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Fetal Foot Measurement

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121. Clinical practice guidelines for the care of girls and women with Turner syndrome: proceedings from the 2016 Cincinnati International Turner Syndrome Meeting (Full text)

of a dilated aorta with rapid increase in diameter (⨁◯◯◯). R 3.16. We suggest that in case of an acute ascending AoD before the fetus is viable, to perform emergency aortic surgery understanding that fetal viability may be at risk. If the fetus is viable, it is reasonable to perform cesarean section first, followed by aortic surgery, which should be performed under near-normothermia, pulsatile perfusion, high pump flow and avoidance of vasoconstrictors (⨁◯◯◯). R 3.17. We suggest that exercise testing (...) suspected or has been confirmed prenatally, a fetal echocardiogram should be performed (⨁⨁◯◯). R 4.11. We recommend that diagnosis of a bicuspid aortic valve or a left-sided obstructive lesion in a female fetus or child should prompt a genetic evaluation for TS (⨁⨁◯◯). R 4.12. We recommend referral to a pediatric cardiologist when congenital heart disease is detected prenatally in a fetus with TS to provide counseling regarding the anatomy and physiology of the specific defect, recommended site and mode

2016 European Society of Human Reproduction and Embryology PubMed abstract

122. Informal (Peer-to-Peer) Milk Sharing: The Use of Unpasteurized Donor Human Milk

handling and processing of the milk is required, precise heating and cooling requirements are followed, and donor milk is tested for bacterial and viral contamination after pasteurization to ensure the milk is safe to distribute? 25 Flash Heating: Flash heating involves placing a measured amount of milk in a glass container that is then placed in a measured amount of water? The water is heated to a rolling boil before the jar is removed and allowed to cool? Flash heating has been found to inactivate (...) conducted between April 2011 and March 2013 reviewed a total of 1,249 posts on two social networking pages that host not-for-profit milk sharing: Eats on Feets and Human Milk 4 Human Babies? 32 A review by the authors of the BC-specific pages of these same milk sharing social network sites revealed 26 separate requests for milk in six months (January–June 2015)? Infants ranged in age from one week to nine months? The most common reasons for requests (when given) were low milk supply and multiples

2016 British Columbia Perinatal Health Program

123. Duavive - oestrogens conjugated / bazedoxifene

with an intact uterus, a progestin has to be added in order to prevent the increased risk of endometrial carcinoma associated with oestrogen alone HRT. Combinations of CE and MPA are approved and available in some EU countries. BZA has both tissue selective oestrogen receptor agonist and antagonist activity, with agonist activity on the skeletal system and antagonist activity in breast and uterine tissues. The multiple oestrogens in CE have tissue selective oestrogen receptor agonist activity. Measured (...) on pilot as well as commercial scale batches. The dissolution method was shown to be discriminatory with regard to the particle size distribution. Although there is no evidence to suggest that the ratio of the amorphous form of BZA to the crystalline active substance form is critical to bioavailability, the proposed dissolution method has been shown to be biorelevant since it has sufficient discriminatory power to detect non-bioequivalent batches and thus provides a measure of holistic control

2015 European Medicines Agency - EPARs

124. Akynzeo (netupitant / palonosetron)

and this was agreed by the CHMP. Administration of netupitant to rabbits during the period of organogenesis was shown to increase the incidence of some foetal malformations: limb and paw positional anomalies, minimal/partial fusion of sternebrae, and agenesis of accessory lung lobe. The NOAEL for embryo-fetal development is 3 mg/kg/day. Taking into account the teratogen effect of netupitant in rabbit without a safety margin, a contraindication of AKYNZEO during pregnancy with a contraception measure for women (...) : IC50 = 8 µM ; Ki = 8 µM. Metabolite = M, netu = netupitant EMA/236963/2015 Page 21/153 Table 2: In vivo pharmacology studies with netupitant and its metabolites Type of study No of animals/dose GLP aspect Doses (mg/kg) Major findings Induced Foot-Tapping in Gerbils Inhibition of NK1 Agonist-Induced Foot-Tapping in Gerbils M + F, number not provided No GLP Netupitant metabolites: M1: 10, M2: 10, M3: 10 oral, ip Netupitant : ED 50 = 0.5 mg/kg p.o. and 1.5 mg/kg i.p.. M1: ED 50 = 2.4 mg/kg p.o

2015 European Medicines Agency - EPARs

125. Xydalba - dalbavancin

plan (PIP). At the time of submission of the application, the PIP P/0245/2013 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 the possible similarity with authorised orphan medicinal products because there is no authorised orphan medicinal product for a condition (...) . At this dose level, general toxic effects were observed in males (mortality, clinical signs, reduced body weights, body weight gains, food consumption, and nephrotoxicity) and in females (reduced body weight gain and food consumption). Assessment report EMA/39820/2015 Page 22/103 In rats, the paternal and maternal NOELs, as well as NOELs for mating and fertility and embryo foetal development, were 15 mg/kg/day (~1-1.5x therapeutic dosing regimen, based on a 14-day cumulative AUC). The NOEL for viability

2015 European Medicines Agency - EPARs

126. Strensiq - asfotase alfa

on weight, with regard to patient compliance issues. In order to provide greater clarity regarding product administration, a dosing table has been included in the SmPC. Another point for clarification was raised with regard to this, concerning feasibility of accurate dose measurement. The Applicant has subsequently provided adequate reassurance with regard to the accuracy of dose measurement using widely available syringes for both proposed dosing regimens. Stability data indicate that the active (...) supplementation. This way PLP (the primary vitamin B6 coenzymic form) measurements would not be affected by dietary intake. The evaluation was carried out as a pilot to a planned study ALP-PT-26, which confirmed the previously submitted results. It has been shown that continuous treatment of Akp2-/- mice with asfotase alfa for the full duration of the study (47 days), partially improved the reduced grip strength in the forelimbs, completely prevented the increase in both plasma PLP and liver glycogen levels

2015 European Medicines Agency - EPARs

127. Orbactiv - oritavancin

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, the application included an EMA Decision P/0056/2013 on the agreement of a paediatric investigation plan (PIP). At the time of submission of the application, the PIP P/0056/2013 was not yet completed as some measures were deferred. Information relating to orphan market (...) Phase IIa Effect studies Study type Test protocol Endpoint value Unit Remarks Algae, Growth Inhibition Test/anabaena flos-aquae OECD 201 NOEC µg/L Not valid, open issue Daphnia sp. Reproduction Test OECD 211 NOEC 460 µg/L Mean measured concentration Fish, Early Life Stage Toxicity Test/ Pimephales promelas OECD 210 NOEC 28 µg/L Mean measured concentration Activated Sludge, Respiration Inhibition Test OECD 209 EC10 14.5 mg/ L Nominal concentration Phase IIb Studies Sediment dwelling organism

2015 European Medicines Agency - EPARs

128. Vargatef - nintedanib

% repolarisation (ADP 10 , ADP 30 and ADP 90 respectively), resting membrane potential, maximal velocity oof phase 0 upstroke, AP overshoot, AP amplitude and the force of concentration was tested (N=5). In the current study setting, BIBF 1120 base had no effect on APD 90 in concentrations up to 10 µM, or any other measured parameters. No effect was observed on myocardial repolarisation at human therapeutic plasma concentrations. Effect on Cardiovascular and Respiratory function In the study performed (...) observed for the remaining parameters measured. Anaesthetised domestic pigs (study U2-1674-02) were administered increasing doses of BIBF 1120 chloride by intravenous infusion, starting at 3.0 mg/kg, escalating to 10 and 30 mg/kg in 30 minute intervals. The following parameters were measured and determined: systolic and diastolic arterial blood pressure, maximal left ventricular dP/dt (LVdP/dtmax), heart rate and ECG-intervals (QT, PR, QRS) from the electrocardiogram. Decrease in systolic and diastolic

2015 European Medicines Agency - EPARs

129. Sivextro - tedizolid phosphate

on the agreement of a paediatric investigation plan (PIP). At the time of submission of the application, the PIP P/0249/2013 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 the possible similarity with authorised orphan medicinal products because there is no authorised orphan (...) to light. The in-use stability of the drug product was assessed on samples reconstituted with 4 ml of WFI. Samples were either immediately analysed, stored for 24 hours under room temperature, in a refrigerator (2-8 °C), or exposed to fluorescent light. The solutions were tested for appearance, pH, visible particulate matter, assay, organic impurities, and sub-visible particulates. No significant changes were observed for any of the parameters measured. Therefore, the data supports that the finished

2015 European Medicines Agency - EPARs

130. Addyi - Flibanserin

Health Drugs (AC) on June 18, 2010. Pivotal to the indication sought were two Phase 3 clinical trials conducted in North America, where efficacy was assessed by two pre-specified co-primary endpoints – satisfying sexual events (SSEs) and sexual desire (measured daily by an electronic diary, eDiary). Notably, both trials failed to show a statistically significant improvement relative to placebo in sexual desire. However, both trials demonstrated nominally statistically significant improvement vs (...) . placebo in sexual desire measured by another instrument – the Female Sexual Function Index desire domain (FSFI-desire). The Applicant stated that the results from the secondary FSFI-desire endpoint should be adequate to support approval. Most of the AC members did not agree with the Applicant’s proposal to alter the methodology of analysis post-hoc. The AC voted 10 to 1 that the Applicant had not provided sufficient evidence of efficacy. Safety concerns raised by the AC included central nervous system

2015 FDA - Drug Approval Package

131. Assessment of the Newborn Infant

less than 100/min, CPAP or assisted ventilation should be commenced. 4 Colour Colour is difficult to assess accurately and is a poor means of judging oxygenation. 12 Normal babies are blue at birth but start to look pink soon after the onset of breathing. Cyanosis can be difficult to recognise and is determined by examining the gums and mucous membranes in good ambient light. Bluish hands and feet are a normal finding after birth. If a baby appears persistently blue, it is important to check (...) for the oximeter to detect a pulse. 2,7,8 Oximetry is recommended when the need for resuscitation is anticipated, when CPAP or positive pressure ventilation is used, when persistent cyanosis is suspected, or when supplemental oxygen is used [Class A, expert consensus opinion]. In babies resuscitated using supplemental oxygen, oximetry can play an important role in avoiding hyperoxaemia. References 1. Dawes GS. Foetal and Neonatal Physiology. A Comparative Study of the Changes at Birth. Chicago: Year Book

2016 Australian Resuscitation Council

132. Newborn Nursing Care Pathway

Norm and Normal Variations • Refer to POS Parent education/ Anticipatory Guidance • Refer to >12 – 24 hr Norm and Normal Variations • Refer to POS • Moulding resolves ~ 3 days • Average head circumference 33 – 35 cm once moulding disappears (ensure consistent way of measuring) 14 Parent education / Anticipatory Guidance • Refer to >12 – 24 hr • Prevent plagiocephaly (flat spots on head) and strengthen neck muscles by placing baby on abdomen when awake (tummy time) for several short periods each day (...) and capacity to identify variances that may require further assessments Norm and Normal Variations • Symmetrical in size, shape, movement & flexion • Intact, straight spine • Full range of motion • Clavicles intact • Bow-legged, flat-footed • Equal gluteal folds • Equal leg length Parent education/ Anticipatory Guidance • Refer to >12 – 24 hr Variance • Asymmetrical extremities • Curvature of spine • Non-intact spine • Tufts of hair along an intact spine – may require ultrasound to rule out spina bifida

2015 British Columbia Perinatal Health Program

133. Breastfeeding Healthy Term Infants

the infant and administer Vitamin K on the mother; delay eye prophylaxis up to one hour 54,55 and postpone infant weight and measur ements until completion of the first feeding • Continue skin-to-skin contact in a position that facilitates the infant to touch the breast if labor has been long or stressful. Place infant skin-to-skin on father or another designate if maternal skin-to-skin is not feasible 56 • Assist mother with breastfeeding as soon as possible or within 1 to 2 hours • Maintain a quiet (...) and foot rest for comfort and to elevate the infant to the level of the mother’s breast Mother’s arm or hand holds and supports the infant’s upper back and shoulders, cradling the neck/ base of the skull 13 • Lying position On the bed, mother and infant side-lie, facing each other; use pillows under mother’s head, behind her back, and as necessary between her legs Hold infant close; infant head and neck positions as described above Following the breastfeeding session the baby is placed on his

2015 British Columbia Perinatal Health Program

134. Parent?infant Psychotherapy for Improving Parental and Infant Mental Health: A Systematic Review (Full text)

or cognitive behavioural therapy (CBT)). We excluded studies of stand‐alone video‐interaction guidance interventions but not studies in which video feedback had been incorporated into a PIP that met the above criteria. 3.1.4 Types of outcome measures We extracted data for the following outcomes at both post‐intervention and follow‐up, provided they had been measured using a standardised parent‐report or independent observation of the type listed as examples for each outcome below. Primary outcomes Parent (...) ‐intervention and infant attachment at post‐intervention and follow‐up to complete Summary of findings table 1. For the comparison of PIP versus alternate intervention in Summary of findings table 2, we used the primary outcomes of parental depression at post‐intervention and follow‐up, and for infant attachment, we used outcomes from post‐intervention and follow‐up. measures such as the Strange Situation Procedure (SSP) ( ), Preschool Measure of Attachment (PMA) ( ), or other measures of emotional

2015 Campbell Collaboration PubMed abstract

135. Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death (Full text)

ventricular fibrillation (VF) and for the prevention of sudden death are detailed in Table . 3.1 Epidemiology of sudden cardiac death In the past 20 years, cardiovascular mortality has decreased in high-income countries 19 in response to the adoption of preventive measures to reduce the burden of CAD and HF. Despite these encouraging results, cardiovascular diseases are responsible for approximately 17 million deaths every year in the world, approximately 25% of which are SCD. 20 The risk of SCD is higher (...) that affect either the integrity of the heart's muscle (see section 7) or its electrical function (see section 8). Every time a heritable disease is identified in a deceased individual, the relatives of the victim may be at risk of being affected and dying suddenly unless a timely diagnosis is made and preventive measures taken. Unfortunately, even when an autopsy is performed, a proportion of sudden deaths, ranging from 2 to 54%, 48 remain unexplained ( Web Table 2 ): this broad range of values is likely

2015 European Society of Cardiology PubMed abstract

136. Hypertension in pregnancy

in primary care if the woman will not be seen by a specialist until after 12 weeks. Seek specialist advice before prescribing aspirin to girls younger than 16 years of age, and in those with thrombophilia or uncontrolled blood pressure. There is no evidence that use of low-dose aspirin in pregnancy is associated with an increased risk of congenital abnormalities or other fetal complications. Dipstick the urine for protein and measure blood pressure at each antenatal visit. Advise the woman to seek (...) the current medication, but seek specialist advice if there is uncertainty. An ACE inhibitor or AIIRA, stop this immediately and prescribe an alternative treatment if necessary. Explain that there is an increased risk of adverse fetal outcomes especially if these drugs are taken during the second and third trimesters of pregnancy. Advise women who have continued to take ACE inhibitors during the first trimester that there is no strong evidence that this is associated with increased risk to the fetus

2019 NICE Clinical Knowledge Summaries

137. Cerebral palsy

policies or guidelines since 1 May 2019. New safety alerts New safety alerts No new safety alerts since 1 May 2019. Changes in product availability Changes in product availability No changes in product availability since 1 May 2019. Goals and outcome measures Goals and outcome measures Goals Goals To support primary health care professionals to: Recognise the specific features of cerebral palsy. Refer for specialist confirmation of a diagnosis where cerebral palsy is suspected. Support and advise (...) people with confirmed cerebral palsy, and their family/carers. Recognise the health issues associated with cerebral palsy and manage, or refer if appropriate. Outcome measures Outcome measures No outcome measures were found during the review of this topic. Audit criteria Audit criteria No audit criteria were found during the review of this topic. QOF indicators QOF indicators No QOF indicators were found during the review of this topic. QIPP - Options for local implementation QIPP - Options for local

2019 NICE Clinical Knowledge Summaries

138. Antenatal care - uncomplicated pregnancy

) to the highest part of the uterus, measured with a non-elastic tape measure. Detailed information on how to measure and record fetal growth using the symphysis–fundal height is given on the website of the , along with examples of . Refer for further investigation (ultrasound biometry, amniotic fluid assessment, and/or Doppler flow) if the first fundal height measurement: Is below the 10th percentile on the customized chart. Is above the 90th percentile or there are other clinical concerns (for example (...) positive for an atypical red cell alloantibody (such as anti-c or anti-Kell), refer to a haematologist for advice and management. Measure and plot symphysis–fundal height (to identify small- or large-for-gestational-age infants). Symphysis–fundal height is the distance from the lowest part of the uterus (near the pubic bone) to the highest part of the uterus, measured with a non-elastic tape measure. Detailed information on how to measure and record fetal growth using the symphysis–fundal height

2019 NICE Clinical Knowledge Summaries

139. Leg ulcer - venous

occurring above the mid-calf or on the foot are likely to have other origins [ ]. Examination of the edge of the wound may help to identify its aetiology. For example, venous leg ulcers generally have gently sloping edges; arterial ulcers often appear well demarcated and 'punched out'; and rolled or everted edges should raise the suspicion of malignancy [ ; ]. Serial measurement of the surface area of the ulcer is important as it is a reliable index of ulcer healing [ ]. Assessing the depth of the ulcer (...) in the management of venous leg ulcers [ ]. Ankle brachial pressure index (ABPI) The ABPI is the ratio of the ankle systolic blood pressure to the brachial systolic blood pressure and can be measured using a sphygmomanometer and a hand held Doppler device [ ]. It is the most reliable way to detect arterial insufficiency. The absence of foot pulses may indicate arterial insufficiency; however, palpation alone is not sufficient to rule this out [ ]. SIGN advises that the measurement of ABPI should be performed

2019 NICE Clinical Knowledge Summaries

140. Propofol-induced death in children: at a Univ. Hospital

and expensive for general use as a laxative New Products New ProductsMED CHECK - TIP AUGUST 2015 / Vol.1 No.2 · Page 25 death, abortion, or other fetal abnormalities. The PMDA acknowledges the applicant’s explanation, but states that prostaglandin-like effects of the drug cannot be excluded as a cause of harmful influences on the embryo/fetus and reproductive function of parental animals. Therefore, lubiprostone is contraindicated in pregnant or possibly- pregnant women. Two abortifacient studies using (...) clotting test are extremely high (R 2 =0.99 for aPTT, R 2 =1.00 for ECT and R 2 =1.00 for thrombin time (TT) (Figure 2, Suppl. 3a and 3b, respectively). The timing of examination and the optimum (safe and effective) test value are still unknown (see section (5) in the following page). However, if an aPTT is prolonged, bleeding time would surely be prolonged (Figure 3, see p19) [1a]. In addition, regarding warfarin, consideration is unnecessary for the timing of INR measurement because its elimination

2015 Med Check - The Informed Prescriber

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