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Article: Safety and Effectiveness of Perioperative Hyperthermic Intraperitoneal Chemotherapy with Gemcitabine in Patients with Resected Pancreatic Ductal Adenocarcinoma: Clinical Trial EudraCT 2016-004298-41.

Padilla-Valverde, David / Bodoque-Villar, Raquel / García-Santos, Esther / Sanchez, Susana / Manzanares-Campillo, Carmen / Rodriguez, Marta / González, Lucia / Ambrós, Alfonso / Cano, Juana M / Padilla-Marcote, Maria / Redondo-Calvo, Javier / Martin, Jesus / Serrano-Oviedo, Leticia

Cancers

2024 Volume 16, Issue 9

Abstract: Background: Despite the improvement in therapies, pancreatic cancer represents one of the most cancer-related deaths. In our hypothesis, we propose that Hyperthermic Intraperitoneal Chemotherapy with gemcitabine after pancreatic cytoreductive surgery ... ...

Abstract	Background: Despite the improvement in therapies, pancreatic cancer represents one of the most cancer-related deaths. In our hypothesis, we propose that Hyperthermic Intraperitoneal Chemotherapy with gemcitabine after pancreatic cytoreductive surgery could reduce tumor progression by reducing residual neoplastic volume and residual pancreatic cancer stem cells. Materials and methods: A randomized trial involving 42 patients. All patients were diagnosed with pancreatic ductal adenocarcinoma. Group I: R0 resection. Group II. R0 resection and HIPEC with gemcitabine (120 mg/m Results: From 2017 to 2023, 63 patients were recruited for our clinical trial; 21 patients were included in each group, and 21 were excluded. Locoregional recurrence, Conclusions: The use of HIPEC with gemcitabine after surgery in patients with resectable pancreatic ductal adenocarcinoma reduces locoregional recurrence and may be associated with a significant decrease in pancreatic cancer stem cells.
Language	English
Publishing date	2024-04-28
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers16091718
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Safety of perioperative hyperthermic intraperitoneal chemotherapy with gemcitabine in patients with resected pancreatic adenocarcinoma: a pilot study of the clinical trial EudraCT 2016-004298-41.

Padilla-Valverde, David / García-Santos, Esther / Sanchez, Susana / Manzanares, Carmen / Rodriguez, Marta / González, Lucia / Ambrós, Alfonso / Cano, Juana M / Serrano, Leticia / Bodoque, Raquel / Vergara, Teresa / Martin, Jesus

Journal of gastrointestinal oncology

2021 Volume 12, Issue Suppl 1, Page(s) S80–S90

Abstract: Background: Hyperthermic intraperitoneal chemotherapy (HIPEC) with gemcitabine, after cytoreductive surgery, may reduce the tumor progression of pancreatic cancer through the reduction of the neoplastic volume and the subpopulation of residual ... ...

Abstract	Background: Hyperthermic intraperitoneal chemotherapy (HIPEC) with gemcitabine, after cytoreductive surgery, may reduce the tumor progression of pancreatic cancer through the reduction of the neoplastic volume and the subpopulation of residual pancreatic cancer stem cells, improving the survival of patients with pancreatic cancer and decreasing the recurrence of the disease. Methods: A pilot study is performed with the first ten patients in the experimental group. A randomized study (phase II-III clinical trial) that requires a population of 42 patients, with 21 patients in each group. All patients have a diagnosis of ductal adenocarcinoma of the pancreas, which will be surgically resected with curative intention. (I) Group I: after an R0 resection, patients receive individualized adjuvant treatments. (II) Group II: after an R0 resection, HIPEC is performed with gemcitabine (120 mg/m Results: From 2018 to 2019, 31 patients were recruited for our clinical trial. Fifteen patients were excluded because of intraoperative unresectability or a different intraoperative histologic diagnosis. Ten patients were included in the experimental group (resection plus HIPEC gemcitabine). The mean age was 65±7 years, and six patients were female (60%). We confirmed the histologic diagnosis of ductal pancreatic adenocarcinoma in all patients prior to HIPEC. Total pancreatectomy was performed in five patients. The surgical median time was 360 min, and the hospital stay was 11 days. Four patients showed complications classified as Clavien-Dindo type II and one showing type I. Six patients were classified as having stage III tumors. To date, no hospital mortality, locoregional recurrence, or differences between the two groups in terms of perioperative complications, biochemical and gasometric values, or Clavien-Dindo complication grades were observed. Conclusions: Our clinical pilot study demonstrated a similar perioperative outcome that allows the trial until main objectives are achieved.
Language	English
Publishing date	2021-05-01
Publishing country	China
Document type	Journal Article
ZDB-ID	2594644-4
ISSN	2219-679X ; 2078-6891
ISSN (online)	2219-679X
ISSN	2078-6891
DOI	10.21037/jgo-20-238
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Article ; Online: Clinical relevance of timing of assessment of ICU mortality in patients with moderate-to-severe Acute Respiratory Distress Syndrome.

Scientific reports

2023 Volume 13, Issue 1, Page(s) 1543

Abstract: Mortality is a frequently reported outcome in clinical studies of acute respiratory distress syndrome (ARDS). However, timing of mortality assessment has not been well characterized. We aimed to identify a crossing-point between cumulative survival and ... ...

Abstract	Mortality is a frequently reported outcome in clinical studies of acute respiratory distress syndrome (ARDS). However, timing of mortality assessment has not been well characterized. We aimed to identify a crossing-point between cumulative survival and death in the intensive care unit (ICU) of patients with moderate-to-severe ARDS, beyond which the number of survivors would exceed the number of deaths. We hypothesized that this intersection would occur earlier in a successful clinical trial vs. observational studies of moderate/severe ARDS and predict treatment response. We conducted an ancillary study of 1580 patients with moderate-to-severe ARDS managed with lung-protective ventilation to assess the relevance and timing of measuring ICU mortality rates at different time-points during ICU stay. First, we analyzed 1303 patients from four multicenter, observational cohorts enrolling consecutive patients with moderate/severe ARDS. We assessed cumulative ICU survival from the time of moderate/severe ARDS diagnosis to ventilatory support discontinuation within 7-days, 28-days, 60-days, and at ICU discharge. Then, we compared these findings to those of a successful randomized trial of 277 moderate/severe ARDS patients. In the observational cohorts, ICU mortality (487/1303, 37.4%) and 28-day mortality (425/1102, 38.6%) were similar (p = 0.549). Cumulative proportion of ICU survivors and non-survivors crossed at day-7; after day-7, the number of ICU survivors was progressively higher compared to non-survivors. Measures of oxygenation, lung mechanics, and severity scores were different between survivors and non-survivors at each point-in-time (p < 0.001). In the trial cohort, the cumulative proportion of survivors and non-survivors in the treatment group crossed before day-3 after diagnosis of moderate/severe ARDS. In clinical ARDS studies, 28-day mortality closely approximates and may be used as a surrogate for ICU mortality. For patients with moderate-to-severe ARDS, ICU mortality assessment within the first week of a trial might be an early predictor of treatment response.
MeSH term(s)	Humans ; Clinical Relevance ; Respiratory Distress Syndrome ; Intensive Care Units ; Respiration, Artificial ; Lung
Language	English
Publishing date	2023-01-27
Publishing country	England
Document type	Multicenter Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-023-28824-5
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Article: Predicting the Length of Mechanical Ventilation in Acute Respiratory Disease Syndrome Using Machine Learning: The PIONEER Study.

Villar, Jesús / González-Martín, Jesús M / Fernández, Cristina / Soler, Juan A / Ambrós, Alfonso / Pita-García, Lidia / Fernández, Lorena / Ferrando, Carlos / Arocas, Blanca / González-Vaquero, Myriam / Añón, José M / González-Higueras, Elena / Parrilla, Dácil / Vidal, Anxela / Fernández, M Mar / Rodríguez-Suárez, Pedro / Fernández, Rosa L / Gómez-Bentolila, Estrella / Burns, Karen E A /

Szakmany, Tamas / Steyerberg, Ewout W / The PredictION Of Duration Of mEchanical vEntilation In Ards Pioneer Network

Journal of clinical medicine

2024 Volume 13, Issue 6

Abstract: ... ...

Abstract	Background
Language	English
Publishing date	2024-03-21
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2662592-1
ISSN	2077-0383
ISSN	2077-0383
DOI	10.3390/jcm13061811
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Article ; Online: Efficacy of dexamethasone treatment for patients with the acute respiratory distress syndrome caused by COVID-19: study protocol for a randomized controlled superiority trial.

Villar, Jesús / Añón, José M / Ferrando, Carlos / Aguilar, Gerardo / Muñoz, Tomás / Ferreres, José / Ambrós, Alfonso / Aldecoa, César / Suárez-Sipmann, Fernando / Thorpe, Kevin E / Jüni, Peter / Slutsky, Arthur S

Trials

2020 Volume 21, Issue 1, Page(s) 717

Abstract: Background: There are no specific generally accepted therapies for the coronavirus disease 2019 (COVID-19). The full spectrum of COVID-19 ranges from asymptomatic disease to mild respiratory tract illness to severe pneumonia, acute respiratory distress ... ...

Abstract	Background: There are no specific generally accepted therapies for the coronavirus disease 2019 (COVID-19). The full spectrum of COVID-19 ranges from asymptomatic disease to mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multisystem organ failure, and death. The efficacy of corticosteroids in viral ARDS remains unknown. We postulated that adjunctive treatment of established ARDS caused by COVID-19 with intravenous dexamethasone might change the pulmonary and systemic inflammatory response and thereby reduce morbidity, leading to a decrease in duration of mechanical ventilation and in mortality. Methods/design: This is a multicenter, randomized, controlled, parallel, open-label, superiority trial testing dexamethasone in 200 mechanically ventilated adult patients with established moderate-to-severe ARDS caused by confirmed SARS-CoV-2 infection. Established ARDS is defined as maintaining a PaO Discussion: This study will assess the role of dexamethasone in patients with established moderate-to-severe ARDS caused by SARS-CoV-2. Trial registration: ClinicalTrials.gov NCT04325061 . Registered on 25 March 2020 as DEXA-COVID19.
MeSH term(s)	Adult ; Humans ; COVID-19 ; COVID-19 Drug Treatment ; Dexamethasone/adverse effects ; Dexamethasone/therapeutic use ; Outcome Assessment, Health Care ; Randomized Controlled Trials as Topic ; Respiratory Distress Syndrome/drug therapy ; Sample Size ; SARS-CoV-2 ; Multicenter Studies as Topic
Chemical Substances	Dexamethasone (7S5I7G3JQL)
Keywords	covid19
Language	English
Publishing date	2020-08-16
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1745-6215
ISSN (online)	1745-6215
ISSN	1468-6694 ; 1745-6215
DOI	10.1186/s13063-020-04643-1
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Article ; Online: Clinical and biological markers for predicting ARDS and outcome in septic patients.

Villar, Jesús / Herrán-Monge, Rubén / González-Higueras, Elena / Prieto-González, Miryam / Ambrós, Alfonso / Rodríguez-Pérez, Aurelio / Muriel-Bombín, Arturo / Solano, Rosario / Cuenca-Rubio, Cristina / Vidal, Anxela / Flores, Carlos / González-Martín, Jesús M / García-Laorden, M Isabel

Scientific reports

2021 Volume 11, Issue 1, Page(s) 22702

Abstract: Sepsis is a common cause of acute respiratory distress syndrome (ARDS) associated with a high mortality. A panel of biomarkers (BMs) to identify septic patients at risk for developing ARDS, or at high risk of death, would be of interest for selecting ... ...

Abstract	Sepsis is a common cause of acute respiratory distress syndrome (ARDS) associated with a high mortality. A panel of biomarkers (BMs) to identify septic patients at risk for developing ARDS, or at high risk of death, would be of interest for selecting patients for therapeutic trials, which could improve ARDS diagnosis and treatment, and survival chances in sepsis and ARDS. We measured nine protein BMs by ELISA in serum from 232 adult septic patients at diagnosis (152 required invasive mechanical ventilation and 72 had ARDS). A panel including the BMs RAGE, CXCL16 and Ang-2, plus PaO
MeSH term(s)	APACHE ; Aged ; Aged, 80 and over ; Angiopoietin-2/blood ; Biomarkers/blood ; Chemokine CXCL16/blood ; Comorbidity ; Female ; Humans ; Intensive Care Units ; Length of Stay ; Male ; Middle Aged ; Organ Dysfunction Scores ; Prognosis ; Receptor for Advanced Glycation End Products/blood ; Respiration, Artificial/methods ; Respiratory Distress Syndrome/blood ; Respiratory Distress Syndrome/epidemiology ; Respiratory Distress Syndrome/mortality ; Respiratory Distress Syndrome/therapy ; Risk ; Sepsis/blood ; Sepsis/epidemiology ; Sepsis/mortality ; Sepsis/therapy
Chemical Substances	AGER protein, human ; ANGPT2 protein, human ; Angiopoietin-2 ; Biomarkers ; CXCL16 protein, human ; Chemokine CXCL16 ; Receptor for Advanced Glycation End Products
Language	English
Publishing date	2021-11-22
Publishing country	England
Document type	Journal Article ; Multicenter Study ; Observational Study ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-021-02100-w
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Article ; Online: Efficacy of dexamethasone treatment for patients with the acute respiratory distress syndrome caused by COVID-19

Villar, Jesús / Añón, José M. / Ferrando, Carlos / Aguilar, Gerardo / Muñoz, Tomás / Ferreres, José / Ambrós, Alfonso / Aldecoa, César / Suárez-Sipmann, Fernando / Thorpe, Kevin E. / Jüni, Peter / Slutsky, Arthur S.

Trials

study protocol for a randomized controlled superiority trial

2020 Volume 21, Issue 1

Keywords	Medicine (miscellaneous) ; Pharmacology (medical) ; covid19
Language	English
Publisher	Springer Science and Business Media LLC
Publishing country	us
Document type	Article ; Online
ZDB-ID	2040523-6
ISSN	1468-6694 ; 1745-6215 ; 1468-6708
ISSN (online)	1468-6694 ; 1745-6215
ISSN	1468-6708
DOI	10.1186/s13063-020-04643-1
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Efficacy of dexamethasone treatment for patients with the acute respiratory distress syndrome caused by COVID-19: study protocol for a randomized controlled superiority trial

Trials

Abstract: BACKGROUND: There are no specific generally accepted therapies for the coronavirus disease 2019 (COVID-19). The full spectrum of COVID-19 ranges from asymptomatic disease to mild respiratory tract illness to severe pneumonia, acute respiratory distress ... ...

Abstract	BACKGROUND: There are no specific generally accepted therapies for the coronavirus disease 2019 (COVID-19). The full spectrum of COVID-19 ranges from asymptomatic disease to mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multisystem organ failure, and death. The efficacy of corticosteroids in viral ARDS remains unknown. We postulated that adjunctive treatment of established ARDS caused by COVID-19 with intravenous dexamethasone might change the pulmonary and systemic inflammatory response and thereby reduce morbidity, leading to a decrease in duration of mechanical ventilation and in mortality. METHODS/DESIGN: This is a multicenter, randomized, controlled, parallel, open-label, superiority trial testing dexamethasone in 200 mechanically ventilated adult patients with established moderate-to-severe ARDS caused by confirmed SARS-CoV-2 infection. Established ARDS is defined as maintaining a PaO2/FiO2 ≤ 200 mmHg on PEEP ≥ 10 cmH2O and FiO2 ≥ 0.5 after 12 ± 3 h of routine intensive care. Eligible patients will be randomly assigned to receive either dexamethasone plus standard intensive care or standard intensive care alone. Patients in the dexamethasone group will receive an intravenous dose of 20 mg once daily from day 1 to day 5, followed by 10 mg once daily from day 6 to day 10. The primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free days, defined as days alive and free from mechanical ventilation at day 28 after randomization. All analyses will be done according to the intention-to-treat principle. DISCUSSION: This study will assess the role of dexamethasone in patients with established moderate-to-severe ARDS caused by SARS-CoV-2. TRIAL REGISTRATION: ClinicalTrials.gov NCT04325061 . Registered on 25 March 2020 as DEXA-COVID19.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #714407
Database	COVID19

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Article ; Online: Efficacy of dexamethasone treatment for patients with the acute respiratory distress syndrome caused by COVID-19

study protocol for a randomized controlled superiority trial

2020

Abstract: Abstract Background There are no specific generally accepted therapies for the coronavirus disease 2019 (COVID-19). The full spectrum of COVID-19 ranges from asymptomatic disease to mild respiratory tract illness to severe pneumonia, acute respiratory ... ...

Abstract	Abstract Background There are no specific generally accepted therapies for the coronavirus disease 2019 (COVID-19). The full spectrum of COVID-19 ranges from asymptomatic disease to mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multisystem organ failure, and death. The efficacy of corticosteroids in viral ARDS remains unknown. We postulated that adjunctive treatment of established ARDS caused by COVID-19 with intravenous dexamethasone might change the pulmonary and systemic inflammatory response and thereby reduce morbidity, leading to a decrease in duration of mechanical ventilation and in mortality. Methods/design This is a multicenter, randomized, controlled, parallel, open-label, superiority trial testing dexamethasone in 200 mechanically ventilated adult patients with established moderate-to-severe ARDS caused by confirmed SARS-CoV-2 infection. Established ARDS is defined as maintaining a PaO2/FiO2 ≤ 200 mmHg on PEEP ≥ 10 cmH2O and FiO2 ≥ 0.5 after 12 ± 3 h of routine intensive care. Eligible patients will be randomly assigned to receive either dexamethasone plus standard intensive care or standard intensive care alone. Patients in the dexamethasone group will receive an intravenous dose of 20 mg once daily from day 1 to day 5, followed by 10 mg once daily from day 6 to day 10. The primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free days, defined as days alive and free from mechanical ventilation at day 28 after randomization. All analyses will be done according to the intention-to-treat principle. Discussion This study will assess the role of dexamethasone in patients with established moderate-to-severe ARDS caused by SARS-CoV-2. Trial registration ClinicalTrials.gov NCT04325061 . Registered on 25 March 2020 as DEXA-COVID19.
Keywords	covid19
Subject code	610
Language	English
Publishing date	2020-08-16
Publishing country	ca
Document type	Article ; Online
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Article: Reversible posterior leukoencephalopathy syndrome in a young trauma patient.

Ortega-Carnicer, Julián / Ambrós, Alfonso / Diarte, Jesús I

Resuscitation

2005 Volume 64, Issue 1, Page(s) 119–120

MeSH term(s)	Adult ; Bicycling/injuries ; Brain/diagnostic imaging ; Coma/diagnosis ; Coma/etiology ; Coma/therapy ; Hematoma/complications ; Humans ; Hypertension/drug therapy ; Hypertension/etiology ; Hypertensive Encephalopathy/diagnosis ; Hypertensive Encephalopathy/etiology ; Hypertensive Encephalopathy/therapy ; Immunoglobulins, Intravenous/therapeutic use ; Male ; Methylprednisolone/therapeutic use ; Mydriasis/diagnosis ; Mydriasis/therapy ; Pelvis/injuries ; Purpura, Thrombocytopenic, Idiopathic/diagnosis ; Purpura, Thrombocytopenic, Idiopathic/drug therapy ; Purpura, Thrombocytopenic, Idiopathic/etiology ; Quadriplegia/diagnosis ; Quadriplegia/drug therapy ; Quadriplegia/etiology ; Renal Insufficiency/etiology ; Respiratory Distress Syndrome, Adult/etiology ; Retroperitoneal Space ; Seizures/diagnosis ; Seizures/therapy ; Syndrome ; Thrombocytopenia/etiology ; Tomography, X-Ray Computed ; Treatment Outcome
Chemical Substances	Immunoglobulins, Intravenous ; Methylprednisolone (X4W7ZR7023)
Language	English
Publishing date	2005-01
Publishing country	Ireland
Document type	Case Reports ; Letter
ZDB-ID	189901-6
ISSN	1873-1570 ; 0300-9572
ISSN (online)	1873-1570
ISSN	0300-9572
DOI	10.1016/j.resuscitation.2004.08.010
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