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4521. EANM Dosimetry Committee Series on Standard Operational Procedures for Pre-Therapeutic Dosimetry II. Dosimetry prior to Radioiodine Therapy of Benign Thyroid Diseases

- ommendations of the medical guideline [1] should be followed. For example, 300–400 Gy absorbed dose should be used to ablate autonomous nodules, and in patients with Graves’disease,thethyroidabsorbeddoseshouldbe150Gy if aiming at euthyroidism or 200–300 Gy for ablation. ThisSOPprovidesrecommendationsonhowtotailorthe therapeutic activity such that the absorbed dose to the thy- roid or diseased parts of the thyroid yields the prescribed value.Itisapplicableifalowactivityof 131 Iisadministered (...) of a tracer activity is described in the guideline; how- ever, general use of the method as well as administration of fixed activities or activity dosing linearly to the target mass and to the targeted absorbed dose is not recommended. A derivationoftheformulasrecommendedfordeterminingthe therapeutic activity as well as a worked example of a pretherapeutic dosimetry can be found in the Electronic supplementary material. The EANM Dosimetry Committee guidance document on good practice of clinical dosimetry

2013 European Association of Nuclear Medicine

4522. Vaginal brachytherapy for treatment of women with high-intermediate risk of endometrial cancer

within your organisation. Apart from any use as permitted under the Copyright Act 1968, all other rights are reserved. Requests and inquiries concerning reproduction and rights should be addressed to Commonwealth Copyright Administration, Attorney General’s Department, Robert Garran Offices, National Circuit, Canberra ACT 2600 or posted at http://www.ag.gov.au/cca Electronic copies can be obtained from http://www.horizonscanning.gov.au Enquiries about the content of the report should be directed (...) packing. A CT is performed to indicate the position of the cylinder in relation to the surrounding anatomical structures and a treatment is guided by computerised planning, thereby ensuring the prescribed radiation dosage treats the appropriate risk areas while sparing proximal healthy tissues from excess radiation. The radioactive source is introduced by way of a custom wire and moves within the cylinder resting at different points for a prescribed time until the treatment concludes. The time

2011 Australia and New Zealand Horizon Scanning Network

4523. Acoustic cardiography for the diagnosis of heart failure

Act 1968, all other rights are reserved. Requests and inquiries concerning reproduction and rights should be addressed to Commonwealth Copyright Administration, Attorney General’s Department, Robert Garran Offices, National Circuit, Canberra ACT 2600 or posted at http://www.ag.gov.au/cca Electronic copies can be obtained from http://www.horizonscanning.gov.au Enquiries about the content of the report should be directed to: HealthPACT Secretariat Department of Health and Ageing MDP 853 GPO Box 9848 (...) with asymptomatic LV dysfunction and beta-blockers when administered early post-myocardial infarction may reduce the subsequent development of CHF in patients with preserved ventricular function. In addition, anti- hypertensive medication may reduce blood pressure and reduce the incidence of CHF (Chronic Heart Failure Guidelines Expert Writing Panel 2006). During 2007–08 in Australia, 3.8 million patients filled in excess of 70 million PBS-subsidised prescriptions for medicines to prevent or treat

2011 Australia and New Zealand Horizon Scanning Network

4524. Targeted screening for cardiovascular risk for all adults between 40-74 years

from any use as permitted under the Copyright Act 1968, all other rights are reserved. Requests and inquiries concerning reproduction and rights should be addressed to Commonwealth Copyright Administration, Attorney General’s Department, Robert Garran Offices, National Circuit, Canberra ACT 2600 or posted at http://www.ag.gov.au/cca Electronic copies can be obtained from http://www.horizonscanning.gov.au Enquiries about the content of the report should be directed to: HealthPACT Secretariat (...) be prescribed (NHS 2010). In the United Kingdom it has been estimated that the NHS Health Check has the potential to prevent 9,500 myocardial infarctions and strokes per year, saving approximately 650 lives (Chamnan et al 2010; NHS 2010). CLINICAL NEED AND BURDEN OF DISEASE The National Health Survey conducted in 2007-08 estimated that 3.4 million Australians, or 16.5 per cent of the population, self-reported that they had one or more long-term diseases of the circulatory system that year

2011 Australia and New Zealand Horizon Scanning Network

4525. Consensus-Based Clinical Practice Guideline for the Management of Volatile Substance Use in Australia

to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given the specific written permission from the Commonwealth to do so. r equests and inquiries concerning reproduction and rights are to be sent to strategic Communications, national health and Medical r esearch Council, gPo box 1421, Canberra a Ct 2600 or via email to nhmrc.publications@nhmrc.gov.au. isbn Print: 1864965185 © Commonwealth of Australia 2011 Electronic document this work is copyright. you (...) are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given the specific written permission from the Commonwealth to do so. r equests and inquiries concerning reproduction and rights are to be sent to strategic Communications, national health and Medical r esearch Council, gPo box 1421, Canberra a Ct 2600 or via email to nhmrc.publications@nhmrc.gov.au. isbn online: 1864965193 Published: september 2011 Copies

2011 National Health and Medical Research Council

4526. Efficacy of Complementary and Alternative Medicine Therapies for Posttraumatic Stress Disorder

-based therapies* Movement-based and energy therapies* KQ1 KQ2 KQ3 KQs 1-3 Adverse effects Population Adults with PTSD Comparators Usual care, empirically-based treatments Primary Outcomes PTSD symptoms • Health-related quality • of life Secondary Outcomes Patient statisfaction • Treatment adherence • Functional status • 11 Efficacy of Complementary and Alternative Medicine Therapies for Posttraumatic Stress Disorder Evidence-based Synthesis Program We supplemented electronic searching by examining (...) of PTSD symptoms (i.e., on self- report and/or clinician-administered measures, including remission rates) or change in quality of life (i.e., functional status and health-related quality of life) Social functioning, patient satisfaction with treatment, treatment adherence/retention (e.g., proportion of prescribed sessions that are completed, completion of between-session assignments), and adverse treatment effects Reported at = 6 weeks after treatment initiation None Setting Patients recruited from

2011 Veterans Affairs Evidence-based Synthesis Program Reports

4527. Treatment of Anemia in Patients with Heart Disease

smaller number of trials evaluating iron and blood transfusion effects. RESULTS We reviewed 1,546 titles and abstracts from the electronic search, and identified an additional 83 from reviewing reference lists, and performing manual searches for recently published studies, and unpublished or ongoing studies. 2 Treatment of Anemia in Patients with Heart Disease: A Systematic Review Evidence-based Synthesis Program After applying inclusion/exclusion criteria at the abstract level, 320 full-text articles (...) -based Synthesis Program SEARCH STRATEGY We conducted a search in Medline ® and the Cochrane database of systematic reviews of literature published from 1947 to November 2010. Appendix A provides the search strategy in detail. We obtained additional articles from systematic reviews, reference lists of pertinent studies, reviews, editorials, and by consulting experts. We also searched for information about unpublished studies on ClinicalTrials.gov. All citations were imported into an electronic

2011 Veterans Affairs Evidence-based Synthesis Program Reports

4528. Brief Psychotherapy for Depression in Primary Care: A Systematic Review of the Evidence

trials as a data source for original research, searching for studies coded as including adults with a mood disorder who received face-to-face psychotherapy at a dose of eight or fewer therapy sessions. Finally, we searched for English-language publications in MEDLINE (via PubMed), PsycINFO, and Embase, from January 2009 (one year prior to the search date of the online database) through August 1, 2010. We supplemented electronic searching by examining the bibliographies of included studies and review (...) practitioners, and graduate students trained specifically to deliver the treatment as prescribed in the study protocol. Length of treatment varied from 3.5 hours of PST (delivered across six sessions) to 18 hours of MBCT (delivered across eight sessions). Finally, treatments were delivered primarily in individual, face-to-face sessions; however, two studies relied on group therapy, and one trial relied on telephone-based psychotherapy. Key Question 4: How commonly reported are the key clinical outcomes

2011 Veterans Affairs Evidence-based Synthesis Program Reports

4529. Assessment and management of polycystic ovary syndrome: summary of an evidence-based guideline

to English language articles and there were no limits on year of publication. The literature was searched until November 2010. The following electronic databases were employed to identify relevant evidence: Australasian Medical Index, CINAHL, the Cochrane Library, the Cochrane Database of Systematic Reviews, DARE (Database of Abstracts of Reviews of Effects), the Cochrane Central Register of Controlled Trials, the Cochrane Database of Methodology Reviews, the Cochrane Methodology Register, Health (...) ( ) and the National Prescribing Service ( ) for detailed prescribing information, including indications, drug dosages, methods and routes of administration, contraindications, supervision and monitoring, product characteristics, and adverse effects. It is intended that this evidence-based guideline summary be used alongside the full guideline. The guideline should be considered according to the limitations outlined within, and used in conjunction with clinical judgement and patient preference. For a detailed

2011 MJA Clinical Guidelines

4530. Guidelines for the management of children referred for dental extractions under general anaesthesia

at Brita in a nd I re la nd) Mrs Julie Spice Senior Nurse (Royal College of Nursing) Declaration The Guidelin e Dev e lopm ent Group is e ditorially i ndepende nt a nd me mber s had trave l expe nses rei mbursed by the AP AGBI according t o i ts published ex penses p olicy. There wer e no Co nflicts of Inter est (available on request from apagbiadministration@aagbi.org ). Return to ToC7 | 3. METHODOLOGY AND EVIDENCE GRADING Electronic and manu al s earches w er e perform e d of the p ublished (...) test, i.e. a healthcare professional is not guilty of negligence if “he has acted in accordance with a practice accepted as proper by a responsible body of men skilled in that particular art”. A healthcare professional may therefore defend a charge of negligence with evidence that (s)he acted in conformity with the practice accepted by another body of opinion. The test applied by the Court is therefore based on what is actually done in practice rather than on a prescription of what should be done

2011 Royal College of Anaesthetists

4531. Motivational interviewing for substance abuse Full Text available with Trip Pro

outcomes Retention in treatment. Improve motivation for change, e.g. measured by the Readiness to Change Questionnaire (RCQ; ). Number of repeat convictions (for convicted substance abusers). Search methods for identification of studies Electronic searches We searched the following electronic databases: Medline (1950 to November Week 3, 2010), Embase (1980 to 2010, week 4), PsycInfo (1806 to November week 4, 2010), PsychExtra (1908 to January 14, 2008), Cochrane Central Register of Controlled Trials (...) (search date: October 2, 2010), Electronic Library of the National Documentation Centre on Drug Use (search date: October 2, 2010), Google Scholar, and Google (search date: February 2, 2010). Year of publication was limited to 1983 and later. Databases were searched using a strategy developed incorporating the filter for the identification of RCTs (Higgins 2009) combined with selected MeSH terms and free text terms relating to substance abuse and motivational interviewing. The MEDLINE search strategy

2011 Campbell Collaboration

4532. Assessment and management of polycystic ovary syndrome: summary of an evidence-based guideline Full Text available with Trip Pro

to English language articles and there were no limits on year of publication. The literature was searched until November 2010. The following electronic databases were employed to identify relevant evidence: Australasian Medical Index, CINAHL, the Cochrane Library, the Cochrane Database of Systematic Reviews, DARE (Database of Abstracts of Reviews of Effects), the Cochrane Central Register of Controlled Trials, the Cochrane Database of Methodology Reviews, the Cochrane Methodology Register, Health (...) ( ) and the National Prescribing Service ( ) for detailed prescribing information, including indications, drug dosages, methods and routes of administration, contraindications, supervision and monitoring, product characteristics, and adverse effects. It is intended that this evidence-based guideline summary be used alongside the full guideline. The guideline should be considered according to the limitations outlined within, and used in conjunction with clinical judgement and patient preference. For a detailed

2011 MJA Clinical Guidelines

4533. The Provision of Medical Services to Residential Aged Care Facilities (RCF's) in Australia

. [36] He commented that the 44 criteria currently in place do not impose a requirement for the provision of adequate medical care, and suggests a review of the decade old criteria. He makes a number of suggestions for improved medical care for this population, including adequate remuneration that acknowledges the high proportion of non face to face work involved, improved recruitment of registered nurses, improved IT infrastructure including remote access and electronic prescribing, improved

2011 Australian and New Zealand Society for Geriatric Medicine

4534. Guidelines for the Investigation of Newborn Infants who suffer a Sudden and Unexpected Postnatal Collapse In the First Week of Life

gauze. Send promptly to cytogenetics laboratory. • Muscle biopsy for electron microscopy, histopathology and enzymology- wrap in aluminium foil, snap freeze and store at –70C. Contact metabolic physician or pathologist before collection of sample. b) Post mortem procedure Every unexpected death must be reported by law to the Coroner/Procurator Fiscal. Every death resulting from an unexpected collapse where the cause is not known must be notified by law to the Coroner/Procurator Fiscal (...) pregnancy (including loss of fetal movement) Medications taken during pregnancy (prescribed or over the counter) Did the mother fall or have any accident during this pregnancy? Were both parents well at the time of birth and at the time of infant collapse? Sudden Unexpected Postnatal Collapse 21 C. Labour, delivery and birth Onset of labour: spontaneous/no labour/ induced If induced, what method? If not spontaneous please give reason for delivery Was there spontaneous rupture of the membranes? How long

2011 Royal College of Radiologists

4535. Specialized Multidisciplinary Community - Based Care for Chronic Wounds: A Field Evaluation

in supporting patients with chronic wounds. In addition to multidisciplinary teams, care is also often provided by family physicians, and visiting nursing and allied health services provided through CCAC’s. Mechanisms to improve coordination of care should be explored, including the potential use of electronic information and referral systems. 1| B a c k g r o u n d Background Chronic Wounds Chronic wounds are defined as wounds that have failed to proceed through an orderly and timely process that results (...) Marsupialization 10 23 Electrical stimulation 8 18 Hyperbaric Oxygen Therapy(HBOT)/Topical Oxygen Therapy (TOT) 5 11 Whirlpool 4 9 Phototherapy 2 5 Pulse lavage suction 2 5 Availability of Wound Healing Best Practice Guidelines Electronic 33 75 Paper 28 64 Wall chart 12 27 Other 1 2 Team Use of Telemedicine NO 24 54 YES 19 43 All teams offered onsite debridement of wounds. Over 75% offered off-loading and almost 60% of teams offer orthotic casting. Other specialized treatments included: electrosurgery

2011 Health Quality Ontario

4536. Icatibant (Firazyr)

presentation in Section 6.1.5, as no conclusions discussed in the original Primary Clinical Review are affected. Reference ID: 3001367--------------------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------- /s (...) angioedema C1-INH complement 1 esterase inhibitor VAS Visual Analog Scale FFP fresh frozen plasma PI Prescribing Information SPA Special Protocol Assessment VDS Verbal Descriptor Scale AE adverse event DSI Division of Scientific Investigations CDRH Center for Devices and Radiologic Health QT-IRT QT-Interdisciplinary Review Team ACE angiotensin converting enzyme ITT intent-to-treat TEAE treatment-emergent adverse event CTCAE Common Terminology Criteria for Adverse Events ULN upper limit of normal NML

2011 FDA - Drug Approval Package

4537. Docetaxel Injection

or unknown safety risk. Reference ID: 2901938 (b) (4)Clinical Review Kristen M. Snyder, MD NDA 22234 Docetaxel 6 Premedication Regimen • Oral corticosteroids such as dexamethasone 16 mg per day (e.g., 8 mg twice a day) for 3 days starting 1 day before administration • HRPC: oral dexamethasone 8 mg at 12, 3, and 1 hr before treatment For dosage adjustments during treatment see full prescribing information. Dosage Forms and Strengths • 20 mg/2 mL single-dose vial • 80 mg/8 mL multi-dose vial • 160 mg/16 mL (...) --------------------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------- /s/ ---------------------------------------------------- KRISTEN M SNYDER 02/07/2011 PATRICIA CORTAZAR 02/08/2011 Reference ID: 2901938 1 Summary Review for Regulatory Action Date August 11, 2008 From Ramzi Dagher, M.D. Subject Deputy Division Director Summary Review NDA

2011 FDA - Drug Approval Package

4538. Glycerol Phenylbutyrate (Ravicti)

disease, whose prevalence is 20 kg – 9.9-13g/m 2 /day NaPBA (Buphenyl®) NDA20573 powder chronic management 20 kg – 9.9-13g/m 2 /day [Ref: Buphenyl prescribing information] Ammonul is another nitrogen scavenging drug, but its indication differs from that of Buphenyl and Ravicti in that it is used as an intravenous formulation for acute management of hyperammonemia. Reviewer’s Comment: The Buphenyl label offers a dosing range based on weight in kilograms. Much discretion is left to the prescribing (...) be sufficient. Treatment should be initiated as early as possible to minimize the risk of death or neurologic damage. The following flowchart illustrates the approach to evaluating hyperammonemia in newborns. Figure 4 Approaches to Hyperammonemia [Ref: ISE, Figure 2.7.3-8, p.28, (Adapted from Summar, 2001b)] 3 Ethics and Good Clinical Practices 3.1 Submission Quality and Integrity The NDA was submitted electronically on 23-DEC-2011. On 20-APR-2012 the applicant submitted the results of pediatric study HPN

2011 FDA - Drug Approval Package

4540. Methylthioninium chloride Proveblue

with Ph Eur. Methylthioninium chloride has a strong affinity for metals, and it is difficult to manufacture a substance that complies with the Ph Eur monograph. The applicant utilises a manufacturing process which allows obtaining an active substance which is metal-free and contains very low levels of organic impurities. Methylthioninium chloride acts as an electron donor for the non-enzymatic reduction of methaemoglobinaemia. A distinct enzyme, NADPH methaemoglobin reductase, converts (...) for methylthioninium chloride for appearance, solubility, assay, identification, methanol-insoluble substances, related substances (Azure B, each other, sum of impurities other than Azure B), loss on drying and sulphated ash. The trace metals are determined by in-house ICP-MS method which is similar to the one prescribed in the Ph Eur monograph. Residual solvents are determined by GC and HPLC methods. Impurities from synthesis are quantified by a HPLC method with UV detection and compendial methods are used

2011 European Medicines Agency - EPARs

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