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Filter by:This study investigates the safety, tolerability and pharmacokinetics of single and repeat doses of PC786.
The aim of the study is to evaluate the efficacy of the prophylactic administration of N-acetyl-L-cysteine (NAC) in acute leukemia patients with complete remission pre- and post-allotransplant on the occurrence of poor graft function (PGF) and prolonged isolated thrombocytopenia (PT) after haploidentical hematopoietic stem cell transplantation. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective treatment of malignant hematopoietic diseases. However, the delayed hematopoietic reconstitution, including PGF and PT, remain serious complication after allo-HSCT, and the effective therapeutic strategies are limited. In murine studies, endothelial cells have been identified as a key cellular component supporting hematopoietic stem cells in the bone marrow microenvironment. Our previous prospective nested case-control study suggested that the frequency of bone marrow endothelial cells was markedly reduced in patients with PGF or PT. Moreover, our recent study further identified reduced bone marrow endothelial cells (<0.1%) pre-allotransplant was associated with significant higher incidences of PGF or PT after allo-HSCT. In addition, NAC treatment in vitro could quantitatively and functionally improve bone marrow endothelial cells derived from the patients with PGF or PT. Therefore, bone marrow endothelial cells (<0.1%) pre-allotransplant can be used to identify patients with a higher incidence of PGF or PT to provide timely prophylactic intervention of NAC to prevent the occurrence of delayed hematopoietic reconstitution post-transplant. The study hypothesis: Prophylactic intervention of NAC pre- and post-allotransplant could reduce the incidence of PGF and PT in acute leukemia patients after haploidentical hematopoietic stem cell transplantation.
This study will examine the effects of almonds consumed by adults with different body fat distributions on indices of carbohydrate and lipid metabolism.
Exocrine pancreatic insufficiency (EPI) is the inability of the pancreas to perform a normal digestive function. The prevalence of IPE in patients with decompensated hepatic cirrhosis (HC) is unknown and most published series are short, old and use a single diagnostic technique with potential risk of false positives and negatives. Demonstrating IPE in a patient with HC can change their vital prognosis with the indication of pancreatic enzymes that can improve their nutritional status and help control their decompensations. Objectives: To assess the prevalence of IPE in patients with decompensated CH. To establish correlation between fecal elastase and 13C triolein breath test. Methodology: Unicentric, transversal study that will be carried out during hospitalization. Patients with HC who enter for decompensation and requiere hospitalization will be included consecutively. Exclusion criteria will include prior diagnosis of IPE, suspicion of biliary obstruction, more than 5 dep / d induced by laxatives or liquid stools. The diagnosis of IPE will be made with the combination of two techniques (13C triolein breath test and fecal elastase). Demographic, epidemiological data, clinical data as well as anthropometric parameters will be collected. A blood test will also be done to assess nutritional status and associated deficits. A multivariate analysis will be performed to assess the predictive factors of IPE
An acute psychotic episode is a severe psychiatric syndrome which might occur in different psychiatric diagnoses. The outcome prediction of relapse rate of a psychotic episode within a certain time frame is difficult and depends on many factors. More and better predictors are required to improve the outcome prediction in order to adjust therapy and follow-up if patients suffer from this acute disease. Copeptin, a surrogate marker for vasopressin, has been proven helpful in the prediction of the outcome in serious somatic diseases. Additionally, a rise of copeptin due to psychological stress was shown. The aim of this study is to investigate the association of the neuroendocrine biomarker copeptin and the prediction of the onset of psychotic episode within one year.
This single and repeat increasing dose study will collect information on safety, tolerability and drug levels in the body of the CCI15106 inhalation powder. The study will also look at the level of CCI15106 that will be released into the air and may be found in the blood of the people standing around the person inhaling it (bystanders). This is a two-part study in which Part 1 will enroll healthy subjects and look at environmental and bystander exposure and Part 2 will enroll subjects with moderate COPD. Approximately 36 healthy subjects and approximately 22 subjects with COPD will be randomized in this study for dosing. The total study duration will be 82 days for Cohort A Part 1; 75 days for Cohort B Part 1 and Cohort C Part 1; 77 days for Cohort A Part 2; and 90 days for Cohort B Part 2.
CAROLE seeks to evaluate the relationship between chest Radiation Therapy and coronary artery disease. The purpose of CAROLE is to check the heart health of women who received breast cancer treatments in the past and protect them from future heart disease.
This study aims to assess barriers that prevent obesity patients from receiving adequate care for their condition. The non-interventional study will be administered in the form of a 30-minute, cross-sectional, online survey to various respondents. There is no experimentation involved in the process of data collection, and each survey poses minimal human risk. The study will evaluate lifestyle habits and weight management strategies perceived and/or practiced by each of 3 stakeholders in obesity: Patients (People with obesity), Providers, and Employers. A customized survey will be administered to each of the 3 stakeholders, and data will be analyzed based on respondents' answers.
This is a prospective, randomized, active control, single-blind, non-inferiority, multicenter clinical trial. 148 subjects will be registered at up to 10 Spanish sites. Subjects will be followed for 5 years. All eligible patients (STEMI < 12 hours from onset of chest pain) will be randomized to - Biotronik MAGMARISTM Sirolimus Eluting Bioresorbable Vascular Scaffold System (M-BRS) or - Biotronik ORSIRO Sirolimus Eluting Coronary Stent System Endothelium-independent vasomotor response (NTG injection) will be analyzed at 12 months angiographic follow-up (Primary endpoint). In a subgroup of 40 patients Optical Coherence Tomography will be performed after the procedure and at 12 months follow-up. Angiographic (QCA pre- and post-procedure and at 12 months follow-up), OCT data (at 12 months follow-up) will be analyzed off-line by an independent core lab.
The main objective of SAFIR is to identify the atherosclerotic genetic factors in these patients, which will identify new therapeutic targets for the treatment of CV and Familial Hypercholesterolemia diseases. In addition, SAFIR will allow the identification of new CV protection biomarkers, which will be useful tools for the development of a personalized medicine for the management of dyslipidemias.