title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
|---|---|---|---|---|
Results | PMC10511465 | |||
Pseudovirus neutralization potencies | Pseudovirus microneutralization assays were performed as previously describedPseudovirus neutralization potencies of NAS. | PMC10511465 | ||
Biocompatibility assessment | A biocompatibility assessment was performed, which included several in vitro and in vivo studies (Fig. Biocompatibility study of NAS. | PMC10511465 | ||
Circulatory levels of human IgG1 anti-SARS-CoV-2 antibodies after intranasal application of NAS | In order to assess the potential systemic effects of intranasal application of NAS, quantitative measurement of human IgG1 anti-SARS-CoV-2 antibodies after intranasal application of NAS was determined in rats. A single dose of NAS (20 µg/kg) was intranasally applied to 10-week-old female Sprague–Dawley rats (n=13). Thi... | PMC10511465 | ||
Safety of NAS application | inflammation | CHRONIC RHINOSINUSITIS, INFLAMMATION, ADVERSE EVENTS, ALLERGIC RHINITIS, ADVERSE EVENT | To evaluate the safety and tolerability of NAS, 38 healthy volunteers were enrolled (Fig. Study flow chart. Thirty-eight healthy volunteers were enrolled to evaluate the safety and detect intranasal neutralizing antibodies before and after a placebo or NAS application. Thirty-six volunteers were randomized into a 1:3 r... | PMC10511465 |
Detection of SARS-CoV-2 neutralizing antibodies in nasal fluids | VIRUS | Nasal fluid was collected by swabbing from both nostrils before and immediately or 6 h after the study product application in both the NAS and placebo groups (see Fig. Assessment of SARS-CoV-2 neutralizing antibodies in nasal fluids before and after a placebo or NAS application. SARS-CoV-2 neutralizing antibodies in na... | PMC10511465 | |
Discussion | toxicity | VIRUS, ADVERSE EVENTS, INFLAMMATION, CAVITY, CYTOTOXICITY | NAS is a medical device innovated to support mucosal immunity against SARS-CoV-2 via a dual mechanism of action in which a potent broadly neutralizing human IgG1 anti-SARS-CoV-2 monoclonal antibody cocktail produces inhibitory effects against multiple variants of concern (VOCs) in nasal fluid, and a steric barrier-form... | PMC10511465 |
Methods | PMC10511465 | |||
Study product | Nasal Antibody Spray or NAS is an HPMC-based nasal spray solution containing human IgG1 anti-SARS-CoV-2 monoclonal antibodies, clones 1D1 and 3D2 | PMC10511465 | ||
Pseudovirus-based neutralization assay | Lentiviral pseudoviruses containing SARS-CoV-2 spike were produced with slight modifications, as previously described by Di Genova et al.To assess the neutralizing activities of Nasal Antibody Spray, a two-fold serial dilution of the NAS was conducted in a culture medium starting at a ratio of 1:40 (high-glucose DMEM w... | PMC10511465 | ||
Biocompatibility testing | toxicity | CYTOTOXICITY | The biocompatibility of NAS was evaluated by the following 5 assessments conforming to the standards of medical devices (ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993 Part 23: 2021, and ISO 10993-11:2017): (1) in vitro cytotoxicity using the direct contact method, (2) skin sensitization using the guinea pig maximizati... | PMC10511465 |
Enzyme-linked immunosorbent assay (ELISA) | ELISA was employed to quantify human IgG1 anti-SARS-CoV-2 antibody levels in the circulation after intranasal application of NAS in rats. In brief, rat serum samples diluted in 3% BSA in PBS buffer at a 1:10 dilution were added (100 µl/well) to an ELISA plate coated with 100 ng/well of Delta-variant RBD proteins (40592... | PMC10511465 | ||
Clinical study design | This study was designed as a single-center, double-blind, randomized, placebo-controlled trial to evaluate the safety, tolerability, and clinical performance of NAS in healthy volunteers. | PMC10511465 | ||
Ethical considerations | This study was approved by the Ethics Committee of the Department of Medical Services, Ministry of Public Health, Thailand (Approval No. 0001/2565, approval date: 12/04/2022) and registered with the ClinicalTrials.gov; Date of first registration: 03/05/2022; Registration number: NCT05358873. All procedures were perform... | PMC10511465 | ||
Participants | We calculated the sample size based on previous recommendationsTo ensure an adequate sample size in case participants dropped out, we added 4 more participants to attain the total number of 36 participants. Healthy volunteers interested in participating in the study were screened according to the inclusion and exclusio... | PMC10511465 | ||
Product application | NAS and normal saline solution (placebo) were produced, packaged, and labeled with a double-blind, randomized code by the Government Pharmaceutical Organization (GPO), Ministry of Public Health, Thailand. Each participant was randomly assigned to receive either NAS or a placebo. Site staff gave participants instruction... | PMC10511465 | ||
Safety evaluation | ADVERSE EVENTS | Safety was assessed based on nasal sinuscopy examination, treatment-emergent adverse events (TEAEs), and Sino-Nasal Outcome Test-22 (SNOT-22) and Total Nasal Symptom Score (TNSS) questionnaires | PMC10511465 | |
SARS-CoV-2 surrogate virus neutralization test | VIRUS | SARS-CoV-2 surrogate virus neutralization test in nasal fluid specimens against the ancestral, Delta, and Omicron BA.2 HRP-conjugated RBD proteins were determined using a SARS-CoV-2 surrogate virus neutralization test (cPass SARS-CoV-2 neutralization antibody detection kit, GenScript; A02087, Z03614, and Z03741). Nasal... | PMC10511465 | |
Statistical analysis | For the safety assessments of NAS, an unpaired two-tailed Mann–Whitney U test was used, and Dunn’s test was applied for multiple testing corrections. For the assessments of intranasal SARS-CoV-2 inhibitory effects of NAS, the difference in % inhibition before and after the study product applications was compared using ... | PMC10511465 | ||
Supplementary Information |
Supplementary Information 1.Supplementary Information 2.Supplementary Information 3.Supplementary Information 4.Supplementary Information 5. | PMC10511465 | ||
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-42539-7. | PMC10511465 | ||
Acknowledgements | Data collection and analysis were supported by Ever Medical Technology Co., Ltd. (Thailand). | PMC10511465 | ||
Author contributions | Conceptualization: T.I., C.B., T.Pisitkun, A.J., and P.A.; Project administration: T.I., S.B., C.B., T.Pisitkun, and S.A.; Funding acquisition: C.B. and T.Pisitkun; Methodology: T.I., T.J., N.Pojdoung, N.Meesiripan, S.Sakarin, C.B., T.W., T.Phakham, T.A., C.A., P.S., P.M., M.X.T., S.Tongchusak, C.S., W.R., Q.D.L., S.D.... | PMC10511465 | ||
Funding | This study was sponsored by HIBIOCY Co., Ltd. and funded by the Program Management Unit Competitiveness (PMU-C), Ministry of Higher Education, Science, Research and Innovation, Thailand (Grant No. C10F650051). The funders had no role in the conceptualization, conduct, or interpretation of this work. | PMC10511465 | ||
Data availability | All data generated or analyzed during this study are included in this published article. | PMC10511465 | ||
Competing interests | The authors declare no competing interests. | PMC10511465 | ||
References | PMC10511465 | |||
Abstract | PMC9873524 | |||
Background | stroke, hemiplegic, task‐based | STROKE | Motor imagery training (MIT) has been widely used to improve hemiplegic upper limb function in stroke rehabilitation. The effectiveness of MIT is associated with the functional neuroplasticity of the motor network. Currently, brain activation and connectivity changes related to the motor recovery process after MIT are ... | PMC9873524 |
Methods | stroke, upper limb motor impairment | STROKE | We recruited 39 stroke patients with moderate to severe upper limb motor impairment and randomly assigned them to either the MIT or control groups. Patients in the MIT group received 4 weeks of MIT therapy plus conventional rehabilitation, while the control group only received conventional rehabilitation. The assessmen... | PMC9873524 |
Results | The MIT group achieved higher improvements in FM‐UL and BI relative to the control group after the treatment. Passive movement of the affected hand evoked an abnormal bilateral activation pattern in both groups before intervention. A significant | PMC9873524 | ||
Conclusions | stroke, upper limb motor impairments | STROKE | MIT could help decrease the compensatory activation at both hemispheres and reshape the FC within the ipsilesional hemisphere along with functional recovery in stroke patients.The neural mechanism of motor imagery training in stroke patients with moderate to severe upper limb motor impairments was investigated using ta... | PMC9873524 |
INTRODUCTION | stroke, upper limb impairment, Stroke, long‐term adult disability | STROKE, STROKE | Stroke represents a major cause of long‐term adult disability worldwide.Mental practice of movements, also known as motor imagery training (MIT), has attracted much interest for its potential for neurorehabilitation to improve upper limb function.Neural plasticity forms the intrinsic basis of neurorehabilitation for mo... | PMC9873524 |
METHODS | PMC9873524 | |||
Patients and interventions | Spasticity, spasticity, cognitive impairment, stroke, apraxia, pain, aphasia, hemorrhage, first‐ever stroke, upper extremity motor function, excessive sensory disturbance, hand hemiplegia, infarct | MULTIPLE ORGAN FAILURE, STROKE, HEMORRHAGE, INFARCT, MALIGNANT DISEASE | This study was a randomized, single‐blind, controlled trial conducted at Huashan Hospital in Shanghai, China. All potential participants were screened by the physicians for eligibility. Each participant signed a written informed consent before participation. This study was approved by the Review Board of Ethics Committ... | PMC9873524 |
fMRI data acquisition | ischemia, stroke, hemorrhage, clench | STROKE, HEMORRHAGE, ISCHEMIA | T1‐ and T2‐weighted structural and task‐based functional images were acquired on a 3 T MRI scanner (Siemens) at Shanghai Key Laboratory of Magnetic Resonance. T1‐weighted images were obtained using a magnetization‐prepared rapid gradient echo sequence (TR = 1900 ms, TE = 3.42 ms, TI = 900 ms, FOV = 240 × 240 mmThe fMRI... | PMC9873524 |
fMRI preprocessing | Images of the patients with left‐sided lesions were flipped before preprocessing. After flipping, the right hemisphere was tagged as the ipsilesional side and the left hemisphere as the contralesional side. fMRI preprocessing was carried out using DPARSF, | PMC9873524 | ||
Activation and FC analysis | A general linear model (GLM) was set for each individual in SPM first‐level statistical analysis to estimate the task‐related activation by contrasting passive movement and rest conditions (Passive movement > Rest). In this model, head motion in the six directions estimated in the preprocessing was added as a regressor... | PMC9873524 | ||
Statistical analysis | stroke | STROKE | The normality of variables (age, days after stroke onset, lesion volume, FM‐UL, and BI score) was tested by Shapiro–Wilk's test, showing that none of these variables conform to the normal distribution. Group differences were tested by chi‐square tests on sex, stroke type, and lesion side, and Mann–Whitney Voxel‐wise 2 ... | PMC9873524 |
RESULTS | PMC9873524 | |||
Clinical outcome | Detailed demographic and clinical data for the patients are shown in Table Improvement in FM‐UL score after rehabilitation in the motor imagery training group (MIT) and control group (CON). (A) FM‐UL score before and after rehabilitation in the two groups; (B) Comparison of FM‐UL improvement between the two groups; (C,... | PMC9873524 | ||
Brain activation to passive movements | Twenty‐nine | BRAIN | Twenty‐nine patients (15 in the MIT group and 14 in the CON group) who had completed task‐fMRI scanning before and after intervention and with good image quality were included in the fMRI analysis.The general activation to passive movements of the affected/unaffected hand is shown in Figure Brain activation in response... | PMC9873524 |
Functional connectivity | BRAIN | The two clusters mentioned above, showing significant Changes in functional connectivity (FC) with the ipsilesional precentral cluster between MIT and CON groups. (A) Brain regions in which FC showed significant Group × Time interactions (threshold‐free cluster enhancement [TFCE] corrected When taking the cluster in th... | PMC9873524 | |
DISCUSSION | excessive head motion, stroke, upper limb motor recovery, upper limb motor function, hand motor tasks | STROKE, CORTEX | Emerging neuroimaging studies have identified neuroimaging biomarkers of functional recovery in stroke patients.The activation of the passive movement of the affected hand showed an abnormal bilateral activation pattern compared with the contralateral‐lateralized activation of the passive movement of the unaffected han... | PMC9873524 |
CONCLUSION | stroke, upper limb motor impairments | STROKE | In conclusion, this is an inaugural study that uses task‐based fMRI to investigate the neural mechanism of MIT in stroke patients with moderate to severe upper limb motor impairments. This work expands our understanding of the effects of MIT on brain reorganization both at the activation and brain network levels. Besid... | PMC9873524 |
AUTHOR CONTRIBUTIONS | LMS, HWW | LMS and XLG were involved in the development and design of the study concept; CHS, BZ, and YMX were involved in intervention and assessment; XX, KXZ, XW, MXF, and SBT were involved in data acquisition and analysis; HWW and XX contributed to the initial manuscript writing. All authors revised and agreed to the final ver... | PMC9873524 | |
CONFLICT OF INTEREST | All the authors declared no conflicts of interest. | PMC9873524 | ||
Supporting information |
Table S1‐S3
Click here for additional data file. | PMC9873524 | ||
ACKNOWLEDGMENTS | This work was supported by the National Natural Science Foundation of China (No. 81974356, No.61771313, and No.82102665), the National Key R&D Program of China (2020YFC2004200), and the Shanghai Sailing Program (No.21YF1404600). The sponsor played no role in the study design, data collection, data analysis, data interp... | PMC9873524 | ||
DATA AVAILABILITY STATEMENT | The data that support the findings of this study are available from the corresponding author upon reasonable request. | PMC9873524 | ||
REFERENCES | PMC9873524 | |||
Purpose | Edited by: Sheikh Mohd Saleem, Ministry of Health and Family Welfare, IndiaReviewed by: György Purebl, Semmelweis University, Hungary; Yanfeng Wang, Xiangya Hospital, Central South University, ChinaThis article was submitted to Public Mental Health, a section of the journal Frontiers in Public Health†These authors have... | PMC10031109 | ||
Methods | poisoning | MAY | This study prospectively enrolled 237 patients who were treated for poisoning at the Fifth Medical Center of PLA General Hospital (Beijing) between May 2021 and May 2022. Patient's basic characteristics, daily activities, mental health status, and history of psychological illnesses were gathered to examine their predic... | PMC10031109 |
Results | anxiety | Of all poisoned patients, 64.6% committed suicide by self-poisoning. With regard to self-poisoning attempted suicide, multivariate analysis demonstrated that female gender, smoking, generalized anxiety disorder-7 (GAD-7), and beck hopelessness scale-20 (BHS-20) were significant risk factors, whereas married status, rel... | PMC10031109 | |
Conclusions | psychiatric, anxiety | This study proposes a prediction model to stratify patients at a high risk of suicide by self-poisoning and to guide individual preventive strategies. Patients in the high-risk group require further mental health counseling to alleviate anxiety and hopelessness, healthy lifestyle like quitting smoking and exercising mo... | PMC10031109 | |
Introduction | ideations, death, cancer | REGRESSION, CANCER | Suicide is the behavior of deliberately causing one's own death, and it is one of serious causes of death all over the world (It is extremely helpful to identify suicide risk factors in order to direct preventive and treatment strategies. Currently, a number of variables haven been shown to be relevant to suicide ideat... | PMC10031109 |
Patients and methods | PMC10031109 | |||
Patients | poisoning, psychiatric | MAY | In this study, 267 patients who were admitted to the Fifth Medical Center of PLA General Hospital (Beijing) for poisoning treatment between May 2021 and May 2022 were prospectively examined. Basic patient characteristics, lifestyle, poison type, length of stay, medical costs, mental health condition, and history of psy... | PMC10031109 |
Data collection | depression, greasy, anxiety, poisoning | DISEASE, EVENT | The following variables were gathered for this study: (1) basic characteristics (age, gender, marital status, education level, and residence), (2) lifestyle (bland diet, greasy food, smoking, drinking, sedentary time per day, sport frequency per week, and monthly income), (3) mental health status (anxiety, depression, ... | PMC10031109 |
Nomogram development and validation | Multivariate analysis was utilized to build the nomogram and discover variables linked to self-poisoning suicide. A nomogram was created using variables that reached statistical significance. The nomogram was displayed | PMC10031109 | ||
Feature importance analysis | For clinical applicability, Shaley Additive exPlanation (SHAP) was used to interpret feature contributions. On explaining SHAP, we adopted the following formula, and in the formula | PMC10031109 | ||
Statistical analysis | In the study, quantitative features were presented as means with standard deviation, and qualitative features were summarized as proportion. Comparison between quantitative features were evaluated using | PMC10031109 | ||
Results | PMC10031109 | |||
Patient's basic characteristics and clinical features | hopelessness, anxiety | A total of 237 patients were enrolled for analysis in the study with a mean age of 33.33 ± 15.83 years. The majority of patients were female (55.3%), married (48.5%), primary education level (37.1%), and lived in city (71.7%). Regarding dietary preference, 54.4% patients intended to bland diet and 84.4% patients had no... | PMC10031109 | |
A comparison analysis based on the presence of suicide | hopelessness, anxiety | Between patients who committed suicide and those who did not, significant differences in gender (A comparison between patients with and without suicide in the training group.SD, standard deviation; GAD-7, generalized anxiety disorder-7; PHQ-9, patient health questionnaire-9; SES-10, self-esteem scale-10; BHS-20, beck h... | PMC10031109 | |
Development of the nomogram | hopelessness, anxiety | Multivariate analysis demonstrated that female gender (Selection of nomogram predictor based on the univariate and multivariate analyses in the training group.OR, odds ratio; CI, confident interval; GAD-7, generalized anxiety disorder-7; PHQ-9, patient health questionnaire-9; SES-10, self-esteem scale-10; BHS-20, beck ... | PMC10031109 | |
Validation of the nomogram | The area under curve (AUC) of the nomogram was up to 0.938 (0.904–0.972) in the training group (Area under the curve (AUC) for the nomogram. Probability curve and discrimination slope for the nomogram. Calibrating evaluation and clinical usefulness of the nomogram. Predictive measures of the nomogram in the training an... | PMC10031109 | ||
Classification of patients at different risk probability of suicide | The average threshold of the training (53.7%) and validation (24.6%) cohorts was regarded as the optimal cut-off value (40%). Based on the best cut-off value of the nomogram, patients in the high-risk group had a nearly 6-time larger likelihood of committing suicide by self-poisoning than patients in the low-risk group... | PMC10031109 | ||
Discussion | PMC10031109 | |||
Main findings | cancer | CANCER | In order to stratify patients at various risk levels for self-poisoning suicide, this study presented a nomogram, and nine features were added to the nomogram for analysis and model building. The predictive performance of the nomogram showed excellent effectiveness of prediction based on the AUC, accuracy rates, and th... | PMC10031109 |
Risk factors associated with suicide behaviors | depression | EVENTS | Studies have shown that a series of variables were associated with suicide attempts, such as sex, grade, residence, family integrity, feeling meaningless in life, depression, bullying perpetrator, autonomy parenting, self-esteem, hopelessness, and stressful life events ( | PMC10031109 |
Prediction models of suicide managements | acute organophosphorus poisoning, cancer, self-poisoning | CANCER | Several prediction models have been developed, according to the literature that is currently accessible, to guide management among self-poisoning patients. For instance, researchers created a nomogram with six features, including age, white cells, albumin, cholinesterase, blood pH, and lactic acid levels, for the bedsi... | PMC10031109 |
Approaches to prevent self-poisoning suicide | Identification of risk and protective factors is a crucial step in developing effective suicide prevention methods since it can be used to choose the right interventions and how to carry them out. In these situations, risk factors serve as markers of whether a person or society has a propensity for suicide, hence the d... | PMC10031109 | ||
Limitations | There are still a few issues with the study. Firstly, because we can only get data from patients who are still alive, the study may pose a risk of survival bias. Patients who had poisoned themselves and died at home or on the way to hospitals were not accessible to us. Additionally, some suicide attempts could be mista... | PMC10031109 | ||
Conclusions | anxiety | This study proposes a prediction model to stratify patients at a high risk of suicide by self-poisoning so that individual preventive strategies can be timely performed. Patients in the high-risk group need more healthcare guidance, including education of health lifestyle such as quitting smoking and doing more exercis... | PMC10031109 | |
Data availability statement | The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation. | PMC10031109 | ||
Ethics statement | The Ethics Committee of the Fifth Medical Center of PLA General Hospital approved the study protocol (No. KY-2021-12-34-1). Data were anonymously analyzed and informed written consent was obtained from all patients. The Ethics Committee waived the requirement of written informed consent for participation. | PMC10031109 | ||
Author contributions | WZ, LG, and CW conceived and designed this study together. WZ and YL undertook the data analysis, results interpretation, and manuscript preparation. CL and XP performed supervision. All authors read and approved the final manuscript. | PMC10031109 | ||
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10031109 | ||
Publisher's note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC10031109 | ||
Supplementary material | The Supplementary Material for this article can be found online at: Click here for additional data file. | PMC10031109 | ||
References | PMC10031109 | |||
Key Points | PMC9975910 | |||
Question | ischemia-reperfusion injury | Can a combined drug approach targeting the preimplantation liver graft and recipient attenuate the degree of ischemia-reperfusion injury? | PMC9975910 | |
Findings | COLD | In this open-label randomized clinical trial of 72 liver transplant recipients allocated to either static cold storage (standard of care) with an add-on combined drug approach delivered to the preimplantation liver and recipient or to standard of care only, peak aspartate aminotransferase serum levels and other functio... | PMC9975910 | |
Meaning | ischemia-reperfusion injury | The findings suggest that use of a downstream combined drug approach that targets the preimplantation liver graft and recipient is not clinically effective for decreasing ischemia-reperfusion injury. | PMC9975910 | |
Importance | In a porcine model of liver transplant, a combined drug approach that targeted the donor graft and graft recipient reduced ischemia-reperfusion injury, a major hurdle to the success of liver transplant. | PMC9975910 | ||
Objective | ischemia-reperfusion injury | To assess the effect of a clinical form of a perioperative combined drug approach delivered immediately before implantation to the procured liver and to the liver recipient on the degree of ischemia-reperfusion injury. | PMC9975910 | |
Design, Setting, and Participants | death | KIDNEY FAILURE, MAY, ACUTE LIVER FAILURE | This unicentric, investigator-driven, open-label randomized clinical trial with 2 parallel arms was conducted in Belgium from September 2013 through February 2018, with 1-year follow-up. Adults wait-listed for a first solitary full-size liver transplant were screened for eligibility. Exclusion criteria were acute liver... | PMC9975910 |
Interventions | COLD | Participants were randomized to a combined drug approach with standard of care (static cold storage) or standard of care only (control group). In the combined drug approach group, following static cold preservation, donor livers were infused with epoprostenol (ex situ, portal vein); recipients were given oral α-tocophe... | PMC9975910 | |
Main Outcomes and Measures | allograft dysfunction, ischemia-reperfusion injury, postreperfusion syndrome, ischemic cholangiopathy, acute kidney injury | SURGICAL COMPLICATIONS | The primary outcome was the posttransplant peak serum aspartate aminotransferase (AST) level within the first 72 hours. Secondary end points were the frequencies of postreperfusion syndrome, ischemia-reperfusion injury score, early allograft dysfunction, surgical complications, ischemic cholangiopathy, acute kidney inj... | PMC9975910 |
Results | Of 93 randomized patients, 21 were excluded, resulting in 72 patients (36 per study arm) in the per protocol analysis (median recipient age, 60 years [IQR, 51.7-66.2 years]; 52 [72.2%] men). Peak AST serum levels were not different in the combined drug approach and control groups (geometric mean, 1262.9 U/L [95% CI, 94... | PMC9975910 | ||
Conclusions and Relevance | ischemic-reperfusion injury | COLD | In this randomized clinical trial, the combined drug approach targeting the post–cold storage graft and the recipient did not decrease ischemic-reperfusion injury. The findings suggest that in addition to a downstream strategy that targets the preimplantation liver graft and the graft recipient, a clinically effective ... | PMC9975910 |
Trial Registration | ClinicalTrials.gov Identifier: | PMC9975910 | ||
Introduction | LIVER FAILURE, LIVER, CDA | Liver transplant is a life-saving therapy for liver failure, but its success is limited by a marked shortage of organs and high mortality among individuals on the waiting list.Livers from extended-criteria donors are more susceptible to ischemia-reperfusion injury (IRI),Over the past decades, evidence from small- and l... | PMC9975910 | |
Methods | PMC9975910 | |||
Study Design | RECRUITMENT | This investigator-initiated, open-label RCT (Combined Drug Approach to Prevent Ischemia-Reperfusion Injury During Transplantation of Livers [CAPITL]) with 2 parallel arms was conducted between September 2013 and February 2018, with 1-year follow-up, at the University Hospitals Leuven, Belgium. Ethical approval was obta... | PMC9975910 | |
Study Population | death | BRAIN DEATH | Adults aged 18 years or older who were wait-listed for a first solitary full-size liver transplant were screened for eligibility at the time of liver offer. Recipients of whole livers from donations after brain death and/or circulatory death (Maastricht category 3 | PMC9975910 |
Components, Doses, Mechanisms, and Relevant Experimental and Clinical Evidence of the Combined Drug Approach | thrombosis, death, TNF-α, tumor necrosis, toxicity, inflammation, kidney reperfusion injury, parenchymal injury, congestion, myocardial injury, ischemia reperfusion, hepatocellular injury | THROMBOSIS, PRINGLE, TUMOR NECROSIS, INFLAMMATION, ACUTE KIDNEY FAILURE, LIVER REGENERATION, CONGESTION, ADHESION, HEPATOCELLULAR INJURY | Improvement of IRI severity, elimination of primary nonfunction, reduction of inflammatory cytokines such as TNF-α, improvement in liver function, reduction of bile salt toxicity, and increase of survival in a stringent pig DCD model of LT Improvement of hepatocellular injury, lipid peroxidation, and function in rat l... | PMC9975910 |
Randomization | End-stage Liver Disease | At the time of organ offer, eligible patients were enrolled and randomized. A random allocation sequence was generated using computer-based random numbers with permuted block sizes of 2, 4, and 6. No stratification was performed on a priori–defined potential confounders such as CIT and priority on the waiting list thro... | PMC9975910 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.