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Fetal Heart Tracing

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241. Evotaz - atazanavir / cobicistat

interval, and prolongation of QRS complex) were only observed in an initial 2-week oral toxicity study and not in subsequent 2-week and 9-month oral toxicity studies performed in dogs. Cobicistat In the isolated heart of the rabbit, shortening of the monophasic action potential duration (MAPD) was also observed at = 1 µM. In addition, COBI was associated with a significant increase in coronary perfusion pressure (at =1.5 µM), decrease in ventricular function (at =1 µM; possibly secondary to interaction (...) . In addition, COBI was associated with a significant increase in coronary perfusion pressure (at =1.5 µM), decrease in ventricular function (at =1 µM; possibly secondary to interaction with cardiac calcium channels and/or the observed increase in perfusion pressure), decrease in the QT interval and increase in the PR and RR interval at =3 µM. However, in vivo, no significant effect on QT interval was observed in the dog, following single oral doses of up to 45 mg/kg. Increases in PR interval were noted

2015 European Medicines Agency - EPARs

242. Odomzo - sonidegib

exposure, there is a 9-fold multiple exposure for hERG inhibition of 20% at a dose of 200 mg QD. The IC50 could not be assessed due to the solubility problems encountered. In vivo studies further evaluated the effect on the cardiac activity performed by telemetry recording of electrocardiogram (ECG) in two beagle dogs [Study report 0670734 and 0770734]. RR interval was prolonged and heart rate was reduced; by contrast other parameters and morphology and rythm of the ECG were not modified (...) (Ptc) in combination with either homozygous deletion of p53 or heterozygous deletion of hypermethylated in cancer (Hic). Ex vivo cell proliferation was inhibited with an IC 50 ranging from 6 to 9 nM (RD-2007-50807). Sonidegib also blocked Gli-1 expression in a human cell line from fetal mesenchymal origin with an IC50 of 12.7 nM (RD-2007-50858). The effect of sonidegib (batch NVP-SONIDEGIB-NX3) was also assessed in ex vivo cultures of skin punch biopsies taken from 17.5 day Ptc+/- LacZ mouse

2015 European Medicines Agency - EPARs

243. Kengrexal - cangrelor

coronary artery bypass graft CAD coronary artery disease CEC Clinical Events Committee CFR cyclic flow reduction CFU Colony Forming Units CI confidence interval Cmax maximum plasma concentration CMR Carcinogenic Mutagenic Reprotoxic Assessment report EMA/137542/2015 Page 4/113 CNS central nervous system CoA Certificate of Analysis CrCl creatinine clearance CSR clinical study report Css concentration at steady state cTn Cardiac Troponin CYP cytochrome P450 d Day D2 dopaminergic DAPT dual antiplatelet (...) therapy DES drug-eluting stent DRF dose range finding ECG electrocardiographic / electrocardiogram(s) EFD embryo fetal development F female FCA Freund’s complete adjuvant FFP fresh frozen plasma g gram GCP Good Clinical Practice GGT gamma glutamyltransferase GLDH glutamate dehydrogenase GLP Good Laboratory Practice GP glycoprotein GTN glyceryl trinitrate GUSTO Global Use of Strategies to Open Occluded Coronary Arteries h hour(s) H2 Histaminergic HDPE High Density Polyethylene HED human equivalent dose

2015 European Medicines Agency - EPARs

244. Trifluridine/tipiracil hydrochloride (TAS102) (Lonsurf)

rather than blood cells in rat, monkey, and human blood. Following single oral administration of ([ 14 C]FTD)FTD:TPI or ([ 14 C]TPI)FTD:TPI to lactating rats, radioactivity was excreted into milk. Thus, women should be advised to avoid breastfeeding during treatment with FTD:TPI. TPI was not substantially metabolized in vitro in human hepatocytes, although the minor metabolite 6-hydroxymethyluracil (6-HMU) was detected in human plasma and urine at trace levels. 6-HMU was also detected in rat plasma (...) , urine, and feces following single oral administration of [ 14 C-TPI]FTD:TPI or 14 C-TPI, providing nonclinical exposure for this metabolite. In human hepatocytes, FTD was metabolized in vitro using human hepatocytes to FTY, uracil-5-carboxylic acid (5-CU), and 5-carboxy-2’-deoxyuridine (5- CdUrd), with FTY being the major metabolite. In keeping with this, trifluridine was metabolized to FTY in human plasma along with 5-CU and 5-CdUrd at low or trace levels. Following a single oral administration

2015 FDA - Drug Approval Package

245. Zykadia - ceritinib

-related pneumonitis Permanently discontinue Zykadia. QT corrected for heart rate (QTc) >500 msec on at least 2 separate electrocardiograms (ECGs) Withhold Zykadia until recovery to baseline or to a QTc =480 msec, check and if necessary correct electrolytes, then reinitiate with dose reduced by one decrement. QTc >500 msec or >60 msec change from baseline and torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia Permanently discontinue Zykadia. Bradycardia (...) a (symptomatic, may be severe and medically significant, medical intervention indicated) Withhold Zykadia until recovery to asymptomatic (grade =1) bradycardia or to a heart rate of 60 beats per minute (bpm) or above. Evaluate concomitant medicinal products known to cause bradycardia, as well as anti-hypertensive medicinal products. If a contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, reinitiate Zykadia at the previous dose upon recovery to asymptomatic

2015 European Medicines Agency - EPARs

246. New-onset lone maternal atrial fibrillation: A case report. Full Text available with Trip Pro

. The obstetric examination was normal.High-sensitive cardiac troponin T (hs-cTnT) was elevated. The 12 lead electrocardiogram (ECG) confirmed AF. The obstetric ultrasound, electronic fetal heart rate (EFHR) trace, and maternal echocardiography were normal.The patient was admitted under joint cardiology and obstetric care and monitored with continuous telemetry. She was commenced on a therapeutic dose of low-molecular weight heparin (LMWH) and intravenous fluid. She received a single 200 Joule synchronized (...) New-onset lone maternal atrial fibrillation: A case report. Atrial fibrillation (AF) is encountered rarely in pregnancy. Management of maternal AF is challenging as it poses a threat to both maternal and fetal well-being.We report a case of a 35 weeks pregnant woman who presented in emergency with sudden-onset palpitations and mild shortness of breath with no personal/family history of cardiac diseases.Patient's pulse was irregularly irregular with an average rate of 179 beats per minute

2020 Medicine

247. Transmission of SARS‐CoV‐2 through breast milk and breastfeeding: a living systematic review Full Text available with Trip Pro

breastfeeding practices or to feeding young children with breast milk from a COVID‐19–positive woman. For the latter, the evidence gathered also includes another 79 breast milk samples, belonging to different women with confirmed COVID‐19, which had no traces of SARS‐CoV‐2 RNA, and this may suggest a low risk of transmission by ingesting breast milk. Interestingly, there were several confirmed COVID‐19 infants by RT‐PCR tests who received SARS‐CoV‐2 negative breast milk; these included two newborns

2020 Annals of the New York Academy of Sciences

248. Successful treatment of neonatal atrial flutter by synchronized cardioversion: case report and literature review. Full Text available with Trip Pro

Successful treatment of neonatal atrial flutter by synchronized cardioversion: case report and literature review. Atrial flutter (AFL) is a supraventricular tachyarrhythmia. In the ECG tracing, it is marked by a fast, irregular atrial activity of 280-500 beats per minute. AFL is known to be a rare and also life-threatening rhythm disorder both at the fetus and neonatal period. AFL may result in circulatory failure, and in a more severe form, it may lead to a non-immune fetal hydrops. However (...) , with early prenatal diagnosis and proper treatment, the majority of AFL cases show a good prognosis.We report a case of a neonate who was born at 34 weeks of gestational age by C-section because of risk for birth asphyxia, based on abnormal CTG tracing, which had no characteristic rhythms for fetal decelerations. A third day his heart rate was 220/bpm. ECG has shown supraventricular tachycardia with narrow QRS. The administration of adenosine resulted in the obvious appearance of "sawtooth wave" typical

2020 BMC Pediatrics

249. Inpatient versus outpatient induction of labour: a systematic review and meta-analysis. Full Text available with Trip Pro

of induction.Of the 588 records identified, 12 publications, representing nine independent randomized controlled trials conducted in Australia, Europe and North America, were included. These reported on 2615 cases of labour induction (1320 outpatients versus 1295 inpatients). Overall, apart from a higher number of suspicious fetal heart rate tracings [RR = 1.43 (1.10, 1.86)] and a shorter mean length of hospital stay [MD = 282.48 min (160.23, 404.73) shorter] in the outpatient group, there were no differences (...) wherein we searched MEDLINE, EMBASE, Biosis Previews®, and International Pharmaceutical Abstracts from inception to January 2020 to identify randomized controlled trials that reported on maternal, fetal and resource-related outcomes following outpatient versus inpatient labour induction. Pooled incidences and mean differences were calculated using random-effects meta-analysis. Risk-of-bias was assessed using the Cochrane Risk of Bias tool. Subgroup analysis was conducted based on the method

2020 BMC Pregnancy and Childbirth

250. Implementation of the Helping Babies Breathe Training Program: A Systematic Review Full Text available with Trip Pro

improvement in early perinatal mortality occurred after HBB training with other supportive neonatal-care interventions that included recruiting new nurses after turnover, introduction of frequent and brief on-site training, initiation of new studies comparing fetal heart monitors and newborn resuscitation monitors, new referral hospital status, and initiatives to engage local HBB trainers. At a tertiary hospital in Nepal, odds of intrapartum stillbirth and first-day mortality were reduced by half after (...) Republic . Mduma E , Kvaløy JT , Soreide E , et al . Frequent refresher training on newborn resuscitation and potential impact on perinatal outcome over time in a rural Tanzanian hospital: an observational study . Mduma ER , Ersdal H , Kvaloy JT , et al . Using statistical process control methods to trace small changes in perinatal mortality after a training program in a low-resource setting . Mersha A , Shibiru S , Gultie T , Degefa N , Bante A . Training and well-equipped facility increases the odds

2020 Pediatrics

251. The Facial Action Coding System for Characterization of Human Affective Response to Consumer Product-Based Stimuli: A Systematic Review Full Text available with Trip Pro

, which allows for diverse application in a variety of fields. Following the work of ; , identified and published a system of action units (AU) or fundamental actions of individual or group muscles. AUs are identified by a number, shorthand name, and include the anatomical basis for each action ( ) and are rated on a 5-point intensity scale (A = trace, B = slight, C = marked or pronounced, D = severe or extreme, E = maximum). later published a significant update to FACS. Although FACS itself includes (...) affect. A more detailed description of the validation measures used in each study can be used in each study can be found in the “Notes” column of . For the explicit externally-reported method, five type of measures were found: manual FACS coding, gross body movements, vocal quality cues, and subjective human judgment of emotion. Also, seven measure categories for the implicit externally-reported method were listed: skin conductance/electro dermal activity, heart rate (HR), electrocardiogram (ECG

2020 Frontiers in psychology

252. Impact of airborne particulate matter on skin: a systematic review from epidemiology to in vitro studies Full Text available with Trip Pro

and cardiovascular system have been extensively studied, and include a strong correlation between different levels of air pollution and mortality, exacerbation of asthma, chronic bronchitis, respiratory tract infections, ischemic heart disease and stroke [ ]. Although most of the attention of airborne PM has focused on the impact on human respiratory and cardiovascular systems [ , ], many other primary and secondary organs (e.g., skin, gut, liver, kidney) are affected upon repetitive exposure to PM [ ]. Indeed (...) dysfunction and AE [ ]. A positive correlation was found between prenatal PM exposure during the first trimester and the skin barrier dysfunction and AE in the offspring: early-onset AE and higher AE severity at age three. It is suggested that PM-induced oxidative stress could induce epigenetic changes in fundamental DNA repair genes in the placenta, which could affect fetal immune development. Pulmonary and intranasal exposure to PM 10 , PM 2.5 , and PM 0.1 have been extensively studied for their ability

2020 Particle and fibre toxicology

253. Right-sided brain lesions predominate among patients with lesional mania: evidence from a systematic review and pooled lesion analysis Full Text available with Trip Pro

-Of-Science, using terms that reflect diagnoses and structures of interest, as well as lesional mechanisms. Two researchers reviewed the articles separately according to PRISMA Guidelines, selecting reports of adult-onset hypomania, mania or mixed state following a focal brain lesion, for pooled-analyses of individual patient data. Eligible lesion images were manually traced onto the corresponding MNI space slices, and lesion topography analyzed using standard brain atlases. Using this approach, data from (...) transcribed onto the corresponding slices of the MNI_ICBM152NLin2009 template ( ), using MITK software v2014.10.00 ( ). We only traced tissue damage that was clearly visible in the available images and did not extrapolate to juxtaposed brain slices. Two of the authors, including a neuroradiologist, performed this task jointly, and a third author, who is a neurosurgeon, independently reviewed lesion traces. When tracing, each case report matched a single individual, except for 5 case series

2020 Translational psychiatry

254. N95 Filtering Facepiece Respirator Use during Pregnancy: A Systematic Review Full Text available with Trip Pro

search for primary literature using Medline, Embase, Scopus, Web of Science, and ClinicalTrials.gov was conducted from inception until April 2020 to find articles reporting outcomes of pregnant women using filtering facepiece respirator (FFR). Studies were selected if they included the use of FFR in pregnant women and reported an outcome of interest including physiologic changes (heart rate, respiratory rate, pulse oximetry, and fetal heart rate tracing) or subjective measures (thermal or exertional (...) during pregnancy. Risk of bias was judged to be low. Studies were consistent in showing no significant increase in maternal heart rate, respiratory rate, oxygen saturation, and fetal heart rate between pregnant and nonpregnant women using N95 FFRs for short durations. Repeat fit testing was not supported for women gaining the recommended amount of weight during pregnancy. No evidence was found to reach conclusions about prolonged N95 FFR use in pregnancy. Conclusion Limited duration N95 FFR use

2020 American journal of perinatology

256. Epidemiology of COVID-19 in Pregnancy: Risk Factors and Associations with Adverse Maternal and Neonatal Outcomes. Full Text available with Trip Pro

, defined as preeclampsia, venous thromboembolism, antepartum admission, maternal intensive care unit admission, need for mechanical ventilation, supplemental oxygen, or maternal death; and (ii) a composite of adverse neonatal outcome, defined as respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, five-minute Apgar score <5, persistent category 2 fetal heart rate tracing despite intrauterine resuscitation, or neonatal death. In order to quantify the associations

2020 American Journal of Obstetrics and Gynecology

257. Effect of embryo stage at transfer on placental histopathology features in singleton live births resulting from fresh embryo transfers. (Abstract)

), delayed villous maturation (OR 8.5, 95% CI 1.2-69.3), chorangiosis (OR 2.0, 95% CI 1.2-3.8), parenchymal calcifications (OR 10.6, 95% CI 1.4-80.2), and intrapartum nonreassuring fetal heart rate tracing (OR 2.4, 95% CI 1.3-4.5). Compared with cleavage-stage ETs, live births resulting from the blastocysts were associated with a lower incidence of velamentous cord insertion (OR 0.5, 95% CI 0.3-0.9), retroplacental hematoma (OR 0.3, 95% CI 0.1-0.8), subchorionic thrombi (OR 0.3, 95% CI 0.1-0.8 (...) ), and avascular villi (OR 0.2, 95% CI 0.03-0.7).Live births resulting from fresh cleavage-stage and blastocyst ETs have different placental histopathology features, with a higher rate of intrapartum nonreassuring fetal heart rate tracing in the blastocyst group.Copyright © 2020 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

2020 Fertility and Sterility

258. Vyndaqel (tafamidis meglumine)

long-term extension study (5.3.5.2.1, Study Fx-006). In humans, 75% of the circulating thyroxine is bound to thyroid binding globulin and 10% is bound to albumin (Suzuki S. Shinshu Medical Journal. 2011;59:403-410) and the effects of the inhibition of TTR function are considered limited. Concerning the effects associated with changes in the biokinetics of vitamin A, although ophthalmic findings (e.g., small eyes) were observed in an embryo-fetal development oral study in rabbits (4.2.3.5.2.4 (...) in the dams and fetuses at 1 hour post-dose on gestation days 15 and 19, indicating that tafamidis- derived materials cross the placental barrier. In the fetuses, the highest radioactivity level was detected in the liver, which was higher than the radioactivity level in the fetal blood. The fetal radioactivity level was higher on gestation day 19 compared to gestation day 15 (4.2.2.3.6). 18) Tafamidis Meglumine was initiated at 300 mg/kg/day, but the dose was reduced to 200 mg/kg/day due to toxicity

2013 Pharmaceuticals and Medical Devices Agency, Japan

259. Genetics of Skin Cancer (PDQ®): Health Professional Version

Syndrome (BCNS) Colloquium Group Recommendations for Surveillance in BCNS For Adults: • MRI of brain (baseline) • Skin examination every 4 months • Panorex of jaw every year • Neurological evaluation (if previous medulloblastoma) • Pelvic ultrasound (baseline) • Gynecologic examination every year • Nutritional assessment • Fetal assessment for hydrocephalus, macrocephaly, and cardiac fibromas in pregnancy • Minimization of diagnostic radiation exposure when feasible For Children: • MRI of brain (...) and is occasionally associated with mast cell leukemia; cutaneous T-cell lymphoma is often confined to the skin throughout its course. Overall, 10% of leukemias and lymphomas have prominent expression in the skin.[ ] Epidermal appendages are also found in the dermal compartment. These are derivatives of the epidermal keratinocytes, such as hair follicles, sweat glands, and the sebaceous glands associated with the hair follicles. These structures are generally formed in the first and second trimesters of fetal

2018 PDQ - NCI's Comprehensive Cancer Database

260. Genetics of Breast and Gynecologic Cancers (PDQ®): Health Professional Version

, in which more than 16,000 women were randomly assigned to receive combined HRT or placebo, was halted early because health risks exceeded benefits.[ , ] Adverse outcomes prompting closure included significant increase in both total (245 vs. 185 cases) and invasive (199 vs. 150 cases) breast cancers (RR, 1.24; 95% CI, 1.02–1.5, P < . 001) and increased risks of coronary heart disease, stroke, and pulmonary embolism. Similar findings were seen in the estrogen-progestin arm of the prospective

2018 PDQ - NCI's Comprehensive Cancer Database

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