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Valproic Acid Toxicity

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161. High Dose IL 2 and Entinostat in RCC

to treatment initiation. Any imaging abnormality indicative of CNS metastases will exclude the patient from the study. Patients with previously excised/gamma knifed solitary or oligometastases and no evidence of recurrent disease for 6 months are eligible. Exclusion Criteria: Concurrent use of valproic acid use is not allowed. Receiving medications that can effect clotting ability: warfarin, aspirin (once-daily aspirin use- maximum dose 325 mg/day is permitted), nonsteroidal anti-inflammatory drugs (NSAIDs (...) , papillary thyroid cancer or other non-melanoma skin cancers. Any medical condition that would preclude adequate evaluation of the safety and toxicity of the study combination. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Association Class II, III, or IV), angina pectoris requiring nitrate therapy, recent myocardial infarction (< the last 6 months), cardiac arrhythmia, history of CVA within 6 months

2018 Clinical Trials

162. A Study of Tolerability and Efficacy of Cannabidiol on Motor Symptoms in Parkinson's Disease

. History of drug or alcohol dependence; defined by prior inpatient stay(s) for this or that patient states s/he has a history of this. Use of dopamine blockers within 180 days and amphetamine, cocaine, and MAO-A inhibitors within 90 days of baseline. Currently taking tolcapone, valproic acid, felbamate, niacin (nicotinic acid) at ≥2000 mg/day or nicotinamide (nicotinic acid amide or nicotinamide) at ≥3000 mg/day, isoniazid and ketoconazole due to risk of liver injury and clobazam and ketoconazole (...) because of risk of toxic interactions with the study drug. These medications need to be stopped 90 days before the baseline visit. Unstable medical condition. Any of the following laboratory test results at screening: Hemoglobin < 10 g/dL WBC <3.0 x 109/L Neutrophils <1.5 x 109/L Lymphocytes < 0.5 x 109/L Platelets <100 x 109/L Hemoglobin A1C > 9% Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limit of normal. Persons with stable liver disease of known

2018 Clinical Trials

163. Benzoate and Sorbate Salts: A Systematic Review of the Potential Hazards of These Invaluable Preservatives and the Expanding Spectrum of Clinical Uses for Sodium Benzoate Full Text available with Trip Pro

1 The monocarboxylate compounds discussed in this article, shown as their sodium salts. The Capacity of Sorbate and Benzoate Preservatives to Promote the Generation of Mutagenic and Carcinogenic Compounds Sorbate can promote the formation of mutagenic or carcinogenic compounds, notably in the presence of nitrite Sorbic acid and sorbates have a very low mammalian toxicity. There is a general consensus that they are intrinsically devoid of carcinogenic activity, but have the potential to undergo (...) and glutamine together with a disordered metabolism of other amino acids. This build‐up of ammonia (the condition of hyperammonemic encephalopathy, hereafter referred to as hyperammonemia) is highly toxic to nerve cells, causing a wide spectrum of neuropsychiatric abnormalities and motor disturbances. Treatments of UCD primarily involve either the lowering of ammonia production and/or increasing ammonia removal. They include a low‐protein diet, supplementation of arginine or citrulline

2017 Comprehensive Reviews in Food Science and Food Safety

164. Clinical Pharmacology in India-A Systematic Review of Research in the Past 5 Years Full Text available with Trip Pro

., 2015). Although there was a positive correlation between plasma methotrexate levels with serum creatinine, cut-off values to determine delayed clearance of methotrexate could not be established. Change in creatinine but not delayed methotrexate clearance predicted hematological toxicity. An observational study showed that maintaining the AUC of mycophenolic acid between of 30-60 mg.h/l in Indian renal transplant patients provides adequate clinical benefit and has minimal adverse effects (Sarangi et (...) , Kaleekal T, Gupta Y K and Tripathi M (2016) Concentration of antiepileptic drugs in persons with epilepsy: a comparative study in serum and saliva Int J Neurosci 126 972-978 Dwivedi R, Gupta YK, Singh M, et al. (2015) Correlation of saliva and serum free valproic acid concentrations in persons withepilepsy Seizure 25 187-190 Gold H (1952) Editorial The Proper Study of Mankind Is Man Am J Med 12 619-620 ISCPT (2002)

2017 Proceedings of the Indian National Science Academy

165. Fycompa - perampanel

, valproic acid, Phenobarbital, and benzodiazepines. Approximately 60% of newly diagnosed patients are seizure-free with monotherapy and an additional 10-20% with polytherapy. It follows that about 30% of patients are not satisfactorily controlled. In addition many patients suffer from significant adverse effects. Assessment report EMA/424476/2012 Page 7/122 Thus, there remains a need for new AEDs with improved efficacy and tolerability profiles, as well as for greater mechanistic diversity. 2.1.2. About (...) consultation 117 3. Benefit-Risk Balance 117 4. Recommendations 121 Assessment report EMA/424476/2012 Page 3/122 List of abbreviations AEDs antiepileptic drugs AMS accelerator mass spectrometry AMPA a-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid BID twice daily DB double blind CHMP Committee for Medicinal Products for Human Use ECG electrocardiogram EEG electroencephalogram EMA European Medcines Agency E2007 perampanel GCP Good Clinical Practice ITT Intent-To-Treat LOCF Last observation carried

2012 European Medicines Agency - EPARs

166. Perampanel (Fycompa)

-emergent SAEs coded to the following preferred terms: aplastic anemia, agranulocytosis, Stevens Johnson syndrome, toxic 2 In the Parkinson’s disease studies, for example, subjects could have clinically significant, but stable disease; in the epilepsy studies, subjects with clinically significant disease were excluded. Reference ID: 3197631Safety Team Leader Memo NDA 202834 7 epidermal necrolysis, acute renal failure, acute liver failure, rhabdomyolysis, angioedema, or anaphylaxis. There was one SAE (...) (2% in the Phase 2/3 Epilepsy DB pool vs 0.8% for placebo, 4.5% in the Epilepsy All Treated Pool, 2.2% vs 0.6% for placebo in the Nonepilepsy DB pool, and 2.5% in the Nonepilepsy All Treated Pool). In the Epilepsy and Nonepilepsy pools, no subjects discontinued for Stevens Johnson syndrome, toxic epidermal necrolysis, acute liver failure, aplastic anemia, agranulocytosis, pancytopenia, or anaphylaxis. In the Epilepsy pool, no subjects discontinued for acute renal failure or, rhabdomyolysis

2012 FDA - Drug Approval Package

167. Childhood Astrocytomas Treatment (PDQ®): Health Professional Version

at specific amino acids in histone genes, and together these account for approximately one-half of pediatric high-grade gliomas. The following pediatric high-grade glioma subgroups were identified on the basis of their DNA methylation patterns, and they show distinctive molecular and clinical characteristics:[ ] H3.3 ( H3F3A ) and H3.1 ( HIST1H3B and, rarely, HIST1H3C ) mutation at K27: The Histone K27–mutated cases occur predominantly in middle childhood (median age, approximately 10 years), are almost

2016 PDQ - NCI's Comprehensive Cancer Database

168. Childhood Acute Lymphoblastic Leukemia Treatment (PDQ®): Health Professional Version

., large effect sizes) comprise another category of genetic predisposition to ALL. PAX5 . A germline variant in PAX5 that substitutes serine for glycine at amino acid 183 and that reduces PAX5 activity has been identified in several families that experienced multiple cases of ALL.[ , ] ETV6 . Several germline ETV6 variants that lead to loss of ETV6 function have been identified in kindreds affected by both thrombocytopenia and ALL.[ - ] Sequencing of ETV6 in remission (i.e., germline) specimens (...) to the and sections of this summary for more information). Despite the treatment advances in childhood ALL, numerous important biologic and therapeutic questions remain to be answered before the goal of curing every child with ALL with the least associated toxicity can be achieved. The systematic investigation of these issues requires large clinical trials, and the opportunity to participate in these trials is offered to most patients and families. Clinical trials for children and adolescents with ALL

2016 PDQ - NCI's Comprehensive Cancer Database

169. Whole genome microarray analysis of neural progenitor C17.2 cells during differentiation and validation of 30 neural mRNA biomarkers for estimation of developmental neurotoxicity. Full Text available with Trip Pro

in neurogenesis (CHRDL1), axonal guidance (BMP4), neuronal connectivity (PLXDC2), axonogenesis (RTN4R) and astrocyte differentiation (S100B). The 30 biomarkers were further validated by exposure to non-cytotoxic concentrations of two DNT-inducing compounds (valproic acid and methylmercury) and one neurotoxic chemical possessing a possible DNT activity (acrylamide). Twenty-eight of the 30 biomarkers were altered by at least one of the neurotoxic substances, proving the importance of these biomarkers during (...) Whole genome microarray analysis of neural progenitor C17.2 cells during differentiation and validation of 30 neural mRNA biomarkers for estimation of developmental neurotoxicity. Despite its high relevance, developmental neurotoxicity (DNT) is one of the least studied forms of toxicity. Current guidelines for DNT testing are based on in vivo testing and they require extensive resources. Transcriptomic approaches using relevant in vitro models have been suggested as a useful tool

2017 PLoS ONE

170. Valproate

Valproate Valproate Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 Valproate Valproate Aka: Valproate , Valproic Acid , Depakote (...) Divide regular and delayed release dosing two to four times daily Extended release may be dosed once daily Initial Depakote ER 500 mg orally daily for 7 days Depakote delayed release 250 mg orally twice daily May increase to 1000 mg/day Loading dose in acute mania: 15-20 mg/kg Starting dose without load: 500 to 750 mg/day in divided dosing Titrate every 2-3 days as tolerated to serum Valproic Acid level of 50 to 125 mcg/ml Target dose: 1000 to 3000 mg daily in divided doses VII. Drug Interactions

2018 FP Notebook

171. Guidelines for the Evaluation and Management of Status Epilepticus

system infection: meningitis, encephalitis, abscess Stroke: ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, cerebral sinus thrombosis Head trauma with or without epidural or subdural hematoma Drug issues Drug toxicity Withdrawal from opioid, benzodiazepine, barbiturate, or alcohol Non-compliance with AEDs Hypoxia, cardiac arrest Hypertensive encephalopathy, posterior reversible encephalopathy syndrome Autoimmune encephalitis (i.e., anti-NMDA receptor antibodies, anti-VGKC complex (...) meningitis, inborn errors of metabolism, and ingestion are frequent causes of SE [34, 35] AED antiepileptic drug; CNS central nervous system; NMDA N-methyl-D-aspartic acid; SE status epilepticus; TBI traumatic brain injury; VGKC voltage-gated potassium channel Table 3 Suggested diagnostic work-up [21] The steps included in the diagnostic work-up should be completed as soon as possible and occur simultaneously and in parallel with treatment. All patients 1. Fingerstick glucose 2. Monitor vital signs. 3

2012 Neurocritical Care Society

172. Medical treatment of infantile spasms

drug ; BD = Breslow-Day ; CI = confidence interval ; ERG = electroretinogram ; FDA = Food and Drug Administration ; IVIg = IV immunoglobulin ; LEV = levetiracetam ; NZP = nitrazepam ; OR = odds ratio ; RCT = randomized controlled trial ; TPM = topiramate ; TRH = thyrotropin-releasing hormone ; TSC = tuberous sclerosis complex ; UKISS = United Kingdom Infantile Spasms Study ; VABS = Vineland Adaptive Behavioral Scale ; VGB = vigabatrin ; VPA = valproic acid ; ZNS = zonisamide Infantile spasms (...) (table e-4)? Previously reviewed and updated evidence. All previous and current studies were rated Class IV for treatment using valproic acid (VPA), , nitrazepam (NZP), , pyridoxine (vitamin B6), , zonisamide (ZNS), , IVIg, thyrotropin-releasing hormone (TRH), topiramate (TPM), ,e1 levetiracetam (LEV), e2 the ketogenic diet, e3,e4 and combination therapies using ACTH and VGB, e5 hydrocortisone, and VPA. e6 Sulthiame. One Class II randomized, double-blind, placebo-controlled study demonstrated a 30

2012 American Academy of Neurology

173. Antiepileptic drug selection for people with hiv/aids

interaction between zidovudine and valproic acid in patients infected with human immunodeficiency virus . 24. Okulicz JF , Grandits GA , French JA , et al . Virologic outcomes of HAART with concurrent use of cytochrome P450 enzyme-inducing antiepileptics: a retrospective case control study . Bates DE , Herman RJ . Carbamazepine toxicity induced by lopinavir/ritonavir and nelfinavir . 26. Bonora S , Calcagno A , Fontana S , et al . Clinically significant drug interaction between tipranavir-ritonavir (...) and phenobarbital in an HIV-infected subject . 27. Burman W , Orr L . Carbamazepine toxicity after starting combination antiretroviral therapy including ritonavir and efavirenz . 28. Cazali N , Tran A , Treluyer JM , et al . Inhibitory effect of stiripentol on carbamazepine and saquinavir metabolism in human . 29. DiCenzo R , Peterson D , Cruttenden K , et al . Effects of valproic acid coadministration on plasma efavirenz and lopinavir concentrations in human immunodeficiency virus-infected adults . 30. Garcia

2012 American Academy of Neurology

174. Monitoring of Nonsteroidal Immunosuppressive Drugs in Patients With Lung Disease and Lung Transplant Recipients

for minimizing such risks include administering these drugs according to established, safe protocols; monitoring to detect manifestations of toxicity; and patient education. Hence, an evidence-based guideline for physicians can improve safety and optimize the likelihood of a successful outcome. To maximize the likelihood that these agents will be used safely, the American College of Chest Physicians established a committee to examine the clinical evidence for the administration and monitoring (...) of immunosuppressive drugs (with the exception of corticosteroids) to identify associated toxicities associated with each drug and appro- priate protocols for monitoring these agents. Methods: Committee members developed and re? ned a series of questions about toxicities of immunosuppressives and current approaches to administration and monitoring. A systematic review was carried out by the American College of Chest Physicians. Committee members were supplied with this information and created this evidence-based

2012 American College of Chest Physicians

176. Tolerated drugs in subjects with severe cutaneous adverse reactions (SCARs) induced by anticonvulsants and review of the literature Full Text available with Trip Pro

symptoms under therapy with phenytoin; 2 out of 6 presented with Stevens-Johnson syndrome under therapy with lamotrigine; and 2 out of 6 presented with a toxic epidermal necrolysis, one of them under therapy with valproic acid, and the other one under therapy with lamotrigine. Alternative anticonvulsants tolerated after the reaction were: clonazepam, levetiracetam, diazepam, delorazepam and lormetazepam.In our cases we observed that non aromatic anticonvulsants and benzodiazepines were well tolerated

2017 Clinical and molecular allergy : CMA

177. Dual Functional Mesoporous Silicon Nanoparticles Enhance the Radiosensitivity of VPA in Glioblastoma Full Text available with Trip Pro

attracted much attention because they selectively increase susceptibility of cancer cells to radiation and thus enhance biological effectiveness of radiotherapy. However, clinical translation of radiosensitizers has been severely limited by their potential toxicity to normal tissue. Recent advances in nanomedicine offer an opportunity to overcome this hindrance. In this study, a dual functional mesoporous silica nanoparticle (MSN) formulation of the valproic acid (VPA) radiosensitizer was developed (...) , which specifically recognized folic acid-overexpressing cancer cells and released VPA conditionally in acidic turmeric microenvironment. The efficacy of this targeted and pH-responsive VPA nanocarrier was evaluated as compared to VPA treatment approach in two cell lines: rat glioma cells C6 and human glioma U87. Compared to VPA treatment, targeted VPA-MSNs not only potentiated the toxic effects of radiation and led to a higher rate of cell death but also enhanced inhibition on clonogenic assay. More

2017 Translational oncology

178. Valproate and sodium butyrate attenuate manganese-decreased locomotor activity and astrocytic glutamate transporters expression in mice Full Text available with Trip Pro

Valproate and sodium butyrate attenuate manganese-decreased locomotor activity and astrocytic glutamate transporters expression in mice Manganese (Mn) is an essential trace element, but chronic overexposure to this metal, either environmentally or occupationally may cause manganism, a disease analogous to Parkinson's disease. Inhibitors of histone deacetylases, such as valproic acid (VPA) and sodium butyrate (NaB) exert neuroprotective effects in various animal models of neurological disorders (...) in the cerebral cortical and cerebellar regions of mice. These results suggest that VPA and NaB exert protective effects against Mn toxicity seem in vitro are also shown in vivo. VPA and NaB pretreatment in mice enhancing astrocytic glutamate transporter GLT-1 expression as well as locomotor activities. Future research endeavors are warranted to determine if the therapeutic potential of VPA and NaB is via common molecular mechanism, namely, inhibition of histone deacetylases.Copyright © 2017. Published

2017 Neurotoxicology

179. Histone deacetylase inhibitors potentiate photodynamic therapy in colon cancer cells marked by chromatin-mediated epigenetic regulation of CDKN1A Full Text available with Trip Pro

fatty acids valproic acid and sodium phenylbutyrate (NaPB), as inhibitors of all-class versus nuclear HDACs, respectively. The selected HDACis manifest a favorable clinical toxicity profile and showed similar potencies and mechanisms in intragroup comparisons but different biological effects in intergroup analyses. HDACi combination with HY-PDT significantly attenuated cancer cell resistance to treatment and caused the two HDACi groups to become similarly potent. However, the short-chain fatty acids (...) treatments due to their non-genotoxic properties and epigenetic potential to sensitize cells to external stimuli. Therefore, this study attempts for the first time to investigate the therapeutic effects of HDACis in combination with visible light-mediated PDT against cancer. Specifically, the colorectal cancer cell model was used due to its known resistance to HY-PDT.Two chemical groups of HDACis were tested in combination with HY-PDT: the hydroxamic acids Saha and Trichostatin A, and the short-chain

2017 Clinical epigenetics

180. Study of the Safety, Pharmacokinetics and Efficacy of EDO-S101, in Patients With Advanced Solid Tumors

to prolong the QT/QTc interval. Patients who are being treated with Valproic Acid for any of its indication (epilepsy, mood disorder) must be excluded or must stop using the medication. Any serious medical condition that interferes with adherence to study procedures. Prior history of solid tumor malignancy diagnosed within the last three (3) years of study enrollment excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer, in situ (...) damage repair. This Phase 1/2 study will enroll patients with various advanced solid tumors. Condition or disease Intervention/treatment Phase Small-cell Lung Cancer Soft Tissue Sarcoma Triple-negative Breast Cancer Ovarian Cancer Endometrial Cancer Drug: Tinostamustine (EDO-S101) Phase 1 Phase 2 Detailed Description: The study consists of 2 phases: Phase 1: Dose Escalation until MAD Phase 2: Evaluation of Toxicity and Response Rate in Selected Solid Tumor Cohorts The study is designed as an open

2017 Clinical Trials

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