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Valproic Acid Toxicity

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184. Pharmacogenomics and histone deacetylase inhibitors (Full text)

Pharmacogenomics and histone deacetylase inhibitors The histone deacetylase inhibitor valproic acid (VPA) has been used for many decades in neurology and psychiatry. The more recent introduction of the histone deacetylase inhibitors (HDIs) belinostat, romidepsin and vorinostat for treatment of hematological malignancies indicates the increasing popularity of these agents. Belinostat, romidepsin and vorinostat are metabolized or transported by polymorphic enzymes or drug transporters. Thus (...) , genotype-directed dosing could improve pharmacotherapy by reducing the risk of toxicities or preventing suboptimal treatment. This review provides an overview of clinical studies on the effects of polymorphisms on the pharmacokinetics, efficacy or toxicities of HDIs including belinostat, romidepsin, vorinostat, panobinostat, VPA and a number of novel compounds currently being tested in Phase I and II trials. Although pharmacogenomic studies for HDIs are scarce, available data indicate that therapy

2016 Pharmacogenomics PubMed

185. The first Mongolian cases of phenylketonuria in selective screening of inborn errors of metabolism (Full text)

. 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 PubMed

186. A Study of Tolerability and Efficacy of Cannabidiol on Tremor in Parkinson's Disease

currently or in the previous 30 days. History of drug or alcohol dependence; defined by prior inpatient stay(s) for this or that patient stats 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, isoniazid and ketoconazole due to risk of liver injury and clobazam and ketoconazole because of risk of toxic interactions with the study drug

2016 Clinical Trials

187. Entinostat in Chinese Postmenopausal Women Patients With Locally Recurrent or Metastatic Breast Cancer

histone deacetylase inhibitor (Valproic acid, Chidamide etc). Known allergy to any ingredients of entinostat and other drugs in the same class. Women who are pregnant or breast-feeding (premenopausal). For women of childbearing potential, agreement to use a medically approved contraception measures (such as the intrauterine device (IUD), birth control pills or condoms) and to continue its use for the duration of study treatment and for 3 months after the last dose of study treatment. Had received (...) Patients receive entinostat PO on days 1, 8, 15, and 22. Entinostat in combination with exemestane will be repeatedly administered every 28 days in the absence of disease progression or unacceptable toxicity. Exemestane wil be orally administered once daily for up to six months. Drug: Entinostat Given PO Other Names: MS-275 SDNX-275 Drug: Exemestane Given PO Outcome Measures Go to Primary Outcome Measures : Adverse events, 12-lead ECG, blood pressure/pulse, temperature, laboratory parameters

2016 Clinical Trials

188. Study of Cytolytic Viral Activation Therapy (CVAT) for Recurrent/Metastatic Nasopharyngeal Carcinoma

according to the body surface area at day 1 and day 8 in a 28 day-treatment cycle. The treatment cycle of 28 days will be repeated maximum 6 times. The first dose level of gemcitabine will be started at 800 mg/m^2. If no subject suffered the dose limit toxicity, 1000 mg/m^2 and even 1250 mg/m^2 will be started by order. If subjects suffered the dose limit toxicity in 800 mg/m^2, the 600 mg/m^2 will be started. Other Name: Gemmis Drug: Valproic acid Valproic acid will be administrated orally by the fixed (...) (CVAT) had been shown some promising result in pilot study of NPC. In our patient derived xenograft (PDX) animal model drug sensitivity screening, gemcitabine (GEM) was shown to be the most effective drug. Furthermore, CVAT with GEM + Valproic acid (VPA) + ganciclovir (GCV) maintaining chemotherapy may benefit but reduce chemotherapy related side effect and prolonging treatment response duration. The following phase I clinical trial will be proposed to test the optimal combination of these drugs

2016 Clinical Trials

189. Continuous 24h Intravenous Infusion of Mithramycin, an Inhibitor of Cancer Stem Cell Signaling, in People With Primary Thoracic Malignancies or Carcinomas, Sarcomas or Germ Cell Neoplasms With Pleuropulmonary Metastases

anticoagulation (i.e. intralumenal heparin) for venous or arterial access devices is allowed. Patients who are concurrently receiving or requiring any of the following agents, which may increase the risk for mithramycin related toxicities, such as hemorrhage: Thrombolytic agents Aspirin or salicylate-containing products, which may increase risk of hemorrhage Dextran Dipyridamole Sulfinpyrazone Valproic acid Clopidogrel Lactating or pregnant females (due to risk to fetus or newborn, and lack of testing (...) will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. Tables will be constructed to summarize the observed incidence by severity and type of toxicity. Overall response rate [ Time Frame: every 8 weeks until at disease progression ] Response rates will be calculated as the percent of patients whose best response is a CR or PR. Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study

2016 Clinical Trials

190. INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)

agents or other agents used in study. Participants taking an enzyme-inducing anti-epileptic drug (EIAED): phenobarbital, phenytoin, fosphenytoin, primidone, carbamazepine, oxcarbazepine, eslicarbazepine, rufinamide, and felbamate. Participant must be off any EIAEDs for at least 7 days prior to planned start of study treatment. A list of EIAED and other inducers of CYP3A4 is provided. Among non-EIAED, caution is recommended with use of valproic acid due to potential for drug interaction. Participants (...) with Standard Therapy [ Time Frame: 2 years ] Secondary Outcome Measures : Incidence of Treatment-Emergent Adverse Events [ Time Frame: 2 years ] Safety will be assessed by quantifying the toxicities and grades experienced by subjects, including serious adverse events (SAEs). The following will also be measured as part of safety: laboratory safety assessments, KPS status, vital signs and physical examinations. Progression Free Survival Among Experimental Arms And Biomarker Groups [ Time Frame: 2 years

2016 Clinical Trials

191. Olaparib, Cediranib Maleate, and Standard Chemotherapy in Treating Patients With Small Cell Lung Cancer

washout period for strong inhibitors is 2 weeks and at least one week for moderate inhibitors; the required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 4 weeks for other agents Patients requiring concomitant therapy with phenytoin, phenobarbital, carbamazepine, or valproic acid Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (...) and etoposide IV over 60 minutes on days 1, 2, and 3. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive treatment as in Arm I and also receive cediranib maleate orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients in Arm I who have stable disease, partial, or a complete response are randomized to receive

2016 Clinical Trials

192. Trial of Panobinostat in Children With Diffuse Intrinsic Pontine Glioma

. Patients have had valproic acid within 28 days prior to enrollment. Patients have had prior bone marrow transplant. NEUROLOGICAL STATUS - Patients have significant acute deterioration in neurologic status in 72 hours prior to enrollment, in the opinion of the treating physician. GASTROINTESTINAL Patients have impairment of GI function or GI disease that may significantly alter the absorption of panobinostat; for example severe inflammatory bowel disease. Patients have diarrhea > CTCAE grade 2. SYSTEMIC (...) panobinostat (LBH589). Drug: LBH589 STRATUM 1: Recurrent/progressive DIPG. Panobinostat will be given every other day, 3 times/ week, p.o. preferably on Mon/Wed/Fri, for three weeks, followed by one week off of therapy. Three weeks of therapy plus the one week rest period (4 weeks) will constitute one course. Treatment will continue for up to 26 courses (about 2 years) barring progressive disease or unacceptable toxicity. STRATUM 2: Non-progressed DIPG. Panobinostat will be given every other day, 3 times

2016 Clinical Trials

193. Pilot Trial of the Effect of Vorinostat and AGS-004 on Persistent HIV-1 Infection

, probucol, procanimide, quinidine, sotalol, sparfloxacxin, terfenadine, thioridizine. Receipt of compounds with HDAC inhibitor-like activity, such as valproic acid within 30 days prior to screening. Potential participants may enroll after a 30-day washout period. Use of any investigational antiretroviral agents within 30 days prior to Screening (Visit 1). Use of antiretroviral medications that cannot be co-administered with Vorinostat within the 4 weeks of the first dose and anytime thereafter while (...) baseline to post-VOR/AGS. Occurrence of 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 AGS-004 any time from the first day of study treatment through the end of study. [ Time Frame: First day of study treatment to between approximately week 73 and week 96 on study ] Safety data will include local and systemic signs and symptoms, laboratory measures of safety/toxicity, and all adverse and serious

2016 Clinical Trials

194. A Trial Evaluating Efficacy & Safety of RVD +/- Panobinostat in Transplant Eligible, Newly Diagnosed Multiple Myeloma (NDMM)

peripheral neuropathy or grade 1 peripheral neuropathy with pain on clinical examination at screening Patient received prior treatment with DAC inhibitors including Panobinostat Patient needing valproic acid for any medical condition during the study or within 5 days prior to first administration of panobinostat/study treatment. Patient taking any anti-cancer therapy concomitantly (bisphosphonates are permitted only if commenced prior to the start of screening period) Patient who received: prior anti (...) continuously in both arms, increasing to 15mg/day after the first 84 day cycle. Panobinostat were to be dosed at 10mg three times a week, every other week. Total planned duration of maintenance therapy were to be 3 years. Patients were to remain on study treatment until they complete the maintenance phase, or until they experience disease progression, unacceptable toxicity, or at the discretion of the Investigator. Condition or disease Intervention/treatment Phase Multiple Myeloma Drug: Revlimid Drug

2016 Clinical Trials

195. Investigate Safety, Tolerability, PK, PD and Efficacy of Risdiplam (RO7034067) in Infants With Type1 Spinal Muscular Atrophy

or longer, of the following medications within 90 days prior to enrollment: riluzole, valproic acid, hydroxyurea, sodium phenylbutyrate, butyrate derivatives, creatine, carnitine, growth hormone, anabolic steroids, probenecid, agents anticipated to increase or decrease muscle strength, agents with known or presumed histone deacetylase (HDAC) inhibitory effect, medications known to or suspected of causing retinal toxicity (deferoxamine, topiramate, latanoprost, niacin, rosiglitazone, tamoxifen (...) ) Protein Levels in Blood [ Time Frame: Days 1, 14 (Part 1 only), 28, 119, 245, 364, 609, 728 ] Survival Motor Neuron (SMN) Messenger Ribonucleic Acid (mRNA) Levels in Blood [ Time Frame: Days 1, 14 (Part 1 only), 28, 245, 364, 609, 728 ] Change From Baseline in the Total Raw Score of the BSID-III Gross Motor Scale at Month 12 and 24 [ Time Frame: Baseline, Month 12, Month 24 ] Percentage of Infants who Achieve the Attainment Levels of the Motor Milestones Assessed in the Hammersmith Infant Neurological

2016 Clinical Trials

196. Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors

prednisone equivalent) or other systemic immunosuppressive medications within 2 weeks Concomitant therapy with valproic acid/valproate-containing therapies Concomitant therapy with allopurinol and other xanthine oxidase inhibitors History of known risks factors for bowel perforation Symptomatic ascites or pleural effusion Major surgery within 28 days before Cycle 1 Day 1 Active infection requiring within 2 weeks prior to first dose of study drug Patients who have HIV, Hepatitis B or C Conditions (...) to Primary Outcome Measures : Safety and Tolerability of INCB001158 as a single agent and in combination with Pembrolizumab: Incidence of Adverse Events [ Time Frame: Every 28 days (single agent INCB001158) or 21 days (INCB001158 in combination with Pembrolizumab) from study start until disease progression or unacceptable toxicity, assessed for an expected average of 6 months ] Evaluation of adverse events (AEs) and changes in laboratory values, vital signs, and physical examinations. Secondary Outcome

2016 Clinical Trials

197. A Study of PDR001 in Combination With LCL161, Everolimus or Panobinostat

/Everolimus Patients requiring treatment with moderate CYP3A4 inhibitors Patients requiring treatment with a strong CYP3A4 inhibitor or inducer Additional exclusion criteria for PDR001/Panobinostat- Patient who received DAC inhibitors Patient needing valproic acid during the study or within 5 days prior to first dose Patients requiring medications that are sensitive CYP2D6 substrates areCYP2D6 substrates with a narrow therapeutic index or are anti-arrhythmic drugs/drugs with QT-prolongation risks Patients (...) escalation. Drug: QBM076 Experimental: NSCLC- PDR001 + QBM076 Dose escalation. Drug: QBM076 Experimental: CRC - PDR001 + HDM201 Dose escalation. Drug: HDM201 Experimental: RCC - PDR001 + HDM201 Dose escalation. Drug: HDM201 Outcome Measures Go to Primary Outcome Measures : Phase 1: Incidence of dose limiting toxicities (DLTs) [ Time Frame: During the first two cycles ] cycle = 28 days Frequency of dose interruptions and reductions [ Time Frame: Through study completion, an average of 6 months ] Frequency

2016 Clinical Trials

198. Study of Lenalidomide With Vorinostat in Pediatric Patients With High Grade or Progressive CNS Tumors

factors within 1 week of study entry Must be on a stable or decreasing dose of steroids for 1 week prior Must not be receiving any chemo, biologic, or radiation therapy Must not be receiving enzyme inducing anticonvulsants or valproic acid Must not be receiving pro-thrombotic agents Karnofsky or Lansky performance status ≥50% Life expectancy of greater than 8 weeks Patients must have normal organ and marrow function, including Absolute neutrophil count ≥1,000/mcL Platelets ≥100,000/mcL Pulse oximetry (...) , unstable angina pectoris, cardiac arrhythmia, patients receiving enzyme inducing anticonvulsants, patients receiving valproic acid, patients receiving antiplatelet agents (aspirin, anti-inflammatory drugs), or psychiatric illness/social situations that would limit compliance with study requirements. Pregnant women are excluded from this study due to the potential for teratogenic effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment

2016 Clinical Trials

199. Characterization of Immune Semaphorin in Non Alcoholic Fatty Liver Disease and NASH

mass index justifying a surgery for obesity (BMI ≥ 40 kg / m2 or BMI ≥ 35 kg / m2 with comorbidities) Consumption of alcohol <20 g / d Patients affiliated to a social security insurance Patients who signed the informed consent Exclusion Criteria: Hemochromatosis Toxic hepatitis Deficiency of alpha-1-antitrypsin Wilson's disease Liver Autoimmune disease (primary biliary cirrhosis, autoimmune hepatitis) Hepatitis B, C Drug-induced hepatitis Presence of HIV status Corticosteroids, amiodarone, valproic (...) acid, tamoxifen, anti-inflammatory drugs, lipid lowering agents, testosterone agonists or beta-adrenergic antagonists, orlistat. Pregnant or breastfeeding women Incarcerated patients or patient under guardianship 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 the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT

2016 Clinical Trials

200. Entinostat in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors

anti-cancer agents are not eligible Patients requiring concurrent administration of valproic acid are not eligible for this trial Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial Patients with a BSA ˂ 1.17 m^2 at time of study enrollment are not eligible Patients who are not able to swallow intact tablets are not eligible Patients with a known history of corrected QT (QTc (...) tolerated dose (MTD) and/or recommended phase 2 dose of entinostat administered as a single-agent, once weekly to children with recurrent or refractory solid tumors. II. To define and describe the toxicities of entinostat administered as a single agent, once weekly to children with recurrent or refractory solid tumors. III. To characterize the pharmacokinetics of entinostat in children with recurrent or refractory cancer. SECONDARY OBJECTIVES: I. To preliminarily define the antitumor activity

2016 Clinical Trials

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