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Fetal Foot Measurement

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41. Adalimumab (Hyrimoz) - Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Crohn Disease, Papulosquamous Skin Diseases, Hidradenitis Suppurativa, Ankylosing Spondylitis, Uveitis

effect on adalimumab clearance. The serum levels of free adalimumab (not bound to anti-adalimumab antibodies, AAA) were observed to be lower in patients with measurable AAA. Hepatic or renal impairment Adalimumab has not been studied in patients with hepatic or renal impairment. 5.3 Preclinical safety data Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose toxicity, and genotoxicity. An embryo-foetal developmental toxicity / perinatal (...) -modifying anti-rheumatic drugs including methotrexate has been inadequate. • the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Hyrimoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination

2018 European Medicines Agency - EPARs

42. Propranolol

. If you wanted the latest trusted evidence on propranolol or other clinical topics then use Trip today. This page lists the very latest high quality evidence on propranolol and also the most popular articles. Popularity measured by the number of times the articles have been clicked on by fellow users in the last twelve months. What is Trip? Trip is a clinical search engine designed to allow users to quickly and easily find and use high-quality research evidence to support their practice and/or care (...) on patients, methods, interventions, outcomes measured, and results using a pre-tested form. Study quality was assessed using two 2017 2. A comparative study of candesartan versus propranolol for migraine prophylaxis: A randomised, triple-blind, placebo-controlled, double cross-over study. 24335848 2016 04 30 2017 02 08 1468-2982 34 7 2014 Jun Cephalalgia : an international journal of headache Cephalalgia A comparative study of candesartan versus propranolol for migraine prophylaxis: A randomised, triple

2018 Trip Latest and Greatest

43. ESC/ESH Management of Arterial Hypertension (Full text)

= transient ischaemic attack; PAD = peripheral artery disease; SCORE = Systematic COronary Risk Evaluation. Table 6 Risk modifiers increasing cardiovascular risk estimated by the Systemic COronary Risk Evaluation (SCORE) system Social deprivation, the origin of many causes of CVD Obesity (measured by BMI) and central obesity (measured by waist circumference) Physical inactivity Psychosocial stress, including vital exhaustion Family history of premature CVD (occurring at age <55 years in men and <60 years (...) in women) Autoimmune and other inflammatory disorders Major psychiatric disorders Treatment for infection with human immunodeficiency virus Atrial fibrillation LV hypertrophy CKD Obstructive sleep apnoea syndrome Social deprivation, the origin of many causes of CVD Obesity (measured by BMI) and central obesity (measured by waist circumference) Physical inactivity Psychosocial stress, including vital exhaustion Family history of premature CVD (occurring at age <55 years in men and <60 years in women

2018 European Society of Cardiology PubMed abstract

44. Ocrelizumab (Ocrevus) - multiple sclerosis

Units F/T Freeze/Thaw; Assessment report EMA/790835/2017 Page 5/180 Fab Antigen Binding Portion Of Immunoglobulin Molecule FBS Fetal Bovine Serum Fc Fragment crystallisable Fc?RIIIa Fc gamma receptor IIIa FcRn neonatal Fc receptor FTIR Fourier Transform Infrared Spectroscopy FVIP filtered viral inactivation pool GPMF Genentech Production Manufacturing Facility HC Heavy Chain; HCCF Harvested Cell Culture Fluid HCP Host Cell Protein HEPES 4-(2-hydroxyethyl)-1-piperazine ethane sulfonic acid HMWS High (...) ATA anti-therapeutic antibody AUC area under the concentration-time curve AUC last area under the concentration-time curve from time 0 to the last measurable concentration AUC inf area under the concentration-time curve from time 0 to infinity AUC t area under the concentration-time curve within a dosing interval BCC basal cell carcinoma BLA Biologics License Application BLQ below the limit of quantification BMI body mass index BSA body surface area CCOD clinical cut-off date CDC complement

2018 European Medicines Agency - EPARs

45. Guidelines For Professional Ultrasound Practice

and neonatal liver and biliary system (including pancreas and spleen) 70 2.11.2 Paediatric urinary system 74 2.11.3 Paediatric gastro-intestinal tract 75 2.11.4 Neonatal hip 76 2.11.5 Neonatal intracranial ultrasound 77 2.12 Musculoskeletal ultrasound examinations 78 Examination specific guidelines and common scenarios 2.12.1 Shoulder 78 2.12.2 Elbow 84 2.12.3 Wrist and hand 88 2.12.4 Hip 91 2.12.5 Knee 94 2.12.6 Foot and ankle 97 2.12.7 Rheumatology ultrasound examinations 101 2.13 Elastography 111 2.14 (...) of Radiographers (SCoR) document. Standard: ‘A required or agreed level of quality or attainment. A standard is a way of ensuring optimum levels of care or service delivery. Standards promote the likelihood of an ultrasound examination being delivered safely and effectively, are clear about what needs to be done to comply, are informed by an evidence base and are effectively measureable’. Guideline: ‘A general rule, principle or piece of advice. Guidelines provide recommendations on how ultrasound examinations

2018 British Medical Ultrasound Society

46. Burosumab (Crysvita) - X-linked hypophosphataemia/hypophosphatemia

albumin ALP alkaline phosphatase API Active Pharmaceutical Ingredient AS Active Substance ATP adenosine triphosphate AUC area under the serum concentration time curve AUC0-8 AUC from zero to infinity AUC0-t AUC from zero to the last detectable time point AUClast AUC from zero to the time of last measured concentration BAL BioAgilytix BALP bone-specific alkaline phosphatase BP Bodily Pain or Blood pressure BPI Brief Pain Inventory BPI-SF Brief Pain Inventory – Short Form BR Batch Record BSV Between (...) 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(s) P/0265/2016 on the agreement of a paediatric investigation plan (PIP). At the time of submission of the application, the PIP P/0265/2016 was not yet completed as some measures were deferred. Assessment report EMA/148319/2018 Page 9/130 Information relating to orphan market exclusivity Similarity Pursuant to Article 8 of Regulation (EC

2018 European Medicines Agency - EPARs

47. Velmanase alfa (Lamzede) - alpha-Mannosidosis

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/0122/2014 on the agreement of a paediatric investigation plan (PIP). At the time of submission of the application, the PIP P/0122/2014 was not yet completed as some measures were deferred. Information relating to orphan market (...) and the clinical phenotype or a defined genotype-phenotype relationship. Diagnosis A diagnosis is made by measuring the enzymatic activity of alpha-D-mannosidase in white blood cells. If there is a decreased level of the enzyme in comparison to standard levels, a diagnosis can be made. It is thought that this disorder might be under-diagnosed for a few different reasons—the diagnosis is often made late in the disease's progression, symptoms are often mild, or the biochemical diagnosis does not yield conclusive

2018 European Medicines Agency - EPARs

48. Ertugliflozin l-pyroglutamic acid (Steglatro) - Diabetes Mellitus, Type 2

’ 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(s) P/0214/2014 on the agreement of a paediatric investigation plan (PIP) and on the granting of a deferral and on the granting of a waiver for ertugliflozin. At the time of submission of the application, the PIP P/0214/2014 was not yet completed as some measures (...) -dose toxicity studies in mice (28-day and 3-month), rats (4-week, 3-, 6-month) and dogs (1-, 3-, 9-month), in fertility and embryonic development study in rats, in embryo-fetal development studies in rats and rabbits, in pre- and postnatal development study in rats, in juvenile toxicity studies in rats, in genotoxicology and carcinogenicity studies in mice and rats. All pivotal safety pharmacological and toxicology studies were conducted according to European guidelines and GLP. 2.3.2. Pharmacology

2018 European Medicines Agency - EPARs

49. Ertugliflozin l-pyroglutamic acid / sitagliptin phosphate monohydrate (Steglujan) - Diabetes Mellitus, Type 2

: Figure 2: Sitagliptin active substance structure The chemical structure of sitagliptin phosphate was elucidated by a combination of UV, IR, MS, 1H- NMR, 13C- NMR. The solid state properties of the active substance were measured by X-ray crystallography. Sitagliptin phosphate monohydrate is a white to off-white powder, non-hygroscopic and soluble in water. Sitagliptin phosphate monohydrate is the subject of a Ph. Eur. monograph (2778). Sitagliptin phosphate exhibits stereoisomerism due to the presence (...) for single-dose pharmacokinetic studies. Quantitative whole body autoradiography (QWBA), liquid scintillation counting and HPLC coupled to radiometric detection were used to measure [ 14 C]ertugliflozin-derived radioactivity. Absorption Ertugliflozin was well absorbed and demonstrated low to moderate clearance (1.6 – 14 mL/min/kg) with a moderate volume of distribution (0.8 – 1.6 L/kg) in the nonclinical species evaluated. Mean apparent terminal half-life (t½) values for ertugliflozin ranged from

2018 European Medicines Agency - EPARs

50. Ertugliflozin l-pyroglutamic acid / metformin hydrochloride (Segluromet) - Diabetes Mellitus, Type 2

were measured in the urinary bladder, liver, kidney medulla, and kidney. The radioactivity did not show affinity for pigmented tissues containing melanin and exposure in the non­circumventricular CNS tissues was lower than blood concentrations (Tissue­to­blood ratio = 0.047 to 0.094 for Cmax and 0.064 to 0.12 for AUClast). Placental transfer of radioactivity was widespread with exposures to most fetal tissues, amniotic sac, amniotic fluid, myometrium, and placenta. Highest concentration (...) under the curve AUCinf area under the concentration-time curve from 0 to infinity AUClast area under the concentration –time curve from zero to time of last measurable concentration BCS biopharmaceutical classification system bid twice daily BMD bone mineral density BMI body mass index Broad pool pooled safety data from all seven ertugliflozin phase III studies BUN blood urea nitrogen CFU colony forming units CHMP Committee for Medicinal Products for Human use CI confidence interval cLDA constrained

2018 European Medicines Agency - EPARs

51. Care around stillbirth and neonatal death

regional differences exist. In New Zealand, perinatal death consists of fetal death (the death of a fetus of from 20 weeks gestation or weighing at least 400 grams if gestation is unknown 7 ) and early neonatal death (the death of a liveborn baby that occurs before the 7 th day of life 5 ). Perinatal related mortality is fetal and neonatal deaths (up to 28 days) at 20 weeks or beyond, or weighing at least 400g if gestation is unknown. Fetal death includes stillbirth and termination of pregnancy 8 (...) , giving a PMR of 11.2 per 1000 (8.1 and 3.1/1000 for fetal and neonatal death rates respectively) 5 . For Indigenous and other disadvantaged women in both settings (similar to other high income settings), the risk of perinatal death is around double 5,6,9,17 . Using the PSANZ classification system the leading causes of stillbirth are congenital anomaly and spontaneous preterm. However in approximately 20-30% of stillbirths, a cause is never identified. Similarly, for neonatal mortality, the main cause

2019 Centre of Research Excellence in Stillbirth

52. Major Blunt Trauma

certain thoracic and abdominal injuries, its relatively lower specificity compared with CT does not make it a sufficient test to exclude injuries to these areas [5]. US is less sensitive for detecting traumatic abdominal injury in the pregnant patient compared with the nonpregnant patient [54]. US Pelvis In pregnant patients with blunt abdominal trauma, both the health of the mother and fetus are of concern. The pelvic US can assess the uterus and evaluate the amniotic fluid level and measure (...) cause of mortality for people in the United States who are 35 mph) motor vehicle collision (MVC), MVC resulting in rollover or passenger ejection, motorcycle trauma, bicycle injury, MVC- pedestrian collision, and a fall from a height of >15 feet. Additional considerations include patient age and functional status, hemodynamic stability, neurological status, and results of initial imaging from portable radiographs of the chest and pelvis, and/or FAST. CT of the chest, abdomen, and pelvis with IV

2019 American College of Radiology

53. Guidelines for the Administration of Electroconvulsive Therapy

be required to anaesthetic management to improve safety including left lateral or pel- vic wedge tilt, adequate pre-oxygenation, avoidance of hyperventilation, premedication with an antacid or H2 blocker and intubation. Close monitoring of mother and foetus is essential before, during and after ECT including consideration of foetal heart rate monitoring with Doppler or cardiotocography (CTG). ECT after 20 weeks gestation should only be administered in hospitals where obstetric support is available. Older (...) Australian & New Zealand Journal of Psychiatry, 00(0) Several systematic reviews have reported on the safety of ECT for the treatment of severe mental illness during pregnancy (Anderson and Reti, 2009; Leiknes et al., 2015; Miller, 1994; Sinha et al., 2017). Although the data are lim- ited, it seems that ECT is an effective treatment during pregnancy and that the risks to mother and foetus are rela- tively low. These risks should be carefully weighed against those of other treatments, or no treatment

2019 American Psychiatric Association

54. Evaluation and management of polyhydramnios (Full text)

anatomy • Placenta for presence of large chorioangiomas • Fetal movement to assess neurologic function • Positioning of fetal hands and feet to rule out arthrogryposis syndromes • Presence and size of fetal stomach to rule out tracheoesophageal fistula or esophageal atresia • Anatomy of the fetal face and palate • Positioning and appearance of the fetal neck to rule out an obstructing mass • Fetal kidneys to assess for ureteropelvic junction obstruction • Lower spine and pelvis for evidence (...) | | | The measured pocket(s) should not contain fetal parts or loops of umbilical cord. Color Doppler is useful to avoid overmeasurement of a pocket that contains loops of umbilical cord. A recent study comparing fluid assessment with and without color Doppler found that compared with grayscale assessment, use of color Doppler decreased the frequency of diagnosis of polyhydramnios without a change in pregnancy outcomes. x 19 Odibo, I.N., Whittemore, B.S., Hughes, D.S., Simmons, P.M., Ounpraseuth, S.T

2019 Society for Maternal-Fetal Medicine PubMed abstract

55. An International Consortium Update: Pathophysiology, Diagnosis, and Treatment of PCOS in Adolescence (Full text)

throughout the life-course: low birth weight and fetal exposure to androgens; postnatal rapid weight gain; precocious adrenarche and early age at pubertal development; adult weight status and lifestyle. Until recently, candidate gene studies have been underpowered leading to poorly reproducible results. The advent of large-scale GWAS with their stringent statistical thresholds has brought robust new insights, although as yet these have been limited to adult PCOS cases and their direct relevance (...) be inversely correlated to obesity [ , ]. Confirmation of biochemical hyperandrogenism is important in symptomatic adolescents before a definitive diagnosis of PCOS can be considered. As described in prior publications on PCOS in adolescents, measurements of total and/or free testosterone have been the most recommended hormone determinations to document hyperandrogenemia [ ]. Methodological problems regarding testosterone determinations include the following: (1) inadequate assay sensitivity to measure low

2019 Pediatric Endocrine Society PubMed abstract

56. Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures

, particularly regarding continuous expired carbon dioxide measurement; to provide updated information from the medical and dental literature; and to suggest methods for further improvement in safety and outcomes. This document uses the same language to define sedation categories and expected physiologic responses as The Joint Commission, the American Society of Anesthesiologists (ASA), and the AAPD. , , – This revised statement reflects the current understanding of appropriate monitoring needs of pediatric (...) . Immediate activation of emergency medical services (EMS) may be required in such settings, but the practitioner is responsible for life-support measures while awaiting EMS arrival. , Rescue techniques require specific training and skills. , , , The maintenance of the skills needed to rescue a child with apnea, laryngospasm, and/or airway obstruction include the ability to open the airway, suction secretions, provide continuous positive airway pressure (CPAP), perform successful bag-valve-mask

2019 American Academy of Pediatrics

58. Management of Stroke in Neonates and Children (Full text)

for the mentioned proteins in the neonatal period may be misleading and requires repeat testing for a confirmatory diagnosis. Magnetic resonance imaging (MRI) should be performed to diagnose the stroke. Magnetic resonance angiography (MRA) and magnetic resonance venography (MRV) also should be performed, especially when venous thrombosis is suspected. Management Supportive care measures for AIS in neonates include the control of seizures, the optimization of oxygenation, and the correction of dehydration (...) of seizures at the time of presentation does not predict the occurrence of long-term epilepsy. Risk Factors and Causes Conditions that are associated with CSVT in neonates include gestational or delivery complications, dehydration, sepsis, meningitis, cardiac defects, and coagulation disorders. Although these factors are commonly thought of as risk factors, no controlled studies have proved the associations. Management Appropriate supportive measures include the control of epileptic seizures

2019 American Heart Association PubMed abstract

59. Heart Disease and Stroke Statistics (Full text)

analyses, lower socioeconomic status was associated with a 12% higher risk for amputation. In 2017, the Centers for Medicare & Medicaid Services decided to cover supervised exercise therapy (up to 36 sessions over 12 weeks) for eligible symptomatic peripheral artery disease patients with intermittent claudication. Quality of Care (Chapter 24) Quality and performance measures for MI have been relatively stable in recent years but have improved longitudinally since data collection began. Among hospitals (...) is based on the Rose Questionnaire; estimates are made regularly for HF; hypertension is based on BP measurements and interviews; and an estimate can be made for total CVD, including MI, AP, HF, stroke, and hypertension. A major emphasis of this Statistical Update is to present the latest estimates of the number of people in the United States who have specific conditions to provide a realistic estimate of burden. Most estimates based on NHANES prevalence rates are based on data collected from 2013

2019 American Heart Association PubMed abstract

60. Appropriate Use Criteria: Imaging of the Abdomen and Pelvis

include: ? CT brain and CT sinus for headache ? MRI brain and MRA brain for headache ? MRI cervical spine and MRI shoulder for pain indications ? MRI lumbar spine and MRI hip for pain indications ? MRI or CT of multiple spine levels for pain or radicular indications ? MRI foot and MRI ankle for pain indications ? Bilateral exams, particularly comparison studies There are certain clinical scenarios where simultaneous ordering of multiple imaging studies is consistent with current literature (...) the uterosacral ligaments, rectovaginal septum, vaginal wall, pouch of Douglas, and rectosigmoid. 7 Obstetric indications Advanced imaging is considered medically necessary for diagnosis and management of ANY of the following: ? Fetal anomalies ? Assessment prior to fetal intervention ? Placental complications ? Complications related to monochorionic twins ? Pelvimetry ? Other obstetrical complications IMAGING STUDY - Ultrasound is required for initial evaluation of fetal and placental conditions - Fetal MRI

2019 AIM Specialty Health

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