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Tongue Carcinoma

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1541. Ertugliflozin l-pyroglutamic acid (Steglatro) - Diabetes Mellitus, Type 2

during any dosing interval at steady state BA bioavailability BCS biopharmaceutical classification system BCRP breast cancer resistance protein BE bioequivalence bid twice (two times) a day BMD bone mineral density BMI body mass index BSA body surface area CFU colony forming units CHMP Committee for Medicinal Products for Human use CKD chronic kidney disease cLDA constrained longitudinal data analysis CL/F apparent clearance of drug C max maximum observed plasma concentration CQA Critical Quality (...) Steglatro International non-proprietary name: ertugliflozin Procedure No. EMEA/H/C/004315/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/86938/2018 Page 2/139 Table of contents 1. Background information on the procedure 6 1.1. Submission of the dossier 6 1.2. Steps taken for the assessment of the product 7 2. Scientific discussion 8 2.1. Problem statement 8 2.1.1. Disease or condition 8 2.1.2. Epidemiology 8

2018 European Medicines Agency - EPARs

1542. Ertugliflozin l-pyroglutamic acid / sitagliptin phosphate monohydrate (Steglujan) - Diabetes Mellitus, Type 2

2.1.1. Disease or condition 9 2.1.2. Epidemiology 9 2.1.3. Clinical presentation 9 2.1.4. Management 10 2.2. Quality aspects 12 2.2.1. Introduction 12 2.2.2. Active Substance - ertugliflozin 12 2.2.3. Active Substance - sitagliptin 15 2.2.4. Finished Medicinal Product 16 2.2.5. Discussion on chemical, pharmaceutical and biological aspects 19 2.2.6. Conclusions on the chemical, pharmaceutical and biological aspects 19 2.2.7. Recommendation(s) for future quality development 19 2.3. Non-clinical (...) 3.1.1. Disease or condition 130 3.1.2. Available therapies and unmet medical need 130 3.1.3. Main clinical studies 130 3.2. Favourable effects 131 3.3. Uncertainties and limitations about favourable effects 133 3.4. Unfavourable effects 133 3.5. Uncertainties and limitations about unfavourable effects 134 3.6. Effects Table 135 3.7. Benefit-risk assessment and discussion 136 3.7.1. Importance of favourable and unfavourable effects 136 3.7.2. Balance of benefits and risks 137 3.7.3. Additional

2018 European Medicines Agency - EPARs

1543. Ertugliflozin l-pyroglutamic acid / metformin hydrochloride (Segluromet) - Diabetes Mellitus, Type 2

9 2.1.1. Disease or condition 9 2.1.2. Epidemiology 9 2.1.3. Clinical presentation 9 2.1.4. Management 10 2.2. Quality aspects 12 2.2.1. Introduction 12 2.2.2. Active Substance - ertugliflozin 12 2.2.3. Active Substance - Metformin hydrochloride 15 2.2.4. Finished Medicinal Product 16 2.2.5. Discussion on chemical, pharmaceutical and biological aspects 19 2.2.6. Conclusions on the chemical, pharmaceutical and biological aspects 20 2.2.7. Recommendation(s) for future quality development 20 2.3 (...) . Therapeutic Context 149 3.1.1. Disease or condition 149 3.1.2. Available therapies and unmet medical need 150 3.1.3. Main clinical studies 150 3.2. Favourable effects 151 3.3. Uncertainties and limitations about favourable effects 153 3.4. Unfavourable effects 153 3.5. Uncertainties and limitations about unfavourable effects 154 3.6. Effects Table 154 3.7. Benefit-risk assessment and discussion 155 3.7.1. Importance of favourable and unfavourable effects 155 3.7.2. Balance of benefits and risks 156 3.7.3

2018 European Medicines Agency - EPARs

1544. Hydrocortisone (Alkindi) - Adrenal Insufficiency

-proprietary name: hydrocortisone Procedure No. EMEA/H/C/004416/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/4145/2018 Page 2/59 Table of contents 1. Background information on the procedure 7 1.1. Submission of the dossier 7 1.2. Steps taken for the assessment of the product 8 2. Scientific discussion 9 2.1. Introduction 9 2.1.1. Disease or condition 10 2.1.2. Epidemiology 11 2.1.3. Clinical presentation (...) a genotoxic potential of hydrocortisone. Carcinogenicity studies have not been identified. However, an abstract of a life span study in rats reports that no evidence of a carcinogenic potential was found for hydrocortisone. The available reproductive toxicity data demonstrate that hydrocortisone and other glucocorticoids in high doses have teratogenic and embryotoxic potential in various animal species. Adverse effects on offspring include cleft palate, sex organ anomalies, polycystic kidney disease

2018 European Medicines Agency - EPARs

1545. Burosumab (Crysvita) - X-linked hypophosphataemia/hypophosphatemia

report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/148319/2018 Page 2/130 Administrative information Table of contents 1. Background information on the procedure 8 1.1. Submission of the dossier 8 1.2. Steps taken for the assessment of the product 9 2. Scientific discussion 10 2.1. Problem statement 10 2.1.1. Disease or condition 10 2.1.2. Epidemiology 10 2.1.3. Aetiology and pathogenesis 11 2.1.4. Clinical presentation, diagnosis (...) 2.6.2. Conclusions on clinical safety 111 2.7. Risk Management Plan 112 2.8. Pharmacovigilance 116 2.9. New Active Substance 116 2.10. Product information 116 2.10.1. User consultation 116 2.10.2. Labelling exemptions 116 2.10.3. Additional monitoring 117 3. Benefit risk assessment 118 3.1. Therapeutic Context 118 3.1.1. Disease or condition 118 3.1.2. Available therapies and unmet medical need 118 3.1.3. Main clinical studies 119 3.2. Favourable effects 119 3.3. Uncertainties and limitations about

2018 European Medicines Agency - EPARs

1546. Letermovir (Prevymis) - to prevent illness caused by cytomegalovirus (CMV) in adults having an allogeneic haematopoietic stem cell transplant

. Discussion on clinical safety 114 2.6.2. Conclusions on the clinical safety 115 2.7. Risk Management Plan 115 2.8. Pharmacovigilance 116 2.9. New Active Substance 116 2.10. Product information 117 2.10.1. User consultation 117 2.10.2. Labelling exemptions 117 Assessment report EMA/CHMP/490007/2017 Page 3/124 2.10.3. Additional monitoring 117 3. Benefit-Risk Balance 118 3.1. Therapeutic Context 118 3.1.1. Disease or condition 118 3.1.2. Available therapies and unmet medical need 118 3.1.3. Main clinical (...) Ganciclovir GV Genotypic variant GVHD Graft-versus-host disease HSCT Hematopoietic stem cell transplant HSV Herpes simplex virus LLoQ Lower limit of quantification LOTTR Last observed time point MDRD Modification of diet in renal disease PET Pre-emptive therapy QTcF Fridericia correction of the QT interval VGCV Valganciclovir VZV Varicella Zoster Virus Assessment report EMA/CHMP/490007/2017 Page 5/124 1. Background information on the procedure 1.1. Submission of the dossier The applicant Merck Sharp

2018 European Medicines Agency - EPARs

1547. Budesonide (Jorveza) - to treat adults with eosinophilic oesophagitis

above, the disease leads to a considerably reduced Quality of Life, and – along with remodelling of the oesophagus – to the development of oesophageal strictures, and the subsequent need for dilation manoeuvers. Rarely, complications such as oesophageal perforation and rupture of the oesophagus from forceful retching (Boerhave’s syndrome) have been observed. EoE has not been observed to be associated with the development of cancer and does not reduce life expectancy. 2.1.5. Management The current (...) of the dossier 7 1.2. Steps taken for the assessment of the product 8 2. Scientific discussion 8 2.1. Problem statement 8 2.1.1. Disease or condition 8 2.1.2. Epidemiology 9 2.1.3. Biologic features, Aetiology and pathogenesis 9 2.1.4. Clinical presentation, diagnosis and prognosis 10 2.1.5. Management 10 2.2. Quality aspects 13 2.2.1. Introduction 13 2.2.2. Active Substance 14 2.2.3. Finished Medicinal Product 15 2.2.4. Discussion on chemical and pharmaceutical aspects 17 2.2.5. Conclusions on the chemical

2018 European Medicines Agency - EPARs

1548. ACE inhibitors

Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 ACE Inhibitor ACE Inhibitor Aka: ACE Inhibitor (...) , Angiotensin Converting Enzyme Inhibitor , Captopril , Capoten , Lisinopril , Prinivil , Zestril , Enalapril , Vasotec , Fosinopril , Monopril , Benzapril , Lotensin , Moexipril (...) Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 ACE Inhibitor ACE Inhibitor Aka: ACE Inhibitor (...) , Angiotensin Converting Enzyme Inhibitor , Captopril , Capoten , Lisinopril , Prinivil , Zestril , Enalapril , Vasotec , Fosinopril , Monopril , Benzapril , Lotensin

2018 Trip Latest and Greatest

1549. Management of Cardiovascular Diseases during Pregnancy Full Text available with Trip Pro

from the American Heart Association and the American College of Cardiology. Furthermore, we considered related Guidelines of the ESC published in 2012–15 on the topics of congenital heart disease, aortic disease, valvular heart disease, cardiomyopathies and heart failure (HF), coronary artery disease (CAD), hypertension, pericardial diseases, pulmonary hypertension (PH), infective endocarditis (IE), ventricular arrhythmias, and acute coronary syndromes, and on the topics of cancer treatment (...) Management of Cardiovascular Diseases during Pregnancy We use cookies to enhance your experience on our website. By continuing to use our website, you are agreeing to our use of cookies. You can change your cookie settings at any time. 2018 ESC Guidelines for the management of cardiovascular diseases during pregnancy | European Heart Journal | Oxford Academic Search Account Menu Menu Navbar Search Filter Mobile Microsite Search Term Close search filter search input Article Navigation Close

2018 European Society of Cardiology

1550. Guideline on the prudent prescription of antibiotics in the dental office

of Periodontology (‘Belgische Vereniging voor Parodontologie’/ ‘Société Belge de Parodontologie’) Canadian Agency for Drugs and Technologies in Health Clinical attachment level 20 Prescription of antibiotics in the dental office KCE Report 332 CCT Controlled clinical trial CDI Clostridioides difficile infection CEBAM Belgian Centre for Evidence-Based Medicine CHD Congenital heart disease CHX Chlorhexidine CI Confidence interval CLSI Clinical & Laboratory Standards Institute CNS Central nervous system CODA (...) with Eosinophilia and Systemic Symptoms EARS-Net European Antimicrobial Resistance Surveillance Network EARSS European Antimicrobial Resistance Surveillance System ECDC European Centre for Disease Prevention and Control EEA European Economic Area EFTA European Free Trade Association ESAC-Net European Surveillance of Antimicrobial Consumption Network ESC European Society of Cardiology EU European Union KCE Report 332 Prescription of antibiotics in the dental office 21 EUCAST European Committee on Antimicrobial

2020 Belgian Health Care Knowledge Centre

1551. CRACKCast E206 – Seizures

had a seizure. There are some features, however, that can help you differentiate between these two disease states. We have created a table below that will help you on your next shift to steward management of your next patient with syncope v. seizure. Features of Seizure Features of Syncope Presence of post-ictal symptoms (confusion, altered mental status) Rapid recovery post-event (seconds) without persistent confusion or altered mental status Longer duration of ictal symptoms (e.g., convulsions (...) , jerking) Short, seconds-long convulsions or myoclonic activity Loss of bowel or bladder control No loss of bowel or bladder control Tongue biting or lateral tongue lacerations No tongue biting or lateral tongue lacerations [4] Differentiate between neurogenic and psychogenic seizures As with the patient with syncope versus seizure, the patient with neurogenic versus psychogenic seizure presents a unique diagnostic challenge to clinicians in the ED. Often times, differentiating neurogenic from

2019 CandiEM

1552. ACR–ASNR–SPR Practice Parameter for the Performance of Magnetic Resonance Imaging (MRI) of the Head and Neck

. Smoker WR. Chapter 27: Oral cavity: anatomy and pathology. In: Som PM, Curtin HD, eds. Head and Neck Imaging. 4th ed. Philadelphia, Pa: Mosby; 2003:1377-1364. 46. Hudgins PA. Sinonasal imaging. Neuroimaging Clin N Am. 1996;6(2):319-331. 47. Kubal WS. Sinonasal imaging: malignant disease. Semin Ultrasound CT MR. 1999;20(6):402-425. 48. Hermans R, De Vuysere S, Marchal G. Squamous cell carcinoma of the sinonasal cavities. Semin Ultrasound CT MR. 1999;20(3):150-161. 49. Eisen MD, Yousem DM, Loevner LA (...) Imaging Clin N Am. 2002;10(3):433-449. 57. Imaizumi A, Yoshino N, Yamada I, et al. A potential pitfall of MR imaging for assessing mandibular invasion of squamous cell carcinoma in the oral cavity. AJNR Am J Neuroradiol. 2006;27(1):114-122. 58. Ginsberg LE. Imaging of perineural tumor spread in head and neck cancer. Semin Ultrasound CT MR. 1999;20(3):175-186. 59. Ginsberg LE. MR imaging of perineural tumor spread. Magn Reson Imaging Clin N Am. 2002;10(3):511- 525. 60. Pameijer FA, Mukherji SK, Balm AJ

2019 American Society of Neuroradiology

1553. Management of Stroke Rehabilitation

individuals annually in the United States (U.S.). Approximately 75% of these are first-time strokes, while the remaining 25% are recurrent strokes.[2] While often viewed as a disease of the elderly, stroke can occur at any age. Approximately 10% of all strokes occur in individuals aged 18-50.[2] Currently, stroke is the fifth most common cause of death in the U.S. and a leading cause of long-term disability.[2] While younger patients may be more physically capable of recovering from stroke than older (...) associated with stroke risk more commonly seen in the older population (e.g., uncontrolled hypertension, atrial dysrhythmias, cerebrovascular disease). Research is ongoing to try to identify patients with the highest risk of cryptogenic stroke recurrence; however, risk factors are difficult to quantify given the lack of a clearly identifiable primary etiology. This is of particular importance in the active duty military population, in which both residual disability and the likelihood of recurrence can

2019 VA/DoD Clinical Practice Guidelines

1554. BTS/SIGN British Guideline on the Management of Asthma

patients with a diagnosis of asthma, although there is less evidence available for people at either age extreme. The guideline does not cover patients whose primary diagnosis is not asthma, for example those with chronic obstructive pulmonary disease (COPD) or cystic fibrosis, but patients with these conditions can also have asthma. Under these circumstances many of the principles set out in this guideline will apply to the management of their asthma symptoms. 1.2.2 Target users of the guideline (...) to withdraw the treatment. 3 | Diagnosis24 British guideline on the management of asthma Table 4: Clinical clues to alternative diagnoses in wheezy children Clinical clue Possible diagnosis Perinatal and family history Symptoms present from birth or perinatal lung problem Cystic fibrosis; chronic lung disease of prematurity; ciliary dyskinesia; developmental lung anomaly Family history of unusual chest disease Cystic fibrosis; neuromuscular disorder Severe upper respiratory tract disease Defect of host

2019 British Thoracic Society

1555. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with awareness and attention to comorbidities Full Text available with Trip Pro

,” “osteoporosis,” “renal disease,” “kidney failure,” “cardiovascular disease,” “coronary heart disease,” “atherosclerosis,” “cardiovascular events,” “uveitis,” “psoriatic arthritis,” “smoking,” “tobacco,” “cigarette,” “smoking cessation,” “environmental smoke,” “cancer,” “neoplasm,” “lymphoma,” “depression,” “psychologic disorder,” “anxiety,” “suicide (attempt, completed),” “sexual dysfunction,” “erectile dysfunction,” “work productivity,” “interpersonal relations,” “alcoholism,” and “drinking.” Table I (...) Clinical questions What are the available screening and/or therapeutic interventions in managing the following comorbidities in adults: i. Psoriatic arthritis ii. Cardiovascular disease iii. Metabolic syndrome iv. Mental health v. Lifestyle choices vi. Inflammatory bowel disease vii. Malignancy viii. Renal disease ix. Sleep apnea x. Chronic obstructive pulmonary disease xi. Uveitis xii. Hepatic disease For a full description of the methodology used herein, please refer to the Appendix . Definition

2019 American Academy of Dermatology

1556. Heart Disease and Stroke Statistics Full Text available with Trip Pro

on the definition used. In addition to well-established associations with poor CVD outcomes and all-cause mortality, the presence of metabolic syndrome also has been shown to be associated with poorer cancer outcomes, including increased risk of cancer recurrence, cancer-related mortality, and overall mortality. Kidney Disease (Chapter 11) According to the United States Renal Data System, the overall prevalence of chronic kidney disease in the United States among NHANES participants ≥20 years of age was 14.8 (...) . CVD prevalence excluding hypertension (CHD, HF, and stroke only) is 9.0% overall (24.3 million in 2016). In 2016, 2 744 248 resident deaths were registered in the United States. Ten leading causes accounted for 74.1% of all registered deaths. The 10 leading causes of death in 2016 were the same as in 2015; these include heart disease (No. 1), cancer (No. 2), unintentional injuries (No. 3), chronic lower respiratory diseases (No. 4), stroke (No. 5), Alzheimer disease (No. 6), DM (No. 7), influenza

2019 American Heart Association

1557. How to interpret an elevated lactate on the inpatient wards

How to interpret an elevated lactate on the inpatient wards How to Interpret an Elevated Lactate on the Inpatient Wards – Clinical Correlations Search How to Interpret an Elevated Lactate on the Inpatient Wards January 24, 2019 9 min read By Rebecca Lazarus, MD Peer Reviewed The concept of lactate is frequently on the tip of the tongue or top of the to-do list in the hospital setting. As a new hospitalist, I am frequently discussing with house staff the clinical significance of this molecule (...) ill. A study published in 1999 looked at patients with acute circulatory failure and the effect of hepatic dysfunction on lactate levels. Though there were no differences in other variables including lowest systolic blood pressure, serum creatinine, and simplified acute physiology score, lactate levels were significantly higher in the group with liver disease (8.24 mmol/L vs 4.29 mmol/L; P < 0.001), [11]. Given no difference in the clinical parameters noted above, the authors ruled out

2019 Clinical Correlations

1558. ASCIA Position Statement - Unorthodox Techniques for the Diagnosis and Treatment of Allergy, Asthma and Immune Disorders

intervals, generally variations of other unorthodox treatments. These treatments have either not been subject to careful study or shown to be unhelpful when subject to formal evaluation. Unorthodox treatments sometimes pander to the common but unrealistic desire of patients to cure disease rather than simply control symptoms. Unfortunately, there are actually few cures for disease, other than those that can be eliminated with antibiotics, the surgeon's knife or sometimes cancer chemotherapy. Treatments (...) ASCIA Position Statement - Unorthodox Techniques for the Diagnosis and Treatment of Allergy, Asthma and Immune Disorders Unorthodox Testing and Treatment - Australasian Society of Clinical Immunology and Allergy (ASCIA) | | Unorthodox Testing and Treatment Use of unproven “allergy tests” is common in Australia Despite advances in scientific knowledge about allergic disorders, 50-70 per cent of adults and children with allergic disease consult alternative practitioners yearly for diagnosis

2019 Australasian Society of Clinical Immunology and Allergy

1560. Palliative care - oral: Examination

painful. Malignant oral ulcers Many oral cancers (e.g. lip, tongue, gingiva, buccal mucosa, floor of the mouth) ulcerate. A typical malignant ulcer is hard, with heaped-up and often everted or rolled edges and a granular floor. Basis for recommendation Examination This recommendation is based on expert opinion in a review article [ ]. Clinical features of candidal infection This recommendation is based on expert opinion in textbooks and a review article [ ; ; ; ; ]. © . (...) plaques and membranes. Local tumour: ulceration, slough, bleeding, malodour. Specifically examine: Lips: dryness, cracking, ulceration, bleeding. Mucous membranes: redness, coating, ulceration, bleeding. Tongue: coating, loss of papillae, any bleeding or evidence of blisters. Gingiva: swelling, redness, spontaneous bleeding or bleeding with pressure. Teeth and dentures: plaque or debris along the gum line or underneath the dental plaque, dental abscess. Saliva: thick or ropey, or absent. Voice: raspy

2019 NICE Clinical Knowledge Summaries

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