IR17-MEDI-2-1-N002 Discipline - Home | Jawaharlal … NEHRU MEDICAL COLLEGE, BELAGAVI...

JAWAHARLAL NEHRU

MEDICAL COLLEGE,

BELAGAVI

IR17-MEDI-2-1-N002

MEDICAL

Parameter

2D.FPPP

S.No. Financial YearName of faculty

(Chief Consultant)

Client

Organization

Title of Consultancy of

project

Amount

received

(in Rupees)

Amount

received

(in words)

1 2015-16

Dr. Rajesh Powar, Dr. K.M. Keluskar, Dr. Kotrashetti

Department of

Plastic Surgery, Pediatric Surgery, Oral and Maxillofacial Surgery, Orthodontics and DentofacialOrthopaedics

Smile Train, USA 1. KLE’S Smile Train project

69,00,000/- Sixty Nine Lakh only

Consultancy Projects

Institute Name

India Ranking 2017

ID

Discipline

Dr. B.S. Kodkany Dr. S.S. Goudar,

Dr. N.S. MahantshettiDr. M.B. BelladDr. R.M. BelladDr. S.M. DhadedDr. YeshitaPujarDr. HemaDhumaleDr. M.c. Metgud

Dept. of Paediatrics, ObG, Physiology, Community Medicne of J.N. Medical College, Belagavi

• NIH, USA• NICHD, USA

• Global Implementation Task Force of American Academy of Pediatrics, USA• Bill and

Melinda Gate’s Foundation, USA• WHO,• Thrasher Research Fund, USA• International Atomic Energy

Agency, Vienna• RHR Division of World Health Organization, Geneva, Switzerland• University of Colorado Health

Sciences Center• The Children

• Research on Women and child Health

• Maternal and Newborn Health Registry (MNH Registry)Dept. of OBG & Paediatrics• Helping babies breathe initiative Dept. of Paediatrics

• The CLIP (Community Level Interventions for Pre- Eclampsia) Cluster randomized controlled trial• Dept. of OBG • Does Implementation of Helping Babies Breathe

(HBB) save lives?• Dept. of Paediatrics• Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries (ACT) in Belagavi District,

Karnataka, India• Dept. of OBG &

21,88,000/- Twenty one lakhs eighty

eight thousand

Dr. M.V, JaliDr. R.S. Mudhol

KLE Dr. Prabhakar Kore Hospital & MRC, Belagavi

Govt. of Karnataka Insurance companies

2. Yashaswini, 3. Balasanjivini, 4. Arogya Bhagya, 5. Vajapayee Arogyashree Scheme, 6. Ex-servicemen

Contributory Health Scheme (ECHS),7. Employe’s State

Insurance (ESI), DBCS

6,18,91,767/- Six crore eighteen lakh ninety one thousand seven hundred and sixty seven

Dr .V. A. Kothiwale - PI

Dr.Aditya.Kulkarni–Sub-I Dr. M S Ganachari-CRCBhupendra Parihar- CRCDisha Khoda- CRC

Norwich 8. Protocol title: “A proof of concept, parallel

design, single treatment, double arm trial of 50 mg quick dissolve tablets containing freeze dried Lactobacillus delbrueckii subsp. bulgaricus lysate (GenCixTM) from FraXon

technologies Inc., USA, conducted on treatment naïve chronic hepatitis C positive patients in one arm and treatment naïve chronic hepatitis C positive patients on dialysis in the other arm”

40,000/- Forty thousand

Dr. Gajanan.S.Gaude– PI Dr.V.A.Kothiwale

–Sub-I

Glenmark 9.Protocol Number: GPL-CT/2011l011/lII“A Phase

III, randomized, open label, Non- inferiority, active-controlled comparative, parallel group, multicentric study of fixed dose combination of formoterol 12 μg plus

fluticasone 250 μg as DPI (Test Drug) with the commercially available fixed dose combination of Salmeterol 50μg and Fluticasone250 μg

(SeretideTMAccuhalerTM

50/250 μg) as DPI in a 12-

week Treatment period of adolescent and adult subjects with moderate-severe stable persistent asthma”


Glenmark 10.Protocol title - C003 –“A double blind,

randomized, placebocontrolled, parallel group,three arm, multicenterand multinational pivotalstudy to assess theefficacy and safety of twodosage regimens of

Crofelemer tablets in thetreatment of moderate tosevere acute waterydiarrhea in adultpatients.”


Dr.N.S.Mahantshetti-PI Dr.

Joshi- Sub-I

Bharat Biotech 11.Protocol title -“A phase II/III randomized, single

blinded, active controlled study to evaluate the immunogenicity and safety of inactivated Japanese encephalitis vaccine in healthy volunteers”.

50,000/- Fifty thousand

Dr. V.D.Patil - PI Dr.Preeti Amarkhed-Sub

I Dr.M S Ganachari- CRC

Biological E. Limited

12. Trial no: BECT/JEV-PII-III/018, Protocol no:

bect018/jev-pii-iii/ctp-02 “A multicentric, open label randomized controlled phase ii/iii study to evaluate the safety and immunogenicity of be’s

inactivated je vaccine in healthy ≥ 1 to <3 year old Indian children”

45,000/- Forty five thousand

Panacea 13. Protocol number: PBL/CR/0032008/CT “A randomized, multicenter, open

label, comparative study to evaluate the Immunogenicity and reactogenicity of a new fully liquidpentavalentDTwP-Hib-IPV vaccine

EasyfourPol™ , Panacea Biotec Ltd) with tetravalent DTwP/Hib vaccine (TetrAct-Hib™) , co-administered with Imovax Polio® (Salk Based Inactivated Polio

Vaccine) of Sanofi Pasteur India Pvt. Ltd. In healthy infants.


Reliance 14. Protocol number :RLS/TP/2010/03:“Prosp

ective, multicentric, open label, clinical study to evaluate efficacy and safety of R-TPR-004 in patients undergoing treatment for acute ischemic stroke”

25,000/- Twenty five thousand

Quintile

15.Protocol number: DU176b-C-U305: “A phase 3, randomized, double-blind, double-dummy, parallel-group,

multi-center, multi-national study for the evaluation of efficacy and safety of (lmw) heparin/edoxaban versus (LMW) Heparin/Warfarin in subjects with

symptomatic deep-vein thrombosis and/or pulmonary embolism”

30,000/- Thirty thousand

George Institute 16. Protocol number BC22140 ALEGLITAZAR

(RO0728804): “Phase 3 multicenter, randomized, double-blind, parallel group, placebo controlled study cardiovascular outcomes study to evaluate the potential of

aleglitazar to reduce cardiovascular risk in patients with a recent acute coronary syndrome (ASC) event and type 2 diabetes mellitus (T2D)”

20,000/- Twenty thousand

Dr. M. Khanpet –PIDr. VinayakEkbot – Sub IDr. M SGanachari - CRC

Clinigene, International Ltd

17. Protocol title: “A phase II, randomized, open label, single subcutaneous dose study


Quintile 18.Protocol number:DU176b-C-U301: “A Phase3, randomised, double-

blind, double dummy,parallel group, multi-

35,000/- Thirty five thousand

GlaxoSmithKline 19. Protocol title: “A phase III, open-label, randomized, multicenter study to evaluate the immunogenicity and


Dr .V. A. Kothiwale –PI Dr.

M. S. Ganachari -CRCKhoremand Bhathena-CRC Atul.Aggrawal-CRC

Thrombosis Research

Institute

20Protocol number TRI08888

GARFIELD:“Prospective, multicentre, international registry of male and female patients newly diagnosed with atrial fibrillation”.


SHAN Pharmaceuticals

21Protocol StudyNumber: SH501:“Safety,immune lot-to-lotconsistency and non-inferiority of Shan 5(DTwP-HepB-Hib)

vaccine in comparison topentavac SD whenadministered as a singlebooster dose at 15-18months and three dose at6-8,10-12 and 14-16weeks of age in healthyindian children and

infants”


Glenmark 22.Protocol number:GPL/CT/2012/III: “Arandomised, double-blind,comparative, prospective,multicentre, parallel study

to assess efficacy, safetyand tolerability ofRepaglidine/Metformin IR tablet monotherapy orrepaglidine tabletmonotherapy in adult

35,000/- Thirty five thousand

Dr. M.V. Jali –PI ICON Clinical Research-

Company

23.Protocol number: CV181169 :A multicentre,

randomised, double-blind, active-controlled, parallel group, phase 3 trial to evaluate the safety of add-on therapy with Saxagliptin and Dapagliflozin added to

Metformin compared to add-on therapy with Saxagliptin in combination with Metformin or Dapagliflozin in combination with Metformin in Subjects

with type 2 Diabetes who have inadequate glycemic control on Metformin alone.”


Glenmark 24. Protocol number:

GRC17536-203: “A Phase2, 4-week randomized,double-blind, parallelgroup, placebo controlledproof of concept study toevaluate efficacy, safetyand tolerability of grc17536 in patients with

painful diabeticperipheral neuropathy.”

30,000/- Thirty

thousand

Dr. M.V. Jali –PI Piramal Healthcare

25.Protocol number: P2202/47/10: “A Phase II,

randomized, double-blind, placebo-controlled, dose-ranging, two-staged, fixed design study to evaluate the efficacy, safety, tolerability and pharmacokinetics of

p2202 in overweight/obese patients of type 2 diabetes mellitus inadequately controlled on metformin, sulphonyl urea, or both.”


Dr .V. A. Kothiwale -PI Dr. MS Ganachari- CRCTarang Shah - CRC

Amgen Technology Pvt.ltd

26.Protocol no: 20110118:“A double-blind, randomized, placebo-controlled, multicenter study assessing the impact of

additional LDL-cholesterol reduction on major cardiovascular events when AMG 145 is used in combination with statin therapy in patients with clinically evident cardiovascular disease”.


Glenmark 27.Study title: “A Phase III prospective, randomized,

open labelled, multicentric, parallel group, three arms clinical study to evaluate the efficacy and safety between monotherapy of Glenmark’sRoflumilast

500 Mcg Tablet and Combination Therapy of Roflumilast 500 Mcg Tablet Plus Tiotropium 9 mcg inhalation and combination therapy of roflumilast 500 mcg tablet plus salmeterol 25mcg

inhalation in adult patients with chronic obstructive pulmonary disease (COPD).”

25,000/- Twenty five thousand

Serum Institute 28.Protocol title: “A multicentricrandomized ,

comparative clinical trial to assess the immunogenicity and reactogenicity of DPTw [meat free] vaccine with standard commercially available DPTw [routine]

vaccine in Indian children aged 6 –14 weeks”.


Reliance 29.Protocol title: To studythe safety and efficacy ofR-TPR –001 (Reteplase-Recombinant

plasminogen activator) inpatients with acutemyocardial infarction andST segment elevation”.


Novonordisk 30.Protocol title: EX 1000-1919: A multicentre,

multinational, randomized, open labeled, two armed, parallel group trial with a 24 week treatment period comparing the efficacy and safety of two

concentrations of Mixtard 30 (333IU/mL) or Mixtard 30 (1000IU/mL)”.


SMO India. 31.Protocol title: A Phase

III , multicenter,randomized , double –blind study to evaluatethe efficacy and safety ofsitagliptin versus glipizide

in patients with type 2diabetes mellitus and

chronic renal insufficiency who have inadequateglycemic control”

30,000/- Thirty

thousand

Medical director Medical Superintendent

Govt. of Karnataka

Balasanjeevini Vajapayee Arogya Scheme

2,00,25,342 Two crore twenty five thousand three

hundred forty two

2 2014-15

13 Dr.Rajesh Powar · Smile Train,USA

1. KLE,S Smile Train project

71,59,000/- Seventy One Lakh Fifty Nine

Thousand only/-

14 · NIH, USA · NICHD,

USA Global Implementation Task Force of American Academy of Pediatrics,

USA Bill and Melinda Gate’s Foundation, USA WHO, Thrasher

Research Fund, USA International Atomic Energy Agency, Vienna • RHR

Division of World Health

2. Research on Women and child Health

3. Maternal and Newborn Health Registry (MNH Registry)Dept. of OBG & Paediatrics4. Helping babies breathe initiative Dept. of Paediatrics

5. The CLIP (Community Level Interventions for Pre- Eclampsia) Cluster randomized controlled trialDept. of OBG 6. Does Implementation of Helping Babies Breathe (HBB) save lives?Dept. of

Paediatrics7. Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries (ACT) in Belagavi District, Karnataka, IndiaDept. of

OBG & Paediatrics8. Emergency obstetrics

20,82,000/- Twenty lakhs eighty two

thousand

15 15. Govt. of Karnataka Insurance companies

• Yashaswini, • Balasanjivini, • Arogya Bhagya, • Vajapayee Arogyashree Scheme, • Ex-servicemen

Contributory Health Scheme (ECHS), • Employe’s State

Insurance (ESI), DBCS

5,09,72,744/- Five crore nine lakh seventy two thousand seven hundred and forty four

Dr.(Mrs)N.S.Mahantshetti -PI

18.Biological E. Limited –

Company

18. Protocol title: A Multicentric double blind

single arm randomized phase IV study to evaluate the safety, reactogenicity and lot consistency of three production lots of BE’s combined liquid Pentavalent DTwP-rHepB-

HIB vaccine administered at 6-10-14 weeks schedule to 6-8 week old healthy Indian infants.

75,000/- Seventy thousand

19.SMO India – CRO

19. Protocol no: GLP114130: “A randomized, double-blind, active-controlled, parallel group, multicenter study to determine the efficacy and safety of Albiglutide as compared with

Sitagliptin in subjects with type 2 Diabetes mellitus with renal impairment”

80,000/- Eighty thousand

20.Abbott 20 Protocol title: A prospective multicenter

observational study to characterize the patient population with cholestasis in chronic liver disease due to non-alcoholic liver disease receiving heptral in

India[P13-163]


21. Panacea Biotec Ltd

21.Protocol number: PBL/CR/0032008/CT “A randomized, multicenter, open label, comparative study to evaluate the immunogenicity and

reactogenicity of a new fully liquid Pentavalent DTwP-Hib-IPV vaccine (easyfourPol™,) with tetravalent DTwP/Hib vaccine (TetrAct-Hib™), co-administered with

Imovax Polio® (Salk Based Inactivated Polio Vaccine) of Sanofi Pasteur India Pvt. Ltd. In Healthy Infants.

1,00,000/- One lakh

22.ICON 22. Protocol no: MB102073: “A

multicenter, randomized, double-blind, placebo-controlled, parallel group, phase iii trial to evaluate the safety and efficacy of dapagliflozin in subjects with type 2 Diabetes with

inadequately controlled Hypertension on an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker”.


23 23. Protocol no: MB102077: “A

multicentre, randomized, double-blind, placebo-controlled, parallel group, phase III trial to evaluate the safety and efficacy of Dapagliflozin in subjects with type @ Diabetes with

inadequately controlled hypertension treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) and an additional antihypertensive

medication”.

40,000/- Fortythousand

24.Clinigene International Ltd

24. Protocol number: MK-0822: “Phase III

randomized, placebo–controlled clinical trial toassess the safety andefficacy of Odanacatib(mk-0822) to reduce therisk of fracture inosteoporotic post

menopausal womentreated with vitamin Dand calcium”.


Dr. V.D.Patil - PIDr. Preeti Amarkhed-

Sub IDr.M S Ganachari – CRC

25. Biological E. Limited -

Company

25. Trial no: BECT/JEV-PII-III/018, Protocol no:

bect018/jev-pii-iii/ctp-02 “A multicentric, openlabel randomizedcontrolled phase II/IIIstudy to evaluate thesafety andimmunogenicity of be’s

inactivated JEvaccine in healthy ≥ 1 to<3 year old Indianchildren”



Govt. of Karnataka


1,61,61,443 One crore Sixty one lakhs sixty one thousand four hundred forty three

3 2013-14Dr.Rajesh. Power · Smile train

USA1. KLE’S Smile Train project

69,12,000/- Sixty Nine Lakh Twelve thousand Only

• NIH, USA• NICHD, USA

• Global Implementation Task Force of American Academy of Pediatrics, USA• Bill and Melinda Gate’s

Foundation, USA• WHO,• Thrasher Research Fund, USA• International Atomic Energy

Agency, Vienna• RHR Division of World Health Organization, Geneva, Switzerland

• University of Colorado Health

Sciences Center• The Children

• Research on Women and Child Health

• Maternal and Newborn Health Registry (MNH Registry) Dept. of OBG & Paediatrics• Helping babies breathe initiative Dept. of Paediatrics• The CLIP (Community

Level Interventions for Pre- Eclampsia) Cluster randomized controlled trial Dept. of OBG • Does Implementation of Helping Babies Breathe (HBB) save lives? Dept. of

Paediatrics• Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries

(ACT) in Belagavi District, Karnataka, India Dept. of

OBG & Paediatrics• Emergency obstetrics

20,58,000/- Twenty lakhs fifty eight

thousand

Govt. of Karnataka

Insurance companies

• Yashaswini,• Balasanjivini,

• Arogya Bhagya, • Vajapayee Arogyashree

Scheme, • Ex-servicemen Contributory Health Scheme (ECHS),

• Employe’s State Insurance (ESI), DBCS

• Psychiatry Day Care

Center KLE Dr. Prabhakar Kore

Hospital & MRC Belagavi

3,55,71,688/- Three crore fifty five lakh

seventy one thousand six hundred and eighty eight

Dr. M.V. Jali –PI ICON Clinical Research- Company

2. Protocol no: CV181169 : “A multicentre, randomised, double-blind,

active-controlled, parallel group, phase 3 trial to evaluate the safety of add-on therapy with saxagliptin and dapagliflozin added to metformin compared to add-on therapy with

saxagliptin in combination with Metformin or Dapagliflozin in combination with Metformin in subjects with Type 2 Diabetes who

have inadequate glycemic control on metformin alone”.

29,97,000/- Twenty nine lakhs ninety thousand

Glenmark - Company

3. Protocol title - C003 - adouble blind, randomized,

placebo controlled,parallel group, three arm,multicenter andmultinational pivotalstudy to assess theefficacy and safety of twodosage regimens of

crofelemer tablets in thetreatment of moderate tosevere acute waterydiarrhea in adult patients.

70,000 Seventy thousand

ZYDUS 4. Protocol no:CLR_10_22 :“Efficacy and safety ofSPIL’s Lubriprostonecapsule, 24 mcg

Lubriprostone in subjectswith chronic idiopathicconstipation : a randomized, double blind,parallel group, active andplacebo controlled,clinical endpointbioequivalence study ”.

30000/- Thirty thousand

Dr. Jayaprakash Appajigol-PI

SUN PHARMA 5. Protocol no: ZYH 1.12.001.01 PROT: “A

multicenter, prospective, randomized, open label phase IV clinical study to evaluate the safety and efficacy of saroglitzar (ZYH1) as compared to fenofibrate in patients

with dyslipidemia”.

50,000/- Fiftythousand

Dr. M.V. Jali –PI ELI LILLY 6. Protocol title: “A demonstration project to evaluate the effectiveness and acceptability of the joint diabetes evaluation

(JADE) & diabetes monitoring database(Diamond) programs in Type 2 Diabetes patients in India”.

50,000/- Fiftythousand

ELI LILLY 7.Protocol title: Protocol I4V-MC-JADX: A

randomized, double-blind, placebo-controlled, phase3 study to evaluate theefficacy and safety ofbaricitinib (LY3009104)in patients withinadequate response to

conventional disease-modifying antirheumaticdrugs with moderately toseverely activerheumatoid arthritis.

60,000/- Sixty thousand

Dr. Udapudi-PI ELI LILLY 8.Protocol title: ProtocolI4V-MC-JADZ- “Arandomized, double-blind,active-controlled, phase 3

study to evaluate theefficacy and safety ofbaricitinib (LY3009104)

in patients withmoderately to severelyactive rheumatoidarthritis who have hadlimited or no treatmentwith disease modifyingantirheumatic drugs”.


Dr.S.Udapudi-PI ELI LILLY 9.Protocol title: I4V-MC-JADY(C): “A Phase 3,

multicenter study to evaluate the long-term safety and efficacy of baricitinib in patients with rheumatoid arthritis”.

40,000/- FortyThousand

Dr.Rajendra.Bhandankar- PIDr. Sudheer Yadwad– Sub I

ELI LILLY 10.Protocol SB2-G31-RA: “A randomized, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, pharmacokinetics

and immunogenicity of SB2 compared to remicade® in subjects with moderate to severe rheumatoid arthritis despite methotrexate therapy”.


ELI LILLY 11.Protocol I4L-MC-ABEL: “A prospective,

randomized, open-labelcomparison of a longacting basal insulinanalog, LY2963016, tolantus® in combinationwith mealtime insulinlispro in adult patients

with type 1 diabetesmellitus: the element 3study”.


BBIL 12. Protocol title: “Addendum to typhoid Vi polysaccharidetetanus

toxoid protein conjugate phase III clinical trial protocol entitled:A phase III, Randomized,multicentre ,controlled study to evaluate the

immunogenicity and safety of BBIL’s typhoid Vi capsular polysaccharide –tetanus toxoid protein conjugate vaccine (Typbar TCV) Vs. Referencevaccine (typbar) in healthy

subjects.”.


ZYDUS 13.Reference protocol no: CLR_13_14:Study Title:

“Pharmacodynamic efficacy and safety of Leuprolide depot 7.5 mg (SPIL) in subjects with Prostatic Adenocarcinoma”.


BBIL 14. Protocol No: BBIL/JEV/IV/2012A: “A Phase IV Single dose, Open labeled, Comparative, Randomized

Controlled study to evaluate the Immunogenicity and Safety of BBIL’s JENVAC(Inactivated JE vaccine)Vs. Chinese SA-14-14-2(Live JE vaccine)vaccine in healthy

volunteers”.


Ranbaxy 15. Ref: Protocol :“Comparative efficacy,

safety and tolerability ofFDC of cephalexinextended release (375mg)and ClavulanatePotassium (125 mg)tablets with Cephalexinextended release (375

mg) tablets in thetreatment ofuncomplicated skin andsoft tissue infection - arandomized, double-blindstudy(study number:r2013006)”.


Ranbaxy 16. Ref: Protocol : “Comparative efficacy, safety and tolerability of FDC of Cephalexin extended release (375mg) and Clavulanate Potassium (125 mg)

tablets with cephalexin extended release (375 mg) tablets in the treatment of upper respiratory tract infections - a randomized,

double-blind study (study number: r2013006)”.


Dr.Jayprakash Appajigol – PI

Asahi Kasei Pharma America

Company

17.Ref:3-001 A randomized double-blind,

placebo-controlled, Phase-3 study to assess the safety and efficacy of ART-123 in subject with severe sepsis and coagulopathy.


Dr.Rajendra.Bhandankar-PI

Sristek Company 18. Protocol title: “A multicenter, double-blind, vehicle controlled, parallel-group study comparing a generic

Diclofenac Sodium topical gel, 1% in the treatment of subjects with osteoarthritis of the knee”.


BBIL 19. Protocol no.:BBIL/ROTA/IV/2013:

“Phase IV, multicenter,randomized, single-blind,study to evaluate theimmunogenicity, reactogenicity& safety ofthe live attenuatedrotavirus vaccine

ROTAVAC® as a 3 doseseries when administeredsimultaneously with orwithout the bufferingagent following in healthyinfants”.


Merc Company 20. Protocol title: MK-0822-083-00: “An observational follow-up study for: a phase III randomized, placebo-controlled clinical trial to assess the safety and efficacy of Odanacatib

(MK-0822) to reduce the risk of fracture in osteoporotic postmenopausal women treated with vitamin D and calcium (protocol 018)”.


Himalaya Drug Company,

Bengaluru

21. “A comparative clinical study to evaluate

the efficacy and safety of two cystone formulations in patients suffering from urolithiasis”.


Progene Research Laboratories, Belagavi

22. “A Randomized,controlled, double blindstudy to evaluate theefficacy and safety ofcapsule progen inimproving parameters of

semen analysis in cases ofmale infertility due todefect in seminalparameters’.



Govt. of Karnataka


1,29,23,090 One crore twenty nine lakhs twenty

three thousand ninety

IR17-MEDI-2-1-N002 Discipline - Home | Jawaharlal … NEHRU MEDICAL COLLEGE, BELAGAVI...

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