanish Intervention and an English Intervention for English Language Learners at Risk for Reading Problems. Identifying English language learners with learning disabilities: Key challenges and possible approaches. Matching student needs to instruction: Teaching reading and spelling using the Wilson Reading System. Study behavior as a function of metacognitive knowledge about critical task variables: An investigation of above average, average, and learning disabled readers. At the same time advances in technology, including functional imaging, Hillis, Department of Neurology, electrophysiologic studies, perfusion imaging, diffusion tensor imaging, and transcranial magnetic Phipps 126, Johns Hopkins Hospital, 600 North Wolfe stimulation, have led to new insights regarding the relationships between language and the brain. Recovery from aphasia depends on resto- ration of tissue function or reorganization of the cognitive/neural network underlying language, which can be facilitated by a number of diverse interventions. The most reli- able finding was that damage to the left hemisphere was discovered in patients who had had language impairment. Another novel and important observation was that damage to more anterior parts of the brain, particularly the left posterior inferior frontal cortex, was usually found in patients whose spoken output was limited or poorly articulated,4 while damage to more posterior regions in the temporal lobe was found in patients whose spoken output was well articulated but meaningless. Although the earliest descriptions of aphasia may have confounded impairments of speech (the motor processes involved in production of verbal language) and language (the abstract symbols or representations and syntactic processes that underlie verbal and written communication), Geschwind and his followers used the term to describe disorders of language. However, in the 1980s three developments revolutionized our thinking about aphasia. In fact, cortical most basic language tasks, such as naming a stimulation of nearby posterior basal tempo- picture or understanding a word. Linguists, ral cortex disrupted reading of kanji (which psychologists, neuroscientists, and mathe- represent meanings, not sounds) and picture maticians began to dissect out the cognitive naming, which both require conversion of se- processes and representations that are com- mantic to phonologic representations, but putationally necessary to accomplish such did not affect comprehension of spoken seemingly simple tasks. Advances in technol- words, reading of kana (which represent sounds of words), copying, or tool use. In fact, hypoper- network of neural regions that are engaged fusion or infarct of this area is strongly asso- during the tasks as revealed by functional im- ciated with impaired oral reading and naming in acute stroke. For exam- ples of these methods of exploring brain/ language relationships are described later, ple, progressive atrophy of left more than after first reviewing recent insights regarding right anterior and inferior temporal cortex the aphasias described by Geschwind. Because the concept is multidimen- have allowed direct tests of hypotheses about sional, it is often difficult to judge. A patient might structure/function relationships derived from have poor melody and/or disrupted articulation, but functional imaging.

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Surgical exploration is reserved for patients with patient develop signs of peritonitis or the fistula fail to signs of decompensation or peritonitis. A non-balloon-type inserted into the tract so as not to risk damage to the replacement, which has a soft internal dome instead of a tract. Finally, an initial placement low profile may lead to tube degradation and failure. G a s t r o e n t e r o l o g y, ment has shown to be useful, but polyurethane initial 1 9 8 7; 9 3: 4 8 5 2. Long-term outcomes of placement and replacement devices may be more resis- patients receiving percutaneous endoscopic gastrostomy tubes. Enteral long-term nutrition via per- cutaneous endoscopic gastrostomy in 210 patients: a four-year prospective study. Percuta- neous endoscopic gastrostomy complications in a tertiary-care cen- Placement of prophylactic gastrostomy feeding tubes ter. Complications of percu- in patients with head and neck cancer has been shown taneous endoscopic gastrostomy. Com- parison of the use of endoscopic and radiologic gastrostomy in a sin- and neck cancer at the stoma site has been reported in gle head and neck cancer unit. Percutaneous endoscopic gastrostomy: high mortality rates in hospitalized patients. Outcomes of surgical, percutaneous endoscopic, and per- implantation has also been reported after open gastros- cutaneous radiologic gastrostomies. Should a patient develop tumor at the gas- niques: evaluation of indications, outcome, and complications. Percutaneous radiologic and endo- that gastroenterologists minimize complications of scopic gastrostomy: a 3-year institutional analysis of procedure per- f o r m a n c. Necrotising fasciitis complicating percutaneous terol,1 9 8 9; 8 4: 7 0 3 7 1 0. Complications of percutaneous endoscopic gastrostomy with or endoscopic gastrostomy: strategies for prevention and management without concomitant antireflux surgery in 96 children. Fatal retroperitoneal hemorrhage: an unusual com- trointest Endosc,2 0 0 3; 5 8: 7 3 9 7 5 1. Complications of percutaneous endoscopic gastros- 1 9 8 8; 1 5 1: 3 0 7 3 0 9. Complications of percutaneous trointestinal bleeding after percutaneous endoscopic gastrostomy. Percutaneous bumper syndrome: prevention and endoscopic approaches to endoscopic gastrostomy: a randomized prospective comparison of removal. G a s t r o e n t e r o l o g i s t, gastrostomy placement by a single physician. Antibiotic prophylaxis in failure of silicone rubber percutaneous gastrostomy tubes. Aliment Pharmacol Ther, infection after percutaneous endoscopic gastrostomy in patients 2 0 0 0; 1 4: 1 2 7 3 1 2 7 7. Longevity of silicone and polyurethane catheters in long- with introducer or pull method: a prospective randomized compari- term enteral feeding via percutaneous endoscopic gastrostomy. Prospective, randomised, double blind trial endoscopic gastrostomy associated gastric metastasis. J Clin Gas of prophylaxis with single dose of co-amoxiclav before percuta- troenterol,2 0 0 3; 3 7: 3 0 7 3 1 1. Implantation metastasis following per- cutaneous endoscopic gastrostomy: comparison of push and pull cutaneous endoscopic gastrostomy.

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They will adjust their existing mass vaccination plans to accommodate the unique requirements of pandemic infiuenza vaccine. Vaccine Clinic or Dispensing Site Facility Information Formal or Vaccination Informal Has Facility Vacc/Disp or Facility Facility Facility Facility Facility Agreement Been capacity per Dispensing Phone Fax Name Address Contact with Facility Assessed for day (# of Site Number Number Owner Adequacyfi These clinics will immunize individuals who cannot afford the vaccine administration fee for pandemic infiuenza vaccine. However, providers cannot charge for federally-supplied pandemic infiuenza vaccine or ancillary supplies. These public health entities will need to collaborate with various community sectors to plan for the allocation and administration for pandemic infiuenza vaccines. The clinic personnel should include a Safety Chief who is responsible for crowd control, determining the security needs, overseeing the security personnel, and coordinating with local law enforcement if additional security is required. Public high schools can be considered as a site for mass vaccination clinics during a pandemic. The Director or designee will contact the Department of Education representative who will facilitate the dedication of appropriate resources for this purpose. These issues, along with the large number of high schools statewide, also preclude on-site assessments for facility adequacy for State Clinics. Vaccine Safety Monitoring Comprehensive screening techniques of potential vaccine recipients will minimize the vaccinating an individual with contraindications or precautions. Individuals will receive educational information prior to vaccination and will be advised of what symptoms to expect after vaccination, if any. Screeners and medical counselors need to have enough experience and training to make adequate clinical judgments about contraindications and risk of exposure. Translators for common languages will be an essential part of staffing a mass vaccination clinic to assure adequate education. Contraindications the level of contraindications will depend on the risk of the infiuenza pandemic. The contraindications for the infiuenza pandemic vaccine are assumed to be the same as the seasonal infiuenza vaccine. Pandemic infiuenza vaccines will be made using the same manufacturing process as seasonal infiuenza vaccines. The safety profile of pandemic infiuenza vaccines is expected to be similar to seasonal infiuenza vaccines. However, for any vaccine, rare side effects can only be detected by monitoring for adverse events after vaccination. This can be either within their mass vaccination clinic or in separate off-site locations. Whenever possible, telephone triage should be used in order to minimize unnecessary use of the post-vaccination adverse events evaluation sites. Adverse Events Management It is difficult to know the precise numbers of people who will seek medical care after mass infiuenza pandemic vaccination. Therefore, mass vaccination will create health care demands for vaccine education, vaccine administration, and evaluation of adverse events. Serious adverse events should be evaluated quickly by a physician or in an emergency department. The vaccine recipient will be told to contact his/her primary care provider for evaluation and management of serious adverse events. Information on American Indian Health Facilities, including tribally-operated 638 health programs, can be accessed at. Mojave Indian Tribe San Juan Southern Paiute Tribe John Manning, Director Carlene Yellowhair Fort Mojave Indian Health Center President 1607 Plantation Rd. Arizona Advisory Council on Indian Maria Dadgar, Executive Director Health Care 2214 N.

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Consequently, tigecycline does not demonstrate significant in vitro activity against Pseudomonas aeruginosa and demonstrates only moderate in vitro activity against microorganisms belonging to Proteeae (Proteus spp. Due to the mechanism of action, the antibacterial activity of tigecycline is not expected to be affected by mechanisms that confer specific resistance to beta-lactam drugs, glycopeptides, quinupristin/dalfopristin, linezolid or other agents potentially useful against Gram-positive and Gram- negative bacterial species. The product is supplied in single dose type I glass vials sealed with rubber stoppers and each vial contains 53 mg of tigecycline. Active Substance Tigecycline is an analogue of minocycline, which is a semi-synthetic tetracycline. It is a t-butylglycyl substituted naphthacenecarboxamide freebase and its chemical name is (4S,4aS,5aR,12aS)-9-[2-(tert- butylamino)acetamido]-4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide. In general, tigecycline is less soluble in organic solvents than in water, due its ionic and hydrophilic nature. When the free base is dissolved in water, it is mostly present as zwitterions with a resulting pH around 8. The levels of the impurities in active substance are supported by the results of toxicological studies and appropriate specifications have been set. At the time of the opinion there were some minor issues concerning aspects of the analytical validation that remained unresolved and will be addressed as post approval commitments. Data from supporting stability studies on two pilot scale batches of tigecycline have also been presented. Tests for specific optical rotation, microbial purity and bacterial endotoxines have been added to the stability protocol for the commercial batches. In all cases the stability results presented were satisfactory and support the proposed shelf life for the active substance. Due to the poor gastrointestinal permeability and low bioavailability of tigecycline the development of an oral dosage form was not feasible. Tigecycline was found to be stable, when protected from moisture, oxygen and heat. Therefore, a lyophilised product has been developed for reconstitution with commonly used intravenous diluents such as 0. The compatibility of the rubber closure with the lyophilisate and with the reconstituted solution has been sufficiently demonstrated. All critical process parameters have been identified and controlled by appropriate in process controls. The validation report from three production scale batches demonstrates that the process is reproducible and provides a drug product that complies with the in-process and finished product specifications. All tests included in the specification have been satisfactorily described and validated. Batch analysis data from several batches including 3 primary stability and 3 process validation batches have been presented. All batches met the test limits as defined in the release specification and test methodology valid at the time of batch release. The parameters tested were: physical appearance and description, strength, purity, pH, water content, particulate matter, bacterial endotoxins and sterility. In addition compatibility studies have been conducted for the product according to the recommended preparation and storage conditions for the intravenous solution intended to be administered through a Y-site. Discussion on chemical, pharmaceutical and biological aspects the quality of Tygacil is adequately established. In general, satisfactory chemical and pharmaceutical documentation has been submitted for marketing authorization. The manufacturing process of the finished product is a standard process that has been adequately described. Tigecycline shows higher binding affinity than tetracyclines, being active against bacterial strains with either mechanism of tetracycline resistance (efflux and ribosomal protection). The fact that tigecycline overcomes most of the known tetracycline resistance mechanisms is interpreted as a result of steric hindrance due to the large substituent at position 9.

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