Tag: nevin manimala

Int J Clin Pract. 2021 Oct 9:e14975. doi: 10.1111/ijcp.14975. Online ahead of print.

ABSTRACT

AIM: To assess impact of pre-specified patient characteristics on efficacy and safety of subcutaneous tanezumab in patients with osteoarthritis (OA).

METHODS: Data were pooled from two (efficacy; N = 1545) or three (safety; N = 1754) phase 3 placebo-controlled trials. Change from baseline to week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain, WOMAC Physical Function, and patient global assessment of OA (PGA-OA) scores was compared between tanezumab (2.5 and 5 mg) and placebo groups via analysis of covariance. Treatment-emergent adverse events (TEAEs) were summarized descriptively. Analyses were done in patient subgroups (male or female; age <65, ≥65, or ≥75 years; body mass index [BMI] <25, 25 to <30, 30 to <35, or ≥35 kg/m² ; diabetes or no diabetes; baseline WOMAC Pain score <7 or ≥7; and Kellgren-Lawrence [KL] grade 2, 3, or 4 in the index joint) and the overall population).

RESULTS: In all subgroups, improvements in WOMAC Pain were numerically greater and often statistically significant (P < .05) for both tanezumab groups compared with placebo. Results were similar for WOMAC Function and PGA-OA. TEAE profiles were generally consistent across subgroups and similar to the overall population (i.e., slightly higher rates of TEAEs, serious TEAEs, and severe TEAEs with tanezumab relative to placebo) with a few exceptions. Exceptions included females reporting slightly more TEAEs with tanezumab than males, and patients with diabetes reporting slightly more severe TEAEs with tanezumab than patients without diabetes. Additionally, TEAEs were more frequent with tanezumab than placebo in the age ≥65 and ≥75 years, but not the age <65 years, subgroups.

CONCLUSIONS: Efficacy and safety/tolerability of tanezumab may not be meaningfully impacted by gender, age, BMI, diabetes status, baseline pain severity or KL grade in the index joint. Conclusions are limited by low patient number in some subgroups.

PMID:34626502 | DOI:10.1111/ijcp.14975

Int J Clin Pract. 2021 Oct 9:e14968. doi: 10.1111/ijcp.14968. Online ahead of print.

ABSTRACT

AIM OF THE STUDY: Subconjunctival hemorrage (SCH) is a frequent bleeding manifestation and a common cause of visits to the primary care. Trauma in young patients and vascular damage such as hypertension in the elderly are the most common causes of SCH and the prevalence of hematological diseases is less than 1%. We aimed to evaluate the prevalence of congenital or acquired bleeding disorders in patients with once or recurrent SCH.

METHODS USED TO CONDUCT THE STUDY: It is a retrospective study and included fifty-two patients with SCH whose etiologic factor was not detected. Hemostatic tests were studied in 52 patients (25 male and 27 females). All patients included were evaluated for congenital or acquired bleeding disorder and SCH with once and those with 2 or more were compared for the laboratory results.

RESULTS OF THE STUDY: Type I von Willebrand disease (vWD) was diagnosed in one patient with recurrent SCH and one patient with single SCH (3.8%). The prevalence of patients with type 1 vWD in the study was not statistically significant when compared with the frequency of vWD in the normal population. Fibrinogen level was found to be statistically higher in patients who had SCH once than those who had recurrent SCH. But fibrinogen level was in normal range in all patients.

CONCLUSIONS DRAWN FROM THE STUDY AND CLINICAL IMPLICATIONS: There was no increase in the incidence of congenital or acquired bleeding disorder in SCH compared to normal population. Fort this reason, it was thought there was no need for evaluation for bleeding disordes in spontaneous SCH.

PMID:34626507 | DOI:10.1111/ijcp.14968

Acta Reumatol Port. 2021 Jul-Sep;46(3):218-229.

ABSTRACT

OBJECTIVE: Biobanks for research (BBR) have enormous value for research, including those specifically oriented to chronic diseases. Knowing public attitudes and perceptions is key to design and implement patient-centered BBR. We assessed patient awareness, perception and choices among rheumatology outpatients regarding aging biobanking activities.

METHODS: We conducted a cross-sectional survey of patients, aged 50 or older, attending an outpatient rheumatology tertiary department. Demographic data and perceptions about biobanking were collected and statistical analysis was performed.

RESULTS: 132 valid questionnaires were obtained (mean age: 63,4; 68,2% female; mean education years: 8,35). 61,7% of respondents did not know the specific term “biobank”, 57,7% knew they could donate biological material for BBR, 89,9% agreed with these infrastructures and 88,3% would consider participation Those participants with more years of education were more knowledgeable and prone to biobank participation. Willingness to participate in BBR was mainly related (86,4%) to the advancement of scientific knowledge and not individual gain. Scientific research institutes were indicated as the most adequate institutions to manage BBR. Informed consent, anonymity and confidentiality ranked as top requisites for biobank participation. 61,3% of respondents expressed their agreement with aging biobanks, considering these as a sign of respect for specific problems of people of older ages such as higher disease burdens.

CONCLUSION: Knowledge of biobanks was found to be limited. Participants were positive toward the setting up of biobanks in general and patient-centered aging biobanks in particular. Knowledge about biobanks and acceptance were higher among participants with higher education years.

PMID:34626462

Database (Oxford). 2021 Oct 9;2021:baab060. doi: 10.1093/database/baab060.

ABSTRACT

Following the European Commission No. 1332/2008 regulation and the consequent necessity of a scientific evaluation of food enzymes (FEs) for their approval for sale on the European Union market, many FE dossiers have been submitted to the European Commission and various documents currently co-exist. In order to centralize all relevant information in one structured location that is easily accessible to support enforcement laboratories and the competent authorities, we developed a web application, called Food Enzyme Database (FEDA). FEDA allows searching and collection of information originating from many different sources in one centralized portal. Queries can be performed using key information types, which include information on the producing company, production source (strain type, genetically modified microorganism status), type of enzyme protein and evaluation status with employed evaluation criteria. The database contains all current publicly available information. Centralizing all information coupled with intuitive searching functionality also allows the generation of general statistics regarding the current market situation. FEDA is open access and is freely available at the following location: https://feda.sciensano.be. Database URL : https://feda.sciensano.be.

PMID:34626475 | DOI:10.1093/database/baab060

Infect Dis Ther. 2021 Oct 9. doi: 10.1007/s40121-021-00537-0. Online ahead of print.

ABSTRACT

INTRODUCTION: Healthcare-associated (HCA) infections represent a growing public health problem. The aim of this study was to compare community-onset healthcare associated (CO-HCA) bacteremic urinary tract infections (BUTI) and hospital-acquired (HA)-BUTI with special focus on multidrug resistances (MDR) and outcomes.

METHODS: ITUBRAS-project is a prospective multicenter cohort study of patients with HCA-BUTI. All consecutive hospitalized adult patients with CO-HCA-BUTI or HA-BUTI episode were included in the study. Exclusion criteria were: patients < 18 years old, non-hospitalized patients, bacteremia from another source or primary bacteremia, non-healthcare-related infections and infections caused by unusual pathogens of the urinary tract. The main outcome variable was 30-day all-cause mortality with day 1 as the first day of positive blood culture. Logistic regression was used to analyze factors associated with clinical cure at hospital discharge and with receiving inappropriate initial antibiotic treatment. Cox regression was used to evaluate 30-day all-cause mortality.

RESULTS: Four hundred forty-three episodes were included, 223 CO-HCA-BUTI. Patients with CO-HCA-BUTI were older (p < 0.001) and had more underlying diseases (p = 0.029) than those with HA-BUTI. The severity of the acute illness (Pitt score) was also higher in CO-HCA-BUTI (p = 0.026). Overall, a very high rate of MDR profiles (271/443, 61.2%) was observed, with no statistical differences between groups. In multivariable analysis, inadequate empirical treatment was associated with MDR profile (aOR 3.35; 95% CI 1.77-6.35), Pseudomonas aeruginosa (aOR 2.86; 95% CI 1.27-6.44) and Charlson index (aOR 1.11; 95% CI 1.01-1.23). Mortality was not associated with the site of acquisition of the infection or the presence of MDR profile. However, in the logistic regression analyses patients with CO-HCA-BUTI (aOR 0.61; 95% CI 0.40-0.93) were less likely to present clinical cure.

CONCLUSION: The rate of MDR infections was worryingly high in our study. No differences in MDR rates were found between CO-HCA-BUTI and HA-BUTI, in the probability of receiving inappropriate empirical treatment or in 30-day mortality. However, CO-HCA-BUTIs were associated with worse clinical cure.

PMID:34626347 | DOI:10.1007/s40121-021-00537-0

Oncol Ther. 2021 Oct 9. doi: 10.1007/s40487-021-00173-1. Online ahead of print.

ABSTRACT

INTRODUCTION: Regorafenib is a multikinase inhibitor approved for the treatment of metastatic colorectal cancer (mCRC). Despite providing a statistically significant survival benefit, a substantial number of patients fail to respond to or continue with treatment, which has resulted in an unmet clinical need for a biomarker of regorafenib efficacy.

METHODS: The JACCRO CC-12 study was a prospective, multicenter, single-arm phase II trial designed to evaluate the usefulness of [¹⁸F]fluorodeoxyglucose positron emission tomography (FDG-PET) as an imaging biomarker of regorafenib in patients with mCRC that progressed after standard chemotherapies. FDG-PET and contrast-enhanced computed tomography (CT) were performed before and after treatment with regorafenib 160 mg once daily 3 weeks on/1 week off. The primary end point was the change in the maximum standardized uptake value in the lesion with the highest uptake at pre-treatment FDG-PET. The secondary end points included overall survival (OS), progression-free survival (PFS), the objective response rate (ORR), safety, and the correlation between FDG-PET and CT.

RESULTS: Twenty patients were enrolled from November 2014 to March 2016, 17 of whom were evaluated for metabolic and morphological changes. Metabolic response with FDG-PET was partial response (PR) in one case (5.9%), stable disease (SD) in four (23.5%), and progressive disease (PD) in 12 (70.6%). The metabolic response rate was 5.9%. On CT imaging, no complete response or PR was observed, and the ORR was 0%. Median PFS and OS were 1.7 and 9.8 months, respectively. The median PFS of patients who achieved PR or SD by FDG-PET was 3.7 months, whereas that of those assessed as PD was 1 month (p = 0.13). The median OS of patients who achieved PR or SD by FDG-PET was 13.0 months, whereas that of patients assessed as PD was 10.6 months (p = 0.43). Frequent adverse events were palmar-plantar erythrodysesthesia syndrome, hypertension, loss of appetite, and fatigue.

CONCLUSIONS: In this study, FDG-PET failed to demonstrate usefulness as an early imaging biomarker of regorafenib in patients with mCRC.

PMID:34626349 | DOI:10.1007/s40487-021-00173-1

Int J Clin Oncol. 2021 Oct 9. doi: 10.1007/s10147-021-02039-y. Online ahead of print.

ABSTRACT

BACKGROUND: More than 50% children with high-risk neuroblastoma (HR-NBL) experience disease progression, which we hypothesise is due to non-response of primary tumour to treatment. Current imaging techniques are unable to characterise response in primary tumour (necrotic versus viable tissue) at diagnosis or follow-up.

OBJECTIVES: Compare clinico-histological characteristics between primary ¹²³ImIBG-avid tumours that became entirely ¹²³ImIBG-non-avid (responders) after induction chemotherapy (IC) versus primary ¹²³ImIBG-avid tumour that remained ¹²³ImIBG-avid (non-responders).

METHODS: Retrospective review of clinico-radiological data of children diagnosed with ¹²³ImIBG-avid HR-NBL at our centre (2005-2016). Patients received Rapid COJEC IC and two additional courses of TVD if metastatic response was inadequate. Primary tumour ¹²³ImIBG response was assessed qualitatively as positive, negative or intermediate at diagnosis and after IC. Post-surgical histopathology slices were marked considering percentage of viable tissue.

RESULTS: Sixteen of 61 patients showed complete primary tumour ¹²³ImIBG response, 20 partial response, while 25 no response. There was no statistically significant difference between clinical demographics of complete responders and group of non- or partial responders. Mean percentage of viable tumour cells was higher in non-responders than in complete responders (44.6% vs 20.6%; p = 0.05). Five-year EFS was significantly higher in complete responders than non-responders (43 ± 15% vs 7 ± 6%; p < 0.005).

CONCLUSIONS: ¹²³ImIBG response in primary HR-NBL correlates with amount of necrotic tissue, skeletal metastatic ¹²³ImIBG response and outcome. An entirely ¹²³ImIBG non-avid tumour can still harbour viable tumour cells. Therefore, our findings do not support utility of primary tumour ¹²³ImIBG response in decision making regarding residual tumour surgery. Combining both, primary and metastatic ¹²³ImIBG response will improve interpretability of clinical trial results.

PMID:34626287 | DOI:10.1007/s10147-021-02039-y

Prev Sci. 2021 Oct 9. doi: 10.1007/s11121-021-01297-6. Online ahead of print.

ABSTRACT

Internationally, youth crime is a significant social problem. Violent youth crime has been rising over the past decade in the state of Victoria, Australia. Communities That Care (CTC) is a coalition training process designed to prevent youth crime. There has been limited evaluation outside the USA. Using a non-experimental design, this study employed official state crime statistics to evaluate the impact on crime as the five-phase CTC process was implemented between 2010 and 2019 across communities in Victoria. The standard five-phase CTC implementation cycle was supplemented with universal programs to reduce sales and supply of alcohol to underage youth (under 18 years). Growth models evaluated community trends in youth crime (all, person, property and deception and other), comparing communities that implemented CTC at phase 4 or greater with communities that had not implemented CTC. In accord with the hypotheses, the study found significant reductions in crimes associated with CTC over the period between 2010 and 2019. A 2% annual reduction in risk was observed for crimes against persons for all age groups (IRR = 0.98, 95% CI [0.96, 0.998]). A 5% annual reduction was observed for crimes of property and deception for adolescents aged between 10 and 17 years (IRR = 0.95, 95% CI [0.90, 0.99]). These findings support CTC as an intervention for preventing youth crime at a population level. Future studies should evaluate intervention mechanisms and economic benefits.

PMID:34626325 | DOI:10.1007/s11121-021-01297-6

Acta Neurochir (Wien). 2021 Oct 9. doi: 10.1007/s00701-021-05007-7. Online ahead of print.

ABSTRACT

BACKGROUND: External ventricular drainage (EVD) is one of the most common neurosurgical procedures in emergencies. This study aims to find out which factors influence the occurrence of EVD-related complications in a comparative investigation of metal needles and polyurethane catheters. This is the first clinical study comparing these two systems.

METHODS: Adult patients undergoing pre-coronal EVD placement via freehand burr hole trepanation were included in this prospective study. The exclusion criteria were the open EVD insertion and/or a pre-existing infectious disease of the central nervous system.

RESULTS: Two hundred consecutive patients were enrolled. Of these, 100 patients were treated by using metal EVD (group 1) and 100 patients with polyurethane catheters (group 2). The overall complication rate was 26% (misplacement 13.5%, hemorrhage 12.5%, infection 2.5%, and dislocation 1%) without statistically significant differences between both groups. Generalized brain edema and midline shift had a significant influence on misplacements (generalized brain edema: p = 0.0002, Cramer-V: 0.307, OR = 7.364, 95% CI: 2.691-20.148; all patients: p = 0.001, Cramer-V: 0.48, OR = 43.5, 95% CI: 4.327-437.295; group 1: p = 0.047, Cramer-V: 0.216, OR = 3.75, 95% CI: 1.064-13.221; group 2: midline shift: p = 0.038, Cramer-V: 0.195, OR = 3.626, 95% CI: 1.389-9.464) all patients: p = 0.053, Cramer-V: 0.231, OR = 5.533, 95% CI 1.131-27.081; group 1: p = 0.138, Cramer-V: 0.168, OR = 2.769, 95% CI: 0.813-9.429 group 2. Hemorrhages were associated with the use of oral anticoagulants or antiplatelet therapy (p = 0.002; Cramer-V: 0.220, OR = 3.798, 95% CI: 1.572-9.175) with a statistically similar influence in both groups.

CONCLUSION: Generalized brain edema has a significant influence on misplacements in both groups. Midline shift lost its significance when considering only the patients in group 2. Patients under oral anticoagulation and antiplatelet therapy have increased odds of EVD-associated hemorrhage. Metal needles and polyurethane catheters are equivalent in terms of patient safety when there are no midline shift and generalized brain edema.

PMID:34626273 | DOI:10.1007/s00701-021-05007-7

Esophagus. 2021 Oct 9. doi: 10.1007/s10388-021-00881-7. Online ahead of print.

ABSTRACT

BACKGROUND: Peroral endoscopic myotomy (POEM) is a standard treatment for achalasia. Several reports have described the efficacy and safety of POEM for elderly patients, but none has reported the efficacy and safety of POEM in a large number of elderly patients for > 3 years postoperatively. In this study, we examined the safety and outcome of POEM for 3 years postoperatively in 100 elderly patients.

METHODS: One hundred consecutive patients aged > 65 years who underwent POEM from September 2011 to March 2020 were included in this study. In analysis 1, we retrospectively investigated the safety and efficacy of POEM in all patients. In analysis 2, the efficacy and safety of POEM were statistically compared between two groups: the early elderly (65-74 years of age, 55 patients) and late elderly (≥ 75 years of age, 45 patients).

RESULTS: The technical success rate of POEM was 100%. In analysis 1, the 3-month, 1-year, 2-year, and 3-year efficacies of POEM (Eckardt score of ≤ 3) were 100% (92/92 cases), 100% (91/91 cases), 97.8% (88/90 cases), and 100% (92/92 cases), respectively. Procedure-related adverse events occurred in 11% of patients, but none was fatal. Two late elderly patients developed aspiration pneumonia due to delirium and underwent long-term hospitalization. In analysis 2, there were no significant differences in the efficacy and safety of POEM between the two age groups.

CONCLUSIONS: POEM is effective and safe for elderly patients. However, precautions are needed regarding the risk of adverse events associated with delirium when POEM is performed in elderly patients.

PMID:34626277 | DOI:10.1007/s10388-021-00881-7