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Tongue Carcinoma

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1601. Zalviso - sufentanil

must use the AAC in order to set up SSTS for a new patient, change a Drug Cartridge, move the security tether, or discontinue therapy. During set-up, which is completed by a healthcare professional, a Drug Cartridge is inserted into a Dispenser, which is then locked into the Controller. The patient places the Dispenser tip under his or her tongue, and depresses the Controller Dose Button to administer a SST 15 µg as needed based on a fixed 20-minute lockout period. The Patient ID Thumb Tag

2015 European Medicines Agency - EPARs

1602. Sivextro - tedizolid phosphate

to Hour 24.I BCRP breast cancer resistance protein BMI body mass index CA-MRSA community-acquired methicillin-resistant Staphylococcus aureus CDAD Clostridium difficile associated disease CE Clinically Evaluable CE-PTE Clinically Evaluable at PTE Cfr chloramphenicol-florfenicol resistance CFU/g CHMP log 10 Committee for Medicinal Products for Human Use CI confidence interval CL clearance CL/F apparent clearance CLSI Clinical and Laboratory Standards Institute cMITT Clinical modified ITT CQAs cSSTI (...) Critical Quality Attributes complicated skin and soft tissue infections CYP Cytochrome P450 dL deciliter Assessment report EMA/83337/2015 Page 5/110 Abbreviation Definition EC European Commission ECDC European Centre for Disease Prevention and Control ECG electrocardiogram eGFR estimated glomerular filtration rate EIE erythema plus induration or oedema EMA European Medicines Agency EOT end of therapy EU European Union FA free acid TR-701/FA is used when reference is made to both the disodium salt (TR

2015 European Medicines Agency - EPARs

1603. Daclatasvir (DCV) (Daklinza)

subjects with a regimen containing the investigational cyclophilin inhibitor, alisporivir. Previous exposure to NS5A inhibitors was prohibited. Subjects enrolled were generally otherwise healthy without evidence or history of cancer, organ transplant, suspected hepatocellular carcinoma, evidence of decompensated liver disease or other medical condition contributing to chronic liver disease other than HCV. Subjects must have tested negative for HIV and chronic Reference ID: 3785303Clinical Review Wendy (...) Dependency for Adverse Events 57 7.5.3 Drug-Demographic Interactions 57 7.5.4 Drug-Disease Interactions 57 7.5.5 Drug-Drug Interactions 58 7.6 Additional Safety Evaluations 58 7.6.1 Human Carcinogenicity 58 7.6.2 Human Reproduction and Pregnancy Data 59 7.6.3 Pediatrics and Assessment of Effects on Growth 59 Reference ID: 3785303Clinical Review Wendy Carter, D.O. NDA 206-843 Daklinza (daclatasvir) 4 7.6.4 Overdose, Drug Abuse Potential, Withdrawal and Rebound 60 7.7 Additional Submissions / Safety Issues

2015 FDA - Drug Approval Package

1604. Addyi - Flibanserin

of flibanserin ? Concerns with the findings from the alcohol interaction study (syncope, severe hypotension) which enrolled predominantly men (23 men, 2 women) ? Concern for increased incidence of appendicitis in flibanserin-treated subjects over placebo in the clinical program ? Discrepant animal carcinogenicity studies – dose-dependent increase in incidence of mice mammary tumor but negative findings in rats – can neither confirm nor exclude a clinical risk of breast cancer in human ? Unresolved metabolic (...) cycles and no new nonclinical data were included in this resubmission. In reviews dated July 16, 2015, August 10, 2015, August 12, 2015, respectively the pharmacology/toxicology review team again noted no approvability issues from the nonclinical perspective. 4.1 Carcinogenicity Flibanserin is not considered to be genotoxic or mutagenic. A two-year carcinogenicity study showed a statistically significant, dose-related increase in the incidence of malignant mammary gland carcinoma in female mice

2015 FDA - Drug Approval Package

1605. Cariprazine HCl (Vraylar)

, cortisol, electrolyte panel and plasma renin activity. 4. In a post-marketing study, a controlled study design is desirable, and, given the rarity of adrenal insufficiency, a single cohort, long-term (e.g. 3-5 years) study could be designed. Each case of adrenal insufficiency identified would be evaluated by endocrinologists with expertise in adrenal diseases in order to determine whether the adrenal failure is primary and, if so, the etiology. Therefore, the risks that were of great concern are better (...) , a controlled study design is desirable, and, given the rarity of adrenal insufficiency, a single cohort, long-term (e.g. 3-5 years) study could be designed. Each case of adrenal insufficiency identified would be evaluated by endocrinologists with expertise in adrenal diseases in order to determine whether the adrenal failure is primary and, if so, the etiology. 5. DMEP also recommends conducting endocrine assessments in the ongoing depression program. Specific recommendations should be tailored

2015 FDA - Drug Approval Package

1606. Breastfeeding Healthy Term Infants

Discharge 16 72 hours to 7 days and beyond 16D. Breastfeeding Challenges in the Postpartum Period 17 Infant Challenges Near -T erm Infant 17 Hypoglycemia 18 Neonatal Jaundice 18 Ankyloglossia (tongue tie) 19 Maternal Challenges Breast Fullness 19 Breast Engorgement 19 Areolar Engorgement 20 Plugged or Blocked Duct 20 Milk Blister or Blocked Nipple Pore 20 Overabundance of Breastmilk 20 Mastitis 21 Breast Abscess 22 Inverted or Flat Nipples 22 Nipple pain 22 Maternal conditions (such as Vasospasm (...) in postpartum care section, 2 – 24 hours) Positions appropriate for breastfeeding for mother and infant Principles for enabling the infant to latch-on effectively Removing the infant from the breast Hand expression of colostrum/breastmilk • Potential contraindications to breastfeeding Contraindications are rare and breastfeeding is recommended during most maternal infectious diseases, antimicrobial therapy, or immunizations. Contraindications are: Permanent conditions: Mothers advised

2015 British Columbia Perinatal Health Program

1607. NHMRC Statement on Homeopathy and NHMRC Information Paper - Evidence on the effectiveness of homeopathy for treating health conditions

, and • that highly diluted preparations retain a ‘memory’ of the original substance. Homeopathic medicines are prepared by taking a substance (e.g. plant, animal material, or chemical), diluting it in water or alcohol, then forcefully hitting the container against a hand or a surface. This process is repeated several times. Homeopathic medicines include pellets placed under the tongue, tablets, liquids, ointments, sprays and creams. Methods The National Health and Medical Research Council (NHMRC) undertook (...) it in water or alcohol. The container holding the preparation is then forcefully hit against a hand or a surface in a process known as ‘potentiation’ or ‘dynamisation’. Homeopathic medicines can include pellets placed under the tongue, tablets, liquids, ointments, sprays and creams. Homeopaths provide either ‘individualised homeopathy’ or ‘clinical homeopathy’. In individualised homeopathy, the homeopath matches all the person’s symptoms to a single homeopathic medicine, rather than treating the person

2015 National Health and Medical Research Council

1608. Guidelines on Prevention, Diagnosis and Treatment of Infective Endocarditis Full Text available with Trip Pro

of presentation. Thus IE should be suspected in a variety of very different clinical situations. It may present as an acute, rapidly progressive infection, but also as a subacute or chronic disease with low-grade fever and non-specific symptoms that may mislead or confuse initial assessment. Patients may therefore present to a variety of specialists who may consider a range of alternative diagnoses, including chronic infection; rheumatological, neurological and autoimmune diseases; or malignancy. The early (...) congenital heart disease CIED cardiac implantable electronic device CoNS coagulase-negative staphylococci CPG Committee for Practice Guidelines CRP C-reactive protein CT computed tomography E. Enterococcus ESC European Society of Cardiology ESR erythrocyte sedimentation rate EuroSCORE European System for Cardiac Operative Risk Evaluation FDG fluorodeoxyglucose HF heart failure HIV human immunodeficiency virus HLAR high-level aminoglycoside resistance i.m. intramuscular i.v. intravenous ICE International

2015 European Society of Cardiology

1609. Drugs to avoid in 2015

. Citalopram and escitalopram, which can cause QT prolongation, are not included in our list (Rev Prescrire n° 369). We are planning to review this adverse effect with the various SSRI antidepressants. Oncology – Catumaxomab, used in malignant ascites, has serious adverse effects (pos- sibly fatal) in more than three-quarters of patients (Prescrire Int n° 109). It is more prudent to drain ascites, at intervals guided by symptoms. – Panitumumab does not prolong sur- vival in metastatic colorectal cancer (...) assess- ment of a drug’s harm-benefit balance based on individual experience can help to guide further research but is subject to major bias and represents only weak evidence (3,4). For example, it can be dif- ficult to attribute a specific outcome to a particular drug, as other factors must be taken into account, including the nat ural history of the disease, the placebo effect, the effect of another treatment the patient may not have mentioned, or a change in lifestyle or diet. Similarly

2015 Prescrire

1610. Transoral Robotic Surgery

of TORS include lack of tactile feedback, difficult hemostasis and initial investment costs. 5 Malignant lesions of the oral or oropharyngeal cavity are relatively uncommon. The estimated annual incidence worldwide is approximately 123,000, with 79,000 deaths annually. 6 Cancers of the oral and oropharyngeal mucosa are most often squamous cell carcinomas and arise from the palate, tonsils, base of tongue, vellecula and aryepiglottic folds. 3,6 Several risk factors are known to be associated (...) total cost for TORS partial pharyngectomy and partial glossectomy (tongue base) in mild to moderate disease compared to open surgery. There was no significant difference between treatment group for partial glossectomy of the anterior tongue. Richmon 7 demonstrated that compared to non-TORS surgery, TORS was associated with a cost savings of $4,285 in patients with malignant oropharyngeal neoplasm. In 2014, Hammoudi 15 showed that TORS was associated with a significantly higher cost of surgery ($7781

2015 Canadian Agency for Drugs and Technologies in Health - Rapid Review

1611. Acute pain management: scientific evidence (3rd Edition)

in every case, early recognition and treatment of incipient chronic pain by a vigilant healthcare system is necessary for cost- effective intervention. The National Pain Strategy document that underpins the 2010 Australian Pain Summit summarises the emerging literature on social, human and economic costs of undertreated acute and chronic pain — establishing pain as a major disease burden ( and proposing an integrated new framework for management of acute, chronic and cancer pain (...) . Anesthesiology 110(5): 955–6. Johnston M, Brouwers M & Browman G (2003) Keeping cancer guidelines current: results of a comprehensive prospective literature monitoring strategy for twenty clinical practice guidelines. Int J Technol Assess Health Care 19: 646–55. Marret E, Elia N, Dahl JB et al (2009) Susceptibility to fraud in systematic reviews. Anesthesiology 111: 1279–89. Neal JM (2009) Retraction. Reg Anesth Pain Med 34(4): 385. NHMRC (1999) A Guide to the Development, Implementation and Evaluation

2015 National Health and Medical Research Council

1612. Candida - oral: What else might it be?

and does not usually require further investigation. Erosive lichen planus manifests as zones of tender erythema and painful ulcers surrounded by white, radiating striae, and may require biopsy to rule out serious causes. Oral cancers, including: Squamous cell carcinoma — early lesions are often asymptomatic, appear as areas of erythroplakia (red patch) or leukoplakia (white patch), and may be ulcerated or exophytic (growing outwards). As the lesion grows, it becomes more symptomatic. Melanoma (...) Candida - oral: What else might it be? Differential diagnosis | Diagnosis | Candida - oral | CKS | NICE Search CKS… Menu Differential diagnosis Candida - oral: What else might it be? Last revised in August 2017 What else might it be? Differential diagnoses of oral candidiasis include: Erythema migrans (also known as geographic tongue or benign migratory glossitis) — an inflammatory disorder affecting 1–3% of the population. It is associated with atopic conditions and psoriasis

2019 NICE Clinical Knowledge Summaries

1613. Bruising: How should I assess a person with bruising?

— suggests corticosteroid use, hypothyroidism, ageing, self-inflicted injury, a collagen defect, or factor XIII deficiency. Laxity — may suggest . Pallor — suggests anaemia, which may be associated with malignancy. Jaundice — suggests liver disease. Petechiae (tiny, round, non-blanching, pinpoint flat spots less than 3 mm in diameter) — for example at clothing line pressure sites may indicate a platelet disorder; or if in the distribution of the superior vena cava they may follow coughing, vomiting (...) , suggesting . Tenderness — may be seen in acute leukaemia or neuroblastoma. Examine the abdomen for: Splenomegaly — suggests malignancy or (rare). Hepatomegaly — suggests malignancy or liver disease. Ascites, caput medusa, and spider telangiectasia — suggest chronic liver disease. Examine the head and neck. The oropharynx — for signs of bleeding, trauma, or healing injury to the frenulae (may suggest other non-accidental injury); gum hypertrophy may occur in monocytic leukaemia; wet purpura on the buccal

2019 NICE Clinical Knowledge Summaries

1614. Blackouts: How do I diagnose the underlying cause of a blackout?

, pleuritic chest pain, thromboembolic (TE) risk factors, such as previous TE disease, prolonged immobilisation (e.g. flight > 4 hours), smoking, contraceptive pill or HRT use, known malignancy, or family history of thromboembolism. Be aware that syncope is a relatively common finding in older people with a PE (24% of people aged over 65 years). For more information, see the CKS topic on . Occult haemorrhage — suggested by recent tissue trauma or signs/symptoms of GI bleeding (haematemesis, and melaena (...) levels, if hypoglycaemia is suspected. Full blood count to check haemoglobin levels, if anaemia or bleeding is suspected. Assess for the presence of a life-threatening cause for blackout, such as: Myocardial infarction and ischaemia — suggested by a history of coronary artery disease (CAD) and preceding chest pain. ECG may show signs of infarction such as ST-segment elevation, new left bundle branch block, and/or arrhythmia. Note that a normal ECG does not exclude CAD. If there is any suggestion

2019 NICE Clinical Knowledge Summaries

1615. Palliative care - oral: Scenario: Halitosis, excessive salivation and altered taste

is expert advice [ ; ]. The authors of a standard textbook on oral care in palliative disease recommend that it is appropriate to offer people with taste disturbance a trial of an oral zinc salt [ ]. However: There is limited and conflicting evidence from small trials of 30 or less people with radiotherapy-related taste problems that use of an oral zinc salt may be effective, but this may not apply to people with other cancer-related taste problems. No zinc salt is licensed for this use in the UK (...) problem Encourage: Regular oral hygiene, including tongue cleaning and good care of dentures. Fluid intake. Modification of diet (for example exclude garlic and onions). Smoking cessation. Regular use of a gargle or mouthwash containing an antimicrobial agent (for example chlorhexidine) may reduce breath odour. Consider artificial saliva if the mouth is very dry. Treat any underlying cause. For more information, see the CKS topic on . Also and in the . Oral hygiene Oral hygiene should include tooth

2019 NICE Clinical Knowledge Summaries

1616. 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

1617. Diarrhoea - prevention and advice for travellers: Scenario: Diarrhoea - prevention and advice for travellers

amenities are limited or unavailable. Bismuth subsalicylate is more suitable for mild diarrhoea; loperamide has a faster onset of action and is more effective than bismuth subsalicylate for controlling diarrhoea and cramping. Bismuth subsalicylate is not suitable for people with aspirin allergy, renal insufficiency, gout, severe enteric disease or HIV (risk of bismuth absorption), or people who are taking an anticoagulant such as warfarin, or pregnant or breastfeeding women. Darkened tongue and stools (...) needs. For more information, see the NaTHNaC website ( ). Groups who may benefit from prophylactic treatment include those who: Have increased susceptibility to infection or are immunocompromised. Have a high risk of complications if they were to develop travellers' diarrhoea, for example: People with chronic gastrointestinal disease (such as Crohn's disease, or ulcerative colitis). People with an ileostomy or colostomy. People with other diseases (such as malignancy, type 1 diabetes mellitus, renal

2019 NICE Clinical Knowledge Summaries

1618. Clinicopathologic features and prognostic analysis of Waldeyer ring B-cell lymphoma. Full Text available with Trip Pro

-myelocytomatosis viral oncogeneav (MYC) gene abnormalities were investigated using interphase fluorescence in situ hybridization.Among the 65 patients, there were 12 nasopharynx cases, 49 tonsil cases, and 4 tongue root cases. Moreover, there were 49 cases of diffuse large BCL (DLBCL) and 16 cases of follicular lymphoma (FL). More than 60% of the patients had Ann Arbor stage III/IV disease, with infiltrated neighboring organs, invaded spleens, and increased lactate dehydrogenase (LDH) levels. Tumor cells were (...) positive for multiple myeloma antigen 1 (MUM1), BCL-2, BCL-6, and C-MYC. EBER expression was detected in lymphoma cells of 2 cases. Alteration frequencies of IRF4, BCL-2, BCL-6, and C-MYC were 24.6%, 32.3%, 27.7%, and 30.7%, respectively. Approximately 67.69% cases had stages 0 to II disease, while 32.31% cases had stage III disease. Five-year overall survival rate was 65.12%. Eastern Cooperative Oncology Group performance status (ECOG) score ≥2 was the only adverse factor for overall survival. IRF4

2020 Medicine

1619. Transoral floor of mouth lipoma resection: A technical multimedia analysis. (Abstract)

Transoral floor of mouth lipoma resection: A technical multimedia analysis. Lipomas are common benign mesenchymal tumors that originate from mature adipocytes throughout the body, with 13-20% occurring in the head and neck region, however only 1-4.4% affect the oral cavity, where they are found predominately in the cheek, followed by the tongue, lips, palatal mucosa, gingiva, and floor of the mouth. Herein, we present a multimedia analysis of transoral floor of mouth lipoma resection in a 58

2020 American Journal of Otolaryngology

1620. Langerhans Cell Histiocytosis Treatment (PDQ®): Patient Version

quickly. This causes LCH cells to build up in certain parts of the body, where they can damage or form . LCH is not a disease of the Langerhans cells that normally occur in the skin. LCH may occur at any age, but is most common in young children. Treatment of LCH in children is different from treatment of LCH in adults. The and the are described in separate sections of this summary. Use our to find NCI-supported cancer clinical trials that are accepting patients. You can search for trials based (...) on the type of cancer, the age of the patient, and where the trials are being done. about clinical trials is also available. Family history of cancer or having a parent who was exposed to certain chemicals may increase the risk of LCH. Anything that increases your risk of getting a disease is called a . Having a risk factor does not mean that you will get ; not having risk factors doesn't mean that you will not get cancer. Talk with your doctor if you think you may be at risk. Risk factors for LCH include

2018 PDQ - NCI's Comprehensive Cancer Database

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