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Valproic Acid Toxicity

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181. 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

182. 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

183. 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

184. Seizure Treatment in Glioma

Medical Center Information provided by (Responsible Party): j.a.f.koekkoek, Leiden University Medical Center Study Details Study Description Go to Brief Summary: Currently, treatment with a specific anti-epileptic drug mainly depends on the physicians' preference, as there are no studies supporting the use of one specific anticonvulsant in glioma patients. The overall aim of this randomized controlled trial is to directly compare the effectiveness of treatment with levetiracetam or valproic acid (...) in glioma patients with a first seizure. Condition or disease Intervention/treatment Phase Glioma Drug: Levetiracetam Drug: Valproic Acid Phase 4 Detailed Description: Currently, treatment of glioma patients with a specific anti-epileptic drug (AED) mainly depends on the physicians' preference, as there is no robust evidence from randomized controlled trials supporting the use of one specific anticonvulsant above the other in glioma patients. Levetiracetam and valproic acid are the most commonly used

2017 Clinical Trials

185. Study of MK-2118 Administered as Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab (MK-3475) or by Subcutaneous Injection in Combination With Pembrolizumab in the Treatment of Adults With Advanced/Metastatic Solid Tumors or Lymph

: strong/moderate Cytochrome P450 2C9 (CYP2C9) inhibitors, such as: amiodarone, felbamate, fluconazole, miconazole, piperine, oxandrolone, fluorouracil and its derivatives (combination drug tegafur/gimeracil/oteracil [TS-1], Uftoral [UFT], tegafur, carmofur, doxifluridine, capecitabine), sulfaphenazole, cyclosporine, bucurol, tienilic acid; UGT1A3 inhibitors (including ritonavir, quinidine, probenecid, and valproic acid); or strong carbonyl reductase (CBR) inhibitors (including quercetin, menadione (...) : Dose-limiting Toxicities (DLTs) [ Time Frame: Arms 1, 2 & 3: Cycle 1 (Up to 21 days); Arm 4: Cycles 1 & 2 (Up to 35 days) ] A DLT is defined as the following toxicities, if related to study treatment: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia (Grade 4 thrombocytopenia of any duration, Grade 3 thrombocytopenia with clinically significant bleeding); Non-hematologic adverse event (AE) ≥Grade 3 (with exceptions); Grade 3 or Grade 4

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. 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

188. BV-CHEP Chemotherapy for Adult T-cell Leukemia or Lymphoma

, ketoconazole, itraconazole, ritonavir, macrolide antibiotics, erythromycin phenytoin, phenobarbital, carbamazepine, and valproic acid). Patients with a parenchymal brain lesion thought to be consistent with active lymphoma on screening CT/MRI. Of note, patients with cerebrospinal fluid (CSF) involvement alone are not excluded. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using (...) . After 6 cycles of BV + CHEP, responders (CR, PR or SD) who are not eligible for BMT and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV, every 21 days) until disease progression, withdrawal due to toxicity or death. Drug: Brentuximab Vedotin Brentuximab Vedotin will be given at 1.8 mg/kg IV over approximately 30 minutes on D1 every 21 days for 4-6 cycles. Responders (CR, PR or SD) who are not eligible for bone marrow transplant (BMT) and have CD30-positive ATLL

2017 Clinical Trials

189. 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

190. 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

191. 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

192. 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

193. 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

194. 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

195. Postnatal treatment using curcumin supplements to amend the damage in VPA-induced rodent models of autism. Full Text available with Trip Pro

Postnatal treatment using curcumin supplements to amend the damage in VPA-induced rodent models of autism. Valproic acid (VPA) is used as a first-line antiepileptic agent and is undergoing clinical trials for use as a treatment for many disorders. Mothers undergoing VPA treatment during early pregnancy reportedly show increased rates of autism among their offspring. The benefits of curcumin supplementation were investigated using an animal model of VPA-induced autism.The study was performed (...) using a rodent model of autism by exposing rat fetuses to valproic acid (VPA) on the 12.5th day of gestation. At 7 days from their birth, the animals were supplemented with a specific dose of curcumin. Forty neonatal male Western Albino rats were divided into four groups. Rats in group I received only phosphate-buffered saline, rats in group II were the prenatal VPA exposure newborns, rats in group III underwent prenatal VPA exposure supplemented with postnatal curcumin, and rats in group IV were

2017 BMC Complementary and Alternative Medicine

196. 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

197. 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

198. 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

199. Fingerprinting of neurotoxic compounds using a mouse embryonic stem cell dual luminescence reporter assay Full Text available with Trip Pro

used drugs (including valproic acid and tyrosine kinase inhibitors). Different classes of compounds showed distinct concentration-response profiles. Plotting of the lowest observed adverse effect concentrations (LOAEL) of the neuronal promoter activity against the general promoter activity or against cytotoxicity, allowed the differentiation between neurotoxic/DNT substances and non-neurotoxic controls. Reporter activity responses in neurons were more susceptible to neurotoxic compounds than (...) the reporter activities in ESCs from which they were derived. To relate the effective/toxic concentrations found in our study to relevant in vivo concentrations, we used a reverse pharmacokinetic modeling approach for three exemplary compounds (teriflunomide, geldanamycin, abiraterone). The dual luminescence reporter assay described in this study allows high-throughput, and should be particularly useful for the prioritization of the neurotoxic potential of a large number of compounds.

2016 Archives of toxicology

200. The first Mongolian cases of phenylketonuria in selective screening of inborn errors of metabolism Full Text available with Trip Pro

. Blood amino acids and acylcarnitines were checked in the patients who had abnormal GC/MS analyses. Mutation analysis was done in the patients, who were suspected having specific inborn errors of metabolism by mass spectrometric analysis.One hundred thirty-nine children had normal urinary organic acid analyses. Thirty one had metabolites of valproic acid, 17 had non- or hypoketotic dicarboxylic aciduria, 14 had tyrosiluria, 12 had ketosis, 4 had elevation of lactate and pyruvate, 3 had increased (...) The first Mongolian cases of phenylketonuria in selective screening of inborn errors of metabolism Inborn errors of metabolism (IEM) are rare genetic disorders in which a single gene defect causes a clinically significant block in a metabolic pathway. Clinical problems arise due to either accumulation of substrates that are toxic or interfere with normal function, or deficiency of the products that are used to synthesize essential compounds. There is no report of screening results or confirmed

2016 Molecular genetics and metabolism reports

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