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1696 Diseases |  |
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- | dexamethasone / Generic mfg.
Journal: Relationship Between Overnight Dexamethasone Suppression Test and Aging. (Pubmed Central) - Dec 7, 2023
Conclusions The negative feedback mechanism for cortisol may be altered in older patients. Therefore, the 1-mg DST may yield a higher rate of false positives in the elderly.
- | prednisone / Generic mfg., methylprednisolone sodium succinate / Generic mfg.
Journal: Effectiveness of oral prednisone tapering following intravenous methylprednisolone for acute optic neuritis in multiple sclerosis. (Pubmed Central) - Dec 7, 2023
In conclusion, the addition of OPT to IVMP did not affect RNFL thickness or the final VA in a retrospective cohort of 51 patients with inaugural acute CIS- or MS-ON. The results of this exploratory study are currently being re-examined in a large-scale, demographically diverse, prospective study.
- | Humira (adalimumab) / AbbVie
Journal: Surgical induced necrotizing scleritis following intraocular lens replacement. (Pubmed Central) - Dec 7, 2023
In refractory cases, anti-TNF-? immunotherapy associated with surgical tectonic graft interventions can achieve promising results.
- || budesonide ER / Generic mfg.
Review, Journal: Management and treatment optimization of patients with mild to moderate ulcerative colitis. (Pubmed Central) - Dec 7, 2023
Realizing individualized plans through informed shared-decision making between health-care providers and fully engaged patients holds promise to maximize quality of life outcomes. Continuous improvement relies on innovation bridging different domains to overcome current limitations and push the field toward more predictive and tailored care.
- | dexamethasone / Generic mfg.
Journal: AG5 is a potent non-steroidal anti-inflammatory and immune regulator that preserves innate immunity. (Pubmed Central) - Dec 7, 2023
AG5 opens up a new class of anti-inflammatories, since contrary to NSAIDs, AG5 is able to inhibit the cytokine storm, like dexamethasone, but, unlike corticosteroids, preserves adequately the innate immunity. This is critical at the early stages of any na
- | Journal, Surgery: Duration of analgesia after forefoot surgery compared between an ankle and a sciatic nerve block at the popliteal crease: A randomised controlled single-blinded trial. (Pubmed Central) - Dec 7, 2023
P=N/A
This is critical at the early stages of any na Compared with the ankle block, the sciatic nerve block at the popliteal crease does not provide a longer duration of analgesia in patients undergoing forefoot surgery in the setting of multimodal analgesia.
- | dexamethasone / Generic mfg., pirfenidone / Generic mfg.
Journal: TrxR/Trx inhibitor butaselen ameliorates pulmonary fibrosis by suppressing NF-?B/TGF-?1/Smads signaling. (Pubmed Central) - Dec 7, 2023
BS and dexamethasone display a synergistic effect in inhibiting pulmonary fibrosis both in vitro and in vivo...Moreover, the knockdown of Trx1 with siRNA can also inhibit NF-?B/TGF-?1/Smads signaling. In conclusion, the TrxR/Trx inhibitor butaselen can suppress pulmonary fibrosis by inhibiting NF-?B/TGF-?1/Smads signaling.
- | dexamethasone injection / Generic mfg., tramadol hydrochloride / Generic mfg.
Journal, Surgery: The effects of dexamethasone added to ilioinguinal/iliohypogastric nerve (IIN/IHN) block on rebound pain in inguinal hernia surgery: a randomized controlled trial. (Pubmed Central) - Dec 7, 2023
P=N/A
In conclusion, the TrxR/Trx inhibitor butaselen can suppress pulmonary fibrosis by inhibiting NF-?B/TGF-?1/Smads signaling. In conclusion, adding IV dexamethasone as a part of multimodal analgesia
- | dexamethasone / Generic mfg.
Journal: Experiences of Parenting a Child Receiving Dexamethasone During Maintenance Chemotherapy for Acute Lymphoblastic Leukemia. (Pubmed Central) - Dec 7, 2023
Discussion A preparatory intervention for parents beginning the dexamethasone journey focused on likely challenges, managing boundary setting and discipline, and their own emotional struggles, could be beneficial. Research into the impact on siblings could further understand the systemic influence of dexamethasone and help develop further interventions.
- || nevanimibe (ATR-101) / Tempest Therap
Review, Journal: Current and novel treatment strategies in children with congenital adrenal hyperplasia. (Pubmed Central) - Dec 7, 2023
It is not known what levels of adrenal androgens are optimal for normal growth, puberty, and bone health. The basis of using glucocorticoids and mineralocorticoids in the treatment of CAH remains, and in some individuals, it may be beneficial to add therapies to reduce the androgen load during certain life stages.
- | Reolysin (pelareorep) / Oncolytics, Andrus Reo
Trial completion date, Combination therapy: Wild-Type Reovirus in Combination With Carfilzomib and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Dec 7, 2023
P1, N=12, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
The basis of using glucocorticoids and mineralocorticoids in the treatment of CAH remains, and in some individuals, it may be beneficial to add therapies to reduce the androgen load during certain life stages. Trial completion date: Nov 2023 --> Nov 2024
- | dexamethasone / Generic mfg.
New P4 trial: Comparative Assessment of Preoperative Versus Postoperative Submucosal Dexamethasone on Postoperative Complications Following Surgical Extraction of Mandibular Third Molar: Randomized Controlled Trial (clinicaltrials.gov) - Dec 7, 2023
P4, N=60, Not yet recruiting, Sponsor: B.P. Koirala Institute of Health Sciences
- | dexamethasone / Generic mfg.
Enrollment open, Trial completion date, Trial primary completion date, Surgery: TAP-DEX: Transversus Abdominis Plane Blocks With and Without Dexamethasone (clinicaltrials.gov) - Dec 7, 2023
P1/2, N=60, Recruiting, Sponsor: University of Saskatchewan
Trial completion date: Nov 2023 --> Nov 2024 Not yet recruiting --> Recruiting | Trial completion date: Mar 2023 --> Aug 2024 | Trial primary completion date: Mar 2023 --> Mar 2024
- ||| Sarclisa (isatuximab-irfc) / Sanofi
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy: Isatuximab in Combination With Novel Agents in RRMM - Master Protocol (clinicaltrials.gov) - Dec 7, 2023
P1/2, N=197, Recruiting, Sponsor: Sanofi
Not yet recruiting --> Recruiting | Trial completion date: Mar 2023 --> Aug 2024 | Trial primary completion date: Mar 2023 --> Mar 2024 N=123 --> 197 | Trial completion date: Nov 2028 --> Dec 2027 | Trial primary completion date: Nov 2028 --> Dec 2027
- | budesonide / Generic mfg.
Journal, HEOR: Postoperative mometasone irrigations improve quality of life in skull base tumor patients. (Pubmed Central) - Dec 7, 2023
Data on patient demographics and postoperative treatment with nasal saline irrigation twice daily with and without dissolved steroids (mometasone or budesonide) was collected...Though corticosteroid irrigations are routine in managing inflammatory sinus disease, their role in postoperative management after ESBS for tumors is unclear. Our findings suggest that mometasone irrigation may be effective at improving postoperative quality of life in patients after ESBS.
- | Trelegy Ellipta (fluticasone furoate/umeclidinium bromide/vilanterol) / GSK, Innoviva, Theravance Biopharma
Journal, Real-world evidence, Real-world: Real-World Study of Single-Inhaler Triple Therapy with Fluticasone Furoate/Umeclidinium/Vilanterol on Asthma Control in the US. (Pubmed Central) - Dec 7, 2023
In this real-world study, patients with asthma had significantly lower OCS use, asthma-related exacerbations, and SABA use following treatment initiation with FF/UMEC/VI compared with their pre-treatment period. These results suggest better asthma control following initiation of FF/UMEC/VI in a routine clinical practice setting.
- | Blincyto (blinatumomab) / Astellas, Amgen
Trial completion date, Trial primary completion date: ECOG-ACRIN E1910: Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia (clinicaltrials.gov) - Dec 7, 2023
P3, N=488, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
These results suggest better asthma control following initiation of FF/UMEC/VI in a routine clinical practice setting. Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Jun 2023
- | methylprednisolone sodium succinate / Generic mfg., prednisone delayed-release tablet / Generic mfg.
Enrollment closed, Enrollment change: High Dose Steroid Therapy (Prednisone or Methylprednisolone) for the Improvement of Symptoms of Late Radiation-Associated Lower Cranial Neuropathy in Oropharyngeal Cancer Survivors (clinicaltrials.gov) - Dec 7, 2023
P1/2, N=15, Active, not recruiting, Sponsor: M.D. Anderson Cancer Center
Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Jun 2023 Recruiting --> Active, not recruiting | N=25 --> 15
- | Darzalex (daratumumab) / J&J
Phase classification, Combination therapy: EQUULEUS: A Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Treatments for the Treatment of Patients With Multiple Myeloma (clinicaltrials.gov) - Dec 6, 2023
P1, N=242, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Recruiting --> Active, not recruiting | N=25 --> 15 Phase classification: P1b --> P1
- || Jakafi (ruxolitinib) / Incyte
New P2 trial: Ruxolitinib With De-Intensified HLH-94 for the Treatment of Hemophagocytic Lymphohistiocytosis (HLH) (clinicaltrials.gov) - Dec 6, 2023
P2, N=36, Not yet recruiting, Sponsor: University of California, San Francisco
- || TYRA-200 / Tyra Biosci
New P1 trial, Metastases: SURF201: Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations (clinicaltrials.gov) - Dec 6, 2023
P1, N=40, Recruiting, Sponsor: Tyra Biosciences, Inc
- | dexamethasone / Generic mfg., amoxycillin/clavulanate / Generic mfg.
Journal: Foamy Macrophages in a Case of Mononucleosis With Amoxicillin-Induced Rash, Hyperlipidemia, and Hemophagocytic Lymphohistiocytosis. (Pubmed Central) - Dec 6, 2023
Four days before, he had started taking amoxicillin/clavulanic acid...After treatment with dexamethasone and immunoglobulin, the skin rash, liver function, and lipid profile progressively improved...In our case, underlying cholestatic hepatopathy with hyperlipidemia was present. We believe that the incidental finding of foamy cells in graft-versus-host disease cases and in our case are likely related to the presence of severe liver disease with cholestatic hepatopathy and secondary hyperlipidemia in different background conditions.
- | Darzalex (daratumumab) / J&J
New P2 trial: DVRd in the Treatment of Patients With Newly Diagnosed Double-hit Multiple Myeloma (clinicaltrials.gov) - Dec 6, 2023
P2, N=40, Recruiting, Sponsor: Institute of Hematology & Blood Diseases Hospital, China
- || budesonide / Generic mfg.
Review, Journal: Systemic and targeted steroids for the treatment of IgA nephropathy. (Pubmed Central) - Dec 6, 2023
However, the limited number of treated patients and the relatively short follow-up suggest caution before considering budesonide superior to the current six-months steroid pulses scheme. Long-term data on the efficacy and safety of TRF budesonide are awaited, together with the design of trials with a head-to-head comparison with systemic steroids before considering TRF-budesonide as the standard of care treatment for IgAN nephropathy.
- || budesonide / Generic mfg.
Review, Journal: Expanding options of supportive care in IgA nephropathy. (Pubmed Central) - Dec 6, 2023
Targeted-release formulation of budesonide should replace systemic corticosteroids in patients with higher proteinuria and active histological lesions...The exact place of monoclonal antibodies and complement inhibitors will need to be determined. This article reviews potential supportive therapies currently available for patients with IgAN.
- || methylprednisolone sodium succinate / Generic mfg.
Review, Journal: Systematic review: clinical characteristics of anti-N-methyl-D-aspartate receptor encephalitis. (Pubmed Central) - Dec 6, 2023
In this study, 97.0% of patients received immunotherapy, with the most commonly used treatment regimen being intravenous methylprednisolone (IVGC) and intravenous immunoglobulin (IVIG)...This study includes case reports, which have obvious selection bias, and there are no unified standards to measure the severity of the disease. Therefore, in the future, larger samples and randomized controlled trials are needed to evaluate the efficacy of different treatment regimens.
- ||| Darzalex Faspro (daratumumab and hyaluronidase-fihj) / J&J
Trial completion date: LEPUS: A Study to Compare Daratumumab, Bortezomib, and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Chinese Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Dec 6, 2023
P3, N=211, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Therefore, in the future, larger samples and randomized controlled trials are needed to evaluate the efficacy of different treatment regimens. Trial completion date: Dec 2023 --> May 2024
- | Airsupra (budesonide/salbutamol) / AstraZeneca, Avillion
New P4 trial, Adverse events: Comparison of Preoperative Inhaled Budesonide With Salbutamol on the Respiratory Adverse Effects in Children Undergoing Tonsillectomy (clinicaltrials.gov) - Dec 6, 2023
P4, N=87, Not yet recruiting, Sponsor: Assiut University
- || Darzalex (daratumumab) / J&J
Clinical, Journal: Experience of Daratumumab in Relapsed/Refractory Multiple Myeloma: A Multicenter Study from Turkey. (Pubmed Central) - Dec 6, 2023
The frequency of neutropenia and thrombocytopenia was higher in the DARA-Rd group (61.9% vs. 24.7%; p < 0.001 and 42.9% vs. 15.7%; p < 0.001). Our study reflects real-life data in terms of DARA therapy for patients with RRMM and supports the early initiation of DARA therapy.
- | prednisone delayed-release tablet / Generic mfg.
Trial completion date, Trial primary completion date: GWIIRT: Gulf War Illness Inflammation Reduction Trial (clinicaltrials.gov) - Dec 6, 2023
P2, N=83, Completed, Sponsor: Minneapolis Veterans Affairs Medical Center
Our study reflects real-life data in terms of DARA therapy for patients with RRMM and supports the early initiation of DARA therapy. Trial completion date: Mar 2022 --> Oct 2023 | Trial primary completion date: Dec 2021 --> Oct 2023
- | Veramyst (fluticasone furoate nasal spray) / GSK
Retrospective data, Journal, HEOR, Cost-effectiveness, Cost effectiveness: Meta-analysis and cost-effectiveness analysis of intranasal corticosteroid treatment in allergic rhinitis with ocular symptoms. (Pubmed Central) - Dec 6, 2023
Trial completion date: Mar 2022 --> Oct 2023 | Trial primary completion date: Dec 2021 --> Oct 2023 FFNS is a cost-effective option compared to alternative INCSs in Thailand for treating AR with ocular symptoms.
- | dexamethasone / Generic mfg., ropivacaine / Generic mfg.
Enrollment open: BLOCK-SAH - PPF-Block for Post-SAH Headache (clinicaltrials.gov) - Dec 6, 2023
P2, N=195, Recruiting, Sponsor: University of Florida
FFNS is a cost-effective option compared to alternative INCSs in Thailand for treating AR with ocular symptoms. Not yet recruiting --> Recruiting
- || triamcinolone acetonide / Generic mfg.
Review, Journal: Analytical Methods for Triamcinolone Acetonide: An Exploratory Literature Review. (Pubmed Central) - Dec 6, 2023
The International Council for Harmonization (ICH) technical requirements for human use suggestions, which include a number of analytical parameters, have been followed in the validation of all the procedures. The present study also clarified the most significant drug combination.
- | methylprednisolone sodium succinate / Generic mfg.
Journal: Intravenous Methylprednisolone in Induction Therapy for ANCA-Associated Vasculitis: How Low Can We Go? (Pubmed Central) - Dec 6, 2023
The present study also clarified the most significant drug combination. No abstract available
- | Empliciti (elotuzumab) / AbbVie, BMS
Phase classification, Trial completion date: Study of Bortezomib,Lenalidomide,Dexamethasone & Elotuzumab in Newly Diagnosed MM (clinicaltrials.gov) - Dec 6, 2023
P2, N=40, Active, not recruiting, Sponsor: Dana-Farber Cancer Institute
No abstract available Phase classification: P2a --> P2 | Trial completion date: Jun 2023 --> Dec 2023
- | Xpovio (selinexor) / Karyopharm
Trial completion date, Trial initiation date, Trial primary completion date, Post-transplantation: Selinexor and Lenalidomide for Consolidation and Maintenance Treatment in Multiple Myeloma Post-transplant (clinicaltrials.gov) - Dec 6, 2023
P2, N=35, Not yet recruiting, Sponsor: Washington University School of Medicine
Phase classification: P2a --> P2 | Trial completion date: Jun 2023 --> Dec 2023 Trial completion date: Oct 2026 --> Jan 2027 | Initiation date: Oct 2023 --> Jan 2024 | Trial primary completion date: Oct 2026 --> Jan 2027
- ||| Carvykti (ciltacabtagene autoleucel) / J&J
Trial completion date, CAR T-Cell Therapy: CARTITUDE-5: A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy (clinicaltrials.gov) - Dec 6, 2023
P3, N=650, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Oct 2026 --> Jan 2027 | Initiation date: Oct 2023 --> Jan 2024 | Trial primary completion date: Oct 2026 --> Jan 2027 Trial completion date: Jan 2034 --> Dec 2034
- | Darzalex Faspro (daratumumab and hyaluronidase-fihj) / J&J
Trial completion date: A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis (clinicaltrials.gov) - Dec 6, 2023
P2, N=150, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Jan 2034 --> Dec 2034 Trial completion date: Nov 2025 --> Dec 2027
- | Carvykti (ciltacabtagene autoleucel) / J&J
Trial completion date, CAR T-Cell Therapy: CARTITUDE-2: A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma (clinicaltrials.gov) - Dec 6, 2023
P2, N=169, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Nov 2025 --> Dec 2027 Trial completion date: Jun 2027 --> Nov 2028
- |||||||||| ABBV-383 IV / AbbVie
New P3 trial, Monotherapy: Study Assessing Activity of Intravenous (IV) ABBV-383 Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Dec 6, 2023
P3, N=380, Not yet recruiting, Sponsor: AbbVie
- ||||||| Breztri Aerosphere (budesonide/formoterol fumarate/glycopyrronium) / AstraZeneca
Trial completion: TORES: Evaluate the Safety Profile of BGF MDI in Chinese Patients With COPD in Routine Clinical Practice (clinicaltrials.gov) - Dec 6, 2023
P=N/A, N=3345, Completed, Sponsor: AstraZeneca
Trial completion date: Jun 2027 --> Nov 2028 Recruiting --> Completed
- ||| Darzalex Faspro (daratumumab and hyaluronidase-fihj) / J&J
Trial completion date: CEPHEUS: A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy (clinicaltrials.gov) - Dec 6, 2023
P3, N=395, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Recruiting --> Completed Trial completion date: Aug 2025 --> Feb 2026
- || Darzalex (daratumumab) / J&J
Phase classification: A Study of Daratumumab (clinicaltrials.gov) - Dec 5, 2023
P3, N=500, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Aug 2025 --> Feb 2026 Phase classification: P3b --> P3
- | Airsupra (budesonide/salbutamol) / AstraZeneca, Avillion
Journal: Albuterol-Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma. (Pubmed Central) - Dec 5, 2023
Phase classification: P3b --> P3 No abstract available
- Calquence (acalabrutinib) / AstraZeneca
Acalabrutinib in Combination with Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy in Relapsed/Refractory B-Cell Lymphoma: A Phase I/II Study of Safety, Efficacy and Immune Correlative Analysis (Stars at Night B4 (Ballroom Level, Henry B. Gonzalez Convention Center); in-person) - Dec 5, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_677;
P1/2
CRP and ferritin levels were typically modestly elevated after axi-cel. Severe CRS was not observed and high-grade ICANS was uncommon.
- | dexamethasone / Generic mfg.
Journal: ROS-Scavenging Lignin-Based Tolerogenic Nanoparticle Vaccine for Treatment of Multiple Sclerosis. (Pubmed Central) - Dec 5, 2023
Additionally, the incorporation of dexamethasone into an LNP-based tolerogenic nanovaccine could further improve the recovery of EAE mice in the severe chronic stage. As lignin is the most abundant biomass and waste byproduct in the pulping industry, a lignin-based tolerogenic vaccine could be a novel, cost-effective, high-value vaccine platform with potent therapeutic efficiency in treating autoimmune diseases.
- ||| Journal, Adverse events: A Pharmacovigilance Study of Drug-Induced Glaucoma Utilizing the Japanese Adverse Event Reporting System. (Pubmed Central) - Dec 5, 2023
A national pharmacovigilance database enabled us to identify the drugs that frequently induce glaucoma. The likelihood of the reporting of glaucoma varied among the drugs, which should be used carefully in clinical practice to avoid it.
- | dexamethasone / Generic mfg.
Journal: Herpes Simplex Virus Encephalitis after Recovery from Coronavirus Disease 2019: A Rare Case Report. (Pubmed Central) - Dec 5, 2023
The patient was treated with dexamethasone, and the infection was cured...The patient was treated with antiviral drugs and recovered from the HSV encephalitis. This case suggests that, in patients with COVID-19 and disorders of consciousness, the possibility of HSV encephalitis should be considered along with COVID-19 encephalitis.
- | Spikevax (elasomeran) / Moderna
Journal: Association of Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease with Coronavirus Disease 2019 Vaccination and Infection: A Case Report of Cortical Encephalitis and Transverse Myelitis Relapse. (Pubmed Central) - Dec 5, 2023
A 34-year-old woman developed cortical encephalitis in the right temporoparietal lobe one week after receiving the mRNA-1273 vaccine...Her symptoms gradually improved after three courses of intravenous methylprednisolone therapy...Despite treatment with plasma exchange, the patient remained paralyzed in both lower limbs. We herein review the relationship between MOGAD and COVID-19 vaccination/infection.
- | dexamethasone / Generic mfg.
Journal: Preoperative dexamethasone administration in hepatectomy of 25-min intermittent Pringle's maneuver for hepatocellular carcinoma: protocol for a randomized controlled trial. (Pubmed Central) - Dec 5, 2023
Based on our previous study, we will explore further the effect of glucocorticoid administration on attenuating the surgical stress response in order to follow securely 25-min hepatic inflow occlusion. Therefore, the trial protocol is reasonable and the results of the trial may be clinically significant.