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Fetal Foot Measurement

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161. Clinical Practice Guidelines on Prevention, Diagnosis and Management of Tuberculosis

isoniazid and rifampicin. Managing patients with MDR-TB is challenging and should be undertaken by individuals with expertise in this field. Risk factors for MDR-TB 60 1. Previous self-administered therapy for active tuberculosis 2. Contact with individuals known to have MDR-TB 3. Non-compliance with previous anti-tuberculosis treatment 4. Individuals originating from areas where MDR-TB is common Managing patients suspected of MDR-TB will involve good infection control measures, rapid and accurate (...) the pleural space (except in children, for whom even minor blunting must be considered a finding that can suggest active tuberculosis). 35 • Hilar or mediastinal lymphadenopathy Enlargement of lymph nodes in one or both hila and/or within the mediastinum, with or without associated atelectasis (volume loss) or consolidation. • Other Any other finding suggestive of active tuberculosis, such as miliary tuberculosis. Miliary tuberculosis demonstrates nodules that are uniform in size, measuring 1 to 2 mm

2016 Ministry of Health, Singapore

162. Guidelines for the use of local anesthesia in office-based dermatologic surgery Full Text available with Trip Pro

. Are the same topical anesthetics used in adults also recommended/safe in children? Local infiltration anesthesia A. Is local infiltration anesthesia safer/more effective than other types of anesthesia to reduce pain? B. Does the method to calculate the maximum anesthetic doses change when infiltrated anesthetics are delivered over an extended time period compared to a short time period? C. Do the local anesthetic serum levels change based on the method of delivery? D. Is there a measure of care better (...) of other commonly used techniques minimize pain? Nerve block/regional anesthesia A. Does nerve block/regional anesthesia represent a clinical benefit over local infiltrative anesthesia for the head and neck, hands, feet, and genitals? B. Does the injection of local anesthesia in the optimal entry points for the head and neck, hands, feet, and genitals pose an increased risk of nerve damage from needle trauma and of toxicity? Tumescent anesthesia A. Is the use of lidocaine in tumescent anesthesia safer

2016 American Academy of Dermatology

163. Hypertensive disorders of pregnancy

and Section 4.3 Severe hypertension Progression • Clinical progression is unpredictable, therefore close clinical surveillance is required for all women with preeclampsia 1 • Increasing severity may be indicated by difficulty in controlling BP and deteriorating clinical condition including 26 : o HELLP syndrome o Impending eclampsia o Worsening thrombocytopenia o Worsening fetal growth and wellbeing o The definitive treatment is always birth of the fetus and placenta VTE • Preeclampsia is an independent (...) restriction) that includes USS, CTG, and maternal wellbeing • Assessment of growth trends by serial USS is recommended 1 • Symphysio-fundal height measurement is a poor screening tool for detection of fetal growth restriction (FGR) 1 Queensland Clinical Guideline: Hypertensive disorders of pregnancy Refer to online version, destroy printed copies after use Page 19 of 32 7.3 Type and frequency of ongoing surveillance Common protocols are based on expert opinion and have not been tested in prospective

2016 Queensland Health

164. ABCD position statement on standards of care for management of adults with type 1 diabetes - this has been superseded by the 2017 version - see above

? Creatinine/(e.gFR) ? Urinary albumin/creatinine ratio ? Foot examination ? Smoking ? Check that retinal screening/ophthalmology review is up to date ? Measure TSH and consider a coeliac screen The following should be discussed at least annually ? Need for medication for BP, lipids, albuminuria etc ? Erectile difficulties/plans for pre.gnancy ? Review of care plan and referral for specialist review if required e.g nephrology, podiatry, cardiology, ophthalmology ? Immunisation requirements 3.3 (...) of care Inpatient care The National Diabetes Inpatient Audit (NaDIA), a snapshot audit of diabetes inpatient care in England and Wales on single day in September in 2013, showed that 15.8% of hospital inpatients had diabetes, of whom 6.6% had type 1 diabetes. The audit monitors staffing levels in the hospital diabetes team and measures of patient harm including medication errors, inappropriate use of intravenous insulin infusions, episodes of hypoglycaemia and DKA arising in hospital and new foot

2016 Association of British Clinical Diabetologists

165. American Association of Clinical Endocrinologists and American College of Endocrinology Clinical Practice Guidelines for Comprehensive Medical Care of Patients with Obesity

Summary 4-30 Evidence Base 30 Post-hoc Question: By inductive evaluation of all evidence-based recommendations, what are the core recommendations for medical care of patients with obesity? 30 Q1. Do the 3 phases of chronic disease prevention and treatment (i.e., primary, secondary, and tertiary) apply to the disease of obesity? 31 Q2. How should the degree of adiposity be measured in the clinical setting? 33 Q2.1. What is the best way to optimally screen or aggressively case-find for overweight (...) incontinence 52 Q3.14. Gastroesophageal reflux disease (GERD) 52 Q3.15. Depression 56 Q4. Does BMI or other measures of adiposity convey full information regarding the impact of excess body weight on the patient’s health? 56 Q5. Do patients with excess adiposity and related complications benefit more from weight loss than patients without complications, and, if so, how much weight loss would be required? 58 Q5.1. Is weight loss effective to treat diabetes risk (i.e., prediabetes, metabolic syndrome

2016 American Association of Clinical Endocrinologists

166. NASPGHAN Clinical Report: Surveillance, Diagnosis, and Prevention of Infectious Diseases in Pediatric Patients with Inflammatory Bowel Disease Receiving Tumor Necrosis Factor - alpha Inhibitors

-TNFa therapy. If a patient has already been diag- nosed and treated for LTBI, then annual screening should include careful assessment of possible exposures, symptoms, and a chest X-ray, as clinically indicated. Prevention/Isolation/Control Measures. Airborne isolation plus standard precautions are recommended for active M. tuberculosis disease, including those with cavitary pulmonary tuberculosis or extensive pulmonary disease, positive sputum AFB smears, and children undergoing procedures (...) and to determine whether the patient is infected with HBV: hepatitis B surface antigen (HBsAg), anti-HBs, and hepatitis B core antibody (anti-HBc). If anti-HBc is the only antibody that is positive, a HBV DNA load should be measured. Patients may be found to have only anti-HBc for the following reasons: (1) False-positive reactivity attributed to nonspeci?c reactions withcompetitiveanti-HBcenzymeimmunoassays(EIAs)and cross-reactivitywithinterferingserumsubstancesorwithIgA- or IgM-related molecules produced

2016 North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition

167. Clinical Practice Guidelines for Sustained Neuromuscular Blockade in the Adult Critically Ill Patient

. 4) We make no recommendation on the use of neuromuscular blockade to improve the accuracy of intravascular-volume assessment in mechanically ventilated patients. 5) We make no recommendation concerning the use of electroencephalogram-derived parameters as a measure of sedation during continuous administration of neuromuscular-blocking agents . 6) We make no recommendation regarding nutritional requirements specific to patients receiving infusions of neuromuscular-blocking agents . 7) We make (...) no recommendation concerning the use of one measure of consistent weight over another when calculating neuromuscular-blocking agent doses in obese patients. 8) We make no recommendation on the use of neuromuscular-blocking agents in pregnant patients. 9) We make no recommendation on which muscle group should be monitored in patients with myasthenia gravis receiving neuromuscular-blocking agents . Finally, in situations in which evidence was lacking or insufficient but expert consensus was unanimous, the Task

2016 Society of Critical Care Medicine

168. CRACKCast E049 – General Principles to Orthopedic Injuries

, meniscus, disks, Ultrasound Can very accurately dx disruptions of bony cortices: Long bones Orbital floor Ankle/foot Rib fractures 1) List 10 complications of fractures Complication Info Key points Hemorrhage Blood loss, shock, and death! Pelvic, femur, tib-fib Vascular injury See chapter 48! Knee – popliteal artery Femoral neck – AVN of femoral head 10-20% of injuries may have normal palpable pulses These injuries can lead to late complications Nerve injury Neuropraxia – contusion to a nerve leading (...) pressure Venous obstruction (DVT) Venous ligation 2) Decreased compartment volume Closure of fascial defects Excessive traction of #’d limbs 3) External pressure Casts, air splints, dressings Lying on a limb 4) Misc: Muscle hypertrophy Popliteal cysts Leaky cannulae Interstitial infusions / pressure infusions Sites: Tibia Forearm Thigh Hand/foot Interesting causes (based on etiology): 1. Content increase anticoagulant/coagulopathic bleed Post-op arterial bypass graft Exercise induced Seizures Eclampsia

2016 CandiEM

169. Neonatal resuscitation

antibody known to cause haemolytic disease in the fetus or baby especially if fetal anaemia or hydrops fetalis present) · Polyhydramnios and oligohydramnios · Reduced fetal movement before onset of labour · Congenital abnormalities which may affect breathing, cardiovascular function or other aspects of perinatal transition · Intrauterine infection · Hydrops fetalis Intrapartum 1 · Abnormal fetal patterns on cardiotocograph (CTG) o Refer to Queensland Clinical Guideline: Intrapartum fetal surveillance 3 (...) Positive pressure ventilation PPROM Preterm prelabour rupture of membranes RhD Rh Blood Type D (Rh positive) SpO2 Peripheral capillary oxygen saturation UVC Umbilical venous catheter Definitions Acrocyanosis Blue hands and feet due to inadequate circulation of blood and oxygen to the extremities normally found in the first few hours after birth. Cold stress Temperature between 36.0 °C and 36.4°C Corrected age Gestation plus postnatal age in weeks Hyperthermia Temperature greater than 37.5 °C Mild

2016 Clinical Practice Guidelines Portal

170. Neonatal resuscitation

antibody known to cause haemolytic disease in the fetus or baby especially if fetal anaemia or hydrops fetalis present) · Polyhydramnios and oligohydramnios · Reduced fetal movement before onset of labour · Congenital abnormalities which may affect breathing, cardiovascular function or other aspects of perinatal transition · Intrauterine infection · Hydrops fetalis Intrapartum 1 · Abnormal fetal patterns on cardiotocograph (CTG) o Refer to Queensland Clinical Guideline: Intrapartum fetal surveillance 3 (...) Positive pressure ventilation PPROM Preterm prelabour rupture of membranes RhD Rh Blood Type D (Rh positive) SpO2 Peripheral capillary oxygen saturation UVC Umbilical venous catheter Definitions Acrocyanosis Blue hands and feet due to inadequate circulation of blood and oxygen to the extremities normally found in the first few hours after birth. Cold stress Temperature between 36.0 °C and 36.4°C Corrected age Gestation plus postnatal age in weeks Hyperthermia Temperature greater than 37.5 °C Mild

2016 Clinical Practice Guidelines Portal

171. Manual exchange blood transfusion protocol

and consider keeping infant Nil By Mouth for four hours post exchange ( ). When using an umbilical arterial or venous line inspect toes, feet and buttocks for signs of circulatory compromise. Sickle cell disease Indications for emergency exchange transfusion in sickle cell disease Acute cerebrovascular accident (stroke). Acute sickle chest syndrome resulting in respiratory failure (clinically defined as an increasing oxygen requirement in a tiring child). Non-resolving mesenteric ('girdle') syndrome (...) - silent, distended abdomen. Multi-organ failure. Fulminant priapism lasting >4 hours despite other measures. (CVA and acute chest syndrome are the commonest reasons for PICU admission.) Elective indications in sickle cell disease Exchange transfusion may be undertaken electively in preparation for a planned surgical procedure to reduce the risks of surgery/anaesthesia or to improve its outcome. Elective transfusions are, as a rule, performed by the local hospital prior to admission to GOSH. Partial

2014 Publication 1593

172. Manual exchange blood transfusion protocol

and consider keeping infant Nil By Mouth for four hours post exchange ( ). When using an umbilical arterial or venous line inspect toes, feet and buttocks for signs of circulatory compromise. Sickle cell disease Indications for emergency exchange transfusion in sickle cell disease Acute cerebrovascular accident (stroke). Acute sickle chest syndrome resulting in respiratory failure (clinically defined as an increasing oxygen requirement in a tiring child). Non-resolving mesenteric ('girdle') syndrome (...) - silent, distended abdomen. Multi-organ failure. Fulminant priapism lasting >4 hours despite other measures. (CVA and acute chest syndrome are the commonest reasons for PICU admission.) Elective indications in sickle cell disease Exchange transfusion may be undertaken electively in preparation for a planned surgical procedure to reduce the risks of surgery/anaesthesia or to improve its outcome. Elective transfusions are, as a rule, performed by the local hospital prior to admission to GOSH. Partial

2014 Publication 1593

173. Tecfidera - dimethyl fumarate

Standard Deviation SF-36 Short Form 36 Heatlh Survey SGOT Serum glutamic oxaloacetic transaminase SGPT Serum Glutamic Pyruvate Transaminase SmPC Summary of Product Characteristics SOC System Organ Class SPMS Secondary Progressive Multiple Sclerosis Srxn 1 Thioredoxin reductase 1 t1/2 Half Life T25FW Time 25-Foot Walk TCA Tricarboxylic Acid TGA Thermogravimetric Analysis TID Three Times Daily Tmax Time to Peak Plasma Concentration TNFa Tumor Necrosis Factor-alpha Trxnd1 Sulfiredoxin 1 TSE Transmissible (...) ) on the agreement of a paediatric investigation plan (PIP). At the time of submission of the application, the PIP P/76/2011 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

2014 European Medicines Agency - EPARs

174. Scenesse - afamelanotide

of submission of the application, the PIP P/292/2011 was not yet completed as some measures were deferred. A waiver was granted for all subsets of the paediatric population from birth to less than 2 years of age and a deferral for the completion of the paediatric investigational plan by June 2022 for paediatric patients from 2 years to less than 18 years of age (EMEA-000737-PIP01-09). Information relating to orphan market exclusivity Similarity Pursuant to Article 8 of Regulation (EC) No. 141/2000 (...) of severity, such as cholelithiasis, mild parenchymal liver disease, and in less than 5% of the EPP-patients progressive hepatocellular disease with end-stage liver disease and acute liver failure. Liver damage is the major disease-associated risk in EPP patients, so surveillance and frequent clinical and biochemical liver follow-up is mandatory (Casanova-Gonzalez et al., 2010). Currently, the main treatment measure is photoprotection with mineral sunscreens containing zinc oxide or titanium dioxide

2014 European Medicines Agency - EPARs

175. Rixubis - nonacog gamma

on the applicants’ 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 P/0159/2012 on the agreement of a paediatric investigation plan (PIP). At the time of submission of the application, the PIP P/0159/2012 was not yet completed as some measures were deferred. Information relating to orphan market exclusivity Similarity (...) gamma and its effects on the cardiovascular and respiratory system. The highest dose tested (750 IU/kg bw) in animals with normal haemostasis was 10 times the intended maximum human prophylactic clinical dose (75 IU/kg). Assessment report EMA/702760/2014 Page 20/103 Table 2: Overview Safety Pharmacology Studies Wessler score was used to measure thrombogenicity, this is based on 7-part ordinal scale (0, 0.5, 1, 2, 3, 3.5, 4), where 0 = no thrombus formation, 4 = high thrombus formation 1 (Wessler S

2014 European Medicines Agency - EPARs

176. Vokanamet - canagliflozin / metformin

concentration AUMC Area under the first moment of the concentration versus time curve from the time of dosing up to a specific time, t, to infinite time, or to the time of the last measurable concentration BA Bioavailability BG blood glucose BID twice daily BLQ below the limit of quantitation BMD bone mineral density BrdU bromo-deoxyuridine BSA body surface area Ca Calcium CANA Canagliflozin CANVAS Study DIA3008 CFU Colony Forming Units CHD coronary heart disease CHMP Committee for Medicinal Products (...) ) cells as measured by inhibition of alpha-methylglycopyranoside (AMG) uptake with an IC 50 of 3.7 nM for rSGLT2 and 4.2 nM hSGLT2, respectively. The inhibition of SGLT1 in the same cell system was more than 150-times lower, with an IC 50 of 550 nM for rSGLT1 and 663 nM for hSGLT1, respectively. Functional activity of canagliflozin on SGLT2 and SGLT1 of other species was not determined. Off target effects on other human glucose transporters such as SGLT3, SGLT4, SGLT6, facilative glucose transporters

2014 European Medicines Agency - EPARs

177. Nerventra - laquinimod

Results SF-36 Short Form 36 Health Survey SIR Standardized incidence ratio SLE Systemic Lupus Erythematosus SmPC Summary of Product Characteristics SMQ Standardised MedDRA Queries SMR Standard Maintenance Diet SOC System Organ Class SPMS Secondary Progressive Multiple Sclerosis SWP Safety Working Party T25FW Timed -25- Foot-Walk TCDD 2,3,7,8-tetrachlorodibenzo-p-dioxin TK Toxicokinetic Tmax Time to maximum plasma concentration TSE Transmissible spongiform encephalopathy UDS Unscheduled DNA synthesis (...) of the application, the PIP P/0027/2012 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 related to the proposed indication. New active

2014 European Medicines Agency - EPARs

178. Moventig - naloxegol

Administration DAMGO [D-Ala2, N-MePhe4, Gly-ol]-enkephalin EC European Commission Assessment report EMA/CHMP/738815/2014 Page 6/120 ECG Electrocardiogram eDiary Electronic diary EDQM European Directorate for the Quality of Medicines & Healthcare EFD Embryo-fetal development EMA European Medicines Agency EU European Union FDA US Food and Drug Administration GC Gas chromatography GI Gastrointestinal GI-EAC Gastrointestinal event adjudication committee HPLC High performance liquid chromatography ICH (...) cardiovascular event MedDRA Medical Dictionary for Regulatory Activities meu Morphine equivalent units mHS Modified Himmelsbach scale MI Myocardial infarction MMRM Mixed model for Repeated Measures MTP Multiple Testing Procedure Naloxegol Also known as NKTR-118, PEG-naloxol, NKT-10018, as naloxol 6a- Assessment report EMA/CHMP/738815/2014 Page 7/120 methoxyhepta(ethylene glycol) ether, also known as a-6-mPEG7-O-naloxol. Naloxegol oxalate salt International Union of Pure and Applied Chemistry (IUPAC) name

2014 European Medicines Agency - EPARs

179. Ledipasvir/Sofosbuvir

pharmacology studies in rats and dogs; repeat-dose toxicology studies in mice, rats and dogs for up to 1, 6 and 9 months duration, respectively; up to 2-week repeat-dose toxicology studies to qualify impurities; phototoxicity studies in mice and rats; fertility and pre- and post-natal developmental (PPND) studies in rats; embryo-fetal developmental studies in rats and rabbits; and genetic toxicology studies (Ames, in vitro chromosomal aberration and in vivo rat micronucleus assays). In addition, numerous (...) -treatment), or last available measurement with no subsequent follow up value – Non-response: HCV RNA persistently =LLOQ through 8 weeks of treatment ? Relapse: – HCV RNA =LLOQ during the post-treatment period having achieved HCV RNA = 800,000 IU/mL 169 (79.0%) 173 (79.7%) 168 (77.4%) 173 (79.7%) Baseline ALT (U/L) Median 63 62 59 62 Min, Max 16, 557 16, 485 17, 360 7, 321 Baseline ALT Category > 1.5 x ULN 120 (56.1%) 119 (54.8%) 109 (50.2%) 112 (51.6%) Source: Adapted from NDA 205834 ION-1 Clinical

2014 FDA - Drug Approval Package

180. Evolocumab (Repatha)

-adjusted p 400 mg/dL, in which case, the calculated LDL-C value was replaced with the ultracentrifugation/directly measured (UC) LDL-C value from the same blood sample, if available. Reference ID: 3810576Clinical Review Eileen Craig, MD BLA 125522 Repatha (evolocumab) 17 LDL-C, or calculated LDL-C values resulted in treatment differences of -57%, -58%, and -59%, (p 2 x ULN; creatine kinase (CK) > 3 x ULN; myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass

2014 FDA - Drug Approval Package

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