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Fetal Foot Measurement

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181. Sonidegib (Odomzo)

and the Applicant agreed on inclusion of the following text in the PATIENT COUNSELING INFORMATION section of the label: Reference ID: 3796270Addendum to Clinical Review Denise Casey NDA 205266 Odomzo ® (sonidegib) 14 Advise the patient to read the FDA-approved patient labeling (Medication Guide). Embryo-Fetal Toxicity[see Warnings and Precautions (5.1) and Use in Specific Populations (8.1,8.3)]. ? Advise female patients of the potential risk to a fetus. ? Advise females of reproductive potential to use (...) label were revised for clarity, brevity, and consistency. Only clinically-relevant, substantive content changes will be discussed in this review (sections pertaining to CMC, clinical pharmacology, or nonclinical issues are not included), with agreed upon wording for the key clinical sections of the product label for sonidegib (Odomzo) provided in italics. Boxed Warning The label originally proposed by the Applicant included a boxed warning for the risk of embryo-fetal toxicity with sonidegib. FDA

2014 FDA - Drug Approval Package

182. Blood sampling, neonatal capillary

, the time the baby cried, and the need to repeat the sample ( ). Manual lancets must not be used ( ). Before commencing the procedure Capillary blood sampling is a painful procedure. Comfort measures and analgesia are recommended to reduce the pain and discomfort caused to the neonate during the blood sampling process ( ) ( ). An assessment of the baby's ability to tolerate handling must be made prior to obtaining the sample. A full explanation should be given to the parents before the procedure (...) of infection ( ) Capillary blood sampling should never be taken from the fingers of a neonate ( ). Obtaining the sample The neonates identity should be confirmed. A social hand wash should be performed and an apron and gloves should be worn ( ). Equipment should be placed in a convenient position ( ). To obtain the sample: Ensure baby is lying in a safe and secure position ( ). Clean the heel by washing with plain water using gauze/cotton wool. The water should not be heated and the baby’s foot should

2014 Publication 1593

183. 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 (...) and standard treatment groups while one suggested lower surgical morbidity in the NAC group which may be due to a lower frequency of urological events. 65, level I In the other review, data showed that serious late toxicity to the bladder, gastrointestinal tract and vagina were similar in both study groups. 52, level I The addition of NAC may improve survival if given in shorter cycle length ( 18 - 22 weeks gestation but before foetal maturity and patient wishes to preserve pregnancy, ? for tumour size 4

2015 Ministry of Health, Malaysia

184. Hypertensive Urgency: Considerations for Management

, eclampsia) Symptoms Asymptomatic; or severe headache, shortness of breath, nosebleeds, severe anxiety Shortness of breath, chest pain, numbness/weakness, change in vision, back pain, difficulty speaking *Note: Signs of end-organ damage/dysfunction may occur at a lower blood pressure in pregnant & pediatric patients Initial Patient Work-Up to Differentiate between Urgency and Emergency: ? Verify blood pressure (BP) reading(s). Ensure proper technique for measuring BP (e.g. patient’s feet flat (...) on the floor & arm supported) (Please refer to Hypertension Canada’s Blood Pressure Measurement Information Sheet for more detailed guidance). ? Obtain medical history & current medication list (prescription, OTC, recreational) ? Physical exam - focus on any signs of target organ damage (e.g. shortness of breath, chest pain, numbness/weakness) ? Lab tests & investigations may be required (e.g. CBC, ECG, urinalysis, renal function; ultrasound for aortic dissection if very high BP) ? Hypertensive urgency

2014 RxFiles

185. Core Competencies for Management of Labour

options • Selecting appropriate interventions to promote maternal/fetal/newborn wellbeing • Interpreting laboratory test and ultrasound results and taking appropriate action • Promoting normal labour and birth • Keeping mother and baby together • Promoting early skin-to- skin contact • Demonstrating self- awareness of own attitudes and beliefs about labour support strategies and use of comfort measures and/or pain relief optionsCore Nursing Practice Competencies: Managing Labour 5 Perinatal Services (...) and expectations for labour support Review antenatal and clinical records Demographic information Obstetrical history Family history Medical/surgical history History of mental health History of present pregnancy, including LMP and EDD Laboratory and ultrasound results Birth and feeding plan Assess psychosocial and cultural factors Check maternal vital signs and urine dipstick Measure symphysis-fundal height Palpate abdomen to assess fetal lie, size, presentation, position, attitude and descent Confirm fetal

2014 British Columbia Perinatal Health Program

186. Prenatal Screening for Down Syndrome, Trisomy 18, and Open Neural Tube Defect

trimester ultrasound 2 are some of the options available for prenatal genetic screening? The risks for fetal Down syndrome, trisomy 18, and open neural tube defects (ONTDs) are calculated using a combination of variables which may include: biochemical serum markers collected from blood work, maternal age, maternal ethnicity, maternal weight, maternal diabetic status, maternal smoking, and, if available, nuchal translucency (NT) ultrasound measurement? There are four different screening tests: SIPS, IPS (...) is available only in a select number of publicly funded centres 4 located around BC and use of the service is prioritized to serve those at higher risk of having a fetus with Down syndrome or trisomy 18 and women with multiple gestations? IPS test results are available within 10 days after the second blood test? If the NT measurement is high and results in a positive screen, counselling and further testing is offered (such as NIPT or amniocentesis) in the first trimester prior to completing the second

2014 British Columbia Perinatal Health Program

187. Choices about first trimester ultrasound scans: A decision aid for pregnant women

, legs, hands and feet can be measured by the woman’s care provider. The baby’s organs, such as the heart and kidneys, can also be examined. Checking how a woman’s baby is developing can allow a care provider to see whether a baby has, or might have, any abnormalities. An abnormality is when a baby is not developing in the usual way. There are different kinds of abnormalities that can be found by looking at a first trimester ultrasound scan. You might like to ask your care provider about (...) . To see how many weeks pregnant a woman is A first trimester ultrasound scan can be a way of estimating how many weeks pregnant a woman is, that is, how long she has been pregnant. Care providers estimate how many weeks pregnant a woman is by looking at the size and development of the baby. For example, care providers can look at the baby’s crown-rump length. The crown-rump length is a measure of the distance in centimetres from the baby’s crown (the top of the head) to the baby’s rump (the bottom

2015 EUnetHTA

188. Gestational diabetes mellitus

Diagnosis of GDM 15 2.7 Diabetes in Pregnancy 15 2.7.1 Standardisation of HbA1c measurement 15 3 Antenatal care 16 3.1 Maternal surveillance 17 3.2 Fetal surveillance 18 3.3 Psychosocial support 18 3.4 Self-monitoring 19 3.5 Medical nutrition therapy 20 3.6 Physical activity 21 3.6.1 Cautions and contraindications for physical activity 22 4 Pharmacological therapy 23 4.1 Metformin 23 4.2 Insulin therapy 24 4.2.1 Insulin type by glycaemic abnormality 24 4.3 Hypoglycaemia 25 4.4 Education for safe self (...) • There is limited evidence or consensus regarding specific antepartum tests or their frequency 54 • Monitoring type and frequency is influenced by the presence of other pregnancy complications (e.g. antepartum haemorrhage, preeclampsia, fetal growth restriction) as well as severity of maternal hyperglycaemia 24 • Fetal abdominal circumference (AC) greater than or equal to 75% for gestational age, measured at 29 to 33 weeks gestation, correlates with an increased risk for birth of an LGA infant 55 Fetal growth

2015 Queensland Health

189. Pediatric Pulmonary Hypertension: ATS/AHA Clinical Practice Guidelines

important, pediatric PH is intrinsically linked to issues of lung growth and development, including many prena- tal and early postnatal influences. 3 The development of PH in the neonate and young infant is often related to impaired functional and structural adaptation of the pulmonary circula- tion during transition from fetal to postnatal life. The timing of pulmonary vascular injury is a critical determinant of the subsequent response of the developing lung to such adverse stimuli, including (...) or related PVD, including the lack of established biomarkers that can predict disease risk, severity, and disease progression. We cur- rently lack sufficient outcome measures that are applicable to Table 1. PH: Definitions PH mPAP =25 mm Hg in children >3 mo of age at sea level PAH mPAP =25 mm Hg PAWP 2 WU/m 2 IPAH or isolated PAH PAH with no underlying disease known to be associated with PAH Referred to as HPAH with positive family or genetic evaluation PHVD Broad category that includes forms of PAH

2015 American Thoracic Society

190. State-of-the-Art Methods for Evaluation of Angiogenesis and Tissue Vascularization

of therapeutic strategies to either promote or inhibit vessel growth depends on reproducible measures and end points in experimental models that are relevant for the treatment of human diseases. Accordingly, the selection of an appropriate experimental model is critical to study specific aspects of the molecular and cellular mechanisms that are of physiological or pathological relevance. This scientific statement summarizes in vitro assays and in vivo models suitable for gaining insights into the basic

2015 American Heart Association

191. Adult Sinusitis Full Text available with Trip Pro

have greater activity limitations, work limitations, and social limitations. The overall annual productivity cost for refractory CRS is estimated at $10,077 per patient. CRS can also have a substantial impact on health-related quality of life. Patients with CRS referred to otolaryngologists score significantly lower on measures of bodily pain and social functioning than do those with angina, back pain, congestive heart failure, and chronic obstructive pulmonary disease. Similarly, patients with CRS (...) with the specific sinuses involved. Last, patient complaints of nasal obstruction correlate with objective measures, such as rhinomanometry or nasal peak flow rate. Since the usual clinical dilemma is to differentiate ABRS from VRS, the specificity of ABRS symptoms has typically been studied in this context. The antecedent history of viral URI likely contributes to the specificity of these symptoms for ABRS, but the extent to which this is true has not been quantified. Similarly, although the differential

2015 American Academy of Otolaryngology - Head and Neck Surgery

192. Physical Activity and Exercise During Pregnancy and the Postpartum Period

of recreational activities is safe. Activities with high risk of abdominal trauma should be avoided (Box 3). Scuba diving should be avoided in pregnancy because of the inability of the fetal pulmonary circulation to filter bubble formation ( ). For lowlanders, physical activity up to 6,000 feet altitude is safe in pregnancy ( ). Special Populations Several reviews have determined that there is no credible evidence to prescribe bed rest in pregnancy, which is most commonly prescribed for the prevention (...) routines may be necessary because of normal anatomic and physiologic changes and fetal requirements. Women with uncomplicated pregnancies should be encouraged to engage in aerobic and strength-conditioning exercises before, during, and after pregnancy. Obstetrician–gynecologists and other obstetric care providers should carefully evaluate women with medical or obstetric complications before making recommendations on physical activity participation during pregnancy. Although frequently prescribed, bed

2015 American College of Obstetricians and Gynecologists

193. Pediatric Pulmonary Hypertension Full Text available with Trip Pro

to diagnose, to moni- tor the disease progression of, and to treat children with PAH. 4 Pediatric PH is distinct from adult PH in several ways. Most important, pediatric PH is intrinsically linked to issues of lung growth and development, including many prena- tal and early postnatal influences. 3 The development of PH in the neonate and young infant is often related to impaired functional and structural adaptation of the pulmonary circula- tion during transition from fetal to postnatal life. The timing (...) circulation and basic mechanisms of disease. It also identified factors that limit the ability to perform clinical trials in children with PH or related PVD, including the lack of established biomarkers that can predict disease risk, severity, and disease progression. We cur- rently lack sufficient outcome measures that are applicable to Table 1. PH: Definitions PH mPAP =25 mm Hg in children >3 mo of age at sea level PAH mPAP =25 mm Hg PAWP 3 WU × M 2 IPAH or isolated PAH PAH with no underlying disease

2015 American Heart Association

194. EANM practice guidelines for lymphoscintigraphy and sentinel lymph node biopsy in melanoma ? SNMMI Endorsement

-dose diagnosticCT protocols of the head (using higher current because of the skull) [124]. Only in a melanoma located rather close to the foetus(overthelowerabdomenorback)isthetheoreticalrisk of exceeding 1 mSv a relevant question. In such a case, the most important modification that may reduce foetal radiation exposurewillbereductionoftheinjectedactivityanda1-day protocolshouldbeused,withashortintervalfrominjectionto operation tominimizedecay [116, 125, 126].To compensate for this lower injected (...) in a 128×128 matrix in word mode) during the first 10 min after injection is recom- mended for detection of SLNs in head and neck melanoma. Although dynamic images are time consuming, dynamic se- riesshould beacquired wheneverpossible because thisfacil- itates image interpretation [83]. In melanoma of the hand/forearm or foot/leg, dynamic imaging should start over theinjectionsiteandfollowthelymphaticdrainagetotheknee or elbow and axilla or groin to reveal ectopic basins and in- transitlymph nodes

2015 Society of Nuclear Medicine and Molecular Imaging

195. 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

196. Acute Pain Management: Scientific Evidence

factors for the development of postoperative acute persistent pain. Trends Anaesth Critical Care 4: 67–70. Shipton EA (2014b) The transition of acute postoperative pain to chronic pain: Part 2 - Limiting the transition. Trends Anaesth Critical Care 4: 71–75. Vidaeff AC, Saade GR, Belfort MA (in press) Interpreting a randomized trial report: evidence-based practice for the clinician. J Matern Fetal Neonatal Med. Walsh M, Woodhouse LJ, Thomas SG, Finch E (2011) Strategies aimed at preventing chronic (...) influences on sensitivity to pain 29 1.7.3 Drug metabolism 31 References 33 2. ASSESSMENT AND MEASUREMENT OF PAIN AND PAIN TREATMENT 43 2.1 Assessment 43 2.2 Measurement 45 2.2.1 Unidimensional measures of pain 45 2.2.2 Functional impact of acute pain 46 2.2.3 Multidimensional measures of pain 47 2.2.4 Patients with special needs 48 2.3 Outcome measures in acute pain management 49 2.3.1 Outcome measures 49 References 51xiv Acute Pain Management: Scientific Evidence 3. PROVISION OF SAFE AND EFFECTIVE

2015 Clinical Practice Guidelines Portal

197. Diagnosis and Management of Aplastic Anaemia

Frequent macrocytosis and anisopoikilocytosis. Neutrophils may show toxic granulation. Platelets are mainly small in size. Exclude presence of dysplastic neutrophils, abnormal platelets, blasts and other abnormal cells, such as ‘hairy’ cells 4. HbF% HbF; measure pre‐transfusion in children – important prognostic factor in children. Note that the level is often elevated in constitutional syndromes 5. Peripheral blood chromosomal breakage analysis: diepoxybutane test (DEB Test) For possible FA if patient (...) marrow (ii) associated with myelofibrosis or rarely (iii) with a hypocellular marrow 12. Chest X‐ray and other radiology Useful at presentation to exclude infection and for comparison with subsequent films. X‐rays of the hands, forearms and feet may be indicated if an IBMFS is suspected. High resolution CT scan of the chest is indicated for suspected DC or constitutional RUNX1 bone marrow failure syndrome 13. Abdominal ultrasound scan and echocardiogram An enlarged spleen and/or lymph nodes raise

2015 British Committee for Standards in Haematology

198. Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada

S124 Management of Stroke in Diabetes S126 Treatment of Diabetes in People with Heart Failure S129 Chronic Kidney Disease in Diabetes S137 Retinopathy S142 Neuropathy S145 Foot Care S150 Erectile Dysfunction Diabetes in Children S153 Type 1 Diabetes in Children and Adolescents S163 Type 2 Diabetes in Children and Adolescents Diabetes in Special Populations S168 Diabetes and Pregnancy S184 Diabetes in the Elderly S191 Type 2 Diabetes in Aboriginal Peoples Appendices S197 Appendix 1: Etiologic Classi (...) : Rapid Screening for Diabetic Neuropathy S211 Appendix 9: Diabetes and Foot Care: A Patient’s Checklist S212 Appendix 10: Diabetic Foot Ulcers: Essentials of Management S212 Appendix 11: A1C Conversion Chart CONTENTS (continued): April 2013 - Volume 37 - Supplement 1Can J Diabetes 37 (2013) A3–A13Acknowledgment / Can J Diabetes 37 (2013) A3–A13Acknowledgment / Can J Diabetes 37 (2013) A3–A13Acknowledgment / Can J Diabetes 37 (2013) A3–A13Acknowledgment / Can J Diabetes 37 (2013) A3–A13Acknowledgment

2013 CPG Infobase

199. Stivarga (regorafenib hydrate)

packaging 36 months Accelerated Pilot scale, 3 lots 40°C 75%RH PTP packaging 6 months In accelerated testing, non-conformance to the specification was found in * of 3 lots at 6 months (while the acceptance criteria for the purity [related substance (Related Substance A)] is ?****%, the actual value measured was ****%). Thus, a test under the intermediate conditions was conducted, and non-conformance to the specification (the actual value measured for the purity 7 [related substance (Related Substance (...) inhibitory effect of regorafenib was evaluated in athymic mice ("nude mice") by subcutaneous implantation of human colorectal cancer cell lines, Colo-205, HT-29, and HCT-15. After the implanted tumor weight reached 75 to 144 mg (5-7 days after implantation), regorafenib was orally administered once daily (QD) at the doses of 3, 10, 29, and 96 mg/kg for 9 days, and the tumor weight was measured (the figure below). In nude mice with Colo-205 and HT-29 cell lines, 10 and 29 mg/kg of regorafenib inhibited

2013 Pharmaceuticals and Medical Devices Agency, Japan

200. Comparing preoperative dating and postoperative dating for second trimester surgical abortions. Full Text available with Trip Pro

measurements. We assigned preoperative GA by ultrasonography for unknown last menstrual period (LMP) or when discrepancy between sonographic and LMP dating exceeded 7 days (<15-6/7 weeks), 10 days (16 to 21-6/7 weeks) or 14 days (22 to 23-6/7 weeks). We determined postoperative GA using fetal foot length pathology standards published by Streeter in 1920 and Drey et al. in 2005. We performed regression analysis to estimate the relationship between pre- and postoperative estimates of GA and to assess (...) demographic effects on these estimates, and χ2 tests to assess whether fetal foot lengths were concordant with, larger than or smaller than the expected range for the preoperative GA.The 469 patients analyzed had a median preoperative GA of 19-4/7 weeks (range 14-0/7 to 23-6/7 weeks). Preoperative dating highly correlated with postoperative dating using both pathology standards (r2=0.95, p<.001), without any clinically relevant effect by body mass index (Streeter and Drey, p=.79), parity (Streeter p=.89

2019 Contraception

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