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International editors often lament that medical research in our country not only lacks quality, but we are even headed in the wrong direction. The research is often “ me too”, and largely irrelevant - it is not done in areas in which it is 'needed' in India (according to distribution, determinants and outcomes of diseases) like infectious diseases and mother and child health.

MGIMS is an exception. Right from its inception, MGIMS has accorded the highest importance to medical research. Several disorders - tuberculosis, filariasis, and leprosy, for example - are prevalent in this area as are snake bites, strokes and heart attacks. MGIMS faculty have focused on these areas and have shown that they have the ability to ask right questions and use appropriate study designs to find out answers to the problems they encounter every day.

The large number of funded projects awarded to the various departments is ample testimony to the potential of the researchers. MGIMS has consistently received funding from the Indian Council of Medical Research, Department of Science and Technology, Department of Biotechnology, University Grants Commission, WHO, UNICEF, PATH (USA), Fogarty AIDS Research and Training Program, USA, Canadian Institute of Health Research, Population Health Research Institute, Canada, National Institutes of Health (NIH), National Heart Lung Blood Institute (NHLBI) and several such organizations.

Being located in Sevagram has never been a hurdle in acquiring either funds or facilities as the enthusiasm and the dedication of the faculty surpasses all other deterrents. With the support from extramural funding agencies, some of the pre and para clinical departments have developed good research laboratories with sophisticated instruments and infrastructure including CPCSEA registered animal house facilitating research in the areas of drug development, applied immunology and cellular and molecular biology. Similarly, researchers from Sevagram have also focused on community based research. Each year, the large numbers of national and international peer reviewed publications from this Institute provide evidence of excellence in research.

Worldwide, in medical schools, the phrase publish or perish (i.e. publish your research or risk losing your job) keeps on reminding young doctors and scientists that the ladder of academic success is best climbed by stepping on the rungs of publications. Despite its cynicism the phrase makes an important point- if science is to grow, research and publications are important. Researchers at MGIMS- young and old- are conscious of this adage and strive hard to generate high quality research, year after year.

In an editorial (Nat Med J India 1998; 11[1]:1-2), Dr Samiran Nundy had pointed out that less than10% of the projects funded by the Indian Council of Medical Research end as publications in indexed journals and in 1991 only 41 out of the 88 Indian medical colleges which received research grants produced any papers at all. This means, Nandi added, that most of the money doled out for research by our premier research body is being wasted. Not so in Sevagram.

Beginning 1971, the MGIMS faculty has published a total of 3160 research papers. These papers have found their way in such prestigious journals as JAMA, Int J Tuberc Lung Dis., PLos One, Trans R Soc Trop Med Hyg, Eur Respir J, PLoS Med, Diagn Cytopathol, Acta Cytol, Int J Fertil and AIDS Care. Several papers have been cited more than 200 times and have been accorded high rank on citation index- a measure of the quality of paper.


Anatomy

Genetic study of deletions and mutations in sperm mitochondrial 15.0 DNA in idiopathic asthenozoospermia, oligoasthenoteratozoospermia of infertile men

Funding Agency: Indian Council of Medical Research, New Delhi
Duration of Study: July 2014- July 2016
Principal Investigator: Dr Asoke K Pal, Professor of Cytogenetics
Co-Investigator: Dr AR Chaudhari, Professor of Physiology
Ethics Approval: Obtained from Institutional Ethics Committee, MGIMS ( MGIMS/IEC/ ANAT/01/2014 dated 25.01.2014)

Married couples run a one in ten risk of being infertile and often are unable to cope with emotional, family and social problems infertility is associated with. Although infertility is a multi-factorial disorder, genetic etiologies play an important role. Semen analysis can be used as an index of human fertility through sperm concentration, motility, morphology, and quality. So, we designed this study to find out the relationship between sperm mitochondrial DNA deletions or mutations in astheno-zoospermia and oligo-astheno-terato-zoospermia and infertility.

The department of Physiology at MGIMS runs an semen analysis unit. We are recruiting 200 astheno-zoospermic and oligo-astheno-terato-zoospermic individuals and 50 fertile men aged between 22 and 45 years of age.

We extract the sperm DNA from the semen samples collected from infertile and fertile men. We amplify and sequence mtDNA genes and find out sperm mitochondrial DNA deletions or mutations by long range polymerase chain reaction (PCR), primer shift PCR method, PCR RFLP method, and semi quantitative PCR method.

Beginning July 2014, we have procured the instrument and chemicals and have standardized the techniques. A third of the target sample has been enrolled and after enrolling 200 individuals, we shall statistically analyse the results.

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Genetic study of deletion and mutation in sperm mitochondrial DNA in idiopathic astheno- zoospermia and oligoasthenoteratozoospermia

Funding Agency: Indian Council of Medical Research, New Delhi
Duration of Study:
Principal Investigator: Dr Asoke K Pal, Professor of Cytogenetics
Amount: 16 Lakhs
Ethics Approval:

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Evaluation of immunomodulatory effect and therapeutical potential of filarial proteins in experimental ulcerative colitis – in collaboration with Biochemistry Dept. MGIMS.

Funding Agency: DST
Duration of Study:
Principal Investigator: Dr. MVR Reddy, Dr MR Shende, Dr AM Tarnekar
Amount: 38.78 Lakhs
Ethics Approval:

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Biochemistry

Maintenance of Repository for Filarial parasites and reagents

Funding agency: Department of Biotechnology (BBT), Ministry of S&T, Govt of India
Duration of Study: 2012-17
Principal Investigator: Dr MVR Reddy, Director-Prof. & Head, Department of Biochemistry
Co-Investigator: Dr K Goswami, Professor in Biochemistry
Ethics Approval: Obtained from Institutional Ethics Committee ( MGIMS/IEC/39/2012 dated 26 March 2013) & Institutional Animal Ethics Committee, MGIMS (MGIMS/IAEC /10/2014 dated 24 July 2014)

Lymphatic filariasis (LF) caused by vector borne nematode parasites mainly Wuchereria bancrofti and Brugia malayi is one of the major public health problems in India. The Global Programme to Eliminate Lymphatic Filariasis (GPELF) has been launched by providing anti-filarial drugs to millions of people through mass drug administration (MDA) strategy, with about 70% of the endemic countries having implemented the program effectively. However several gaps still exist in understanding the "epidemiology of elimination" of LF. There is need for a multi-pronged research approach including conduction of epidemiological surveys, effective surveillance, development and validation of effective alternative diagnostic tools, development of novel and alternative drugs and vaccine as adjunct measures to strengthen the filariasis elimination task.

We have designed this study to maintain a national level bio-tech facility serving as a resource cum training centre and to ensure the availability of filarial animal models, filarial parasites and sera, cDNA libraries and drugs and vaccines screening systems needed for filariasis research at this institute and for other filarial research groups in India. The research activities planned under this programme include conduction of epidemiological surveys in selected endemic areas, development of diagnostic test and its validation as a tool to monitor the effect of MDA, identification and screening of novel anti-filarial drugs, studies on the mechanism of action involved, experimental animal studies on filarial vaccine development, and assessment of the immunomodulatory effect and therapeutic potential of filarial proteins in autoimmune disorders. Another component of this programme is regular conduction of national level training courses on molecular and immunological methods applied to research in infectious diseases using filariasis as model.

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Evaluation of immunomodulatory effect and therapeutical potential of filarial proteins in experimental ulcerative colitis

Funding agency: Department of Science and Technology, Ministry of S&T, GOI
Duration of study: 2013-16
Principal Investigator: Dr MVR Reddy, Director-Prof. & Head, Department of Biochemistry
Co-Investigators: Dr K Goswami, Professor in Biochemistry; Dr MR Shende, Prof. & Head, Department of Anatomy; Dr. A Tarnekar, Professor in Anatomy
Ethics approval: Obtained from Institutional Animal Ethical Committee, MGIMS (MGIMS/ IAEC/ 01/2012 dated 12 November 2012)

There is no medication that can cure ulcerative colitis (UC), a disease characterized by chronic inflammation of the colonic mucosa. In this context, helminth therapy is being explored as safe and effective option, which possibly induces strong Th2 response and enhancement of Treg cell function in the host causing a net suppressive effect in intestinal inflammation. Though protective response in ulcerative colitis has been demonstrated followed by treatment with different helminths, the disadvantages of using whole worm for therapy are explicit, suggesting further studies on the identification of specific molecules to serve the purpose. Filarial parasite derived immunomodulators, which are known to be instrumental in suppressing host’s immune response to favour their long time survival are ideal candidates to be explored for their therapeutic effect in ulcerative colitis.

To meet this important end, this study is proposed to explore filarial proteins cystatin, abundant larval transcript (ALT-2) and a RAL family protein (WbL2) for their immunomodulatory effect and therapeutic potential in experimental colitis induced by dextran sodium sulfate (DSS) in Balb/c mice. This study is expected to pave the way in development of an effective medication which can ameliorate ulcerative colitis.

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DST- Fund for Improvement in S & T Infrastructure

Funding agency: Department of Science and Technology, Ministry of S&T, GOI
Duration: 2011-15
Principle Investigator: Dr. MVR Reddy, Director-Prof. & Head, Department of Biochemistry
Ethics approval: Not needed as this is research infrastructure strengthening project

Funding from FIST program aims to provide facilities like building of basic infrastructure, create environment to promote research and development in new & emerging areas to utilize the talent in new generation. DST has identified the Department of Biochemistry for this support to improve research and training infrastructural facilities. Fund received under this grant is being utilized to purchase advanced instruments such as Real Time PCR System, 2D Gel Electrophoresis, Gel Documentation System, -80 Freezer and CO2 Incubator and for setting up computer systems to create networking facility for faculty and PG students and for procuring books to update departmental library.

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Assessment of serum adiponectin levels and its association with Lipid profile parameters in patients of Acute Myocardial Infarction

Funding Agency : University Grant Commission
Duration of Study : 2013 - 2015
Principal Investigator : Dr Kumud N. Harley, Associate professor, Dept. of Biochemistry
Co-Investigator : Dr. Satish Kumar, Professor, Dept. of Biochemistry
Ethics Approval: Submitted for Institutional Ethics Committee approval

Cardiovascular disease is the leading cause of death in the world. Every year, nearly 1.5 million people in the US are affected or debilitated by myocardial infarction (MI). A similar trend of mortality and morbidity exists in many developing nations, which account for 80% of CVD-related mortality worldwide. One important mediator of coronary artery disease (CAD) progression is adiponectin. Adiponectin (ADPN) is a protein hormone made of 224 amino acids produced by the adipose tissue. It is considered to have anti-inflammatory and anti-atherogenic effects and have pronounced effects on the metabolism of both carbohydrates and lipids in liver and muscle promoting uptake and oxidation of fatty acids by myocytes. Moreover, association of dyslipidemia in CAD development is extensively studied and is one of most important risk factor in cardiovascular events.

In this study, we plan to analyze serum adiponectin levels in 120 patients of acute myocardial infarction admitted to the ICCU, MGIMS aged between 40-70 years and diagnosed by ECG findings and raised CK-MB. Age and sex matched 60 healthy subjects will also be included as controls in this study.

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Evaluation of Diagnostic Potential of Adenosine Deaminase and its isoenzymes activity in pulmonary, extrapulmonary tuberculosis & HIV-TB coinfection

Funding agency : UGC
Duration of Study : 2013 - 2015
Principal Investigator :Dr Kanchan M. Mohod, Assistant Professor of Biochemistry
Co-Investigators :Dr Aakash Bang, Associate Professor of Paediatrics
Ethics Approval: Submitted for Institutional Ethics Committee approval

Tuberculosis is common infection in India. Accurate diagnosis of the infection is necessary for the prompt initiation and monitoring of treatment and for preventing further spread of the disease. Adenosine deaminase (ADA) has recently been proposed to be a useful surrogate marker for tuberculosis and thus has become a valuable tool in diagnosis of TB. ADA is an enzyme catalyzing deamination reaction from adenosine to inosine. The increase in ADA activity in biological fluids from tuberculosis and HIV patients might be due to interaction of mycobacterium & HIV with host factors. Hence this study is undertaken to evaluate the role of ADA in the diagnosis of TB and to assess the existence of any predictive value of serum concentration of ADA and its isoenzymes to the outcome of disease.

We are recruiting 300 individuals, belonging to different groups of TB viz; pulmonary TB, extra pulmonary TB, and HIV-TB coinfection. Selection of the cases would done by using pretested and predesigned Proforma with the patient’s clinical history which includes present, past, treatment history and various investigations including Radiology, AFB smear, Culture, Histopathology & Hematology. Age and sex matched 50 healthy subjects will also be included as controls in this study. The samples will be analyzed for the activity of ADA and its isoenzymes.

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Anti-tubercular bioassays of plants and marine algal extracts

Funding Agency: CSIR - CSMCRI, Bhavnagar
Duration of study: 2013-2015
Principal Investigators: Dr. B.C. Harinath, Director, JBTDRC , Dr. Pranita Waghmare
Asst. Prof. Dept of Biochemistry , MGIMS and Dr. A.K. Sidhhnata, CSIR - CSMCRI, Bhavnagar
Co- Investigators: Dr. Arup Ghosh, Dr. Soumya Haldar, Dr. Shruti Chatterji, Dr. M. R. Rathod, Mr. Supravat
Ethics Approval: Submitted for Institutional Ethics Committee approval

Tuberculosis is a major problem till date in spite of revolution in the field of diagnostics and treatment. Newly emerged threats of drug resistant and multi drug resistant tuberculosis have dampened the dream of tubercular eradication globally. It is the need of time to discover new drug targets with highly potential drugs against the TB bacilli, with minimal or no side effects with maximum benefit. Salicornia Brachiata, (US patented) algal extracts are shown to have anti-tubercular activity.

Under this project we have tested 120 different extracts of the same by rapid screening of extracts for anti-tubercular potential followed by further in vitro axenic culture and MTT assay to confirm their therapeutic activity. We have also started the phytochemical analysis of extracts showing most potent anti-tubercular activity.

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Clinical usefulness of exploring immunological host response in tubercular infection

Funding Agency: MUHS, LTRG, NASHIK
Duration of study: 2014-2016
Principal investigator: Dr. Pranita Waghmare, Assistant Professor in Dept. of Biochemistry, MGIMS
Co-Investigator: Dr. Satish Kumar, Professor in Biochemistry and Dr. Anshu, Professor in Pathology
Ethics approval: Approval obtained from IEC, MGIMS

Tuberculosis is a disease in which the outcome of the disease depends on bacillary load, regular treatment with anti-tubercular drug and timely follow up with precise prognostic test. Once bacilli get enter the body, various cytokines and chemokines are produced as a result of body’s immune response to Mtb bacillary infection. It includes both pro-inflammatory (TH1) and anti-inflammatory responses. Pro-inflammatory response markers are interleukin-12, interferon gamma, tumor necrosis factor alpha, IL -1, IL-2, etc. To counterbalance these cytokine Th2 responses are developed which includes IL-10, IL-4, IL-5, IL-6, IL-13, etc. Under this project, the above cytokines will be analyzed in a total of 75 newly diagnosed, relapsed and drug resistant tuberculosis cases and 25 healthy controls to check their utility to know infection status, severity of disease and response to treatment.

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Community Medicine

Surveillance of neonatal infection – An ICMR task force study

Funded Agency: ICMR
Duration of Study: 2011-15
Principal Investigator:Garg BS, Maliye CH, Mendiratta DK, Dikshit S, Deotale V
Ethics Approval:

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Concurrent Monitoring for Quality Improvement in ICDS,

Funded Agency: Govt of India (NIPCCD)
Duration of Study:
Principal Investigator: Garg BS, Subodh S Gupta, Maliye CH, Raut AV, Solanki RS, Ambilkar A, Kalantri A
Ethics Approval:

Total Grant: 1.74 Lakhs

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Phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of live attenuated Bovine-Human Rotavirus Reassortant Pentavalent Vaccine (BRV-PV) against severe Rotavirus gastroenteritis in healthy Indian infants

Funded Agency: PATH/SIIL
Duration of Study: 2013- 2016
Principal Investigator: Garg BS, Gupta SS, Maliye CH, Jain M, Bahulekar PV, Raut AV, Solanki RS
Total Grant: 814 Lakhs

Ethics Approval: Obtained from Institutional Ethics Committee, MGIMS (MGIMS/IEC/ COMMED/16/2013 dated 8.5.2013)

A promising new rota virus vaccine candidate called ‘BRV-PV’ is being tested in a Phase 3 efficacy study in India to determine if its administration to infants can reduce the incidence of severe diarrhea due to rota virus.

Each year, approximately 600,000 children die from severe, dehydrating diarrhea worldwide. Rota virus is the most common cause of severe infantile diarrhea—accounting for approximately one-third of these child deaths. In India alone, an estimated 11.37 million episodes of rota virus gastroenteritis occur each year, with 78,000 cases resulting in death. The development of new rota virus vaccines have the potential to make an enormous impact on public health by reducing rota virus-related illness and deaths worldwide, particularly in low-resource countries.

World Health Organization (WHO) strongly recommends use of rota virus vaccine in countries where diarrhea accounts for more than 10 percent of deaths among children less than five years of age, as is the case in India. However, they are not yet widely available or affordable for most low-income communities. A key strategy for creating and maintaining a long-term, financially sustainable supply of rota virus vaccines is entry of more vaccine products - particularly those based in emerging countries - in the market.

MGIMS is one of the six sites in the phase 3 trial sponsored by Serum Institute of India Ltd. (SIIL) and PATH. The purpose of the trial is to find out whether vaccination with BRV-PV can reduce the incidence of severe diarrhea due to rota virus among children in India. MGIMS will enroll 1000 study subjects out of total 7,500 proposed enrollment for all study sites. By January 2015, Sevagram site had completed 80% of enrollments allocated to the site under this study.

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Audit of information regarding malnutrition, under-five & maternal deaths in Melghat tribal area of Maharashtra

Funded Agency: UNICEF, Mumbai
Duration of Study:
Principal Investigator: Garg BS, Gupta SS, Raut AV, Bahulekar PV, Bharambe MS, Ambilkar A, Kalantri A
Ethics Approval:

Total Grant: 9.05 Lakhs

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Centre for Advanced Research for Community Based Maternal,Newborn and Child Health (ICMR)

A. Community-owned Management Information System: an Alternative Model of Community Monitoring for Health

Funded Agency:
Duration of Study:
Principal Investigator: Garg BS, Gupta SS, Maliye CH, Bharambe MS, Bahulekar PV, Raut AV, Solanki RS, Pawar R
Ethics Approval:

B. Central India Rural Pregnancy Cohort

Funded Agency:
Duration of Study:
Principal Investigator: Garg BS, PV Shivkumar, Gupta SS, Maliye CH, Bharambe MS, Bahulekar PV, Raut AV, Solanki RS, Pawar R
Ethics Approval:

C. Improving health care seeking for morbidities among newborns and young infants in rural Wardha

Funded Agency:
Duration of Study:
Principal Investigator: Garg BS, Gupta SS, Maliye CH, Jain M, Bharambe MS, Bahulekar PV, Raut AV, Solanki RS, Pawar R
Ethics Approval:

Surveillance of infection in neonates (0-28 days) : A Multi-centric Task Force Study

Funding Agency: ICMR
Principal Investigator: Dr.BS. Garg, Dr. CH Malliye , Dikshit S, Deotale V
Ethics Approval: Institutional Ethics Committee, MGIMS (MGIMS/IEC/16/2010 dated 11/05/2010)

In India approx. 65% deliveries takes place at home and 30-50% neonatal deaths are due to sepsis. There are no community based studies of neonatal sepsis and limited data are available from first level health facilities and home delivered babies. Prospective microbiological surveillance is important to guide empiric therapy, identify new agents of importance to neonates. Moreover organisms associated with neonatal infection are different in different geographic area. In this background it is proposed to carry out a surveillance study to identify organisms causing sepsis and their antimicrobial susceptibility. The study is aimed at identifying organism causing sepsis in neonates in the community and their profile. In addition, the study also aimed to validate agreement between suspected sepsis, culture positive sepsis and positive sepsis screen and shall use this knowledge for capacity building at district hospital.

This is a prospective study for understanding prevalence, etiology/ causative agents and antimicrobial susceptibility patterns of organism causing sepsis in young infants(<60 days).

Because a district hospital is a referral unit for the community and primary health centers, the cases enrolled in the facilities are likely to represent the community. All newborns either delivered in the facilities or referred from periphery for admission and treatment were evaluated for symptoms and signs of probable sepsis using established criteria for diagnosis of sepsis. On enrollment detailed history was obtained on duration of symptoms, details of delivery, period of gestation, antenatal care received by the mother, problems during pregnancy, and treatment history before admission. A detailed clinical examination was done and data were collected in pre-designed structured proforma. All blood samples were collected from each newborn enrolled, for microbiological evaluation as well as for sepsis screen (absolute neutrophill count, total WBC count, Immature neutrophil ratio, C Reactive Protein) following standard methodology.

Pediatrician / medical officers of district hospital managed the neonates according to the standard protocol. All newborns were followed during hospital stay and their status at discharge was recorded. Attempts are being made to record outcome on day 28 / 1 month by the project staff.

A total of 7422 babies have been screened for sepsis and 213 babies were suspected for sepsis. Blood culture was sent to the Microbiology laboratory at Kasturba Hospital, Sevagram.

Perception of non-surgical permanent contraception

Principal Investigator: Dr BS Garg & Dr PV Shivkumar
Ethics Approval: Obtained from Institutional Ethics Committee, MGIMS (MGIMS/IEC/ COMMED/41/2013 dated 28/09/2013)

Female permanent contraception, also known as sterilization, is a highly effective contraceptive method that is widely used in both high and low resource settings. Yet it is the only method of contraception for women that requires surgery. The development of a non-surgical method of permanent contraception (NSPC) will offer women another contraceptive choice, improve safety by avoiding surgery, and change the delivery method for sterilization. Gynecologists and women’s health advocates overwhelmingly support the development of new forms of contraception, yet there is little understanding of how women users and male partners would respond to a non-surgical form of permanent sterilization.

The purpose of this qualitative and comparative study is to understand how socio-cultural norms, the historical and medical context of sterilization, and gender-based power dynamics impact attitudes towards permanent contraception. This study will examine the perspectives of the following five groups: 1) married/partnered women; 2) male husbands/partners; 3) mothers-in-law; 4) women’s health providers (OB/GYNs); and 5) women’s health advocates. Through interviews, focus group discussions, and a survey, this comparative study will examine attitudes towards sterilization and surgery, responses to new technology, and contraceptive decision-making in the U.S. (Portland, Oregon) and India (Sevagram, Maharashtra and Delhi). Qualitative data will be analyzed using a grounded theory approach, where emerging themes are analyzed during the data collection period. This study will generate important social science data on issues surrounding permanent contraception that will be useful as new methods of contraception are developed.

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JBTDRC & Bioinformatics Centre

Sub-Distributed Information Centre under BTISnet Programme

Funding Agency: Department of Biotechnology, New Delhi
Duration : From March 1999 till 12th 5 year plan, 2017. Financial support for this Centre is likely to be extended for next 5 year plan
Principal Investigator: Dr. B. C. Harinath, Director, JBTDRC
Co - Investigator: Dr. Satish Kumar, Professor, Biochemistry

Bioinformatics Centre at Mahatma Gandhi Institute of Medical Sciences was established in March 1999 with support from Department of Biotechnology, as part of National Bioinformatics Network. The Centre has thrust on Medical / Health Informatics since inception and is actively involved in infectious disease diagnostic research, Yoga & Naturopathy and training. In addition to providing academic bibliography search service and in-house training programs, the Centre organizes National level Workshops / Seminars / Symposia also and 17 such events organized so far have been well appreciated. SEVAMED a Quarterly Update on Infectious Disease Research and Lifestyle Diseases published by this Centre enters 16th year of its publication and has been well received by the medical teachers and scientists throughout India. With recent thrust on non communicable diseases by Government of India, lifestyle diseases have been added. ‘SEVAMED’ is available online with complete bibliography and link to abstracts for easy retrieval with interactive web pages. The Centre also publishes Arogyadham e-newsletter alerting and educating the people with tips for healthy living. BIC has developed databases on Mycobacterial proteases (Mycoprotease-DB, http://www.bicjbtdrc-mgims.in/MycoProtease-DB/), Mycobacterium tuberculosis Proteome comparison (MTB-PCDB, http://www.bicjbtdrc-mgims.in/MTB-PCDB/) and Human Papillomavirus Proteome (hpvPDB, http://www.bicjbtdrc-mgims.in/hpvPDB/) in collaboration with ACTREC, Mumbai. Centre has developed customized database software for patients’ information and launched a web portal MGIMS-JBTDRC Arogya on Holistic Healthcare and Research in Lifestyle diseases and MGIMS-JBTDRC Health Update for current awareness on emerging infectious diseases. The Centre also conducts curriculum based training and research program in Biotechnology & Bioinformatics and provides research platform to the aspirants in these disciplines under DBT’s studentship and traineeship programs. This Centre has launched online Health Informatics Course in July 2010 with quarterly enrolment arrangement and 34 students from UK, Uganda, Mauritius, Ethiopia, Saudi Arabia and from different states of India have registered so far.

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Microbiology

Confirmation of diseases of public health importance under the IDSP (Integrated Disease surveillance Project) State surveillance net work (Referral Lab)

Funding Agency: Govt. of Maharashtra
Duration: 2010 onwards
Principal Investigator: Deotale V, Maraskolhe D
Ethics Approval:

The Integrated Disease Surveillance Project (IDSP) aims to improve the disease surveillance in the country and support the strengthening of the public health laboratories at different levels to enable confirmation of agents causing outbreaks to enable appropriate local response. The two authorities, namely State surveillance Unit (SSU), Maharashtra and our medical college have decided to cooperate and collaborate with each other in order to provide access, to the selected districts of the state, to a quality assured referral lab for confirmation of disease outbreaks of epidemic prone diseases under the state referral lab network plan using an output based arrangement.

We are providing services as state referral laboratory under IDSP for the following district as per agreed terms in the MoU - Wradha, Chandrapur, Yavatmal, Gadchiroli.

Services provided by our college are – · Microbiological testing for outbreak investigation in the linked district. · Provide support to the Rapid Response Teams of the linked districts (Such as providing transport media etc). · Participate in training / mentoring of lab technicians of attached district laboratories. · Strengthen internal quality control following Standard Operating Procedure. · Report the lab results of outbreak related samples to the DSO and SSO expeditiously maintaining confidentiality.

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Sentinel Surveillance Hospitals Vector Borne Disease

Funding Agency: Govt. of Maharashtra
Duration: 2011 onwards
Principal Investigator: Thamke D, Deotale V, Attal R
Ethics Approval:

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Surveillance of selected zoonotic diseases in Central India

Funding Agency: ICMR
Duration: 2015 onwards
Principal Investigator: Narang R, Deshmukh P, Deotale V, Maraskolhe D, Jain M, Narang U, Raut A, Kalore DR, Kurkure NV
Ethics Approval:

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Multi-centric cohort study of recurrence of tuberculosis among newly diagnosed sputum positive pulmonary tuberculosis patients treated under RNTCP: Version 6.0: 18 Jan 2014

Funding Agency: Central TB Division
Principal Investigator: Dr P Narang, Dr Rahul Narang, DTO Wardha and CTO Nagpur
Ethics Approval: Institutional Ethics Committee, (MGIMS/IEC/ 34/2010 dated 03.08.2010)

In the RNTCP, newly diagnosed smear – positive tuberculosis patients are treated with a 6-month thrice-weekly regimen, consisting of an initial intensive phase for two months followed by a continuation phases for four months, given under direct observation. The country reports around 87% ‘cure’ among smear-positive patients treated with this regimen. A TB recurrence rate of 10-12% has been reported from localized studies. There is little information on the proportion and predictors of patients who develop recurrent TB among those patients who had a successful outcome at the end of treatment and on proportion of recurrence TB due to re-infection or to endogenous reactivation. This knowledge would have a bearing on the efficacy of the regimen. This study is aimed (1) to estimate the recurrence of TB among newly diagnosed sputum positive pulmonary TB patients who have been successfully treated under RNTCP and (2) to distinguish between relapse and re-infection among those who have recurrence of TB and (3) identify risk factors for unfavourable treatment outcomes (treatment failed, lost to treatment follow-up and died) and recurrence.

This is a prospective, multi-centric cohort study being conducted at six centers -MGIMS is one such center. The other centers are National Institute for Research in Tuberculosis (NIRT), Chennai, National Tuberculosis Institute (NTI), Bangalore, National Institute of Tuberculosis and Respiratory Diseases (NITRD), New Delhi, Regional Medical Research Centre for Tribals (RMRCT), Jabalpur, Thiruvananthapuram Medical College, Thiruvananthapuram (TMCT). New smear positive PTB patients treated under RNTCP are enrolled. They are being followed up till they complete treatment, and those with successful treatment outcome will be followed up for a period of 12 months after completing treatment. These patients are subjected to the following procedures: Structured interview, sputum examination for TB smear, culture, DST and genotyping and blood test for diabetes mellitus and HIV infection.

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Multi centric hospital based surveillance of acute encephalitis syndrome of viral etiology among children in selected districts of Maharashtra and Andhra Pradesh

Funding agency: ICMR
Principal Investiagtor: Dr. Rahul Narang, Dr Manish Jain, Dr Vijayshri Deotale, Dr Nitian Gangane, Dr Ruchita Attal and Investigators from JNMC Sawangi (Meghe) & VNGMC Yavatmal
Ethics Approval: Obtained from Institutional Ethics Committee, (MGIMS/IEC/APRIL/36/2011 dated 20/04/2011)

Surveillance is an integral part for any disease control programme, especially for acute encephalitis syndromes (AES) like Japanese encephalitis (JE) and Chandipura viral encephalitis, which have epidemic potential with high case fatality. An intensified surveillance for JE was felt necessary and for the first time in India, a national level “Acute Encephalitis Syndrome (with Special Reference to Japanese Encephalitis) surveillance guidelines” were developed in November 2006 by Directorate of National Vector Borne Diseases Control Programme. Chandipura virus (CHPV) is a vesiculovirus from the Rhabdoviridae family. Chandipura viral encephalitis is now considered as one of the important cause of AES in central India. By providing laboratory facility in the affected area through collaborations with local institutes, cold chain would be maintained and thus it will maintain the quality of clinical specimen till laboratory testing along with quick reporting of results. This will also help physicians in guiding case management.

MGIMS, along with GMC Nagpur and Kakatiya Medical College (KMC), Warangal, Telangana is working with the National Institute of Virology (NIV) Pune. Viral diagnostic testing for JE and Chandipura virus would be provided free of cost by the site laboratory established in Microbiology Department of MGIMS, as well as two other medical colleges. The project activities are being undertaken by surveillance and investigations of AES cases with the help of hospital pediatricians and health services officials/staff in the area. Clinical specimens from AES cases are being accepted by the site laboratories for provision of viral diagnostic testing for JE IgM and Chandipura virus RT PCR. Since there is one more site laboratory in Vidharba, clinical samples from Nagpur, Bhandara, Gondia and Gadchiroli district are sent to GMC Nagpur and clinical samples from Wardha, Chandrapur, Yavatmal and Amravati to MGIMS.

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Medicine

The HOPE-3 (Heart Outcomes Prevention Evaluation) study

Funding Agency: The Population Health Research Institute at McMaster University, Canada
Study Design: Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
Intervention: Rosuvastatin, Candesartan/Hydrochlorothiazide, Factorial vs. placebo
Duration of Study: 7 years (May 2007- October 2015)
Number of Patients: 12,705 Patient Populations: Cardiovascular Disease, Stroke, Asymptomatic individuals at moderate risk for CV events
Principal Investigator: Dr SP Kalantri, Director- Professor of Medicine
Ethics Approval: Obtained from Institutional Ethics Committee, MGIMS (MGIMS/IEC/ MS/154/2008 dated 07/05/2008)

Of the approximately 16 million people who die from heart disease and stroke annually, about half have no warning symptoms or previous incidence of cardiovascular disease. It is well known that lowering blood pressure and reducing cholesterol levels are two highly effective strategies to prevent heart disease and stroke, but the benefits of these interventions have only been studied in people who have traditionally-defined high blood pressure and cholesterol levels. However, most heart attacks and strokes occur in people who are considered to have normal blood pressure and cholesterol levels.

HOPE-3 is a large, simple trial evaluating the effects of lipid modification and blood pressure lowering and their combination in a wide range of middle aged people, who are at average risk for vascular events. HOPE-3 tested the concept of whether or not we can slow down, or better yet, reverse the process in most people before they develop cardiovascular disease. The trial randomized 12,705 women 60 years or older and men 55 years or older from 21 countries without known heart disease or prior stroke and without a clear indication or contraindication to any of the study medications. The department of Medicine at MGIMS was one of the centers that recruited eligible and consenting individuals from villages around Sevagram for the trial. Participants were randomly assigned to a fixed combination of candesartan (16 mg per day) and hydrochlorothiazide (12.5 mg per day) or placebo and to rosuvastatin (10 mg per day) or placebo. The rates of heart attacks, strokes, deaths and other cardiovascular events were compared between subjects receiving the active drugs and those on placebo. The median follow-up was 5.6 years.

The primary results of the Heart Outcomes Prevention Evaluation (HOPE)–3 trial were reported in three articles in the New England Journal of Medicine. (N Engl J Med 2016; 374:2021-2031; N Engl J Med 2016; 374:2032-2043 and N Engl J Med 2016; 374:2009-2020).

The study showed that rosuvastatin at a dose of 10 mg per day is more effective in preventing cardiovascular events than is candesartan at a dose of 16 mg per day plus hydrochlorothiazide at a dose of 12.5 mg per day in a relatively low-risk population. The study results provide support for the use of statins as a safe and effective intervention to prevent cardiovascular events in such patients.

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Obstetrics and Gynecology

Epidemiological determinants of hypertensive disorders of pergnancy in women in Central India

Funding Agency: ICMR
Duration: 2015 onwards
Principal Investigator: Jain S
Ethics Approval:

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Hypertensive disorders of pregnancy, prevention, early detection, prevention of severity and mortality through cost effective sustainable ways in two tertiary centres in two states of India

Funding Agency: Shrimant Shankaradevi University of Health Sciences, Guwahati, Assam
Duration: 2015 onwards
Principal Investigator: Chhabra S
Ethics Approval:

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Health seeking practices amongst women of low resource rural terrain

Funding Agency: Indo- Canadian – Shastri Institute through University of British Colombia
Duration: 2014 onwards
Principal Investigator: Chhabra S
Ethics Approval:

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Ensuring the complete and accurate plotting of modified WHO partograph in all laboring women (100%) assessing the reduction in existing maternal and fetal complication rates at tertiary care centre.

Funding Agency: Jiv Daya Foundation, Dallas, Texas, USA
Duration of Study: 2013 onwards
Principal Investigator: Shivkumar PV
Ethics Approval: Obtained from Institutional Ethics Committee, MGIMS (MGIMS/IEC/ OBGY/40/2013; dated 31/08/2103)

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Community based study of magnitude of abortions, spontaneous and induced, immediate and late complications and care sought by rural women of two districts of Maharashtra

Duration of Study: 2013 onwards
Principal Investigator: Dr. S. Chhabra
Study Design: Cross-sectional epidemiological study using a pretested tool with some questions closed ended (yes or no) and others open ended
Sample Size: 2500 to 3000 women.
Ethics Approval: Obtained from Institutional Ethics Committee, MGIMS (MGIMS/IEC/ OBGY/42/2013; dated 28/09/2103)

Abortions, spontaneous or induced, are most common adverse outcome of pregnancy. Yet, prevalence and underlying causes are subject to continuing investigation. The reported prevalence of spontaneous abortions is around 10 to 15% of clinically recognized pregnancies and WHO reports that globally approximately 42 million pregnancies are voluntarily terminated each year, 22 million within the legal system and 20 million by unskilled providers or in unhygienic conditions, or both. No wonder in 2008, worldwide 47 000 women died due to unsafe abortions, representing 13% of pregnancy- related deaths. Abortion, whether spontaneous or induced, may be associated with complications that constitute global public health challenge, more so in developing countries because of problem of quality of post-abortion care, women’s willingness to turn to medical services, and readiness of health system to promptly deal with complications.

This study intends to measure the burden and etiology of spontaneous and induced abortions. The study shall also collect data on sex selective abortions, lack of knowledge or use of contraception and the need for induced abortions, post-abortion care in rural tribal women from tribal region with difficult access, lack of infrastructure and scarce health care in Central India.

Study Subjects and Methodology: Every 4th household in villages with women between 15 and 44 years with history of spontaneous or induced abortions or both in last five years will be randomly interviewed. Information regarding women seeking abortion services from medical college, district hospital, sub district hospital, PHC, Sub center and private hospital from both districts will also be collected. Focus group discussions regarding perceptions and common beliefs about abortion with no age bar for participation will also be carried out.

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Preventing parent to child transmission (PPTCT) through early identification, care and support of pregnant women for improving maternal health outcomes in two high HIV prevalent districts of India.

Principal Investigator: Shivkumar PV
Duration of Study: 2013 onwards
Ethics Approval: Obtained from Institutional Ethics Committee, MGIMS (MGIMS/IEC/OBGY/99/2013; dated 14/12/2013)

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Pathology

“HPV”Ahead: Role of human papillomavirus infection and other co-factors in the etiology of head and neck cancer in Europe and India

Funding Agency: IARC
Duration: 2015-16
Principal Investigator: Gangane NM
Ethics Approval:

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Expression of ER,PR, HER2/neu, Ki67 and p53 markers in endometrial carcinoma: Clinicopathological implications and prognostic value

Funding Agency: MUHS Nashik
Duration: 2015-16
Principal Investigator: Shivkumar VB, Atram M, Gangane N
Ethics Approval:

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Prognostic value of expression of cytokeratin 5/6, EGFR,E-cadherin and p53 in triple negative breast cancers in central India

Funding Agency: MUHS Nashik
Duration: 2015-16
Principal Investigator: Anshu, Waghmare S, Gangane N
Ethics Approval:

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Population Based Cancer Registry of Wardha District

Funding Agency: ICMR
Duration of Study: 2010 onwards
Principal Investigator: Dr Nitin Gangane
Ethics Approval: Obtained from Institutional Ethics Committee, MGIMS

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Prognostic value of expression of cytokeratin 5/6, EGFR, e-cadherin and p53 in triple negative breast cancers in central India

Funding Agency: MUHS
Pricipal Investigator: Dr Anshu, Dr Nitin Gangane
Duration of Study: 2014 onwards

Ethics Approval: Obtained from Institutional Ethics Committee, MGIMS (MGIMS/ IEC/PATH/56/2014; dated 06/09/2014)

Breast cancer is the one of the commonest malignancies in Indian women. It is a complex disease entity with different biological characteristics and clinical behavior. Although the incidence of breast cancer is very high, the overall mortality due to breast cancer has decreased, attributed partly to the early application of various therapies. To reduce mortality from breast cancer further, there is a desire to examine and characterize tumours of poor prognosis, predict their biology, ensure appropriate therapy and improve patient outcome. Many clinical and pathological features have been defined to predict treatment response and outcome in breast cancer. Classically these include: age, tumor size, axillary node involvement, angio-lymphatic invasion, histological grade, estrogen receptor status (ER), progesterone receptor status (PR) and HER-2/neu expression.

Tumours which do not express ER, PR and HER-2/ neu are called triple negative breast cancer (TNBC). Emerging data on the clinical implications of infiltrating duct carcinoma (IDC) with the triple-negative phenotype indicates an aggressive course of the disease and poor clinical outcome. Despite the widespread acknowledgment of the poor clinical outcome, the prognostic value of specific morphological and biological features of these tumors continues to raise a substantial degree of uncertainty and controversy. Availability of additional tumor markers might allow identification of patients at higher risk.

It should be emphasized that triple negative breast cancers currently include a heterogeneous group of tumors, and that the identification of tumor subtypes amenable to targeted treatments still represents a research priority. There is currently no specific targeted treatment for patients with TNBC, due to the lack of data on which to base treatment selection. An easily obtainable immunohistochemical profile is the most suitable approach for the proper identification of triple-negative breast cancers.

The aim of this study is to identify further immunohistochemical markers which will help in identifying tumours with more aggressive behaviour and poor prognosis. The specific objective of this study is to determine expression of epidermal growth factor receptor (EGFR), e-cadherin, CK 5/6, and p53 in triple negative breast cancers (TNBC). As part of this study, the investigators will conduct immunohistochemical studies on archival paraffin sections of breast carcinoma. They will compare expression of these markers in cases of triple negative breast cancer with cases that express hormonal receptors. This will provide further insights into the behavior of this group of cancers and the usefulness of these markers to predict prognosis.

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Physiology

Electrophysiologic studies in lumbo-sacral radiculopathy

Funding Agency: University Grants Commission
Duration of Study: 2013-15
Principal Investigator: Dr. S Pawar
Ethics Approval: Obtained from Institutional Ethics Committee, MGIMS (MGIMS/ IEC/24/2011; dated 23/07/2011)

The present study was carried out in the Clinical Neurophysiology unit of the Department of Physiology, Mahatma Gandhi Institute of Medical Sciences, Sewagram. Specific aim of the study was to study diagnostic efficacy of motor and sensory nerve conduction study, F wave, H reflex and needle electromyography for detection of lumbosacral nerve root compression. In this cross- sectional study, a total of 283 subjects aged 40 years and above who were clinically diagnosed as having lumbosacral radiculopathy were enrolled after taking their informed written consent. The study population was selected from patients attending orthopedic department, with supportive inclusion and exclusion criteria under supervision of consultant orthopedic surgeon. The study population comprised of 168 males and 115 females. All the patients were subjected to electrophysiological evaluation using RMS EMG EP Mark –II machine. Statistical analysis was done by using descriptive and inferential statistics using Kappa Statistics, z-test for difference between two means and diagnostic accuracy.

Analysis of result revealed that Motor nerve conduction studies have reliable sensitivity and specificity in diagnosing lumbosacral radiculopathy. However, sensory nerve conduction studies are having relatively low sensitivity in the diagnosis though they have comparable specificity. Among various F-wave parameters studied, F-minimum and F-maximum latencies are highly sensitive and specific in diagnosing lumbosacral radiculopathy. Therefore, apart from F-minimum latency, the other F-wave parameters like F-maximum latency, F-mean latency, F-M latency and F-velocity should be taken into consideration while diagnosing lumbosacral radiculopathy. Among various H-reflex parameters studied, H- latency is the most sensitive and specific parameter for the diagnosis of lumbosacral radiculopathy. Other H-reflex parameters like M-latency, H-M latency and H-amplitude are less sensitive in diagnosing this disease. Among all the electrophysiological parameters studied, needle EMG has the highest sensitivity and specificity for the diagnosis of lumbosacral radiculopathy. So, it is the most effective electrophysiological method in evaluation of lumbosacral radiculopathy. Therefore, it can be concluded that electrophysiological tests are useful supportive diagnostic tool for lumbosacral radiculopathy. They should be combined with other modalities like clinical examination, radiological imaging etc. before confirming or refuting the diagnosis of lumbosacral radiculopathy.

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The role of late responses in the diagnosis of diabetic polyneuropathy

Funding Agency: MUHS, Nashik
Duration of Study: 2012 onwards
Principal Investigator: Dr. S Pawar
Ethics Approval: Obtained from Institutional Ethics Committee, MGIMS (MGIMS/ IEC/PHY/92/2012; dated 22/09/2012)

Diabetic peripheral neuropathy (DPN) is one of the most common complications of the nervous system affecting people with diabetes mellitus. However, the early stages of DPN are often symptomless, providing patients with no warning of their developing condition. In many cases, the diagnosis of DPN may also require electrophysiological testing. One such test involves measurement of the H-reflex and F-wave (late response study) which have been found to be more frequently altered in patients with recently diagnosed diabetes mellitus. Studies have shown that alterations in the late response study provide an early indication of DPN, since they are apparent before any changes in motor nerve conduction velocity (NCV) occur. Therefore, the present study was proposed to determine the proportion of patients with positive DPN diagnoses made by clinical evaluation or by measurement of the late responses, among adult patients with type- 2 diabetes mellitus referred for neuropathy screening as well as to evaluate the predictive value of the late response study in DPN diagnosis. It is a diagnostic cross-sectional study which will include 100 study subjects diagnosed with type 2 diabetes mellitus aged 20-80 years. The presence of neuropathy in study subjects will be identified using the Michigan Neuropathy Screening Instrument (MNSI). The present study will be performed on RMS EMG EP Mark-II machine in the Clinical Neurophysiology Unit, Department of Physiology, MGIMS. Electrophysiological profile includes Motor nerve conduction, sensory nerve conduction, F wave study and H-reflex study. Beginning in April 2013, we have conducted the study on 30 subjects.

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Prevalence and risk factors of obstructive sleep apnea- hypopnea syndrome in rural Indian population: A community based cross-sectional study

Funding Agency: ICMR, 2015-2017
Duration of Study:
Principal Investigator: Dr. S Pawar
Ethics Approval:
Grant received: Rs 20, 52, 960

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