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Valproic Acid Toxicity

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141. High Dose IL 2 and Entinostat in RCC

to treatment initiation. Any imaging abnormality indicative of CNS metastases will exclude the patient from the study. Patients with previously excised/gamma knifed solitary or oligometastases and no evidence of recurrent disease for 6 months are eligible. Exclusion Criteria: Concurrent use of valproic acid use is not allowed. Receiving medications that can effect clotting ability: warfarin, aspirin (once-daily aspirin use- maximum dose 325 mg/day is permitted), nonsteroidal anti-inflammatory drugs (NSAIDs (...) , papillary thyroid cancer or other non-melanoma skin cancers. Any medical condition that would preclude adequate evaluation of the safety and toxicity of the study combination. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Association Class II, III, or IV), angina pectoris requiring nitrate therapy, recent myocardial infarction (< the last 6 months), cardiac arrhythmia, history of CVA within 6 months

2018 Clinical Trials

142. Randomized, Phase II Clinical Trial of Sulforaphane in Bladder Cancer Chemoprevention

systemic chemotherapy for any other cancer, excluding non-melanoma skin cancer; Any treatment for the bladder tumor other than intravesical therapy; Prior treatment with a known histone deacetylase inhibitor (including but not limited to valproic acid, suberoylanilide hydroxamic acid (SAHA), Panobinostat (LBH589), etc.) within 6 months prior to starting study treatment or while on study therapy; Current treatment with warfarin; Use of dietary supplements or herbal remedies which may affect the study (...) /adjacent cells. Occurrence of Adverse Events per Study Arm [ Time Frame: End of study, approximately 30 days ] Safety of SFN at this dose (vs. Placebo) as indicated by incidence of adverse events and toxicities, monitored using Common Toxicity Criteria version 5.0, complete blood count (CBC), and complete metabolic panel (CMP) from baseline at mid-point and at end of trial. Mid-study Bioavailability of Sulforaphane [ Time Frame: Mid-study, approximately 15 days ] Bioavailability, of SFN at this dose vs

2018 Clinical Trials

143. A Pilot Study of the Combination of Entinostat With Capecitabine in High Risk Breast Cancer After Neo-adjuvant Therapy

to study treatment. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. If female, is pregnant or breastfeeding. The following medications are prohibited while the patient is receiving entinostat: Any other HDAC Inhibitor, including valproic acid DNA methyltransferase inhibitors Any additional anticancer agents (excluding entinostat and capecitabine), such as chemotherapy, immunotherapy, targeted therapy, biological response (...) . Other Name: Xeloda Outcome Measures Go to Primary Outcome Measures : Identification of a maximum tolerated dose combination (MTDC) of entinostat and capecitabine [ Time Frame: During the first cycle of treatment (each cycle is 21 days) for each participant ] This will be defined based on the number of "dose limiting toxicities" in participants at each dose level. Frequency of adverse events (AEs) in participants with high-risk breast cancer after neo-adjuvant therapy [ Time Frame: AEs from consent

2018 Clinical Trials

144. A Study of Tolerability and Efficacy of Cannabidiol on Motor Symptoms in Parkinson's Disease

. History of drug or alcohol dependence; defined by prior inpatient stay(s) for this or that patient states 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 (nicotinic acid) at ≥2000 mg/day or nicotinamide (nicotinic acid amide or nicotinamide) at ≥3000 mg/day, isoniazid and ketoconazole due to risk of liver injury and clobazam and ketoconazole (...) because of risk of toxic interactions with the study drug. These medications need to be stopped 90 days before the baseline visit. Unstable medical condition. Any of the following laboratory test results at screening: Hemoglobin < 10 g/dL WBC <3.0 x 109/L Neutrophils <1.5 x 109/L Lymphocytes < 0.5 x 109/L Platelets <100 x 109/L Hemoglobin A1C > 9% Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limit of normal. Persons with stable liver disease of known

2018 Clinical Trials

145. Entinostat Versus Placebo Combined With Endocrine Therapy in Chinese Patients With Advanced Breast Cancer in Chinese Patients With Hormone Receptor-Positive Advanced Breast Cancer

affect intake, transportation or absorption of oral administration of drugs (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.); Unrecovered toxicity resulted from previous medication or toxicity, evaluation score is still > grade 1 or baseline (except alopecia); Use of HDAC inhibitor (e.g., valproic acid, Entinostat, Vorinostat, chidamide, etc.) prior to enrollment or intended use of HDAC inhibitor during the study; Known allergic to Exemestane, Entinostat or other drugs (...) of Medicine related topics: related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Active Comparator: ARM Entinostat+Exemestane Patients receive Exemestane orally (PO) once daily (QD) on days 1-28 and Entinostat PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Drug: Entinostat Entinostat will be repeatedly administered PO on days 1, 8, 15 and 22 of each treatment cycle. Exemestane PO once daily on day

2018 Clinical Trials

146. Epacadostat in Combination With Radiation Therapy and Avelumab in Patients With Recurrent Gliomas

screening through follow-up period, including acitretin, amitriptyline, androsterone, cyclosporine, dasatinib, diclofenac, diflunisal, efavirenz, erlotinib, estradiol (17-beta), flutamide, gefitinib, gemfibrozil, glycyrrhetinic acid, glycyrrhizin, imatinib, imipramine, ketoconazole, linoleic acid supplements, mefenamic acid, mycophenolic acid, niflumic acid, nilotinib, phenobarbital, phenylbutazone, phenytoin, probenecid, propofol, quinidine, ritonavir, sorafenib, sulfinpyrazone, valproic acid (...) blood at time of progression only; if no progression has occurred by this time point, the Cycle 12 will be the last collection). Outcome Measures Go to Primary Outcome Measures : Safety run-in only: Safety and tolerability of the regimen as measured by dose-limiting toxicities (DLTs) in cycle 1 [ Time Frame: Completion of cycle 1 for all patients in Safety Run-In (estimated to be 6 months) ] 6 patients will be enrolled at the 100 mg BID dose of epacadostat during the safety run-in DLT

2018 Clinical Trials

147. Valproate serum concentrations in patients with hypoalbuminemia and medical complications (Full text)

Valproate serum concentrations in patients with hypoalbuminemia and medical complications Valproic acid (VPA) and its derivatives are highly protein bound with free fraction increasing with dose and serum concentration. Consensus guidelines regarding dose adjustment for hypoalbuminemia are not available.A literature search was performed using PubMed to identify articles with the following key terms: "valproate," "valproic acid," "protein binding," "albumin," and "hypoalbuminemia." We report our (...) , age, serum creatinine, or dose). Female patients with similar albumin had higher free fractions than the 1 male patient.Due to the variability in pharmacokinetic impact of hypoalbuminemia, it is important to monitor patients closely for signs of VPA toxicity in cases involving altered albumin levels. It would be prudent to use free serum VPA concentrations when patients experience fluctuations in albumin or have unexpected response to medication.

2018 The Mental Health Clinician PubMed

148. Rechallenge of lamotrigine after development of rash (Full text)

Rechallenge of lamotrigine after development of rash Lamotrigine (LTG) is associated with the potential for a life-threatening rash (eg, Stevens-Johnson syndrome or toxic epidermal necrolysis). The incidence has been linked to rapid titration and an interaction with valproic acid that can increase the level of LTG. Providers often have difficulty discriminating between serious versus benign rashes, and the package insert recommends discontinuing the medication at the first sign of a rash

2018 The Mental Health Clinician PubMed

149. Primary Care Management of Headache in Adults

) Treatment of Migraine for more information on tablet sizes, daily dosage, drug titration, and side effects of acute medications for migraine. For more information on the use of acute medications in migraine, including a discussion of how to organize them into treatment strategies, see the Canadian Headache Society guidelines, available at ? NSAIDs and Acetaminophen Acetylsalicylic acid (ASA) 1,000 mg, ibuprofen 400 mg

2012 Toward Optimized Practice

150. Maintaining mood stability in bipolar disorder: a clinical perspective on pharmacotherapy (Full text)

. Vieta E , Günther O , Locklear J , et al . Effectiveness of psychotropic medications in the maintenance phase of bipolar disorder: a meta-analysis of randomized controlled trials . Cipriani A , Reid K , Young AH , et al . Valproic acid, valproate and divalproex in the maintenance treatment of bipolar disorder (review) . (accessed 23 Jul 2014 ). Malhi GS , Tanious M , Das P , et al . The science and practice of lithium therapy . Birch N , Gallichio V , Becker R Grof P . Excellent lithium responders (...) planning pregnancy, while older patients may be at greater risk for acute or chronic toxicity and renal dysfunction. Naturally, different medications require separate schedules for monitoring side-effects or toxicity, and given that polypharmacy is common, patients may require quite frequent investigations and follow-up. summarises recommended schedules for review. View this table: Table 2 Assessment frequency for reviewing health effects of bipolar medications Patient diversity: disease and individual

2015 Evidence-Based Mental Health PubMed

151. 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 midchildhood (median age, approximately 10 years), are almost (...) that contour the radiation to the tumor and avoid normal brain tissue ( , , , and ) all appear effective and may potentially reduce the acute and long-term toxicities associated with these modalities.[ , ]; [ ][ ] Care must be taken in separating radiation-induced imaging changes from disease progression, which usually occurs during the first year after radiation, but may occur even after the first year, especially in patients with pilocytic astrocytomas

2016 PDQ - NCI's Comprehensive Cancer Database

152. Childhood Acute Lymphoblastic Leukemia Treatment (PDQ®): Health Professional Version

of hyperdiploid (51–65 chromosomes) precursor B-cell ALL. ARID5B is a gene that encodes a transcriptional factor important in embryonic development, cell type–specific gene expression, and cell growth regulation.[ , ] Other genes with polymorphisms associated with increased risk of ALL include GATA3 ,[ ] IKZF1 ,[ , , ] CDKN2A ,[ ] CDKN2B ,[ , ] CEBPE ,[ ] PIP4K2A ,[ , ] and TP63 .[ ] Rare germline variants with high penetrance. A germline variant in PAX5 that substitutes serine for glycine at amino acid 183 (...) % surviving at 5 years.[ - ] 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 are generally designed to compare

2016 PDQ - NCI's Comprehensive Cancer Database

153. DNA Polymerase Gamma (POLG)-related disorders

controlling eye movement), and progressive intellectual disability. In addition, hepatopathy (liver dysfunction) may occur in affected individuals. Importantly, the use of valproic acid (sodium valproate) in the treatment of seizures is known to precipitate liver failure (often rapidly and with fatal consequences) in those with POLG gene variants. Liver dysfunction may also occur in the absence of an exposure to valproic acid. With regard to the diagnosis of POLG-related disorders, affected individuals (...) POLG-positive patients, particularly in the early stages of the disease. In addition, each of these findings may be evident in individuals with other mitochondrial conditions. At the present time, the care for patients with POLG gene variants is symptom specific and primarily supportive in nature, with the goals of managing symptoms and preventing secondary complications (e.g., medication-induced liver toxicity). Final publication URL The report may be purchased from: Indexing Status Subject

2013 Health Technology Assessment (HTA) Database.

154. 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

155. Postnatal treatment using curcumin supplements to amend the damage in VPA-induced rodent models of autism. (Full text)

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 PubMed

156. 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

157. 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

158. 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

159. 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

160. 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

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