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Brain Diseases clinical trials

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NCT ID: NCT04063215 Active, not recruiting - Clinical trials for Traumatic Brain Injury

A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy for the Treatment of Traumatic Brain Injury and Hypoxic-Ischemic Encephalopathy

Start date: January 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This study aims to determine the safety of HB-adMSC infusion and treatment effects of HB-adMSC infusion on brain structure, neurocognitive/functional outcomes, and neuroinflammation after subacute and chronic neurological injury in adults.

NCT ID: NCT04058327 Completed - Clinical trials for Hepatic Encephalopathy

A Study of MHE in Patients With Liver Diseases

Start date: May 1, 2019
Phase:
Study type: Observational

The study analyzes the diagnostic efficacy of neurophysiological tests and blood biomarkers on MHE, predicts risk factors on the development of OHE and investigate the mortality of MHE in patients with cirrhosis and acute on chronic liver failure.

NCT ID: NCT04054453 Active, not recruiting - Epilepsy Clinical Trials

Prevention of Epilepsy by Reducing Neonatal Encephalopathy

PREVENT
Start date: March 1, 2020
Phase: N/A
Study type: Interventional

The aim of the study is to examine if a pragmatic, evidenced based and generalisable intrapartum care bundle involving birth companions and empowering mothers will reduce birth injury-related epilepsy at 18 months of age in India. The care bundle will have four key elements (interventions): (1) birth companion providing constant 1:1 care during labour and early perinatal period; (2) fetal surveillance during active labour by a nurse or midwife using a graphic display Doppler; (3) labour management by an electronic partogram with an 'alert' and 'nag' feature based on the current WHO guidelines; (4) brain oriented early newborn care with resuscitation where indicated. The care bundle will be evaluated using a prospective interrupted time series design, recruiting 80,000 women delivering in one of the three participating centres in south India, over two years. Accurate baseline data will be collected during the first year and the optimised care bundle will be introduced during the second year. All full term newborn infants admitted to the neonatal unit with perinatal brain injury during both periods, will have detailed assessments including video electroencephalography, and magnetic resonance imaging, and will be followed up until 18 months of age. Primary outcome is the number of infants with epilepsy (categorised per current ILAE guidelines) at 18 months of age expressed as per 1000 term livebirths. The investigators will use a segmented logistic regression to divide the time series into pre- and post-intervention segments, with the intervention date as the intersection between segments. The difference in the two segments will be quantified using the level (step change) and slope (trend change). The total duration of the study is four years including 24 months of recruitment and 18 months of follow-up.

NCT ID: NCT04044248 Recruiting - Cirrhosis, Liver Clinical Trials

TIPS Plus Transvenous Obliteration for Gastric Varices

Start date: April 4, 2019
Phase:
Study type: Observational

Variceal hemorrhage (VH) from gastric varices (GVs) results in significant morbidity and mortality among patients with liver cirrhosis. In cases of acute bleeding, refractory bleeding, or high risk GVs, the transjugular intrahepatic portosystemic shunt (TIPS) creation and transvenous variceal obliteration procedures have used to treat GVs. While these techniques are effective, each is associated with limitations, including non-trivial rebleeding and hepatic encephalopathy rates for TIPS and aggravation of esophageal varices, development of new or worsening ascites, and formation of difficult to treat ectopic varices for transvenous obliteration. Increasingly, however, TIPS and transvenous obliteration are viewed as complimentary procedures that can be combined to reduce bleeding risk and ameliorate sequelae of portal hypertension. Yet, despite a strong mechanistic basis for their combination, there are few studies investigating the combined effectiveness of TIPS plus transvenous obliteration. Thus, the aim of this single center prospective pilot study is to assess the effectiveness and safety of combined TIPS creation plus transvenous obliteration for the treatment of GVs, with the overall goal of improving the clinical outcomes of patients with VH related to GVs. The work proposed could lead to important advances in the treatment of bleeding complications due to liver cirrhosis.

NCT ID: NCT04042272 Completed - Clinical trials for Kidney Transplant; Complications

Evaluation of s100β, NSE and GFAP Levels in Renal Transplantation

Start date: August 15, 2019
Phase:
Study type: Observational

Uremic encephalopathy is an organic brain disorder may be frequently seen in patients with acute or chronic renal failure. Certain neurological symptoms can be found under clinical glomerular filtration rate of 15 ml/minutes. The above mentioned neurological disorders can be due to uremic toxins as well as many other reasons such as metabolic and hemodynamic disturbances, inflammation, or oxidative stress. Most frequent symptoms are impaired consciousness, lethargy, cranial nerve involvement, nystagmus, dysarthria, and even coma and death. Brain tissue may receive damage and some secondary biomarkers may appear in case BUN (Blood Urea Nitrogen) level is >175 mg/dl together with neuroinflammation. Although hemodialysis is a temporary solution in terms of treatment, these symptoms may be reversible in the long-run with organ transplantation. A rigorous neurological assessment before transplantation is important for identifying the severity and distribution of the neurological disorder as well as defining the abnormalities that are responding to the current treatments and foreseeing potential postoperative prognosis. S100β is excreted by astrocytes in brain damage cases. S100β level rises when brain damage starts, thus it may be used in the prognosis of brain damage in its early period. Neuron-specific enolase (NSE) functions as intracytoplasmic enzyme and serum level rises in neuron damage. Glial fibrillary acidic protein (GFAP), on the other hand, is the intermediary filament cytoskeleton protein found in astrocytes. It has the same root structure with S100β. The purpose of this study is to assess neurological damage by looking at the levels of S100β, NSE and GFAP in patients who underwent kidney transplantation and to analyze the impacts on the prognosis.

NCT ID: NCT04014413 Recruiting - Obesity Clinical Trials

Safety and Efficacy of Fecal Microbiota Transplantation

Start date: July 15, 2019
Phase: N/A
Study type: Interventional

The gut microbiota is critical to health and functions with a level of complexity comparable to that of an organ system. Dysbiosis, or alterations of this gut microbiota ecology, have been implicated in a number of disease states. Fecal microbiota transplantation (FMT), defined as infusion of feces from healthy donors to affected subjects, is a method to restore a balanced gut microbiota and has attracted great interest in recent years due to its efficacy and ease of use. FMT is now recommended as the most effective therapy for CDI not responding to standard therapies. Recent studies have suggested that dysbiosis is associated with a variety of disorders, and that FMT could be a useful treatment. Randomized controlled trial has been conducted in a number of disorders and shown positive results, including alcoholic hepatitis, Crohn's disease (CD), ulcerative colitis (UC), pouchitis, irritable bowel syndrome (IBS), hepatic encephalopathy and metabolic syndrome. Case series/reports and pilot studies has shown positive results in other disorders including Celiac disease, functional dyspepsia, constipation, metabolic syndrome such as diabetes mellitus, multidrug-resistant, hepatic encephalopathy, multiple sclerosis, pseudo-obstruction, carbapenem-resistant Enterobacteriaceae (CRE) or Vancomycin-resistant Enterococci (VRE) infection, radiation-induced toxicity, multiple organ dysfunction, dysbiotic bowel syndrome, MRSA enteritis, Pseudomembranous enteritis, idiopathic thrombocytopenic purpura (ITP), and atopy. Despite FMT appears to be relatively safe and efficacious in treating a wide range of disease, its safety and efficacy in a usual clinical setting is unknown. More data is required to confirm safety and efficacy of FMT. Therefore, the investigators aim to conduct a pilot study to investigate the efficacy and safety of FMT in a variety of dysbiosis-associated disorder.

NCT ID: NCT04001595 Recruiting - Clinical trials for Limb Girdle Muscular Dystrophy

Global FKRP Registry

Start date: November 2013
Phase:
Study type: Observational [Patient Registry]

Mutations in the Fukutin Related Protein (FKRP) gene cause the condition Limb Girdle Muscular Dystrophy type R9 (LGMDR9) also known as LGMD2I, and the rarer conditions Congenital Muscular Dystrophy (MDC1C), Muscle Eye Brain Disease (MEB) and Walker-Warburg Syndrome (WWS). LGMDR9 is the most common FKRP-related condition, and is especially prevalent in Northern Europe. The aim is to facilitate a questionnaire based research study in order to better characterise and understand the disease globally. By maintaining a global registry this will help identify potential participants eligible for clinical trials in the future.

NCT ID: NCT04000334 Recruiting - Cardiac Arrest Clinical Trials

Early Transcranial Doppler Goal Directed Therapy After Cardiac Arrest: a Pilot Study

GOODYEAR
Start date: July 29, 2020
Phase: N/A
Study type: Interventional

Hypoxic-ischaemic brain injury (HIBI) is the main cause of death in patients who are comatose after resuscitation from cardiac arrest. Current guidelines recommend to target a mean arterial pressure (MAP) above 65 mmHg to achieve an adequate organ perfusion. Moreover, after cardiac arrest, cerebral autoregulation is dysregulated and cerebral blood flow (CBF) depends on the MAP. A higher blood pressure target could improve cerebral perfusion and HIBI. Transcranial Doppler (TCD) is a non-invasive method to study CBF and its variations induced by MAP. The aim of this study is to test the feasibility of an early-goal directed hemodynamic management with TCD during the first 12 hours after return of spontaneous circulation (ROSC).

NCT ID: NCT03996317 Withdrawn - Clinical trials for Respiratory Distress Syndrome, Newborn

Maternal Hyperoxygenation for Intrapartum Fetal Heart Rate Tracing Abnormalities

Start date: June 2021
Phase: N/A
Study type: Interventional

Hyperoxygenation for resuscitation of abnormal fetal heart rate tracings has been routine obstetric practice. However, there have not been any studies to support this practice. Recent literature have either found no associated benefit to intrapartum maternal oxygen administration, or in a number of studies demonstrated higher risk of neonatal complications. Despite these studies, the evidences have not been adequate to change the clinical practice because the majority of these studies either focused on biological differences rather than clinical outcomes data or were retrospective rather than randomized trials. Therefore, the investigators propose a large single center randomized clinical trial to determine the effects of maternal hyperoxygenation therapy for the treatment of fetal heart rate tracing abnormalities.

NCT ID: NCT03994822 Completed - Clinical trials for Cardiovascular Diseases

pRESET for Occlusive Stroke Treatment

PROST
Start date: October 4, 2019
Phase: N/A
Study type: Interventional

Compare the safety and effectiveness of pRESET to Solitaire in the treatment of stroke related to large vessel occlusion