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Fetal Heart Tracing

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261. Rezolsta - darunavir / cobicistat

rabbit heart, shortening of the monophasic action potential duration was also observed as well as an increase in coronary perfusion pressure and a decrease in ventricular function at concentrations = 1-1.5 µM and decrease in the QT interval and increase in the PR and RR interval at =3 µM. 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 at =15 mg/kg where the plasma levels were reported to be 3.2 (...) human angiotensin converting enzyme, caspase 3, caspase 7, cathepsin C, cathepsin D, cathepsin E, factor VIIa, factor Xa, matrix metalloproteinase-2, matrix metalloproteinase-9, metalloproteinase neutral endopeptidase, thrombin, and renin. In vitro, hERG current was not inhibited (up to 10 µM, which is similar to 10-fold the human free maximum plasma level) and the cardiac action potential (sheep isolated cardiac Purkinje fibres) remained unaffected after 10 µM darunavir. In conscious telemetered

2014 European Medicines Agency - EPARs

262. Latuda - lurasidone

/2014) Rev05.13 Page 27/147 lurasidone to cause QT/QTc prolongation should be based on the available clinical data (see Discussion on clinical safety, section 2.6.1) Dedicated cardiac toxicity studies in the dog and monkey were performed and two findings relating to an increase in heart rate in the monkey and a lack of nocturnal reduction in heart rate in a dog were identified. A further discussion of the toxicological significance of these findings has been provided by the applicant. The transient (...) increase in heart rate observed in monkeys was seen in doses exceeding 250 mg/kg/day, and no further changes in cardiac parameters were observed in these animals. On the other hand, clinical findings showed slight changes in heart rate following dosing with lurasidone at 120 mg and 600 mg, although these changes were inconsistent. The applicant’s argument that the finding in monkeys may have been related to D2/D3 receptor binding by lurasidone in the monkey brain may seem plausible. The CHMP agreed

2014 European Medicines Agency - EPARs

263. Core Competencies for Management of Labour

) • Using the appropriate methods of fetal health surveillance – IA or EFM, assess and document fetal heart rate at the recommended frequency 2. Uterine Activity • Identify uterine contraction patterns that might adversely affect oxygen delivery to the fetus • Assessment of uterine activity is performed in conjunction with IA or EFM, and is necessary in order to correctly classify the fetal heart rate patterns with EFM • Palpate by hand and/or • Assess using an external tocotransducer or an internal (...) rate is stable • Systematic Interpretation of Electronic Fetal Monitoring, assess: ¦ Quality of tracing ¦ Paper speed and graph range ¦ If mode is external or internal ¦ Uterine activity pattern - frequency, duration, and intensity and resting tone by palpation if exter- nal tocotransducer is used ¦ Baseline FH rate ¦ Baseline variability ¦ Fetal heart rate accelerations ¦ Periodic or episodic decelerations ¦ Classify the EFM tracing as normal, atypical, abnormal (see Appendix 3) ¦ Evaluate

2014 British Columbia Perinatal Health Program

264. Harvoni - sofosbuvir / ledipasvir

in partially pigmented rats highest levels of radiolabel were generally determined at 4 to 6 hours post-dose. Tissues with highest radioactivity included liver, alimentary canal, renal cortex, lymph node, spleen, thymus, bone marrow and lung. Levels in brain were low, but quantifiable up to 24 hours. There was no specific association of radioactive material with melanin. Studies in pregnant rats showed that sofosbuvir crossed the placenta. Foetal blood and brain sofosbuvir derived radioactivity was higher (...) than in dams, but foetal liver and kidney had lower levels than corresponding organs in dams. Sofosbuvir derived radioactivity was also quantifiable in milk from day 2 postpartum rats, but nursing pups did not appear to be extensively exposed to drug-derived radioactivity. Milk to plasma ratios were 0.1 at 1 hour and 0.8 at 24 hours. In vitro studies in human liver microsomes showed that sofosbuvir was an efficient substrate for Cathepsin A (Cat A) and carboxyesterase 1 (CES1). There were

2014 European Medicines Agency - EPARs

265. Vizamyl - flutemetamol (18F)

in humans after a single injection of 20 µg flutemetamol into the 3 L plasma volume of the standard man. Effects of flutemetamol on cardiovascular function in the telemetered dog (B067003, GLP) This study was conducted to determine the effects of intravenously administered flutemetamol on the cardiovascular system of conscious (telemetered) male Beagle dogs. No treatment related effects were observed on blood pressure, heart rate or ECG parameters. A single intravenous administration of flutemetamol

2014 European Medicines Agency - EPARs

266. Evolocumab (Repatha)

% Asia Pacific. Approximately 30% (n = 958) of participants were = 65 years old. Approximately 20% of participants in the integrated efficacy analysis population had a prior diagnosis of CAD and 10% had a diagnosis of cerebrovascular or peripheral arterial disease. Approximately 300 (10%) participants had a history of myocardial infarction; only 69 (2%) participants had a history of stroke at baseline. Approximately 4% (136) had a history of congestive heart failure, with 1.7% of participants having (...) -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

267. Neostigmine Methylsulfate Injection, USP

for neostigmine methylsulfate 4. An embryo-fetal developmental toxicology study using the rat model for neostigmine methylsulfate 5. An embryo-fetal developmental toxicology study using the rabbit model for neostigmine methylsulfate Reference ID: 3674251Clinical Review Arthur Simone, MD, PhD NDA 203629 (Complete Response) Neostigmine Methylsulfate Injection, USP 8 6. A peri-and post-natal developmental toxicology study in the rat model for neostigmine methylsulfate 7. An adequate extractable/leachable safety (...) secretions, and other parasympathomimetic side effects, which are reduced or prevented by the inclusion of atropine sulfate in the drug product. Atropine sulfate has an immediate effect on heart rate which reaches a peak in 2 to 16 minutes following intravenous administration and lasts 170 minutes after an average 0.02 mg/kg dose. Pyridostigmine is another anticholinesterase product. It was first approved as Mestinon (NDA 009830) in 1955, and later approved as Regonol (NDA 017398). Mestinon is used most

2014 FDA - Drug Approval Package

268. Impavido (miltefosine)

for Post-market Requirements and Commitments 10 Executive Summary 10 Leishmaniasis 10 Miltefosine 11 Summary of Efficacy 12 VL Caused by L. donovani 12 CL Due to Members of the Subgenus Viannia 18 ML Due to Members of the Subgenus Viannia 22 Summary of Safety 23 Visceral Leishmaniasis 23 Cutaneous Leishmaniasis 26 Ophthalmic Effects 28 Reproductive Effects 29 Cardiac Safety 31 Introduction and Regulatory Background 31 Leishmaniasis 31 Product Information 34 Tables of Currently Available Treatments (...) , rats and rabbits. The NOAEL for fetotoxicity was 2.15 mg/kg/day in mice, 1.3 mg/kg/day in rats, and 2.4 mg/kg/day for rabbits. All malformed fetuses showed misshapen cerebral structures, misshapen eyes, and hemo-or hydrocephalus. Cardiovascular Toxicity Miltefosine did not affect hERG channel at concentrations up to 3 µM (equivalent to1.22 ug/mL). Higher doses could not be tested because the test system was disturbed by the cytotoxic effects of the drug. There was no effect on heart rate

2014 FDA - Drug Approval Package

269. Ledipasvir/Sofosbuvir

for complete details. In addition, please refer to the SOF NDA 204671 Pharmacology/Toxicology Review for a detailed summary of SOF nonclinical data. Rodent 2-year SOF carcinogenicity studies were reviewed with this application. Notable findings are summarized in this section. SOF: The major target organs identified in the SOF nonclinical studies include the heart and gastrointestinal tract. Heart degeneration and inflammation were observed in rats following GS-9851 (a stereoisomeric mixture containing (...) approximately 50% SOF) doses of 2000 mg/kg/day for up to 5 days. At this dose, AUC exposure to the predominant circulating metabolite GS-331007 is approximately 17-fold higher than human exposure at the recommended clinical dose. No heart degeneration or inflammation was observed in mice, rats or dogs in studies up to 3 months, 6 months or 9 months at GS-331007 AUC exposures approximately 24-, 5- or 17-fold higher, respectively, than human exposure at the recommended clinical dose. No heart degeneration

2014 FDA - Drug Approval Package

270. Dapagliflozin (Farxiga)

and Endocrinology Products NDA New Drug Application DOP Division of Oncology Products NME New Molecular Entity DPP4 Dipeptidyl Peptidase-4 Inhibitor NYHA New York Heart Association DPV I Division of Pharmacovigilance I OAD Oral Antidiabetic Drug DVT Deep Vein Thrombosis OSE Office of Surveillance and Epidemiology OSI Office of Scientific Investigations OSI Office of Scientific Investigations P-Y Patient-years SGLT2 Sodium-Glucose Co-Transporter 2 PCI Percutaneous Coronary Intervention SMQ System MedDRA Query PD (...) Aminotransferase HbA1c Hemoglobin A1c ANCOVA Analysis of Covariance HER2 Human Epidermal Growth Factor Recepto ARB Angiotensin Receptor Blocker HR Hazard Ratio AST Aspartate Aminotransferase HTN Hypertension BBN Hydroxybutyl nitrosamine ICH International Conference on Harmonizatio BMD Bone Mineral Density IND Investigational New Drug BMI Body Mass Index IR Immediate-Release BP Blood Pressure IRR Incidence Risk Ratio CABG Coronary Artery Bypass Graft IRS Insulin Receptor Substrate CAD Coronary Artery Disease

2014 FDA - Drug Approval Package

271. DuoResp Spiromax - budesonide / formoterol

such as C-reactive protein and plasma fibrinogen. In clinical studies, serum IL-6 was consistently linked with an increased risk of cardiovascular disease. In a study using a mouse model of lung injury, a single pretreatment with budesonide and formoterol combined reduced IL translocation and the systemic increase of IL-6 expression and prevented the endothelial and cardiac dysfunction related to lipopolysaccharide-induced acute lung injury (Suda, 2011). A study was conducted to investigate the effect (...) budesonide. Budesonide oleate appeared to have no effect on plasma levels of budesonide (Jendbro, 2001). CHMP assessment report EMA/CHMP/175692/2014 Page 27/117 The distribution of formoterol following inhalation exposure (species not specified) was reported to be in the following order: trachea- lung- kidney- liver- plasma- heart- brain. Half- lives of the drug ranged from 2 to 4 hours (FDA, 2006). Formoterol was shown to readily cross the placenta of pregnant rats (FDA, 2006). Metabolism Budesonide

2014 European Medicines Agency - EPARs

273. BiResp Spiromax (budesonide / formoterol fumarate dihydrate)

. In clinical studies, serum IL-6 was consistently linked with an increased risk of cardiovascular disease. In a study using a mouse model of lung injury, a single pretreatment with budesonide and formoterol combined reduced IL translocation and the systemic increase of IL-6 expression and prevented the endothelial and cardiac dysfunction related to lipopolysaccharide-induced acute lung injury (Suda, 2011). CHMP assessment report EMA/CHMP/175684/2014 Page 24/106 A study was conducted to investigate (...) and persistent concentrations of active budesonide. Budesonide oleate appeared to have no effect on plasma levels of budesonide (Jendbro, 2001). The distribution of formoterol following inhalation exposure (species not specified) was reported to be in the following order: trachea- lung- kidney- liver- plasma- heart- brain. Half- lives of the drug ranged from 2 to 4 hours (FDA, 2006). Formoterol was shown to readily cross the placenta of pregnant rats (FDA, 2006). Metabolism Budesonide was rapidly metabolised

2014 European Medicines Agency - EPARs

274. Olysio - simeprevir

, placental transfer was negligible. Total radioactivity in foetal liver and foetus were below the LLOQ, indicating limited distribution of TMC435-related radioactivity to the procreative tissues. The in vitro metabolism of 14C-TMC435 was investigated in hepatocytes and liver microsomes of mouse, rat, rabbit, monkey and human. The metabolic activity reported in vitro from animals and man was low. Phase II conjugation pathways of Phase I metabolites were formed in hepatocytes. Parent TMC435 was found (...) PBO placebo PegIFN(a) pegylated interferon (alfa) PegIFN/RBV combination of PegIFN and RBV P-gp P-glycoprotein PI protease inhibitor PIP Paediatric Investigation Plan PMDA Pharmaceuticals and Medical Devices Agency (in Japan) PR PegIFN and RBV PT preferred term q.d. quaque die; once daily QTc QT interval corrected for heart rate RBV ribavirin RGT response-guided treatment SBP systolic blood pressure RVR rapid virologic response SVR sustained virologic response t max time to reach Cmax UGT1A1

2014 European Medicines Agency - EPARs

275. Nerventra - laquinimod

Gastrointestinal GLP Good Laboratory Practices GPRD General Practice Research Database HCT Hematocrit hERG human ether-a-go-go-related gene HIV Human Immunodeficiency Virus HPLC High Performance Liquid Chromatography HR Hazard Ratio I3C Indol-3-Carbinol ICH International Conference On Harmonization IFN Interferon Ig Immunoglobulin IHD Ischaemic Heart Disease IM or i.m Intramuscular IR Infrared ITT Intention to Treat IV or i.v Intravenous IVRS Centralised Interactive Voice Response System IWRS Interactive Web (...) Interval Corrected For Heart Rate Using the Bazett Formula QTCF QT Interval Corrected For Heart Rate Using the Fridericia Formula QTCI Individually Corrected QT Interval QTPP Quality Target Product Profile RBC Red Blood Cell RH Relative Humidity RMP Risk Management Plan RMS Relapsing Multiple Sclerosis RR Rate Ratio RRMS Relapsing Remitting Multiple Sclerosis SAE Serious Adverse Event SD Sprague Dawley Nerventra EMA/451905/2014 Page 7/138 SD Standard Deviation SEER Surveillance Epidemiology and End

2014 European Medicines Agency - EPARs

276. Umbilical Cord Prolapse

section should be performed with the aim of achieving birth within 30 minutes or less if the cord prolapse is associated with a suspicious or pathological fetal heart rate pattern but without compromising maternal safety. Category 2 caesarean birth can be considered for women in whom the fetal heart rate pattern is normal, but continuous assessment of the fetal heart trace is essential. If the cardiotocograph (CTG) becomes abnormal, re-categorisation to category 1 birth should immediately (...) of Obstetricians and Gynaecologists Category 2 caesarean birth can be considered for women in whom the fetal heart rate pattern is normal, but continuous assessment of the fetal heart trace is essential. If the cardiotocograph (CTG) becomes abnormal, re-categorisation to category 1 birth should immediately be considered. Discussion with the anaesthetist should take place to decide on the appropriate form of anaesthesia. Regional anaesthesia can be considered in consultation with an experienced anaesthetist

2014 Royal College of Obstetricians and Gynaecologists

277. Use of Continuous Electronic Fetal Monitoring in a Preterm Fetus: Clinical Dilemmas and Recommendations for Practice Full Text available with Trip Pro

heart rate and the resultant features observed on the CTG trace differs in the preterm fetus as compared to a fetus at term making interpretation difficult. This review describes the features of normal fetal heart rate patterns at different gestations and the physiological responses of a preterm fetus compared to a fetus at term. We have proposed an algorithm "ACUTE" to aid management. (...) Use of Continuous Electronic Fetal Monitoring in a Preterm Fetus: Clinical Dilemmas and Recommendations for Practice The aim of intrapartum continuous electronic fetal monitoring using a cardiotocograph (CTG) is to identify a fetus exposed to intrapartum hypoxic insults so that timely and appropriate action could be instituted to improve perinatal outcome. Features observed on a CTG trace reflect the functioning of somatic and autonomic nervous systems and the fetal response to hypoxic

2011 Journal of pregnancy

278. Tybost - cobicistat

the potential for QT prolongation. In the rabbit purkinje fibre assay, COBI at =1 µM caused a significant shortening of action potential duration (APD60 and/or APD90); however, no changes in the other action potential parameters (that are predictive of QT prolongation) were observed. 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 (...) electrocardiographic interval between the beginning of the Q wave and termination of the T wave, representing the time for both ventricular depolarization and repolarization to occur QTc QT interval corrected for heart rate QUAD elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate, coformulated /r boosted with ritonavir RAL raltegravir Assessment report Page 5/86 RTV ritonavir SAE serious adverse event SD standard deviation SmPC Summary of Product Characteristics SOC system organ class STR single

2013 European Medicines Agency - EPARs

279. Provenge - autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (sipuleucel-T)

Deoxyribonucleic acid cDNA coding DNA DOR Duration of Response EC European Commission ECOG Eastern Cooperative Oncology Group ED50 Effective Dose 50 EDQM European Department for the Quality of Medicines ELISA Enzyme-linked immunosorbent assay ELISPOT Enzyme-linked immunosorbent spot EMA European Medicines Agency EU European Union FBS Fetal Bovine Serum FDA Food and Drug Administration FP Final product FPRC Final Product Reference Control GC Gas Chromatography GCP Good clinical practices GM-CSF Granulocyte

2013 European Medicines Agency - EPARs

280. Stivarga - regorafenib

related effect on malformations was clearly observed at 1.6 mg/kg/day (mainly findings of the urinary system, the heart, and the axial skeleton) and at 0.8 mg/kg/day (mainly malposition of forelimb(s) or hind limb(s), findings of the heart and major vessels, urinary system, and skeleton [skull bones, caudal vertebral bodies]). A treatment related effect on external and visceral deviations is assumed for findings of the urinary system at 1.6 mg/kg/day and 0.8 mg/kg/day. Foetal examinations for skeletal (...) injection) attenuated while injection of 1 mg/kg completely prevented the hypotensive response to VEGF. Also M-2 and M-5 inhibited the transient hypotensive effect induced by VEGF injection. Safety pharmacology programme In vitro data from the whole-cell voltage-clamp technique on HEK293 cells stably transfected with the HERG K+ channel indicated that regorafenib as well as M-2 and M-5 can inhibit the hERG K+ current in a concentration-dependent manner. However, exposure of rabbit cardiac Purkinje

2013 European Medicines Agency - EPARs

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