There are about 5618 clinical studies being (or have been) conducted in India. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This study will investigate the effect of tirzepatide on the reduction of morbidity and mortality in adults living with obesity and provide additional evidence for the potential clinical benefits of tirzepatide in this population.
As a follow-up to the RAPIDIRON Trial (NCT05358509), and in combination with the RAPIDIRON-KIDS Study (NCT05504863), this study will involve infants of RAPIDIRON Trial participants recruited at one site in Karnataka and is designed to implement a magnetic resonance imaging (MRI) protocol and incorporate neuroimaging measures. Implementation of this study will promote an understanding of the effects on fetal and neonatal brain development, including iron deposition in brain tissues, when a woman is treated for iron deficiency anemia (IDA) by either (a) providing her oral iron tablets and instructions for use; or (b) administering a single-dose IV iron infusion for the treatment of IDA during pregnancy.
The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).
Group 1 (BBV154): In this group, 3000 participants will be recruited, randomized in 1:1:1 ratio receive 3 consecutive lots (Lot 1: 1000, Lot 2: 1000, Lot 3: 1000) of the BBV154 vaccine (0.5 mL each dose) on day 0 and day 28 via intranasal route. Group 2 (COVAXIN®): In this group, 160 participants will be recruited and administered with COVAXIN® vaccine on day 0 and on day 28 via intramuscular route. A total sample size of 3160 healthy volunteer's age's ≥18 years will be recruited in this study. BBV154-Subjects- Part 1 ( Immunogenicity Group)- First 640 Subjects BBV154-Subjects- Part 2 ( Safety Group)- (Remaining 2520 subjects) Visit 1: Baseline (Day 0) Visit 2 (Day 28+2) Visit 3 (Day 42 ± 7 days) Visit 4 (Day 90 ± 7 days) and Visit 5 (Day 180± 7 days)
The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in infants and toddlers. This study is enrolling participants who are: - Born after at least 36 weeks of pregnancy and about 2 months of age at the time of entering the study - Have a bodyweight of at least 3 kg Participants will receive either the study vaccine (20vPnC) or a licensed vaccine (13vPnC) as a 4-dose schedule as a shot in the muscle. Participants will receive Dose 1 on study day 1. Dose 2 will be given 28-70 days after Dose 1, and Dose 3 will be given 28-70 days after Dose 2. Dose 4 will be given at 365-455 days (approximately 12-15 months) of age. Participation in the study will take approximately 15 months, during which participants will come to the study clinic for 6 times. The study team will ask questions about the participant's health and take some blood samples during the visit.
A Phase III randomized, modified double-blind, multi-centric, comparative study, to evaluate the noninferiority of immunogenicity and safety of single strain oral cholera vaccine Hillchol® (BBV131) to the comparator vaccine Shanchol™ along with lot-to-lot consistency of Hillchol® (BBV131). Study Population: A total of 1800 participants will be enrolled in three descending age groups (Group I- >18, Group II: > 5 to <18 and Group-III: >1 to <5) in 3(1350):1(450) ratio. In each group 600 participants will be enrolled and among 600 participants 450 participants will receive any lot of Hillchol® (BBV131) and 150 participants will receive Shanchol™. DSMB and report:After completion of 7 days post 1st dose for 40 participants (Hillchol (BBV131):10-Lot-I,10-Lot-II,10-Lot-III and 10-shanchol) in the Group I, safety data of these participants will be reviewed by Data Safety Monitoring Board (DSMB) and based on their recommendation, study will progress by recruiting remaining 560 participants in the group I and starting recruitment of participants for group II. After completion of 7 days post 1st dose for 40 participants (Hillchol (BBV131):10-Lot-I,10-Lot-II,10-Lot-III and 10-shanchol) in the Group II, safety data of these participants will be reviewed by Data Safety Monitoring Board (DSMB) and based on their recommendation, study will progress by recruiting remaining 560 participants in the group II and starting recruitment of participants for group III. After completion of 7 days post 1st dose for 40 participants (Hillchol (BBV131): 10-Lot-I, 10-Lot-II, 10-Lot-III and 10-shanchol) in the Group III, safety data of these subjects will be reviewed by Data Safety Monitoring Board (DSMB) and based on their recommendation, study will progress by recruiting remaining 560 participants in the group III. A Final report will be generated, based on the safety and immunogenicity of the oral cholera vaccine (Hillchol®) will be notified to the Data safety monitoring board and Central Drugs Standard Control Organization (CDSCO), India.
As a follow-up to the RAPIDIRON Trial (NCT05358509), this study will follow the previously randomized mothers as well as their offspring after birth to assess neurodevelopmental, hematologic, and health outcomes. The study's overarching goal is to determine if the offspring born to RAPIDIRON Trial mothers in the intravenous iron groups, compared to the oral iron group, will achieve superior neurodevelopment, iron stores, and growth at specific time points during the first three years of life. Differences will be assessed between offspring based on the iron deficiency anemia (IDA) treatment of the mother.
This study aims to compare the implementation and effectiveness of the Tobacco-Free Teachers, Tobacco-Free Society (TFT-TFS) program when delivered through in-person training vs. a smartphone-based training model. Investigators will conduct a comparative effectiveness trial using a cluster-randomized design in which headmasters at schools in the Indian state of Madhya Pradesh (MP) will be trained in person or via a smartphone to deliver TFT-TFS in their schools. Schools will be randomly assigned to each training arm, and investigators will compare program effectiveness (tobacco use cessation), implementation outcomes, and program cost and reach.
This study will assess the efficacy and safety of the combination of ceralasertib and durvalumab versus standard of care docetaxel in patients with locally advanced and metastatic NSCLC after progression on prior anti-PD-(L)1 therapy and platinum-based chemotherapy.
To evaluate the effect injectable platelet rich fibrin (i-PRF) along with microneedling on gingival thickness in patients with thin gingival phenotype undergoing non extraction fixed orthodontic treatment