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Fetal Foot Measurement

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81. Nusinersen sodium (Spinraza) - Spinal Muscular Atrophy

of Regulation (EC) No 1901/2006, the application included an EMA Decision P/0251/2016 on the agreement of a paediatric investigation plan (PIP). At the time of submission of the application, the PIP Decision P/0251/2016 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 and Article 3 of Commission Regulation (EC) No 847/2000, the applicant did not submit a critical report addressing (...) in the presence of drug, thereby allowing these to be called fixation-induced vacuoles. Vacuolation in the inferior hippocampus was absent in tissues immersion-fixed in Carnoy’s or perfusion-fixed with Karnovsky’s fixative. Results of the two developmental and reproductive toxicity studies were negative for drug- related effects on fertility and embryo-fetal development. Biodistribution results indicated that nusinersen did not cross the placenta and, therefore, maternal exposure does not lead to any

2017 European Medicines Agency - EPARs

82. Chenodeoxycholic acid sigma-tau - cerebrotendinous xanthomatosis

Conference of Harmonisation IEC Independent Ethic Committee LCA Lithocholic acid LDH Lactic Dehydrogenase MedDRA Medical Dictionary for Regulatory Activities MEPs Motor Evoked Potentials MMRM Mixed Model for Repeated Measures MMSE Mini Mental State Examination MRI Magnetic Resonance Imaging NCS Non-clinically Significant PT Preferred Term PTH Parathyroid Hormone RBC Red Blood Cell SAE Serious Adverse Event SAP Statistical Analysis Plan SAS Statistical Analysis System SD Standard Deviation SI (...) substances have been quantified by TLC, but a more accurate HPLC method will be used from now on as requested by the CHMP. The HPLC method will also be used to measure assay (previously determined via acid-base determination) henceforward. So far the new HPLC method has only been used to measure long term stability data from one batch for up 12 months. Data on two additional batches for up to 12 months has been requested by CHMP. Full compliance with the proposed specification was reported

2017 European Medicines Agency - EPARs

83. Revised ATA guidelines for the management of medullary thyroid carcinoma

or the thyroidectomy specimen 16–18 578 [H] The diagnosis of MTC in patients presenting with a thyroid nodule 578 [H-1] Fine-needle aspiration biopsy 19 578–580 [H-2] Measurement of the serum Ctn level in patients with nodular thyroid disease 20 580 [I] Management of patients with a thyroid nodule and histological documentation of MTC 580 [I-1] Preoperative imaging studies 21–23 580–581 [I-2] The initial surgical treatment of patients with MTC 24–26 581–582 [J] Results of thyroidectomy in patients with MTC 582–583 (...) for children with MEN2B 33–36 586–587 [P] Management of PHEO in patients with MEN2A and MEN2B 37–41 587–588 [Q] Management of HPTH in patients with MEN2A 42–44 588 [R] Evaluation of patients following thyroidectomy 45–48 588–590 [R-1] Measurement of doubling times of serum Ctn and CEA to determine rate of progression of MTC 49 590–591 [S] Treatment of patients with regional metastatic MTC 591 [S-1] Neck exploration 50 591 [S-2] Role of postoperative radioiodine ablation 51 591 [S-3] Adjunctive EBRT

2015 Pediatric Endocrine Society

84. Management of Cervical Cancer

) MoH, Putrajaya Dr. Azura Deniel Consultant Oncologist Hospital Kuala Lumpur, Kuala Lumpur Dr. Carol Lim Consultant Maternal Fetal Medicine Hospital Sultan Haji Ahmad Shah, Pahang Ms. Chan Pek Har Clinical Psychologist Hospital Kuala Lumpur, Kuala Lumpur Dr. Cindy Teoh Cy Oun Fellow in Palliative Medicine Hospital Selayang, Selangor Dr. Faizatuddarain Mahmood Consultant Radiologist Hospital Kajang, Selangor Dr. Fuziah Paimin Family Medicine Specialist Klinik Kesihatan Salak, Selangor Ms. Gillian

2015 Ministry of Health, Malaysia

85. Management of Venous Leg Ulcers: Clinical Practice Guidelines of the Society for Vascular Surgery and the American Venous Forum

with iliofemoral DVT of duration <14 days. [GRADE - 2; LEVEL OF EVIDENCE - B] Guideline 8.4: Primary Prevention—Education Measures In patients with C1-4 disease, we suggest patient and family education, regular exercise, leg elevation when at rest, careful skin care, weight control, and appropriately fitting foot wear. [BEST PRACTICE] Guideline 8.5: Primary Prevention—Operative Therapy In patients with asymptomatic C1-2 disease from either primary or secondary causes, we suggest against prophylactic (...) Definition We suggest use of a standard definition of venous ulcer as an open skin lesion of the leg or foot that occurs in an area affected by venous hypertension. [BEST PRACTICE] VENOUS ANATOMY AND PATHOPHYSIOLOGY Guideline 2.1 : Venous Anatomy Nomenclature We recommend use of the International Consensus Committee on Venous Anatomical Terminology for standardized venous anatomy nomenclature. [BEST PRACTICE] Guideline 2.2 : Venous Leg Ulcer Pathophysiology We recommend a basic practical knowledge

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2014 American Venous Forum

86. Detection and Nonoperative Management of Pediatric Developmental Dysplasia of the Hip in Infants up to Six Months of Age

folds, and limited hip abduction” are common in papers related to this topic, no clear or widely accepted clinical definitions exist by which to compare patient populations to each other. In particular, the term “click” has been problematic as it has been used in screening literature as a term describing a range of situations from a normal snapping sensation to a surrogate for clinically detectable hip instability. Similarly, discussion of risk factors for terms such as “foot deformities, talipes (...) , we use the following measures listed in order of priority: 1) MCID/MID 2) PASS or Impact 3) Another validated measure 4) Statistical Significance LITERATURE SEARCHES We begin the systematic review with a comprehensive search of the literature. Articles we consider were published prior to September 2013 in four electronic databases; PubMed, EMBASE, CINAHL, and The Cochrane Central Register of Controlled Trials. The medical librarian conducts the search using key terms determined from the work

2014 American Academy of Orthopaedic Surgeons

87. Routine newborn assessment

/premature – stage as clinically indicated Review history • Maternal medical/obstetric/social and family • Current pregnancy • Labour and birth • Gender, gestational age, Apgar scores and resuscitation • Since birth: medications, observations, feeding Environment • Warmth, lighting • Correct identification • Infection control precautions • Privacy Equipment • Overhead warmer if required • Stethoscope • Ophthalmoscope • Tongue depressor • Pencil torch • Tape measure, infant scales, growth charts • Pulse (...) • Review any concerns the family have about the newborn and attempt to address them • Review any problems arising or suspected from antenatal screening, family history or labour (e.g. mental health issues, drug use/misuse, child protection issues, genetic conditions) • Review weight and head circumference measurements • Check the newborn has passed urine and meconium • Recognise common neonatal problems and give advice about management • Diagnose congenital malformations and arrange appropriate

2014 Queensland Health

88. Acromegaly

measurement of IGF-1 levels in patients with typical clinical manifestations of acromegaly, especially those with acral and facial features. (1|⊕⊕⊕○) 1.2 We suggest the measurement of IGF-1 in patients without the typical manifestations of acromegaly, but who have several of these associated conditions: sleep apnea syndrome, type 2 diabetes mellitus, debilitating arthritis, carpal tunnel syndrome, hyperhidrosis, and hypertension. (2|⊕⊕○○) 1.3 We recommend measuring serum IGF-1 to rule out acromegaly (...) |⊕○○○) Surgical debulking 4.5 In a patient with parasellar disease making total surgical resection unlikely, we suggest surgical debulking to improve subsequent response to medical therapy. (2|⊕⊕○○) Postoperative testing 4.6 Following surgery, we suggest measuring an IGF-1 level and a random GH at 12 weeks or later (2|⊕⊕⊕○). We also suggest measuring a nadir GH level after a glucose load in a patient with a GH greater than 1 μg/L. (2|⊕⊕⊕○) 4.7 We recommend performing an imaging study at least 12 weeks after

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2014 The Endocrine Society

89. Safe Prevention of the Primary Cesarean Delivery

of Obstetricians and Gynecologists recommends preparations for imminent delivery in the event that intrauterine resuscitative measures do not improve the fetal heart rate pattern (48). In contrast, Category I fetal heart tracings are normal and do not require intervention other than ongoing assessment with continuous or intermittent monitoring, given that patterns can change over time. Moderate variability and the presence of accelerations, which are features of Category I patterns, have proved to be reliable (...) indicators of normal neonatal umbilical cord arterial pH (7.20 or greater) ( , ). Most intrapartum fetal heart rate tracings are Category II (50, ). Category II tracings are indeterminate and comprise a diverse spectrum of fetal heart rate patterns that require evaluation, continued surveillance, initiation of appropriate corrective measures when indicated, and re-evaluation (48). Based on the high rate of first cesarean deliveries performed for the indication of “nonreassuring fetal heart rate” (also

2014 American College of Obstetricians and Gynecologists

90. Guidelines for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack

by clinical judgment and recognition that acute illness may temporarily perturb measures of plasma glucose. In general, HbA 1c may be more accurate than other screening tests in the immediate postevent period (Class IIa; Level of Evidence C ). New recommendation Obesity All patients with TIA or stroke should be screened for obesity with measurement of BMI (Class I; Level of Evidence C ). New recommendation Given the demonstrated beneficial effects of weight loss on cardiovascular risk factors (...) . These seemingly silent infarctions are associated with typical risk factors for ischemic stroke, increased risk for future ischemic stroke, and unrecognized neurological signs in the absence of symptoms. Clinicians who diagnose silent infarction routinely ask whether this diagnosis warrants implementation of secondary prevention measures. The writing committee, therefore, identified silent infarction as an important and emerging issue in secondary stroke prevention. Although data to guide management

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2014 American Heart Association

91. Type 1 Diabetes Mellitus and Cardiovascular Disease: A Scientific Statement From the American Heart Association and American Diabetes Association

without DM PAD Jonasson et al, 2008 PMID: 18443192 31 354 Patients with T1DM from the Swedish Inpatient Registry identified from 1975–2004 compared with the Swedish population; white northern Europeans Administrative database, ICD-9 coding ND 12.5 Incident nontraumatic lower-extremity amputations: 85.5 (95% CI, 72.9–100.3) The hazard ratio (HR) is a measure of how often a particular event happens in one group compared to how often it happens in another group, over time. HRs are as reported (...) increasing age, male sex, history of foot lesions or ulcers, diastolic BP, low-density lipoprotein cholesterol (LDL-C), glycosylated hemoglobin (HbA 1c ), DM duration, hypertension, albumin excretion rate, glomerular filtration rate (GFR), smoking status, and retinopathy. , , , In a meta-analysis of 5 studies of T1DM patients, with each 1% increase in HbA 1c the risk of PAD increased by 18%. Interestingly, aggressive glycemic control to lower the HbA 1c did not appear to reduce rates of peripheral

2014 American Heart Association

92. Guidelines for the Primary Prevention of Stroke: A Statement for Healthcare Professionals From the American Heart Association/American Stroke Association

for primary stroke prevention. 14,15 Some of the goals of such risk assessment tools are to identify people at elevated risk who might be unaware of their risk, to assess risk in the presence of >1 condition, to measure an individual’s risk that can be tracked and lowered by appropri- ate modifications, to estimate risk for selecting treatments or stratification in clinical trials, and to guide appropriate use of further diagnostic testing. Although stroke risk assessment tools exist, the complexi- ties (...) hypertrophy on ECG. Additional refinements include a measure of carotid intima-media thickness (IMT); however, these refinements result in only a small improvement in 10-year risk predic- tion of first-time MI or stroke that is unlikely to be of clinical importance. 17 FSP scores can be calculated to estimate sex-spe- cific, 10-year cumulative stroke risk. The initial FSP has been updated to account for the use of antihypertensive therapy and the risk of stroke and stroke or death among individuals

2014 American Heart Association

94. Antidepressant Use During Pregnancy: Considerations for the Newborn Exposed to SSRIs/SNRIs

=?1 ?hour? =? 88% >?1 ?hour? >? 94%? Key ACoRN? Acute?Car e?of?at-Risk?Newbor ns? NICU? Neonatal?Intensive?Car e?Unit? =? less?than?or?equal?to? HCP Health Care Provider SpO 2 Oxygen Saturation > greater than NB Newborn O 2 Saturation Protocol • Ensure to measure the preductal SpO 2 (right hand or wrist) and not the postductal SpO 2 (either foot or left hand) • Take reading while newborn in a quiet state • Document on NB Clinical Path • If SpO 2 remains below normal range, consult pediatrics (...) to improve outcomes in babies suffering neonatal abstinence syndrome, including skin-to-skin contact. This has been shown to improve temperature regulation, breathing regularity, behavioural state, weight gain, and overall newborn health in babies suffering from NAS. Persistent pulmonary hypertension of the newbor n (PPHN) is defined as a failur e of the normal r elaxation in the fetal pulmonary vascular bed during the circulatory transition that occurs shortly after birth. PPHN is very rare, and occurs

2013 British Columbia Perinatal Health Program

95. General practice management of type 2 diabetes 2014-15

2 diabetes to approach/reach these goals Diet Normal healthy eating. If concerns regarding cardiovascular risk, advise Mediterranean diet. Body mass index (kg/m 2 ) Therapeutic goal is 5–10% loss for people overweight or obese with type 2 diabetes. With BMI >35 and comorbidities or BMI >40, greater weight loss measures should be considered. Note that BMI is a difficult parameter to standardise between different population groups. Physical activity At least 30 minutes of moderate physical (...) glucose in low-risk patients who are using oral glucose-lowering drugs (with the exception of sulphonylureas) is not recommended. HbA1c (mmol/mol; %) Needs individualisation according to patient circumstances. Generally: • =53 mmol/mol (range 48–58) • =7% (range 6.5–7.5). Allowing for normal variation in test accuracy, HbA1c results which range between 6.5 and 7.5% would reflect this goal. Total cholesterol (mmol/L) 35 and comorbidities or BMI >40, greater weight loss measures should be considered

2014 Clinical Practice Guidelines Portal

96. Votrient (pazopanib hydrochloride)

to conduct all-case surveillance until data from a certain number of patients are accumulated after market launch, in order to identify the background information of patients treated with the product and collect safety and efficacy data on the product in the early post-marketing period, thereby take necessary measures to ensure proper use of the product. *Japanese Accepted Name (modified INN) This English version of the Japanese review report is intended to be a reference material to provide convenience (...) treated with the product and collect safety and efficacy data on the product in the early post-marketing period, therby take necessary measures to ensure proper use of the product. 3 Review Report (1) July 31, 2012 I. Product Submitted for Registration [Brand name] Votrient Tablets 200 mg [Non-proprietary name] Pazopanib Hydrochloride [Applicant] GlaxoSmithKline K.K. [Date of application] December 13, 2011 [Dosage form/Strength] Tablets; each tablet contains 216.7 mg of Pazopanib Hydrochloride (200 mg

2012 Pharmaceuticals and Medical Devices Agency, Japan

97. Tetrabik (adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine)

in *** medium and *** medium supplemented with **********) ? ? Culture assay (growth of the cultures as measured by OD 650) ? ? Antigen production assay (hemagglutinating activities of antigens [FHA and PT]) ? ? Antigen production rate (ELISA) ? ? Nucleotide sequencing of the antigen genes ? ? ?: Tested, -: Not tested a) Sterility test (test for presence of contaminating bacteria using selective media etc.) was also performed when the MS was established in 19**. The MS has been stored at *°C and the WS has (...) measured to determine the following: (a) neutralizing antibody seropositivity rate (the percentage of subjects with neutralizing antibody titers of =1:8), (b) neutralizing antibody seroconversion rate (the percentage of subjects who converted from seronegative [antibody titer <1:8] before vaccination to seropositive after vaccination and subjects with a post-vaccination antibody titer =4-fold the pre-vaccination antibody titer), and (c) mean neutralizing antibody titer (log 2 ). In the FAS

2012 Pharmaceuticals and Medical Devices Agency, Japan

98. Routine newborn assessment

/premature – stage as clinically indicated Review history • Maternal medical/obstetric/social and family • Current pregnancy • Labour and birth • Gender, gestational age, Apgar scores and resuscitation • Since birth: medications, observations, feeding Environment • Warmth, lighting • Correct identification • Infection control precautions • Privacy Equipment • Overhead warmer if required • Stethoscope • Ophthalmoscope • Tongue depressor • Pencil torch • Tape measure, infant scales, growth charts • Pulse (...) • Review any concerns the family have about the newborn and attempt to address them • Review any problems arising or suspected from antenatal screening, family history or labour (e.g. mental health issues, drug use/misuse, child protection issues, genetic conditions) • Review weight and head circumference measurements • Check the newborn has passed urine and meconium • Recognise common neonatal problems and give advice about management • Diagnose congenital malformations and arrange appropriate

2014 Clinical Practice Guidelines Portal

99. Occupational Health and the Anaesthetist

-exposure prophylaxis for hepatitis B and C is not available. • Respiratory infections are an occupational hazard and anaesthetists should take appropriate measures to protect themselves. These include immunisation, use of personal protective equipment – masks, gloves and aprons/gowns, and good hand hygiene. • Infections that can cause severe illness if acquired include influenza, SARS, novel coronavirus or tuberculosis. When managing patients who may have such infections, doctors should seek and follow (...) liaise with the various hospitals to which trainees rotate to minimise the number of pre-employment screens needed. This is particularly an issue where trainees undertake many attachments of short duration. Consideration should be given to trainees having either a lead employer for the whole of training, or a ‘health passport’ which would be accepted by all hospitals within a school. These measures will save much time and cost for individual hospitals, and minimise delays before new trainees may

2014 Association of Anaesthetists of GB and Ireland

100. Heart Disease and Stroke Statistics?2016 Update

of how many people have a disease at a given point or period in time. The NCHS conducts health examination and health interview surveys that provide estimates of the prevalence of diseases and risk factors. In this Update, the health interview part of the NHANES is used for the prevalence of CVDs. NHANES is used more than the NHIS because in NHANES, AP is based on the Rose Questionnaire; estimates are made regularly for HF; hypertension is based on BP measurements and interviews; and an estimate can

2014 American Heart Association

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