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Department of Medicine

Dr. Parag Khatavkar

Dr. Parag Khatavkar

Study Title: Pulmonary rehabilitation delivered in low resource settings for people with chronic respiratory disease: a 3-arm assessor-blind randomised implementation trial

Status: Ongoing


Dr. Pradeep D'Costa

Dr. Pradeep D'Costa

Study Title: A prospective, multicentre, randomised, active-controlled, observer-blind, Phase II study seamlessly followed by a Phase III study to evaluate the safety, tolerability and immunogenicity of the candidate HGCO19 (COVID-19 vaccine) in healthy subjects

Status: Closed


Study Title: A randomised trial to determine the effect of vitamin D and zinc supplementation for improving treatment outcomes among COVID-19 patients in India

Status: Closed


Cardiovascular Department

Dr. Milind Gadkari

Dr. Milind Gadkari

Study Title: A Phase 3, randomised, double-blind, placebo-controlled, event-driven study to demonstrate the efficacy and safety of Milvexian, an Oral Factor XIa Inhibitor, after a recent acute coronary syndrome. (LIBREXIA-ACS)

Duration: 3 Years 6 Months

Status: Ongoing


Study Title: “A Phase 3, randomised, double-blind, double-dummy, parallel group, active controlled study to evaluate the efficacy and safety of Milvexian, an Oral Factor Xla Inhibitor, versus Apixaban in participants with Atrial Fibrillation (LIBREXIA-AF)”

Duration: 3 Years

Status: Ongoing


Study Title: “HERMES: Effects of ziltivekimab versus placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation (EX6018-4915)”

Duration: 4 Years

Status: Ongoing


Study Title: A multicentre, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of finerenone on morbidity and mortality in participants with heart failure (NYHA II-IV) and left ventricular ejection fraction ≥ 40% (LVEF ≥ 40%)

Duration: 4 Years

Status: Closed


Study Title: International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA)

Duration: 4 Years

Status: Closed


Study Title: International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA)

Duration: 4 Years

Status: Completed


Medicine Department: Nephrology – Renal Unit

Dr. Vipul Chakurkar

Dr. Vipul Chakurkar

Study Title: A multicentre, randomised, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune-complex-mediated membranoproliferative glomerulonephritis (IC-MPGN)

Duration: 2 Years

Status: Ongoing


Study Title: A multicentre, single-arm, open label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult aHUS patients who are naive to complement inhibitor therapy

Duration: 2 Years

Status: Ongoing


Study Title: A multicentric, randomised, prospective, double blind, parallel group, comparative, active controlled, phase III clinical study to evaluate the efficacy, safety and tolerability of Fixed Dose Combination of Dapagliflozin 10 mg and Telmisartan 80 mg versus concurrent use Dapagliflozin 10mg tablets and Telmisartan 80mg tablets in patients with chronic kidney disease.

Duration: 6 Months

Status: Closed


Study Title: Catalytic iron and hepcidin in patients with COVID-19 and their association with adverse outcomes.

Duration: 1 Year

Status: Closed


Study Title: Catalytic iron and hepcidin in patients with COVID-19 and their association with adverse outcomes.

Duration: 1 Year

Status: Closed


Study Title: A multicentre, single-arm, open label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult aHUS patients who are naive to complement inhibitor therapy

Duration: 2 Years

Status: Ongoing


The Paediatric Nephrology Unit

Dr. Jyoti Singhal

Dr. Jyoti Singhal

Project Title: Clinical profile and short-term outcome of children with atypical haemolytic uremic syndrome

Duration: 3 Months

Status: Closed


Dr. Jyoti Sharma

Dr. Jyoti Sharma

Project Title: Genetics of Paediatric Kidney Diseases in Western in India: a Multicentre Registry

Duration: 6 Months

Status: Ongoing


Project Title: Optimal dosing regimen of cholecalciferol supplementation in children with chronic kidney disease-An open label multicentre randomised controlled trial Dr Jyoti Sharma Landmark trial completed in last 10 years Publications from this data: Iyengar A, Kamath N, Hamsa V, Uthup S, Sharma J, Singhal J, Sudha E, Rukshana S. Study Protocol: Determining the optimal dose of Cholecalciferol Supplementation in Children with Chronic kidney Disease (C3 trial): Design of an Open Label Multicentred Randomised Controlled Trial.”

Duration: 6 Months

Status: Closed


Diabetes Research Unit

Dr Yajnik

Dr Yajnik

Study Title: Follow-up of children born in a B12-multi micronutrient supplementation primordial trial (PRIYA) to reduce diabesity risk and improve neurocognitive performance

Duration: 1 Year

Status: Ongoing


Study Title: Study of causal mechanisms of early life determinants of adiposity: Analysis in a longitudinal study

Duration: 3 Years

Status: Ongoing


Study Title: A type–II Hybrid effectiveness – Implementation trial of community health workers to improve screening for postpartum diabetes in urban slums of India

Duration: 5 Years

Status: Ongoing


Study Title: Maharashtra Anaemia Study Phase 3 (MAS3): Longitudinal study of nutritional, economic, and environmental impacts on anaemia, physical and cognitive development in Indian children from birth to age 18 years, nested within ‘The Pune Maternal Nutrition Study’ (PMNS)

Duration: 1 Year

Status: Closed


Study Title: Molecular basis of nutritional foetal programming of ‘diabesity’ - Pune Rural Intervention in Young Adolescents (PRIYA) trial

Duration: 5 Years

Status: Closed


Study Title: Molecular basis of nutritional foetal programming of ‘diabesity’ - Pune Rural Intervention in Young Adolescents (PRIYA) trial.

Duration: 5 Years

Status: Closed


Dr Rishikesh Behere

Dr Rishikesh Behere

Study Title: Follow-up of children born in a B12-multi micronutrient supplementation primordial trial (PRIYA) to reduce diabesity risk and improve neurocognitive performance

Duration: 1 Year

Status: Ongoing


Dr Anand Ahankari

Study Title: Maharashtra Anaemia Study Phase 3 (MAS3): Longitudinal study of nutritional, economic, and environmental impacts on anaemia, physical and cognitive development in Indian children from birth to age 18 years, nested within ‘The Pune Maternal Nutrition Study’ (PMNS)

Duration: 1 Year

Status: Closed


Paediatric Research Unit

Dr. Sheila Bhave

Dr. Sheila Bhave

Study Title: Persistence of immunogenicity of a single dose of Live Attenuated Hepatitis A Vaccine: A Follow-up Study 20 Years after vaccination

Duration: 6 Months

Status: Ongoing


Dr. Ashish Bavdekar

Dr. Ashish Bavdekar

Study Title: A randomised, double-blind, placebo-controlled, phase 3 trial to investigate the safety and immunogenicity of a Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) administered subcutaneously to healthy subjects aged 4 to 60 years in India

Duration: 9 Months

Status: Ongoing


Study Title: Surveillance of viral pathogens causing respiratory infections

Duration: 4 Years

Status: Ongoing


Study Title: Enhancing capacity of KEM Hospital Research Centre, Pune for conduction of community-based human clinical trials on vaccines for COVID-19

Duration: 1 Year

Status: Closed


Study Title: Multicentric hospital-based surveillance of pertussis amongst infants admitted in tertiary care facilities in India

Duration: 2 Years

Status: Closed


Dr. Sandeep Kadam

Dr. Sandeep Kadam

Study Title: Risk factor, antibiotic sensitivity & outcome of culture – proven neonatal sepsis in intensive care unit: A 2 years retrospective study.

Duration: 2 Years

Status: Closed


Obstetrics and Gynaecology Department 

Dr. Shubha Ambardekar

Dr. Shubha Ambardekar

Study Title: Foetal Movement Awareness in Pregnancy – Utility, Compliance and Outcomes in Pregnancy - Pilot Study

Status: Completed


Dr. Suhas Otiv

Dr. Suhas Otiv

Study Title: Respectful Maternity Care Initiative – ICMR Task Force Study in Collaboration with Centre for Catalyzing Change/White Ribbon Alliance India (WRAI)

Status: Completed


Study Title: Supplementation of Vitamin B12 to Improve B12-Folate ratio in Pregnancy and its Effect on Birth Outcome

Status: Completed


Study Title: National Registry on COVID-19 Infection Among Pregnant Women and Their Neonates

Status: Ongoing


Department of Medicine: Psychiatry Research Unit

Dr. Suchita Agarwal

Dr. Suchita Agarwal

Study Title: Exploring remote treatment strategy for persons with pedohebephilia in India

Duration: 10 Months

Status: Ongoing


Study Title: PATH India: Exploring Paedophilia - Access/Attitudes, Treatment, and Help-seeking in India.

Duration: 2 Years

Status: 2 Years


Dr. Rishikesh Behere

Dr. Rishikesh Behere

Study Title: Explaining resilience and vulnerability to the impact on mental health of the Covid – 19 pandemics in the Pune maternal nutrition study birth cohort.

Duration: 6 Months

Status: Ongoing


Dr. Vasudeo Paralikar

Dr. Vasudeo Paralikar

Study Title: The impact of the COVID-19 Pandemic on Well-Being, Stress, and Resilience of Adolescents and Caregivers in South Asia

Duration: 6 Months

Status: Ongoing


Study Title: Feasibility of expansion of clinical services and public health action to prevent & respond to sexual violence against children (Project with Charite, Berlin)

Duration: 1 Year

Status: Closed


Study Title: Program for Primary Prevention of Sexual Violence with a focus on treatment for persons with paedophilia (Project with Charite, Berlin)

Duration: 6 Months

Status: Closed


Study Title: Multinational field trial of CFI

Duration: 6 Months

Status: completed


Dr. Manjiri Datar

Study Title: Sociocultural framework for comprehensive case formulation of sexually gender diverse (LGBTIQI) Individuals

Duration: 1 Year 1 Month

Status: Ongoing


Dr Paralikar VP (Co-guide)

Dr Paralikar VP (Co-guide)

Study Title: Sociocultural framework for comprehensive case formulation of sexually gender diverse (LGBTIQI) Individuals

Duration: 1 Year 1 Month

Status: Ongoing


Dr. Ujjwal Nene

Dr. Ujjwal Nene

Study Title: Feasibility of expansion of clinical services and public health action to prevent & respond to sexual violence against children (Project with Charite, Berlin)

Duration: 1 Year

Status: Closed


Study Title: Program for Primary Prevention of Sexual Violence with a focus on treatment for persons with paedophilia (Project with Charite, Berlin)

Duration: 6 Months

Status: Closed


Medicine Department: Oncology Research Unit 

Dr. Minish Jain

Dr. Minish Jain

Study Title: A prospective, randomised, double blind, multicentric, parallel group Phase-III clinical study to evaluate the efficacy, safety, and immunogenicity of BP01 (Bevacizumab) versus EU approved Avastin® along with chemotherapy XELOX in metastatic colorectal cancer patients.

Duration: 2 Years

Status: Ongoing


Study Title: A prospective, multicentric, single arm, Open label, Phase IV Clinical study to evaluate safety and efficacy of DenosuRelTM containing Denosumab manufactured by Reliance Life sciences Pvt. Ltd. India for prevention of skeletal related events in patients with bone metastases from solid tumours. (RLS/PMS/2021/01)

Duration: 2 Years

Status: Ongoing


Study Title: Prospective, multi-centre, randomized, open-label, two arm, parallel group, active-control, comparative clinical study to evaluate efficacy, safety and pharmacokinetics of R-TPR-023/ AvastinTM intravenously in patients with Metastatic colorectal cancer”

Duration: 2 Years

Status: Closed


Study Title: A multicentre, open label, randomised, two-treatment, two-period, two-sequence, single dose, cross-over bioequivalence study of Doxorubicin Hydrochloride (Pegylated liposomal) concentrate for solution for infusion 20 mg/10mL (2 mg/ml) of Dr. Reddy’s Laboratories Ltd, India, with that of Caelyx® 2 mg/mL [Doxorubicin Hydrochloride (Pegylated Liposomal) concentrate for solution for infusion (20 mg/10mL)] of Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium in advanced ovarian cancer and/or metastatic breast cancer patients under fed condition.

Duration: 2 Years

Status: Closed


Study Title: A prospective, multicentre, randomised, double blind, Phase III study to compare the efficacy and safety of Biosimilar Bevacizumab of Enzene Biosciences Ltd. versus Innovator Bevacizumab both in Combination with CAPEOX in Patients with Metastatic Colorectal Cancer

Duration: 1 Year 4 Months

Status: Closed


Social Science and Service Project Unit

Dr. Laila Garda

Dr. Laila Garda

Study Title: Infosys Foundation’s Community Engagement Model for Maternal & Child Health

Status: Ongoing


Study Title: Addressing Water Scarcity and Hunger in Tribal Population - Soygaon Taluka, Maharashtra

Status: Closed


Ms. Varsha Tol

Ms. Varsha Tol

Study Title: Upscaling: Don’t Offend India – Initiative under Program for Primary Prevention of Sexual Violence (PPPSV)

Status: Ongoing


Study Title: Creating Sustainable Livelihoods and Economic Opportunities for Community with a Focus on Women and Youth in Rural and Urban Areas of Pune

Status: Closed