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Active clinical trials for "Otitis"

Results 41-50 of 243

Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media

Acute Otitis Media

To determine whether tympanostomy tube placement (TTP) compared with nonsurgical management will meaningfully improve children's acute otitis media (AOM) experience over the succeeding 2 years.

Completed9 enrollment criteria

The Effects of Ventilation Tubes - The SIUTIT Trial

Otitis Media

The prevalence of otitis media among Greenlandic children is one of the highest in the world and twenty per cent of schoolchildren have impaired hearing in the frequencies for normal speech. Yet, there are no national guidelines to ensure prevention and treatment of recurrent acute otitis media and chronic otitis media with effusion and impaired hearing in Greenlandic children. International studies from the developed part of the world have shown that otitis prone children may benefit from tubulation of the tympanic membrane. However, it is unknown if these results can be applied to Greenlandic children. This PhD project will conduct a randomised controlled trial comparing tubulation of the tympanic membrane, in Greenlandic children aged 9-36 months with recurrent acute otitis media and/or chronic otitis media with effusion, to conservative treatment. The children will be followed for two years. Outcome measures will include number of visits to health clinics, number of tympanic membrane perforations, number of episodes with acute otitis media according to medical records, Quality of life, measured by the validated questionnaires OM6 and Caregiver Impact Questionnaire, number of episodes where per oral or intravenous antibiotics have been administered according to medical records and serious adverse events The trial will be conducted in collaboration with the Greenlandic health authorities and Copenhagen Trial Unit. With this trial the investigators hope to decrease the number of episodes with acute otitis media, the number of Greenlandic children with chronic perforations of the tympanic membrane and hearing impairment and increase quality of life. The results will add important knowledge to the effect of ventilation tube treatment also in an international aspect. There are to date only less than a handful of high quality studies concerning this issue on an international basis. The study will be among the first addressing this problem among populations with high risk of otitis media and is also of interest to other indigenous populations and the developing part of the world.

Terminated10 enrollment criteria

Video Discharge Instructions for Acute Otitis Media

Otitis Media

Thorough, understandable discharge instructions empower caregivers, allowing them to provide optimum care of their children during illness. Unfortunately discharge instructions are often incomplete and difficult to understand. The use of video discharge instructions has been shown to increase patient understanding of their illness. The investigators would like to know if using video discharge instructions for caregivers of children with middle ear infections helps to better understand how to take care of children at home, potentially allowing the child to feel better faster. The investigators will be comparing video discharge instructions to a paper handout to see if the former leads to improved well-being of the child and improved caregiver knowledge, satisfaction and anxiety.

Completed11 enrollment criteria

Phase 3 Study to Compare the Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain...

Acute Otitis Media

Children ages 2 months to less than 19 years old, who have been diagnosed with a middle ear infection may receive either medicated ear drops (AR01) or glycerin (placebo) ear drops. The patient or caregiver will measure the amount of ear pain before and after the ear drops to establish if the medicated ear drops decrease the amount of pain more than the placebo ear drops. The subject may leave the clinic 60 minutes after the first dose. The ear drops can be used up to 4 days, as needed for ear pain.

Completed24 enrollment criteria

Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa...

Acute Otitis Externa

The purpose of the study is to demonstrate the clinical therapeutic non-inferiority of EXL CDOS to commercially available Ciprofloxacin 0.3% and Dexamethasone 0.1% Sterile Otic Suspension (Ciprodex®, Alcon) in the treatment of acute otitis externa (AOE) when administered twice daily for 7 days.

Completed36 enrollment criteria

Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy...

Otitis Media

This was a non-significant risk (NSR), prospective, multi-center, single arm clinical trial that aimed to evaluate safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS).

Completed9 enrollment criteria

A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone...

Otitis Externa

The objective of this study is to compare the efficacy and safety profiles of the test product containing 2 mg/mL ciprofloxacin hydrochloride associated with 10 mg/mL of hydrocortisone with the reference product Cipro HC®, in patients with acute otitis externa.

Completed12 enrollment criteria

A Phase III Study of an Otic Formulation in Acute Otitis Externa

Acute Otitis Externa

The purpose of this study is to determine if an otic formulation is safe and effective for the treatment of acute otitis externa (AOE).

Completed16 enrollment criteria

Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes

Acute Otitis Media

The purpose of this study is to determine if a topical otic formulation is safe and effective in treating middle ear infections in patients with ear tubes.

Completed17 enrollment criteria

Acute Otitis Media (AOM) Therapy Trial in Young Children

Acute Otitis Media

The purpose of this study is to learn whether or not all children with ear infections (acute otitis media or AOM) should be treated with antibiotics. The study will compare two treatment strategies, "watchful waiting" or treatment with antibiotics, to determine which is more appropriate for children with AOM. About 268 children in Pittsburgh, between the ages of 6-23 months, with AOM will be enrolled in the study. They will be treated either with Augmentin (an antibiotic) or placebo for 10 days and closely followed for about 1 month. Parents will be asked to write information about their child in a Patient Diary. A general physical exam, including an ear exam, will be performed 4 times during the study. A mucus sample will be collected from the back of each child's nose. Parents will be asked questions during phone calls and at every visit. If a child has not improved or has worsened, the investigators will prescribe a different antibiotic that is known to kill resistant germs.

Completed18 enrollment criteria
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