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Brain Diseases clinical trials

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NCT ID: NCT02444091 Completed - Clinical trials for Chronic Fatigue Syndrome (CFS)

Cyclophosphamide in Myalgic Encephalopathy/ Chronic Fatigue Syndrome (ME/CFS)

CycloME
Start date: March 2015
Phase: Phase 2
Study type: Interventional

Significant clinical improvements of ME/CFS symptoms were observed in two patients with long-standing ME/CFS who received adjuvant chemotherapy including cyclophosphamide for breast cancer, also in one ME/CFS patient who received chemotherapy including iphosphamide for Hodgkin lymphoma. Three pilot ME/CFS patients were thereafter treated with six intravenous infusions four weeks apart, in two of these with a significant clinical response. The hypothesis is that a subset of ME/CFS patients have an activated immune system, and that ME/CFS symptoms may be alleviated by treatment with cyclophosphamide as intravenous pulse infusions four weeks apart, six infusions in total. The purpose of the present study is to treat ME/CFS patients with cyclophosphamide as intravenous pulse infusions four weeks apart, six infusions in total. The effects on ME/CFS symptoms and tolerability/side effects during 12 months follow-up will be registered, and additional tests will be performed to objectively register changes in physical ability during follow-up. Studies to investigate possible large vessel endothelial dysfunction and skin microvascular dysfunction will be performed before start of intervention and during follow-up.

NCT ID: NCT02442986 Completed - Myopathy Clinical Trials

Neurological Outcome in Surgical and Non-surgical Septic Patients

NOSEPP
Start date: November 2012
Phase: N/A
Study type: Observational

Systemic inflammation and sepsis cause multi organ failure including severe neurologic impairment in the course of disease. Neurologic failure typically presents as critical-illness-polyneuropathy/-myopathy and septic encephalopathy during sepsis and is associated with an increased mortality rate. Clinical parameters to determine the neurologic entities during the course of sepsis are heterogeneous. Further research for an association of clinical parameters and the patients' outcome is needed. The study aims toward differences in the clinical and neurological outcome of surgical and non-surgical septic patients in comparison to non-septic patients on ICU. The aim of the study is to identify clinical and diagnostic outcome predictors in septic patients.

NCT ID: NCT02439307 Terminated - Liver Cirrhosis Clinical Trials

Effycacy of Rifaximin on Reverse Minimal Hepatic Encephalopathy and Elimation Small Intestinal Bacterial

Start date: February 28, 2017
Phase: N/A
Study type: Interventional

A total of 46 patients diagnosed with liver cirrhosis will be recruited. All patients will be evaluated with five psychometric tests and critical flicker frequency to diagnosis minimal hepatic encephalopathy (MHE). A breath test sample will be performed in all patients with MHE with 10 g of lactulose to establish the diagnosis of small intestinal bacterial overgrowth (SIBO). Patients diagnosed with EHM and SIBO will be randomized to receive per day 1200 mg of rifaximin (group A) or placebo (group B) for 2 weeks. A complete medical history, nutritional assessment, biochemical studies, and evaluation of quality of life will be performed in all patients included in the study. Besides the initial visit, patients will receive subsequent care 2, 4, 8, 12, and 24 weeks after the beginning of the study.

NCT ID: NCT02435810 Recruiting - Brain Disease Clinical Trials

Inflammatory and Infectious Diseases of the Nervous System

Start date: May 6, 2015
Phase:
Study type: Observational

Background: - Inflammation is how the body reacts to infection or injury. Infections or inflammation in the brain and nerves can be serious. There aren t always good tests to detect this. Researchers want to learn more about how diseases affect the brain and nerves to develop better tests and treatments. Objective: - To learn more about how inflammation and infections hurt the brain and nervous system. Eligibility: - People at least 2 years old with a diagnosis or suspected diagnosis of nervous system infection or inflammation. Design: - For some participants, a clinician outside of NIH will collect blood, tissue, and other samples. These will be sent to NIH and analyzed. - Other participants will have several visits to NIH. Children may not have all these tests. - Participants will have: - Medical history. - Physical and neurological exam. - Blood and urine samples collected. - Saliva collected. They will chew on a piece of sterile cotton for one minute. - Magnetic resonance imaging (MRI) scan. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder. Participants will get a contrast agent through an intravenous (IV) catheter during the MRI. A needle will be used to guide a thin plastic tube (catheter) into an arm vein. - Lumbar puncture. Skin will be numbed and a needle will be inserted into the space between the bones in the back. Fluid will be removed. - Some participants may have optional study procedures. These may include eye tests, memory and thinking testing, tests with electrodes on the head, or skin biopsy.

NCT ID: NCT02434965 Withdrawn - Clinical trials for Severe Hypoxic-ischemic Encephalopathy

Autologous Cord Blood and Human Placental Derived Stem Cells in Neonates With Severe Hypoxic-Ischemic Encephalopathy

HPDSC+HIE
Start date: December 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the safety and effectiveness of autologous human placental-derived stem cells (HPDSC) in combination with autologous cord blood in neonates with severe hypoxic-ischemic encephalopathy.

NCT ID: NCT02431780 Completed - Epilepsy Clinical Trials

A Multicentre Clinical Investigation of a Decision Support Algorithm for Neonatal Seizure Detection

ANSeR
Start date: February 12, 2015
Phase: N/A
Study type: Interventional

The ANSeR Clinical Investigation is a multi-centre, randomised, controlled, clinical investigation of a standalone decision support Algorithm for Neonatal Seizure Recognition, the ANSER Software system.

NCT ID: NCT02427906 Recruiting - Cirrhosis Clinical Trials

Effect of Transjugular Intrahepatic Portosystemic Shunt on Gut Microbiota in Cirrhotic Patients

Start date: August 2014
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study is to determine the effect of transjugular intrahepatic portosystemic shunt on gut microbiota and associated inflammatory factors in cirrhotic patients.

NCT ID: NCT02418039 Terminated - Liver Cirrhosis Clinical Trials

High Protein Diet Versus Normal Protein Diet in Treating Patients With Minimal Hepatic Encephalopathy

Start date: March 10, 2017
Phase: N/A
Study type: Interventional

A total of 80 patients diagnosed with liver cirrhosis and minimal hepatic encephalopathy will be recruited. They will be randomized to receive high protein diet ( n = 40) and a normal protein diet ( n = 40 ) during one month. Randomization will be conducted by an external monitor and will keep the secret codes until the end of the study. All patients will be provided with structured menus and two snacks a day as an amaranth protein supplement. The supplement will content the same amount of fiber but the protein content will vary depending on the group to which the patient is assigned.

NCT ID: NCT02401490 Recruiting - Cirrhosis Clinical Trials

Albumin Infusion Effects in Mortality in Patients With Cirrhosis and Hepatic Encephalopathy

BETA
Start date: April 2015
Phase: Phase 4
Study type: Interventional

To assess whether albumin administration after an episode of hepatic encephalopathy (≥ grade II) improves survival at 90 days (mortality endpoint treated as a composite endpoint death and/ or liver transplantation).

NCT ID: NCT02387385 Completed - Clinical trials for Neonatal Encephalopathy

Hypothermia for Encephalopathy in Low and Middle-Income Countries Trial

HELIX
Start date: August 2015
Phase: N/A
Study type: Interventional

Neonatal Encephalopathy is a serious condition arising from unexpected lack of cerebral blood flow and oxygen supply to the foetal brain at the time of birth. Every year, approximately one million babies die from neonatal encephalopathy in low and middle-income countries and a quarter of these deaths occur in India. In the past decade, a number of clinical trials in high-income countries has shown that cooling therapy along with optimal neonatal intensive care reduces death and neurodisability after neonatal encephalopathy. Cooling therapy is now used as a standard therapy after neonatal encephalopathy in all high income countries, including the UK. Although the burden of neonatal encephalopathy is far higher in low and middle-income countries, the safety and efficacy data on cooling therapy from high income cooling trials cannot be extrapolated to these settings, due to the difference in population co-morbidities and sub-optimal neonatal intensive care. The HELIX trial proposes to examine whether whole body cooling to 33.5°C initiated within 6 hours of birth and continued for 72 hours reduces death or neurodisability at 18 months after neonatal encephalopathy in public sector neonatal units in India. A total of 408 babies with moderate or severe neonatal encephalopathy will be recruited from the participating centres in India over an 18 to 24 month period. The babies will be randomly allocated to whole body cooling or usual care. The cooling therapy will be achieved using an approved cooling device (Tecotherm) that is already in clinical use in the UK and in India. MR imaging and spectroscopy will be performed at 1 week of age to examine the brain injury. Neurodevelopmental outcomes will be assessed at 18 months of age. Primary outcome measure is death or moderate/severe neurodisability at 18 months.