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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Healthy Volunteer

Researchers are studying the effects of antibiotics in children aged 9 to 36 months who have chronic wet cough CWC. This study is a phase 4, double-blind, placebo-controlled, randomized trial conducted across multiple centers nationwide. The goals are to understand how effective antibiotics are in treating CWC, whether the length of antibiotic treatment affects recovery or relapse, and to explore the role of respiratory pathogens, microbiomes, inflammation, immunology, and genetics in these children compared to healthy controls. The study consists of two randomized controlled trials, AMIC 1 and AMIC 2. In AMIC 1, 90 children will be randomly assigned to receive either amoxicillin-clavulanate syrup or a placebo syrup for 14 days. In AMIC 2, 210 children will be randomly assigned to receive either 14 days of amoxicillin-clavulanate with 14 days of placebo or a full 28 days of the antibiotic syrup. Additionally, 50 healthy children will be included for comparison and will have two visits spaced six months apart. During the study, children will be followed for up to 24 months after starting treatment to assess response and relapse of symptoms. Researchers will evaluate treatment response 14 days after antibiotic completion and monitor for any relapse up to two years later. Assessments include cough scoring, microbiome analysis from airway and gut samples, and examination of inflammation, immunology, and genetics. The study also involves regular monitoring to ensure safety and adherence to treatment protocols throughout the trial period.

Age: 9Months - 36MonthsAll GendersPhase 4
7 locations
O

Actively Recruiting

This research aims to observe and evaluate clinical differences in patients with migraine who receive preventive treatment targeting calcitonin gene-related peptide CGRP or its receptor. The study focuses on monoclonal antibodies erenumab, galcanezumab, fremanezumab, eptinezumab and gepants rimegepant, atogepant over a 2-year observation period. It includes patients who meet local reimbursement criteria and have a confirmed migraine diagnosis following international standards. Participants will start treatment with one of the anti-CGRP monoclonal antibodies or gepants as prescribed. Baseline assessments will be done before treatment begins. Follow-up visits will occur every 6 months to check treatment effectiveness, side effects, patient-reported outcome measures, and eligibility to continue using the study drug. The observation phase will last for 2 years. During the study, participants will undergo regular evaluations including headache frequency, migraine impact, anxiety, depression, sleep quality, and quality of life measures through various questionnaires. Researchers will monitor changes in monthly headache and migraine days, along with other clinical and patient-reported outcomes. The study will ensure ongoing safety and treatment monitoring throughout the 2-year period.

Age: 18Years +All Genders
26 locations