Tag: nevin manimala

J Anesth Analg Crit Care. 2023 Sep 15;3(1):34. doi: 10.1186/s44158-023-00120-8.

ABSTRACT

BACKGROUND: Septoplasty, a common surgical procedure to correct a deviated septum, can be performed under either general anesthesia or deep sedation anesthesia. The choice of anesthesia can influence the duration of anesthesia and surgical outcomes, impacting the feasibility of outpatient procedures.

METHODS: The institutional review board approved the protocol, and we obtained written informed consent from all participants. This retrospective, single-center observational study analyzed data from 586 patients who underwent rhino septoplasty at Santo Stefano Hospital in Prato, Italy, from 2017 to 2021. Patients received either general anesthesia or deep sedation anesthesia. Propensity score matching and inverse probability weighting were used to balance patient characteristics. The main outcome variable was discharge time, with anesthesia time and surgical time as covariates. Statistical analysis was conducted using R software.

RESULTS: Patients who received deep sedation anesthesia had a significantly shorter duration of anesthesia compared to those who received general anesthesia. A multivariate linear regression model showed that the type of anesthesia had a strong positive association with discharge time, while anesthesia time had a weaker negative association, although not statistically significant.

CONCLUSIONS: Deep sedation anesthesia is associated with a shorter duration of anesthesia compared to general anesthesia during nasal septal surgery, suggesting it could be a more feasible option for outpatient procedures. However, the choice of anesthesia should be tailored to individual patient factors and surgical requirements. Further research is needed to confirm these findings and explore the potential benefits of sedation anesthesia in outpatient nasal septal surgery.

QUESTION: How do general anesthesia and deep sedation anesthesia compare in terms of duration of anesthesia and surgical outcomes during nasal septal surgery?

FINDINGS: Our study found that deep sedation anesthesia was associated with a shorter duration of anesthesia compared to general anesthesia in patients undergoing nasal septal surgery. However, there were no significant differences in the duration of the surgical procedure.

MEANING: The findings suggest that deep sedation anesthesia could potentially make nasal septal surgery more feasible as an outpatient procedure.

PMID:37715286 | DOI:10.1186/s44158-023-00120-8

Pilot Feasibility Stud. 2023 Sep 15;9(1):162. doi: 10.1186/s40814-023-01387-y.

ABSTRACT

BACKGROUND: Delirium affects over 20% of all hospitalised older adults. Delirium is associated with a number of adverse outcomes following hospital admission including cognitive decline, anxiety and depression, increased mortality and care needs. Previous research has addressed prevention of delirium in hospitals and care homes, and there are guidelines on short-term treatment of delirium during admission. However, no studies have addressed the problem of longer-term recovery after delirium and it is currently unknown whether interventions to improve recovery after delirium are effective and cost-effective. The primary objective of this feasibility study is to test a new, theory-informed rehabilitation intervention (RecoverED) in older adults delivered following a hospital admission complicated by delirium to determine whether (a) the intervention is acceptable to individuals with delirium and (b) a definitive trial and parallel economic evaluation of the intervention are feasible.

METHODS: The study is a multi-centre, single-arm feasibility study of a rehabilitation intervention with an embedded process evaluation. Sixty participants with delirium (aged > 65 years old) and carer pairs will be recruited from six NHS acute hospitals across the UK. All pairs will be offered the intervention, with follow-up assessments conducted at 3 months and 6 months post-discharge home. The intervention will be delivered in participants’ own homes by therapists and rehabilitation support workers for up to 10 intervention sessions over 12 weeks. The intervention will be tailored to individual needs, and the chosen intervention plan and goals will be discussed and agreed with participants and carers. Quantitative data on reach, retention, fidelity and dose will be collected and summarised using descriptive statistics. The feasibility outcomes that will be used to determine whether the study meets the criteria for progression to a definitive randomised controlled trial (RCT) include recruitment, delivery of the intervention, retention, data collection and acceptability of outcome measures. Acceptability of the intervention will be assessed using in-depth, semi-structured qualitative interviews with participants and healthcare professionals.

DISCUSSION: Findings will inform the design of a pragmatic multi-centre RCT of the effectiveness and cost-effectiveness of the RecoverED intervention for helping the longer-term recovery of people with delirium compared to usual care.

TRIAL REGISTRATION: The feasibility study was registered: ISRCTN15676570.

PMID:37715277 | DOI:10.1186/s40814-023-01387-y

Trials. 2023 Sep 15;24(1):591. doi: 10.1186/s13063-023-07421-x.

ABSTRACT

BACKGROUND: About 50% of older patients with acute myeloid leukemia (AML) fail to attain complete remission (CR) following cytarabine plus anthracycline-based induction therapy. Salvage chemotherapy regimens are based on high-dose cytarabine (HiDAC), which is frequently combined with mitoxantrone (HAM regimen). However, CR rates remain low, with less than one-third of the patients achieving a CR. FLT3-ITD has consistently been identified as an unfavorable molecular marker in both relapsed and refractory (r/r)-AML. One-quarter of patients who received midostaurin are refractory to induction therapy and relapse rate at 2 years exceeds 40%. The oral second-generation bis-aryl urea tyrosine kinase inhibitor quizartinib is a very selective FLT3 inhibitor, has a high capacity for sustained FLT3 inhibition, and has an acceptable toxicity profile.

METHODS: In this multicenter, upfront randomized phase II trial, all patients receive quizartinib combined with HAM (cytarabine 3g/m² bidaily day one to day three, mitoxantrone 10mg/m² days two and three) during salvage therapy. Efficacy is assessed by comparison to historical controls based on the matched threshold crossing approach with achievement of CR, complete remission with incomplete hematologic recovery (CRi), or complete remission with partial recovery of peripheral blood counts (CRh) as primary endpoint. During consolidation therapy (chemotherapy and allogeneic hematopoietic cell transplantation), patients receive either prophylactic quizartinib therapy or measurable residual disease (MRD)-triggered preemptive continuation therapy with quizartinib according to up-front randomization. The matched threshold crossing approach is a novel study-design to enhance the classic single-arm trial design by including matched historical controls from previous clinical studies. It overcomes common disadvantages of single-armed and small randomized studies, since the expected outcome of the observed study population can be adjusted based on the matched controls with a comparable distribution of known prognostic and predictive factors. Furthermore, balanced treatment groups lead to stable statistical models. However, one of the limitations of our study is the inability to adjust for unobserved or unknown confounders. Addressing the primary endpoint, CR/CRi/CRh after salvage therapy, the maximal sample size of 80 patients is assessed generating a desirable power of the used adaptive design, assuming a logistic regression is performed at a one-sided significance level α=0.05, the aspired power is 0.8, and the number of matching partners per intervention patient is at least 1. After enrolling 20 patients, the trial sample size will be recalculated in an interim analysis based on a conditional power argument.

CONCLUSION: Currently, there is no commonly accepted standard for salvage chemotherapy treatment. The objective of the salvage therapy is to reduce leukemic burden, achieve the best possible remission, and perform a hemopoietic stem-cell transplantation. Thus, in patients with FLT3-ITD mutation, the comparison of quizartinib with intensive salvage therapy versus chemotherapy alone appears as a logical consequence in terms of efficacy and safety.

ETHICS AND DISSEMINATION: Ethical approval and approvals from the local and federal competent authorities were granted. Trial results will be reported via peer-reviewed journals and presented at conferences and scientific meetings.

TRIAL REGISTRATION: ClinicalTrials.gov NCT03989713; EudraCT Number: 2018-002675-17.

PMID:37715270 | DOI:10.1186/s13063-023-07421-x

J Cardiothorac Surg. 2023 Sep 15;18(1):259. doi: 10.1186/s13019-023-02362-7.

ABSTRACT

OBJECTIVES: Since the introduction of surgical implantation of conduit for right ventricle-to-pulmonary artery pathway reconstruction, there has been a number of studies on possible factors which might potentially affect conduit longevity, as well as patient’s reintervention-free and overall survival. Still, no definite consensual agreement could be made thus far. We aimed to compare conduit longevity, reintervention-free survival, and overall survival between patients with congenital heart diseases indicated for operations involving right ventricle-to-pulmonary artery pathway reconstruction whose conduits were placed heterotopically to those with orthotopically placed ones.

MATERIALS AND METHODS: We retrospectively collected data from electronic medical records of Ramathibodi hospital from 1st January 2005 to 31st December 2022. Patients with congenital heart diseases whose operations involved reconstruction of right ventricle-to-pulmonary artery continuity were included. Patients whose medical record data were significantly missing were excluded. Demographic data, operative, and postoperative details were collected and reviewed.

RESULTS: There were 67 patients included in our study, with 25 receiving orthotopic and the other 42 receiving heterotopic conduit implantation. Conduit dysfunction-free, reintervention-free, and overall survival were not statistically different between both groups. There was 1 early and no late death up to the end date of our study.

CONCLUSIONS: Conduits placed on a heterotopic position did not result in worse longevity, reintervention-free survival, as well as overall survival when compared to conduits placed on an orthotopic position. This suggested that the less technically demanding heterotopic conduit placement could be recommended as an operation of choice for right ventricular outflow tract reconstruction.

PMID:37715260 | DOI:10.1186/s13019-023-02362-7

Malar J. 2023 Sep 16;22(1):275. doi: 10.1186/s12936-023-04706-z.

ABSTRACT

BACKGROUND: In 2021, Brazil was responsible for more than 25% of malaria cases in the Americas. Although the country has shown a reduction of cases in the last decades, in 2021 it reported over 139,000 malaria cases. One major malaria control strategy implemented in Brazil is the “Malaria Supporters Project”, which has been active since 2012 and is directed to municipalities responsible for most Brazil’s cases. The objective of this study is to analyse the intervention effect on the selected municipalities.

METHODS: An ecological time-series analysis was conducted to assess the “Malaria Supporters Project” effect. The study used data on Annual Parasitic Incidence (API) spanning the period from 2003 to 2020 across 48 intervention municipalities and 88 control municipalities. To evaluate the intervention effect a Prais-Winsten segmented regression model was fitted to the difference in malaria Annual Parasitic Incidence (API) between control and intervention areas.

RESULTS: The intervention group registered 1,104,430 cases between 2012 and 2020, a 50.6% reduction compared to total cases between 2003 and 2011. In 2020 there were 95,621 cases, 50.4% fewer than in 2011. The number of high-risk municipalities (API > 50 cases/1000) reduced from 31 to 2011 to 17 in 2020. The segmented regression showed a significant 42.0 cases/1000 residents annual decrease in API compared to control group.

CONCLUSIONS: The intervention is not a silver bullet to control malaria, but it has reduced API in locations with high malaria endemicity. Furthermore, the model has the potential to be replicated in other countries with similar epidemiological scenarios.

PMID:37715245 | DOI:10.1186/s12936-023-04706-z

BMC Womens Health. 2023 Sep 15;23(1):492. doi: 10.1186/s12905-023-02640-5.

ABSTRACT

BACKGROUND: The unmet need for limiting childbearing (UNLC) remains a problem in Nigeria. Conception after four pregnancies is considered a high-risk pregnancy. We examined the level, reasons for non-use of contraception, and predictors of UNLC among high parity (≥ 4 live birth) women in Nigeria.

METHODS: This cross-sectional design study was based on the analysis of nationally representative weighted data (2018 Nigeria Demographic Health Survey). The study focused on high-parity women of reproductive age (n = 4260) who do not want to have any more children irrespective of the number of their surviving children. Multi-stage cluster sampling approach was used for sample selection. Data were analyzed using logistic regression (α_0.05).

RESULTS: Mean age of the respondents and children ever born was 38.92 ± 5.7 and 6.54 ± 2.3 respectively. The prevalence of UNLC was 40.9%, higher in the rural (48.8%) than urban (32.8%) areas, highest among women with no formal education (52.0%), higher among Muslims (48.4%) than Christians (34.8%), highest in the North-West (51.7%) and least in the South-East (26.1%). The most reported reasons for non-use of family planning (FP) were; respondents opposed (25.0%), infrequent sex (15.0%), fatalistic (13.2%), husband/partner opposed (11.2%), fear of side effects/health (8.5%), and religious prohibition (3.3%). The odds of UNLC was 100% higher among women aged 40-49 years compared to the younger women in age group 20-29 years. Living in the rural area predisposes high parity women of reproductive age to higher risks of UNLC (OR = 1.35, 95% C.I = 1.14-1.59, p < 0.001). Lack of access to family planning information through health workers (OR = 1.94, 95% C.I = 1.63-2.30, p < 0.001) increased the risks of UNLC. Being an Igbo or a Yoruba ethnic group was protective for UNLC compared to Fulani/Hausa women.

CONCLUSIONS: A high level of UNLC was found among high-parity women in Nigeria. Access to FP information reduces the risk of UNLC. Expanding FP services would help respond to the expressed desires for contraception among high-parity Nigerian women who want to stop childbearing.

PMID:37715218 | DOI:10.1186/s12905-023-02640-5

J Anesth Analg Crit Care. 2023 Sep 15;3(1):35. doi: 10.1186/s44158-023-00114-6.

ABSTRACT

BACKGROUND: Four-hundred forty-nine patients affected by Covid-19 were hospitalized at the Rome Military Hospital between March 2020 and July 2022. Depending on the severity of the disease, they were assigned either to the Functional Health Emergency Unit – if suffering from interstitial pneumonia with a clinical manifestation of dyspnea associated with peripheral oxygen saturation < 92%, and oxygen atmospheric pressure therapy – or to the intensive care unit – if the blood gas-lytic index P/F (ratio between partial pressure of arterial O2 and inspired fraction of O2) was below 150. This prospective observation and monocentric study aim to verify the outcome (healing/death) of early use of remdesivir in pneumonia patients.

RESULTS: The results highlight the importance of the adoption of remdesivir in the initial stages of infection to prevent the systemic spread and viral multiplication and, in the subsequent phase, a cytokine storm resulting in acute respiratory failure and multiorgan failure. The use of the drug in the most advanced stages of the disease is not associated with a real impact on patient outcomes. Therefore, there is a statistically significant correspondence between the early use of remdesivir in the treatment of SARS-CoV-2 disease – in addition to guidelines therapies – and a favorable clinical outcome.

CONCLUSIONS: This work shows therapeutic efficacy in the first 5 days of intravenous administration of remdesivir, following the loading dose. It is also necessary to underline the different behaviors of the drug when administered late in patients undergoing mechanical ventilation, compared to those who only needed low-flow oxygen therapy, whose share of recovery – decidedly relevant – reaches statistical significance.

PMID:37715210 | DOI:10.1186/s44158-023-00114-6

J Transl Med. 2023 Sep 15;21(1):626. doi: 10.1186/s12967-023-04450-7.

ABSTRACT

BACKGROUND: Fibroblast growth factor receptor (FGFR) gene family alterations are found in several cancers, indicating their importance as potential therapeutic targets. The FGFR-tyrosine kinase inhibitor (TKI) pemigatinib has been introduced in the treatment of advanced cholangiocarcinoma and more recently for relapsed or refractory myeloid/lymphoid neoplasms with FGFR2 and FGFR1 rearrangements, respectively. Several clinical trials are currently investigating the possible combination of pemigatinib with immunotherapy. In this study, we analyzed the biological and molecular effects of pemigatinib on different cancer cell models (lung, bladder, and gastric), which are currently objective of clinical trial investigations.

METHODS: NCI-H1581 lung, KATO III gastric and RT-112 bladder cancer cell lines were evaluated for FGFR expression by qRT-PCR and Western blot. Cell lines were treated with Pem and then characterized for cell proliferation, apoptosis, production of intracellular reactive oxygen species (ROS), and induction of senescence. The expression of microRNAs with tumor suppressor functions was analyzed by qRT-PCR, while modulation of the proteins coded by their target genes was evaluated by Western blot and mRNA. Descriptive statistics was used to analyze the various data and student’s t test to compare the analysis of two groups.

RESULTS: Pemigatinib exposure triggered distinct signaling pathways and reduced the proliferative ability of all cancer cells, inducing G1 phase cell cycle arrest and strong intracellular stress resulting in ROS production, senescence and apoptosis. Pemigatinib treatment also caused the upregulation of microRNAs (miR-133b, miR-139, miR-186, miR-195) with tumor suppressor functions, along with the downregulation of validated protein targets with oncogenic roles (c-Myc, c-MET, CDK6, EGFR).

CONCLUSIONS: These results contribute to clarifying the biological effects and molecular mechanisms mediated by the anti-FGFR TKI pemigatinib in distinct tumor settings and support its exploitation for combined therapies.

PMID:37715207 | DOI:10.1186/s12967-023-04450-7

Arthritis Res Ther. 2023 Sep 15;25(1):171. doi: 10.1186/s13075-023-03157-w.

ABSTRACT

BACKGROUND: Several observational studies have explored the associations between Sjögren’s syndrome (SS) and certain cancers. Nevertheless, the causal relationships remain unclear. Mendelian randomization (MR) method was used to investigate the causality between SS and different types of cancers.

METHODS: We conducted the two-sample Mendelian randomization with the public genome-wide association studies (GWASs) summary statistics in European population to evaluate the causality between SS and nine types of cancers. The sample size varies from 1080 to 372,373. The inverse variance weighted (IVW) method was used to estimate the causal effects. A Bonferroni-corrected threshold of P < 0.0031 was considered significant, and P value between 0.0031 and 0.05 was considered to be suggestive of an association. Sensitivity analysis was performed to validate the causality. Moreover, additional analysis was used to assess the associations between SS and well-accepted risk factors of cancers.

RESULTS: After correcting the heterogeneity and horizontal pleiotropy, the results indicated that patients with SS were significantly associated with an increased risk of lymphomas (odds ratio [OR] = 1.0010, 95% confidence interval [CI]: 1.0005-1.0015, P = 0.0002) and reduced risks of prostate cancer (OR = 0.9972, 95% CI: 0.9960-0.9985, P = 2.45 × 10^-5) and endometrial cancer (OR = 0.9414, 95% CI: 0.9158-0.9676, P = 1.65 × 10^-5). Suggestive associations were found in liver and bile duct cancer (OR = 0.9999, 95% CI: 0.9997-1.0000, P = 0.0291) and cancer of urinary tract (OR = 0.9996, 95% CI: 0.9992-1.0000, P = 0.0281). No causal effect of SS on other cancer types was detected. Additional MR analysis indicated that causal effects between SS and cancers were not mediated by the well-accepted risk factors of cancers. No evidence of the causal relationship was observed for cancers on SS.

CONCLUSIONS: SS had significant causal relationships with lymphomas, prostate cancer, and endometrial cancer, and suggestive evidence of association was found in liver and bile duct cancer and cancer of urinary tract, indicating that SS may play a vital role in the incidence of these malignancies.

PMID:37715206 | DOI:10.1186/s13075-023-03157-w

BMC Musculoskelet Disord. 2023 Sep 15;24(1):738. doi: 10.1186/s12891-023-06859-z.

ABSTRACT

OBJECTIVE: Ni-Ti memory alloys are unusual materials for hard-tissue replacement because of their unique superelasticity, good biocompatibility, high strength, low specific gravity, low magnetism, wear resistance, corrosion resistance and fatigue resistance. The current study aims to evaluate its mechanical properties and provide biomechanical basis for the clinical application of the prosthesis.

METHODS: Ten adult metacarpophalangeal joint specimens were randomly divided into a prosthesis group (n = 5, underwent metacarpophalangeal joint prosthesis) and a control group (n = 5, underwent sham operation). Firstly, the axial compression strength was tested with BOSE material testing machine to evaluate its biomechanical strength. Secondly, these specimens were tested for strain changes using BOSE material testing machine and GOM non-contact optical strain measurement system to evaluate the stress changes. Thirdly, fatigue test was performed between groups. Lastly, the mechanical wear of the metacarpophalangeal joint prosthesis was tested with ETK5510 material testing machine to study its mechanical properties.

RESULTS: Axial compression stiffness in the prosthesis group was greater than that in the control group in terms of 30 ° and 60 ° flexion positions (P < 0.05). There was no statistically significant difference between two groups with regards to axial compression stiffness and stress change test (P > 0.05). In the fatigue wear test, the mean mass loss in the prosthesis group’s prosthesis was 17.2 mg and 17.619 mm³, respectively. The mean volume wear rate was 0.12%. There was no statistically significant difference in the maximum pull-out force of the metacarpal, phalangeal, and polymer polyethylene pads between the prosthesis group and the control group specimens.

CONCLUSIONS: Ni-Ti memory alloy metacarpophalangeal joint prosthesis conforms to the biomechanical characteristics of metacarpophalangeal joints without implants, and the fatigue strength can fully meet the needs of metacarpophalangeal joint activities after joint replacement.

PMID:37715199 | DOI:10.1186/s12891-023-06859-z