Safety and Efficacy Study of Ad2/Hypoxia Inducible Factor (HIF)-1α/VP16 Gene Transfer in Patients...
Intermittent ClaudicationPeripheral Vascular Disease1 moreThe purpose of this Phase 2 clinical research study is to examine the safety of an experimental gene transfer agent, Ad2/HIF-1α/VP16, and its ability to stimulate the growth of new blood vessels from existing blood vessels (a process called angiogenesis) in an attempt to improve the flow of blood in the legs of patients with peripheral arterial disease (PAD). Specifically, this study will enroll patients with severe intermittent claudication (IC) which is the stage of PAD in which a patient's walking ability is severely limited, causing pain in the legs upon exercise due to inadequate blood flow to the muscles of the lower limbs.
Higher vs. Lower Doses of Dexamethasone for COVID-19 and Severe Hypoxia
Covid19HypoxiaWe aim to assess the benefits and harms of higher (12 mg) vs lower doses (6 mg) of dexamethasone on patient-centered outcomes in patients with COVID-19 and severe hypoxia.
Effect of 8-week Intake of 2S-hesperidin on Performance, Body Composition and Biochemicals Markers...
PowerMetabolic Disturbance9 moreThis clinical study evaluates the effect of 500 mg of 2S-hesperidin for 8 weeks on performance (power generated in different metabolic zones), body composition (fat and muscle mass) and biochemical (antioxidant, inflammatory status) and metabolic (capillary blood in finger) markers in amateur cyclists. Our hypothesis is that chronic intake of 2S-hesperidin can improve performance (maximum power generated). To justify this hypothesis, we measured the parameters mentioned above, which could establish a cause-effect relationship between 2S-hesperidin intake and possible yield improvement.
Effects of a Face Mask on Oxygenation During Exercise
HypoxemiaThere is concern that wearing a face mask during COVID will affect oxygen uptake, especially during intense exercise. This study will assess the effect of wearing two different face masks (disposable and cloth) on blood and muscle oxygenation during cycling exercise.
Assessment of Portable Oxygen Concentrators in Infants Undergoing Hypoxic Challenge Testing.
HypoxiaAltitudeHypoxic Challenge Testing (HCT) is the recommended method for inflight hypoxia risk assessment. Onboard oxygen administration remains controversial. The Federal Aviation Administration approved portable oxygen concentrators (POCs) for onboard oxygen supply but there is lack of evidence about the use, especially in children. The aim of our study is to establish the effectiveness and safety of POCs in infants undergoing HCT.
Intermittent Hypoxia Therapy in Cardiac Rehabilitation
Cardiovascular DiseaseExercise1 moreThis is a randomized control pilot study to assess the effect of intermittent hypoxia therapy on functional capacity vs conventional care in old patients with functional impairment admitted to a Phase 2 in-hospital cardiac rehabilitation program.
Acute Effects of SGLT2 Inhibition on Renal Oxygenation and Autonomic Function in Type 1 Diabetes...
NephropathyHypoxia4 moreBackground: Inhibiting the sodium-glucose cotransporter-2 (SGLT2) has been observed to reduce risk of cardiovascular events and kidney failure in type 2 diabetes. The exact mechanisms of the beneficial effects of SGLT2 inhibition (SGLT2i) are still unknown. Kidney hypoxia has been demonstrated in diabetic kidney disease and SGLT2i is thought to relieve hypoxia in the kidneys. Mitochondrial dysfunction and autonomic dysfunction might also contribute to kidney hypoxia. Objective: The primary aim of the study is to assess the acute effects of SGLT2 inhibition on parameters reflecting oxygenation and oxygen consumption of the human kidney in persons with type 1 diabetes. Exploratory aims are to investigate acute changes in oxygen availability and oxygen access to the kidneys after SGLT2i. This include measures of peripheral blood oxygenation, mitochondrial function and autonomic function. Methods: Acute intervention study with oral dapagliflozin given in two doses each of 50 mg or matching placebo as intervention. Kidney oxygenation and perfusion parameters will be assessed by blood-oxygen-dependant level magnetic resonance imaging. Mitochondrial function will be assessed by extracellular flux analysis on lymphocytes. Autonomic function will be assessed by measuring baroreflex sensitivity. Design: Randomized, double blinded, placebo-controlled, cross-over intervention study. Study population: Fifteen healthy controls are recruited by advertisement and 15 patients with type 1 diabetes recruited from Steno Diabetes Center Copenhagen. Endpoints: Primary end-point: Renal cortical and medullary oxygenation (T2*). Exploratory end-points: Renal cortical and medullary perfusion, renal artery flow, renal oxygen consumption, peripheral capillary oxygen saturation (SpO2), arterial oxygen partial pressure (PaO2), arterial oxygen saturation (SaO2), lymphocyte mitochondrial function, baroreflex sensitivity. Timeframe: Inclusion of patients from January 2020. Last patient last visit January 2021. Data analysis completed spring 2021, presentation autumn 2021 and publications Winter 2021.
The Clinical Trial of CL2020 Cells for Neonatal Hypoxic Ischemic Encephalopathy
Hypoxia-IschemiaBrainThe purpose of this study is to evaluate the safety and the tolerability of CL2020 cells in hypoxic ischemic encephalopathy neonates with hypothermia therapy. In addition, we will evaluate the efficacy of CL2020 cells for infant development.
Intra-uterine Fetal Brain Activity Monitoring.
Fetal HypoxiaFetal cardiac monitoring is used during labor. Fetal decelerations may imply fetal hypoxia and distress. Brain activity monitoring is not used to evaluate fetal distress during labor. In this study the investigators intend to use an EEG based algorithm to evaluate and monitor fetal brain activity during the 2nd stage of labor.
Study of hCT-MSC in Newborn Infants With Moderate or Severe HIE
Moderate to Severe Hypoxic-ischemic EncephalopathyTo determine the safety of single and repeated intravenous doses of hCT-MSC in newborn infants with HIE.