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81. Cresemba - isavuconazole

alkaline phosphatase ALT alanine transaminase AST Aspartate transaminase AmB amphotericin B AML acute myeloid leukemia ANC absolute neutrophil count AST aspartate transaminase AUC area under the concentration time curve BAL4815 isavuconazole BAL8557 isavuconazonium sulfate (prodrug) BAL8728 Inactive cleavage product of isavuconazonium sulfate ß-HCG urine or serum pregnancy test b.i.d. twice daily BLQ below the limit of quantification BMI body mass index BMT bone marrow transplant bpm beats per minute (...) /MSG European Organisation for the Research and Treatment of Cancer/Mycoses Study Group ESCMID European Society of Clinical Microbiology and Infectious Diseases EUCAST European Committee on Antimicrobial Susceptibility Testing FDA US Food and Drug Administration FLU fluconazole FU follow-up period GCP Good Clinical Practice GGT gamma glutamyl transpeptidase GM galactomannan GMR GTI geometric mean ratio Genotoxic Impurity h hour HIV human immunodeficiency virus HSCT hematopoietic stem cell

2015 European Medicines Agency - EPARs

82. Orkambi - lumacaftor / ivacaftor

. 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 substituting/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 P/0337/2014 on the agreement of a paediatric investigation plan (PIP). At the time of submission of the application, the PIP P/0337 (...) into a secondary container for storage and shipping. The LDPE is compliant with EU Regulation 1183/2012, and the European Pharmacopoeia Monograph 3.1.3 “Polyolefins”. Specification The control strategy for lumacaftor consists of the specifications of the active substance starting materials, reagents and solvents, the active substance synthesis design spaces, the in-process controls and the active substance specification. The active substance specification includes tests for: appearance (visual inspection

2015 European Medicines Agency - EPARs

83. Keytruda - pembrolizumab

for this study was strictly controlled at 2.5% (one-sided) with 0.5% allocated to PFS at the second interim analysis and 2% allocated to OS. PFS was only be tested at the second interim analysis. The Bonferroni method was used for testing the two null hypotheses on PFS at the second interim analysis with each tested at 0.25%. If any of the two null hypotheses was rejected, the corresponding alpha level was rolled into the overall OS hypothesis (i.e., the OS hypothesis tested Page 54/160 at 2%, 2.25% and 2.5 (...) no pembrolizumab arms would be dropped earlier. Between-treatment comparison of OS was tested using stratified log-rank test, the hazard ratio and its 95% confidence interval was estimated using the stratified Cox model with efron’s tie handling. OS curve is estimated using Kaplan-Meier (KM) method in each treatment group. Results Participant flow Table 17: Disposition of subjects (ITT population) At the time of this interim analysis, 86 SOC chemotherapy subjects had crossed over to the pembrolizumab treatment

2015 European Medicines Agency - EPARs

84. Trifluridine/tipiracil hydrochloride (TAS102) (Lonsurf)

and a 3% per year loss to survival follow-up. No interim analyses were planned. The primary analysis of OS included follow-up data (including death events) through the date of the 571st death. The difference in survival between the two treatment arms was assessed in the ITT population using the stratified log-rank test (Score statistic from PHREG and ties=Breslow) from a Cox proportional hazards (CPH) model including treatment and the 3 stratification factors in the model. Survival for each arm (...) Special Animal and/or In Vitro Testing 66 7.2.4 Routine Clinical Testing 66 7.2.5 Metabolic, Clearance, and Interaction Workup 66 7.2.6 Evaluation for Potential Adverse Events for Similar Drugs in Drug Class .. 67 7.3 Major Safety Results 67 7.3.1 Deaths 68 7.3.2 Nonfatal Serious Adverse Events 72 7.3.3 Dropouts and/or Discontinuations 75 7.3.4 Significant Adverse Events 75 7.3.5 Submission Specific Primary Safety Concerns 80 7.4 Supportive Safety Results 80 7.4.1 Common Adverse Events 80 7.4.2

2015 FDA - Drug Approval Package

85. Orthotics and prosthetics workforce planning

Health Professions Australia AIHW Australian Institute of Health and Welfare ALS Artificial Limb Service AOPA Australian Orthotic Prosthetic Association Ltd CAD Computer-aided design CASP Critical Appraisal Skills Programme CNC Computer Numerical Controlled CPD Continuing Professional Development DVA Department of Veterans Affairs HARP Hospital Admission Risk Program HECS Higher Education Contribution Scheme HRF High risk foot HRFS High risk foot services IELTS International English Language Testing (...) practice for certain patient groups resulting in OPs having to retain a diverse skill set. • Diabetic foot (a High Risk Foot disorder) is a leading cause of non-traumatic lower extremity amputation. The evidence indicates prevalence of diabetes in Australia is rising, which will lead to a commensurate increase in demand for services provided by High Risk Foot (HRF) clinics. • The National Disability Insurance Scheme (NDIS), being rolled out across NSW in 2018, will provide more access to orthotic

2015 Sax Institute Evidence Check

86. Pulmonary Rehabilitation for Postacute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): A Cost-Effectiveness and Budget Impact Analysis

is rather low, the relatively wide 95% prediction interval (0.11, 1.21) of IRR (in comparison to the 95% CI) and the heterogeneity test results (I 2 = 40%) reflect the inconsistency of effects across studies. Pulmonary Rehabilitation for Postacute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): A Cost-Effectiveness and Budget Impact Analysis. February 2015; pp. 1-47 20 Figure 2: Effect of PR on Reduction of Rehospitalization Rate Abbreviations: CI, confidence interval; IRR, incidence rate (...) details of the parameter inputs for the PSA are available on request. Pulmonary Rehabilitation for Postacute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): A Cost-Effectiveness and Budget Impact Analysis. February 2015; pp. 1-47 21 Table 4: Distributions of Parameters Parameter Distribution Unit cost of professional time Uniform Effectiveness of PR program, incidence rate ratio of PR vs. usual care Log normal Cost of hospitalization for acute exacerbation Gamma Rehospitalization rate

2015 Health Quality Ontario

87. Psychosocial Interventions for School Refusal with Primary and Secondary School Students: A Systematic Review Full Text available with Trip Pro

facilitates approach behavior in anxious youth are still unclear. Occasionally, with younger children, exposure is implemented in the form of flooding whereby parents block the young person's avoidance and enforce attendance at school (e.g., ). Relaxation can help young people manage the stress (negative emotional responses and physiological arousal) that occurs in situations associated with school attendance (e.g., getting ready to go to school; taking tests; giving a class talk; being around other (...) It was anticipated that most studies would report outcomes at post‐test and thus post‐test outcomes were the primary focus of this review; however, if studies reported follow‐up data or a subsequent report was published with outcomes examined at a follow‐up time point, data from the follow‐up time points were recorded. 3.1.6 Types of settings The review included interventions conducted in any setting that served primary or secondary school students with the exception of studies conducted in residential

2015 Campbell Collaboration

88. Strategies to Increase the Ownership and Use of Insecticide?Treated Bednets to Prevent Malaria Full Text available with Trip Pro

Goal (MDG) number six, which aims to ‘Combat HIV/AIDS, Malaria and other diseases’ ( ). This review can help policy‐makers and practitioners make appropriate and evidence‐based decisions regarding ITN programs to help roll back malaria by identifying effective strategies to increase the ownership and appropriate use of ITNs, and the contexts and populations in which these strategies are effective. 2 Objectives To assess the evidence on the effectiveness of available strategies (subsidies (...) and appropriate use of ITNs will result in measurable differences in these clinical outcomes, as demonstrated in a previous systematic review ( ). Our outcome measures are congruent with the Roll Back Malaria Monitoring & Evaluation Reference Group (MERG) minimum standards recommended for assessing malaria impact in countries in sub‐Saharan Africa ( ; ). We planned to record any adverse or any unintended effects reported (e.g. unable to afford other necessities due to money used by households to purchase ITNs

2015 Campbell Collaboration

89. Economic Self?Help group Programs for Improving Women's Empowerment: A Systematic Review Full Text available with Trip Pro

converted the odds ratios to log odds ratios and the log odds ratios to standardized mean differences in order to make the effect sizes for continuous and dichotomous outcome variables comparable to each other. We describe the procedure for calculating the effect sizes in more detail in Appendix 10. We converted all effect sizes to standardized mean differences to ensure we could use studies with different measurement scales in the same analysis. We found it appropriate to use dichotomous variables

2015 Campbell Collaboration

90. Self-management of psychological distress for people with cancer

sample size, however, 10 of the 12 participants logged in weekly. Positive feedback for the program was provided by 11 participants. Another Australian online program was the recently published My Road Ahead (MRA) website (www.myroadahead.org), developed for and tested on men with prostate cancer. 28 The 142 participants were randomised to one of three groups: The MRA website, an online moderated forum, or MRA plus the forum. MRA consisted of online cognitive behavioural therapy, providing psycho (...) and anxious preoccupation) At three months, the intervention group had lower levels of traumatic stress, helplessness/hopelessness, cognitive avoidance than control group. Intervention was more effective for women with higher levels of distress. However intervention group had poorer body image than control which was still significant at six months Beatty 2011 27 Australia 12 adults receiving or recently completed curative treatment for breast, gynaecological, lymphoma or bowel cancer Pre-test/post-test

2015 Sax Institute Evidence Check

91. A guide to understanding the implications of the Ionising Radiation (Medical Exposure) Regulations in diagnostic and interventional radiology

and provides a framework intended to protect individuals from the hazards associated with medical exposures involving ionising radiation. Breaches of IR(ME)R can result in civil or criminal proceedings, including the serving of Improvement or Prohibition notices (civil action). If the notice is not complied with, this may proceed to prosecution (a criminal activity). To date, IR(ME)R compliance has not been tested in the courts. As a definitive interpretation of the law can only be established (...) the referrer provides the required information for the practitioner to justify the procedure ? Providing a record of all requested procedures which can assist the audit process. These systems rely on a user log-in to identify the referrer rather than a signature. RCR guidance suggests the trust’s procedures should ensure it is a disciplinary offence to request a procedure using someone else’s log-in, just as it is to request a procedure on a pre-signed request card.’ 18 Users should receive appropriate

2015 Royal College of Radiologists

92. Guidelines for the screening, care and treatment of persons with chronic hepatitis C infection

, and to develop and report recommendations Negative predictive value The probability that when a person’s test result is negative, they truly do not have the infection/disease. Predictive values are influenced by the prevalence of the disease in the population Non-response Detectable HCV RNA throughout treatment Null response Less than 2 log reduction in HCV RNA level by week 12 of treatment Partial response 2 log reduction in HCV RNA by week 12 of treatment but HCV RNA remains detectable at week 24 or end (...) by the United States Centers for Disease Control and Prevention, USA and the Ministry of Health, Labour and Welfare of Japan.8 AASLD American Association for the Study of Liver Disease ALT alanine aminotransferase APRI AST-to-platelet ratio index ART antiretroviral therapy ARV antiretroviral ASSIST Alcohol, Smoking and Substance Involvement Screening Test AST aspartate aminotransferase BCRP breast cancer resistance protein CI confidence interval CrI credible interval DAA direct-acting antiviral (drug) DDI

2016 World Health Organisation Guidelines

93. Diagnosis, Staging and Treatment of Patients with Prostate Cancer

cancer The diagnosis, staging and treatment of patients with prostate 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) illustrated the economic burden of cancer on the European Union (...) to the guideline recommendations’. 1.7 Patient advocacy A collaborative approach is used in the development 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

2016 National Clinical Guidelines (Ireland)

94. Sensitivity and specificity of two dried blood spot methods for HIV-1 viral load monitoring among patients in Hanoi, Vietnam. Full Text available with Trip Pro

Sensitivity and specificity of two dried blood spot methods for HIV-1 viral load monitoring among patients in Hanoi, Vietnam. The use of dried blood spot (DBS) specimens for HIV viral load (VL) monitoring is recommended to support the roll-out of routine VL monitoring in low and middle income countries (LMICs). To better understand the use of DBS for VL monitoring, we evaluated two DBS testing methods, Roche TaqMan® Free Virus Evolution protocol (DBS-FVE) and Roche TaqMan® SPEX protocol (DBS (...) %) and specificity was 98.2% (96.9%-99.1%) at the threshold of 1000 copies/ml. We found that the Roche DBS-FVE method, with a +0.7 log copies/ml correction factor, performed well with sensitivity and specificity greater than 96% at a VL threshold of 1000 copies/m. These findings add to the growing body of evidence supporting the use of DBS VL testing for ART monitoring. Future research should evaluate the association between VL results by DBS and clinical outcome measures such as HIV drug resistance, morbidity

2018 PLoS ONE

95. Recommended Dietary Pattern to Achieve Adherence to the American Heart Association/American College of Cardiology (AHA/ACC) Guidelines: A Scientific Statement From the American Heart Association

Recommended Dietary Pattern to Achieve Adherence to the American Heart Association/American College of Cardiology (AHA/ACC) Guidelines: A Scientific Statement From the American Heart Association Recommended Dietary Pattern to Achieve Adherence to the American Heart Association/American College of Cardiology (AHA/ACC) Guidelines: A Scientific Statement From the American Heart Association | Circulation Search Hello Guest! Login to your account Email Password Keep me logged in Search October 2019 (...) -Style Dietary Patterns: Specific and Well-Documented Across Age, Sex, and Ethnically Diverse Groups The DASH dietary pattern was developed as part of a study to test the effects of modifying the whole diet on BP. The DASH dietary pattern emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in SFAs, red meat, sweets, and beverages containing added sugars. This dietary pattern is broadly effective in lowering BP and is particularly

2016 American Heart Association

96. Formative assessment and design of a complex clinical decision support tool for pulmonary embolism Full Text available with Trip Pro

support tool for pulmonary embolism Sundas Khan , Lauren McCullagh , Anne Press , Manish Kharche , Andy Schachter , Salvatore Pardo , Thomas McGinn Statistics from Altmetric.com Extract Electronic health record (EHR)-based clinical decision support (CDS) tools are rolled out with the urgency to meet federal requirements without time for usability testing and refinement of the user interface. As part of a larger project to design, develop and integrate a pulmonary embolism CDS tool for emergency (...) Formative assessment and design of a complex clinical decision support tool for pulmonary embolism Formative assessment and design of a complex clinical decision support tool for pulmonary embolism | 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

2016 Evidence-Based Medicine

97. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection

. Additional recommendations in the guidelines aim to help programmes deliver services closer to people’s homes; expedite reporting of test results; integrate HIV treatment more closely with antenatal, tuberculosis, drug dependence and other services; and use a wider range of health workers to administer treatment and follow-up care. If we are to achieve universal health coverage, we need to ensure that ART and broader HIV services reach those in greatest need and are sustainable in the long term (...) 2.2 Retesting prior to enrolment in care 19 2.3 Pre- and post-test services 20 2.4 Principles of and approaches to service delivery 24 2.5 HIV diagnosis in infants and children 28 2.6 Other priority populations 42 2.7 Diagnostics 45 3. CLINICAL GUIDELINES: ANTIRETROVIRAL DRUGS FOR HIV PREVENTION 51 3.1 Oral pre-exposure prophylaxis for preventing the acquisition of HIV 52 3.2 Post-exposure prophylaxis 61 3.3 Combination HIV prevention 64 4. CLINICAL GUIDELINES: ANTIRETROVIRAL THERAPY 71 4.1

2016 World Health Organisation HIV Guidelines

98. Moventig - naloxegol

cardiovascular event MedDRA Medical Dictionary for Regulatory Activities meu Morphine equivalent units mHS Modified Himmelsbach scale MI Myocardial infarction MMRM Mixed model for Repeated Measures MTP Multiple Testing Procedure Naloxegol Also known as NKTR-118, PEG-naloxol, NKT-10018, as naloxol 6a- Assessment report EMA/CHMP/738815/2014 Page 7/120 methoxyhepta(ethylene glycol) ether, also known as a-6-mPEG7-O-naloxol. Naloxegol oxalate salt International Union of Pure and Applied Chemistry (IUPAC) name (...) to: Article 8.3 of Directive 2001/83/EC - complete and independent application. The applicant indicated that naloxegol was considered to be a new active substance. 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 substituting/supporting certain test(s) or study(ies). Information on Paediatric requirements Pursuant to Article 7 of Regulation (EC) No 1901/2006

2014 European Medicines Agency - EPARs

99. Entyvio - vedolizumab

to: Article 8.3 of Directive 2001/83/EC - complete and independent application. The applicant indicated that vedolizumab was considered to be a new active substance. 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 substituting/supporting certain test(s) or study(ies). Information on Paediatric requirements Pursuant to Article 7 of Regulation (EC) No 1901 (...) the circulation to enter antigen-containing tissues. An essential step in this migration process is the adhesion of circulating lymphocytes to the endothelium of post capillary venules, which is a multistep process. In the first step, which is mediated by selectins or integrins, lymphocytes are captured (“tethering”) and poorly interact with the endothelial cells (“rolling”). Once they are rolling, they can undergo “activation,” which is usually mediated by chemokines presented on the venular endothelium

2014 European Medicines Agency - EPARs

100. Triumeq - abacavir sulfate / dolutegravir sodium / lamivudine

after an interruption of Triumeq therapy”). Abacavir should not be used in patients known to carry the HLA-B*5701 allele, unless no other therapeutic option is available in these patients, based on the treatment history and resistance testing (see section 4.4 and 4.8)”. 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. Information on Paediatric requirements Pursuant to Article 7 of Regulation (EC) No 1901/2006, the application included an EMA Decision P/0287/2012 on the agreement of a paediatric investigation plan PIP. At the time of submission of the application, the PIP P/0287/2012 was not yet completed as some measures were deferred. Information relating to orphan market exclusivity Similarity Pursuant to Article 8 of Regulation (EC) No. 141/2000

2014 European Medicines Agency - EPARs

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