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Valproic Acid Toxicity

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141. Prevention of Acute Nausea and Vomiting due to Antineoplastic Medication in Pediatric Cancer Patients

summary or in which the emetogenicity of the antineoplastic therapy administered was not able to be determined. Headache 44, 96, 97 and constipation 96 were often reported to be the most common adverse effects. Abnormal liver function tests were reported in 4 of 22 children in one study. 31 Two studies prospectively evaluated cardiovascular toxicity including continuous electrocardiographic monitoring for 24 hours after receipt of granisetron. 95, 98 No dysrhythmias were observed in 64 children

2013 SickKids Supportive Care Guidelines

142. Maintaining mood stability in bipolar disorder: a clinical perspective on pharmacotherapy Full Text available with Trip Pro

. Vieta E , Günther O , Locklear J , et al . Effectiveness of psychotropic medications in the maintenance phase of bipolar disorder: a meta-analysis of randomized controlled trials . Cipriani A , Reid K , Young AH , et al . Valproic acid, valproate and divalproex in the maintenance treatment of bipolar disorder (review) . (accessed 23 Jul 2014 ). Malhi GS , Tanious M , Das P , et al . The science and practice of lithium therapy . Birch N , Gallichio V , Becker R Grof P . Excellent lithium responders (...) planning pregnancy, while older patients may be at greater risk for acute or chronic toxicity and renal dysfunction. Naturally, different medications require separate schedules for monitoring side-effects or toxicity, and given that polypharmacy is common, patients may require quite frequent investigations and follow-up. summarises recommended schedules for review. View this table: Table 2 Assessment frequency for reviewing health effects of bipolar medications Patient diversity: disease and individual

2015 Evidence-Based Mental Health

143. 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

144. 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

146. A Pilot Study of the Combination of Entinostat With Capecitabine in High Risk Breast Cancer After Neo-adjuvant Therapy

to study treatment. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. If female, is pregnant or breastfeeding. The following medications are prohibited while the patient is receiving entinostat: Any other HDAC Inhibitor, including valproic acid DNA methyltransferase inhibitors Any additional anticancer agents (excluding entinostat and capecitabine), such as chemotherapy, immunotherapy, targeted therapy, biological response (...) . Other Name: Xeloda Outcome Measures Go to Primary Outcome Measures : Identification of a maximum tolerated dose combination (MTDC) of entinostat and capecitabine [ Time Frame: During the first cycle of treatment (each cycle is 21 days) for each participant ] This will be defined based on the number of "dose limiting toxicities" in participants at each dose level. Frequency of adverse events (AEs) in participants with high-risk breast cancer after neo-adjuvant therapy [ Time Frame: AEs from consent

2018 Clinical Trials

147. 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

148. Epacadostat in Combination With Radiation Therapy and Avelumab in Patients With Recurrent Gliomas

screening through follow-up period, including acitretin, amitriptyline, androsterone, cyclosporine, dasatinib, diclofenac, diflunisal, efavirenz, erlotinib, estradiol (17-beta), flutamide, gefitinib, gemfibrozil, glycyrrhetinic acid, glycyrrhizin, imatinib, imipramine, ketoconazole, linoleic acid supplements, mefenamic acid, mycophenolic acid, niflumic acid, nilotinib, phenobarbital, phenylbutazone, phenytoin, probenecid, propofol, quinidine, ritonavir, sorafenib, sulfinpyrazone, valproic acid (...) blood at time of progression only; if no progression has occurred by this time point, the Cycle 12 will be the last collection). Outcome Measures Go to Primary Outcome Measures : Safety run-in only: Safety and tolerability of the regimen as measured by dose-limiting toxicities (DLTs) in cycle 1 [ Time Frame: Completion of cycle 1 for all patients in Safety Run-In (estimated to be 6 months) ] 6 patients will be enrolled at the 100 mg BID dose of epacadostat during the safety run-in DLT

2018 Clinical Trials

149. Assessment of new HDAC inhibitors for immunotherapy of malignant pleural mesothelioma Full Text available with Trip Pro

of cancer cells. We previously showed that a hypomethylating agent (decitabine) and a histone deacetylase inhibitor (HDACi) (valproic acid (VPA)) combination was immunogenic and led to the induction of an anti-tumor immune response in a mice model of mesothelioma. However, VPA is not very specific, is active at millimolar concentrations and is responsible for side effects in clinic. To improve this approach, we studied four newly synthetized HDACi, two hydroxamates (ODH and NODH) and two benzamides (ODB (...) and NODB), in comparison with VPA and SAHA. We evaluated their toxicity on immune cells and their immunogenicity on MPM cells in combination with decitabine.All the tested HDACi were toxic for immune cells at high concentrations. Combination with decitabine increased toxicity of HDACi only towards T-cell clone. A decrease in the proportion of regulatory T cells and natural killer cells was observed in particular with VPA and ODH. In MPM cells, all HDACi combinations induced NY-ESO-1 cancer testis

2018 Clinical epigenetics

150. Valproate serum concentrations in patients with hypoalbuminemia and medical complications Full Text available with Trip Pro

Valproate serum concentrations in patients with hypoalbuminemia and medical complications Valproic acid (VPA) and its derivatives are highly protein bound with free fraction increasing with dose and serum concentration. Consensus guidelines regarding dose adjustment for hypoalbuminemia are not available.A literature search was performed using PubMed to identify articles with the following key terms: "valproate," "valproic acid," "protein binding," "albumin," and "hypoalbuminemia." We report our (...) , age, serum creatinine, or dose). Female patients with similar albumin had higher free fractions than the 1 male patient.Due to the variability in pharmacokinetic impact of hypoalbuminemia, it is important to monitor patients closely for signs of VPA toxicity in cases involving altered albumin levels. It would be prudent to use free serum VPA concentrations when patients experience fluctuations in albumin or have unexpected response to medication.

2018 The Mental Health Clinician

151. 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

152. Image-guided Targeted Doxorubicin Delivery With Hyperthermia to Optimize Loco-regional Control in Breast Cancer

, cyclosporine, carbamazepine, phenytoin, valproic acid, paclitaxel, trastuzumab and other liposomal drugs (Abelect, Ambisome, Nyotran, etc.) or lipid-complexed drugs. Caution will be exercised with all the medications mentioned in appendix C, for interactions are theoretically possible. Contraindications to MR imaging (e.g., pacemaker in situ, severe claustrophobia, metal implants incompatible with the MRI-scan, body size incompatible with MR bore). Contraindications to gadolinium-based contrast agent (...) that by substituting doxorubicin (A) in the AC-chemotherapy regimen for the combination of LTLD and MR-HIFU induced hyperthermia, optimal local tumour control can be achieved without compromising systemic toxicity or efficacy. This will be the first study to evaluate LTLD with MR-HIFU hyperthermia in breast cancer patients. Condition or disease Intervention/treatment Phase Metastatic Breast Cancer Breast Cancer Breast Neoplasms Stage IV Breast Cancer Metastatic Cancer Invasive Ductal Carcinoma of Female Breast

2018 Clinical Trials

153. 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

154. Randomized, Phase II Clinical Trial of Sulforaphane in Bladder Cancer Chemoprevention

systemic chemotherapy for any other cancer, excluding non-melanoma skin cancer; Any treatment for the bladder tumor other than intravesical therapy; Prior treatment with a known histone deacetylase inhibitor (including but not limited to valproic acid, suberoylanilide hydroxamic acid (SAHA), Panobinostat (LBH589), etc.) within 6 months prior to starting study treatment or while on study therapy; Current treatment with warfarin; Use of dietary supplements or herbal remedies which may affect the study (...) /adjacent cells. Occurrence of Adverse Events per Study Arm [ Time Frame: End of study, approximately 30 days ] Safety of SFN at this dose (vs. Placebo) as indicated by incidence of adverse events and toxicities, monitored using Common Toxicity Criteria version 5.0, complete blood count (CBC), and complete metabolic panel (CMP) from baseline at mid-point and at end of trial. Mid-study Bioavailability of Sulforaphane [ Time Frame: Mid-study, approximately 15 days ] Bioavailability, of SFN at this dose vs

2018 Clinical Trials

155. LRAs United as a Novel Anti-HIV Strategy.

the size of the reservoir as measured by TILDA, HIV-DNA, HIV-RNA and level of acetylation/BAF expression after stimulation by pyrimethamine, valproic acid or both, and this will be correlated to these observed reservoir measurements outcomes in vivo at week 2 and week 6. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 6 week ] The clinical and biochemical adverse events will be assessed by the Common Toxicity Criteria. Plasma HIV-RNA [ Time Frame: 6 week ] The proportion of subjects (...) , Erasmus Medical Center Study Details Study Description Go to Brief Summary: A translational proof of concept study in humans on the primary research question whether novel anti-human immunodeficiency virus (HIV) latency strategies, including a BAF inhibitor and a histone deacetylase inhibitor, result in HIV reservoir reduction in HIV patients on antiretroviral therapy. Condition or disease Intervention/treatment Phase HIV-1-infection Drug: Valproic Acid Drug: Pyrimethamine Phase 1 Phase 2 Detailed

2018 Clinical Trials

156. Entinostat Versus Placebo Combined With Endocrine Therapy in Chinese Patients With Advanced Breast Cancer in Chinese Patients With Hormone Receptor-Positive Advanced Breast Cancer

affect intake, transportation or absorption of oral administration of drugs (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.); Unrecovered toxicity resulted from previous medication or toxicity, evaluation score is still > grade 1 or baseline (except alopecia); Use of HDAC inhibitor (e.g., valproic acid, Entinostat, Vorinostat, chidamide, etc.) prior to enrollment or intended use of HDAC inhibitor during the study; Known allergic to Exemestane, Entinostat or other drugs (...) of Medicine related topics: related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Active Comparator: ARM Entinostat+Exemestane Patients receive Exemestane orally (PO) once daily (QD) on days 1-28 and Entinostat PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Drug: Entinostat Entinostat will be repeatedly administered PO on days 1, 8, 15 and 22 of each treatment cycle. Exemestane PO once daily on day

2018 Clinical Trials

157. Anticonvulsant and reproductive toxicological studies of the imidazole-based histamine H3R antagonist 2-18 in mice Full Text available with Trip Pro

Anticonvulsant and reproductive toxicological studies of the imidazole-based histamine H3R antagonist 2-18 in mice The imidazole-based H3R antagonist 2-18 with high in vitro H3R antagonist affinity, excellent in vitro selectivity profile, and high in vivo H3R antagonist potency was tested for its anticonvulsant effect in maximal electroshock (MES)-induced convulsions in mice having valproic acid (VPA) as a reference antiepileptic drug (AED). Additionally, H3R antagonist 2-18 was evaluated (...) for its reproductive toxicity in the same animal species. The results show that acute systemic administration (intraperitoneal; i.p.) of H3R antagonist 2-18 (7.5, 15, 30, and 60 mg/kg, i.p.) significantly and dose dependently protected male as well as female mice against MES-induced convulsion. The protective action observed for H3R antagonist 2-18 in both mice sexes was comparable to that of VPA and was reversed when mice were pretreated with the selective H3R agonist (R)-alpha-methylhistamine (RAMH

2018 Drug design, development and therapy

158. Rechallenge of lamotrigine after development of rash Full Text available with Trip Pro

Rechallenge of lamotrigine after development of rash Lamotrigine (LTG) is associated with the potential for a life-threatening rash (eg, Stevens-Johnson syndrome or toxic epidermal necrolysis). The incidence has been linked to rapid titration and an interaction with valproic acid that can increase the level of LTG. Providers often have difficulty discriminating between serious versus benign rashes, and the package insert recommends discontinuing the medication at the first sign of a rash

2018 The Mental Health Clinician

160. Atopic dermatitis – Treatment with phototherapy and systemic agents Full Text available with Trip Pro

. Guidelines of care for the management of psoriasis and psoriatic arthritis, section 5: guidelines of care for the treatment of psoriasis with phototherapy and photochemotherapy. J Am Acad Dermatol . 2010 ; 62 : 114–135 | | | | | , x 19 Morison, W.L., Baughman, R.D., Day, R.M., Forbes, P.D., Hoenigsmann, H., Krueger, G.G. et al. Consensus workshop on the toxic effects of long-term PUVA therapy. Arch Dermatol . 1998 ; 134 : 595–598 | | | , x 22 Uetsu, N. and Horio, T. Treatment of persistent severe atopic (...) arthritis, section 5: guidelines of care for the treatment of psoriasis with phototherapy and photochemotherapy. J Am Acad Dermatol . 2010 ; 62 : 114–135 | | | | | , x 19 Morison, W.L., Baughman, R.D., Day, R.M., Forbes, P.D., Hoenigsmann, H., Krueger, G.G. et al. Consensus workshop on the toxic effects of long-term PUVA therapy. Arch Dermatol . 1998 ; 134 : 595–598 | | | , x 20 Goldsmith LK, Katz SI, Gilchrest B, Paller A, Lefell D, Wolff K. Fitzpatrick's dermatology in general medicine. 8th ed. New

2014 American Academy of Dermatology

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