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Tongue Carcinoma

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1581. Compliance with quality assurance measures in patients treated for early oral tongue cancer. Full Text available with Trip Pro

Compliance with quality assurance measures in patients treated for early oral tongue cancer. The objective of this study was to identify measurable parameters that provide quality data for assessing how well cancer care adheres to accepted treatment guidelines and is delivered to any given patient with oral tongue cancer.A retrospective chart review included 116 patients treated for T1-T2/N0-N1 squamous cell carcinoma (SCC) of the oral tongue between 1998 and 2003. A set of quality measures (...) compliance with documenting the 4 parameters designated as quality measures for treatment of oral tongue SCC was acceptable, thus demonstrating that it is possible to use these data for measuring effective cancer care.Copyright (c) 2010 American Cancer Society.

2010 Cancer

1582. Freeze-Dried Black Raspberries in Preventing Oral Cancer Recurrence in High-Risk Appalachian Patients Previously Treated With Surgery For Oral Cancer

Appalachian Oral Cancer Additional relevant MeSH terms: Layout table for MeSH terms Carcinoma Carcinoma, Squamous Cell Oropharyngeal Neoplasms Carcinoma, Verrucous Mouth Neoplasms Tongue Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Mouth Diseases Tongue Diseases (...) encompasses cancers of the oral cavity including lips, buccal mucosa, teeth, floor of the mouth and gums and those of the oropharynx consisting of the base of the tongue, soft palate, tonsillar area, and the posterior pharyngeal wall will be eligible Patients who have followed the advice of their physician and have been definitively treated for their tumor by any method and are currently disease free will be eligible Patients may be enrolled as early as their first follow-up post-operative clinic visit

2011 Clinical Trials

1583. Cetuximab and Everolimus in Treating Patients With Metastatic or Recurrent Colon Cancer or Head and Neck Cancer

ways. Some block the ability of the tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor. Giving cetuximab together with everolimus may be an effective treatment for colon cancer or head and neck cancer Condition or disease Intervention/treatment Phase Recurrent Adenoid Cystic Carcinoma of the Oral Cavity Recurrent Basal Cell Carcinoma of the Lip Recurrent (...) , Adenoid Cystic Neoplasms, Unknown Primary Carcinoma, Mucoepidermoid Granuloma Esthesioneuroblastoma, Olfactory Papilloma, Inverted Tongue Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms by Site Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases

2011 Clinical Trials

1584. Patterns of extralaryngeal spread of laryngeal cancer: Thyroid Cartilage Penetration Occurs in a Minority of Patients with Extralaryngeal Spread of Laryngeal Squamous Cell Cancers. (Abstract)

Patterns of extralaryngeal spread of laryngeal cancer: Thyroid Cartilage Penetration Occurs in a Minority of Patients with Extralaryngeal Spread of Laryngeal Squamous Cell Cancers. Laryngeal preservation programs for patients with advanced laryngeal squamous cell carcinomas (SCC) have generally excluded patients with T4 disease. The accuracy of preoperative imaging in evaluating thyroid cartilage penetration and extralaryngeal spread (ELS) has previously been questioned. Clinically, SCC spread (...) into noncartilaginous structures may have less of a functional impact when compared with thyroid cartilage penetration. The current study was designed to characterize and quantify the routes and frequency of ELS.A total of 103 laryngectomy specimens with preoperative contrast-enhanced neck computed tomography scans were coded according to the observed extent of disease by pathological and radiological data. Previously irradiated tumors or those of pyriform sinus origin were omitted. Routes of spread were

2011 Cancer

1585. Tagrisso - osimertinib

interval at steady state BCRP Breast Cancer Resistance Protein BCS Biopharmaceutics Classification System BICR Blinded independent central review CAS chemical abstract service CEP certificate European pharmacopoeia CFU colony-forming unit CI Confidence interval Cmax Maximum plasma concentration Cmin Minimum plasma concentration CMC Chemistry manufacturing and controls c-QTc Concentration-QTc CR Complete Response Ct Circulating tumour CTCAE Common terminology criteria for adverse events CTD common (...) QTcF QTc Fredericia corrected QTPP Quality target product profile r correlation coefficient RECIST Response Evaluation Criteria in Solid Tumours RH relative humidity RSD relative standard deviation SAE Serious adverse event SAP Statistical Analysis Plan SD Stable disease SmPC Summary of Product Characteristics TAMC total aerobic microbial count THF tetrahydrofuran TKI Tyrosine kinase inhibitor tmax Time to reach maximum concentration TTC threshold of toxicological concern TYMC total combined yeasts

2016 European Medicines Agency - EPARs

1586. Vaxelis - diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed)

and invasive diseases caused by Haemophilus influenzae type b (Hib), in children from the age of 6 weeks up to the fifth birthday. Vaxelis should be used in accordance with official recommendations. The legal basis for this application refers to: Article 8.3 of Directive 2001/83/EC - complete and independent application. The applicant indicated that ‘diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed (...) discussion within the Committee, issued a positive opinion for granting a Marketing Authorisation to Vaxelis. 2. Scientific discussion 2.1. Introduction Vaxelis or PR5I is a hexavalent paediatric combination vaccine for primary and booster immunization of infants and toddlers above the age of 6 weeks. Vaxelis is referred to as PR5I throughout the report. It is designed to provide active immunization against diseases caused by Corynebacterium diphtheria, Clostridium tetani, Bordetella pertussis

2016 European Medicines Agency - EPARs

1587. Point prevalence survey of healthcare-associated infections and antimicrobial use in European acute care hospitals ? protocol version 5.3

Suggested citation: European Centre for Disease Prevention and Control. Point prevalence survey of healthcare- associated infections and antimicrobial use in European acute care hospitals – protocol version 5.3. Stockholm: ECDC; 2016. Stockholm, October 2016 ISBN 978-92-9193-993-0 doi 10.2900/374985 TQ-04-16-903-EN-N © European Centre for Disease Prevention and Control, 2016 Reproduction is authorised, provided the source is acknowledged. TECHNICAL DOCUMENT PPS of HAIs and antimicrobial use in European (...) AM Antimicrobial/antimicrobial agent AMR Antimicrobial resistance ATC Anatomical Therapeutic Chemical classification system (WHO) AU Antimicrobial use BSI Bloodstream infection CDC Centres for Disease Control and Prevention (Atlanta, USA) CDI Clostridium difficile infections CFU Colony-forming units CVC Central vascular catheter DSN Dedicated surveillance network EARS-Net European Antimicrobial Resistance Surveillance Network (at ECDC) ECDC European Centre for Disease Prevention and Control EEA

2016 European Centre for Disease Prevention and Control - Technical Guidance

1588. Management of Infusion Reactions to Systemic Anticancer Therapy: ESMO Clinical Practice Guidelines

disorders). - Severe atopic disease. - Concurrent medications which increase the risk (e.g.b-adrenergic blockers, angiotensin-converting enzyme inhibitors). • If there is a high risk of a rapid tumour lysis at initiation of chemotherapy and/or targeted therapies, in malignancies with a high tumour burden, consider: - Addition of rasburicase and increased hydration [I, A]. - Delivering MoAbs in a fractionated way [III, B]. Signsandsymptoms • The National Cancer Institute CTCAE version 4.03 distinguishes (...) for developing an anaphylactic reaction are: age-related fac- tors, concomitant diseases such as chronic respiratory dis- eases, cardiovascular diseases, mastocytosis or clonal mast cell disorders and severe atopic disease [V, C] [15]. Some concur- rent medications such as b-adrenergic blockers and angiotensin-converting enzyme inhibitors might also increase the risk. In malignancies with a high tumour burden and at risk of a rapid tumour lysis or shrinkage at initiation of chemotherapy and/or targeted

2017 European Society for Medical Oncology

1589. Clinical practice guidelines for the care of girls and women with Turner syndrome: proceedings from the 2016 Cincinnati International Turner Syndrome Meeting Full Text available with Trip Pro

Department of Pediatrics, Doernbecher Children’s Hospital, Portland, Oregon, USA 16 Väestöliitto Fertility Clinics, Helsinki, Finland 17 Center for Rare Diseases, Department of Pediatrics, Aarhus University Hospital, Aarhus, Denmark 18 Department of Pediatric Endocrinology, Radboud University Medical Center, Amalia Children’s Hospital, Nijmegen, The Netherlands 19 Department of Pediatric Endocrinology, Children’s Hospital, University of Bonn, Bonn, Germany 20 Cincinnati Children’s Hospital Medical Center (...) each addressed important areas in TS care: 1) diagnostic and genetic issues, 2) growth and development during childhood and adolescence, 3) congenital and acquired cardiovascular disease, 4) transition and adult care, and 5) other comorbidities and neurocognitive issues. These groups produced proposals for the present guidelines. Additionally, four pertinent questions were submitted for formal GRADE (Grading of Recommendations, Assessment, Development and Evaluation) evaluation with a separate

2016 European Society of Human Reproduction and Embryology

1590. Laryngeal Cancer

How to Treat Nosebleeds (Epistaxis) SOCIAL MEDIA Add to Any Platform Loading , MD, Montefiore Medical Center, The University Hospital of Albert Einstein College of Medicine Click here for Patient Education NOTE: This is the Professional Version. CONSUMERS: Topic Resources Ninety percent of laryngeal cancer is squamous cell carcinoma. Smoking, alcohol abuse, lower socioeconomic status, and being male and > 60 yr increase risk. Early diagnosis is common with vocal cord tumors because hoarseness (...) in smoking habits. Annual deaths are about 3700. Sixty percent of patients present with localized disease alone; 25% present with local disease and regional nodal metastatic disease; and 15% present with advanced disease, distant metastases, or both. Lymph node metastasis are more common in supraglottic and subglottic tumors than with glottic cancers due to the minimal lymphatic drainage of the glottis. Distant metastases occur most frequently in the lungs and liver. Common sites of origin are the true

2013 Merck Manual (19th Edition)

1591. 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

1592. 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

1593. 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

1594. 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

1595. 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

1596. 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

1597. 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

1598. 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

1599. 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

1600. 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

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