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442. Evolocumab (Repatha)

barrier prevents access to cholesterol carrying lipoproteins from the circulation. 7 This should allow the brain to remain largely independent from circulating levels of cholesterol. Nevertheless, to examine this potential cognitive safety issue more thoroughly, a search was done of neurocognitive-related adverse event terms that included deliria (including confusion), cognitive and attention disorders and disturbances, dementia and amnestic conditions, disturbances in thinking and perception

2014 FDA - Drug Approval Package

443. Lenvatinib (Lenvima)

(Modified from the protocol for brevity) b. Efforts should be made to conduct study visits on the day scheduled (± 1 day). Clinical laboratory assessments may be conducted anytime within 72 hours prior to the scheduled visit, unless otherwise specified. d. pTNM staging g. A comprehensive physical examination (including a neurological examination) will be performed at the Screening or Baseline Visit, on Cycle 1/Day 15, on Day 1 of each subsequent cycle, and at the off-treatment assessment. A symptom (...) -directed physical examination will be performed on C1D1 and at any time during the study, as clinically indicated. h. Required if screening physical examination was performed > 7 days prior C1D1. i. Single 12-lead ECG. Subjects must be in the recumbent position for a period of 5 minutes prior to the ECG. j. Echocardiogram during screening, every 16 weeks, and at end of treatment visit, or sooner if clinically indicated. k. Clinical chemistry and hematology results must be reviewed prior

2014 FDA - Drug Approval Package

444. Early Management of Head Injury in Adults

Appendix 3 Glasgow Coma Scale and Score 52 Appendix 4 Head Chart 53 Appendix 5 Discharge Advice for Head Injury 54 Appendix 6 Canadian Cervical Rule (CCR) 55 Appendix 7 The NEXUS Low-Risk Criteria for 56 Low Probability of Cervical Injury Early Management of Head Injury in Adults Appendix 8 Equipments for Transfer 57 Appendix 9 Transfer Checklist for Neurosurgical Patients 58 Appendix 10 Safe Extubation Criteria in Head Injury 59 Appendix 11 Drug Dosing Regimen for Initial Management 60 List (...) ecchymosis (“Battle’s sign”), cerebrospinal fluid leakage either from the nose [cerebral spinal fluid (CSF) rhinorhoea] or ear (CSF otorhoea), or seventh and eighth cranial nerves deficits causing facial paralysis and hearing loss respectively.5 Early Management of Head Injury in Adults 3. CLASSIFICATION OF SEVERITY The severity of head injury can be classified according the presenting Glasgow Coma Score (GCS): 9 level III • mild head injury (MHI): GCS 13 - 15 • moderate head injury: GCS 9 - 12 • severe

2015 Ministry of Health, Malaysia

445. Evaluation and Management of Gallstone-Related Diseases in Non-Pregnant Adults

The evaluation for gallstone-related disease is summarized in Table 1. The evaluation routinely includes 1. Complete physical exam 2. Laboratory evaluation – CBC, comprehensive metabolic panel, amylase/lipase 3. Imaging – Right upper quadrant (RUQ) ultrasound In the vast majority of patients with acute cholecystitis, the diagnosis can be made based upon the history, physical findings, laboratory tests, and ultrasound (see Table 3 for the sonographic diagnostic criteria for acute cholecystitis In rare cases (...) dysfunction (Elevated PT/INR >1.5) Hematological dysfunction (Platelet count 55 years Glucose >200 mg/dL LDH >350 mg/dL AST >250 units/L WBC >16 K/mm3 BISAP Criteria BUN >25 mg/dl Impaired mental status (any): - disorientation, lethargy, coma, somnolence, stupor SIRS* Age >60 years Pleural Effusion Severity Classification Mild Gallstone Pancreatitis a. Clinical stability with admission to non-monitored bed • No significant hypovolemia • BUN 38º C OR 90; RR > 20 OR Pa CO2 12,000 OR 10% bands 9 UMHS

2015 University of Michigan Health System

446. Resources for flooding and poor water sanitation

Collection. The burden caused by natural disasters adds to the existing burden of morbidity and mortality from diarrhoeal diseases. According to the World Health Organization (WHO), diarrhoeal disease is the second leading cause of death in children under five years old and kills 1.5 million children each year.(2) Cochrane systematic reviews can contribute to the use of effective interventions to prevent and treat water-related diseases, and they have also examined interventions to improve sanitation (...) for effectiveness in an RCT. Japanese encephalitis is a viral disease of the central nervous system with general symptoms of headache, fever, vomiting, and diarrhoea. Most people recover within a week without further complications, but approximately 1 in 300 suffers additional and severe symptoms such as disorientation, seizures, paralysis, and coma. Around 30% of the severe cases are fatal, and most survivors are left with serious and often chronic disabilities such as mental impairment, limb paralysis

2014 Evidence Aid

447. Prediction rule: CT should not be relied on for cases of isolated vomiting in children with blunt head trauma Full Text available with Trip Pro

department (ED) after <24 h of trauma; Glasgow Coma Scale score of 14–15; and acute head CT. Clinicians completed a standardised patient history and physical examination before head CT. History of vomiting, the number of vomiting episodes, timing of onset and the time since last episode were recorded. Isolated vomiting was defined in two ways: extensive (based on an extensive list of variables) versus an age-specific list of prediction rule variables defined by the Pediatric Emergency Care Applied (...) Research Network (PECARN) on initial ED examination. Two categories of outcomes were defined: clinically-important TBI and TBI on CT. Outcomes were analysed in three groups: children with non-isolated vomiting; children with isolated vomiting (extensive definition); and children with isolated vomiting (PECARN definition). The rates of clinically-important TBI and TBI on CT were compared for children with and without isolated vomiting using the Newcombe-Wilson continuity-adjusted method. Findings Of 43

2015 Evidence-Based Medicine

448. Does a normal CT scan within 6?h rule out subarachnoid haemorrhage?

(complete) Three Part Question In [patients presenting with a history of sudden onset headache] is a [CT scan within 6 h] sufficient to rule out [subarachnoid haemorrhage]. Clinical Scenario A normally fit and well 26-year-old man presents to the emergency department with a sudden onset headache. It came on 2 h ago, and is the worst he has ever had. He has taken paracetamol without success. The headache made him feel very unwell, but he has no neurological symptoms. His Glasgow Coma Scale (GCS) is 15 (...) and clinical examination is normal. You are concerned that he may have had a subarachnoid haemorrhage (SAH) and want to rule this out. He has a CT scan within 6 h of the onset of the headache. It is reported as normal. You wonder if this excludes a diagnosis of SAH. Search Strategy (subarachnoid.mp. OR sub-arachnoid.mp.) AND (haemorrhage.mp. OR hemorrhage.mp. or exp Hemorrhage/) AND (6 hours.mp. OR six hours.mp.) AND (csf.mp. or exp Cerebrospinal Fluid/ OR lumbar puncture.mp. or exp Spinal Puncture

2015 BestBETS

449. Paediatric trauma protocols

radiation burden. ? An example of a suitable contrast and timings calculator is included (see the Camp Bastion contrast wheel, Appendix 2). ? A hand injection of contrast is appropriate in very small children and babies. ? There are no mechanisms of injury which mandate abdominal CT as an isolated factor. Decisions to perform abdominal CT should be made on the basis of the clinical history and examination. 29 ? Where there is an isolated head injury, a reduced Glasgow Coma Scale (GCS) score should (...) minutes of hospital presentation, and immediately if there is any reduction in conscious level. Adequate resuscitation, clinical examination and administration of analgesia should take place in the process of deciding whether to perform CT. Isolated head injuries are common in childhood and fulfilling the criteria for a cranial CT scan is not an indication on its own for a CT of the cervical spine or any other body part. Cranial CT should be performed before administration of intravenous contrast

2014 Royal College of Radiologists

450. Consolidated guidelines on HIV testing services

other health services, such as TB, STI or viral hepatitis services, antenatal care (ANC), contraceptive and other family planning services and screening and care for other conditions, including noncommunicable diseases. In vitro diagnostic (IVD) medical device: a medical device, used alone or in combination, intended by the manufacturer for the examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes

2015 World Health Organisation HIV Guidelines

451. Guidelines for Transport of Critically Ill Patients

history and clinical examination findings of their patients. Documentation should include an ongoing record of physiological status, clinical procedures, and any subsequent interventions. A copy of this patient record should be provided to the receiving hospital along with the clinical record and investigations from the referring facility, where available. For intrahospital transport, this documentation may form part of the inpatient notes. 10. MONITORING Monitoring of certain physiological variables (...) , measurement of the arterial blood pressure and assessment of peripheral perfusion. 10.1.2 Respiration Respiratory rate should be assessed and recorded at frequent and clinically appropriate intervals. 10.1.3 Oxygenation The patient’s oxygenation should be assessed at frequent and clinically appropriate intervals by observation and use of pulse oximetry. 10.1.4 Level of consciousness by Glasgow Coma Scale and pupil reaction. 10.1.5 Pain score Patients’ pain should be monitored including regular assessment

2015 Australian and New Zealand College of Anaesthetists

452. Systematic review of needs for medical devices for ageing populations

health. The United Nations applies 60 years as the cut- off for older people, so the health conditions that are the subject of this project were identified by examining the top five causes of loss of DALYs in people aged 60–79 years in the Western Pacific Region. 1.4 AGEING AND DISEASE Damage at the cellular level that is attributed to the process of ageing has been linked to the pathology of certain diseases associated with the ageing population, such as atherosclerosis and cancers (13 (...) ; • supporting or sustaining life; • control of conception; • disinfection of medical devices; • providing information by means of in vitro examination of specimens derived from the human body and which does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means (4,5). 2.3 INTERVENTION The intervention for this project is defined as “needed devices”. The devices were categorized

2015 Publication 80

453. Treatment of Acute Hyperkalaemia in Adults

that the first presentation may be an arrhythmia. (1C) Guideline 2.2 – Hyperkalaemia: Clinical Assessment; History and examination We recommend that all patients presenting with hyperkalaemia undergo a comprehensive medical and drug history and clinical examination to determine the cause of hyperkalaemia. (1B) 3. Hyperkalaemia (Guidelines Hyperkalaemia 3.1 - 3.2) Guideline 3.1 – Hyperkalaemia: ECG We recommend that all patients with a serum K + value = 6.0 mmol/L have an urgent 12-lead ECG performed (...) obstruction. B – Breathing – Assess adequacy of ventilation: clinical examination, respiratory rate, O 2 saturation, arterial blood gas. Give oxygen aiming for ‘normal’ oxygen saturation and provide ventilatory support if necessary. C – Circulation – Assess cardiovascular status: colour, pulse, BP, volume status, peripheral circulation, urine output (check for palpable bladder), cardiac rhythm (ECG, cardiac monitor), electrolytes (Urea and electrolytes, Mg 2+ , Ca 2+ , Phosphate). Establish intravenous

2014 Renal Association

454. Guidelines for Transport of Critically Ill Patients

history and clinical examination findings of their patients. Documentation should include an ongoing record of physiological status, clinical procedures, and any subsequent interventions. A copy of this patient record should be provided to the receiving hospital along with the clinical record and investigations from the referring facility, where available. For intrahospital transport, this documentation may form part of the inpatient notes. 10. MONITORING Monitoring of certain physiological variables (...) , measurement of the arterial blood pressure and assessment of peripheral perfusion. 10.1.2 Respiration Respiratory rate should be assessed and recorded at frequent and clinically appropriate intervals. 10.1.3 Oxygenation The patient’s oxygenation should be assessed at frequent and clinically appropriate intervals by observation and use of pulse oximetry. 10.1.4 Level of consciousness by Glasgow Coma Scale and pupil reaction. 10.1.5 Pain score Patients’ pain should be monitored including regular assessment

2015 Australian and New Zealand College of Anaesthetists

455. Cervical Spine Collar Clearance in the Obtunded Adult Blunt Trauma Patient

reassessment, cervical collar complication (e.g., pressure ulcer), and time to cervical collar clearance. The term obtunded required an operationalized definition using the terms Glasgow Coma Scale , altered , intoxicated , intubated , unconscious , and/or u nreliable exam . Unstable injuries were identified primarily using the system delineated by White and Punjabi and the three-column model of Denis. [9–11] C-spine instability required either a fracture or fractures involving contiguous columns or levels (...) Eligibility Our PICO question and protocol were registered with the PROSPERO international prospective register of systematic reviews [7][8] on August 23, 2013 (Registration Number: CRD42013005461) and last revised on June 18, 2014. Inclusion criteria consisted of adult blunt trauma patients 16 years or older, who underwent C-spine CT with axial thickness of less than 3 mm and who were obtunded with any author-specified definition of this term (Glasgow Coma Scale [GCS] score < 15, unconscious, intubated

2015 Eastern Association for the Surgery of Trauma

456. Heart Failure Management in Skilled Nursing Facilities Full Text available with Trip Pro

begins with accurate identification of residents diagnosed with HF. The clinical diagnosis of HF may largely rely on data from care before SNF admission. Residents without an HF diagnosis who develop pulmonary congestion or volume overload should have a physical examination, chest radiograph, and blood chemistry tests to confirm congestion and volume overload within the SNF setting if possible. Results from laboratory tests may take 24 hours or longer to return in SNFs; thus, appropriate clinical (...) for potential adverse effects (including drug-drug and drug-disease interactions). On Medicare-reimbursed units, the SNF bears medication costs, which adds further incentive for an appropriate pharmacological regimen. HF With Reduced Ejection Fraction Numerous randomized controlled trials have examined a wide range of pharmacological agents for the treatment of HF with reduced ejection fraction (HF r EF), usually defined as an ejection fraction <45%. A detailed review of agents shown to be effective

2015 American Heart Association

457. A Practice Guideline from the American College of Medical Genetics and Genomics and the National Society of Genetic Counselors: Referral Indications for Cancer Predisposition Assessment

the ACMG nor the NSGC “approve” or “endorse” any specific methods, practices, or sources of information. Volume 17 | Number 1 | January 2015 | GeNetiCS in MediCiNe71 A practice guideline for cancer genetics referral | HAMPEL et al ACMG PrACtiCe Guidelines risk assessment or diagnosis, which typically includes personal and family history, genetic and other laboratory results, results from procedures and imaging studies, and physical examination findings. Genetic counseling is an important component (...) , trichodis- comas or angiofibromas, and acrochordons), bilateral and multifocal renal tumors (chromophobe clear cell renal car- cinoma, renal oncocytoma, oncocytic hybrid tumor, and less often, clear cell renal carcinoma), and multiple bilateral lung cysts often associated with spontaneous pneumothorax. 15 GeNetiCS in MediCiNe | Volume 17 | Number 1 | January 201572 HAMPEL et al | A practice guideline for cancer genetics referral ACMG PrACtiCe Guidelines table 1 Common benign and malignant tumors

2015 American College of Medical Genetics and Genomics

458. Update on Prevention of Cardiovascular Disease in Adults With Type 2 Diabetes Mellitus in Light of Recent Evidence Full Text available with Trip Pro

diabetes mellitus is needed to elucidate the role of physical activity and weight loss in reducing clinical CVD end points. Another study examining the role of intensive lifestyle management on CVD risk factors was the Italian Diabetes and Exercise Study (IDES). The IDES was an RCT designed to examine the effects of an intensive exercise intervention strategy on modifiable CVD risk factors in 606 sedentary subjects with type 2 diabetes mellitus enrolled in 22 outpatient diabetes mellitus clinics across (...) to reduce the risk of stroke. Trials examining the effect of aspirin for primary prevention in patients with diabetes mellitus are summarized: 6 trials were conducted in the general population that also included patients with diabetes mellitus, and 3 other trials specifically examined patients with diabetes mellitus. Trials ranged from 3 to 10 years in duration and have examined a wide range of aspirin doses. Participants were mainly late middle-aged adults; 3 trials , , included only men. The range

2015 American Heart Association

459. Guidelines for the Management of Spontaneous Intracerebral Hemorrhage

of patients with ICH is crucial, because early deterioration is common in the first few hours after ICH onset. More than 20% of patients will experience a decrease in the Glasgow Coma Scale (GCS) of 2 or more points between the prehospital emergency medical services (EMS) assessment and the initial evaluation in the emergency department (ED). 6 Furthermore, another 15% to 23% of patients demonstrate continued deterioration within the first hours after hospital arrival. 7,8 The risk for early neurological (...) - tory, physical examination, and diagnostic studies that should be obtained in the ED. A routine part of the evaluation should include a stan- dardized severity score, because such scales can help stream- line assessment and communication between providers. The National Institutes of Health Stroke Scale (NIHSS) score, commonly used for ischemic stroke, may also be useful in ICH. 24,25 However, ICH patients more often have depressed consciousness on initial presentation, and this may diminish

2015 Congress of Neurological Surgeons

460. Guidelines for the management of spontaneous intracerebral hemorrhage Full Text available with Trip Pro

. More than 20% of patients will experience a decrease in the Glasgow Coma Scale (GCS) of 2 or more points between the prehospital emergency medical services (EMS) assessment and the initial evaluation in the emergency department (ED). Furthermore, another 15% to 23% of patients demonstrate continued deterioration within the first hours after hospital arrival. , The risk for early neurological deterioration and the high rate of poor long-term outcomes underscore the need for aggressive early (...) should be contacted as quickly as possible while the patient is in the ED, and the clinical evaluation should be performed efficiently, with physicians and nurses working in parallel. Consultation via telemedicine can be a valuable tool for hospitals without on-site presence of consultants. , describes the integral components of the history, physical examination, and diagnostic studies that should be obtained in the ED. Table 4. Integral Components of the History, Physical Examination, and Workup

2015 American Academy of Neurology

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