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Tongue Carcinoma

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1661. Assessing Fitness to Drive

to relevant medical systems/diseases. The medical requirements for unconditional and conditional licences are summarised in a tabulated to differentiate between the requirements for private and commercial vehicle drivers. Additional information, including the rationale for the standards, as well as a general assessment and management considerations, is provided in the supporting text of each chapter. 5 Part A: 1 About this publication Assessing Fitness to Drive 2016 Part C comprises further supporting (...) • endurance/fatigue and vigilance demands associated with long periods spent on the road. 2.2 Medical conditions and driving 2.2.1 Conditions likely to affect driving Given the many causal factors in motor vehicle crashes, the extent to which medical conditions contribute to vehicle crashes is difficult to assess. There is, however, recognition of the potential for certain conditions to cause serious impairments. Examples of such conditions include: • blackouts • cardiovascular disease • diabetes

2016 Cardiac Society of Australia and New Zealand

1662. ASCIA Clinical Update - Anaphylaxis

tumours (e.g. carcinoid syndrome, VIPomas) • Alcohol related • Medullary carcinoma of thyroid • “Red Man Syndrome” (vancomycin related) Neurological syndromes • Epileptic seizures • Strokes Other causes of collapse • Vasovagal episodes • Systemic Capillary Leak Syndrome • Shock (septic, cardiogenic, haemorrhagic) Acute respiratory distress • Asthma Panic disorders • Globus hystericus • Laryngospasm (can be triggered by anxiety but more commonly triggered by oesophageal reflux) • Vocal cord dysfunction (...) for insect allergy) Anaphylaxis Watch for any one of the following signs of anaphylaxis: • Difficult/noisy breathing • Swelling of tongue • Swelling/tightness in throat • Difficulty talking and/or hoarse voice • Wheeze or persistent cough • Persistent dizziness or collapse • Pale and floppy (young children) Note: Urticaria, erythema and angioedema may be transient, subtle and easily overlooked. In 1 out of 6 fatal food induced anaphylaxis cases, severe cardiovascular symptoms developed without skin

2016 Australasian Society of Clinical Immunology and Allergy

1663. Clearing the Smoke on Cannabis: Medical Use of Cannabis and Cannabinoids ? An Update

for medical purposes are not assured the reliable, standardized and reproducible dose they would otherwise receive from using cannabinoid products delivered in controlled doses (e.g., capsules, oral sprays). • Research is currently examining the efficacy of potential therapeutic uses of cannabinoid products for conditions such as multiple sclerosis, psychiatric disorders, epilepsy, inflammatory diseases, cancer, obesity, glaucoma and neurodegenerative disorders. Although findings from this research (...) studied in cell cultures (test-tube studies) and in animals with tumours, no firm conclusions about their clinical use are yet possible. It has been confirmed repeatedly that THC and various other cannabinoids binding to CB 1 and CB 2 cannabinoid receptors, and CBD acting through different mechanisms, can promote cancer cell death, or retard or prevent the growth of cancer cells of various types, including lung, prostate, pancreas, colon and brain cancer (Dando et al., 2013; De Petrocellis et al

2016 Canadian Centre on Substance Abuse

1664. Salivary Gland Tumors Treated With Adjuvant Intensity-Modulated Radiotherapy With or Without Concurrent Chemotherapy. (Abstract)

Salivary Gland Tumors Treated With Adjuvant Intensity-Modulated Radiotherapy With or Without Concurrent Chemotherapy. To analyze the recent single-institution experience of patients with salivary gland tumors who had undergone adjuvant intensity-modulated radiotherapy (IMRT), with or without concurrent chemotherapy.We performed a retrospective analysis of 35 salivary gland carcinoma patients treated primarily at the Dana-Farber Cancer Institute between 2005 and 2010 with surgery and adjuvant (...) IMRT. The primary endpoints were local control, progression-free survival, and overall survival. The secondary endpoints were acute and chronic toxicity. The median follow-up was 2.3 years (interquartile range, 1.2-2.8) among the surviving patients.The histologic types included adenoid cystic carcinoma in 15 (43%), mucoepidermoid carcinoma in 6 (17%), adenocarcinoma in 3 (9%), acinic cell carcinoma in 3 (9%), and other in 8 (23%). The primary sites were the parotid gland in 17 (49%), submandibular

2010 Biology and Physics

1665. Early side effects after embolization of a carotid body tumor using Onyx. Full Text available with Trip Pro

Early side effects after embolization of a carotid body tumor using Onyx. The case of a 20-year-old woman with a carotid body tumor of Shamblin class III is reported. Ten hours after preoperative direct intralesional embolization with 20 mL Onyx (ethylene-vinyl alcohol copolymer; Micro Therapeutics, Irvine, Calif), the patient showed symptoms of Horner syndrome and deficits of the hypoglossal and glossopharyngeal nerves. Intraoperative examination 12 hours after Onyx embolization revealed (...) a massive swelling of the hypoglossal and glossopharyngeal nerves. The patient's tongue motility and glossopharyngeal function improved after surgery, but Horner syndrome was still present. Owing to the delayed occurrence of these adverse effects, the optimal time of surgical intervention after Onyx embolization should be discussed and perhaps expedited.

2010 Journal of Vascular Surgery

1666. Solitary Granular Cell Tumor of Cecum: A Case Report Full Text available with Trip Pro

Solitary Granular Cell Tumor of Cecum: A Case Report Granular cell tumor (GCT) was first described by Abrikossof in 1926. This tumor is a benign neoplasm of unclear histogenesis that is generally believed to be of nerve sheath origin. GCT is not common and most often affects the tongue, skin, and soft tissue, although it may occur anywhere in the body. Gastrointestinal tract involvement, and especially that of the colon, is very rare. This usually benign tumor appears as a submucosal nodule (...) , measuring less than 2 cm in diameter and is often found incidentally during colorectal examinations. We describe the case of a 27-year-old man with a GCT in the cecum that was detected after a screening colonoscopy. Endoscopic examination revealed a yellowish submucosal tumor, 0.7 cm in diameter. An endoscopic mucosal polypectomy was done for histological confirmation and treatment.

2010 ISRN gastroenterology

1667. Mouth care

. Acute pseudomembranous candidiasis (thrush) is usually an acute infection. It may however persist for months in patients receiving inhaled corticosteroids, cytotoxic drugs or broad-spectrum antibiotics. Thrush may also occur in patients with serious systemic disease or receiving treatment associated with a reduced immunity e.g. cancer, chemotherapy, and HIV infection ( ). Treatment of oral candidiasis in IMMUNE COMPETENT children and young people For the treatment of oropharyngeal candidiasis (...) of sugar-free medicines ( ). Many healthy eating tips can be found on . Lifestyle Young people should be advised against smoking or using smokeless tobacco as this can increase the risk of periodontal disease, and also oral cancers ( ). Young people should also be advised about alcohol intake and its effect on oral health ( ). Encourage regular dental check-ups – every six months ( ). For children and young people with cancer a dental assessment is recommended every three to four months

2014 Publication 1593

1668. Anoro (umeclidinium bromide / vilanterol trifenatate)

-therapeutic group (ATC Code): Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics (R03AL03) Therapeutic indication(s): Anoro is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Pharmaceutical form(s): Inhalation powder, pre-dispensed Strength(s): 55 micrograms / 22 micrograms Route(s) of administration: Inhalation use Packaging: blister (alu) Package size(s): 1 x 7 dose inhaler (...) Chronic Obstructive Pulmonary Disease CRQ-SAS Chronic Respiratory Disease Questionnaire – Self-Administered Standardized CYP2D6 Cytochrome P450 2D6 CYP3A4 Cytochrome P450 3A4 DB Double blind DD Double dummy DPI Dry Powder inhaler ECG Electrocardiogram EET Exercise Endurance Test Emax Maximum effective dose EMA European Medicines Agency EQ-5D EuroQol-5D ESWT Exercise shuttle walk test EU European Union FDA Food and Drug Administration FEV 1 Forced expiratory volume in one second FF Fluticasone Furoate

2014 European Medicines Agency - EPARs

1669. Velphoro - mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches

AUC0-24 Area under the plasma concentration-time curve from time 0 to 24 AUC0-infinity Area under the concentration-time curve from time 0 extrapolated to infinite time AV Arteriovenous BL Baseline BMI Body mass index BP Blood pressure BW body weight Ca × P Calcium-phosphorus product Chol Cholesterol CI Confidence interval CKD Chronic kidney disease CKD-MBD Chronic kidney disease-metabolic bone disorder Cmax Peak plasma concentration Cmax Peak serum concentration CPK Creatine phosphokinase Crea (...) Creatinine CRF Chronic renal failure CSR Clinical study report CYP Cytochrome P450 DDI Drug-drug interaction DPD Deoxypyrodinoline ECG Electrocardiogram EMA European Medicines Agency (previously EMEA) Epi Epithelium ESA Erythropoiesis stimulating agent ESRD End stage renal disease EU European Union FAS Full analysis set FDA Food and Drug Administration FGF-23 Fibroblast growth factor 23 FUP2 Follow-Up 2 GCP Good Clinical Practice Assessment report EMA/567960/2014 Page 5/112 GI Gastrointestinal GLP Good

2014 European Medicines Agency - EPARs

1670. Tivicay - dolutegravir

at the following site(s): Dr Mills Inc., Suite 812, 9201 Sunset Blvd., Los Angeles, 90069, California, United States, Dr Sloan North Texas Infectious Disease Consultants, Suite 710, 3409 Worth Street Dallas, 75246, Texas, United States and at the sponsor site located in Five Moore Drive, Research Triangle Park (RTP), North Carolina 27709, United States between 19 June and 18 July 2013, was issued on 1 st August 2013. • The Rapporteurs circulated the Joint Assessment Report on the applicant’s responses (...) ) Cynomolgus monkey (7-9M, 7-9F) 0, 3, 10, 15, 50/30, PO 38 weeks +1 month recovery =15mg/kg: Diarrhea, salivation, vomiting. Moncoytes, neutrophils ? (M). APTT ? (F) =50/30 mg/kg: Deaths, 2 M. Activity ?, emaciation. Bw. ?. Neutrophils, leukocytes ?. APTT, fibrinogen ?. RBC, Hb, HCT ? (F). Protein, inorg. phosph. ? (M). TG ? (F). Glucose, chloride ?. Stomach red mucosa (F). Mononuclear cell infiltration, hemorrhage lamina propria cecum and colon (M), esophagius and tongue inflammatory cell infiltration (M

2014 European Medicines Agency - EPARs

1671. Zydelig - idelalisib

number of subjects in a population (N) or subset (n) NA not applicable NCCN National Comprehensive Cancer Network NCI National Cancer Institute (US) NE not evaluable NHL non-Hodgkin lymphoma NR not reached; not reported OAT organic anion transporter OATP organic anion transporting polypeptide OCT organic cation transporter ORR overall response rate OS overall survival PD progressive disease PFS progression-free survival Pgp P-glycoprotein PI3K phosphatidylinositol 3-kinase PI3K d phosphatidylinositol (...) detected at high levels by western blot in all of the samples tested (n=40). Treatment with idelalisib caused a dose-dependent induction of apoptosis in primary CLL cells (n=7); the mean percentage of apoptotic cells at 1 µM was 28% with range from 0% to 54% and at 10 µM was 60% with a range from 26% to 78%. Nurse-like cells (NLC) present within the tumour microenvironment support malignant B-cell viability and growth. NLCs secrete the chemokines CXCL12 and CXCL13 which attract or induce homing of iNHL

2014 European Medicines Agency - EPARs

1672. Jardiance - empagliflozin

for the vascular tumors (vascular obstruction, chronic antigenic stimulation and increased hemolysis, hemosiderosis and iron overload), and the absence of vascular neoplasms in any other species following empagliflozin administration suggest a low relevance of this finding to human safety. The exposure multiple to the dose of 300 mg/kg/day at which the finding was not considered empagliflozin-related is 26x relative to the steady state Assessment report EMA/CHMP/137741/2014 Page 24/99 exposure in clinical (...) of the zona fasciculata, was observed in males and females at all dose levels. The etiology of these effects were not further discussed by the Applicant, but may reflect an adaptive response to reduced glucose levels triggering increased glucocorticoid (cortisol) synthesis. In the rat carcinogenicity study, vessel mineralization was observed in the heart, tongue, kidney, eye, axillary and mesenteric lymph nodes, mandibular salivary gland and pancreas. In addition, tissue mineralization was seen in seminal

2014 European Medicines Agency - EPARs

1673. Laventair - umeclidinium bromide / vilanterol

-therapeutic group (ATC Code): Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics (R03AL03) Therapeutic indication(s): Laventair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Pharmaceutical form(s): Inhalation powder, pre-dispensed Strength(s): 55 micrograms / 22 micrograms Route(s) of administration: Inhalation use Packaging: blister (alu) Package size(s): 1 x 7 dose (...) Chronic Obstructive Pulmonary Disease CRQ-SAS Chronic Respiratory Disease Questionnaire – Self-Administered Standardized CYP2D6 Cytochrome P450 2D6 CYP3A4 Cytochrome P450 3A4 DB Double blind DD Double dummy DPI Dry Powder inhaler ECG Electrocardiogram EET Exercise Endurance Test Emax Maximum effective dose EMA European Medicines Agency EQ-5D EuroQol-5D ESWT Exercise shuttle walk test EU European Union FDA Food and Drug Administration FEV 1 Forced expiratory volume in one second FF Fluticasone Furoate

2014 European Medicines Agency - EPARs

1674. Lymphoseek - tilmanocept

V09IA Therapeutic indication: This medicinal product is for diagnostic use only. Radiolabelled Lymphoseek is indicated for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity. External imaging and intraoperative evaluation may be performed using a gamma detection device. Pharmaceutical form: Kit for radiopharmaceutical preparation Strength: 250 µg Route (...) In patients with breast cancer, melanoma, HNSCC, and multiple other solid tumor cancers, the ability to identify whether the cancer has spread greatly influences patients’ outcomes and future treatment. Intraoperative lymphatic mapping (ILM) and lymph node biopsy have been used in cancer patients to evaluate the association of the tumour with the lymphatic system and determine whether the primary tumour has spread to the regional lymph nodes. ILM is a procedure whereby a surgeon tracks lymphatic drainage

2014 European Medicines Agency - EPARs

1675. Ledipasvir/Sofosbuvir

and in vivo mouse micronucleus assays. No increase in the incidence of drug-related neoplasms were observed at the highest SOF doses tested in 2-year carcinogenicity studies in mice and rats, resulting in AUC exposure to the predominant circulating metabolite GS-331007 of approximately 4- and 18-fold (in mice) and 8- and 10-fold (in rats), in males and females respectively, the exposure in humans at the recommended clinical dose. LDV: The nonclinical safety profile of LDV has been evaluated in: safety (...) exposure in patients with mild and moderate renal impairment may be lower in HCV-infected patients. Based on these data, currently it will be recommended that LDV/SOF can be administered to patients with mild or moderate renal impairment. Please refer to Section 7.5.4 Drug-Disease Interactions for additional details. Hepatic Impairment: ? LDV PK was studied with a single LDV 90 mg dose in HCV-negative subjects with severe hepatic impairment (Child-Pugh Class C). LDV plasma exposure (AUC inf

2014 FDA - Drug Approval Package

1676. Evolocumab (Repatha)

, or stroke within 3 months prior to randomization; and malignancy (except non- melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) within the last 5 years. Thus, individuals with these conditions were not represented in the trials. Deaths: There were 15 deaths reported during the clinical program. Four deaths occurred during the parent trials [1/2080 (0.05%) any control; 3/3946 (0.08%) any EvoMab], 7 deaths occurred during the open-label (...) 7.5.1 Dose Dependency for Adverse Events 313 7.5.2 Time Dependency for Adverse Events 313 7.5.3 Drug-Demographic Interactions 315 7.5.4 Drug-Disease Interactions 323 Reference ID: 3810576Clinical Review Eileen Craig, MD BLA 125522 Repatha (evolocumab) 5 7.5.5 Drug-Drug Interactions 328 7.6 Additional Safety Evaluations 328 7.6.1 Human Carcinogenicity 328 7.6.2 Human Reproduction and Pregnancy Data 329 7.6.3 Pediatrics and Assessment of Effects on Growth 330 7.6.4 Overdose, Drug Abuse Potential

2014 FDA - Drug Approval Package

1677. Secukinumab (Cosentyx)

Table 24 : Adverse Events related to infections reported in psoriasis studies 58 Table 25: Autoimmune Adverse Events by Preferred Term (Pool B entire treatment period) 62 Table 26: Exposure-adjusted incidence of inflammatory bowel disease (Pool B entire treatment period) 65 Table 27: Overview of plaque psoriasis cases of MACE on secukinumab treatment 71 Table 28: Malignancies and Skin Tumors (Pool A) 74 Table 29: Exposure-adjusted incidence of the most frequent (>=0.05 per 100 patient- years in any (...) group) AEs of malignant or unspecified tumors (Pool B Entire treatment period) 75 Reference ID: 3669014Clinical Review Amy S. Woitach, DO BLA 125-504 Cosentyx (secukinumab) 7 Table 30: Most common Treatment-Emergent Adverse Events during the Induction Period (Pool A) of Pivotal Phase 3 Trials 79 Table 31: Most frequent (>=2.0% in any group) AEs by preferred term for induction period (Pool A) 80 Table 32: Proposed labeling of adverse reactions 81 Table 33: Hematology: number (%) of patients

2014 FDA - Drug Approval Package

1678. Neostigmine Methylsulfate Injection, USP

. Summary of the Caldwell et al. study results 111 Table 21. TOF ratios at different times following vecuronium and neostigmine administration (Table 2 on p. 1170 of the article) 114 Table 22. Summary of pharmacodynamic effects of neostigmine for patients with normal renal function (NL) and end-stage renal disease (RF) [mean (SD)] (based on Table 1 on p. 135 of the article) 117 Reference ID: 3187027Clinical Review Arthur Simone, MD, PhD NDA 203629 Neostigmine Sulfate Injection, USP 6 Table 23. Time (...) neostigmine, function at the neuromuscular junction sites of cholinergic transmission and reverse the effects of drug-induced neuromuscular blockade. They are approved for the following indications, quoted from their respective labels: ENLON is recommended for the differential diagnosis of myasthenia gravis and as an adjunct in the evaluation of treatment requirements in this disease. It may also be used for evaluating emergency treatment in myasthenic crises. Because of its brief duration of action

2014 FDA - Drug Approval Package

1679. Systematic review of needs for medical devices for ageing populations

for ageing populations 4. MALIGNANT NEOPLASMS . . . . . . . . . . . . . . . . . . . . . . . 28 4.1 INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28 Table 10 Incidence of cancer, worldwide and Western Pacific Region . . . . . . . . . . . . . . . . . . . . . . . .28 Table 11 Mortality due to cancer, worldwide and Western Pacific Region . . . . . . . . . . . . . . . . . . . . . . .29 4.2 CANCER OF THE MOUTH AND OROPHARYNX (...) Region. Five main health conditions, with 19 associated sub-topics, were identified: • cardiovascular diseases; • malignant neoplasms; • respiratory diseases; • sense organ diseases; • neuropsychiatric conditions. This report provides a literature-based review of medical devices needed by older people. The results have been used to create lists of devices categorized in terms of whether they are preventive, diagnostic or therapeutic. Broad clinical safety and effectiveness information has also been

2015 ASERNIP-S

1680. Allergic Rhinitis

Bloomfield Hospital, 6777 West Maple Rd, West Bloomfield, MI 48322, USA. Email: Abstract Objective Allergic rhinitis (AR) is one of the most common diseases affecting adults. It is the most common chronic disease in children in the United States today and the fifth most common chronic disease in the United States overall. AR is estimated to affect nearly 1 in every 6 Americans and generates $2 to $5 billion in direct health expenditures annually. It can impair quality of life and, through loss of work (...) provided no recommendation regarding the use of herbal therapy for patients with AR. Keywords , , , , , , , , , , , , , , Introduction Allergic rhinitis (AR) is one of the most common diseases affecting adults. It is the most common chronic disease in children in the United States today and is the fifth most common chronic disease in the United States overall. AR is estimated to affect nearly 1 in every 6 Americans and generates $2 to $5 billion in direct health expenditures annually. , It can impair

2015 American Academy of Otolaryngology - Head and Neck Surgery

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