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101. Dinutuximab (Unituxin)

% of patients in Study 3: nasal congestion (20%) and wheezing (15%). Table 7 provides the per-patient incidence of laboratory abnormalities in Study 3. Table 7: Per-Patient Incidence of Selected (= 5% Grade 3-4) Laboratory Abnormalities in Study 3 Laboratory Test 1 Grade 2 All Grades % Grades 3-4 % HEMATOLOGY Anemia 100 46 Neutropenia 99 63 Thrombocytopenia 98 49 CHEMISTRY Hypoalbuminemia 100 8 Hypocalcemia 97 7 Hyponatremia 93 36 Hyperglycemia 87 6 Aspartate Aminotransferase Increased 84 8 Alanine (...) (dinutuximab) Page 44 of 50 6.2 Immunogenicity As with all therapeutic proteins, patients treated with Unituxin may develop anti-drug antibodies. In clinical studies, 52 of 284 (18%) patients from Study 2 and 13 of 103 (13%) patients from Study 3 tested positive for anti-dinutuximab binding antibodies. Neutralizing antibodies were detected in 3.6% of patients who were tested for anti- dinutuximab binding antibodies in study 2 and study 3. However, due to the limitations of the assay, the incidence

2014 FDA - Drug Approval Package

102. National Clinical Guideline for the Diagnosis, Staging and Treatment of Prostate Cancer

will require diagnostic tests (radiology, pathology) and depending on the treatment plan may require surgery, chemotherapy and radiation therapy. A proportion of patients may also require palliative care. A recent population-based cost analysis (Luengo-Fernandez et al., 2013) illustrated the economic burden of cancer on the European Union (EU). In 2009, cancer is estimated to have cost the EU €126 billion, with healthcare costs accounting for €51 billion (40%). Prostate cancer is estimated to have cost (...) of the NCCP patient information, clinical guidelines and other national projects. All NCCP booklets are submitted to the National Adult Literacy Agency (NALA) (www.nala.ie) for the Plain English Award. This is to ensure comprehension and readability are in line with health literacy best practice standards. Service user testing is a key part of the process, and includes liaising with the HSE Patient Forum, online surveys, and engaging with other relevant patient groups e.g. Irish Cancer Society, Marie

2015 Health Service Executive (Ireland) - Clinical Guidelines

103. Diagnosis, staging and treatment of patients with Breast Cancer

and standard of care. 1.2 Clinical and financial impact of breast cancer The diagnosis, staging and treatment of patients with breast cancer requires multidisciplinary care in an acute hospital setting. The majority of patients will require diagnostic tests (radiology, pathology) and depending on the treatment plan may require surgery, chemotherapy and radiation therapy. A proportion of patients may also require palliative care. A recent population-based cost analysis (Luengo-Fernandez et al., 2013 (...) was the largest solid tumour diagnosed annually in Ireland. The Guideline Development Group (GDG) endorses the American Society of Clinical Oncology/ College of American Pathologists (ASCO/CAP) clinical guideline (Wolff et al., 2013) for the following two pathology clinical questions: 1) What is the optimal testing algorithm for the assessment of HER2 status? 2) What strategies can help ensure optimal performance, interpretation, and reporting of established assays? 1.4.2 Target population Patients

2015 Health Service Executive (Ireland) - Clinical Guidelines

104. Clinical Handover in Acute and Children’s Hospital Services

for the patient throughout their episode of care in the acute hospital. Rationale Staff report that the transfer of responsibility for the patient during clinical handover is often ambiguous (Bomba and Prakash 2005; Williams et al. 2007; Philibert et al. 2009; Bost et al. 2012; Chin et al. 2012; Wayne et al. 2008) and this may lead to issues in relation to the follow up of test results (Horwitz et al. 2009a) or instances where patients are handed over to a new unit without a clinician being assigned

2015 National Clinical Guidelines (Ireland)

105. Diagnosis, Staging and Treatment of Patients with Breast Cancer

and standard of care. 1.2 Clinical and financial impact of breast cancer The diagnosis, staging and treatment of patients with breast cancer requires multidisciplinary care in an acute hospital setting. The majority of patients will require diagnostic tests (radiology, pathology) and depending on the treatment plan may require surgery, chemotherapy and radiation therapy. A proportion of patients may also require palliative care. A recent population-based cost analysis (Luengo-Fernandez et al., 2013 (...) was the largest solid tumour diagnosed annually in Ireland. The Guideline Development Group (GDG) endorses the American Society of Clinical Oncology/ College of American Pathologists (ASCO/CAP) clinical guideline (Wolff et al., 2013) for the following two pathology clinical questions: 1) What is the optimal testing algorithm for the assessment of HER2 status? 2) What strategies can help ensure optimal performance, interpretation, and reporting of established assays? 1.4.2 Target population Patients

2015 National Clinical Guidelines (Ireland)

106. Systematic review with meta-analysis: Fruit and vegetable consumption is associated with reduced all-cause and cardiovascular mortality (Full text)

Systematic review with meta-analysis: Fruit and vegetable consumption is associated with reduced all-cause and cardiovascular mortality Fruit and vegetable consumption is associated with reduced all-cause and cardiovascular mortality | BMJ Evidence-Based Medicine We use cookies to improve our service and to tailor our content and advertising to you. You can manage your cookie settings via your browser at any time. To learn more about how we use cookies, please see our . Log in using your (...) username and password For personal accounts OR managers of institutional accounts Username * Password * your user name or password? Search for this keyword Search for this keyword Main menu Log in using your username and password For personal accounts OR managers of institutional accounts Username * Password * your user name or password? You are here Fruit and vegetable consumption is associated with reduced all-cause and cardiovascular mortality Article Text Therapeutics/Prevention Systematic review

2015 Evidence-Based Medicine PubMed abstract

107. Allergic Rhinitis

: With institutional access I can: View or download all content the institution has subscribed to. Society If you have access to journal via a society or associations, read the instructions below Members of _ can log in with their society credentials below Username (required) Password (required) Society (required) Access to society journal content varies across our titles. If you have access to a journal via a society or association membership, please browse to your society journal, select an article to view (...) , and follow the instructions in this box. Contact us if you experience any difficulty logging in. AAO-HNS Member Access AAO-HNS members have access to this journal as part of their membership. Sign in using your membership username and password. Some society journals require you to create a personal profile, then activate your society account I am signed in via: With society access I can: View or download all the content the society has access to. Need Help? Search in: Add Email Alerts You are adding

2015 American Academy of Otolaryngology - Head and Neck Surgery

108. Social Determinants of Risk and Outcomes for Cardiovascular Disease

Social Determinants of Risk and Outcomes for Cardiovascular Disease Social Determinants of Risk and Outcomes for Cardiovascular Disease | Circulation Search Hello Guest! Login to your account Email Password Keep me logged in Search March 2019 March 2019 March 2019 March 2019 March 2019 February 2019 February 2019 February 2019 February 2019 January 2019 January 2019 January 2019 January 2019 January 2019 This site uses cookies. By continuing to browse this site you are agreeing to our use

2015 American Heart Association

109. Management of chronic Hepatitis C consensus update

Canadian Association for the Study of the Liver consensus guidelines on the management of hepatitis C was produced. The present docu- ment reviews the epidemiology of hepatitis C in Canada, preferred diagnostic testing approaches and recommendations for the treatment of chronically infected patients with the newly approved antiviral agents, including those who have previously failed peginterferon and ribavirin-based therapy. In addition, recommendations are made regarding approaches to reducing (...) of drug administration, side effects, and the requirement for careful on-treatment monitoring of symptoms and laboratory tests. The most successful model to deliver comprehensive CHC care is via a multidisciplinary approach including experienced physicians, nurses and allied health professionals (eg, psychologists, psychiatrists, addiction specialists and social workers). Currently in Canada, a relatively small number of physicians treat CHC, leading in some cases to prolonged wait times for patients

2015 Canadian Association of Gastroenterology

110. Somatropin Biopartners

immunglobulin positive control IPC In process control IPT In-Process tests ITT Insulin Tolerance Test IU International Units kD Kilodalton kDa Kilodalton kg Kilogramme KIGS Kabi Pharmacia International Growth Study L Litre LB03002 Biopartners human growth hormone sustained release formulation LBM Lean Body Mass LC Liquid Chromatography LDL Low-Density Lipoprotein LLOQ Lower limit of quantification LPC low dose positive control LS Least Square MAA Marketing Authorization Application mAb Monoclonal antibody (...) . Adult-onset: Patients with growth hormone deficiency in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone not being prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a growth hormone deficiency. Childhood-onset: In patients with childhood-onset isolated growth hormone deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic

2013 European Medicines Agency - EPARs

111. Kadcyla - trastuzumab emtansine

. The application submitted is composed of administrative information, complete quality data, non-clinical and clinical data based on applicants’ own tests and studies and bibliographic literature supporting certain tests or studies. Information on Paediatric requirements Pursuant to Article 7 of Regulation (EC) No 1901/2006, the application included an EMA Decision EMA/973755/2011; CW/1/2011 on the granting of a class waiver. Information relating to orphan market exclusivity Similarity Pursuant to Article 8 (...) -maleimidomethyl] cyclohexane-1-carboxylate) linker. Trastuzumab emtansine is produced from two intermediates (DM1 and trastuzumab) and a starting material (SMCC), each of which is tested and released using methods and specifications appropriate to its molecular type (small molecule or protein). The resulting antibody conjugate product exhibits a unique and specific set of product characteristics, distinct from the intermediates used in its production. Manufacture The drug substance manufacturer

2013 European Medicines Agency - EPARs

112. Stribild - elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil

environmental risk assessment for tenofovir, including an adsorption/desorption study (OECD 106), transformation studies in aquatic sediment systems (OECD 308) and an Early-Life Stage Toxicity Test (OECD 210). Transformation products =10% will be fully characterized. These additional studies will be provided by Q2 2015. Table 1. Summary of main study results on EVG Substance (INN/Invented Name): EVG CAS-number (if available): PBT screening Result Conclusion Bioaccumulation potential- log K ow OECD117 3.39 (...) (if available): PBT screening Result Conclusion Bioaccumulation potential- log K ow OECD122 0.992-1.18 Not > 4.5; not PBT. Phase I Calculation Value Unit Conclusion PEC surfacewater , default or refined (e.g. prevalence, literature) For Fpen (1%): 1.5 For Fpen (with from data Etonie): 0.17 µg/l Then > 0.01 µg/l Phase II Physical-chemical properties and fate Study type Test protocol Results Remarks Adsorption-Desorption OECD 106 Koc soil: 18L/Kg No high adsorption with TDF. Ready Biodegradability Test OECD

2013 European Medicines Agency - EPARs

113. Cardiac Pacing and Cardiac Resynchronization Therapy

intermittent. Provocative testing or an electro- physiological study (EPS) may be required when a bradycardia is suspected but not documented (Figure 2). Since there is no de?ned heart rate below which treatment is indi- cated, correlation between symptoms and bradyarrhythmia is essen- tial when deciding on the need for cardiac pacing therapy. This can be dif?cult to establish in patients with competing mechanisms for their symptoms—for example, HF or pulmonary disease. Another common dilemma (...) , the suspicion should be corroborated by an ECG documen- tation of bradyarrhythmia or, alternatively, by laboratory testing. w25 The most useful tests and their diagnostic yield are listed inTable6. † ECGmonitoring. Short-term monitoring (Holter, telemetry and ex- ternal loop recorder) is useful, soon after the index episode, in patients who have very frequent symptoms (at least once per week). Since most patients with syncope have infrequent symp- toms, recurring over months or years, ILRs are often

2013 European Society of Cardiology

114. Diabetes, Pre-Diabetes and Cardiovascular Diseases

dinucleotide phosphate hydrogen NDR National Diabetes Register NHANES NationalHealth and NutritionExamination Survey ESC Guidelines 3038 Downloaded from https://academic.oup.com/eurheartj/article-abstract/34/39/3035/503593 by guest on 02 April 2019NICE National Institute for Health and Clinical Excel- lence (UK) NNT number needed to treat NO nitric oxide NOAC new oral anticoagulants NYHA New York Heart Association OAT Occluded Artery Trial OGTT oral glucose tolerance test OMT optimal medical treatment (...) Health Organization (WHO) and the American Diabetes Associ- ation (ADA). 2– 6 Glycated haemoglobin A 1c (HbA 1c ) has been recommended as a diagnostic test for DM, 7,8 but there remain con- cerns regarding its sensitivity in predicting DM and HbA 1c values ,6.5% do not exclude DM that may be detected by blood glucose measurement, 7 –10 as further discussed in Section 3.3. Four main aetiological categories of DM have been identi?ed: type 1 diabetes (T1DM), T2DM, ‘other speci?c types’ of DM

2013 European Society of Cardiology

115. Teacher burnout: can we prevent it, or is that the wrong question?

at the moment, but is it effective? I know many teachers who roll their eyes when they hear the word. There are a wide range of interventions available to schools and the question is which one should they select? A recent meta-analysis by Iancu et al (2017), categorises interventions into 6 different types: Cognitive Behavioural Therapy (CBT) : this aims to restructure thoughts or enhance problem solving and is aimed at enhancing employee coping skills Mindfulness and relaxation techniques : these encourage (...) of psychosocial interventions, to see which was most promising for reducing levels of teacher burnout. Methods Studies were selected if: They assessed general burnout, core burnout, or its components (exhaustion, depersonalisation or personal accomplishment) They assessed the above variables at both pre-test and post-test They had included a passive control group in the design (i.e. no intervention or waitlist) The burnout levels of the compared groups were equivalent at baseline (i.e., randomised allocation

2018 The Mental Elf

116. Should we screen new Dads for depression? #DadsMHday

, but will it work? A fair answer from this research is probably: not yet. The 12-question Edinburgh-Gotland Depression Scale (EGDS) is a step forward in that it combines questions that are perhaps a better fit for the range of symptoms experienced by many new dads with depression. However, this current iteration of the test is not ready for rolling out nationwide, and this is something that the authors accept in their measured conclusion: This is an important first step towards identifying a set of items (...) study carried out by researchers in Sweden aimed to develop a better tool for screening depression in fathers of children aged 0-18 months. Their two main aims were to: “investigate whether depressive symptoms in fathers postnatally comprise both typical depressive symptoms and externalizing, depressive equivalents” “test the hypothesis that the addition to the EPDS of items addressing depressive equivalents would result in increased sensitivity in detecting fathers with elevated, burdening

2018 The Mental Elf

117. Mindfulness may help university students reduce stress

aimed at the well student population, separate from specific mental health services, is a useful addition to robust clinical interventions delivered by university counselling services. The 8-week mindfulness course adapted for university students tested in this trial is an acceptable, feasible, and effective component of wider mental health strategies. Students could benefit from access to a preventative intervention, such as mindfulness. Strengths and limitations This is study had a large sample (...) Faculty of Brain Sciences. She has worked at the Tavistock as an assistant psychologist in both adult and children’s services and, prior to that, worked for several years in book publishing and for a literacy charity, promoting reading in libraries, prisons and schools. She has a particular interest in how reading and reading groups can improve wellbeing, and has run therapeutic readings groups for mental health service users. Follow me here – Logging In... Profile or Comment Name Email Not published

2018 The Mental Elf

118. Genetics of depression: understanding risk and improving treatment (Full text)

of significance for GWAS data (p<5 x 10-8) based on estimates of the number of “independent” tests across the genome (around 1 million). Here, 102 sequence variants (single-nucleotide polymorphisms; SNPs) were significant and statistically independent of each other, compared with 15 (23andMe), 17 (a smaller UKB analysis) and 44 (PGC including smaller parts of 23andMe and UKB). Then, the significance of evidence for association in each gene was tested by combining results from nearby SNPs while accounting (...) and major depressive disorder), using genetic association, linkage and resequencing methodologies. - Follow me here – Logging In... Profile or Comment Name Email Not published Website Last reply was 3 months ago View For the record, there was no actual replication of previous findings, nor did they perform an actual independent GWAS on the 23andMe replication dataset to compare significant variants. In short, to date there has not been a single independently replicated, significant genetic variant

2018 The Mental Elf PubMed abstract

119. Just how effective are digital mental health workplace interventions? (Full text)

with hope (or relief) as accessible, scalable tools that employers can offer. The market is being flooded with new tools and re-purposed versions of existing tools. These are targeted at employees and sold into a market very keen on low cost, high volume solutions. In October 2017, I , which welcomed innovation in this field and drew out the necessity of digital interventions to be tested in and adapted for workplace settings for maximum effectiveness. This recent review from Elizabeth Stratton and her (...) stated, we need to do more to understand the factors that affect roll-out in workplace settings. The ideal scenario is creating a crucible where agile development, service design and robust evidence can combine to create products and services that meet an obvious need. We must be aware of the problem or opportunity being addressed, the audience, and the evidence of effectiveness in this context before deploying tools in the workplace. That means collecting good data and engaging employees as well

2018 The Mental Elf PubMed abstract

120. Constella - linaclotide

Syndrome Mixed IBS-U Irritable Bowel Syndrome Unsubtyped ICAC independent central adjudication committee ICH International Conference on Harmonisation IMMPACT Initiative on Methods, Measurement and Pain Assessment in Clinical Trials IR Immediate Release IS Internal Standard ISS Integrated Summary of Safety (US) ITT Intent-To-Treat IV intravenous(ly) IVRS Interactive Voice Response System K2EDTA Dipotassium ethylenediaminetetraacetic acid LC Liquid Chromatography LFT liver function test LLOQ lower limit (...) . The applicant applied for the following indication: Constella is indicated for the symptomatic treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C) in adults. The legal basis for this application refers to: Article 8.3 of Directive 2001/83/EC - complete and independent application. The application submitted is composed of administrative information, complete quality data, non- clinical and clinical data based on applicants’ own tests and studies and/or bibliographic literature

2012 European Medicines Agency - EPARs

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