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A Phase III study of PLX-PAD for CLI patients with minor tissue loss who are unsuitable for revascularization has been initiated (PLX-CLI-03, PACE study). In parallel, this expanded access program (EAP) will be conducted to allow the treatment of patients who are ineligible to be enrolled in the PACE study. The EAP treatment is administered in addition to standard of care of the subjects.PLX-PAD 300×106 cells in a mixture containing 10% DMSO, 5% human serum albumin and Plasma-Lyte, will be administered via 30 IM injections (0.5 mL each) delivered into the leg twice,at 8 weeks interval. The locations of injections of the PLX-PAD are detailed in Appendix 1. Antihistamine treatment should be given at least 1 hour and no more than 1.5 hours prior to PLXPAD administration to ensure coverage for 24 hours, and as long as necessary post PLX-PAD treatment. Consider treatment with second generation H1 inhibitors such as Cetirizine 10 mg once per day.Subjects will be followed-up until 12 months after the 2nd treatment according to the schedule of routine medical visits at the medical institutions. In addition to this routine follow-up, a phone call will be made 12 months after 2nd treatment to inquire on the occurrence of subsequent intervention, amputation, or death.
This phase II trial studies how well enasidenib works in treating in patients with acute myeloid leukemia with an IDH2 gene mutation that has come back or has not responded to treatment. Enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. In this study we are investing if enasidenib can be used a maintenance therapy post salvage induction chemotherapy.
The aim of this study to evaluate the ability of perfusion index to detect ulnar sparing and to estimate the proper time for the perfusion index ratio to determine successful block.
The purpose of this study is to evaluate the safety and the efficacy of Human T Lymphoid Progenitor (HTLP) injection to accelerate immune reconstitution after partially HLA compatible allogeneic hematopoietic stem cell transplantation in SCID patients.
Aluminum phosphide poisoning (ALP) is a global public health problem, and self-poisoning accounts for one-third of the world's suicide rate. In fact, in some parts of developing countries, pesticide poisoning causes more deaths than infection. ALP is very common in our government and the prognosis of the cases is usually so bad. Toxicity by ALP is caused by the liberation of phosphine gas, which causes cell hypoxia due to inhibition of oxidative phosphorylation leading to circulatory failure.
To evaluate split renal function using Tc-99m DTPA versus Tc-99m DMSA.
Clinical trial with medical devices. A diagnostic trial conducted to find a better (less invasive) procedure for predicting the onset of spontaneous bacterial peritonitis(SBP), which is a complication of liver cirrhosis with ascites.The current recommendation for primary prophylaxis of SBP include a low protein content of the ascitic fluid or a gastrointestinal bleeding. This trial will use the CLE (confocal laser endomicroscopy) technic in order to quantify the intestinal permeability in patients with liver cirrhosis and correlate this to the onset of spontaneous bacterial peritonitis.We aim to evaluate a new diagnostic tool (the confocal laser endoscopy(CLE) technique -cellvizio- in the setting of endoscopy and defining parameters that are altered in cirrhotic patients of different severity and being at risk of developing a SBP (spontaneous bacterial peritonitis).The parameters assessed by confocal laser endomicroscopy will be correlated with the protein content in ascitic fluid and the patient will be monitored for time to occurrence of spontaneous bacterial peritonitis. Defining a correlation between the quantified loss of intestinal integrity and i) total protein concentration in the ascitic fluid and ii) stadium of liver disease (Child class A, B or C)
The primary objective is to explore the effect of azacytidine + HAG regimen in objective response rate in elderly patients with MDS/AML/CMML in China. This is a post-marketing, interventional, single-center, single-arm, prospective, open-label study in elderly patients with MDS/AML/CMML in China. Patients will be recruited consecutively from the study sites during the enrollment period. The enrolled patients will be given azacytidine + HAG regimen under the conditions of informed consent and frequent monitoring according to the clinical guideline.
Traditional conscious sedation for endoscopic retrograde cholangiopancreatography in prone position places patients at risk of desaturation, and high-flow nasal oxygen may reduce the risk. The aim of this study is to evaluate the role of high-flow nasal oxygen during endoscopic retrograde cholangiopancreatography. The investigators will compare the lowest SpO2 of standard nasal oxygen cannula group and that of high-flow humidified oxygen-delivery system group during the procedure.
The non-invasive measurement of dysfunctional hemoglobins allows physicians to monitor levels in affected individuals without requiring blood samples or laboratory testing. Nonin Medical Inc, has recently developed a multi-wavelength device that measures carboxyhemoglobin and methemoglobin non-invasively. The primary objective of this study is to validate %MetHb and SpO2 accuracy performance of the study device. Evaluations will be for the range of 0 to 15% MetHb with 95-100% SaO2 as assessed by CO-oximetry, and 0-15% MetHb accuracy under conditions of elevated HHb (SaO2 80-100%) as assessed by CO-oximetry, and SpO2 with 80-100% SaO2 during elevated MetHb as assessed by CO-oximetry.