更新于：2024-11-01

Hospital Clinico Universitario de Santiago

Spain

更新于：2024-11-01

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项与 Hospital Clinico Universitario de Santiago 相关的临床试验

NCT06506812 / Not yet recruiting临床4期IIT

Pooled Analysis of Methodologically Harmonized Pragmatic Randomized Trials of High-Dose vs. Standard-Dose Influenza Vaccine Against Severe Clinical Outcomes

This prespecified analysis will pool the datasets from two pragmatic randomized trials evaluating the relative vaccine effectiveness of high-dose vs. standard-dose influenza vaccine against severe clinical outcomes: the DANFLU-2 (A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults) trial and the GALFLU (Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Adults Aged 65 to 79 Years in Galicia, Spain) trial. The purpose of the pooled analysis is to ensure adequate statistical power for evaluating relative vaccine effectiveness against severe clinical outcomes and to increase generalizability of the results by combining data from two countries.

开始日期2024-08-01

申办/合作机构

Herlev and Gentofte Hospital

[+2]

NCT06422221 / Not yet recruiting临床4期IIT

An Oral Doxycycline Regimen to Prevent Bacteremia Following Dental Procedures

Although controversy exists regarding the efficacy of antibiotic prophylaxis for patients at risk of infective endocarditis, expert committees continue to publish recommendations for antibiotic prophylactic regimens. The last American Heart Association (AHA) and European Society of Cardiology (ESC) guidelines include several important changes, highlighting that clindamycin (CLI) is no longer recommended as an alternative to amoxicillin in those allergic to penicillin. This new project aims to evaluate the effectiveness of oral doxycycline in preventing post-dental extraction bloodstream infection.

开始日期2024-07-15

申办/合作机构

University of Santiago de Compostela

[+1]

NCT06401486 / RecruitingN/AIIT

Video Versus Direct Laryngoscopy for Double-lumen Tube Tracheal Intubation in Thoracic Surgery

Tracheal intubation (TI) is one of the fundamental and most recognized techniques in Anesthesiology, also essential in all units treating urgent pathology and critical patients. It involves advancing a tube through the vocal cords into the trachea to ventilate the patient. In thoracic surgery, it is often necessary to achieve lung isolation, ventilating only one lung while the operated lung remains collapsed and immobile. To achieve this, it is common to intubate the patient with a special tube: a double-lumen tube (DLT), larger than usual because it provides two ventilation channels, one for each lung.
Tracheal intubation with a DLT presents some peculiarities: its larger size and stiffness make manipulation and orientation in the oropharynx difficult. It has a curve at its distal end (the bronchial lumen) designed to slide into the left or right main bronchus as needed. The fact that the DLT passes between the vocal cords does not ensure its proper placement and function. Therefore, DLT intubation requires practice and experience, both to slide it between the vocal cords and to position it properly.
The classic technique for DLT intubation is "Direct Laryngoscopy" (DL). A traditional laryngoscope with a Macintosh blade is used to move the upper airway structures aside to allow direct visualization of the glottis. In recent years, to facilitate tracheal intubation, different videolaryngoscopes have appeared. A videolaryngoscope is a device similar to a traditional laryngoscope that allows, thanks to an image sensor located at its end, indirect visualization of the glottis on an integrated or external screen.
There is strong evidence for the benefit of using a VL over traditional DL in single-tube intubation in adult patients. However, although the use of VL for DLT intubation is becoming more common, there are few studies with small sample sizes comparing VL to DL for DLT intubation, so the evidence of its advantages or disadvantages is of low quality. It could improve glottic exposure and the percentage of success on the first attempt, although there is a possibility of increased tube malposition incidence and delayed intubation.
Therefore, Investigators propose a prospective, multicenter, randomized study comparing the traditional Macintosh blade laryngoscope (direct laryngoscopy) with the videolaryngoscope to facilitate orotracheal intubation with double-lumen tube in patients scheduled for thoracic surgery requiring lung isolation.

开始日期2024-07-02

申办/合作机构

Hospital Clinico Universitario de Santiago

100 项与 Hospital Clinico Universitario de Santiago 相关的临床结果

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0 项与 Hospital Clinico Universitario de Santiago 相关的专利（医药）

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598

项与 Hospital Clinico Universitario de Santiago 相关的文献（医药）

2024-12-31·Human Vaccines & Immunotherapeutics

A phase 4, open-label study to evaluate the safety and immunogenicity of DTaP5-HBV-IPV-Hib in children previously vaccinated with DTaP2-HBV-IPV-Hib or DTaP5-HBV-IPV-Hib (V419-016)

Article

作者: Lumley, Jessie ; Chen, Ziqiang ; Costantino, Claudio ; Johnson, David ; Martinon-Torres, Federico ; Lambeth, Courtney ; Westerholt, Soeren ; Guerra, Andrea ; Marcek, Tomas ; Wilck, Marissa

DTaP5-HBV-IPV-Hib (Vaxelis®) is a hexavalent combination vaccine (HV) indicated in infants and toddlers for the prevention of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive disease due to Haemophilus influenzae type b. Switching between HVs during the childhood vaccination series is sometimes necessary due to, for example, vaccine availability, health-care provider preference, and/or tender awards. The purpose of this study was to describe the safety, tolerability, and immunogenicity of a booster dose of Vaxelis® in participants who previously received a primary infant series of either DTaP2-HBV-IPV-Hib (Hexyon®) or Vaxelis®. Healthy participants approximately 11-13 months of age who previously received a two-dose primary series of Hexyon® (HHV group) or Vaxelis® (VVV group) all received a Vaxelis® booster dose. Immunogenicity was evaluated by measuring antibody levels to individual vaccine antigens approximately 30 days following booster vaccination. Safety was evaluated as the proportion of participants with adverse events (AEs). The proportions of participants with antibody-specific responses for antigens contained in both Vaxelis® and Hexyon® at 30 days post-toddler-booster vaccination with Vaxelis® were comparable between groups, and higher in the VVV group for Vaxelis® antigens PRN and FIM2/3. The overall proportions of participants with AEs were generally comparable between groups. Following a booster dose of Vaxelis®, immune responses were comparable between groups for all shared antigens, and higher in the VVV group for antigens found only in Vaxelis®. The booster was well tolerated in both groups. These data support the use of Vaxelis® as a booster in mixed HV regimens.

2024-10-01·Hepatology

Predictive factors for decompensating events in patients with cirrhosis with primary biliary cholangitis under different lines of therapy

Article

作者: Fernández-Rodríguez, Conrado ; Gómez, Elena ; Simón, Miguel Á. ; Casado, Marta ; Sousa, Jose M. ; Álvarez-Navascuez, Carmen ; Valdivia, Carlos ; Londoño, María Carlota ; Morillas, Rosa ; Jorquera, Francisco ; García-Retortillo, Montserrat ; Arenas, Juan ; Pérez-Medrano, Indhira ; Lucena, Ana ; Berenguer, Marina ; García-Buey, Luisa ; Gómez-Camarero, Judith ; Martínez, Javier ; Olveira, Antonio ; Díaz-González, Álvaro ; Ampuero, Javier ; Molina, Esther ; Hernández-Guerra, Manuel

Background and Aims:The landscape in primary biliary cholangitis (PBC) has changed with the advent of second-line treatments. However, the use of obeticholic acid (OCA) and fibrates in PBC-related cirrhosis is challenging. We assessed the impact of receiving a second-line therapy as a risk factor for decompensated cirrhosis in a real-world population with cirrhosis and PBC, and identify the predictive factors for decompensated cirrhosis in these patients.Approach and Results:Multicenter study enrolling 388 patients with PBC-cirrhosis from the Spanish ColHai registry. Biopsy (20%), ultrasound (59%), or transient elastography (21%) defined cirrhosis, and the presence of varices and splenomegaly defined clinically significant portal hypertension (CSPH). Paris-II and PBC OCA international study of efficacy criteria determined the response to ursodeoxycholic acid (UDCA), fibrates (n=93), and OCA (n=104). The incidence of decompensated cirrhosis decreased for UDCA versus OCA or fibrates in the real-world population, but they were similar considering the propensity score–matched cohort (UDCA 3.77 vs. second-line therapy 4.5 100 persons-year, respectively), as patients on second-line therapy exhibited advanced liver disease. Consequently, GGT, albumin, platelets, clinically significant portal hypertension, and UDCA response were associated with a decompensating event. OCA response (achieved in 52% of patients) was associated with bilirubin (OR 0.21 [95% CI: 0.06–0.73]) and AST (OR 0.97 [95% CI: 0.95–0.99]), while fibrate response (achieved in 55% of patients) with AST [OR 0.96 (95% CI: 0.95–0.98]). In patients treated with OCA, drug response (sHR 0.23 [95% CI: 0.08–0.64]), diabetes (sHR 5.62 [95% CI: 2.02–15.68]), albumin (sHR 0.34 [95% CI: 0.13–0.89]), and platelets (sHR 0.99 [95% CI: 0.98–1.00]) were related to decompensation. In patients treated with fibrate, drug response (sHR 0.36 (95% CI: 0.14–0.95]), albumin (sHR 0.36 (95% CI: 0.16–0.81]), and clinically significant portal hypertension (sHR 3.70 (95% CI: 1.17–11.70]) were associated with decompensated cirrhosis.Conclusions:Advanced PBC, rather than OCA and fibrates, was found to be associated with decompensating events. Therefore, biochemical and clinical variables should be considered when making decisions about the management of these drugs. Moreover, a positive response to OCA and fibrates reduced the risk of decompensation.

2024-08-01·Gastroenterología y Hepatología

Combination of granulocyte–monocyte apheresis and tofacitinib: Multicentre and retrospective study

Article

作者: Iglesias, Eva ; Cañete, Fiorella ; Ginard, Daniel ; Herrera-deGuise, Claudia ; Zabana, Yamile ; Leo, Eduardo ; Barreiro-de Acosta, Manuel ; Rodríguez-Lago, Iago ; Cabriada, José Luis ; Guerra-Del-Río, Elena

OBJECTIVEGranulocyte-monocyte apheresis (GMA) has shown to be safe and effective in treating ulcerative colitis (UC), also in combination with biologics. The objective of this study is to evaluate the efficacy and safety of combining GMA after primary non-response (PNR) or loss of response (LOR) to tofacitinib (TOFA) in patients with UC.PATIENTS AND METHODSRetrospective study including all patients with refractory UC who received GMA plus TOFA. Efficacy was assessed 1 and 6 months after finishing GMA by partial Mayo score, C-reactive protein (CRP) and fecal calprotectin (FC). Descriptive statistics and non-parametric tests were used in the statistical analysis.RESULTSTwelve patients were included (median 46 years [IQR, 37-58]; 67% female; 67% E3). Patients were mostly receiving TOFA 10mg bid (75%), and 33% also concomitant steroids at baseline. Median partial Mayo score at baseline was 7 (IQR, 5-7), and it decreased to a median of 2 (IQR, 0-3) and 0 (IQR, 0-3) after 1 and 6 months (p=0.027 and 0.020, respectively), while no differences were found in CRP and FC. Clinical remission was achieved by 6 patients both at 1 (50%) and 6 months (67%). CF values<250mg/kg were achieved by 2 and 4 patients at 1 and 6 months (data available in 5 and 7 patients, respectively). No patient required dose-escalation of TOFA, and one patient was able to de-escalate the drug. No patient required colectomy and all patients under steroids were able to stop them.CONCLUSIONThe combination of GMA and TOFA can be effective in selected cases of UC after PNR or LOR to this drug.

项与 Hospital Clinico Universitario de Santiago 相关的新闻（医药）

2022-12-22

·BioSpace

American CryoStem Announces the Addition of Agustin Legido, MD, PhD, MBA to Its Advisory Board

Eatontown, New Jersey--(News - December 22, 2022) - American CryoStem Corporation (OTC Pink: CRYO), a clinical-stage therapeutics company with a proprietary end-to-end core biotechnology platform of tissue-based cellular technologies powering its clinical pipeline, announced today that Agustin Legido, MD, PhD, MBA has joined its Scientific and Medical Advisory Board. Dr. Legido, a pediatric neurologist who holds a PhD in biochemical endocrinology, is Board Certified by the Board of Pediatrics and the Board of Psychiatry and Neurology with special qualification in pediatric neurology. He has over 35 years of clinical experience having held positions of distinction as Chief of Neurology, Cooper University Hospital, Camden, NJ; and Chief, Section of Child Neurology - St. Christopher's Hospital for Children in Philadelphia, PA for 29 years. He has held a professorship at Drexel University College of Medicine in Philadelphia for 19 years as well as served as editor-in-chief of seminars in pediatric neurology for 6 years. A prolific researcher, he is the author and co-author of more than 200 publications and 300 abstracts in different areas of neurology, including clinical manifestations and treatment of epilepsy in infants, children, and young adults; mechanisms of brain tumors; and mitochondrial dysfunction in neurological conditions such as autism, epilepsy, migraine, brain tumors and neuromuscular disorders. An acclaimed physician and researcher, Dr. Legido received 18 commendations, awards, honors and membership in honorary societies both domestic and international including being featured as a "Marquis Who's Who Top Doctor" in May 2022. He maintains affiliations with the: American Academy of Pediatrics; American Child Neurology Society; American Academy of Neurology; American Epilepsy Society; American Society for Pediatric Research; Spanish Pediatric Society; Spanish Child Neurology Society; Ibero American Academy of Child Neurology; and the International Child Neurology Association. Hailing from Spain, Dr. Legido obtained a Doctor of Medicine and a Doctor of Philosophy from the University of Zaragoza and served a residency in pediatrics with Hospital Clinico Universitario. After immigrating to the United States in 1995, he earned an Executive MBA from Temple University and a Certified Physician Executive (CPE) from the American College of Physician Executives, in Philadelphia, Pennsylvania. Dr. Legido completed residencies in pediatrics at St. Christopher's Hospital for Children in Philadelphia and in neurology at Medical College of Pennsylvania. He completed a fellowship in pediatric neurology at The Children's Hospital of Philadelphia and conducted neurology research at the University of Pennsylvania School of Medicine. John Arnone, CEO of American CryoStem Corporation, commented, "The addition of Dr. Legido, as an accomplished neurologist and researcher, will be integral to advance our clinical research for our current and future target indications including mTBI, Long COVID, and neuromuscular diseases." "American CryoStem's focus on neurologic conditions including those resulting from concussive injuries and Long COVID conditions is of tremendous interest to me." Dr. Legido stated, "The Company's ongoing plan to pursue these conditions with their robust pipeline of planned clinical studies, is of great value to patients with these unmet medical needs." For further information please visit: , send email to: IR@americancryostem.com or contact the Company directly at 732-747-1007. About American CryoStem Corporation American CryoStem is a clinical-stage therapeutics developer delivering autologous regenerative therapeutics and advanced tissue treatments harnessing the power of mesenchymal stem cells (MSCs) and adipose tissue. We target medical indications with high unmet medical need where effective treatments are limited. The Company's centralized laboratory model and patented "CryoStem Core Platform" is a best-in-class, end-to-end regenerative medicine solution to treat chronic diseases, disorders, and injuries. Through a single adipose-tissue (fat) collection, the Company processes and cryopreserves master samples for a lifetime of therapies on demand; and prepares and CryoBanks pure adipose tissue for serial or multiple advanced treatments. The Company maintains a strategic portfolio of intellectual property [36 patents] that form its Core Platform consisting of the "Collection - Processing - Cryobanking - Delivery to Point-of-Care" of pure adipose tissue ATGRAFT™, AT-ReStore™, and adipose-derived mesenchymal stem cells (MSCs) ATCELL™ Therapeutics. Our Platform supports a growing pipeline of cellular therapeutics, adipose tissue therapies, products, processes and international licensing opportunities. For further detailed information please visit: , email us at IR@americancryostem.com, or call 732-747-1007. To view the source version of this press release, please visit

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100 项与 Hospital Clinico Universitario de Santiago 相关的转化医学

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