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Ravine lands are the worst type of land degradation affecting soil quality and biodiversity. Crop production in such lands is impossible without adopting proper conservation measures. In-situ moisture conservation techniques could play an instrumental role in restoring ravine lands by improving soil moisture. We hypothesized that restoring ravine land through a combination of tree planting, fruit crop cultivation, and in-situ moisture conservation practice would result in significant improvements in productivity, profitability, and soil fertility. An experiment was conducted involving the combination of Malabar Neem (Melia dubia) and Dragon fruit (Hylocereus undatus) in conjunction with in-situ soil moisture conservation measures specifically involving half-moon structures (HM). The experiment was conducted under randomized block design (RBD) comprising eight treatments. These treatments include sole Melia cultivation (MD 3m × 3m), sole cultivation of dragon fruit (DF 3m × 3m), silviculture system (MDF-3m × 3m), horti-silviculture system with larger spacing (MDF-4m × 4m), sole Melia cultivation with in-situ moisture conservation (MDH-3m × 3m), sole Dragon fruit cultivation with in-situ moisture conservation (DFH-3m × 3m), horti-silviculture system of Melia and Dragon fruit with in-situ moisture conservation (MDFH-3m × 3m), and horti-silviculture system with larger spacing and in-situ moisture conservation (MDFH-4m × 4m). Each treatment was replicated thrice to evaluate their impact on productivity, profitability, soil fertility, and carbon sequestration for 8 years (2016-2023). The results revealed that the horti-silviculture system (MDFH-3 × 3 m) exhibited the highest total tree biomass and total carbon sequestration with an increase of 183.2% and 82.8% respectively, compared to sole Melia cultivation without HM and sole Melia with HM. Furthermore, sole Melia with HM augmented soil nutrients (N, P, K, and SOC) by 74.4%, 66.4%, 35.2%, and 78.3%, respectively, compared to control (no planting), with performance at par with MDFH-3 × 3 m. Similarly, sole Melia with HM enhanced SOC stock and SOC sequestration rate by 79.2% and 248% over control. However, it was found at par with MDFH-3 × 3 m. The horti-silviculture system (MDFH-3 × 3 m) consistently produced the highest fruit yield throughout the years surpassing other treatments. This treatment increased the average dragon fruit yield by 115.3% compared to sole dragon fruit without HM. Hence, the adoption of the horti-silviculture system (MDFH-3 × 3 m) could be a promising strategy for achieving enhanced environmental and economic benefits in ravine lands. Therefore, dragon fruit based horti-silviculture system (MDFH-3 × 3 m) could be recommended for restoration of ravine lands, improving land productivity, and mitigating impact of soil erosion particularly in Western India or similar agro-climatic regions of the world.
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Conservación de los Recursos Naturales , Suelo , Agricultura/métodosRESUMEN
Pearl millet (Pennisetum glaucum R. Br.) is an important staple and nutritious food crop in the semiarid and arid ecologies of South Asia (SA) and Sub-Saharan Africa (SSA). In view of climate change, depleting water resources, and widespread malnutrition, there is a need to accelerate the rate of genetic gains in pearl millet productivity. This review discusses past strategies and future approaches to accelerate genetic gains to meet future demand. Pearl millet breeding in India has historically evolved very comprehensively from open-pollinated varieties development to hybrid breeding. Availability of stable cytoplasmic male sterility system with adequate restorers and strategic use of genetic resources from India and SSA laid the strong foundation of hybrid breeding. Genetic and cytoplasmic diversification of hybrid parental lines, periodic replacement of hybrids, and breeding disease-resistant and stress-tolerant cultivars have been areas of very high priority. As a result, an annual yield increase of 4% has been realized in the last three decades. There is considerable scope to further accelerate the efforts on hybrid breeding for drought-prone areas in SA and SSA. Heterotic grouping of hybrid parental lines is essential to sustain long-term genetic gains. Time is now ripe for mainstreaming of the nutritional traits improvement in pearl millet breeding programs. New opportunities are emerging to improve the efficiency and precision of breeding. Development and application of high-throughput genomic tools, speed breeding, and precision phenotyping protocols need to be intensified to exploit a huge wealth of native genetic variation available in pearl millet to accelerate the genetic gains.
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Although tobacco use is declining in several countries including India (dropping from 35% in 2009-10 to 29% 2016-17 among adults)-it still poses a huge burden on India, as the world's second largest consumer of tobacco products. In Bihar state, with a prevalence of 25%, the Bihar School Teachers Study (BSTS) successfully enlisted teachers as role models for encouraging quitting and changing social norms pertaining to tobacco. The study used a mixed-methods approach to identify factors associated with teachers' quitting. Qualitative data were collected through focus groups with teachers and school principals. Quantitative data were collected through a written survey administered to school personnel post-intervention. Key findings from focus groups were that teachers and principals quit using tobacco and promoted cessation because they wanted to model positive behaviors; specific information about tobacco's harms aided cessation; and the BSTS intervention facilitated a school environment that supported quitting. Survey results indicated teachers who reported knowing people who quit using tobacco in the prior year were far more likely to quit as were teachers who reported that their school's tobacco policy was completely enforced. The combination of qualitative and quantitative data yielded important insights with strong implications for future interventions.
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Docentes/estadística & datos numéricos , Rol Profesional , Instituciones Académicas/organización & administración , Cese del Uso de Tabaco/estadística & datos numéricos , Logro , Adulto , Femenino , Grupos Focales , Humanos , India/epidemiología , Masculino , Prevalencia , Instituciones Académicas/normas , Normas Sociales , Adulto JovenRESUMEN
BACKGROUND: Ensuring the quality and effectiveness of counselling is imperative for enabling people living with HIV to cope with treatment adherence. Countrywide assessment of antiretroviral therapy (ART) centres was undertaken to assess the quality and effectiveness of counselling. The insights gained from the assessment are expected to build an improved understanding of the counselling aspect and contribute to informing decisions strengthening the counselling provided at ART centres. METHODS: Assessment of counselling at 357 ART centres entailed interviews with counsellors and beneficiaries using a structured questionnaire administered by trained technical experts. Two counsellors and five beneficiaries at each ART centre were interviewed to assess both the quality and effectiveness of counselling. Beneficiaries were selected from different risk groups to understand their varied concerns and experiences. RESULTS: During the assessment, 618 counsellors were interviewed (45% women); also, 1785 beneficiaries were interviewed, consisting of 892 (49.9%) men, 857 (48.1%) women and 36 (2.0%) transgender. Counsellors were found to be relatively well informed on topics pertaining to pre-ART, ART preparedness and positive healthy living, and the psychosocial support extended to patients. Counsellors surveyed were not aware of critical areas such as counselling of pregnant women (44.5%) , drug adherence (44.8%) and the use of information, education and communication material during counselling, and pill count. The majority of beneficiaries reported being informed on issues pertaining to retention; however, 30-40% of beneficiaries were not informed regarding the critical elements of adherence such as counselling on ART side effects (68.5%), pill count (62.8%) and information on access to social benefit schemes (25.7%). Factors such as client volume, the training of the counsellors and adequate space for counselling affected the quality of counselling. CONCLUSION: With concerted efforts in bridging the gaps in knowledge, infrastructure and information needs, India's national AIDS control programme (NACP) can enhance the counselling services at ART centres and improve the quality of services for patient retention.
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Antirretrovirales/uso terapéutico , Consejo/estadística & datos numéricos , Infecciones por VIH/tratamiento farmacológico , Sistemas Recordatorios/estadística & datos numéricos , Adulto , Consejeros/estadística & datos numéricos , Femenino , Humanos , India , Masculino , Cumplimiento de la Medicación/estadística & datos numéricos , Programas Nacionales de Salud , Embarazo , Evaluación de Programas y Proyectos de Salud , Factores Socioeconómicos , Encuestas y Cuestionarios , Adulto JovenRESUMEN
PurposeAssess long-term outcome of combined trabeculotomy-trabeculectomy (CTT) in primary congenital glaucoma (PCG).MethodsData of PCG patients treated with CTT by a single surgeon between 1976 and 1993 were reviewed for reduction in intraocular pressure (IOP), visual acuities, surgical success rates, and need for repeat surgeries at last follow-up (FU). At the last FU, IOP<21 mm Hg without any topical antiglaucoma medication (TAM) was complete success and with 1-2 TAMs was qualified success. IOP reduction ≥30% without any TAM was modified complete success and with 1-2 TAMs was modified qualified success. IOP>21 mm Hg, IOP reduction <30%, or use of >2 TAM at last FU, or need for additional surgery was considered as failure.ResultsTwo hundred thirty eyes of 121 patients had been followed up for 21.5-38 years (mean 28.87±2.77 years). Eyes that were pthisical (3), had immeasurable IOP (2), or IOP<6 mm Hg (3) were excluded from the success analysis. At last FU, mean IOP reduction was 22.71±11.28 mm Hg and TAM score was 1.71 (0-4). Complete success was achieved in 14 (6.3%), modified complete success in 14 (6.3%), qualified success in 148 (66.7%), and modified qualified success in 140 (63.1%). Success probability was 95% till 25 years and 92, 90, 85, 79 and 68% at 26, 27, 28, 29, and 30 years, respectively. Severe visual impairment or functional blindness was found in only 13 (10.7%) patients.ConclusionCTT shows long-term success in PCG patients. All patients must be monitored for IOP control to avoid need for repeat surgeries.
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Glaucoma/cirugía , Trabeculectomía/métodos , Preescolar , Femenino , Estudios de Seguimiento , Glaucoma/congénito , Glaucoma/fisiopatología , Humanos , Lactante , Recién Nacido , Presión Intraocular/fisiología , Estimación de Kaplan-Meier , Masculino , Análisis de Regresión , Reoperación , Estudios Retrospectivos , Agudeza Visual/fisiologíaRESUMEN
BACKGROUND: A novel fusion gene of echinoderm microtubule-associated protein-like 4 (EML4) and anaplastic lymphoma kinase (ALK) has been identified in a subset of non-small-cell lung cancers (NSCLCs). Patients with the ALK-EML4 fusion gene demonstrate unique clinicopathological and physiological characteristics. Here we present an analysis of clinicopathological profile of patients of metastatic adenocarcinoma harboring the ALK-EML4 fusion gene and their response to targeted therapy in the form of crizotinib. METHODS: A retrospective analysis of advanced ALK positive NSCLC, who presented at this tertiary care hospital of armed forces from September 2014 to December 2016 was conducted. The primary goal was to evaluate demographic and clinicopathological profile of ALK positive advanced NSCLC. Detection of ALK fusion was done by IHC on formalin fixed paraffin embedded cell blocks. Out of 20 ALK positive patients, ten patients received upfront cytotoxic chemotherapy, and rest received crizotinib. Patients progressing on cytotoxic chemotherapy received crizotinib as subsequent therapy. RESULTS: Out of 270 patients of NSCLC, fifteen(7.4%) tested positive for ALK-EML4 fusion. Rate of positivity was higher in females(13.7%) than in males (5%). The correlation of the ALK-EML4 fusion gene and clinicopathological characteristics of NSCLC patients demonstrated a significant difference in smoking status, histological types, stage, & metastatic pattern. Median PFS with first line cytotoxic chemotherapy was 5.9 months. Median PFS with upfront crizotinib was not reached, but was significantly superior than cytotoxic chemotherapy. CONCLUSION: Our analysis indicated that ALK-EML4 positive NSCLC comprised a unique subgroup of adenocarcinomas with distinct clinicopathological characteristics. Incidence of ALK positivity was found to be higher in females and never smokers. These patients have distinct pathological and radiological characteristics. Crizotinib, whether used upfront or as subsequent therapy was found to be superior in PFS (not yet reached at the time of writing this article), and maintaining quality of life as compared to cytotoxic chemotherapy.
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Adenocarcinoma/tratamiento farmacológico , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Proteínas de Ciclo Celular/genética , Neoplasias Pulmonares/tratamiento farmacológico , Proteínas Asociadas a Microtúbulos/genética , Proteínas Tirosina Quinasas Receptoras/genética , Serina Endopeptidasas/genética , Adenocarcinoma/genética , Adenocarcinoma/patología , Adenocarcinoma del Pulmón , Adulto , Anciano , Quinasa de Linfoma Anaplásico , Carcinoma de Pulmón de Células no Pequeñas/genética , Carcinoma de Pulmón de Células no Pequeñas/patología , Crizotinib , Supervivencia sin Enfermedad , Femenino , Humanos , Neoplasias Pulmonares/genética , Neoplasias Pulmonares/patología , Masculino , Persona de Mediana Edad , Proteínas de Fusión Oncogénica/genética , Inhibidores de Proteínas Quinasas/administración & dosificación , Pirazoles/administración & dosificación , Piridinas/administración & dosificación , Calidad de Vida , Estudios RetrospectivosRESUMEN
Background: Following a decade of provision of free antiretroviral therapy (ART) in India, a nationwide assessment of ART services was conducted to review quality of care at ART centers. This paper presents the methods and defines replicable model of undertaking large scale assessments. Methods: During the period January 2014-March 2015, 357 ART centers were reviewed under four domains, namely, operations, technical, monitoring and evaluation (M&E), and logistics. Mixed methods, comprising of desk review and on-site facility assessment; random sample of records, interviews with both health-care staff and people living with HIV (PLHIV) were used. Grading for each of the domain was done on a scale of 5, with 1 (Very poor) being the lowest and 5 (Excellent) as highest. Results: 1720 health-care staff and 1762 beneficiaries were interviewed; 34 600 patient cards were reviewed. Of the 357 centers assessed 60, 169 and 128 scored Excellent, Average and Poor, respectively, in operations domain; 147, 176, 34 in Technical domain; 215, 115, 27 in M&E domain; 263, 71, 23 centers in logistics domain scored Excellent, Average and Poor, respectively. About 95% (1698/1785) of PLHIV were satisfied with the care provided at ART centers. Conclusion: The methodology used for the assessment of ART centers in India yielded insights on the different domains that impact implementation and quality of service delivery. The design of this exercise may inform other researchers and managers planning similar large-scale assessments.
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Antirretrovirales/uso terapéutico , Infecciones por VIH/tratamiento farmacológico , Instituciones de Salud , Calidad de la Atención de Salud/estadística & datos numéricos , Humanos , IndiaRESUMEN
INTRODUCTION: Around 80% of colorectal carcinoma are associated with chromosomal instability (CIN) while rest of 20 % are euploid, possessing defect in mis match repair system (MMR) quintessential for surveillance and correction of errors in introduced into microsatellites. MATERIALS AND METHODS: We analyse all stage II CRC for MSI who presented at MDTC at Army hospital (research and refrral) new delhi during last 2 years (Jan 14 to Dec 2015). RESULTS: We found that 22.2% patients out of 45 patients with stageII CRC being MSI-. high. We also noticed all suchcases were associated with loss of expression of PMS2 & MLH1, that was in contrast other studies where loss of MLH1 and MSH@, MSH6 were seen more commonly. CONCLUSION: MSI occurs in a significant proportion of colorectal cancers in young (<50 years old) patients. Young age at colorectal cancer diagnosis, proximal tumor location, family history of colorectal cancer were independent predictors of MSI status in our patients. In a proportion of these young patients with MSI tumors, loss of expression of proteins by 2 MMR genes PMS2 and hMLH1 has been identified.
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Neoplasias Colorrectales/genética , Neoplasias Colorrectales/patología , Inestabilidad de Microsatélites , Endonucleasa PMS2 de Reparación del Emparejamiento Incorrecto/biosíntesis , Homólogo 1 de la Proteína MutL/biosíntesis , Adulto , Anciano , Reparación de la Incompatibilidad de ADN/genética , Femenino , Humanos , India , Masculino , Persona de Mediana Edad , Endonucleasa PMS2 de Reparación del Emparejamiento Incorrecto/análisis , Homólogo 1 de la Proteína MutL/análisis , Estadificación de NeoplasiasRESUMEN
With the rapid scale-up in use of antiretroviral therapy (ART), monitoring the quality of care and factors that may lead to emergence of HIV drug resistance (HIVDR) is an important focus point for programme managers. The National AIDS Control Organisation of India embarked on strengthening the ART programme for continuous quality improvement (CQI), using defined quality-of-care indicators (QCIs), including World Health Organization (WHO) early-warning indicators (EWIs) for HIVDR. In this feasibility study, done during July 2014, an integrated QCI and EWI tool developed by WHO India was pilot tested across 18 purposively selected ART centres. At seven ART centres, the EWI 1 target of >90% on-time pill pick-up was achieved for adult patients, while among the paediatric age group (<15 years old) it was not achieved by any centre. EWI 2 (retention of patients in ART care at 12 months after initiation) showed that two centres had retention of both adult and paediatric patients of >85% at 12 months of ART, while 11 centres had retention between 75% and 85%. EWI 3 (pharmacy stock-out) for adult and paediatric patients showed that 11 ART centres reported a minimum of one stock-out for the first-line ART drugs in the reporting period, while EWI 4 targets (pharmacy dispensing practices) were achieved by all the centres, for both adults and children. Average retention in care at 6, 12 and 24 months after ART initiation was 82%, 77% and 71%, respectively. This feasibility study showed that EWI analyses were much simpler to conduct if information was sought only for patients receiving ART, for whom the quality of record-keeping is better and more consistent. The activity has highlighted the need for improved quality of record-keeping at the facilities and implementation of specific interventions to ensure better patient follow-up. After modifications, use of the tool will be phased in across all the ART centres in India.
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BACKGROUND: Aim of this study was to investigate the prognostic significance of CD3+ TILs in infiltrating ductal carcinoma (IDC) of the breast. MATERIALS AND METHODS: Immuno-histochemistry was done with CD3 antibodies in tissue sections of 127 breast cancer patients, and CD3+ intra-tumoral and stromal TILs were counted in relation to clinico-pathological variables. RESULTS: Intra-tumoral and stromal CD3+ TILs were significantly associated with positive lymph node status (P = 0.006, P = 0.043, respectively) without significant association with age, menopausal status, family history, and hormonal status. The higher CD3 intra-tumoral and stromal counts both showed significant association with good prognosis (P = 0.039, P = 0.044, respectively). The intra-tumoral count was higher than stromal count and was independently associated with disease-free survival in stage I and II cancer (P = 0.021). CONCLUSIONS: CD3+ TILs may serve as independent marker of good prognosis in IDC breast. The findings of this study need further validation on a larger sample size.
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Neoplasias de la Mama/inmunología , Neoplasias de la Mama/mortalidad , Carcinoma Ductal de Mama/inmunología , Carcinoma Ductal de Mama/mortalidad , Linfocitos Infiltrantes de Tumor/inmunología , Adulto , Anciano , Anciano de 80 o más Años , Neoplasias de la Mama/patología , Complejo CD3/inmunología , Carcinoma Ductal de Mama/patología , Supervivencia sin Enfermedad , Femenino , Humanos , Inmunohistoquímica , Estimación de Kaplan-Meier , Persona de Mediana Edad , Pronóstico , Modelos de Riesgos ProporcionalesRESUMEN
Traumatic abdominal wall injuries have been described in literature for over 100 years. These injuries involve abdominal wall from skin to the level of fascia. These are often associated with underlying visceral injuries. The diagnosis requires a high index of suspicion and is based on clinical examination and radiologic investigations. Management ranges from conservative management to complex abdominal wall reconstruction. In the following review we describe the incidence, clinical features, diagnosis, management and possible interventions for prevention of these injuries.
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Traumatismos Abdominales , Pared Abdominal , Traumatismos Abdominales/diagnóstico , Traumatismos Abdominales/terapia , Humanos , Puntaje de Gravedad del Traumatismo , Heridas no Penetrantes/diagnóstico , Heridas no Penetrantes/terapiaRESUMEN
Infection by one of the 4 distinct serotypes of dengue virus (DENV) threatens >40% of the world's population, with no efficacious vaccine or antiviral agent currently available. DENV replication through the virus-encoded nonstructural protein (NS) 5 protein occurs in the infected cell cytoplasm, but NS5 from DENV2 has thus far been shown to localize strongly in the nucleus throughout infection. Here we use specific antibodies cross-reactive with NS5 from DENV1-4 to demonstrate nuclear localization of NS5 from all DENV serotypes for the first time in both infected as well as transfected cells, although to differing extents. The small-molecule inhibitor Ivermectin was inhibitory towards both DENV 1 and 2 NS5 interaction with its nuclear transporter importin α/ß in vitro, and protected against infection from DENV1-4. Ivermectin thus has potential in the clinical setting as a dengue antiviral.
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Antivirales/farmacología , Núcleo Celular/virología , Virus del Dengue/efectos de los fármacos , Dengue/virología , Ivermectina/farmacología , Proteínas no Estructurales Virales/metabolismo , Citoplasma/virología , Dengue/tratamiento farmacológico , Virus del Dengue/clasificación , Virus del Dengue/genética , Virus del Dengue/metabolismo , Humanos , Transporte de Proteínas/efectos de los fármacos , Proteínas no Estructurales Virales/genéticaRESUMEN
This article describes the development of a high-throughput process development (HTPD) platform for developing chromatography steps. An assessment of the platform as a tool for establishing the "characterization space" for an ion exchange chromatography step has been performed by using design of experiments. Case studies involving use of a biotech therapeutic, granulocyte colony-stimulating factor have been used to demonstrate the performance of the platform. We discuss the various challenges that arise when working at such small volumes along with the solutions that we propose to alleviate these challenges to make the HTPD data suitable for empirical modeling. Further, we have also validated the scalability of this platform by comparing the results from the HTPD platform (2 and 6 µL resin volumes) against those obtained at the traditional laboratory scale (resin volume, 0.5 mL). We find that after integration of the proposed correction factors, the HTPD platform is capable of performing the process optimization studies at 170-fold higher productivity. The platform is capable of providing semi-quantitative assessment of the effects of the various input parameters under consideration. We think that platform such as the one presented is an excellent tool for examining the "characterization space" and reducing the extensive experimentation at the traditional lab scale that is otherwise required for establishing the "design space." Thus, this platform will specifically aid in successful implementation of quality by design in biotech process development. This is especially significant in view of the constraints with respect to time and resources that the biopharma industry faces today.
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Biotecnología/métodos , Cromatografía por Intercambio Iónico/métodos , Factor Estimulante de Colonias de Granulocitos/aislamiento & purificación , Biotecnología/instrumentación , Cromatografía por Intercambio Iónico/instrumentación , Factor Estimulante de Colonias de Granulocitos/química , Humanos , Control de Calidad , Proyectos de InvestigaciónRESUMEN
A decoupled input-output linearizing controller (DIOLC) was designed as an alternative advanced control strategy for controlling bioprocesses. Simulation studies of its implementation were carried out to control ethanol and biomass production in Saccharomyces cerevisiae and its performance was compared to that of a proportional-integral-derivative (PID) controller with parameters tuned according to a linear schedule. The overall performance of the DIOLC was better in the test experiments requiring the controllers to respond accurately to simultaneous changes in the trajectories of the substrate and dissolved oxygen concentration. It also exhibited better performance in perturbation experiments of the most significant parameters q (S,max), q (O2,max), and k ( s ), determined through a statistical design of experiments involving 730 simulations. DIOLC exhibited a superior ability of constraining the process when implemented in extreme metabolic regimes of high oxygen demand for maximizing biomass concentration and low oxygen demand for maximizing ethanol concentration.
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Biomasa , Etanol/metabolismo , Saccharomyces cerevisiae/metabolismo , FermentaciónRESUMEN
BACKGROUND: Vaikranta has very important place in Rasa sastra and is placed under Maharasa and Upratna group. It has been mentioned that vaikranta can be used in the place of diamond, which is a very precious stone and whose use is beyond the limit of the common man. Vaikranta possesses pharmacological and therapeutic properties similar to diamond, but still very few researchers have worked on it. AIMS AND OBJECTIVES: The main aim of the present study is to analyze vaikranta bhasma by employing various organoleptic methods mentioned in Ayurvedic science along with analysis as per tools available today. SETTINGS AND DESIGN: In the present study, vaikranta bhasma was prepared according to method mentioned in Rasa Ratna Samuccaya. Final product is prepared according to classical parameters described in Ayurvedic science. MATERIALS AND METHODS: Ayurvedic scholars have described various parameters for the qualitative evaluation of vaikranta bhasma, but all those are subjective in nature and cannot be evaluated numerically for reproducibility of the result. With this in mind, in the present study, tests as per Ayurvedic science and analytical parameters such as scanning electron microscopy, energy dispersive X-ray analysis, Fourier transform infrared spectrometry and inductively coupled plasma spectrometry were adopted to analyze the final product. RESULTS AND CONCLUSIONS: Data suggests that vaikranta bhasma is a multi-mineral compound, which contains iron and silica as major constituents and others are present as trace elements. The data obtained in this study suggest that quality specifications for vaikranta bhasma can be developed using tests described in Ayurvedic science along with analytical tools available today.
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The concept of "design space" plays an integral part in implementation of quality by design for pharmaceutical products. ICH Q8 defines design space as "the multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality. Working within the design space is not considered as a change. Movement out of the design space is considered to be a change and would normally initiate a regulatory post-approval change process. Design space is proposed by the applicant and is subject to regulatory assessment and approval." Computational fluid dynamics (CFD) is increasingly being used as a tool for modeling of hydrodynamics and mass transfer. In this study, a laboratory-scale aerated bioreactor is modeled using CFD. Eulerian-Eulerian multiphase model is used along with dispersed k-ε turbulent model. Population balance model is incorporated to account for bubble breakage and coalescence. Multiple reference frame model is used for the rotating region. We demonstrate the usefulness of CFD modeling for evaluating the effects of typical process parameters like impeller speed, gas flow rate, and liquid height on the mass transfer coefficient (k(L)a). Design of experiments is utilized to establish a design space for the above mentioned parameters for a given permissible range of k(L)a.
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Reactores Biológicos , Hidrodinámica , Modelos Teóricos , Simulación por ComputadorRESUMEN
Membrane-based separations are the most ubiquitous unit operations in biotech processes. There are several key reasons for this. First, they can be used with a large variety of applications including clarification, concentration, buffer exchange, purification, and sterilization. Second, they are available in a variety of formats, such as depth filtration, ultrafiltration, diafiltration, nanofiltration, reverse osmosis, and microfiltration. Third, they are simple to operate and are generally robust toward normal variations in feed material and operating parameters. Fourth, membrane-based separations typically require lower capital cost when compared to other processing options. As a result of these advantages, a typical biotech process has anywhere from 10 to 20 membrane-based separation steps. In this article we review the major developments that have occurred on this topic with a focus on developments in the last 5 years.
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Biotecnología/instrumentación , Filtración/instrumentación , Membranas Artificiales , Biotecnología/métodos , Diseño de Equipo , Filtración/métodos , ÓsmosisRESUMEN
In order to ascertain possible correlation between alterations in trace elemental profile and the progression or regression of two most common potentially malignant disorders affecting oral cavity, namely oral submucous fibrosis and leukoplakia, blood from 60 patients from each group of patients as well from 30 healthy individuals was analyzed for elemental profiling employing EDXRF technique. Out of the 16 detected elements (K, Si, Ca, V, Cr, Ni, Mn, Fe, Cu, Zn, Se, Br, Rb, Sr, Co, and Pb), Mn, Fe, Zn, Br, and Co showed remarkable alteration in their profile in both leukoplakia and oral submucous fibrosis patients with respect to the normal healthy individuals. While Zn, Br, and Fe reflected similar changes--showing gross depletion in both the diseased groups, Mn and Co depicted inverse pattern of alterations in their concentrations in the two types of precancerous disorders when compared to the control subjects.
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Leucoplasia/sangre , Fibrosis de la Submucosa Bucal/metabolismo , Oligoelementos/sangre , Oligoelementos/metabolismo , Adulto , Progresión de la Enfermedad , Humanos , India , Masculino , Persona de Mediana Edad , Neoplasias de la Boca/diagnóstico , Neoplasias de la Boca/metabolismo , Lesiones Precancerosas/diagnóstico , Lesiones Precancerosas/metabolismo , Espectrometría por Rayos X , Oligoelementos/análisis , Adulto JovenRESUMEN
Mannose-binding lectin (MBL) is a circulating pattern-recognition molecule involved in the innate immune system that mediates phagocytosis and activates complement by binding to carbohydrate motifs. MBL-2 allelic variants are associated with deficiencies in innate immunity and have been found to be correlated with human immunodeficiency virus (HIV) infection. The present study investigated the role of MBL-2 exon-1 gene polymorphism (A, B, C and D) in 180 HIV-1 seropositive (HSP) stratified on the basis of disease severity (stage I, II, III), 50 HIV-1 exposed seronegative (HES) and 305 HIV-1 seronegative (HSN) individuals as a possible factor in the susceptibility to HIV-1 infection and the influence on disease progression among North Indian individuals. In our population, gene frequencies of MBL-2 variants were 15%, 5% and 2% for B, C and D alleles, respectively. The frequency of A/O heterozygous genotype was higher (42.00%), mainly because of A/D in HES group compared with HSP (35.00%) and HSN (36.72%) group. Homozygous B/B genotype was more frequent in HSP (6.11%) group than in HSN (1.31%; P = 0.005; odds ratio (OR) = 4.898) and was significantly associated with fourfold risk of acquiring HIV-1 infection. Our findings indicate that homozygosity for the codon 54-allele associated with low MBL production in the exon-1 of the MBL-2 gene is associated with increased susceptibility to HIV-1 infection in the studied population.
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Predisposición Genética a la Enfermedad , Infecciones por VIH/genética , VIH-1 , Lectina de Unión a Manosa/genética , Polimorfismo Genético , Frecuencia de los Genes , Genotipo , Infecciones por VIH/inmunología , Humanos , India , Población Blanca/genéticaRESUMEN
Computational fluid dynamics (CFD) is well established as a tool of choice for solving problems that involve one or more of the following phenomena: flow of fluids, heat transfer,mass transfer, and chemical reaction. Unit operations that are commonly utilized in biotechnology processes are often complex and as such would greatly benefit from application of CFD. The thirst for deeper process and product understanding that has arisen out of initiatives such as quality by design provides further impetus toward usefulness of CFD for problems that may otherwise require extensive experimentation. Not surprisingly, there has been increasing interest in applying CFD toward a variety of applications in biotechnology processing in the last decade. In this article, we will review applications in the major unit operations involved with processing of biotechnology products. These include fermentation,centrifugation, chromatography, ultrafiltration, microfiltration, and freeze drying. We feel that the future applications of CFD in biotechnology processing will focus on establishing CFD as a tool of choice for providing process understanding that can be then used to guide more efficient and effective experimentation. This article puts special emphasis on the work done in the last 10 years.