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Nevin Manimala Statistics

The effect of sequential embryo transfer on pregnancy outcomes in patients with recurrent implantation failure: a systematic review and meta-analysis of randomized controlled trials

Arch Gynecol Obstet. 2024 Oct 23. doi: 10.1007/s00404-024-07764-z. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of our study was to assess the impact of sequential embryo transfer on pregnancy outcomes among patients with recurrent implantation failure (RIF).

METHODS: We conducted a comprehensive search across various databases for eligible clinical trials from inception to January 2024. Randomized controlled trials (RCTs) were included if they compared sequential embryo transfer, comprising both cleavage-stage and blastocyst-stage embryos, with other transfer protocols in infertile women with repeated implantation failure. Meta-analysis was performed using Revman software. Our primary focus was on the ongoing pregnancy rate. Our secondary measures included rates of chemical pregnancies, clinical pregnancies, miscarriages, and multiple pregnancies.

RESULTS: Seven RCTs, encompassing 909 patients, met the inclusion criteria. Sequential embryo transfer demonstrated a significant increase in the ongoing pregnancy rate compared to the control group (OR = 2.28, 95% CI [1.46, 3.56], p = 0.003). Moreover, the sequential embryo transfer group exhibited notable improvements in chemical and clinical pregnancy rates. There were no statistically significant differences between the groups regarding multiple pregnancy and miscarriage rates (p > 0.05).

CONCLUSIONS: Sequential embryo transfer shows promise in enhancing pregnancy outcomes among RIF patients. However, additional trials are warranted to validate our findings.

PMID:39443375 | DOI:10.1007/s00404-024-07764-z

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Nevin Manimala Statistics

Laparoscopic lateral suspension with mesh for severe anterior and apical pelvic organ prolapse: an observational cohort study for safety and efficacy at 2-year follow-up

Arch Gynecol Obstet. 2024 Oct 23. doi: 10.1007/s00404-024-07792-9. Online ahead of print.

ABSTRACT

PURPOSE: This study aimed to investigate the clinical safety and efficacy of laparoscopic lateral suspension (LLS) with mesh in the treatment of severe anterior and apical pelvic organ prolapse (POP) Chinese women with a 2-year follow-up.

METHODS: We conducted an observational cohort study. Sixty patients who presented apical (uterovaginal or vault) and anterior prolapse at stage 3 or higher were enrolled. The LLS surgical procedure was performed in accordance with Dubuisson standard operation. The objective and subjective cures as well as the surgery-related complications were evaluated. The POP-related questionnaires were used to evaluate the quality of life before operation and at 24 months after operation follow-up.

RESULTS: Objective cure rates at 2 years of follow-up were 88.3% for the anterior compartment, 100% for the apical compartment and 93.3% for the posterior compartment. The subjective cure rate reached to 93.3%. There were statistically significant lower scores of the pelvic floor impact questionnaire-7 (PFIQ-7) and the pelvic floor distress inventory-short form-20 (PFDI-20) for all women after surgery and they exhibited similar scores of the pelvic organ prolapsed-urinary incontinence sexual questionnaire-12 (PISQ-12) (P = 0.317). And no significant difference was demonstrated in international consultation on the incontinent questionnaire short form (ICI-Q-SF) (P = 0.551). No major complications associated with LLS were observed in our study.

CONCLUSION: We consider that LLS with mesh operation is safe, feasible and effective to correct severe apical and anterior POP after 2-year follow-up.

PMID:39443373 | DOI:10.1007/s00404-024-07792-9

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Nevin Manimala Statistics

Development of Predictive Statistical Model for Gaining Valuable Insights in Pharmaceutical Product Recalls

AAPS PharmSciTech. 2024 Oct 23;25(8):255. doi: 10.1208/s12249-024-02970-z.

ABSTRACT

The rapid progress in artificial intelligence (AI) has revolutionized problem-solving across various domains. The global challenge of pharmaceutical product recalls imposes the development of effective tools to control and reduce shortage of pharmaceutical products and help avoid such recalls. This study employs AI, specifically machine learning (MI), to analyze critical factors influencing formulation, manufacturing, and formulation complexity which could offer promising avenue for optimizing drug development processes. Utilizing FDAZilla and SafeRX tools, an open database model was constructed, and predictive statistical models were developed using Multivariate Analysis and the Least Absolute Shrinkage and Selection Operator (LASSO) Approach. The study focuses on key descriptors such as delivery route, dosage form, dose, BCS classification, solid-state and physicochemical properties, release type, half-life, and manufacturing complexity. Through statistical analysis, a data simplification process identifies critical descriptors, assigning risk numbers and computing a cumulative risk number to assess product complexity and recall likelihood. Partial Least Square Regression and the LASSO approach established quantitative relationships between key descriptors and cumulative risk numbers. Results have identified key descriptors; BCS Class I, dose number, release profile, and drug half-life influencing product recall risk. The LASSO model further confirms these identified descriptors with 71% accuracy. In conclusion, the study presents a holistic AI and machine learning approach for evaluating and forecasting pharmaceutical product recalls, underscoring the importance of descriptors, formulation complexity, and manufacturing processes in mitigating risks associated with product quality.

PMID:39443361 | DOI:10.1208/s12249-024-02970-z

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Nevin Manimala Statistics

Evaluation of clinical and radiographic warning signs for prediction of oroantral communication following tooth extractions

Clin Oral Investig. 2024 Oct 23;28(11):609. doi: 10.1007/s00784-024-06000-x.

ABSTRACT

OBJECTIVES: Oroantral communication (OAC) is a relatively common and mild complication of maxillary tooth extractions. Preoperative prediction of OAC can reduce treatment duration and prepare both operators and patients for the procedure. This study aims to identify alarming radiographic and clinical indicators that can predict OAC therefore assisting clinical decision making to practicing general dentists.

METHODS: In this retrospective case-control study the OAC group consisting of 97 cases and a control group twice the size was established. Clinical data were collected, and measurements were conducted separately by two blinded observers on digital panoramic radiographs. Inter-rater reliability was assessed. In case of disagreement a third observer’s results were utilized. The correlation between OAC and demographic data (age, sex), as well as various factors assessed on panoramic radiographs (including, but not limited to, the length of the root, root projection into the sinus, bone width, presence of mesial and distal adjacent teeth), was statistically evaluated.

RESULTS: Inter-rater reliability was found to be excellent. Several factors were identified as potential predictors of OAC. According to our model, the strongest predictors were the distance between the cemento-enamel junction and marginal bone, extent of root projection into the sinus, presence of sinus recess around the roots, angulation, and absence of the mesial adjacent tooth.

CONCLUSIONS: Well-defined measurements on panoramic radiographs may aid in predicting OAC. Further prospective investigations are necessary to confirm these indicators and address factors related to clinical examination and operation.

CLINICAL RELEVANCE: We present several clinical and radiographic warning signs of OAC that can facilitate pre-extraction decision-making.

PMID:39443353 | DOI:10.1007/s00784-024-06000-x

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Risk of first hip fracture under treatment with zoledronic acid versus alendronate: a NOREPOS cohort study of 88,000 Norwegian men and women in outpatient care

Arch Osteoporos. 2024 Oct 23;19(1):102. doi: 10.1007/s11657-024-01458-4.

ABSTRACT

We aimed to investigate the risk of hip fracture associated with zoledronic acid treatment compared to alendronate on a population level. The risk of hip fracture was lower in women using zoledronic acid and higher in women who had discontinued treatment. The findings support the effectiveness of intravenous bisphosphonate.

PURPOSE: To investigate whether zoledronic acid (ZOL) was associated with a lower risk of the first hip fracture than alendronate (ALN) in Norway using real-world data.

METHODS: Nationwide data on drugs dispensed in outpatient pharmacies were individually linked with all hospital-treated hip fractures. Individuals aged 50-89 years without previous hip fracture were included at their first filling of a prescription for ALN or ZOL during 2005-2016. Hazard ratios (HRs) with 95% confidence intervals (95% CIs) for first hip fracture by time-varying exposure to ZOL versus ALN were estimated in sex-stratified flexible parametric survival analyses. Covariates included time-varying accumulated ALN exposure and comorbidity level expressed by the prescription-based Rx-Risk Comorbidity Index, marital status, education, and residential urbanity.

RESULTS: Of 75,250 women who initiated treatment, 72,614 (96.5%) were exposed to ALN and 6366 (8.5%) to ZOL. Of 12,739 men who initiated treatment, 12,311 (96.6%) were exposed to ALN and 784 (6.2%) to ZOL. In women, the HR for first hip fracture was 0.75 (95% CI: 0.61-0.91) for ZOL versus ALN. In men, the corresponding HR was 0.59 (95% CI: 0.32-1.07). Discontinued treatment was associated with increased risk compared with current ALN treatment in women (HR: 1.33; 95% CI: 1.24-1.42, men: HR 1.13 (95% CI: 0.95-1.35)).

CONCLUSIONS: In women, the risk of first hip fracture when treated with ZOL was 25% lower than when treated with ALN. Discontinued treatment was associated with a 33% increase in hip fracture risk. Similar, albeit statistically non-significant, results were observed in men.

PMID:39443347 | DOI:10.1007/s11657-024-01458-4

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Meta-analysis and systematic review of factors predicting conversion to radical nephrectomy following robotic-assisted partial nephrectomy in renal cancer patients

J Robot Surg. 2024 Oct 24;18(1):377. doi: 10.1007/s11701-024-02147-7.

ABSTRACT

Evaluating the risk factors for the conversion from robotic-assisted partial nephrectomy (RAPN) to radical nephrectomy (RN). Through a comprehensive database search encompassing PubMed, Web of Science, Embase, and the Cochrane Library, we identified pertinent English-language research published by June 2024. We utilized the NOS scale for quality assessment. The aggregate effect was quantified via the odds ratio (OR), alongside a 95% confidence interval (CI). Sensitivity analyses were conducted using both fixed-effects and random-effects models to evaluate reliability. The meta-analytical process was facilitated by the Stata 18 software suite. Our meta-analysis encompassed a total of 8 retrospective studies and 3 prospective studies, totaling 4056 patients. We found that increasing patient age (OR: 1.04; 95% CI 1.00-1.08; P = 0.005), higher American Society of Anesthesiologists (ASA) scores (3 or above) (OR: 2.74; 95% CI 1.52-4.93; P = 0.001), elevated R.E.N.A.L. scores (7 or above) (OR: 2.49; 95% CI 1.57-3.95; P < 0.001), and the use of off-clamp RAPN (OR: 7.21; 95% CI 2.60-19.93; P < 0.001) significantly raised the odds of surgical conversion. On the other hand, male sex (OR: 1.04; 95% CI 0.67-1.62; P = 0.858), the side of the tumor (OR: 0.97; 95% CI 0.48-1.95; P = 0.936), tumor size (OR: 3.43; 95% CI 0.57-20.55; P = 0.177), body mass index (BMI) (OR: 1.03; 95% CI 0.96-1.11; P = 0.426), clinical stage (OR: 3.78; 95% CI 0.46-30.70; P = 0.214), and the use of single-port RAPN (OR: 0.54; 95% CI 0.16-1.78; P = 0.31) did not show a statistically significant link to an increased conversion risk. This meta-analysis elucidates the critical risk factors for the conversion from robotic-assisted partial nephrectomy to radical nephrectomy, providing significant guidance for preoperative risk assessment and clinical decision-making. However, our findings necessitate validation through studies with larger sample sizes.

PMID:39443332 | DOI:10.1007/s11701-024-02147-7

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Robotics can decrease the rate of post-operative ventral hernia: a single centre retrospective cohort study

J Robot Surg. 2024 Oct 24;18(1):380. doi: 10.1007/s11701-024-02126-y.

ABSTRACT

Midline incision for extra-corporeal anastomosis is common with traditional laparoscopic right hemicolectomy. Incisional hernias develop in up to 20% of these patients within a year adding considerable morbidity and healthcare costs. Robotic assisted surgery (RAS) improves technical ease of intra-corporeal anastomosis, preventing midline extraction but its benefit over laparoscopy remains debated. We aimed to determine if robotic assisted surgery and Pfannenstiel extraction decreased the rate of radiologically detected incisional hernias compared to standard laparoscopy with extra-corporeal anastomosis. The secondary outcomes aimed to evaluate incidence of port site hernias in 8 mm robotic ports for which routine closure is not followed. Our single centre retrospective cohort study included patients who had minimally invasive right hemicolectomy and had cross-sectional imaging at least 1-year later. Patient demographics, body mass index, history of smoking or previous surgery was recorded. At imaging, evidence of new extraction site or port site-site hernia, contents and clinical impact was noted. A total of 100 patients (50 robotic and 50 laparoscopic) were included. Baseline characteristics appeared equally distributed. 16% (8 patients) who had laparoscopic surgery developed midline extraction site hernias which was significantly higher to RAS group (0 patients). 3 patients developed hernias at the site of robotic ports and this was more commonly at the right iliac fossa port. RAS, by simplifying intra-corporeal anastomosis has potential to eliminate incisional hernias, particularly when Pfannenstiel extraction is used. The potential for 8 mm robotic ports to develop clinically significant hernias cannot be ignored and meticulous closure can prevent patient harm.

PMID:39443327 | DOI:10.1007/s11701-024-02126-y

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Clinical Efficacy of 830 nm LED Photobiomodulation Therapy on Postoperative Blepharoplasty Complications

Aesthetic Plast Surg. 2024 Oct 23. doi: 10.1007/s00266-024-04374-7. Online ahead of print.

ABSTRACT

BACKGROUND: Blepharoplasty is the most prevalent cosmetic surgery procedure in Asia. There are three main types of blepharoplasty procedures: incision, threading, and spotting, with incision being the most common procedure. However, after incisional surgery, patients experience prolonged periorbital swelling, bruising, and scarring. In order to help patient reduce periorbital swelling and erythema and ease the discomfort. In this research, the authors introduce a photobiomodulation therapy and to investigate the efficacy and safety of 830 nm light-emitting diode (LED) phototherapy in improving complications after incisional blepharoplasty.

METHOD: Participants were randomly assigned 830 nm LED phototherapy (novel care model) or traditional care model for postoperative care. The efficacy of different care measures on postoperative complications after incisional blepharoplasty was assessed using swelling score, pain score (VAS), wound healing grading, and anxiety scale (SAS).

RESULTS: A total of 145 patients were included, including 73 in the novel care model group and 72 in the traditional care model group. The new care model based on 830 nm LED phototherapy could significantly improve the swelling, pain, wound healing, and anxiety self-assessment scale assessment of the patients compared with the traditional care model, and the difference was statistically significant (P<0.05).

CONCLUSION: Photobiomodulation using 830 nm LED can markedly reduce postoperative swelling and pain, promote effective wound healing, lessen postoperative patient anxiety, and have no negative side effects.

LEVEL OF EVIDENCE I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

PMID:39443322 | DOI:10.1007/s00266-024-04374-7

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Association between remnant cholesterol and risk of kidney stones: a case-control study in Chinese adults

Urolithiasis. 2024 Oct 24;52(1):151. doi: 10.1007/s00240-024-01651-7.

ABSTRACT

Remnant cholesterol (RC), a key indicator of dyslipidemia, has been validated as a contributing factor to metabolic and cardiovascular diseases, both of which are closely associated with kidney stones (KS). This study aimed to investigate the association between RC and the risk of KS in Chinese adults. A total of 8,576 KS cases (mean age 55.87, 69.37% male) and 137,523 controls (mean age 54.57, 51.62% male) were included in this case-control study. RC was calculated using the formula: RC = TC-HDL-LDL. KS was ascertained with ultrasound by well-trained physicians. Multivariable logistic and restricted cubic spline (RCS) were applied to investigate the relationship between RC and KS. A total of 146,099 subjects (weighted mean age 54.64 years and 52.66% male) were included with mean RC = 0.8 for controls and RC = 0.72 for KS cases (P < 0.001). The multivariable-adjusted OR for KS occurrence across consecutive quartiles was 1.00 (reference), 1.05 (0.98-1.12), 1.15 (1.07-1.22), and 1.44 (1.35-1.53), respectively. Moreover, each standard deviation increment of RC was associated with a 15% (OR:1.15, 95% CI: 1.12-1.19) higher risk of KS occurrence. RCS showed significant and linear dose-response relationships between RC and KS occurrence (P-overall < 0.001, P-nonlinear = 0.270). The positive associations between RC and KS risk persisted in sensitivity analyses, suggesting the robustness of the results. In this case-control study of Chinese adults, elevated RC was associated with the occurrence of KS.

PMID:39443318 | DOI:10.1007/s00240-024-01651-7

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Rapid evaluation of vegetable oil varieties and geographical origins by ambient corona discharge ionization mass spectrometry

Food Chem. 2024 Oct 19;464(Pt 2):141699. doi: 10.1016/j.foodchem.2024.141699. Online ahead of print.

ABSTRACT

The composition and ratio of unsaturated fatty acids in vegetable oils play a crucial role in determining their overall quality. In this study, we present a corona discharge ionization mass spectrometry (MS) method for the rapid differentiation of vegetable oil varieties and their geographical origins under environmental conditions. Abundant water dimer radical cations, (H2O)2+•, were generated by the ionization setup, which effectively activated carbon‑carbon double bonds (C=C) to form epoxidized products. These epoxidation products were analyzed using tandem MS, generating diagnostic fragment ions that precisely identified CC bond positions. Statistical analysis models were subsequently developed using the resulting MS fingerprint data, revealing significant differences between various vegetable oils and olive oils from different origins. Key advantages of this method include minimal sample preparation, rapid analysis, and easily interpretable spectra. This study provides a new MS-based strategy for food quality assessment and offers a promising tool for identifying CC positional isomers in complex systems.

PMID:39442212 | DOI:10.1016/j.foodchem.2024.141699