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Neurotoxicity clinical trials

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NCT ID: NCT03823768 Completed - Clinical trials for Liver Transplant; Complications

Envarsus Neurotoxicity Burden in Liver Transplant Patients

Start date: January 31, 2020
Phase: Phase 4
Study type: Interventional

This study will compare neurologic side effects associated with two immunosuppressant medications used in liver transplant patients. The standard therapy of twice daily immediate release Tacrolimus will be compared to Envarsus once daily. We hypothesize that Envarsus will show a lower rate of neurologic side effects than immediate release tacrolimus.

NCT ID: NCT03628300 Completed - Sepsis Clinical Trials

Neurotoxicity Evaluation of Beta-lactams in Intensive Care Unit and Identification of the Risk Factors

NebuLar
Start date: January 1, 2017
Phase:
Study type: Observational

Beta-lactams are the most prescribed antibiotics in intensive care units. The lack of linearity between the dose administered and the exposition due to the very high variability of the pharmacokinetics in critically ill patients requires that the treatment be adapted on a case-by-case basis depending on the drug serum concentration. However, maximum concentrations not to be exceeded in order to limit beta-lactams toxicity are generally unknown. The main toxic risk of beta-lactams in intensive care is indeed neurological, but the neurotoxicity is probably underdiagnosed due to the variability of the signs observed, their time to onset, and confounding factors. Apart from recommendations for dose adjustment in the event of renal insufficiency, the procedures for the proper use of beta-lactams in intensive care are poorly established. The study presented here aims to assess the impact of the neurotoxic risk of beta-lactams in intensive care based on therapeutic drug monitoring, and thus to improve beta-lactam safety in critically ill patients. This is a prospective cohort study evaluating change in neurological status of patients admitted to the ICU and treated with a beta-lactam antibiotic with therapeutic drug monitoring. Neurological evaluation and scoring (Glasgow scale, CAM-ICU, Richmond agitation-sedation scale) and beta-lactam serum concentration assay are performed together 2 to 3 times a week.

NCT ID: NCT03461445 Completed - Clinical trials for Kidney Transplant; Complications

A Pilot Study to Evaluate Impact on Neurological Side Effects (Cognition, Memory, and Tremor) in Elderly (Age>65) Patients

Start date: April 1, 2018
Phase: Phase 4
Study type: Interventional

Previous studies have shown that elderly patients experience higher trough levels of tacrolimus and are more sensitive to the effects of medications, they experience higher occurrence and severity of such medication related toxicities. Therefore, the investigators hypothesize that by transitioning patients from tacrolimus immediate release to Envarsus ®, the peak-dose effect will be eliminated or attenuated, leading to a significant decrease in neurocognitive toxicities in the older patient population.

NCT ID: NCT03330964 Recruiting - Clinical trials for Gastrointestinal Neoplasms

Clinical Trial of Electroacupuncture Stimulation on Prevention and Treatment of Oxaliplatin Neurotoxicity

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

The clinical trail of electroacupuncture combined with oxaliplatin regimen on gastrointestinal carcinoma.This trail is randomized controled.Patients are diagnosed gastrointestinal cancer based on pathology or cell biology.They are randomized into 2 groups:both groups receive Oxaliplatin regimen.The treatment group receives electroacupuncture in addition to the chemotherapy.The control group only receive the same chemotherapy with the treatment group.Both group have the same adjuvant therapy.

NCT ID: NCT03213392 Completed - Neurotoxicity Clinical Trials

Enzymatic Evaluation of General Anesthetic Induced Neurotoxicity in Patients With Aneurysmal Subarachnoid Hemorrhage

Start date: January 1, 2016
Phase: N/A
Study type: Observational [Patient Registry]

General anesthetic induced neurotoxicity has received considerable attention in the past decade from various pre-clinical studies in rodents and non-human primates. Which demonstrated that exposure to general anesthetic agents for a longer duration can induce neuronal cell death that can lead to adverse neurodevelopmental outcomes. The neuroapoptosis and impairment of neurodevelopmental processes has been postulated as the underlying mechanism, but the molecular mechanisms was not completely understood. Various hypothesis has been proposed they are- Antagonistic effect on N-methyl-D-aspartate receptors and agonistic effect on gamma-aminobutyric acid type A receptors; mitochondrial perturbations and activation of reactive oxygen species and dysregulation of intracellular calcium homeostasis. They trigger neuroapoptosis and cell death through the activation of caspases.3 Caspases, a group of cysteine proteases, plays an important role in regulation and execution of apoptosis. Caspase-3 is most important since it is activated by many cell death signals and cleaves a variety of important cellular proteins.4 Various anesthetic agents like isoflurane, halothane, sevoflurane, nitrous oxide and propofol causes neurotoxicity by activation of caspase-3. Which has been proven from various animal studies western blot analysis, immunohistochemical analysis and flow cytometric analysis.3, 5-9 Though it is documented that exposure to general anesthetics causes neurotoxicity during active brain growth in animals, there is no evidence of such effects in adult humans.10 and it is difficult to separate the effects of anesthetics from surgical impact and other factors associated with diseases.11 The patients with aneurysmal subarachnoid hemorrhage (SAH) have variable degree of neurological insults and it is possible, based on the evidence from animal models that administration of general anesthetics could add to the neuronal insults.

NCT ID: NCT03089905 Active, not recruiting - Anesthesia Clinical Trials

A Study to Compare the Long-term Outcomes After Two Different Anaesthetics

TREX
Start date: August 10, 2017
Phase: Phase 3
Study type: Interventional

There is considerable evidence that most general anaesthetics modulate brain development in animal studies. The impact is greater with longer durations of exposure and in younger animals. There is great controversy over whether or not these animal data are relevant to human clinical scenarios. The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha 2 agonists (such as dexmedetomidine). Some, but not all, human cohort studies show an association between exposure to anaesthesia in infancy or early childhood and later changes in cognitive tests, school performance or risk of developing neurodevelopmental disorders. The evidence is weak due to possible confounding. A recent well designed cohort study (the PANDA study) comparing young children that had hernia repair to their siblings found no evidence for a difference in a range of detailed neuropsychological tests. In that study most children were exposed to up to two hours of anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under regional or general anesthesia and has found no evidence for a difference in neurodevelopment when tested at two years of age. The GAS and PANDA studies confirm the animal data that short exposure is unlikely to cause any neurodevelopmental impact. The impact of longer exposures is still unknown. In humans the strongest evidence for an association between surgery and poor neurodevelopmental outcome is in infants having major surgery. However, this is also the group where confounding is most likely. The aim of our study is to see if a new combination of anaesthetic drugs results in a better long-term developmental outcome than the current standard of care for children having anaesthesia expected to last 2 hours or longer. Children will be randomised to receive either a low dose sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic. They will receive a neurodevelopmental assessment at 3 years of age to assess global cognitive function.

NCT ID: NCT02864030 Completed - Clinical trials for Metastatic Breast Cancer

PAINTER: Polymorphism And INcidence of Toxicity in ERibulin Treatment

Start date: May 2014
Phase: Phase 4
Study type: Interventional

On March 17th, 2011, the European Commission issued a marketing authorization valid throughout the European Union for Eribulin mesylate (Halaven; Eisai Limited), for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapic regimens for advanced disease. As the use of Eribulin will be widespread in this tumor setting, a better knowledge of its safety profile outside clinical trials is warranted. Indeed the possibility to select patients at risk for developing Eribulin-induced neuropathy, will allow the exclusion from these treatment of those patients harbouring the specific single nucleotide polymorphism (SNP). Given that Eribulin toxicity often results in treatment discontinuation, the ability to anticipate which patients will experience severe toxicity could allow for either early intervention or even possibly for prophylactic therapy, or for selection of the patients to be treated.

NCT ID: NCT02500810 Recruiting - Neurotoxicity Clinical Trials

Monosialoganglioside Preventing Neurotoxicity Induced by Albumin-bound Paclitaxel Chemotherapy in Lung Cancer Patients

Start date: July 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether monosialoganglioside are effective in the prevention of neurotoxicity induced by albumin-bound paclitaxel chemotherapy in lung cancer patients, and improve the quality of life of patients.

NCT ID: NCT02486198 Completed - Neurotoxicity Clinical Trials

Monosialotetrahexosylganglioside for Treatment of Oxaliplatin Induced Neurotoxicity in Gastrointestinal Cancer

Start date: May 5, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether Monosialotetrahexosylganglioside sodium injection can relieve the neurotoxicity caused by oxaliplatin in GI cancer.

NCT ID: NCT01982591 Completed - Clinical trials for Peripheral Neuropathy

Heavy Metal Exposure in Predicting Peripheral Neuropathy in Patients With Stage I-III Breast Cancer Undergoing Chemotherapy

Start date: January 3, 2011
Phase: N/A
Study type: Observational

This research trial studies heavy metal exposure in predicting peripheral neuropathy in patients with stage I-III breast cancer undergoing chemotherapy. Studying samples of blood and urine in the laboratory for heavy metal exposure from patients receiving chemotherapy may help doctors find out whether side effects from chemotherapy are related to heavy metal exposure.