Vibrio harveyi biofilm as immunostimulant candidate for high-health pacific white shrimp, Penaeus vannamei farming.

The study was to develop Vibrio harveyi biofilm-based novel microbial product and its oral delivery for high health Penaeus vannamei farming. Yield of bacterial biofilm was optimized on chitin substrate (size: <360, 360-850 and 850-1250 µm; concentration: 0.3, 0.6 and 0.9%) in tryptone soy broth (0.15%). The biofilm was characterized by crystal violet assay, SEM and LSCM imaging; protein profiling by SDS-PAGE and LC-ESI-MS/MS. The immune stimulatory effect of the biofilm in yard experiments was evaluated by relative quantification of immune genes using real-time PCR effect on overall improvement on health status under field trials. The highest biofilm yield (6.13 ±â€¯0.2 × 107 cfu/ml) was obtained at 0.6% of <360 µm chitin substrate. The biofilm formation was stabilized by 96 h of incubation at 30 °C. Protein profiling confirmed expression of six additional proteins (SDS-PAGE) and 11 proteins were differentially expressed (LC-ESI-MS/MS) in biofilm cells over free cells of V. harveyi. Oral administration of the biofilm for 48 h confirmed to enhance expression of antimicrobial peptides, penaeidin, crustin and lysozyme in P. vannamei. Further Oral administration of biofilm for two weeks to P. vannamei (1.8 ±â€¯0.13 g) improved the growth (2.66 ±â€¯0.06 g) and survival (84.44 ±â€¯1.82%) compared to control (2.15 ±â€¯0.03 g; 70.94 ±â€¯0.66%) Nursery trials showed a significant reduction in occurrence of anatomical deformities like antenna cut (12.67 ±â€¯0.66%), rostrum cut (4.66 ±â€¯0.87%), and tail rot (3.33 ±â€¯0.88%), compared to animals fed with normal diet which was 24.33 ±â€¯2.72; 14 ±â€¯1.52 and 10.66 ±â€¯1.45% respectively. In vitro and in vivo studies suggest inactivated biofilm cells of V. harveyi on chitin substrate express additional antigenic proteins and when administered orally through feed at regular intervals stimulates immune response and improve growth, survival and health status of shrimp.

Democratizing Health Care in the Metaverse: How Video Games can Monitor Eye Conditions Using the Vision Performance Index: A Pilot Study.

Objective: In a world where digital media is deeply engrained into our everyday lives, there lies an opportunity to leverage interactions with technology for health and wellness. The Vision Performance Index (VPI) leverages natural human-technology interaction to evaluate visual function using visual, cognitive, and motor psychometric data over 5 domains: field of view, accuracy, multitracking, endurance, and detection. The purpose of this study was to describe a novel method of evaluating holistic visual function through video game-derived VPI score data in patients with specific ocular pathology. Design: Prospective comparative analysis. Participants: Patients with dry eye, glaucoma, cataract, diabetic retinopathy (DR), age-related macular degeneration, and healthy individuals. Methods: The Vizzario Inc software development kit was integrated into 2 video game applications, Balloon Pop and Picture Perfect, which allowed for generation of VPI scores. Study participants were instructed to play rounds of each video game, from which a VPI score was compiled. Main Outcome Measures: The primary outcome was VPI overall score in each comparison group. Vision Performance Index component, subcomponent scores, and psychophysical inputs were also compared. Results: Vision Performance Index scores were generated from 93 patients with macular degeneration (n = 10), cataract (n = 10), DR (n = 15), dry eye (n = 15), glaucoma (n = 16), and no ocular disease (n = 27). The VPI overall score was not significantly different across comparison groups. The VPI subcomponent "reaction accuracy" score was significantly greater in DR patients (106 ± 13.2) versus controls (96.9 ± 11.5), P = 0.0220. The VPI subcomponent "color detection" score was significantly lower in patients with DR (96.8 ± 2.5; p=0.0217) and glaucoma (98.5 ± 6.3; P = 0.0093) compared with controls (101 ± 11). Psychophysical measures were statistically significantly different from controls: proportion correct (lower in DR, age-related macular degeneration), contrast errors (higher in cataract, DR), and saturation errors (higher in dry eye). Conclusions: Vision Performance Index scores can be generated from interactions of an ocular disease population with video games. The VPI may offer utility in monitoring select ocular diseases through evaluation of subcomponent and psychophysical input scores; however, future larger-scale studies must evaluate the validity of this tool. Financial Disclosures: Proprietary or commercial disclosure may be found after the references.

Study of Cutaneous Manifestations in Alcohol Dependence Syndrome Patients in a Rural Tertiary Care Center in India.

Background: Chronic alcoholism is a multifactorial condition predisposed by environmental, social, and psychological factors. Alcohol dependence syndrome (ADS) can present with varied cutaneous and systemic manifestations. The effects of alcohol use include cutaneous infections, infestations, features of malnutrition, exacerbation of pre-existing dermatoses, and alcohol-related dermatoses. This study aimed to analyze and document cutaneous manifestations secondary to infections, infestations, malnutrition, and modifications of pre-existing dermatoses in ADS patients and investigate the correlation between the presence of cutaneous manifestations and duration and quantity of alcohol intake. Methods: The present observational study was carried out in the Department of Dermatology for a period of one year. A total of 172 male patients with ADS presenting with skin manifestations were included in the study. Detailed analysis of history, clinical examination, and relevant investigations were conducted. Findings: Out of 172 male patients with ADS, the most common dermatoses noted were infections (166, 96.5%) and features of malnutrition (161, 93.6%). Exacerbation of pre-existing dermatoses (101, 58.7%) and alcohol-related dermatoses (85, 49.4%) were also observed. Conclusion: Most of the dermatoses were significantly correlated with the quantity of alcohol intake than with its duration, implying that higher quantity of alcohol intake has more impact on cutaneous and systemic manifestations. Identifying the cutaneous manifestations in ADS patients plays an important role in recognizing the underlying systemic disorders which in turn facilitates early intervention and thereby prevents complications.

Bone Marrow Quality Index: A Predictor of Acute Graft-versus-Host Disease in Hematopoietic Stem Cell Transplantation for Thalassemia.

Bone marrow (BM) continues to be the preferred source of stem cells in allogenic transplantation for nonmalignant disorders. Granulocyte colony-stimulating factor (G-CSF)-primed BM is associated with low rates of acute graft-versus-host disease (aGVHD) and allows reduced collection volumes while ensuring speedy engraftment. However, variability in BM harvest quality is a concern. This study evaluated the utility of a novel indicator, the Bone Marrow Quality Index (BMQI), to predict aGVHD. We analyzed 184 consecutive first matched related donor bone marrow transplants for thalassemia using G-CSF-primed bone marrow over 6 years from March 2017 to April 2023 across 2 centers in India. BMQI was defined as the ratio of the G-CSF-primed BM WBC count to the peripheral blood WBC count within 24 hours of harvest. European Society for Blood and Marrow Transplantation criteria were used to grade aGVHD. The log-rank test was used to assess the impact of BMQI on aGVHD. The chi-square test was used to compare categorical data, and the Wilcoxon rank-sum test was used to compare the numerical data. A Cox proportional hazards model was used to investigate the association of BMQI vis-à-vis other factors on aGVHD. Of the 184 patients studied, 19 had a BMQI <.9, 18 had a BMQI between .9 and 1, and the remaining 147 had a BMQI >1. The rate of aGVHD grade II-IV was 37% in patients with a BMQI <.9 , 22% in those with BMQI .9 to 1, and 12% in those with BMQI >1 (P = .018). Patients with BMQI <.9 had a 3.1-fold greater chance (95% confidence interval [CI], .9 to 10.6) and those with BMQI .9 to 1 had a 2-fold greater chance (95% CI, .5 to 6.6) of developing aGVHD grade II-IV. BMQI was the significant predictor associated with aGVHD hazard (P = .014). BMQI appears to be the most relevant and controllable predictor of aGVHD. It is a novel, informative, and very simple indicator that could influence aGVHD prophylaxis decision making. Our indicator is accurately measurable, inexpensive, precise, and timely; furthermore, it does not involve any sophisticated equipment and thus may be widely applicable. Prior knowledge of poor BM quality may help intensify prophylaxis and monitoring for aGVHD, as well as trigger a review of collection procedures.

Do Weekly Surveillance Cultures Contribute to Antibiotic Stewardship and Correlate with Outcome of HSCT in Children? A Multicenter Real-World Experience of 5 Years from the Indian Subcontinent.

The utility of weekly rectal swab surveillance cultures (RSSCs) as a resource to identify gut colonization with extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli or Klebsiella pneumoniae carbapenemase (KPC)-producing organisms and guide empirical antibiotic therapy in hematopoietic stem cell transplantation (HSCT) recipients continues to be a subject of interest. There is an urgent need to assess and justify modifications to empirical antibiotics based on regional epidemiology and patient groups. This study aimed to study the utility of weekly rectal swab surveillance cultures (RSSCs) to guide empirical antibiotic therapy and to examine the impact of gut colonization on transplantation outcomes. This retrospective analysis of 317 successive first HSCTs performed mainly for hemoglobinopathies was conducted in 3 pediatric bone marrow transplantation centers in the Indian subcontinent between April 2016 and April 2021. Transplantation, infection control, and febrile neutropenia management protocols were identical in the 3 centers. First-line antibiotics were chosen based on RCCS reports, with meropenem used for ESBL and high-dose meropenem with colistin used for carbapenemase-resistant colonization for first half of the study, with no adjustment made in the second half. Clinical response to antibiotics, long-term outcomes, antibiotic-resistant bacteremia, and acute graft-versus-host disease (GVHD) were analyzed. The log-rank test, chi-square, and Wilcoxon rank-sum tests were used to compare data using R Statistical software. Of the 871 weekly RSSCs done, 162 were positive for ESBL- or KPC-resistant organism. RCCSs were ESBL-positive in 106 patients (33%) and KPC-positive in 10 patients (3%). Among the 97 ESBL-positive patients for whom a antimicrobial susceptibility testing report was available, only 22 (25%) demonstrated clinical resistance to piperacillin-tazobactam (Pip-Taz). Among the 10 KPC-positive patients, only 4 (40%) demonstrated clinical resistance to Pip-Taz and 3 (30%) had clinical resistance to meropenem. Two-thirds of patients with ESBL-positive RSSC in whom first-line empirical antibiotics were used responded clinically. Even among the 15 patients who were resistant to first-line empirical antibiotics (Pip-Taz) on RSSC reports, 67% responded clinically to Pip-Taz. Twenty-seven of these patients (56%) never needed carbapenem therapy. Empirical Pip-Taz therapy in ESBL-positive patients did not prolong meropenem use within 100 days of transplantation (P = .18). All patients with a KPC-positive RSSC who received first-line empirical antibiotics responded clinically, including 4 who were resistant to Pip-Taz and 3 who were meropenem-resistant on RCCS. Comparing patients who were ESBL-positive, KPC-positive, and not positive for either showed no statistically significant differences in overall survival (OS) (P = .95), disease-free survival (DFS) (P = .45), transplantation-related mortality (TRM) (P = .97), graft rejection (P = .68), or rate of acute GVHD grade II-IV (P = .78). No statistically significant differences were seen between the ESBL-positive patients who received and those who did not receive higher-level empirical antibiotics in OS (P = .32), DFS (P = .64), TRM (P = .65), graft rejection (P = .46), acute GVHD grade II-IV (P = .26), or antibiotic-resistant bacteremia (P = .3). In the context of HSCT for nonmalignant hematologic disorders, choosing empiric antibiotic therapy based on RSSCs is not justified, even in regions with a high prevalence of antimicrobial resistance. Antimicrobial susceptibility testing reports in surveillance cultures did not correlate with in vivo clinical response. Colonization reported on weekly RSSCs showed no correlation with clinical outcomes. © 2021 American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc.

Efficacy and Safety of Molnupiravir in Mild COVID-19 Patients in India.

Background At the peak of the coronavirus disease 2019 (COVID-19) pandemic, the need for an orally administered agent to prevent the progression of acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection became increasingly evident, which was the impetus behind our investigations with molnupiravir. Molnupiravir has been shown to be effective in preventing hospitalizations and/or clinical complications in patients with mild-to-moderate COVID-19. In this study, we evaluate the efficacy and safety of molnupiravir in Indian patients with mild SARS-CoV-2 infection and at least one risk factor for disease progression (CTRI/2021/05/033739). Methodology This was a phase III, multicenter, randomized, open-label, controlled study conducted in Indian adults aged 18-60 years with mild SARS-CoV-2, reverse transcription polymerase chain reaction (RT-PCR)-positive within 48 hours of enrollment in the study, and within five days of first symptom onset. Enrolled patients were randomized to treatment arms in a 1:1 ratio to receive molnupiravir or placebo in addition to the standard of care (SoC) for SARS-CoV-2 infection. The SoC was in compliance with Government of India guidelines that were in force at the time. The primary endpoint was the rate of hospitalization up to day 14. Safety endpoints included incidence of adverse events (AEs). Results Eligible patients were randomized in a 1:1 ratio to receive molnupiravir in addition to SoC treatment (n = 608) or SoC alone (n = 610). In the molnupiravir group, nine (1.48%) patients required hospitalization versus 26 (4.26%) patients in the control group (risk difference = -2.78%; 95% CI = -4.65, -0.90; p = 0.0053). Overall, 45 (3.70%) patients reported 47 AEs during the study, most of which were mild and resolved completely. The molnupiravir group reported 30 AEs compared to 17 AEs in the control group. Headache and nausea were the two most commonly reported AEs. Conclusions The molnupiravir arm showed a lower rate of hospitalization and a shorter time for the improvement of clinical symptoms coupled with early RT-PCR negativity. Molnupiravir was well tolerated, and AEs were mild and rare. The addition of molnupiravir to standard therapy has the potential to prevent the progression of mild COVID-19 disease to the severe form.

Melanin production by Pseudomonas sp. and in silico comparative analysis of tyrosinase gene sequences.

Background: Melanin finds enormous applications in different industries for its unique photoprotective and anti-oxidant properties. Due to its emerging demand, scientific researchers are putting efforts to unravel more microorganisms with a potential of producing melanin on large scale. Hence, the present study was aimed at the isolation of extracellular melanin producing microorganisms from lime quarries of Karnataka, India. Besides this, the tyrosinase gene governing melanin synthesis in different organisms were compared in silico to understand its evolutionary aspects. Material and methods: Melanin producing microorganisms were screened on tyrosine gelatin beef extract agar medium. Potential isolate was explored for submerged production of melanin in broth containing L-tyrosine. Melanin was characterized by UV-Vis spectroscopy, thin layer and high performance liquid chromatographic techniques. Antibacterial activity of melanin was performed by agar well assay. Comparative tyrosinase gene sequence analysis was performed by using Geneious 2021.1 trial version software. Results: Pseudomonas otitidis DDB2 was found to be potential for melanin production. No antibacterial activity was exerted by the melanin against tested pathogens. The in silico studies showed that the common central domain of tyrosinase protein sequence of selected Pseudomonas sps. exhibited 100% identity with the common central domain of Homo sapiens tyrosinase (NP_000363.1). Conclusions: Our study shows the production of melanin in good quantities by the isolate Pseudomonas otitidis DDB2 which can be explored for scale-up process. Since the melanin formed is of eumelanin type and the tyrosinase gene sequence of several Pseudomonas sp. showed relatedness to humans, this molecule may be further developed for sunscreen formulations.

Efficacy and Safety of Orally Administered Acotiamide Extended-Release Tablets Among Functional Dyspepsia-Postprandial Distress Syndrome Patients: A Randomized, Double-Blind, Multicenter Study.

BACKGROUND: Acotiamide, is the world's first-in-class, prokinetic drug and world's first approved treatment for postprandial distress syndrome (PDS) symptoms of functional dyspepsia (FD). An extended-release (ER) formulation of this drug product, developed first-time in the world has been evaluated in phase 3, a comparative trial to explore the efficacy and safety in patients with FD-PDS. METHODS: In this study, 219 patients with FD-PDS aged 18-65 years were randomized (1:1) to receive either acotiamide ER 300 mg once daily or acotiamide 100 mg three times daily for four weeks. The primary efficacy endpoint was responder rates for the overall treatment effect (OTE) at end of week 4. Secondary efficacy endpoints included OTE at each week, elimination rate of postprandial fullness, upper abdominal bloating and early satiation, improvement of individual symptom scores, and quality of life (QoL). The safety endpoints included assessments of treatment-emergent adverse events (TEAEs). RESULTS: The responder rate for OTE at the end of the four week period, in acotiamide ER 300 mg OD versus acotiamide 100 mg TID group was 92.66% and 94.39% (97.5% CI -8.3,4.8), respectively, in per-protocol (PP) population and 92.66% and 92.73% (97.5% CI -7.0,6.8), respectively, in intent to treat (ITT) population. All other secondary efficacy endpoints, including QoL, were significantly improved with acotiamide ER 300 mg. Both the formulations of acotiamide significantly improved symptom severity and eliminated meal-related symptoms in patients with FD. Adverse events were reported by 7.9% of patients in acotiamide ER 300 mg and 9.2% in acotiamide 100 mg patients; the most common adverse event reported was a headache. CONCLUSIONS: The efficacy and safety of acotiamide ER 300 mg once daily were observed to be comparable to acotiamide immediate release 100 mg thrice daily. A significant improvement in QoL over a four-week treatment period in FD-PDS patients was observed.

Efficacy and Safety of Acotiamide Versus Mosapride in Patients With Functional Dyspepsia Associated With Meal-Induced Postprandial Distress Syndrome: A Phase III Randomized Clinical Trial.

BACKGROUND:  Acotiamide is a novel prokinetic drug that acts by enhancing the release of acetylcholine and is used in the treatment of functional dyspepsia-postprandial distress syndrome (FD-PDS). Mosapride is indicated to FD-PDS as per the Rome III treatment guidelines. Mosapride 5 mg three times daily (TID) is approved by the Drugs Controller General of India (DCGI) for the treatment of FD-PDS. The objective of this study was to determine the efficacy and safety of Acotiamide in comparison with Mosapride on FD-PDS. METHODS: The 220 patients of either gender (aged 18-64 years) with active PDS included in the study were centrally randomized 1:1 to receive either 100 mg Acotiamide (test product) or 5 mg Mosapride (reference product) TID for four weeks. Responder rates for the overall treatment effect (OTE) at the end of four weeks were the primary efficacy endpoint. Secondary efficacy endpoints included the elimination rate of postprandial fullness, upper abdominal bloating, and early satiation. The study also evaluated the OTE at each week, individual symptom scores, and quality of life (QoL) assessed by the Short Form-Nepean Dyspepsia Index questionnaire (SF-NDI). The safety endpoints included assessments of treatment-emergent adverse events (TEAEs). RESULTS:  At the end of four weeks, the responders in the Acotiamide versus Mosapride group for OTE was 98% versus 93.27% in the per-protocol (PP) population. Among the intent to treat (ITT) population, the comparison of Acotiamide versus Mosapride stood at 95.15% versus 89.81%. Secondary efficacy endpoints were significantly improved with 100 mg TID Acotiamide, which was evident from the improvement in postprandial fullness (14.56%), upper abdominal bloating (15.53%), early satiation (10.68%), and QoL (13.7 ± 4.67). CONCLUSIONS:  Our study results demonstrated that Acotiamide is effective, safe, and well-tolerated and had significantly improved the QoL over a four-week treatment period in FD-PDS patients. The efficacy and safety profiles of Acotiamide were similar to Mosapride.

A Phase III Prospective Active and Placebo-Controlled Randomized Trial of Vilazodone in the Treatment of Major Depressive Disorder.

Background Depression is a leading cause of psychiatric morbidity in the modern world, and the introduction of selective serotonin reuptake inhibitors (SSRIs) is a revolution in the treatment of depression. Vilazodone, a novel SSRI and 5-HT1A partial agonist, received FDA approval in 2011 to treat the major depressive disorder (MDD) in adults. This study conducted in India aimed to evaluate the efficacy and safety of vilazodone when compared to escitalopram or placebo in patients with MDD. Methods This was a prospective, multicentre, randomized, comparative study of 375 participants over eight weeks of treatment with either vilazodone (10-40mg/day) or escitalopram (10-40 mg/day) or placebo in adult patients with MDD. Primary efficacy was assessed using the Hamilton Rating Scale for Depression (HAM-D-17); secondary efficacy was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) score and Hamilton Anxiety Scale (HAM-A) score. Safety parameters included adverse events (AEs), clinical laboratory results, vital signs, electrocardiogram ( ECG), and Columbia-Suicide Severity Rating Scale (C-SSRS). Results Mean change in the HAM-D-17 total score from baseline to week 8 for vilazodone, escitalopram, and placebo-treated patients in intent-to-treat (ITT) population was: -18.9 (± 7.49), -17.8 (± 6.06), and -7.4 (± 6.32); in ITT population (with Last Observation Carried Forward( LOCF) imputation) was: -17.9 (± 7.71), -17.4 (± 6.19), and -6.4 (± 6.84), and in per-protocol (PP) population was: -19.1 (± 7.20), -17.8 (± 6.08), and -7.7 (± 6.29), respectively. The upper limit of 95% CI (0.56 (ITT); 0.90 (ITT with LOCF Imputation); 0.23 (PP)) of difference in HAM-D-17 between vilazodone 40mg and escitalopram 40mg, which is lower than the defined non-inferiority margin (3.56), proving non-inferiority. The difference between vilazodone 40mg, escitalopram 40mg, and the placebo was statistically significant (p<0.0001). No deaths or serious adverse events were reported in this study. Conclusion Vilazodone demonstrated comparable efficacy to escitalopram and superior efficacy over the placebo in the treatment of MDD.

Video-assisted teaching versus traditional didactic lecture in undergraduate psychiatry teaching.

OBJECTIVES: The objectives of this study are as follows: (1) To compare video-assisted teaching versus didactic lectures using the pretest and posttest. (2) To compare the feedback on the two teaching methods using a teaching feedback form. MATERIALS AND METHODS: Two consecutive batches of 22 and 20 students, respectively, of the 3rd year medical undergraduate students posted to the department of psychiatry were included for the study. The first batch underwent video-assisted schizophrenia class and didactic lecture in bipolar disorder (BPAD). A crossover of the topics was done. The students underwent pretest and posttest for each topic using the same set of topic-specific validated multiple choice questions and also filled a prevalidated teaching feedback form for each class. RESULTS: Difference between pre- and post-test scores after all classes was significant, indicating effective gain of knowledge by both methods. Feedback analysis indicated that most students favored video-assisted teaching (total mean feedback score - 61.99) compared to the conventional method (total mean feedback score - 60.58). Increase in mean feedback scores indicates the students' preference. CONCLUSION: Both didactic and video-assisted lectures were effective in terms of knowledge gained and students' feedback. Using video assistance as a complement to lectures and not to replace the traditional methods is the way forward.

Randomized, single-blind, crossover comparison of two rupatadine tablet formulations on histamine-induced cutaneous response in healthy adult volunteers.

BACKGROUND: Rupatadine is a histamine receptor type 1 antagonist that has been used to treat allergic rhinitis and urticaria. OBJECTIVE: The aim of this study was to compare the effect of 2 rupatadine tablet formulations on the inhibition of histamine-induced wheal-and-flare cutaneous responses. METHODS: In this single-blind, single oral dose, crossover study, healthy male volunteers were randomized to receive 10 mg of either a rupatadine reference or test formulation after an overnight fast. After a 10-day washout period, the subjects were crossed over to receive the other formulation. Subjects were asked to sit with their arm resting on the table while histamine was injected intradermally. The skin prick test was performed on the upper half of the volunteers' forearms before administration and at 1, 2, 4, 6, 12, and 24 hours after study drug administration. Fifteen minutes after each skin prick test, the wheal-and-flare responses were visualized under a bright lamp. AUC0-24 was the primary end point.The 90% CI of least squares mean ratio (%) of the test: reference formulations for maximum inhibition of histamine-induced wheal-and-flare response (Imax%), Tmax, AUC0-24 mm(2)/h, and AUC0-24%/hr were expected to be within 80% to 125% of untransformed data and 80% to 120% of log-transformed data for the 2 formulations to be considered pharmacodynamically equivalent. Subjects were monitored for any spontaneously reported adverse event (AE) throughout the study. In addition, they were specifically asked about the occurrence of any AEs on a checklist (ie, drowsiness, dizziness, dryness of mouth, itching sensation, headache, nausea) throughout the study. RESULTS: Of the 15 subjects assessed for inclusion, 12 healthy male volunteers (mean [SD] age, 30 [5] years; height, 162 [6] cm; weight, 58 [6] kg) participated in the study. Administration of reference and test formulations of rupatadine significantly inhibited the histamine-induced cutaneous responses in all subjects (P <0.001). Wheal Imax% with the reference and test formulations was 67.97% (11.57%) and 66.76% (9.40%), respectively. Flare Imax% was 59.06% (11.95%) and 56.92% (16.31%), respectively. None of the subjects withdrew from the study due to AEs. Both formulations were well tolerated except for an itching sensation on injection of histamine in all patients; no subject complained of any adverse drug reaction. CONCLUSION: In this small study of healthy adult males, the test formulation of the rupatadine tablet was found to be pharmacodynamically equivalent to the reference formulation, as measured by inhibition of histamine-induced cutaneous wheal-and-flare responses.

Resolution of MRS applied to the characterization of hard-rock aquifers.

The performance of the Magnetic Resonance Sounding (MRS) method applied to the investigation of heterogeneous hard-rock aquifers was studied. It was shown using both numerical modeling and field measurements that MRS could be applied to the investigation of the weathered part of hard-rock aquifers when the product of the free water content multiplied by the thickness of the aquifer is >0.2 (for example, 10-m-thick layer with a 2% water content). Using a currently available one-dimensional MRS system, the method allows the characterization of two-dimensional subsurface structures with acceptable accuracy when the size of the subsurface anomaly is equal to or greater than the MRS loop. However, the fractured part of hard-rock aquifers characterized by low effective porosity (<0.5%) cannot be resolved using currently available MRS equipment. It was found that shallow water in the weathered part of the aquifer may screen MRS signals from deeper water-saturated layers, thus further reducing the possibility of investigating deeper fractured aquifers. A field study using the NUMIS(plus) MRS system developed by IRIS Instruments was carried out on an experimental watershed in southern India. A heterogeneous unconfined aquifer in a gneissic formation was successfully localized, and MRS results were confirmed by drilling shortly after the geophysical study. The top of the aquifer revealed by MRS was found to be in a good agreement with observed static water level measurements in boreholes.

Nutrition and aging.

Nutritional concerns are common among older adults seen in the primary care office. The food pyramid for people over the age of 70 years is a useful starting point for discussions about what reasonably healthy older adults should be eating and drinking. If there is a decline in the ability to perform IADLs or if there is a decrease in appetite or the discovery of unintended weight loss, careful assessment followed by targeted interventions may improve health outcomes and the quality of life. Restrictive diets are often not well tolerated, especially by frail older adults. Dietary recommendations blending the elements of the pyramid and the essential components of accepted medical nutritional therapy that are most consistent with the patient's lifelong eating patterns are most likely to succeed.

Efficacy and tolerability of fixed-dose combination of simvastatin plus ezetimibe in patients with primary hypercholesterolemia: Results of a multicentric trial from India.

OBJECTIVE: To compare the efficacy and safety of fixed-dose combination (FDC) of simvastatin and ezetimibe vs simvastatin monotherapy in Indian patients with primary hypercholesterolemia. METHODS: This multicentric, double-blind, comparative, study conducted in India enrolled 230 patients with hypercholesterolemia (baseline low-density lipoprotein cholesterol [LDL-C] >120 mg/dL for patients on previous hypolipidemic drugs or >135 mg/dL for naïve subjects) were randomly assigned to receive either simvastatin (10 mg/day) or simvastatin (10 mg) plus ezetimibe (10 mg) FDC for 12 weeks. The primary efficacy endpoint was the mean percentage change in LDL-C from baseline to 12 weeks of therapy for simvastatin monotherapy vs simvastatin plus ezetimibe FDC. Secondary efficacy endpoints were mean percentage of changes in total cholesterol (TC), triglycerides (TG), and high-density lipoprotein cholesterol (HDL-C) from baseline to end of treatment, as well as proportion of patients achieving National Cholesterol Education Program Adult Treatment Panel III target LDL-C levels in each risk category. RESULTS: At the end of 12 weeks, the mean percentage reduction from baseline in LDL-C (-33.7%) was significantly greater with simvastatin and ezetimibe FDC compared to simvastatin alone (-26.28%, P < 0.05). Significantly greater percentage of patients (88%, P < 0.001) attained National Cholesterol Education Program Adult Treatment Panel III LDL-C target levels following ezetimibe/simvastatin treatment compared to simvastatin monotherapy (71%). Reductions in TG were significantly greater with ezetimibe/simvastatin than simvastatin (P < 0.001). Increases in HDL-C, and reduction in TC were similar between treatment groups. Safety and tolerability profiles were comparable for both treatments. CONCLUSION: Fixed-dose combination of simvastatin and ezetimibe provides a more effective means for reducing LDL cholesterol levels in Indian patients with hypercholesterolemia than simvastatin monotherapy without compromising the safety and tolerability profile.

Are chest radiographs routinely necessary following thoracostomy tube removal?

OBJECTIVE: Chest radiographs (CXRs) are routinely obtained at many institutions in all pediatric patients following thoracostomy tube removal to search for pneumothorax (PTX). To aid in evaluating the necessity of this practice, this study investigates whether clinical signs and symptoms may be a sensitive predictor of PTX in such patients. MATERIALS AND METHODS: Reports from CXRs obtained following chest tube removal in all pediatric patients (374 patients) who underwent cardiac surgery with chest tube placement over 1 year were reviewed. For cases with reported PTX, the PTX was quantified and chart review was performed to assess whether signs and symptoms of PTX preceded the CXR result. RESULTS: Fifty-one of 374 children (13.6%) had a radiographically defined PTX within 6 h after thoracostomy tube removal. The PTX was large (>40%) in 2 children, moderate (20-40%) in 5 children, and small (<20%) in 44 children. Symptoms (dyspnea, tachypnea, respiratory distress) or signs (increased oxygen requirement, worsening arterial blood gas and/or hypotension) of respiratory distress were present at the time of the initial CXR in six of seven patients, who later underwent a major clinical intervention, and in one patient who did not. Major clinical interventions were performed in all patients with a large PTX, four of five patients with a moderate PTX, and one patient with a small PTX that later enlarged. CONCLUSIONS: Clinical signs and symptoms identified nearly all patients with significant pneumothoraces. Future prospective investigations may examine reserving chest radiography following chest tube removal for select groups, such as symptomatic patients or those with tenuous cardiovascular status.