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Tongue Carcinoma

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1661. 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

1662. 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

1663. 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

1664. 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

1665. 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

1666. 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

1667. 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

1668. 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

1669. 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

1670. 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

1671. 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

1672. 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

1673. 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

1674. 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 Publication 80

1675. 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

1676. Adult Bronchoscopy Training

, and endobronchial or transbronchial biopsy. An additional 10 must be therapeutic procedures, including “core out” of tumor, laser, dilatation of strictures, stent placement, and photodynamic therapy, or other interventions such as cryotherapy, electrocautery, or argon plasma coagula- tion. Investigation of mediastinal adenopathy requires performing 30 procedures, 10 of which must include EBUS with fi ne needle aspiration. 22 A thorough understanding of the role of bronchoscopy is necessary in the diagnostic (...) evaluation and manage- ment of patients with benign and malignant disorders of the chest. Th is understanding is of paramount impor- tance in selecting the ideal bronchoscopic technique and its role in selecting the best surgical treatment of a particular airway or pulmonary problem. Th is point is where a signifi cant diff erence emerges between pulmo- nary and thoracic surgery trainees. Whereas pulmonary fellows may be more focused on the diagnostic and palliative management of a particular chest

2015 American College of Chest Physicians

1677. Acute Pain Management: Scientific Evidence

Zealand College of Anaesthetists and its Faculty of Pain Medicine xi INTRODUCTION References Jadad AR, Moore RA, Carroll D et al (1996) Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 17(1): 1–12. Johnston ME, Brouwers MC & Browman GP (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(4): 646–55. Liberati (...) 307 8.6.1 Acute abdominal pain 307 8.6.2 Herpes zoster-associated pain 310 8.6.3 Acute cardiac pain 312 8.6.4 Acute pain associated with haematological disorders 313 8.6.5 Acute headache 317 8.6.6 Acute pain associated with neurological disorders 327 8.6.7 Orofacial pain 329 8.6.8 Acute pain in patients with HIV infection 336 8.7 Acute cancer pain 339 8.7.1 Assessment of acute cancer pain 339 8.7.2 Principles of management of acute cancer pain 339xviii Acute Pain Management: Scientific Evidence

2015 Clinical Practice Guidelines Portal

1678. Menopausal Symptoms: Comparative Effectiveness of Therapies

controlled trials provided the evidence base for symptom relief. Standardized mean differences were calculated to allow pooling of outcomes from varied measures. Network meta-analyses were performed when possible, along with pairwise comparisons. Systematic reviews, cohort studies, and case-control studies provided evidence for the following long-term benefits and harms: breast, colon, endometrial, and ovarian cancer; coronary heart disease and venous thromboembolic events; gallbladder disease (...) . Over the long term, estrogen combined with progestogen has both beneficial effects (fewer osteoporotic fractures) and harmful effects (increased risk of breast cancer, gallbladder disease, venous thromboembolic events, and stroke). Estrogens given alone do not appear to increase breast cancer risk, although endometrial cancer risk is increased. There is limited evidence on the long-term effects of most nonhormone treatments. No studies were identified that examined the efficacy or safety

2015 Effective Health Care Program (AHRQ)

1679. Long noncoding RNA MPRL promotes mitochondrial fission and cisplatin chemosensitivity via disruption of pre-miRNA processing. Full Text available with Trip Pro

Long noncoding RNA MPRL promotes mitochondrial fission and cisplatin chemosensitivity via disruption of pre-miRNA processing. The overall biological roles and clinical significance of most long noncoding RNAs (lncRNA) in chemosensitivity are not fully understood. We investigated the biological function, mechanism, and clinical significance of lncRNA NR_034085, which we termed miRNA processing-related lncRNA (MPRL), in tongue squamous cell carcinoma (TSCC).LncRNA expression in TSCC cell lines (...) fission and cisplatin sensitivity through miR-483-5p. In exploring the underlying interaction between MPRL and miR-483-5p, we identified that cytoplasmic MPRL directly binds to pre-miR-483 within the loop region and blocks pre-miR-483 recognition and cleavage by TRBP-DICER-complex, thereby inhibiting miR-483-5p generation and upregulating miR-483-5p downstream target-FIS1 expression. Furthermore, overexpression or knockdown MPRL altered tumor apoptosis and growth in mouse xenografts. Importantly, we

2019 Clinical Cancer Research

1680. FAM168A participates in the development of chronic myeloid leukemia via BCR-ABL1/AKT1/NFκB pathway. Full Text available with Trip Pro

FAM168A participates in the development of chronic myeloid leukemia via BCR-ABL1/AKT1/NFκB pathway. Although the prognosis of chronic myeloid leukemia (CML) has dramatically improved, the pathogenesis of CML remains elusive. Studies have shown that sustained phosphorylation of AKT1 plays a crucial role in the proliferation of CML cells. Evidence indicates that in tongue cancer cells, FAM168A, also known as tongue cancer resistance-associated protein (TCRP1), can directly bind to AKT1 (...) ) -Abelson murine leukemia (ABL1) fusion protein and AKT1, respectively. Animal experiments confirmed that FAM168A interference prolonged the survival and reduced the tumor formation in mice inoculated with K562 cells. The results of clinical specimens showed that FAM168A expression and AKT1 phosphorylation were significantly elevated in CML patients.This study demonstrates that FAM168A may act as a linker protein that binds to BCR-ABL1 and AKT1, which further mediates the downstream signaling pathways

2019 BMC Cancer

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