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Valproic Acid Toxicity

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21. A Phase II Trial of Valproic Acid in Patients with Advanced, Radioiodine-Resistant Thyroid Cancers of Follicular Cell Origin (PubMed)

A Phase II Trial of Valproic Acid in Patients with Advanced, Radioiodine-Resistant Thyroid Cancers of Follicular Cell Origin Valproic acid (VA) is a histone deacetylase (HDAC) inhibitor that has antiproliferative effects on several types of cancer, including thyroid cancer. In addition, VA has been reported to upregulate the sodium-iodine symporter in thyroid cancer cells and increases radioiodine uptake in preclinical studies. The aim of this study was to assess the antiproliferative effects (...) with grade-3 hepatic toxicity, one with disease progression and one for noncompliance. Four of 13 patients had decreased stimulated serum thyroglobulin with VA treatment. None of the patients had complete or partial responses based on Response Evaluation Criteria in Solid Tumors (RECIST), and six patients had disease progression.Valproic acid does not increase radioiodine uptake and does not have anticancer activity in patients with advanced, radioiodine-negative thyroid cancer of follicular cell origin

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2016 Clinical endocrinology

22. Phase II clinical study of valproic acid plus cisplatin and cetuximab in recurrent and/or metastatic squamous cell carcinoma of Head and Neck-V-CHANCE trial. (PubMed)

acetylation of peripheral blood mononuclear cell, tested on blood samples at baseline and at different time points during treatment.Overall, this study could provide a less toxic and more effective first-line chemotherapy regimen in patients with recurrent/metastatic squamous cell carcinoma of the head and neck by demonstrating the feasibility and efficacy of cisplatin/cetuximab plus valproic acid. Moreover, correlative studies could help to identify responder patients, and will add insights (...) Phase II clinical study of valproic acid plus cisplatin and cetuximab in recurrent and/or metastatic squamous cell carcinoma of Head and Neck-V-CHANCE trial. Recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN) has a poor prognosis and the combination of cisplatin and cetuximab, with or without 5-fluorouracil, is the gold standard treatment in this stage. Thus, the concomitant use of novel compounds represents a critical strategy to improve treatment results. Histone

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2016 BMC Cancer

23. Data on novel DNA methylation changes induced by valproic acid in human hepatocytes (PubMed)

Data on novel DNA methylation changes induced by valproic acid in human hepatocytes Valproic acid (VPA) is a widely prescribed antiepileptic drug in the world. Despite its pharmacological importance, it may cause liver toxicity and steatosis. However the exact mechanism of the steatosis formation is unknown. The data presented in this DIB publication is used to further investigate the VPA-induced mechanisms of steatosis by analyzing changes in patterns of methylation. Therefore, primary human

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2017 Data in brief

24. Valproic acid in combination with all-trans retinoic acid and intensive induction therapy for acute myeloid leukemia in older patients. (PubMed)

Valproic acid in combination with all-trans retinoic acid and intensive induction therapy for acute myeloid leukemia in older patients. The outcome of patients with acute myeloid leukemia who are older than 60 years has remained poor because of unfavorable disease characteristics and patient-related factors. The randomized German-Austrian AML Study Group 06-04 protocol was designed on the basis of in vitro synergistic effects of valproic acid (VPA) and all-trans retinoic acid with chemotherapy (...) . Between 2004 and 2006, 186 patients were randomly assigned to receive 2 induction cycles with idarubicin, cytarabine, and all-trans retinoic acid either with VPA or without (STANDARD). In all patients, consolidation therapy was intended. Complete remission rates after induction tended to be lower in VPA compared with STANDARD (40% vs 52%; P = .14) as a result of a higher early death rate (26% vs 14%; P = .06). The main toxicities attributed to VPA were delayed hematologic recovery and grade 3/4

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2014 Blood

25. Massive scalp hematoma: An unusual presentation of valproic acid toxicity (PubMed)

Massive scalp hematoma: An unusual presentation of valproic acid toxicity Valproic acid (VPA) is a commonly used broad-spectrum antiepileptic drug especially in children, with various side-effects reported with its usage. Hematologic toxicity is dose related and intracranial bleeding complications have been reported. We are reporting a rare case of massive scalp hematoma requiring surgical intervention, following a trivial fall associated with high-VPA levels.

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2012 Annals of Indian Academy of Neurology

26. Valproic Acid Toxicity

Valproic Acid Toxicity Valproic Acid Toxicity 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 Valproic Acid Toxicity Valproic Acid (...) Toxicity Aka: Valproic Acid Toxicity , Valproate Toxicity , Depakote Toxicity , VPA Toxicity II. Mechanism is a simple 2-n-propylpentanoic acid Eight carbon branched-chain carboxylic acid Metabolism: Three primary mechanisms Hepatic Glucuronidation (50%) Glucuronic acid conjugation occurs in the liver Primary metabolism pathway Non-hepatic metabolism Mitochondrial Beta-oxidation (40%) Primary and preferred non-hepatic pathway undergoes beta-oxidation in the mitochondria Requires acetyl-coA to enter

2015 FP Notebook

27. Chemoprevention of Head and Neck Squamous Cell Carcinoma (HNSCC) With Valproic Acid

Chemoprevention of Head and Neck Squamous Cell Carcinoma (HNSCC) With Valproic Acid Chemoprevention of Head and Neck Squamous Cell Carcinoma (HNSCC) With Valproic Acid - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before (...) adding more. Chemoprevention of Head and Neck Squamous Cell Carcinoma (HNSCC) With Valproic Acid (GAMA) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT02608736 Recruitment Status : Completed First Posted : November 20, 2015 Last Update Posted : February 1, 2018 Sponsor: Barretos Cancer Hospital

2015 Clinical Trials

28. Liquid chromatography–tandem mass spectrometry method for simultaneous determination of valproic acid and its ene-metabolites in epilepsy patient plasma (PubMed)

Liquid chromatography–tandem mass spectrometry method for simultaneous determination of valproic acid and its ene-metabolites in epilepsy patient plasma A simple and high throughput method was developed and validated for simultaneous determination of valproic acid and its two toxicant ene-metabolites, 2-enevalproic acid and 4-enevalproic acid in epilepsy patient plasma using liquid chromatography-tandem mass spectrometry. Probenecid was used as internal standard and solid-phase extraction (...) was selected for sample preparation. A chromatographic separation was performed on an Agilent Poroshell SB-C18 column (50 mm×4.6 mm i.d., 2.7 μm) by an optimized gradient elution at a flow rate of 0.9 mL/min. The total run time was 7 min. Electrospray ionization was used in negative ion mode by multiple reaction monitoring of the precursor-to-product ion transitions at m/z 143.0→143.0 for valproic acid, m/z 140.9→140.9 for 2-enevalproic acid and 4-enevalproic acid for their poor fragments, and m/z 283.9

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2015 Journal of Pharmaceutical Analysis

29. Valproic acid-induced hepatotoxicity in alpers syndrome is associated with mPTP opening dependent apoptotic sensitivity in an iPSC model. (PubMed)

Valproic acid-induced hepatotoxicity in alpers syndrome is associated with mPTP opening dependent apoptotic sensitivity in an iPSC model. Valproic acid (VPA) is widely used to treat epilepsy, migraine, chronic headache, bipolar disorder, and as adjuvant chemotherapy, but potentially causes idiosyncratic liver injury. Alpers-Huttenlocher syndrome (AHS), a neurometabolic disorder caused by mutations in mitochondrial DNA polymerase gamma (POLG), is associated with an increased risk of developing (...) is mediated by mPTP opening. Toxicity models in genetic diseases using iPSCs enable the evaluation of drugs for therapeutic targets.© 2015 by the American Association for the Study of Liver Diseases.

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2015 Hepatology

30. Results of phase 2 randomized study of low-dose decitabine with or without valproic acid in patients with myelodysplastic syndrome and acute myelogenous leukemia. (PubMed)

remission, overall response, or survival. Subset analyses did not demonstrate a benefit within the MDS or AML categories. Toxicities-particularly neurotoxicities-were higher with the combination arm.Adding valproic acid to decitabine was not associated with improved outcome in the treatment of patients with MDS or elderly patients with AML. Future therapies may consider combining hypomethylating agents with better HDAC inhibitors and using different schedules.© 2014 American Cancer Society. (...) Results of phase 2 randomized study of low-dose decitabine with or without valproic acid in patients with myelodysplastic syndrome and acute myelogenous leukemia. Hypomethylating agents have demonstrated activity in patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Preclinical and single-arm trials have suggested that adding histone deacetylase (HDAC) inhibitors may synergize the epigenetic modulation of hypomethylating agents and improve treatment results.The

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2015 Cancer

31. Vidaza and Valproic Acid Post Allogeneic Transplant for High Risk AML and MDS

progression-free survival, relapse, and toxicity. The primary toxicity endpoint from this will be cytopenias and infections. Condition or disease Intervention/treatment Phase Acute Myelogenous Leukemia AML Myelodysplastic Syndrome MDS Drug: Vidaza and Valproic Acid Phase 2 Detailed Description: To assess the combination of valproic acid and azacitidine in preventing relapse in patients with high-risk Acute Myeloid Leukemia (AML) and myelodysplastic syndrome (MDS) after allogeneic stem cell transplant (...) Vidaza and Valproic Acid Post Allogeneic Transplant for High Risk AML and MDS Vidaza and Valproic Acid Post Allogeneic Transplant for High Risk AML and MDS - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more

2014 Clinical Trials

32. Adjuvant Sunitinib or Valproic Acid in High-Risk Patients With Uveal Melanoma

malate orally (PO) daily for 6 months in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive valproic acid PO daily for 6 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 150 (...) for: resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: Sunitinib Patients receive sunitinib malate PO daily for 6 months in the absence of disease progression or unacceptable toxicity Drug: Sunitinib Given PO Other Names: Sunitinib malate Sutent SU11248 Experimental: Valproic acid Patients receive valproic acid PO daily for 6 months in the absence of disease progression or unacceptable toxicity Drug: Valproic Acid Given PO Other Names: VPA Valproate Valproate sodium Depakote

2014 Clinical Trials

33. Stevens-Johnson Syndrome triggered by a combination of clobazam, lamotrigine and valproic acid in a 7-year-old child (PubMed)

Stevens-Johnson Syndrome triggered by a combination of clobazam, lamotrigine and valproic acid in a 7-year-old child Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) are diseases within the spectrum of severe cutaneous adverse reactions affecting skin and mucous membranes. Antiepileptic drugs (AEDs) are used in combination, leading to potential pharmacokinetic or pharmacodynamic interactions, causing more adverse effects than might occur when the AED is taken as monotherapy (...) . Here, we report a rare case of SJS triggered by a combination of clobazam, lamotrigine and valproic acid in a 7-year-old boy. Because of inadequate seizure control, lorazepam was replaced with clobazam. Four weeks after the addition of clobazam, the patient developed SJS with a generalized rash, fever, with liver and kidney involvement, and eosinophilia one week after the initiation of treatment. All antiepileptic drugs were discontinued, and intravenous methylprednisolone, prophylactic systemic

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2014 Annals of burns and fire disasters

34. Sorafenib Tosylate, Valproic Acid, and Sildenafil Citrate in Treating Patients With Recurrent High-Grade Glioma

for: resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: Treatment (sorafenib tosylate, valproic acid, sildenafil) Patients receive sorafenib tosylate PO, valproic acid* PO, and sildenafil citrate PO BID for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. * NOTE: Patients not receiving antiepileptic therapy begin valproic acid 1 week prior to the first day of sorafenib tosylate and sildenafil citrate. Drug: sorafenib tosylate (...) Sorafenib Tosylate, Valproic Acid, and Sildenafil Citrate in Treating Patients With Recurrent High-Grade Glioma Sorafenib Tosylate, Valproic Acid, and Sildenafil Citrate in Treating Patients With Recurrent High-Grade Glioma - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved

2013 Clinical Trials

35. A Study to Evaluate the Safety and Tolerability of Valproic Acid in Healthy Volunteers or Trauma Patients

(Depacon) Valproic acid by IV infusion over one hour Drug: Valproic Acid By infusion over 1 hour Other Name: Depacon Placebo Comparator: Isotonic saline solution The placebo administered by IV infusion over 1 hour Drug: Isotonic saline solution By infusion over 1 hour Outcome Measures Go to Primary Outcome Measures : Dose limiting toxicity (DLT) [ Time Frame: Subjects will be monitored for 4 days after the one hour infusion. Dose escalation may occur if less than 2 subjects in any cohort of 8 (...) A Study to Evaluate the Safety and Tolerability of Valproic Acid in Healthy Volunteers or Trauma Patients A Study to Evaluate the Safety and Tolerability of Valproic Acid in Healthy Volunteers (Part 1) - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please

2013 Clinical Trials

36. Valproic Acid and Topiramate Induced Hyperammonemic Encephalopathy in a Patient With Normal Serum Carnitine (PubMed)

Valproic Acid and Topiramate Induced Hyperammonemic Encephalopathy in a Patient With Normal Serum Carnitine A 17-year-old female developed hyperammonemic encephalopathy 2 weeks after valproic acid (VPA), 500 mg twice a day, was added to her regimen of topiramate (TPM), 200 mg twice a day. She presented to the emergency department (ED) with altered mental status, hypotension, bradycardia, and lethargy. Laboratory analysis showed mild non-anion gap hyperchloremic acidosis, serum VPA concentration (...) mechanisms that VPA and TPM may affect serum ammonia and carnitine concentrations and the use of levocarnitine for patients or treating toxicity.

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2013 The Journal of Pediatric Pharmacology and Therapeutics : JPPT

37. A genomics-based framework for identifying biomarkers of human neurodevelopmental toxicity. (PubMed)

as candidate biomarkers in the context of toxicogenomic studies focused on the effects of retinoic acid, valproic acid, or carbamazepine in hESC models of neurodifferentiation. The results revealed genes, including 13 common targets of the 3 compounds, that were candidate biomarkers of neurotoxicity in hESC-based studies of environmental toxicants.Copyright © 2016 Elsevier Inc. All rights reserved. (...) A genomics-based framework for identifying biomarkers of human neurodevelopmental toxicity. Human embryonic stem cell (hESC) neural differentiation models have tremendous potential for evaluating environmental compounds in terms of their ability to induce neurodevelopmental toxicity. Genomic based-approaches are being applied to identify changes underlying normal human development (in vitro and in vivo) and the effects of environmental exposures. Here, we investigated whether mechanisms

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2018 Reproductive toxicology (Elmsford, N.Y.)

38. Valproic Acid in Subjects With Intact Cognition

Valproic Acid in Subjects With Intact Cognition Valproic Acid in Subjects With Intact Cognition - Proof of Concept Study - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Valproic Acid in Subjects With Intact (...) by (Responsible Party): Gregory Jicha, 323-5550, University of Kentucky Study Details Study Description Go to Brief Summary: The purpose of this study is to evaluate the safety of administration and effects of valproic acid on clusterin expression in cognitively-intact, healthy, elderly subjects. Clusterin mutations have recently been identified as a risk factor for the development of Alzheimer's Disease and changes in clusterin expression are seen in the elderly who develop Alzheimer's disease irrespective

2012 Clinical Trials

39. Bevacizumab, Temsirolimus, Valproic Acid, Cetuximab

Thyroid Gland Neoplasm Biological: Bevacizumab Biological: Cetuximab Other: Laboratory Biomarker Analysis Other: Pharmacological Study Drug: Temsirolimus Drug: Valproic Acid Phase 1 Detailed Description: PRIMARY OBJECTIVES: I. To determine the maximum tolerated doses (MTDs) and dose-limiting toxicities (DLTs) of treatment with bevacizumab and temsirolimus in combination and plus valproic acid or cetuximab. SECONDARY OBJECTIVES: I. Preliminary descriptive assessment of anti-tumor efficacy of each (...) receive temsirolimus and bevacizumab as in Group I and valproic acid orally (PO) daily on days 1-7 and 15-21. GROUP III: Patients receive temsirolimus and bevacizumab as in Group I. In all groups, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 216 participants Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking

2012 Clinical Trials

40. Chronotolerance study of the antiepileptic drug valproic acid in mice (PubMed)

Chronotolerance study of the antiepileptic drug valproic acid in mice Valproic acid (VPA) is an antiepileptic drug widely used for the treatment of absence seizures and generalized tonic-clonic seizures. The present work aims to study whether VPA-induced toxicity varies according to the dosing-time in the 24 hour-scale.The influence of dosing-time on tolerance to VPA was investigated in 120 male Swiss mice synchronized under a light-dark cycle (12:12). The mean VPA lethal dose was first (...) dosing at 9 HALO resulted in -9 % weight loss whereas drug dosing at 17 HALO was -15 % (Ø = 20.3 HALO ± 1.1 h, p ≤ 0.0001). Lethal toxicity also varied according to circadian dosing-time (χ2 = 42.1, p < 0.0001). The highest (60 %) and the lowest (6.67 %) survival rates were observed at 9 HALO and 17 HALO respectively. Cosinor analyses validated a significant circadian rhythm in survival duration with an acrophase at 8.4 HALO ± 0.75 h (p < 0.001).With regards to these data the optimal tolerance to VPA

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2012 Journal of Circadian Rhythms

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