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Brain Diseases clinical trials

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NCT ID: NCT04736836 Completed - Clinical trials for Hepatic Encephalopathy

Microbial Resistance of Rifaximin in Hepatic Encephalopathy

Start date: January 2015
Phase: Phase 4
Study type: Interventional

Aims and Objectives: To determine the safety and efficacy of rifaximin plus lactulose as secondary prophylaxis of HE compared to lactulose alone. To evaluate the effect of long-term administration of rifaximin on development of resistant mutants and investigating its correlation with its efficacy. Methods: An open label parallel, prospective interventional study was conducted. One hundred patients experienced at least one attack of hepatic encephalopathy were included in the study. Patients were randomly allocated either to receive rifaximin plus lactulose or lactulose alone for 6 months. Conn score, Model of End stage Liver Disease (MELD) score, asterixis grade, complete blood count (CBC), liver function tests, kidney function tests, urine and stool analysis and abdominal ultrasonography were compared in both groups. The primary efficacy endpoint was the time to the first breakthrough. The secondary efficacy endpoint was the time to the first hospitalization involving HE. Safety assessment was done by reporting any adverse events, serious adverse events and by repeating biochemical evaluation every 2 weeks. Determination of the minimum inhibitory concentration (MIC) of rifaximin for lactose fermenter isolates was done for the entire patients before starting treatment and at the end of treatment.

NCT ID: NCT04705142 Completed - HIE Clinical Trials

Beneficial Effect of Intravenous Magnesium Sulphate in Term Neonates With Hypoxic Ischemic Encephalopathy(HIE)

Start date: May 1, 2019
Phase: Phase 2
Study type: Interventional

Neonatal mortality rate is the highest in Pakistan. And Birth Asphyxia is one of the main reversible causes. Outcomes related to birth asphyxia can be improved, if intervention done in time with proper measures. MgSO4 is cheaper and easily available drug.

NCT ID: NCT04698148 Completed - Clinical trials for Irritable Bowel Syndrome

Establishment of the Human Intestinal and Salivary Microbiota Biobank - Gastrointestinal Diseases

BIOMIS-Gastr
Start date: February 8, 2021
Phase:
Study type: Observational

This is a prospective, clinical, multicentre study aimed to collect biological samples and study microbiota from subjects with Clostridium Difficile (CDI), subjects affected by Multi Drug Resistant Organisms (MDRO) infection, subjects with Chronic Inflammatory Bowel Disease (IBD), subjects with Irritable Bowel Syndrome (IBS), subjects with Hepatic Encephalopathy and from healthy volunteers. Microbiota is a complex consortium of microorganisms, located at the mucosal level (in particular intestinal, oral and vaginal) having a key role in human health and in the onset of several diseases. Microbiota alterations have been found in several diseases (gastrointestinal, metabolic, renal, oncological, gynaecological) The study will allow to: - Provide biological samples (faeces, saliva, blood, urine) from healthy volunteers and patients to the first Italian microbiota biobank; - Study microorganisms using different in vitro and in vivo techniques; - Study the link between the microbiota and the disease. This study is part of the BIOMIS project (Project Code: ARS01_01220), presented as part of the "Avviso per la presentazione di progetti di ricerca industriale e sviluppo sperimentale nelle 12 aree di specializzazione individuate dal PNR 2015-2020" and admitted to funding under the National Operational Program "Ricerca e Innovazione" 2014-2020 by directorial decree of MIUR - Department for Higher Education and Research - n. 2298 of 12 September 2018. BIOMIS includes several clinical studies that enrol patients with different pathologies to collect and store biological samples and study microbiota.

NCT ID: NCT04675775 Completed - Sarcopenia Clinical Trials

The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.

Start date: January 21, 2021
Phase: N/A
Study type: Interventional

This study is being completed for patients with cirrhosis, including patients with a prior history of hepatic encephalopathy (HE) to evaluate the feasibility and benefits of medically-tailored meals as an intervention. Patients will be enrolled from the University of Michigan and will complete the baseline assessments in-person or remotely. In addition participants will complete study related materials before, during and after treatment with medically-tailored meals (MTM). After completing the study meals, participants will return for follow-up or have this visit completed remotely as well as have an observational period for 12 more weeks.

NCT ID: NCT04643821 Completed - Clinical trials for HIE - Perinatal Hypoxic - Ischemic Encephalopathy

NVD in Hypothermic HIE Neonates

Start date: January 1, 2015
Phase: Early Phase 1
Study type: Interventional

Neonatal hypoxic ischemic (HI) injury is an unpredictable neurologic injury with devastating, long term consequences for parents who are expecting a normal child. Hypothermia for 72 hr within 6 hrs of birth improves the combined outcome of death or severe disability, and hypothermia is now standard of care in tertiary centers throughout the world. However, approximately 50% of infants with hypoxic ischemic encephalopathy (HIE) treated with hypothermia still have adverse neurologic outcomes, due to ongoing neuroinflammation and oxidative stress in spite of hypothermia. Further, the majority of HIE infants are insufficient or deficient in a critical neurosteroid, 25(OH)vitamin D, which has been shown to adversely affect outcome after adult stroke. By adding vitamin D to N-acetylcysteine (NAC), an antioxidant, the investigators hypothesized that both drugs would increase glutathione (GSH) concentrations in critical brain areas, mitigate continuing oxidative stress after injury during hypothermia and after rewarming, and improve neurodevelopmental outcomes. This is an open-label, non-randomized, escalating dose, pilot trial to evaluate the disposition and safety of NAC in combination with active vitamin D in neonates who present within 6 hrs of hypoxia ischemia/asphyxial event and received moderate hypothermia to 33 degrees C for 72 hours per routine protocol.

NCT ID: NCT04640077 Completed - Alzheimer Disease Clinical Trials

A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)

Start date: November 23, 2020
Phase: Phase 2
Study type: Interventional

The main goals of this study are to further determine whether the study drug donanemab is safe and effective in participants with Alzheimer's disease and to validate video scale assessments.

NCT ID: NCT04625101 Completed - Clinical trials for Epileptic Encephalopathy

Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep

Start date: April 26, 2021
Phase: Phase 2
Study type: Interventional

This is a phase 2, double-blind study to assess the efficacy, safety, tolerability, and pharmacokinetics of NBI-827104 when administered once daily for 13 weeks in pediatric subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep (EECSWS).

NCT ID: NCT04511546 Completed - Brain Diseases Clinical Trials

Exploratory Study Using a New Head-only PET Scanner

ExploreBPET
Start date: October 27, 2020
Phase: N/A
Study type: Interventional

The "BPET prototype" is a small aperture PET scanner. The BPET prototype will be used with patients, which have just finished their regularly scheduled PET examination on a clinical whole body PET system. The radioactive tracer used for this procedure will still be active. This remaining acitivity will be used for an image acquisition with the BPET prototype without the need for an additional radioactive tracer dose. The control intervention is be a brain PET scan as part of standard clinical routine. It will be done immediately before the scan on the BPET prototype.

NCT ID: NCT04506788 Completed - Cardiac Arrest Clinical Trials

EEG Slow Wave Activity in Hypoxic Brain Injury

BrainICU
Start date: June 15, 2015
Phase:
Study type: Observational

BrainICU is a prospective observational study investigating the EEG slow wave activity in comatose cardiac arrest survivors under propofol anesthesia and its association with neurological outcome.

NCT ID: NCT04467762 Completed - Critical Illness Clinical Trials

Neurocognitive Impairment in Pediatric Patients With Meningoencephalitis and Sepsis-associated Encephalopathy

NCIPED
Start date: August 3, 2020
Phase:
Study type: Observational

Neurocognitive impairment is frequently observed in pediatric patients with meningoencephalitis (ME) and sepsis-associated encephalopathy (SAE) which represent two relevant central nervous system (CNS) diseases in pediatric patients. It is uncertain, if the the origin of the disease, located primarily in the CNS of patients with ME or secondarily in patients with SAE in the course of sepsis, is of importance for the severity of injury to the brain. Prospective clinical studies combining clinical and laboratory examinations including specific biomarkers of neuroaxonal injury were not performed in a comparative study. Biomarkers of neuroaxonal injury are therefore not only of great interest to detect and monitor neurocognitive impairment but also to quantify the severity of brain injury in patients with ME and SAE.