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Valproic Acid Toxicity

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161. Entinostat Neuroendocrine (NE) Tumor

of the fever. Patients who have been treated with any investigational drug within 28 days prior to the first dose of study medication, or who are receiving concurrent treatment with other experimental drugs or anti-cancer therapy. Prior treatment with histone deacetylase (HDAC) inhibitors (e.g. valproic acid, Zolinza® (SAHA), romidepsin (Istodax®). History of pericarditis or pericardial effusion that had required medical or surgical intervention in the last 6 months, or myocardial infarction or arterial (...) Study Details Study Description Go to Brief Summary: This is an open-label, single arm, multi-center Phase II trial of entinostat given as a 5 mg oral dose every week (days 1, 8, 15, and 22 of a 4-week cycle) in patients with relapsed or refractory abdominal neuroendocrine (NE) tumors. Patients will continue on treatment until disease progression or intolerable toxicity occurs. Condition or disease Intervention/treatment Phase Neuroendocrine Tumors Drug: Entinostat Phase 2 Detailed Description

2017 Clinical Trials

162. 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

163. Toxicological Screening by GC-MS Among Children Admitted for a First Afebrile Seizure

will be performed on blood and urine samples to extensively screen for proconvulsive molecules (alcohols, polycyclic antidepressants, salicylates, anticonvulsive medications (carbamazepine, phenytoin, valproic acid), drugs (cocaine and its metabolites, amphetamines, methamphetamine (ecstasy), cannabis, buprenorphine, methadone, mephedrone, codeine, pholcodine, hydromorphone), benzodiazepines, caffeine, theophylline, lidocaine, isoniazid, mefenamic acid, tramadol, ephedrine). This analysis will be performed (...) of the patient and other associated symptoms or clinical signs. A seizure can be the first sign of acute intoxication and represents a severity criterion. Failure to detect the toxic cause of a seizure can lead to a delay in the access or administration of an antidote if applicable. This can lead to target organ toxicity due to the absence of specific treatment. In the current French guidelines for a first seizure, a toxicological analysis is recommended if there is a possibility of exposure to toxic

2017 Clinical Trials

164. Epigenetic Reprogramming in Relapse/Refractory AML

period. -They have significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results. -They have a known allergy to any of the drugs used in the study. -Patients with Down syndrome are excluded. Patients with DNA fragility syndromes are excluded (e.g. Fanconi Anemia, Bloom Syndrome) They are receiving valproic acid (VPA) therapy. Patients (...) decitabine, vorinostat, fludarabine, high dose cytarabine, filgrastim (G-CSF) Drug: Decitabine Dose Level #0: 5 mg/m2 Dose Level #1: 7.5 mg/m2 Dose Level #2: 10 mg/m2 Dose Level #3: 15 mg/m2 Dose Level #4: 20 mg/m2 given IV over __ hour on days 1 through 5 Other Name: Dacogen Drug: Vorinostat Age <18: 180 mg/m2/day once daily PO. Age≥18: 200 mg twice daily PO. Other Name: Zolinza, SAHA, suberoylanilide acid Drug: Filgrastim (G-CSF) Given on days 5 until evidence of ANC recovery (>500/µL)5µg/kg/dose IV

2017 Clinical Trials

165. RCT of Olanzapine for Control of CIV in Children Receiving HSCT Conditioning

(PRN) for treatment of breakthrough CINV. For patients receiving busulfan, scheduled administration of benzodiazepines such as lorazepam for seizure prophylaxis is permitted on the days that busulfan is given and for 24 hours after. Receipt of cranial boost radiation within 14 days of the first day of HSCT conditioning. Planned co-administration of citalopram, amifostine, medications known to alter the metabolism of olanzapine (e.g. ciprofloxacin, valproic acid) Previous participation in this study (...) control [ Time Frame: up to 1 month ] CINV control - no vomiting/retching and no nausea (Pediatric Nausea Assessment Tool [PeNAT] score=1) during phase of interest Safety profile of olanzapine based on toxicities [ Time Frame: up to 1 month ] Based on descriptive statistics on reported toxicities. Safety profile of olanzapine based on weight [ Time Frame: up to 1 month ] Based on descriptive statistics on reported body weight Safety profile of olanzapine based on Pediatric Adverse Event Rating Scale

2017 Clinical Trials

166. Population Pharmacokinetics of Antiepileptic in Pediatrics

and renal function; estimate maximum, minimum and exposure concentrations from the individual pharmacokinetic parameters for each patient; propose adaptations of doses for certain classes of children (according to age, weight etc.) and individualize the doses. Condition or disease Intervention/treatment Epilepsy Biological: Valproic acid Biological: carbamazepine Biological: phenobarbital Biological: phenytoin Biological: levetiracetam Biological: lamotrigine Biological: topiramate Biological (...) for the following antiepileptic drugs in children: valproic acid, carbamazepine, phenobarbital, phenytoin, levetiracetam, lamotrigine, topiramate, oxcarbazepine, stiripentol and clobazam. The interest of these models is multiple: describe the pharmacokinetics of these molecules in children and explain the interindividual variability of concentrations through covariates such as weight, age, co-treatments and renal function; estimate maximum, minimum and exposure concentrations from the individual pharmacokinetic

2017 Clinical Trials

167. LEAn Body Mass Normalization of OXaliplatin Based Chemotherapy

Pre-existing peripheral neuropathy of any grade. Prior treatment with neurotoxic chemotherapy such as Oxaliplatin, cisplatin, taxanes, or vinca alkaloids. Treatment with 1) the anticonvulsants carbamazepine (e.g., Tegretol®), phenytoin (e.g., Dilantin®), valproic acid (e.g. Depakine®), gabapentin (Neurontin®); pregabalin (Lyrica®); 2) the following neurotropic agents: venlafaxine (Effexor®), desvenlafaxine (Pristiq®), milnacipran (Savella®) or duloxetine (Cymbalta®); 3) Tricyclic antidepressants (...) Cancer de Montpellier - Val d'Aurelle Information provided by (Responsible Party): Institut du Cancer de Montpellier - Val d'Aurelle Study Details Study Description Go to Brief Summary: Cytotoxic chemotherapy is usually scaled to the body surface area (BSA), and is currently not adjusted to the body proportions of lean and fat (i.e. body composition) of individual patients. Patients with low muscle mass behave like patients "overdosed" with chemotherapy resulted in dose-limiting toxicities (e.g. dose

2017 Clinical Trials

168. Epacadostat in Combination With Pembrolizumab and Azacitidine in Subjects With Metastatic Colorectal Cancer

), flutamide, geftinib, gemfibrozil, glycyrrhetinic acid glycyrrhizin, imatinib, imipramine, ketoconazole, linoleic acid, mefenamic acid, mycophenolic acid, niflumic acid, nilotinib, phenobarbital, phenylbutazone, phenytoin, probenecid, propofol, quinidine, ritonavir, Sorafenib, sulfinpyrazone, valproic acid, and verapamil within 21 days of cycle 1 day 1. Note: Propofol, when used for short-term sedation during surgical/biopsy procedures, is allowed after consultation with the protocol chair or sponsor (...) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. Has a known additional malignancy that is progressing or requires active

2017 Clinical Trials

169. Pembrolizumab and Vorinostat in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, or Hodgkin Lymphoma

: subjects with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study; Note: if subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy Has taken valproic acid, or another histone deacetylase inhibitor, within 2 weeks prior to study day 1 Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin (...) Diffuse Large B-Cell Lymphoma Refractory Follicular Lymphoma Refractory Mediastinal (Thymic) Large B-Cell Cell Lymphoma Other: Laboratory Biomarker Analysis Biological: Pembrolizumab Drug: Vorinostat Phase 1 Detailed Description: PRIMARY OBJECTIVES: I. To assess the safety and tolerability of vorinostat plus pembrolizumab therapy by evaluation of toxicities including: type, frequency, severity, attribution, time course and duration. II. To determine the maximum tolerated dose (MTD) and the recommended

2017 Clinical Trials

170. Dual Functional Mesoporous Silicon Nanoparticles Enhance the Radiosensitivity of VPA in Glioblastoma (PubMed)

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

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2017 Translational oncology

171. Histone deacetylase inhibitors potentiate photodynamic therapy in colon cancer cells marked by chromatin-mediated epigenetic regulation of CDKN1A (PubMed)

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

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2017 Clinical epigenetics

172. Valproate and sodium butyrate attenuate manganese-decreased locomotor activity and astrocytic glutamate transporters expression in mice (PubMed)

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

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2017 Neurotoxicology

173. Tolerated drugs in subjects with severe cutaneous adverse reactions (SCARs) induced by anticonvulsants and review of the literature (PubMed)

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

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2017 Clinical and molecular allergy : CMA

174. How popular is quackery? A Harris Poll answers: Very, particularly among Millennials!

to post comments By Eric Lund (not verified) on 11 May 2016 to post comments By Daniel Corcos (not verified) on 11 May 2016 Seizures, huu? I note the particularly hepatotoxic valproic acid (Depakote™) is an anti-seizure prescribed off-label as a 'mood stabilizer'. Bentley is an asshole: A number of district attorneys across North Alabama are issuing public notices that Kratom is now illegal statewide. This includes the sale and possession of Kratom or any product containing Kratom. If you’re caught (...) , the government was levying taxes from users and shops involved in the opium trade. Because of the increasing opium costs, many users were switching to kratom to manage their withdrawal symptoms. However, the launch of the Greater East Asia War in 1942 and declining revenues from the opium trade pushed the Thai government into action to curb and suppress competition in the opium market by making kratom illegal. This is not 'woo'. It is another example of efficatious natural herbs butting up against more toxic

2016 Respectful Insolence

175. Uptravi (selexipag) - pulmonary arterial hypertension

Endothelin receptor antagonist GC Gas Chromatography GCP Good Clinical Practice GLP good laboratory practice GMP Good Manufacturing Practice HCl Hydrochloric acid HIV Human immunodeficiency virus HPAH Heritable pulmonary arterial hypertension (formerly familial PAH) HPLC(/DAD) High performance liquid chromatography (/Diode Array Detector) ICH International Conference on Harmonisation IMP Investigational medicinal product IPAH Idiopathic pulmonary arterial hypertension IPC In-process control IP receptor (...) manufacturing process, therefore the CHMP recommended that further stability data from the first three continuous Process Verification Batches to demonstrate consistent quality of the active substance should be provided. The stability of the active substance was also investigated one batch under stress conditions according to the Notes for Guidance Q1A (R2) and ICH Q1B. Samples were exposed to heat and moisture, light (solid state and solution), acidic, basic and oxidising conditions. Hydrolysis occurred

2016 European Medicines Agency - EPARs

176. Osteoporosis: Prevention and Treatment

) • Thiazolidinediones (pioglitazone/Actos®, rosiglitazone/Avandia®) Miscellaneous • Anticonvulsants (phenytoin or phenobarbital > carbamazepine or valproic acid) b • Heparins (unfractionated > low molecular weight) Possible risk Miscellaneous • Lithium • Selective serotonin reuptake inhibitors • Antipsychotics (may cause hyperprolactinemia) • Excessive supplemental fluoride • Proton pump inhibitors • Topiramate >, greater than; >>, much greater than. a Inhaled beclomethasone (>1600 µg gaily) is associated with risk (...) acid, teriparatide, or denosumab; fractures occurring despite treatment; considering discontinuation of therapy; etc. b Lowest T-score from femoral neck, total hip, or combination of lumbar vertebra. Wards triangle is not predictive of fracture risk [D]. c If patient has had fracture without significant trauma, consider other causes of bone abnormality, e.g., malignancy. d Lifestyle = ensure appropriate intake of calcium and vitamin D, along with weight bearing exercise. 3 UMHS Osteoporosis

2013 University of Michigan Health System

177. 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

178. 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

179. 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

180. 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

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