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Neurotoxicity Syndromes clinical trials

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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: NCT03157336 Completed - Clinical trials for Neurotoxicity Syndrome, Cyanate

Cassava Intervention Project

Start date: July 30, 2017
Phase: N/A
Study type: Interventional

Investigators will implement a novel cassava processing method (wetting method, WTM) that safely removes cyanogenic compounds from cassava flour prior to human consumption in a stratified village-cluster randomized non-inferiority trial so as to compare the effectiveness of a peer-led intervention (women training other women in the WTM) with that by community-health worker specialists.

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: NCT03067285 Completed - HIV Infections Clinical Trials

A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study

DREAM
Start date: September 8, 2017
Phase: Phase 4
Study type: Interventional

A phase IV, multicentre, randomised, open-label, pilot clinical trial designed to evaluate HIV-infected, aviremic patients who receive treatment with the combination of DTG/3TC/ABC and who have neuropsychiatric adverse effects that, in the opinion of the investigators, may be related to taking DTG/3TC/ABC, if they improve after switching antiretroviral therapy to the combination of ELV/COBI/FTC/TAF.

NCT ID: NCT02577263 Active, not recruiting - Stomach Neoplasms Clinical Trials

Impact of Adjuvant FOLFOX on Quality of Life and Sensory Neurotoxicity in Patients With Advanced Gastric Cancer

Start date: April 2015
Phase: N/A
Study type: Observational

The primary objective of this trial is to determine the impact of the FOLFOX regimen on quality of life and the incidence of chemotherapy induced neurotoxicity.

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: NCT02481336 Active, not recruiting - Clinical trials for Neurotoxicity Syndromes

To Study the Individual Variants of Chemotherapy-Induced Neurotoxicity

Start date: March 2015
Phase:
Study type: Observational

To study the risk prediction of chemotherapy-induced peripheral neuropathy (CIPN) by the clinical bioinformatics and genomic profile.

NCT ID: NCT02468739 Completed - Breast Cancer Clinical Trials

Effect of GM1 in Prevention of Taxanes Induced Neurotoxicity in Operable Breast Cancer

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

Background: Taxane plays a key role in the treatment of breast cancer and taxane-induced peripheral neuropathy (TIPN) is a dose-limiting adverse effect leading to treatment discontinuation. Ganglioside-monosialic acid (GM1) functions as a neuroprotective factor. However, the effects of GM1 on TIPN in breast cancer patients remains unknown. Purpose: This randomized phase III trial is designed to evaluate the potential effects of GM1 for preventing TIPN in breast cancer patients.

NCT ID: NCT02311907 Completed - Pain Clinical Trials

Glutathione in Preventing Peripheral Neuropathy Caused by Paclitaxel and Carboplatin in Patients With Ovarian Cancer, Fallopian Tube Cancer, and/or Primary Peritoneal Cancer

Start date: December 2009
Phase: Phase 3
Study type: Interventional

This randomized phase III trial is studying glutathione to see how well it works in preventing peripheral neuropathy caused by paclitaxel and carboplatin in patients with ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as glutathione, may help prevent peripheral neuropathy caused by paclitaxel and carboplatin. It is not yet known whether glutathione is more effective than a placebo in preventing peripheral neuropathy.