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Assessment of Safety and Effectiveness of Glaritus<sup>®</sup>(Wockhardt’s Insulin Glargine) in a Prospective, Multi-centric Post Marketing Observational Study in Nepalese Having Type 2 Diabetes Mellitus

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Open Journal of Endocrine and Metabolic Diseases 2019年第2期9卷 21-33页

作者： Ansumali joshi Bhojraj Adhikari Basant Tamrakar Gaurav Puppalwar Agam Shah Rishi Jain Kathmandu Diabetes & Thyroid centre Pvt. Ltd. Kathmandu Nepal Pushpanjali Hospital Bharatpur Nepal Fishtail Hospital & Research centre Pvt. Ltd. Pokhara Nepal Medical Affairs Wockhardt Ltd. Mumbai India

Background: Nepal is one of the fastest urbanizing countries in South Asia and is facing the consequences of urban lifestyle leading to obesity and metabolic syndrome. Type 2 diabetes mellitus (T2DM) is currently a high-burden disease in Nepal with a prevalence of 8.4%. Of these 8% - 18% patients are on insulin and 42% patients were reported to have uncontrolled diabetes in the past year. This suggests a need for better therapy options in terms of efficacy and safety. The current study was designed to investigate the effects of Insulin glargine-based therapy in Nepalese with T2DM who could not achieve adequate glycemic control with oral and non-glargine-insulin therapy. Methods: This is a prospective, multi-centric, single arm and post marketing observational study to assess the safety and effectiveness of Glaritus®(Wockhardt’s Insulin Glargine) in 52 T2DM patients from 3 (three) different study sites in Nepal (Bharatpur, Kathmandu and Pokhra) from September 2015 to December 2016. The primary objective of the study was to evaluate the safety of Glaritus®, mainly in terms of hypoglycemia, renal function tests and liver function tests. The secondary objectives were to evaluate the effectiveness of Glaritus®in terms of percentage of patients achieving HbA1c goal of less than 7%, mean changes in HbA1c & fasting plasma glucose (FPG) levels from baseline till the end of study. Results: 3.85% of subjects experienced hypoglycemia during first 3 months of therapy whereas 1.92% had similar experience in next 3 months of therapy. The mean HbA1c values reduced from 9.16% to 7.15% at the end of study. 21.05% of the enrolled subjects achieved the goal of HbA1c ®was well tolerated by the study patients. conclusion: In patients with type 2 diabetes mellitus inadequately.c.ntrolled on oral hypoglycemic agents and/or insulin, initiation with Glaritus®significantly improved glycemic control with good tolerability and acceptability. This analysis in T2DM Nepalese pa

关键词： Insulin Glargine Type 2 Diabetes Nepalese Patients Hypoglycemia Basal Insulin HbA1c Fasting Plasma Glucose Post Marketing Surveillance

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Prevalence of Anti-cardiolipin and Anti-β2 Glycoprotein Antibodies in Indian Systemic Lupus Erythematosus Patients

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International Journal of clinical Medicine 2011年第3期2卷 339-345页

作者： Vandana Pradhan Anjali Rajadhyaksha Pranaya joshi Manisha Patwardhan Shruti Dighe Kanjaksha Ghosh 不详

Anti-phospholipid antibodies (APA) like anti-cardiolipin antibodies (AcA) and anti-β2glycoprotien (anti-β2GP) are important cause of venous and arterial thrombosis and other occlusive vascular diseases. The prevalence of these antibodies in SLE patients at the time of diagnosis is not known in Indian SLE patients. This study was conducted to evaluate the prevalence of AcA and anti-β2GP autoantibodies in SLE patients and to correlate them with disease activity and immune parameters such as c3, c4 and cRP levels. where 85 SLE patients referred from Rheumatology Department, KEM hospital, Mumbai were studied. SLE disease activity was evaluated by SLE Disease Activity Index (SLEDAI) score at the time of evaluation. All patients studied were in an active stage of disease of which 37.6% patients had renal disorders, which were categorized as Lupus Nephritis (LN) and 62.3% patients did not show any renal manifestations (non-LN). AcA and anti-β2GP autoantibodies, to IgG and IgM subclasses were tested by ELISA. c3, c4 and cRP levels were detected by nephelometer. It was observed that 12.9% patients were IgG-AcA and IgM-AcA positive and AcA positivity was noted more among LN group Anti-β2GP autoantibody positivity was 27.1% for IgG and 31.8% for IgM., IgG-anti-β2GP antibodies were slightly higher in non-LN patients, whereas a higher incidence of IgM-anti-β2GP antibodies were detected in LN patients. Hence detection both AcA and anti-β2GP antibodies along with associated immune parameters were helpful to evaluate their possible association with disease severity in SLE patients. A long term follow up of patients having AcA and anti-β2GP antibodies without thrombotic event is also needed to detect their possible thrombotic event in future along with their clinical presentation.

关键词： Systemic Lupus Erythematosus (SLE) Anti-cardiolipin Antibodies (AcA) Anti-β2glycoprotein Antibodies (anti-β2GP) Lupus Nephritis (LN) SLE without Nephritis (Non-LN)

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印度农业推广改革现状：战略重点和政策选择

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世界农业 2017年第7期 174-177页

作者： Suresh c Babu P K joshi claire J.Glendenning Kwadwo Asenso-Okyere Rasheed Sulaiman V 蔡彦虹(翻译) 国际粮食政策研究所美国华盛顿国际粮食政策研究所印度新德里国际粮食政策研究所埃塞俄比亚亚的斯亚贝巴创新和科技政策研究中心印度海得拉巴安得拉邦农业部科技发展中心北京100122

独立以来,虽然印度农业推广经历了翻天覆地的变化,但是小农农民和其他弱势群体仍未参与到公共推广体系之中。许多组织性能问题妨碍了公共推广体系的效率和效果。这些问题包括人员的匮乏,较低的合作伙伴关系以及继续自上而下的线性推广... 详细信息

独立以来,虽然印度农业推广经历了翻天覆地的变化,但是小农农民和其他弱势群体仍未参与到公共推广体系之中。许多组织性能问题妨碍了公共推广体系的效率和效果。这些问题包括人员的匮乏,较低的合作伙伴关系以及继续自上而下的线性推广方式。本文回顾了印度农业推广改革的现状,并基于比哈尔、喜马偕尔邦、马哈拉施特拉邦和泰米尔纳德邦等4个邦的实地调研,分析并进一步细化了当前的改革进程,在此基础上,提出了促进农业公共推广体系有序发展和运行的优先政策和战略选择。

关键词：印度农业推广战略重点政策选择推广改革

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Glycemic Indices of Multiple Oral Nutritional Supplements: A Randomized cross-Over Study in Indian Adults

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Food and Nutrition Sciences 2023年第10期14卷 941-962页

作者： Deepti Khanna Jaladhi Bhatt Jayanti Gupta Simran Sethi Parth joshi Manoj Pareek Divya Agrawal Hindustan Unilever Limited R&D Department Gurugram India Independent Biostatistician & Researcher Mumbai India cliantha Research Ahmedabad India

Background: A randomized cross-over study was conducted to assess the glycemic index (GI) of seven Oral Nutritional Supplements (ONSs). These ONSs are designed to support the nutritional requirements of different age-groups, physiological states, or health conditions among Indian adults. Methods: The study had two phases viz., phase1 (n = 18) studied two ONSs: A1 and B1 and phase 2 (n = 20) studied five ONSs: A2, B2, c2, D2 & E2. The subjects were healthy, non-diabetic adults, aged between 20 - 44 years with a mean Body Mass Index of 21.2 ± 1.52 kg/m2 (Phase 1) and 21.0 ± 1.45 kg/m2 (Phase 2). All these ONSs were compared with reference drinks (glucose). The carbohydrates in one serving of each ONS were matched to carbohydrates from 25 grams of glucose following ISO 2010 guidelines. capillary blood was assessed for blood glucose response at baseline, 15, 30, 45, 60, 90 and 120 minutes. GI was calculated as the incremental area under the curve (iAUc) for the test drinks and expressed as a percentage of the average iAUc from glucose. Results: Phase 1 indicated that the high fiber diabetes-specific nutrition supplement A1 with higher protein (23% energy), higher fat (25% energy) and reduced carbohydrates (40% energy) had a significantly (p = 0.002) lower GI [34 (±6)] as compared to B1 [63 (±7)] (protein 19%, fat 7% and carbohydrates 60% energy) even with similar amount (22%) and type of fiber. Phase 2 reported that all test products [A2 (32 ± 5), B2 (37 ± 4), c2 (31 ± 5), D2 (31 ± 5) and E2 (55 ± 4)] had a low GI. As compared to phase 1, ONSs in phase 2 had lower fiber content (1.6% - 4.6% energy). conclusion: The glycemic index of oral nutrition supplements is influenced not only by their fiber content, but also by the overall macronutrient composition including protein (≥17% energy), fat (≥10% - 27% energy) and carbohydrates (40% - 57.5% energy).

关键词： Glycemic Index Oral Nutritional Supplements Incremental Area under the curve Diabetes

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护士和医生行常规诊断性上消化道内镜检查的准确度比较:一项随机、对照试验

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世界核心医学期刊文摘（胃肠病学分册） 2006年第11期2卷 11-12页

作者： Meaden c. joshi M. Hollis S. 程妍 Royal Lancaster Infirmary Ashton Road Lancaster LA1 4RP United Kingdom Dr.

Background and Study Aims: Rising demand for general diagnostic upper gastrointestinal endoscopy in the UK is outgrowing the capacity of doctors to provide this service within a reasonable time. One solution is to train nurses to carry out the procedure, but it is not known whether nurses can perform general diagnostic upper gastrointestinal endoscopy as competently as doctors. Patients and Methods: A randomized controlled non-inferiority trial compared the adequacy and the accuracy of diagnostic upper gastrointestinal endoscopies performed by five medical and two nurse endoscopists. The videotaped procedures were assessed by a consultant gastroenterologist blinded to the identity of the endoscopist. Results: 641 patients were randomly allocated (before attendance and consent procedure) to endoscopy.c.rried out either by a doctor or a nurse. Of these, 412 were enrolled and 367 (89%) were included in the analysis. An adequate view was obtained throughout in 53.4%(93/177) of doctor endoscopies and 91.6%(174/190) of nurse endoscopies (difference 38.2%, 95%cI 30.5%, 47.2%). In adequately viewed areas, the mean agreement between doctor and expert was 81.0%and between nurse and expert it was 78.3%(difference between the means 2.7%, 95%cL -1.0%, 6.4%). There was no difference between doctors and nurses in the rate of biopsy performance (90.4%and 91.1%, respectively, P=0.862). Nurses took longer (8.1 minutes vs. 4.6 minutes, P cy of view correlated positively with endoscopy duration (Pc accuracy.c.rrelated inversely with duration (Pcy or accuracy.c.rrelated significantly with use of intravenous sedation. conclusions: In endoscopies performed by nurses, the proportion of adequate examinations was much higher than that found for doctors. In areas with an adequate view, there is no significant difference in accuracy between nurses and doctors. Nurses can pro

关键词：消化道内镜检查对照试验常规诊断上消化道内镜胃肠病学持续时间显著性差异随机分配负相关

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Stability-indicating assay method for determination of actarit,its process related impurities and degradation products:Insight into stability profile and degradation pathways

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Journal of Pharmaceutical Analysis 2014年第6期4卷 374-383页

作者： A.Abiramasundari Rahul P.joshi Hitesh B.Jalani Jayesh A.Sharma Dhaivat H.Pandya Amit N.Pandya Vasudevan Sudarsanam Kamala K.Vasu Department of Medicinal chemistry B.V. Pat el PERD Centre Ahmedcibad Gujarat 380054 India

The stability of the drug actarit was studied under different stress conditions like hydrolysis（acid,alkaline and neutral）,oxidation,photolysis and thermal degradation as recommended hy International conference on Harmonization（IcH） *** was found to be unstable in acidic,basic and photolytic conditions and produced a common degradation product while oxidative stress condition produced three additional degradation *** was impassive to neutral hydrolysis,dry thermal and accelerated stability *** products were identified,isolated and characterized by different spectroscopic *** and the degradation products were synthesized by a new route using green *** chromatographic separation of the drug and its impurities was achieved in a phenomenex luna c18 column employing a step gradient elution by high performance liquid chromatography.c.upled to photodiode array and mass spectrometry detectors（HPLc-PDAMS）.A specilic and sensitive stability-indicating assay method for the simultaneous determination of the drug *** process related impurities and degradation products was developed and validated.

关键词： Actarit Forced degradation Stability-indicating assay method

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Paraoxonase activity in type 2 diabetes mellitus patients with and without complications

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海南医学院学报 2010年第8期16卷 992-994页

作者： Renuka Suvarna Soumya S Rao chitralekha joshi Vivekananda Kedage Manjunatha S Muttigi Mungli Prakash Department of Biochemistry Kasturba Medical CollegeManipal

Objective:Type 2 diabetes mellitus(DM)is a disease of metabolic *** study was undertaken to know the relation between fasting lipid profile and paraoxonase 1(PON1)activity in type 2 diabetic patients with and without ***:The study group consisted of a total of 155 subjects which included non-diabetic healthy.c.ntrol subjects(n = 50)and diabetic patients with complications(group I,n = 66)and without complications(group II,n=39).PON1 activity was measured all the subjects based on spectrophotometric methods,and fasting lipid profile and fasting plasma glucose(FPG)levels were determined in clinical chemistry analyzer Hitachi ***:FPG(Pcantly increased,and HDL-c(Pcantly decreased in group I patients when compared to normal *** group II patients FPG(Pc(Pcantly increased and HDL-c(Pcantly decreased when compared to normal *** Pearson correlation,HDL-c was positively.c.rrelated with PON1 in group I patients(r=0.317,Pconclusion:type 2 DM patients with complications have significantly decreased HDL-c levels and PON1 activity possibly indicating its decreased biochemical role in these patients.

关键词：糖尿病代谢疾病血糖活性

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PRL Near Infrared camera NIcMOS-3

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天文研究与技术 1999年第S1期 57-62页

作者： U. c. joshi, S. Ganesh, K. S. Baliyan, N. M. Vadher, A. B. Shah (Physical Research Laboratory Ahmedabad 380 009, India)

Physical Research Laboratory (PRL), Ahmedabad operates an Astrophysical Observatory equipped with an Infrared camera NIcMOS. 3 (PRLNIc). In this paper characteristics of this camera like dark current, read noise, gain and linearity are discussed. The dark current is found to be quite different in four quadrant varying from 15e /s in one quadrant to 82e /sec in other quadrant. Non linearity is found at both the end of the signal: at low signal level (below 1000ADU) and on the higher end (above 12000ADU) the response becomes non linear. The gain in four quadrant is nearly same.

关键词： PRL Near Infrared camera NIcMOS-3 In

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Effect of Annealing on Structural, Morphological, Electrical and Optical Studies of Nickel Oxide Thin Films

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Journal of Surface Engineered Materials and Advanced Technology 2011年第2期1卷 35-41页

作者： Vikas Patil Patil Shailesh Pawar Manik chougule Prasad Godse Ratnakar Sakhare Shashwati Sen Pradeep joshi Materials Research Laboratory School of Physical Sciences Solapur University Solapur-413255 M.S. India

Sol gel spin coating method has been successfully employed for the deposition of nanocrystalline nickel oxide (NiO) thin films. The films were annealed at 400°c - 700°c for 1 h in an air and changes in the structural, morphological, electrical and optical properties were studied. The structural properties of nickel oxide films were studied by means of X-ray diffraction (XRD) and scanning electron microscopy (SEM). XRD analysis shows that all the films are crystallized in the cubic phase and present a random orientation. Surface morphology of the nickel oxide film consists of nanocrystalline grains with uniform coverage of the substrate surface with randomly oriented morphology. The electrical conductivity showed the semiconducting nature with room temperature electrical conductivity increased from 10-4 to 10-2(Ωcm)-1 after annealing. The decrease in the band gap energy from 3.86 to 3.47 eV was observed after annealing NiO films from 400oc - 700oc. These mean that the optical quality of NiO films is improved by annealing.

关键词： Nickel Oxide Sol Gel Method Structural Properties Optoelectronic Properties

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Mnk kinase pathway: cellular functions and biological outcomes

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World Journal of Biological chemistry 2014年第3期5卷 321-333页

作者： Sonali joshi Leonidas c Platanias Department of Molecular and cellular Oncology University of Texas MD Anderson Cancer Center Robert H Lurie comprehensive cancer center and Division of Hematology-Oncology Northwestern University Medical School Jesse Brown VA Medical Center

The mitogen-activated protein kinase(MAPK) interacting protein kinases 1 and 2(Mnk1 and Mnk2) play important roles in controlling signals involved in mRNA translation. In addition to the MAPKs(p38 or Erk), multiple studies suggest that the Mnk kinases can be regulated by other known kinases such as Pak2 and/or other unidentified kinases by phosphorylation of residues distinct from the sites phosphorylated by the MAPKs. Several studies have established multiple Mnk protein targets, including PSF, heterogenous nuclear ribonucleoprotein A1, Sprouty 2 and have lead to the identification of distinct biological functions and substrate specificity for the Mnk kinases. In this review we discuss the pathways regulating the Mnk kinases, their known substrates as well as the functional consequences of engagement of pathways controlled by Mnk kinases. These kinases play an important role in mRNA translation via their regulation of eukaryotic initiation factor 4E(eIF4E) and their functions have important implications in tumor biology as well as the regulation of drug resistance to anti-oncogenic therapies. Other studies have identified a role for the Mnk kinases in cap-independent mRNA translation, suggesting that the Mnk kinases can exert important functional effects independently of the phosphorylation of eIF4 E. The role of Mnk kinases in inflammation and inflammationinduced malignancies is also discussed.

关键词： Mnk kinases mRNA translation Mitogenactivated protein kinase signaling eIF4E phosphorylation Drug resistance cytokine production cytokine signaling

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