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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the safety and effectiveness of tezepelumab in children aged 5 to under 12 years with severe uncontrolled asthma. These children are already on medium to high doses of inhaled corticosteroids and at least one other asthma controller medication. The study is a phase 3, randomized, double-blind, placebo-controlled trial aimed at assessing tezepelumabs impact on asthma control and safety in this pediatric population. Participants will be randomly assigned in a 21 ratio to receive either subcutaneous injections of tezepelumab or a matching placebo over a 52-week double-blind treatment period. Before this, there is a 4 to 6 week screening and run-in period. After the treatment phase, there is a 12-week off-treatment follow-up for those not continuing. Additionally, an optional 104-week open-label extension allows eligible participants to receive tezepelumab, followed by another 12-week post-treatment follow-up. Throughout the study, participants will undergo regular assessments including lung function tests, asthma control questionnaires, symptom diaries, and blood tests to measure inflammation and immune response. Researchers will monitor asthma exacerbations, medication use, quality of life, and any side effects. Safety will be tracked during treatment and follow-up periods, with total study involvement potentially lasting over three years for those in the extension phase.

Age: 5Years - 11YearsAll GendersPhase 3
143 locations
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Actively Recruiting

Researchers are evaluating the treatment of acute watery travelers diarrhea TD by comparing a single dose of rifaximin with loperamide to the current standard treatment of a single dose of azithromycin with loperamide. This Phase 4 randomized controlled trial aims to assess the therapeutic efficacy of these antibiotic regimens combined with loperamide. Participants are active duty military members aged 18 to 60 who have acute watery diarrhea lasting less than 96 hours that affects their daily activities or duties. Participants will be randomly assigned to one of two treatment groups one group receives a single oral dose of rifaximin 550 mg plus loperamide 4 mg initially followed by 2 mg after each unformed stool, not exceeding 16 mg per day for 2 days, and the other group receives a single oral dose of azithromycin 500 mg plus the same loperamide dosing. Both treatments are combined with loperamide as an adjunct therapy. This study uses quadruple masking to maintain objectivity. During the study, participants are asked to provide blood and stool samples at various times to assess infection and immune response. They will also complete daily symptom diaries after treatment and attend follow-up visits with study doctors to monitor illness and recovery. A brief electronic questionnaire will be completed at 3 months. Researchers will measure the primary outcome of therapeutic efficacy up to one week after treatment, along with secondary outcomes such as symptom resolution at 24 and 72 hours, recurrence of illness, and any serious adverse events within 21 days. Participants must be able to follow up for at least 7 days or have arrangements for follow-up elsewhere.

Age: 18Years - 60YearsAll GendersPhase 4
4 locations