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Valproic Acid Toxicity

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61. Temsirolimus and Valproic Acid in Treating Young Patients With Relapsed Neuroblastoma, Bone Sarcoma, or Soft Tissue Sarcoma

of temsirolimus, valproate, and VEGF-A with toxicity and disease response. To evaluate the ability of selected member divisions of a newly developed North Carolina-based pediatric oncology consortium to cooperate in clinical trials. OUTLINE: This a multicenter, dose-escalation study of temsirolimus. Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22 and oral valproic acid* 3 times daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease (...) progression or unacceptable toxicity. Blood samples are collected at baseline and periodically during study for pharmacokinetic and VEGF-A studies. Tumor tissue samples from archived biopsy are also analyzed for IGF-IR, mTOR expression, HDAC, and autophagy biomarkers. After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 2 years, and then every 6 months for 2 years. NOTE: * Doses of valproic acid are titrated beginning 3-7 days prior to starting

2010 Clinical Trials

62. Bevacizumab, Chemotherapy and Valproic Acid in Advanced Sarcomas

if there is no residual toxicity from previous treatments. Toxicity must be graded as 0 or 1 prior to study. Patients must have had disease progression on or following their most recent treatment regimen or on presentation for the first time with locally advanced unresectable or metastatic disease. 1.All subtypes of sarcoma are eligible for the trial. Exclusion Criteria: Prior use of Bevacizumab for the treatment of cancer. Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer. Patients who (...) Bevacizumab, Chemotherapy and Valproic Acid in Advanced Sarcomas Bevacizumab, Chemotherapy and Valproic Acid in Advanced Sarcomas - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Bevacizumab, Chemotherapy

2010 Clinical Trials

63. Determination of Drug Toxicity Using 3D Spheroids Constructed From an Immortal Human Hepatocyte Cell Line (PubMed)

, amiodarone, diclofenac, metformin, phenformin, and valproic acid) to LD(50) data (mg compound/mg cellular protein) showed that the variation in LD(50) values was generally less than that suggested by the original LC(50) data. Toxicological analysis of these six compounds in 3D spheroid culture (either published or presented here) demonstrated similar LD(50) values. Although in vitro 2D HepG2 data showed a poor correlation, the primary hepatocyte and 3D spheroid data resulted in a much higher degree (...) Determination of Drug Toxicity Using 3D Spheroids Constructed From an Immortal Human Hepatocyte Cell Line Numerous publications have documented that the immortal cells grown in three-dimensional (3D) cultures possess physiological behavior, which is more reminiscent of their parental organ than when the same cells are cultivated using classical two-dimensional (2D) culture techniques. The goal of this study was to investigate whether this observation could be extended to the determination of LD

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2012 Toxicological Sciences

64. Practice Parameter update: Managment issues for women with epilepsy - Focus on pregnancy: Vitamin K, folic acid, blood levels, and breastfeeding

1980;18:31–42. 18. Nau H, Rating D, Koch S, Hauser I, Helge H. Valproic acid and its metabolites: Placental transfer, neonatal phar- macokinetics, transfer via mother’s milk and clinical status in neonates of epileptic mothers. J Pharmacol Exp Ther 1981;219:768–777. 19. Takeda A, Okada H, Tanaka H, et al. Protein binding of four antiepileptic drugs in maternal and umbilical cord serum. Epilepsy Res 1992;13:147–151. 20. Ishizaki T, Yokochi K, Chiba K, et al. Placental transfer of anticonvulsants (...) (phenobarbital, phenytoin, valproic acid) and elimination from neonates. Pediatr Pharmacol 1981;1:291–303. 148 Neurology 73 July 14, 200921. Gomita Y, Furuno K, Akaki Y, et al. Phenobarbital in sera of epileptic mothers and their infants. Am J Ther 1995;2: 968–971. 22. YerbyMS,FrielPN,McCormickK,etal.Pharmacokinet- ics of anticonvulsants in pregnancy: alterations in plasma protein binding. Epilepsy Res 1990;5:223–228. 23. Tomson T, Palm R, Ka ¨lle ´n K, et al. Pharmacokinetics of levetiracetam during

2009 American Epilepsy Society

65. Management issues for women with epilepsy-focus on pregnancy: vitamin k, folic acid, blood levels, and breastfeeding

on the timing of the return to the prepregnancy pharmacokinetic state after pregnancy. One study demonstrated that following an empiric postpartum taper schedule of LTG reduced the occurrence of postpartum toxicity, but more systematic information is needed regarding the pharmacokinetic alterations in AED metabolism postpartum for all AEDs in order to determine the management of AED dosing in the postpartum period. RECOMMENDATIONS FOR FUTURE RESEARCH The issue of whether preconceptional folic acid (...) phenobarbital, PEMA and hydroxyphenobarbital in neonates and infants of epileptic mothers. Eur J Clin Pharmacol 1980 ; 18 : 31 –42. Nau H, Rating D, Koch S, Hauser I, Helge H. Valproic acid and its metabolites: Placental transfer, neonatal pharmacokinetics, transfer via mother’s milk and clinical status in neonates of epileptic mothers. J Pharmacol Exp Ther 1981 ; 219 : 768 –777. Takeda A, Okada H, Tanaka H, et al. Protein binding of four antiepileptic drugs in maternal and umbilical cord serum. Epilepsy

2009 American Academy of Neurology

66. Valproic acid toxicity profile: a systematic review and meta-analysis

Valproic acid toxicity profile: a systematic review and meta-analysis Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites. Email salutation (e.g. "Dr Smith" or "Joanne") for correspondence: Organisation web address: Timing and effect measures

2013 PROSPERO

67. Valproic Acid and Radiation Followed by Maintenance Valproic Acid and Bevacizumab in Children With High Grade Gliomas or Diffuse Intrinsic Pontine Glioma

was incompletely resected. Primary spinal cord malignant gliomas will receive a total dose of between 50.4-54 Gy in 28-30 fractions over 5-6 weeks. Outcome Measures Go to Primary Outcome Measures : Event free survival [ Time Frame: 24 months ] To determine the efficacy of combining valproic acid (VPA) with radiation, followed by maintenance VPA and bevacizumab in children with newly diagnosed high-grade gliomas and brainstem gliomas, as measured by EFS at one-year and two-years. To determine toxicities of VPA (...) Valproic Acid and Radiation Followed by Maintenance Valproic Acid and Bevacizumab in Children With High Grade Gliomas or Diffuse Intrinsic Pontine Glioma Valproic Acid and Radiation Followed by Maintenance Valproic Acid and Bevacizumab in Children With High Grade Gliomas or Diffuse Intrinsic Pontine Glioma - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail

2009 Clinical Trials

68. DuoCover - clopidogrel / acetylsalicylic acid

DuoCover - clopidogrel / acetylsalicylic acid European Medicines Agency 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: mail@ema.europa.eu http://www.ema.europa.eu London, 17 December 2009 Doc. Ref: EMA/CHMP/195986/2010 CHMP ASSESSMENT REPORT FOR DuoCover International Nonproprietary Name: clopidogrel / acetylsalicylic acid Procedure No. EMEA/H/C/001144 TABLE OF CONTENTS 1. BACKGROUND INFORMATION ON THE PROCEDURE 3 1.1 Submission (...) indication: DuoCover is indicated for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). DuoCover is a fixed-dose combination product for continuation of therapy in: ? Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary intervention ? ST segment elevation acute myocardial infarction in medically treated

2010 European Medicines Agency - EPARs

69. DuoPlavin - clopidogrel / acetylsalicylic acid

DuoPlavin - clopidogrel / acetylsalicylic acid European Medicines Agency 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: mail@ema.europa.eu http://www.ema.europa.eu London, 17 December 2009 Doc. Ref: EMA/CHMP/196090/2010 CHMP ASSESSMENT REPORT FOR DuoPlavin International Nonproprietary Name: clopidogrel / acetylsalicylic acid Procedure No. EMEA/H/C/001143 TABLE OF CONTENTS 1. BACKGROUND INFORMATION ON THE PROCEDURE 3 1.1 Submission (...) for the following indication: DuoPlavin is indicated for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). DuoPlavin is a fixed-dose combination product for continuation of therapy in: ? Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary intervention ? ST segment elevation acute myocardial infarction

2010 European Medicines Agency - EPARs

70. Study of Decitabine Alone or in Combination With Valproic Acid and All-trans Retinoic Acid in Acute Myeloid Leukemia

Study of Decitabine Alone or in Combination With Valproic Acid and All-trans Retinoic Acid in Acute Myeloid Leukemia Study of Decitabine Alone or in Combination With Valproic Acid and All-trans Retinoic Acid in Acute Myeloid Leukemia - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number (...) of saved studies (100). Please remove one or more studies before adding more. Study of Decitabine Alone or in Combination With Valproic Acid and All-trans Retinoic Acid in Acute Myeloid Leukemia (DECIDER) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT00867672 Recruitment Status : Completed First

2009 Clinical Trials

72. Lithium

Psychotropic Drugs 614OI1Z5WI Valproic Acid IM Int J Geriatr Psychiatry. 2001 Oct;16(10):1004-9 11607947 J Clin Psychiatry. 2002 Oct;63(10):942-7 12416605 BMJ. 2003 May 3;326(7396):960-1 12727769 Psychiatry Clin Neurosci. 2004 Feb;58(1):25-9 2015 15. Every reason to discontinue lithium 26092398 2015 06 20 2015 06 20 2017 02 20 2 1 2014 Dec International journal of bipolar disorders Int J Bipolar Disord Every reason to discontinue lithium . 12 10.1186/s40345-014-0012-y Lithium as a gold standard therapy (...) suffering from bipolar disorders and preventing acute suicidal and manic episodes. But there is a fine line – a narrow 2014 6. Lithium toxicity - emergency management 2017 7. Lithium Use in Pregnancy and the Risk of Cardiac Malformations. Background There has been concern that exposure to lithium early in pregnancy may be associated with a marked increase in the risk of Ebstein's anomaly (a right ventricular outflow tract obstruction defect) in infants and overall congenital cardiac defects, but data

2018 Trip Latest and Greatest

73. Clonazepam

and clonazepam . 1612 Carroll W M WM Walsh P J PJ eng Case Reports Journal Article England Br Med J 0372673 0007-1447 0 Benzodiazepinones 5PE9FDE8GB Clonazepam 614OI1Z5WI Valproic Acid C1LJO185Q9 5 (...) -Hydroxytryptophan AIM IM Brain. 1978 Mar;101(1):143-62 638722 Brain. 1977 Sep;100(3):455-87 412560 5-Hydroxytryptophan therapeutic use Adult Benzodiazepinones therapeutic use Clonazepam therapeutic use Drug Therapy, Combination Female Humans Hypoxia, Brain complications Myoclonus drug therapy etiology (...) Valproic Acid therapeutic use PMC1608844 1978 12 9 1978 12 9 0 1 1978 12 9 0 0 ppublish 365292 PMC1608844 1978 14. Clonazepam add-on therapy for refractory epilepsy in adults and children [Cochrane Protocol] Clonazepam add-on therapy for refractory epilepsy in adults and children [Cochrane Protocol] PROSPERO International prospective register of systematic reviews Clonazepam add-on therapy for refractory epilepsy in adults and children [Cochrane Protocol] Lin Song, Fang Liu, Ruoqi Zhang, Huanhuan Ji

2018 Trip Latest and Greatest

74. Psychiatric Aspects of Infertility

infertility treatment. Ginekologia polska, 88(2), pp.109–112. Golub, M. et al., 2005. NTP-CERHR Expert Panel Report on the reproductive and developmental toxicity of amphetamine and methamphetamine. Birth defects research. Part B, Developmental and reproductive toxicology, 74(6), pp.471–584. Gotlib, D. et al., 2017. Valproic Acid in Women and Girls of Childbearing Age. Current psychiatry reports, 19(9), p.58. Hall, E. & Steiner, M., 2013. Serotonin and female psychopathology. Women’s health , 9(1), pp.85 (...) be increased by treatment with certain mood stabilizers. Studies show a significantly higher rate of menstrual cycle disorders, hyperandrogenism and PCOS (which have been associated with infertility), in women receiving prolonged valproate therapy for bipolar disorder (Okanovic & Zivanovic 2016; Gotlib et al. 2017; Morrell et al. 2003). Given the risk of teratogenic effects (e.g., neural tube defects), valproic acid should be avoided in women planning a pregnancy (Gotlib et al. 2017). Additionally, given

2019 American Psychiatric Association

76. Guidance on the clinical management of anxiety disorders, specifically focusing on diagnosis and treatment strategies

and GAD, but their use raises concerns about side effects, tolerability and danger in overdose. TCAs should generally be reserved for patients who have not responded to, or been unable to tolerate, SSRIs and SNRIs. The irreversible monoamine oxidase inhibitors (MAOIs) have proven efficacy in SAD and panic disorder. However, their use in the treatment of these disorders has been lim- ited, due to significant potential adverse effects, the need for dietary restrictions, toxicity in overdose

2018 Royal Australian and New Zealand College of Psychiatrists

77. Allopurinol / lesinurad (Duzallo) - Gout

5/100 PRAC Pharmacovigilance Risk assessment Committee PRO Patient reported outcome PSUR Periodic Safety Update Report PT Preferred Term pUA Plasma uric acid (also referred to as plasma urate) PV Pharmacovigilance PVA Polyvinyl alcohol PVC polyvinyl chloride PVDC polyvinylidene chloride PYE Person years of exposure QbD Quality by design QD Once daily RH Relative Humidity RMP Risk Management Plan SAE Serious adverse event sCr Serum creatinine SMs Starting materials SmPC Summary of Product (...) Characteristics SOC System Organ Class sUA Serum uric acid (also referred to as serum urate) SURI Selective UA reabsorption inhibitor TEAE Treatment emergent adverse event TTC Threshold of Toxicological Concern UA Uric acid ULT Urate-lowering therapy URAT1 Uric acid transporter 1 US United States USP United States Pharmacopoeia UV Ultraviolet XOI Xanthine oxidase inhibitor XRPD X-ray powder diffraction Assessment report EMA/474026/2018 Page 6/100 1. Background information on the procedure 1.1. Submission

2018 European Medicines Agency - EPARs

78. CRACKCast E206 – Seizures

IM or IV at max rate of 150 mg/min Valproic Acid 20-40 mg/kg at 3-6 mg/kg/min Keppra 1000-3000 mg of 15 minutes If the seizure still has not stopped with second line therapies: Intubation and EEG recommended Treat with one of the following third-line medications: Pentobarbitol 5 mg/kg IV at 1-5 mg/kg/hr, then 0.5-3.0 mg/kg/hr infusion as needed Phenobarbitol 20 mg/kg IV at 50-75 mg/min Midazolam 0.2mg/kg IV, then 0.1-0.4 mg/kg/hr Propofol 2 mg/kg IV at 2-5 mg/kg/hr, then 5-10 mg/kg/hr as needed (...) activity and increased synchronicity allows you to both explain the initial presentation and progression of seizure activity. Seizures can be characterized as falling into one of the categories: Primary versus Secondary Primary seizures are by definition unprovoked and not linked to some inciting event Secondary seizures occur as the result of some underlying pathophysiologic process such as toxic ingestion, trauma, metabolic disturbances, structural lesions etc… Generalized versus Focal Generalized

2019 CandiEM

79. Valproic Acid in Treating Patients With Previously Treated Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Chronic Lymphocytic Leukemia

valproic acid daily for 3 weeks. Treatment repeats every 3 weeks for at least 2 courses and up to 2 years in the absence of disease progression or unacceptable toxicity. Blood samples are collected periodically. Samples are analyzed for valproic acid levels; and hyperacetylation (caused by the valproic acid N-terminals of the histones H3 and H4) via western blot. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 52 participants (...) Valproic Acid in Treating Patients With Previously Treated Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Chronic Lymphocytic Leukemia Valproic Acid in Treating Patients With Previously Treated Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Chronic Lymphocytic Leukemia - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have

2009 Clinical Trials

80. A Study of Imatinib and Valproic Acid in Patients With Chronic Myelogenous Leukemia (CML)

will be monitored to see if the addition of valproate produced a further reduction. Patients will be monitored for efficacy and toxicity. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 0 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Phase II Study of Imatinib and Valproic Acid in Patients With CML Study Start Date : September 2009 Actual Primary Completion (...) A Study of Imatinib and Valproic Acid in Patients With Chronic Myelogenous Leukemia (CML) A Study of Imatinib and Valproic Acid in Patients With Chronic Myelogenous Leukemia (CML) - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more

2009 Clinical Trials

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