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FOUR Score Coma Exam

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101. Psychosocial and Environmental Pregnancy Risks (Follow-up)

for pulsed Doppler, color flow, first trimester ultrasonography with a long transvesical path (>5 cm), second or third trimester exams when bone is in the focal zone, when scanning tissue with minimal perfusion (ie, embryonic), or in patients who are febrile. Operators can minimize risk by limiting dwell time, limiting exposure to critical structures, and following equipment-generated exposure information. Current equipment approved for use typically includes monitoring for application-specific intensity (...) is 20-25 mcg/mL, levels as low as 10 mcg/mL in maternal or cord blood are associated with transient cognitive defects in children. One article assessed the neurocognitive status of 6-month-old infants whose mothers were exposed to low but varying amounts of lead during pregnancy. Lead levels in cord blood were then compared to performance on infant intelligence and visual recognition tests. Infants scored lower if the lead concentration in blood was higher. [ ] Studies have also reported

2014 eMedicine.com

102. Psychosocial and Environmental Pregnancy Risks (Diagnosis)

for pulsed Doppler, color flow, first trimester ultrasonography with a long transvesical path (>5 cm), second or third trimester exams when bone is in the focal zone, when scanning tissue with minimal perfusion (ie, embryonic), or in patients who are febrile. Operators can minimize risk by limiting dwell time, limiting exposure to critical structures, and following equipment-generated exposure information. Current equipment approved for use typically includes monitoring for application-specific intensity (...) is 20-25 mcg/mL, levels as low as 10 mcg/mL in maternal or cord blood are associated with transient cognitive defects in children. One article assessed the neurocognitive status of 6-month-old infants whose mothers were exposed to low but varying amounts of lead during pregnancy. Lead levels in cord blood were then compared to performance on infant intelligence and visual recognition tests. Infants scored lower if the lead concentration in blood was higher. [ ] Studies have also reported

2014 eMedicine.com

104. Ezogabine (Potiga)

spontaneously and one after a fall at a “rest home”. Following a craniotomy for the second subdural hematoma the patient remained poorly responsive (Glasgow coma scale 3-4 non sedated) and a decision was made to withdrawal ventilator support. The record indicates ezogabine was among the discharge medications to the “rest home”. Death #2- Study VRX-RET-E22-303 (subject 15201): A 33 year old Hispanic male was treated with ezogabine for approximately 4 years at the time of death. The patient apparently had (...) frequency) 6 (0.4) 7 (0.5) 6 (0.4)b Dizziness 5 (0.4) 5 (0.4) 6 (0.4) Chest pain 5 (0.4) 5 (0.4) 5 (0.4) Grand mal convulsion 5 (0.4) 6 (0.4) 8 (0.6) Somnolence 4 (0.3) 4 (0.3) 4 (0.3) Headache 4 (0.3) 4 (0.3) 4 (0.3) Conversion disorder 4 (0.3) 4 (0.3) 4 (0.3) Pneumonia 4 (0.3) 5 (0.4) 5 (0.4) Urinary retention 4 (0.3) 4 (0.3) 4 (0.3) Hyponatremia 4 (0.3) 5 (0.4) 5 (0.4) Pregnancy 4 (0.3) 4 (0.3) 2 (0.1)c Coma 3 (0.2) 3 (0.2) 3 (0.2) Reference ID: 2957637Clinical Review Steven T. Dinsmore NDA 22345

2011 FDA - Drug Approval Package

105. Guidelines for the management of aneurysmal subarachnoid hemorrhage

by early treatment of the ruptured aneurysm, the risk of rebleeding is not increased by the ventriculostomy. 148 Numerous systems have been reported for grading the clinical outcome in patients with SAH from a ruptured intracranial aneurysm, but the current literature remains substantially deficient with respect to intraobserver and in- terobserver uniformity or consistency. 9,149–151 Recent reports have tended to use the Glasgow Coma Scale or Glasgow Outcome Scale. 149,150,152–178 It should be noted (...) that the Glasgow Coma Scale was designed to predict outcome after head injury and has not been fully assessed in outcome after SAH. In addition, patients who have no grossly evident neurological deficits after SAH frequently have subtle cog- nitive or neurobehavioral difficulties that impair their social adjustment and ability to return to their previous occupa- tions. 179–183 At least 1 study has suggested that these neu- robehavioral deficits are not correlated with tissue loss as seen on recent MRI 184

2009 American Academy of Neurology

106. Methylphenidate and amantadine to stimulate reawakening in comatose patients resuscitated from cardiac arrest. (PubMed)

performance category (CPC), and modified Rankin scale (mRS). We compared characteristics and outcomes to a control cohort matched on TH and 72 h FOUR score ± 1.Of 588 patients, 8 received methylphenidate, 6 received amantadine, and 2 both. Most were female suffering OHCA with median age 61 years. All received TH and a multi-modal neurological evaluation. Initial exam revealed median GCS 6 and FOUR 7, which was unchanged at 72 h. Six patients (38%) followed commands prior to discharge at median 2.5 days (...) Methylphenidate and amantadine to stimulate reawakening in comatose patients resuscitated from cardiac arrest. Despite critical-care packages including therapeutic hypothermia (TH), neurologic injury is common after cardiac arrest (CA) resuscitation. Methylphenidate and amantadine have treated coma in traumatically-brain-injured patients with mixed success, but have not been explored in post-arrest patients.Compare the outcome of comatose post-arrest patients treated with neurostimulants

2013 Resuscitation

107. The Vermont Oxford Neonatal Encephalopathy Registry: rationale, methods, and initial results. (PubMed)

(stupor, coma) during the first 72 hours of life, a 5 minute Apgar score of ≤ 3, or receiving HT. Infants with central nervous system birth defects were excluded.From 2006-2010, 95 centers registered 4232 infants. Of those, 59% suffered a seizure, 50% had a 5 minute Apgar score of ≤ 3, 38% received HT, and 18% had stupor/coma documented on neurologic exam. Some infants experienced more than one eligibility criterion. Only 53% had a cord gas obtained and only 63% had a blood gas obtained within 24 (...) hours of birth, important components for determining HT eligibility. Sixty-four percent received ventilator support, 65% received anticonvulsants, 66% had a head MRI, 23% had a cranial CT, 67% had a full channel encephalogram (EEG) and 33% amplitude integrated EEG. Of all infants, 87% survived.The VON NER describes the heterogeneous population of infants with NE, the subset that received HT, their patterns of care, and outcomes. The optimal routine care of infants with neonatal encephalopathy

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2012 BMC Pediatrics

108. Buprenorphine Transdermal System (Butrans)

of the cases were consistent with allergic contact dermatitis. The applicant also identified four articles describing a total of nine case reports of allergic contact dermatitis, confirmed by patch testing. Of the 1335 cases, 183 cases contained latency information. Approximately 45% of the cases with latency data had skin reactions within the first 10 days and 36% within the first day. However, 55% of patch site reactions occurred after 10 days and approximately 24% occurred after 100 days (...) electronic ECG data was to have been transmitted to for cardiologist interpretation. A copy of these and all subsequent ECGs were to have been saved in the subject’s file • Blood, urine and pregnancy testing If and when subjects met all eligibility criteria (with exception of the daily pain scores), the Investigator or site staff were to have immediately contacted the subjects by telephone and instructed them to discontinue all analgesic medications and other medications used for chronic pain. Subjects

2010 FDA - Drug Approval Package

109. Concussion

are associated with . It is not unusual for symptoms to last up to four weeks. Common causes include , , and . Risk factors include drinking . The mechanism may involve either a direct blow to the head or forces elsewhere on the body that are transmitted to the head. This is believed to result in dysfunction, as there is increased requirements but insufficient supply. Diagnosis requires less than 30 minutes of loss of consciousness, memory loss of less than 24 hours and a score of 13 to 15. Otherwise (...) –48 hours. A brain CT or brain MRI should be avoided unless there are progressive neurological symptoms, focal neurological findings or concern of skull fracture on exam. Diagnosis of MTBI is based on physical and neurological examination findings, duration of unconsciousness (usually less than 30 minutes) and post-traumatic amnesia (PTA; usually less than 24 hours), and the (MTBI sufferers have scores of 13 to 15). exist to measure cognitive function and the international consensus meeting

2012 Wikipedia

110. Phase IIb Study of MP4OX in Traumatic Hemorrhagic Shock Patients

to dosing (≤ 2.2 mmol/L) Patients with evidence of severe traumatic brain injury as defined by ANY one of the following: Known non-survivable head injury or open brain injury; Glasgow Coma Score (GCS) = 3, 4 or 5; Known AIS (head region) ≥ 4 shown by an appropriate imaging methodology; Contemplated CNS surgery; or Abnormal physical exam indicative of severe CNS or any spinal cord injury above T5 level Cardiac arrest prior to randomization Age below the legal age for consenting Estimated time from injury (...) alone is not sufficient to achieve resuscitation, and that the effects of MP4OX are additional to those of blood. Additional support comes from a recently completed phase IIa trauma study in 51 patients with lactic acidosis due to severe hemorrhage. MP4OX treatment was associated with a more rapid and sustained reduction of high lactate levels, and a greater proportion of MP4OX-treated patients who normalized lactate by four hours after dosing. There was also a trend toward shorter median hospital

2010 Clinical Trials

111. Pramipexole Dihydrochloride Extended-Release Tablets (Mirapex)

at Week 18 63 Table 23 Advanced PD Trial: Distribution of PGI responses at week 18 64 Table 24 Advanced PD Trial: Responder rate by UPDRS II+III (source: Sponsor) 65 Table 25 Advanced PD Trial: UPDRS Part II ADL outcome (source: Sponsor) 65 Table 26 Advanced PD Trial: UPDRS Part III Motor Exam outcome (source: Sponsor)66 Table 27 Advanced PD Trial: Mean concomitant daily levodopa dose 66 Table 28 Early PD Trial Checklist (source: Sponsor) 71 Table 29 Early PD Trial: 248.524 reviewer's efficacy (...) Beck Depression Inventory by age 48 Figure 8 Advanced PD Trial: BDI baseline distribution, means and confidence interval49 Figure 9 Advanced PD Trial: Mini Mental Status Exam baseline distribution, mean and confidence interval 50 Figure 10 Advanced PD Trial: Improvement in UPDRS II+III in the FAS1 LOCF cohort (source: Sponsor) 55 Figure 11 Advanced PD Trial: Maintenance of UPDRS improvement (source: Sponsor) 58 Figure 12 Advanced PD Trial: Maintenance of off-time improvement at 33 weeks (source

2009 FDA - Drug Approval Package

112. Coartem (artemether/lumefantrine)

). In the dispersible tablet group, four patients had an arrhythmia (reported on Day 2, 4, 8, and 43), three of which were reported as mild and one that was reported as moderate in severity; no action were taken as a result of these cardiac AEs. In addition, a 4 year old patient in the dispersible tablet group had tachycardia that began on Day 15 and lasted for one day. A pulse rate of 114 bpm and body temperature of 37.8°C was measured. The AE was reported as mild and no action was taken. Three 3 cardiac AEs

2008 FDA - Drug Approval Package

113. Stroke Assessment Across the Continuum of Care

Pathologist, Reg. CASLPO, St. Joseph’s Health Centre – Parkwood Site. London, Ontario William Winterburn Consumer Reviewer. Nipigon, Ontario The Heart and Stroke Foundation of Ontario and the Registered Nurses’ Association of Ontario would also like to express their appreciation for the contributions of the Stroke Canada Optimization of Rehabilitation by Evidence (SCORE) Project and M. Patrice Lindsay RN, PhD of the Canadian Stroke Quality of Care Study. Nursing Best Practice GuidelineTable of Contents (...) . This neurological assessment, facilitated with a validated tool (such as the Canadian Neurological Scale, National Institutes of Health Stroke Scale or Glasgow Coma Scale), should include at minimum: ¦ Level of consciousness; ¦ Orientation; ¦ Motor (strength, pronator drift, balance and coordination); ¦ Pupils; ¦ Speech/Language; ¦ Vital signs (TPR, BP , SpO 2 ); and ¦ Blood glucose. 3.1 Nurses in all practice settings should recognize that signs of decline in IV neurological status may be related

2005 Registered Nurses' Association of Ontario

114. Caregiving Strategies for Older Adults with Delirium, Dementia and Depression

requires a concerted effort of four groups: nurses themselves, other healthcare colleagues, nurse educators in academic and practice settings, and employers. After lodging these guidelines into their minds and hearts, knowledgeable and skillful nurses and nursing students need healthy and supportive work environments to help bring these guidelines to life. We ask that you share this NBPG, and others, with members of the interdisciplinary team. There is much to learn from one another. T ogether, we can (...) Context 26 References 27 Chapter One - Practice Recommendations for Delirium 29 References 45 Chapter Two - Practice Recommendations for Dementia 47 References 63 Chapter Three -Practice Recommendations for Depression 67 References 76 Chapter Four - Practice Recommendations for Delirium, Dementia and Depression 79 References 85 Chapter Five - Education Recommendation 87 References 89 Chapter Six - Organization & Policy Recommendations 90 References 98 Evaluation & Monitoring of Guideline 100

2004 Registered Nurses' Association of Ontario

115. Screening for Delirium, Dementia and Depression in the Older Adult

of four groups: nurses themselves, other healthcare colleagues, nurse educators in academic and practice settings, and employers. After lodging these guidelines into their minds and hearts, knowledgeable and skillful nurses and nursing students need healthy and supportive work environments to help bring these guidelines to life. We ask that you share this NBPG, and others, with members of the interdisciplinary team. There is much to learn from one another. T ogether, we can ensure that Ontarians (...) Assessment/Mental Status Questions . . . . . . . . . . . . . 60 Appendix E – Mini-Mental State Exam (MMSE) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 Appendix F – Clock Drawing Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 Appendix G – Neecham Confusion Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66 Appendix H – Confusion Assessment Method Instrument (CAM) . . . . . . . . . . . . . . . . . 72 Appendix I

2003 Registered Nurses' Association of Ontario

116. APA Guidelines on Multicultural Education, Training, Research, Practice and Organizational Change for Psychologists

of efficacy as they address the first four levels of the Layered Ecological Model of the Multicultural Guidelines. Guideline 10. Psychologists actively strive to take a strength-based approach when working with individuals, families, groups, communities, and organizations that seeks to build resilience and decrease trauma within the sociocultural context. 6 I. Introduction Since the initial version of the Guidelines on Multicultural Education, Training, Research, Practice, and Organizational Change (...) individuals and their respective roles (e.g., interactions between clinician and client; educator and student; researcher and research participant; consultant and consultee). These two bidirectional circles (Level 1) are layered with four surrounding circles (Levels 2–5) that represent successively expanding sources of influence. These are labeled on Figure 1 as: Bidirectional Model of Self-Definition and Relationships (Level 1) ; Community, School, and Family Context (Level 2); Institutional Impact

2002 American Psychological Association

117. Natural History of West Nile Virus Infection

PCR for WNV, physical examination, serial neurologic examinations, a baseline MRI scan, and four functional and cognitive assessments that have been validated in neurologic illness in adults: the Barthel Index (BI), the Modified Rankin Scale (MRS), the Glasgow Outcome Score (GOS) and the modified Mini-Mental Status Examination (3MS). The subset of study participants who develop motor weakness of an extremity (ies) will have electromyograms, nerve conduction studies and spinal MRI performed (...) Description Go to Brief Summary: This study will examine how West Nile virus (WNV) infection affects the body. Some people infected with WNV have no symptoms. In others, symptoms may vary from fever and headache to a polio-like syndrome with paralysis, to coma and brain changes like those of a stroke. Many patients recover with no lasting effects, while a few can have long-lasting neurological damage or may die. This study will collect clinical, laboratory, diagnostic, and radiographic information

2003 Clinical Trials

118. Chloroquine Alone or in Combination for Malaria in Children in Malawi

of severe malaria included one or more of the following: Hemoglobin ≤5 g/dL; prostration; respiratory distress; bleeding; recent seizures, coma or obtundation (Blantyre coma score < 5); inability to drink, or persistent vomiting. All cases were then adjudicated by a panel of investigators prior to analysis. Mean Hemoglobin at the Last Study Visit in Each Treatment Arm for the Age Group of Participants 3 Years of Age or Younger. [ Time Frame: 1 year ] Hemoglobin values were assessed from blood collected (...) Weight greater than or equal to 5kg. Positive malaria smear for P. falciparum mono-infection with parasite density 2,000-200,000/mm^3. Planning to remain in the study area for 1 year. Willingness to return for four-weekly routine visits, as well as unscheduled sick visits. Parental/guardian consent for each participant. Exclusion Criteria: Signs of severe malaria: One or more of the following: hemoglobin less than or equal to 5 g/dL prostration respiratory distress bleeding recent seizures, coma

2006 Clinical Trials

119. Loss of consciousness: when to perform computed tomography? (PubMed)

Loss of consciousness: when to perform computed tomography? To determine the diagnostic value of physical examination (including neurologic exam) for positive computed tomography scan findings in children with closed head injury, Glasgow Coma Scale score 13-15 in the emergency department, and loss of consciousness or amnesia.Prospective descriptive study.A large, tertiary, pediatric trauma center in San Diego County.Children ages 2-16 with an isolated closed head injury, history of loss (...) of consciousness or amnesia, and Glasgow Coma Scale 13-15 who were referred for pediatric trauma evaluation and received a head computed tomography as part of this evaluation.A standardized physical examination including skull/scalp exam, pupils, tympanic membrane, and brief neurologic exam was documented on each patient.Subjects age 2-16 being evaluated by the pediatric trauma team for closed head injury with loss of consciousness or amnesia and Glasgow Coma Scale 13-15 received a standardized physical exam

2004 Pediatric Critical Care Medicine

120. Thoracolumbar fracture in blunt trauma: is clinical exam enough for awake patients? (PubMed)

April 2002 to December 2003. During the study period, thoracolumbar radiography was performed on patients with signs or symptoms of TLFx, and also on patients with significant blunt trauma and any alteration in mentation, including drowsiness or apparent intoxication. All patients were classified as reliable if Glasgow coma score was >13 and the treating physician judged them capable of accurately reporting pain, and those who did not met both these conditions were deemed unreliable. Patients (...) Thoracolumbar fracture in blunt trauma: is clinical exam enough for awake patients? Physical examination is widely used to screen trauma patients for thoracolumbar fracture (TLFx). Retrospective data suggests that patients with altered sensorium may not manifest symptoms after TLFx. This study was designed to prospectively test the sensitivity of physical examination for detection of TLFx in patients with altered mentation.Prospective data collection in a large urban Level I trauma center from

2006 Journal of Trauma

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