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Actively Recruiting

Healthy Volunteer

Researchers are investigating the clinical effectiveness of antibiotics in young children aged 9 to 36 months who have chronic wet cough, a condition often related to protracted bacterial bronchitis. The study aims to compare the impact of different treatment durations on symptom improvement and relapse, while also exploring the role of respiratory bacteria, airway and gut microbiomes, inflammation, immune response, and genetics in this condition. This academic, phase 4, double-blind, placebo-controlled, multicenter trial includes two randomized controlled trials and healthy controls for comparison. The study consists of two parts: AMIC 1 and AMIC 2. In AMIC 1, 90 children will be randomly assigned to receive either amoxicillin-clavulanate syrup or a placebo, both given three times daily for 14 days. In AMIC 2, 210 children will be randomly assigned to receive amoxicillin-clavulanate syrup three times daily for either 14 or 28 days. A group of 50 healthy children will also be included for comparison and will have a follow-up visit six months after enrollment. Participants will be followed for 24 months after the start of the treatment to monitor response to antibiotics, with assessments conducted 14 days after finishing treatment. Researchers will study respiratory pathogens, microbiome changes, inflammation, and immune factors, as well as collect genetic data. The study will include clinical evaluations, cough scoring, and comparisons with healthy controls to better understand the condition and treatment effects over time.

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

Actively Recruiting

Researchers are conducting a 2-year, multicenter observational study to evaluate clinical differences in patients with migraine who are treated with medications targeting calcitonin gene-related peptide (CGRP) or its receptor. These medications include monoclonal antibodies such as erenumab, galcanezumab, fremanezumab, and eptinezumab, as well as gepants like rimegepant and atogepant. The study includes patients diagnosed with migraine according to specific criteria and who meet local reimbursement guidelines for these treatments. Participants will begin treatment with one of the anti-CGRP drugs or gepants, and a baseline assessment will be performed. Follow-up visits will occur every 6 months to monitor treatment effectiveness, side effects, patient-reported outcomes, and eligibility to continue the study medication. The observation period for each participant will last for 2 years. During the study, researchers will track changes in the number of monthly headache days and monthly migraine days as primary outcomes. Participants will undergo regular assessments including clinical evaluations and questionnaires. Safety and treatment adherence will be monitored throughout the two-year observation period to better understand real-world use of these migraine preventive therapies.

Age: 18Years +All Genders
26 locations
Lillestrom Clinical Trials | DecenTrialz