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NCT ID: NCT05361473 Active, not recruiting - Clinical trials for Newborn Hypoxic-Ischemic Encephalopathy

Evaluation of a PCM Mattress to Treat HIE Infants During Transport

PCMhypo
Start date: August 2013
Phase: N/A
Study type: Interventional

Background the research proposed herein is in line with the Swedish Research Council's current focus on International collaborations and postdoctoral work abroad. In this case the child brain and translational and clinical infant brain research. Neonatal hypoxic ischemic encephalopathy in term infants constitutes a serious health problem, not the least due to its often life-long consequences in the form of cerebral palsy and other forms of brain dysfunction. An estimated 3-5 of every 1000 live term births are affected, a quarter of which with severe symptoms; 10-30% of the affected children do not survive, 30% suffer life-long disabilities. The incidence may be 10-fold higher in the developing world. In Sweden, an estimated 200 children are born each year with hypoxic ischemic asphyxia or oxygen deprivation during delivery of a severity necessitating treatment, in order to reduce future handicap. Not only the brain, but also other organs, such as the heart, liver or kidney can be damaged by hypoxic ischemia. In clinical trials, proof has been obtained that cooling can have positive effects counteracting brain injury induced by oxygen deprivation (asphyxia). Recent research suggests that cooling may also have a positive effect in stroke during the pre-treatment/transportation to hospital phase. PCM. A material with phase change properties (PCM) can be a chemical element, a solution or a substance with high melting energy. It melts/solidifies at a precise temperature and can store considerable amounts of energy (heat) before changing from one phase to another. The study group have used elements or solutions that change between solid and fluid phases within a narrow temperature interval. The most common use of PCM today is for energy storage, accomplished by having the PCM change between solid and fluid phases. Phase changes that include other PCMs, high temperatures and/or gas phases are less useful in medical applications due to the need of either large volumes in a low pressure setting or smaller amounts in a high pressure setting, increasing the risk for mistakes or secondary injury to medical staff or patients. For the clinical purposes of hypothermic treatment described here, the Glauber salt-based PCM in a mattress form developed by the applicant has near ideal properties; it is completely safe, does not cause over-cooling, can be reused many times, eliminates cooling fluctuations, is easy to handle and biodegradable.

NCT ID: NCT05297448 Active, not recruiting - Clinical trials for Hepatic Encephalopathy

Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis

RED-C-3132
Start date: August 3, 2022
Phase: Phase 3
Study type: Interventional

Study RNLC3132 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin SSD-40mg IR for the delay of the first episode of overt hepatic encephalopathy (OHE) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites.

NCT ID: NCT05102747 Active, not recruiting - Brain Metastasis Clinical Trials

Stereotactic Radiotherapy in Oligometastatic Brain Disease: a Randomised Phase III Study Comparing Hypofractionated Stereotactic Radiation Therapy (3*10 Gy) to the Historical Single-dose Radiosurgery (1*20 to 25 Gy) With Medico-economic Evaluation.

OligoBM-01
Start date: June 29, 2022
Phase: N/A
Study type: Interventional

Brain metastases (BM) are a common systemic cancer manifestation which incidence increases. Therapeutic options include whole-brain radiotherapy (WBRT), surgery, and stereotactic radiosurgery (SRS). The concept of "oligometastatic" cerebral disease (oligoBM) has emerged and led to consider alternative approaches. The main challenge is to preserve neurological function and independence the longest as possible. Stereotactic radiotherapy (SRT) has emerged as an alternative treatment modality for selected oligoBM patients. It allows to achieve the balance of tumour destruction and normal tissue preservation by precisely and accurately delivering a very high dose of radiation in one (SRS) or a few (HSRT) fractions to a limited, well-defined volume. However, no standard exists for decision-making between SRS and HSRT and this important question is being discussed in the recent literature. HSRT appears particularly interesting, assuming the patient convenience of few fractions, the normal tissue sparing achieved through focal irradiation, and the improved normal tissue tolerance of high dose radiation through fractionation. Common adverse effects of SRT are rare but can occasionally be serious, notably radionecrosis that may induce neurological deficits in patients. Although SRS is often less well-tolerated, it remains the mainstay of treatment. To investigators knowledge, SRS and HSRT have not been prospectively compared.

NCT ID: NCT05071716 Active, not recruiting - Clinical trials for Hepatic Encephalopathy

Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis

RED-C-3131
Start date: April 7, 2022
Phase: Phase 3
Study type: Interventional

Study RNLC3131 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin SSD-40mg IR for the delay of the first episode of overt hepatic encephalopathy (OHE) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites.

NCT ID: NCT05048550 Active, not recruiting - Premature Birth Clinical Trials

Babies in Glasses; a Feasibility Study.

BiG
Start date: September 9, 2021
Phase: N/A
Study type: Interventional

This is a feasibility study to begin investigating the possibility that early use of near vision glasses will improve vision in infants at risk of Cerebral Visual Impairment (CVI), leading to further improvement in other areas of development. This active intervention, starting at either 2 or 4 months of age (depending on randomisation), could be more effective than waiting until a problem is detected before giving glasses. As this is a feasibility study, the investigators are looking at a small sample of babies (n=75) to see whether their parents/carers are willing to take part in a 3-arm study comparing two differently timed interventions to a control group, as well as looking at different aspects of the research plan in preparation for a larger final study.

NCT ID: NCT04937452 Active, not recruiting - Dementia Clinical Trials

Dopaminergic Therapy for Frontotemporal Dementia Patients

Start date: June 3, 2021
Phase: Phase 2
Study type: Interventional

This is a phase IIa 24-week randomized, double-blind, placebo-controlled study. The study is designed to evaluate the efficacy and safety of Rotigotine (RTG) transdermal administration at the dosage of 4 mg or 6 mg per day versus Placebo (PLC) in newly diagnosed behavioural Frontotemporal Dementia (bvFTD) patients. 75 patients with a diagnosis of probable bvFTD will be randomly allocated to the 3 treatment arms (RTG 4mg/day, RTG 6mg/day or PLC), with 25 patients per group. Clinical and neurophysiological measurements and brain metabolism via FDG-PET will be collected before and after drug administration.

NCT ID: NCT04766541 Active, not recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

THE ROLE OF CARDIAC MARKERS IN HYPOXIC ISCHEMIC ENCEPHALOPATHY IN LONG-TERM NEURODEVELOPMENTAL FOLLOW UP

TRCMHIE
Start date: December 30, 2020
Phase:
Study type: Observational

In this study, the correlation of cardiac marker values (Troponin I, CK, CK-MB) measured before treatment with the long-term neurodevelopmental score of newborns diagnosed with perinatal asphyxia and treated with therapeutic hypothermia with a diagnosis of hypoxic ischemic encephalopathy (HIE) will be evaluated. Physical examination, laboratory (especially cardiac markers), aEEG findings and diffusion MRI findings of babies who have been hospitalized in the neonatal intensive care unit between 2015-2020 due to respiratory distress and who have undergone perinatal asphyxia but have undergone therapeutic hypothermia treatment will be recorded from their files in the hospital system. The neurological evaluations and neurodevelopmental scores of the babies in the follow-up in the neonatal high risk follow-up clinic after discharge will be recorded from their files.

NCT ID: NCT04602988 Active, not recruiting - Delirium Clinical Trials

Study to Assess and Monitor Brain Activity

SAMBA
Start date: August 10, 2020
Phase:
Study type: Observational

A mainstay in the diagnosis and care of hospitalized patients is the assessment of mental status. Changes in mental status can have broad clinical significance, and while some patients are admitted with mental status changes, nearly half of the patients who experience delirium in the hospital develop it after admission in a manner that is hard to predict on the level of individual patients. Patients with altered mental status such as delirium have worse clinical outcomes, suggesting that early monitoring of mental status can identify important clinical populations who may benefit from targeted delirium prevention and intervention. Delirium remains under-recognized in the hospital, in part due to its fluctuating nature. Typically, mental status is assessed sporadically, perhaps once a day, through intermittent and subjective clinical interactions. As such, there is a clear clinical need for objective, continuous methods to monitor mental status. Such methods could potentially improve detection of delirium, potentially even predicting it prior to clinical recognition, and therefore direct multimodal delirium prevention and intervention strategies when most effective-before delirium becomes fully manifest. In this proposal we plan on testing noninvasive, continuous monitors of mental status in the inpatient setting, primarily through the use of EEG.

NCT ID: NCT04378621 Active, not recruiting - Depression Clinical Trials

Effect of Antiinflammatory Treatment Versus Hand Training on Neuropsychiatric Comorbidity in RA-patients

NeuMRA
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate how RA affect the brain structures in RA-patients and if anti-inflammatory treatment that target TNF-α or JAK OR physical training of hands has positive impact on neuropsychiatric symptoms and morphological changes in the brain caused by the disease. The goal of this research project is to improve the knowledge of morphological changes in brain developed in connection to RA and to identify clinical and serological markers to predict development of those changes and finally, to investigate if anti-rheumatic interventions counteract destructive processes in the central nervous system (CNS) and improve the patient's health with respect to functionality, pain experience and psychological well-being.

NCT ID: NCT04360148 Active, not recruiting - Overweight Clinical Trials

Th Effect of Ketogenic Metabolic Nutritional Pattern on High-frequency Episodic Migraine (EMIKETO)

EMIKETO
Start date: February 6, 2020
Phase: N/A
Study type: Interventional

The study aims to investigate the impact of 2 nutritional patterns on high-frequency episodic migraine. Subjects enrolled will be randomized in two arms: a) very-low-calorie-ketogenic-diet (VLCKD), b) hypocaloric balanced non ketogenic-diet (HBD).