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Valproic Acid Toxicity

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181. 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

182. 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

183. 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

184. 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

185. A Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma

and procedures. Are pregnant or breastfeeding. Infection with HIV or hepatitis B or C. Patients on immunosuppressive agents. Requiring concurrent administration of valproic acid. Patients with diverticulitis, intra-abdominal abscess, or GI obstruction Any contraindication to oral agents. Another active malignancy ≤ 3 years prior to registration with the exception of non-melanotic skin cancer or carcinoma-in-situ of any type. Unwilling or unable to follow the study schedule for any reason. Evidence of ascites (...) study drug-related toxicities [ Time Frame: 4 years ] Progression free survival (PFS) status at 6, 12 and 24 months. [ Time Frame: 2 years ] Overall survival (OS) [ Time Frame: 4 years ] OS at 6 months, at 1, 2 and 3 years [ Time Frame: 3 years ] Duration of response (DOR) [ Time Frame: 4 years ] Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about

2017 Clinical Trials

186. 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

187. 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

188. Study to Evaluate Effects of Vorinostat and HXTC on Persistent HIV-1 Infection in HIV-Infected Subjects Started on ART

of treatment). Note: In cases of untreated syphilis, participant may re-screen following documentation of adequate treatment of syphilis All male participants expecting to father children within the projected duration of the study. Receipt of compounds with HDAC inhibitor-like activity, such as valproic acid within 30 days prior to screening. Use of any investigational antiretroviral agents within 30 days prior to screening (Visit 1). If the study PI (or designee) or protocol team is unable to construct (...) Outcome Measures Go to Primary Outcome Measures : Number of participants w/ at least one ≥ Grade 3 adverse event including signs/symptoms, lab toxicities, and/or clinical events that is possibly or definitely related to VOR or HXTC any time from the first day of study treatment through the end of study [ Time Frame: Up to end of study, approximately 96 weeks ] Safety data will include local and systemic signs and symptoms, laboratory measures of safety/toxicity, and all adverse and serious adverse

2017 Clinical Trials

189. A Phase IB/II Study of Alectinib Combined With Cobimetinib in Advanced ALK-Rearranged (ALK+) NSCLC

, valproic acid, gabapentin, topiramate or lacosamide. Patients requiring steroids must be at a stable or decreasing dose for at least 1 week prior to enrollment Patients with asymptomatic leptomeningeal disease are eligible for participation in this trial. However, patients who had progression of leptomeningeal disease on alectinib will be required to undergo CNS radiation to meet eligibility. Exclusion Criteria: Participants who have had chemotherapy within 3 weeks prior to entering the study or those (...) on crizotinib, a 7 day washout is sufficient. A shorter washout period may be considered in the event of disease flare, after discussion with the Sponsor. No washout is required if the most recent anti-neoplastic therapy is alectinib. Patients must have recovered from treatment toxicities to ≤ Grade 1 or to their pretreatment levels except for adverse events (AEs) that in the investigator's judgment do not constitute a safety risk for the patient. Patients can either be chemotherapy-naive or have received

2017 Clinical Trials

190. 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

191. 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

192. 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

193. Brilique (ticagrelor)

inhibitory effect and no transport-enhancing effect on the URAT1-mediated [14C]-uric acid uptake. Ticagrelor has a high plasma protein binding (>99%). Ticagrelor is likely to be combined with aspirin. Aspirin is known to displace a number of drugs (tolbutamide, chlorpropamide, methotrexate, phenytoin, probenecid, valproic acid and NSAIDs) from protein binding sites in the blood. Furthermore, as much as 80% of therapeutic doses of salicylic acid is metabolised in the liver. No pre-clinical studies were (...) infarction (MI). Despite the widespread adoption of intensive monitoring and prompt treatment of cardiac electrical instability, thrombolytic therapy, acute invasive interventions, and dual antiplatelet therapy with acetylsalicylic acid (ASA) and thienopyridines, approximately 1 in 3 ACS patients dies, has a repeat MI, or requires re-hospitalisation within 6 months. Current guidelines indicate dual antiplatelet therapy with ASA and clopidogrel for all ACS patients. An electrocardiogram (ECG) shows ST

2011 European Medicines Agency - EPARs

194. Trobalt - retigabine

SAE Serious adverse event SD Standard deviation SmPC Summary of Product Characteristics SPA Special Protocol Assessment SUDEP Sudden unexplained death in epilepsy TEAE Treatment-emergent adverse event TESAE Treatment-emergent serious adverse event TID Three times daily TK Toxicokinetic Tmax Time to maximum concentration / reach Cmax TPM Topiramate US United States UV Ultraviolet VNS Vagus nerve stimulation VPA Valproic acid Vss Steady State Volume of Distribution Medicinal product no longer (...) Central nervous system CrCL Creatinine clearance CSR Clinical Study Report ECF Ethyl Chloroformate ECG Electrocardiogram EMA European Medicines Agency FD Fluorescence Direct FDA Food and Drug Administration GABA Gamma-aminobutyric acid GCP Good Clinical Practice GI Gastrointestinal GLP Good Laboratory Practice GMP Good Manufacturing Practice IA Intraarterial ICH International Conference of Harmonization ID Intradermal ILAE International League Against Epilepsy IP Intraperitoneal IR Immediate release

2011 European Medicines Agency - EPARs

195. Ezogabine (Potiga)

Potiga / ezogabine 31 Number (%) of Patients EZG (N=1365) Preferred Term ISS Integrated Data Cut-off: 30 June 2008 120-Day Safety Data Cut-off: 2 October 2009 Final Safety Data Cut-off: 30 September 2010 Mental status changes 3 (0.2) 3 (0.2) 3 (0.2) Drug toxicity 3 (0.2) 3 (0.2) 5 (0.4) Overdose 3 (0.2) 3 (0.2) 3 (0.2) Abdominal pain 3 (0.2) 3 (0.2) 3 (0.2) Diarrhea 3 (0.2) 3 (0.2) 3 (0.2) Nausea 3 (0.2) 3 (0.2) 4 (0.3) Vomiting 3 (0.2) 3 (0.2) 4 (0.3) Fatigue 3 (0.2) 3 (0.2) 3 (0.2) Urinary tract

2011 FDA - Drug Approval Package

196. I love it when an antivax “study” meant to show how “dirty” vaccines are backfires so spectacularly

found dangerous contaminants, including red blood cells in one vaccine and metal toxicants in every single sample tested – except in one animal vaccine. Using extremely sensitive new technologies not used in vaccine manufacturing, Italian scientists reported they were “baffled” by their discoveries which included single particles and aggregates of organic debris including red cells of human or possibly animal origin and metals including lead, tungsten, gold, and chromium, that have been linked (...) for their research into toxic emissions. Grillo launched the campaign to raise €378,000 for a new EM that would allow the vital work to continue. All culminating in accusations that Gatti and Montanari are using their toy not for environmental activism, but for a profitable business selling analyses through their company Nanodiagnostic Ltd.; and accusations from Montanari that Grillo just raised all that money for them as a way of exploiting them for political gain. Lawyers and defamation suits are involved

2017 Respectful Insolence

198. Inhibition of histone deacetylases in melanoma-a perspective from bench to bedside. (Abstract)

. Some studies proposed that HDAC inhibition may overcome the resistance of melanoma cells to BRAF inhibition. Several inhibitors such as vorinostat, entinostat and valproic acid have recently been tested in phase I and early phase II trials, yet most agents show limited efficacy and tolerability as single agents. The most frequent adverse events of HDAC inhibition comprise haematological toxicity, fatigue, nausea and laboratory abnormalities. Existing evidence supports the hypothesis that HDAC

2016 Experimental Dermatology

199. Temozolomide Accord

identified as the 8-carboxylic acid derivative of temozolomide was observed in mice but not in humans. Toxicology A review of the literature was submitted which described the toxicology aspects of temozolomide. There were no toxicology studies submitted as part of the application. Single dose toxicity studies were performed in mice, rats, and Beagle dogs. The maximum non-lethal dose was 500 mg/m² (oral, i.p.) in mice, 750 (oral) and 1000 mg/m² (i.p.) in rats and 200 (males)-1500 mg/m² (females) in dogs (...) and corticosteriods were to be allowed during the course of the trial. Co-adminstration of sodium valproate was not to be allowed as administration of valproic acid decreases the clearance of temozolomide. If drug therapy other than that specified in the protocol was required prior to or during the study, decisions was to be taken by the investigator to continue or discontinue the patient based on the pharmacology and pharmacokinetics of the non-study medication, the likelihood of an interaction and the time

2010 European Medicines Agency - EPARs

200. Possia - ticagrelor

weak inhibitory effect and no transport-enhancing effect on the URAT1-mediated [14C]-uric acid uptake. Ticagrelor has a high plasma protein binding (>99%). Ticagrelor is likely to be combined with aspirin. Aspirin is known to displace a number of drugs (tolbutamide, chlorpropamide, methotrexate, phenytoin, probenecid, valproic acid and NSAIDs) from protein binding sites in the blood. Furthermore, as much as 80% of therapeutic doses of salicylic acid is metabolised in the liver. No pre-clinical (...) with acetylsalicylic acid (ASA) and thienopyridines, approximately 1 in 3 ACS patients dies, has a repeat MI, or requires re-hospitalisation within 6 months. Current guidelines indicate dual antiplatelet therapy with ASA and clopidogrel for all ACS patients. An electrocardiogram (ECG) shows ST-elevation myocardial infarction (STEMI) or a non-ST elevation (NSTEMI) ACS event. Those with STEMI usually receive accelerated care, including cardiac catheterisation, leading to percutaneous coronary intervention (PCI

2010 European Medicines Agency - EPARs

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