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Tongue Carcinoma

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1601. 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

1602. 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

1603. Lenvima - lenvatinib

cancer OOL optional open label ORR objective response rate OS overall survival PD pharmacodynamic(s) PD progressive disease PFS progression-free survival P-gp P-glycoprotein PK pharmacokinetic(s) PPE palmar-plantar erythrodysaesthesia PR partial response QD quaque die, once a day RAF Rapidly Accelerated Fibrosarcoma RECIST Response Evaluation Criteria in Solid Tumors EMA/250082/2015 Page 7/169 RPLS reversible posterior leukoencephalopathy syndrome RPSFT rank-preserving structural failure time RR (...) complete response CRF case report form CSE Clinically significant adverse event CSR clinical study report CTCAE Common Terminology Criteria for Adverse Event CV coefficient of variance CYP cytochrome P450 CYP3A4 Cytochrome P450 3A4 DBP diastolic blood pressure DECISION acronym for the Phase 3 sorafenib trial: “StuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer” DCR disease control rate DDI drug-drug interaction DFG motif central to function

2015 European Medicines Agency - EPARs

1604. 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

1605. 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

1606. 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

1607. 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

1608. 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

1609. Ulcerative colitis

: thiopurines may increase the risk of non-melanoma skin cancer, and people should be monitored for skin cancer and given appropriate sun protection advice. Biologic therapy — the anti-tumour necrosis factor (TNF)-alpha monoclonal antibody agents intravenous infliximab and subcutaneous adalimumab and golimumab are effective at inducing remission in people with severe active disease which has not responded to conventional therapy, or where conventional therapy is not tolerated. These drugs are also effective (...) incidence ratios of ulcerative colitis (based on relatively low absolute numbers), with a cumulative incidence of colorectal cancer of less than 1% at 10 years, 0.4%–2.0% at 15 years, and 1.1–2.5% at 20 years. It concluded that ulcerative colitis increases the risk of colorectal cancer 2.4-fold [ ]. The risk is increased in people with disease diagnosed in childhood, those with a long disease duration, co-morbid primary sclerosing cholangitis, or a family history of colorectal cancer in a first-degree

2019 NICE Clinical Knowledge Summaries

1610. Bipolar disorder

and abuse with quetiapine [ ]. October 2015 — minor update. Muscle weakness and rhabdomyolysis have been included as possible adverse effects of lithium [ ]. May 2015 — minor update. Three updates based on updates to manufacturers' Summaries of Product Characteristics (SPCs): Mitochondrial disorders added as a contraindication to the use of valproate [ ]. Renal tumours (microcysts, oncocytomas, and collecting duct renal carcinoma) added as possible adverse effects of prolonged use (over 10 years (...) have also been associated with schizophrenia. Environmental factors/triggers that have been associated with the onset, or with relapses of bipolar disorder include: Early life stress, maternal death before a child reaches five years of age, childhood trauma, childhood abuse, emotional neglect/abuse. Toxoplasma gondii exposure. Cannabis use, cocaine exposure. [ ; ; ; ] Incidence and prevalence How common is it? Data collected between 1990 and 2010 for the Global Burden of Disease study suggests

2019 NICE Clinical Knowledge Summaries

1611. Sepsis

in children and young people. Capillary refill time and oxygen saturation (abnormal results may indicate poor peripheral perfusion). Mottled or ashen skin; pallor or cyanosis of the skin, lips or tongue; cold peripheries. A non-blanching rash which may suggest meningococcal disease. See the CKS topic on for more information on assessment and emergency management. Weak high-pitched or continuous cry (in children under 5 years of age). Any breach of skin integrity (for example cuts, burns, or skin (...) (under one year of age) and older people (over 75 years of age). People who are very frail. People who are immunocompromised due to a co-morbid condition (such as diabetes mellitus, HIV, cirrhosis, sickle cell disease, or asplenia). See the CKS topics on , , , , and for more information. People who are immunosuppressed due to drug treatment (such as anticancer treatment, oral corticosteroids, or other immunosuppressive drugs). See the CKS topics on , , and for more information. People who have had

2019 NICE Clinical Knowledge Summaries

1612. Meningitis - bacterial meningitis and meningococcal disease

Meningitis - bacterial meningitis and meningococcal disease Meningitis - bacterial meningitis and meningococcal disease - NICE CKS Share Meningitis - bacterial meningitis and meningococcal disease: Summary Bacterial meningitis is a life-threatening condition that can affect all ages, but is most common in babies and children. Transmission occurs through close contact, droplets, or direct contact with respiratory secretions. The annual incidence of acute bacterial meningitis in developed (...) mental state (confusion, delirium and drowsiness, impaired consciousness), non-blanching rash, back rigidity, bulging fontanelle (in children younger than 2 years of age), photophobia, Kernig's sign, Brudzinski's sign, coma, paresis, focal neurological deficit, and seizures. All suspected cases of meningitis are medical emergencies requiring immediate hospital admission by telephoning 999. For suspected meningococcal disease (meningitis with non-blanching rash or meningococcal septicaemia

2019 NICE Clinical Knowledge Summaries

1613. Hypertension in pregnancy

in their first pregnancy and 1.7% of women in their second pregnancy have pre-eclampsia [ ]. Haemolysis, Elevated Liver enzymes, and Low Platelets (HELLP) syndrome occurs in 0.5–0.9% of all pregnancies overall, and in 10–20% of women with severe pre-eclampsia [ ]. Eclampsia complicates 2.7 per 10,000 births [ ]. Risk factors What are the risk factors? Women are at high risk of pre-eclampsia if they have: One of the following high risk factors: A history of hypertensive disease during a previous pregnancy (...) . Chronic kidney disease. Autoimmune disease, such as systemic lupus erythematosus or antiphospholipid syndrome. Type 1 or type 2 diabetes. Chronic hypertension. Thrombophilia. Two or more of the following moderate risk factors: First pregnancy. Aged 40 years or older. Pregnancy interval of more than 10 years. Body mass index (BMI) of 35 kg/m 2 or greater at the first visit. Family history of pre-eclampsia. Multiple pregnancy. [ ] Prognosis What is the prognosis? Prognosis for current pregnancy Chronic

2019 NICE Clinical Knowledge Summaries

1614. Epilepsy

for epilepsy vary by age group, but include: Premature birth. Complicated febrile seizures. A genetic condition that is known to be associated with epilepsy, such as tuberous sclerosis or neurofibromatosis. Brain development malformations – usually associated with epilepsy developing before adulthood. A family history of epilepsy or neurologic illness. Head trauma, infections (for example meningitis, encephalitis), or tumours — can occur at any age. Comorbid conditions such as cerebrovascular disease (...) Epilepsy Epilepsy - NICE CKS Share Epilepsy - Summary A seizure is the transient occurrence of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. Epilepsy is a disease of the brain defined by any of the following: At least two unprovoked seizures occurring more than 24 hours apart. One unprovoked seizure and a probability of further seizures similar to the general recurrence risk after two unprovoked seizures, occurring over the next 10 years. Diagnosis

2019 NICE Clinical Knowledge Summaries

1615. Pelvic inflammatory disease

Pelvic inflammatory disease Pelvic inflammatory disease - NICE CKS Share Pelvic inflammatory disease: Summary Pelvic inflammatory disease (PID) is a general term for infection of the upper genital tract. PID is almost always due to a sexually transmitted infection (STI). Chlamydia trachomatis is the most common causative organism, accounting for 14–35% of cases. Other causative organisms include Neisseria gonorrhoeae (2–3% of cases) , Mycoplasma genitalium, and organisms in normal vaginal flora (...) for the management of pelvic inflammatory disease [ ] and the European guideline for the management of pelvic inflammatory disease [ ]. This CKS topic covers the management of acute pelvic inflammatory disease (PID) in primary care. This CKS topic does not cover the management of chronic PID, chronic pelvic pain, postpartum endometritis, or PID following childbirth. There are separate CKS topics on , , , , , and . The target audience for this CKS topic is healthcare professionals working within the NHS in the UK

2019 NICE Clinical Knowledge Summaries

1616. Crohn's disease

emboli, arterial or venous thrombosis, or vasculitis. Acute appendicitis — acute terminal ileum disease can mimic acute appendicitis. See the CKS topic on for more information. Diverticulitis — see the CKS topic on for more information. Coeliac disease — see the CKS topic on for more information. Irritable bowel syndrome — see the CKS topic on for more information. Anal fissure — see the CKS topic on for more information. Malignancy (such as colorectal cancer, small bowel cancer, and lymphoma) — see (...) , or if the corticosteroid dose cannot be tapered as planned. These drugs are are also effective at maintaining remission. Thiopurines may increase the person's risk of non-melanoma skin cancer, and people should be monitored for skin cancer and given appropriate sun protection advice. Biologic therapy — the anti-tumour necrosis factor alpha monoclonal antibody agents infliximab and adalimumab are effective at inducing remission in people with severe active disease which has not responded to conventional therapy

2019 NICE Clinical Knowledge Summaries

1617. Diarrhoea - prevention and advice for travellers

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 are common adverse effects. Advise the person not to use loperamide or bismuth subsalicylate (for example Pepto-Bismol ® ) if they have blood or mucous in the stool and/or high (...) 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 disease, stroke, congestive heart failure, or sickle cell disease) in whom

2019 NICE Clinical Knowledge Summaries

1618. Anaemia - B12 and folate deficiency

, for example, due to: Pregnancy and lactation, prematurity. Malignancy (for example leukaemia, carcinoma, or lymphoma). Blood disorders (for example haemolytic anaemias, sickle cell anaemia, myelofibrosis). Inflammatory diseases (for example tuberculosis, Crohn's disease, or malaria). Exfoliative skin diseases. Excessive urinary excretion (for example due to congestive heart failure, acute liver damage, or chronic dialysis). Liver disease. Malabsorption — due to coeliac disease, tropical sprue, congenital (...) (Imerslund Gräsback syndrome). Intestinal causes — malabsorption, ileal resection, Crohn's disease. Nutritional — malnutrition, vegan diet. Folate deficiency is often caused by problems with dietary intake alone, or in a combination with increased folate usage, or malabsorption. For example: Drugs — alcohol, anticonvulsants, nitrofurantoin, sulfasalazine, methotrexate, trimethoprim. Excessive requirements in pregnancy, malignancy, blood disorders, or malabsorption. Excessive urinary excretion. Liver

2019 NICE Clinical Knowledge Summaries

1619. Polymyalgia rheumatica

and butterfly rash), cardiopulmonary, and neurological features. Cancer , including: Multiple myeloma — weakness, fatigue, bone pain. Less commonly renal failure, hypercalcaemia, and acute infection. Acute leukaemia — pallor, petichiae, bruising, and fever. Lymphoma — palpable non-tender lymphadenopathy. Less commonly fever, night sweats, and weight loss. Lung carcinoma — apical (Pancoast) tumour may cause progressive, constant pain in the shoulder, upper chest or interscapular region. There may also (...) , such as vision loss. Features include abrupt onset headache (usually temporal) and temporal tenderness; visual disturbance, including diplopia; jaw or tongue claudication; prominence, beading, or diminished pulse on examination of the temporal artery; upper cranial nerve palsies; and limb claudication or other evidence of large vessel involvement. For more information on diagnosis and management, see the CKS topic on . Active infection or cancer because treatment with corticosteroids may mask

2019 NICE Clinical Knowledge Summaries

1620. Urethritis - male

on expert opinion in a guideline published by the British Association for Sexual Health and HIV UK national guideline on the management of non-gonococcal urethritis [ ], European Urology guidelines Guidelines on urological infections [ ], and a Canadian guideline Non-gonococcal urethritis - public health notifiable disease management guidelines [ ]. Diagnosis How should I make a working diagnosis of urethritis in primary care? Refer all men with suspected urethritis to a genito-urinary medicine (GUM (...) and central nervous system disease, as there is a risk of neurological aggravation. Severe liver disease or hepatic encephalopathy, due to substantial impairment of metronidazole clearance, which may contribute to symptoms of encephalopathy. Prescribe one-third of the daily dosage once daily. Alcohol dependency — there may be a disulfiram-like reaction (flushing, increased respiratory rate, increased pulse rate, nausea, headache, and dizziness) if taken with alcohol. [ ; ] Drug interactions What

2019 NICE Clinical Knowledge Summaries

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