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Cerebrovascular Accident Risk in Women

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161. Improving Quality of Life: Substance Use and Aging

, becoming noticeable only later in life. And although prevalence of substance use is much lower among older adults than other age groups, they are at elevated risk for experiencing harms associated with non-prescription substance use. Most importantly, we know quality of life can be improved significantly by addressing problematic substance use, regardless of a person’s age. Older adults can indeed live long, healthy and productive lives while in recovery. Unfortunately, addressing the issue (...) for the healthcare system, and why treating these complex cases requires new and innovative approaches. Licit and Illicit Drug Use during Pregnancy addressed the medical and obstetrical consequences of problematic drug use and dependency in pregnant women, as well as the short- and long-term effects that prenatal exposure to drugs can have on a child’s development. Childhood and Adolescent Pathways to Substance Use Disorders explored influences during childhood and adolescence that can affect problematic

2018 Canadian Centre on Substance Abuse

162. Regorafenib (Stivarga) indicated as monotherapy for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib treatment

liver cancer (about 90% of the cases). The pattern of HCC occurrence has a clear geo- graphical distribution, with the highest incidence rates in Eastern and South-eastern Asia and in sub-Saharan Black Africans [8], where around 85% of cases occur. HCC has a strong male pre- ponderance with a male to female ratio estimated to be 2.4:1 [9]. HCC usually occurs in the setting of liver cirrhosis, which represents the largest single risk factor present in about 80–90% of all HCC cases [10]. Cirrhosis may (...) Guidelines for diagnosis and management 62 PTJA02 - Regorafenib indicated as monotherapy for the treatment of adult patients with hepatocellular carcinoma who have been previously treated with Sorafenib Version 1.2, October 2017 EUnetHTA Joint Action 3 WP4 5 Evidence tables of individual studies included for clinical effectiveness and safety 66 List of ongoing and planned studies 68 Risk of bias tables 75 Applicability tables 76 APPENDIX 2: REGULATORY AND REIMBURSEMENT STATUS 77 LIST OF TABLES

2018 EUnetHTA

163. Venetoclax (Venclyxto) - Chronic, B-Cell Lymphocytic Leukemia

2.2.3. Finished Medicinal Product 14 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 17 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 18 2.2.6. Recommendations for future quality development 18 2.3. Non-clinical aspects 18 2.3.1. Introduction 18 2.3.2. Pharmacology 19 2.3.3. Pharmacokinetics 23 2.3.4. Toxicology 25 2.3.5. Ecotoxicity/environmental risk assessment 31 2.3.6. Discussion on non-clinical aspects 33 2.3.7. Conclusion on the non-clinical (...) aspects 35 2.4. Clinical aspects 36 2.4.1. Introduction 36 2.4.2. Pharmacokinetics 37 2.4.3. Pharmacodynamics 41 2.4.4. Discussion on clinical pharmacology 46 2.4.5. Conclusions on clinical pharmacology 49 2.5. Clinical efficacy 49 2.5.1. Dose response study(ies) 49 2.5.2. Main study(ies) 59 2.5.3. Discussion on clinical efficacy 80 2.5.4. Conclusions on the clinical efficacy 82 2.6. Clinical safety 82 2.6.1. Discussion on clinical safety 109 2.6.2. Conclusions on the clinical safety 114 2.7. Risk

2017 European Medicines Agency - EPARs

164. Adalimumab (Solymbic)

Product 17 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 22 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 24 2.2.6. Recommendations for future quality development 24 2.3. Non-clinical aspects 24 2.3.1. Introduction 24 2.3.2. Pharmacology 25 2.3.3. Pharmacokinetics 33 2.3.4. Toxicology 34 2.3.5. Ecotoxicity/environmental risk assessment 35 2.3.6. Discussion on non-clinical aspects 35 2.3.7. Conclusion on the non-clinical aspects 36 2.4. Clinical (...) aspects 36 2.4.1. Introduction 36 2.4.2. Pharmacokinetics 37 2.4.3. Pharmacodynamics 45 2.4.4. Discussion on clinical pharmacology 46 2.4.5. Conclusions on clinical pharmacology 47 2.5. Clinical efficacy 47 2.5.1. Dose response study(ies) 47 2.5.2. Main study(ies) 48 2.5.3. Discussion on clinical efficacy 85 2.5.4. Conclusions on the clinical efficacy 88 2.6. Clinical safety 89 Immunological events 97 2.6.1. Discussion on clinical safety 101 2.6.2. Conclusions on the clinical safety 103 2.7. Risk

2017 European Medicines Agency - EPARs

165. Adalimumab (Amgevita)

13 General information 13 Manufacture, characterisation and process controls 13 2.2.3. Finished Medicinal Product 16 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 21 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 23 2.2.6. Recommendations for future quality development 23 2.3. Non-clinical aspects 23 2.3.1. Introduction 23 2.3.2. Pharmacology 24 2.3.3. Pharmacokinetics 31 2.3.4. Toxicology 32 2.3.5. Ecotoxicity/environmental risk assessment 33 (...) ) 51 Assessment report Amgevita EMA/106922/2017 Page 3/120 Statistical methods 51 Participant flow 52 Recruitment 53 Conduct of the study 53 Baseline data 54 Numbers analysed 57 Outcomes and estimation 57 2.5.3. Discussion on clinical efficacy 85 2.5.4. Conclusions on the clinical efficacy 89 2.6. Clinical safety 89 Immunological events 97 2.6.1. Discussion on clinical safety 101 2.6.2. Conclusions on the clinical safety 103 2.7. Risk Management Plan 103 2.8. Pharmacovigilance 114 2.9. Product

2017 European Medicines Agency - EPARs

166. Osteoporosis to Prevent Fractures: Screening

fracture who currently smokes and drinks 3 or more units of alcohol per day. Similar to women, risk factors for fractures in men include low body mass index, excessive alcohol consumption, current smoking, long-term corticosteroid use, previous fractures, and history of falls within the past year. A recent systematic review of risk factors for osteoporosis in men also found that hypogonadism, history of cerebrovascular accident, and history of diabetes are associated with an increased risk of fractures (...) includes questions about previous DXA results but does not require this information to estimate fracture risk. Because the benefits of treatment are greater in persons at higher risk of fracture, one approach is to perform bone measurement testing in postmenopausal women younger than 65 years who have a 10-year FRAX risk of major osteoporotic fracture (MOF) (without DXA) greater than that of a 65-year-old white woman without major risk factors. For example, in the United States, a 65-year-old white

2018 U.S. Preventive Services Task Force

167. British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders: An update

risk of hypertension in insomnia with objectively measured short sleep duration (II) ? Absenteeism, accidents at work and road accidents are increased in insomnia (II) What is not known ? What are the potential confounding effects of medication and comorbid disorders in reports of increased accidents? ? To what extent do treatments rectify the health risks of insomnia? Severallargestudieshavedemonstratedreducedqualityoflife, increasedfunctionalimpairmentandincreasedhealthcarecosts in insomnia (...) and depression, or by physical illness such as cancer or arthritis. The nature of sleep changes with age. Older age is associ- atedwithpoorerobjectivelymeasuredsleepwithshortersleep time,diminishedsleepe?ciency,andmorearousals,andthese changesmaybemoremarkedinmenthaninwomen,accord- ingtoaverylargestudyofelderlypeoplelivingathomeinthe USA (Sleep Heart Health Study, Unruh et al., 2008). In the same study the association of subjective report of poor sleep with older age was stronger in women. The higher

2019 British Association for Psychopharmacology

168. ThermoCool SmartTouch catheter for percutaneous radiofrequency ablation in atrial fibrillation

). The risk of atrial fibrillation increases with age, and is more common in men than women. PVI catheter ablation is typically done under fluoroscopy guidance and therefore not recommended in people who are pregnant. Age, sex and pregnancy are protected characteristics under the Equality Act 2010. ThermoCool SmartT ouch catheter for percutaneous radiofrequency ablation in atrial fibrillation (MIB61) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms (...) ), including pericardial effusion, cardiac tamponade, atrioesophageal fistula, perforation, cerebrovascular accident and steam pop. ThermoCool SmartT ouch catheter for percutaneous radiofrequency ablation in atrial fibrillation (MIB61) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 12 of 47Malfunction (172 records), including catheter damage, internal components exposed, noise on all signals, char on catheter tip

2016 National Institute for Health and Clinical Excellence - Advice

169. Recent mortality trends in Glasgow: 1981-2015

9), it can be seen that, in 1981, the two most common causes of death were cancer (29%) and cerebrovascular disease (13%). In 2015, the most common causes were drug related (25%) and cancer (19%). In the rest of Scotland, the two most common causes of death among women aged 15-44 in 1981 were cancer (34%) and motor vehicle traffic accidents (10%), and in 2015 they were cancer (24%) and drug related (15%) (data not shown). Figure 9: Relative distribution of causes of death, 1981-2015, Glasgow (...) . In 2011-2015 the female MVTA mortality rate in Glasgow was slightly higher than the rate in the rest of Scotland. In contrast, the male MVTA mortality rate in Glasgow has been lower than the rate in the rest of Scotland for the last 35 years with the gap between the two rates widening slightly by 2011-2015 (see Table 2 and Figures 22 & 23, pages 32-33). Figure 18: Standardised mortality rate for motor vehicle traffic accidents, 1981-2015, Glasgow versus the rest of Scotland, men and women aged 15-44

2017 Glasgow Centre for Population Health

170. Clinical Practice Guideline on the Management of Osteoarthritis of the Hip

, complimentary document. 4 RISK ASSESSMENT TOOLS Moderate strength evidence supports that the practitioner could use risk assessment tools to assist in predicting adverse events, assessing surgical risks and educating patients with symptomatic osteoarthritis of the hip undergoing total hip arthroplasty. Strength of Recommendation: Moderate Evidence Description: Evidence from two or more “Moderate” strength studies with consistent findings, or evidence from a single “High” quality study for recommending (...) for or against the intervention. OBESITY AS A RISK FACTOR a) Moderate strength evidence supports that obese patients with symptomatic osteoarthritis of the hip, when compared to non-obese patients, may achieve lower absolute outcome scores but a similar level of patient satisfaction and relative improvement in pain and function after total hip arthroplasty. Strength of Recommendation: Moderate Evidence Description: Evidence from two or more “Moderate” strength studies with consistent findings, or evidence

2017 American Academy of Orthopaedic Surgeons

171. Diagnosis and treatment of osteoporosis.

thrombosis and pulmonary embolism, hot sweats, leg cramp, and cerebrovascular accident. Conjugated estrogens/bazedoxifene acetate (Duavee) carries a risk of endometrial cancer, cardiovascular disorders and probable dementia. Other side effects include diarrhea, indigestion, nausea, upper abdominal pain, neck pain, spasm, dizziness, pain in throat, venous thromboembolism (VTE), cerebrovascular accident, retinal vascular disorder, primary malignant neoplasm of endometrium. Peripheral DXA (pDXA (...) . Benefit-Harm Assessment : For most patients with osteoporosis, the benefits of the medication outweigh the risks. However, the benefit-harm assessment should be done for each individual patient to evaluate whether this medication is appropriate. Relevant Resources : Postmenopausal women with osteoporosis: Eriksen, Diez-Perez, & Boonen, 2014; Miller et al., 2012; Eisman et al., 2008; Black et al., 2007; Chestnut et al., 2005; Chestnut et al., 2004; McClung et al., 2001; Black et al., 2000; Fogelman et

2017 National Guideline Clearinghouse (partial archive)

172. CRACKCast E125 – Electrolyte Disorders

) Pneumonia Tuberculosis Abscess Central Nervous System Disorders Infection (meningitis, brain abscess) Mass (subdural, postoperative, cerebrovascular accident) Psychosis (with psychogenic polydipsia) Drugs Thiazide diuretics Narcotics Oral hypoglycemic agents Barbiturates Antineoplastics Treatment: free water restriction! [12] Describe the management of hyponatremia in the following patients: Actively seizing In more severe cases when the sodium value is 120 mEq/L or less and the patient has alterations (...) potential, to decrease cell excitability, and for function of the Na+ K+-ATPase pump. Patients With Acute Coronary Artery Disease and Ventricular Arrhythmias Make sure you check and correct any low serum K / Mg levels, otherwise these patients are at high risk for dysrhythmias Patients on certain medications: Long term PPI use, patients with bowel preps for colonoscopy aminoglycosides, amphotericin B, cisplatin, and pentamidine [19] What are the five most common causes of hyperphosphatemia

2017 CandiEM

173. Primary & Secondary Prevention of CVD

of major risk factors for CVD. This is followed by CPGs on the Management of Acute Myocardial Infarction, Heart Failure and Cerebrovascular Accidents. More recently, in 2010, the MOH launched the National Strategic Plan for Non-Communicable Disease (NSP-NCD) in response to the global challenge in combatting NCD in general and CVD in particular. This document is now being updated by the MOH to reflect latest developments in the field and more current global targets set by the World Health Organisation (...) o Individuals with multiple CV risk factors or very high levels of a single CV risk factor – Section 4 o Individuals who are at high risk for a CV event – Section 5 & 6 ? Secondary prevention strategies directed at individuals who: o Have established CVD. • CVD includes: ? Coronary heart disease (CHD) ? Cerebrovascular accident (CVA) ? Peripheral artery disease (PAD) ? Asymptomatic individuals with: o “Silent” myocardial ischemia (MI) detected by non-invasive testing. o Significant atheromatous

2017 Ministry of Health, Malaysia

174. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults

in adults ACC/AHA 2013 Cardiovascular diseases during pregnancy ESC 2011 Effectiveness-based guidelines for the prevention of cardiovascular disease in women AHA/ACC 2011 Secondary prevention and risk-reduction therapy for patients with coronary and other atherosclerotic vascular disease AHA/ACC 2011 Assessment of cardiovascular risk in asymptomatic adults ACC/AHA 2010 Thoracic aortic disease ACC/AHA/AATS/ACR/ASA/SCA/SCAI/SIR/STS/SVM 2010 Diagnosis, evaluation, and treatment of high blood pressure (...) prevalence of hypertension and its associated increased risk of CHD, stroke, and end-stage renal disease (ESRD), the population-attributable risk of these outcomes associated with hypertension is high. In the population-based ARIC (Atherosclerosis Risk in Communities) study, 25% of the cardiovascular events (CHD, coronary revascularization, stroke, or HF) were attributable to hypertension. In the Northern Manhattan study, the percentage of events attributable to hypertension was higher in women (32

2017 American Heart Association

175. Diagnosis and Management of Noncardiac Complications in Adults With Congenital Heart Disease: A Scientific Statement From the American Heart Association Full Text available with Trip Pro

adult lives in increasing numbers, this development has resulted in an epidemiological shift and a generation of patients who are at risk of developing chronic multisystem disease in adulthood. Noncardiac complications significantly contribute to the morbidity and mortality of adults with CHD. Reduced survival has been documented in patients with CHD with renal dysfunction, restrictive lung disease, anemia, and cirrhosis. Furthermore, as this population ages, atherosclerotic cardiovascular disease (...) and its risk factors are becoming increasingly prevalent. Disorders of psychosocial and cognitive development are key factors affecting the quality of life of these individuals. It is incumbent on physicians who care for patients with CHD to be mindful of the effects that disease of organs other than the heart may have on the well-being of adults with CHD. Further research is needed to understand how these noncardiac complications may affect the long-term outcome in these patients and what modifiable

2017 American Heart Association

176. Heart Disease and Stroke Statistics 2017 Update: A Report From the American Heart Association Full Text available with Trip Pro

Outcomes (KDIGO) working group. Total Cardiovascular Diseases (Chapter 13) • An estimated 92.1 million US adults have at least 1 type of CVD. By 2030, 43.9% of the US adult population is projected to have some form of CVD. • From 2004 to 2014, death rates attributable to CVD declined 25.3%. The actual number of CVD deaths decreased 6.7%. • Globally, 80% of CVD deaths take place in low- and middle-income countries and occur almost equally in males and females. Stroke and Cerebrovascular Disease (Chapter (...) . • The percentage of US adults with a 10-year pre- dicted CVD risk =20% decreased from 13.0% in 1999 to 2000 to 9.4% in 2011 to 2012. • Among US males and females 80 years of age. Venous Thromboembolism (Deep Vein Thrombosis and Pulmonary Embolism), Chronic Venous Insufficiency, Pulmonary Hypertension (Chapter 23) Venous Thrombosis • The main complications after venous thrombo- embolism are postthrombotic syndrome, which occurs in ˜40% of patients with deep vein thrombo- sis (DVT), and chronic thromboembolic PH

2017 American Heart Association

177. 2017 ACC/AHA/HRS Guideline for the Evaluation and Management of Patients With Syncope Full Text available with Trip Pro

that estimated risk scores are summarized in . , , , , , , , , Table 5. Short- and Long-Term Risk Factors Short-Term Risk Factors (≤30 d) Long-Term Risk Factors (>30 d) History: Outpatient Clinic or ED Evaluation Male sex , , , Male sex , Older age (>60 y) Older age , , , No prodrome Absence of nausea/vomiting preceding syncopal event Palpitations preceding loss of consciousness VA , Exertional syncope Cancer Structural heart disease , , , , Structural heart disease , HF , , , HF Cerebrovascular disease (...) Cerebrovascular disease Family history of SCD Diabetes mellitus Trauma , High CHADS-2 score Physical Examination or Laboratory Investigation Evidence of bleeding Abnormal ECG , , Persistent abnormal vital signs Lower GFR Abnormal ECG , , , , Positive troponin * Definitions for clinical endpoints or serious outcomes vary by study. The specific endpoints for the individual studies in this table are defined in and summarized in for selected studies. This table includes individual risk predictors from history

2017 American Heart Association

178. 2017 ACC/AHA/HRS Guideline for the Evaluation and Management of Patients With Syncope: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines, and the Heart Rhythm Society Full Text available with Trip Pro

-Term Risk Factors (>30 d) History: Outpatient Clinic or ED Evaluation Male sex , Male sex , Older age (>60 y) Older age , , , No prodrome Absence of nausea/vomiting preceding syncopal event Palpitations preceding loss of consciousness VA , Exertional syncope Cancer Structural heart disease , , , , Structural heart disease , HF , , , HF Cerebrovascular disease Cerebrovascular disease Family history of SCD Diabetes mellitus Trauma , High CHADS-2 score Physical Examination or Laboratory Investigation (...) 2. General Principles e30 2.1. Definitions: Terms and Classification e30 2.2. Epidemiology and Demographics e31 2.3. Initial Evaluation of Patients with Syncope: Recommendations e31 2.3.1. History and Physical Examination: Recommendation e31 2.3.2. Electrocardiography: Recommendation e31 2.3.3. Risk Assessment: Recommendations e32 2.3.4. Disposition After Initial Evaluation: Recommendations e32 3. Additional Evaluation and Diagnosis e33 3.1. Blood Testing: Recommendations e33 3.2. Cardiovascular

2017 American Heart Association

179. Prevention, Diagnosis & Management of infective endocarditis

INTRODUCTION 24 2.0 EPIDEMIOLOGY 27 3.0 DIAGNOSIS 29 3.1 Clinical evaluation of suspected infective endocarditis 30 3.1.1 Pre-existing risk factors 30 3.1.2 Clinical manifestations 31 3.2 Investigations 34 3.2.1 Laboratory investigations 34 3.2.2 Microbiological diagnosis 34 3.2.3 Histopathological diagnosis 40 3.3 Imaging 43 3.3.1 Echocardiography 43 3.3.2 Other imaging modalities 50 3.4 Diagnostic criteria 53 3.4.1 The modified Duke criteria and its limitations 53 4.0 MANAGEMENT 57 4.1 Clinical (...) Transcatheter aortic valve implantation/ transcatheter aortic valve replacement 126 7.4 Infective endocarditis in cardiac implantable electronic devices 127 7.5 Infective endocarditis in pregnancy 129 8.0 ANTIMICROBIAL PROPHYLAXIS FOR INFECTIVE ENDOCARDITIS 130 8.1 Introduction 130 8.2 Cardiac conditions associated with the highest risk of infective endocarditis 130 8.3 Antimicr obial pr ophylaxis for specific pr ocedur es 131 8.3.1 Dental procedures 131 8.3.2 Non-dental procedures 132 8.4 Antimicrobial

2017 Ministry of Health, Malaysia

180. Syncope: Guideline For Evaluation and Management of Patients With

1.INTRODUCTION ... e43 1.1. Methodology and Evidence Review e43 1.2. Organization of the Writing Committee .. e44 1.3. Document Review and Approval . e44 1.4. Scope of the Guideline .. e44 2.GENERAL PRINCIPLES ... e45 2.1. De?nitions: Terms and Classi?cation e45 2.2. Epidemiology and Demographics e45 2.3. Initial Evaluation of Patients With Syncope e47 2.3.1. History and Physical Examination: Recommendation .. e48 2.3.2. Electrocardiography: Recommendation .. e49 2.3.3. Risk Assessment (...) 10.4. Driving and Syncope: Recommendation.. e82 10.5. Athletes: Recommendations e84 11.QUALITY OF LIFE AND HEALTHCARE COST OF SYNCOPE ... .. e85 11.1. Impact of Syncope on Quality of Life e85 11.2. Healthcare Costs Associated With Syncope e85 12.EMERGING TECHNOLOGY, EVIDENCE GAPS, AND FUTURE DIRECTIONS . .. e85 12.1. De?nition, Classi?cation, and Epidemiology .. e85 12.2. Risk Strati?cation and Clinical Outcomes . e85 12.3. Evaluation and Diagnosis e86 12.4. Management of Speci?c Conditions e86

2017 American College of Cardiology

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