UC-MSCs in the Treatment of Severe and Critical COVID-19 Patients With Refractory Hypoxia
Mesenchymal Stem CellCOVID-19 PneumoniaThe goal of this randomized, controlled, open-labeled interventional clinical trial is to test the efficacy and safety of umbilical cord mesenchymal stem cells (UC- MSCs) in the treatment of severe and critical COVID-19 patients with refractory hypoxia even after sufficient standard treatment according to the tenth edition of Chinese guidelines for COVID-19 infection. The main questions it aims to answer are: 1. The efficacy of UC-MSCs in the treatment of severe and critical COVID-19 patients with refractory hypoxia. 2. The safety of UC-MSCs in the treatment of severe and critical COVID-19 patients. 3. The potential immune mechanisms of UC- MSCs in the treatment of severe and critical COVID-19 patients. Participants will receive standard therapy, or the UC-MSCs treatment. For the standard treatment, it will be conducted according the 10th edition of Chinese guidelines for severe or critical COVID-19 infection. For UC-MSCs treatment, participants will be given UC-MSCs instillation at the first and fourth day after assignment. Blood examples will be taken at indicated time for arterial blood gas analysis and other tests. And participants should also objectively report their symptoms change and other information related to the treatment as listed the research protocol.
Impact of Selective Radiation Dose Escalation and Tumour Hypoxia Status on Locoregional Tumour Control...
Locally Advanced Head and Neck CancerThe major clinical problem and predominant cause of death after radio-oncological treatment of H+N cancers are loco-regional relapses. This randomized trial tests the hypothesis that dose escalated Intensity Modulated Radiotherapy (IMRT) selectively applied to the macroscopic primary tumor and involved neck nodes - which both in 80% - are hypoxic improves loco-regional control by at least 15% at 2 years. IMRT is combined with concurrent Cis-Platin chemotherapy. Tumor volume which correlates with number of malignant cells as well as tumor hypoxia are important biological parameters which increase radio-resistance, failure of local control and tumor progression. Basing on data of experimental and clinical radiation oncology we consider hypoxia as a useful parameter for pre-therapeutic strati-fication in future randomized radio-chemotherapy trials. In addition, hypoxia imaging by PET can be used for testing the significance of selective dose escalation on hypoxic tumor sub-volumes ("Dose Painting"). As a prerequisite for such innovative studies addressing hypoxia the translational part investigates the following key issues: correlation between the size of total tumor volume (primary, lymph nodes) and hypoxic sub-volume, the spatial shift of the hypoxic sub-volume before start of treatment and the correlation of loco-regional control and hypoxia. Before starting the main study a pre-study to assess the occurrence of radiation induced toxicities is mandatory to be performed. In a step-wise dose-escalation in a cohort-design the safety of dose-escalation should be determined. Step one: 6 patients Step two: 14 patients. In the pre-study the 1st group (6 patients) should be treated with 2.2 Gy up to 77.0 Gy for DEVPT and DEVLK. After evaluation of the toxicity the next 14 patients should be treated by this scheme.
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071...
Hypoxic-Ischemic EncephalopathyHypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant neurocognitive disability. Despite this vital unmet medical need, no pharmacological adjunct or alternative therapy has proven beneficial in improving outcomes in neonatal HIE. RLS-0071 is a novel peptide being developed for the treatment of neonatal HIE. This study is designed to evaluate the safety and tolerability of RLS-0071 in the treatment of newborns with moderate or severe HIE.
Safety and Effectiveness of Intermittent Hypoxia Treatment in Parkinson's Disease
Parkinson DiseaseTo explore the safety, feasibility and net symptomatic effects of multiple (3x/week, for 4 weeks) intermittent hypoxia treatment sessions in individuals with PD. Secondary outcomes include exploring induction of relevant neuroprotective pathways as measured in serum.
Oxygen Therapy in Patients With Chronic Heart Failure With Reduced Ejection Fraction
Chronic Heart FailureOxygen DeficiencyThe purpose of this study is to assess patients with chronic heart failure and moderate-severe ventricular dysfunction (left ventricular ejection fraction (FEVE) <40%) with nocturnal desaturation (mean Oxygen saturation (SatO2) <90% and/or Cummulative time (TC) <90% > 22 minutes) without underlying respiratory disease, oxygen treatment during hours of night rest will reduce exacerbations, improve the ability to effort, sleep quality and poor prognostic parameters of heart failure, compared to patients not receiving oxygen treatment.
buRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest
Hypoxia-IschemiaBrain7 moreRESTORE is a randomized clinical trial investigating the safety and feasibility of using EEG treatment targets (burst suppression vs. seizure suppression) for post-cardiac arrest refractory status epilepticus treatment.
Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
Cardiac ArrestOut-Of-Hospital4 moreThis is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest. The study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome.
Intermittent Hypoxia and Balance Control
Intermittent HypoxiaNormoxiaThis study aims to determine the effect of acute mild intermittent hypoxia on ankle plantarflexor muscle output during balance regulation and walking in younger and older adults. Fifteen younger adults and 15 older adults will be recruited to participate in the cross-over design study that requires 2 visits (at least 1-week apart). Participants will be pseudo-randomly assigned to receive either intermittent hypoxia or sham during the first visit, and then switch over to receive sham or intermittent hypoxia during the 2nd visit. Muscle activation patterns and kinetic and kinematics during standing and walking will be recorded before and after the intermittent hypoxia/sham. It is hypothesized that compared to the sham condition, both younger and older participants will show greater increases in ankle plantarflexor muscle activation during gait and balance assessments following intermittent hypoxia.
Desferal Administration to Improve the Impaired Reaction to Hypoxia in Diabetes
Diabetes MellitusType 1The general aim of this study is to investigate the influence of systemic administration of Desferal (Deferoxamine [DFO]) on the response to hypoxic challenge in patients with diabetes mellitus (DM). The investigation will elucidate if DFO can restore: the impaired angiogenetic response to hypoxia in patients with type 1 DM. the disturbed respiratory and cardiovascular regulation in response to hypoxia in patients with DM type 1
Neonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment...
Neonatal Hypoxic-ischaemic EncephalopathyNeonatal hypoxic-ischaemic encephalopathy is a dramatic perinatal complication due to brain asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal damage and loss. Currently, only total or partial body hypothermia can partially prevent cell loss. However, no treatment exists to restore neuronal functions. Cord blood stem cells are a promising treatment for the near future. The primary objective of this study is to test the safety and feasibility of a curative treatment with autologous cord blood stem cell in neonatal hypoxic-ischaemic encephalopathy. The secondary objectives are to test the efficacy of this curative treatment with cell with neurogenic potential on the prevention of neurologic sequelae, as well as to test the optimum timing of cell preparation administration