N-Acetyl-Cysteine (NAC) for Healing of Amputation Stumps in the Setting of Diabetes
Diabetes MellitusCritical Limb Ischemia2 moreIn this pilot clinical study the investigators propose to conduct a prospective, randomized, double-blinded, placebo-controlled clinical trial for 30 days for participants with critical limb ischemia (CLI) who undergo a major (above-knee or below-knee) lower extremity amputation. By exploring the primary endpoints we aim to determine whether NAC can affect amputation stump perfusion and healing. Based on preclinical data, the investigators hypothesize that NAC will augment both amputation stump perfusion as well as healing. The investigators will utilize the data from this trial to determine the true effect size that is necessary for a larger clinical trial to determine the clinical efficacy of NAC is healing surgical sites such as major lower extremity amputation stumps.
Early vs Postponed Parenteral Nutrition After Emergency Abdominal Surgery
LaparotomyBowel Obstruction2 moreThe aim of this study is to investigate the effect of early, supplementary parenteral nutrition following emergency laparotomy. Currently, parenteral nutrition is used in postoperative patients if or when oral or enteral nutrition is not feasible. However, little data exists on the optimal timing of parenteral nutrition. Oral and enteral nutrition is encouraged. Participants will randomized on the second postoperative day if their calorie intake (oral + enteral) is below 30% of the calculated requirement. Patients will be randomized to early (postoperative day 2) or postponed (postoperative day 5) start of parenteral nutrition. The combined oral + enteral + parenteral calorie target is 70-80% of the calculated requirement. Participants in the postponed group will be re-assessed on postoperative day 5, and if their calorie intake is less than 50% parenteral nutrition will be administered. The intervention will continue until oral + enteral intake is at least 70% of the calculated requirement or the participant is at his/her habitual intake.
Safety of Autologous Human Umbilical Cord Blood Treatment for Perinatal Arterial Ischemic Stroke...
Perinatal Arterial Ischemic StrokeAutologous human umbilical cord blood (hUCB) stored at Cord Blood Registry will be given to children who have suffered from a Perinatal Arterial Ischemic Stroke. The aim is to determine if hUCB infusion is safe, if late functional outcome is improved, if hUCB treatment improves physiologic response in the child's SSEP & EEG, and the effect of hUCB infusion in altering anatomic findings on MRI.
ReStore Thrombectomy Trial for Flow Restoration in Acute Ischemic Stroke Patients
Ischemic StrokeThe ReStore™ Thrombectomy device restores blood flow in the neurovascular by removing thrombus in patients experiencing ischemic stroke. Patients enrolled in the ReStore Trial will be randomized to treatment with the ReStore™ Thrombectomy Device (investigational treatment) or to treatment with a commercially available thrombectomy device It is expected that the investigational treatment safety profile in terms of clinically significant procedural adverse events will be comparable to the control group.
The Pilot Experimental Study of the Neuroprotective Effects of Exosomes in Extremely Low Birth Weight...
Premature BirthExtreme Prematurity4 moreTo study the safety and efficacy of intranasal administration of exosomes derived from mesenchymal stromal cells on long-term neurodevelopmental outcome in extremely low birth weight infants born at gestational age 25/0-27/6 weeks.
Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries...
Critical Limb IschemiaThe purpose is to demonstrate the safety and effectiveness of the Stellarex DCB for the treatment of stenosis or occlusions of below-the-knee arteries.
Correlation Between Cognition and Neuroimaging in TIA Patients
Transient Ischemic AccidentContext: Cognitive impairment is common after a stroke. Out of 100 patients who have suffered a stroke, 50 will develop cognitive impairment. For 16 of them, they will be responsible for an impact on autonomy (major cognitive disorder). They are conventionally attributed either to the location of the lesions or to their general volume. However, recent literature emphasizes the presence of cognitive impairment after a transient ischemic attack (TIA), when by definition the symptoms are transient and imaging without recent ischemic injury. The mechanisms of cognitive impairment in TIA are therefore poorly understood at present. There is evidence in animal models and humans for persistent brain toxicity from ischemia even in the absence of established necrosis. However, to what extent this toxicity may explain the cognitive impairment seen in TIA is not known. Indeed, the latter could just as much have the effect of vascular risk factors which significantly increase cognitive risk even in the absence of an acute event. Objective: The objective of the Cog-TIA program is therefore to identify whether the transient ischemic attack may be responsible for long-term structural changes in neuroimaging in the ischemic territory and whether these changes are correlated with changes in cognitive efficiency. Material and methods: The project is based on the Normandy-Stroke population cohort which includes patients from Caen and the surrounding area who have had a stroke or TIA. The protocol provides for neuropsychological tests evaluating the main cognitive domains at 1 year and 3 years after the initial event. The Cog-TIA project is designed as an ancillary study to the Normandy-Stroke project with the objective of including 50 patients from this cohort who presented with a transient ischemic attack. Each patient will receive a structural MRI at the same time as the neuropsychological assessments scheduled for the Normandy-Stroke study. Analyzes will be performed from T1 sequences, Proton density with centered on the hippocampus and diffusion tensors. For the T1 and proton density sequences, the analyzes will compare the volumes of the different structures longitudinally (in particular: the total hippocampal volume and of the subfields, lobar, thalamic and pallidal volumes). For the diffusion tensor analyzes, the anisotropy maps will be compared longitudinally. For each structure showing significant variation during follow-up, correlations will be made with the decline in performance on neuropsychological tests calculated using composite scores. Cognitive decline may be partly attributed to TIA if it is correlated with abnormalities in the affected hemisphere.
Effects of Remote Ischemic Pre-Conditioning in Moyamoya Disease Patients
Moyamoya DiseaseRemote Ischemic PreconditioningIn the present study, investigators evaluated whether RIPC reduce the major neurological complications in adult moyamoya disease patients undergoing encephaloduroarteriosynangiosis (EDAS).
SY007 in Patients With Acute Ischemic Stroke
Acute Ischemic StrokeThis Phase 1b multiple center, randomized, double-blind, placebo-controlled study is a dose escalation trial evaluating the safety, tolerability, PK characteristics and efficacy of SY-007 after injection in acute ischemicstroke patients. The immunogenicity of SY-007 will be evaluated and this study will provide the recommended dosage for subsequent clinical trials.
ARISE: After 8 Hours Reperfusion in Ischemic Stroke Embolization
Ischemic StrokeA prospective pilot study to evaluate the recanalization and safety of mechanical thrombectomy through a cerebral angiogram in patients with stroke symptoms last seen normal between 8 - 24 hours.