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MedAITools AI summaryInvasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention

A Study of Vaccination With 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years

September 28, 2026

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This AI summary is based on ClinicalTrials.gov (India locations). The original source link and last refresh date are saved here for you to check.

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Summary

Phase not stated. Randomized study of a 9-valent ExPEC conjugate vaccine (ExPEC9V; JNJ-78901563/VAC52416) to prevent invasive extraintestinal pathogenic E. coli disease (IED) in adults ≥60 with a urinary tract infection history in the past 2 years. IED is defined by E. coli isolated from blood/sterile sites, or from urine in urosepsis without another source. Design: inferentially seamless group-sequential. Phases: screening (up to 8 days pre–Day 1), randomization, single vaccination (Day 1), and follow-up up to 4 years; total study duration about 6 years 9 months. Rationale notes that conjugate vaccine efficacy is not expected to differ by antimicrobial resistance due to O-polysaccharide targeting. Ongoing; outcomes not reported.

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AI summaryBreast Neoplasms, Triple Negative Breast Neoplasms

A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)

October 6, 2026

Phase not stated. Randomized study in high-risk, early-stage (non‑metastatic) triple‑negative or HR‑low/HER2‑negative breast cancer. Compares sacituzumab tirumotecan (MK‑2870) plus pembrolizumab and chemotherapy versus pembrolizumab with chemotherapy alone. Primary aims: assess reduction of residual cancer in breast/lymph nodes at surgery and determine whether adding MK‑2870 improves time without cancer growth, spread, or return. Targeted therapy mechanism is described generally; specific efficacy and safety outcomes are not yet established. Key eligibility includes previously untreated, high‑risk, early‑stage disease; detailed T/N criteria truncated in source. Study status and timelines not provided.

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Based on ClinicalTrials.gov (India locations) and saved with the original source record.

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AI summaryCervical Spinal Cord Injury

Incomplete Cervical SCI Without Instability

October 6, 2026

Prospective multicenter observational study enrolling 50 adults with acute traumatic incomplete cervical SCI (AIS D or sensory‑only deficits) without biomechanical instability. Management follows local standard of care. Assessments at baseline, 3, and 6 months include ISNCSCI, gait/balance (10‑m walk, WISCI II), upper‑extremity measures (grip/pinch strength, GRASSP v2). PROMs (SF‑36 v2, NPS) and SCIM v3, plus key/tip pinch, at 3 and 6 months only. Optional quantitative spinal cord MRI/DTI at all timepoints per surgeon discretion. Objective is to gather data on feasibility and outcomes; no interventional comparisons or efficacy claims are specified.

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Based on ClinicalTrials.gov (India locations) and saved with the original source record.

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AI summaryNASH With Fibrosis, MASH With Fibrosis

A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

October 6, 2026

Phase 3, multicenter, randomized, double‑blind, placebo‑controlled trial of efruxifermin (EFX) in non‑cirrhotic NASH/MASH with F2–F3 fibrosis. About 1,650 participants in two cohorts: Cohort 1 (n≈750, F2–F3) with histologic endpoints at Week 52; Cohort 2 (n≈900, F3, NAS not required) with biopsy at Week 96. Randomization 1:1:1 to EFX 28 mg weekly, EFX 50 mg weekly, or placebo. Procedures include up to 12‑week screening, primary/secondary histology periods, long‑term treatment and outcomes follow‑up (up to ~240 weeks), and 30‑day post‑dose visit. Evaluates histologic improvement, fibrosis regression, and noninvasive/biochemical markers. Efficacy and safety outcomes not yet known.

About this update

Based on ClinicalTrials.gov (India locations) and saved with the original source record.

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AI summaryInvasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention

A Study of Vaccination With 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years

September 28, 2026

Phase not stated. Randomized study of a 9-valent ExPEC conjugate vaccine (ExPEC9V; JNJ-78901563/VAC52416) to prevent invasive extraintestinal pathogenic E. coli disease (IED) in adults ≥60 with a urinary tract infection history in the past 2 years. IED is defined by E. coli isolated from blood/sterile sites, or from urine in urosepsis without another source. Design: inferentially seamless group-sequential. Phases: screening (up to 8 days pre–Day 1), randomization, single vaccination (Day 1), and follow-up up to 4 years; total study duration about 6 years 9 months. Rationale notes that conjugate vaccine efficacy is not expected to differ by antimicrobial resistance due to O-polysaccharide targeting. Ongoing; outcomes not reported.

About this update

Based on ClinicalTrials.gov (India locations) and saved with the original source record.

View official source
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AI summaryDiabetes Mellitus, Type 2

A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India

September 28, 2026

Interventional study in India assessing safety of insulin lispro‑aabc (LY900014) in adults with type 2 diabetes mellitus. Duration ~33 weeks: screening (1 week), 4‑week lead‑in, 26‑week treatment, 2‑week follow‑up. Key eligibility includes: T2DM ≥1 year; on multiple daily injections (various basal and bolus insulins or premixed regimens) ≥90 days; up to 3 stable oral agents allowed; HbA1c 7.5%–10%; BMI ≤45 kg/m²; access to phone and refrigeration; regular wake–sleep schedule. Objective is safety evaluation; efficacy endpoints not specified here. Status not stated; no results reported.

About this update

Based on ClinicalTrials.gov (India locations) and saved with the original source record.

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