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Nevin Manimala Statistics

A Novel, Sustainable and Eco-Friendly Spectrophotometric and chemometric Approach for Determination of Severely Overlapped Spectrum via Unified Regression Equation; Greenness and Whiteness Assessment

J AOAC Int. 2023 Mar 16:qsad037. doi: 10.1093/jaoacint/qsad037. Online ahead of print.

ABSTRACT

BACKGROUND: Nebivolol and valsartan in combination with each other successfully control blood pressure and improve hypertension patient outcomes.

OBJECTIVE: to develop and validate innovative, simple, and sustainable spectrophotometric methods for the simultaneous analysis of Nebivolol and Valsartan.

METHODS: The new modified difference amplitude modulation method uses only unified regression equation and doesn’t require any resolution techniques. Other different approaches were also applied for the determination of the same mixture including univariate and multivariate spectrophotometric methods. The multivariate methods were (PLS and PCR), while the univariate methods were derivative ratio(DD1), ratio difference(RD), Constant center(CC), Constant center spectrum subtraction(CC-SS), constant value coupled with amplitude difference (CV-AD), and Advanced concentration value(ACV), amplitude difference(AD). The proposed methods utilize a green solvent; thus, the environmental impact of the presented procedures was evaluated qualitatively and quantitatively using six well-known evaluation tools.

RESULTS: All methods were applied successfully for the analysis of the studied drugs in their bulk powder, pharmaceutical dosage form Byvalson, and in vitro release at intestinal pH (7.4) using a USP dissolution tester. Results obtained were compared statistically with the reported method and with each other using One-way ANOVA statistical test and no significant differences were found.

CONCLUSION: All green and white analytical chemistry evaluation tools results confirm the safety, sustainability, and cost-effectiveness of the approaches, indicating that the methods are regarded green and sustainable. results were agreeable, encouraging their applicability in quality control laboratories for dosage form and making these methods an eco-friendly substitute for the analysis of this combined dosage form and for evaluating dissolution profile.

HIGHLIGHTS: For the first time, a severely overlapped spectrum was determined using unified regression equation without the need of extended part or zero contribution regions by the novel method MD-AM. The proposed methods are the first study of in vitro dissolution profiling of Nebivolol hydrochloride and Valsartan and the first sustainable and green methods applied without compromising the analytical criteria.

PMID:36924427 | DOI:10.1093/jaoacint/qsad037

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Nevin Manimala Statistics

Dermatoscopy and Optical Coherence Tomography in Vulvar High-Grade Squamous Intraepithelial Lesions and Lichen Sclerosus: A Prospective Observational Trial

J Low Genit Tract Dis. 2023 Mar 16. doi: 10.1097/LGT.0000000000000731. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to examine potential discriminatory characteristics of dermatoscopy and dynamic optical coherence tomography (D-OCT) on vulvar high-grade squamous intraepithelial lesions (vHSIL) and lichen sclerosus (LS) compared with healthy vulvar skin.

METHODS: A prospective observational clinical trial was performed in 10 healthy volunteers, 5 vHSIL and 10 LS patients. Noninvasive imaging measurements using dermatoscopy and D-OCT were obtained at several time points, including lesional and nonlesional vulvar skin. Morphologic features of vHSIL and LS were compared with healthy controls. Epidermal thickness and blood flow were determined using D-OCT. Patients reported tolerability of each study procedure, including reference vulvar biopsies. The main outcome measures were feasibility and tolerability of imaging modalities, dermatoscopy and OCT characteristics, OCT epidermal thickness and D-OCT dermal blood flow.

RESULTS: The application of dermatoscopy and D-OCT is feasible and tolerable. In vHSIL, dermatoscopic warty structures were present. In LS, sclerotic areas and arborizing vessels were observed. Structural OCT in the vulvar area aligned with histology for hyperkeratosis and dermal-epidermal junction visualization. Currently, the OCT algorithm is unable to calculate the epidermal thickness of the uneven vulvar area. Dynamic optical coherence tomography showed statistically significant increased blood flow in LS patients (mean ± SD, 0.053 ± 0.029) to healthy controls (0.040 ± 0.012; p = .0024).

CONCLUSIONS: The application of dermatoscopy and D-OCT is feasible and tolerable in vHSIL and LS patients. Using dermatoscopy and D-OCT, we describe potential characteristics to aid differentiation of diseased from healthy vulvar skin, which could complement clinical assessments.

PMID:36924426 | DOI:10.1097/LGT.0000000000000731

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Nevin Manimala Statistics

Assessing deviations for HPCs obtained during COVID-19 (ADHOC): Evaluating impact of the COVID-19 pandemic on cellular therapy products and processes, the BEST collaborative study

Transfusion. 2023 Mar 16. doi: 10.1111/trf.17311. Online ahead of print.

ABSTRACT

BACKGROUND: The success of allogeneic hematopoietic stem cell transplantation is dependent on a world-wide network of collection centers providing donations that predominantly have been infused as fresh cells. The logistics chain that supports the just-in-time delivery model for stem cell and immunotherapy products was severely stressed by the COVID pandemic, and in early 2020 a number of national and international bodies recommended that cells should be cryopreserved at the collection or transplant center to avoid interruptions in their acquisition or delivery to patients who had started conditioning.

STUDY DESIGN: To assess the potential consequences of such pandemic-related deviations to normal practice, we surveyed nine international laboratories to determine if the characteristics or transplant outcomes of allogeneic stem cell donations differed in the immediate periods before and after the switch to routine cryopreservation.

RESULTS: Nine centers on two continents provided data for 72 HSC donations just before, and 71 just after, switching to cryopreservation for allogeneic HSC products. No statistically significant differences between the period before and after cryopreservation were noted for time from product collection to receipt, product temperature at receipt, or CD34+ cell viability at receipt. There was an indication of slower absolute neutrophil count recovery after cryopreservation was required (mean time of 15 vs. 17.6 days).

DISCUSSION: While there were no apparent changes to most parameters studied, there was an indication of slower neutrophil engraftment that will need to be examined in larger, longer term studies.

PMID:36924403 | DOI:10.1111/trf.17311

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Nevin Manimala Statistics

Interplay of “leukemia inhibitory factor receptor gene” (rs3099124) polymorphism, leukemia inhibitory factor and ovarian steroids with unexplained infertility

Nucleosides Nucleotides Nucleic Acids. 2023 Mar 16:1-13. doi: 10.1080/15257770.2023.2188911. Online ahead of print.

ABSTRACT

OBJECTIVE OF THE STUDY: To explore the association of leukemia inhibitory factor receptor (LIFR) gene variant rs3099124, ovarian steroids, and leukemia inhibitory factor with unexplained infertility in Pakistani females.

METHODOLOGY: A case-control investigation in which eighty-one (81) females with unexplained infertility and one hundred and sixty-two (162) fertile counterparts (age and body mass index compared) were recruited between October 2016 and 2018. Ten milliliters of venous blood was collected from all participants. “Genomic DNA” was taken out from lymphocytes in peripheral blood samples. “Tetra Amplification Refractory Mutation System Polymerase Chain Reaction (T-ARMS-PCR)” was constructed through software “Primer-I”. Amplification was carried out by “T-ARMS-PCR” followed by subsequent sequencing for confirmation and extensive consonance. Estradiol, Progesterone and Leukemia Inhibitory Factor (LIF) were measured in serum by ELISA.

RESULTS: Statistically significant difference was noticed in genotype frequency in “LIFR-gene variant; rs3099124” (χ2 = 28.222, P value < 0.01) between research participants. Although, rs “3099124” “AA” (OR = 0.000; 95%CI = 0-0) and “GA” genotypes (OR = 0.525; 95%CI = 0.226-1.22) showed non-significant safety/protection against unexplained infertility yet minor/risk allele “A” frequency was greater in women with unexplained infertility suggesting a possible explanation of implantation failure. LIF concentration varied between fertile and infertile groups (χ2 = 9.857, P < 0.05) revealing significant threat of unexplained infertility in women with decreased LIF concentration (OR = 2.316, 95%CI = 1.214-4.416). Progesterone was significantly related to unexplained infertility in both study groups (χ2 = 20.347, P < 0.05). High progesterone reduced the possibility of unexplained infertility (OR = 0.306; 95% CI = 0.166-0.567).

CONCLUSION: LIFR gene variation (rs3099124) and reduced LIF secretion may cause implantation failure in women with unexplained infertility.

PMID:36924393 | DOI:10.1080/15257770.2023.2188911

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Nevin Manimala Statistics

Comparative study between Tamsulosin, Silodosin and Tadalafil as a medical expulsive therapy for lower ureteral stones

Arch Ital Urol Androl. 2023 Feb 22. doi: 10.4081/aiua.2023.10849. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare the efficacy of Tamsulosin, Silodosin and Tadalafil as a medical expulsive therapy for treatment of distal ureteral calculi.

PATIENTS AND METHODS: Over a period of 6 months (January 2022 to June 2022) this prospective randomized study was conducted on 170 patients with distal ureteric stone ≤ 10 mm. Patients were randomly divided into three groups. Patients in group A received Tamsulosin 0.4mg, in group B received Silodosin, and in group C receive Tadalafil 5 mg. Therapy was given for a maximum of 4 weeks. The rate and time of stone expulsion, the analgesic use, attacks of colic and hospital visits for pain, and adverse effects of drugs were recorded.

RESULTS: Among 170 patients who were enrolled in study, 20 were lost to follow-up (7, 8, 5 in group A, B, And C respective-ly). There was a significant higher stone passage rate in group C than group A and B (90% vs. 70% and 76% respectively; p-value = 0.043) and shorter expulsion time in group C (8.7 ± 3.3 days) vs. group A (12.5 ± 5.2 days) and group B (11.3 ± 4.2 days) with (p-value = 0.001)(highly statistically significant with p-value < 0.001) and increased amount of analgesics required in group A (225 ± 115.7 mg) and group B (163 ± 77.5 mg) when compared with group C (120 ± 55.3 mg).

CONCLUSION: Tadalafil is more effective than Tamsulosin and Silodosin in treatment of patients with distal ureteric stones ≤ 10 mm as regard stone expulsion rate, expulsion time with decreased number of colicky episodes and side effects.

PMID:36924384 | DOI:10.4081/aiua.2023.10849

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Safety profile of treatment with greenlight versus Thulium Laser for benign prostatic hyperplasia

Arch Ital Urol Androl. 2023 Feb 22. doi: 10.4081/aiua.2023.11101. Online ahead of print.

ABSTRACT

OBJECTIVE: The major strengths of surgical treatment of benign prostatic hyperplasia with laser are reduced morbidity compared to endoscopic resec-tion. No studies analysed the different risk of intra/peri-opera-tive events between patients undergoing Thulium and GreenLight procedures.

MATERIALS AND METHODS: We retrospectively reviewed 100 con-secutive cases undergoing GreenLight vaporization and Thulium procedures performed during the learning curve of two expert endoscopic surgeons. Pre-operative data, intra and post-opera-tive events at 90 days were analysed.

RESULTS: Patients on antiplatelet/anticoagulant therapy were pre-dominant in the Green group (p < 0.0001). Rates of blood trans-fusion (p < 0.0038), use of resectoscope (p < 0.0086), and tran-sient stress urinary incontinence were statistically higher in the Thulium group. On the contrary conversions to TURP (p < 0.023) were more frequent in GreenLight patients. Readmissions were more frequently necessary in GreenLight group (24%) vs. Thulium group (26.6%). The overall complica-tion rate in GreenLight and Thulium groups were 31% and 53%respectively; Clavien 3b complications were 13% in Thulium patients versus 1% in GreenLight patients.

CONCLUSIONS: GreenLight and Thulium treatments show similar safety profiles. Randomized controlled trial are needed to better clarify the rate of major complications in Thulium group, and the incidence of post-operative storage symptoms in these patients’ populations.

PMID:36924373 | DOI:10.4081/aiua.2023.11101

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Nevin Manimala Statistics

Congenital penile curvature as a possible risk factor for the onset of Peyronie’s disease, and psychological consequences of penile curvature

Arch Ital Urol Androl. 2023 Mar 15. doi: 10.4081/aiua.2023.11238. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate a possible relationship between a history of congenital penile curvature (CPC) and Peyronie’s disease (PD), and to characterize the psychological profile of patients suffering from PD, with or without concomitant CPC.

METHODS: We included 519 patients with Peyronie’s disease (PD), of which 73 were found to have underlaying CPC. As a comparator population, we selected 2166 patients without PD, referring to our tertiary care clinic. In this population we detected 15 subjects with CPC. All patients completed the GAD-7 (Generalized-Anxiety-Disorder – 7 questions) and the PHQ-9 (Patient-Health-Questionnaire – 9 questions) questionnaires.

RESULTS: The overall prevalence of CPC in PD-patients was 14.07%, compared to a prevalence of 0.69% in the non-PD control population (p < 0.00001). Moderate-to-severe anxiety was found to be present in 89.4% of all PD-patients. Significantly higher proportions of patients with CPC associated with PD showed severe anxiety, compared to patients with PD alone (57.5% vs. 36.7%, respectively, p = 0.0008). Moderate- severe depression was found to be present in 57.8% of all PD- patients. Significantly higher proportions of PD patients with a history of CPC showed severe depression, compared to patients with PD alone (13.6% vs. 3.36%, respectively, p < 0.0002). GAD-7 median scores were significantly higher in patients with more severe penile curvatures (> 45°; p = 0.029). We did not detect a statistically significant difference between PHQ-9 medi- an scores based on the severity of PD (p = 0.53). Analysis of PHQ-9 and GAD-7 median scores showed significantly worse depressive and anxious symptoms in younger patients (p < 0.001 and p = 0.0013, respectively).

CONCLUSIONS: The presence of congenital-penile-curvature may represent a risk factor for the subsequent onset of Peyronie’s disease. Moderate/severe anxiety and moderate/severe depression were reported in a high fraction of cases. Anxiety was significantly higher in patients with more severe penile-curvatures, and depression was present independently of the degree of penile curvature. Depression and anxiety were found to be more severe in younger subjects.

PMID:36924365 | DOI:10.4081/aiua.2023.11238

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Nevin Manimala Statistics

Causes of death in endometrial cancer survivors: A Surveillance, Epidemiology, and End Result-based analysis

Cancer Med. 2023 Mar 16. doi: 10.1002/cam4.5804. Online ahead of print.

ABSTRACT

BACKGROUND: Increasing attention has been paid to the survival of endometrial cancer (EC) patients, but the non-cancer causes of death from EC are rarely reported. This study primarily aimed to investigate the non-cancer causes of death in patients with EC.

METHODS: The study collected relevant data, including age, tumour stage and treatment mode, on patients diagnosed with endometrial malignancies from 2000 to 2015 in the Surveillance, Epidemiology, and End Results (SEER) Programme. We analysed the standardised mortality ratio (SMR) to determine the cause of death.

RESULTS: The study included 135,831 patients with EC. During the follow-up, 46,604 (34.3%) patients died, of whom 42.9%, 15.6% and 41.5% died of EC, other cancers and non-cancer causes, respectively. As the diagnosis time increased, the number of EC-associated mortalities gradually decreased. The most common non-cancer causes of death were heart disease, cerebrovascular disease and diabetes. Regarding the general population of the United States, patients with EC died of heart disease (SMR: 1.06; 95% confidence interval [CI]: 1.03-1.09), diabetes (SMR: 1.56; 95% CI: 1.47-1.65) and septicaemia (SMR: 1.40; 95% CI: 1.28-1.52), which were statistically significant.

CONCLUSIONS: For patients with EC, the number of deaths from non-cancer causes (mainly heart disease, cerebrovascular disease and diabetes mellitus) is equivalent to that of EC. In addition, compared with the general population, EC survivors have a higher risk of death from sepsis and diabetes. These discoveries support how survivors can avoid future-related health risks. By doing this, clinicians can improve the quality of life and chances of the survival of patients with EC.

PMID:36924355 | DOI:10.1002/cam4.5804

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Nevin Manimala Statistics

Making community pharmacies psychologically informed environments (PIE): a feasibility study to improve engagement with people using drug services in Scotland

Prim Health Care Res Dev. 2023 Mar 16;24:e20. doi: 10.1017/S1463423623000087.

ABSTRACT

AIM: This developmental study tested the feasibility of training pharmacy staff on the psychologically informed environments (PIE) approach to improve the delivery of care.

BACKGROUND: Community pharmacies provide key services to people who use drugs (PWUD) through needle exchange services, medication-assisted treatment and naloxone distribution. PWUD often have trauma backgrounds, and an approach that has been demonstrated to work well in the homeless sector is PIEs.

METHODS: Bespoke training was provided by clinical psychologists and assessed by questionnaire. Staff interviews explored changes made following PIE training to adapt the delivery of care. Changes in attitude of staff following training were assessed by questionnaire. Peer researchers interviewed patient/client on observed changes and experiences in participating pharmacies. Staff interviews were conducted six months after training to determine what changes, if any, staff had implemented. Normalisation process theory (NPT) provided a framework for assessing change.

FINDINGS: Three pharmacies (16 staff) participated. Training evaluation was positive; all participants rated training structure and delivery as ‘very good’ or ‘excellent’. There was no statistically significant change in attitudes. COVID-19 lockdowns restricted follow-up data collection. Staff interviews revealed training had encouraged staff to reflect on their practice and communication and consider potentially discriminatory practice. PIE informed communication skills were applied to manage COVID-19 changes. Staff across pharmacies noted mental health challenges for patients. Five patients were interviewed but COVID-19 delays in data collection meant changes in delivery of care were difficult to recall. However, they did reflect on interactions with pharmacy staff generally. Across staff and patient interviews, there was possible conflation of practice changes due to COVID-19 and the training. However, the study found that training pharmacy teams in PIE was feasible, well received, and further development is recommended. There was evidence of the four NPT domains to support change (coherence, cognitive participation, collective action and reflexive monitoring).

PMID:36924346 | DOI:10.1017/S1463423623000087

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Exploring Children’s Self-Reported Activity Compensation: The REACT Study

Med Sci Sports Exerc. 2023 Mar 10. doi: 10.1249/MSS.0000000000003164. Online ahead of print.

ABSTRACT

PURPOSE: Previous research has focused on device-based measures of activity compensation, with little understanding of how children perceive potential compensatory responses to activity or inactivity, or whether these change following periods of activity or inactivity. The aim of this study was to (a) explore the alignment between children’s self-reported usual compensation and compensation recall following experimental conditions; and (b) examine sex differences.

METHODS: In total, 360 children (47% boys) participated in at least one of three experimental conditions over six weeks (a) restricted physical activity (PA; indoor play); (b) imposed moderate-to vigorous PA (MVPA; sports class); and (c) imposed light PA (LPA; standing lesson). Prior to the first condition, children reported their ‘usual compensation’ behavior to examples of restricted/imposed PA and 2-3 days after each experimental condition they completed a recall measure of their compensation following the condition. Multilevel regression models were conducted to determine whether children’s perceptions of ‘usual compensation’ score were associated with recalled compensation score following imposed or restricted physical activity. Additional models were fitted for sex-specific associations.

RESULTS: Overall and among girls, the usual compensation score was positively associated with the compensatory recall score for the additional MVPA and LPA conditions (p < 0.0005; e.g., they thought they would usually compensate for additional MVPA and then perceived that they compensated following additional MVPA). A negative association was seen in the restricted activity condition among girls (p = 0.03). All associations in the boys’ analyses were statistically non-significant.

CONCLUSIONS: These findings suggest some alignment between children’s self-reported usual compensation and compensation recall following imposed changes to routine activity. Future research should consider device-measured comparisons and identify characteristics of children at-risk of activity compensation in future interventions.

PMID:36924338 | DOI:10.1249/MSS.0000000000003164